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BACKGROUND: A general practitioner (GP) standardly provides contraceptive counselling and care in the Netherlands. Recent years have seen the rise of mobile health technologies that aim to prevent pregnancy based on fertility awareness-based methods (FABMs). We lack high-quality evidence of these methods' effectiveness and clarity on how healthcare professionals include them in contraceptive counselling. OBJECTIVES: To analyse how Dutch healthcare professionals include pregnancy-prevention mobile health technologies (mHealth contraception) in contraceptive counselling and to propose practice recommendations based on our findings. METHODS: We used ethnographic methods, including semi-structured interviews with nine professionals who were recruited using purposive sampling, 10 observations of contraceptive counselling by four professionals, six observations of teaching sessions in medical training on contraception and reproductive health, one national clinical guideline, and seven Dutch patient decision aids. Data were collected between 2018 and 2021 and analysed inductively using praxiographic and thematic analysis. RESULTS: In contraceptive counselling and care, professionals tended to blend two approaches: 1) individual patient-tailored treatment and 2) risk minimisation. When interviewed about mHealth contraception, most professionals prioritised risk minimisation and forewent tailored treatment. Some did not consider mHealth contraception or FABMs as contraceptives or deemed them inferior methods. CONCLUSION: To minimise risk of unintended pregnancy, professionals hesitated to include mHealth contraception or other FABMs in contraceptive consultations. This may hamper adequate patient-centred counselling for patients with preference for mHealth contraception.Based on these results, we proposed recommendations that foster a patient-tailored approach to mHealth contraceptives.
KEY MESSAGESPrioritisation of risk minimisation precluded professionals from including FABMs and mHealth contraception in their counselling.For patient-centred counselling, professionals need differentiated information about FABM use and effectiveness through adequate guidelines and training.
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Medicina Geral , Clínicos Gerais , Telemedicina , Feminino , Gravidez , Humanos , Anticoncepcionais , AconselhamentoRESUMO
BACKGROUND: Adverse childhood events (ACEs) are prevalent and lead to well-established adverse health sequelae in adulthood. Recent literature has claimed that exposure to trauma in early life may worsen lower urinary tract symptoms (LUTS) because emotion can alter the perception of bodily distress in the brain. Specifically, depressive symptoms might influence the association between ACEs and LUTS. We aimed to describe the associations between ACEs and LUTS among males and females and to determine whether depressive symptoms mediated these associations. METHODS: This study was a secondary analysis of the Coevorden observational cohort study (n = 1691, age ≥16 years). For this observational study participants filled in the male or female modules of the International Consultation on Incontinence Questionnaire for LUTS (ICIQ-MLUTS and ICIQ-FLUTS, respectively), the NEMESIS Childhood Trauma Questionnaire (emotional neglect, psychological abuse, physical abuse, and sexual abuse within the family), and the Patient Health Questionnaire (PHQ-9) for depression. RESULTS: Overall, 564 males and 811 females answered all required items related to LUTS and ACEs. A series of regression models were then estimated to test for mediation: LUTS on ACEs, depression on ACEs, and LUTS on both ACEs and depression. The models were also adjusted for the following covariates: age, body mass index, diabetes mellitus, current smokers, educational level, and vaginal delivery (if female). Depressive symptoms were shown to mediate the association between ACEs and LUTS in both males and females. CONCLUSION: Childhood adversity and depression are areas of interest during the clinical assessment of patients with LUTS. Early detection of these conditions might help to manage risk, aid in the prevention of LUTS, and facilitate trauma-informed care.
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Depressão , Sintomas do Trato Urinário Inferior , Testes Psicológicos , Humanos , Masculino , Feminino , Adolescente , Depressão/psicologia , Autorrelato , Sintomas do Trato Urinário Inferior/epidemiologia , Sintomas do Trato Urinário Inferior/psicologia , EmoçõesRESUMO
At the end of 2022, the Erasmus Medical Centre (Rotterdam) drew attention to testicular cancer with the 'Balls alarm' campaign. Testicular cancer is the most common cancer in young men. They were called upon to do a monthly self-examination. There are some caveats to this campaign. First, the alleged increase in the incidence of testicular cancer is not accurate. Second, on the basis of evidence-based research and the use of the criteria of Wilson and Jungner, testicular screening by self-examination appears to be ineffective. And thirdly, the opportunistic comparison with periodically self-examination of breasts does not hold true because this has proven to be ineffective as is stated by authoritative organizations in the Netherlands.
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Neoplasias Testiculares , Masculino , Humanos , Neoplasias Testiculares/diagnóstico , Detecção Precoce de Câncer , AutoexameRESUMO
OBJECTIVES: Researchers and clinicians tend to focus on one pelvic floor symptom (PFS) at the time. However, the pelvic floor acts as one functional unit, increasing the likelihood of concurrent PFS in patients with pelvic floor dysfunction. There is also a paucity of literature on the prevalence of concomitant PFS, especially in males. Therefore, we explored the occurrence of concomitant PFS in community-dwelling males and females. MATERIALS AND METHODS: This prospective observational population-based cohort study included males and females aged ≥16 years from a single Dutch municipality. Participants completed validated questionnaires on lower urinary tract symptoms (LUTS), defecation problems, sexual dysfunction, pelvic pain, and pelvic organ prolapse. Medical general practitioner records were examined. Furthermore, a randomly selected group of non-responders aged <80 years received a short questionnaire, to study response bias. RESULTS: We invited 11 724 people, among which 839 females and 566 males completed the questionnaires. Of the female participants, 286 (34.1%) reported no PFS, and 251 (29.9%) reported two or more PFS. The most prevalent PFS clusters in females were sexual dysfunction and pelvic pain, sexual dysfunction and defecation problems, LUTS and defecation problems, and LUTS, defecation problems, and pelvic pain. Of the male participants, 212 (37.5%) reported no PFS, and 191 (33.7%) reported two or more PFS. The most prevalent clusters in males were sexual dysfunction and LUTS, defecation problems and LUTS, and sexual dysfunction, LUTS, and defecation problems. CONCLUSION: A considerable overlap existed between PFS, with differences in PFS clusters between females and males. Of note, females reported pelvic pain more than males. We conclude that healthcare providers should address all PFS in males and females.
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Sintomas do Trato Urinário Inferior , Distúrbios do Assoalho Pélvico , Disfunções Sexuais Fisiológicas , Humanos , Masculino , Feminino , Diafragma da Pelve , Vida Independente , Estudos de Coortes , Inquéritos e Questionários , Dor PélvicaRESUMO
BACKGROUND: The World Health Organization has indicated that GPs can safely and effectively provide mifepristone and misoprostol for medical termination of pregnancy (TOP). Dutch GPs are allowed to treat miscarriages with mifepristone and misoprostol, but few do so. Current Dutch abortion law prohibits GPs from prescribing these medications for medical TOP. Medical TOP is limited to the specialised settings of abortion clinics and hospitals. Recently, the House of Representatives debated shifting abortion to the domain of primary care, following the example of France and the Republic of Ireland. This would improve access to sexual and reproductive health care, and increase choices for women. Nevertheless, little is known about GPs' willingness to provide medical TOP and miscarriage management. AIM: To gain insight into Dutch GPs' willingness to prescribe mifepristone and misoprostol for medical TOP and miscarriages, as well as the anticipated barriers. DESIGN AND SETTING: Mixed-methods study among Dutch GPs. METHOD: A questionnaire provided quantitative data that were analysed using descriptive methods. Thematic analyses were performed on qualitative data collected through in-depth interviews. RESULTS: The questionnaire was sent to 575 GPs; the response rate was 22.1% (n = 127). Of the responders, 84.3% (n = 107) were willing to prescribe mifepristone and misoprostol, with 58.3% (n = 74) willing to provide this medication for both medical TOP and miscarriage management. A total of 57.5% (n = 73) of participants indicated a need for training. The main barriers influencing participants' willingness to provide medical TOP and miscarriage management were lack of experience, lack of knowledge, time constraints, and a restrictive abortion law. CONCLUSION: Over 80.0% of responders were willing to prescribe mifepristone and misoprostol for medical TOP or miscarriages. Training, (online) education, and a revision of the abortion law are recommended.
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A medical termination of pregnancy can be carried out effectively and safely up to 9 weeks' amenorrhea by general practitioners. In the case of an early pregnancy, reliable anamnesis and absence of risk factors for an EUG, ultrasound diagnostics are not strictly necessary before a medical termination of pregnancy. Anamnesis and/or b-HCG monitoring are a sound alternative. If there is no loss of blood 4 hours after insertion of misoprostol the woman can insert the extra 2 tablets of misoprostol. If there is heavy blood loss (soaking more than two large pads per hour for two consecutive hours) and/or suspicion of an EUG, the general practitioner should consult a gynecologist. In the event of a positive pregnancy test after 3 weeks, the test can be repeated after a week if there are no symptoms. Rhesus prophylaxis is not necessary.
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Abortivos não Esteroides , Aborto Induzido , Clínicos Gerais , Misoprostol , Feminino , Gravidez , Humanos , Segundo Trimestre da GravidezRESUMO
In the Netherlands, medical treatment to women with a non-vital pregnancy is provided in secondary care. In a Dutch pilot study, it has been shown that treatment of a missed miscarriage with misoprostol in primary care is an acceptable alternative. However, there are clear indications that medical treatment in women with a non-vital pregnancy is greatly improved when mifepristone is prescribed in addition to misoprostol. The authors state that this treatment is also justified in primary care.
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Abortivos não Esteroides/uso terapêutico , Aborto Retido/tratamento farmacológico , Mifepristona/uso terapêutico , Atenção Primária à Saúde , Aborto Legal , Adulto , Quimioterapia Combinada , Feminino , Humanos , Misoprostol/uso terapêutico , Países Baixos , Projetos Piloto , GravidezRESUMO
The World Health Organization launched a campaign on elimination of cervical cancer on November 17th 2020. In this article the authors give an overview of HPV-related cancer in The Netherlands and stress that HPV-vaccinations for boys and girls and screening for women is of utmost importance to eliminated cervical cancer in The Netherlands and the benefit for boys to avoid HPV related cancer themselves. They state that HPV vaccinations are efficient and safe. All Health Workers should counsel boys and girls and their parents toward HPV-vaccination for all.
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Infecções por Papillomavirus/prevenção & controle , Vacinas contra Papillomavirus/uso terapêutico , Neoplasias do Colo do Útero/prevenção & controle , Atitude Frente a Saúde , Feminino , Humanos , Masculino , Programas de Rastreamento/estatística & dados numéricos , Países Baixos , Vacinação/estatística & dados numéricos , Organização Mundial da SaúdeRESUMO
BACKGROUND: Provoked Vulvodynia (PVD) is the most common cause of vulvar pain. General practitioners (GPs) are insufficiently familiar with it, causing a delay in many women receiving correct diagnosis and treatment. Besides patients factors, this delay can partly be explained by the reluctance of GPs to explore the sexual context of PVD and by their negative emotional reactions such as helplessness and frustration when consulted by patients with medically unexplained symptoms like PVD. OBJECTIVE: To gain insight into how women with PVD perceive and evaluate condition management by their GP, in order to support GPs in the consultation of women with PVD. METHODS: We performed face-to-face in-depth interviews with women diagnosed with PVD. The interviews were recorded, transcribed verbatim and thematically analysed. The Consolidated Criteria for reporting Qualitative Research (COREQ-criteria) were applied. RESULTS: Analysis of the interviews generated four interrelated themes: Doctor-patient relationship, Lack of knowledge, Referral process and Addressing sexual issues. Empathy of the GP, involvement in decision-making and referral were important factors in the appreciation of the consultation for women with PVD who were referred to a specialist. Because women were reluctant to start a discussion about sexuality, they expected a proactive attitude from their GP. The communication with and the competence of the GP ultimately proved more important in the contact than the gender of the GP. CONCLUSION: Women with PVD prefer a patient-centred approach and want GPs to acknowledge their autonomy and to address sexuality proactively.
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Tomada de Decisão Clínica , Empatia , Medicina Geral , Clínicos Gerais/psicologia , Vulvodinia/diagnóstico , Mulheres/psicologia , Adulto , Dor Crônica , Diagnóstico Diferencial , Feminino , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Entrevistas como Assunto , Pessoa de Meia-Idade , Países Baixos , Relações Médico-Paciente , Pesquisa Qualitativa , Encaminhamento e Consulta , Incerteza , Vulvodinia/terapia , Adulto JovemAssuntos
Comportamento Sexual/estatística & dados numéricos , Parceiros Sexuais/psicologia , Adolescente , Feminino , Conhecimentos, Atitudes e Prática em Saúde , Inquéritos Epidemiológicos , Humanos , Estilo de Vida , Masculino , Prevalência , Educação Sexual/organização & administração , Comportamento Sexual/psicologia , Reino Unido/epidemiologia , Adulto JovemRESUMO
BACKGROUND: Provoked vulvodynia (PVD) is a chronic vulvar pain condition affecting up to 8.3% of the female population. Despite many years of research, no clear cause for PVD has been identified. Several risk factors have been studied, including vulvovaginal candidiasis (VVC). However, to date, the role of Candida infections in PVD has remained unclear. VVC and PVD have an overlap of symptoms that may contribute to diagnostic inaccuracy and mistreatment. AIM: To systematically review the literature on the relationship between VVC and PVD. METHODS: Cohort and case-control studies were included that compared women with PVD with healthy controls with respect to the presence of a history of Candida vulvovaginitis. PVD had to be diagnosed by Friedrich's criteria or the International Society for the Study of Vulvovaginal Disease criteria. The inclusion process as well as the quality appraisal of the studies, using the Newcastle-Ottawa Quality Assessment Scale, were performed independently by 2 authors. MAIN OUTCOME MEASURE: Outcomes of the population-based case-control studies were listed as odds ratio. Outcomes of the pathophysiological studies were based on local pro-inflammatory responses on Candida in vitro. RESULTS: We included a total of 14 studies, both population and clinic-based case-control, and pathophysiological research. 7 studies were of low methodological quality, and 7 studies were of medium methodological quality. The population-based case-control studies showed a significantly increased odds ratio for self-reported VVC in PVD cases compared with controls. The pathophysiological studies revealed a tendency for an increased local proinflammatory response on Candida in vitro in patients with PVD. Owing to the substantial heterogeneity of the studies, meta-analysis was not performed. CLINICAL IMPLICATIONS: Health care providers may consider a diagnosis of PVD in women with self-reported VVC, and to act on this properly. Reiteration of antifungal prescriptions by physicians without a decent diagnosis, will lead to mistreatment. Women should be informed by their health care provider that intercourse during (or shortly after) the treatment of VVC might worsen the vulnerability of the vulvar skin. STRENGTH AND LIMITATIONS: This is the first systematic review performed to describe the relation between VVC and PVD. An independently performed in- and exclusion process and quality appraisal, ensured optimal internal validity. However, there were important methodological limitations and the size of heterogeneity prevented establishing a meta-analysis. CONCLUSION: This systematic review is unable to draw conclusions regarding a relationship between actual VVC and PVD because studies were based on self-reported VVC. Until new evidence becomes available, we advocate that PVD should be considered as an unexplained chronic pain condition. In women with recurrent or persistent VVC-like complaints, physicians should consider a diagnosis of PVD. Leusink P, van de Pasch S, Teunissen D, et al. The Relationship Between Vulvovaginal Candidiasis and Provoked Vulvodynia: A Systematic Review. J Sex Med 2018;15:1310-1321.
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Candidíase Vulvovaginal/fisiopatologia , Vulvodinia/fisiopatologia , Adulto , Candidíase Vulvovaginal/complicações , Estudos de Casos e Controles , Estudos de Coortes , Feminino , Humanos , Medição da Dor , Autorrelato , Vulvodinia/complicaçõesRESUMO
At the end of 2017, the worldwide spread of the #MeToo symbol clearly showed the extent of sexual harassment in both the public domain and the workplace. In healthcare too, it is known that some doctors have unwanted sexual contact with their patients and with young doctors in training. In the opinion of the authors, measures taken against sexual harassment in healthcare so far do not seem to be very effective. Therefore, we are calling for an intrinsically motivated conscious attitude to recognize the problem as a professional risk and to strive for a professional approach that extends over the entire medical career. The professional associations should take the lead in this.
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Preconceito , Assédio Sexual/legislação & jurisprudência , Local de Trabalho/legislação & jurisprudência , Adulto , Feminino , Humanos , Relações Interprofissionais , Masculino , Sexismo/legislação & jurisprudência , Assédio Sexual/éticaRESUMO
BACKGROUND: The gap between the relatively high prevalence of provoked vulvodynia (PVD) in the general population and the low incidence in primary care can partly be explained by physicians' lack of knowledge about the assessment and management of PVD. OBJECTIVES: To recognize barriers and facilitators of GPs in the diagnostic process of women presenting with recurrent vulvovaginal complaints. METHODS: A qualitative focus group study in 17 Dutch GPs, five men and 12 women. An interview guide, based on the scientific literature and the expertise of the researchers, including a vignette of a patient, was used to direct the discussion between the GPs. The interviews were audiotaped and transcribed verbatim. A systematic text analysis of the transcripts was performed after data saturation was reached. RESULTS: Analysis of the interviews generated three major themes: Identifying and discussing sexual complaints, importance of gender in professional experience, and coping with professional uncertainty. Within these themes, the reluctance regarding sexual complaints, male gender, negative emotional responses when faced with professional uncertainty, as well as lack of education were barriers to the diagnostic process and management of PVD. Female gender and understanding that patients can profit from enquiring about sexual health issues were found to be facilitating factors. CONCLUSIONS: To improve the care for women with PVD, attitude and skills of GPs regarding taking a sexual history and performing a vulvovaginal examination should be addressed, as well as GPs' coping strategies regarding their professional uncertainty.
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Tomada de Decisão Clínica , Medicina Geral , Atenção Primária à Saúde , Vulvodinia/diagnóstico , Adulto , Atitude do Pessoal de Saúde , Diagnóstico Diferencial , Feminino , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Entrevistas como Assunto , Masculino , Pessoa de Meia-Idade , Pesquisa Qualitativa , Incerteza , Vulvodinia/terapiaRESUMO
AIMS: The identification and discussion of sexual care needs in people with type 2 diabetes mellitus (T2DM) in primary care is currently insufficient. The objective of this study was to determine the prevalence of sexual dissatisfaction, sexual problems and need for help by using a screening instrument among people with T2DM in primary care. METHODS: Data were collected in 45 general practices in the Netherlands from January 2015 to February 2016. The Brief Sexual Symptom Checklist (BSSC) was used to screen among 40-75 year old men and women. RESULTS: In total, 786 people with T2DM (66.5% men) were screened. The prevalence of sexual dissatisfaction was 36.6%, significantly higher among men than among women (41.1% vs. 27.8%). Sexually dissatisfied men most often reported erectile dysfunction (71.6%); for sexually dissatisfied women, low sexual desire (52.8%) and lubrication problems (45.8%) were most common. More than half of all dissatisfied people had a need for care (61.8%), significantly more men than women (66.8% vs. 47.2%). CONCLUSIONS: One third of people with T2DM is sexually dissatisfied and more than half of these people report a need for help. The BSSC could be used a tool to proactively identify sexually dissatisfied people in primary care.
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Diabetes Mellitus Tipo 2/complicações , Aceitação pelo Paciente de Cuidados de Saúde , Atenção Primária à Saúde , Disfunções Sexuais Fisiológicas/diagnóstico , Disfunções Sexuais Psicogênicas/diagnóstico , Adulto , Idoso , Diabetes Mellitus Tipo 2/fisiopatologia , Diabetes Mellitus Tipo 2/psicologia , Diabetes Mellitus Tipo 2/terapia , Feminino , Medicina Geral , Humanos , Masculino , Programas de Rastreamento , Pessoa de Meia-Idade , Avaliação das Necessidades , Países Baixos/epidemiologia , Orgasmo , Prevalência , Escalas de Graduação Psiquiátrica , Ensaios Clínicos Controlados Aleatórios como Assunto , Autorrelato , Fatores Sexuais , Disfunções Sexuais Fisiológicas/complicações , Disfunções Sexuais Fisiológicas/epidemiologia , Disfunções Sexuais Fisiológicas/fisiopatologia , Disfunções Sexuais Psicogênicas/complicações , Disfunções Sexuais Psicogênicas/epidemiologia , Disfunções Sexuais Psicogênicas/psicologiaRESUMO
BACKGROUND: A recent Dutch study in general practice showed a clear relationship between the diagnosis of vulvovaginal candidiasis (VVC) and symptoms suggestive of provoked vulvodynia (PVD). PVD accounts for the largest group of vulvar pains, but is often not recognised by GPs. AIM: To investigate whether diagnostic uncertainty about VVC in general practice could also point to the diagnosis of PVD, and whether and how this diagnostic uncertainty affects management. DESIGN & SETTING: An observational study in 2014 in Dutch general practices of the NIVEL Primary Care Database. METHOD: Women with an uncertain diagnosis of VVC were distinguished from those with certain VVC based on the occurrence of recurrent episodes and persisting complaints, despite treatment. Factors known to be associated with PVD were hypothesised to be more prevalent in women with uncertain VVC. Data on symptom management by GPs were collected. RESULTS: In total 7066 women with VVC or uncertain VVC were included. Uncertain VVC was found to account for 28% of these patients. Compared to VVC, the group uncertain VVC included significantly more women with female genital symptoms, tiredness, irritable bowel syndrome (all P<0.001), feeling anxious, reduced sexual desire, depressive disorder, relationship problems, and micturition symptoms (all P<0.05). Compared to VVC, the group uncertain VVC included significantly higher mean numbers of telephone consultations (P<0.001), more referrals to gynaecology (P = 0.009), and higher mean numbers of prescriptions per patient (P<0.001). CONCLUSION: This study's findings indicate that uncertain VVC could be a marker of PVD. GPs might reconsider their diagnostics and management when women present recurrent and persistent vulvovaginal complaints, especially if accompanied by dyspareunia, functional syndromes, micturition symptoms, and psychological conditions.
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The Dutch College of General Practitioners practice guideline on 'Sexual problems' describes the diagnostics and management of common sexual problems. An adequate sexual anamnesis is essential in order to obtain a good picture of the patient's symptoms and of any underlying causes. Additional physical or other medical examination is of limited value. The provision of information and advice are central to the treatment of sexual problems. Attention should be paid to the different aspects of sexual functioning: physical, psychological, relational and sociocultural, and to gender differences. In many cases, management is determined by the causal factor, for instance comorbidity, sexual trauma or relational problems. In other cases, a more specific problem is diagnosed, and management is based on this.
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Clínicos Gerais/normas , Padrões de Prática Médica , Comportamento Sexual , Disfunções Sexuais Fisiológicas/diagnóstico , Disfunções Sexuais Psicogênicas/diagnóstico , Gerenciamento Clínico , Humanos , Países Baixos , Exame FísicoRESUMO
Recently, the Dutch College of General Practitioners released a Practice Guideline on Sexual Problems which provides clear directives for the diagnosis and management of various sexual disorders in men and women. Patients who are managed in general practice and in outpatient clinics might experience distress related to sexual problems due to their age, medical condition or treatment, or distress related to problems in establishing and maintaining intimate relationships. We present two clinical cases. The first case is a woman aged 44 years with breast cancer treated by mastectomy and adjuvant tamoxifen. The second case is a man aged 54 years with heart failure due to myocardial infarction and resultant loss of physical strength. Both cases illustrate that taking a short sexual history could result in the right treatment and patient satisfaction, without having to go into detail about very intimate and private matters.
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Neoplasias da Mama/psicologia , Medicina de Família e Comunidade/normas , Anamnese , Comportamento Sexual , Disfunções Sexuais Psicogênicas/diagnóstico , Adulto , Neoplasias da Mama/cirurgia , Feminino , Humanos , Masculino , Mastectomia/psicologia , Pessoa de Meia-Idade , Satisfação do Paciente , Tamoxifeno/uso terapêuticoRESUMO
IMPORTANCE: In August 2015, the US Food and Drug Administration (FDA) approved flibanserin as a treatment for hypoactive sexual desire disorder (HSDD) in premenopausal women, despite concern about suboptimal risk-benefit trade-offs. OBJECTIVE: To conduct a systematic review and meta-analysis of randomized clinical trials assessing efficacy and safety of flibanserin for the treatment of HSDD in women. DATA SOURCES: Medical databases (among others, Embase, Medline, Psycinfo) and trial registries were searched from inception to June 17, 2015. Reference lists of retrieved studies were searched for additional publications. STUDY SELECTION: Randomized clinical trials assessing treatment effects of flibanserin in premenopausal and postmenopausal women were eligible. No age, language, or date restrictions were applied. Abstract and full-text selection was done by 2 independent reviewers. DATA EXTRACTION AND SYNTHESIS: Data were extracted by one reviewer and checked by a second reviewer. Results were pooled using 2 approaches depending on the blinding risk of bias. MAIN OUTCOMES AND MEASURES: Primary efficacy outcomes included number of satisfying sexual events (SSEs), eDiary sexual desire, and Female Sexual Function Index (FSFI) desire. Safety outcomes included, among others, 4 common adverse events (AEs): dizziness, somnolence, nausea, and fatigue. RESULTS: Five published and 3 unpublished studies including 5914 women were included. Pooled mean differences for SSE change from baseline were 0.49 (95% CI, 0.32-0.67) between 100-mg flibanserin and placebo, 1.63 (95% CI, 0.45-2.82) for eDiary desire, and 0.27 (95% CI, 0.17-0.38) for FSFI desire. The risk ratio for study discontinuation due to AEs was 2.19 (95% CI, 1.50-3.20). The risk ratio for dizziness was 4.00 (95% CI, 2.56-6.27) in flibanserin vs placebo, 3.97 (95% CI, 3.01-5.24) for somnolence, 2.35 (95% CI, 1.85-2.98) for nausea, and 1.64 (95% CI, 1.27-2.13) for fatigue. Women's mean global impression of improvement scores indicated minimal improvement to no change. CONCLUSIONS AND RELEVANCE: Treatment with flibanserin, on average, resulted in one-half additional SSE per month while statistically and clinically significantly increasing the risk of dizziness, somnolence, nausea, and fatigue. Overall, the quality of the evidence was graded as very low. Before flibanserin can be recommended in guidelines and clinical practice, future studies should include women from diverse populations, particularly women with comorbidities, medication use, and surgical menopause.
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Benzimidazóis/uso terapêutico , Satisfação do Paciente , Pré-Menopausa , Disfunções Sexuais Psicogênicas/tratamento farmacológico , Tontura/induzido quimicamente , Fadiga/induzido quimicamente , Feminino , Humanos , Libido , Náusea/induzido quimicamente , Resultado do TratamentoRESUMO
BACKGROUND: The lifetime prevalence of women suffering from provoked vestibulodynia (PVD) is estimated to be approximately 15%. The etiology of PVD is not yet clear. Recent studies approach PVD as a chronic multifactorial sexual pain disorder. PVD is associated with pain syndromes, genital infections, and mental disorders, which are common diseases in family practice. PVD, however, is not included in the International Classification of Primary Care. Hence, the vulvovaginal symptoms, which could be suggestive of PVD, are likely to be missed. AIM: To explore the relationship between specific vulvovaginal symptoms that could be suggestive of PVD (genital pain, painful intercourse, other symptoms/complaints related to the vagina/vulva), and related diseases such as pain syndromes, psychological symptom diagnoses, and genital infections in family practice. METHODS: A retrospective analysis of all episodes from 1995 to 2008 in 784 women between 15 and 49 years were used to determine the posterior probability of a selected diagnosis in the presence of specific vulvovaginal symptoms suggestive of PVD expressed in an odds ratio. Selected comorbidities were pain syndromes (muscle pain, general weakness, irritable bowel syndrome [IBS]), psychological symptom diagnoses (anxiety, depression, insomnia), vulvovaginal candidiasis, and sexual and physical abuse. RESULTS: Women with symptoms suggestive of PVD were 4 to 7 times more likely to be diagnosed with vulvovaginal candidiasis and 2 to 4 times more likely to be diagnosed with IBS. Some symptoms suggestive of PVD were 1 to 3 times more likely to be diagnosed with complaints of muscle pain, general weakness, insomnia, depressive disorder, and feeling anxious. CONCLUSION: Data from daily family practice showed a clear relationship between symptoms suggestive of PVD and the diagnoses of vulvovaginal candidiasis and IBS in premenopausal women. Possibly, family doctors make a diagnosis of vulvovaginal candidiasis or IBS based only on clinical manifestations in many women in whom a diagnosis of PVD would be more appropriate.