title: Placebo controlled evaluation of Xilei San, a herbal preparation in patients with intractable ulcerative proctitis.
abstract: OBJECTIVE
  Topical mesalamine or corticosteroid has shown efficacy in patients with ulcerative proctitis, but patients often become refractory to these interventions. Xilei San is a herbal preparation with evidence of anti-inflammatory effects. We evaluated the efficacy of topical Xilei San in ulcerative proctitis patients.
  
  
  METHODS
  In a double blind setting, 30 patients with intractable ulcerative proctitis despite ≥ 4 weeks of topical mesalamine or corticosteroid were randomly assigned to True (n = 15) and placebo (n = 15). Patients in True received suppository Xilei San (0.1 g/dose per day of Xilei San), the other 15 received placebo suppository. The initial efficacy was evaluated on day 14. Primary endpoint of the trial was avoiding relapse during 180 days, relapse meant recurrence of active disease. Riley's index was applied for endoscopic and histological evaluations, while patients' quality of life was evaluated by an inflammatory bowel disease questionnaire.
  
  
  RESULTS
  On day 14, the number of patients who achieved remission, clinical activity index ≤ 4 in True was significantly higher versus placebo (P < 0.04). Likewise, at day 180, an 81.8% of patients in True were without relapse versus 16.7% in placebo (P < 0.001). Further, significant endoscopic (P < 0.01), histological (P < 0.02) and inflammatory bowel disease questionnaire (P < 0.04) improvements were observed in True, but not in placebo.
  
  
  CONCLUSIONS
  This is the first controlled investigation showing significant clinical and endoscopic efficacy for Xilei San in patients with intractable ulcerative proctitis. Topical Xilei San was well tolerated, and was without safety concerns.
authors: Division of Lower Gastroenterology, Department of Internal medicine, Hyogo College of Medicine, Nishinomiya, Japan.
authors: Ken
authors: K
authors: Fukunaga
authors: Yoshio
authors: Y
authors: Ohda
authors: Nobuyuki
authors: N
authors: Hida
authors: Masaki
authors: M
authors: Iimuro
authors: Yoko
authors: Y
authors: Yokoyama
authors: Koji
authors: K
authors: Kamikozuru
authors: Kazuko
authors: K
authors: Nagase
authors: Shiro
authors: S
authors: Nakamura
authors: Hiroto
authors: H
authors: Miwa
authors: Takayuki
authors: T
authors: Matsumoto
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011350:Proctocolitis / Q000188:drug therapy*; D011446:Prospective Studies; D013488:Suppositories; D016896:Treatment Outcome
chemical_list: D004365:Drugs, Chinese Herbal; D013488:Suppositories; C515633:ba-wei-xi-lei