Important note: Information in this article was accurate in 1994. The state of the art may have changed since the publication date.
A randomized placebo-controlled trial of Saccharomyces boulardii in combination with standard antibiotics for Clostridium difficile disease [published erratum appears in JAMA 1994 Aug 17;272(7):518]
JAMA. 1994 Jun 22-29;271(24):1913-8. Unique Identifier : AIDSLINE MED/94260673 McFarland LV; Surawicz CM; Greenberg RN; Fekety R; Elmer GW; Moyer KA; Melcher SA; Bowen KE; Cox JL; Noorani Z; et al; Department of Medicinal Chemistry, School of Pharmacy, University; of Washington, Seattle 98195.
Abstract:
OBJECTIVE--To determine the safety and efficacy of a new combination treatment for patients with Clostridium difficile-associated disease (CDD). The treatment combines the yeast Saccharomyces boulardii with an antibiotic (vancomycin hydrochloride or metronidazole). DESIGN--A double-blind, randomized, placebo-controlled, parallel-group intervention study in patients with active CDD. Patients received standard antibiotics and S boulardii or placebo for 4 weeks, and were followed up for an additional 4 weeks after therapy. Effectiveness was determined by comparing the recurrence of CDD in the two groups using multivariate analysis to control for other risk factors for CDD. SETTING--National referral study of ambulatory or hospitalized patients from three main study coordinating centers. PATIENTS--A total of 124 eligible consenting adult patients, including 64 who were enrolled with an initial episode of CDD, and 60 who had a history of at least one prior CDD episode. Patients who were immunosuppressed due to acquired immunodeficiency syndrome or cancer chemotherapy within 3 months were not eligible. INTERVENTION--Treatment with oral S boulardii (1 g/d for 4 weeks) or placebo in combination with a standard antibiotic. MAIN OUTCOME MEASURE--Recurrence of active CDD. RESULTS--A history of CDD episodes dramatically increased the likelihood of further recurrences. Multivariate analysis revealed that patients treated with S boulardii and standard antibiotics had a significantly lower relative risk (RR) of CDD recurrence (RR, 0.43; 95% confidence interval, 0.20 to 0.97) compared with placebo and standard antibiotics. The efficacy of S boulardii was significant (recurrence rate 34.6%, compared with 64.7% on placebo; P = .04) in patients with recurrent CDD, but not in patients with initial CDD (recurrence rate 19.3% compared with 24.2% on placebo; P = .86). There were no serious adverse reactions associated with S boulardii. CONCLUSIONS--The combination of standard antibiotics and S boulardii was shown to be an effective and safe therapy for these patients with recurrent CDD; no benefit of S boulardii was demonstrated for those with an initial episode of CDD.
Keywords: Adult Aged Clostridium difficile Double-Blind Method Drug Therapy, Combination Enterocolitis, Pseudomembranous/*DRUG THERAPY Female Human Male Metronidazole/*THERAPEUTIC USE Middle Age Recurrence Support, Non-U.S. Gov't Vancomycin/*THERAPEUTIC USE Yeast, Dried/*THERAPEUTIC USE CLINICAL TRIAL JOURNAL ARTICLE MULTICENTER STUDY RANDOMIZED CONTROLLED TRIAL
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Important note: Information in this article was accurate in 1994. The state of the art may have changed since the publication date.
