title: Mebeverine for pediatric functional abdominal pain: a randomized, placebo-controlled trial.
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.
authors.affiliation: Child Growth and Development Research Center, Isfahan University of Medical Sciences, Hezar Jerib Avenue, Isfahan 81746-75731, Iran.
authors.forename: Zahra
authors.identifier: 0000-0002-5424-3919
authors.initials: Z
authors.lastname: Pourmoghaddas
authors.affiliation: Child Growth and Development Research Center, Isfahan University of Medical Sciences, Hezar Jerib Avenue, Isfahan 81746-75731, Iran.
authors.forename: Hossein
authors.initials: H
authors.lastname: Saneian
authors.affiliation: Psychosomatic Research Center, Isfahan Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan 81746-75731, Iran.
authors.forename: Hamidreza
authors.identifier: 0000-0003-3582-0431
authors.initials: H
authors.lastname: Roohafza
authors.affiliation: Poursina Hakim Research Institute, Isfahan 81465-1798, Iran.
authors.forename: Ali
authors.identifier: 0000-0001-8674-450X
authors.initials: A
authors.lastname: Gholamrezaei
mesh_terms: D015746:Abdominal Pain / Q000188:drug therapy*; D000293:Adolescent; D002648:Child; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D059408:Pain Management / Q000379:methods*; D010276:Parasympatholytics / Q000627:therapeutic use*; D010349:Patient Compliance; D010627:Phenethylamines / Q000627:therapeutic use*; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D010276:Parasympatholytics; D010627:Phenethylamines; C005096:mebeverine
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