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Mebeverine for pediatric functional abdominal pain: a randomized, placebo-controlled trial
Zahra Pourmoghaddas1, Hossein Saneian1, Hamidreza Roohafza2
1Child Growth and Development Research Center, Isfahan University of Medical Sciences, Hezar Jerib Avenue, Isfahan 81746-75731, Iran.
Insights
Mebeverine may help childhood functional abdominal pain (FAP), but this study did not find statistically significant results compared to placebo. Further research with more patients is recommended to confirm its effectiveness.
Area of Science:
- Pediatric Gastroenterology
- Pharmacology
Background:
- Childhood functional abdominal pain (FAP) is a common condition impacting children's quality of life.
- Identifying effective treatments for FAP is crucial for pediatric healthcare.
Purpose of the Study:
- To evaluate the efficacy of mebeverine, an antispasmodic, in treating childhood functional abdominal pain (FAP).
Main Methods:
- A randomized, placebo-controlled trial involving 115 children (aged 6-18 years) with FAP.
- Participants received either mebeverine (135 mg twice daily) or placebo for 4 weeks, with a 12-week follow-up.
- Treatment response was measured by a reduction in a 6-point pain scale and physician-rated global severity.
Main Results:
- At 12 weeks, the per-protocol treatment response rate was 72.7% for mebeverine versus 53.4% for placebo (P = 0.0503).
- No statistically significant differences were observed in physician-rated global severity scores between groups at 4 or 12 weeks.
- While trends suggested potential benefit, mebeverine did not demonstrate a statistically significant effect over placebo in this study.
Conclusions:
- Mebeverine shows potential as a treatment for childhood FAP, but the study did not achieve statistical significance compared to placebo.
- Larger-scale clinical trials are warranted to definitively establish the efficacy of mebeverine for pediatric FAP.
Abstract:
We evaluated the effectiveness of an antispasmodic, mebeverine, in the treatment of childhood functional abdominal pain (FAP). Children with FAP (n = 115, aged 6-18 years) received mebeverine (135 mg, twice daily) or placebo for 4 weeks. Response was defined as ≥ 2 point reduction in the 6-point pain scale or "no pain." Physician-rated global severity was also evaluated. Patients were followed up for 12 weeks. Eighty-seven patients completed the trial (44 with mebeverine). Per-protocol and intention-to-treat (ITT) analyses were conducted. Treatment response rate in the mebeverine and placebo groups based on per-protocol [ITT] analysis was 54.5% [40.6%] and 39.5% [30.3%] at week 4 (P = 0.117 [0.469]) and 72.7% [54.2%] and 53.4% [41.0] at week 12, respectively (P = 0.0503 [0.416]). There was no significant difference between the two groups in change of the physician-rated global severity score after 4 weeks (P = 0.723) or after 12 weeks (P = 0.870) in per-protocol analysis; the same results were obtained in ITT analysis. Mebeverine seems to be effective in the treatment of childhood FAP, but our study was not able to show its statistically significant effect over placebo. Further trials with larger sample of patients are warranted.
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