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. Issue 7 (2nd April 2021)

• Record Type: Journal Article
• Authors: Meng, Fandong; Li, Wenyan; Zhi, Fachao; Li, Zhaoshen; Xue, Zhanxiong; He, Shuixiang; Chen, Weifeng; Chen, Yingxuan; Xing, Xiangbin; Yao, Chen; Wu, Yongdong; Zhang, Shutian
• Is Part Of: Digestive endoscopy. Volume 33:Issue 7(2021)
• Page Start: 1110
• Page End: 1119
• Publication Date: 2021-04-02
• Subjects: Chinese -- gastric peristalsis -- l‐menthol -- upper gastrointestinal endoscopy; Digestive organs -- Diseases -- Periodicals; Digestive organs -- Diseases -- Diagnosis -- Periodicals; Endoscopy -- Periodicals; Digestive System Diseases -- diagnosis -- Periodicals; Digestive System Diseases -- therapy -- Periodicals; Endoscopy -- Periodicals; 616.3
• DOI: 10.1111/den.13941
• Languages: English
• ISSNs: 0915-5635

Abstract

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.