Safety, tolerability and side effects of human papillomavirus vaccines: a systematic quantitative review

Recently, many studies have evaluated HPV vaccine safety and adverse effects. Two vaccine shave 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 HPV vaccines were compared with placebo regarding safety, tolerability and adverse effects. Studies were searched up to March 2013 in the databases: Pubmed, Embase, Scielo and Cancerlit. Odds Ratios (OR) of most incident adverse effects were obtained. Twelve reports, involving 29,540 subjects, were included. In the HPV 16/18 group, the most frequently reported events related to the vaccine were pain (OR 3.29; 95% CI: 3.00–3.60), swelling (OR 3.14; 95% CI: 2.79–3.53) and redness (OR 2.41; 95% CI: 2.17–2.68). For the HPV 6/11/16/18 group the events were pain (OR 2.88; 95% CI: 2.42–3.43) and swelling (OR 2.65; 95% CI: 2.0–3.44). Concerning the HPV 16/18 vaccine, pain was the most common outcome detected. These effects can be due to a possible VLP-related inflammation process. Fatigue was the most relevant general effect observed followed by fever, gastrointestinal symptoms, and headache. In the HPV 6/11/16/18 group, only general symptoms, pain and swelling were observed. Pain and swelling were the most frequent. Comparing HPV 16/18 to HPV 6/11/16/18 vaccines, the former presented more adverse effects, perhaps because there are many more trials evaluating the bivalent vaccine. Other studies are needed to clarify this issue.

Vulvovaginitis and the treatment of asymptomatic partners: a systematic review and meta-analysis / Vulvovaginite e o tratamento de parceiros assintomáticos: uma revisão sistemática e metanálise

Treating sexual partners of women with vaginal candidiasis and bacterial vaginosis is a discussed topic. Despite the recommendations of international guidelines, doctors are still known to treat asymptomatic partners. Objective: To evaluate the influence of asymptomatic partner treatment inthe cure and recurrence of vulvovaginitis in women. Methods: The following databases were searched using Mesh terms: PubMed, Embase, SciELO and CINAHAL. The selection criteria included randomized clinical trials published from 1982 to 2012. Studies involving pregnant women were excluded.Methodological quality was assessed using Jadads scale. Review Manager 5.1 was used for statistical analysis. Results: Eight randomized clinical trials were included based on the chosen criteria: 1,088 women were enrolled. For bacterial vaginosis, the relative risk for cure was 1.00 (95%CI 0.95-1.05,p=0.13), and for recurrence 0.84 (95%CI 0.62-1.14, p=0.34). Vaginal candidiasis had a RR of 1.03 (95%CI 0.94-1.14, p=0.48) for cure, and 1.02 (95% CI0.77-1.33, p=0.91) for recurrence. Conclusion: Treatment of asymptomatic sexual partners of women with vaginal candidiasis or bacterial vaginosis does not affect the cure or recurrence rates and may increase the risk of side effects and unnecessary financial costs.

O tratamento de parceiros sexuais de mulheres com candidíase vaginal e vaginose bacteriana é um assunto muito abordado. Apesar das recomendações estabelecidas nos manuais internacionais, este tópico ainda é muito questionado por um grande número de médicos que prosseguem desobedecendo estes manuais. Objetivo: Avaliar a influência do tratamento de parceiros assintomáticos na cura e recorrência de vulvovaginite em mulheres. Métodos: Foi realizada busca com descritores específicos nas seguintes bases de dados: PubMed, Embase, SciELO e CINAHAL. No critério de seleção foram incluídos ensaios clínicos randomizados publicados no período de 1982 a 2012. Estudos envolvendo mulheres grávidas foram excluídos. Na avaliação qualitativa, utilizou-se a Escala de Jadad. A análise dos dados foi realizada por meio do programa estatístico Review Manager 5.1. Resultados:Oito ensaios clínicos randomizados foram selecionados: 1.088 mulheres foram escolhidas. Na vaginose bacteriana, o risco relativo para cura foi de 1,00(IC95% 0,95-1,05, p=0,13) e para recorrência foi de 0,84 (IC95% 0,62-1,14, p=0,34). A candidíase vaginal apresentou risco relativo de 1,03 (IC95% 0,94-1,14, p=0,48) para cura e de 1,02 (IC95% 0,77-1,33, p=0,91) para recorrência. Conclusão: O tratamento do parceiro sexual assintomático de mulheres com candidíase vaginal e vaginose bacteriana não afetaria as suas taxas de cura e recorrência, como também poderia causar efeitos colaterais e custos desnecessários.

Relação entre ducha vaginal e vaginose bacteriana, doenças sexualmente transmissíveis e infecção por HIV: uma revisão sistemática / Relationship between vaginal douching and bacterial vaginosis, sexually transmitted diseases and HIV infection: a systematic review

Apesar de ducha vaginal estar fortemente condenada pela maioria dos profissionais de saúde; esta prática continua a ser um hábito muito comum entre as mulheres, por diversas razões. Objetivo: Avaliar se há relação entre a prática de duchas vaginais e vaginose bacteriana, DST e HIV.Métodos: Foi realizada uma revisão sistemática e meta-análise para avaliar a relação entre a ducha vaginal e vaginose bacteriana, doenças sexualmente transmissíveis e infecção pelo HIV. Os seguintes bancos de dados foram pesquisados utilizando descritores: PubMed, Embase, Scielo e Google Scholar.Os critérios de seleção: (1) estudos prospectivos de mulheres que usam ducha vaginal; (2) mulheres com 12 anos ou mais e (3) estudos publicados de 2000a outubro de 2011. Estudos envolvendo mulheres grávidas foram excluídos. A qualidade metodológica foi avaliada usando a escala de Newcastle-Ottawa.Coleta de dados e análise: Review Manager 5.1 foi utilizado para análise estatística. Resultados: Sete estudos (2 STD, 3 vaginose bacteriana e 2 HIV)foram incluídos com base nos critérios escolhidos: 9,796 mulheres foram incluídos. A razão de risco global para a vaginose bacteriana, DST e aquisição do HIV foram, (IC95% 1,12-1,43) 1,24 (IC95% 0,94-1,32) 1,12 e (IC95% 0,92-2,01) 1,36, respectivamente. Conclusão: Há poucos estudos para verificar a associação entre a ducha vaginal e STD, VB e infecção pelo HIV. Foi encontrada uma correlação positiva entre a ducha vaginal e vaginose bacteriana, mas não para DST e infecção pelo HIV

Despite of vaginal douching has been strongly condemned by most of health care professionals; this practice remains a very common habit among women for several reasons. Objective: To assess if there is any association between vaginal douching and bacterial vaginoses, STD and HIV Methods: We conducted a systematic review and metanalysis to evaluate the relation ship between vaginal douching and bacterial vaginosis, sexually transmitted diseases and HIV infection. The following databases were searched using Mesh terms: PubMed, Embase, Scielo and Google Scholar. Selection criteria: (1) prospective cohort studies of women using vaginal douching; (2) women 12 years or older and (3) studies published from 2000 to October2011. Studies involving pregnant women were excluded. Methodological quality was assessed using Newcastle-Ottawa scale. Data collection and analysis:Review Manager 5.1 was used for statistical analysis. Results: Seven studies (2 STD, 3 Bacterial Vaginosis and 2 HIV) were included based on the chosen criteria: 9.796 women were enrolled. The global Risk Ratios for Bacterial Vaginosis, STD and HIV acquisition were, 1.24 (95%CI 1.12?1.43), 1.12 (95%CI0.94?1.32), and 1.36 (95%CI 0.92?2.01) respectively. Conclusion: There are few studies checking the association between vaginal douching and STD, BVand HIV infection. A weak positive correlation was found between vaginal douching and bacterial vaginosis, but not to STD and HIV infection.

Vulvovaginitis and the treatment of asymptomatic partners: a systematic review and metanalisis

Treating sexual partners of women with vaginal candidiasis and bacterial vaginosis is an issue in debate. Despite the present recommendations of the international guidelines to not to treat the asymptomatic sexual partners, this is a frequent practice between gynecologists. Objective: evaluate the influence of treating asymptomatic sexual partner of women with recurrent vulvovaginitis. Methods: databases searched: PubMed, Embase, Scielo and CINAHAL. Selection criteria: randomized clinical trials published from 1982 to 2012 were included. Studies involving pregnant women were excluded. Methodological quality was assessed using the Jadad scale. Data collection and analysis: Review Manager 5.1 was used for statistical analysis. Results: eight randomized clinical trials were included based on the chosen criteria: 1,088 women were enrolled. For bacterial vaginosis, the RR for cure was 1.00 (95%CI: 0.95?1.05) (p = 0.13), and for recurrence 0.84 (95%CI: 0.62-1.14) (p = 0.34). Vaginal candidiasis had a RR of 1.03 (95%CI: 0.94-1.14) (p = 0.48) for cure, and 1.02 (95%CI: 0.77?1.33 p = 0.91) for recurrence. Conclusion: treatment of asymptomatic sexual partners of women with vaginal candidiasis or bacterial vaginosis does not affect the cure or recurrence rates and may increase the risk of side effects and unnecessary financial costs.

Avaliação da incidência do câncer ginecológico e das lesões precursoras em pacientes portadoras de HIV / Evaluation of the incidence of gynaecological cancer and precursor lesions in HIV patients

Esta revisão sistemática tem como objetivo demonstrar a incidência do câncer ginecológico e de suas lesões precursoras em mulheres que vivem com HIV/AIDS. Foi realizada ampla pesquisa nas bases de dados, MedLine-PubmMed, Scielo-Lilacs e Embase. Após a aplicação dos critérios de elegibilidade, foram incluídos 15 estudos que pesquisaram a incidência de lesões intraepiteliais vulvares, vaginais e cervicais, bem como de carcinomas de mama, endométrio, ovário, vulva, vagina e colo uterino. Observou-se que mulheres infectadas por HIV têm maior risco de apresentarem lesões de vulva, vagina e colo, assim como câncer desses sítios. Por outro lado, essas mulheres apresentam menor incidência de carcinomas mamários, endometriais e ovarianos do que a população feminina geral.(AU)

The aim of this systematic review is to demonstrate the incidence of gynaecological cancer and intraepithelial lesions among women living with HIV/AIDS. A broad research has been done in MedLine-PubMed, Scielo-Lilacs and Embase databases. Fifteen studies that described the incidence of vulvar, vaginal and cervical intraepithelial lesions, as well as breast, ovary, endometrial, vulva, vagina and uterine cervical cancer met the inclusion criteria. Women living with HIV have a greater risk to develop vulvar, vaginal and cervical intraepithelial lesions, as well as cancer in these sites. However, they present a lower incidence of breast, endometrial and ovarian cancer than the general female population.(AU)