Table 1.

Clinical trials with GTEs

Organ siteType of clinical trialSubjectsGTE formulationTreatmentsResultsComments
Oral leukoplakiaRandomized, double-blind, placebo-controlled.59 patients with oral mucosa leukoplakiaMixed tea capsule prepared by the Institute of Tea Science and Research, Chinese Academy of Agricultural Science.3 g of mixed tea daily (760 mg mixed tea capsule, q.i.d.) plus topical treatment with mixed tea in glycerin at 10%, t.i.d.37.9% response rate in treatment arm vs 10% in control armN/a
Li 1999 (80)Each capsule contained 40% GTPs
EGCG content not reported.
High-risk OPLsPhase II trial41 patients with high risk OPLsTHEA-FLAN 30 ARG supplied by Ito En Ltd.Placebo TID, vs GTE capsule, 500 mg/m2 t.i.d. vs 750 mg/m2 t.i.d. vs 1,000 mg/m2 t.i.d. (132 mg/m2 t.i.d. EGCG)50% response rate in treatment arm vs 18.2% in placebo armHigher 12-wk histologic response rate in never drinkers (P = 0.01)
Tsao 2009 (35)Each capsule contains 350 mg of GTE, 13.2% EGCGNeither clinical nor histologic response to GTE intervention was associated with oral cancer development
Refractory solid tumorsPhase I trial49 patients with solid tumors refractory to standard treatmentGTE capsule Supplied by Ito En Ltd.GTE capsule, 0.5-5.05 g/m2 dailyNo major clinical response.Optimal dose suggested was 1 g/m2 t.i.d.
Pisters 2001 (81)Each capsule contained 13.2% EGCGMTD was 4.2 g/m2 of GTE daily for up to 6 mo. Dose-limiting toxicities were caffeine related.
Advanced lung cancerPhase I trial17 patients with advanced lung cancerGTE capsule Supplied by Ito En Ltd.0.5 g/m2 GTE with dose escalation scheme up to 8 g/m2 GTE.No major clinical responseN/a
Laurie 2005 (92)Each capsule contained 13.2% EGCGMTD was 3 g/m2 of oral GTE, once daily.
High-risk cervical lesionsPilot study51 patients with cervical lesionsContent of Poly E ointment or capsule was not reported.Poly E ointment twice weekly vs 200 mg Poly E oral daily + Poly E ointment twice weekly vs, 200 mg Poly E orally daily, vs, EGCG 200 mg orally daily vs nontreatedOverall 69% (35/51) in treatment arms vs 10% (4/39) patients in nontreated control (P < 0.05)N/a
Ahn 2003 (85)
Colorectal adenomasRandomized trial136 patients status 1 y postpolypectomyGTE tablet provided by the Green Tea Union of Saitama.GTE tablet 1,500 mg (157.5 mg EGCG) daily for 12 moIncidence of metachronous adenoma was 31% in the control group and 15% in the GTE group. (P < 0.05)N/a
Shimizu 2008 (84)One 500-mg tablet contains 52.5 mg EGCG.
Prostate cancerSingle arm phase II trial26 men with positive prostate biopsy awaiting prostectomyPolyphenon E provided by Mitsui-Norin Co Ltd/Polyphenon E International, Inc.1,300 mg Polyphenon E (800 mg EGCG) daily during the interval between the prostate biopsy and radical prostectomy. Median period was 34.5 dSerum levels of HGF, VEGF, IGF-BP3, IGF-I, and PSA were decreasedN/a
McLarty 2009 (36)Each Polyphenon E 325 mg capsule contains 200 mg EGCGNo liver toxicities were observed.
HG-PINDouble-blind placebo-controlled trial60 patients with HG-PINGreen tea catechin capsules.600 mg green tea catechins capsule daily (311 mg, EGCG) vs placebo for 1 yIncidence of prostate cancer was 30.0% in the control group vs 3.3% in the GTE group (P < 0.01)GTE treatment did not significantly affect PSA values
Bettuzzi 2006 (82)Each capsule contains 51.8% EGCG.

Abbreviations: N/a, not applicable; MTD, maximally tolerated dose.