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From Medscape Gastroenterology
Irritable Bowel Syndrome Expert Column
On the Relationship Between Colon Ischemia, Irritable Bowel Syndrome, and Serotonergic Therapy of Irritable Bowel Syndrome
Posted 09/24/2004
Lawrence J. Brandt, MD
Introduction and Context
The Problem
Colon ischemia and irritable bowel syndrome (IBS) are 2 common gastroenterologic disorders that, until recently, were thought to occur independently in very different populations. We know now, however, that there is a complex association between the 2: (1) colon ischemia appears to be more common in the IBS patient than was recognized previously; and (2) there is concern that the newly developed serotonin receptor agonists or antagonists may increase the risk of colon ischemia, and serotonergic signaling may be abnormal in patients with colitis. This review highlights some of the relationships between colon ischemia, IBS, and therapy for IBS.
IBS -- Pathophysiology and Clinical Presentation
IBS is a disorder that is diagnosed by various symptom-based criteria, such as the Manning, Rome, and Rome II criteria. IBS lacks any biologic, physiologic, structural, or serologic marker, and so diagnosis is symptom-based. Symptoms typically include abdominal discomfort or pain, bloating, diarrhea, fecal urgency, and constipation. Symptoms may change with time, and patients who have diarrhea or constipation as a major part of their illness may evolve to the opposite bowel habit or develop a pattern in which they alternate between the 2. IBS must never be considered as the explanation for rectal bleeding, bloody diarrhea, weight loss, fever, constitutional symptoms, or anemia, and in the presence of these "alarm" symptoms or signs, organic disease must be excluded using conventional stool tests, endoscopic, and radiologic examinations. For the IBS patient without alarm symptoms, the routine use of these tests is not recommended, although for patients with IBS and diarrhea, serologic testing for celiac sprue may be appropriate and cost-effective.[1,2] Of course, screening tests for colon cancer are recommended for all patients 50 years of age or older, including those with IBS.
Colon Ischemia -- Pathophysiology and Clinical Presentation
Colon ischemia generally presents in individuals older than 55 years, a population considerably older than that typically affected by IBS. The known causes of colon ischemia are many, but in the usual case, no definitive cause is found; most episodes of colon ischemia are thought to be caused by brief periods of localized nonocclusive ischemia. The acute onset of mild, lower abdominal pain accompanied or followed by diarrhea, rectal bleeding, or bloody diarrhea is typical. Most patients with colon ischemia have spontaneous resolution of symptoms within several days. Computed tomography of the abdomen usually shows segmental thickening of the colon, although this is not a specific finding. Colonoscopy, if performed within the first 24-48 hours, usually will show submucosal hemorrhage or edema in a segmental pattern (ischemic colopathy). If the examination is repeated within a few days after the onset of symptoms, it will show the disease process to have evolved into a segmental (ischemic) colitis pattern with ulceration and even pseudopolyp formation, an appearance that may mimic inflammatory bowel disease or infectious colitis; biopsy usually is nonspecific, with only infarction and ghost cells pathognomonic of ischemic injury. In general, mesenteric angiography is not used to evaluate patients suspected of having colon ischemia, because by the time of presentation, colonic blood flow usually has normalized.
It is important for primary care practitioners to be aware of colon ischemia because it is a common cause of bloody diarrhea in the elderly and can be seen in patients of all ages, especially those who have a coagulation disorder, systemic illness associated with vasculitis, or those with IBS. Moreover, colon ischemia can mimic or be mimicked by infectious colitis or inflammatory bowel disease. Most patients who develop colon ischemia do well with conservative management. For the patient who continues to have symptoms for more than 2 weeks, referral to a gastroenterologist is recommended because it is likely that these individuals will have a complicated course.
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Section 1 of 6 Next Page: Issues in Epidemiology
Lawrence J. Brandt, MD, Chief of Gastroenterology, Montefiore Medical Center, Bronx, New York; Professor of Medicine and Surgery, Albert Einstein College of Medicine, Bronx, New York
Disclosure: Lawrence J. Brandt, MD, has served as an advisor or consultant for Novartis, GlaxoSmithKline, Solvay, and TAP. He has also disclosed he is on the speakers bureau for AstraZeneca.
Medscape Gastroenterology 6(2), 2004. © 2004 Medscape
Continue reading this article here http://www.medscape.com/viewarticle/488174_2
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Irritable Bowel Syndrome Medications Side Effects Survey.
Journal of Clinical Gastroenterology. 38(9):776-781, October 2004.
Lembo, Anthony MD
Abstract:
Objectives: This study was conducted to determine the frequency and severity of side effects (SEs) experienced during treatment with standard medications used to treat patients with irritable bowel syndrome (IBS) with constipation (IBS-C).
Methods: In January of 2002, 668 subjects responded to a survey addressed to an online panel of 25,000 physician-diagnosed IBS sufferers. Of the survey respondents, 504 had constipation as a predominant bowel habit (median age 45 years, and 88% were women). Respondents answered questions about the therapies they used to relieve their IBS symptoms and about any SEs they experienced while taking these therapies; they were also asked to rate their satisfaction with their current/past medications. To gauge IBS impact, respondents were also asked about the number of times they either visited or called their health-care provider about their IBS symptoms and approximately how many days of work or school they missed because of their IBS symptoms.
Results: Subjects reported having tried an average of 3.9 +/- 3.3 medications for their IBS-C symptoms with virtually all subjects (99%) having tried at least 1 medication. Subjects reported an average of 3.3 +/- 2.7 SEs. Nearly three quarters reported discontinuing treatment because of SEs, and many sought medical help or missed work, school, or social activities because of SEs.
Conclusions: Traditional therapies for IBS-C, including laxatives, fiber, and stool softeners, are associated with SEs that negatively affect the lives of IBS sufferers.
(C) 2004 Lippincott Williams & Wilkins, Inc.
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The American Journal of Gastroenterology
Volume 100 Issue 1 Page 115 - January 2005
doi:10.1111/j.1572-0241.2005.40365.x
A Dose-Ranging, Phase II Study of the Efficacy and Safety of Alosetron in Men with Diarrhea-Predominant IBS
Lin Chang, M.D.1, Vanessa Z. Ameen, M.D.1, George E. Dukes, Pharm.D.1, David J. McSorley M.S.1, Eric G. Carter, M.D., Ph.D.1, and Emeran A. Mayer, M.D.1
BACKGROUND: A randomized, double blind, placebo-controlled dose-ranging study was conducted to assess the efficacy of alosetron in men with diarrhea-predominant irritable bowel syndrome (IBS).
METHODS: Six hundred and sixty-two men were randomized to treatment with alosetron 0.5, 1.0, 2.0, 4.0 mg, or placebo twice daily for 12 wk, followed by a 4-wk posttreatment period. Adequate relief of IBS pain and discomfort during week 512 of the treatment phase was the primary endpoint; secondary endpoints included bowel urgency, stool frequency, and consistency, incomplete evacuation, bloating, and abdominal pain or discomfort.
RESULTS: Subjects ranked urgency and abdominal pain as their most bothersome IBS symptoms. The average rate of adequate relief during week 512 was significantly higher in the alosetron 1.0 mg twice-daily group compared to placebo (53%vs 40%, p= 0.04), and all doses of alosetron significantly reduced stool consistency scores (p< 0.001) indicating firmer stools. No significant effects of alosetron were seen with regard to urgency, number of bowel movements, bloating, and incomplete evacuation. Constipation was the most common adverse event and occurred in a dose-related manner among subjects receiving alosetron, 9% (0.5 mg twice daily), 15% (1.0 mg twice daily), 11% (2.0 mg twice daily), and 21% (4.0 mg twice daily). No serious adverse events of constipation were reported. One subject in the 0.5 mg twice-daily group had an episode of rectal bleeding suggestive of a possible diagnosis of ischemic colitis.
CONCLUSIONS: Alosetron 1 mg twice daily provided adequate relief of IBS pain and discomfort, and improved stool consistency in men with diarrhea-predominant IBS.
http://www.blackwell-synergy.com/links/doi/10.1111/j.1572-0241.2005.40365.x/abs/
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The American Journal of Gastroenterology
Volume 100 Issue 3 Page 664 - March 2005
doi:10.1111/j.1572-0241.2005.30375.x
Clinical Response to Tricyclic Antidepressants in Functional Bowel Disorders is not Related to Dosage
Albena Halpert, M.D.1, Christine B. Dalton, P.A.-C.1, Nicholas E. Diamant, M.D.1, Brenda B. Toner, Ph.D.1, Yuming Hu, Ph.D.1, Carolyn B. Morris, Ph.D.1, Shrikant I. Bangdiwala, Ph.D.1, William E. Whitehead, Ph.D.1, and Douglas A. Drossman, M.D.1
BACKGROUND: As shown in the per protocol analysis of a recent randomized, controlled trial, when tolerated, Desipramine (DES) is effective over placebo (PLA) in treating moderate-to-severe functional bowel disorders (FBD). Clinical experience suggests that the benefit from tricyclic antidepressants (TCA) in FBD can be achieved at doses lower than those used to treat major depression. Within psychiatry, when using higher dosage of TCAs, plasma levels can be used to adjust daily dosage to optimize a treatment response. However, in FBD, it is not known whether plasma levels at the lower dosage are similarly related to a clinical response.
AIM: To determine in treating FBD, whether DES blood levels or dose taken can predict a clinical response.
METHODS: As part of a study of 12 wk of antidepressant and psychological treatment in 431 patients with FBD at UNC and U of Toronto, we studied those participants who completed treatment (per protocol analysis) taking DES (N = 97, dose 50150 mg/day) or pill placebo (PLA) (N = 55 13 pills/day). The primary outcome measure was defined as a composite score (Satisfaction with Treatment, McGill Pain Questionnaire, Global Well-being, and IBS-QOL). The composite score was correlated with: (i) DES plasma levels at week 6, and (ii) number of pills taken over the duration of the 12-wk treatment period. In addition, we also compared DES dose with DES plasma levels.
RESULTS: There was a modest correlation between mean DES dose at weeks 5 and 6 and DES blood level at week 6 (R = 0.2 p< 0.07). However, there were no significant correlations between the composite score either with DES dose or with DES blood levels.
CONCLUSIONS: Detectible blood levels of DES are associated with a clinical response in FBD. However, with dosages up to 150 mg, there is no relationship between total dose or plasma level and the clinical response.
http://www.blackwell-synergy.com/links/doi/10.1111/j.1572-0241.2005.30375.x/abs/
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Zelnorm Associated With Rare Cases of Severe Diarrhea, Ischemic Colitis
Yael Waknine
April 29, 2004 — The U.S. Food and Drug Administration (FDA) and Novartis notified healthcare professionals on April 26 of revisions to the warnings and precautions sections of labeling for tegaserod maleate (Zelnorm). The warning refers to serious consequences of diarrhea (including hypovolemia, hypotension, and syncope) that occurred both during clinical trials and during marketed use, in some cases requiring hospitalization.
Tegaserod maleate is a serotonin 5-HT4 receptor partial agonist, indicated for the short-term treatment of women with irritable bowel syndrome whose primary bowel symptom is constipation.
According to the FDA, tegaserod maleate should be discontinued in patients who develop hypotension or syncope. It should not be initiated in patients who frequently experience or are currently experiencing diarrhea.
The precaution refers to rare cases of ischemic colitis and other forms of intestinal ischemia that have been reported during marketed use of tegaserod maleate, although no causal relationship has been established.
The FDA recommends discontinuation of the drug in patients who develop symptoms of ischemic colitis such as rectal bleeding, bloody diarrhea, or new/worsening abdominal pain. These patients should be evaluated promptly and treatment with tegaserod maleate should not be resumed if a diagnosis of ischemic colitis is confirmed.
Healthcare professionals should report all serious adverse events suspected to be associated with the use of tegaserod maleate to Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 07936, or call 1-888-669-6682, or via the Internet at http://www.novartis.com.
Alternatively, this information may be reported to the FDA's MedWatch safety information and adverse event reporting program by calling 1-800-FDA-1088, by fax at 1-800-FDA-0178, or via the Internet using Form 3500 at http://www.fda.gov/medwatch/index.html.
Reviewed by Gary D. Vogin, MD
Yael Waknine is a freelance writer for Medscape.
http://www.medscape.com/viewarticle/474771
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From American Journal of Health-System Pharmacy
Rationale for Using Serotonergic Agents to Treat Irritable Bowel Syndrome
Danial E. Baker
Abstract and Introduction
Abstract
Purpose: The role of serotonin in gastrointestinal (GI)-tract functioning, the pharmacologic rationale for using serotonergic agents in the treatment of irritable bowel syndrome (IBS), and clinical experience with novel serotonergic agents are described.
Summary: IBS is a common multisymptom disorder that is associated with a high socioeconomic burden. The goal of treatment is to provide rapid and sustained global relief of the multiple symptoms of IBS with a single, effective, well-tolerated agent. Traditional treatment options target single symptoms, and many patients are dissatisfied with the level of relief achieved and adverse effects. Research has revealed that serotonin is involved in three major actions in the gut: (1) mediating intestinal motility, (2) mediating intestinal secretion in the GI tract, and (3) modulating perception in the bowels. Serotonin is also a vital link in the brain-gut axis. Alterations in key elements of serotonin signaling have been demonstrated in patients with IBS. Tegaserod, a selective serotonin type 4 (5-HT4)-receptor partial agonist, is indicated for use in women with IBS whose primary bowel symptom is constipation. Alosetron, a 5-HT3-receptor antagonist, is indicated for use in women with severe diarrhea-predominant IBS in whom traditional therapies have failed. The clinical usefulness of several other serotonergic agents for IBS is being investigated.
Conclusion: The use of serotonergic agents in patients with IBS is based on the critical role that serotonin plays in the maintenance of normal gut function and brain-gut communication. Pharmacologic therapies targeting specific serotonin receptors represent an important step in the management of IBS.
Introduction
Irritable bowel syndrome (IBS) is a functional gastrointestinal (GI) disorder characterized by abdominal pain or discomfort and altered bowel habits.[1] Traditional treatment options for patients with IBS target single symptoms, are often ineffective, and can cause bothersome adverse effects in some patients.[2] During the past two decades, important research strides have enhanced our understanding of the underlying pathophysiology of IBS. The understanding of the critical role that serotonin plays in maintaining normal GI-tract function (e.g., motility, secretion, and sensation) and of the vital link between serotonin and the enteric nervous system (ENS), the autonomic nervous system (ANS), and the central nervous system (CNS)[3] has resulted in the development of several serotonergic agents as potential therapies for IBS.[1,4]
Two serotonergic agents currently have FDA-approved labeling for use in the treatment of IBS: tegaserod maleate, a selective serotonin type 4 (5-HT4)-receptor partial agonist indicated for women with IBS whose primary bowel symptom is constipation (IBS-C),[5] and alosetron hydrochloride, a 5-HT type 3 (5-HT3)-receptor antagonist indicated for women with severe IBS with diarrhea (IBS-D) in whom traditional therapies have failed to provide adequate relief.[6] Other serotonergic agents are currently in development.
This article discusses the role of serotonin in GI-tract functioning, the pharmacologic rationale for using serotonergic agents in the treatment of IBS, and clinical experience with novel serotonergic agents.
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Section 1 of 10 Next Page: Review of IBS
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Danial E. Baker, Pharm.D., FASCP, FASHP, is Associate Dean, Clinical Programs; Director, Drug Information Center; and Professor of Pharmacotherapy, Department of Pharmacotherapy, College of Pharmacy, Washington State University, Spokane, WA
Am J Health-Syst Pharm. 2005; 62 (7): 700-711. ©2005 American Society of Health-System Pharmacists
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Neurogastroenterology and Motility
Volume 0 Issue 0 - May 2005
doi:10.1111/j.1365-2982.2005.00675.x
Basic and clinical pharmacology of new motility promoting agents
j. j. galligan* & s. vanner*
Department of Pharmacology and Toxicology and The Neuroscience Program, Michigan State University, East Lansing, MI, USA
Gastrointestinal Diseases Research Unit, Queen's University, Kingston, Ontario, Canada
Abstract
Recent research has provided new information about drugs that could be used to treat functional motility disorders. Promotility drugs accelerate gastric emptying or colonic transit and these properties may contribute to their efficacy in treating symptoms associated with gastroparesis, functional dyspepsia or constipation. 5-Hydroxytryptamine4 receptors are targets for drugs (tegaserod, renzapride) that treat symptoms in constipated irritable bowel syndrome patients and in gastroparesis. Drugs acting at motilin (erythromycin) and cholecystokinin-1 (dexloxiglumide) receptors accelerate gastric emptying. Dexloxiglumide might be useful in the treatment of functional dyspepsia particularly that associated with lipid intake.
Alvimopan is a -opioid receptor antagonist that does not cross the blood brain barrier. Alvimopan is effective in treating postsurgical ileus and perhaps opiate-induced bowel dysfunction. Successes and failures of recent efforts to develop promotility agents revealed opportunities and challenges for developing new promotility drugs. The pharmacological properties of partial agonists might be exploited to develop effective promotility drugs. However, opposing actions of promotility agents on motility (increased contraction vs decreased accommodation) limit the clinical efficacy of drugs with these opposing actions. Selection of appropriate patient populations for evaluation of new drugs is also critical.
http://www.blackwell-synergy.com/doi/abs/10.1111/j.1365-2982.2005.00675.x?cookieSet=1
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The U.S. Food and Drug Administration approved in February revisions to safety labeling to advise that use of alosetron HCl has been associated rarely with serious gastrointestinal tract adverse events and concomitant administration of alosetron HCl and fluvoxamine is contraindicated; caspofungin acetate should be administered concomitantly with cyclosporine only in those patients for whom the potential benefit outweighs the potential risk of elevated liver enzyme levels; the atenolol component of atenolol-chlorthalidone tablets is associated with a risk of clinically significant bradycardia in neonates born to mothers receiving the fixed-dose combination drug at parturition or while breast-feeding.
Alosetron (Lotronex) Associated Rarely With Serious Gastrointestinal Adverse Events
On Feb. 18, the FDA approved revisions to the safety labeling for alosetron HCl tablets (Lotronex, made by GlaxoSmithKline) to advise of contraindications and warnings associated with its use.
Concomitant use of alosetron with fluvoxamine is contraindicated. Fluvoxamine is a known strong inhibitor of CYP1A2 that has been shown in clinical studies to increase mean alosetron plasma concentrations by approximately sixfold and prolong its half-life by approximately threefold.
The FDA warns that use of alosetron has been associated with infrequent reports of serious gastrointestinal tract adverse events such as ischemic colitis and complications of constipation. Some of these events have occurred without warning and have resulted in hospitalization, but rarely have resulted in blood transfusion, surgery, or death.
Serious complications of constipation, including obstruction, ileus, impaction, toxic megacolon, and secondary bowel ischemia, have been reported in alosetron clinical trials and during postapproval use. Intestinal surgery, including colectomy, has been required in some cases. Postmarketing reports have also included rare incidences of perforation and death.
In clinical trials, constipation-related adverse events resulted in a discontinuation rate of approximately 10% among alosetron recipients (overall incidence rate for patients is about 0.1%; 1 per 1,000 patients).
The FDA notes that the risk of serious complications of constipation may be increased in patients who are elderly, debilitated, or concurrently receiving medications that reduce gastrointestinal motility.
Alosetron therapy has also been associated with rare reports of ischemic colitis in clinical trials and during postapproval use.
In clinical trials, the cumulative incidence of ischemic colitis was 0.2% in women receiving alosetron for three months (2 per 1,000 patients; 95% confidence interval [CI], 1 - 3) and 0.3% after six months of therapy (3 per 1,000 patients; 95% CI, 1 - 4). According to the FDA, these data from controlled studies are insufficient to estimate the incidence of ischemic colitis in patients receiving alosetron therapy for longer than six months.
Alosetron is indicated for the treatment of chronic, severe, diarrhea-predominant irritable bowel syndrome in women who have not responded adequately to conventional therapy.
http://www.medscape.com/viewarticle/504287
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Acute Hepatitis Associated With Alosetron (Lotronex(R)).
Journal of Clinical Gastroenterology. 39(7):641-642, August 2005.
Turgeon, D Kim MD; Tayeh, Nadia BS; Fontana, Robert J MD
Abstract:
Alosetron hydrochloride (Lotronex(R), GlaxoSmithKline, Inc) is a safe and effective agent for selective patients with severe irritable bowel syndrome when prescribed as recommended. We describe the first reported case of acute liver injury in a 39-year-old white woman who developed symptomatic hepatitis 28 days after starting alosetron. All other competing causes of acute hepatitis were excluded by radiologic and laboratory studies and the liver injury resolved after drug discontinuation. Although the mechanism of alosetron hepatotoxicity is unknown, metabolic idiosyncrasy is suspected since the drug is known to be extensively metabolized by cytochrome-P450 enzymes. Clinicians prescribing alosetron should be aware of this potential side effect if unexplained abdominal pain, jaundice,or abnormal liver biochemistries are encountered in a treated patient.
(C) 2005 Lippincott Williams & Wilkins, Inc.
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Lack of Lasting Effectiveness of Miralax Laxative Treatment of Constipation.
Journal of Clinical Gastroenterology. 39(7):600-602, August 2005.
Tran, Lily C MD; Di Palma, Jack A MD
Abstract:
Purpose: PEG 3350 (MiraLax, Braintree Laboratories Inc., Braintree, MA) 17 g daily has been shown to be safe and effective in a 14-day trial for constipation. This present investigation was designed to extend the treatment and safety experience with PEG 3350 and to evaluate any lasting effectiveness during a 30-day post-treatment observation period.
Methods: Study subjects met Rome II criteria for constipation and reported <3 bowel movements a week. They were treated with PEG 3350 17 g daily for 14 days. Treatment efficacy was defined by resolution of constipation symptoms as determined by the Rome II and stool frequency definitions during the treatment period.
Results: Fifty healthy constipated subjects formed the study group. There were 42 females and 8 males. Mean age was 52 +/- 15.5 years (+/-SD). Symptom duration was 22.6 +/- 16.7 months (+/-SD). At baseline, all had <3 bowel movements a week and met Rome II criteria. Two were lost to follow-up. Two took enemas or laxatives and 2 discontinued active treatment because of "gas" and were considered treatment failures. At the end of 14 days, 40 of 48 (83.3%) had >3 stools in the last week and no longer met Rome criteria. Thirty-two of 45 (71.1%) reported satisfaction with the first bowel movement after initiating treatment. Thirty days after active treatment, 29 of 47 (61.7%) responded that they needed laxative treatment.
Conclusion: PEG 3350 relieved constipation in most treated study subjects. During a 30-day post-treatment observation period, 29 of 47 (61.7%) had additional constipation treatment interventions.
(C) 2005 Lippincott Williams & Wilkins, Inc.
http://www.mdlinx.com/GILinx/thearts.cfm?artid=1291584&specid=13&ok=yes
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