title: A pilot study to evaluate the safety and efficacy of an oral dose of (-)-epigallocatechin-3-gallate-rich polyphenon E in patients with mild to moderate ulcerative colitis.
abstract: BACKGROUND
  Green tea and its main polyphenolic component, (-)-epigallocatechin-3-gallate (EGCG), exert powerful anti-inflammatory effects that are protective against both inflammatory diseases and cancer. Research with animal and human cell lines provide plausible support for these claims. Poor absorption results in low systemic bioavailability of EGCG after oral administration but high colonic mucosal exposure.
  
  
  METHODS
  Patients with mild to moderate ulcerative colitis (UC) were randomized to daily doses of oral Polyphenon E (400 mg or 800 mg of total EGCG daily, administered in split doses) or placebo in a double-blinded, placebo-controlled pilot study. Response was measured by the UC disease activity index and the inflammatory bowel disease questionnaire on day 56.
  
  
  RESULTS
  Twenty patients were randomized to active therapy or placebo in a 4:1 ratio. Nineteen subjects received >1 dose of study medication (15 Polyphenon E, 4 placebo). The mean UC disease activity index score at study entry was 6.5 ± 1.9 in the treatment group and 7.3 ± 1.7 in the placebo group. After 56 days of therapy, the response rate was 66.7% (10 of 15) in the Polyphenon E group and 0% (0 of 4) in the placebo group (P = 0.03). The active treatment remission rate was 53.3% (8 of 15) compared with 0% (0 of 4) for placebo (P = 0.10). Polyphenon E treatment resulted in only minor side effects.
  
  
  CONCLUSIONS
  Administration of Polyphenon E resulted in a therapeutic benefit for patients who were refractory to 5-aminosalicylic and/or azathioprine. This agent holds promise as a novel option for the treatment of patients with UC with mild to moderately active disease.
authors.affiliation: Division of Gastroenterology, Hepatology and Nutrition, University of Louisville, Louisville, KY 40202, USA. tad.dryden@louisville.edu
authors.forename: Gerald W
authors.initials: GW
authors.lastname: Dryden
authors.forename: Allan
authors.initials: A
authors.lastname: Lam
authors.forename: Karen
authors.initials: K
authors.lastname: Beatty
authors.forename: Hassan H
authors.initials: HH
authors.lastname: Qazzaz
authors.forename: Craig J
authors.initials: CJ
authors.lastname: McClain
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D001682:Biological Availability; D002392:Catechin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000737:chemistry / Q000494:pharmacology; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011379:Prognosis; D011788:Quality of Life; D012074:Remission Induction; D013662:Tea / Q000737:chemistry*; D055815:Young Adult
chemical_list: D013662:Tea; D002392:Catechin; C045651:epigallocatechin gallate; C472086:polyphenon E