Original Contribution | Published:

Functional GI Disorders

A Randomized Double-Blind Placebo-Controlled Trial of Rifaximin in Patients with Abdominal Bloating and Flatulence

The American Journal of Gastroenterology volume 101, pages 326333 (2006) | Download Citation

Drs. Sharara and Aoun contributed equally to this manuscript.

Subjects

Abstract

AIMS:

To study the efficacy of rifaximin, a nonabsorbable antibiotic, in relieving chronic functional symptoms of bloating and flatulence.

METHODS:

Randomized double-blind placebo-controlled trial consisting of three 10-day phases: baseline (phase 1), treatment with rifaximin 400 mg b.i.d. or placebo (phase 2), and post-treatment period (phase 3). Primary efficacy variable was subjective global symptom relief at the end of each phase. A symptom score was calculated from a symptom diary. Lactulose H2-breath test (LHBT) was performed at baseline and end of study.

RESULTS:

One hundred and twenty-four patients were enrolled (63 rifaximin and 61 placebo). Baseline characteristics were comparable and none had an abnormal baseline LHBT. Rome II criteria were met in 58.7% and 54.1%, respectively. At the end of phase 2, there was a significant difference in global symptom relief with rifaximin versus placebo (41.3%vs 22.9%, p= 0.03). This improvement was maintained at the end of phase 3 (28.6%vs 11.5%, p= 0.02). Mean cumulative and bloating-specific scores dropped significantly in the rifaximin group (p <0.05). Among patients with IBS, a favorable response to rifaximin was noted (40.5%vs 18.2%; p= 0.04) persisting by the end of phase 3 (27%vs 9.1%; p= 0.05). H2-breath excretion dropped significantly among rifaximin responders and correlated with improvement in bloating and overall symptom scores (p= 0.01). No adverse events were reported.

CONCLUSIONS:

Rifaximin is a safe and effective treatment for abdominal bloating and flatulence, including in IBS patients. Symptom improvement correlates with reduction in H2-breath excretion. Future trials are needed to examine the efficacy of long-term or cyclic rifaximin in functional colonic disorders.

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Author information

Affiliations

  1. Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon

    • Ala I Sharara
    • , Elie Aoun
    • , Heitham Abdul-Baki
    •  & Ihab ElHajj
  2. School of Medicine, American University of Beirut, Beirut, Lebanon

    • Rawad Mounzer
    •  & Shafik Sidani

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Correspondence to Ala I Sharara.

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DOI

https://doi.org/10.1111/j.1572-0241.2006.00458.x

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