Effect of Daikenchuto, a Traditional Japanese Herbal Medicine, after Total Gastrectomy for Gastric Cancer

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase II Trial

Kozo Yoshikawa, Mitsuo Shimada, Go Wakabayashi, Koichiro Ishida, Takashi Kaiho, Yuukou Kitagawa, Junichi Sakamoto, Norio Shiraishi, Keisuke Koeda, Erito Mochiki, Yoshiro Saikawa, Kazuya Yamaguchi, Masayuki Watanabe, Satoshi Morita, Seigo Kitano, Shigetoyo Saji, Takashi Kanematsu, Masaki Kitajima

Research output: Contribution to journalArticle

25 Citations (Scopus)

Abstract

Background Daikenchuto (DKT) has widely been used to improve abdominal symptoms by being expected to accelerate bowel motility. The purpose of this study is to examine the efficacy and safety of DKT for prevention of ileus and associated gastrointestinal symptoms after total gastrectomy. Study Design Two hundred and forty-five gastric cancer patients who underwent total gastrectomy were enrolled. Patients received either DKT (15.0 g/d) or matching placebo from postoperative days 1 to 12. Primary end points were time to first flatus, time to first bowel movement (BM), and frequency of BM. Secondary end points included quality of life, C-reactive protein level, symptoms indicative of a severe gastrointestinal disorder, and incidence of postoperative ileus. Results A total of 195 patients (DKT, n = 96; placebo, n = 99) were included in the per-protocol set analysis. There were no significant differences between the groups in terms of patient background characteristics. Median time to first BM was shorter in the DKT group than in the placebo group (94.7 hours vs 113.9 hours; p = 0.051). In patients with high medication adherence, median time to first BM was significantly shorter in the DKT group than in the placebo group (93.8 hours vs 115.1 hours; p = 0.014). Significantly fewer patients in the DKT group had ≥2 symptoms of gastrointestinal dysfunction than those in the placebo group on postoperative day 12 (p = 0.026). Conclusions Administration of DKT during the immediate postoperative period after total gastrectomy appears to promote early recovery of postoperative bowel function.

Original languageEnglish
Pages (from-to)571-578
Number of pages8
JournalJournal of the American College of Surgeons
Volume221
Issue number2
DOIs
Publication statusPublished - 2015 Aug 1

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Herbal Medicine
Gastrectomy
Stomach Neoplasms
Placebos
Ileus
Flatulence
Medication Adherence
dai-kenchu-to
Postoperative Period
C-Reactive Protein
Quality of Life
Safety
Incidence

ASJC Scopus subject areas

  • Surgery
  • Medicine(all)

Cite this

Effect of Daikenchuto, a Traditional Japanese Herbal Medicine, after Total Gastrectomy for Gastric Cancer : A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase II Trial. / Yoshikawa, Kozo; Shimada, Mitsuo; Wakabayashi, Go; Ishida, Koichiro; Kaiho, Takashi; Kitagawa, Yuukou; Sakamoto, Junichi; Shiraishi, Norio; Koeda, Keisuke; Mochiki, Erito; Saikawa, Yoshiro; Yamaguchi, Kazuya; Watanabe, Masayuki; Morita, Satoshi; Kitano, Seigo; Saji, Shigetoyo; Kanematsu, Takashi; Kitajima, Masaki.

In: Journal of the American College of Surgeons, Vol. 221, No. 2, 01.08.2015, p. 571-578.

Research output: Contribution to journalArticle

Yoshikawa, K, Shimada, M, Wakabayashi, G, Ishida, K, Kaiho, T, Kitagawa, Y, Sakamoto, J, Shiraishi, N, Koeda, K, Mochiki, E, Saikawa, Y, Yamaguchi, K, Watanabe, M, Morita, S, Kitano, S, Saji, S, Kanematsu, T & Kitajima, M 2015, 'Effect of Daikenchuto, a Traditional Japanese Herbal Medicine, after Total Gastrectomy for Gastric Cancer: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase II Trial', Journal of the American College of Surgeons, vol. 221, no. 2, pp. 571-578. https://doi.org/10.1016/j.jamcollsurg.2015.03.004
Yoshikawa, Kozo ; Shimada, Mitsuo ; Wakabayashi, Go ; Ishida, Koichiro ; Kaiho, Takashi ; Kitagawa, Yuukou ; Sakamoto, Junichi ; Shiraishi, Norio ; Koeda, Keisuke ; Mochiki, Erito ; Saikawa, Yoshiro ; Yamaguchi, Kazuya ; Watanabe, Masayuki ; Morita, Satoshi ; Kitano, Seigo ; Saji, Shigetoyo ; Kanematsu, Takashi ; Kitajima, Masaki. / Effect of Daikenchuto, a Traditional Japanese Herbal Medicine, after Total Gastrectomy for Gastric Cancer : A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase II Trial. In: Journal of the American College of Surgeons. 2015 ; Vol. 221, No. 2. pp. 571-578.
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abstract = "Background Daikenchuto (DKT) has widely been used to improve abdominal symptoms by being expected to accelerate bowel motility. The purpose of this study is to examine the efficacy and safety of DKT for prevention of ileus and associated gastrointestinal symptoms after total gastrectomy. Study Design Two hundred and forty-five gastric cancer patients who underwent total gastrectomy were enrolled. Patients received either DKT (15.0 g/d) or matching placebo from postoperative days 1 to 12. Primary end points were time to first flatus, time to first bowel movement (BM), and frequency of BM. Secondary end points included quality of life, C-reactive protein level, symptoms indicative of a severe gastrointestinal disorder, and incidence of postoperative ileus. Results A total of 195 patients (DKT, n = 96; placebo, n = 99) were included in the per-protocol set analysis. There were no significant differences between the groups in terms of patient background characteristics. Median time to first BM was shorter in the DKT group than in the placebo group (94.7 hours vs 113.9 hours; p = 0.051). In patients with high medication adherence, median time to first BM was significantly shorter in the DKT group than in the placebo group (93.8 hours vs 115.1 hours; p = 0.014). Significantly fewer patients in the DKT group had ≥2 symptoms of gastrointestinal dysfunction than those in the placebo group on postoperative day 12 (p = 0.026). Conclusions Administration of DKT during the immediate postoperative period after total gastrectomy appears to promote early recovery of postoperative bowel function.",
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T1 - Effect of Daikenchuto, a Traditional Japanese Herbal Medicine, after Total Gastrectomy for Gastric Cancer

T2 - A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase II Trial

AU - Yoshikawa, Kozo

AU - Shimada, Mitsuo

AU - Wakabayashi, Go

AU - Ishida, Koichiro

AU - Kaiho, Takashi

AU - Kitagawa, Yuukou

AU - Sakamoto, Junichi

AU - Shiraishi, Norio

AU - Koeda, Keisuke

AU - Mochiki, Erito

AU - Saikawa, Yoshiro

AU - Yamaguchi, Kazuya

AU - Watanabe, Masayuki

AU - Morita, Satoshi

AU - Kitano, Seigo

AU - Saji, Shigetoyo

AU - Kanematsu, Takashi

AU - Kitajima, Masaki

PY - 2015/8/1

Y1 - 2015/8/1

N2 - Background Daikenchuto (DKT) has widely been used to improve abdominal symptoms by being expected to accelerate bowel motility. The purpose of this study is to examine the efficacy and safety of DKT for prevention of ileus and associated gastrointestinal symptoms after total gastrectomy. Study Design Two hundred and forty-five gastric cancer patients who underwent total gastrectomy were enrolled. Patients received either DKT (15.0 g/d) or matching placebo from postoperative days 1 to 12. Primary end points were time to first flatus, time to first bowel movement (BM), and frequency of BM. Secondary end points included quality of life, C-reactive protein level, symptoms indicative of a severe gastrointestinal disorder, and incidence of postoperative ileus. Results A total of 195 patients (DKT, n = 96; placebo, n = 99) were included in the per-protocol set analysis. There were no significant differences between the groups in terms of patient background characteristics. Median time to first BM was shorter in the DKT group than in the placebo group (94.7 hours vs 113.9 hours; p = 0.051). In patients with high medication adherence, median time to first BM was significantly shorter in the DKT group than in the placebo group (93.8 hours vs 115.1 hours; p = 0.014). Significantly fewer patients in the DKT group had ≥2 symptoms of gastrointestinal dysfunction than those in the placebo group on postoperative day 12 (p = 0.026). Conclusions Administration of DKT during the immediate postoperative period after total gastrectomy appears to promote early recovery of postoperative bowel function.

AB - Background Daikenchuto (DKT) has widely been used to improve abdominal symptoms by being expected to accelerate bowel motility. The purpose of this study is to examine the efficacy and safety of DKT for prevention of ileus and associated gastrointestinal symptoms after total gastrectomy. Study Design Two hundred and forty-five gastric cancer patients who underwent total gastrectomy were enrolled. Patients received either DKT (15.0 g/d) or matching placebo from postoperative days 1 to 12. Primary end points were time to first flatus, time to first bowel movement (BM), and frequency of BM. Secondary end points included quality of life, C-reactive protein level, symptoms indicative of a severe gastrointestinal disorder, and incidence of postoperative ileus. Results A total of 195 patients (DKT, n = 96; placebo, n = 99) were included in the per-protocol set analysis. There were no significant differences between the groups in terms of patient background characteristics. Median time to first BM was shorter in the DKT group than in the placebo group (94.7 hours vs 113.9 hours; p = 0.051). In patients with high medication adherence, median time to first BM was significantly shorter in the DKT group than in the placebo group (93.8 hours vs 115.1 hours; p = 0.014). Significantly fewer patients in the DKT group had ≥2 symptoms of gastrointestinal dysfunction than those in the placebo group on postoperative day 12 (p = 0.026). Conclusions Administration of DKT during the immediate postoperative period after total gastrectomy appears to promote early recovery of postoperative bowel function.

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