Efficacy of Daikenchuto in the prevention of bowel obstruction in patients with colorectal cancer undergoing laparoscopic surgery: An observational study using a Japanese administrative claims database.

Abstract

Daikenchuto is an herbal medicine widely used in Japan without clear evidence to prevent bowel obstruction after abdominal surgery. We evaluated the efficacy of Daikenchuto in laparoscopic surgery for colorectal cancer (CRC). We included patients from the medical claims databases diagnosed with CRC between January 2012 and December 2019 and treated with laparoscopic surgery. We compared the Daikenchuto and control groups to evaluate early bowel obstruction (EBO) events for 1year. The Daikenchuto group included patients prescribed Daikenchuto on postoperative day (POD) 0 or 1. An EBO event was defined as the use of a nasogastric tube, transnasal ileus tube, endoscopic balloon dilatation, or the requirement of reoperation for bowel obstruction from PODs 1 to 364. In total, 46,458 patients met the eligibility criteria; 2407 and 44,051 patients were included in the Daikenchuto and control groups, respectively. Some of the patient's characteristics were significantly different between the groups. The frequencies of EBO events in the Daikenchuto and control groups were 5.7% (95% confidence interval: 4.8-6.7) and 4.6% (4.4-4.8), respectively. The most frequent events were nasogastric tube (3.1%, 2.9%) and transnasal ileus tube insertions (1.4%, 0.8%) in the Daikenchuto and control groups, respectively. The hospital stay was significantly shorter in the Daikenchuto group than in the control; this trend was confirmed in the sensitivity analysis. Daikenchuto did not demonstrate efficacy for EBO. It might be adequate for shortening patient's hospital stay. Further studies are warranted.