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%)].
  
  
  CONCLUSIONS
  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.
authors.affiliation: Center of Excellence in Women's Health, The University of Arizona, Tucson, AZ 85724, United States; University of Arizona Cancer Center, Tucson, AZ 85724, United States.
authors.forename: Francisco A R
authors.initials: FA
authors.lastname: Garcia
authors.affiliation: Division of Cancer Prevention, National Cancer Institute, Bethesda, MD 20892, United States.
authors.forename: Terri
authors.initials: T
authors.lastname: Cornelison
authors.affiliation: Center of Excellence in Women's Health, The University of Arizona, Tucson, AZ 85724, United States; University of Arizona Cancer Center, Tucson, AZ 85724, United States. Electronic address: tnuno@email.arizona.edu.
authors.forename: Tomas
authors.initials: T
authors.lastname: Nuño
authors.affiliation: Maricopa Integrated Health System, Phoenix, AZ 85008, United States.
authors.forename: David L
authors.initials: DL
authors.lastname: Greenspan
authors.affiliation: The Southern Pines Women's Health Center, Southern Pines, NC 28388, United States.
authors.forename: John W
authors.initials: JW
authors.lastname: Byron
authors.affiliation: University of Arizona Cancer Center, Tucson, AZ 85724, United States.
authors.forename: Chiu-Hsieh
authors.initials: CH
authors.lastname: Hsu
authors.affiliation: University of Arizona Cancer Center, Tucson, AZ 85724, United States.
authors.forename: David S
authors.initials: DS
authors.lastname: Alberts
authors.affiliation: University of Arizona Cancer Center, Tucson, AZ 85724, United States.
authors.forename: H-H Sherry
authors.initials: HH
authors.lastname: Chow
mesh_terms: D000293:Adolescent; D000328:Adult; D002392:Catechin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008875:Middle Aged; D030361:Papillomavirus Infections / Q000188:drug therapy* / Q000473:pathology; D015990:Placebo Effect; D013662:Tea / Q000737:chemistry; D002583:Uterine Cervical Neoplasms / Q000473:pathology / Q000517:prevention & control* / Q000821:virology; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000473:pathology / Q000517:prevention & control*
chemical_list: D013662:Tea; D002392:Catechin; C472086:polyphenon E
keywords: Cervical intraepithelial neoplasia; HPV infection; Polyphenon E