title: Clinical efficacy of Daikenchuto for gastrointestinal dysfunction following colon surgery: a randomized, double-blind, multicenter, placebo-controlled study (JFMC39-0902).
abstract: OBJECTIVE
  This exploratory trial was performed to determine whether Daikenchuto accelerates recovery of gastrointestinal function in patients undergoing open colectomy for colon cancer.
  
  
  METHODS
  A total of 386 patients undergoing colectomy at 1 of the 51 clinical trial sites in Japan from January 2009 to June 2011 were registered for the study (JFMC39-0902). Patients received either placebo or Daikenchuto (15.0 g/day, t.i.d) between post-operative day 2 and post-operative day 8. Primary end-points included time to first bowel movement, frequency of bowel movement and stool form. The incidence of intestinal obstruction was evaluated post-operatively. The safety profile of Daikenchuto until post-operative day 8 was also evaluated.
  
  
  RESULTS
  The results for 336 patients (Daikenchuto, n = 174; placebo, n = 162) were available for statistical analysis. The time to first bowel movement did not differ significantly between the two groups. All patients reported having diarrhea or soft stools immediately after surgery, and the time until stool normalization (50th percentile) in the Daikenchuto and placebo groups was 6 days and 7 days, respectively. The placebo group had a significantly greater number of hard stools at post-operative day 8 (P = 0.016), and bowel movement frequency continued to increase until post-operative day 8 as well. In contrast, bowel movement frequency in the Daikenchuto group increased until post-operative day 6, however decreased from post-operative day 7 and was significantly lower at post-operative day 8 compared with the placebo group (P = 0.024).
  
  
  CONCLUSIONS
  The moderate effects of Daikenchuto were observed ∼1 week after the operation. Although Daikenchuto had an effect on gastrointestinal function after open surgery in patients with colon cancer, this study did not show its clinical benefits adequately.
authors.affiliation: Department of Surgery, Fujita Health University, School of Medicine, Toyoake katsuno@fujita-hu.ac.jp.
authors.forename: Hidetoshi
authors.initials: H
authors.lastname: Katsuno
authors.affiliation: Department of Surgery, Fujita Health University, School of Medicine, Toyoake.
authors.forename: Koutarou
authors.initials: K
authors.lastname: Maeda
authors.affiliation: Department of Surgery, Kimitsu Chuo Hospital, Kisarazu.
authors.forename: Takashi
authors.initials: T
authors.lastname: Kaiho
authors.affiliation: Department of Surgery, Gifu Prefectural General Medical Center, Gifu.
authors.forename: Katsuyuki
authors.initials: K
authors.lastname: Kunieda
authors.affiliation: Department of General and Gastroenterological Surgery, Toho University Omori Medical Center, Tokyo.
authors.forename: Kimihiko
authors.initials: K
authors.lastname: Funahashi
authors.affiliation: Tokai Central Hospital, Kagamihara.
authors.forename: Junichi
authors.initials: J
authors.lastname: Sakamoto
authors.affiliation: Advanced Surgery Center, Sapporo Higashi Tokushukai Hospital, Sapporo.
authors.forename: Toru
authors.initials: T
authors.lastname: Kono
authors.affiliation: Department of Surgery, Keio University School of Medicine, Tokyo.
authors.forename: Hirotoshi
authors.initials: H
authors.lastname: Hasegawa
authors.affiliation: Kawasaki South Hospital, Kawasaki.
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Furukawa
authors.affiliation: Shiba Daimon Imazu Clinic, Tokyo.
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Imazu
authors.affiliation: Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Morita
authors.affiliation: Department of Surgery, Kitasato University School of Medicine, Sagamihara, Japan.
authors.forename: Masahiko
authors.initials: M
authors.lastname: Watanabe
mesh_terms: D000328:Adult; D000368:Aged; D003082:Colectomy / Q000009:adverse effects*; D003110:Colonic Neoplasms / Q000601:surgery; D003672:Defecation; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007422:Intestines / Q000187:drug effects* / Q000503:physiopathology*; D007564:Japan; D008297:Male; D008875:Middle Aged; D005894:Panax; D010528:Peristalsis / Q000187:drug effects*; D010936:Plant Extracts / Q000627:therapeutic use*; D011184:Postoperative Period; D013997:Time Factors; D016896:Treatment Outcome; D032106:Zanthoxylum; D030521:Zingiberaceae
chemical_list: D010936:Plant Extracts; C121414:dai-kenchu-to
keywords: Daikenchuto; bowel movement; colon cancer; herbal medicine