title: Evaluation of the efficacy of daikenchuto (TJ -100) for the prevention of paralytic ileus after pancreaticoduodenectomy: A multicenter, double-blind, randomized, placebo-controlled trial.
abstract: BACKGROUND
  We assessed the efficacy of TJ-100 taken perioperatively to recovery among patients with periampullary tumor or tumor of the head of the pancreas who underwent pancreaticoduodenectomy (PD).
  
  
  METHODS
  In this multicenter, randomized, double-blinded, placebo-controlled, phase II trial (JAPAN-PD Study), patients were assigned randomly in a 1:1 ratio to receive TJ-100 or placebo. The coprimary endpoints were (1) incidence of postoperative paralytic ileus lasting >72 hours after surgery and (2) time to occurrence of postoperative paralytic ileus. This trial is registered at the UMIN Clinical Trials Registry (000007975) and at ClinicalTrials.gov (NCT01607307).
  
  
  RESULTS
  From August 2012 through July 2013, we assessed 273 patients for eligibility, and 224 underwent randomization; 112 patients received TJ-100, and 112 patients received placebo. The population for analysis consisted of 104 patients who received TJ-100 and 103 who received placebo. Paralytic ileus occurred 35 (33.7%) in the TJ-100 group and 38 (36.9%) in the placebo group (P = .626). Time to first flatus was 2.25 (2.00-2.50) days in the TJ-100 group and 2.50 (1.50-2.50) days in the placebo group (P = .343). Among 23 patients who underwent a pylorus ring-preserving PD, time to first flatus was lower in the TJ-100 group than in the placebo group: 0.50 (0.50-1.00) days versus 1.50 (0.50-3.00) days (P = .034).
  
  
  CONCLUSIONS
  Our findings suggest that use of TJ-100 did not improve recovery from paralytic ileus after PD, and may preclude the routine use of TJ-100 in clinical practice after PD operation.
authors.affiliation: Second Department of Surgery, Wakayama Medical University, Wakayama, Japan.
authors.forename: Ken-ichi
authors.initials: K
authors.lastname: Okada
authors.affiliation: Second Department of Surgery, Wakayama Medical University, Wakayama, Japan.
authors.forename: Manabu
authors.initials: M
authors.lastname: Kawai
authors.affiliation: Second Department of Surgery, Wakayama Medical University, Wakayama, Japan.
authors.forename: Seiko
authors.initials: S
authors.lastname: Hirono
authors.affiliation: Department of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine, Nagoya, Japan.
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Fujii
authors.affiliation: Department of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine, Nagoya, Japan.
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Kodera
authors.affiliation: Department of Surgery, Nara Medical University, Kashihara, Japan.
authors.forename: Masayuki
authors.initials: M
authors.lastname: Sho
authors.affiliation: Department of Surgery, Nara Medical University, Kashihara, Japan.
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Nakajima
authors.affiliation: Department of Surgery, Kansai Medical University, Hirakata, Japan.
authors.forename: Sohei
authors.initials: S
authors.lastname: Satoi
authors.affiliation: Department of Surgery, Kansai Medical University, Hirakata, Japan.
authors.forename: A-Hon
authors.initials: AH
authors.lastname: Kwon
authors.affiliation: Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, Nagoya, Japan.
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Shimizu
authors.affiliation: Department of Surgery, Teine-keijinkai Hospital, Sapporo, Japan.
authors.forename: Yoshiyasu
authors.initials: Y
authors.lastname: Ambo
authors.affiliation: Department of Surgery, Institute of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.
authors.forename: Naru
authors.initials: N
authors.lastname: Kondo
authors.affiliation: Department of Surgery, Institute of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Murakami
authors.affiliation: Department of Surgical Oncology and Regulation of Organ Function, Miyazaki University School of Medicine, Miyazaki, Japan.
authors.forename: Jiro
authors.initials: J
authors.lastname: Ohuchida
authors.affiliation: Department of Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan.
authors.forename: Hidetoshi
authors.initials: H
authors.lastname: Eguchi
authors.affiliation: Department of Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan.
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Nagano
authors.affiliation: Department of Biostatistics and Epidemiology, Yokohama City University Medical Center, Yokohama, Japan.
authors.forename: Mari S
authors.initials: MS
authors.lastname: Oba
authors.affiliation: Department of Biomedical Statistical and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Morita
authors.affiliation: Tokai Central Hospital, Kakamigahara, Japan.
authors.forename: Junichi
authors.initials: J
authors.lastname: Sakamoto
authors.affiliation: Second Department of Surgery, Wakayama Medical University, Wakayama, Japan. Electronic address: yamaue-h@wakayama-med.ac.jp.
authors.forename: Hiroki
authors.initials: H
authors.lastname: Yamaue
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D006801:Humans; D015994:Incidence; D007418:Intestinal Pseudo-Obstruction / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D005894:Panax; D010190:Pancreatic Neoplasms / Q000601:surgery*; D016577:Pancreaticoduodenectomy; D019990:Perioperative Care; D010936:Plant Extracts / Q000627:therapeutic use*; D011183:Postoperative Complications / Q000453:epidemiology / Q000517:prevention & control*; D016016:Proportional Hazards Models; D016896:Treatment Outcome; D032106:Zanthoxylum; D030521:Zingiberaceae
chemical_list: D005765:Gastrointestinal Agents; D010936:Plant Extracts; C121414:dai-kenchu-to