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HeatherAdministrator

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Pharmaceutical
      #13949 - 07/14/03 01:50 PM

All articles related to gastrointestinal pharmaceutical research should be posted here.



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Combined use of SSRIs and NSAIDs increases the risk of GI adverse effects new
      #13977 - 07/14/03 03:15 PM

British Journal of Clinical Pharmacology
Volume 55 Issue 6 Page 591 - June 2003
doi:10.1046/j.0306-5251.2002.01770.x

Combined use of SSRIs and NSAIDs increases the risk of gastrointestinal adverse effects

Jeroen C. F. de Jong, Paul B. van den Berg, Hilde Tobi & Lolkje T. W. de Jong - van den Berg

Aims To investigate the relationship between the use of antidepressants with or without NSAIDs and the risk of gastrointestinal side-effects.

Methods This was a population-based cohort study. Medication data of 180 000 patients from 16 pharmacies in The Netherlands were studied. The subjects were a group of 15 445 new users of antidepressants with or without NSAIDs. A review of patient profiles for cases of gastrointestinal adverse effects caused by first time use of antidepressants with or without NSAIDs was carried out. The number of first prescriptions for peptic ulcer drugs (Anatomical Therapeutic Chemical classification A02B) in the period from day 2 after starting antidepressants with or without NSAIDs until 10 days after the last dose was the main outcome measure.

Results In the reference group of 619 new users of nonselective antidepressants (TCAs), the incidence of first prescriptions for peptic ulcer drugs was 0.051 (95% confidence interval 0.021, 0.105). The use of SSRIs (n = 1181) caused a slightly higher incidence rate ratio (IRR) of 1.2 (0.5, 2.8). The combined use of SSRIs and NSAIDs (n = 86) increased the IRR to 12.4 (3.2, 48.0). In contrast, the combination of nonselective antidepressants and NSAIDs (n = 74) increased the IRR to 2.5 (0.3, 20.3).

Conclusions SSRIs increase the risk of gastrointestinal adverse effects in first time users as compared with nonselective antidepressants. The combined use of SSRIs and NSAIDs strongly increases the risk of gastrointestinal adverse effects and should be avoided. The combination of nonselective antidepressants and NSAIDs does not have this effect.

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Use of Antidepressants in the Treatment of IBS? new
      #13991 - 07/14/03 03:58 PM

Gastroenterology Ask the Expert

Use of Antidepressants in the Treatment of IBS?

Posted 04/08/2003 from Medscape Gastroenterology


Question
When is it recommended to start antidepressant therapy in patients with irritable bowel syndrome (IBS)? Which is the preferred approach: tricyclic antidepressants or selective serotonin reuptake inhibitors (SSRIs)?

Amir Belson, MD

Response
from Yehuda Ringel, MD, 04/08/2003

The treatment approach in patients with IBS is usually guided by the predominant symptoms (ie, pain, diarrhea, or constipation) as well as the severity of the disorder.

Most patients with IBS have mild and infrequent symptoms with no, or only little, associated disability. These patients do not usually need antidepressants. Reassurance, education, recommendations for dietary changes, and short-term symptomatic treatment are sufficient in most of these cases. Patients who have moderate or severe symptoms that considerably affect their daily activities and quality of life may require additional pharmacologic treatments, including psychopharmacologic (eg, antidepressants) and/or psychological and behavioral therapies.[1]

The rationale for the use of antidepressants in IBS is the coexistence of psychological disturbances, particularly in patients with more severe symptoms who seek medical care, and their effect/action on reducing gut sensation. The latter neuromodulatory analgesic effect of these agents is unrelated to their psychotropic effects. Thus, antidepressants can be used in IBS patients with or without psychiatric comorbidity (eg, depression, anxiety).

A recent meta-analysis of 12 studies concluded that antidepressants are effective in IBS patients. On average, 3.2 patients need to be treated to achieve 1 positive response in a patient's symptoms.[2] Tricyclic antidepressants have been best studied in IBS patients with pain and diarrhea. Low doses of desipramine (50-100 mg) or amitriptyline (25-75 mg) appear to be effective in controlling IBS symptoms in these patients. Although data on SSRIs are still limited, the current information suggests a beneficial effect. SSRIs may be preferred in older patients or in those with constipation because they have little or no anticholinergic effects.[1]

Long-term adverse effects are common with antidepressant treatment and relate to the anticholinergic, serotonergic, sedative antihistaminic, and alpha-adrenergic effects. These effects must be considered in choosing the treatment approach. In addition, because psychotropic agents also affect intestinal motility,[3] the patient's bowel function should also be considered when selecting an antidepressant medication.

Finally, because the disorder is multidetermined, it is important to view medication therapy as part of a more comprehensive management plan in the setting of IBS.[4]



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References
Drossman DA, Camilleri M, Mayer EA, Whitehead WE. AGA technical review on irritable bowel syndrome. Gastroenterology. 2002;123:2108-2131. Abstract
Jackson JL, O'Malley PG, Tomkins G, Balden E, Santoro J, Kroenke K. Treatment of functional gastrointestinal disorders with antidepressant medications: a meta-analysis. Am J Med. 2000;108:65-72. Abstract
Chial HJ, Camilleri M, Burton D, Thomforde G, Olden KW, Stephens D. Selective effects of serotonergic psychoactive agents on gastrointestinal functions in health. Am J Physiol Gastrointest Liver Physiol. 2003;284:G130-G137. Abstract
Ringel Y, Drossman DA. Psychosocial factors in functional gastrointestinal disorders: Toward a more comprehensive understanding and approach to treatment. Medscape Conference Coverage, Digestive Disease Week 2001; Medscape Gastroenterology, 2001. Available at: http://www.medscape.com/viewarticle/418547 Accessed April 3, 2003.
About the Panel Members
Yehuda Ringel, MD, Assistant Professor, Department of Medicine, University of North Carolina at Chapel Hill; Attending Physician, Department of Digestive Diseases and Nutrition, University of North Carolina Hospitals, Chapel Hill



Medscape Gastroenterology 5(1), 2003. © 2003 Medscape

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HeatherAdministrator

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Antidepressants in the Treatment of IBS and Other Functional GI Disorders new
      #14338 - 07/18/03 12:20 PM

Use of Antidepressants in the Treatment of irritable Bowel Syndrome and Other Functional GI Disorders

Christine B. Dalton, PA-C
Laura A. Keeter, MSIV
Douglas A. Drossman. MD

Your doctor has recommended the use of antidepressants for your symptoms from irritable bowel syndrome (IBS) or another functional G.I. disorder. You may have questions and concerns about the use of these medications. The following information should help answer some of these questions.

Click here for the full article from UNC:

http://www.med.unc.edu/medicine/fgidc/antidepressentsandibs.htm



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HeatherAdministrator

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Hypersensitivity and hyperreactivity in IBS: opportunity for drug discovery new
      #14349 - 07/18/03 12:39 PM

Dig Dis. 1999;17(2):90-9. Related Articles, Links


Hypersensitivity and hyperreactivity in the irritable bowel syndrome: An opportunity for drug discovery.

Sanger GJ.

Department of Neuroscience Research, SmithKline Beecham Pharmaceuticals, Harlow, Essex, UK. Gareth_J_Sanger@sbphrd.com.uk

The gastrointestinal tract of many patients with irritable bowel syndrome (IBS) is hypersensitive to different stimuli. The mechanisms of this hypersensitivity are unclear, but could involve enteric, visceral afferent/efferent, spinal and/or central nervous systems. Such complexity, the absence of animal models or anatomical, molecular or genetic markers of IBS, means that it is difficult to create new types of drugs which specifically treat the condition of IBS. To help in this process, current pre-clinical and early-clinical approaches are evaluated in terms of their ability to intervene within the gut-spinal cord/brain axis and inhibit gastrointestinal 'hypersensitivity' and 'hyperreactivity'. Thus, by developing a rational process the pharmaceutical industry may better understand how to design truly effective drugs for the treatment of IBS.

Publication Types:
Review
Review, Academic

PMID: 10545714 [PubMed - indexed for ME web page DLINE]


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HeatherAdministrator

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Pain Relievers and Intestinal Disorders new
      #20928 - 09/16/03 04:20 PM

Pain Relievers and Intestinal Disorders

Chris Woolston
CONSUMER HEALTH INTERACTIVE

• Why are NSAIDs hard on the stomach?
• Who is at risk for NSAIDs-related intestinal trouble?
• What are the symptoms of NSAIDs-related stomach trouble?
• What is the treatment for NSAIDs-related stomach trouble?
• Can NSAIDs-related stomach trouble be prevented?



Ever since aspirin hit the market in the late 1800s, it has been a fixture in medicine cabinets everywhere -- and for good reason. It erases headaches, soothes arthritis, lowers fevers, helps prevent heart disease, and may even ward off some types of cancer. If it were discovered today, doctors would hail it as a medical breakthrough.

But for some people, aspirin has a serious downside -- especially if taken regularly. At the same time it's easing your pain, it could be giving you an ulcer. Aspirin is just one of many painkillers known as nonsteroidal anti-inflammatory drugs (NSAIDs), which can cause serious damage to your digestive system. Other members of the NSAID class include the over-the-counter pain relievers ibuprofen and naproxen and at least 15 prescription drugs.

According to the American College of Gastroenterology, up to 60 percent of the approximately 14 million patients with arthritis who consume NSAIDs regularly will develop side effects related to the drugs. Although most are minor, side effects may include stomach ulcers, bleeding, holes in tissue, and even death.

The danger is real. According to a report in the May 2001 issue of Postgraduate Medicine, more than 100,000 Americans are hospitalized each year with intestinal trouble caused by aspirin and other NSAIDs. Only a small percentage of cases are fatal, but it's enough to make NSAIDs-related stomach trouble the 15th most common cause of death in the United States, ahead of asthma, cervical cancer, and Hodgkin's disease.

Why are NSAIDs hard on the stomach?
The drugs cause ulcers by interfering with the stomach's ability to protect itself from stomach acids, according to the National Digestive Diseases Information Clearinghouse. "Normally the stomach has three defenses against digestive juices: mucus that coats the stomach lining and shields it from stomach acid, the chemical bicarbonate that neutralizes stomach acid, and blood circulation to the stomach lining that aids in cell renewal and repair," the clearinghouse explains. "NSAIDs hinder all of these protective mechanisms, and with the stomach's defenses down, digestive juices can damage the sensitive stomach lining and cause ulcers."

How do NSAIDS undermine the stomach's defenses? All but the newest block an enzyme called cyclooxygenase 1, or COX-1. This enzyme helps prevent ulcers by enhancing blood flow to the stomach and increasing the production of protective mucous. If there's a shortage of COX-1, your stomach may not develop its usual protective lining, making it more vulnerable to attack by stomach acid.

In most cases, the damage is minor and your stomach heals completely about five days later. Still, regular doses can cause dyspepsia, lingering pain, or discomfort in the stomach. And if your stomach doesn't heal quite as quickly as it should, you could easily develop an ulcer or serious internal bleeding.

Who is at risk for NSAIDs-related intestinal trouble?
The typical person with NSAIDs-related intestine problems is an arthritis sufferer who takes several pills every day. For some people, however, just one pill each day can be enough to cause trouble. Older people are especially prone to complications of NSAIDs. The risk climbs if you have a history of ulcers, if you're currently taking corticosteroids or anticoagulants, or if you have a serious illness such as cancer or cirrhosis.

There's some evidence that smoking and drinking can also increase the likelihood of an NSAIDs-induced ulcer. According to the American Family Physician, alcohol consumption can also increase the risk for major bleeding in the upper GI tract, which includes the esophagus (or gullet), the stomach, and the beginning of the small intestine. In a study of more than 1,200 patient admitted for upper GI bleeding, researchers found that those who drank heavily and used aspirin or ibuprofen regularly had a much higher relative risk of intestinal bleeding. What's more, this was true even for people who were taking low-dose aspirin. (Because NSAIDs cause system-wide effects, even "enteric-coated" aspirins can cause ulcers.)

What are the symptoms of NSAIDs-related stomach trouble?
NSAIDs can inflict serious damage before they ever cause any symptoms. As reported in Postgraduate Medicine, more than 80 percent of patients hospitalized with serious complications of NSAIDs never notice any warning signs.

For some patients, mild stomach discomfort (dyspepsia) and nausea may be an early sign of trouble. If an ulcer develops, you may feel a gnawing, burning pain in your abdomen. The pain usually comes and goes. You may also feel nauseous and lose your appetite. If the ulcer causes internal bleeding, you may become tired and anemic and your stools may turn black or tarry. If you notice these symptoms, you should make an appointment with your doctor right away.

If the bleeding is severe, you could start vomiting bright-red blood and go into shock. Obviously, these are signs of a medical emergency: Call 911 or have someone drive you to an emergency room immediately.

What is the treatment for NSAIDs-related stomach trouble?
For most people, giving up NSAIDs is the key to treatment. If it's impossible to quit, you'll have to at least lower the dose. Either way, your stomach will quickly begin to heal. If you have an ulcer, your doctor might speed the recovery by prescribing acid-blocking drugs, proton-pump inhibitors, or other medications. If you are infected with Helicobacter pylori, a bacterium that can irritate the stomach and cause ulcers, your doctor will prescribe antibiotics to wipe out the germs.

If you have serious internal bleeding or a hole in your stomach or intestine, you'll need treatment that may include endoscopy or surgery.

Can NSAIDs-related stomach trouble be prevented?
One way to avoid NSAIDs-related stomach trouble is to avoid NSAIDs. If you have osteoarthritis, for example, you may be able to control the pain with acetaminophen (Tylenol) and capsaicin creams along with physical therapy and exercise. You might want to ask your doctor about complementary medicine, too: Some research indicates that fish oil supplements might ease inflammation in people with arthritis, for instance, and certain herbs, self-hypnosis, biofeedback, and other alternative therapies may also prove beneficial. Whatever alternative methods you explore, however, be sure to discuss these options with your doctor.

For many people, though, giving up NSAIDs isn't the best option. Other pain relievers may not be up to the task, and when it comes to preventing heart attacks, aspirin is in a class by itself.

Practically everyone can safely take an NSAID every now and then, but you should talk to your doctor before making it a regular habit. Let your doctor know all the other prescription drugs, herbs, and over-the-counter supplements you're taking, as well as how much alcohol you drink on a regular basis. If your doctor believes the benefits of NSAIDs outweigh the risks, you can proceed with caution.

If you do start an NSAID routine, think small. For instance, a single baby aspirin (about 80 milligrams) every day can give you strong protection against heart disease with relatively few side effects. Whatever your reason for taking an NSAID, your doctor can help you find the lowest effective dose.

Some NSAIDs are more dangerous than others. If you need a prescription NSAID to fight pain, ask your doctor if you¹re at high risk for stomach trouble. If so, you should take less harsh drug such as nabumetone (Relafen) or etodolac (Lodine) instead of more problematic drugs such as ketorolac tromethamine (Toradol) or meclofenamate sodium (Meclomen).

If you suffer from rheumatoid arthritis or osteoarthritis, the newest generation of NSAIDs may be somewhat safer. These drugs, which include celecoxib (Celebrex) and rofecoxib (Vioxx), specifically target the COX-2 enzyme, a major player in pain and inflammation. (The new drugs can also block the Cox-1 enzyme, but to a far smaller extent than traditional NSAIDs). According to a report in the January 8, 2001 issue of the American Journal of Medicine, these drugs don't appear to raise the risk of ulcers. And compared with other NSAIDs, celecoxib and rofecoxib are less likely to cause dyspepsia.

If you regularly take a traditional NSAID and are at high risk for ulcers, your doctor may prescribe a medication to protect your stomach. The drug misoprostol (Cytotec) has been shown to slightly reduce the rate of ulcers in long-term NSAID users. However, the minor benefit is coupled with a high incidence of diarrhea and other side effects. Proton-pump inhibitors, such as omeprazole (Prilosec) have also been shown to protect against ulcers in NSAID users, without frequent side effects.

-- Chris Woolston, M.S., is a health and medical writer with a master's degree in biology. He is a contributing editor at Consumer Health Interactive, and was the staff writer at Hippocrates, a magazine for physicians. He has also covered science issues for Time Inc. Health, WebMD, and the Chronicle of Higher Education. His reporting on occupational health earned him an award from the northern California Society of Professional Journalists.

References

Alcohol and NSAIDs increase risk for upper GI bleeding. Karl E. Miller, American Family Physician. May 1, 2000.

American College of Gastroenterology. Effects of NSAIDs on the upper
gastrointestinal tract. www.acg.org/phyforum/gifocus/2eiv.html

Emery P. Cyclooxygenase-2: A major therapeutic advance? American Journal of
Medicine. January 8, 2001. 110(1A): 42S-45S.

Graumlich JF. Preventing gastrointestinal complications of NSAIDs.
Postgraduate Medicine. May 2001. 109(5): 117-128.

NSAIDs and Peptic Ulcers. National Digestive Diseases Information Clearinghouse. www.niddk.nih.gov/heath/disgest/summary/nsaids/

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Evaluation of drug treatment in irritable bowel syndrome new
      #22096 - 09/30/03 12:52 PM

British Journal of Clinical Pharmacology
Volume 56 Issue 4 Page 362 - October 2003
doi:10.1046/j.1365-2125.2003.01966.x

Evaluation of drug treatment in irritable bowel syndrome
Nicholas J. Talley

The irritable bowel syndrome (IBS) remains a therapeutic challenge in part because of the limited understanding of the pathophysiology. The placebo response rate varies in randomized controlled trials from 20 to 70%, and can persist for up to at least 1 year. Anticholinergic and antispasmodic agents are of questionable benefit in IBS despite positive meta-analyses of poor quality trials. A meta-analysis concluded that the tricyclic antidepressants were superior to placebo in IBS, although the individual trial results were variable. Selective serotonin reuptake inhibitors are of uncertain benefit. Laxatives are used for constipation but probably poorly control the IBS symptom complex. Loperamide is superior to placebo in improvement of diarrhoea but not abdominal pain in IBS. Tegaserod is a well- tolerated aminoguanidine indole derivative of serotonin that is a partial 5HT4-receptor agonist with prokinetic properties; a therapeutic gain over placebo of 5% to 15% has been observed in constipation-predominant IBS in females. Alosetron is a 5HT3-receptor antagonist that is efficacious in females with diarrhoea-predominant IBS, with a 12% to 17% therapeutic gain; the risk of ischaemic colitis is 1 in 350, with very severe constipation occurring in about 1 in 1000. Optimizing study design remains a challenge in IBS. New visceral analgesic and motility modifying agents, as well as anti-inflammatory agents are in trials, and hopefully additional efficacious therapeutic options for patients with IBS will soon emerge.

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Step-down dosage of PPI drugs for hearburn new
      #22106 - 09/30/03 01:26 PM

Step-down from multiple- to single-dose proton pump inhibitors (PPIs): a prospective study of patients with heartburn or acid regurgitation completely relieved with PPIs

John M. Inadomi a,b,c * , Lisa McIntyre a , Latoya Bernard a and A. Mark Fendrick c
Received: 9/12/2002. Accepted: 5/12/2003.

Abstract

Objectives
Management costs for gastroesophageal reflux disease are high because of the expensive medications used for maintenance therapy. Previous studies have illustrated the success of step-down from proton pump inhibitors (PPIs) to less-expensive therapy once symptoms have abated. This study was conducted to determine whether patients requiring greater than single-dose PPI for initial symptom resolution could be stepped-down to single-dose PPI and whether this intervention decreased costs or adversely affected quality of life.


Methods


Consecutive patients in whom greater than single-dose PPI had completely alleviated reflux-type symptoms (heartburn or acid regurgitation) were recruited through the use of pharmacy records of PPI prescriptions. Eligible subjects completed baseline demographic information and quality-of-life surveys and were stepped-down to single-dose PPI (lansoprazole 30 mg or omeprazole 20 mg daily). Follow-up continued for 6 months or until subjects reported recurrence of reflux-type symptoms, at which point PPIs were reinstituted at the dose that had originally alleviated the subjects' symptoms. The primary outcome was the proportion of subjects in whom step-down was successful, defined as no recurrence of reflux-type symptoms on single-dose PPI.


Results


A total of 117 subjects enrolled in the study; all were followed to the primary endpoint. 79.5% did not report recurrent symptoms of heartburn or acid regurgitation during the 6 months after step-down to single-dose PPI. Logistic regression revealed that longer duration of PPI use before study enrollment was associated with greater likelihood of symptom recurrence with step-down. Although quality of life was not significantly altered, dyspepsia (excluding reflux-type symptoms) increased. Overall costs of management were reduced.


Conclusions


The majority of patients rendered asymptomatic on greater than single-dose PPI might be subsequently stepped-down to single-dose therapy without recurrence of reflux-type symptoms. This intervention can decrease management costs without adversely affecting quality of life.

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HeatherAdministrator

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FDA Orders Novartis To Pull Zelnorm Ads new
      #22768 - 10/07/03 11:25 PM

FDA Orders Novartis To Pull Zelnorm Ads

June 30, 2003

WASHINGTON (AP) -- The government says an ad campaign implies a drug for irritable bowel syndrome works far better than it really does, and ordered Zelnorm's maker to stop the advertising.

The Food and Drug Administration cited ads by Novartis Pharmaceuticals that pictured a smiling woman and said, "Novartis and Gloria ended 30 years of debilitating abdominal pain, bloating and constipation in just three days."

While the ad doesn't mention Zelnorm's name, it discussed a "treatment from Novartis" that is "beating IBS."

The ad implies Zelnorm cured Gloria and could help millions of women when in fact it's not a cure, doesn't work in just three days, and helps only a very small proportion of patients, FDA officials wrote Novartis on Friday in ordering such ads to immediately cease.

"The ads are messages of hope based on true patient experiences," that let people know they should ask doctors about new treatments, said Novartis spokesman Greg Baird.

The ads run periodically and aren't running now, but Novartis will discuss FDA's concerns with agency officials, he said.

Zelnorm was approved last summer to treat women with one form of irritable bowel syndrome, the type associated with constipation. In studies FDA stressed at the time, patients fared only a little better -- 5 percent to 10 percent better -- when taking Zelnorm than when taking dummy pills.

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Measuring Treatment Effects in IBS Trials new
      #24040 - 10/20/03 03:30 PM

American College of Gastroenterology 68th Annual Scientific Meeting

Baltimore, Wednesday, October 15, 2003

Measuring Treatment Effects in IBS Trials

There is no single therapeutic approach to IBS. Most patients (ie, those with mild symptoms and minimal impairment) with IBS can be managed at a primary-care level. Fewer than 25% of patients with IBS have more severe symptoms with significant lifestyle impairment requiring management by a gastroenterologist, and 5% of patients with IBS have such severe and incapacitating symptoms that they require referral to a center with multispecialty capability.[9] Goals of therapy should focus on symptom management rather than cure.

It would seem intuitive that investigators performing therapeutic trials for IBS would measure changes in individual IBS symptoms, such as abdominal pain, bloating, and bowel habit satisfaction in order to determine therapeutic efficacy. Reliance on changes in individual symptoms, however, may not be as sensitive an endpoint as global IBS symptom relief, likely due to the nonspecific, variable, and subjective complaints that are common with IBS.

Dunger-Baldauf and colleagues[10] presented data from a large Nordic trial assessing tegaserod for treatment of IBS symptoms in 647 patients (83% women) with nondiarrhea-predominant disease. These investigators examined the primary outcome variable -- global IBS symptom relief -- relative to changes in the individual symptoms of IBS. They demonstrated that global relief is responsive to changes in the individual symptoms of IBS and is therefore appropriate as a primary outcome of IBS therapy trials. This is an important concept because trials that show improvement in individual IBS symptoms may not translate into overall improvement of the patient with IBS. Clinicians examining IBS therapy trials should look for this outcome.

9. Drossman DA, Thompson WG. The irritable bowel syndrome: review and a graduated, multicomponent treatment approach. Ann Intern Med. 1992;116:1009-1016.

10. Dunger-Baldauf C, Nyhlin H, Ruegg P, et al. Subject's global assessment of satisfactory relief as a measure to assess treatment effect in clinical trials in irritable bowel syndrome (IBS). Am J Gastroenterol. 2003;98:S269.[Abstract #809]



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