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 Garcia, Terri Cornelison, Tomas Nuño, David L. Greenspan, John W. Byron, Chiu-Hsieh Hsu, David S Alberts, Hsiao-Hui Chow

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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.

Original languageEnglish (US)
Pages (from-to)377-382
Number of pages6
JournalGynecologic Oncology
Volume132
Issue number2
DOIs
StatePublished - Feb 2014

Fingerprint

Cervical Intraepithelial Neoplasia
Papillomavirus Infections
Placebos
Tea
Catechin
Uterine Cervical Neoplasms
polyphenon E
Randomized Controlled Trials
Outcome Assessment (Health Care)

Keywords

  • Cervical intraepithelial neoplasia
  • HPV infection
  • Polyphenon E

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Oncology

Cite this

@article{37b3f02fd47e469db62856750afd89bf,
title = "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",
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.",
keywords = "Cervical intraepithelial neoplasia, HPV infection, Polyphenon E",
author = "Garcia, {Francisco A} and Terri Cornelison and Tomas Nu{\~n}o and Greenspan, {David L.} and Byron, {John W.} and Chiu-Hsieh Hsu and Alberts, {David S} and Hsiao-Hui Chow",
year = "2014",
month = "2",
doi = "10.1016/j.ygyno.2013.12.034",
language = "English (US)",
volume = "132",
pages = "377--382",
journal = "Gynecologic Oncology",
issn = "0090-8258",
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T1 - 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

AU - Garcia, Francisco A

AU - Cornelison, Terri

AU - Nuño, Tomas

AU - Greenspan, David L.

AU - Byron, John W.

AU - Hsu, Chiu-Hsieh

AU - Alberts, David S

AU - Chow, Hsiao-Hui

PY - 2014/2

Y1 - 2014/2

N2 - 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.

AB - 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.

KW - Cervical intraepithelial neoplasia

KW - HPV infection

KW - Polyphenon E

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