Daikenchuto accelerates the recovery from prolonged postoperative ileus after open abdominal surgery: a subgroup analysis of three randomized controlled trials

Abstract

Purpose Prolonged postoperative ileus (POI) is a common complication after open abdominal surgery (OAS). Daikenchuto (DKT), a traditional Japanese medicine that peripherally stimulates the neurogenic pathway, is used to treat prolonged POI in Japan. To analyze whether DKT accelerates the recovery from prolonged POI after OAS, we conducted a secondary analysis of three multicenter randomized controlled trials (RCTs). Methods A secondary analysis of the three RCTs supported by the Japanese Foundation for Multidisciplinary Treatment of Cancer (project numbers 39-0902, 40-1001, 42-1002) assessing the effect of DKT on prolonged POI in patients who had undergone OAS for colon, liver, or gastric cancer was performed. The subgroup included 410 patients with no bowel movement (BM) before the first diet, a DKT group ( n = 214), and a placebo group ( n = 196). Patients received either 5 g DKT or a placebo orally, three times a day. The primary endpoint was defined as the time from the end of surgery to the first bowel movement (FBM). A sensitivity analysis was also performed on the age, body mass index and dosage as subgroup analyses. Results The primary endpoint was significantly accelerated in the DKT group compared with the placebo group ( p = 0.004; hazard ratio 1.337). The median time to the FBM was 113.8 h in the placebo group and 99.1 h in the DKT treatment group. Conclusions The subgroup analysis showed that DKT significantly accelerated the recovery from prolonged POI following OAS. Trial registration number UMIN000026292.

The clinical effect of Kampo medicine in multimodal treatment for Gastrointestinal Cancer in Japan

“…However, after surgery, patients experience general dysfunction, such as bowel and physical dysfunction, due to the long surgical duration and large abdominal incisions. Among Kampo medicines, several investigators have reported that Daikenchuto (TJ-100) showed clinical efficacy after abdominal digestive surgery [10][11][12][13][14][15]. TJ-100 is a traditional Japanese medicine containing processed ginger, ginseng, and Zanthoxylum fruit.…”

The Japanese Extracted Herbal Medicine Daikenchuto Increases the Contractile Activity of the Internal Anal Sphincter Muscle in Conscious Dogs

“…A clinical pharmacology study has also revealed that DKT enhances small intestinal motility in healthy volunteers [14]. In addition, placebo-controlled DB-RCT for POI has also been shown to improve POI symptoms in patients with abdominal surgery [15,16]. In the United States, DKT has also been approved as an investigational drug by the Food and Drug Administration and is primarily used for the treatment of POI [15][16][17].…”

The inhibitory effect of TU-100 on hepatic stellate cell activation in the tumor microenvironment

“…Many of these compounds have been used to treat a variety of diseases in clinical, even in CRC [7]. TU-100 (Daikenchuto) is a commonly prescribed Japanese herbal medicine that has been used to treat gastrointestinal motility and prevent post-operative intestinal dysfunction providing the most preclinical and clinical efficacy in several trials [8][9][10][11][12][13][14]. TU-100 is a mixture of herbal medicines such as processed ginger (Zingiberis Siccatum Rhizoma), ginseng (Ginseng radix), Japanese pepper (Zanthoxylum fruit), and maltose sugar by a weight ratio of 5.6%, 3.3%, 2.2%, 88.9%, respectively [10,15].…”