Kozo Yoshikawa1, Mitsuo Shimada2, Go Wakabayashi3, Koichiro Ishida4, Takashi Kaiho5, Yuko Kitagawa6, Junichi Sakamoto7, Norio Shiraishi8, Keisuke Koeda3, Erito Mochiki9, Yoshiro Saikawa6, Kazuya Yamaguchi10, Masayuki Watanabe11, Satoshi Morita12, Seigo Kitano13, Shigetoyo Saji14, Takashi Kanematsu15, Masaki Kitajima16. 1. Department of Surgery, Tokushima University, Tokushima, Japan. Electronic address: yoshikawa.kozo@tokushima-u.ac.jp. 2. Department of Surgery, Tokushima University, Tokushima, Japan. 3. Department of Surgery, Iwate Medical University, School of Medicine, Morioka, Japan. 4. Department of Surgery, National Hospital Organization Osaka Minami Medical Center, Osaka, Japan. 5. Kimitsu Hospital, Chiba, Japan. 6. Department of Surgery, Keio University, School of Medicine, Tokyo, Japan. 7. Tokai Central Hospital, Kakamigahara, Japan. 8. Department of Surgery, Center for Community Medicine, Faculty of Medicine, Oita University, Oita, Japan. 9. Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Saitama, Japan. 10. Department of Surgical Oncology, Gifu University School of Medicine, Gifu, Japan. 11. Department of Gastroenterological Surgery, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan. 12. Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan. 13. Oita University, Oita, Japan. 14. Japanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo, Japan. 15. Nagasaki City Hospital Organization, Nagasaki, Japan. 16. International University of Health and Welfare, Tokyo, Japan.
Abstract
BACKGROUND:Daikenchuto (DKT) has widely been used to improve abdominal symptoms by being expected to accelerate bowel motility. The purpose of this study is to examine the efficacy and safety of DKT for prevention of ileus and associated gastrointestinal symptoms after total gastrectomy. STUDY DESIGN:Two hundred and forty-five gastric cancer patients who underwent total gastrectomy were enrolled. Patients received either DKT (15.0 g/d) or matching placebo from postoperative days 1 to 12. Primary end points were time to first flatus, time to first bowel movement (BM), and frequency of BM. Secondary end points included quality of life, C-reactive protein level, symptoms indicative of a severe gastrointestinal disorder, and incidence of postoperative ileus. RESULTS: A total of 195 patients (DKT, n = 96; placebo, n = 99) were included in the per-protocol set analysis. There were no significant differences between the groups in terms of patient background characteristics. Median time to first BM was shorter in the DKT group than in the placebo group (94.7 hours vs 113.9 hours; p = 0.051). In patients with high medication adherence, median time to first BM was significantly shorter in the DKT group than in the placebo group (93.8 hours vs 115.1 hours; p = 0.014). Significantly fewer patients in the DKT group had ≥2 symptoms of gastrointestinal dysfunction than those in the placebo group on postoperative day 12 (p = 0.026). CONCLUSIONS: Administration of DKT during the immediate postoperative period after total gastrectomy appears to promote early recovery of postoperative bowel function.
RCT Entities:
BACKGROUND: Daikenchuto (DKT) has widely been used to improve abdominal symptoms by being expected to accelerate bowel motility. The purpose of this study is to examine the efficacy and safety of DKT for prevention of ileus and associated gastrointestinal symptoms after total gastrectomy. STUDY DESIGN: Two hundred and forty-five gastric cancerpatients who underwent total gastrectomy were enrolled. Patients received either DKT (15.0 g/d) or matching placebo from postoperative days 1 to 12. Primary end points were time to first flatus, time to first bowel movement (BM), and frequency of BM. Secondary end points included quality of life, C-reactive protein level, symptoms indicative of a severe gastrointestinal disorder, and incidence of postoperative ileus. RESULTS: A total of 195 patients (DKT, n = 96; placebo, n = 99) were included in the per-protocol set analysis. There were no significant differences between the groups in terms of patient background characteristics. Median time to first BM was shorter in the DKT group than in the placebo group (94.7 hours vs 113.9 hours; p = 0.051). In patients with high medication adherence, median time to first BM was significantly shorter in the DKT group than in the placebo group (93.8 hours vs 115.1 hours; p = 0.014). Significantly fewer patients in the DKT group had ≥2 symptoms of gastrointestinal dysfunction than those in the placebo group on postoperative day 12 (p = 0.026). CONCLUSIONS: Administration of DKT during the immediate postoperative period after total gastrectomy appears to promote early recovery of postoperative bowel function.
Authors: Jun Miyoshi; Kentaro Nobutani; Mark W Musch; Daina L Ringus; Nathaniel A Hubert; Masahiro Yamamoto; Yoshio Kase; Mitsue Nishiyama; Eugene B Chang Journal: Evid Based Complement Alternat Med Date: 2018-02-22 Impact factor: 2.629