The DOI matches its Crossref record; 58 of the 58 references it cites were found in a registry or an index.
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 [291]”
From Gut microbiota role in irritable bowel syndrome: New therapeutic strategies (2016) · cites this paper as [291]
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“¶Salix Pharmaceuticals, Inc., Raleigh, NC, USA.”
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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)”
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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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“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].”
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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
“A meta-analysis that included five clinical trials demonstrated global IBS symptom and bloating improvement, but no significant effect on bowel function [47].”
MethodZheng, H., Li, Y., Zhang, W., Zeng, F., Zhou, S., Zheng, H., Zhu, W., Jing, X., Rong, P., Tang, C., et al. (2016) · Medicine · doi:10.1097/md.0000000000003884 · Cited by 49
“HZ, YL, and WZ contributed equally to this study.”
Pharmacotherapy for Irritable Bowel Syndrome
Camilleri, M., & Ford, A. C. (2017) · Journal of Clinical Medicine · doi:10.3390/jcm6110101 · Cited by 53
“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.”
MethodMari, A., Baker, F. A., Mahamid, M., Sbeit, W., & Khoury, T. (2020) · Journal of Clinical Medicine · doi:10.3390/jcm9030685 · Cited by 57
“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
Caecal pH is a biomarker of excessive colonic fermentation
Farmer, A. D. (2014) · World Journal of Gastroenterology · doi:10.3748/wjg.v20.i17.5000 · Cited by 47
Clinical practice guidelines for irritable bowel syndrome in Korea, 2017 revised edition
Song, K. H., Jung, H.-K., Kim, H. J., Koo, H. S., Kwon, Y. H., Shin, H. D., Lim, H. C., Shin, J. E., Kim, S. E., Cho, D. H., et al. (2018) · Journal of Neurogastroenterology and Motility · doi:10.5056/jnm17145 · Cited by 47
Self-citationThe Colonic Microbiota and Colonic Disease
Shanahan, F. (2012) · Current Gastroenterology Reports · doi:10.1007/s11894-012-0281-5 · Cited by 49
“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].”
BackgroundScarpignato, C., Blandizzi, C., & Viscomi, G. C. (2014) · Drug Design Development and Therapy · doi:10.2147/dddt.s72572 · Cited by 46
“20 27 Preclinical studies have shown that polymorphs α and β of rifaximin are the least absorbed ones.”
Irritable bowel syndrome: new and emerging treatments
Halland, M., & Saito, Y. (2015) · British medical journal · doi:10.1136/bmj.h1622 · Cited by 46
Chang, F. (2014) · World Journal of Gastroenterology · doi:10.3748/wjg.v20.i10.2499 · Cited by 46
Foxx–Orenstein, A. E. (2016) · Therapeutic Advances in Gastroenterology · doi:10.1177/1756283x16633050 · Cited by 45
“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
Salem, A., Singh, R., Ayoub, Y. K., Khairy, A. M., & Mullin, G. E. (2018) · Arab Journal of Gastroenterology · doi:10.1016/j.ajg.2018.02.008 · Cited by 45
Probiotics in Irritable Bowel Syndrome: A Review of Their Therapeutic Role
Kumar, L. S., Pugalenthi, L. S., Ahmad, M., Reddy, S., Barkhane, Z., & Elmadi, J. (2022) · Cureus · doi:10.7759/cureus.24240 · Cited by 58
“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].”
BackgroundTuteja, A. K., Talley, N. J., Stoddard, G. J., & Verne, G. N. (2019) · Digestive Diseases and Sciences · doi:10.1007/s10620-018-5344-5 · Cited by 42
Pharmacologic, Pharmacokinetic, and Pharmacogenomic Aspects of Functional Gastrointestinal Disorders
Camilleri, M., Bueno, L. P., Andresen, V., Ponti, F. D., Choi, M., & Lembo, A. J. (2016) · Gastroenterology · doi:10.1053/j.gastro.2016.02.029 · Cited by 45
König, J., & Brummer, R. J. (2014) · Beneficial Microbes · doi:10.3920/bm2013.0033 · Cited by 43
“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
Engsbro, A. L., Stensvold, C. R., Nielsen, H. V., & Bytzer, P. M. (2012) · American Journal of Tropical Medicine and Hygiene · doi:10.4269/ajtmh.2012.11-0761 · Cited by 39
Mazzawi, T. R. E., Hausken, T., Hov, J. R., Valeur, J., Sangnes, D. A., El‐Salhy, M., Gilja, O. H., Hatlebakk, J. G., & Lied, G. A. (2019) · Scandinavian Journal of Gastroenterology · doi:10.1080/00365521.2019.1624815 · Cited by 43
“The role of gut microbiota alterations in IBS has led to increased interest in using probiotic [2] and antibiotic [3] approaches for improving IBS symptoms [2].”
BackgroundЛазебник, Л. Б., Голованова, Е. В., Volel, B. A., Korochanskaya, N. V., Lyalyukova, E. A., Мокшина, М. В., Насрединович, М. С., Мехтиева, О. А., Metsaeva, Z. V., Petelin, D. S., et al. (2021) · Экспериментальная и клиническая гастроэнтерология · doi:10.31146/1682-8658-ecg-192-8-5-117 · Cited by 43
Drug Development for the Irritable Bowel Syndrome: Current Challenges and Future Perspectives
Ponti, F. D. (2013) · Frontiers in Pharmacology · doi:10.3389/fphar.2013.00007 · Cited by 40
“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).”
BackgroundHawrelak, J. A., Wohlmuth, H., Pattinson, M., Myers, S. P., Goldenberg, J. Z., Harnett, J., Cooley, K., Venter, C. V. D., Reid, R., & Whitten, D. L. (2019) · Complementary Therapies in Medicine · doi:10.1016/j.ctim.2019.102233 · Cited by 40
Shah, E. D., Salwen‐Deremer, J. K., Gibson, P. R., Muir, J. G., Eswaran, S. L., & Chey, W. D. (2020) · Clinical Gastroenterology and Hepatology · doi:10.1016/j.cgh.2020.09.043 · Cited by 40
Self-citationRifaximin, gut microbes and mucosal inflammation: unraveling a complex relationship
Gao, J., Gillilland, M. G., & Owyang, C. (2014) · Gut Microbes · doi:10.4161/gmic.32130 · Cited by 39
Schmulson, M. J., Bielsa, M. V., Carmona-Sánchez, R., Hernández, A., López‐Colombo, A., López‐Vidal, Y., Peláez‐Luna, M., Remes-Troche, J. M., Tamayo, J. L., & Valdovinos, M. A. (2014) · Revista de Gastroenterología de México (English Edition) · doi:10.1016/j.rgmxen.2014.01.001 · Cited by 38
“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.
Jacobson, I. M. (2016) · PubMed Central · Cited by 38
Lacy, B. (2018) · Alimentary Pharmacology and Therapeutics · doi:10.1111/apt.14948 · Cited by 36
“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
Halmos, E. P. (2017) · Journal of Gastroenterology and Hepatology · doi:10.1111/jgh.13701 · Cited by 37
Metadata
- 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 › Gastroenterology › 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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