Table 7.

Peppermint Oil (PMO) Randomized Controlled Trials for Childhood Functional Abdominal Pain

Reference	Population	Design	Findings	Adverse Events
Kline (2001)72	Childhood IBS and FAP; n=50; 8 withdrawals	Double-blind parallel group study comparing PMO 187 mg or 0.1mL/capsule; 2 capsules TID (>45kg) or 1 capsule TID (30-45 kg) (n=21) vs. placebo (n=21) × 2 weeks Primary objective: Achieving a “better” or “much better” symptom score at 2 weeks	A greater number of subjects receiving PMO vs. placebo achieved a better or much better symptom score [15 (71%) vs. 9 (42.8%), P<0.01]	No adverse events identified
Asgarshirazi (2015)73	Children with FAP (n=120); 32 excluded because they didn’t complete the trial	Three group unblinded parallel randomized study comparing PMO 187 mg TID (BID for children < 45 kg) (n=34) vs. probiotic/prebiotic tablet (Bacillus coagulans and fructooligosaccharides) (n=29) vs. placebo (1 mg folic acid) (n=25) × 1 month Primary objective: Assessment of abdominal pain severity (0-10 scale), duration, and frequency after one-month	Decrease in pain duration (26.2 ± 11.6 vs. 51.6 ± 23.7 minutes, P<0.001), severity (3.1 ± 1.4 vs. 4.2 ± 1.3, P<0.01), frequency (2.0 ± 1.0 vs. 3.4 ± 1.4 episodes per week, P<0.001) greater with PMO compared with placebo	No adverse events identified

FAP = Functional abdominal pain