title: Effect of TU-100, a traditional Japanese medicine, administered after hepatic resection in patients with liver cancer: a multi-center, phase III trial (JFMC40-1001).
abstract: BACKGROUND
  This multi-center, phase III trial assesses the efficacy of daikenchuto (TU-100) on gastrointestinal disorders after hepatic resection (UMIN Registration No. 000003103).
  
  
  METHODS
  A total of 231 patients, who underwent hepatic resection at 26 Japanese centers, were enrolled. Patients were randomly assigned to receive either oral doses (15 g/day, three times a day) of TU-100 or placebo control from preoperative day 3 to postoperative day 10, except on the day of surgery. Primary end points were the time from extubation until the first postoperative bowel movement (FBM-T), serum C-reactive protein (CRP) and ammonia levels.
  
  
  RESULTS
  Finally, 209 patients (TU-100: n = 108, placebo: n = 101) were included in the statistical analysis. The median FBM-T was 88.2 h (95 % CI 74.0-94.1) in the TU-100 group and 93.1 h (95 % CI 83.3-99.4) in the placebo group, demonstrating that TU-100 accelerated the time to first bowel movement significantly more than placebo control. Serum CRP levels did not differ significantly during the study period, although serum CRP levels in the TU-100 group tended to be lower than those in the placebo group in patients with grade B liver damage. Meanwhile, the two groups had similar serum ammonia levels. TU-100-related serious adverse events did not occur during the study.
  
  
  CONCLUSIONS
  TU-100 appears to improve gastrointestinal dysmotility and reduce serum CRP levels in patients with grade B liver damage after hepatectomy. TU-100 is an effective treatment option after hepatic resection in patients with liver cancer.
authors.affiliation: Department of Surgery, Institute of Health Biosciences, The University of Tokushima Graduate School, 3-18-15 Kuramoto-cho, Tokushima, 770-8503, Japan, mitsuo.shimada@tokushima-u.ac.jp.
authors.forename: Mitsuo
authors.initials: M
authors.lastname: Shimada
authors.forename: Yuji
authors.initials: Y
authors.lastname: Morine
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Nagano
authors.forename: Etsuro
authors.initials: E
authors.lastname: Hatano
authors.forename: Takashi
authors.initials: T
authors.lastname: Kaiho
authors.forename: Masaru
authors.initials: M
authors.lastname: Miyazaki
authors.forename: Toru
authors.initials: T
authors.lastname: Kono
authors.forename: Toshiya
authors.initials: T
authors.lastname: Kamiyama
authors.forename: Satoshi
authors.initials: S
authors.lastname: Morita
authors.forename: Junichi
authors.initials: J
authors.lastname: Sakamoto
authors.forename: Mitsuo
authors.initials: M
authors.lastname: Kusano
authors.forename: Shigetoyo
authors.initials: S
authors.lastname: Saji
authors.forename: Takashi
authors.initials: T
authors.lastname: Kanematsu
authors.forename: Masaki
authors.initials: M
authors.lastname: Kitajima
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000641:Ammonia / Q000097:blood; D044466:Asian People; D002097:C-Reactive Protein / Q000378:metabolism; D005260:Female; D005767:Gastrointestinal Diseases / Q000188:drug therapy*; D006498:Hepatectomy / Q000379:methods; D006801:Humans; D008099:Liver / Q000378:metabolism / Q000601:surgery; D008113:Liver Neoplasms / Q000601:surgery*; D008297:Male; D008518:Medicine, East Asian Traditional / Q000379:methods; D008875:Middle Aged; D009285:Naphthoquinones / Q000008:administration & dosage*; D011184:Postoperative Period
chemical_list: C559645:12,13-dihydro-N-methyl-6,11,13-trioxo-5H-benzo(4,5)cyclohepta(1,2-b)naphthalen-5,12-imine; D009285:Naphthoquinones; D000641:Ammonia; D002097:C-Reactive Protein