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Annals of Oncology : Official Journal... Feb 2020Although local treatments for cervical intraepithelial neoplasia (CIN) are highly effective, it has been reported that treated women remain at increased risk of cervical... (Meta-Analysis)
Meta-Analysis
Incidence and mortality from cervical cancer and other malignancies after treatment of cervical intraepithelial neoplasia: a systematic review and meta-analysis of the literature.
BACKGROUND
Although local treatments for cervical intraepithelial neoplasia (CIN) are highly effective, it has been reported that treated women remain at increased risk of cervical and other cancers. Our aim is to explore the risk of developing or dying from cervical cancer and other human papillomavirus (HPV)- and non-HPV-related malignancies after CIN treatment and infer its magnitude compared with the general population.
MATERIALS AND METHODS
Design: Systematic review and meta-analysis. Eligibility criteria: Studies with registry-based follow-up reporting cancer incidence or mortality after CIN treatment.
DATA SYNTHESIS
Summary effects were estimated using random-effects models.
OUTCOMES
Incidence rate of cervical cancer among women treated for CIN (per 100 000 woman-years). Relative risk (RR) of cervical cancer, other HPV-related anogenital tract cancer (vagina, vulva, anus), any cancer, and mortality, for women treated for CIN versus the general population.
RESULTS
Twenty-seven studies were eligible. The incidence rate for cervical cancer after CIN treatment was 39 per 100 000 woman-years (95% confidence interval 22-69). The RR of cervical cancer was elevated compared with the general population (3.30, 2.57-4.24; P < 0.001). The RR was higher for women more than 50 years old and remained elevated for at least 20 years after treatment. The RR of vaginal (10.84, 5.58-21.10; P < 0.001), vulvar (3.34, 2.39-4.67; P < 0.001), and anal cancer (5.11, 2.73-9.55; P < 0.001) was also higher. Mortality from cervical/vaginal cancer was elevated, but our estimate was more uncertain (RR 5.04, 0.69-36.94; P = 0.073).
CONCLUSIONS
Women treated for CIN have a considerably higher risk to be later diagnosed with cervical and other HPV-related cancers compared with the general population. The higher risk of cervical cancer lasts for at least 20 years after treatment and is higher for women more than 50 years of age. Prolonged follow-up beyond the last screening round may be warranted for previously treated women.
Topics: Alphapapillomavirus; Female; Humans; Incidence; Middle Aged; Papillomavirus Infections; Uterine Cervical Neoplasms; Uterine Cervical Dysplasia
PubMed: 31959338
DOI: 10.1016/j.annonc.2019.11.004 -
BJOG : An International Journal of... May 2020No consensus on the management of symptomatic cysts or abscesses of the Bartholin's gland exists.
BACKGROUND
No consensus on the management of symptomatic cysts or abscesses of the Bartholin's gland exists.
OBJECTIVES
To assess the effectiveness and safety of surgical interventions for a symptomatic Bartholin's cyst or abscess.
SEARCH STRATEGY
We searched bibliographical databases from inception to April 2019.
SELECTION CRITERIA
Randomised trials evaluating a surgical intervention for the treatment of a symptomatic Bartholin's cyst or abscess.
DATA COLLECTION AND ANALYSIS
Eight trials, reporting data from 699 women, were included. Study characteristics and methodological quality were recorded for each trial. Summary estimates were calculated using random-effects methods.
MAIN RESULTS
When considering the recurrence of a symptomatic Bartholin's cyst or abscess, the evidence was consistent with notable effects in either direction (risk ratio [RR] 0.76; 95% confidence interval [CI] 0.41-1.40) when comparing marsupialisation with incision, drainage and insertion of a Word catheter. Limited inference could be made when comparing marsupialisation with incision, drainage and silver nitrate insertion (RR 1.00; 95% CI 0.57-1.75), and incision, drainage and cavity closure (RR 0.25; 95% CI 0.01-4.89). There was limited reporting of secondary outcomes, including haematoma, infectious morbidity and persistent dyspareunia.
CONCLUSIONS
Current randomised trial evidence does not support the use of any single surgical intervention for the treatment of a symptomatic cyst or abscess of the Bartholin's gland.
PROSPECTIVE REGISTRATION
PROSPERO: International Prospective Register of Systematic Reviews; CRD42018088553.
TWEETABLE ABSTRACT
Further research is needed to identify an effective treatment for #Bartholin's cyst or abscess. @jamesmnduffy.
Topics: Ablation Techniques; Abscess; Bartholin's Glands; Cysts; Drainage; Female; Gynecologic Surgical Procedures; Humans; Needs Assessment; Randomized Controlled Trials as Topic; Vulvar Diseases
PubMed: 31876985
DOI: 10.1111/1471-0528.16079 -
American Journal of Obstetrics and... Sep 2015The aim of this study was to systematically review the findings of publications addressing the epidemiology of anal human papillomavirus (HPV) infection, anal... (Review)
Review
The aim of this study was to systematically review the findings of publications addressing the epidemiology of anal human papillomavirus (HPV) infection, anal intraepithelial neoplasia, and anal cancer in women. We conducted a systematic review among publications published from Jan. 1, 1997, to Sept. 30, 2013, to limit to publications from the combined antiretroviral therapy era. Three searches were performed of the National Library of Medicine PubMed database using the following search terms: women and anal HPV, women anal intraepithelial neoplasia, and women and anal cancer. Publications were included in the review if they addressed any of the following outcomes: (1) prevalence, incidence, or clearance of anal HPV infection, (2) prevalence of anal cytological or histological neoplastic abnormalities, or (3) incidence or risk of anal cancer. Thirty-seven publications addressing anal HPV infection and anal cytology remained after applying selection criteria, and 23 anal cancer publications met the selection criteria. Among HIV-positive women, the prevalence of high-risk (HR)-HPV in the anus was 16-85%. Among HIV-negative women, the prevalence of anal HR-HPV infection ranged from 4% to 86%. The prevalence of anal HR-HPV in HIV-negative women with HPV-related pathology of the vulva, vagina, and cervix compared with women with no known HPV-related pathology, varied from 23% to 86% and from 5% to 22%, respectively. Histological anal high-grade squamous intraepithelial lesions (anal intraepithelial neoplasia 2 or greater) was found in 3-26% of the women living with HIV, 0-9% among women with lower genital tract pathology, and 0-3% for women who are HIV negative without known lower genital tract pathology. The incidence of anal cancer among HIV-infected women ranged from 3.9 to 30 per 100,000. Among women with a history of cervical cancer or cervical intraepithelial neoplasia 3, the incidence rates of anal cancer ranged from 0.8 to 63.8 per 100,000 person-years, and in the general population, the incidence rates ranged from 0.55 to 2.4 per 100,000 person-years. This review provides evidence that anal HPV infection and dysplasia are common in women, especially in those who are HIV positive or have a history of HPV-related lower genital tract pathology. The incidence of anal cancer continues to grow in all women, especially those living with HIV, despite the widespread use of combined antiretroviral therapy.
Topics: Antiretroviral Therapy, Highly Active; Anus Diseases; Anus Neoplasms; Carcinoma in Situ; Carcinoma, Squamous Cell; Coinfection; Female; HIV Infections; Humans; Incidence; Papillomavirus Infections; Prevalence; Proctitis
PubMed: 25797230
DOI: 10.1016/j.ajog.2015.03.034 -
Archives of Gynecology and Obstetrics Sep 2022Despite the vaginal mucosa is able to respond to allergenic stimuli, vaginal allergic responses have been under investigated in clinical practice. Thus, we aimed to... (Review)
Review
PURPOSE
Despite the vaginal mucosa is able to respond to allergenic stimuli, vaginal allergic responses have been under investigated in clinical practice. Thus, we aimed to identify the most frequent etiological agents responsible for vulvovaginal allergies, the prevalent signs/symptoms, and the diagnostic tests applied in this clinical condition.
METHODS
Literature search was performed on PubMed, Scopus, Scielo, Web of Science, and EMBASE. The study protocol was registered on PROSPERO (CRD42020167238). Studies were divided in two groups depending on allergen exposure route. Due to a significant number of studies correlating allergy to Candida infection, subgroup analysis was included.
RESULTS
In direct exposure cases, Human Seminal Plasma was the most prevalent allergen, sensitizing 73% of affected women. These women presented localized swelling and burning as prevalent symptoms, affecting 42/68 and 36/68 women, respectively. Cutaneous Prick tests were applied in 58/68 women, either alone or combined with IgE measurements. Regarding cases of indirect/unidentified exposure, house dust mites was the most prevalent allergen (54%), followed by pollen (44%). Predominant symptoms were vulvar pruritus and burning, affecting 67/98 and 52/98 women. Skin prick test was the most prevalent diagnostic method used among different studies. Hypersensitivity toward Candida antigen was present in only half (163/323) of women presenting concomitant allergy and Candida infection.
CONCLUSION
From the two types of allergen exposure that can cause vulvovaginal allergic responses, direct contact of the antigen with the vulva and/or vagina was the most prevalent. Still, allergens can also sensitize the vaginal mucosa secondarily to other exposure route, specifically aeroallergens.
Topics: Allergens; Candidiasis; Female; Humans; Hypersensitivity; Skin Tests; Vulvovaginitis
PubMed: 34825938
DOI: 10.1007/s00404-021-06332-z -
Journal of Clinical Virology : the... Jul 2023Human papillomavirus associated anogenital cancers are a significant global burden. The detection of biomarkers (circulating tumour DNA; ctDNA or circulating HPV DNA;... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Human papillomavirus associated anogenital cancers are a significant global burden. The detection of biomarkers (circulating tumour DNA; ctDNA or circulating HPV DNA; cHPV DNA) in blood referred to as "liquid biopsy" may support the early diagnosis and monitoring of affected individuals.
METHODS
A systematic review, including meta-analysis of studies available in the literature on the utilization of ctDNA and cHPV DNA as diagnostic, predictive, and monitoring biomarker tests of HPV associated anogenital cancers was performed following the criteria of PRISMA.
RESULTS
A total of 31 studies were eligible for systematic review; 20 used cHPV DNA in cervical cancers; 7 used ctDNA in cervical cancer; 5 used cHPV DNA in anal cancer; no eligible studies on vulva, vaginal or penile cancer were available. The meta-analysis identified low sensitivity (0.36) and high specificity (0.96) of cHPV DNA as diagnostic for cervical cancer. Comparatively, there was high sensitivity (0.95) and specificity (1.0) of cHPV DNA for the diagnosis of anal cancer. cHPV DNA and/or ctDNA in cervical cancer were prognostic markers associated with poor clinical outcomes. Additionally, in anal cancer the post treatment detection of cHPV DNA was informative in the prediction of treatment response or progression-free survival.
CONCLUSION
ctDNA and cHPV DNA are promising diagnostic and prognostic biomarkers for the detection of anogenital disease. Evolution and refinement of molecular tools is likely to improve performance further. Additionally the comparative absence of studies in the vulval, vaginal and penile context warrants further exploration and research.
Topics: Female; Humans; Uterine Cervical Neoplasms; Papillomavirus Infections; Human Papillomavirus Viruses; Anus Neoplasms; DNA
PubMed: 37163963
DOI: 10.1016/j.jcv.2023.105469 -
The Cochrane Database of Systematic... Nov 2019Uptake of human papillomavirus (HPV) vaccine remains low in many countries, although the bivalent and quadrivalent HPV vaccines given as a three-dose schedule are... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Uptake of human papillomavirus (HPV) vaccine remains low in many countries, although the bivalent and quadrivalent HPV vaccines given as a three-dose schedule are effective in the prevention of precancerous lesions of the cervix in women. Simpler immunisation schedules, such as those with fewer doses, might reduce barriers to vaccination, as may programmes that include males.
OBJECTIVES
To evaluate the efficacy, immunogenicity, and harms of different dose schedules and different types of HPV vaccines in females and males.
SEARCH METHODS
We conducted electronic searches on 27 September 2018 in Ovid MEDLINE, the Cochrane Central Register of Controlled Trials (CENTRAL) (in the Cochrane Library), and Ovid Embase. We also searched the WHO International Clinical Trials Registry Platform, and ClinicalTrials.gov (both 27 September 2018), vaccine manufacturer websites, and checked reference lists from an index of HPV studies and other relevant systematic reviews.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) with no language restriction. We considered studies if they enrolled HIV-negative males or females aged 9 to 26 years, or HIV-positive males or females of any age.
DATA COLLECTION AND ANALYSIS
We used methods recommended by Cochrane. We use the term 'control' to refer to comparator products containing an adjuvant or active vaccine and 'placebo' to refer to products that contain no adjuvant or active vaccine. Most primary outcomes in this review were clinical outcomes. However, for comparisons comparing dose schedules, the included RCTs were designed to measure antibody responses (i.e. immunogenicity) as the primary outcome, rather than clinical outcomes, since it is unethical to collect cervical samples from girls under 16 years of age. We analysed immunogenicity outcomes (i.e. geometric mean titres) with ratios of means, clinical outcomes (e.g. cancer and intraepithelial neoplasia) with risk ratios or rate ratios and, for serious adverse events and deaths, we calculated odds ratios. We rated the certainty of evidence with GRADE.
MAIN RESULTS
We included 20 RCTs with 31,940 participants. The length of follow-up in the included studies ranged from seven months to five years. Two doses versus three doses of HPV vaccine in 9- to 15-year-old females Antibody responses after two-dose and three-dose HPV vaccine schedules were similar after up to five years of follow-up (4 RCTs, moderate- to high-certainty evidence). No RCTs collected clinical outcome data. Evidence about serious adverse events in studies comparing dose schedules was of very low-certainty owing to imprecision and indirectness (three doses 35/1159; two doses 36/1158; 4 RCTs). One death was reported in the three-dose group (1/898) and none in the two-dose group (0/899) (low-certainty evidence). Interval between doses of HPV vaccine in 9- to 14-year-old females and males Antibody responses were stronger with a longer interval (6 or 12 months) between the first two doses of HPV vaccine than a shorter interval (2 or 6 months) at up to three years of follow-up (4 RCTs, moderate- to high-certainty evidence). No RCTs collected data about clinical outcomes. Evidence about serious adverse events in studies comparing intervals was of very low-certainty, owing to imprecision and indirectness. No deaths were reported in any of the studies (0/1898, 3 RCTs, low-certainty evidence). HPV vaccination of 10- to 26-year-old males In one RCT there was moderate-certainty evidence that quadrivalent HPV vaccine, compared with control, reduced the incidence of external genital lesions (control 36 per 3081 person-years; quadrivalent 6 per 3173 person-years; rate ratio 0.16, 95% CI 0.07 to 0.38; 6254 person-years) and anogenital warts (control 28 per 2814 person-years; quadrivalent 3 per 2831 person-years; rate ratio 0.11, 95% CI 0.03 to 0.38; 5645 person-years). The quadrivalent vaccine resulted in more injection-site adverse events, such as pain or redness, than control (537 versus 601 per 1000; risk ratio (RR) 1.12, 95% CI 1.06 to 1.18, 3895 participants, high-certainty evidence). There was very low-certainty evidence from two RCTs about serious adverse events with quadrivalent vaccine (control 12/2588; quadrivalent 8/2574), and about deaths (control 11/2591; quadrivalent 3/2582), owing to imprecision and indirectness. Nonavalent versus quadrivalent vaccine in 9- to 26-year-old females and males Three RCTs were included; one in females aged 9- to 15-years (n = 600), one in females aged 16- to 26-years (n = 14,215), and one in males aged 16- to 26-years (n = 500). The RCT in 16- to 26-year-old females reported clinical outcomes. There was little to no difference in the incidence of the combined outcome of high-grade cervical epithelial neoplasia, adenocarcinoma in situ, or cervical cancer between the HPV vaccines (quadrivalent 325/6882, nonavalent 326/6871; OR 1.00, 95% CI 0.85 to 1.16; 13,753 participants; high-certainty evidence). The other two RCTs did not collect data about clinical outcomes. There were slightly more local adverse events with the nonavalent vaccine (905 per 1000) than the quadrivalent vaccine (846 per 1000) (RR 1.07, 95% CI 1.05 to 1.08; 3 RCTs, 15,863 participants; high-certainty evidence). Comparative evidence about serious adverse events in the three RCTs (nonavalent 243/8234, quadrivalent 192/7629; OR 0.60, 95% CI 0.14 to 2.61) was of low certainty, owing to imprecision and indirectness. HPV vaccination for people living with HIV Seven RCTs reported on HPV vaccines in people with HIV, with two small trials that collected data about clinical outcomes. Antibody responses were higher following vaccination with either bivalent or quadrivalent HPV vaccine than with control, and these responses could be demonstrated to have been maintained for up to 24 months in children living with HIV (low-certainty evidence). The evidence about clinical outcomes and harms for HPV vaccines in people with HIV is very uncertain (low- to very low-certainty evidence), owing to imprecision and indirectness.
AUTHORS' CONCLUSIONS
The immunogenicity of two-dose and three-dose HPV vaccine schedules, measured using antibody responses in young females, is comparable. The quadrivalent vaccine probably reduces external genital lesions and anogenital warts in males compared with control. The nonavalent and quadrivalent vaccines offer similar protection against a combined outcome of cervical, vaginal, and vulval precancer lesions or cancer. In people living with HIV, both the bivalent and quadrivalent HPV vaccines result in high antibody responses. For all comparisons of alternative HPV vaccine schedules, the certainty of the body of evidence about serious adverse events reported during the study periods was low or very low, either because the number of events was low, or the evidence was indirect, or both. Post-marketing surveillance is needed to continue monitoring harms that might be associated with HPV vaccines in the population, and this evidence will be incorporated in future updates of this review. Long-term observational studies are needed to determine the effectiveness of reduced-dose schedules against HPV-related cancer endpoints, and whether adopting these schedules improves vaccine coverage rates.
Topics: Adolescent; Adult; Child; Dose-Response Relationship, Immunologic; Female; Humans; Male; Papillomavirus Infections; Papillomavirus Vaccines; Randomized Controlled Trials as Topic; Uterine Cervical Neoplasms; Young Adult
PubMed: 31755549
DOI: 10.1002/14651858.CD013479 -
The British Journal of Dermatology Sep 2013Symptoms and signs of vulval skin disorders are common. These conditions can have a considerable impact on quality of life, restricting physical activities and causing... (Review)
Review
Symptoms and signs of vulval skin disorders are common. These conditions can have a considerable impact on quality of life, restricting physical activities and causing difficulty in everyday activities and may also affect social, psychosexual and psychological well-being. There are no standardized measures routinely used to assess the impact of vulval disease on daily life. To report outcome measures used in clinically based randomized controlled trials (RCTs) investigating therapeutic interventions in vulval disease. The Medline, EMBASE and CENTRAL databases were searched to identify RCTs of vulval skin conditions written in English. Studies with laboratory tests or survival rates as the primary outcome, or those investigating menopausal symptoms or infections were excluded. Twenty-eight published RCTs were included. The vulval conditions represented were vulvodynia (n = 14), lichen sclerosus (n = 9), vulval intraepithelial neoplasia (n = 2), vulval pruritus (n = 2) and lichen planus (n = 1). The 28 RCTs measured 25 different outcomes, using 49 different scales. The method of outcome assessment was lacking on nine occasions. Only 21% (six of 28) of included trials had a clearly stated primary outcome. Patient-reported outcomes were more commonly reported than clinician-related outcome measures. The most commonly reported patient-rated outcome measure was a reduction in pain (measured 15 times) and an overall improvement in symptoms using a patient global assessment (measured 11 times). The most commonly reported clinician-rated outcome was an overall assessment of the appearance of affected sites (measured 13 times). There were no agreed standard scales used for the global assessments. Only nine of the recorded outcome measure tools were designed to assess vulval disease or sexual functioning, the remainder were general measures. There is heterogeneity in the outcome measures used when reporting therapeutic interventions in vulval disease. This field of dermatology would benefit from development of a vulval-specific outcome measure and the establishment of a core outcome measure set.
Topics: Female; Humans; Randomized Controlled Trials as Topic; Skin Diseases; Treatment Outcome; Vulvar Diseases
PubMed: 23600623
DOI: 10.1111/bjd.12391 -
Pediatric Dermatology Jul 2021In children, distinguishing anogenital warts (AGW) acquired innocently from those acquired by child sexual abuse (CSA) is challenging. High-quality studies examining... (Meta-Analysis)
Meta-Analysis
BACKGROUND/OBJECTIVES
In children, distinguishing anogenital warts (AGW) acquired innocently from those acquired by child sexual abuse (CSA) is challenging. High-quality studies examining this relationship are sparse. Here, we sought to evaluate the association between AGW and sexual abuse in children 12 years of age and younger with respect to wart location, age, and gender.
METHODS
A systematic review of Ovid MEDLINE, Embase, and Web of Science was performed for studies published on or before 2/16/2018. Studies were eligible for inclusion if they contained at least 10 patients 12 years old and younger and reported the number of patients who were sexually abused. The principal summary measures were the odds ratios (OR) of reported CSA with respect to subject age, wart location, and gender.
RESULTS
Three hundred twenty-seven studies were identified through record search. Twenty five were included in a summary synthesis (791 subjects); 10 were included in the final statistical analysis (199 subjects). In our overall review, 102 of 468 (21%) females and 36 of 204 (18%) males with AGW were abused or probably abused. Overlapping HPV types were found in abused and non-abused subjects. Perianal location and gender were not significant predictors of abuse. Both age and genital wart location (penis, vulva) did significantly predict CSA (α = .05). The odds ratio for sexual abuse of children aged 3-4 years was 7.45; 6.52 for ages 5-8 years; and 6.93 for ages 9-12 years compared to those 0-2 years of age. Genital location was associated with an OR of CSA of 5.93.
CONCLUSIONS
Our systematic review supports a significant association between AGW in a child greater than 2 years of age and odds of CSA. Genital wart location significantly predicts CSA as well. HPV typing is not a reliable method to ascertain CSA. Male family members and acquaintances were the most likely perpetrators of abuse.
Topics: Child; Child Abuse, Sexual; Child, Preschool; Condylomata Acuminata; Female; Humans; Male; Papilloma; Papillomavirus Infections; Warts
PubMed: 34060139
DOI: 10.1111/pde.14650 -
The Cochrane Database of Systematic... Nov 2014BackgroundPubic or perineal shaving is a procedure performed before birth in order to lessen the risk of infection if there is a spontaneous perinealtear or if an... (Meta-Analysis)
Meta-Analysis Review
BackgroundPubic or perineal shaving is a procedure performed before birth in order to lessen the risk of infection if there is a spontaneous perinealtear or if an episiotomy is performed.ObjectivesTo assess the effects of routine perineal shaving before birth onmaternal and neonatal outcomes, according to the best available evidence.Search methodsWe searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (12 June 2014).Selection criteriaAll controlled trials (including quasi-randomised) that compare perineal shaving versus no perineal shaving.Data collection and analysisTwo review authors independently assessed all potential studies for inclusion, assessed risk of bias and extracted the data using apredesigned form. Data were checked for accuracy.Main resultsThree randomised controlled trials (1039 women) published between 1922 and 2005 fulfilled the prespecified criteria. In the earliesttrial, 389 women were alternately allocated to receive either skin preparation and perineal shaving or clipping of vulval hair only. In thesecond trial, which included 150 participants, perineal shaving was compared with the cutting of long hairs for procedures only. In thethird and most recent trial, 500 women were randomly allocated to shaving of perineal area or cutting of perineal hair. The primaryoutcome for all three trials was maternal febrile morbidity; no differences were found (risk ratio (RR) 1.14, 95% confidence interval(CI) 0.73 to 1.76). No differences were found in terms of perineal wound infection (RR 1.47, 95% CI 0.80 to 2.70) and perinealwound dehiscence (RR 0.33, 95% CI 0.01 to 8.00) in the most recent trial involving 500 women, which was the only trial to assessthese outcomes. In the smallest trial, fewer women who had not been shaved had Gram-negative bacterial colonisation compared withwomen who had been shaved (RR 0.83, 95% CI 0.70 to 0.98). There were no instances of neonatal infection in either group in theone trial that reported this outcome. There were no differences in maternal satisfaction between groups in the larger trial reporting this outcome (mean difference (MD) 0.00, 95% CI -0.13 to 0.13). No trial reported on perineal trauma. One trial reported on side-effectsand these included irritation, redness, burning and itching.The overall quality of evidence ranged from very low (for the outcomes postpartum maternal febrile morbidity and neonatal infection)to low (for the outcome maternal satisfaction and wound infection).Authors’ conclusionsThere is insufficient evidence to recommend perineal shaving for women on admission in labour.
Topics: Confidence Intervals; Female; Hair Removal; Humans; Labor, Obstetric; Odds Ratio; Patient Admission; Patient Satisfaction; Perineum; Pregnancy; Pregnancy Outcome; Randomized Controlled Trials as Topic
PubMed: 25398160
DOI: 10.1002/14651858.CD001236.pub2 -
PloS One 2014It is unclear whether L1-VLP-based human papillomavirus (HPV) vaccines are efficacious in reducing the likelihood of anogenital pre-cancer in women with evidence of... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
It is unclear whether L1-VLP-based human papillomavirus (HPV) vaccines are efficacious in reducing the likelihood of anogenital pre-cancer in women with evidence of prior vaccine-type HPV exposure. This study aims to determine whether the combined results of the vaccine trials published to date provide evidence of efficacy compared with control (hepatitis A vaccine/placebo).
METHODS
A systematic review and meta-analysis was conducted. Randomized-controlled trials (RCTs) were identified from MEDLINE, Embase, Web of Science, PubMed, Cochrane Central Register of Controlled Trials and references of identified studies. The bivalent vaccine containing HPV-16 and 18 VLPs from GlaxoSmithKline Biologicals (Rixenstart, Belgium), the quadrivalent vaccine containing HPV-6, 11, 16, and 18 VLPs from Merck & Co., Inc., (Whitehouse Station, NJ USA), and the HPV-16 monovalent vaccine from Merck Research Laboratories (West Point, PA USA) were evaluated.
FINDINGS
Three RCT reports and two post-trial cohort studies were eligible, comprising data from 13,482 women who were included in the vaccine studies but had evidence of HPV infection at study entry. Data on efficacy was synthesized using the Mantel-Haenszel weighted fixed-effect approach, or where there was heterogeneity between studies, the DerSimonian and Laird weighted random-effect approach. The mean odds ratio (OR) and 95% confidence interval (CI) for the association between Cervarix, Gardasil and HPV-16 monovalent vaccine and HPV-associated cervical intraepithelial neoplasia grade 3 or worse was 0·90 (95% CI: 0·56, 1·44). For the association between Gardasil and HPV-associated vulval/vaginal intraepithelial neoplasia grades 2-3, the overall OR and 95% CI was 2.25 (95% CI: 0·78, 6.50). Sample size and follow-up were limited.
CONCLUSIONS
There was no evidence that HPV vaccines are effective in preventing vaccine-type HPV associated pre-cancer in women with evidence of prior HPV exposure. Small effects of vaccination however cannot be excluded and a longer-term benefit in preventing re-infection remains possible.
Topics: Alphapapillomavirus; Anus Neoplasms; Cohort Studies; Female; Genital Neoplasms, Female; Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; Humans; Papillomavirus Vaccines; Precancerous Conditions; Randomized Controlled Trials as Topic
PubMed: 24595046
DOI: 10.1371/journal.pone.0090348