Randomised clinical trial: the effects of daikenchuto, TU‐100, on gastrointestinal and colonic transit, anorectal and bowel function in female patients with functional constipation

Summary 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. Aim 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