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Daikenchuto (DKT) Helps Improve Postoperative Functional Gastrointestinal Disorder After Total Gastrectomy in Patients With Gastric Cancer: a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial(Jfmc42-1002)
Keisuke Koeda*1, Go Wakabayashi1, Mitsuo Shimada2, Kohichiro Ishida3, Takashi Kaiho4, Yuko Kitagawa5, Junichi Satamoto6, Norio Shiraishi7, Satoshi Morita8, Masaki Kitajima9, Shigetoyo Saji10, Seigo Kitano11
1Surgery, Iwate Medical University, Morioka, Japan; 2Surgery, The University of Tokushima, Tokushima, Japan; 3Surgery, Natinal Hospital Organization Osaka Minami Medical Center, Osaka, Japan; 4Surgery, Kimitsu Chuo Hospital, Kisarazu, Japan; 5Surgery, Keio University, School of Medicine, Tokyo, Japan; 6Tokai Central Hospital, Kakamigahara, Japan; 7Surgery, Center for Community Medicine, Faculty of Medicine, Oita University, Oita, Japan; 8Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan; 9International University of Health and Welfare, Tokyo, Japan; 10Japanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo, Japan; 11Oita University, Oita, Japan
Background and Aim
Prolonged postoperative paralytic ileus and/or adhesive intestinal obstruction remain serious and inevitable consequences in certain number of cases after abdominal surgery. Intestinal ileus results in not only protracted hospital stay, but also deteriorates quality of life of the patients. Daikenchuto (DKT), a traditional herbal medicine (Kampo), has widely been used to improve abdominal symptoms by accelerating bowel motility. In this study, we examined the efficacy and safety of DKT for prevention of ileus and associated gastrointestinal symptoms after total gastrectomy by a double-blind placebo-controlled randomized phase II clinical trial.
Methods
Two hundred forty-five gastric cancer patients who underwent total gastrectomy at 40 Japanese institutions from January 2011 to December 2012 were enrolled. Patients received either DKT (15.0 g/day) or matching placebo from postoperative day (POD) 1 to POD12. Primary endpoints were time to first passage of flatus, time to first bowel movement (BM), and frequency of BM. Secondary endpoints included quality of life, C reactive protein level, symptoms of severe gastrointestinal problems (i.e., abdominal pain, bloating, nausea and vomiting), and the incidence of postoperative ileus. Quality of life was evaluated at baseline, POD3 and POD12. Symptoms of gastrointestinal dysfunction and C reactive protein level were also assessed at baseline, POD1, POD5, and POD12.
Results
One hundred ninety-five patients (DKT, n=96; placebo, n=99) were included in per protocol set analysis. Significant differences were not found between the groups in terms of patient background characteristics (age, sex, body mass index, operation time, intraoperative bleeding, and tumor stage). The median time to first BM was shorter in the DKT group than in the placebo group [97.4 h (95% CI, 90.0-114.1) vs. 113.9 h (95% CI, 96.5-119.1); p=0.051, Wilcoxon test]. In patients with high medication adherence, the median time to first BM was also shorter in the DKT group than in the placebo group [93.8 h (95% CI, 87.9-105.3) vs. 115.1 h (95% CI, 95.2-123.8); p=0.014, generalized Wilcoxon test]. Significantly fewer patients in the DKT group had two or more symptoms of gastrointestinal dysfunction than those in the placebo group on POD12 (p =0.026, Fisher's exact test). Other outcome measures such as time to first flatus, frequency of BM, quality of life, C reactive protein level, and the incidence of postoperative ileus did not show significant differences between the groups. None of the patients developed serious adverse drug reactions during the study.
Conclusion
DKT administration during the immediate postoperative period appears to promote and improves early recovery of postoperative bowel function and is presumed to prevent postoperative ileus after total gastrectomy for patients with gastric cancer.
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