Clinical efficacy of Daikenchuto for gastrointestinal dysfunction following colon surgery: a randomized, double-blind, multicenter, placebo-controlled study (JFMC39-0902)

被引:34
作者
Katsuno, Hidetoshi [1 ]
Maeda, Koutarou [1 ]
Kaiho, Takashi [2 ]
Kunieda, Katsuyuki [3 ]
Funahashi, Kimihiko [4 ]
Sakamoto, Junichi [5 ]
Kono, Toru [6 ]
Hasegawa, Hirotoshi [7 ]
Furukawa, Yoshiyuki [8 ]
Imazu, Yoshihiro [9 ]
Morita, Satoshi [10 ]
Watanabe, Masahiko [11 ]
机构
[1] Fujita Hlth Univ, Sch Med, Dept Surg, Toyoake, Aichi 4701192, Japan
[2] Kimitsu Chuo Hosp, Dept Surg, Kisarazu, Japan
[3] Gifu Prefectural Gen Med Ctr, Dept Surg, Gifu, Japan
[4] Toho Univ Omori Med Ctr, Dept Gen & Gastroenterol Surg, Tokyo, Japan
[5] Tokai Cent Hosp, Kagamihara, Japan
[6] Sapporo Higashi Tokushukai Hosp, Adv Surg Ctr, Sapporo, Hokkaido, Japan
[7] Keio Univ, Sch Med, Dept Surg, Tokyo 160, Japan
[8] Kawasaki South Hosp, Kawasaki, Kanagawa, Japan
[9] Shiba Daimon Imazu Clin, Tokyo, Japan
[10] Kyoto Univ, Grad Sch Med, Dept Biomed Stat & Bioinformat, Kyoto, Japan
[11] Kitasato Univ, Sch Med, Dept Surg, Sagamihara, Kanagawa 228, Japan
关键词
Daikenchuto; bowel movement; colon cancer; herbal medicine; DAI-KENCHU-TO; TRADITIONAL JAPANESE MEDICINE; GENE-RELATED PEPTIDE; HERBAL MEDICINE; POSTOPERATIVE ILEUS; HUMAN PLASMA; CONSCIOUS DOGS; BLOOD-FLOW; TRANSIT; KAMPO;
D O I
10.1093/jjco/hyv056
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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, bowel movement frequency in the Daikenchuto group increased until post-operative day 6, however decreased from post-operative day 7 and was significantly lower at post-operative day 8 compared with the placebo group (P = 0.024). Conclusion: The moderate effects of Daikenchuto were observed similar to 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.
引用
收藏
页码:650 / 656
页数:7
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