Antiperistaltic effect and safety of l‐menthol oral solution on gastric mucosa for upper gastrointestinal endoscopy in Chinese patients: Phase III, multicenter, randomized, double‐blind, placebo‐controlled study

Abstract

Objective The topical antispasmodic agent l‐menthol is commonly used for gastric peristalsis suppression during diagnostic upper gastrointestinal (GI) endoscopy. We evaluated the efficacy and safety of a single dose l‐menthol solution in suppressing gastric peristalsis during upper GI endoscopy in Chinese patients. Methods In this phase III, multicenter, randomized, double‐blind, placebo‐controlled study (ClinicalTrials.gov: NCT03263910), 220 patients scheduled to undergo upper GI endoscopy at five Chinese referral centers received a single dose of either 160 mg of l‐menthol (n = 109) or placebo (n = 111). Both treatments were sprayed endoscopically on the gastric mucosa. An independent committee evaluated the degree of gastric peristalsis (peristaltic score: grade 1–5). Results At baseline, the proportion of patients with grade 1 peristalsis (no peristalsis) did not differ between the groups. The proportion of patients with grade 1 peristalsis post‐treatment was significantly higher in the l‐menthol group (40.37%, 44/109) versus the placebo group (16.22%, 18/111; P < 0.001); the difference between the groups was 24.15% (95% confidence interval: 12.67%–35.63%; P < 0.001). In the l‐menthol group, 61.47% of patients had grade 1 peristalsis after endoscopy versus 24.55% in the placebo group (P < 0.001). The ease of intragastric examination correlated significantly with the grade of peristalsis. The incidence of adverse events was comparable between the groups (P = 0.340). Conclusions During upper GI endoscopy, a single dose of l‐menthol solution (160 mg) sprayed on the gastric mucosa significantly attenuated gastric peristalsis versus placebo, thereby improving the visual stability without any safety concerns.

Antiperistaltic effect and safety of l-menthol for esophagogastroduodenoscopy in the elderly with contraindication to hyoscine-N-butylbromide

“…From the view of the examinees, the discomfort level and hemodynamic changes were similar in the two groups. Half of the elderly had AEs after EGD, with the incidence rate higher than the results of previous studies enrolling the general population 22 , 23 , 28 , 29 . This is reasonable because the risk of complications of EGD was increased for elderly patients due to their underlying disease 31 .…”