title: Clinical pharmacology of daikenchuto assessed by transit analysis using radiopaque markers in patients with colon cancer undergoing open surgery: a multicenter double-blind randomized placebo-controlled study (JFMC39-0902 additional study).
abstract: BACKGROUND
  This exploratory trial was conducted to investigate whether daikenchuto accelerates the recovery of gastrointestinal function in patients undergoing open surgery for sigmoid or rectosigmoid cancer.
  
  
  METHODS
  Eighty-eight patients who underwent colectomy at one of the 11 clinical trial sites in Japan from January 2009 to June 2011 were registered in the study. Patients received either placebo or daikenchuto (15.0 g/day, 5 g three times a day) from postoperative day 2 to postoperative day 8. The study end points included the gastrointestinal tract transit time evaluated with radiopaque markers and the time to first flatus. The safety profile of daikenchuto was also evaluated until postoperative day 8.
  
  
  RESULTS
  Seventy-one patients (daikenchuto, n = 38; placebo, n = 33) were statistically analyzed. Although the number of radiopaque markers in the anal side of the small intestine at 6 h was significantly greater in the daikenchuto group than in the placebo group (15.19 vs 10.06, p = 0.008), the total transit analysis results and the mean time to first flatus did not differ significantly between the two groups.
  
  
  CONCLUSIONS
  Daikenchuto has a positive effect on the resolution of delayed gastric emptying, but has a limited effect on the resolution of postoperative paralytic ileus after open surgery in patients with sigmoid or rectosigmoid cancer. Daikenchuto may contribute to early oral intake in the postoperative course.
authors.affiliation: Department of Surgery, Fujita Health University School of Medicine, Dengakugakubo 1-98, Kutsukake, Toyoake, Aichi, 470-1192, Japan. 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, Dengakugakubo 1-98, Kutsukake, Toyoake, Aichi, 470-1192, Japan.
authors.forename: Koutarou
authors.initials: K
authors.lastname: Maeda
authors.affiliation: Department of Surgery, Dokkyo Medical University Koshigaya Hospital, Koshigaya, Japan.
authors.forename: Masatoshi
authors.initials: M
authors.lastname: Ohya
authors.affiliation: Department of Surgery, Kansai Medical University Takii Hospital, Moriguchi, Japan.
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Yoshioka
authors.affiliation: Department of Surgery, Kameda Medical Center, Kamogawa, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Tsunoda
authors.affiliation: Department of Surgery, Teikyo University Chiba Medical Center, Ichihara, Japan.
authors.forename: Keiji
authors.initials: K
authors.lastname: Koda
authors.affiliation: Department of Surgery, Kyorin University Hospital, Mitaka, Japan.
authors.forename: Hiroyoshi
authors.initials: H
authors.lastname: Matsuoka
authors.affiliation: Department of Surgery, Hiroshima University School of Medicine, Hiroshima, Japan.
authors.forename: Hiroki
authors.initials: H
authors.lastname: Ohge
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: 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, Otawara, Japan.
authors.forename: Masaki
authors.initials: M
authors.lastname: Kitajima
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003082:Colectomy / Q000009:adverse effects* / Q000379:methods; D003287:Contrast Media; D004311:Double-Blind Method; D005260:Female; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D005769:Gastrointestinal Motility / Q000187:drug effects; D006801:Humans; D045823:Ileus / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D005894:Panax; D010936:Plant Extracts / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D012811:Sigmoid Neoplasms / Q000601:surgery*; D032106:Zanthoxylum; D030521:Zingiberaceae
chemical_list: D003287:Contrast Media; D005765:Gastrointestinal Agents; D010936:Plant Extracts; C121414:dai-kenchu-to
keywords: Colon cancer; Daikenchuto; Herbal medicine; Radiopaque marker; Transit analysis