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Title: Rifaximin Helps in the Treatment of Irritable Bowel Syndrome: Presented at ACG

"Rifaximin Helps in the Treatment of Irritable Bowel Syndrome: Presented at ACG"

By Paula Moyer HONOLULU, HI -- November 2, 2005 -- Patients with irritable bowel syndrome (IBS) often get relief from one 10-day course of rifaximin (Xifaxan), according to investigators who presented their findings here November 1[^st at the 70^th annual meeting of the American College of Gastroenterology (ACG).

Rifaximin is currently approved for the treatment of traveler's diarrhea but is often used off-label to treat IBS. The current research was designed to see whether the treatment is effective in the IBS setting.

"This is the first treatment I've seen for IBS with which the benefit is sustained when the treatment is stopped," said principal investigator Mark Pimentel, MD, Director, GI Motility Program, Cedars-Sinai Medical Center, Los Angeles. "Typically when you stop the treatment, you're right back to baseline."

Dr. Pimentel and colleagues randomized 87 patients who met Rome I criteria for IBS to receive either placebo or 400 mg of rifaximin orally three times daily for 10 days. During the treatment phase and for 7 days after treatment ended, subjects completed a stool diary and responded to a symptom questionnaire and lactulose breath test. Subjects and investigators were blinded to the test results.

The 43 patients in the rifaximin group had an average overall symptom improvement of 37.7%, compared to compared to 23.4% of the 44 placebo patients (P < .05). In treatment group, 37% of participants were classified as clinical responders, compared to 16% of those in the placebo group. The study defined response as at least a 50% overall improvement.

Subjects with diarrhea were more likely than those with constipation to respond to treatment with rifaximin, Dr. Pimentel said. The clinical response among those with diarrhea was 49% for those on rifaximin compared to 23% of those on placebo (P < .05). Bloating was also improved, but not in a statistically significant manner, and the investigators documented no difference in patients with constipation.

The study was funded by Salix Pharmaceuticals, Ltd., which manufactures Xifaxan.

[Presentation title: Rifaximin, a Non-Absorbable Antibiotic Improves the Symptoms of Irritable Bowel Syndrome: a Double-Blind Randomized Controlled Study. Abstract 42]

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