Ramosetron Reduces Symptoms of Irritable Bowel Syndrome With Diarrhea and Improves Quality of Life in Women
Open accessAbstract
Background & aims Previous studies have indicated that serotonin-3-receptor antagonists might have a sex-specific effect in patients with irritable bowel syndrome with diarrhea (IBS-D). Alosetron has been approved for the treatment of only women, and ramosetron has been approved for the treatment for only men. We performed a randomized, placebo-controlled, phase 3 study to determine whether ramosetron reduces symptoms of IBS-D in women. Methods We performed a prospective study of 576 female outpatients with IBS-D (according to the Rome III criteria), from February 2013 through February 2014, at 70 academic Gastroenterology Departments in Japan. After a 1-week baseline period, subjects received either 2.5 μg ramosetron (n = 292) or placebo (n = 284) once daily for 12 weeks. Primary end points were the monthly rates of response for relief from overall IBS symptoms and increased stool consistency at the last evaluation point. Quality of life (QOL) also was quantified. Results A significantly higher proportion of patients given ramosetron reported global improvement (50.7%; 95% confidence interval [CI], 44.8-56.6) than patients given placebo (32.0%; 95% CI, 26.7-37.8)--a difference of 18.6% (95% CI, 10.7-26.5; P Conclusions In a randomized, placebo-controlled study of 576 women with IBS-D, 2.5 μg ramosetron per day reduced symptoms and increased stool consistency and QOL. Clinicaltrials.gov no: NCT01870895.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
All these drugs (5-HT3 antagonists, eluxadoline, rifaximin) have demonstrated efficacy over placebo in IBS-D.
“Although all these drugs have demonstrated efficacy over placebo”
From Irritable bowel syndrome (2020) · cites this paper as [124]
Cites
FRANCIS, C. Y., MORRIS, J., & WHORWELL, P. J. (1997) · Alimentary Pharmacology & Therapeutics · doi:10.1046/j.1365-2036.1997.142318000.x · Cited by 1,708 · see citing works
Patrick, D. L., Drossman, D. A., Frederick, I. O., Dicesare, J., & Puder, K. L. (1998) · Digestive Diseases and Sciences · doi:10.1023/a:1018831127942 · Cited by 761 · see citing works
Yadav, S., Dave, M., Edakkanambeth Varayil, J., Harmsen, W. S., Tremaine, W. J., Zinsmeister, A. R., Sweetser, S. R., Melton, L. J., Sandborn, W. J., & Loftus, E. V. (2015) · Clinical Gastroenterology and Hepatology · doi:10.1016/j.cgh.2014.07.061 · Cited by 164 · see citing works
Flagged first, then by citations
Cited by
Sorted by citations
Ford, 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
Sex-gender differences in irritable bowel syndrome
Kim, Y. S., & Kim, N. (2018) · Journal of Neurogastroenterology and Motility · doi:10.5056/jnm18082 · Cited by 322 · see citing works
The Intestinal Microenvironment and Functional Gastrointestinal Disorders
Barbara, G., Feinle-Bisset, C., Ghoshal, U. C., Santos, J., Vanner, S. J., Vergnolle, N., Zoetendal, E. G., & Quigley, E. M. (2016) · Gastroenterology · doi:10.1053/j.gastro.2016.02.028 · Cited by 335 · see citing works
Black, C. J., Burr, N. E., Camilleri, M., Earnest, D. L., Quigley, E. M., Moayyedi, P., Houghton, L. A., & Ford, A. C. (2020) · Gut · doi:10.1136/gutjnl-2018-318160 · Cited by 191 · see citing works
Sex- and Gender-Related Differences in Common Functional Gastroenterologic Disorders
Narayanan, S. P., Anderson, B., & Bharucha, A. E. (2021) · Mayo Clinic Proceedings · doi:10.1016/j.mayocp.2020.10.004 · Cited by 131 · see citing works
Xu, Y., Wang, J., Wu, X., Jing, H., Zhang, S., Hu, Z., Rao, L., Chang, Q., Wang, L., & Zhang, Z. (2023) · Gut Microbes · doi:10.1080/19490976.2023.2168101 · Cited by 61 · see citing works
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 · see citing works
- Authors
- Fukudo, S., Kinoshita, Y., Okumura, T., Ida, M., Akiho, H., Nakashima, Y., Nishida, A., & Haruma, K.
- Affiliations
- Tohoku University (JP)
- Shimane University (JP)
- Asahikawa Medical University (JP)
- Astellas Pharma (Japan) (JP)
- Kawasaki Medical School (JP)
- Corresponding author
- Fukudo, Shin
- Venue
- Gastroenterology
- Publisher
- Elsevier BV
- Published
- 2016-02
- Volume
- 150
- Issue
- 2
- Pages
- 358-366.e8
- ISSN
- 0016-5085 (ISSN-L)
- OpenAlex
- W2168877909
- Cited by
- 125
- References
- 3
- Citations by year
- 2026: 7 · 2025: 9 · 2024: 10 · 2023: 11 · 2022: 6 · 2021: 20 · 2020: 7 · 2019: 11 · 2018: 12 · 2017: 19 · 2016: 12 · 2014: 1
- FWCI
- 14.88
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Gastroenterology (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Funders
- Astellas Pharma
- 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
- ramosetron, irritable bowel syndrome with diarrhea, serotonin-3 receptor antagonists, sex differences in drug response, women, quality of life, stool consistency, abdominal pain, alosetron, constipation, Rome III criteria, drug safety and tolerability, adverse events, treatment response rate, number needed to treat, number needed to harm, number needed to benefit
- MeSH terms
- Adult, Benzimidazoles, Constipation, Diarrhea, Female, Gastrointestinal Agents, Humans, Japan, Middle Aged, Prospective Studies, Quality of Life, Risk Factors, Sex Factors, Time Factors, Treatment Outcome, Irritable Bowel Syndrome, Young Adult, Serotonin 5-HT3 Receptor Antagonists
About these checks
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.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
