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

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...

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Bibliographic Details
Published in:BioMed research international 2014-01, Vol.2014 (2014), p.1-6
Main Authors: Gholamrezaei, Ali, Roohafza, Hamidreza, Saneian, Hossein, Pourmoghaddas, Zahra
Format: Article
Language:English
Subjects:
Abdomen
Abdominal pain
Abdominal Pain - drug therapy
Adolescent
Antibiotics
Antispasmodics
Chi-square test
Child
Children & youth
Clinical Study
Clinical trials
Dosage and administration
Drug therapy
Families & family life
Family income
Female
Follow-Up Studies
Humans
Male
Motility
Pain
Pain in children
Pain Management - methods
Parasympatholytics - therapeutic use
Parents & parenting
Pathophysiology
Patient Compliance
Pediatrics
Phenethylamines - therapeutic use
Severity of Illness Index
Software
Treatment Outcome
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Summary: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.
ISSN:2314-6133
2314-6141
DOI:10.1155/2014/191026