Effect of Daikenchuto, a Traditional Japanese Herbal Medicine, after Total Gastrectomy for XXXX : A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase II Trial.

@entity1 @entity2616 @entity344 @entity86 @entity356 @entity1851
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 @entity2616 and associated @entity344 after total gastrectomy. STUDY DESIGN: Two hundred and forty-five @entity356 @entity1 who underwent total gastrectomy were enrolled. @entity1 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, @entity1851 level, symptoms indicative of a severe @entity344 , and incidence of @entity86 . RESULTS: A total of 195 @entity1 (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 @entity1 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 @entity1 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 @entity1 in the DKT group had >= 2 symptoms of @entity344 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.
