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

Abstract

ObjectiveThis exploratory trial was performed to determine whether Daikenchuto accelerates recovery of gastrointestinal function in patients undergoing open colectomy for colon cancer.MethodsA 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.ResultsThe 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 as well. 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).ConclusionThe 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.

Perioperative Administration of Traditional Japanese Herbal Medicine Daikenchuto Relieves Postoperative Ileus in Patients Undergoing Surgery for Gastrointestinal Cancer: A Systematic Review and Meta-analysis

“…Three out of the seven included studies involved patients who underwent colon or colorectal cancer surgery (21,27,28). Among the remaining four studies, two involved patients who underwent surgery for gastric cancer (23,24) and two involved patients who underwent surgery for tumors of the pancreas head and periampullary tumors (29,30).…”

“…Among the remaining four studies, two involved patients who underwent surgery for gastric cancer (23,24) and two involved patients who underwent surgery for tumors of the pancreas head and periampullary tumors (29,30). These seven studies comprised six RCTs (21,23,24,27,28,30), and one prospective study (29). All studies originated from Japan: five were written in English (21,23,24,29,30) and two in Japanese (27,28).…”

“…These seven studies comprised six RCTs (21,23,24,27,28,30), and one prospective study (29). All studies originated from Japan: five were written in English (21,23,24,29,30) and two in Japanese (27,28). Among the seven studies, two involved patients who all underwent open surgery (21,27) and two studies included a proportion of patients who underwent laparoscopic surgery (23,28).…”

“…All studies originated from Japan: five were written in English (21,23,24,29,30) and two in Japanese (27,28). Among the seven studies, two involved patients who all underwent open surgery (21,27) and two studies included a proportion of patients who underwent laparoscopic surgery (23,28). The basic characteristics of the seven included studies are shown in Tables I-III. Association between perioperative administration of DKT and occurrence of PI after GI surgery.…”

“…Although several randomized controlled trials (RCTs) have confirmed the effects of DKT (19), previously demonstrated in animal models (13,20), for improving postoperative GI motility in patients undergoing abdominal surgery (21)(22)(23)(24)(25), few studies have investigated whether DKT reduces the occurrence of postoperative ileus (PI) in patients undergoing surgery for GI cancer as a primary end-point. Therefore, it seems reasonable to assume that, if DKT improves postoperative GI motility, this effect would also reduce the occurrence of PI.…”