Evidence map›Paper›PMID 24388920›Full record

Trial reportGynecologic oncology2014

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, Terri Cornelison, Tomas Nuño, David L Greenspan, John W Byron, Chiu-Hsieh Hsu, David S Alberts, H-H Sherry Chow

Open access · greenAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Gynecologic oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 4 pooled it
2.8field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 4 syntheses or guidelines pooled it, 73 citations in OpenAlex.

  1. Pooled it
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  4. Green tea (Camellia sinensis) for the prevention of cancer.The Cochrane database of systematic reviews · 2020
    Pooled it
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  13. Navigating the redox landscape: reactive oxygen species in regulation of cell cycle.Redox report : communications in free radical research · 2024
    Review
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  20. The Hallmarks of Flavonoids in Cancer.Molecules (Basel, Switzerland) · 2021
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 4 institutions in 1 country.

Francisco A R GarciaCenter 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.
Terri CornelisonDivision of Cancer Prevention, National Cancer Institute, Bethesda, MD 20892, United States.
Tomas NuñoCenter 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.
David L GreenspanMaricopa Integrated Health System, Phoenix, AZ 85008, United States.
John W ByronThe Southern Pines Women's Health Center, Southern Pines, NC 28388, United States.
Chiu-Hsieh HsuUniversity of Arizona Cancer Center, Tucson, AZ 85724, United States.
David S AlbertsUniversity of Arizona Cancer Center, Tucson, AZ 85724, United States.
H-H Sherry ChowUniversity of Arizona Cancer Center, Tucson, AZ 85724, United States.
University of Arizona · USUniversity of Arizona Cancer CenterNational Cancer Institute · USValleywise Health · US

Funding

VITAMIN AP30CA023074 · NCI · UNIVERSITY OF ARIZONA · PI Dan Theodorescu · 1985 to 2026
$110.2M
Cancer Prevention and Control Translational ResearchR25CA078447 · NCI · UNIVERSITY OF ARIZONA · PI ALBERTS, DAVID SAMUEL · 1998 to 2014
$7.6M
PHASE I AND II CLINICAL TRIALS OF CANCER CHEMOPREVENTIVE AGENTS-261035-261035158N01CN035158 · CN · UNIVERSITY OF ARIZONA · PI ALBERTS, DAVID S · 2004 to 2006
–
NCI NIH HHS N01 CN035158NCI NIH HHS N01-CN35158NCI NIH HHS P30 CA023074NCI NIH HHS P30CA023074NCI NIH HHS R25 CA078447NCI NIH HHS R25CA078447
6 · The paper itself

Abstract

objectiveIn 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.

methodsNinety-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.

resultsPolyphenon 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%)].

conclusionBased 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.

Indexed as

AdolescentAdultCatechinDouble-Blind MethodFemaleHumansMiddle AgedPapillomavirus InfectionsPlacebo EffectTeaUterine Cervical DysplasiaUterine Cervical NeoplasmsYoung AdultCatechinpolyphenon ETeaCervical intraepithelial neoplasiaHPV infectionPolyphenon E

Identifiers

PMID24388920
PMCPMC3955221
OpenAlexW2158007101

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.