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Peppermint Oil and Sweets in Pediatric Irritable Bowel Syndrome and Functional Abdominal Pain: A Randomized Trial
N K Vermeijden1, C van der Feen2, M Groeneweg3
1Emma's Children Hospital, Amsterdam UMC, University of Amsterdam, Pediatric Gastroenterology, Hepatology, and Nutrition, Amsterdam, The Netherlands; Amsterdam Reproduction and Development Research Institute, Amsterdam University Medical Centers, Location Academic Medical Center/Emma Children's Hospital, Amsterdam, The Netherlands; Amsterdam UMC, University of Amsterdam, Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology Metabolism Research Institute, Amsterdam, The Netherlands; Department of Pediatrics, St Antonius Hospital, Nieuwegein, The Netherlands.
Insights
Peppermint oil and sweets did not effectively treat pediatric irritable bowel syndrome (IBS) or functional abdominal pain (FAP-NOS) compared to placebo. Gut-brain axis interventions are recommended for these conditions.
Area of Science:
- Gastroenterology
- Pediatric Medicine
- Pharmacology
Background:
- Pharmacologic treatments for pediatric irritable bowel syndrome (IBS) and functional abdominal pain-not otherwise specified (FAP-NOS) are limited.
- Peppermint oil, an antispasmodic, is a potential treatment option for these conditions.
Purpose of the Study:
- To evaluate the efficacy and safety of peppermint oil and peppermint sweets in children diagnosed with IBS or FAP-NOS.
- To compare these interventions against a placebo in a randomized controlled trial.
Main Methods:
- A randomized controlled trial involving 228 children (aged 8-18 years) across 13 Dutch hospitals.
- Participants received double-blind peppermint oil capsules, open-label peppermint sweets, or double-blind placebo twice or three times daily for 8 weeks.
- Treatment success was defined as a ≥30% reduction in abdominal pain intensity after 8 weeks.
Main Results:
- No significant difference in treatment success was observed between peppermint oil (44.0%) and placebo (37.3%) (P=0.44).
- Peppermint sweets also showed no significant difference compared to placebo (38.7% vs. 37.3%, P=0.91).
- Adequate symptom relief was comparable across all groups, and adverse events were mild and infrequent.
Conclusions:
- Neither peppermint oil nor peppermint sweets demonstrated superiority over placebo for treating pediatric IBS and FAP-NOS.
- The study suggests that interventions targeting the gut-brain axis should be prioritized for managing these conditions in children.
Background & Aims:
Effective pharmacologic treatment for pediatric irritable bowel syndrome (IBS) and functional abdominal pain-not otherwise specified (FAP-NOS) is lacking. This study evaluated the efficacy and safety of peppermint oil, an antispasmodic agent, and peppermint sweets in children with IBS or FAP-NOS.
Methods:
This randomized controlled trial was conducted across 13 Dutch hospitals. Participants (aged 8-18 years) with IBS or FAP-NOS were randomized (1:1:1) to double-blind peppermint oil capsules (containing 182 mg of peppermint oil), open-label peppermint sweets (9.2 mg peppermint oil), or double-blind placebo (2.0 mg peppermint oil to enhance blinding) twice daily (8-11 years) or 3 times daily (12-18 years), with dose escalation if needed. The intervention lasted 8 weeks with a 4-week follow-up. The primary endpoint was treatment success, defined as a ≥30% reduction of abdominal pain intensity after 8 weeks. The key secondary endpoint was adequate relief of symptoms.
Results:
In 228 children (8-11 years: n = 92; 12-18 years: n = 135; 75-78 per group), treatment success was comparable between patients receiving peppermint oil (n = 30; 44.0%) and placebo (n = 28; 37.3%) (odds ratio [OR], 1.33; 97.5% confidence interval [CI], 0.58-3.09; P = .44), and between placebo and peppermint sweets (n = 30; 38.7%) (OR, 1.05; 97.5% CI, 0.45-2.44; P = .91). Adequate relief was comparable between treatment groups: peppermint oil (n = 40; 53.3%) vs placebo (n = 37; 49.3%) (OR, 1.15; 97.5% CI, 0.54-2.47; P = .68), and placebo vs peppermint sweets (n = 35; 44.9%) (OR, 0.81; 97.5% CI, 0.39-1.71; P = .53). Adverse events were mild and infrequent.
Conclusions:
Neither peppermint oil nor peppermint sweets were superior to placebo in treating pediatric IBS and FAP-NOS. These findings suggest prioritizing proven gut-brain axis-targeted interventions for this population.
Clinicaltrials:
gov, Number: NCT05799053.
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