caa a22 4500 445888091 CHVBK 20180317145606.0 cr unu---uuuuu 170323e20110701xx s 000 0 eng 10.1007/s00535-011-0395-9 doi (NATIONALLICENCE)springer-10.1007/s00535-011-0395-9 An open-label, single-arm study assessing the efficacy and safety of l -menthol sprayed onto the gastric mucosa during upper gastrointestinal endoscopy [Elektronische Daten] [Naoki Hiki, Michio Kaminishi, Satoshi Tanabe, Junko Fujisaki, Junji Yoshino, Mikitaka Iguchi, Hiroyuki Kobayashi, Kiyoshi Ashida, Takao Kawabe, Tatsuyuki Kawano, Sachiyo Nomura, Naohisa Yahagi, Hisao Tajiri, Hiroaki Suzuki] Background and aims: The results of a phase III, placebo-controlled study demonstrated that endoscopic direct spraying of l-menthol onto the gastric mucosa effectively suppressed gastric peristalsis in the study patients. The aim of the study reported here was to determine whether the anti-peristaltic effect of an l-menthol preparation facilitates endoscopic examinations in a clinical setting. Methods: This was a multicenter, open-label, single-arm trial in which the study cohort comprised patients in whom l-menthol was likely to be used to facilitate endoscopic examination in clinical settings. The primary outcome was the proportion of subjects with no peristalsis (Grade 1) after treatment and at the end of endoscopy (defined as the complete suppression of gastric peristalsis). This variable was assessed according to the level of anti-Helicobacter pylori immunoglobulin G (IgG) antibody, pepsinogen test results, whether sedation was performed, and whether subjects were considered unsuitable for the use of conventional antispasmodics. Results: Of the 119 enrolled subjects, data from 112 were included in the primary efficacy analysis. Gastric peristalsis was completely suppressed in 37.5% of the patients [42/112 patients; 95% confidence interval (CI) 28.5-47.1]. Subgroup analyses revealed that the rate of peristalsis suppression was significantly higher in patients with elevated levels of anti-H. pylori IgG antibody (26/44, 59.1%; 95% CI 43.2-73.7); P<0.001] and positive pepsinogen test results (21/35, 65.6%; 95% CI 46.8-81.4; P<0.001]. There was no significant difference according to sedation (17/52, 32.7%; 95% CI 20.3-47.1; P=0.434) or whether subjects were considered unsuitable for use of conventional antispasmodic agents (14/28, 50.0%; 95% CI 30.6-69.4; P=0.12]. Conclusion: These findings are comparable to those of the phase III placebo-controlled study and provide further evidence that endoscopic direct spraying of l-menthol effectively suppresses gastric peristalsis during upper gastrointestinal endoscopy. Springer, 2011 Gastric peristalsis nationallicence Endoscopic diagnosis nationallicence Peppermint oil nationallicence Gastric cancer nationallicence Hiki Naoki Department of Gastroenterological Surgery, Gastroenterological Center, Cancer Institute Hospital, Japanese Foundation for Cancer Research, 3-10-6 Ariake, 135-8550, Koto-ku, Tokyo, Japan aut Kaminishi Michio Showa General Hospital, Tokyo, Japan aut Tanabe Satoshi Department of Gastroenterology, Kitasato University School of Medicine, Sagamihara, Japan aut Fujisaki Junko Division of Endoscopy, Cancer Institute Ariake Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan aut Yoshino Junji Department of Internal Medicine, Second Teaching Hospital, Fujita Health University School of Medicine, Nagoya, Japan aut Iguchi Mikitaka Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan aut Kobayashi Hiroyuki Division of Gastroenterology, Matsuyama Red Cross Hospital, Matsuyama, Japan aut Ashida Kiyoshi Department of Gastroenterology and Hepatology, Saiseikai Nakatsu Hospital, Osaka, Japan aut Kawabe Takao Department of Endoscopy and Endoscopic Surgery, Faculty of Medicine, University of Tokyo, Tokyo, Japan aut Kawano Tatsuyuki Department of Esophageal and Gastric Surgery, Tokyo Medical and Dental University Graduate School, Tokyo, Japan aut Nomura Sachiyo Department of Gastrointestinal Surgery, Graduate School of Medicine, University of Tokyo, Tokyo, Japan aut Yahagi Naohisa Division for Research and Development of Minor Invasive Treatment, Tumor Center, Keio University School of Medicine, Tokyo, Japan aut Tajiri Hisao Division of Gastroenterology and Hepatology, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan aut Suzuki Hiroaki Jikei University School of Medicine, Tokyo, Japan aut Journal of Gastroenterology Springer Japan 46/7(2011-07-01), 873-882 0944-1174 46:7<873 2011 46 535 https://doi.org/10.1007/s00535-011-0395-9 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s00535-011-0395-9 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Hiki Naoki Department of Gastroenterological Surgery, Gastroenterological Center, Cancer Institute Hospital, Japanese Foundation for Cancer Research, 3-10-6 Ariake, 135-8550, Koto-ku, Tokyo, Japan aut NATIONALLICENCE 700 1- Kaminishi Michio Showa General Hospital, Tokyo, Japan aut NATIONALLICENCE 700 1- Tanabe Satoshi Department of Gastroenterology, Kitasato University School of Medicine, Sagamihara, Japan aut NATIONALLICENCE 700 1- Fujisaki Junko Division of Endoscopy, Cancer Institute Ariake Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan aut NATIONALLICENCE 700 1- Yoshino Junji Department of Internal Medicine, Second Teaching Hospital, Fujita Health University School of Medicine, Nagoya, Japan aut NATIONALLICENCE 700 1- Iguchi Mikitaka Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan aut NATIONALLICENCE 700 1- Kobayashi Hiroyuki Division of Gastroenterology, Matsuyama Red Cross Hospital, Matsuyama, Japan aut NATIONALLICENCE 700 1- Ashida Kiyoshi Department of Gastroenterology and Hepatology, Saiseikai Nakatsu Hospital, Osaka, Japan aut NATIONALLICENCE 700 1- Kawabe Takao Department of Endoscopy and Endoscopic Surgery, Faculty of Medicine, University of Tokyo, Tokyo, Japan aut NATIONALLICENCE 700 1- Kawano Tatsuyuki Department of Esophageal and Gastric Surgery, Tokyo Medical and Dental University Graduate School, Tokyo, Japan aut NATIONALLICENCE 700 1- Nomura Sachiyo Department of Gastrointestinal Surgery, Graduate School of Medicine, University of Tokyo, Tokyo, Japan aut NATIONALLICENCE 700 1- Yahagi Naohisa Division for Research and Development of Minor Invasive Treatment, Tumor Center, Keio University School of Medicine, Tokyo, Japan aut NATIONALLICENCE 700 1- Tajiri Hisao Division of Gastroenterology and Hepatology, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan aut NATIONALLICENCE 700 1- Suzuki Hiroaki Jikei University School of Medicine, Tokyo, Japan aut NATIONALLICENCE 773 0- Journal of Gastroenterology Springer Japan 46/7(2011-07-01), 873-882 0944-1174 46:7<873 2011 46 535 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer