Efficacy of pharmacological therapies in patients with IBS with diarrhoea or mixed stool pattern: systematic review and network meta-analysis
Open accessAbstract
Objective: Over half of patients with IBS have either diarrhoea (IBS-D) or a mixed stool pattern (IBS-M). The relative efficacy of licenced pharmacological therapies is unclear in the absence of head-to-head trials. We conducted a network meta-analysis to resolve this uncertainty. Design: We searched MEDLINE, Embase, Embase Classic, the Cochrane central register of controlled trials, and Clinicaltrials.gov through January 2019 to identify randomised controlled trials (RCTs) assessing the efficacy of licenced pharmacological therapies (alosetron, eluxadoline, ramosetron and rifaximin) in adults with IBS-D or IBS-M. Trials included in the analysis reported a dichotomous assessment of overall response to therapy, and data were pooled using a random effects model. Efficacy and safety of all pharmacological therapies were reported as a pooled relative risk with 95% CIs to summarise the effect of each comparison tested. Treatments were ranked according to their p score. Results: We identified 18 eligible RCTs (seven alosetron, five ramosetron, two rifaximin and four eluxadoline), containing 9844 patients. All were superior to placebo for the treatment of IBS-D or IBS-M at 12 weeks, according to the Food and Drug Administration (FDA)-recommended endpoint for trials in IBS. Alosetron 1 mg twice daily was ranked first for efficacy, based on the FDA-recommended composite endpoint of improvement in both abdominal pain and stool consistency, effect on global symptoms of IBS and effect on stool consistency. Ramosetron 2.5µg once daily was ranked first for effect on abdominal pain. Total numbers of adverse events were significantly greater with alosetron 1 mg twice daily and ramosetron 2.5µg once daily, compared with placebo. Rifaximin 550 mg three times daily ranked first for safety. Constipation was significantly more common with all drugs, except rifaximin 550 mg three times daily. Conclusion: In a network meta-analysis of RCTs of pharmacological therapies for IBS-D and IBS-M, we found all drugs to be superior to placebo, but alosetron and ramosetron appeared to be the most effective.
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A network meta-analysis comparing the relative efficacy of all these licensed therapies for IBS-D demonstrated that alosetron 1 mg two times per day ranked first for the FDA composite end point for IBS-D and global symptoms, with ramosetron 2.5 μg once a day second.
“A network meta-analysis comparing the relative efficacy of all these licensed therapies for IBS-D, across various end points, 153 demonstrated that alosetron 1 mg two times per day ranked first for the FDA composite end point for IBS-D and global symptoms (online supplemental figures 10 and 11), with ramosetron 2.5 μg once a day second.”
From British Society of Gastroenterology guidelines on the management of irritable bowel syndrome (2021) · cites this paper as [153]
Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measuredIn a meta-analysis of 2 RCTs, which recruited 1260 patients, rifaximin 550 mg three times a day for 14 days was more efficacious than placebo for the FDA composite end point for IBS-D (RR 0.92; 95% CI 0.86 to 0.98) and for stool consistency alone, but not for global symptoms or abdominal pain.
“In a meta-analysis of 2 RCTs, 153 which recruited 1260 patients, rifaximin 550 mg three times a day for 14 days was more efficacious than placebo for the FDA composite end point for IBS-D (RR 0.92; 95% CI 0.86 to 0.98) (online supplemental figure 10) and for stool consistency alone (online supplemental figure 12), but not for global symptoms or abdominal pain (online supple- mental figures 11 and”
From British Society of Gastroenterology guidelines on the management of irritable bowel syndrome (2021) · cites this paper as [153]
Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measuredFor abdominal pain, ramosetron 2.5μg once a day and ramosetron 5 μg once a day were ranked first and second, respectively.
“For, abdominal pain, ramosetron 2.5μg once a day and ramosetron 5 μg once a day were ranked first and second, respectively (online supplemental figure 13).”
From British Society of Gastroenterology guidelines on the management of irritable bowel syndrome (2021) · cites this paper as [153]
The ‘Failure to achieve an abdominal pain response’ section (page unavailable) ranks ramosetron 2.5 µg once daily first and reports that ramosetron 5 µg once daily was more effective than placebo. It does not state that the 5 µg dose ranked second for abdominal pain. (LLM, conf=0.84)
Experimental — accuracy not yet measuredAdverse events included constipation, nausea and headache, and adverse events leading to drop out were significantly higher with active drug than placebo.
“Adverse events included constipation, nausea and headache, and adverse events leading to drop out were significantly higher with active drug than placebo.”
From British Society of Gastroenterology guidelines on the management of irritable bowel syndrome (2021) · cites this paper as [153]
The Outcome assessment section (page unavailable) lists constipation, nausea and headache among the individual adverse events assessed. The Safety section (page unavailable) reports significantly more adverse-event-related dropouts than placebo for both studied doses of eluxadoline and for alosetron 1 mg twice daily, but not for active drugs generally. (LLM, conf=0.88)
Experimental — accuracy not yet measuredAdverse events included constipation, nausea and headache; patients assigned to both drugs were more likely to report adverse events than with placebo.
“Adverse events included constipation, nausea and headache; patients assigned to both drugs were more likely to report adverse events than with placebo.”
From British Society of Gastroenterology guidelines on the management of irritable bowel syndrome (2021) · cites this paper as [153]
The Safety section (page unavailable) reports significantly more overall adverse events with alosetron 1 mg twice daily and ramosetron 2.5 µg once daily than with placebo. The Discussion identifies constipation as an adverse event, but our copy does not identify nausea or headache among the reported events. (LLM, conf=0.86)
Experimental — accuracy not yet measured
Headache was the most common adverse event, but side effects were no more common with rifaximin than with placebo.
“Headache was the most common adverse event, but side effects were no more common with rifaximin than with placebo.”
From British Society of Gastroenterology guidelines on the management of irritable bowel syndrome (2021) · cites this paper as [153]
The Safety section (page unavailable) reports that rifaximin ranked best for overall adverse events and does not identify a significant increase versus placebo. The Outcome assessment section lists headache among the adverse events assessed, but our copy does not say it was the most common. (LLM, conf=0.84)
Experimental — accuracy not yet measuredIn a previous meta-analysis, both alosetron 1 mg two times per day and ramosetron 2.5 μg or 5 μg once a day were superior to placebo across various end points, including the FDA composite end point for IBS-D (3 RCTs of alosetron 1 mg two times per day, 787 patients, RR 0.69; 95% CI 0.60 to 0.80, and 1 RCT of ramosetron 2.5 μg once a day, 348 patients, RR 0.78; 95% CI 0.67 to 0.91).
“In a previous metaanalysis, 153 both alosetron 1 mg two times per day and ramosetron 2.5 μg or 5 μg once a day were superior to placebo across various end points, including the FDA composite end point for IBS-D (3 RCTs of alosetron 1 mg two times per day, 787 patients, RR 0.69; 95% CI 0.60 to 0.80, and 1 RCT of ramosetron 2.5 μg once a day, 348 patients, RR 0.78; 95% CI 0.67 to 0.91) (online supp”
From British Society of Gastroenterology guidelines on the management of irritable bowel syndrome (2021) · cites this paper as [153]
Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measuredFor the most part, licensed and unlicensed drugs tested in IBS are of similar efficacy.
“However, for the most part, these are of similar efficacy, and many patients are refractory to medical management.”
From Efficacy of psychological therapies for irritable bowel syndrome: systematic review and network meta-analysis (2020) · cites this paper as [25]
The Results report that all studied treatments were more effective than placebo, but the primary analysis found alosetron significantly more effective than every other active treatment except ramosetron 2.5 µg once daily. The Search strategy and study selection section limits the analysis to four licensed drugs for adults with IBS-D or IBS-M; it does not support a general claim about licensed and unlicensed drugs tested across IBS. (LLM, conf=0.85)
Experimental — accuracy not yet measuredRamosetron is only available in Asia. There have been no reports of ischaemic colitis associated with the drug.
“Ramosetron is only available in Asia. 153 There have been no reports of ischaemic colitis associated with the drug.”
From British Society of Gastroenterology guidelines on the management of irritable bowel syndrome (2021) · cites this paper as [153]
For stool consistency alosetron 1 mg two times per day ranked first, with ramosetron 5 μg once a day second.
“Finally, for stool consistency alosetron 1 mg two times per day ranked first, with ramosetron 5 μg once a day second (online supplemental figure 12).”
From British Society of Gastroenterology guidelines on the management of irritable bowel syndrome (2021) · cites this paper as [153]
Eluxadoline 100 mg two times per day was also superior to placebo for abdominal pain.
“Eluxadoline 100 mg two times per day was also superior to placebo for abdominal pain (online supplemental figure 13).”
From British Society of Gastroenterology guidelines on the management of irritable bowel syndrome (2021) · cites this paper as [153]
For the FDA composite end point, alosetron was superior to all treatments, except ramosetron 2.5 μg once a day.
“For the FDA composite end point, alosetron was superior to all treatments, except ramosetron 2.5 μg once a day”
From British Society of Gastroenterology guidelines on the management of irritable bowel syndrome (2021) · cites this paper as [153]
Both alosetron and ramosetron were also more efficacious than placebo for global symptoms, abdominal pain and stool consistency.
“Both drugs were also more efficacious than placebo for global symptoms, abdominal pain and stool consistency (online supplemental figures 11-13).”
From British Society of Gastroenterology guidelines on the management of irritable bowel syndrome (2021) · cites this paper as [153]
All drugs except rifaximin were more likely to cause constipation than placebo.
“All drugs, except rifaximin, were more likely to cause constipation than placebo”
From Irritable bowel syndrome (2020) · cites this paper as [125]
A network meta-analysis of 18 RCTs demonstrated that 5-HT3 receptor antagonists ranked first for improvement in global symptoms, abdominal pain, and stool consistency.
“A network meta-analysis of 18 RCTs demonstrated that 5-HT3 receptor antagonists ranked first for improvement in global symptoms, abdominal pain, and stool consistency”
From Irritable bowel syndrome (2020) · cites this paper as [125]
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Oka, P., Parr, H., Barberio, B., Black, C. J., Savarino, E. V., & Ford, A. C. (2020) · The Lancet Gastroenterology & Hepatology · doi:10.1016/s2468-1253(20)30217-x · Cited by 882 · see citing works
Self-citationFord, A. C., Sperber, A. D., Corsetti, M., & Camilleri, M. (2020) · The Lancet · doi:10.1016/s0140-6736(20)31548-8 · Cited by 818 · see citing works
Self-citationFunctional gastrointestinal disorders: advances in understanding and management
Black, C. J., Drossman, D. A., Talley, N. J., Ruddy, J., & Ford, A. C. (2020) · The Lancet · doi:10.1016/s0140-6736(20)32115-2 · Cited by 605 · see citing works
Self-citationBritish Society of Gastroenterology guidelines on the management of irritable bowel syndrome
Vasant, D. H., Paine, P. A., Black, C. J., Houghton, L. A., Everitt, H. A., Corsetti, M., Agrawal, A., Aziz, I., Farmer, A. D., Eugenicos, M. P., et al. (2021) · Gut · doi:10.1136/gutjnl-2021-324598 · Cited by 547 · see citing works
Self-citationBlack, C. J., Thakur, E. R., Houghton, L. A., Quigley, E. M. M., Moayyedi, P., & Ford, A. C. (2020) · Gut · doi:10.1136/gutjnl-2020-321191 · Cited by 299 · see citing works
Self-citationIaniro, G., Eusebi, L. H., Black, C. J., Gasbarrini, A., Cammarota, G., & Ford, A. C. (2019) · Alimentary Pharmacology & Therapeutics · doi:10.1111/apt.15330 · Cited by 188 · see citing works
Self-citationBlack, C. J., Yuan, Y., Selinger, C. P., Camilleri, M., Quigley, E. M. M., Moayyedi, P., & Ford, A. C. (2020) · The Lancet Gastroenterology & Hepatology · doi:10.1016/s2468-1253(19)30324-3 · Cited by 171 · see citing works
Self-citationEfficacy of Probiotics in Irritable Bowel Syndrome: Systematic Review and Meta-analysis
Goodoory, V. C., Khasawneh, M., Black, C. J., Quigley, E. M. M., Moayyedi, P., & Ford, A. C. (2023) · Gastroenterology · doi:10.1053/j.gastro.2023.07.018 · Cited by 128 · see citing works
Self-citationNo distinct microbiome signature of irritable bowel syndrome found in a Swedish random population
Hugerth, L. W., Andreasson, A., Talley, N. J., Forsberg, A. M., Kjellström, L., Schmidt, P. T., Agreus, L., & Engstrand, L. (2020) · Gut · doi:10.1136/gutjnl-2019-318717 · Cited by 102 · see citing works
An evidence-based update on the diagnosis and management of irritable bowel syndrome
Black, C. J., & Ford, A. C. (2025) · Expert Review of Gastroenterology & Hepatology · doi:10.1080/17474124.2025.2455586 · Cited by 27 · see citing works
Self-citationPeppermint Oil in Irritable Bowel Syndrome
Black, C. J., Moayyedi, P., Quigley, E. M. M., & Ford, A. C. (2020) · Gastroenterology · doi:10.1053/j.gastro.2019.09.055 · Cited by 12 · see citing works
Self-citation
- Authors
- Black, C. J., Burr, N. E., Camilleri, M., Earnest, D. L., Quigley, E. M., Moayyedi, P., Houghton, L. A., & Ford, A. C.
- Affiliations
- University of Leeds (GB)
- Mayo Clinic (US)
- University of Arizona (US)
- Houston Methodist (US)
- McMaster University (CA)
- Corresponding author
- Ford, Alexander C
- ORCID
- Venue
- Gut
- Publisher
- BMJ
- Published
- 2019-04-17
- Volume
- 69
- Issue
- 1
- Pages
- 74-82
- ISSN
- 0017-5749 (ISSN-L)
- 1468-3288
- OpenAlex
- W2939585492
- Cited by
- 191
- References
- 64
- Citations by year
- 2026: 24 · 2025: 17 · 2024: 20 · 2023: 19 · 2022: 41 · 2021: 39 · 2020: 23 · 2019: 6
- FWCI
- 4.93
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Gut (publishedVersion)
- PubMed (publishedVersion)
- White Rose Research Online (University of Leeds, The University of Sheffield, University of York) (acceptedVersion)
- HighWire Press Open Archive (submittedVersion)
- Topics
- Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Inflammatory Bowel Disease
- Health Sciences › Health Professions › Pharmacy › Infant Health and Development
- Keywords
- irritable bowel syndrome, pharmacotherapy, alosetron, ramosetron, eluxadoline, rifaximin, drug efficacy, drug safety, adverse events, abdominal pain, stool consistency, constipation
- MeSH terms
- Diarrhea, Gastrointestinal Agents, Humans, Abdominal Pain, Randomized Controlled Trials as Topic, Treatment Outcome, Treatment Failure, Endpoint Determination, Irritable Bowel Syndrome, Pain Management
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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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