Efficacy and safety of oral sulfate solution for bowel preparation in Japanese patients undergoing colonoscopy: Noninferiority-based, randomized, controlled study.

Takehiro Arai, Hisao Tajiri, Shoichi Saito, Kiyonori Kobayashi, Shiori Ichinose, Toshio Uraoka, Masakatsu Fukuzawa, Seiji Shimizu, Noriya Uedo, Shinji Tanaka, Haruhiko Ogata, Yukihiro Hamahata, Yoshio Omae, Tatsuya Shirakura, Nobutoshi Kuniyoshi, Toyoki Kudo, Naoto Tamai, Shiro Oka, Yutaka Saito

Journal: Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society 2021;33(7):1131-1138

PMID: 33476415

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Abstract

OBJECTIVES

To compare the efficacy and safety of oral sulfate solution administered using the same-day dose and the split-dose regimens with those of polyethylene glycol plus ascorbate solution, used for bowel preparation in Japanese patients undergoing colonoscopy.

METHODS

This multicenter (n = 13), randomized, active-controlled, colonoscopist- and image evaluator-blinded, noninferiority study with parallel-group comparison recruited 632 patients from December 2018 to June 2019. Of these, 602 patients were divided into the oral sulfate solution same-day dose group (n = 200); oral sulfate solution split-dose group (n = 202); and polyethylene glycol plus ascorbate same-day dose group (n = 200). Differences in the efficacy rates between the polyethylene glycol plus ascorbate group and each oral sulfate solution group were calculated using the asymptotic method. The safety of the oral sulfate solution was evaluated, based on the occurrence of adverse events and reactions.

RESULTS

Both oral sulfate solution protocols were confirmed as noninferior to the polyethylene glycol plus ascorbate protocol for bowel-cleansing. The occurrence of adverse reactions was significantly lower in the oral sulfate solution same-day dose group than in the polyethylene glycol plus ascorbate group (P = 0.010). The occurrence of adverse reactions was not significantly different between the oral sulfate solution split-dose and the polyethylene glycol plus ascorbate group.

CONCLUSIONS

Oral sulfate solution is not only safe and efficacious but also not inferior to polyethylene glycol plus ascorbate solution (active control). It could be used for bowel preparation in Japanese patients scheduled for colonoscopy (Clinical trial registration number: NCT03794310).

Address: Endoscopy Division, National Cancer Center Hospital, Tokyo, Japan.; Department of, Gastroenterology and Metabolism, Hiroshima University Hospital, Hiroshima, Japan.; Department of, Endoscopy, The, Tokyo, Japan.; Digestive Disease Center, Showa University Northern Yokohama Hospital, Kanagawa, Japan.; Department of Internal Medicine, Kuniyoshi Hospital, Kochi, Japan.; Coloproctology Center Matsushima Hospital, Kanagawa, Japan.; Department of Gastroenterology, Kawasaki Saiwai Hospital, Kanagawa, Japan.; Department of Coloproctology, Tsujinaka Hospital Kashiwanoha, Chiba, Japan.; Gastroenterology Division, Tokatsu-Tsujinaka Hospital, Chiba, Japan.; Department of, Endoscopy, Hiroshima University Hospital, Hiroshima, Japan.; Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan.; Departments of Gastroenterology and Hepatology, Osaka General Hospital of West Japan Railway Company, Osaka, Japan.; Department of Gastroenterology and Hepatology, Tokyo Medical University, Tokyo, Japan.; Department of Gastroenterology and Hepatology, Gunma University Graduate School of Medicine, Gunma, Japan.; Nihon Pharmaceutical Co., Ltd., Tokyo, Japan.; Center for Diagnostic and Therapeutic Endoscopy, Keio University School of Medicine, Tokyo, Japan.; Research and Development Center for New Medical Frontiers, Kitasato University School of Medicine, Kanagawa, Japan.; Department of Gastroenterology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.; Department of, Innovative Interventional Endoscopy Research, The Jikei University School of Medicine, Tokyo, Japan.

DOI: 10.1111/den.13930

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MeSH Terms: Cathartics, Colonoscopy, Humans, Japan, Polyethylene Glycols, Sulfates