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BioMed Research International
Volume 2014, Article ID 191026, 6 pages
http://dx.doi.org/10.1155/2014/191026
Clinical Study

Mebeverine for Pediatric Functional Abdominal Pain: A Randomized, Placebo-Controlled Trial

1Child Growth and Development Research Center, Isfahan University of Medical Sciences, Hezar Jerib Avenue, Isfahan 81746-75731, Iran
2Psychosomatic Research Center, Isfahan Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan 81746-75731, Iran
3Poursina Hakim Research Institute, Isfahan 81465-1798, Iran

Received 28 February 2014; Revised 3 June 2014; Accepted 11 June 2014; Published 25 June 2014

Academic Editor: Sachiyo Nomura

Copyright © 2014 Zahra Pourmoghaddas et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

We evaluated the effectiveness of an antispasmodic, mebeverine, in the treatment of childhood functional abdominal pain (FAP). Children with FAP ( , 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 ( [0.469]) and 72.7% [54.2%] and 53.4% [41.0] at week 12, respectively ( [0.416]). There was no significant difference between the two groups in change of the physician-rated global severity score after 4 weeks ( ) or after 12 weeks ( ) 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.