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).

SUBMITTER: Meng F 

PROVIDER: S-EPMC8596731 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature