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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

Dryden, Gerald W. MD, MSPH*; Lam, Allan DO*; Beatty, Karen RN, BS; Qazzaz, Hassan H. PhD*; McClain, Craig J. MD*

doi: 10.1097/MIB.0b013e31828f5198
Original Clinical Articles

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.

Article first published online 10 July 2013

*Division of Gastroenterology, Hepatology and Nutrition,

Clinical Research Center, University of Louisville, Louisville, Kentucky.

Reprints: Gerald W. Dryden, MD, MSPH, MSc, Division of Gastroenterology, Hepatology and Nutrition, 550 South Jackson Street, Louisville, KY 40202 (e-mail: tad.dryden@louisville.edu).

Supported by the National Institutes of Health grant (5K23DK073750), University of Louisville Research Foundation Project Initiation Grant, Polyphenon E supplied by Mitsui-Norin (Fujieda, Japan) through the Chemoprevention Agent Development Group of the National Cancer Institute. Mitsui-Norin had no input in the analysis or reporting of this clinical trial.

The authors have no conflicts of interest to disclose.

Received December 04, 2012

Accepted February 09, 2013

© Crohn's & Colitis Foundation of America, Inc.
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