Background And Aims: Pediatric irritable bowel syndrome (IBS) and functional abdominal pain - not otherwise specified (FAP-NOS) lack effective pharmacologic interventions. We evaluated the efficacy of mebeverine, an antispasmodic agent, and the effect of labeling within a pediatric cohort.
Methods: This randomized trial was conducted across 13 hospitals. Participants (12-17 years) with IBS or FAP-NOS received mebeverine (200 mg twice daily) or placebo for 8 weeks. Treatment was labelled as "mebeverine or placebo" (blinded trial label) or "mebeverine" (mebeverine label), creating four 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 endpoint was treatment success (>50% reduction of abdominal pain intensity and frequency) after 8 weeks. The key secondary endpoint was adequate relief of symptoms.
Results: Of the 269 randomized patients, treatment success was similar between those receiving mebeverine (group 1 and 2) (n=31 (23.4%)) and placebo (group 3 and 4) (n=30 (22.0%))(OR 1.08, 95%CI 0.59-1.99, P=0.81). Treatment success was higher in groups with the mebeverine label (2 and 4) (n=42 (31.6%)) compared to the blinded trial label (1 and 3)(n=19 (14.1%))(OR 2.84 (95%CI 1.52-5.34), P=0.001). 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=0.46), but higher in mebeverine labelled groups (n=67 (50.4%)) compared to blinded trial labelled groups (n=49 (36.3%)) (OR 1.78, 95%CI 1.1-2.9, P=0.02). Adverse events were mild and infrequent.
Conclusion: Mebeverine was ineffective in pediatric IBS and FAP-NOS treatment. However, a positive drug label significantly enhanced treatment outcomes compared to a blinded trial label.
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