Efficacy of spraying l-menthol solution during endoscopic treatment of early gastric cancer: a phase III, multicenter, randomized, double-blind, placebo-controlled study

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• 作者：Mitsuhiro Fujishiro (1)
  Michio Kaminishi (2)
  Naoki Hiki (3)
  Ichiro Oda (4)
  Junko Fujisaki (5)
  Noriya Uedo (6)
  Mitsuru Kaise (7)
  Satoshi Tanabe (8)
  Mikitaka Iguchi (9)
  Nobuyuki Matsuhashi (10)
  Sachiyo Nomura (11)
  Hisao Tajiri (12)
  Naohisa Yahagi (13)
  Hiroaki Suzuki (14)
  
• 关键词：Endoscopic submucosal dissection ; Gastric motility ; Gastric relaxation ; l ; Menthol
• 刊名：Journal of Gastroenterology
• 出版年：2014
• 出版时间：March 2014
• 年：2014
• 卷：49
• 期：3
• 页码：446-454
• 全文大小：900 KB
• 参考文献：1. Jemal A, Bray F, Center MM, et al. Global cancer statistics. CA Cancer J Clin. 2011;61:69-0. CrossRef
  2. Nashimoto A, Akazawa K, Isobe Y, et al. Gastric cancer treated in 2002 in Japan: 2009 annual report of the JGCA nationwide registry. Gastric Cancer. 2012.
  3. Yoshida S, Kozu T, Gotoda T, et al. Detection and treatment of early cancer in high-risk populations. Best Pract Res Clin Gastroenterol. 2006;20:745-5. CrossRef
  4. Tsukuma H, Oshima A, Narahara H, et al. Natural history of early gastric cancer: a non-concurrent, long term, follow up study. Gut. 2000;47:618-1. CrossRef
  5. Hiki N, Kaminishi M, Hasunuma T, et al. A phase I study evaluating tolerability, pharmacokinetics, and preliminary efficacy of L-menthol in upper gastrointestinal endoscopy. Clin Pharmacol Ther. 2011;90:221-. CrossRef
  6. Hiki N, Kaminishi M, Yasuda K, et al. Multicenter phase II randomized study evaluating dose-response of antiperistaltic effect of L-menthol sprayed onto the gastric mucosa for upper gastrointestinal endoscopy. Dig Endosc. 2012;24:79-6. CrossRef
  7. Hiki N, Kaminishi M, Yasuda K, et al. Antiperistaltic effect and safety of L-menthol sprayed on the gastric mucosa for upper GI endoscopy: a phase III, multicenter, randomized, double-blind, placebo-controlled study. Gastrointest Endosc. 2011;73:932-1. CrossRef
  8. Hiki N, Kaminishi M, Tanabe S, et al. An open-label, single-arm study assessing the efficacy and safety of L-menthol sprayed onto the gastric mucosa during upper gastrointestinal endoscopy. J Gastroenterol. 2011;46:873-2. CrossRef
  9. Hawthorn M, Ferrante J, Luchowski E, et al. The actions of peppermint oil and menthol on calcium channel dependent processes in intestinal, neuronal and cardiac preparations. Aliment Pharmacol Ther. 1988;2:101-8. CrossRef
  10. Hills JM, Aaronson PI. The mechanism of action of peppermint oil on gastrointestinal smooth muscle. An analysis using patch clamp electrophysiology and isolated tissue pharmacology in rabbit and guinea pig. Gastroenterology. 1991;101:55-5.
  11. Fujishiro M, Jung HY, Goda K, et al. Desirable training and roles of Japanese endoscopists towards the further penetration of endoscopic submucosal dissection in Asia. Dig Endosc. 2012;24(Suppl 1):121-. CrossRef
  12. Niwa H, Nakamura T, Fujino M. Endoscopic observation on gastric peristalsis and pyloric movement [in Japanese with English abstract]. Gastroenterol Endosc. 1975;17:236-2.
  13. Japanese classification of gastric carcinoma: 3rd English edition. Gastric Cancer. 2011;14:101-2.
  14. Fleiss JL, Levin B, Paik MC. The measurement of interrater agreement. Statistical methods for rates and proportions, 3rd ed. Hoboken, NJ: Wiley; 2003. p. 603-.
  15. Oda I, Gotoda T, Hamanaka H. Endoscopic submucosal dissection for early gastric cancer: technical feasibility, operation time and complications from large consecutive series. Dig Endosc. 2005;17:54-. CrossRef
  16. Fujishiro M. Endoscopic submucosal dissection for stomach neoplasms. World J Gastroenterol. 2006;12:5108-2.
  
• 作者单位：Mitsuhiro Fujishiro (1)
  Michio Kaminishi (2)
  Naoki Hiki (3)
  Ichiro Oda (4)
  Junko Fujisaki (5)
  Noriya Uedo (6)
  Mitsuru Kaise (7)
  Satoshi Tanabe (8)
  Mikitaka Iguchi (9)
  Nobuyuki Matsuhashi (10)
  Sachiyo Nomura (11)
  Hisao Tajiri (12)
  Naohisa Yahagi (13)
  Hiroaki Suzuki (14)
  
  1. Department of Endoscopy and Endoscopic Surgery, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan
  2. Showa General Hospital, Tokyo, Japan
  3. Department of Gastroenterological Surgery, Gastroenterological Center, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan
  4. Endoscopy Division, National Cancer Center Hospital, Tokyo, Japan
  5. Department of Gastroenterology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan
  6. Department of Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan
  7. Department of Gastroenterology Health Management Center, Toranomon Hospital, Tokyo, Japan
  8. Department of Gastroenterology, Kitasato University School of Medicine, Sagamihara, Japan
  9. Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan
  10. Department of Gastroenterology, Kanto Medical Center, NTT East, Tokyo, Japan
  11. Department of Gastrointestinal Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
  12. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan
  13. Division of Research and Development for Minimally Invasive Treatment, Cancer Center, School of Medicine, Keio University, Tokyo, Japan
  14. Jikei University School of Medicine, Tokyo, Japan
  
• ISSN：1435-5922

文摘

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-) 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 70.8-4.4: 35/41 subjects) than in the placebo group (39.0?%, 24.2-5: 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.