title: Randomised clinical trial: the effects of daikenchuto, TU-100, on gastrointestinal and colonic transit, anorectal and bowel function in female patients with functional constipation.
abstract: BACKGROUND
  Daikenchuto, a Japanese herbal medicine used for post-operative ileus and constipation, dose dependently stimulates gastrointestinal (GI) motility and decreases rectal compliance and sensation. Effects of TU-100 (commercial form of daikenchuto) in adults with constipation are unknown.
  
  
  OBJECTIVE
  To compare the effects of oral TU-100, 2.5 g t.d.s. or 5 g t.d.s. and placebo t.d.s. on GI and colonic transit (CT), rectal compliance (RC) and sensation thresholds (RST), anal sphincter pressures (ASP) and bowel function in female patients with functional constipation (FC).
  
  
  METHODS
  We conducted a single-centre, randomised, parallel-group, double-blind, pharmacodynamic study; 45 female patients with FC without evidence of rectal evacuation disorder were assigned to 28 days' treatment with oral placebo or TU-100 (Tsumura USA, Princeton, NJ, USA). Demographic data and CT were measured at baseline and randomisation stratified by baseline CT (GC> or <1.9) and by BMI (<25 or ≥25 kg/m(2) ). At the end of treatment period, we measured GI and CT by scintigraphy, RST and RC by barostat, ASP by manometry, psychosensory sensations, bowel function by daily diary and quality of life (QOL). The study had power to detect effect sizes of 33% (CT), 40% (RC) and 46% (RST). Statistical analysis included BMI as covariate.
  
  
  RESULTS
  TU-100 had no significant effects on GI or CT, RC, ASP, recto-anal pressure difference, or RST. The 5 g t.d.s./day dose was associated with lower RST for first sensation and gas (unadjusted P: 0.045 and 0.024 respectively). There were no treatment effects on psychosensory symptoms, stool frequency, stool consistency or QOL.
  
  
  CONCLUSIONS
  Mechanisms underlying the observed clinical benefit of TU-100 remain unclear (ClinicalTrials.gov NCT01139216).
authors: Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), College of Medicine, Mayo Clinic, Rochester, MN, USA.
authors: J
authors: J
authors: Iturrino
authors: M
authors: M
authors: Camilleri
authors: B S
authors: BS
authors: Wong
authors: S J
authors: SJ
authors: Linker Nord
authors: D
authors: D
authors: Burton
authors: A R
authors: AR
authors: Zinsmeister
mesh_terms: D000284:Administration, Oral; D000328:Adult; D003248:Constipation / Q000188:drug therapy*; D003672:Defecation / Q000187:drug effects*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005769:Gastrointestinal Motility / Q000187:drug effects; D005772:Gastrointestinal Transit / Q000187:drug effects*; D006801:Humans; D007564:Japan; D008518:Medicine, East Asian Traditional; D008875:Middle Aged; D005894:Panax; D008517:Phytotherapy; D010936:Plant Extracts / Q000008:administration & dosage* / Q000494:pharmacology; D011788:Quality of Life; D014057:Tomography, X-Ray Computed; D032106:Zanthoxylum; D030521:Zingiberaceae
chemical_list: D010936:Plant Extracts; C121414:dai-kenchu-to