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Clinical Trial
. 2014 Feb;132(2):377-82.
doi: 10.1016/j.ygyno.2013.12.034. Epub 2014 Jan 2.

Results of a phase II randomized, double-blind, placebo-controlled trial of Polyphenon E in women with persistent high-risk HPV infection and low-grade cervical intraepithelial neoplasia

Francisco A R Garcia  1 , Terri Cornelison  2 , Tomas Nuño  3 , David L Greenspan  4 , John W Byron  5 , Chiu-Hsieh Hsu  6 , David S Alberts  6 , H-H Sherry Chow  6
Affiliations
Clinical Trial

Results of a phase II randomized, double-blind, placebo-controlled trial of Polyphenon E in women with persistent high-risk HPV infection and low-grade cervical intraepithelial neoplasia

Francisco A R Garcia et al. Gynecol Oncol. 2014 Feb.

Abstract

Objective: In vitro data and pilot data suggest that green tea catechins may possess chemopreventive activity for cervical cancer and precursor lesions. We conducted a randomized, double-blind, placebo-controlled trial of Polyphenon E (decaffeinated and enriched green tea catechin extract) in women with persistent human papillomavirus (HPV) infection and low-grade cervical intraepithelial neoplasia (CIN1) to evaluate the potential of Polyphenon E for cervical cancer prevention.

Methods: Ninety-eight eligible women were randomized to receive either Polyphenon E (containing 800 mg epigallocatechin gallate) or placebo once daily for 4 months. The primary study outcome was oncogenic HPV clearance and clearance of CIN1.

Results: Polyphenon E was shown to be acceptable, safe and well tolerated. There was no difference in the response rate by treatment allocation. Complete response, defined as negative for high-risk HPV and normal histopathology, was noted in 7 (17.1%) and 6 (14.6%) women in the Polyphenon E and placebo arms, respectively. Progression, defined as persistent oncogenic HPV with histopathologic evidence of progression, was more common in the Polyphenon E group than in the placebo group [6 (14.6%) vs. 3 (7.7%)].

Conclusion: Based on the largest randomized placebo-controlled trial of a green tea extract for HPV related cervical disease, we conclude that 4 months of Polyphenon E intervention did not promote the clearance of persistent high-risk HPV and related CIN1. Further studies may be necessary to better delineate the risk factors for persistent HPV infection and biology of the disease to facilitate the evaluation of chemopreventive strategies.

Trial registration: ClinicalTrials.gov NCT00303823.

Keywords: Cervical intraepithelial neoplasia; HPV infection; Polyphenon E.

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Conflict of interest statement

Conflict of Interest Statement

The authors declare no financial conflicts of interest.

Figures

Figure 1
Figure 1
Consort flow diagram.
See this image and copyright information in PMC

References

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