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

Introduction: Few studies are conducted on the efficacy of antispasmodics in the treatment of functional gastrointestinal disorders in children. We evaluated the effectiveness of a smooth-muscle relaxant (mebeverine) in the treatment of childhood functional abdominal pain (FAP).   Materials and Methods: Children (n=115, aged 6-18 years) with FAP were randomized to receive mebeverine 135 mg twice daily or placebo for 4 weeks. Response was defined as ≥ 2 point reduction in the 6-point pain rating scale or “no pain”. Secondary outcome measures were physician-assessed global severity and improvement. Patients were followed for 8 weeks after medication period.   Results: Eighty seven patients completed the trial (44 in the mebeverine group). Response rate in the mebeverine and the placebo group was 54.5% and 39.5% at week 4 (P=0.117) and 72.7% and 53.4% at week 12 (P=0.050), respectively. No significant difference was observed between the two groups in change of the global severity or improvement at week 4 (P=0.723 and 0.057) or at week 12 (P=0.870 and 0.183), respectively. In regression analysis, male gender (Beta=3.470, P=0.025) and baseline pain score (Beta=3.665, P