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Rifaximin appears safe, effective for treating SIBO
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Rifaximin appeared safe and effective for the treatment of small intestinal bacterial overgrowth in adults, according to the results of a systematic review and meta-analysis.
However, investigators noted that available studies are of generally poor quality, and that randomized controlled trials are needed to confirm these findings and optimize rifaximin regimens for SIBO.
“Rifaximin is a poorly absorbed antibiotic with a broad spectrum of antibacterial activity, covering Gram-positive and Gram-negative microorganism, both aerobes and anaerobes,” Luigi Gatta, MD, PhD, of the University of Parma and Versilia Hospital in Italy, told Healio Gastroenterology. “This antibiotic fulfills all the characteristics set by DuPont and Ericsson for the ideal antimicrobial that should be used for the treatment of gastrointestinal infections (including dysbiosis and SIBO). For this reason, over the past decades, rifaximin has been largely used to treat SIBO even if there was a lack of a critical summary of evidence.”
To assess the clinical effectiveness and safety of rifaximin for treating SIBO, Gatta and Carmelo Scarpignato, MD, also of the University of Parma, searched for randomized controlled trial and observational study data published up to March 12, 2015, and included 32 studies involving 1,331 patients in their analysis.
They found that rifaximin led to an overall SIBO eradication rate of 70.8% (95% CI, 61.4-78.2) based on intention-to-treat (ITT) analysis of 26 studies, and 72.9% (95% CI, 65.5-79.8) based on per protocol (PP) analysis of all 32 studies.
A subset of studies in IBS patients showed the pooled SIBO eradication rate was 71.6% (95% CI, 56.7-84.4) based on ITT analysis and 75.4% (95% CI, 65-84.5) based on PP analysis.
Because there was significant heterogeneity among trials, the researchers performed meta-regression analysis, and found drug dose, study design and co-therapy were all independently associated with a higher eradication rate.
Regarding safety, the overall adverse event rate was 4.6% (95% CI, 2.3-7.5).
Finally, a subset of 10 studies showed 67.7% (95% CI, 44.7-86.9) of SIBO patients experienced improvement or resolution of symptoms after eradication therapy.
“Concomitant administration of rifaximin with fibers (both soluble and insoluble), probiotics (Lactobacilli and Bifidobacteria), or mesalazine, three gut microbiota-directed therapies, consistently gave higher eradication rate,” the researchers noted.
“To the best of our knowledge, this is the first systematic review and meta-analysis assessing the clinical effectiveness and safety of rifaximin to eradicate SIBO in randomized and non-randomized studies in adult patients,” Gatta said. “Our results show that rifaximin treatment seems to be effective and safe for the treatment of SIBO. However, the quality of the available studies is generally not high. For this reason, further well-designed RCTs are needed to substantiate these findings and to establish the optimal regimen.” – by Adam Leitenberger
Disclosures: Scarpignato reports he is a member of the speakers bureau and scientific advisory board for Alfa Wassermann, the manufacturer and marketer of rifaximin.
Editor's note: This article was updated on Feb. 6 with comments from a study investigator.
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