Efficacy of Daikenchuto for the Intestinal Hypomotility after Open Abdominal Surgery: A Pooled Analysis of Three Randomized Controlled Trials.

801 Background: Postoperative intestinal hypomotility (IH) is very common after open abdominal (OAS) surgery. Although several advances have been made in medical therapy, very few recognized treatment or prevention methods are currently available. Daikenchuto (DKT), a traditional Japanese prescribed medicine, peripherally stimulates the neurogenic pathway, attempted to reduce postoperative IH in three exploratory randomized controlled trials (RCT). For further analysis of whether DKT accelerates IH recovery after scheduled OAS we conducted a pooled analysis of three RCTs. Methods: A pooled retrospective subset analysis of OAS patients with colon, liver, or gastric cancer in DKT RCTs was performed; RCTs were supported by the Japanese Foundation for Multidisciplinary Treatment of Cancer (JFMC). Among all patients enrolled and randomized in the three RCTs (JFMC project numbers 39-0902, 40-1001, and 42-1002), 740 patients who were eligible were included for the efficacy analysis. The modified intent-to-treat population was 410 patients, who did not have their bowel movement before the first meal; these patients were randomized to receive either 5 g DKT (n = 214) or placebo (n = 196) orally, three times a day for up to 12 days. The primary end point of each trial was the time from the end of the surgery (extubation) to the first bowel movement; this was assessed using survival analysis. Results: Compared with the placebo group, the time from the end of the surgery to the first bowel movement was accelerated in the DKT group (p = 0.004, hazard ratio;1.337 (95% CI 1.096-1.631)), with a difference of median 14.8 h. The tolerability profiles were similar in both the groups. Conclusions: Compared with the placebo, DKT was well tolerated, and it significantly accelerated IH recovery in patients who underwent OAS. Clinical trial information: UMIN000026292.