Clinical efficacy of Daikenchuto for gastrointestinal dysfunction following colon surgery

A randomized, double-blind, multicenter, placebo-controlled study (JFMC39-0902)

Hidetoshi Katsuno, Koutarou Maeda, Takashi Kaiho, Katsuyuki Kunieda, Kimihiko Funahashi, Junichi Sakamoto, Toru Kono, Hirotoshi Hasegawa, Yoshiyuki Furukawa, Yoshihiro Imazu, Satoshi Morita, Masahiko Watanabe

Research output: Contribution to journalArticle

15 Citations (Scopus)

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 aswell. In contrast, bowelmovement frequency in theDaikenchuto group increased until post-operative day 6, however decreased frompost-operative day 7 andwas significantly lower at post-operative day 8 compared with the placebo group (P = 0.024). Conclusion: 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.

Original languageEnglish
Pages (from-to)650-656
Number of pages7
JournalJapanese Journal of Clinical Oncology
Volume45
Issue number7
DOIs
Publication statusPublished - 2015

Fingerprint

Colon
Placebos
Colectomy
Colonic Neoplasms
Intestinal Obstruction
Recovery of Function
dai-kenchu-to
Diarrhea
Japan
Clinical Trials
Safety
Incidence

Keywords

  • Bowel movement
  • Colon cancer
  • Daikenchuto
  • Herbal medicine

ASJC Scopus subject areas

  • Oncology
  • Cancer Research
  • Radiology Nuclear Medicine and imaging

Cite this

Clinical efficacy of Daikenchuto for gastrointestinal dysfunction following colon surgery : A randomized, double-blind, multicenter, placebo-controlled study (JFMC39-0902). / Katsuno, Hidetoshi; Maeda, Koutarou; Kaiho, Takashi; Kunieda, Katsuyuki; Funahashi, Kimihiko; Sakamoto, Junichi; Kono, Toru; Hasegawa, Hirotoshi; Furukawa, Yoshiyuki; Imazu, Yoshihiro; Morita, Satoshi; Watanabe, Masahiko.

In: Japanese Journal of Clinical Oncology, Vol. 45, No. 7, 2015, p. 650-656.

Research output: Contribution to journalArticle

Katsuno, H, Maeda, K, Kaiho, T, Kunieda, K, Funahashi, K, Sakamoto, J, Kono, T, Hasegawa, H, Furukawa, Y, Imazu, Y, Morita, S & Watanabe, M 2015, 'Clinical efficacy of Daikenchuto for gastrointestinal dysfunction following colon surgery: A randomized, double-blind, multicenter, placebo-controlled study (JFMC39-0902)', Japanese Journal of Clinical Oncology, vol. 45, no. 7, pp. 650-656. https://doi.org/10.1093/jjco/hyv056
Katsuno, Hidetoshi ; Maeda, Koutarou ; Kaiho, Takashi ; Kunieda, Katsuyuki ; Funahashi, Kimihiko ; Sakamoto, Junichi ; Kono, Toru ; Hasegawa, Hirotoshi ; Furukawa, Yoshiyuki ; Imazu, Yoshihiro ; Morita, Satoshi ; Watanabe, Masahiko. / Clinical efficacy of Daikenchuto for gastrointestinal dysfunction following colon surgery : A randomized, double-blind, multicenter, placebo-controlled study (JFMC39-0902). In: Japanese Journal of Clinical Oncology. 2015 ; Vol. 45, No. 7. pp. 650-656.
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AU - Katsuno, Hidetoshi

AU - Maeda, Koutarou

AU - Kaiho, Takashi

AU - Kunieda, Katsuyuki

AU - Funahashi, Kimihiko

AU - Sakamoto, Junichi

AU - Kono, Toru

AU - Hasegawa, Hirotoshi

AU - Furukawa, Yoshiyuki

AU - Imazu, Yoshihiro

AU - Morita, Satoshi

AU - Watanabe, Masahiko

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N2 - 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 aswell. In contrast, bowelmovement frequency in theDaikenchuto group increased until post-operative day 6, however decreased frompost-operative day 7 andwas significantly lower at post-operative day 8 compared with the placebo group (P = 0.024). Conclusion: 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.

AB - 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 aswell. In contrast, bowelmovement frequency in theDaikenchuto group increased until post-operative day 6, however decreased frompost-operative day 7 andwas significantly lower at post-operative day 8 compared with the placebo group (P = 0.024). Conclusion: 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.

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KW - Herbal medicine

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