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Mebeverine and the Influence of Labeling in Adolescents With Irritable Bowel Syndrome or Functional Abdominal Pain
Robyn Rexwinkel1, Nicolaas Koen Vermeijden2, Judith Zeevenhooven3
1Department of Pediatric Gastroenterology, Hepatology and Nutrition, University of Amsterdam, Emma's Children Hospital, Amsterdam University Medical Center, Amsterdam, the Netherlands; Amsterdam Reproduction and Development Research Institute, Emma Children's Hospital, Amsterdam University Medical Center, Amsterdam, the Netherlands; Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology Metabolism Research Institute, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
Background & Aims:
Pediatric irritable bowel syndrome and functional abdominal pain-not otherwise specified lack effective pharmacologic interventions. The efficacy of mebeverine, an antispasmodic agent, and the effect of labeling within a pediatric cohort were evaluated.
Methods:
This randomized trial was conducted across 13 hospitals. Participants (12-17 years) with irritable bowel syndrome or functional abdominal pain-not otherwise specified received mebeverine (200 mg twice daily) or placebo for 8 weeks. Treatment was labeled as "mebeverine or placebo" (blinded trial label) or "mebeverine" (mebeverine label), creating the following 4 groups: (1) mebeverine-blinded trial label, (2) mebeverine-mebeverine label, (3) placebo-blinded trial label, and (4) placebo-mebeverine label. Randomization (1:1:1:1) was masked to physicians, except for drug labeling. Primary end point was treatment success (>50% reduction of abdominal pain intensity and frequency) after 8 weeks. The key secondary end point was adequate relief of symptoms.
Results:
Of the 269 randomized patients, treatment success was similar between those receiving mebeverine (groups 1 and 2) (n = 31 [23.4%]) and placebo (groups 3 and 4) (n = 30 [22.0%]; odds ratio [OR], 1.08; 95% CI, 0.59-1.99; P = .81). Treatment success was higher in groups with the mebeverine label (groups 2 and 4) (n = 42 [31.6%]) compared with the blinded trial label (groups 1 and 3) (n = 19 [14.1%]; OR, 2.84; 95% CI, 1.52-5.34; P = .001). Adequate relief rates were similar between mebeverine (n = 55 [41.0%]) and placebo groups (n = 61 [45.5%]; OR, 0.83; 95% CI, 0.51-1.35; P = .46), but higher in mebeverine-labeled groups (n = 67 [50.4%]) compared with blinded trial-labeled groups (n = 49 [36.3%]; OR, 1.78; 95% CI, 1.1-2.9; P = .02). Adverse events were mild and infrequent.
Conclusions:
Mebeverine was ineffective in treatment of pediatric irritable bowel syndrome and functional abdominal pain-not otherwise specified. However, a positive drug label significantly enhanced treatment outcomes compared with a blinded trial label. (International Clinical Trials Registry Platform, Number: NL-OMON55563.).
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