A review of the pharmacology, clinical outcomes, and real-world effectiveness, safety, and non-contraceptive effects of NOMAC/E2.

Selecting an appropriate oral contraceptive can be challenging for healthcare professionals due to the abundance of marketed contraceptive options with different clinical and real-world effectiveness and safety profiles. Nomegestrol acetate + 17ß-estradiol (NOMAC/E2) is a combined oral contraceptive (COC) that inhibits ovulation by suppressing ovarian function by a 17-hydroxy-progesterone derivative and an estrogen identical to that endogenously produced by the ovaries. This narrative review examines clinical and real-world studies of NOMAC/E2 based on a background literature search using PubMed and Google Scholar. The review outlines the pharmacology of NOMAC/E2, including its progestational activity, pharmacokinetics, and effects on carbohydrate metabolism, lipid metabolism, and coagulation parameters, and summarizes key clinical efficacy and safety data that led to the approval of NOMAC/E2 in Europe, Brazil, and Australia. To help elucidate how NOMAC/E2 clinical trial data translate into a real-world setting, this review describes the effectiveness and safety of NOMAC/E2 in prospective studies that include over 90,000 users (half of whom received NOMAC/E2), outlining its effects on risk of thrombosis, menstrual bleeding patterns, weight, mood, acne, bone health, and patient quality of life. Non-contraceptive benefits of NOMAC/E2 for women with endometriosis, dysmenorrhea, or pre-menstrual dysphoric disorder are also discussed. These data demonstrate that NOMAC/E2 has a long half-life and rapid absorption, is effective at preventing unwanted pregnancies, and exhibits a favorable safety profile in both clinical trials and real-world settings. Importantly, NOMAC/E2 is not associated with increased risk of venous thromboembolism, a major safety concern of healthcare professionals for women receiving hormonal contraceptives. This review highlights NOMAC/E2 as a differentiated option among COCs and could help inform oral contraceptive choice to ultimately improve patient management and outcomes in real-world settings.

Nonoperative vs Operative Management of Uncomplicated Acute Appendicitis: A Systematic Review and Meta-analysis.

Importance: Appendectomy remains the standard of care for uncomplicated acute appendicitis despite several randomized clinical trials pointing to the safety and efficacy of nonoperative management of this disease. A meta-analysis of randomized clinical trials may contribute to the body of evidence and help surgeons select which patients may benefit from surgical and nonsurgical treatment. Objective: To assess the efficacy and safety of nonoperative management vs appendectomy for acute uncomplicated appendicitis. Data Sources: A systematic review was conducted using indexed sources (Embase and PubMed) to search for published randomized clinical trials in English comparing nonoperative management with appendectomy in adult patients presenting with uncomplicated acute appendicitis. To increase sensitivity, no limits were set for outcomes reported, sex, or year of publication. All nonrandomized or quasi-randomized trials were excluded, and validated primers were used. Study Selection: Among 1504 studies imported for screening, 805 were duplicates, and 595 were excluded for irrelevancy. A further 96 were excluded after full-text review, mainly owing to wrong study design or inclusion of pediatric populations. Eight studies met the inclusion criteria and were selected for the meta-analysis. Data Extraction and Synthesis: Meta-extraction was conducted with independent extraction by multiple reviewers using the Covidence platform for systematic reviews and in accordance with PRISMA guidelines. Data were pooled by a random-effects model. Main Outcomes and Measures: Treatment success and major adverse effects at 30 days' follow-up. Results: The main outcome (treatment success proportion at 30 days of follow-up) was not significantly different in the operative and nonoperative management cohorts (risk ratio [RR], 0.85; 95% CI, 0.66-1.11). Likewise, the percentage of major adverse effects was similar in both cohorts (RR, 0.72; 95% CI, 0.29-1.79). However, in the nonoperative management group, length of stay was significantly longer (RR, 1.48; 95% CI, 1.26-1.70), and a median cumulative incidence of 18% of recurrent appendicitis was observed. Conclusions and Relevance: These results point to the general safety and efficacy of nonoperative management of uncomplicated acute appendicitis. However, this strategy may be associated with an increase in duration of hospital stay and a higher rate of recurrent appendicitis. This meta-analysis may help inform decision-making in nonoperative management of uncomplicated acute appendicitis.

Influência da utilização de métodos contraceptivos sobre as taxas de gestação não planejada em mulheres brasileiras / Influence of contraceptive use on unplanned pregnancy rates in Brazilian women

Este estudo teve como objetivo primário analisar a taxa de gestações não planejadas e sua relação com o uso de métodos contraceptivos no Brasil. Secundariamente, procurou-se identificar o impacto da pandemia por SARS-CoV-2 sobre o desejo reprodutivo e a utilização de contraceptivos. Foram entrevistadas mulheres entre 16 e 45 anos que tiveram pelo menos uma gestação, por meio de questionário on-line, em todas as regiões brasileiras. Foram analisados dados de 1.000 mulheres com média etária de 34,7 anos, paridade média de 1,69 filho e número médio de 2,01 gestações. Entre as mulheres, 62% referiram ter tido pelo menos uma gestação não planejada, com maior percentual entre as mulheres que utilizam o sistema público de saúde (65%) em relação ao sistema privado (55%). Entre as mulheres que referiram ao menos uma gestação não planejada, 46% usavam algum método contraceptivo na ocasião. O uso atual de métodos contraceptivos atingiu 81% das mulheres entrevistadas, sendo os contraceptivos orais utilizados por 31%, seguidos dos preservativos (20%), laqueadura tubária (10%) e métodos de longa ação (LARC, 9%). Entre as mulheres, 53% considerariam um LARC como modalidade contraceptiva, especialmente entre as que referiram esquecimento frequente de pílulas. Durante a pandemia, 7% das mulheres entrevistadas referiram suspender o uso de contraceptivos. Para 80%, não houve mudanças no planejamento reprodutivo durante a pandemia, porém observaram-se 10% de gestações não planejadas. Em conclusão, a menor adoção de métodos contraceptivos, aliada ao uso incorreto/ falha do método, associa-se a maiores taxas de gestações não planejadas. Métodos com maior índice de eficácia são considerados por mulheres que já experimentaram gestações não planejadas. Houve pequeno impacto da pandemia sobre o uso de métodos contraceptivos e sobre o planejamento reprodutivo.(AU)

Different Perceptions among Women and Their Physicians Regarding Contraceptive Counseling: Results from the TANCO Survey in Brazil.

OBJECTIVE: The optimal use of contraceptive methods requires that women participate in targeted choice of methods that meet their individual needs and expectations. The Thinking About Needs in Contraception (TANCO) study is a quantitative online survey of the views of health professionals and women on aspects of contraceptive counseling and contraceptive use. METHODS: Physicians and women attending clinics for contraception were invited to complete online questionnaires. The research explored the knowledge and use of contraceptive methods, satisfaction with the current method and interest in receiving more information on all methods. Aspects related to contraceptive practice among physicians were gathered in parallel. The results obtained in the Brazilian research were compared with those of the European research, which involved 11 countries. RESULTS: There was a high prevalence of contraceptive use and general satisfaction with the current method. A total of 63% of the women were using short-acting contraceptive (SAC) methods, and 9% were using a long-acting reversible contraceptive (LARC). Sixty-six percent of women were interested in receiving more information on all methods; 69% of women said they would consider LARC if they received more comprehensive information about it. Health professionals tend to underestimate the interest of women in receiving information about contraception in general, and more specifically about LARCs. CONCLUSION: Despite the high levels of use and satisfaction with the current methods, women were interested in receiving more information on all contraceptive methods. Structured contraceptive counseling based on individual needs and expectations may lead to greater knowledge and a greater likelihood of proper contraceptive choice.

OBJETIVO: A utilização ideal de métodos contraceptivos requer que as mulheres participem da escolha orientada sobre métodos que atendam às suas necessidades e expectativas individuais. O estudo Thinking About Needs in Contraception (TANCO)­Pensando nas Necessidades em Contracepção­é uma pesquisa quantitativa online de opiniões de profissionais de saúde e de mulheres sobre aspectos do aconselhamento contraceptivo e uso de anticoncepcionais. MéTODOS: Médicos e mulheres que frequentam consultórios de atendimento visando contracepção foram convidados a preencher questionários online. A pesquisa explorou o conhecimento e o uso de métodos contraceptivos, a satisfação com o método atual, e o interesse em receber mais informações sobre todos os métodos. Aspectos relacionados à prática contraceptiva entre médicos foram reunidos em paralelo. Os resultados obtidos na pesquisa brasileira foram comparados aos da pesquisa europeia, que envolveu 11 países. RESULTADOS: Houve alta prevalência do uso de contraceptivos e satisfação geral com o método atual. Sessenta e três por cento das mulheres estavam usando métodos de curta duração (SAC, na sigla em inglês), e 9% estavam usando um método de longa ação (LARC, na sigla em inglês). Sessenta e seis por cento das mulheres estavam interessadas em receber mais informações sobre todos os métodos; 69% das mulheres disseram que considerariam um LARC se recebessem informações mais abrangentes sobre esse método. Os profissionais de saúde tendem a subestimar o interesse das mulheres em receber informações sobre a contracepção em geral e, mais especificamente, sobre os LARC. CONCLUSãO: Apesar dos altos níveis de uso e satisfação com os métodos atuais, as mulheres estavam interessadas em receber mais informações sobre todos os métodos contraceptivos. O aconselhamento contraceptivo estruturado, baseado nas necessidades e expectativas individuais pode levar ao maior conhecimento e à maior probabilidade de escolha contraceptiva adequada.

Different perceptions among women and their physicians regarding contraceptive counseling: results from the TANCO survey in Brazil / Diferentes percepções entre mulheres e seus médicos sobre o aconselhamento contraceptivo: Resultados da pesquisa TANCO no Brasil

Abstract Objective The optimal use of contraceptive methods requires that women participate in targeted choice of methods that meet their individual needs and expectations. The Thinking About Needs in Contraception (TANCO) study is a quantitative online survey of the views of health professionals and women on aspects of contraceptive counseling and contraceptive use. Methods Physicians and women attending clinics for contraception were invited to complete online questionnaires. The research explored the knowledge and use of contraceptive methods, satisfaction with the current method and interest in receiving more information on all methods. Aspects related to contraceptive practice among physicians were gathered in parallel. The results obtained in the Brazilian research were compared with those of the European research, which involved 11 countries. Results There was a high prevalence of contraceptive use and general satisfaction with the current method. A total of 63% of the women were using short-acting contraceptive (SAC) methods, and 9% were using a long-acting reversible contraceptive (LARC). Sixty-six percent of women were interested in receiving more information on all methods; 69% of women said they would consider LARC if they received more comprehensive information about it. Health professionals tend to underestimate the interest of women in receiving information about contraception in general, and more specifically about LARCs. Conclusion Despite the high levels of use and satisfaction with the current methods, women were interested in receiving more information on all contraceptive methods. Structured contraceptive counseling based on individual needs and expectations may lead to greater knowledge and a greater likelihood of proper contraceptive choice.

Resumo Objetivo A utilização ideal de métodos contraceptivos requer que as mulheres participem da escolha orientada sobre métodos que atendam às suas necessidades e expectativas individuais. O estudo Thinking About Needs in Contraception (TANCO)- Pensando nas Necessidades em Contracepção-é uma pesquisa quantitativa online de opiniões de profissionais de saúde e de mulheres sobre aspectos do aconselhamento contraceptivo e uso de anticoncepcionais. Métodos Médicos e mulheres que frequentam consultórios de atendimento visando contracepção foram convidados a preencher questionários online. A pesquisa explorou o conhecimento e ouso de métodos contraceptivos, a satisfação com o método atual, e o interesse em receber mais informações sobre todos os métodos. Aspectos relacionados à prática contraceptiva entre médicos foram reunidos em paralelo. Os resultados obtidos na pesquisa brasileira foram comparados aos da pesquisa europeia, que envolveu 11 países. Resultados Houve alta prevalência do uso de contraceptivos e satisfação geral com o método atual. Sessenta e três por cento das mulheres estavam usando métodos de curta duração (SAC, na sigla em inglês), e 9% estavam usando um método de longa ação (LARC, na sigla em inglês). Sessenta e seis por cento das mulheres estavam interessadas em receber mais informações sobre todos os métodos; 69% das mulheres disseram que considerariam um LARC se recebessem informações mais abrangentes sobre esse método. Os profissionais de saúde tendem a subestimar o interesse das mulheres em receber informações sobre a contracepção em geral e, mais especificamente, sobre os LARC. Conclusão Apesar dos altos níveis de uso e satisfação com os métodos atuais, as mulheres estavam interessadas em receber mais informações sobre todos os métodos contraceptivos. O aconselhamento contraceptivo estruturado, baseado nas necessidades e expectativas individuais pode levar ao maior conhecimento e à maior probabilidade de escolha contraceptiva adequada.

Reactional changes in short-term levonorgestrel-releasing intrauterine system (lng-ius) use.

OBJECTIVE: To evaluate endocervical and vaginal environment changes in women using a levonorgestrel-releasing intrauterine system (LNG-IUS). METHODS: A quasi-experimental study included sixty women who had an LNG-IUS inserted in the Family Planning Clinic of UNICAMP between April and November of 2016. Women in reproductive age, non-pregnant, without the use of antibiotics and contraceptives seeking for LNG-IUS insertion were selected for this study. All women were evaluated with regard to vaginal and endocervical pH, vaginal and endocervical Gram-stained bacterioscopy, and Pap-smear before and two months after LNG-IUS insertion. Clinical aspects such as cervical mucus, vaginal discharge, and cervical ectopy were also observed. RESULTS: After LNG-IUS insertion, there was an increase in the following parameters: endocervical pH>4.5 (p=0.02), endocervical neutrophil amount (p<0.0001), vaginal cytolysis (p=0.04). There was a decrease in vaginal discharge (p=0.01). No statistically significant changes were found in vaginal pH, neutrophils amount in the vaginal mucosa, vaginal discharge appearance, vaginal candidiasis, bacterial vaginosis, vaginal coccobacillary microbiota, cervical mucus appearance, or cervical ectopy size. CONCLUSIONS: Short-term LNG-IUS use did not increase vulvovaginal candidiasis or bacterial vaginosis, and led to diminished vaginal discharge. Notwithstanding, this device promoted reactional changes in the vaginal and endocervical environment, without modification on cervical ectopy size.

An individualized approach to the management of vaginal atrophy in Latin America.

OBJECTIVE: In the absence of guidelines specific for Latin America, a region where the impact of menopause is becoming increasingly important, an evidence-based specialist opinion on management of vaginal atrophy will help improve outcomes. METHODS: An advisory board meeting was convened in São Paulo, Brazil, to discuss practical recommendations for managing vaginal atrophy in women in Latin America. Before the meeting, physicians considered various aspects of the condition, summarizing information accordingly. This information was discussed during the meeting. The expert consensus is now summarized. RESULTS: In Latin America, given the relatively early age of menopause, it will be beneficial to raise awareness of vaginal atrophy among women before they enter menopause, considering cultural attitudes and involving partners as appropriate. Women should be advised about lifestyle modifications, including attention to genital hygiene, clothing, and sexual activity, and encouraged to seek help as soon as they experience vaginal discomfort. Although treatment can be started at any time, prompt treatment is preferable. A range of treatments is available. By addressing the underlying pathology, local estrogen therapy can provide effective symptom relief, with choice of preparation guided by patient preference. An individualized treatment approach should be considered, giving attention to patients' specific situations. CONCLUSIONS: It is critical that women are empowered to understand vaginal atrophy. Educating women and healthcare providers to engage in open dialogue will facilitate appreciation of the benefits and means of maintaining urogenital health, helping to improve outcomes in middle age and beyond. Women should receive this education before menopause.

Reactional changes in short-term levonorgestrel-releasing intrauterine system (lng-ius) use

SUMMARY OBJECTIVE: To evaluate endocervical and vaginal environment changes in women using a levonorgestrel-releasing intrauterine system (LNG-IUS). METHODS: A quasi-experimental study included sixty women who had an LNG-IUS inserted in the Family Planning Clinic of UNICAMP between April and November of 2016. Women in reproductive age, non-pregnant, without the use of antibiotics and contraceptives seeking for LNG-IUS insertion were selected for this study. All women were evaluated with regard to vaginal and endocervical pH, vaginal and endocervical Gram-stained bacterioscopy, and Pap-smear before and two months after LNG-IUS insertion. Clinical aspects such as cervical mucus, vaginal discharge, and cervical ectopy were also observed. RESULTS: After LNG-IUS insertion, there was an increase in the following parameters: endocervical pH>4.5 (p=0.02), endocervical neutrophil amount (p<0.0001), vaginal cytolysis (p=0.04). There was a decrease in vaginal discharge (p=0.01). No statistically significant changes were found in vaginal pH, neutrophils amount in the vaginal mucosa, vaginal discharge appearance, vaginal candidiasis, bacterial vaginosis, vaginal coccobacillary microbiota, cervical mucus appearance, or cervical ectopy size. CONCLUSIONS: Short-term LNG-IUS use did not increase vulvovaginal candidiasis or bacterial vaginosis, and led to diminished vaginal discharge. Notwithstanding, this device promoted reactional changes in the vaginal and endocervical environment, without modification on cervical ectopy size.

RESUMO OBJETIVO: Avaliar as alterações do ambiente endocervical e vaginal em mulheres usuárias de sistema intrauterino liberador de levonorgestrel (SIU-LNG). MÉTODOS: Um estudo quase-experimental incluiu 60 mulheres que inseriram o SIU-LNG na Clínica de Planejamento Familiar da UNICAMP entre abril e novembro de 2016. Mulheres em idade reprodutiva, não gestantes, sem uso de antibióticos e contraceptivos, em busca pela inserção do SIU-LNG, foram selecionadas para este estudo. Todas as mulheres foram avaliadas quanto ao pH vaginal e endocervical, bacterioscopia vaginal e endocervical por coloração de Gram, exame de Papanicolau antes e dois meses após a inserção de SIU-LNG. Aspectos clínicos como muco cervical, corrimento vaginal e ectopia cervical também foram observados. RESULTADOS: Após a inserção do SIU-LNG houve aumento nos seguintes parâmetros: pH endocervical >4,5 (p=0,02), quantidade de neutrófilos endocervicais (p<0,0001), citolise vaginal (p=0,04). Houve diminuição do conteúdo vaginal (p=0,01). Não foram encontradas alterações estatisticamente significativas no pH vaginal, na quantidade de neutrófilos na mucosa vaginal, apecto do corrimento vaginal, candidíase vaginal, vaginose bacteriana, microbiota cocobacilar vaginal, aparência de muco cervical ou tamanho da ectopia cervical. CONCLUSÃO: O uso do SIU-LNG em curto prazo não aumentou a candidíase vulvovaginal ou a vaginose bacteriana, levou à diminuição do conteúdo vaginal. No entanto, este dispositivo promoveu mudanças reacionais no ambiente vaginal e endocervical, sem modificação no tamanho da ectopia cervical.

Anticoncepção na adolescência / Contraception in adolescence

Adolescentes desejam método seguro e efetivo de contracepção, mas encontram barreiras ao conhecimento de diferentes opções e a seu acesso. A idade isoladamente não contraindica qualquer método contraceptivo. Ao contrário, adolescentes têm maior número de opções contraceptivas em virtude das condições de saúde próprias da idade. As formas mais populares de contracepção em adolescentes são preservativos e o coito interrompido, seguidos das pílulas combinadas. Observa-se, no entanto, que os métodos que dependem do uso correto das adolescentes apresentam maior número de falhas quando comparadas a mulheres adultas. Profissionais de saúde envolvidos em medidas contraceptivas devem priorizar o aconselhamento e a capacitação para a oferta dos métodos contraceptivos para adolescentes, observando aspectos culturais e éticos nessa importante fase da vida feminina.(AU)

Uso de dispositivos intrauterinos (DIU) em nulíparas / Use of intrauterine devices (IUDs) in nulliparous women

Objetivo: Avaliar as evidências para o uso de dispositivos intrauterinos (DIUs) em mulheres nulíparas. Métodos: Revisão da lteratura,com seleção de publicações relacionadas ao uso do dispositivo intrauterino de cobre e do sistema intrauterino de levonorgestrel em nulíparas no período entre 1980 e 2018. Resultados: Os DIUs utilizados em nulíparas associam-se à elevada eficácia e segurança, sem riscos adicionais de doença inflamatória pélvica e infertilidade. Não há maior risco de perfurações e expulsões em nulíparas. Os DIUs apresentam boa tolerabilidade, aceitação e continuidade de uso, embora associem-se a maior grau de dor durante a inserção quando comparados ao uso em nulíparas. Conclusão: Os dispositivos intrauterinos são eficazes e seguros para nulíparas,recomendando-se que devam ser incluídos nas opções contraceptivas oferecidas rotineiramente.