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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 -
The Cochrane Database of Systematic... Nov 2014Groin dissection is commonly performed for the treatment of a variety of cancers, including melanoma, and squamous cell carcinoma of the skin, penis or vulva. It is... (Review)
Review
BACKGROUND
Groin dissection is commonly performed for the treatment of a variety of cancers, including melanoma, and squamous cell carcinoma of the skin, penis or vulva. It is uncertain whether insertion of a drain reduces complication rates, and, if used, the optimum time for drain removal after surgery is also unknown.
OBJECTIVES
To assess the current level of evidence to determine whether placement of a drain is beneficial after groin dissection in terms of reducing seroma, haematoma, wound dehiscence and wound infection rates, and to determine the optimal type and duration of drainage following groin dissection if it is shown to be beneficial.
SEARCH METHODS
In September 2014 we searched the following electronic databases using a pre-designed search strategy: the Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library). In November 2013 we searched Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE and EBSCO CINAHL. We did not restrict the search and study selection with respect to language, date of publication or study setting.
SELECTION CRITERIA
We considered all randomised controlled trials (RCTs) comparing wound drainage with no wound drainage in individuals undergoing groin dissection, where the most superior node excised was Cloquet's node (the most superior inguinal lymph node). No limits were applied to language of publication or trial location. Two review authors independently determined the eligibility of each trial.
DATA COLLECTION AND ANALYSIS
Two review authors, working independently, screened studies identified from the search; there were no disagreements.
MAIN RESULTS
We did not identify any RCTs that met the inclusion criteria for the review.
AUTHORS' CONCLUSIONS
There is a need for high quality RCTs to guide clinical practice in this under-researched area.
Topics: Adult; Drainage; Groin; Humans; Lymph Node Excision; Neoplasms
PubMed: 25387103
DOI: 10.1002/14651858.CD010933.pub2 -
The Cochrane Database of Systematic... Mar 2014This is an updated version of an original Cochrane review published in The Cochrane Library, 2011, Issue 1.Vulval intraepithelial neoplasia (VIN) is a pre-malignant... (Review)
Review
BACKGROUND
This is an updated version of an original Cochrane review published in The Cochrane Library, 2011, Issue 1.Vulval intraepithelial neoplasia (VIN) is a pre-malignant condition of the vulval skin. This uncommon chronic skin condition of the vulva is associated with a high risk of recurrence and the potential to progress to vulval cancer. The condition is complicated by its multicentric and multifocal nature. The incidence of this condition appears to be rising, particularly in the younger age group. There is a lack of consensus on the optimal surgical treatment method. However, the rationale for the surgical treatment of VIN has been to treat the symptoms and exclude any underlying malignancy, with the continued aim of preserving the vulval anatomy and function. Repeated treatments affect local cosmesis and cause psychosexual morbidity, thus impacting he individual's quality of life.
OBJECTIVES
To evaluate the effectiveness and safety of surgical interventions in women with high-grade VIN.
SEARCH METHODS
We searched the Cochrane Gynaecological Cancer Group Trials Register and the Cochrane Central Register of Controlled Trials (CENTRAL) Issue 11,2013 and MEDLINE and EMBASE up to December 2013. We also searched registers of clinical trials, abstracts of scientific meetings and reference lists of included studies, and contacted experts in the field.
SELECTION CRITERIA
Randomised controlled trials (RCTs) that compared surgical interventions in adult women diagnosed with high-grade VIN.
DATA COLLECTION AND ANALYSIS
Two review authors independently abstracted data and assessed risk of bias.
MAIN RESULTS
We identified one RCT, including 30 women, that met our inclusion criteria; this trial reported data on carbon dioxide (CO2) laser surgery versus cavitational ultrasonic surgical aspiration (CUSA). There were no statistically significant differences in the risks of disease recurrence after one year of follow-up, pain, scarring, dysuria or burning, adhesions, infection, abnormal discharge or eschar between women who underwent CO2 laser surgery and those who received CUSA. The trial lacked statistical power due to the small number of women in each group and the low number of observed events, but was at low risk of bias.
AUTHORS' CONCLUSIONS
The included trial lacked statistical power due to the small number of women in each group and the low number of observed events. The absence of reliable evidence regarding the effectiveness and safety of the two surgical techniques for the management of VIN therefore precludes any definitive guidance or recommendations for clinical practice.
Topics: Adult; Carcinoma in Situ; Female; Humans; Lasers, Gas; Precancerous Conditions; Randomized Controlled Trials as Topic; Suction; Ultrasonic Therapy; Vulvar Neoplasms
PubMed: 24596022
DOI: 10.1002/14651858.CD007928.pub3 -
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 -
European Journal of Cancer (Oxford,... Jan 2014Overexpression of the human papillomavirus (HPV) oncogenes E6 and E7 is necessary for the development of distinct lower genital tract cancers. However, secondary... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Overexpression of the human papillomavirus (HPV) oncogenes E6 and E7 is necessary for the development of distinct lower genital tract cancers. However, secondary cellular genomic alterations are mandatory to promote progression of HPV-induced premalignant stages. We aimed at identifying the chromosomal regions most frequently gained and lost and the disease stage at which the latter occurs. These regions might be relevant for carcinogenesis and could serve as diagnostic markers to identify premalignant lesions with high progression risk towards invasive cancer.
METHODS
We performed a systematic literature review and meta-analysis of studies listed in PubMed that analysed chromosomal copy number alterations by comparative genomic hybridisation (CGH) in HPV-positive and -negative cancers or premalignant lesions of the anogenital tract (cervix, anus, vagina, penis and vulva).
FINDINGS
Data were extracted and analysed from 32 studies. The most common alterations in cervical squamous cell carcinoma (SCC) (12 studies, 293 samples) were gains at 3q with a rate of 0.55 (95% confidence interval (CI) 0.43-0.70), losses at 3p (0.36, 95%CI 0.27-0.48) and losses at 11q (0.33, 95%CI 0.26-0.43). Gains at 3q were particularly frequent in HPV16-positive cervical SCC (0.84, 95%CI 0.78-0.90). Also more than one quarter of high grade cervical intraepithelial neoplasia (CIN) harboured gains of 3q (0.27, 95%CI 0.20-0.36), but the rate in low grade CIN was low (0.02, 95%CI 0.00-0.09). For HPV-associated vulvar SCC (four studies, 30 samples) the same common alterations as in cervical SCC were reported. Studies on non-cervical and non-vulvar SCC and premalignant lesions of the lower genital tract are scarce.
INTERPRETATION
3q gains were most frequently found in HPV16-positive cervical SCC. The results suggest the selection of HPV-transformed cell clones harbouring 3q gains in high grade premalignant lesions, while alterations in low grade lesions are rare.
Topics: Chromosome Aberrations; Female; Genomic Instability; Humans; Papillomaviridae; Papillomavirus Infections; Uterine Cervical Neoplasms; Uterine Cervical Dysplasia
PubMed: 24054023
DOI: 10.1016/j.ejca.2013.08.022 -
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 -
The Cochrane Database of Systematic... Aug 2011Vulvovaginal candidiasis (VVC) is one of the most common fungal infections that recur frequently in HIV infected women. Symptoms of VVC are pruritis, discomfort,... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Vulvovaginal candidiasis (VVC) is one of the most common fungal infections that recur frequently in HIV infected women. Symptoms of VVC are pruritis, discomfort, dyspareunia, and dysuria. Vulval infection presents as a morbiliform rash that may extend to the thighs. Vaginal infection is associated with white discharge, and plaques are seen on erythematous vaginal walls.Even though rarely or never resulting in systemic fungal infection or mortality, left untreated these lesions contribute considerably to the morbidity associated with HIV infection. Prevention and treatment of this condition is an essential part of maintaining the quality of life for these individuals.
OBJECTIVES
-To compare the efficacy of various antifungals given vaginally or orally for the treatment and prophylaxis of VVC in HIV-infected women and to evaluate the risks of the same.
SEARCH STRATEGY
The search strategy was comprehensive, iterative and based on that of the HIV/AIDS Cochrane Review Group. The aim was to locate all relevant trials, irrespective of publication status or language. Electronic databases :CENTRAL,Medline, EMBASE, LILACS and CINAHL were searched for randomised controlled trials for the years 1980 to 1st October 2010. WHO ICTRP site and other relevant web sites were also searched for conference abstracts.
SELECTION CRITERIA
Randomised controlled trials (RCTs) of palliative, preventative or curative therapy were considered. Participants were HIV positive women receiving one or more of the following:treatment / prophylaxis for VVC or HAART(Highly Active Antiretroviral Therapy).
DATA COLLECTION AND ANALYSIS
Three authors independently assessed the methodological quality of the trials and extracted data. The quality of the evidence generated was graded using the GRADE PRO approach.
MAIN RESULTS
Our search did not yield any trial investigating treatment of VVC in HIV positive women.Two trials dealing with prophylaxis were eligible for inclusion.One trial (n= 323) favoured the use of weekly Fluconazole as compared to placebo (RR 0.68; 95% CI 0.47 to 0.97).The second trial with three arms of comparison;Clotrimazole,Lactobacillus and Placebo gave no definitive results in preventing an episode of VVC. Clotrimazole against placebo (RR 0.49; 95% CI 0.22 to 1.09), Clotrimazole against lactobacillus (RR 1.11; 95% CI 0.45 to 2.76) and lactobacillus against placebo (RR 0.54 ;95% CI 0.26 to 1.13).
AUTHORS' CONCLUSIONS
Implications for practiceNo trials were found addressing treatment of VVC in HIV positive women.In comparison to placebo,Fluconazole was found to be an effective preventative intervention. However, the potential for resistant Candida organisms to develop might impact the feasibility of implementation.Direction of findings suggests that Clotrimazole and Lactobacillus improved the prophylactic outcomes when compared to placebo.Implications for research There is a need to evaluate drugs and drug regimens for VVC treatment and prophylaxis in HIV positive women through randomised clinical trials. Development of resistance to azoles remains under-studied and more work must be done in this area, so as to determine whether routine prophylaxis for VVC is at all needed or whether adequate ART would be sufficient to prevent recurrent VVC. The viral load in vaginal secretions with or without treatment or prophylaxis has not been studied, this is very relevant to the spread of HIV.
Topics: AIDS-Related Opportunistic Infections; Adult; Antifungal Agents; Candidiasis, Vulvovaginal; Clotrimazole; Female; Fluconazole; Humans; Lactobacillus; Probiotics; Randomized Controlled Trials as Topic
PubMed: 21833970
DOI: 10.1002/14651858.CD008739.pub2 -
The Cochrane Database of Systematic... Apr 2011Vulval intraepithelial neoplasia (VIN) is a pre-malignant condition of the vulval skin; its incidence is increasing in women under 50 years. VIN is graded histologically... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Vulval intraepithelial neoplasia (VIN) is a pre-malignant condition of the vulval skin; its incidence is increasing in women under 50 years. VIN is graded histologically as low grade or high grade. High grade VIN is associated with infection with human papilloma virus (HPV) infection and may progress to invasive disease. There is no consensus on the optimal management of high grade VIN. The high morbidity and high relapse rate associated with surgical interventions call for a formal appraisal of the evidence available for less invasive but effective interventions for high grade VIN.
OBJECTIVES
To evaluate the effectiveness and safety of medical interventions for high grade VIN.
SEARCH STRATEGY
We searched the Cochrane Gynaecological Cancer Group Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2010, Issue 3), MEDLINE and EMBASE (up to September 2010). We also searched registers of clinical trials, abstracts of scientific meetings, reference lists of included studies and contacted experts in the field.
SELECTION CRITERIA
Randomised controlled trials (RCTs) that assessed medical interventions, in adult women diagnosed with high grade VIN.
DATA COLLECTION AND ANALYSIS
Two review authors independently abstracted data and assessed risk of bias. Where possible the data were synthesised in a meta-analysis.
MAIN RESULTS
Four trials met our inclusion criteria: three assessed the effectiveness of topical imiquimod versus placebo in women with high grade VIN; one examined low versus high dose indole-3-carbinol in similar women. Meta-analysis of three trials found that the proportion of women who responded to treatment at 5 to 6 months was much higher in the group who received topical imiquimod than in the group who received placebo (relative risk (RR) = 11.95, 95% confidence interval (CI) 3.21 to 44.51). A single trial showed similar results at 12 months in (RR = 9.10, 95% CI 2.38 to 34.77). Only one trial reported adverse events, which were more common in the imiquimod group. One trial found no significant differences in quality of life (QoL) or body image between the imiquimod and placebo groups.
AUTHORS' CONCLUSIONS
Imiquimod appears to be effective, but its safety needs further examination. Its use is associated with side effects which are tolerable, but more extensive data on adverse effects are required. Long term follow-up should be mandatory in view of the known progression of high grade VIN to invasive disease. Alternative medical interventions, such as cidofovir, should be explored.
Topics: Administration, Topical; Adult; Aminoquinolines; Anticarcinogenic Agents; Antineoplastic Agents; Carcinoma in Situ; Female; Humans; Imiquimod; Indoles; Randomized Controlled Trials as Topic; Vulvar Neoplasms
PubMed: 21491403
DOI: 10.1002/14651858.CD007924.pub2 -
The Cochrane Database of Systematic... Jan 2011Vulval intraepithelial neoplasia (VIN) is a pre-malignant condition of the vulval skin. This uncommon chronic skin condition of the vulva is associated with a high risk... (Review)
Review
BACKGROUND
Vulval intraepithelial neoplasia (VIN) is a pre-malignant condition of the vulval skin. This uncommon chronic skin condition of the vulva is associated with a high risk of recurrence and the potential to progress to vulval cancer. The condition is complicated by its' multicentric and multifocal nature. The incidence of this condition appears to be rising particularly in the younger age group.There is a lack of consensus on the optimal surgical treatment method. However, the rationale for surgical treatment of VIN has been to treat symptoms and exclude underlying malignancy with the continued aim of preservation of vulval anatomy and function. Repeated treatments affect local cosmesis and cause psychosexual morbidity thus impacting on the patients' quality of life.
OBJECTIVES
To evaluate the effectiveness and safety of surgical interventions for high grade VIN.
SEARCH STRATEGY
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), Issue 3, 2010, Cochrane Gynaecological Cancer Group Trials Register, MEDLINE and EMBASE up to September 2010. We also searched registers of clinical trials, abstracts of scientific meetings, reference lists of included studies and contacted experts in the field.
SELECTION CRITERIA
Randomised controlled trials (RCTs) that compared surgical interventions, in adult women diagnosed with high grade vulval intraepithelial neoplasia.
DATA COLLECTION AND ANALYSIS
Two review authors independently abstracted data and assessed risk of bias.
MAIN RESULTS
We found only one RCT which included 30 women that met our inclusion criteria and this trial reported data on carbon dioxide laser (CO(2) laser) versus ultrasonic surgical aspiration (USA).There was no statistically significant difference in the risk of disease recurrence after one year follow-up, pain, presence of scarring, dysuria or burning, adhesions, infection, abnormal discharge and eschar between women who received CO(2) laser and those who received USA. The trial lacked statistical power due to the small number of women in each group and the low number of observed events, but was at low risk of bias.
AUTHORS' CONCLUSIONS
The included trial lacked statistical power due to the small number of women in each group and the low number of observed events. Therefore in the absence of reliable evidence regarding the effectiveness and safety of the two surgical techniques for the management of vulval intraepithelial neoplasia precludes any definitive guidance or recommendations for clinical practice.
Topics: Adult; Carcinoma in Situ; Female; Humans; Lasers, Gas; Precancerous Conditions; Randomized Controlled Trials as Topic; Suction; Ultrasonic Therapy; Vulvar Neoplasms
PubMed: 21249698
DOI: 10.1002/14651858.CD007928.pub2 -
International Journal of Gynecological... Oct 2009Human papillomavirus (HPV) types cause approximately 70% of cervical cancer worldwide. Two vaccines have been recently evaluated in randomized controlled trials: the... (Review)
Review
Human papillomavirus (HPV) types cause approximately 70% of cervical cancer worldwide. Two vaccines have been recently evaluated in randomized controlled trials: the bivalent vaccine for HPV 16 and 18 (Cervarix, GlaxoSmithKline Biologicals, Rixensart, Belgium) and the quadrivalent vaccine for HPV 6, 11, 16, and 18 (Gardasil, Merck and Co, Inc, Whitehouse Station, NJ). We have performed a systematic review of all randomized controlled trials in which vaccines against HPV were compared with placebo regarding efficacy, safety, and immunogenicity. Six studies met the inclusion criteria, which included 47,236 women. The first objective in this systematic review was to assess vaccine efficacy in the prevention of cytologically and/or histologically proven lesions. And the secondary objective was the evaluation of safety and vaccine immunogenicity. Bivalent and quadrivalent HPV vaccines significantly reduced the rate of lesions in the cervix, vulva, vagina, and anogenital region, with efficacy of 93% (95% confidence interval [CI], 87-96) and 62% (95% CI, 27-70), respectively, when compared with the control groups according to intention to treat. Regarding safety, we found more symptoms in the bivalent vaccine group (35%; 95% CI, 5-73) when compared with the control groups. In regard to vaccine immunogenicity, there was seroconversion in the group that received the vaccine when compared with the placebo group in the bivalent and quadrivalent vaccines. Prophylactic vaccination can prevent HPV infection in women aged 9 to 26 years not previously infected with the HPV subtypes covered by the vaccines. To evaluate cervical cancer incidence and mortality, a longer follow-up is necessary.
Topics: Adolescent; Adult; Child; Controlled Clinical Trials as Topic; Female; Humans; Papillomavirus Infections; Papillomavirus Vaccines; Randomized Controlled Trials as Topic; Treatment Outcome; Uterine Cervical Neoplasms; Young Adult; Uterine Cervical Dysplasia
PubMed: 19823051
DOI: 10.1111/IGC.0b013e3181a3d100