Genetic Variants Affect Weight-Associated Cholesterol Metabolism
Researchers have found that variants in two metabolic genes alter how the body adjusts cholesterol metabolism in response to weight loss, a finding that may lead to screening tools to identify the optimal method of reducing cholesterol levels in specific individuals.
Dietary intake clearly contributes to elevated cholesterol levels. However, inherited factors such as mutations in proteins that regulate how much dietary cholesterol is absorbed, specifically ABCG5 and ABCG8, also influence the effect of diet on cholesterol trafficking. Several variants of ABCG5 and ABCG8 exist in the general population, each with different metabolic properties.
To study how these variants affect cholesterol metabolism in response to changes in weight loss from diet and exercise, Peter Jones and colleagues performed a before and after analysis of 35 women with elevated cholesterol who lost an average of 25 pounds over 20 weeks. They found two variants that were linked to significant changes in cholesterol metabolism. People with the 604E variant of ABCG5 experienced far larger decreases in cholesterol absorption and consequently had increased cholesterol synthesis after weight loss, while individuals with a 54Y variant of ABCG8 exhibited lower post-weight loss cholesterol synthesis.
The researchers believe these results can lead to better therapy for overweight individuals. Knowing which variants are present will increase the understanding of how weight loss will affect cholesterol metabolism, and the best combination of diet, exercise, and medicine can be prescribed.
Corresponding Author: Peter Jones, Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba, Winnipeg.
Crohn's Disease Increases Progression of Atherosclerosis
While chronic inflammation is a known risk factor for atherosclerosis (hardening of the arteries) and heart disease, researchers have now shown that the sporadic but recurrent inflammation caused by Crohn's disease also poses serious cardiovascular risk.
Sander van Leuven and his colleagues imaged 60 Crohn's patients and 122 healthy controls for signs of arterial hardening; they found that the thickness of the carotid artery, a common marker for plaque buildup, was increased in Crohn's disease.
They next examined the subjects' HDL (high density lipoprotein, the "good" cholesterol) content. HDL helps prevent arterial hardening by shuttling cholesterol from blood vessels back to the liver as well as exerting anti-oxidant properties, and is often impaired during inflammation. They discovered that patients with active Crohn's had profoundly reduced HDL levels compared to controls or Crohn's patients in remission.
Interestingly, both active Crohn's patients and those in remission had HDL with lower antioxidant potential than healthy individuals, revealing that acute inflammation episodes not only reduce total HDL, but alter the molecules biochemically, likely slowing down the recovery process during remission.
The researchers note their findings highlight the cardiovascular risks facing Crohn's patients, even those who successfully manage their outbreaks, and suggest that early detection and prevention measures are critical.
Corresponding Author: Sander I. van Leuven, Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, The Netherlands.
Breaking the Vicious Cycle of Bile Acid Disorders
Researchers have found a potential new and improved avenue for treating defective bile acid absorption, a primary contributor to chronic diarrhea.
Liver-produced bile acids are intestinal detergents that break apart fats for easier absorption. Normally, most of the bile acids also reabsorb, but during certain conditions (e.g. infection or short bowel syndrome) excess bile acids enter the colon and impair water absorption, leading to diarrhea.
What makes bile acid malabsorption particularly insidious is that if enough bile acids don't reabsorb, the liver churns out even more acids to compensate, which produces even more problems.
Antonio Moschetta and colleagues targeted the intestinal receptor FXR to see if they could break this vicious cycle. When bile acids reenter intestinal cells, they attach to FXR, which in turn activates a hormone called FGF15 to helps suppress bile acid production.
The researchers fed a synthetic FXR target to engineered mice with defective bile absorption and found that treatment increased the FGF15 activation and reduced the total amount of bile acids present in both the liver and feces. They achieved similar results if they directly introduced FGF15 into the livers of the mice.
Moschetta and colleagues note that FXR drugs would be more beneficial than current treatments that use resins to sequester bile acids, which alleviates the diarrhea but doesn't solve the underlying absorption problem.
Corresponding Author: David Mangelsdorf, Howard Hughes Medical Institute and Department of Pharmacology, University of Texas Southwestern Medical Center, Dallas.
----------------------------
Article adapted by Medical News Today from original press release.
----------------------------
The American Society for Biochemistry and Molecular Biology is a nonprofit scientific and educational organization with over 11,900 members in the United States and internationally. Most members teach and conduct research at colleges and universities. Others conduct research in various government laboratories, nonprofit research institutions and industry. The Society's student members attend undergraduate or graduate institutions.
Founded in 1906, the Society is based in Bethesda, Maryland, on the campus of the Federation of American Societies for Experimental Biology. The Society's purpose is to advance the science of biochemistry and molecular biology through publication of the Journal of Biological Chemistry, the Journal of Lipid Research, and Molecular and Cellular Proteomics, organization of scientific meetings, advocacy for funding of basic research and education, support of science education at all levels, and promoting the diversity of individuals entering the scientific work force.
For more information about ASBMB, see the Society's Web site at http://www.asbmb.org/.
Source: Nick Zagorski
American Society for Biochemistry and Molecular Biology
Tuesday, March 17, 2009
ASGE Offers Guidelines On Endoscopic Treatment Of Dyspepsia
The American Society for Gastrointestinal Endoscopy (ASGE) has issued guidelines for the role of endoscopy in treating dyspepsia, discomfort thought to arise from the upper-gastrointestinal tract, which affects a fourth of the population in Western countries. An upper endoscopy is a procedure which uses an instrument to evaluate the inside of the esophagus, stomach and small intestine. The guidelines, prepared by ASGE's Standards of Practice Committee, appear in the December issue of Gastrointestinal Endoscopy, the monthly peer-reviewed scientific journal of the American Society for Gastrointestinal Endoscopy.
Dyspepsia may encompass a variety of more specific symptoms, including epigastric discomfort, bloating, anorexia, and heartburn. These nonspecific symptoms can be indicative of an underlying diagnosis such as peptic ulcer disease, GERD, functional disorders (nonulcer dyspepsia), and malignancy. The appropriate role of endoscopy in the evaluation of dyspepsia is both a pragmatic concern for the gastroenterologist and an important determinant in healthcare costs.
"Since dyspepsia affects large numbers of people across a broad spectrum of symptoms, it is not practical to perform endoscopy in all patients with dyspepsia," said Todd Baron, MD, chair of the ASGE Standards of Practice Committee. "In review of the medical data available, we concluded in these guidelines that age and alarm features offer the best guidance for the physician in managing patients and in determining if an endoscopy is appropriate treatment."
Patients With Alarm Features (Symptoms)
Dyspepsia is not only a convenient descriptor for upper-gastrointestinal (GI) symptoms, but also a marker for the risk of structural disease: malignancy is present in 1 to 3 percent of patients with dyspepsia, and peptic ulcer disease in another 5 to 15 percent. Endoscopy offers the potential for early diagnosis of structural disease.
Age and alarm features have been used in an attempt to identify those patients with dyspepsia who harbor structural disease. Alarm features include new onset of symptoms in someone over 50, family history of upper-GI malignancy, unintended weight loss, GI bleeding or iron deficiency anemia, progressive trouble swallowing, pain with swallowing, persistent vomiting, palpable mass or lymphadenopathy, and jaundice.
The guidelines recommend that patients older than 50 years of age with recent onset of dyspepsia or patients of any age with alarm features should undergo an endoscopy. An endoscopy should also be considered for patients in whom there is a clinical suspicion of malignancy even in the absence of alarm features.
Patients Without Alarm Features
Patients with dyspepsia who are younger than age 50 and without alarm features are commonly evaluated by one of three methods: noninvasive testing for Helicobacter pylori (H. pylori), with subsequent treatment if positive (the "test-and-treat" approach), a trial of acid suppression or an initial endoscopy.
In many patients with dyspepsia who have peptic ulcer disease, H. pylori infection will be present. Noninvasive testing options for this infection include a blood test, urea breath testing (UBT), and stool antigen. There is growing evidence that patients who are managed with the test-and-treat approach have similar outcomes when compared with those undergoing initial endoscopy. In addition, the test-and-treat approach is more cost effective. Results from a meta-analysis of five randomized studies of test-and-treat versus an initial endoscopy showed a negligible improvement of symptoms in the endoscopy group, but a savings of $389 per patient in the test-and-treat group.
Many investigators and societies advocate acid-suppressive therapy as the initial strategy for patients with dyspepsia. Proton pump inhibitors (PPI) are more effective than H2 blockers in this approach. Initiation of empiric acid suppression will not address underlying H. pylori in those patients with H. pylori-associated peptic ulcer disease, risking recurrent symptoms when acid suppression is withdrawn. This may prompt long-term acid suppression if no further investigation is performed.
One advantage of early endoscopy is the possibility of establishing a specific diagnosis, such as peptic ulcer disease or erosive esophagitis. The risk of malignancy is quite low in young patients without alarm features. Many patients, however, with early stage malignancy do not have alarm symptoms. Another advantage of a negative endoscopy in the evaluation of patients with dyspepsia is a reduction in anxiety and an increase in patient satisfaction. Yet, there is little evidence to suggest significant improvement in outcomes by the initial endoscopy approach. Most studies demonstrate an increased cost with the initial endoscopic approach compared with the test-and-treat method.
Recommendations
* Patients with dyspepsia who are older than 50 years of age and/or those with alarm features should undergo endoscopic evaluation
* Patients with dyspepsia who are younger than 50 years of age and without alarm features may undergo an initial test-and-treat approach for H. pylori
* Patients who are younger than 50 years of age and are H. pylori negative can be offered an initial endoscopy or a short trial of PPI acid suppression
* Patients with dyspepsia who do not respond to empiric PPI therapy or have recurrent symptoms after an adequate trial should undergo endoscopy
----------------------------
Article adapted by Medical News Today from original press release.
----------------------------
About the American Society for Gastrointestinal Endoscopy
Founded in 1941, the mission of the American Society for Gastrointestinal Endoscopy is to be the leader in advancing patient care and digestive health by promoting excellence in gastrointestinal endoscopy. ASGE, with more than 10,000 physician members worldwide, promotes the highest standards for endoscopic training and practice, fosters endoscopic research, recognizes distinguished contributions to endoscopy, and is the foremost resource for endoscopic education. Visit http://www.asge.org and http://www.asge.org/ for more information.
About Endoscopy
Endoscopy is performed by specially-trained physicians called endoscopists using the most current technology to diagnose and treat diseases of the gastrointestinal tract. Using flexible, thin tubes called endoscopes, endoscopists are able to access the human digestive tract without incisions via natural orifices. Endoscopes are designed with high-intensity lighting and fitted with precision devices that allow viewing and treatment of the gastrointestinal system. In many cases, screening or treatment of conditions can be delivered via the endoscope without the need for further sedation, treatment or hospital stay.
Source:
Anne Brownsey
American Society for Gastrointestinal Endoscopy
Dyspepsia may encompass a variety of more specific symptoms, including epigastric discomfort, bloating, anorexia, and heartburn. These nonspecific symptoms can be indicative of an underlying diagnosis such as peptic ulcer disease, GERD, functional disorders (nonulcer dyspepsia), and malignancy. The appropriate role of endoscopy in the evaluation of dyspepsia is both a pragmatic concern for the gastroenterologist and an important determinant in healthcare costs.
"Since dyspepsia affects large numbers of people across a broad spectrum of symptoms, it is not practical to perform endoscopy in all patients with dyspepsia," said Todd Baron, MD, chair of the ASGE Standards of Practice Committee. "In review of the medical data available, we concluded in these guidelines that age and alarm features offer the best guidance for the physician in managing patients and in determining if an endoscopy is appropriate treatment."
Patients With Alarm Features (Symptoms)
Dyspepsia is not only a convenient descriptor for upper-gastrointestinal (GI) symptoms, but also a marker for the risk of structural disease: malignancy is present in 1 to 3 percent of patients with dyspepsia, and peptic ulcer disease in another 5 to 15 percent. Endoscopy offers the potential for early diagnosis of structural disease.
Age and alarm features have been used in an attempt to identify those patients with dyspepsia who harbor structural disease. Alarm features include new onset of symptoms in someone over 50, family history of upper-GI malignancy, unintended weight loss, GI bleeding or iron deficiency anemia, progressive trouble swallowing, pain with swallowing, persistent vomiting, palpable mass or lymphadenopathy, and jaundice.
The guidelines recommend that patients older than 50 years of age with recent onset of dyspepsia or patients of any age with alarm features should undergo an endoscopy. An endoscopy should also be considered for patients in whom there is a clinical suspicion of malignancy even in the absence of alarm features.
Patients Without Alarm Features
Patients with dyspepsia who are younger than age 50 and without alarm features are commonly evaluated by one of three methods: noninvasive testing for Helicobacter pylori (H. pylori), with subsequent treatment if positive (the "test-and-treat" approach), a trial of acid suppression or an initial endoscopy.
In many patients with dyspepsia who have peptic ulcer disease, H. pylori infection will be present. Noninvasive testing options for this infection include a blood test, urea breath testing (UBT), and stool antigen. There is growing evidence that patients who are managed with the test-and-treat approach have similar outcomes when compared with those undergoing initial endoscopy. In addition, the test-and-treat approach is more cost effective. Results from a meta-analysis of five randomized studies of test-and-treat versus an initial endoscopy showed a negligible improvement of symptoms in the endoscopy group, but a savings of $389 per patient in the test-and-treat group.
Many investigators and societies advocate acid-suppressive therapy as the initial strategy for patients with dyspepsia. Proton pump inhibitors (PPI) are more effective than H2 blockers in this approach. Initiation of empiric acid suppression will not address underlying H. pylori in those patients with H. pylori-associated peptic ulcer disease, risking recurrent symptoms when acid suppression is withdrawn. This may prompt long-term acid suppression if no further investigation is performed.
One advantage of early endoscopy is the possibility of establishing a specific diagnosis, such as peptic ulcer disease or erosive esophagitis. The risk of malignancy is quite low in young patients without alarm features. Many patients, however, with early stage malignancy do not have alarm symptoms. Another advantage of a negative endoscopy in the evaluation of patients with dyspepsia is a reduction in anxiety and an increase in patient satisfaction. Yet, there is little evidence to suggest significant improvement in outcomes by the initial endoscopy approach. Most studies demonstrate an increased cost with the initial endoscopic approach compared with the test-and-treat method.
Recommendations
* Patients with dyspepsia who are older than 50 years of age and/or those with alarm features should undergo endoscopic evaluation
* Patients with dyspepsia who are younger than 50 years of age and without alarm features may undergo an initial test-and-treat approach for H. pylori
* Patients who are younger than 50 years of age and are H. pylori negative can be offered an initial endoscopy or a short trial of PPI acid suppression
* Patients with dyspepsia who do not respond to empiric PPI therapy or have recurrent symptoms after an adequate trial should undergo endoscopy
----------------------------
Article adapted by Medical News Today from original press release.
----------------------------
About the American Society for Gastrointestinal Endoscopy
Founded in 1941, the mission of the American Society for Gastrointestinal Endoscopy is to be the leader in advancing patient care and digestive health by promoting excellence in gastrointestinal endoscopy. ASGE, with more than 10,000 physician members worldwide, promotes the highest standards for endoscopic training and practice, fosters endoscopic research, recognizes distinguished contributions to endoscopy, and is the foremost resource for endoscopic education. Visit http://www.asge.org and http://www.asge.org/ for more information.
About Endoscopy
Endoscopy is performed by specially-trained physicians called endoscopists using the most current technology to diagnose and treat diseases of the gastrointestinal tract. Using flexible, thin tubes called endoscopes, endoscopists are able to access the human digestive tract without incisions via natural orifices. Endoscopes are designed with high-intensity lighting and fitted with precision devices that allow viewing and treatment of the gastrointestinal system. In many cases, screening or treatment of conditions can be delivered via the endoscope without the need for further sedation, treatment or hospital stay.
Source:
Anne Brownsey
American Society for Gastrointestinal Endoscopy
Using Newly Approved Device, Doctors Do "incision-less" GERD Surgery
If you're constantly reaching for antacids to control your heartburn, you may have a more serious problem called reflux disease. Some 25 million Americans have it* and now they have a new option to treat it. Using a newly-approved device for the first time in the U.S., doctors have performed surgery to fix reflux problems without making a single incision.
Developing the technology took decades, but the operation only took an hour. When it was over, doctors at Ohio State University Medical Center may have ushered in a new era of surgery when it comes to fixing reflux problems. Experts at OSUMC say they're the first in the U.S. to use recently approved remote control instruments to repair the valve between the esophagus and stomach without using a scalpel.
"This device eliminates the need for any incisions whatsoever. The entire reconstruction, or rebuilding of the valve, can be done from the inside all with an instrument through the mouth," says Scott Melvin, MD, at Ohio State University Medical Center.
By going entirely through a patient's mouth, doctors don't have to cut into the body. That can dramatically cut down on recovery time and the risk of complications. Gertrude Green was one of the first patients in the country to try the procedure, after 20 years of trying nearly everything else to control her reflux.
"Over the last 20 years I've taken over-the-counter medications, prescriptions and seen more than one doctor," says Green.
Gertrude has known for years that surgery was an option, but in the past, it was more invasive and would require more time to recover. Now this new technique can change that and possibly more.
"Reflux can give people heartburn, but it also has been associated with an increased risk of esophageal cancer. Right now in North America, esophageal cancer has increased dramatically over the last decade - doubling even tripling the number of cases," says Melvin.
It's too early to tell if this surgery will impact the number of cancer cases, but it's clear to patients like Gertrude that it's already addressed the burning issue of reflux.
Doctors say getting heartburn once in a while is normal. If you get it 3 or 4 times a week, you should get it checked. Right now, through-the-mouth surgery is only available at certain hospitals. It is expected to become more common in the coming years.
*NIDDK Strategic Plan 2000, National Institute of Diabetes and Digestive and Kidney Diseases, US Department of Health & Human Services, retrieved December 2007 from www2.niddk.nih.gov
Developing the technology took decades, but the operation only took an hour. When it was over, doctors at Ohio State University Medical Center may have ushered in a new era of surgery when it comes to fixing reflux problems. Experts at OSUMC say they're the first in the U.S. to use recently approved remote control instruments to repair the valve between the esophagus and stomach without using a scalpel.
"This device eliminates the need for any incisions whatsoever. The entire reconstruction, or rebuilding of the valve, can be done from the inside all with an instrument through the mouth," says Scott Melvin, MD, at Ohio State University Medical Center.
By going entirely through a patient's mouth, doctors don't have to cut into the body. That can dramatically cut down on recovery time and the risk of complications. Gertrude Green was one of the first patients in the country to try the procedure, after 20 years of trying nearly everything else to control her reflux.
"Over the last 20 years I've taken over-the-counter medications, prescriptions and seen more than one doctor," says Green.
Gertrude has known for years that surgery was an option, but in the past, it was more invasive and would require more time to recover. Now this new technique can change that and possibly more.
"Reflux can give people heartburn, but it also has been associated with an increased risk of esophageal cancer. Right now in North America, esophageal cancer has increased dramatically over the last decade - doubling even tripling the number of cases," says Melvin.
It's too early to tell if this surgery will impact the number of cancer cases, but it's clear to patients like Gertrude that it's already addressed the burning issue of reflux.
Doctors say getting heartburn once in a while is normal. If you get it 3 or 4 times a week, you should get it checked. Right now, through-the-mouth surgery is only available at certain hospitals. It is expected to become more common in the coming years.
*NIDDK Strategic Plan 2000, National Institute of Diabetes and Digestive and Kidney Diseases, US Department of Health & Human Services, retrieved December 2007 from www2.niddk.nih.gov
Acid Reflux Study Looks At Lifespan Of Sufferers
Gastroesophageal reflux disease (GERD), often known as acid reflux, is a common problem that has been associated with cancers, asthma, recurrent aspiration and pulmonary fibrosis. A new study published in The American Journal of Gastroenterology examines whether GERD sufferers may have shorter lifespans than those without the disease.
Drawing on over 50,000 person-years of data, the study provides reassuring evidence that people with acid reflux symptoms do not have an increased risk of death, finding no difference in survival rates between sufferers and non-sufferers.
In fact, the study finds that people with infrequent acid reflux may actually have better survival rates than those with either daily symptoms, or none at all. "It may be that occasional reflux symptoms are a reflection of potential protective behaviors that are associated with reflux, such as regular exercise or modest amounts of alcohol ingestion," suggest Nicholas J. Talley and G. Richard Locke, III, co-authors of the study.
The study adds perspective to the risk of acid reflux symptoms. While there are a large number of acid reflux sufferers in the U.S., incidences of related cancer are extremely rare. "Although extraesophageal manifestations occur in some people with reflux disease, our results suggest that this disease is a benign condition in the vast majority of sufferers," say the authors.
----------------------------
Article adapted by Medical News Today from original press release.
----------------------------
This study is published in The American Journal of Gastroenterology.
Nicholas J. Talley, M.D., Ph.D., is Editor-in-Chief of The American Journal of Gastroenterology; a Professor of Medicine and Epidemiology at the Mayo Clinic College of Medicine; and Chair of the Department of Internal Medicine at the Mayo Clinic, Jacksonville.
G. Richard Locke, III, M.D., is a Professor of Medicine at the Mayo Clinic College of Medicine; Consultant, Division of Gastroenterology and Hepatology, Department of Internal Medicine; and Consultant, Division of Health Care Policy & Research, Department of Health Sciences Research at the Mayo Clinic.
The American College of Gastroenterology (ACG) was founded in 1932 to advance the scientific study and medical practice of diseases of the gastrointestinal (GI) tract. The College promotes the highest standards in medical education and is guided by its commitment to meeting the individual and collective needs of clinical GI practitioners. For more information, please visit http://www.acg.gi.org/.
The American Journal of Gastroenterology is the official publication of the American College of Gastroenterology, and the #1 clinical journal in gastroenterology. The journal brings a broad-based, interdisciplinary approach to the study of gastroenterology, including articles reporting on current observations, research results, methods of treatment, drugs, epidemiology, and other topics relevant to clinical gastroenterology. For more information, please visit http://www.blackwellpublishing.com/ajg.
Source: Sean Wagner
Blackwell Publishing Ltd.
Drawing on over 50,000 person-years of data, the study provides reassuring evidence that people with acid reflux symptoms do not have an increased risk of death, finding no difference in survival rates between sufferers and non-sufferers.
In fact, the study finds that people with infrequent acid reflux may actually have better survival rates than those with either daily symptoms, or none at all. "It may be that occasional reflux symptoms are a reflection of potential protective behaviors that are associated with reflux, such as regular exercise or modest amounts of alcohol ingestion," suggest Nicholas J. Talley and G. Richard Locke, III, co-authors of the study.
The study adds perspective to the risk of acid reflux symptoms. While there are a large number of acid reflux sufferers in the U.S., incidences of related cancer are extremely rare. "Although extraesophageal manifestations occur in some people with reflux disease, our results suggest that this disease is a benign condition in the vast majority of sufferers," say the authors.
----------------------------
Article adapted by Medical News Today from original press release.
----------------------------
This study is published in The American Journal of Gastroenterology.
Nicholas J. Talley, M.D., Ph.D., is Editor-in-Chief of The American Journal of Gastroenterology; a Professor of Medicine and Epidemiology at the Mayo Clinic College of Medicine; and Chair of the Department of Internal Medicine at the Mayo Clinic, Jacksonville.
G. Richard Locke, III, M.D., is a Professor of Medicine at the Mayo Clinic College of Medicine; Consultant, Division of Gastroenterology and Hepatology, Department of Internal Medicine; and Consultant, Division of Health Care Policy & Research, Department of Health Sciences Research at the Mayo Clinic.
The American College of Gastroenterology (ACG) was founded in 1932 to advance the scientific study and medical practice of diseases of the gastrointestinal (GI) tract. The College promotes the highest standards in medical education and is guided by its commitment to meeting the individual and collective needs of clinical GI practitioners. For more information, please visit http://www.acg.gi.org/.
The American Journal of Gastroenterology is the official publication of the American College of Gastroenterology, and the #1 clinical journal in gastroenterology. The journal brings a broad-based, interdisciplinary approach to the study of gastroenterology, including articles reporting on current observations, research results, methods of treatment, drugs, epidemiology, and other topics relevant to clinical gastroenterology. For more information, please visit http://www.blackwellpublishing.com/ajg.
Source: Sean Wagner
Blackwell Publishing Ltd.
Hospitalizations Due To GERD Rose 103% Between 1998 And 2005, USA
The number of people hospitalized because of GERD (gastroesophageal reflux disease) in the USA rose 103% between the period 1998 and 2005, according to details published by the Agency for Healthcare Research and Quality (AHRC). During that same period there was a 216% rise in the number of patients hospitalized for other ailments but who also had milder forms of GERD.
A person who suffers GERD experiences chronic heartburn because stomach acid backs up into the esophagus. Left untreated GERD can cause bleeding in the esophagus, the patient may have difficulty swallowing - in some extreme cases cancer of the esophagus can develop.
The AHRQ also reports that the number of people hospitalized just for GERD rose from 91,000 in 1998 to 95,000 in 2005, an increase of about 5%. Among those hospitalizations, the number of people suffering from severe symptoms, such as vomiting, anemia and weight loss rose 39%. There was a 43% increase in the number of patients hospitalized for less severe symptoms, such as chronic coughing, bloating, belching and hoarseness.
During the same period there was an 84% increase in the number of 2-17 year olds hospitalized for GERD, and a 42% increase among infant under the age of 2.
A person who suffers GERD experiences chronic heartburn because stomach acid backs up into the esophagus. Left untreated GERD can cause bleeding in the esophagus, the patient may have difficulty swallowing - in some extreme cases cancer of the esophagus can develop.
The AHRQ also reports that the number of people hospitalized just for GERD rose from 91,000 in 1998 to 95,000 in 2005, an increase of about 5%. Among those hospitalizations, the number of people suffering from severe symptoms, such as vomiting, anemia and weight loss rose 39%. There was a 43% increase in the number of patients hospitalized for less severe symptoms, such as chronic coughing, bloating, belching and hoarseness.
During the same period there was an 84% increase in the number of 2-17 year olds hospitalized for GERD, and a 42% increase among infant under the age of 2.
Does The Doctor Assess Your Heartburn Correctly?
A simple scale (None, Mild, Moderate, Severe) is frequently used to grade heartburn severity in clinical trials as well as in clinical practice and the question is whether this scale captures the heartburn severity well enough.
In a recent study, "Validation of a 4-Graded Scale for Severity of Heartburn In Patients with Symptoms of Gastroesophageal Reflux Disease", published in Value in Health, the scale was examined to see whether it stands up to established criteria for a functional scale. The study was co-authored by Ola Junghard and Ingela Wiklund (now GSK, UK) of AstaZeneca R&D, Mölndal.
The examination indicates that in terms of the criteria validity, reliability and responsiveness, the scale works well, both when used by the doctor to assess heartburn severity retrospectively, and when used by the patient to record the severity in daily diary cards. The study is based on data from clinical trials in patients with heartburn but without esophagitis.
It is estimated that at least 10% of Western population have symptoms of gastroesophageal reflux disease (Dent et al, GUT 2005;54(5)).
Dr. Junghard comments "Although this scale has been used in clinical trials in gastroesophageal reflux disease for more than 10 years, it has not been validated before. In light of the increasing focus on patient reported outcomes, the evaluation of patient diary card data is of particular interest."
Value in Health (ISSN 1098-3015) publishes papers, concepts, and ideas that advance the field of pharmacoeconomics and outcomes research and help health care leaders to make decisions that are solidly evidence-based. The journal is published bi-monthly and has a regular readership of over 3,000 clinicians, decision-makers, and researchers worldwide.
ISPOR is a nonprofit, international organization that strives to translate pharmacoeconomics and outcomes research into practice to ensure that society allocates scarce health care resources wisely, fairly, and efficiently.
Value in Health Volume 11 Issue 6
ABSTRACT
http://www.ispor.org
In a recent study, "Validation of a 4-Graded Scale for Severity of Heartburn In Patients with Symptoms of Gastroesophageal Reflux Disease", published in Value in Health, the scale was examined to see whether it stands up to established criteria for a functional scale. The study was co-authored by Ola Junghard and Ingela Wiklund (now GSK, UK) of AstaZeneca R&D, Mölndal.
The examination indicates that in terms of the criteria validity, reliability and responsiveness, the scale works well, both when used by the doctor to assess heartburn severity retrospectively, and when used by the patient to record the severity in daily diary cards. The study is based on data from clinical trials in patients with heartburn but without esophagitis.
It is estimated that at least 10% of Western population have symptoms of gastroesophageal reflux disease (Dent et al, GUT 2005;54(5)).
Dr. Junghard comments "Although this scale has been used in clinical trials in gastroesophageal reflux disease for more than 10 years, it has not been validated before. In light of the increasing focus on patient reported outcomes, the evaluation of patient diary card data is of particular interest."
Value in Health (ISSN 1098-3015) publishes papers, concepts, and ideas that advance the field of pharmacoeconomics and outcomes research and help health care leaders to make decisions that are solidly evidence-based. The journal is published bi-monthly and has a regular readership of over 3,000 clinicians, decision-makers, and researchers worldwide.
ISPOR is a nonprofit, international organization that strives to translate pharmacoeconomics and outcomes research into practice to ensure that society allocates scarce health care resources wisely, fairly, and efficiently.
Value in Health Volume 11 Issue 6
ABSTRACT
http://www.ispor.org
Heartburn Surgery Done Through Patient's Mouth
If you're constantly reaching for antacids to control your heartburn, you may have a more serious problem called reflux disease. Some 25 million Americans have it* and now they have a new option to treat it. Using a newly-approved device for the first time in the U.S., doctors have performed surgery to fix reflux problems without making a single incision.
Developing the technology took decades, but the operation only took an hour. When it was over, doctors at Ohio State University Medical Center may have ushered in a new era of surgery when it comes to fixing reflux problems. Experts at OSUMC say they're the first in the U.S. to use recently approved remote control instruments to repair the valve between the esophagus and stomach without using a scalpel.
"This device eliminates the need for any incisions whatsoever. The entire reconstruction, or rebuilding of the valve, can be done from the inside all with an instrument through the mouth," says Scott Melvin, MD, at Ohio State University Medical Center.
By going entirely through a patient's mouth, doctors don't have to cut into the body. That can dramatically cut down on recovery time and the risk of complications. Gertrude Green was one of the first patients in the country to try the procedure, after 20 years of trying nearly everything else to control her reflux.
"Over the last 20 years I've taken over-the-counter medications, prescriptions and seen more than one doctor," says Green.
Gertrude has known for years that surgery was an option, but in the past, it was more invasive and would require more time to recover. Now this new technique can change that and possibly more.
"Reflux can give people heartburn, but it also has been associated with an increased risk of esophageal cancer. Right now in North America, esophageal cancer has increased dramatically over the last decade - doubling even tripling the number of cases," says Melvin.
It's too early to tell if this surgery will impact the number of cancer cases, but it's clear to patients like Gertrude that it's already addressed the burning issue of reflux.
Doctors say getting heartburn once in a while is normal. If you get it 3 or 4 times a week, you should get it checked. Right now, through-the-mouth surgery is only available at certain hospitals. It is expected to become more common in the coming years.
*NIDDK Strategic Plan 2000, National Institute of Diabetes and Digestive and Kidney Diseases, US Department of Health & Human Services, retrieved December 2007 from http://www2.niddk.nih.gov.
Ohio State University
Developing the technology took decades, but the operation only took an hour. When it was over, doctors at Ohio State University Medical Center may have ushered in a new era of surgery when it comes to fixing reflux problems. Experts at OSUMC say they're the first in the U.S. to use recently approved remote control instruments to repair the valve between the esophagus and stomach without using a scalpel.
"This device eliminates the need for any incisions whatsoever. The entire reconstruction, or rebuilding of the valve, can be done from the inside all with an instrument through the mouth," says Scott Melvin, MD, at Ohio State University Medical Center.
By going entirely through a patient's mouth, doctors don't have to cut into the body. That can dramatically cut down on recovery time and the risk of complications. Gertrude Green was one of the first patients in the country to try the procedure, after 20 years of trying nearly everything else to control her reflux.
"Over the last 20 years I've taken over-the-counter medications, prescriptions and seen more than one doctor," says Green.
Gertrude has known for years that surgery was an option, but in the past, it was more invasive and would require more time to recover. Now this new technique can change that and possibly more.
"Reflux can give people heartburn, but it also has been associated with an increased risk of esophageal cancer. Right now in North America, esophageal cancer has increased dramatically over the last decade - doubling even tripling the number of cases," says Melvin.
It's too early to tell if this surgery will impact the number of cancer cases, but it's clear to patients like Gertrude that it's already addressed the burning issue of reflux.
Doctors say getting heartburn once in a while is normal. If you get it 3 or 4 times a week, you should get it checked. Right now, through-the-mouth surgery is only available at certain hospitals. It is expected to become more common in the coming years.
*NIDDK Strategic Plan 2000, National Institute of Diabetes and Digestive and Kidney Diseases, US Department of Health & Human Services, retrieved December 2007 from http://www2.niddk.nih.gov.
Ohio State University
Patients Encouraged To See A Physician If They Experience Symptoms Suggestive Of GERD
A recent study from the Agency for Healthcare Research and Quality shows that hospitalizations for disorders caused by gastroesophageal reflux disease or GERD rose 103 percent between 1998 and 2005. Also, hospitalizations for patients who had milder forms of GERD (in addition to the condition for which they were admitted), rose by 216 percent during the same time period. The numbers underscore the importance of seeing a physician if symptoms suggestive of GERD are present.
Gastroesophageal reflux is a normal physiologic event, which occurs in all individuals. When this occurs frequently, however, and an individual develops recurrent symptoms and/or complications, then this is considered gastroesophageal reflux disease (GERD). It is estimated that GERD affects up to 30 million people in the U.S., with 10 percent of those individuals experiencing symptoms on a daily basis.
"If you suspect you or a loved one may have GERD, the first step is to consult your healthcare provider or a gastrointestinal specialist to obtain an accurate diagnosis," said Grace H. Elta, MD, FASGE, president of the American Society for Gastrointestinal Endoscopy (ASGE). "GERD is very common. Classic symptoms include heartburn and regurgitation. Work in partnership with your physician to initiate the best available treatment plan and avoid emergency trips to the hospital."
The study suggests that one of the factors leading to the increase in GERD hospitalizations may be the obesity epidemic, since obesity has been linked to GERD. The study also notes that across age groups, the elderly accounted for roughly 30 percent of hospitalizations with a primary GERD diagnosis, and 50 percent of all GERD diagnoses in both 1998 and 2005. The largest increase in discharges with any primary or secondary GERD diagnosis between 1998 and 2005 was for patients age 18 to 34, increasing at a rate of 273 percent. This age group, however, also had the steepest decline in primary GERD diagnosis, down 16 percent. GERD hospital stays occurred more among women than men.
The most typical symptoms of GERD are heartburn and regurgitation. Contents of the stomach, including acid, reflux (move back up) into the esophagus, which may result in uncomfortable symptoms as well as damage to the lining of the esophagus. Individuals with these symptoms are straightforward in their diagnosis. Symptoms, however, may be varied, including, but not limited to: chest discomfort (often difficult to discern from cardiac-related pain), asthma, cough, nausea, bad breath and loss of tooth enamel.
Complications of acid reflux can include dysphagia (difficulty swallowing), regurgitation, and an increased risk of esophageal cancer. This is due to progressive damage to the esophagus, resulting in inflammation, ulceration and possible scarring with narrowing. In addition, these symptoms may be indicative of esophageal cancer. All of these symptoms merit seeing a doctor for further care. At that time, the physician may perform an upper endoscopy to evaluate the source of the problem.
In some cases, individuals can alter their diet and take over-the-counter antacids to reduce symptoms. Dietary changes include avoiding acidic foods, fat-laden foods and overeating. Specific foods, such as chocolate, peppermints and tomato products, can exacerbate symptoms. Other lifestyle measures, such as losing weight, reducing or eliminating smoking and alcohol consumption, not eating late at night and elevating the head of the bed, may be helpful as well. Obesity is strongly associated with both GERD and its complications.
Some individuals may be on medications that promote acid reflux, such as calcium channel blockers and nitrates. These medications, however, should not be stopped by the patient without consultation from their doctor.
For individuals who do not have adequate symptom improvement with lifestyle alterations, medications may be necessary. These include histamine2-receptor antagonists (H2RAs), proton pump inhibitors (PPIs) and prokinetic agents. Although H2RAs and PPIs are available over the counter, patients who have frequent GERD symptoms or use these OTC medications regularly should see a physician.
Surgical therapy is available for those who do not respond to lifestyle and medication therapy or who do not wish to remain on medications. Surgery consists of wrapping the top of the stomach to reform the natural acid barrier and fixing the defect in the diaphragm and hiatal hernia if present. Surgical therapy is --at least over the short term -- equivalent to medical therapy. The decision of medical versus surgical therapy depends on how well the patient would tolerate surgery, their response to medical therapy and the underlying causes of the GERD. In addition, there are several endoscopic treatments for GERD. However, these are still relatively new and, for the most part, unproven or still investigational.
Do you have GERD?
If you can answer "yes" to two or more of the following questions, you may have GERD.
Do you frequently have one or more of the following?
* An uncomfortable feeling behind the breastbone that seems to be moving upward from the stomach?
* A burning sensation in the back of your throat?
* A bitter acid taste in your mouth?
* Do you often experience these problems after meals?
* Do you experience heartburn or acid indigestion two or more times per week?
* Do you find that antacids only provide temporary relief from your symptoms?
* Are you taking prescription medication to treat heartburn, but still having symptoms?
Seek diagnosis and treatment if symptoms occur on a regular basis. Your GI specialist can help you enjoy every day by defining your discomfort and providing treatment designed for you. To find a gastrointestinal endoscopist in your area who can diagnose and treat you or a loved one, visit http://www.asge.org/
----------------------------
Article adapted by Medical News Today from original press release.
----------------------------
About the American Society for Gastrointestinal Endoscopy
Founded in 1941, the mission of the American Society for Gastrointestinal Endoscopy is to be the leader in advancing patient care and digestive health by promoting excellence in gastrointestinal endoscopy. ASGE, with more than 10,000 physician members worldwide, promotes the highest standards for endoscopic training and practice, fosters endoscopic research, recognizes distinguished contributions to endoscopy, and is the foremost resource for endoscopic education. Visit http://www.asge.org/ and www.screen4coloncancer.org for more information.
About Endoscopy
Endoscopy is performed by specially-trained physicians called endoscopists using the most current technology to diagnose and treat diseases of the gastrointestinal tract. Using flexible, thin tubes called endoscopes, endoscopists are able to access the human digestive tract without incisions via natural orifices. Endoscopes are designed with high-intensity lighting and fitted with precision devices that allow viewing and treatment of the gastrointestinal system. In many cases, screening or treatment of conditions can be delivered via the endoscope without the need for further sedation, treatment or hospital stay.
Source: Anne Brownsey
American Society for Gastrointestinal Endoscopy
Gastroesophageal reflux is a normal physiologic event, which occurs in all individuals. When this occurs frequently, however, and an individual develops recurrent symptoms and/or complications, then this is considered gastroesophageal reflux disease (GERD). It is estimated that GERD affects up to 30 million people in the U.S., with 10 percent of those individuals experiencing symptoms on a daily basis.
"If you suspect you or a loved one may have GERD, the first step is to consult your healthcare provider or a gastrointestinal specialist to obtain an accurate diagnosis," said Grace H. Elta, MD, FASGE, president of the American Society for Gastrointestinal Endoscopy (ASGE). "GERD is very common. Classic symptoms include heartburn and regurgitation. Work in partnership with your physician to initiate the best available treatment plan and avoid emergency trips to the hospital."
The study suggests that one of the factors leading to the increase in GERD hospitalizations may be the obesity epidemic, since obesity has been linked to GERD. The study also notes that across age groups, the elderly accounted for roughly 30 percent of hospitalizations with a primary GERD diagnosis, and 50 percent of all GERD diagnoses in both 1998 and 2005. The largest increase in discharges with any primary or secondary GERD diagnosis between 1998 and 2005 was for patients age 18 to 34, increasing at a rate of 273 percent. This age group, however, also had the steepest decline in primary GERD diagnosis, down 16 percent. GERD hospital stays occurred more among women than men.
The most typical symptoms of GERD are heartburn and regurgitation. Contents of the stomach, including acid, reflux (move back up) into the esophagus, which may result in uncomfortable symptoms as well as damage to the lining of the esophagus. Individuals with these symptoms are straightforward in their diagnosis. Symptoms, however, may be varied, including, but not limited to: chest discomfort (often difficult to discern from cardiac-related pain), asthma, cough, nausea, bad breath and loss of tooth enamel.
Complications of acid reflux can include dysphagia (difficulty swallowing), regurgitation, and an increased risk of esophageal cancer. This is due to progressive damage to the esophagus, resulting in inflammation, ulceration and possible scarring with narrowing. In addition, these symptoms may be indicative of esophageal cancer. All of these symptoms merit seeing a doctor for further care. At that time, the physician may perform an upper endoscopy to evaluate the source of the problem.
In some cases, individuals can alter their diet and take over-the-counter antacids to reduce symptoms. Dietary changes include avoiding acidic foods, fat-laden foods and overeating. Specific foods, such as chocolate, peppermints and tomato products, can exacerbate symptoms. Other lifestyle measures, such as losing weight, reducing or eliminating smoking and alcohol consumption, not eating late at night and elevating the head of the bed, may be helpful as well. Obesity is strongly associated with both GERD and its complications.
Some individuals may be on medications that promote acid reflux, such as calcium channel blockers and nitrates. These medications, however, should not be stopped by the patient without consultation from their doctor.
For individuals who do not have adequate symptom improvement with lifestyle alterations, medications may be necessary. These include histamine2-receptor antagonists (H2RAs), proton pump inhibitors (PPIs) and prokinetic agents. Although H2RAs and PPIs are available over the counter, patients who have frequent GERD symptoms or use these OTC medications regularly should see a physician.
Surgical therapy is available for those who do not respond to lifestyle and medication therapy or who do not wish to remain on medications. Surgery consists of wrapping the top of the stomach to reform the natural acid barrier and fixing the defect in the diaphragm and hiatal hernia if present. Surgical therapy is --at least over the short term -- equivalent to medical therapy. The decision of medical versus surgical therapy depends on how well the patient would tolerate surgery, their response to medical therapy and the underlying causes of the GERD. In addition, there are several endoscopic treatments for GERD. However, these are still relatively new and, for the most part, unproven or still investigational.
Do you have GERD?
If you can answer "yes" to two or more of the following questions, you may have GERD.
Do you frequently have one or more of the following?
* An uncomfortable feeling behind the breastbone that seems to be moving upward from the stomach?
* A burning sensation in the back of your throat?
* A bitter acid taste in your mouth?
* Do you often experience these problems after meals?
* Do you experience heartburn or acid indigestion two or more times per week?
* Do you find that antacids only provide temporary relief from your symptoms?
* Are you taking prescription medication to treat heartburn, but still having symptoms?
Seek diagnosis and treatment if symptoms occur on a regular basis. Your GI specialist can help you enjoy every day by defining your discomfort and providing treatment designed for you. To find a gastrointestinal endoscopist in your area who can diagnose and treat you or a loved one, visit http://www.asge.org/
----------------------------
Article adapted by Medical News Today from original press release.
----------------------------
About the American Society for Gastrointestinal Endoscopy
Founded in 1941, the mission of the American Society for Gastrointestinal Endoscopy is to be the leader in advancing patient care and digestive health by promoting excellence in gastrointestinal endoscopy. ASGE, with more than 10,000 physician members worldwide, promotes the highest standards for endoscopic training and practice, fosters endoscopic research, recognizes distinguished contributions to endoscopy, and is the foremost resource for endoscopic education. Visit http://www.asge.org/ and www.screen4coloncancer.org for more information.
About Endoscopy
Endoscopy is performed by specially-trained physicians called endoscopists using the most current technology to diagnose and treat diseases of the gastrointestinal tract. Using flexible, thin tubes called endoscopes, endoscopists are able to access the human digestive tract without incisions via natural orifices. Endoscopes are designed with high-intensity lighting and fitted with precision devices that allow viewing and treatment of the gastrointestinal system. In many cases, screening or treatment of conditions can be delivered via the endoscope without the need for further sedation, treatment or hospital stay.
Source: Anne Brownsey
American Society for Gastrointestinal Endoscopy
Black Raspberries Protect Against Cancer - New Study Finds Black Raspberries Help Barrett's Esophagus Patients
It usually starts as reflux, but for 700 thousand Americans, it turns into something called Barrett's Esophagus.* Now the black raspberry may be one of the weapons Barrett's Esophagus patients have to stay strong and prevent the condition from turning into a deadly cancer.
For more than 10 years, Danny Harris has struggled with heartburn after he eats. He learned his reflux has turned into something more serious - a condition called Barrett's Esophagus. He also learned an interesting thing happened when he ate black raspberries.
"I really didn't have any flare-ups or episodes after I had taken the berries," says Harris.
Danny was part of a new study, led by a research team at Ohio State University's Comprehensive Cancer Center. For six months he and other Barrett's Esophagus patients drank a black raspberry powder and water mix. Turns out, the fruit helped many patients reverse the negative impact of the reflux acid. Nearly 4 in 10 saw a boost in a protective enzyme and 6 in 10 saw a decline in oxidative stress, which can cause cell damage.
"If we can feed something in the diet that may help us protect against these injurious agents, then that may potentially impact progression of this disease," says Laura Kresty, PhD at Ohio State University's Comprehensive Cancer Center.
That's important because 1 in 10 people with Barrett's Esophagus develops a deadly cancer of the esophagus. Researchers believe the fruit's combination of nutrients gives it super healing power.
"They're really strong antioxidants. They're also a good source of multi-vitamins and minerals," says Kresty.
A larger study is likely the next step to see if black raspberries yield more positive results for patients with Barrett's Esophagus.
*National Institutes of Health, "Barrett's Esophagus"
Ohio State University's Comprehensive Cancer Center
For more than 10 years, Danny Harris has struggled with heartburn after he eats. He learned his reflux has turned into something more serious - a condition called Barrett's Esophagus. He also learned an interesting thing happened when he ate black raspberries.
"I really didn't have any flare-ups or episodes after I had taken the berries," says Harris.
Danny was part of a new study, led by a research team at Ohio State University's Comprehensive Cancer Center. For six months he and other Barrett's Esophagus patients drank a black raspberry powder and water mix. Turns out, the fruit helped many patients reverse the negative impact of the reflux acid. Nearly 4 in 10 saw a boost in a protective enzyme and 6 in 10 saw a decline in oxidative stress, which can cause cell damage.
"If we can feed something in the diet that may help us protect against these injurious agents, then that may potentially impact progression of this disease," says Laura Kresty, PhD at Ohio State University's Comprehensive Cancer Center.
That's important because 1 in 10 people with Barrett's Esophagus develops a deadly cancer of the esophagus. Researchers believe the fruit's combination of nutrients gives it super healing power.
"They're really strong antioxidants. They're also a good source of multi-vitamins and minerals," says Kresty.
A larger study is likely the next step to see if black raspberries yield more positive results for patients with Barrett's Esophagus.
*National Institutes of Health, "Barrett's Esophagus"
Ohio State University's Comprehensive Cancer Center
FDA Approves Nexium For Use In Children Ages 1-11 Years
The U.S. Food and Drug Administration approved Nexium (esomeprazole magnesium) for short-term use in children ages 1-11 years for the treatment of gastroesophageal reflux disease (GERD). The agency approved Nexium in two forms, a delayed-release capsule and liquid form. Nexium is approved in 10 milligrams (mg) or 20 mg daily for children 1-11 years old compared to 20 mg or 40 mg recommended for pediatric patients 12 to 17 years of age.
"This approval provides important information for appropriate dosing for children ages 1-11 years with GERD," said Julie Beitz, M.D., director of the FDA's Office of Drug Evaluation III in the Center for Drug Evaluation and Research. "Children prescribed this drug should be monitored by their physicians for any adverse drug reactions."
Nexium is part of a class of drugs known as proton pump inhibitors (PPIs). PPIs decrease the amount of acid produced in the stomach and help heal erosions in the lining of the esophagus known as erosive esophagitis.
FDA approved the use of Nexium in patients 1 to 11 years for short-term treatment of GERD based upon the extrapolation of data from previous study results in adults to the pediatric population, as well as safety and pharmacokinetic studies performed in pediatric patients. In one study, 109 patients 1-11 in age, diagnosed with GERD, were treated with Nexium once-a-day for up to eight weeks to evaluate its safety and tolerability. Most of these patients demonstrated healing of their esophageal erosions after eight weeks of treatment.
The most common adverse reactions in children treated with Nexium were headache, diarrhea, abdominal pain, nausea, gas, constipation, dry mouth and sleepiness. The safety and efficacy of Nexium has not been established in children less than one year of age.
Nexium is manufactured by AstraZeneca of Wilmington, DE.
http://www.fda.gov
View drug information on Nexium.
"This approval provides important information for appropriate dosing for children ages 1-11 years with GERD," said Julie Beitz, M.D., director of the FDA's Office of Drug Evaluation III in the Center for Drug Evaluation and Research. "Children prescribed this drug should be monitored by their physicians for any adverse drug reactions."
Nexium is part of a class of drugs known as proton pump inhibitors (PPIs). PPIs decrease the amount of acid produced in the stomach and help heal erosions in the lining of the esophagus known as erosive esophagitis.
FDA approved the use of Nexium in patients 1 to 11 years for short-term treatment of GERD based upon the extrapolation of data from previous study results in adults to the pediatric population, as well as safety and pharmacokinetic studies performed in pediatric patients. In one study, 109 patients 1-11 in age, diagnosed with GERD, were treated with Nexium once-a-day for up to eight weeks to evaluate its safety and tolerability. Most of these patients demonstrated healing of their esophageal erosions after eight weeks of treatment.
The most common adverse reactions in children treated with Nexium were headache, diarrhea, abdominal pain, nausea, gas, constipation, dry mouth and sleepiness. The safety and efficacy of Nexium has not been established in children less than one year of age.
Nexium is manufactured by AstraZeneca of Wilmington, DE.
http://www.fda.gov
View drug information on Nexium.
New Advice On Treating GERD: Johns Hopkins Health Alerts Reports On The Latest Research
Johns Hopkins Health Alerts has just published a review of the new GERD guidelines, for safe, effective treatment of your acid reflux.
Treating GERD Effectively
There are four types of treatments for gastroesophageal reflux disease (GERD): lifestyle measures, medication, surgery, and endoscopic procedures.
Why it is important to treat GERD
Treating GERD is important. Untreated GERD can lead to serious complications, such as esophageal ulcers (nonhealing mucosal defects), esophageal strictures, Barrett's esophagus (a disorder of the cells lining the esophageal mucosa, which may lead to cancer), and even esophageal cancer.
Lifestyle changes to treat GERD
Doctors often recommend lifestyle changes as the first-line treatment for acid reflux. These measures can include elevating the head of the bed during sleep, not eating late at night, and avoiding alcohol or spicy foods.
New findings on effective treatments for GERD
However, a new study reported in "The Archives of Internal Medicine" (Volume 166, page 965) shows that NOT ALL of these changes are helpful in relieving GERD symptoms, and some may be unnecessarily restrictive.
Researchers looked at the results of 100 studies conducted on various lifestyle measures for GERD. Only losing weight and elevating the head of the bed showed a CLEAR BENEFIT in well-designed studies.
Other measures not found to be effective
In comparison, there was little evidence to support avoiding many suspected GERD triggers, such as alcohol, caffeine, chocolate, spicy foods, citrus, carbonated beverages, fatty foods, and mint. The same was true for sleeping on your left side or avoiding food late at night.
Although there was evidence that some of these substances and practices can cause GERD symptoms, evidence was lacking that avoiding them will relieve symptoms.
Bottom line advice on treating GERD
However, if you experience worsening GERD symptoms after eating certain foods or drinking specific beverages you should probably avoid them. In addition, you should certainly give lifestyle changes a chance before trying medication to relieve your GERD symptoms.
For the latest health alerts on GERD (acid reflux), sour stomach, and other digestive disorders, please visit the Johns Hopkins Health Alerts Digestive Disorders Topic Page at: Johns Hopkins Health Alerts Digestive Disorders
This article is exceprted from the annual Johns Hopkins White Paper: Digestive Disorders. For more information about this book, please visit: Johns Hopkins White Paper: Digestive Disorders
Johns Hopkins Health Alerts
Treating GERD Effectively
There are four types of treatments for gastroesophageal reflux disease (GERD): lifestyle measures, medication, surgery, and endoscopic procedures.
Why it is important to treat GERD
Treating GERD is important. Untreated GERD can lead to serious complications, such as esophageal ulcers (nonhealing mucosal defects), esophageal strictures, Barrett's esophagus (a disorder of the cells lining the esophageal mucosa, which may lead to cancer), and even esophageal cancer.
Lifestyle changes to treat GERD
Doctors often recommend lifestyle changes as the first-line treatment for acid reflux. These measures can include elevating the head of the bed during sleep, not eating late at night, and avoiding alcohol or spicy foods.
New findings on effective treatments for GERD
However, a new study reported in "The Archives of Internal Medicine" (Volume 166, page 965) shows that NOT ALL of these changes are helpful in relieving GERD symptoms, and some may be unnecessarily restrictive.
Researchers looked at the results of 100 studies conducted on various lifestyle measures for GERD. Only losing weight and elevating the head of the bed showed a CLEAR BENEFIT in well-designed studies.
Other measures not found to be effective
In comparison, there was little evidence to support avoiding many suspected GERD triggers, such as alcohol, caffeine, chocolate, spicy foods, citrus, carbonated beverages, fatty foods, and mint. The same was true for sleeping on your left side or avoiding food late at night.
Although there was evidence that some of these substances and practices can cause GERD symptoms, evidence was lacking that avoiding them will relieve symptoms.
Bottom line advice on treating GERD
However, if you experience worsening GERD symptoms after eating certain foods or drinking specific beverages you should probably avoid them. In addition, you should certainly give lifestyle changes a chance before trying medication to relieve your GERD symptoms.
For the latest health alerts on GERD (acid reflux), sour stomach, and other digestive disorders, please visit the Johns Hopkins Health Alerts Digestive Disorders Topic Page at: Johns Hopkins Health Alerts Digestive Disorders
This article is exceprted from the annual Johns Hopkins White Paper: Digestive Disorders. For more information about this book, please visit: Johns Hopkins White Paper: Digestive Disorders
Johns Hopkins Health Alerts
Orexo Announces Results Confirming The Clinical Profile Of OX17 In Reflux Disease (GERD)
New clinical data from a phase II study confirms the competitive profile of Orexo's product OX17 in GERD patients, i.e. fast, effective and sustained inhibition of gastric acid production, a prerequisite for effective symptom relief in the patient. The result demonstrates the clinical potential of OX17 and is an important step in the development of a competitive product.
GERD, gastroesofageal reflux disease, is a common ailment in the Western world. Orexos product OX17 combines the advantages (rapid onset and sustained duration of effect) of two existing treatments and therefore has the potential to become an important alternative in the treatment of reflux disease. OX17 is a combination of two well-known active substances both inhibiting the secretion of gastric acid; a H2 receptor antagonist (famotidine) and a proton pump inhibitor (omeprazole).
In a controlled clinical trial with 59 GERD patients treated for 14 days, the anti-secretory effect of OX17 was compared to omeprazole and famotidine. The study was performed at Sahlgrenska university hospital in Gothenburg and Berzelius Clinical Research Center in Linköping, Sweden. The primary endpoint was fulfilled: OX17 significantly reduces the acid production compared to omeprazole day 1. The time with pH>4 the first 12 hours after dosing was on average 60% longer with OX17 compared to omeprazole. (p<0.05). After 14 days treatment, the time with gastric pH above 4 was twice as long as after treatment with famotidine. The patients need for rescue medication (antacids) during the 14 day study period was considerably lower for OX17 compared to both famotidine and omeprazole indicating good control of GERD symptoms.
"The results confirm that OX17 has a favorable and unique clinical profile for a drug intended for the treatment of GERD. This is an important strategic step in our OX17-project, which further increases the project's commercial value. In 2006, the combined market for H2 receptor antagonists and proton pump inhibitors amounted to some USD 27 bn", said Torbjörn Bjerke, President and CEO of Orexo.
About Orexo
Orexo is a specialty pharmaceutical company, focusing on development of new, patented drugs by combining well-documented substances with innovative technologies, and the development of new treatments for respiratory and inflammatory diseases.
Orexo has a broad and competitive late-stage product portfolio, including two marketed products, five products in clinical phase and two undergoing registration.
To date, Orexo have out-licensed the market rights for Rapinyl for the US, the EU and Japan markets, and signed a research collaboration with Boehringer Ingelheim regarding the development of a new class of drugs to treat pain and inflammation. Also, Orexo has established a Nordic sales force by entering into a joint venture with ProStrakan.
Orexo has head office in Uppsala and is listed on the OMX Nordic Exchange Stockholm, Small Cap (ticker: ORX).
http://www.orexo.com
GERD, gastroesofageal reflux disease, is a common ailment in the Western world. Orexos product OX17 combines the advantages (rapid onset and sustained duration of effect) of two existing treatments and therefore has the potential to become an important alternative in the treatment of reflux disease. OX17 is a combination of two well-known active substances both inhibiting the secretion of gastric acid; a H2 receptor antagonist (famotidine) and a proton pump inhibitor (omeprazole).
In a controlled clinical trial with 59 GERD patients treated for 14 days, the anti-secretory effect of OX17 was compared to omeprazole and famotidine. The study was performed at Sahlgrenska university hospital in Gothenburg and Berzelius Clinical Research Center in Linköping, Sweden. The primary endpoint was fulfilled: OX17 significantly reduces the acid production compared to omeprazole day 1. The time with pH>4 the first 12 hours after dosing was on average 60% longer with OX17 compared to omeprazole. (p<0.05). After 14 days treatment, the time with gastric pH above 4 was twice as long as after treatment with famotidine. The patients need for rescue medication (antacids) during the 14 day study period was considerably lower for OX17 compared to both famotidine and omeprazole indicating good control of GERD symptoms.
"The results confirm that OX17 has a favorable and unique clinical profile for a drug intended for the treatment of GERD. This is an important strategic step in our OX17-project, which further increases the project's commercial value. In 2006, the combined market for H2 receptor antagonists and proton pump inhibitors amounted to some USD 27 bn", said Torbjörn Bjerke, President and CEO of Orexo.
About Orexo
Orexo is a specialty pharmaceutical company, focusing on development of new, patented drugs by combining well-documented substances with innovative technologies, and the development of new treatments for respiratory and inflammatory diseases.
Orexo has a broad and competitive late-stage product portfolio, including two marketed products, five products in clinical phase and two undergoing registration.
To date, Orexo have out-licensed the market rights for Rapinyl for the US, the EU and Japan markets, and signed a research collaboration with Boehringer Ingelheim regarding the development of a new class of drugs to treat pain and inflammation. Also, Orexo has established a Nordic sales force by entering into a joint venture with ProStrakan.
Orexo has head office in Uppsala and is listed on the OMX Nordic Exchange Stockholm, Small Cap (ticker: ORX).
http://www.orexo.com
Recurring Symptoms Experienced By Nearly 40 Percent Of GERD Patients Taking PPIs
Despite daily use of doctor-recommended proton pump inhibitors (PPIs) to control gastroesophageal reflux disease (GERD) symptoms, nearly 40 percent of patients who take them continue to experience breakthrough, which is a return of GERD symptoms, such as acid regurgitation and heartburn. These breakthrough symptoms lead more than half of GERD sufferers to use over-the-counter (OTC) remedies, according to a survey recently conducted by the American Gastroenterological Association (AGA) Institute.
The survey of 1,064 people with GERD found that approximately 56 percent of those who experienced breakthrough used an OTC treatment - the majority using an antacid - to manage breakthrough symptoms. Further, taking an OTC in addition to a PPI has become routine for these respondents. In fact, more than 70 percent have been using OTC medications for at least one year.
"The survey results show that people with GERD are not only using their prescribed PPI, but also are turning to over-the-counter remedies as a stop-gap when they have breakthrough symptoms," said John Inadomi, MD, associate professor of medicine, University of California, San Francisco.
Additional survey findings showed that:
* More than 40 percent of respondents on a PPI who experience breakthrough symptoms, report those symptoms occur two to four times per week.
* Respondents report breakthrough symptoms occur throughout the day, sometimes multiple times per day. Sixty-five percent of GERD sufferers experienced breakthrough at night and 28 percent report sleep disruption because of their symptoms.
* Among patients suffering from breakthrough symptoms, at least 50 percent are not fully satisfied with the specific symptom relief (e.g., acid regurgitation and heartburn) they get from their once-daily PPI.
* While 98 percent of respondents who experience breakthrough symptoms report taking their PPI as directed, more than 40 percent have not spoken to their physician about these symptoms.
* Nearly two-thirds (57 percent) of respondents report that their physician has not asked about their habitual use of OTC medications, such as Alka-Seltzer, Mylanta, Pepcid Complete and Pepto-Bismol, in addition to their PPI.
"Breakthrough symptoms can be bothersome and frustrating to GERD sufferers, but they aren't talking about it with their physician as often as they should," said Dr. Inadomi. "By discussing the frequency, severity and timing of breakthrough symptoms, physicians and patients can determine if changes need to be made to their GERD treatment."
About GERD
GERD stands for gastroesophageal reflux disease. It is caused by frequent or regular back up of stomach juices from the stomach into the esophagus. It is estimated that GERD affects between 25-35 percent of the U.S. population. Common symptoms of GERD include: heartburn, dyspepsia, regurgitation, chest sensations or pain, acid laryngitis and dysphagia. Proton pump inhibitors decrease acid production by turning off many of the acid pumps in the stomach.
About the Survey
The survey was conducted by Harris Interactive and funded through a grant by TAP Pharmaceutical Products Inc. The survey consisted of a 10-minute online, self-administered survey. Participants were 40 percent male, 60 percent female. Forty percent of the respondents were under age 49 and 60 percent were 50 and over. All patients suffered from GERD and had been taking a PPI to control their symptoms for at least three months.
The main sample is associated with a margin of sampling error plus or minus 3 percentage points; for results based on subgroups the sampling error is higher. Where comparisons were made, significance testing was done at 95 percent confidence. Testing differences between groups at the 95 percent confidence level indicates that there is no more than a 5 in 100 chance that the difference observed between the groups could have been obtained by chance.
----------------------------
Article adapted by Medical News Today from original press release.
----------------------------
Full survey results are available at http://www.gastro.org/.
About the AGA Institute
The American Gastroenterological Association (AGA) is dedicated to the mission of advancing the science and practice of gastroenterology. Founded in 1897, the AGA is one of the oldest medical-specialty societies in the U.S. Comprised of two non-profit organizations - the AGA and the AGA Institute - our more than 16,000 members include physicians and scientists who research, diagnose and treat disorders of the gastrointestinal tract and liver. The AGA, a 501(c6) organization, administers all membership and public policy activities, while the AGA Institute, a 501(c3) organization, runs the organization's practice, research and educational programs. On a monthly basis, the AGA Institute publishes two highly respected journals, Gastroenterology and Clinical Gastroenterology and Hepatology. The organization's annual meeting is Digestive Disease Week®, which is held each May and is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. For more information, please visit http://www.gastro.org/.
To find more information about GERD and locate a gastroenterologist in their area, patients can visit http://www.gastro.org/patient.
About Harris Interactive
Harris Interactive is a global leader in custom market research. With a long and rich history in multimodal research, powered by our science and technology, we assist clients in achieving business results. Harris Interactive serves clients globally through our North American, European and Asian offices and a network of independent market research firms.
Source: Molly Rabinovitz
American Gastroenterological Association
View drug information on Pepcid Complete.
The survey of 1,064 people with GERD found that approximately 56 percent of those who experienced breakthrough used an OTC treatment - the majority using an antacid - to manage breakthrough symptoms. Further, taking an OTC in addition to a PPI has become routine for these respondents. In fact, more than 70 percent have been using OTC medications for at least one year.
"The survey results show that people with GERD are not only using their prescribed PPI, but also are turning to over-the-counter remedies as a stop-gap when they have breakthrough symptoms," said John Inadomi, MD, associate professor of medicine, University of California, San Francisco.
Additional survey findings showed that:
* More than 40 percent of respondents on a PPI who experience breakthrough symptoms, report those symptoms occur two to four times per week.
* Respondents report breakthrough symptoms occur throughout the day, sometimes multiple times per day. Sixty-five percent of GERD sufferers experienced breakthrough at night and 28 percent report sleep disruption because of their symptoms.
* Among patients suffering from breakthrough symptoms, at least 50 percent are not fully satisfied with the specific symptom relief (e.g., acid regurgitation and heartburn) they get from their once-daily PPI.
* While 98 percent of respondents who experience breakthrough symptoms report taking their PPI as directed, more than 40 percent have not spoken to their physician about these symptoms.
* Nearly two-thirds (57 percent) of respondents report that their physician has not asked about their habitual use of OTC medications, such as Alka-Seltzer, Mylanta, Pepcid Complete and Pepto-Bismol, in addition to their PPI.
"Breakthrough symptoms can be bothersome and frustrating to GERD sufferers, but they aren't talking about it with their physician as often as they should," said Dr. Inadomi. "By discussing the frequency, severity and timing of breakthrough symptoms, physicians and patients can determine if changes need to be made to their GERD treatment."
About GERD
GERD stands for gastroesophageal reflux disease. It is caused by frequent or regular back up of stomach juices from the stomach into the esophagus. It is estimated that GERD affects between 25-35 percent of the U.S. population. Common symptoms of GERD include: heartburn, dyspepsia, regurgitation, chest sensations or pain, acid laryngitis and dysphagia. Proton pump inhibitors decrease acid production by turning off many of the acid pumps in the stomach.
About the Survey
The survey was conducted by Harris Interactive and funded through a grant by TAP Pharmaceutical Products Inc. The survey consisted of a 10-minute online, self-administered survey. Participants were 40 percent male, 60 percent female. Forty percent of the respondents were under age 49 and 60 percent were 50 and over. All patients suffered from GERD and had been taking a PPI to control their symptoms for at least three months.
The main sample is associated with a margin of sampling error plus or minus 3 percentage points; for results based on subgroups the sampling error is higher. Where comparisons were made, significance testing was done at 95 percent confidence. Testing differences between groups at the 95 percent confidence level indicates that there is no more than a 5 in 100 chance that the difference observed between the groups could have been obtained by chance.
----------------------------
Article adapted by Medical News Today from original press release.
----------------------------
Full survey results are available at http://www.gastro.org/.
About the AGA Institute
The American Gastroenterological Association (AGA) is dedicated to the mission of advancing the science and practice of gastroenterology. Founded in 1897, the AGA is one of the oldest medical-specialty societies in the U.S. Comprised of two non-profit organizations - the AGA and the AGA Institute - our more than 16,000 members include physicians and scientists who research, diagnose and treat disorders of the gastrointestinal tract and liver. The AGA, a 501(c6) organization, administers all membership and public policy activities, while the AGA Institute, a 501(c3) organization, runs the organization's practice, research and educational programs. On a monthly basis, the AGA Institute publishes two highly respected journals, Gastroenterology and Clinical Gastroenterology and Hepatology. The organization's annual meeting is Digestive Disease Week®, which is held each May and is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. For more information, please visit http://www.gastro.org/.
To find more information about GERD and locate a gastroenterologist in their area, patients can visit http://www.gastro.org/patient.
About Harris Interactive
Harris Interactive is a global leader in custom market research. With a long and rich history in multimodal research, powered by our science and technology, we assist clients in achieving business results. Harris Interactive serves clients globally through our North American, European and Asian offices and a network of independent market research firms.
Source: Molly Rabinovitz
American Gastroenterological Association
View drug information on Pepcid Complete.
Researcher Reports On Noninvasive Device For GERD, Obesity
A new, noninvasive gastroplasty device to treat two separate disorders gastroesophageal-reflux disease (GERD) and morbid obesity was reported by its inventor, Charles J. Filipi, M.D., professor of surgery at Creighton University School of Medicine.
Filipi spoke about the device, which could be available for human trials later this year, on Monday, May 19, at the 49th annual Digestive Disease Week in San Diego, Calif. The meeting is considered the largest and most prestigious meeting worldwide on digestive diseases.
"Gastroesophageal-reflux disease and morbid obesity are particularly serious health issues in the western hemisphere and major contributors to the escalating cost of health care in the United States," Filipi said. "We believe that this device will result in much more effective treatments for both conditions, fewer complications and less patient expense, while permitting each procedure to be performed on an outpatient basis."
Typically, operations for GERD or obesity are performed using incisions, which requires hospitalization and have the potential for significant complications, he said. The device, a flexible tube with a metal capsule that is 3-feet-long and less than 4/5 of an inch in diameter avoids the need for incisions, Filipi noted.
To treat obesity, Filipi's device is introduced through the mouth and esophagus, suctioning two sides of the stomach lining into position for suturing, impaling the mucosa (stomach lining), and placing a row of stitches through the stomach's two sides. To assist in healing, part of the inner lining of the stomach is removed, and the remaining areas are brought together by adjacent stitches to form a small stomach "pouch" that accommodates only a few bites of food. Bringing the remaining areas together for healing and scarring increases the strength of the stomach-pouch wall so it will last longer, distinguishing this procedure from other noninvasive methods that have been attempted for obesity and reflux disease.
To treat GERD a condition in which a patient's gastroesophageal junction does not close completely and acid or bile from the stomach enters and can damage the esophagus the device is inserted through the mouth and esophagus until it reaches the esophageal junction, the opening at the bottom of the esophagus that connects the esophagus to the stomach. A surgeon can then use the instrument to suture the esophageal junction to make it smaller. Usually two stitches are necessary on one side of the gastroesophageal junction.
SafeStitch Medical Inc., a publicly traded medical-device company based in Miami, is developing Filipi's device with licensed intellectual property from Creighton University. Filipi is medical director for SafeStitch.
About Creighton University: Creighton (pronounced Cray-ton) University, a comprehensive Jesuit, Catholic institution located in Omaha, Neb., has embarked on the most ambitious fundraising campaign in the school's history with a goal of raising $350 million. The Willing to Lead campaign reflects Creighton's commitment to prepare and inspire tomorrow's leaders. The freshman class profile consistently ranks in the top five among Midwestern universities of our size and the top 10 Catholic universities nationwide. We enroll more than 4,000 undergraduate and 2,900 professional school and graduate students in its College of Arts and Sciences, College of Business Administration, Graduate School, and Schools of Dentistry, Law, Medicine, Nursing and Pharmacy and Health Professions. For more information visit our website at: http://www.creighton.edu.
Creighton University
2500 California Plaza
Omaha, NE 68178
United States
http://www.creighton.edu
Filipi spoke about the device, which could be available for human trials later this year, on Monday, May 19, at the 49th annual Digestive Disease Week in San Diego, Calif. The meeting is considered the largest and most prestigious meeting worldwide on digestive diseases.
"Gastroesophageal-reflux disease and morbid obesity are particularly serious health issues in the western hemisphere and major contributors to the escalating cost of health care in the United States," Filipi said. "We believe that this device will result in much more effective treatments for both conditions, fewer complications and less patient expense, while permitting each procedure to be performed on an outpatient basis."
Typically, operations for GERD or obesity are performed using incisions, which requires hospitalization and have the potential for significant complications, he said. The device, a flexible tube with a metal capsule that is 3-feet-long and less than 4/5 of an inch in diameter avoids the need for incisions, Filipi noted.
To treat obesity, Filipi's device is introduced through the mouth and esophagus, suctioning two sides of the stomach lining into position for suturing, impaling the mucosa (stomach lining), and placing a row of stitches through the stomach's two sides. To assist in healing, part of the inner lining of the stomach is removed, and the remaining areas are brought together by adjacent stitches to form a small stomach "pouch" that accommodates only a few bites of food. Bringing the remaining areas together for healing and scarring increases the strength of the stomach-pouch wall so it will last longer, distinguishing this procedure from other noninvasive methods that have been attempted for obesity and reflux disease.
To treat GERD a condition in which a patient's gastroesophageal junction does not close completely and acid or bile from the stomach enters and can damage the esophagus the device is inserted through the mouth and esophagus until it reaches the esophageal junction, the opening at the bottom of the esophagus that connects the esophagus to the stomach. A surgeon can then use the instrument to suture the esophageal junction to make it smaller. Usually two stitches are necessary on one side of the gastroesophageal junction.
SafeStitch Medical Inc., a publicly traded medical-device company based in Miami, is developing Filipi's device with licensed intellectual property from Creighton University. Filipi is medical director for SafeStitch.
About Creighton University: Creighton (pronounced Cray-ton) University, a comprehensive Jesuit, Catholic institution located in Omaha, Neb., has embarked on the most ambitious fundraising campaign in the school's history with a goal of raising $350 million. The Willing to Lead campaign reflects Creighton's commitment to prepare and inspire tomorrow's leaders. The freshman class profile consistently ranks in the top five among Midwestern universities of our size and the top 10 Catholic universities nationwide. We enroll more than 4,000 undergraduate and 2,900 professional school and graduate students in its College of Arts and Sciences, College of Business Administration, Graduate School, and Schools of Dentistry, Law, Medicine, Nursing and Pharmacy and Health Professions. For more information visit our website at: http://www.creighton.edu.
Creighton University
2500 California Plaza
Omaha, NE 68178
United States
http://www.creighton.edu
Dysplasia In Barrett's Esophagus Treated Effectively By Radiofrequency Ablation
Interim results from a nationwide clinical trial led by a University of North Carolina at Chapel Hill researcher suggest that radiofrequency ablation is an effective treatment for dysplasia in people with Barrett's esophagus, a condition that can lead to deadly gastrointestinal cancer.
"The interim results show there is a substantial difference between treatment with radiofrequency ablation and a placebo or 'sham' treatment," said Dr. Nicholas Shaheen, principal investigator of the study and director of UNC's Center for Esophageal Diseases and Swallowing. "It's a strongly positive finding."
Shaheen, who is also an associate professor of medicine and epidemiology in UNC's Schools of Medicine and Public Health, presented the results Monday, May 19 at the annual Digestive Disease Week meeting in San Diego.
Barrett's esophagus is a condition in which repeated acid reflux causes the cells that normally line the esophagus to be replaced by a different type of cell, similar to those normally found in the intestines. This process is called intestinal metaplasia. By itself Barrett's is not a life-threatening problem, but a small percentage of people with Barrett's will develop esophageal adenocarcinoma, an especially deadly form of cancer.
Radiofrequency ablation, a non-invasive technique that uses thermal energy, or heat, to destroy cells, is very effective at destroying abnormal cells in the esophagus. The new UNC-led study is the first randomized trial to evaluate radiofrequency ablation for treating dysplasia, a more advanced stage of Barrett's esophagus in which the abnormal cells acquire precancerous traits.
The radiofrequency ablation system used in the study uses thermal energy provided by a set of electromagnetic coils on the surface of a balloon, Shaheen said. "The balloon is placed in the area of the esophagus where the offending cells are and the balloon is inflated. Energy is then passed through the electromagnetic coils and, because we know how far apart the coils are spaced and how much energy is being put through them, we get a very reliable depth of burn, such that you can kill the abnormal cells on the inner surface without damaging the whole organ."
In the study to date, 127 people were randomized to receive either radiofrequency ablation or a simulated, "sham" version of the procedure at one of 19 participating medical centers. Among those who received radiofrequency ablation, 85 percent were free of dysplasia 12 months after treatment. Seventy-four percent had no evidence of Barrett's at all in their biopsies. In comparison, none that received sham treatment were free of Barrett's.
----------------------------
Article adapted by Medical News Today from original press release.
----------------------------
The study will be completed in June 2008. It was funded by BARRX Medical Inc., which manufactures the HALO360 radiofrequency ablation system used in the study.
Digestive Disease Week (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 17-22, 2008, at the San Diego Convention Center, San Diego, CA. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit http://www.ddw.org/.
Source: Stephanie Crayton
University of North Carolina at Chapel Hill
"The interim results show there is a substantial difference between treatment with radiofrequency ablation and a placebo or 'sham' treatment," said Dr. Nicholas Shaheen, principal investigator of the study and director of UNC's Center for Esophageal Diseases and Swallowing. "It's a strongly positive finding."
Shaheen, who is also an associate professor of medicine and epidemiology in UNC's Schools of Medicine and Public Health, presented the results Monday, May 19 at the annual Digestive Disease Week meeting in San Diego.
Barrett's esophagus is a condition in which repeated acid reflux causes the cells that normally line the esophagus to be replaced by a different type of cell, similar to those normally found in the intestines. This process is called intestinal metaplasia. By itself Barrett's is not a life-threatening problem, but a small percentage of people with Barrett's will develop esophageal adenocarcinoma, an especially deadly form of cancer.
Radiofrequency ablation, a non-invasive technique that uses thermal energy, or heat, to destroy cells, is very effective at destroying abnormal cells in the esophagus. The new UNC-led study is the first randomized trial to evaluate radiofrequency ablation for treating dysplasia, a more advanced stage of Barrett's esophagus in which the abnormal cells acquire precancerous traits.
The radiofrequency ablation system used in the study uses thermal energy provided by a set of electromagnetic coils on the surface of a balloon, Shaheen said. "The balloon is placed in the area of the esophagus where the offending cells are and the balloon is inflated. Energy is then passed through the electromagnetic coils and, because we know how far apart the coils are spaced and how much energy is being put through them, we get a very reliable depth of burn, such that you can kill the abnormal cells on the inner surface without damaging the whole organ."
In the study to date, 127 people were randomized to receive either radiofrequency ablation or a simulated, "sham" version of the procedure at one of 19 participating medical centers. Among those who received radiofrequency ablation, 85 percent were free of dysplasia 12 months after treatment. Seventy-four percent had no evidence of Barrett's at all in their biopsies. In comparison, none that received sham treatment were free of Barrett's.
----------------------------
Article adapted by Medical News Today from original press release.
----------------------------
The study will be completed in June 2008. It was funded by BARRX Medical Inc., which manufactures the HALO360 radiofrequency ablation system used in the study.
Digestive Disease Week (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 17-22, 2008, at the San Diego Convention Center, San Diego, CA. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit http://www.ddw.org/.
Source: Stephanie Crayton
University of North Carolina at Chapel Hill
MGH Study Confirms Benefit Of Surgery For Gastroesophageal Reflux
Despite the growing availability of prescription and over-the-counter medications for gastroesophageal reflux disease (GERD), surgical treatment remains a viable alternative for patients whose symptoms persist. In the May 2008 Archives of Surgery, surgeons from Massachusetts General Hospital (MGH) report their survey of almost 200 patients who had laparoscopic antireflux surgery at the MGH over a 10-year period. Specifically designed to assess GERD-related symptoms, the survey produced near-normal quality-of-life scores from most respondents, who also indicated considerable satisfaction with their long-term results.
"Our results indicate that, in appropriate selected patients, antireflux surgery is an excellent treatment alternative that provides very good results for patient quality of life," says David Rattner, MD, chief of General and Gastrointestinal Surgery at MGH and senior author of the report.
Many individuals experience gastroesophageal reflux - when acidic stomach contents rise into the lower esophagus, producing the burning sensation called heartburn. When those symptoms become chronic and occur more than twice a week, they are considered GERD. In addition to persistant discomfort, GERD can lead to serious consequences, including bleeding of the esophageal lining and, in the most serious cases, esophageal cancer. Lifestyle changes can reduce some GERD symptoms; and while many patients are helped by over-the-counter or prescription medications, symptoms persist for some individuals. Surgery designed to rebuild and strengthen the muscular valve between the esophagus and the stomach offers an option for these patients and for those who would like to avoid lifetime medication use.
Rattner explains that some recent reports in the medical literature have questioned whether the long-term benefits of surgical repair outweigh the risks present in any sort of surgery. Previous outcomes evaluations, which had inconsistent results, have used a survey designed to assess quality-of-life issues relevant to a number of disorders. This new study uses the Gestroesophageal Reflux Disease - Health-Related Quality-of-Life Scale (GERD-HRQL), which focuses on GERD symptoms. Copies of the GERD-HRQL survey were mailed to about 350 patients who had laparoscopic antireflux surgery at the MGH from 1997 to 2006.
Completed surveys were returned by 191 patients, who were responding an average of five years after surgery. Among patients whose procedure was their first antireflux operation, the average GERD-HRQL score was 5.71, similar to that of the normal population. Scores on the GERD-HRQL can range from 0 to 45, with 0 indicating no GERD-related symptoms. Patients whose procedure had been a reoperation had an average score of 14.25. Among first-procedure respondents, 71 percent indicated they were satisfied with their outcomes, and 88 percent responded that they would have the procedure again.
While 43 percent of respondents reported taking some antireflux medications after their surgery, most of those patients had not had any testing to verify the recurrence of GERD. "Some reports have claimed that resumption of antireflux medications indicates that surgery is a failure, but that isn't necessarily true," Rattner says. "The symptoms of GERD are so non-specific, and patients may resume taking medications on their own. When patients who resume these drugs have been actually tested for the presence of reflux, most of them are shown not to have GERD.
"Only 1.2 percent of survey respondents reported needing repeat surgery, which does not support others' assertions that about half these procedures fail," Rattner adds. "Our results let us say that, when this surgery is performed by an expert surgical team at a high-volume center, the outcome for most patients is excellent." Rattner is a professor of Surgery at Harvard Medical School. The study's co-authors are lead author Denise Gee, MD, MGH Department of Surgery, and Michael Andreoli, Boston University School of Medicine.
Massachusetts General Hospital, established in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH conducts the largest hospital-based research program in the United States, with an annual research budget of more than $500 million and major research centers in AIDS, cardiovascular research, cancer, computational and integrative biology, cutaneous biology, human genetics, medical imaging, neurodegenerative disorders, regenerative medicine, systems biology, transplantation biology and photomedicine.
"Our results indicate that, in appropriate selected patients, antireflux surgery is an excellent treatment alternative that provides very good results for patient quality of life," says David Rattner, MD, chief of General and Gastrointestinal Surgery at MGH and senior author of the report.
Many individuals experience gastroesophageal reflux - when acidic stomach contents rise into the lower esophagus, producing the burning sensation called heartburn. When those symptoms become chronic and occur more than twice a week, they are considered GERD. In addition to persistant discomfort, GERD can lead to serious consequences, including bleeding of the esophageal lining and, in the most serious cases, esophageal cancer. Lifestyle changes can reduce some GERD symptoms; and while many patients are helped by over-the-counter or prescription medications, symptoms persist for some individuals. Surgery designed to rebuild and strengthen the muscular valve between the esophagus and the stomach offers an option for these patients and for those who would like to avoid lifetime medication use.
Rattner explains that some recent reports in the medical literature have questioned whether the long-term benefits of surgical repair outweigh the risks present in any sort of surgery. Previous outcomes evaluations, which had inconsistent results, have used a survey designed to assess quality-of-life issues relevant to a number of disorders. This new study uses the Gestroesophageal Reflux Disease - Health-Related Quality-of-Life Scale (GERD-HRQL), which focuses on GERD symptoms. Copies of the GERD-HRQL survey were mailed to about 350 patients who had laparoscopic antireflux surgery at the MGH from 1997 to 2006.
Completed surveys were returned by 191 patients, who were responding an average of five years after surgery. Among patients whose procedure was their first antireflux operation, the average GERD-HRQL score was 5.71, similar to that of the normal population. Scores on the GERD-HRQL can range from 0 to 45, with 0 indicating no GERD-related symptoms. Patients whose procedure had been a reoperation had an average score of 14.25. Among first-procedure respondents, 71 percent indicated they were satisfied with their outcomes, and 88 percent responded that they would have the procedure again.
While 43 percent of respondents reported taking some antireflux medications after their surgery, most of those patients had not had any testing to verify the recurrence of GERD. "Some reports have claimed that resumption of antireflux medications indicates that surgery is a failure, but that isn't necessarily true," Rattner says. "The symptoms of GERD are so non-specific, and patients may resume taking medications on their own. When patients who resume these drugs have been actually tested for the presence of reflux, most of them are shown not to have GERD.
"Only 1.2 percent of survey respondents reported needing repeat surgery, which does not support others' assertions that about half these procedures fail," Rattner adds. "Our results let us say that, when this surgery is performed by an expert surgical team at a high-volume center, the outcome for most patients is excellent." Rattner is a professor of Surgery at Harvard Medical School. The study's co-authors are lead author Denise Gee, MD, MGH Department of Surgery, and Michael Andreoli, Boston University School of Medicine.
Massachusetts General Hospital, established in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH conducts the largest hospital-based research program in the United States, with an annual research budget of more than $500 million and major research centers in AIDS, cardiovascular research, cancer, computational and integrative biology, cutaneous biology, human genetics, medical imaging, neurodegenerative disorders, regenerative medicine, systems biology, transplantation biology and photomedicine.
TAK-390MR Phase 3 Data Presented At Digestive Disease Week
TAP Pharmaceutical Products Inc. have reported results from three pivotal Phase 3 studies evaluating investigational new drug TAK-390MR, the first proton pump inhibitor (PPI) with an innovative dual delayed release technology, in healing patients with erosive esophagitis (EE) and in maintenance of healed EE. The data were presented at the Digestive Disease Week (DDW) annual meeting in San Diego.
"The innovative dual delayed release technology delivers TAK-390MR in two separate releases, which is a first in the PPI class and makes TAK-390MR a very interesting potential future treatment option," said Dr. David Peura, professor of medicine, University of Virginia Health System, past president of the American Gastroenterological Association.
Data from the two separate EE healing studies demonstrated that patients treated with TAK-390MR 60 mg and 90 mg experienced higher overall healing after eight weeks, versus patients taking lansoprazole 30 mg. In addition, data from a six-month maintenance of healed EE study demonstrated that patients treated with TAK-390MR 30 mg and 60 mg experienced statistically significant overall maintenance and symptom relief over placebo.
Healing of Erosive Esophagitis Studies
TAK-390MR was compared to lansoprazole in two identically designed, double-blind, randomized, controlled trials in patients with confirmed EE. A total of 4,092 patients were enrolled in the two global studies. The primary objective was to evaluate overall healing rates over eight weeks after once-daily administration of TAK-390MR 60 mg or 90 mg or lansoprazole 30 mg. The results for each study were analyzed using life table and crude rate methods.
Results from these trials demonstrated that TAK-390MR 60 mg and 90 mg produced consistently high healing rates for patients with EE. In one study, the life table analysis showed that 93 percent and 95 percent of TAK-390MR patients (60 mg and 90 mg, respectively) experienced healing versus 92 percent of lansoprazole 30 mg patients. The crude rate analysis showed that 87 percent of 60 mg and 89 percent of 90 mg TAK-390MR patients experienced healing versus 85 percent of lansoprazole 30 mg patients.
In a second study, the life table analysis demonstrated that 92 percent of both 60 mg and 90 mg patients experienced healing versus 86 percent of patients on lansoprazole 30 mg. The crude rate evaluation showed that 85 percent and 86 percent of patients treated with TAK-390MR (60 mg and 90 mg, respectively) experienced healing versus 79 percent of patients taking lansoprazole 30 mg. The results for TAK-390MR 90 mg were statistically significantly higher than lansoprazole 30 mg in both studies using crude rate analysis.
The most frequent treatment-related adverse event (AE) for patients in the combined healing studies was diarrhea, which occurred in similar rates across groups (three percent for TAK-390MR 60 mg and 90 mg, versus two percent for lansoprazole 30 mg).
"Findings from both studies demonstrated that patients taking TAK-390MR 60 mg and 90 mg showed numerically higher overall healing than those taking lansoprazole with a similar rate of AEs across groups," said Dr. Prateek Sharma, professor of medicine, gastroenterology section, University of Kansas School of Medicine.
Maintenance of Healed Erosive Esophagitis
TAK-390MR was compared to placebo in a double-blind, randomized, controlled trial in patients with confirmed healing of EE. A total of 445 patients were enrolled in the global, six-month study. The primary objective was to evaluate the overall maintenance rate of healed EE after once-daily administration of TAK-390MR 30 mg, 60 mg, or placebo. A secondary objective was to evaluate the frequency of heartburn over the six-month study.
Results from the trial showed that TAK-390MR 30 mg and 60 mg produced high maintenance rates for patients with healed EE. Maintenance rates were analyzed using both life table and crude rate analyses.
The life table analysis showed that 75 and 83 percent of patients (30 mg and 60 mg respectively) were maintained over six months versus 27 percent of those patients taking placebo. According to the crude rate analysis, 66 percent of patients taking TAK-390MR 30 mg and 60 mg were maintained over six months versus 14 percent on placebo.
TAK-390MR also demonstrated heartburn relief rates during the six month trial. Patients treated with TAK-390MR were heartburn free a median of 99 and 96 percent of nights (30 mg and 60 mg respectively) versus 71 percent of nights for patients treated with placebo. In addition, patients treated with TAK-390MR were heartburn free a median 96 and 91 percent of 24-hour days (30 mg and 60 mg, respectively) versus 29 percent of 24-hour days for patients treated with placebo.
The most frequent treatment related AEs for patients in the six-month maintenance study taking TAK-390MR included flatulence, bloating and distension (2%), diarrhea (2%), dyspeptic signs and symptoms (1%), gastritis (1%), and nausea/vomiting (1%) and were generally similar to placebo.
"The heartburn relief rates are encouraging, particularly when you consider that they reflect symptom relief during the complete 24-hour period," said Dr. David Metz, professor of medicine, University of Pennsylvania School of Medicine. "These maintenance results coupled with the overall healing results are encouraging for the potential of TAK-390MR in treating patients with gastroesophageal reflux disease."
About TAK-390MR
TAK-390MR, an enantiomer of lansoprazole, employs an innovative dual delayed release technology, which is designed to provide two separate releases of drug for extended duration of acid suppression.
These Phase 3 data are part of the new drug application (NDA) filed in December 2007 for TAK-390MR for the treatment of patients with symptomatic GERD, the healing of erosive esophagitis, and the maintenance of healed erosive esophagitis. The NDA was based on global studies conducted in more than 20 countries evaluating approximately 6,000 subjects with erosive and non-erosive GERD.
----------------------------
Article adapted by Medical News Today from original press release.
----------------------------
About Digestive Disease Week (DDW)
DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 17-22, 2008, at the San Diego Convention Center, San Diego, CA. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit http://www.ddw.org/.
About TAP Pharmaceutical Products Inc.
TAP Pharmaceutical Products Inc., located in Lake Forest, Ill., is a wholly-owned subsidiary of Takeda America Holdings, Inc. For more information about TAP Pharmaceutical Products Inc., visit the company's web site at http://www.tap.com/.
Source: Kelly Thornicroft
"The innovative dual delayed release technology delivers TAK-390MR in two separate releases, which is a first in the PPI class and makes TAK-390MR a very interesting potential future treatment option," said Dr. David Peura, professor of medicine, University of Virginia Health System, past president of the American Gastroenterological Association.
Data from the two separate EE healing studies demonstrated that patients treated with TAK-390MR 60 mg and 90 mg experienced higher overall healing after eight weeks, versus patients taking lansoprazole 30 mg. In addition, data from a six-month maintenance of healed EE study demonstrated that patients treated with TAK-390MR 30 mg and 60 mg experienced statistically significant overall maintenance and symptom relief over placebo.
Healing of Erosive Esophagitis Studies
TAK-390MR was compared to lansoprazole in two identically designed, double-blind, randomized, controlled trials in patients with confirmed EE. A total of 4,092 patients were enrolled in the two global studies. The primary objective was to evaluate overall healing rates over eight weeks after once-daily administration of TAK-390MR 60 mg or 90 mg or lansoprazole 30 mg. The results for each study were analyzed using life table and crude rate methods.
Results from these trials demonstrated that TAK-390MR 60 mg and 90 mg produced consistently high healing rates for patients with EE. In one study, the life table analysis showed that 93 percent and 95 percent of TAK-390MR patients (60 mg and 90 mg, respectively) experienced healing versus 92 percent of lansoprazole 30 mg patients. The crude rate analysis showed that 87 percent of 60 mg and 89 percent of 90 mg TAK-390MR patients experienced healing versus 85 percent of lansoprazole 30 mg patients.
In a second study, the life table analysis demonstrated that 92 percent of both 60 mg and 90 mg patients experienced healing versus 86 percent of patients on lansoprazole 30 mg. The crude rate evaluation showed that 85 percent and 86 percent of patients treated with TAK-390MR (60 mg and 90 mg, respectively) experienced healing versus 79 percent of patients taking lansoprazole 30 mg. The results for TAK-390MR 90 mg were statistically significantly higher than lansoprazole 30 mg in both studies using crude rate analysis.
The most frequent treatment-related adverse event (AE) for patients in the combined healing studies was diarrhea, which occurred in similar rates across groups (three percent for TAK-390MR 60 mg and 90 mg, versus two percent for lansoprazole 30 mg).
"Findings from both studies demonstrated that patients taking TAK-390MR 60 mg and 90 mg showed numerically higher overall healing than those taking lansoprazole with a similar rate of AEs across groups," said Dr. Prateek Sharma, professor of medicine, gastroenterology section, University of Kansas School of Medicine.
Maintenance of Healed Erosive Esophagitis
TAK-390MR was compared to placebo in a double-blind, randomized, controlled trial in patients with confirmed healing of EE. A total of 445 patients were enrolled in the global, six-month study. The primary objective was to evaluate the overall maintenance rate of healed EE after once-daily administration of TAK-390MR 30 mg, 60 mg, or placebo. A secondary objective was to evaluate the frequency of heartburn over the six-month study.
Results from the trial showed that TAK-390MR 30 mg and 60 mg produced high maintenance rates for patients with healed EE. Maintenance rates were analyzed using both life table and crude rate analyses.
The life table analysis showed that 75 and 83 percent of patients (30 mg and 60 mg respectively) were maintained over six months versus 27 percent of those patients taking placebo. According to the crude rate analysis, 66 percent of patients taking TAK-390MR 30 mg and 60 mg were maintained over six months versus 14 percent on placebo.
TAK-390MR also demonstrated heartburn relief rates during the six month trial. Patients treated with TAK-390MR were heartburn free a median of 99 and 96 percent of nights (30 mg and 60 mg respectively) versus 71 percent of nights for patients treated with placebo. In addition, patients treated with TAK-390MR were heartburn free a median 96 and 91 percent of 24-hour days (30 mg and 60 mg, respectively) versus 29 percent of 24-hour days for patients treated with placebo.
The most frequent treatment related AEs for patients in the six-month maintenance study taking TAK-390MR included flatulence, bloating and distension (2%), diarrhea (2%), dyspeptic signs and symptoms (1%), gastritis (1%), and nausea/vomiting (1%) and were generally similar to placebo.
"The heartburn relief rates are encouraging, particularly when you consider that they reflect symptom relief during the complete 24-hour period," said Dr. David Metz, professor of medicine, University of Pennsylvania School of Medicine. "These maintenance results coupled with the overall healing results are encouraging for the potential of TAK-390MR in treating patients with gastroesophageal reflux disease."
About TAK-390MR
TAK-390MR, an enantiomer of lansoprazole, employs an innovative dual delayed release technology, which is designed to provide two separate releases of drug for extended duration of acid suppression.
These Phase 3 data are part of the new drug application (NDA) filed in December 2007 for TAK-390MR for the treatment of patients with symptomatic GERD, the healing of erosive esophagitis, and the maintenance of healed erosive esophagitis. The NDA was based on global studies conducted in more than 20 countries evaluating approximately 6,000 subjects with erosive and non-erosive GERD.
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Article adapted by Medical News Today from original press release.
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About Digestive Disease Week (DDW)
DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 17-22, 2008, at the San Diego Convention Center, San Diego, CA. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit http://www.ddw.org/.
About TAP Pharmaceutical Products Inc.
TAP Pharmaceutical Products Inc., located in Lake Forest, Ill., is a wholly-owned subsidiary of Takeda America Holdings, Inc. For more information about TAP Pharmaceutical Products Inc., visit the company's web site at http://www.tap.com/.
Source: Kelly Thornicroft
The Features Of Chinese Patients With Reflux Esophagitis
Gastroesophageal reflux disease (GERD) is described as the chronic symptoms and/or tissue damage caused by the reflux of abnormal gastric contents to the esophagus. GERD is a common disease, with associated typical symptoms of heartburn and regurgitation.
An article published in the World Journal of Gastroenterology evaluated the clinical and endoscopic features in Chinese patients with reflux esophagitis. This study was conducted by Dr. Wei Li of the Department of Gastroenterology, Beijing Friendship Hospital affiliated with the Capital Medical University.
Of 18,823 patients undergoing endoscopic examination, 1,405 (895 male and 510 female) patients were diagnosed as having reflux esophagitis, with a detection rate of 7.46% (male 9.13% and female 5.65%). The ratio of male to female patients was 1.75:1, with a significant difference. The age of onset was 15¨C89 years, with the mean age of 54.56 ¡À 14.19 years. The mean age of male and female patients was 53.82 ¡À 14.19 and 55.85 ¡À 14.08 years, respectively, with significant difference. The peak age of onset was 40¨C60 years for patients with reflux esophagitis. According to Los Angeles Classification, patients with grade A and B accounted for 90.1% of all patients. There were significant differences in the ages of patients with A and B compared with patients with grade C and D. A total of 277 patients were infected with H pylori , with a significantly decreased infection rate. Of the 1405 patients, 195 patients had associated esophageal hiatal hernia. Combination with esophageal hiatal hernia was not associated with the presence of H pylori infection and gender, but was significantly associated with the severity of esophagitis and age.
The results and conclusions demonstrated the peak age of onset was 40¨C60 years for patients with reflux esophagitis, with more male patients than female ones. The mean age of onset is lower in males than females. The infection rate of H pylori is significantly decreased in patients with esophagitis, but the severity of patients with esophagitis is not associated with H pylori infection. Old age and combination with esophageal hiatal hernia were associated with more severe esophagitis. Right esophageal mucosal damage can occur more often in patients with reflux esophagitis.
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Article adapted by Medical News Today from original press release.
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Reference: Li W, Zhang ST, ZL. Clinical and endoscopic features of Chinese reflux esophagitis patients. World J Gastroenterol 2008; 14(12): 1866-1871 http://www.wjgnet.com/1007-9327/14/1866.asp
Correspondence to: Shu-Tian Zhang, Department of Gastroenterology, Beijing Friendship Hospital affiliated with the Capital Medical University; Faculty of Gastroenterology, Capital Medical University; Beijing Digestive Disease Center, Beijing 100050, China.
About World Journal of Gastroenterology
World Journal of Gastroenterology (WJG), a leading international journal in gastroenterology and hepatology, has established a reputation for publishing first class research on esophageal cancer, gastric cancer, liver cancer, viral hepatitis, colorectal cancer, and H pylori infection for providing a forum for both clinicians and scientists. WJG has been indexed and abstracted in Current Contents/Clinical Medicine, Science Citation Index Expanded (also known as SciSearch) and Journal Citation Reports/Science Edition, Index Medicus, MEDLINE and PubMed, Chemical Abstracts, EMBASE/Excerpta Medica, Abstracts Journals, Nature Clinical Practice Gastroenterology and Hepatology, CAB Abstracts and Global Health. ISI JCR 2003-2000 IF: 3.318, 2.532, 1.445 and 0.993. WJG is a weekly journal published by WJG Press. The publication dates are the 7th, 14th, 21st, and 28th day of every month. The WJG is supported by The National Natural Science Foundation of China, No. 30224801 and No. 30424812, and was founded with the name of China National Journal of New Gastroenterology on October 1, 1995, and renamed WJG on January 25, 1998.
An article published in the World Journal of Gastroenterology evaluated the clinical and endoscopic features in Chinese patients with reflux esophagitis. This study was conducted by Dr. Wei Li of the Department of Gastroenterology, Beijing Friendship Hospital affiliated with the Capital Medical University.
Of 18,823 patients undergoing endoscopic examination, 1,405 (895 male and 510 female) patients were diagnosed as having reflux esophagitis, with a detection rate of 7.46% (male 9.13% and female 5.65%). The ratio of male to female patients was 1.75:1, with a significant difference. The age of onset was 15¨C89 years, with the mean age of 54.56 ¡À 14.19 years. The mean age of male and female patients was 53.82 ¡À 14.19 and 55.85 ¡À 14.08 years, respectively, with significant difference. The peak age of onset was 40¨C60 years for patients with reflux esophagitis. According to Los Angeles Classification, patients with grade A and B accounted for 90.1% of all patients. There were significant differences in the ages of patients with A and B compared with patients with grade C and D. A total of 277 patients were infected with H pylori , with a significantly decreased infection rate. Of the 1405 patients, 195 patients had associated esophageal hiatal hernia. Combination with esophageal hiatal hernia was not associated with the presence of H pylori infection and gender, but was significantly associated with the severity of esophagitis and age.
The results and conclusions demonstrated the peak age of onset was 40¨C60 years for patients with reflux esophagitis, with more male patients than female ones. The mean age of onset is lower in males than females. The infection rate of H pylori is significantly decreased in patients with esophagitis, but the severity of patients with esophagitis is not associated with H pylori infection. Old age and combination with esophageal hiatal hernia were associated with more severe esophagitis. Right esophageal mucosal damage can occur more often in patients with reflux esophagitis.
----------------------------
Article adapted by Medical News Today from original press release.
----------------------------
Reference: Li W, Zhang ST, ZL. Clinical and endoscopic features of Chinese reflux esophagitis patients. World J Gastroenterol 2008; 14(12): 1866-1871 http://www.wjgnet.com/1007-9327/14/1866.asp
Correspondence to: Shu-Tian Zhang, Department of Gastroenterology, Beijing Friendship Hospital affiliated with the Capital Medical University; Faculty of Gastroenterology, Capital Medical University; Beijing Digestive Disease Center, Beijing 100050, China.
About World Journal of Gastroenterology
World Journal of Gastroenterology (WJG), a leading international journal in gastroenterology and hepatology, has established a reputation for publishing first class research on esophageal cancer, gastric cancer, liver cancer, viral hepatitis, colorectal cancer, and H pylori infection for providing a forum for both clinicians and scientists. WJG has been indexed and abstracted in Current Contents/Clinical Medicine, Science Citation Index Expanded (also known as SciSearch) and Journal Citation Reports/Science Edition, Index Medicus, MEDLINE and PubMed, Chemical Abstracts, EMBASE/Excerpta Medica, Abstracts Journals, Nature Clinical Practice Gastroenterology and Hepatology, CAB Abstracts and Global Health. ISI JCR 2003-2000 IF: 3.318, 2.532, 1.445 and 0.993. WJG is a weekly journal published by WJG Press. The publication dates are the 7th, 14th, 21st, and 28th day of every month. The WJG is supported by The National Natural Science Foundation of China, No. 30224801 and No. 30424812, and was founded with the name of China National Journal of New Gastroenterology on October 1, 1995, and renamed WJG on January 25, 1998.
Cutting Edge Acid Reflux Test Patient-Friendly And Accurate, Improving Diagnosis And Treatment - Restech Dx-pH Measurement System Adopted By CCENT
The Restech Corporation announced that the Central California Ear, Nose & Throat Medical Group (CCENT) of Fresno, California, has adopted the Restech Dx-pH Measurement System to detect acid reflux in the throat. An alarming increase in the incidence of gastroesophageal reflux disease (GERD) and laryngopharyngeal reflux disease (LPRD) in Americans has led to the need for accurate diagnosis of acid reflux as provided by this system.
"The Restech Dx-pH Measurement System allows us to easily measure stomach acid levels in the throats of patients and to correlate these levels with patient symptoms," said Dr. Bret Sherman, M.D., Ph.D., an Otolaryngologist at CCENT specializing in acid reflux disorders. "It is the easiest, most comfortable, and most reliable procedure available to measure acid levels in the upper airway of patients. The system vastly improves treatment as we are now able to determine exactly when and how much stomach acid reaches the throat. This leads to significantly better healthcare for our patients with throat and voice problems."
Patients are first seen by a CCENT ear, nose and throat specialist or speech pathologist because of throat irritation or voice problems. If an initial examination indicates voice pathology, the Restech Dx-pH Measurement System can be used to determine whether stomach acid is refluxing into the larynx. If acid reflux is indeed present, the correct drug treatment plan can be prescribed. If no acid is detected in the upper airway, a different cause for symptoms can be investigated. Prior to the Restech Dx-pH Measurement System, patients were routinely prescribed drug treatments because there were no accurate tests to determine whether stomach acid was refluxing into the upper airway and throat.
Restech Dx-pH Measurement System
The Restech Dx-pH Measurement System is a revolutionary system that comfortably measures pH in the airway. It had been difficult to detect such reflux in the upper airway because, until now, available pH catheters only measured liquid reflux in the esophagus and not the aerosolized form of stomach acid found in the larynx and throat.
Gastric reflux in the upper airway, or laryngopharyngeal reflux, commonly takes a gaseous form that cannot easily be measured using conventional technology. The miniaturized pH sensor at the tip of the Dx-pH Probe is the only sensor able to measure pH in this area. By measuring such pH levels, the Dx-System enables physicians to determine the existence of laryngopharyngeal reflux and to correlate the reflux to various patient symptoms.
The first device capable of measuring pH in the throat in real-time, the Restech Dx-pH Measurement System sends measurements wirelessly to a miniature recording device which is easily carried by the patients during the test period, providing a simple and effective way to monitor reflux. Upon completion of the testing period (usually 24 hours), the patient returns to the physician's office where the device is plugged into a computer and measurements are downloaded for evaluation.
The Dx-pH Probe is 1.5mm in diameter and rests at a comfortable position in the back of the throat behind the soft palate and does not disrupt normal activity or eating. Prior to the development of the Restech Dx-pH Measurement System, physicians testing for reflux had to send their patients home with a probe extending into the patient's esophagus. The positioning and size of those probes were very uncomfortable and interfered with normal activity such as eating and sleeping. The Restech Dx-pH Measurement System allows patients to carry on normal, everyday behavior including eating, exercise, work, bathing, and sleeping with minimal disruption to their lives.
About Central California Ear, Nose & Throat Medical Group
Central California Ear, Nose & Throat Medical Group (CCENT) is a prominent otolaryngology practice that was established in 1966. The practice and facilities are located between Los Angeles and San Francisco in the San Joaquin Valley, with offices in Fresno and Visalia. CCENT currently has eight ENT physicians with general otolaryngology and sub-specialty expertise. The facility includes comprehensive audiologic and vestibular testing, speech pathology, videostroboscopy, and an ambulatory surgical pavilion. CCENT enjoys affiliation with the University of California San Francisco. The practice thrives in a community with five major hospitals and complements patient care with excellent support services. Their on-site ambulatory surgery center is state-of-the-art and outfitted with advanced resources like image guidance technology.
About Restech
Restech is a leader in engineering world class medical technologies that provide comfortable, reliable solutions to assist physicians in the diagnosis of reflux related health problems quickly and reliably.
The innovative engineering team at Restech is led by professionals with over two decades experience each in medical device development. Together, the Restech staff hold over 30 patents in the areas of sensor technology, data recording & monitoring systems, and other medical devices.
"The Restech Dx-pH Measurement System allows us to easily measure stomach acid levels in the throats of patients and to correlate these levels with patient symptoms," said Dr. Bret Sherman, M.D., Ph.D., an Otolaryngologist at CCENT specializing in acid reflux disorders. "It is the easiest, most comfortable, and most reliable procedure available to measure acid levels in the upper airway of patients. The system vastly improves treatment as we are now able to determine exactly when and how much stomach acid reaches the throat. This leads to significantly better healthcare for our patients with throat and voice problems."
Patients are first seen by a CCENT ear, nose and throat specialist or speech pathologist because of throat irritation or voice problems. If an initial examination indicates voice pathology, the Restech Dx-pH Measurement System can be used to determine whether stomach acid is refluxing into the larynx. If acid reflux is indeed present, the correct drug treatment plan can be prescribed. If no acid is detected in the upper airway, a different cause for symptoms can be investigated. Prior to the Restech Dx-pH Measurement System, patients were routinely prescribed drug treatments because there were no accurate tests to determine whether stomach acid was refluxing into the upper airway and throat.
Restech Dx-pH Measurement System
The Restech Dx-pH Measurement System is a revolutionary system that comfortably measures pH in the airway. It had been difficult to detect such reflux in the upper airway because, until now, available pH catheters only measured liquid reflux in the esophagus and not the aerosolized form of stomach acid found in the larynx and throat.
Gastric reflux in the upper airway, or laryngopharyngeal reflux, commonly takes a gaseous form that cannot easily be measured using conventional technology. The miniaturized pH sensor at the tip of the Dx-pH Probe is the only sensor able to measure pH in this area. By measuring such pH levels, the Dx-System enables physicians to determine the existence of laryngopharyngeal reflux and to correlate the reflux to various patient symptoms.
The first device capable of measuring pH in the throat in real-time, the Restech Dx-pH Measurement System sends measurements wirelessly to a miniature recording device which is easily carried by the patients during the test period, providing a simple and effective way to monitor reflux. Upon completion of the testing period (usually 24 hours), the patient returns to the physician's office where the device is plugged into a computer and measurements are downloaded for evaluation.
The Dx-pH Probe is 1.5mm in diameter and rests at a comfortable position in the back of the throat behind the soft palate and does not disrupt normal activity or eating. Prior to the development of the Restech Dx-pH Measurement System, physicians testing for reflux had to send their patients home with a probe extending into the patient's esophagus. The positioning and size of those probes were very uncomfortable and interfered with normal activity such as eating and sleeping. The Restech Dx-pH Measurement System allows patients to carry on normal, everyday behavior including eating, exercise, work, bathing, and sleeping with minimal disruption to their lives.
About Central California Ear, Nose & Throat Medical Group
Central California Ear, Nose & Throat Medical Group (CCENT) is a prominent otolaryngology practice that was established in 1966. The practice and facilities are located between Los Angeles and San Francisco in the San Joaquin Valley, with offices in Fresno and Visalia. CCENT currently has eight ENT physicians with general otolaryngology and sub-specialty expertise. The facility includes comprehensive audiologic and vestibular testing, speech pathology, videostroboscopy, and an ambulatory surgical pavilion. CCENT enjoys affiliation with the University of California San Francisco. The practice thrives in a community with five major hospitals and complements patient care with excellent support services. Their on-site ambulatory surgery center is state-of-the-art and outfitted with advanced resources like image guidance technology.
About Restech
Restech is a leader in engineering world class medical technologies that provide comfortable, reliable solutions to assist physicians in the diagnosis of reflux related health problems quickly and reliably.
The innovative engineering team at Restech is led by professionals with over two decades experience each in medical device development. Together, the Restech staff hold over 30 patents in the areas of sensor technology, data recording & monitoring systems, and other medical devices.
Revolutionary Non-Invasive Surgery For Acid Reflux Disease Now Available At Mercy Medical Center
Mercy Medical Center has become the first hospital in the Northeast to offer a new, revolutionary non-invasive procedure that surgically treats chronic heartburn resulting from GastroEsophageal Reflux Disease (GERD).
A team headed by Shawn Garber, MD, Chief of Bariatric Surgery at Mercy, with colleague Spencer Holover, MD, is one of only a handful in the entire country to offer the technique, known as EsophyXTM Transoral Incisionless Fundoplication (TIF), a form of Natural Orifice Surgery (NOS) in which a device for performing reconstructive gastrointestinal procedures is introduced into the body through the mouth, rather than through an abdominal incision.
"EsophyX transoral incisionless surgery provides an important new option in the treatment of intractable acid reflux disease," explained Dr. Garber, who heads the New York Bariatric Group. "Unlike conventional laparoscopic procedures for surgical remediation of GERD, the transoral technique that introduces the surgical instruments through the mouth, reduces the risk of infection from incisions, preserves future treatment options, nearly eliminates pain for the patient, and requires less recovery time."
In the first operation of its kind in the Northeast, the team at Mercy Medical Center recently performed the EsophyX procedure several weeks ago on a 65-year-old New Jersey woman who had been experiencing severe heartburn from acid reflux disease for many years, and had obtained no relief from dietary and lifestyle changes, or any over-the-counter or prescription medication treatments. As a result of the surgery, her GERD has dissipated and she no longer requires medication.
It's been estimated that as many as one in four people in Western nations suffer from heartburn at least once per month; that 12 percent experience the burning and pain at least once per week; and that more than 5 percent suffer on a daily basis. Those experiencing heartburn twice a week or more over a six month period are likely to have GastroEsophageal Reflux Disease, which results from excess stomach acid backing-up into the esophagus (the tube connecting the mouth to the stomach) due the failure of a muscular valve at the bottom of the esophagus to close properly.
Dietary and lifestyle changes, as well as over-the-counter and prescription medications treat GERD by reducing the amount of acid produced in the stomach. Medications can alleviate symptoms but generally do not stop the progression of the condition, and often must be taken for the rest of a patient's life. For severe cases, conventional laparoscopic surgery can repair the gastroesophageal valve with instruments introduced into the abdomen through small incisions. The EsophyX transoral procedure, developed by EndoGastric SolutionsTM of Redmond, Washington, eliminates the need for incisions, and the associated pain and risk of infection, by introducing the surgical instruments through the patient's mouth.
A similar bariatric procedure, called StomaphyXTM, for reducing the size of a patient's stomach for individuals who gain weight a few years after gastric bypass surgery, has been available at Mercy Medical Center since last July.
A team headed by Shawn Garber, MD, Chief of Bariatric Surgery at Mercy, with colleague Spencer Holover, MD, is one of only a handful in the entire country to offer the technique, known as EsophyXTM Transoral Incisionless Fundoplication (TIF), a form of Natural Orifice Surgery (NOS) in which a device for performing reconstructive gastrointestinal procedures is introduced into the body through the mouth, rather than through an abdominal incision.
"EsophyX transoral incisionless surgery provides an important new option in the treatment of intractable acid reflux disease," explained Dr. Garber, who heads the New York Bariatric Group. "Unlike conventional laparoscopic procedures for surgical remediation of GERD, the transoral technique that introduces the surgical instruments through the mouth, reduces the risk of infection from incisions, preserves future treatment options, nearly eliminates pain for the patient, and requires less recovery time."
In the first operation of its kind in the Northeast, the team at Mercy Medical Center recently performed the EsophyX procedure several weeks ago on a 65-year-old New Jersey woman who had been experiencing severe heartburn from acid reflux disease for many years, and had obtained no relief from dietary and lifestyle changes, or any over-the-counter or prescription medication treatments. As a result of the surgery, her GERD has dissipated and she no longer requires medication.
It's been estimated that as many as one in four people in Western nations suffer from heartburn at least once per month; that 12 percent experience the burning and pain at least once per week; and that more than 5 percent suffer on a daily basis. Those experiencing heartburn twice a week or more over a six month period are likely to have GastroEsophageal Reflux Disease, which results from excess stomach acid backing-up into the esophagus (the tube connecting the mouth to the stomach) due the failure of a muscular valve at the bottom of the esophagus to close properly.
Dietary and lifestyle changes, as well as over-the-counter and prescription medications treat GERD by reducing the amount of acid produced in the stomach. Medications can alleviate symptoms but generally do not stop the progression of the condition, and often must be taken for the rest of a patient's life. For severe cases, conventional laparoscopic surgery can repair the gastroesophageal valve with instruments introduced into the abdomen through small incisions. The EsophyX transoral procedure, developed by EndoGastric SolutionsTM of Redmond, Washington, eliminates the need for incisions, and the associated pain and risk of infection, by introducing the surgical instruments through the patient's mouth.
A similar bariatric procedure, called StomaphyXTM, for reducing the size of a patient's stomach for individuals who gain weight a few years after gastric bypass surgery, has been available at Mercy Medical Center since last July.
New Test Could Aid Children Suffering From Reflux Disease
A nuclear medicine imaging test was used to confirm that children with respiratory problems may be more likely to develop gastroesophageal reflux disease, according to researchers at SNM's 55th Annual Meeting. The nuclear imaging technique, known as scintigraphy, was also shown to be more effective in detecting the disease in these children than traditional barium X-ray technology. The results indicate that scintigraphy could become an important diagnostic tool for detecting reflux disease, a serious condition that can lead to chronic chest pain, vomiting, weight loss and lung impairment in children who suffer from it.
"Unfortunately, reflux disease is a common problem in children, especially for those with respiratory problems," said Wajiha Nasir, a researcher at the Nuclear Medicine Oncology and Radiotherapy Institute (NORI), Islamabad, Pakistan. "If left untreated, the disease can seriously impede children's health, growth and development, not to mention their quality of life. Our results show that scintigraphy is highly effective at safely diagnosing the condition."
Reflux disease occurs when the esophagus becomes irritated or inflamed by stomach contents. The stomach produces hydrochloric acid after a meal to aid in the digestion of food. Normally, a ring of muscle at the bottom of the esophagus, called the lower esophageal sphincter, prevents the acid from going back up the esophagus. With reflux disease, however, the sphincter relaxes between swallows, allowing stomach contents and corrosive acid to well up and damage the lining of the esophagus.
The chronic condition affects up to a third of adults, and many infants and children also suffer from it. Some of these children outgrow the condition as their digestive systems mature, but many do not. Researchers have long suspected that children who have respiratory problems such as asthma might also be more susceptible to reflux disease.
Scintigraphy is a diagnostic test in which a two-dimensional picture is obtained through detection of a radiation emitted by a radioactive source given to the body. In this study, 55 children aged six months to 12 years who had asthma or lower respiratory tract infections were orally administered a commonly used radioactive imaging agent that was then detected through scintigraphy technology.
The test detected reflux disease in 66.6 percent of the children, revealing a strong association between reflux disease and respiratory disease. In addition, scintigraphy proved more effective at detecting the disease than traditional barium x-rays. Children in the study who exhibited reflux disease were given medication to treat reflux. At a three-month follow-up visit, most of the children's symptoms had improved after receiving the medication.
"Scintigraphy is one of the simplest radionuclide tests to administer, with a very low radiation burden," said Nasir. If performed routinely for children suffering from bronchial asthma and recurrent respiratory tract infections, this test could get children the treatment they deserve."
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Article adapted by Medical News Today from original press release.
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Scientific Paper 151: W. Nasir, S. Fatima, R. Jaffari, J. Irfan, NORI, Islamabad, Pakistan, "Role of Radionuclide Gastroesophageal Reflux Study in Children Suffering from Bronchial Asthma and Recurrent Lower Respiratory Tract Infections," SNM's 55th Annual Meeting, June 14-18, 2008.
About SNM - Advancing Molecular Imaging and Therapy
SNM is an international scientific and medical organization dedicated to increasing understanding and sound practice of molecular imaging throughout the medical community and with the public. Due to the work of SNM members, molecular imaging is a vital element of today's medical practice, adding an additional dimension to diagnosis that can change the way common and devastating diseases are understood and treated.
Our more than 16,000 members set the standard for molecular imaging practice by creating procedure guidelines, sharing information through our Journal and meetings, and leading advocacy on key issues that affect imaging research and practice. For more information visit http://www.snm.org/.
Source: Amy Shaw
Society of Nuclear Medicine
"Unfortunately, reflux disease is a common problem in children, especially for those with respiratory problems," said Wajiha Nasir, a researcher at the Nuclear Medicine Oncology and Radiotherapy Institute (NORI), Islamabad, Pakistan. "If left untreated, the disease can seriously impede children's health, growth and development, not to mention their quality of life. Our results show that scintigraphy is highly effective at safely diagnosing the condition."
Reflux disease occurs when the esophagus becomes irritated or inflamed by stomach contents. The stomach produces hydrochloric acid after a meal to aid in the digestion of food. Normally, a ring of muscle at the bottom of the esophagus, called the lower esophageal sphincter, prevents the acid from going back up the esophagus. With reflux disease, however, the sphincter relaxes between swallows, allowing stomach contents and corrosive acid to well up and damage the lining of the esophagus.
The chronic condition affects up to a third of adults, and many infants and children also suffer from it. Some of these children outgrow the condition as their digestive systems mature, but many do not. Researchers have long suspected that children who have respiratory problems such as asthma might also be more susceptible to reflux disease.
Scintigraphy is a diagnostic test in which a two-dimensional picture is obtained through detection of a radiation emitted by a radioactive source given to the body. In this study, 55 children aged six months to 12 years who had asthma or lower respiratory tract infections were orally administered a commonly used radioactive imaging agent that was then detected through scintigraphy technology.
The test detected reflux disease in 66.6 percent of the children, revealing a strong association between reflux disease and respiratory disease. In addition, scintigraphy proved more effective at detecting the disease than traditional barium x-rays. Children in the study who exhibited reflux disease were given medication to treat reflux. At a three-month follow-up visit, most of the children's symptoms had improved after receiving the medication.
"Scintigraphy is one of the simplest radionuclide tests to administer, with a very low radiation burden," said Nasir. If performed routinely for children suffering from bronchial asthma and recurrent respiratory tract infections, this test could get children the treatment they deserve."
----------------------------
Article adapted by Medical News Today from original press release.
----------------------------
Scientific Paper 151: W. Nasir, S. Fatima, R. Jaffari, J. Irfan, NORI, Islamabad, Pakistan, "Role of Radionuclide Gastroesophageal Reflux Study in Children Suffering from Bronchial Asthma and Recurrent Lower Respiratory Tract Infections," SNM's 55th Annual Meeting, June 14-18, 2008.
About SNM - Advancing Molecular Imaging and Therapy
SNM is an international scientific and medical organization dedicated to increasing understanding and sound practice of molecular imaging throughout the medical community and with the public. Due to the work of SNM members, molecular imaging is a vital element of today's medical practice, adding an additional dimension to diagnosis that can change the way common and devastating diseases are understood and treated.
Our more than 16,000 members set the standard for molecular imaging practice by creating procedure guidelines, sharing information through our Journal and meetings, and leading advocacy on key issues that affect imaging research and practice. For more information visit http://www.snm.org/.
Source: Amy Shaw
Society of Nuclear Medicine
FDA Approves ACIPHEX(R) (rabeprazole Sodium) 20 Mg For Short-Term Treatment Of GERD In Adolescents
Eisai Corporation of North America, a wholly-owned subsidiary of Tokyo-based Eisai Co., Ltd., announced that the Food and Drug Administration (FDA) has approved ACIPHEX (rabeprazole sodium) 20 mg for the short-term (up to eight weeks) treatment of gastroesophageal reflux disease (GERD) in adolescents ages 12 and above.
Included in the submission was a 12-week, multi-center, open-label, randomized, parallel-group study of 111 adolescent GERD patients. In this study, ACIPHEX was well tolerated in adolescent subjects, with a safety profile similar to that of adults. The adverse events reported without regard to relationship to ACIPHEX that occurred in greater than or equal to 2 percent of 111 patients were headache (9.9 percent), diarrhea (4.5 percent), nausea (4.5 percent), vomiting (3.6 percent) and abdominal pain (3.6 percent). Efficacy results demonstrated that once-daily treatment with ACIPHEX 20 mg for eight weeks reduced the severity and frequency of GERD symptoms compared to symptoms prior to treatment.
ACIPHEX was discovered and developed by Eisai and is copromoted in the United States with PriCara(R), a Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
About ACIPHEX(R) (rabeprazole sodium)
ACIPHEX(R) is a prescription medication. ACIPHEX 20 mg tablet once daily is approved for use in adults:
-- for the short-term (4 to 8 weeks) treatment in the healing and symptom relief of damaging (erosive) Gastroesophageal Reflux Disease (GERD).
-- to maintain healing of damage (erosions) and relief of heartburn symptoms with GERD. ACIPHEX has not been studied for treatment lasting longer than 12 months (1 year).
-- for the treatment of day-time and night-time heartburn and other symptoms that happen with GERD.
ACIPHEX 20 mg once daily is now also indicated for adolescents ages 12 and above for the short-term treatment (up to 8 weeks) for heartburn and other GERD symptoms. The safety and effectiveness of ACIPHEX has not been established for children under the age of 12.
Important Safety Information
ACIPHEX has a well-established safety profile. The most common side effect possibly related to ACIPHEX is headache. Symptom relief does not rule out other serious stomach conditions. Patients on warfarin (such as Coumadin(R)) may need to be monitored more closely by their doctor. To learn more, talk to your doctor and see the full product information at http://www.aciphex.com.
About Eisai Corporation of North America
Eisai Corporation of North America is a wholly-owned subsidiary of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: neurology, gastrointestinal disorders and oncology/critical care.
Eisai Corporation of North America supports the activities of its operating companies in North America. These operating companies include: Eisai Research Institute of Boston, Inc., a discovery operation with strong organic chemistry capabilities; Morphotek, Inc., a biopharmaceutical company specializing in the development of therapeutic monoclonal antibodies; Eisai Medical Research Inc., a clinical development group; Eisai Inc., a commercial operation with manufacturing and marketing/sales functions; MGI PHARMA, INC., an R&D and commercial operation with manufacturing and marketing/sales functions; and Eisai Machinery U.S.A., which markets and maintains pharmaceutical manufacturing machinery.
For more information about Eisai, please visit http://www.eisai.com.
ACIPHEX is a registered trademark of Eisai Co., Ltd.
Coumadin is a registered trademark of Bristol-Myers Squibb Pharma Company.
Eisai Corporation of North America
http://www.eisai.com
View drug information on Aciphex; Warfarin Sodium tablets.
Included in the submission was a 12-week, multi-center, open-label, randomized, parallel-group study of 111 adolescent GERD patients. In this study, ACIPHEX was well tolerated in adolescent subjects, with a safety profile similar to that of adults. The adverse events reported without regard to relationship to ACIPHEX that occurred in greater than or equal to 2 percent of 111 patients were headache (9.9 percent), diarrhea (4.5 percent), nausea (4.5 percent), vomiting (3.6 percent) and abdominal pain (3.6 percent). Efficacy results demonstrated that once-daily treatment with ACIPHEX 20 mg for eight weeks reduced the severity and frequency of GERD symptoms compared to symptoms prior to treatment.
ACIPHEX was discovered and developed by Eisai and is copromoted in the United States with PriCara(R), a Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
About ACIPHEX(R) (rabeprazole sodium)
ACIPHEX(R) is a prescription medication. ACIPHEX 20 mg tablet once daily is approved for use in adults:
-- for the short-term (4 to 8 weeks) treatment in the healing and symptom relief of damaging (erosive) Gastroesophageal Reflux Disease (GERD).
-- to maintain healing of damage (erosions) and relief of heartburn symptoms with GERD. ACIPHEX has not been studied for treatment lasting longer than 12 months (1 year).
-- for the treatment of day-time and night-time heartburn and other symptoms that happen with GERD.
ACIPHEX 20 mg once daily is now also indicated for adolescents ages 12 and above for the short-term treatment (up to 8 weeks) for heartburn and other GERD symptoms. The safety and effectiveness of ACIPHEX has not been established for children under the age of 12.
Important Safety Information
ACIPHEX has a well-established safety profile. The most common side effect possibly related to ACIPHEX is headache. Symptom relief does not rule out other serious stomach conditions. Patients on warfarin (such as Coumadin(R)) may need to be monitored more closely by their doctor. To learn more, talk to your doctor and see the full product information at http://www.aciphex.com.
About Eisai Corporation of North America
Eisai Corporation of North America is a wholly-owned subsidiary of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: neurology, gastrointestinal disorders and oncology/critical care.
Eisai Corporation of North America supports the activities of its operating companies in North America. These operating companies include: Eisai Research Institute of Boston, Inc., a discovery operation with strong organic chemistry capabilities; Morphotek, Inc., a biopharmaceutical company specializing in the development of therapeutic monoclonal antibodies; Eisai Medical Research Inc., a clinical development group; Eisai Inc., a commercial operation with manufacturing and marketing/sales functions; MGI PHARMA, INC., an R&D and commercial operation with manufacturing and marketing/sales functions; and Eisai Machinery U.S.A., which markets and maintains pharmaceutical manufacturing machinery.
For more information about Eisai, please visit http://www.eisai.com.
ACIPHEX is a registered trademark of Eisai Co., Ltd.
Coumadin is a registered trademark of Bristol-Myers Squibb Pharma Company.
Eisai Corporation of North America
http://www.eisai.com
View drug information on Aciphex; Warfarin Sodium tablets.
The Link Between Gastric Reflux And Asthma
Researchers at Duke University Medical Center appear to have solved at least a piece of a puzzle that has mystified physicians for years: why so many patients with asthma also suffer from GERD, or gastroesophageal reflux disease.
Clinicians first noted a relationship between the two diseases in the mid-1970s. Since then, studies have shown that anywhere from 50 to 90 percent of patients with asthma experience some aspect of GERD. But can GERD cause asthma, or, is it the other way around? Perhaps there is some shared mechanism at the root of both disorders causing them to arise together. Physicians could make a case for each scenario, but until now, the exact nature of the relationship was not clear.
Working in laboratory experiments with mice, Dr. Shu Lin, an assistant professor of surgery and immunology at Duke, discovered that inhaling tiny amounts of stomach fluid that back up into the esophagus - a hallmark of GERD - produces changes in the immune system that can drive the development of asthma.
In the experiments, researchers inserted miniscule amounts of gastric fluid into the lungs of mice (mimicking the human process of micro-aspiration, or breathing in tiny amounts) over a period of eight weeks. They compared these animals' immune systems with those of mice that were exposed to allergens but not the gastric fluid.
The immune systems of the two sets of mice responded very differently. Those that had the gastric fluid in their lungs developed what researchers call a T-helper type 2 response, a type of immune system reaction characteristic of asthma. The other mice responded in a more balanced manner, mounting an immune reaction consisting of both T-helper type 1 and T-helper type 2 responses.
"This is the first experimental evidence in a controlled, laboratory setting linking these two very common conditions in humans," says Lin, the senior author of the study published online in the European Journal of Clinical Investigation. "These data suggest that chronic micro-aspiration of gastric fluid can drive the immune system toward an asthmatic response."
"This does not mean that everyone with GERD is going to develop asthma, by any means," says William Parker, an assistant professor of surgery at Duke and a co-author of the study. "But it may mean that people with GERD may be more likely to develop asthma. If there is an upside to this, it is that developing GERD is something we can pretty much treat and control."
Parker says poor diet, a lack of exercise and obesity all contribute to the development of GERD, and that rising rates of reflux disease are part of a "perfect storm" of environmental and behavioral factors driving escalating rates of asthma, particularly in Western cultures. "People should avoid the risk factors for GERD. We strongly believe that the rise in asthma, particularly among adults in the country, is in large measure due to lifestyle choices that can be changed."
Lin and Parker agree that much more work needs to be done to fully understand the cellular and molecular mechanisms involved in the relationship between reflux disease and asthma, but both feel their study offers new directions for developing additional treatment options for both problems.
Lin says patients who already have GERD can minimize gastric reflux - and thereby lessen their chances of developing asthma - by following a few simple guidelines: Eat smaller meals and eat several hours before going to bed; raise the head of the bed a few inches; maintain a healthy weight; and limit fatty foods, coffee, tea, caffeine and alcohol - they can relax the esophageal sphincter and make reflux more likely.
----------------------------
Article adapted by Medical News Today from original press release.
----------------------------
Funding for the study came from the Society of American Gastrointestinal Endoscopic Surgeons Research Grant and the Parks Protocol Memorial Fund.
Additional co-authors from Duke include lead author Andrew Barbas, Tacy Downing, Keki Balsara, Hung-Enn Tan, Gregory Rubinstein, Zoie Holzknecht, Bradley Collins and R. Duane Davis.
Source: Michelle Gailiun
Clinicians first noted a relationship between the two diseases in the mid-1970s. Since then, studies have shown that anywhere from 50 to 90 percent of patients with asthma experience some aspect of GERD. But can GERD cause asthma, or, is it the other way around? Perhaps there is some shared mechanism at the root of both disorders causing them to arise together. Physicians could make a case for each scenario, but until now, the exact nature of the relationship was not clear.
Working in laboratory experiments with mice, Dr. Shu Lin, an assistant professor of surgery and immunology at Duke, discovered that inhaling tiny amounts of stomach fluid that back up into the esophagus - a hallmark of GERD - produces changes in the immune system that can drive the development of asthma.
In the experiments, researchers inserted miniscule amounts of gastric fluid into the lungs of mice (mimicking the human process of micro-aspiration, or breathing in tiny amounts) over a period of eight weeks. They compared these animals' immune systems with those of mice that were exposed to allergens but not the gastric fluid.
The immune systems of the two sets of mice responded very differently. Those that had the gastric fluid in their lungs developed what researchers call a T-helper type 2 response, a type of immune system reaction characteristic of asthma. The other mice responded in a more balanced manner, mounting an immune reaction consisting of both T-helper type 1 and T-helper type 2 responses.
"This is the first experimental evidence in a controlled, laboratory setting linking these two very common conditions in humans," says Lin, the senior author of the study published online in the European Journal of Clinical Investigation. "These data suggest that chronic micro-aspiration of gastric fluid can drive the immune system toward an asthmatic response."
"This does not mean that everyone with GERD is going to develop asthma, by any means," says William Parker, an assistant professor of surgery at Duke and a co-author of the study. "But it may mean that people with GERD may be more likely to develop asthma. If there is an upside to this, it is that developing GERD is something we can pretty much treat and control."
Parker says poor diet, a lack of exercise and obesity all contribute to the development of GERD, and that rising rates of reflux disease are part of a "perfect storm" of environmental and behavioral factors driving escalating rates of asthma, particularly in Western cultures. "People should avoid the risk factors for GERD. We strongly believe that the rise in asthma, particularly among adults in the country, is in large measure due to lifestyle choices that can be changed."
Lin and Parker agree that much more work needs to be done to fully understand the cellular and molecular mechanisms involved in the relationship between reflux disease and asthma, but both feel their study offers new directions for developing additional treatment options for both problems.
Lin says patients who already have GERD can minimize gastric reflux - and thereby lessen their chances of developing asthma - by following a few simple guidelines: Eat smaller meals and eat several hours before going to bed; raise the head of the bed a few inches; maintain a healthy weight; and limit fatty foods, coffee, tea, caffeine and alcohol - they can relax the esophageal sphincter and make reflux more likely.
----------------------------
Article adapted by Medical News Today from original press release.
----------------------------
Funding for the study came from the Society of American Gastrointestinal Endoscopic Surgeons Research Grant and the Parks Protocol Memorial Fund.
Additional co-authors from Duke include lead author Andrew Barbas, Tacy Downing, Keki Balsara, Hung-Enn Tan, Gregory Rubinstein, Zoie Holzknecht, Bradley Collins and R. Duane Davis.
Source: Michelle Gailiun
Compliance To Proton Pump Inhibitors Reduces Costs
A new study reveals that patients with gastroesophageal reflux disease (GERD) who receive proton pump inhibitor (PPI) drugs require fewer health care services and incur lower costs if they conform to the recommended usage frequency.
Using health insurance claims data from over 40,000 adults with GERD, the Analysis Group and AstraZeneca authors investigated whether patients who are "compliant" to their PPI therapies, including omeprazole, esomeprazole, lansoprazole, pantoprazole, and rabeprazole, by regularly taking the drug as directed by their physician, offer greater cost savings to payers compared to "non-compliant" patients.
They found that although patients compliant with PPIs had higher drug costs, they had fewer hospital admissions and outpatient visits, which translates into a net economic benefit of an approximately $855 reduction in annual cost per patient relative to PPI non-compliant patients.
"Given the large numbers of people who take PPIs, this study suggests that increasing compliance can be an effective way to improve the management of GERD, reduce costs, and improve health," said Dr. Mei Sheng Duh, co-author of the study and Vice President of Analysis Group, Inc., a national economic consulting firm.
This study, "The Impact of Proton Pump Inhibitor Compliance on Health Care Resource Utilization and Costs in Patients with Gastroesophageal Reflux Disease," will be discussed in Value in Health, the official journal of the International Society for Pharmacoeconomics and Outcomes Research. The study was funded by AstraZeneca.
Value in Health (ISSN 1098-3015) publishes papers, concepts, and ideas that advance the field of pharmacoeconomics and outcomes research and help health care leaders to make decisions that are solidly evidence-based. The journal is published bi-monthly and has a regular readership of over 3,000 clinicians, decision-makers, and researchers worldwide.
ISPOR is a nonprofit, international organization that strives to translate pharmacoeconomics and outcomes research into practice to ensure that society allocates scarce health care resources wisely, fairly, and efficiently.
Analysis Group provides economic consulting to leading corporations, government agencies, and law firms. The firm has more than 400 professionals, with offices in Boston, Chicago, Dallas, Denver, Los Angeles, Menlo Park, New York, San Francisco, Washington, and Montreal.
Using health insurance claims data from over 40,000 adults with GERD, the Analysis Group and AstraZeneca authors investigated whether patients who are "compliant" to their PPI therapies, including omeprazole, esomeprazole, lansoprazole, pantoprazole, and rabeprazole, by regularly taking the drug as directed by their physician, offer greater cost savings to payers compared to "non-compliant" patients.
They found that although patients compliant with PPIs had higher drug costs, they had fewer hospital admissions and outpatient visits, which translates into a net economic benefit of an approximately $855 reduction in annual cost per patient relative to PPI non-compliant patients.
"Given the large numbers of people who take PPIs, this study suggests that increasing compliance can be an effective way to improve the management of GERD, reduce costs, and improve health," said Dr. Mei Sheng Duh, co-author of the study and Vice President of Analysis Group, Inc., a national economic consulting firm.
This study, "The Impact of Proton Pump Inhibitor Compliance on Health Care Resource Utilization and Costs in Patients with Gastroesophageal Reflux Disease," will be discussed in Value in Health, the official journal of the International Society for Pharmacoeconomics and Outcomes Research. The study was funded by AstraZeneca.
Value in Health (ISSN 1098-3015) publishes papers, concepts, and ideas that advance the field of pharmacoeconomics and outcomes research and help health care leaders to make decisions that are solidly evidence-based. The journal is published bi-monthly and has a regular readership of over 3,000 clinicians, decision-makers, and researchers worldwide.
ISPOR is a nonprofit, international organization that strives to translate pharmacoeconomics and outcomes research into practice to ensure that society allocates scarce health care resources wisely, fairly, and efficiently.
Analysis Group provides economic consulting to leading corporations, government agencies, and law firms. The firm has more than 400 professionals, with offices in Boston, Chicago, Dallas, Denver, Los Angeles, Menlo Park, New York, San Francisco, Washington, and Montreal.
Pre-Cancerous Condition Linked To Chronic Acid Reflux Faces Several Hurdles
A pre-cancerous condition linked to chronic acid reflux often gets overlooked. Can the medical community do a better job intervening? Researchers from the Hutchinson-MRC Research Centre in Cambridge think so.
In a review published in the inaugural issue of Disease Models & Mechanisms (DMM), http://dmm.biologists.org, experts on a disease known as "Barrett's oesophagus" discuss how "Barrett's" presents unique challenges in diagnosis and treatment. They cite key factors which make this illness difficult to detect, and suggest how scientists and doctors can team up to improve the odds of intervention.
Doctors want to understand more about this condition because patients with Barrett's have 30 to 125 times increased risk of an often fatal cancer of the oesophagus. One of the most common indicators of Barrett's is severe and chronic acid reflux. The authors of the review article discuss several reasons why most Barrett's cases are undiagnosed. The wide-spread availability of over-the-counter antacid medications may contribute by suppressing symptoms such that only the most severe and persistent cases of acid reflux are recommended for screening. Additionally, in order to screen for Barrett's, the oesophagus must be examined with a small light and camera (endoscope) which is not a routine procedure.
The biological basis of Barrett's is an abnormal change, or dysplasia, in the oesophagus. Normally, the oesophagus is lined with flat-shaped cells known as squamous cells. However, in patients with Barrett's, the cell lining consists of rectangular-shaped columnar cells. This process of normal cells morphing into abnormal cells is common to several types of cancer, not just oesophageal cancer. Thus, a greater understanding of Barrett's can also lead to potential therapies for similar pre-cancerous conditions.
In order to advance the diagnosis of Barrett's oesophagus, researchers recommend identifying standardized indicators which can be used to identify the presence of Barrett's as well as predict the likelihood that it will progress into cancer. Additionally, they recommend developing less costly screening methods to allow routine checks for Barrett's in patients with acid reflux. They point out the need for developing laboratory animal models of this disease in order to study the underlying molecular mechanisms of Barrett's, as well as to test potential novel therapies.
The review was written by Massimilian di Pietro, Christopher J. Peters and Rebecca C. Fitzgerald of the Hutchinson-MRC Research Centre in Cambridge, UK. The report was published in the inaugural July/August issue of a new research journal, Disease Models & Mechanisms (DMM), published by The Company of Biologists, a non-profit based in Cambridge, UK.
The DMM website is located at: http://dmm.biologists.org
About Disease Models & Mechanisms
Disease Models & Mechanisms (DMM) is a new research journal publishing both primary scientific research, as well as review articles, editorials, and research highlights. The journal's mission is to provide a forum for clinicians and scientists to discuss basic science and clinical research related to human disease, disease detection and novel therapies. DMM is published by the Company of Biologists, a non-profit organization based in Cambridge, UK. The Company also publishes the international biology research journals Development, Journal of Cell Science, and The Journal of Experimental Biology.
In a review published in the inaugural issue of Disease Models & Mechanisms (DMM), http://dmm.biologists.org, experts on a disease known as "Barrett's oesophagus" discuss how "Barrett's" presents unique challenges in diagnosis and treatment. They cite key factors which make this illness difficult to detect, and suggest how scientists and doctors can team up to improve the odds of intervention.
Doctors want to understand more about this condition because patients with Barrett's have 30 to 125 times increased risk of an often fatal cancer of the oesophagus. One of the most common indicators of Barrett's is severe and chronic acid reflux. The authors of the review article discuss several reasons why most Barrett's cases are undiagnosed. The wide-spread availability of over-the-counter antacid medications may contribute by suppressing symptoms such that only the most severe and persistent cases of acid reflux are recommended for screening. Additionally, in order to screen for Barrett's, the oesophagus must be examined with a small light and camera (endoscope) which is not a routine procedure.
The biological basis of Barrett's is an abnormal change, or dysplasia, in the oesophagus. Normally, the oesophagus is lined with flat-shaped cells known as squamous cells. However, in patients with Barrett's, the cell lining consists of rectangular-shaped columnar cells. This process of normal cells morphing into abnormal cells is common to several types of cancer, not just oesophageal cancer. Thus, a greater understanding of Barrett's can also lead to potential therapies for similar pre-cancerous conditions.
In order to advance the diagnosis of Barrett's oesophagus, researchers recommend identifying standardized indicators which can be used to identify the presence of Barrett's as well as predict the likelihood that it will progress into cancer. Additionally, they recommend developing less costly screening methods to allow routine checks for Barrett's in patients with acid reflux. They point out the need for developing laboratory animal models of this disease in order to study the underlying molecular mechanisms of Barrett's, as well as to test potential novel therapies.
The review was written by Massimilian di Pietro, Christopher J. Peters and Rebecca C. Fitzgerald of the Hutchinson-MRC Research Centre in Cambridge, UK. The report was published in the inaugural July/August issue of a new research journal, Disease Models & Mechanisms (DMM), published by The Company of Biologists, a non-profit based in Cambridge, UK.
The DMM website is located at: http://dmm.biologists.org
About Disease Models & Mechanisms
Disease Models & Mechanisms (DMM) is a new research journal publishing both primary scientific research, as well as review articles, editorials, and research highlights. The journal's mission is to provide a forum for clinicians and scientists to discuss basic science and clinical research related to human disease, disease detection and novel therapies. DMM is published by the Company of Biologists, a non-profit organization based in Cambridge, UK. The Company also publishes the international biology research journals Development, Journal of Cell Science, and The Journal of Experimental Biology.
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