Functional abdominal pain in kids: Drotaverine, peppermint oil similar in head-to-head trial

Both drotaverine and peppermint oil are safe and help alleviate abdominal pain in children whose pain cannot be attributed to a specific medical condition, with neither treatment demonstrating clear superiority over the other, according to the results of a single-blind, randomized controlled trial.

After 4 weeks of treatment, scores on the Revised Abdominal Pain Index (rAPI) significantly dropped from baseline for participants who received drotaverine (from 2.17 to 0.96; p<0.0001) and those who received peppermint oil (from 2.42 to 1.27; p<0.0001). [ESPGHAN 2025, abstract G-OP077]

However, there was no significant difference in how much the rAPI scores decreased between the two treatment arms (–1.21 vs –1.15; p=0.67), reported one of the study authors Dr Rishi Bolia from the All India Institute of Medical Sciences in Rishikesh, India.

Likewise, physical function and visceral hypersensitivity/gastrointestinal (GI) symptom-specific anxiety improved following treatment with either drotaverine or peppermint oil, Bolia added.

The Functional Disability Index (FDI) score decreased from 33.60 at baseline to 24.92 at the end of week 4 in the drotaverine arm (p=0.0002) and from 28.32 to 17.44, respectively, in the peppermint oil arm (p=0.0008). Meanwhile, the Visceral Sensitivity Index (VSI) score increased from 59.68 to 74.08 in the drotaverine arm (p=0.0002) and from 56.04 to 69.84 in the peppermint oil arm (p=0.0001).

The magnitude of change in both the FDI and VSI scores did not significantly differ between the two treatment arms (p=0.31 and p=0.81, respectively).

In terms of safety, the number of treatment-emergent adverse events (TEAEs) was similar between the drotaverine and peppermint oil arms (nine vs seven; p=0.54), as was the number of TEAEs deemed related to study medication (five vs five; p=1.00). Nausea was the most common TEAE probably causally related to study medication (three vs two), followed by bloating (two vs two) and unpleasant smell (zero vs one).

“Both drotaverine and peppermint oil did not cause serious adverse effects,” Bolia noted.

The study included 50 children with functional abdominal pain–not otherwise specified, as per ROME-IV criteria. These participants were randomly assigned to treatment with drotaverine (20 mg for those 4–6 years or 40 mg for those 6–18 years) (n=25) or peppermint oil (one 0.2-ml capsule for those <45 kg or two 0.2-ml capsules for those >45 kg) (n=25), administered orally three times a day. Only investigators who performed assessments for the final outcomes were blinded to the treatment assignment. Five participants overall were lost to follow-up.

“Alterations in GI motility and visceral sensation play a role in the development of abdominal pain. And antispasmodics [such as drotaverine and peppermint oil] function as smooth muscle relaxants or antagonists to block excitatory neuromuscular neurotransmission,” he explained.

The findings suggest that drotaverine and peppermint oil are both useful in the treatment of functional abdominal pain–not otherwise specified in children, Bolia said.

However, he acknowledged that the study was limited by its small sample size, short follow-up duration, and the absence of double-blinding.