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

Fandong Meng, Wenyan Li, Fachao Zhi, Zhaoshen Li, Zhanxiong Xue, Shuixiang He, Weifeng Chen, Yingxuan Chen, Xiangbin Xing, Chen Yao, Yongdong Wu, Shutian Zhang, Fandong Meng, Wenyan Li, Fachao Zhi, Zhaoshen Li, Zhanxiong Xue, Shuixiang He, Weifeng Chen, Yingxuan Chen, Xiangbin Xing, Chen Yao, Yongdong Wu, Shutian Zhang

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.

Keywords: Chinese; gastric peristalsis; l-menthol; upper gastrointestinal endoscopy.

Conflict of interest statement

Authors declare no conflicts of interest for this article.

© 2021 The Authors. Digestive Endoscopy published by John Wiley & Sons Australia, Ltd on behalf of Japan Gastroenterological Endoscopy Society.

Figures

Figure 1
Figure 1
Patient disposition.
Figure 2
Figure 2
Proportion of patients with no peristalsis (grade 1) after treatment and at the end of endoscopy with l‐menthol or placebo sprayed directly on the gastric mucosa. *P < 0.001, Cochran–Mantel–Haenszel test.
Figure 3
Figure 3
Proportion of patients with no peristalsis (grade 1) for each time period assessed in the l‐menthol and placebo groups. *P < 0.05, McNemar's test (intragroup comparison); ***P < 0.001, McNemar's test (intragroup comparison); ***P < 0.001, Cochran–Mantel–Haenszel test (intergroup comparison).
Figure 4
Figure 4
Proportion of patients with no peristalsis (grade 1) after treatment with l‐menthol or placebo directly on the gastric mucosa in patients who had no peristalsis before treatment. *P < 0.05, Cochran–Mantel–Haenszel test.
Figure 5
Figure 5
Proportion of patients according to peristaltic grade for each period in the L‐menthol and placebo group. Numbers shown on the stacked columns indicate the number of patients in each subgroup.

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