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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)

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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.

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Acknowledgment

This study was supported by the Japanese Foundation for Multidisciplinary Treatment of Cancer.

Author information

Authors and Affiliations

  1. Department of Surgery, Fujita Health University School of Medicine, Dengakugakubo 1-98, Kutsukake, Toyoake, Aichi, 470-1192, Japan

    Hidetoshi Katsuno & Koutarou Maeda

  2. Department of Surgery, Dokkyo Medical University Koshigaya Hospital, Koshigaya, Japan

    Masatoshi Ohya

  3. Department of Surgery, Kansai Medical University Takii Hospital, Moriguchi, Japan

    Kazuhiko Yoshioka

  4. Department of Surgery, Kameda Medical Center, Kamogawa, Japan

    Akira Tsunoda

  5. Department of Surgery, Teikyo University Chiba Medical Center, Ichihara, Japan

    Keiji Koda

  6. Department of Surgery, Kyorin University Hospital, Mitaka, Japan

    Hiroyoshi Matsuoka

  7. Department of Surgery, Hiroshima University School of Medicine, Hiroshima, Japan

    Hiroki Ohge

  8. Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan

    Satoshi Morita

  9. Japanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo, Japan

    Shigetoyo Saji

  10. Nagasaki City Hospital Organization, Nagasaki, Japan

    Takashi Kanematsu

  11. International University of Health and Welfare, Otawara, Japan

    Masaki Kitajima

Authors
  1. Hidetoshi Katsuno
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  2. Koutarou Maeda
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Correspondence to Hidetoshi Katsuno.

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Katsuno, H., Maeda, K., Ohya, M. et al. 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). J Gastroenterol 51, 222–229 (2016). https://doi.org/10.1007/s00535-015-1100-1

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  • DOI: https://doi.org/10.1007/s00535-015-1100-1

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