• J. Am. Coll. Surg. · Aug 2015

    Randomized Controlled Trial Multicenter Study

    Effect of Daikenchuto, a Traditional Japanese Herbal Medicine, after Total Gastrectomy for Gastric Cancer: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase II Trial.

    • Kozo Yoshikawa, Mitsuo Shimada, Go Wakabayashi, Koichiro Ishida, Takashi Kaiho, Yuko Kitagawa, Junichi Sakamoto, Norio Shiraishi, Keisuke Koeda, Erito Mochiki, Yoshiro Saikawa, Kazuya Yamaguchi, Masayuki Watanabe, Satoshi Morita, Seigo Kitano, Shigetoyo Saji, Takashi Kanematsu, and Masaki Kitajima.
    • Department of Surgery, Tokushima University, Tokushima, Japan. Electronic address: yoshikawa.kozo@tokushima-u.ac.jp.
    • J. Am. Coll. Surg. 2015 Aug 1; 221 (2): 571-8.

    BackgroundDaikenchuto (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 DesignTwo 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.ResultsA 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).ConclusionsAdministration of DKT during the immediate postoperative period after total gastrectomy appears to promote early recovery of postoperative bowel function.Copyright © 2015 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

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