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Can the prophylactic quadrivalent HPV vaccine be used as a therapeutic agent in women with CIN? A randomized trial
BACKGROUND: Human papillomavirus (HPV) is one of the most significant risk factors for cervical cancer. The HPV vaccine has a very significant impact on the incidence of cervical cancer. The present study aimed to investigate the impact of prophylactic quadrivalent HPV vaccine in the treatment of wo...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7045378/ https://www.ncbi.nlm.nih.gov/pubmed/32106837 http://dx.doi.org/10.1186/s12889-020-8371-z |
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author | Karimi-Zarchi, Mojgan Allahqoli, Leila Nehmati, Ameneh Kashi, Abolfazl Mehdizadeh Taghipour-Zahir, Shokouh Alkatout, Ibrahim |
author_facet | Karimi-Zarchi, Mojgan Allahqoli, Leila Nehmati, Ameneh Kashi, Abolfazl Mehdizadeh Taghipour-Zahir, Shokouh Alkatout, Ibrahim |
author_sort | Karimi-Zarchi, Mojgan |
collection | PubMed |
description | BACKGROUND: Human papillomavirus (HPV) is one of the most significant risk factors for cervical cancer. The HPV vaccine has a very significant impact on the incidence of cervical cancer. The present study aimed to investigate the impact of prophylactic quadrivalent HPV vaccine in the treatment of women with cervical intraepithelial neoplasia (CIN 1–3). METHODS: This randomized controlled trial was conducted in the Shahid Sadoughi University of Medical Sciences (SSUMS), Yazd, Iran, from October 2011 to November 2015 in women with histologically confirmed residual/recurrent CIN 1 or high-grade CIN (CIN 2–3). Eligible women were assigned randomly to an intervention and a control group. Women in the intervention group were given HPV vaccinations while those in the control group were not. Participants were followed up for 24 months. Primary and secondary outcomes, and adverse effects of the treatment in the two groups were compared using Student’s t test, the chi-square test, or Fisher’s exact test. P values < 0.05 or less were considered statistically significant. RESULTS: Three-hundred and twelve women were randomized to the two groups; the data of 138 in the intervention group and 104 in the control group were analyzed. The mean age of the women was 32.59 ± 4.85 years. Differences in age, marital status, and grades of CIN weren’t significant between the two groups. At the end of the two-year follow-up period, the number of women with CIN 2–3 in the intervention and control groups was reduced by 75% (from 93 to 23) versus 40% (from 69 to 41). The efficacy of the HPV vaccine in women with CIN 1–3 was 58.7% (p = 0.018). No serious adverse effects related to the vaccines were reported. CONCLUSIONS: The prophylactic quadrivalent HPV vaccine after treatment may have a therapeutic effect in women with residual/recurrent CIN 1 or high-grade CIN (CIN 2–3). TRIAL REGISTRATION: Iranian Registry of Clinical Trials, IRCT20190603043801N1. Registered 24 July 2019 – Retrospectively registered, http://www.irct.ir/user/trial/40017/view |
format | Online Article Text |
id | pubmed-7045378 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-70453782020-03-03 Can the prophylactic quadrivalent HPV vaccine be used as a therapeutic agent in women with CIN? A randomized trial Karimi-Zarchi, Mojgan Allahqoli, Leila Nehmati, Ameneh Kashi, Abolfazl Mehdizadeh Taghipour-Zahir, Shokouh Alkatout, Ibrahim BMC Public Health Research Article BACKGROUND: Human papillomavirus (HPV) is one of the most significant risk factors for cervical cancer. The HPV vaccine has a very significant impact on the incidence of cervical cancer. The present study aimed to investigate the impact of prophylactic quadrivalent HPV vaccine in the treatment of women with cervical intraepithelial neoplasia (CIN 1–3). METHODS: This randomized controlled trial was conducted in the Shahid Sadoughi University of Medical Sciences (SSUMS), Yazd, Iran, from October 2011 to November 2015 in women with histologically confirmed residual/recurrent CIN 1 or high-grade CIN (CIN 2–3). Eligible women were assigned randomly to an intervention and a control group. Women in the intervention group were given HPV vaccinations while those in the control group were not. Participants were followed up for 24 months. Primary and secondary outcomes, and adverse effects of the treatment in the two groups were compared using Student’s t test, the chi-square test, or Fisher’s exact test. P values < 0.05 or less were considered statistically significant. RESULTS: Three-hundred and twelve women were randomized to the two groups; the data of 138 in the intervention group and 104 in the control group were analyzed. The mean age of the women was 32.59 ± 4.85 years. Differences in age, marital status, and grades of CIN weren’t significant between the two groups. At the end of the two-year follow-up period, the number of women with CIN 2–3 in the intervention and control groups was reduced by 75% (from 93 to 23) versus 40% (from 69 to 41). The efficacy of the HPV vaccine in women with CIN 1–3 was 58.7% (p = 0.018). No serious adverse effects related to the vaccines were reported. CONCLUSIONS: The prophylactic quadrivalent HPV vaccine after treatment may have a therapeutic effect in women with residual/recurrent CIN 1 or high-grade CIN (CIN 2–3). TRIAL REGISTRATION: Iranian Registry of Clinical Trials, IRCT20190603043801N1. Registered 24 July 2019 – Retrospectively registered, http://www.irct.ir/user/trial/40017/view BioMed Central 2020-02-27 /pmc/articles/PMC7045378/ /pubmed/32106837 http://dx.doi.org/10.1186/s12889-020-8371-z Text en © The Author(s). 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Research Article Karimi-Zarchi, Mojgan Allahqoli, Leila Nehmati, Ameneh Kashi, Abolfazl Mehdizadeh Taghipour-Zahir, Shokouh Alkatout, Ibrahim Can the prophylactic quadrivalent HPV vaccine be used as a therapeutic agent in women with CIN? A randomized trial |
title | Can the prophylactic quadrivalent HPV vaccine be used as a therapeutic agent in women with CIN? A randomized trial |
title_full | Can the prophylactic quadrivalent HPV vaccine be used as a therapeutic agent in women with CIN? A randomized trial |
title_fullStr | Can the prophylactic quadrivalent HPV vaccine be used as a therapeutic agent in women with CIN? A randomized trial |
title_full_unstemmed | Can the prophylactic quadrivalent HPV vaccine be used as a therapeutic agent in women with CIN? A randomized trial |
title_short | Can the prophylactic quadrivalent HPV vaccine be used as a therapeutic agent in women with CIN? A randomized trial |
title_sort | can the prophylactic quadrivalent hpv vaccine be used as a therapeutic agent in women with cin? a randomized trial |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7045378/ https://www.ncbi.nlm.nih.gov/pubmed/32106837 http://dx.doi.org/10.1186/s12889-020-8371-z |
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