Mebeverine not superior to placebo in pediatric IBS; active drug labeling improved efficacy
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Key takeaways:
- Mebeverine was not superior to placebo, with similar treatment success and symptom relief reported between treatment and placebo groups.
- Active drug labeling improved efficacy compared with neutral labeling.
WASHINGTON — Mebeverine was not superior to placebo for the treatment of pediatric irritable bowel syndrome and functional abdominal pain, although active drug labeling significantly improved treatment success, researchers reported.
In a multicenter, double-blind trial, Marc A. Benninga, MD, PhD, professor of pediatric gastroenterology at Amsterdam UMC, and colleagues evaluated the safety and efficacy of the antispasmodic mebeverine, as well as the effect of labeling, among 268 children aged 12 to 18 years with IBS or functional abdominal pain not otherwise specified.
Researchers randomly assigned patients to mebeverine 200 mg twice daily or placebo for 8 weeks with 4 weeks of follow-up. The study medication had a blinded (mebeverine or placebo) or unblinded (mebeverine) label, which generated four treatment groups: mebeverine with blinded trial label, mebeverine with mebeverine label, placebo with blinded trial label and placebo with mebeverine label.
The primary endpoint was the proportion of patients who achieved treatment success, defined as at least 50% reduction in abdominal pain intensity and frequency at 8 weeks; the secondary endpoint was the proportion who achieved adequate relief of their symptoms.
According to results, treatment success was similar between placebo and mebeverine groups (24.1% vs. 23.7%, respectively), with 10.4% of mebeverine blinded trial label participants achieving treatment success compared with 37.2% of mebeverine label participants. Similarly, patients who received placebo with the mebeverine label had higher treatment success vs. those with the placebo blinded trial label (28.5% vs. 19.8%).
Researchers reported similar results for the outcome of adequate relief of symptoms.
Adverse events were infrequently reported among all groups, ranging from 20.9% to 28.8%, with only one serious adverse event in the mebeverine blind trial label group.
“Mebeverine was not significantly better than placebo, it may still play a therapeutic role for these children,” Benninga told attendees. “Labeled as active drug resembles clinical practice because this study showed that it achieved adequate relief in more than 50% of the children, and it’s safe and very cheap.”
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Benninga MA, et al. Mebeverine and drug labeling in pediatric functional abdominal pain. Presented at: Digestive Disease Week; May 18-21, 2024; Washington (hybrid).
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