title: Effect of Daikenchuto, a Traditional Japanese Herbal Medicine, after Total Gastrectomy for Gastric Cancer: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase II Trial.
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.
  
  
  METHODS
  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.
authors.affiliation: Department of Surgery, Tokushima University, Tokushima, Japan. Electronic address: yoshikawa.kozo@tokushima-u.ac.jp.
authors.forename: Kozo
authors.initials: K
authors.lastname: Yoshikawa
authors.affiliation: Department of Surgery, Tokushima University, Tokushima, Japan.
authors.forename: Mitsuo
authors.initials: M
authors.lastname: Shimada
authors.affiliation: Department of Surgery, Iwate Medical University, School of Medicine, Morioka, Japan.
authors.forename: Go
authors.initials: G
authors.lastname: Wakabayashi
authors.affiliation: Department of Surgery, National Hospital Organization Osaka Minami Medical Center, Osaka, Japan.
authors.forename: Koichiro
authors.initials: K
authors.lastname: Ishida
authors.affiliation: Kimitsu Hospital, Chiba, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Kaiho
authors.affiliation: Department of Surgery, Keio University, School of Medicine, Tokyo, Japan.
authors.forename: Yuko
authors.initials: Y
authors.lastname: Kitagawa
authors.affiliation: Tokai Central Hospital, Kakamigahara, Japan.
authors.forename: Junichi
authors.initials: J
authors.lastname: Sakamoto
authors.affiliation: Department of Surgery, Center for Community Medicine, Faculty of Medicine, Oita University, Oita, Japan.
authors.forename: Norio
authors.initials: N
authors.lastname: Shiraishi
authors.affiliation: Department of Surgery, Iwate Medical University, School of Medicine, Morioka, Japan.
authors.forename: Keisuke
authors.initials: K
authors.lastname: Koeda
authors.affiliation: Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Saitama, Japan.
authors.forename: Erito
authors.initials: E
authors.lastname: Mochiki
authors.affiliation: Department of Surgery, Keio University, School of Medicine, Tokyo, Japan.
authors.forename: Yoshiro
authors.initials: Y
authors.lastname: Saikawa
authors.affiliation: Department of Surgical Oncology, Gifu University School of Medicine, Gifu, Japan.
authors.forename: Kazuya
authors.initials: K
authors.lastname: Yamaguchi
authors.affiliation: Department of Gastroenterological Surgery, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
authors.forename: Masayuki
authors.initials: M
authors.lastname: Watanabe
authors.affiliation: Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Morita
authors.affiliation: Oita University, Oita, Japan.
authors.forename: Seigo
authors.initials: S
authors.lastname: Kitano
authors.affiliation: Japanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo, Japan.
authors.forename: Shigetoyo
authors.initials: S
authors.lastname: Saji
authors.affiliation: Nagasaki City Hospital Organization, Nagasaki, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Kanematsu
authors.affiliation: International University of Health and Welfare, Tokyo, Japan.
authors.forename: Masaki
authors.initials: M
authors.lastname: Kitajima
mesh_terms: D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005743:Gastrectomy; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D006801:Humans; D045823:Ileus / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D015994:Incidence; D008297:Male; D008875:Middle Aged; D005894:Panax; D008517:Phytotherapy; D010936:Plant Extracts / Q000627:therapeutic use*; D011182:Postoperative Care; D011183:Postoperative Complications / Q000453:epidemiology / Q000517:prevention & control*; D013274:Stomach Neoplasms / Q000601:surgery*; D016896:Treatment Outcome; D032106:Zanthoxylum; D030521:Zingiberaceae
chemical_list: D005765:Gastrointestinal Agents; D010936:Plant Extracts; C121414:dai-kenchu-to