Abstract
Background
The topical antispasmodic agent l-menthol is useful for inhibiting gastric peristalsis during diagnostic upper gastrointestinal endoscopy. However, it remains unclear whether l-menthol is similarly effective during therapeutic endoscopy, thereby improving treatment outcomes in a clinical setting.
Methods
A total of 83 patients scheduled to undergo endoscopic treatment at 8 Japanese referral centers were randomly assigned to receive l-menthol or placebo. The degree of gastric peristalsis (peristaltic score: grade 1–5) was assessed by an independent committee. The primary outcome was the proportion of subjects in whom no or mild peristalsis (grade 1 or 2) was maintained throughout endoscopic treatment. Secondary outcomes were the duration of sustained response and the incidence of adverse drug reactions.
Results
The proportion of patients with no or mild peristalsis was significantly higher in the l-menthol group (85.4 %, 95 % confidence intervals 70.8–94.4: 35/41 subjects) than in the placebo group (39.0 %, 24.2–55: 16/41; P < 0.001). The sustained response rates in the l-menthol and the placebo were, respectively, 90.0 and 39.6 % 30 min post-dose, and 79.9 and 35.7 % at the completion of the resection. The sustained response rates were significantly higher in the l-menthol group than in the placebo group (P < 0.001, log-rank test). The incidence of adverse drug reactions did not differ significantly between the two groups (P = 1.000).
Conclusions
During gastric endoscopic submucosal dissection, spraying l-menthol on the gastric mucosa significantly suppressed peristalsis, with minimal adverse drug reactions as compared with placebo. l-menthol solution might be useful for therapeutic endoscopy.
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Acknowledgments
We thank the patients who participated in this trial and the following clinicians who recruited and treated the patients in this study: Shinya Kodashima, Satoshi Ono, and Keiko Niimi, Graduate School of Medicine, The University of Tokyo; Shu Hoteya, Daisuke Kikuchi, and Toshiro Iizuka, Toranomon Hospital, Tokyo; Satoru Nonaka, Seiichiro Abe, and Ken Nakajima, National Cancer Center Hospital, Tokyo; Toshiaki Hirasawa and Yorimasa Yamamoto, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo; Ken Ohhata, Kanto Medical Center, NTT East, Tokyo; Katsuhiko Higuchi and Toru Sasaki, Kitasato University School of Medicine, Sagamihara; Ryu Ishihara and Yoji Takeuchi, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka; Kosaku Morihata and Hisanobu Deguchi, Wakayama Medical University, Wakayama.
Conflict of interest
Mitsuhiro Fujishiro has served a lecturer for Eisai Pharmaceuticals Co., Ltd and his department has obtained a donation from Dainihon Sumitomo Pharmaceuticals Co., Ltd. Hiroaki Suzuki has served as a consultant for Nihon Pharmaceuticals Co., Ltd.
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Fujishiro, M., Kaminishi, M., Hiki, N. et al. Efficacy of spraying l-menthol solution during endoscopic treatment of early gastric cancer: a phase III, multicenter, randomized, double-blind, placebo-controlled study. J Gastroenterol 49, 446–454 (2014). https://doi.org/10.1007/s00535-013-0856-4
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DOI: https://doi.org/10.1007/s00535-013-0856-4