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Effect of Daikenchuto, a Traditional Japanese Herbal Medicine, after Total Gastrectomy for Gastric Cancer: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase II Trial.
J Am Coll Surg 2015; 221(2):571-8JA

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.

Authors+Show Affiliations

Department of Surgery, Tokushima University, Tokushima, Japan. Electronic address: yoshikawa.kozo@tokushima-u.ac.jp.Department of Surgery, Tokushima University, Tokushima, Japan.Department of Surgery, Iwate Medical University, School of Medicine, Morioka, Japan.Department of Surgery, National Hospital Organization Osaka Minami Medical Center, Osaka, Japan.Kimitsu Hospital, Chiba, Japan.Department of Surgery, Keio University, School of Medicine, Tokyo, Japan.Tokai Central Hospital, Kakamigahara, Japan.Department of Surgery, Center for Community Medicine, Faculty of Medicine, Oita University, Oita, Japan.Department of Surgery, Iwate Medical University, School of Medicine, Morioka, Japan.Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Saitama, Japan.Department of Surgery, Keio University, School of Medicine, Tokyo, Japan.Department of Surgical Oncology, Gifu University School of Medicine, Gifu, Japan.Department of Gastroenterological Surgery, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.Oita University, Oita, Japan.Japanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo, Japan.Nagasaki City Hospital Organization, Nagasaki, Japan.International University of Health and Welfare, Tokyo, Japan.

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26141466

Citation

Yoshikawa, Kozo, et al. "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, 2015, pp. 571-8.
Yoshikawa K, Shimada M, Wakabayashi G, et al. Effect of Daikenchuto, a Traditional Japanese Herbal Medicine, after Total Gastrectomy for Gastric Cancer: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase II Trial. J Am Coll Surg. 2015;221(2):571-8.
Yoshikawa, K., Shimada, M., Wakabayashi, G., Ishida, K., Kaiho, T., Kitagawa, Y., ... 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, 221(2), pp. 571-8. doi:10.1016/j.jamcollsurg.2015.03.004.
Yoshikawa K, et al. Effect of Daikenchuto, a Traditional Japanese Herbal Medicine, After Total Gastrectomy for Gastric Cancer: a Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase II Trial. J Am Coll Surg. 2015;221(2):571-8. PubMed PMID: 26141466.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of Daikenchuto, a Traditional Japanese Herbal Medicine, after Total Gastrectomy for Gastric Cancer: 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,Yuko, 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, Y1 - 2015/03/14/ PY - 2015/01/02/received PY - 2015/02/28/revised PY - 2015/03/09/accepted PY - 2015/7/5/entrez PY - 2015/7/5/pubmed PY - 2015/10/6/medline SP - 571 EP - 8 JF - Journal of the American College of Surgeons JO - J. Am. Coll. Surg. VL - 221 IS - 2 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. SN - 1879-1190 UR - https://www.unboundmedicine.com/medline/citation/26141466/Effect_of_Daikenchuto_a_Traditional_Japanese_Herbal_Medicine_after_Total_Gastrectomy_for_Gastric_Cancer:_A_Multicenter_Randomized_Double_Blind_Placebo_Controlled_Phase_II_Trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1072-7515(15)00196-9 DB - PRIME DP - Unbound Medicine ER -