TY - JOUR
T1 - Daikenchuto accelerates the recovery from prolonged postoperative ileus after open abdominal surgery
T2 - a subgroup analysis of three randomized controlled trials
AU - Kono, Toru
AU - Shimada, Mitsuo
AU - Nishi, Masaaki
AU - Morine, Yuji
AU - Yoshikawa, Kozo
AU - Katsuno, Hidetoshi
AU - Maeda, Koutarou
AU - Koeda, Keisuke
AU - Morita, Satoshi
AU - Watanabe, Masahiko
AU - Kusano, Mitsuo
AU - Sakamoto, Junichi
AU - Saji, Shigetoyo
AU - Sokuoka, Hiroki
AU - Sato, Yasuto
AU - Maehara, Yoshihiko
AU - Kanematsu, Takashi
AU - Kitajima, Masaki
N1 - Funding Information:
Daikenchuto (DKT), which is a mixture of extract powders from dried Japanese pepper, processed ginger and ginseng radix, is a scientifically validated and frequently prescribed traditional Japanese Kampo medicine [7, 8]. Kampo medicines meet the strict specifications for coverage under the Japanese National Health Insurance plan, which is comparable to Western counterparts in terms of ensuring the quality and therapeutic efficacy. Furthermore, DKT, which is known to stimulate the enteric and sensory neural pathways in the intestinal wall, has been approved as an investigational drug by the US Food and Drug Administration. DKT is primarily used for the treatment of POI [7–9]. To gather clinical evidence, three randomized controlled trials (RCTs) supported by the Japanese Foundation for Multidisciplinary Treatment of Cancer (JFMC; project numbers 39-0902, 40-1001, 42-1002) were conducted to determine whether or not DKT ameliorated POI [10–12]. The results of one of the RCTs indicated a significant decrease in time until the first passage of stool [11]. The remaining two RCTs showed a slight tendency toward amelioration of POI [10, 12].
Funding Information:
Conflict of interest The trial was conducted by the Japanese Foundation for Multidisciplinary Treatment of Cancer, and funded by Tsumu-ra Co., Ltd. The potential conflicts of interest with regard to our study are as follows: Toru Kono, Mitsuo Shimada and Yoshihiko Maehara received grant support from Tsumura Co., Ltd.; Hiroki Sokuoka is an
Publisher Copyright:
© 2019, The Author(s).
PY - 2019/8/9
Y1 - 2019/8/9
N2 - 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.
AB - 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.
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U2 - 10.1007/s00595-019-01787-9
DO - 10.1007/s00595-019-01787-9
M3 - Article
C2 - 30805720
AN - SCOPUS:85062074957
VL - 49
SP - 704
EP - 711
JO - Surgery Today
JF - Surgery Today
SN - 0941-1291
IS - 8
ER -