Digestive Health Research Share
While progress is being made in our understanding of the gastrointestinal disorders, important questions remain. For example:
- What causes the disorders?
- Why do certain people get them?
- How do we best treat the conditions?
- How do we prevent the disorders?
- How do we cure them?
Sound medical research is needed to explore these questions. Here we report a sampling of research studies and medical news that provide clues to better understanding GI disorders. Each new advance adds a small piece to the puzzle, making the big picture clearer.
To learn more about medical research, visit our web site at www.giResearch.org.
Topics - Newest Postings Listed First
- Three FGIMDs represented in new FDA Patient Perspective Initiative
- FDA Approves Lubiprostone to Treat Opioid-Induced Constipation
- FDA Approves Gattex to Treat Short Bowel Syndrome
- Linaclotide (Linzess) Now Available in U.S. Pharmacies
- FDA Approves Label Change for Amitiza
- Linaclotide Approved in Europe to Treat IBS-C
- Lubiprostone Available in Japan for Treatment of Chronic Constipation
- Participants Sought for IBS-D Study
- Lubiprostone Approved in U.K. to treat Chronic Constipation
- TSA Cares Help Line – Help for Those Traveling With Medical Conditions
- New Drug Application filed with FDA for Lubiprostone to treat Opioid-Induced Constipation
- The Human Microbiome in Health and Disease
- New Drug in Development for Treatment of IBS-D begins Phase 3 Study
- Positive Results Reported for Treatment of Anal Fissures
- Improving Patient Care through Innovation
- Understanding the Underlying Disease Process of Gastroparesis
- FDA Approves New Treatment for GERD
- FDA Issues Safety Alert Regarding PPI Risk Factor
- Lubiprostone Results Positive in Treating Opioid-Induced Bowel Dysfunction
- Opioids Increasingly Prescribed for Chronic Abdominal Pain in Adults despite Shortcomings
- Gastroparesis May Occur Less Often Than Thought in People with Diabetes
- FDA will Review the New Drug Application for Gattex to treat Short Bowel Syndrome
- Simple Breathing Exercises May Help GERD
- Advancing Treatments for Rare Diseases
- FDA Accepts Review of New Drug for IBS-C and for Chronic Constipation
- New Guides Compare Benefits and Risks of GERD Treatments
- New VA Rule Helps Veterans with Functional GI Disorders
- Defining Severity in IBS and Functional GI Disorders
- Better Understanding and More Education about Gastroparesis Needed
- New NIH Public Program about Difficult GI Problem
- Solesta is a New Treatment for Bowel Incontinence
- New Treatment for C.-diff
- InterStim is a New Treatment for Bowel Incontinence
- Long-term use of PPIs may be Linked to Low Blood Levels of an Essential Mineral
- Lubiprostone Dose-Dependent Improvement of Constipation
- New Way to Detect Pre-Cancerous Cells in People with Barrett's Esophagus
- Fidaxomicin a Developing New Treatment for C. diff Infection
- Gattex Shows Promise for Treating Short Bowel Syndrome
- Gastric Electrical Stimulation for Patients with Severe Gastroparesis
- Rifaximin Results Positive for Treatment of Non-constipating IBS
- FDA Panel Endorses Solesta for Treatment of Incontinence, or Loss of Bowel Control
- New U.S. Food Safety Laws
- Research Findings in Chronic GI Conditions
- Linaclotide Results Positive for Treatment of IBS with Constipation, and Chronic Constipation
- Health Care Reform Act
- FDA Announces Labeling Change for PPIs due to Possible Increased Risk
- Preliminary News on Treatments Reported at 2010 Digestive Disease Week Meeting
- Future Peanut Allergy May be Predictable in Infants With Egg or Milk Allergy
- Functional GI Disorders and Gulf War Veterans
- Lactose Intolerance and Health
- Not All "Probiotics" are Alike
- Genetic Factors in IBS?
- Safety Recall - Products May Cause Gastrointestinal Events
- Environment and the Increasing Prevalence of Celiac Disease
- The Complexity of IBS - Veterans Study
- Soluble Fiber versus Insoluble Fiber in Treating IBS
- Obesity and GERD
- GERD and IBS – Is there a Link?
- Probiotics in the Treatment of IBS
- Do Dietary Changes Help in Coping with GI Symptoms?
- 5-HT Agents in the Treatment of IBS
- Understanding IBS Severity
- Peanut butter and peanut product recall information
- Treatment guidelines for IBS
- The use of probiotics for GI conditions
- Diverticular disease and nuts, corn, and popcorn
- Bacterium and Crohn's disease
- Barrett's esophagus risk factors
- Narcotic bowel syndrome
- Updated guidelines for treating constipation in children
- Does allergy play a role in IBS and in constipation?
- How common is food allergy in children?
- Do infants with GERD become adults with GERD?
- Do genetic or environmental factors contribute to IBS?
- How does the patient-doctor relationship help treat IBS?
- Is childhood GERD a risk factor for adult symptoms?
- Is there a relationship between IBS, dyspepsia, and quality of life in GERD sufferers?
(April 25, 2013) The U.S. Food and Drug Administration (FDA) has announced that irritable bowel syndrome (IBS), gastroparesis, and gastroesophageal reflux disease (GERD) with persistent regurgitation symptoms on proton pump inhibitors were selected as disease areas to be addressed during the first three years of its Patient-Focused Drug Development, a part of the Prescription Drug User Fee Act (PDUFA). Learn more.
(April 23, 2013) The U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for lubiprostone (Amitiza) to treat opioid-induced constipation in adult patients with chronic non-cancer pain.
The drug was FDA approved in 2006 to treat chronic idiopathic constipation (CIC) in adults and in 2008 to treat irritable bowel syndrome with constipation (IBS-C) in adult women. Learn more
(December 21, 2012) The FDA today approved teduglutide (Gattex) for the treatment of adults with short bowel syndrome (SBS). Learn more
(December 17, 2012) Linaclotide (Linzess) is now available in U.S. pharmacies for the treatment of chronic idiopathic constipation and to treat irritable bowel syndrome with constipation (IBS-C) in adults aged 17 and older. Learn more
(November 30, 2012) The FDA approved a Prescribing Label change for Amitiza that removed all pregnancy-related warnings and precautions. Nursing mothers who are taking Amitiza are advised to monitor their infants for diarrhea. Amitiza is a drug prescribed to treat chronic constipation in adults or IBS-C in women aged 18 and over.
(November 28, 2012) Almirall S.A. and Ironwood Pharmaceuticals report that the European Commission has granted marketing authorization for linaclotide (marketed under the brand name Constella) in Europe to treat IBS with constipation in adults. Constella is expected to be available in Europe in the first half of 2013.
The U.S. Food and Drug Administration (FDA) on August 30, 2012 approved linaclotide (Linzess) to treat irritable bowel syndrome with constipation (IBS-C) and to treat chronic idiopathic constipation in adults aged 17 and older. More...
(November 26, 2012) Lubiprostone (Amitiza), a prescription medicine for the treatment of functional chronic constipation, has been introduced in Japan by Sucampo Pharmaceuticals, Inc., a global pharmaceutical company, and Abbott. Amitiza was approved by the Ministry of Health, Labor and Welfare (MHLW) in Japan in June.(November 9, 2013) A study sponsored by Furiex Pharmaceuticals, Inc. is seeking people to participate in clinical trials of a new investigational medication for patients with diarrhea-predominant irritable bowel syndrome (IBS-D).
Purpose of the study: To evaluate the effectiveness, safety, and tolerability of JNJ-27018966 (the Investigational drug) compared with an inactive placebo in patients with irritable bowel syndrome (IBS) with the subtype of diarrhea.
Participation: Eligible male and female patients aged 18 to 80 years with a diagnosis of irritable bowel syndrome (IBS) with a subtype of diarrhea.
For information call: 1-877-345-2145
(September 12, 2012) Sucampo Pharmaceuticals announced that it has received approval in the U.K. from the Medicines and Healthcare products Regulatory Agency for lubiprostone (Amitiza) 24 mcg twice daily for the treatment of chronic idiopathic constipation (CIC) and associated symptoms in adults, when response to diet and other non-pharmacological measures are inappropriate.
(August 1, 2012) The Transportation Security Administration (TSA) has a new helpline for travelers with disabilities and medical conditions.
Travelers may call TSA Cares toll free at 1-855-787-2227 prior to traveling, for help with questions about screening policies, procedures and what to expect at the security checkpoint with regards to their specific medical condition. If necessary, TSA Cares may be able to arrange checkpoint support with a TSA Customer Service Manager located at the airport.
TSA recommends that passengers call 72 hours ahead of travel. The TSA Cares helpline hours are Monday through Friday 8 a.m. – 11 p.m. EST and weekends and Holidays 9 a.m. – 8 p.m. EST.
(July 26, 2012) Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals U.S.A. Inc. announced the filing of a supplemental new drug application (sNDA) with the U.S. Food and Drug Administration (FDA) seeking approval for a new indication for lubiprostone for the treatment of opioid-induced constipation (OIC) in patients with chronic, non-cancer pain. Opioids are narcotics, such as morphine and codeine, used to treat pain. Lubiprostone currently is available under the name Amitiza to treat chronic idiopathic (functional) constipation and irritable bowel syndrome with constipation.
(June 25, 2012) The National Institutes of Health (NIH) reported that researchers have mapped the normal bacteria that live in and on the healthy human body. The accomplishment sets the stage for better understanding how bacterial communities affect human health and disease.
The human body is host to trillions of microbes. These microbes outnumber the body’s cells by 10 to 1. Most of the time they are beneficial to human health, but sometimes they can cause illness. Scientists are using new genomic techniques to study these microbial communities and their genes, which collectively are known as the microbiome.
The Human Microbiome Project (HMP) was launched by NIH in 2007 to characterize the microbes found in different regions of the body, including the digestive tract. The scientists studied the microbes of 242 healthy adult volunteers by collecting tissue from 15 body sites in men and 18 in women. The scientists found that more than 10,000 microbial species occupy the human body. They estimated that the microbiome provides more genes that contribute to human survival than the human genome itself provides (8 million vs. 22,000). Humans need bacterial genes to aid in basic processes such as digestion.
“Enabling disease-specific studies is the whole point of the Human Microbiome Project,” says Dr. Barbara Methé of the J. Craig Venter Institute. “Now that we understand what the normal human microbiome looks like, we should be able to understand how changes in the microbiome are associated with, or even cause, illnesses.”
Source: National Institutes of Health (NIH). NIH Research Matters web page: nih.gov/researchmatters/june2012/06252012microbiome.htm (Accessed June 25, 2012)
(June 15, 2012) Recruitment of male and female adult patients has started for the Phase 3 clinical study of MuDelta (JNJ-27018966), a novel drug under development for the treatment of irritable bowel syndrome with diarrhea as the predominant bowel symptom (IBS-D). Learn more here.
(June 1, 2012) Ventrus Biosciences reported positive data from a Phase 3 study treating patients suffering from anal fissures with its diltiazem hydrochloride cream (VEN 307). Ventrus reported the cream met the main goal of reducing pain.
An anal fissure is a tear in the anal lining that can cause severe anal pain, associated with or after bowel movements.
The double-blind, placebo-controlled study included 465 people across 31 centers in Europe. Ventrus plans to request a meeting with the US Food and Drug Administration (FDA) to discuss steps toward filing for approval.
(May 4, 2012) "The concept of the separation of mind and body is dominant and pervasive in Western thinking. This has had profound negative effects on research, patient care, and the patient-physician relationship," said Douglas Drossman, MD at a 12gurus: Health conference. These negative effects are often present with functional GI and motility disorders, complex conditions that many healthcare providers, as well as patients, find difficult to understand, manage, and treat.
Here is a video of the presentation by Dr. Drossman that talks about this concept and ways in which healthcare professionals can improve diagnosis and treatment of people with functional GI and motility disorders. View video here.
The 12gurus: Health conference held in March 2012 was attended by health care leaders and innovators to share ideas about changing and improving the health care system. Dr. Drossman was formerly the Co-director of the UNC Center for Functional GI and Motility Disorders. He is now in private practice at Drossman Gastroenterology, Chapel Hill, NC.
(April 18, 2012) Researchers have found evidence of changes at the cellular level in the stomachs of individuals with gastroparesis, yielding new insights into this digestive disorder.
Gastroparesis is a chronic condition characterized by impaired motility – the muscular contractions that move food along the gastrointestinal tract. This limited motility results in delayed food emptying from the stomach into the intestines, as well as many symptoms that compromise quality of life, including nausea, vomiting, bloating, weight loss, and abdominal pain. Gastroparesis is commonly associated with diabetes, which is thought to damage nerves connecting to the stomach that control muscular contractions. However, most often the cause of the disorder is unknown or “idiopathic.”
Clinical studies on this disorder have been limited. Scientists in the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Gastroparesis Clinical Research Consortium are now conducting research at sites across the nation to improve understanding of disease processes and develop effective treatments for this disorder. For this study, they collected stomach tissue samples from individuals with diabetic and idiopathic forms of gastroparesis, as well as control samples from patients undergoing gastric bypass surgery who did not have gastroparesis, in order to compare their cellular structures. Scientists identified the types of cells in each sample and noted any cell damage.
Researchers noticed cellular abnormalities in the majority of samples from patients with either diabetic or idiopathic gastroparesis. The most frequent type of abnormality seen in stomach tissue from gastroparesis patients was a reduction in the number of interstitial cells of Cajal (ICCs), which play an important role as “pacemakers,” controlling muscular contractions in the stomach. Another common alteration was seen in the shape and increased number of immune cells present in the muscle layer. Some alterations in the gut nervous system were also observed. In addition to seeing certain cellular changes the researchers observed lack of visible contact between ICCs and neighboring nerve or muscle cells. Some unique cellular features were also noted between diabetic and idiopathic gastroparesis.
The finding of cellular abnormalities in the stomachs of most individuals with this disorder – including changes in the structure and number of ICCs, nerve cells, and immune cells – sheds light on the underlying disease processes at work in both forms of gastroparesis, and paves the way for future therapeutic development. Future research by the Consortium members will continue to explore these abnormalities, such as how loss of contact among these cells might translate into the limited gastrointestinal motility seen in patients with gastroparesis.
Adapted from: NIDDK Recent Advances & Emerging Opportunities.February 2012. Source: Grover M, Farrugia G, Lurken MS, et al. Cellular changes in diabetic and idiopathic gastroparesis. Gastroenterology. 140:1575-1585, 2011.
(March 27, 2012) Torax Medical announced that the U.S. Food and Drug Administration (FDA) approved the LINX Reflux Management System, a medical device for treating gastroesophageal reflux disease (GERD). The LINX System uses a small, implantable device to prevent the back-flow of stomach contents (reflux) in people with GERD who have not been helped by other treatments.
The LINX System is comprised of interlinked titanium beads with magnetic cores. The magnetic attraction between the beads augments the existing lower esophageal sphincter’s (LES) barrier function to prevent reflux. The device is implanted with a standard minimally invasive laparoscopic procedure.
Torax conducted a feasibility study of 44 patients at four centers with a five-year follow-up plan. In addition, the company conducted a pivotal study of 100 patients at 14 centers with a five-year follow-up plan. Patients enrolled had GERD and chronic GERD symptoms, despite medical therapy. Results from both the feasibility and pivotal trials indicate that the benefits obtained with the LINX Reflux Management System outweigh its risks.
The most common side effects experienced with the LINX included difficulty swallowing, pain when swallowing food, chest pain, vomiting, and nausea.
Torax said that they will work with medical centers that have a specific expertise in the treatment of reflux disease to create “Centers of Excellence” for the LINX System. Patients will have access to the LINX procedure within the next 30 days.
(February 8, 2012) The U.S. FDA today recommended that patients taking the stomach acid drugs known as proton pump inhibitors (PPIs) should immediately contact their healthcare professional and seek care if they develop diarrhea that does not improve. The FDA notice states that PPIs may be associated with an increased risk of Clostridium difficile–associated diarrhea. These PPIs include:
Find more from the FDA at http://tinyurl.com/7ltpxm4
- AcipHex (rabeprazole sodium)
- Dexilant (dexlansoprazole)
- Nexium (esomeprazole magnesium)
- Omeprazole (omeprazole) Over-the-Counter (OTC)
- Prevacid (lansoprazole) and OTC Prevacid 24hr
- Prilosec (omeprazole) and OTC
- Protonix (pantoprazole sodium)
- Vimovo (esomeprazole magnesium and naproxen)
- Zegerid (omeprazole and Sodium bicarbonate) and OTC
(February 2, 2012) Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals U.S.A., Inc. announced that lubiprostone met the primary endpoint in a phase 3 clinical trial for the treatment of opioid-induced bowel dysfunction (OBD) in patients with chronic, non-cancer pain, excluding those taking methadone.
Opioids are narcotics, such as morphine and codeine, used to treat pain. A number of gastrointestinal (GI) symptoms are potential side effects of using opioid-based medications. The most common symptom is constipation. Others symptoms may include decreased gastric emptying, abdominal cramping, spasm, bloating, and delayed GI transit.
This phase 3, randomized, placebo-controlled, double-blinded trial looked at the efficacy and safety of lubiprostone in patients with opioid-induced bowel dysfunction. The primary endpoint was the overall spontaneous bowel movement (SBM) response rate. Over a 12 week period, the response rate for 219 lubiprostone-treated patients was 26.9% versus 18.6% for 220 placebo-treated patients.
The trial included patients in the U.S. and Europe who continued opioid therapy throughout the study.
No drug-related serious adverse events were reported for patients taking lubiprostone. The most common treatment-related adverse events (experienced by 5–10% of patients) were diarrhea, nausea, and abdominal pain.
Lubiprostone currently is available under the name Amitiza to treat chronic idiopathic (functional) constipation and irritable bowel syndrome with constipation. Submission of a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) for lubiprostone to treat opioid-induced bowel dysfunction is anticipated in the first half of 2012.
(February 2012) Opioids are narcotics used to treat pain. They are sometimes prescribed to treat chronic abdominal pain, such as pain in irritable bowel syndrome, as well as in other conditions. However, the use of opioids to treat non-cancer chronic pain is supported by evidence that is limited at best. Moreover, opioids are associated potentially with drug misuse and other gastrointestinal symptoms, particularly constipation. Over long time periods, even when used as directed, they may actually worsen abdominal pain.
A study published by Dorn and colleagues concluded that prescriptions for opioids to treat chronic abdominal pain in adults more than doubled during the period between 1997 and 2008. To conduct the survey, they looked at chronic abdominal pain-related visits by adults to U.S. outpatient clinics using reason-for-visit codes from the National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey (1997–2008). Data were weighted to produce national estimates of opioid prescriptions over time.
The researchers speculate that several factors contributed to the increased prescribing including a tendency to generalize recommendations for the use of opioids in treating acute pain to include chronic pain, campaigns to recognize pain as the “fifth vital sign,” product advertising, and growing challenges clinicians face trying to manage chronic abdominal pain while unprepared to take the integrated approach that experts suggest.
Source: Dorn SD, Meek PD, Shah ND. Increasing frequency of opioid prescriptions for chronic abdominal pain in US outpatient clinics. Clin Gastroenterol Hepatol. 2011 Dec;9(12):1078-85.e1.
(February 2012) When people with diabetes experience upper GI symptoms – such as nausea, vomiting, and stomach discomfort – gastroparesis is often considered. However, it may not be as common in this group as previously thought. A study by researchers at Mayo Clinic found that, while diabetes is a risk factor, only 5% of people with type 1 diabetes and 1% of people with type 2 diabetes developed gastroparesis over a 10-year period. Only 0.2% of people in the study without diabetes (controls) developed gastroparesis.
The researchers concluded that gastroparesis is a relatively uncommon complication of diabetes. Consequently, other causes of upper GI symptoms in people with diabetes need to be considered first. People suspected of having gastroparesis typically undergo tests, including examination of the esophagus and stomach. Testing to measure how fast the stomach empties is often used to confirm a diagnosis of gastroparesis. When testing shows normal emptying, functional dyspepsia is more likely the diagnosis.
The study gathered data on 1,226 people, including 587 with either type 1 or type 2 diabetes, and 639 without diabetes who served as controls.
Source: Choung RS, Locke GR, Schleck CD, Zinsmeister AR, Melton LJ, Talley NJ. Risk of gastroparesis in subjects with type 1 and 2 diabetes in the general population. Am J Gastroenterol. 2012 Jan;107(1):82-8. doi: 10.1038/ajg.2011.310. Epub 2011 Nov 15.
(January 31, 2012 – NPS Pharmaceuticals, Inc. announced that the FDA has accepted and filed for review the company's New Drug Application (NDA) for Gattex (teduglutide) for the treatment of adults with short bowel syndrome (SBS). Gattex works by regeneration of cells in the intestinal lining, slowing down transit through the gut and increasing blood flow, allowing for increased nutrient absorption. The acceptance of the Gattex NDA is the FDA’s determination that the application is sufficiently complete to permit a substantive review. More...
(January 2012) Looking for a way to help control gastroesophageal reflux (GERD) symptoms through lifestyle changes? A recent scientific study suggests that learning a simple breathing exercise may help.
Reflux is prevented by the lower esophageal sphincter (LES), which is surrounded by the diaphragm muscle. In a recent scientific study of 19 people who had active GERD without esophageal erosion, 10 were trained by a physical therapist to practice abdominal breathing exercises to strengthen the diaphragm muscle and 9 served as controls not doing breathing exercises. After one month, those doing the exercises reported an average improvement in quality of life, compared to the control group.
For long-term follow-up, after one month, all 19 were invited to continue active breathing training and were further assessed regarding quality of life and medication usage. Eleven people continued practice of abdominal breathing for nine months. They reported improved quality of life and using less on-demand reflux medication. The 8 people who quit the breathing exercises reported no changes in quality of life or medication use.
The study was very small and limited, so further research is needed before we know if this is a generally effective treatment for people with GERD symptoms. The study participants who did not stick with the breathing exercises through the whole nine-month follow-up period gave a variety of reasons – some preferred to take medication, some said they were “too lazy,” some reported that they did not have the time, and some that they thought the training was “useless.” So you’ll need to be dedicated about practicing these techniques if you hope to see results.
Source: Eherer AJ, Netolitzky F, Högenauer C, et al. Positive effect of abdominal breathing exercise on gastroesophageal reflux disease: a randomized, controlled study. Am J Gastroenterol advance online publication 6 December 2011; doi: 10.1038/ajg.2011.420.
Want to try an abdominal breathing exercise for yourself? Follow the instructions below:
A Simple Breathing Technique
Typically, our breathing is either shallow and irregular (chest or thoracic breathing), or deep and regular (abdominal or diaphragmatic). Shallow chest breathing is often associated with tension. Deeper abdominal breathing, on the other hand, is associated with reduced tension and relaxation.
There are many breathing techniques that can be quickly and easily learned. While initially the positive effects are often subtle, benefits increase over time. Here is a simple breathing technique:
- Lie on your back with your knees bent, or sit straight in a comfortable position with your arms and legs uncrossed
- Breathe in through your nose comfortably into your abdomen – the area between your chest and your hips. (If you are not used to diaphragmatic breathing, place your palm over your belly button to feel it rise and fall with each breath.) Pause briefly before you exhale.
- Breath out through your mouth with your lips nearly closed or pursed (making a sound like a steady wind).
- Each time your exhale, count silently to yourself, “One…two…three…four.”
- Repeat this cycle for five to ten minutes.
Notice your breathing gradually slowing, your body relaxing, and your mind calming as you practice this breathing technique.
(November 9, 2011) The Congressional Rare Disease Caucus held a briefing to educate the staff of Members of Congress on the experiences of rare disease patients and their families, as well as rare disease treatment development.
The National Institutes of Health Office of Rare Diseases Research (ORDR) maintains a list of rare (orphan) diseases, which are generally considered to have a prevalence of fewer than 200,000 affected individuals in the United States. Listed rare diseases affecting the functional GI and motility disorders community include:
- Cyclic vomiting syndrome (CVS)
- Hirschsprung's disease
- Intestinal pseudo-obstruction
- Levator syndrome
- Rumination disorder
- Short bowel syndrome
- SMA Syndrome
Dr. Tim Cote, Chief Medical Officer of the National Organization for Rare Disorders (NORD) hosted the briefing. In his opening remarks, he discussed how orphan drug products are transformative for patients of rare diseases, and that they present a public health opportunity. The speakers that followed continued to highlight the importance of increasing the speed of achieving Food and Drug Administration (FDA) approval, and increasing incentives for pharmaceutical companies to invest in rare disease treatment research. Below is a list of the speakers followed by a summary of their remarks.
Ann Pariser, MD, Associate Director for Rare Diseases, FDA, Center for Drug Evaluation and Research (CDER), Office of New Drugs, Rare Diseases Program – Outlined FDA initiatives to reduce the time it takes for an FDA approval for rare disease treatments, and demonstrated that as a result, more orphan drug products have been approved. These initiatives include:
- Fast track designation
- Accelerated approval
- Priority review
- Expanded access
- Critical Path Initiative orphan drug designation
- CDER Rare Disease Program (in development)
Steve Groft, PharmD – Director, Office of Rare Diseases Research (ORDR), National Institutes of Health – discussed the Rare Disease Clinical Research Network which has increased the number of researchers with experience collaborating in multi-center and international research projects.
Parents of children suffering from rare diseases discussed their experiences with treating their children for a rare disease, including developing their own molecular compounds because the medication wasn’t available due to lack of investment by pharmaceutical companies. They also discussed their ideas for increasing the speed of FDA approvals for rare disease drugs, such as establishing an Accelerated Approval process for Ultra-Rare Disease Treatments.
(October 24, 2011) The FDA has accepted for review the New Drug Application (NDA) for linaclotide to treat irritable bowel syndrome with constipation (IBS-C) and chronic constipation (CC). The review, which will determine whether or not the FDA approves the drug, is expected to take 10 months with a target date to occur in June 2012.
(September 23, 2011) New plain-language publications from the U.S. Department of Health and Human Services’ (HHS) Agency for Healthcare Research and Quality (AHRQ) compare the benefits and risks of treatments for gastroesophageal reflux disease (GERD). The digestive condition affects millions of Americans and can be treated with medications or surgery. The publications are based on an updated evidence report.
The report concluded that established drug-based therapy is effective. It also concluded that a type of surgical treatment known as laparoscopic fundoplication is at least as effective as drug-based medical treatment for some patients, but also had a higher risk of serious side effects. Another surgical treatment using an endoscopic variation of fundoplication also has been used to treat GERD, but AHRQ’s analysis found there is not enough evidence to compare this type of surgery’s effectiveness with other treatments.
The AHRQ report found that Proton Pump Inhibitors (PPIs) tend to be more effective than other drugs, but comparisons show few consistent differences between PPI types or dosages. PPIs cause some side effects, such as diarrhea and headaches, but these were generally not serious.
GERD, sometimes known as acid reflux disease, occurs when stomach contents frequently back up into the esophagus. GERD often causes heartburn, which occurs when stomach acid irritates the esophagus. Some patients with GERD develop a condition called Barrett’s esophagus, a disorder in which the lining of the esophagus is damaged by stomach acid, which can increase the risk of esophageal cancer.
Many patients have frequent, severe symptoms requiring long-term regular use of antireflux medications. For these people with chronic GERD, the goals of therapy usually are improvement in symptoms and quality of life and the prevention of complications such as Barrett’s esophagus. However, experts remain unsure how best to achieve this.
The report also found that fundoplication, surgery in which the upper portion of the stomach is wrapped and sewn around the esophagus, decreased, but did not eliminate, the use of antireflux medications. In addition, some patients who underwent antireflux surgery demonstrated improvement in reflux symptoms and quality of life. However, the report found severe side effects associated with surgery, including postoperative infections, difficulty swallowing, and postmeal bloating.
The new publications – a summary for consumers and a companion publication for clinicians – are based on the findings of a comprehensive report updated for AHRQ’s Effective Health Care Program by the Tufts Medical Center Evidence-based Practice Center. The report and the consumer and clinicians publications are available at www.effectivehealthcare.ahrq.gov.
The report, Comparative Effectiveness of Management Strategies for Adults with Gastroesophageal Reflux Disease, is an update to a 2005 report. The systematic review of 166 clinical studies published between January 2004 and August 2010 examined the comparative effectiveness, benefits, and adverse effects of treatments for GERD and investigated whether there are factors that influence or predict treatment effectiveness. It helps provide information that doctors and patients can use when considering a plan for treatment.
The review did not evaluate diagnostic approaches, treatment options for patients with symptoms resistant to treatments, or the effect of lifestyle modifications on GERD symptoms. It does not represent clinical recommendations or guidelines.
(August 15, 2011) The Department of Veterans Affairs (VA) implemented a new rule with broad, positive implications for the functional gastrointestinal and motility disorders (FGIMDs) community. This rule states that there is a “presumptive service connection” for veterans affected by functional gastrointestinal (GI) disorders who served in Southwest Asia during the Persian Gulf War.
This federal policy decision means that if a veteran deployed during the Persian Gulf War now suffers with a functional GI disorder, it is presumed that they developed the condition as a result of their military service for the purposes of assessing disability benefits. Find out more on this IFFGD page.
(July 25, 2011) Any treatment plan for a functional GI disorder, as well as for most other diseases, is determined in part by the severity of the condition in an individual. But agreement on what defines severity of functional GI disorders has been lacking. To address this, the Rome Foundation, through a Working Team consensus report, has developed guidelines to better describe severity looking at IBS, the most studied functional GI disorder.
Unlike many diseases where severity can be measured by abnormality in blood or tissue markers, severity in functional GI disorders is determined by symptom reports and patient experiences. Understanding and standardization of severity in functional GI disorders will help with clinical research, therapeutic development, and effective treatment.
The Rome Foundation findings are as follows:
- Severity is defined by a composite of reported...
- Symptoms in the GI tract
- Symptoms outside the GI tract
- Degree of disability
- Degree that illness relates to activities
- Severity is affected by biological function and activity factors in both the GI tract and the central nervous system
- As severity increases, the central nervous system provides a greater contribution
- Severity is related to and influences health-related quality of life and behaviors, and also guides diagnostic and therapeutic clinical decision making
- Severity can be subcategorized into clinically meaningful subgroups as mild (about 40 %), moderate (about 35 %), and severe (about 25 %), and this provides a working model for use in future research and clinical care
These new findings incorporated 3 recently published studies that were aimed at gaining additional knowledge about factors influencing severity: a qualitative focus group of 16 IBS patients conducted in collaboration by the Rome Foundation and the International Foundation for Functional Gastrointestinal Disorders (IFFGD), a survey of 755 tertiary-care IBS patients from the UCLA database, and an Internet survey of 1,966 IBS patients conducted in collaboration by IFFGD and the University of North Carolina in Chapel Hill.
Future work is required to understand more precisely the factors contributing to severity and to develop a valid patient-reported instrument to measure severity in IBS and the functional GI disorders.
Source: Drossman DA, Chang L, et al. Severity in irritable bowel syndrome: a Rome Foundation working team report. Am J Gastroenterol. 2011 Jul 12. doi: 10.1038/ajg.2011.201. [Epub ahead of print]
(June 2011) A research group from University of Louisville School of Medicine in Kentucky conducted a survey of physicians to determine physicians’ perception of gastroparesis and identify areas that need further research and education. The survey included questions on the causes, symptoms, management, and perceived complications of gastroparesis. A total of 397 physicians participated in the national survey.
Gastroparesis is a disorder in which the stomach empties very slowly. Symptoms can vary from person to person and range from mild to severe. Clinical characteristics that indicate the severity of gastroparesis are poorly defined. Objective markers for complications of severe gastroparesis are lacking. Misconceptions of gastroparesis among physicians may be common. Because of symptom overlap with functional dyspepsia, gastroparesis may be under-recognized and misdiagnosed.
The researchers found that more physician awareness and education are needed on gastroparesis and the standardized four-hour gastric scintigraphy diagnostic method. They also concluded that more research is needed on abdominal pain in patients with gastroparesis and to clarify the management strategy for this condition.
Source: Brilley LC, Harrell SP, et al. National survey of physicians’ perception of the cause, complications, and management of gastroparesis. South Med J.2011 Jun;104(6):412-7.
(June 2, 2011) A new program to help patients and health care professionals feel more comfortable talking about bowel control problems is now available from the National Institutes of Health (NIH).
Bowel control problems affect an estimated 18 million U.S. adults – 1 out of 12 people. People with bowel control problems are often reluctant to discuss the condition, even with their doctor. The Bowel Control Awareness Campaign and its Web resources raises awareness of bowel control problems, also known as fecal incontinence.
The awareness campaign stems from the recommendations of an independent panel of experts convened by the NIH to assess the current prevalence, risk factors, diagnosis, treatment, and management of the condition.
"Fecal incontinence is a significant public health burden in the United States – affecting close to 10 percent of the adult population over 40 years old," said Griffin P. Rodgers, M.D., director of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the NIH Institute leading the effort. "The Bowel Control Awareness Campaign's main objective is raising public awareness to aid in prevention of incontinence and to improve the lives of men and women living with the condition."
Developed by the NIDDK, along with professional and voluntary organizations that focus on fecal incontinence, the awareness campaign offers resources about the symptoms, diagnosis, treatment, and management of bowel control problems for patients and health care professionals. These resources are available through the Awareness Campaign's website.
The embarrassment associated with fecal incontinence can have a crippling impact on quality of life for millions, and the condition is believed to be widely under-diagnosed.
"The lack of communication between health care professionals and patients appears to be one of the main challenges with bowel control problems. Being able to talk about the problem is the first step in both prevention and treatment," said Stephen P. James, M.D., director of the Division of Digestive Diseases and Nutrition at the NIDDK. "People experiencing bowel control problems need to know they are not alone and that the condition can be managed. The Bowel Control Awareness Campaign will inform health care professionals and the public that bowel incontinence is a common condition and that effective treatments are available."
NIDDK, part of NIH, conducts and supports basic and clinical research and research training on some of the most common, severe and disabling conditions affecting Americans. NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases.
Source: NIH News Release
(May 27, 2011) The U.S. Food and Drug Administration (FDA) approved Solesta, a sterile, injectable gel to treat fecal (bowel) incontinence in patients for whom conservative therapies have failed. Find out more here.
(May 27, 2011) The U.S. Food and Drug Administration (FDA) has approved the macrolide antibiotic fidaxomicin (Dificid®) for the treatment of Clostridium difficile-associated diarrhea. The approval was based on two studies which showed that fidaxomicin was associated with a similar rate of clinical response to the drug vancomycin in patients; in addition more patients treated with fidaxomicin had a sustained cure three weeks after the end of the treatment course. See related story here.
(April 1, 2011) The U.S. Food and Drug Administration (FDA) approved InterStim Therapy for the treatment of chronic bowel or fecal incontinence in patients who have failed or are not candidates for more conservative treatments. InterStim Therapy, previously available to treat the symptoms of overactive bladder and non-obstructive urinary retention, is now also approved for the treatment of chronic fecal incontinence in patients who have failed or are not candidates for more conservative treatments.
The implantable system consists of a thin wire lead and a neurostimulator, or pacemaker-like device, as well as external clinician and patient programmers. InterStim Therapy allows patients and physicians to determine probable success of the therapy through a test stimulation procedure prior to committing to long-term therapy.
The therapy significantly reduced fecal incontinent episodes for a high percentage of clinical trial patients. The 120-patient, multi-center study examined the efficacy of InterStim Therapy in patients with chronic fecal incontinence who had failed or were not candidates for more conservative treatments. At 12 months of follow-up, 83 percent of patients experienced therapeutic success, defined as a greater than 50 percent reduction in the number of fecal incontinent episodes per week. Complete continence (no incontinent episodes) was achieved in more than 40 percent of the patients. In addition, patients in the study showed significant improvement in quality of life.
In the study, the most common device or therapy-related adverse events that occurred during the implant phase included implant site pain; a sensation of tingling, pricking, or numbness of the skin; and implant site infection. The majority of the events were successfully handled by minimal interventions.
Physicians who will implant InterStim Therapy for Bowel Control include colorectal surgeons, urologists, gynecologists and urogynecologists who receive appropriate training. Originally approved by the FDA in 1997 for urinary urge incontinence, InterStim Therapy now can be used for both urinary control and bowel control in many geographies, including the United States, Europe, Canada and Australia. To date, more than 85,000 people have received InterStim Therapy worldwide.
(March 2, 2011) The FDA issued a safety announcement on March 2, 2011, informing the public that long-term use of Proton Pump Inhibitor drugs (PPIs) may lower magnesium levels in the blood. Magnesium is a mineral in the body essential to good health.
Recent investigation has found that patients’ long-term use of prescription PPIs may be connected with low magnesium levels in the blood (hypomagnesemia) – typically in adults who have taken the drug for over a year. Having low levels of magnesium in the blood can result in serious adverse effects such as muscle spasms, irregular heartbeat, and convulsions; however, patients do not always present these symptoms. Over half of affected individuals were able to stabilize their blood magnesium levels by taking a magnesium supplement; however, a quarter of patients had to stop taking PPI treatment.
Over-the-counter (OTC) PPIs are marketed at low doses and are only intended for a 14 day course of treatment up to 3 times per year. The FDA believes that – when taken as directed – over-the-counter PPIs pose little risk of causing lowering magnesium levels in the blood.
PPIs work to reduce the amount of acid secreted into the stomach, and are commonly prescribed for those suffering from gastroesophageal reflux (GERD) and digestive ulcers. On average, patients who are prescribed PPIs generally take the medication for about 6 months. Prescription PPIs include Nexuim, Dexilant, Prilosec, Prevacid, and Zegerid. Over-the-counter PPIs include Prilosec OTC, Zegerid OTC, and Prevacid 24HR.
If you use a PPI talk to your doctor about risk factors and whether a lower dose or shorter duration of therapy would be appropriate for you.
Additionally, the FDA advises:
- Seek immediate care if experiencing an abnormal heart rate, muscle spasm, convulsions while taking a PPI drug
- Tell your healthcare professional if you have ever tested positive for low magnesium levels in your blood, or if you take the drug digoxin, diuretics, or other drugs that may cause hypomagesemia
- Do not stop taking your prescription PPI drug without talking to your healthcare professional
- If you take an over-the-counter (OTC) PPI drug, follow the directions on the package carefully
- If you have any questions or concerns, talk with your doctor
Details are on this FDA web page
(February 14, 2011) A 2-week study in Japan looked at lubiprostone (Amitiza® in the U.S.) for the treatment of chronic functional constipation in 170 patients with or without irritable bowel syndrome (IBS). The results suggest that lubiprostone produced a steady and effective improvement in the symptoms of constipation with or without IBS in a dose-dependent manner with a good safety profile and tolerability in a Japanese population. The study also suggests the optimal dose and usage of lubiprostone to improve spontaneous bowel movement in constipated patients regardless of ethnicity.
Source: Fukudo S, et al. Efficacy and safety of oral lubiprostone in constipated patients with or without irritable bowel syndrome: a randomized, placebo-controlled and dose-finding study. Neurogastroenterol Motil. 2011 Feb 9. doi: 10.1111/j.1365-2982.2011.01668.x. [Epub ahead of print]
(February 11, 2011) Barrett’s esophagus, a condition marked by cellular changes, is a risk factor for esophageal cancer. People with the condition are regularly monitored to look for cellular changes that are considered pre-cancerous, or more likely to develop cancer than normal tissue.
A new screening technique that uses light and sensors at the end of an endoscope shows promise in more accurately identifying pre-cancerous cells. This is important because early detection increases effectiveness of treatment.
A group of researchers from Duke University, UNC, Thompson Cancer Survival Center, and Cleveland Clinic reported on the technology in the January issue of Gastroenterology. The technology, known as angle-resolved low coherence interferometry (a/LCI) is not yet available as a device but may be in 2012.
Source: Terry NG, et al. Detection of dysplasia in Barrett’s esophagus with in vivo depth-resolved nuclear morphology measurements. Gastroenterology. 2011 Jan;140(1):42-50.
(February 3, 2011) Fidaxomicin is a new drug being developed for the treatment of Clostridium difficile (C. difficile or C. diff) a type of bacteria. C. difficile is a major causative agent of infection in the colon (colitis) and diarrhea that may occur following antibiotic intake. C. difficile infection represents one of the most common hospital infections around the world and can be quite serious. Treatment is directed toward eliminating C. difficile in the colon. Most patients respond well to antibiotic treatment, but 20–30% will experience a recurrence of diarrhea and other symptoms weeks or months after initial therapy is completed.
A study involving 629 patients, published in the February 3, 2011 issue of the "New England Journal of Medicine," compared fidaxomicin to another antibiotic, vancomycin, used to treat C. difficile. Researchers reported that fidaxomicin was associated with a 40% lower rate of recurrence within four weeks of the end of treatment (15.4% versus 25.3%), which was dependent on the strain of C. difficile. This appears due to fidaxomicin's ability to precisely target C. difficile bacteria in the gut. Both antibiotics had a similar clinical cure rate, but fidaxomicin kills less “good” intestinal bacteria that help hold back C. difficile.
The study was funded by Optimer Pharmaceuticals, the manufacturer of fidaxomicin. Optimer has applied to the FDA for accelerated approval of the antibiotic, and a decision is expected later this year.
Source: Medpage Today
(January 31, 2011) Gattex® (teduglutide) is a drug currently under investigation for the treatment of short bowel syndrome (SBS), a rare condition related to poor absorption of nutrients that typically occurs in people who have had half or more of their small intestine removed. People with short bowel syndrome cannot absorb enough water, vitamins, and other nutrients from food. They may then need to use parenteral nutrition, which is the slow infusion of a solution of nutrients into a vein. Gattex works by regeneration of cells in the intestinal lining, slowing down transit through the gut and increasing blood flow, allowing for increased nutrient absorption.
Results from a Phase 3 pivotal study reported by NPS Pharmaceuticals showed that Gattex met the primary efficacy endpoint of reducing parenteral nutrition (PN) dependence in patients with adult short bowel syndrome (SBS). Response was defined as achieving a 20% or greater reduction in weekly volume of parenteral nutrition at week 20 and week 24. The 24-week trial included 86 patients that depended on parenteral nutrition; 63% of Gattex-treated patients showed a response to the drug, compared to 30% of those on placebo. Application to the FDA seeking approval is expected later this year according to NPS Pharmaceuticals, the drug’s maker.
Gastric electric stimulation (GES) uses a surgically implanted battery operated device (pacemaker) on the stomach to help control symptoms of nausea and vomiting in gastroparesis when other methods have failed. A study to assess the long-term clinical outcomes of GES therapy looked back at records for a period of 1 to 11 years (4.5 years mean) of 221 patients with severe gastroparesis that were treated with Enterra Therapy System. The reviewers observed significant improvement in symptom scores and reduced medication use in 48% to 53% of patients. Weight increased significantly and in 89% J-tubes could be removed. The therapy was found generally safe and well tolerated, with improvement sustained for up to 10 years.
This study was reported in the December 2010 issue of the journal Clinical Gastroenterology and Hepatology. The Enterra therapy is approved by the US Food and Drug Administration (FDA) as a Humanitarian Device Exemption. Medtronic, the device manufacturer, partially funded this study.
(January 6, 2011) Rifaximin is an antibiotic currently under investigation for the treatment of non-constipation irritable bowel syndrome (Non-C IBS) and IBS-related bloating. Rifaximin works by reducing or altering bacteria in the gut. In studies it has been found to improve IBS symptoms of bloating, belly pain, and diarrhea (watery or loose stools) after a 10–14 day course of treatment. It is only slightly absorbed in the gut and is generally tolerated well. Rifaximin is not yet approved by the FDA for the treatment of IBS. Results from two Phase 3 clinical trials involving 1,260 non-constipated male and female patients with irritable bowel syndrome (Non-C IBS) were reported in the January 6, 2011 issue of the New England Journal of Medicine (NEJM) showing adequate relief of multiple IBS symptoms.
Find out more on this IFFGD web page.
(December 2, 2010) Solesta is a product under investigation for the treatment of incontinence, or loss of bowel control. It is a bulking agent that is injected into a part of the anal canal to improve bowel control. Solesta has been available in Europe since 2006, but is not yet approved by the U.S. FDA. On December 2, 2010 an FDA advisory panel voted 5-0, with one abstention, that the benefits of Solesta outweigh its risks. Solesta, which has been under development as a minimally invasive treatment for patients who have failed conservative therapy, is administered in an outpatient setting without the need for anesthesia.
Find out more on this IFFGD web page.
(November 30, 2010) With bipartisan support, the Senate today approved the biggest overhaul to U.S. food safety laws since the 1930s. The House already passed a similar version. There have been numerous past national outbreaks of food poisoning involving various products in which thousands of people were sickened and more than a dozen died. The legislation gives new authorities to the FDA, places new responsibilities on farmers and food companies to prevent contamination, and for the first time sets safety standards for imported foods. The Senate version includes an amendment that would exempt small farmers and those who sell directly to consumers at farmers markets and farm stands.
Source: Washington Post
(November 9, 2010) Here is a brief summary of research findings presented at the multi-disciplinary 6th Annual Research Day held at UNC, Chapel Hill, NC.
- Changes (reduced neurons/nerves) in areas of the body that control pain are observed in patients with histories of physical and emotional trauma (including war trauma), functional GI conditions, and chronic pain conditions. Targeted treatments using medications and psychological therapies may regrow these neurons in the brain and the intestines and reverse this process, thus improving symptoms. Doctors need to be aware of and sensitive to these issues in order to optimize treatment.
- Patients satisfaction with care received from their provider for functional GI conditions results in better communication and understanding, lower healthcare costs, and improved health results. There is need to understand the components of optimal care and widely inform healthcare practitioners.
- Pain is a trait that may be part heritable (genetic) and part environmental (injury, stress, infection, life events, chemical). Identifying genetic factors may lead to individualized treatments for functional GI conditions.
- Mitochondria are energy sources within cells. Mitochondrial dysfunctions are associated with diseases that are made worse by infection or stress. Maternal inheritance and mitochondrial dysfunction may be factors in functional GI conditions.
- Aging does not cause bowel incontinence, but factors which may accumulate over time can lead to incontinence.
- Treatment for kids with incontinence is often delayed due to parental misconceptions. Discussion with the child’s doctor and education is needed for parents to change misperceptions about the causes of incontinence.
- A simple physical digital examination combined with a balloon evacuation test can identify people with structural outlet obstruction, a significant cause of chronic constipation, without the need for extensive or further tests.
- Disease afflicts one person but affects many. IBS creates a degree of partner burden at least on a par with major organic diseases like cancer and dementia.
- Food borne GI infection (gastroenteritis) is common in the U.S. About 10–25% of gastroenteritis patients develop post-infectious IBS (PI-IBS).
- Both expressive writing (thoughts and feelings) and non-expressive writing (facts and details) is helpful in coping with IBS by those who accept this approach as therapeutic.
- Well designed training in mindfulness (techniques that induce a relaxed state calmly focused on the present moment – a quieting of the mind) may significantly reduce IBS symptom severity.
- One-third to one-half of patients with IBD also have IBS-like symptoms. Many patients with IBD are on narcotics for pain, even though use is associated with increased complication.
- Narcotic bowel syndrome (NBS) is a little recognized condition where use of narcotics (for pain treatment) actually results in worsening of pain over time. The syndrome is occurring more and more in the healthcare system among patients with non-malignant pain conditions. Detox is successful in nearly all patients with NBS, pain is significantly reduced, yet about half return to narcotic use. Public and provider education is needed about the risks of NBS.
- The commonly used patient care model based on acute care (for short-term illnesses that resolve with time or treatment) is not effective for chronic disease. A new, effective multi-component model for chronic functional GI conditions is needed.
Source: Research findings presented at the 6th Annual Research Day held in Chapel Hill, NC, sponsored by University of North Carolina, Center for Functional GI and Motility Disorders, in collaboration with Indiana University, Boston University, Tohoku University, and the University of Wisconsin.
(November 1, 2010) Linaclotide is a drug being studied to relieve symptoms of abdominal pain, discomfort, bloating, and bowel symptoms in people who have irritable bowel syndrome with constipation (IBS-C), or chronic constipation. It has proved safe and effective in trials, but is not yet FDA approved. Linaclotide works by increasing the amount of fluid that flows into the bowel, allowing stool to pass more easily. Positive results from the 2nd of two Phase 3 clinical trials were reported on November 1, 2010. At therapeutic doses, linaclotide acts locally in the gut. Exposure in the body outside the gut has not been detected.
Find out more on this IFFGD web page.
(September 26, 2010) Mid-September marked the 6-month milestone of enactment of the Patient Protection and Affordable Care Act – health care reform in the U.S. Several provisions went into effect, including:
- Prohibits insurers from retroactively canceling insurance coverage solely because an enrollee made an honest mistake on the insurance application.
- Prohibits insurers from denying coverage on parents' policy to children (up to age 19) who have a pre-existing condition.
- Prohibits insurers from imposing lifetime benefit caps.
- Requires insurers to allow young adults to stay on their parents’ policy until age 26.
Find out more on this IFFGD web page.
(May 25, 2010) The U.S. Food and Drug Administration (FDA) today warned consumers and health care professionals about a possible increased risk of fractures of the hip, wrist, and spine with high doses or long-term use of the class of medications called proton pump inhibitors (PPIs). The product labeling will be changed to describe this possible increased risk.
Findings from several studies have suggested the possibility of increased risk. What role PPIs might play is unclear and the presence of other co-existing risk factors may play a part. Further investigations continue. Meanwhile healthcare providers and consumers are being alerted to weigh the known benefits against the potential risks when deciding to use a PPI. Healthcare providers are urged to consider whether lower dosage and/or shorter duration of therapy would be adequate when prescribing a PPI to a patient.
Proton pump inhibitors work by reducing the amount of acid in the stomach. Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, Aciphex, and Vimovo are available by prescription to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus. Prilosec OTC, Zegerid OTC, and Prevacid 24HR are sold over-the-counter (OTC) for the treatment of frequent heartburn.
If you use a PPI talk to your doctor about risk factors and whether a lower dose or shorter duration of therapy would be appropriate for you.
Here is some guidance from the FDA to consumers:
- PPIs are effective in treating various GI disorders. Don’t stop taking your PPI unless told to do so by your doctor.
- An increased risk of fractures has been reported in some studies of patients using PPIs. The greatest increased risk for this was seen in patients who receive high doses of PPIs or use them longer (a year or more).
- If you buy a PPI over the counter (OTC), read and follow the directions on the Drug Facts label.
- OTC proton pump inhibitors should only be used as directed for 14 days for the treatment of frequent heartburn. No more than three 14-day treatment courses should be used in one year. If your heartburn continues, talk to your doctor.
- Talk to your doctor about any concerns you may have about using proton pump inhibitors.
Details are on this FDA web page.
Digestive Disease Week (DDW) is the largest annual gathering of researchers and clinicians investigating and treating digestive disorders. Here are some brief reports on preliminary data presented at 2010 meeting in early May. None of these findings have been published in a peer-reviewed journal.
- Obesity and Reflux
While obesity is associated with increased esophageal acid exposure in people with reflux, being heavy does not reduce the effects of proton pump inhibitors (PPIs) on acid exposure according to researchers.
- Pregnancy and Reflux
Researchers urged caution before using PPIs or H2 Blockers to control reflux in the first trimester of pregnancy because it may increase risk of babies being born with heart problems. They also urge that women take folic acid, a B vitamin, during this time noting that it decreases the risk.
- Chronic Constipation
The investigational drug linaclotide, which works by boosting intestinal fluid secretion, to relieve chronic constipation was effective and caused no unexpected safety issues in two phase 3 trials according to researchers. A significant difference in responder rates between active drug and placebo was the studies' primary endpoint.
The investigational antibiotic rifaximin met its primary endpoints for adequate relief of symptoms in two phase 3 trials in nonconstipational irritable bowel syndrome (IBS) showing modest improvement over placebo sustained for 10 weeks after treatment stopped according to researchers.
- IBS with Diarrhea
An investigational drug tested in early Phase 2a studies (LX1031) to treat irritable bowel syndrome by blocking serotonin synthesis appeared to significantly reduce pain and discomfort in some patients with diarrheal or mixed IBS according to the manufacturer.
Source: www.medpagetoday.com (Accessed May 11, 2010)
Early results from a study of more than 500 infants with egg or milk allergy indicate that they are highly likely to test positive for allergic antibodies that are specific to peanuts. This unexpected finding suggests that these infants are at risk for developing peanut allergy later in life. The researchers encourage parents of children with egg or milk allergy to talk to their doctor before incorporating peanuts or peanut products into their child's diet.
Source: National Institute of Allergy and Infectious Diseases (News Release. Accessed May 11, 2010)
A National Academy of Science Institute of Medicine committee report released on April 9, 2010 concluded, in part, that there is sufficient evidence for an association between deployment to the Persian Gulf War and gastrointestinal symptoms consistent with functional GI disorders such as irritable bowel syndrome and functional dyspepsia.
The committee also found sufficient evidence of a causal relationship for PTSD, for an association with other disorders such as substance abuse and anxiety disorders, and for an association with multi-symptom illness.
Functional gastrointestinal (GI) disorders (FGIDs) are among the many chronic disorders looked at in the 300 page report. FGIDs are described as recurrent or prolonged clusters of symptoms that occur together. They result from known disturbances in GI functioning and dysregulation of this GI function in signals between the brain and the gut.
Among the areas looked at, there is compelling emerging evidence for exposure to enteric pathogens (e.g., bacteria) during deployment leading to the development of post infectious IBS. Exposure to infectious agents normally causes acute (short term) GI infection (gastroenteritis). But exposure may trigger post infectious IBS when, occurring along with coexistent stress, such as from deployment to the Gulf War, the symptoms are sustained.
Among recommendations, the committee called for a focused effort to support high-quality clinical trials to assist VA and other healthcare providers in diagnosing and treating the health problems of Gulf War veterans and preventing illness in future veterans.
Source: IOM (Institute of Medicine). 2010. Gulf War and Health, Volume 8: Update of Health Effects of Serving in the Gulf War. Washington, DC: The National Academies Press.
Lactose intolerance is a digestive condition where symptoms of diarrhea, abdominal pain, gas, and/or bloating arise after ingesting lactose-containing foods and beverages. The symptoms are produced by malabsorption of lactose, a sugar found in milk and other dairy products.
Many people with lactose intolerance – or who mistakenly think they have lactose intolerance – avoid dairy products. These products are readily available sources of calcium, other nutrients, and vitamin D (when fortified). Not getting enough of these nutrients may increase the risk for chronic health problems, including osteoporosis and decreased bone health.
Symptoms of lactose intolerance are similar to those in some other digestive disorders such as IBS or inflammatory bowel disease. Some people have both lactose intolerance and another disorder like IBS. So diagnosis by a doctor is important to accurately determine what is wrong and how to best treat it.
A National Institutes of Health (NIH) Consensus Development panel was convened February 22–24, 2010 to assess the available evidence on lactose intolerance. The panel’s report reviews what is known about diagnosis, risk factors, treatment, and areas of research needed about this disorder.
The panel drafted its statement based on scientific evidence. The panel concluded that:
Lactose intolerance is a real and important clinical syndrome, but its true prevalence is not known.
The majority of people with lactose malabsorption do not have clinical lactose intolerance. Many individuals who think they are lactose intolerant are not lactose malabsorbers.
Many individuals with real or perceived lactose intolerance avoid dairy and ingest inadequate amounts of calcium and vitamin D, which may predispose them to decreased bone accrual, osteoporosis, and other adverse health outcomes. In most cases, individuals do not need to eliminate dairy consumption completely.
Evidence-based dietary approaches with and without dairy foods and supplementation strategies are needed to ensure appropriate consumption of calcium and other nutrients in lactose-intolerant individuals.
Educational programs and behavioral approaches for individuals and their healthcare providers should be developed and validated to improve the nutrition and symptoms of individuals with lactose intolerance and dairy avoidance.
What amount of daily lactose intake is tolerable in people with diagnosed lactose intolerance?
Among individuals appropriately diagnosed with lactose intolerance, differences in a variety of factors can greatly influence their susceptibility to develop intolerance symptoms. Differences in intensity of symptoms result from abdominal pain perception, and psychological impact of pain and social discomfort. Determining the amounts of lactose that can be tolerated is an important step in developing evidenced-based dietary recommendations that meet the needs of the individual.
The available evidence suggests that adults and adolescents who have been diagnosed with lactose malabsorption could comfortably ingest . . .
at least 12 grams of lactose (equivalent to 1 cup of milk) when administered in a single dose with no or minor symptoms
larger amounts of lactose if ingested with meals and distributed throughout the day
However, 50 grams of lactose (equivalent to 1 quart of milk) usually induces symptoms in those adults with lactose malabsorption when administered as a single dose without meals. For women with lactose malabsorption, tolerance to dietary lactose may improve during pregnancy but then worsen after delivery.
Some data suggest that the routine ingestion of lactose increases the amount of lactose that is tolerable in both adults and adolescents. There is no scientific evidence to identify the tolerable dose of lactose for children with lactose malabsorption.
The panel stressed the importance of additional scientific studies to better understand and manage lactose intolerance. Additional work needs to be done to improve the management of patients with IBS and a hypersensitive colon who also may have lactose intolerance.
The consensus statement is an independent report of the panel and is not a policy statement of NIH or the Federal Government.
Source: NIH Consensus Development Conference: Lactose Intolerance and Health. Draft Statement. February 24, 2010. (http://consensus.nih.gov/2010/images/lactose/lactose_draftstatement.pdf; Accessed Feb 26, 2010)
A recent study suggests that some bacteria thought to have "probiotic" benefit may have an unfavorable effect.
Probiotics are defined as: live microorganisms which when administered in adequate amounts confer a health benefit on the host.
Of the over 500 different intestinal bacteria that live in the digestive tract, some are believed capable of conferring a health benefit in people with digestive conditions. But only a few have been studied and most studies are small or of questionable design.
For example, one strain, Lactobacillus (L.) plantarum MF1298 was found to have the best in vitro probiotic properties of 22 strains of lactobacilli isolated from fermented food products. “In vitro” means studied in lab test tubes or petri dishes – not in people.
However, in a recently published study, a group of researchers from Norway looked at this strain in a small group of persons with IBS and found that it did not confer a health benefit in people. The main take-away point of the study is that not all strains that demonstrate probiotic benefit in vitro actually “confer a health benefit on the host” and their use may even be associated with unfavourable effects. L. plantarum MF1298 might be an unfavourable strain in people. This demonstrates the need for more research about probiotics.[Ligaarden 2010]
In the latest issue of our publication, Digestive Health Matters, you can find an in-depth article by researchers from the UNC Center for Functional GI and Motility Disorders in Chapel Hill to help you sort out when, why, and which probiotics may or may not be of health benefit for a functional GI disorder. Go »
Reference: Ligaarden SC,et al. A candidate probiotic with unfavourable effects in subjects with irritable bowel syndrome: a randomised controlled trial. BMC Gastroenterol. 2010 Feb 10;10(1):16. [Epub ahead of print] (Accessed on www.biomedcentral.com Feb 13, 2010)
Do genetic differences put some people more at risk for developing IBS? After about 2,300 people in Walkerton, Ontario developed GI infections from drinking contaminated water a decade ago, more than 1 in 3 (36%) developed IBS. Why did some develop the condition while others did not?
When IBS occurs after a sudden bout of infection in the stomach and intestines it is known as post-infectious (PI) IBS. Risk factors noted in the past for developing PI-IBS include the severity of the initial illness; host factors at the time of infection; and the harmfulness of the infecting organism.
In a study to be published in the March issue of the journal Gastroenterology, a group of investigators from Canada looked at whether there might be a genetic difference that could make some of the people in Walkerton more susceptible to developing IBS. They studied data from infected individuals, comparing 228 who reported PI-IBS with 581 who did not develop PI-IBS.
The researchers in this study found variations in certain genes that might increase the risk of developing PI-IBS.
Source: Vallini A-C, et al. Genetic risk factors for post-infectious irritable bowel syndrome following a waterborne outbreak of gastroenteritis. Gastroenterology. Article in Press. 2010.
(Jan 15, 2010) McNeil Consumer Healthcare and the U.S. Food and Drug Administration (FDA) notified healthcare professionals of an expansion of a December 2009 recall that involved Tylenol Arthritis Pain Caplet 100 count bottles. McNeil Consumer Healthcare has now applied broader criteria to identify and remove all product lots that it believes may have the potential to be affected, even if they have not been the subject of consumer complaints.
The voluntarily recall involves certain lots of OTC products in the Americas, the United Arab Emirates (UAE), and Fiji including certain Motrin, Benadryl, Tylenol, Rolaids, Simply Sleep, and St. Joseph Aspirin products for children as well as adults.
Find specifics and a link to a complete list of the products involved at this FDA page
Research studies in the United States and Europe show that celiac disease (an immune reaction to gluten, a protein found in wheat, rye, and barley) is four times more common today than a half-century ago. The increase cannot be a result of changes in the genetic factors that underlie celiac disease. Plus our consumption of wheat is less than it was a century ago. They theorize that the increase may be due to:
- An environmental change, most likely a change involving the grain in our diets. Wheat itself has undergone extensive hybridization as a crop and undergoes dramatic changes during processing. This involves oxidizers, new methods of yeasting, and other chemical processes. No one knows what effect these changes may have on the immune system.
- Another factor may be the “hygiene hypothesis.” This theory proposes that the developing immune system has to be stimulated by exposure to infectious agents, bacteria, or parasites in order to develop properly. An increasingly clean environment reduces the number of factors that challenge and stimulate the developing immune system, making infants and children more susceptible to immune disorders and allergic diseases. This may account, in part, for the increases observed not only in celiac disease, but in other allergies and immune disorders.
“Diet, hygiene, and multiple environmental factors that interact to trigger the onset in people who are genetically predisposed may play a role in the increase. “The increasing prevalence makes it more important that health care providers and patients are alert to the possibility of celiac disease,” said Joseph Murray, M.D., professor of medicine at the Mayo Clinic in Rochester, MN.
Source: NIH Publication No. 10–6246, November 2009.
In a study reported at the 2009 Annual ACG Meeting, using data available from 433 Gulf War veterans with and without IBS, researchers looked at the prevalence of non-intestinal symptoms. Those with IBS had a high prevalence of disorders such as headache, insomnia, fatigue, stiffness, joint pains, dizziness and weakness.
The researchers concluded these symptoms were not explained by psychological disorders. Rather, the results suggest a dysfunction in systems throughout the body.
Source: Tuteja A, Tolman K, Stoddard G, Talley N, Verne N. Extra-intestinal Symptoms in Gulf War Veterans with Irritable Bowel Syndrome (Abstract Poster 1147; ACG 2009)
Dietary changes are often the first treatment suggested to patients with irritable bowel syndrome (IBS). The addition of dietary fiber is most common. A recent study looked at how effective dietary fiber is to treat IBS symptoms. Soluble fiber (psyllium) was compared to insoluble fiber (bran).
A total of 275 persons diagnosed with IBS were assigned to 12 weeks of treatment. They were treated with either psyllium, bran, or placebo to see if they experienced adequate symptom relief during at least 2 weeks in the previous month. Results were analyzed after 1, 2 and 3 months of treatment.
A total of 164 persons completed the study. The greatest dropout rate occurred during the first month of the study among the bran group. This is thought due to worsening of IBS symptoms.
Researchers found that after 3 months of study, mean symptom severity (on the IBS Symptom Severity Score) improved by 34% in the psyllium group, 22% in the bran group, and 18% in the placebo group.
The study concluded, "The addition of soluble fiber (psyllium) but not insoluble fiber (bran) was effective in the clinical management of patients with IBS in primary care. Bran may worsen symptoms of IBS, especially at the beginning of treatment and should be advised only with caution.”
Source: Bijkerk, CJ, de Wit, NJ, Muris, JW, Whorwell, PJ, Knotternus, JA, Hoes AW. Soluble or insoluble fibre in irritable bowel syndrome in primary care? Randomised placebo controlled trial. BMJ (2009) Aug 27;339:b3154.
In a study that looked at data from 1,659 patients with reflux symptoms, researchers at the University of Southern California (USC) found a link between obesity and GERD. GERD is a condition which develops when the back-flow (reflux) of stomach contents causes troublesome symptoms and/or complications.
Compared to patients with normal weight, obese patients were more than twice as likely to have a defective LES, the muscle that acts as a valve to prevent acid reflux. The study concluded that increasing weight is strongly linked to the degree of acid exposure in the esophagus.
Diets high in volume, fat, and calories have been shown to increase esophageal acid exposure. The same dietary habits may promote both obesity and GERD.
Weight loss therapy has reduced obesity-related conditions such as diabetes and heart disease. The possibility that weight loss may also reduce complications of GERD needs to be studied.
Source: Ayazi S, Hagen JA, Chan LS, et al. Obesity and gastroesophageal reflux: quantifying the association between body mass index, esophageal acid exposure, and lower esophageal sphincter status in a large series of patients with reflux symptoms. J Gastrointest Surg (2009) 13:1440–1447.
A significant proportion of IBS patients report gastroesophageal reflux disease (GERD) symptoms, and likewise, a significant proportion of GERD patients report irritable bowel syndrome (IBS) symptoms. The reason(s) for this is unknown.
One principal theory suggests that the two common conditions overlap. This theory is supported by genetic studies and similarities in gastrointestinal sensory-motor abnormalities. The high overlap rate may be due to similar underlying GI dysfunction.
Another theory suggests that IBS-like symptoms are part of the spectrum of GERD signs and symptoms affecting different levels of the GI tract. This theory is supported primarily by studies demonstrating improvement of IBS-like symptoms in some GERD patients receiving anti-reflux treatment.
Or it may be that a recently growing interest in the full range of GERD symptoms, including those that are unusual and outside the esophagus, is leading to the recognition that lower abdominal symptoms may also be encountered in patients with GERD.
Source: Gasiorowska A, Poh CH, Fass R. Gastroesophageal reflux disease (GERD) and irritable bowel syndrome (IBS)—is it one disease or an overlap of two disorders? Dig Dis Sci (2009) 54:1829–1834.
A number of researchers have been looking at whether probiotics might improve symptoms of IBS. Probiotics are live micro-organisms found in foods and supplements that can have a beneficial effect.
A group of investigators conducted an independent comprehensive review of literature, published in English, reporting on randomized controlled trials that have looked at the effectiveness, safety, and tolerability of probiotics in the treatment of IBS. The review study selection criteria included randomized controls, adults diagnosed with IBS, single or combination probiotic compared to placebo, and improvement in IBS symptoms.
Of 16 randomized controlled trials that appeared to meet initial selection criteria, 11 studies were suboptimal in design (e.g., inadequate blinding, length, size). After carefully assessing the methods and designs of all the studies reviewed, only one probiotic (B. infantis 35624) showed repeated efficacy, with improvements noted in bloating, pain or discomfort, and bowel habit. However, the two studies performed with this probiotic were of short duration and longer studies are needed.
The remaining studies were limited by inadequate study design and reporting of the data. The low quality of most of the studies made it difficult to determine whether or not other probiotics may be of clinical benefit.
The review study concluded that B. infantis 35624, based on current evidence, appears to be an effective treatment for some people with IBS. Other probiotics may prove beneficial in the future, but well designed studies are needed first.
[To find out more about probiotics (and antibiotics) in the treatment of IBS go to this IFFGD web page.]
Source: Brenner DM, Moeller MJ, Chey WD, Schoenfeld PS. The utility of probiotics in the treatment of irritable bowel syndrome: a systematic review. Am J Gastroenterol. 2009 Apr;104(4):1033-49.
Dietary changes are often considered first-line treatment in public health diseases that apply to many gastrointestinal (GI) disorders. In general, different foods and beverages may change GI motor and sensory functions, and may provoke GI symptoms. However, the role of food in functional GI disorders remains controversial. Moreover, any link between symptoms and food intake, if any, is likely to differ among persons and may vary over time for the same person.
A study by a group in Sweden looked at dietary habits and changes in food and beverage intake in relation to GI symptoms reported by identified irritable bowel syndrome (IBS) patients compared with a control population, and whether any differences between males and females were observed in these respects.
The IBS patients were recruited from Swedish primary healthcare centers on the basis of diagnoses stored in computerized medical records. A total of 515 IBS patients between the ages of 18–65 were identified during a 5-year period (1997-2001). Among the IBS patients, 14% had IBS with constipation, 31% IBS with diarrhea, and 55% mixed IBS with constipation/diarrhea. A control group of 4,500 people were randomly selected from the general population. All participants were sent a questionnaire with specific questions about self-reported food and beverage increase or decrease of GI symptoms and self-reported changes in dietary habits. Less than 1% of the study population reported lactose or gluten intolerance.
Dietary changes in general because of GI problems were reported among one-half (51%) of the female IBS patients and among nearly one-third (31%) of male IBS patients. Significantly fewer females and males in the control group reported dietary changes because of GI problems. Good or very good improvement of their GI symptoms because of dietary changes was reported by more than 1 in 3 (39%) of the female patients and 1 in 4 (24%) of the male IBS patients. Among the control group, about 1 in 10 or less (11% of females and 7% of males) reported improvement of their GI symptoms because of dietary changes.
The study concluded that female IBS patients reported more changes in their dietary habits because of their GI problems than men with IBS compared with controls. The majority of both women and men that changed their dietary habits because of GI problems reported improvement in their symptoms. Dietary advice because of functional GI problems could possibly be different for female and male IBS patients in primary care.
Several foods were reported to cause more GI complaints among both female and male IBS patients compared with the controls. These included fatty food (including fast food), certain vegetables (mainly onion, garlic, beans, peas, cabbage, pepper, or cucumber), coffee or tea, dairy products, and eggs.
[To find out more about diet and IBS go to this IFFGD web page.]
Source: Faresjö A, Johansson S, Faresjö T, Roos S, Hallert C. Sex differences in dietary coping with gastrointestinal symptoms. Eur J Gastroenterol Hepatol. 2009 Jun 22. [Epub ahead of print]
Serotonin (5-HT) is a key modulator of gastrointestinal sensory and motor function. Many patients have IBS that can be difficult to treat, which has led to the development of newer agents, such as 5-HT3 antagonists and 5-HT4 agonists.
A systematic review and meta-analysis of randomized controlled trials (RCTs) was conducted to estimate the efficacy of all available 5-HT agents in IBS. Trials recruiting adults with IBS in primary, secondary, or tertiary care comparing 5-HT3 antagonists or 5-HT4 agonists with placebo were eligible. A total of 29 RCTs were eligible for inclusion; trial quality was high.
The authors concluded that alosetron, a 5-HT3 antagonist, and tegaserod, a 5-HT4 agonist (and cilansetron, a 5-HT3 antagonist) were shown to be more effective than placebo in the treatment of IBS. Despite concerns regarding serious adverse events, which were rare in the trials identified, they are effective drugs in IBS, and their use should be considered, where availability allows, for patients who have failed conventional first- or second-line therapies.
The authors noted that while the drugs seem to have only a modest efficacy in the treatment of IBS, they may be of use in individual patients, particularly those who have failed other therapies. The risk-benefit ratio needs to be considered carefully before they are prescribed. The FDA considers the risks severe enough to require that their use be restricted. The authors compared this situation with that of NSAIDs (non-steroidal anti-inflammatory drugs), which are only modestly effective pain relievers (analgesics). The use of these agents is associated with an increased risk of heart attack (myocardial infarction), in addition to the well-established risks of GI bleeding. They stated that the absolute magnitude of the risk of serious adverse events with NSAIDs is undoubtedly higher than for 5-HT3 antagonists and 5-HT4 agonists, yet the use of NSAIDs remains entirely unrestricted, and in most countries they are freely available for purchase over-the-counter.
The application of consistent criteria to drug availability may allow a more generalized use of 5HT3 antagonists and 5HT4 agonists for IBS, as high-quality trials show that they are low risk, and are moderately effective in IBS, a disorder that is difficult to treat.
Source: Ford AC, Brandt LJ, Young C, Chey WD, Foxx-Orenstein AE, Moayyedi P. Efficacy of 5-HT3 antagonists and 5-HT4 agonists in irritable bowel syndrome: systematic review and meta-analysis. Am J Gastroenterol. 2009 May 26. [Epub ahead of print]
Those affected by IBS are well aware of how severely symptoms can impact their lives. In the general community, however, IBS severity is often underappreciated. Yet treatment decisions by patients and their doctors or therapists are based on severity. Furthermore, investigators in treatment trials need to be able to measure severity when developing drugs. Lacking objective measures, severity must be based on patient experience.
The Rome Foundation and IFFGD collaborated to conduct focus groups to understand the patient’s experience of IBS and the factors that contribute to severity. Using standardized focus group assessment, this qualitative study looked at 16 participants in 3 groups with moderate to severe IBS symptoms. The groups were divided into IBS with mixed bowel patterns, IBS with diarrhea, and IBS with mixed and constipation.
In summary, pain and bowel symptoms were reported by all. Other common symptoms included bloating, nausea, and muscle pains. The participants reported disruption and restrictions on daily functioning related to symptoms. These restrictions were imposed on daily living even when the symptoms were not present due to their uncertain and unpredictable nature. Frustrations with inability to control symptoms and feelings of social isolation were common. Avoidance of activities, emotional withdrawal and fatigue were reported. Yet despite all the difficulties, most participants were optimistic that new treatments would be found. All valued peer support.
Severity was linked to health related quality of life (HRQOL). HRQOL covered a wide range of experiences, not just symptoms. The study confirms the diverse nature of IBS in terms of its symptoms and impact on patient thoughts, feelings, and behaviors. All these factors contribute to health status and illness severity regardless of the stool subtypes. These qualitative data provide a basis for assessments in larger studies.
Source: Drossman DA, Chang L, Schneck S, Blackman C, Norton WF, Norton NJ. A focus group assessment of patient perspectives on irritable bowel syndrome and illness severity. Dig Dis Sci. 2009 Apr 1. [Epub ahead of print]
(Feb 11, 2009) Here is information provided by the U.S. Food and Drug Administration about the nationwide salmonella outbreak linked to certain peanut products. Go »
(Dec 22, 2008) An American College of Gastroenterology (ACG) Task Force on Irritable Bowel Syndrome has completed a series of evidence-based systematic reviews of previously published studies looking at the diagnosis and treatment of irritable bowel syndrome (IBS). The resulting report, “An Evidence-Based Position Statement on the Management of Irritable Bowel Syndrome” was published in a Supplement to The American Journal of Gastroenterology, (Volume 104, Supplement 1, January 2009).
We previously reported the preliminary findings of the Task Force in the Winter 2008 issue of Digestive Health Matters. Here, now, is a summary of highlights from the final report.
Burden of Illness
The Task Force recognized that while IBS occurs more often in women, it is significant in men as well. Particularly, IBS is recognized to be a key component of the multi-symptom Gulf War Syndrome affecting soldiers (a predominantly male population) deployed in the 1991 Gulf War.
The Task Force reported a significant burden of illness imposed by IBS on the sufferer and on the community. Compared to patients without IBS, patients with IBS:
- visit the doctor more frequently,
- use more diagnostic tests,
- consume more medications,
- miss more workdays,
- have lower work productivity,
- are hospitalized more frequently, and
- consume more overall direct costs.
Patients with IBS have a lower health related quality of life compared with persons without IBS. The Task Force reported that in some persons, this diminished quality of life impact increases the risk of suicidal behavior.
It is important for doctors to be aware of the burden that IBS symptoms can place on patients. Bothersome symptoms that impair daily functioning need to be discussed and treated.
The Statement describes IBS as a common disorder defined by abdominal pain or discomfort that occurs in association with altered bowel habits over a period of at least 3 months. No biochemical markers or structural abnormalities are present on which to make a diagnosis. Instead, there are typical symptoms on which to base the diagnosis (symptom-based criteria).
The Task Force reported that little formal testing is necessary to diagnose IBS when the symptom-based criteria are met and in the absence of “alarm” features – such as anemia, (unexplained) weight loss, and a family history of colorectal cancer, inflammatory bowel disease, or celiac sprue.
However, they noted that in IBS patients where diarrhea or mixed diarrhea/constipation is the predominant bowel symptom a blood test for celiac sprue is in order (a positive test should be confirmed by a biopsy). Celiac sprue has been seen to occur more often in persons with IBS than in otherwise healthy controls.
Treatment and Management
Recommendations in the report were graded based on a system to indicate the strength of evidence. They were classified based on:
- strong (grade 1), or
- weak (grade 2),
Strength of evidence
- strong (level A),
- moderate (level B), or
- weak (level C).
Of interest in the review were a number of agents used to treat IBS which were shown to be more effective than placebo. Not everyone will be helped by these agents and individual responses will vary. Always be sure to ask your doctor about possible side effects, which can occur with any treatment. Here are some of the therapies included in the findings for the treatment of IBS:
- Ispaghula husk (psyllium), a soluble fiber, is moderately more effective than placebo in improving bowel function (bran, an insoluble fiber, is no better than placebo). Bloating is a possible side effect. (Grade 2C)
- Laxatives have been studied in patients with chronic constipation, but there are no published placebo-controlled, randomized studies of laxatives in IBS.
- Certain antispasmodic agents (such as hyoscine, cimetropium, pinaverium) (Grade 2C) and some peppermint oil preparations (Grade 2B) may provide short-term relief for abdominal discomfort; data on long-term effects are lacking. [Note: Peppermint oil capsules must be swallowed whole because the raw oil can cause intense heartburn.] Much of the data is old and of poor quality. Evidence for safety and tolerability is limited.
- The antidiarrheal loperamide (e.g., Imodium, Imotil) may reduce stool frequency and improve consistency, but is no better than placebo in treating pain, bloating, or overall symptoms of IBS. There are no randomized controlled trials comparing loperamide with other antidiarrheal agents and safety and tolerability data on loperamide are lacking. (Grade 2C)
- The gut-selective antibiotic rifaxamin (Xifaxan), currently FDA approved for the treatment of travelers’ diarrhea, may reduce overall IBS symptoms, especially bloating, with short-term dosing, although symptom recurrence is common. In 3 well-designed, randomized, placebo-controlled Phase II trials that evaluated 545 patients with IBS, rifaximin was shown to provide statistically significant improvement in overall IBS symptoms, particularly where bloating or diarrhea are the predominant bowel symptoms. There are no data available to support the long-term safety and effectiveness of rifaximin for the management of chronic IBS symptoms. Any recommendation regarding continuous or intermittent use of this agent in IBS must await further, long-term studies. (Grade 1B)
- Probiotic products based on Bifidobacteria and certain combinations of probiotics have shown some benefit to relieve pain and bloating. Study designs had limitations and were short-term. (Grade 2C)
- Lactobacillus-based probiotics have not shown to be effective for patients with IBS.
- Alosetron (Lotronex) may reduce overall IBS symptoms when diarrhea is the predominant bowel symptom in males (Grade 2B) and females (Grade 2A). In 8 large, well-designed clinical trials that evaluated alosetron use in 4,840 patients, this drug has demonstrated superiority over placebo for abdominal pain, urgency, overall IBS symptoms, and diarrhea-related complaints. Review of the clinical and post-marketing surveillance data from IBS patients and the general population confirmed a greater incidence of severe complicated constipation and ischemic colitis in patients taking alosetron, however, the incidence of these events was low, with a rate of 1.1 cases of ischemic colitis and 0.66 cases of complicated constipation per 1,000 patients-years of alosetron use. Because of this risk, it is available to women only through a special access program. [Note: As a measure of comparison, the risk of major bleeding from taking 80 mg of aspirin per day is 1 to 2 cases per 1,000 patient-years of treatment. (Dalen, JE. Aspirin to prevent heart attack and stroke: what’s the right dose? Am J Med. 2006 Mar;119(3):198-202. )]
- Tegaserod (Zelnorm) may reduce overall IBS symptoms in females when constipation is the predominant bowel symptom (Grade 1A) or when mixed diarrhea/constipation is the predominant bowel symptom (Grade 1B). Diarrhea is the most common side effect; and a small number (0.11%) of cardiovascular events were reported among patients who had received tegaserod in clinical trials. The drug is not available for use in North America.
- Lubiprostone (Amitiza) in a dose of 8 mg twice daily may reduce overall IBS symptoms, especially in women when constipation is the predominant bowel symptom. The drug should not be used in patients with bowel obstruction, preexisting diarrhea, or in pregnant women and use of a contraception is advised while taking the drug. (Grade 1B)
- In the antidepressant class of drugs, selective serotonin receptor antagonists may reduce pain and overall symptoms of IBS when constipation is the predominant bowel symptom; low dose tricyclic agents may reduce pain and overall symptoms of IBS when diarrhea is the predominant bowel symptom. The use of this drug class for treatment of IBS symptoms is not linked to depression, but rather likely to effects on the brain and the gut. (Grade 1B)
- Psychological therapies, including cognitive therapy, dynamic psychotherapy, and hypnotherapy, but not relaxation therapy, are more effective than usual care in relieving overall symptoms of IBS (Grade 1B). There are no known serious adverse events associated with these therapies; however, their mechanisms of benefit remain unclear.
Source: Brandt L, et al. An evidence-based position statement on the management of irritable bowel syndrome: american college of gastroenterology IBS task force. Am J Gastroenterol 2008; 104: S1-S34.
A review of existing studies, by Kligler and Cohrssen, published by the American Academy of Family Physicians, looked at evidence for the use and effectiveness of probiotics. Probiotics are live microorganisms that benefit the health of the host when administered in adequate amounts. Several mechanisms have been proposed to explain the actions of probiotics. In most cases, it is likely that more than one mechanism is at work simultaneously.
Most of the identified benefits of probiotics relate to GI conditions.
The most consistent studies providing good-quality patient-oriented evidence found that:
- Probiotics may reduce the incidence of antibiotic-associated diarrhea, and
- Probiotics may reduce the duration and severity of acute infectious diarrhea.
Additionally the reviewers report, based on only small studies to date which provide less consistent or limited patient-oriented evidence, that:
- Probiotics (Bifidobacteria) may reduce symptoms of irritable bowel syndrome, particularly the severity of abdominal pain and bloating.
Significant adverse effects were rare. Side effects, reported now and then, included flatulence or mild abdominal discomfort. A variety of species were commonly used (including Lactobacillus sp., Bifidobacterium sp., S. thermophilus, and S. boulardii).Probiotics are generally sold as capsules, powder, tablets, liquid, or are incorporated into food. Typical dosages vary based on the product, but common dosages range from 5 to 10 billion colony-forming units (CFUs) per day for children, and from 10 to 20 billion colony-forming units per day for adults.
Source: Kligler B, Cohrssen A. Probiotics. Am Fam Physician. 2008;78(9):1073-1078.
A gut diverticulum (singular) is an outpouching of the wall of the gut to form a sac. Diverticula (plural) may occur at any level from esophagus to colon. In Western societies, half the population will develop at least one, usually a few dozen diverticula, by age 60.
Uncomplicated diverticular disease is called diverticulosis and most individuals who possess colonic diverticula have no symptoms and are unaware of them. Nevertheless, colonic diverticula (one of many) can occasionally become the source of serious illness. These few may bleed or perforate thus becoming complicated diverticular disease.
Physicians usually advise individuals with diverticular disease to avoid nuts, seeds, popcorn, corn and other high-fiber foods.
Is eating nuts and other high fiber foods associated with diverticular complications? A study by Strate, et al examined the association between nut, corn, and popcorn consumption and complicated diverticular disease. Information was gathered through the Health Professionals Follow-Up Study (HPFS). HPFS is sponsored by the Harvard School of Public Health and is funded by the National Heart, Lung, and Blood Institute and National Cancer Institute. The study began in 1986. The purpose of the study is to evaluate a series of hypotheses about men’s health relating nutritional factors to the incidence of serious illnesses. This all-male study is designed to complement the all-female Nurses’ Health Study, which examines similar hypotheses.
As a part of this study, men reporting newly diagnosed diverticulosis or diverticulitis were mailed supplemental questionnaires. The study included 47,228 men aged 40 to 75 years who at baseline were free of diverticulosis or its complications, cancer, and inflammatory bowel disease and returned a food frequency questionnaire. During 18 years of follow-up (1986 to 2004), there were 801 incident cases of diverticulitis and 383 incident cases of diverticular bleeding.
In this study no associations were seen between corn consumption and diverticulitis or between nut, corn, or popcorn consumption and diverticular bleeding or uncomplicated diverticulosis. In this large study of men without known diverticular disease, nut, corn, and popcorn consumption did not increase the risk of diverticulosis or diverticular complications. The authors concluded that recommendations to avoid these foods to prevent diverticular complications should be reconsidered.
[For more information about diverticulosis and diverticular disease, see IFFGD fact sheet #169, Diverticula, Diverticulosis, Diverticulitis: What’s the Difference? and fact sheet #176, Nuts, Seeds, and Diverticula.]
Source:  Strate LL, Liu YL, Syngal S, Aldoori WH, Giovannucci EL. Nut, corn and popcorn consumption and the incidenceof diverticular disease. JAMA, August 27, 2008–Vol 300, No 8;907-914.
People with Crohn’s disease (CD) are seven-fold more likely to have in their gut tissues the bacterium that causes a digestive-tract disease in cattle called Johne’s disease. The role this bacterium may or may not play in causing CD is a top research priority. A report from the American Society for Microbiology (ASM) points out that the cause of Crohn’s disease is unknown, and the possible role of this bacterium, which could conceivably be passed up the food chain to people, has received too little attention from the research community. The ASM is the oldest and largest single life science membership organization in the world. To view the report Go ».
Source: American Academy of Microbiology (AAM) colloquia report publications (August 2008).
Elucidating Risk Factors for Barrett's Esophagus
Scientists report that extra abdominal fat may be a risk factor for Barrett’s esophagus. Barrett’s esophagus is a precancerous condition where the cells lining the esophagus change in shape and organization. Short of surgical removal of the esophagus, there is no effective cure for the condition. Known risk factors for Barrett’s esophagus include being male, Caucasian, or over the age of 40. Individuals with gastroesophageal reflux disease (GERD), in which stomach acid flows backward into the esophagus, also are at increased risk of developing Barrett’s esophagus. In turn, the condition puts patients at greater risk of developing esophageal adenocarcinoma, which is rapidly increasing in the United States. Therefore, research to further understanding of the risk factors for Barrett’s esophagus may yield information that also would provide insight into the development of esophageal adenocarcinoma.
Scientists recently examined the association between obesity and abdominal girth and the occurrence of Barrett’s esophagus and GERD. Obesity is thought to be a risk factor for GERD, and extra abdominal fat could directly promote acid reflux by placing added pressure on the stomach. Obesity was determined using body mass index (BMI), a measure that takes both height and weight into account, and abdominal girth was measured simply as waist size. In this study, while there was no association of BMI with Barrett’s esophagus, larger abdominal circumference was moderately associated with the condition. The association was strongest in individuals with no GERD symptoms. When GERD symptoms were included in the analysis, the association between abdominal girth and Barrett’s esophagus was decreased, which was expected as GERD symptoms may partly mediate the effect of abdominal girth in the development of Barrett’s esophagus. These data suggest that larger abdominal girth may be a risk factor for both GERD and Barrett’s esophagus. Although the mechanism by which extra abdominal fat raises the risk of these conditions is unknown, it could act by increasing pressure on the stomach and contributing to GERD symptoms through effects on gastrointestinal mobility. The results of this research suggest that larger abdominal circumference, but not overall obesity, is a risk factor for Barrett’s esophagus. Based on these findings, reduction of waist size may be advisable for patients at high risk of developing this condition or subsequent esophageal carcinoma.
– Corley DA, Kubo A, Levin T, Block G, Habel L, Zhao W, Leighton P, Quesenberry C, Rumore GJ, and Buffler PA: Abdominal obesity and body mass index as risk factors for Barrett’s esophagus. Gastroenterology 133: 34-41, 2007.
Source: NIDDK Recent Advances & Emerging Opportunities: Digestive Diseases and Nutrition, January 2008.
Narcotics are drugs, usually opiates such as morphine or oxycodone, which can relieve pain. In the U.S. narcotics are commonly prescribed for treating patients with pain, usually injuries, sudden painful conditions, or cancer. However, persons with chronic functional GI disorders should not be treated with narcotics, though this may at times be done. We are learning that under some circumstances, the use of narcotics can actually cause pain. Over time, narcotics can make nerves more sensitive, and make pain worse; they also can slow the bowel, and lead to symptoms of constipation, bloating, or nausea. This relates to the well known effects of narcotics on the bowel, opiate bowel dysfunction.
In a review article by a group from the University of North Carolina, a subset of opiate bowel dysfunction called narcotic bowel syndrome (NBS) is described. This under-recognized syndrome may be becoming more prevalent because of increasing use of narcotics for chronic painful disorders as well as lack of awareness that increased sensation to pain may be caused by long-term narcotic use. The syndrome is characterized by chronic or periodic abdominal pain that gets worse when the effect of the narcotic drug wears down. In addition to pain, which is the primary feature, other symptoms may include nausea, bloating, periodic vomiting, abdominal distension, and constipation.
The UNC group has developed the following diagnostic criteria for narcotic bowel syndrome:
Chronic or frequently recurring abdominal pain that is treated with acute high-dose or chronic narcotics and all of the following:
- The pain worsens or incompletely resolves with continued or escalating dosages of narcotics;
- There is marked worsening of pain when the narcotic dose wanes and improvement when narcotics are re-instituted (soar and crash);
- There is a progression of the frequency, duration, and intensity of pain episodes;
- The nature and intensity of the pain is not explained by a current or previous GI diagnosis.
The key to diagnosis is the recognition that long-term or increasing dosages of narcotics lead to continued or worsening symptoms rather than benefit.
The UNC group has also developed a treatment approach. The narcotic is withdrawn and substituted with effective alternative medications to help manage the pain and the bowel symptoms until the narcotics are removed from the system. This requires the doctor and patient working closely together. The doctor must take time to explain the condition, the reasons for withdrawing the narcotics, and the alternative treatment plan. The treatment process may take several weeks or months to implement satisfactorily, with the doctor staying in touch with the patient during this period.
Source: Grunkemeier DMS, Cassara JE, Dalton CB, Drossman DA. The narcotic bowel syndrome: clinical features, pathophysiology, and management. Clin Gastroenterol Hepatol 2007;5:1126-1139.
Constipation is a common pediatric problem. To assist health care professionals who care for children with constipation, the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) previously published a clinical guideline based on an integration of medical evidence with expert opinion. To evaluate studies published since then, the NASPGHAN Constipation Guideline Committee performed a comprehensive and systematic review of the medical literature since 1997, to identify, review and rate the quality of new evidence. Based on this review, the recommendations of the original clinical guideline were reaffirmed with several modified according to the new evidence. Among the updates reported:
Source: North American Society for Pediatric Gastroenterology, Hepatology and Nutrition. Evaluation and treatment of constipation in children: summary of updated recommendations of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition. J Pediatr Gastroenterol Nutr. 2006 Sep;43(3):405-7. Review.
- There are conflicting reports on the value of fiber for constipated children. Some studies find that constipated children are consuming less fiber than unaffected children; other studies find constipated children are consuming more fiber; and still others find no difference. The society recommends that further studies are needed before it can make a recommendation one way or the other.
- Polyethylene glycol 3350 (PEG 3350) is an osmotic laxative which has been found to help disimpaction in constipated children. However, before it can recommend this laxative for use in babies the society recommends further safety studies.
- The society has reviewed studies looking at biofeedback to help improve symptoms of constipation in children. No study showed long-term improvement; however, short-term improvements (about three months in length) were seen. The society recommends that biofeedback therapy can be an effective short-term treatment in some patients.
- Studies looking at the effect of cow’s milk in the diet show mixed results. The society recommends that in children whose constipation does not improve on standard medical and behavioral management, it is worth considering a short trial of a cow’s milk-free diet to see if symptoms improve.
There is a common belief that allergy contributes to constipation or irritable bowel syndrome (IBS) with symptoms of constipation. However, reports have not been able to conclusively show that restricting allergens from a diet improves IBS or constipation symptoms. This study from Italy of children aged 3–13 years tried to find an answer looking in the other direction, by looking at whether children with demonstrated allergies – such as asthma, eczema, or food allergy – are more prone to have constipation or IBS. A group 196 children with allergic symptoms were enrolled and compared to a second group 127 nonallergic children as controls. Both groups were tested for allergies to a wide range of common food and other allergens, using a rigorous test called a skin prick test (SPT). Using a symptom questionnaire based on the Rome criteria for functional gastrointestinal disorders, the occurrence of constipation was found to be similar in both groups. IBS was found in 6.6% of the allergic children and in 6.3% of the nonallergic controls.
The study found that allergic children were not more likely than nonallergic children to have IBS or constipation symptoms. It was found that children who had at least one SPT allergic reaction to a food item were more likely to have IBS than children with no reaction to the food SPTs. The study concludes that children with allergies do not need to fear increased chances of developing IBS, but if they have positive SPT tests to food, they should also be examined for the presence of IBS symptoms.
Source: Caffarelli C, Coscia A, Baldi F, Borghi A, Capra L, Cazzato S, Migliozzi L, Pecorari L, Valenti A, Cavagni G. Characterization of irritable bowel syndrome and constipation in children with allergic diseases. Eur J Pediatr. 2007 Mar 8; [Epub ahead of print]
This study from Brazil reviewed current research (2000–2006) on food allergies in children. Their primary conclusion is that food allergies are very often over-diagnosed. Other specific findings include:
- Diagnoses of allergic diseases, and especially allergies to food, have increased in the last 20 years or so.
- Children are much more likely to be diagnosed as having food allergies than adults.
- Food intolerance is often mistaken for food allergy. Food intolerance occurs when the body cannot adequately digest a portion of a particular food. Food allergy is an immune system response where the body creates antibodies as a reaction to certain food.
- Patients and their families are known to overestimate their own food allergies. In one study of 500 newborn babies, 28% of them were thought to have food allergies by their parents. However, a rigorous test for food allergies found that only 6% had a reaction to the suspect food.
- Elimination diets (a doctor-supervised diet in which a specific food or ingredients is removed from the diet to test whether symptoms disappear in the absence of the suspect food item) is not always a reliable test for true food allergy. The recommended diagnostic procedure is skin testing followed by IgE antibody testing.
- Currently, the only strategy for managing a food allergy is a diet with total elimination of the offending food item. To prevent malnutrition or other ill effects, these diets must be supervised by a physician.
- Most parents are unable to identify common allergic food ingredients on product labels, so any restrictive diet should be accompanied by extensive education about dietary management needs.
- Cow’s milk allergy usually goes away within the first three years of life in most patients.
While soy-based formulas have been successfully used to treat babies with demonstrated food allergies or food intolerance, there is no basis for recommending soy formula as a way to prevent food allergies.
Source: Ferreira CT, Seidman E. Food allergy: a practical update from the gastroenterological viewpoint. J Pediatr (Rio J). 2007 Jan-Feb;83(1):7-20.
It is commonly accepted that reflux symptoms will usually resolve during the first year or two of life. Data collected over a one-year period in 19 infants assigned to a placebo group as part of a placebo-controlled drug treatment study of 100 infants total was looked at. It was found that symptoms resolved in more than one-half of those in the placebo assigned group. However, the study also found that microscopic inflammation might continue to be present in the esophagus even after symptoms appear to be gone.
This raises a question. Are these individuals at risk for later problems? The results of this study call attention to the need for better understanding about GERD in infancy and childhood including screening and treatment approaches.
Source: Orenstein SR, Shalaby TM, Kelsey SF, Frankel E. Natural history of infant reflux esophagitis: symptoms and morphometric histology during one year without pharmacotherapy. Am J Gastroenterol. 2006 Mar;101(3):628-40.
A study looked at 12,700 Norwegian twins born between 1967 and 1979. It found that both genetic and external factors may contribute to IBS. Identical twins share exactly the same genes. Non-identical twins share 50% of the same genes. The identical twins were more likely to develop IBS due to external factors, such as low birth rate, as well as due to the influence of genetic makeup.
Source: Bengtson MB, Ronning T, Vatn M, Harris J. IBS in twins: genes and environment. Gut. 2006 Dec;55(12):1694-1946.
In a Mexico City study of 55 patients seeing a doctor in a specialty referral clinic for the first time, 4 factors were looked at in relation to their seeking health care:
- abdominal pain/discomfort
- fear of cancer
- impairment in daily function
- symptom stressfulness
Of these, pain/discomfort and symptom stressfulness were the most important factors that drove the patients to seek care. Feelings of anxiety, depression, and quality of life impairment arising from cancer fear, daily function impairment, and stress from symptoms were present.
Patients want to talk about and to be given information about their disease. A thorough explanation of the disease and reassurance from the doctor decreased the self-perception of impairment in daily function and cancer fear.
Source: Schmulson M, Oritz-Garrido O, Hinojosa C, Arcila D. A single session of reassurance can acutely improve the self-perception of impairment in patients with IBS. Journal of Psychosomatic Research 2006;61:461-467.
A study in Texas examined the prevalence and risk factors for current gastroesophageal reflux disease (GERD) symptoms in 113 young adults (mean age 18 years) with a history of childhood GERD (mean age at the time of childhood diagnosis was 10 years). Almost half of the young adults with a history of GERD as children reported that they currently suffer from heartburn and reflux symptoms a minimum of once every week with most of these taking medications to control their symptoms.
The study cautions that the prevalence of GERD found in this group is considerably higher than previously found in a group of this age. Nevertheless, they conclude that childhood GERD should be considered a risk factor for adolescent and adult GERD.
Source: El-Serag HB, Richardson P, Pilgrim P, Gilger MA. Determinants of gastroesophageal reflux disease in adults with a history of childhood gastroesophageal reflux disease Clin Gastroenterol Hepatol 2007 Jun;5(6):696-701.
Numerous studies show patients diagnosed with GERD are more likely than others to also suffer from irritable bowel syndrome (IBS) or functional dyspepsia (pain or discomfort in the upper abdominal area). A recent study in The Netherlands confirmed this and examined health-related quality of life in these individuals. In patients with GERD (confirmed through a 24-hour pH monitoring test that measures reflux), 25% had dyspepsia, 35% had IBS, and 5% had both. Only 35% had neither IBS nor dyspepsia.
Researchers used a questionnaire with 9 subscales to measure health-related quality of life (HRQoL) in the study participants. Patients who had only GERD had lower scores on 1 of the 9 subscales. GERD patients who also had functional dyspepsia had lower scores on 6 subscales. GERD patients with IBS scored lower on 8 subscales. Patients with GERD, IBS, and functional dyspepsia scored lower on 7 subscales.
The study concluded that in patients with proven GERD, functional dyspepsia and IBS are more prevalent than in the general population; and this prevalence is higher among care-seeking GERD patients. Those GERD patients who also have functional dyspepsia and/or IBS have a much lower HRQoL, suggesting that when GERD is properly treated, health related quality of life is affected mainly by coexisting functional disorders and not by GERD itself.
Source: De Vries DR, Van Herwaarden MA, Baron A, Smout AJ, Samsom M. Concomitant functional dyspepsia and irritable bowel syndrome decrease health-related quality of life in gastroesophageal reflux disease Scand J Gastroenterol 2007 Aug;42(8):951-6.
New Drug Application filed with FDA for Lubiprostone to treat Opioid-Induced Constipation