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)

Hidetoshi Katsuno, Koutarou Maeda, Masatoshi Ohya, Kazuhiko Yoshioka, Akira Tsunoda, Keiji Koda, Hiroyoshi Matsuoka, Hiroki Ohge, Satoshi Morita, Shigetoyo Saji, Takashi Kanematsu, Masaki Kitajima

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13 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)222-229
Number of pages8
JournalJournal of Gastroenterology
Volume51
Issue number3
DOIs
Publication statusPublished - 01-03-2016

All Science Journal Classification (ASJC) codes

  • Gastroenterology

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