Expert Opinion on the Efficacy and Safety of Antispasmodics with a Focus on Irritable Bowel Syndrome
Turkish gastroenterology expert panel · 2025 · Türkiye
Source and licence
- Authors
- Serhat Bor, Hasan Özen, İsmail Hakkı Kalkan et al.
- Title
- Expert Opinion on the Efficacy and Safety of Antispasmodics with a Focus on Irritable Bowel Syndrome
- Journal
- The Turkish Journal of Gastroenterology, 2025
- Licence
- CC BY 4.0
- Changes
- Verbatim excerpts; formatting adapted
Full text retrieved 2026-10-27 from Europe PMC · PMC13007261
Licence statement of the original publication
Content of this journal is licensed under a Creative Commons Attribution 4.0 International License.
This page reproduces excerpts of the original publication; the original is authoritative. It has not been reviewed by a physician, does not state a recommendation of Medelix and does not replace medical advice. The guideline may have been updated since.
Open the original publication →Full text on Europe PMC
Recommendations
Verbatim, with grade of recommendation or strength of consensus where given.
Hyoscine-N-Butylbromide
- Conclusion: Hyoscine-N-Butylbromide is not effective in IBS treatment (Grade C). Long term safety is not clear. There is no data in the literature concerning the safety of HBB when used in pregnancy or lactation.
Cimetropium Bromide
- Conclusion: Cimetropium bromide seems to be effective in the treatment of IBS based on 5 heterogenous, old RCTs (Grade C). Consistent efficacy was observed in most studies in 4 weeks. According to 5 variable designed/duration studies, CB has mild AE related to anticholinergic effect. There is no data about safety during pregnancy and lactation.
Peppermint-oil
- Conclusion: Peppermint oil seems to be effective for the treatment of IBS according to 9 heterogenous RCTs (Grade B). The majority of studies demonstrated consistent effectiveness within a 4-week period. According to nine studies with varying designs and treatment durations, PO appears to be a safe agent for the management of IBS.However, therapy discontinuation rate is higher in PO groups. There is no data in the literature concerning the safety of oral PO when used in pregnancy or lactation.
Otilonium Bromide
- Conclusion: Otilonium bromide is a safe medication that is significantly superior to placebo in global efficacy assessment, abdominal pain, and abdominal distension, with a side-effect profile comparable to placebo in patients with IBSGrade B
Trimebutine Maleate
- Conclusion: The effectiveness of TM in the treatment of IBS has not been conclusively demonstrated, based on RCTs of varying designs and generally low quality (Grade C). This conclusion is derived from four RCTs with heterogeneous designs and treatment durations.
Prifinium Bromide
- Conclusion: There are limited data regarding the efficacy of PRB in the treatment of IBSGrade D
Dicylomine Hydrocloride
- Conclusion: The efficacy of DH in the treatment of IBS has not been established (Grade D), and its use is not recommended due to its higher rate of AEs.
Simeticone
- Conclusion: The efficacy of simeticone in the treatment of IBS has not been established (Grade D). Its role in current clinical practice remains negligible.
Mebeverine Hydrochloride
- Conclusion: Mebeverine hydrochloride is not superior to placebo according to meta-analysis of RCTs (Grade C). In drug-drug comparison studies, the efficacy was similar to that of other drugs, except for Alosetron.
Alverine Citrate
- Conclusion: There is insufficient data in the literature to recommend AC or Alverine citrate/Simeticone combination for the treatment of IBSGrade C
Drotaverine Hydrochloride
- Conclusion: While DRH appears to be beneficial for IBS treatment, the evidence is restricted to only two RCTs found in the current literatureGrade C
Simeticone
- Conclusion: There was substantial heterogeneity among the studies regarding diagnostic criteria, dosage and duration of treatment, methods of randomization, outcome measures, and overall methodological quality. The available evidence does not provide conclusive support for the efficacy of simeticon in the treatment of infantile colic.Grade D
Peppermint oil
- Conclusion: Further well designed researches with larger number of participants and are neededGrade C
Mebeverine Hydrochloride
- Conclusion: Mebeverine hydrochloride is not recommended in pediatric patients with FAPGrade D
Hyoscine and Its Derivatives
- Conclusion: The efficacy of hyoscyamine in the treatment of IC is not established (Grade D). Due to its numerous adverse effects and potential drug–drug interactions, its use in children is generally discouraged.
Cimetropium Bromide
- Conclusion: Compared to placebo, CB may be beneficial in reducing crying time or relieving other symptoms of IC, but the quality of evidence is lowGrade C
Trimebutine Maleate
- Conclusion: There are not enough studies to recommend its useGrade D
Abstract
Antispasmodics are commonly used to treat irritable bowel syndrome (IBS) symptoms. They are generally regarded as safe.However, some have been found to be ineffective or not cost-effective. Marked discrepancies in the availability and formulation of antispasmodic agents across countries—ranging from the limitation to only fundamental compounds in regions such as the United States to the marketing of diverse combination products elsewhere—have generated considerable ambiguity and debate within the field. Meta-analyses show varying results on the efficacy of antispasmodics, indicating the need for further analysis. This article aims to evaluate the effectiveness of antispasmodic drugs in relieving symptoms in IBS patients. We conclude that most drugs are considered safe and effective, with pinaverium, otilonium, and peppermint oil having meta-analyses supporting their efficacy. However, there is a lack of high-quality data for drugs like alverine, trimebutine, and cimetropium, and some drugs, such as simeticone or combinations of spasmolytic agents and simeticone, have insufficient research data. Clinicians should prioritize evidence-based medicine when selecting antispasmodic agents.
Contents of the original publication
The section headings of the original.
- Introduction
- Materials and Methods
- Drugs
- Hyoscine-N-Butylbromide
- Cimetropium Bromide
- Peppermint-oil
- Pinaverium Bromide
- Otilonium Bromide
- Trimebutine Maleate
- Prifinium Bromide
- Dicylomine Hydrocloride
- Simeticone
- Mebeverine Hydrochloride
- Alverine Citrate
- Drotaverine Hydrochloride
- Future Perspectives
- Use of Antispasmodics in Children
- Simeticone
- Peppermint oil
- Mebeverine Hydrochloride
- Drotaverin Hydrochloride
- Hyoscine and Its Derivatives
- Dicyclomine Hydrochloride
- Cimetropium Bromide
- Trimebutine Maleate
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