The Efficacy and Safety of Rifaximin for the Irritable Bowel Syndrome: A Systematic Review and Meta-Analysis
Abstract
OBJECTIVES: Irritable bowel syndrome (IBS) affects 10-15% of the population, and treatment options are limited. Rifaximin is a minimally absorbed antibiotic that has shown efficacy in IBS patients. The objective of our study was to perform a meta-analysis and systematic review of available randomized, placebo controlled trials evaluating the efficacy and tolerability of rifaximin in patients with IBS. METHODS: We performed a systematic literature search of multiple online electronic databases regardless of language. Inclusion criteria entailed randomized, placebo controlled trials and IBS defined by accepted symptom-based criteria. Meta-analysis was conducted to evaluate the summary odds ratios (ORs) and 95% confidence intervals (CIs) of combined studies for the primary and secondary outcomes using a random-effects model based on the DerSimonian and Laird method to reflect both within- and between study variability. We assessed heterogeneity using χ(2) test and the inconsistency index statistic (I(2)). Significant heterogeneity was defined as I(2) ≥25%. Meta-regression was performed using generalized linear mixed-effects model and study as random effects to estimate the summary OR adjusting for covariate differences across studies and treatment group. Publication bias was assessed by funnel plot analysis. RESULTS: Systematic review identified 13,700 citations. Eighteen were deemed to be potentially relevant, of which five articles met eligibility. Meta-analysis found rifaximin to be more efficacious than placebo for global IBS symptom improvement (OR=1.57; 95% CI=1.22, 2.01; therapeutic gain=9.8%; number needed to treat (NNT)=10.2), with mild heterogeneity (P=0.25, I(2)=26%). For the key secondary outcome of bloating, raw data were available for four studies. Rifaximin was significantly more likely to improve bloating than placebo (OR=1.55; 95% CI=1.23-1.96; therapeutic gain=9.9%; NNT=10.1), with no significant heterogeneity (P=0.27, I(2)=23%). We found that studies with older patients and more females demonstrated higher response rates, which was consistent regardless of treatment group. In addition, studies with higher cumulative dose tended to report a higher response rate. Of the covariates evaluated, we found age to be most predictive of response, with a correlation coefficient of 0.97 between aggregate response rate and mean age in the placebo groups. Although studies with higher cumulative dose tended to show increased response rates, this was also seen consistently in both the treated and placebo groups. Adverse effects were similar among patients receiving rifaximin or placebo in all studies. The most common adverse events (AEs) (≤10%) with rifaximin were headache, upper respiratory infection, nausea, nasopharygitis, diarrhea, and abdominal pain. Serious AEs were rare (<1%) and similar with rifaximin and placebo. CONCLUSIONS: Rifaximin proved more effective than placebo for global symptoms and bloating in IBS patients. The modest therapeutic gain was similar to that yielded by other currently available therapies for IBS. AEs were similar between rifaximin and placebo.
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Available metanalysis tend to show a beneficial profile of rifaximin vs placebo on global IBS symptoms and bloating.
“available metanalysis tend to show a beneficial profile of rifaximin vs placebo on global IBS symptoms and bloating [291]”
From Gut microbiota role in irritable bowel syndrome: New therapeutic strategies (2016) · cites this paper as [291]
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Management Options for Irritable Bowel Syndrome
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“involving 5 high quality studies, found efficacy for global IBS symptoms, with secondary outcome analysis indicating that bloating could be the key symptom responding to rifaximin in nonconstipated IBS.(206) Adverse effects were similar among patients receiving rifaximin or placebo in all studies.”
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“¶Salix Pharmaceuticals, Inc., Raleigh, NC, USA.”
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“The support for this concept has been based on breath test studies [6,7,25–28], small bowel culture studies [8,9], and the success of antibiotic treatments in improving IBS symptoms [6,29,30].”
BackgroundThe colonic microbiota in health and disease
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“In addition, although early studies of bacterial overgrowth in irritable bowel syndrome, based largely on breath testing, have not found widespread confirmation, the efficacy of the locally active, nonabsorbed antibiotic rifaximin merits further investigation [54].”
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“After only a short treatment period (10 - 14 days), the efficacy of rifaximin was observed to persist up to 12 weeks (88).”
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“14, 46 However, to date there is little evidence to suggest that rifaximinmediated improvements in IBS symptoms are attributed to direct effects on gut motility.(16)”
BackgroundLayer, P., Andresen, V., Allescher, H. ‐., Bischoff, S. C., Claßen, M., Elsenbruch, S., Freitag, M., Frieling, T., Gebhard, M., Goebel‐Stengel, M., et al. (2021) · Zeitschrift für Gastroenterologie · doi:10.1055/a-1591-4794 · Cited by 78 · see citing works
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“Rifaximin showed similar changes in response rates when compared with placebo.(10,11,13) However, this assumption needs further study to confirm.”
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“tently been shown to be associated with a very low rate of side effects, which can be explained by the minimal systemic absorption of this antibiotic.(18) Therefore, in our opinion, the use of rifaximin for management of IBS”
BackgroundResultCan fecal microbiota transplantation cure irritable bowel syndrome?
Halkjær, S. I., Boolsen, A. W., Günther, S., Christensen, A. H., & Petersen, A. M. (2017) · World Journal of Gastroenterology · doi:10.3748/wjg.v23.i22.4112 · Cited by 59 · see citing works
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Self-citationUse of rifaximin in gastrointestinal and liver diseases
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“Currently, non-absorbable antibiotics (eg, rifaximin) are used to alleviate SIBO-associated symptoms.(8,9) This beneficial effect of antibiotics may in part be due altered location or quality of the patient’s gastrointestinal microbiota.”
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“Antidepressants Pain Moderate Psychological, antinociceptive, slow (TCA) or fast (SSRI) transit effects dry mouth and drowsiness [110, 112]”
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“coli DH5α than rifaximin, considered to be the antibiotic of choice for treating SIBO [34].”
BackgroundIntestinal Targeting of Drugs: Rational Design Approaches and Challenges
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Targeting the gut microbiota for the treatment of irritable bowel syndrome
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Irritable Bowel Syndrome: Modern Concepts and Management Options
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“needed-to-treat around 11),(108, 109) the effect persisting beyond the duration of use.”
BackgroundCurrent and future pharmacological treatments for diarrhea-predominant irritable bowel syndrome
Camilleri, M. (2013) · Expert Opinion on Pharmacotherapy · doi:10.1517/14656566.2013.794223 · Cited by 50 · see citing works
“A meta-analysis that included five clinical trials demonstrated global IBS symptom and bloating improvement, but no significant effect on bowel function [47].”
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“HZ, YL, and WZ contributed equally to this study.”
Pharmacotherapy for Irritable Bowel Syndrome
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“A meta-analysis of five randomized controlled trials of rifaximin [80], comprising 1803 patients, reported similar efficacy with an NNT of 10 for improvement in global symptoms and bloating.”
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“001), with a comparable adverse events occurrence in both groups [75].”
BackgroundSmall Intestinal Bacterial Overgrowth
Bushyhead, D. W., & Quigley, E. M. M. (2021) · Gastroenterology Clinics of North America · doi:10.1016/j.gtc.2021.02.008 · Cited by 48 · see citing works
Caecal pH is a biomarker of excessive colonic fermentation
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Self-citationThe Colonic Microbiota and Colonic Disease
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“Regardless, the focus on the microbiota has been intensified by evidence for a therapeutic role for some, but not all, probiotics [20] and for the use of a locally active nonabsorbed antibiotic, rifaximin [21].”
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“20 27 Preclinical studies have shown that polymorphs α and β of rifaximin are the least absorbed ones.”
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“Regarding its safety profile, meta-analyses of rifaximin trials showed no difference in the overall incidence of AEs compared with placebo [Ford et al. 2014a; Menees et al. 2012; Shah et al. 2012].”
BackgroundThe gut microbiome and irritable bowel syndrome: State of art review
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“Antibiotics like rifaximin showed an overall improvement in global symptoms and bloating but did not affect the frequency of bowel movements, urgency, or stool consistency [45].”
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“These results are supported by a meta-analysis that included five studies and found improvement of IBS symptoms using rifaximin with a modest therapeutic gain similar to other currently available IBS therapies (Menees et al. , 2012).”
Treatment of Dientamoeba fragilis in Patients with Irritable Bowel Syndrome
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“This is quite low, considering the numbers needed to treat reported in the literature for drugs in IBS (Brandt et al., 2009; Camilleri and Mayer, 2009; Menees et al., 2012).”
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“In 2 later systematic reviews with meta-analyses published 2 years apart, the second one with 10 times more patients treated with rifaximin vs placebo, it was concluded, and with a good level of evidence, that the antibiotic at doses of 400 to 550 mg, 2 to 3 times/day, was twice as effective as the placebo at improvin…”
Advances in IBS 2016: A Review of Current and Emerging Data.
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“001).(53) In two phase 3, identically designed, placebo‐controlled trials, which were included in the meta‐analysis publication, a significantly greater percentage of patients with IBS‐D treated with a 2‐week course of”
BackgroundWhen the low FODMAP diet does not work
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- Authors
- Menees, S. B., Maneerattannaporn, M., Kim, H. M., & Chey, W. D.
- Affiliations
- Michigan Medicine (US)
- Corresponding author
- Chey, William D
- Venue
- American Journal of Gastroenterology
- Published
- 2012-01
- Volume
- 107
- Issue
- 1
- Pages
- 28-35
- ISSN
- 0002-9270 (ISSN-L)
- OpenAlex
- W2049004338
- Cited by
- 283
- References
- 58
- Citations by year
- 2026: 6 · 2025: 10 · 2024: 11 · 2023: 12 · 2022: 13 · 2021: 20 · 2020: 21 · 2019: 13 · 2018: 24 · 2017: 24 · 2016: 29 · 2015: 27 · 2014: 39 · 2013: 21 · 2012: 12
- FWCI
- 3.86
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The American Journal of Gastroenterology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
- Health Sciences › Medicine › Epidemiology › Microscopic Colitis
- Keywords
- rifaximin, irritable bowel syndrome, bloating, treatment efficacy, tolerability, cumulative dose, subgroup analysis, publication bias, number needed to treat, subgroup heterogeneity
- MeSH terms
- Rifaximin, Anti-Infective Agents, Humans, Rifamycins, Randomized Controlled Trials as Topic, Irritable Bowel Syndrome
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