M. Tech. / The climacteric describes the ongoing changes and symptoms, of the phase or transition period that may last 15-20 years in a woman’s lifecycle, when ovarian function and hormonal production declines. Menopause is the permanent cessation of the menses, identified retrospectively after one year without menses and occurs within this period of climacteric (Bernstein et al. 1996). The most common symptoms of climacteric include hot flushes, night sweats, sleep disturbances, nervousness, depressive moods, feelings of vertigo, inability to concentration, joint pain, headache and heart palpitations. The most commonly used allopathic medication to palliate these symptoms is hormone replacement therapy (HRT). There are adverse side effects and risks associated with this treatment and not all women feel better on HRT (Stoppard, 2001). The aim of this research study was to determine the efficacy of the Homoeopathic complexes Dr Reckeweg R10® and R20® (Homoeopathic complexes) in relieving the symptoms of the climacteric. The methodology and Ethics were accepted by Higher Degrees Committee and Academic Ethics Committee on the 25 August 2008 (Ethical clearance no: 40/08). Participants were recruited by advertisements (Appendix A) at the University of Johannesburg, in health food shops and in pharmacies. This was a double blind, placebo controlled study involving thirty-two participants who were divided into two matched groups based on the severity of the menopausal symptoms. Volunteers were selected using the exclusion and inclusion criteria. Volunteers meeting the inclusion criteria completed the information and consent form (Appendix B), and a patient profile and case history (Appendix C) were taken. The participants were randomly allocated to an experimental or control group, and given sets of medication (Remedy A and B, 50ml bottles) to take for a period of eight weeks (Appendix D). The participants took 10 drops of Remedy A (R10® or placebo) in the morning and Remedy B (R20® or placebo) at night. The participants were requested to complete the abbreviated Kupperman Menopause Index (KMI) weekly. The abbreviated KMI (Appendix E) scores were added v up on the participant’s full KMI (Appendix F) at the end of the trial (Kupperman et al. 1959). The results of this study showed that treatment with the Homoeopathic complexes Dr Reckeweg R10® and R20® was significantly effective in alleviating the climacteric symptoms.

Submitted by William Justo Figueiro (williamjf) on 2015-07-18T12:01:27Z No. of bitstreams: 1 39c.pdf: 875476 bytes, checksum: 8a8b6c4934cfff87a473a3b3a24ea27c (MD5) / Made available in DSpace on 2015-07-18T12:01:27Z (GMT). No. of bitstreams: 1 39c.pdf: 875476 bytes, checksum: 8a8b6c4934cfff87a473a3b3a24ea27c (MD5) Previous issue date: 2013 / UNISINOS - Universidade do Vale do Rio dos Sinos / Trata-se de um estudo transversal para investigar a relação entre transtornos psiquiátricos menores e sintomas do climatério, bem como os fatores associados, em 615 mulheres, de 40 aos 65 anos, atendidas em um ambulatório de climatério e cirurgia ginecológica do sistema público de saúde no sul do Brasil. Avaliou-se Transtornos Psiquiátricos Menores (TPM) pelo Self Reporting Questionnaire (SRQ-20) e Sintomas do climatério pelo Menopause Rating Scale (MRS). Criou-se um escore para sintomas do climatério e categorizado em 3 níveis de sintomas: nenhum/leves; moderados; e altos/muito altos. Foram calculadas as razões de chances brutas e ajustadas, com seus respectivos intervalos de confiança de 95%, utilizandose Regressão Logística Ordinal. A prevalência de sintomas do climatério nenhum/ leves foi de 34,1% (IC 95% 30,3-37,9); moderados 29,6% (IC 95% 25,8-33,1) e altos/ muito altos 36,3% (IC 95% 32,4-40,0). A prevalência de TPM foi de 66,6% (IC 95% 62,8-70,3). Após ajuste, mulheres acima de 50 anos, com companheiro, de menor escolaridade, fumantes, com maior número de gestações durante a vida reprodutiva, obesas, em uso de medicação psicotrópica e que estavam na pós-menopausa apresentaram maior chance de ter sintomas do climatério. Apresentar TPM esteve associado a uma chance cerca de 8 vezes maior para sintomas do climatério, quando comparadas com aquelas mulheres sem estes transtornos. Os TPM estão fortemente associados à presença de sintomas do climatério, independente de fatores sociodemográficos, comportamentais, reprodutivos e uso de medicação psicotrópica. / This paper is about a cross-sectional study which aimed to investigate the relationship between minor psychiatric disorders and climacteric symptoms as well as the associated factors in 615 women, aged from 40 to 65 years, assisted at an outpatient climacterium and gynecological surgery clinic of the public health system in the south of Brazil. Minor Psychiatric Disorders were evaluated by Self-Reporting Questionnaire (SRQ-20) and the symptoms of menopause by Menopause Rating Scale (MRS). A score for climacteric symptoms was created and categorized in 3 levels of symptoms: none / mild, moderate, and high / very high. The unadjusted and adjusted hazard ratios were calculated with their respective confidence intervals of 95%, using Ordinal Logistic Regression. The prevalence of climacteric symptoms none / mild was 34.1% (95% CI 30.3 to 37.9), moderate 29.6% (95% CI 25.8 to 33.1) and high / very high 36.3% (95% CI 32.4 to 40.0). The prevalence of minor psychiatric disorders was 66.6% (95% CI 62.8 to 70.3). After adjustment, women over 50 years old with a partner, less educated, smokers, with more pregnancies during reproductive life, overweight, on medication for nerves and who were in their postmenopausal had a higher occurrence of climacteric symptoms. Minor psychiatric disorders led to 8 times higher chance for climacteric symptoms compared with those without these disorders. The minor psychiatric disorders are strongly associated with the presence of climacteric symptoms, independent of sociodemographic, behavioral, reproductive factors, and the use of psychotropic medication.

Introduction: Hormone therapy (HT) has been considered as a safe treatment for menopausal symptoms. Use of HT increased dramatically in the 1980s and 1990s. Results from large randomized clinical trials (RCT) could, around the turn of the century, however not find evidence for long-term benefits with HT. These results attracted great attention from media and the scientific community leading to changed treatment guidelines and decreased use of HT. Aim: The overall aim of this thesis was to explore Swedish women’s conceptions, knowledge, management, and attitudes regarding the menopausal transition and HT. Material and methods: To explore and describe women’s conceptions of the menopausal transition women seeking medical advice due to climacteric symptoms were interviewed (n=20) and their statements were analyzed with a qualitative method (paper I). In 1999 (n=1760) and 2003 (n=1733) attitudes to (paper II) and knowledge of (paper III) the menopausal transition and HT among 53- and 54 year old women were investigated with a cross-sectional design using postal questionnaires. We also analyzed if attitudes differed before and after new scientific findings were published on risks and benefits of HT and if knowledge differed between educational levels. Since many women try to abandon use of HT a RCT was performed to study the effect of two different methods to discontinue HT, on recurrence of hot flushes, resumption of HT and on health related quality of life (HRQoL). Women (n=87) with vasomotor symptoms before initiating HT participated. Results: We found that the majority of the middle aged women in our study viewed the menopausal transition as a natural process the nature of which is affected by both hormonal changes and by ageing. Each woman seems to experience a set of psychological and physical symptoms that are in some sense unique to her experience. Women’s answers to the questions about HT demonstrate that attitudes towards HT held by women going through menopause have changed rather dramatically between 1999 and 2003. These changes probably reflect the influence on the women of media reports based on research that identified risks associated with HT that had not been identified before 1998. Women’s knowledge of the effects of HT seems to be unsatisfactory from a clinical perspective. No differences in hot flush frequency and resumption of HT were found between the women randomized to two different modes of discontinuation of HT. Almost 50 % of the women restarted HT within one year after discontinuation. Deteriorated wellbeing and severity of hot flushes were important predicting factors for resumption of HT. Conclusion: It is important to be aware of the individual woman’s conceptions and attitudes about and knowledge of the menopausal transition and HT to be able to individualize the counselling situation. Women who initiate HT due to hot flushes may experience recurrence of vasomotor symptoms and deteriorated HRQoL after discontinuation. A great proportion of them may resume HT. At present knowledge of possible advantages for the taper-down method when discontinuing HT is still lacking.

Objetivo: Sintetizar la evidencia primaria con respecto a la eficacia y seguridad de los estilbenos en el tratamiento de la sintomatología climatérica en las mujeres de edad mediana. Métodos: Llevamos a cabo una revisión sistemática de la literatura según las recomendaciones del Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Realizamos la búsqueda primaria en Pubmed-Medline, Embase, Scopus, Web of Science, WOS-Medline, LILACS, CINAHL, PsycINFO, SciELO, CENTRAL y en registros internacionales de ensayos clínicos, sobre la eficacia y seguridad de los estilbenos en sintomatología climatérica. Consultamos fuentes de literatura gris, hasta diciembre del 2018, sin restricción de idioma. Usamos la herramienta de la Colaboración Cochrane para la evaluación de riesgo de sesgo de los estudios incluidos. Resultados: Obtuvimos 2752 registros en la búsqueda primaria, a partir de los cuales seleccionamos cuatro ensayos clínicos controlados aleatorizados (ECAs) que reportaron desenlaces de eficacia y seguridad. Existe alta heterogeneidad entre los estudios en cuanto a la dosis, combinaciones con otros fitoestrógenos, duración de la suplementación, escalas de medición y reporte de desenlaces. En cuanto a la eficacia, un estudio reportó disminución significativa en todos los síntomas somáticos, en el grupo con resveratrol, con mayor reducción en el ítem de molestias musculares y articulares, donde solo el 16.7% de la población reportó estas molestias al final de la intervención, comparado a un 73.3% del brazo placebo (p<0.001). Por otro lado, un segundo estudio demostró mejoría significativa en el número (p=0.0077) e intensidad (p=0.018) de los episodios vasomotores en el grupo de la intervención. En contraparte, un tercer estudio mostró diferencias no significativas en el puntaje total de la subescala somática (7.7 ± 2.2; p ITT= 0.760) para el grupo de la intervención y (8.6 ± 2.2; p ITT= 0.760) para el grupo control. En relación a la eficacia de los estilbenos en sintomatología urogenital y psicológica, los resultados fueron contradictorios. En términos de seguridad, dos de los cuatro ECAs reportaron la ausencia de eventos adversos con la suplementación de resveratrol. Conclusión: La evidencia proveniente de los ECAs incluidos no es concluyente con respecto a la eficacia en la suplementación con estilbenos, particularmente con resveratrol, en el manejo de la sintomatología climatérica. Los ensayos clínicos reportaron la ausencia de eventos adversos con la suplementación de resveratrol, aunque este desenlace fue evaluado solo en la mitad de los estudios. Por ello, se requiere llevar a cabo futuros ensayos clínicos aleatorizados con un mejor diseño y mayor muestra, con el fin de alcanzar una conclusión definitiva sobre el uso de estilbenos. / Objective: To synthesize the evidence regarding the efficacy and safety of stilbenes to treat climacteric symptoms in middle-aged women. Methods: We conducted a systematic literature review according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We searched in Pubmed-Medline, Embase, Scopus, Web of Science, WOS-Medline, LILACS, CINAHL, PsycINFO, SciELO, CENTRAL and international registries of clinical trials, about the efficacy and safety of stilbenes in climacteric symptomatology. We consulted grey literature sources, until December 2018, without language restriction. We used the Cochrane Collaboration tool for risk of bias assessment of the included studies. Results: We obtained 2752 records in the primary search, from which we selected four randomized controlled trials (RCTs) that reported efficacy and safety outcomes. We found that the included clinical trials were highly heterogeneous in terms of dose, combinations with other phytoestrogens, duration of supplementation, measurement scales, and outcome reporting. Regarding efficacy, one trial reported a significant decrease in all somatic symptoms in the resveratrol group, with the most significant reduction in muscular and joint discomfort, where only 16.7% of the population reported these symptoms at the end of the intervention, compared to 73.3% for the placebo arm (p<0.001). On the other hand, a second RCT showed significant improvement in the number (p=0.0077) and intensity (p=0.018) of vasomotor episodes in the intervention group. In contrast, a third trial showed non-significant differences in the somatic subscale total score, (7.7 ± 2.2; p ITT= 0.760) for the intervention group and (8.6 ± 2.2; p ITT= 0.760) for the control group. In terms of safety, two of four RCTs reported the absence of adverse events with resveratrol supplementation. Conclusion: Evidence from included RCTs is inconclusive regarding the efficacy of stilbene supplementation, particularly resveratrol, to manage climacteric symptomatology. Clinical trials reported the absence of adverse events with resveratrol supplementation, although this outcome was assessed in only half of the studies. Thus, future randomized clinical trials with a better design and larger sample are required to reach a definitive conclusion on stilbenes's use. / Tesis

Introdução: O tratamento hormonal para amenizar sintomas do climatério é bem conhecido, mas nem sempre pode ser indicado para grande parte das mulheres. Por estes motivos, tem-se testado várias opções de tratamento não hormonal, cujos resultados nem sempre são satisfatórios e conclusivos. Objetivo: Avaliar a eficácia da cinarizina no tratamento dos sintomas climatéricos. Casuística e método: Foram estudadas prospectivamente 62 mulheres climatéricas sintomáticas com predomínio de ondas de calor que preencheram os critérios de inclusão e exclusão com idade variando de 45 a 60 anos, as quais foram avaliadas pelo Índice Menopausal de Kupperman (IMK), e atendidas no Setor de Ginecologia Endócrina e Climatério do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo. Foram divididas aleatoriamente em dois grupos: S com 27 pacientes (25 mg de Cinarizina a cada 12 hs, v.o., por 6 meses) e M com 35 pacientes (1 comprimido de placebo a cada 12hs, v.o., por 6 meses). Resultados: No grupo S a média etária foi 53,9 anos; 51,9% brancas e 48,1% negras; e no grupo M a média etária foi de 54,7 anos; 51,4% brancas e 48,6% negras. Os níveis pressóricos e o índice de massa corpórea foram semelhantes, entre os grupos. A análise do IMK e suas variantes comparativamente nos grupos S e M nos tempos 0 e 1 foi p=0,235 e p=0,406, respectivamente. Conclusões: A cinarizina foi semelhante ao placebo no alívio dos sintomas do climatério avaliados pelo IMK. Houve melhora significante do sintoma vertigem nas pacientes que receberam cinarizina. / Introduction: The hormonal treatment for relief of climateric symptoms is well-known but most women can not be treated with homones. For this reason several treatments without hormones has been evaluated with no conclusive results yet. Objective: Evaluate the efficacy of cinnarizine in the treatment of climacteric symptoms. Casuistry and Method: Were prospectively studied 62 symptomatic climacteric women with prevalence of hot flashes who met the inclusion and exclusion criteria aged from 45 to 60 years, evaluated by Kupperman\'s Menopause Index (KMI) attended at the Sector of Endocrinology Gynecology and Climacteric from the Medical School of the Hospital das Clinicas of the University of São Paulo. The subjects were divided alleatory in two: 27 patients Group S (Cinnarizine 25mg every 12h) and Group M with 35 (1 Placebo each 12h). Results: In group S the mean age was 53.9 years; 51.9% white and 48.1% black; and in group M the mean age was 54.7 years; 51.4% white and 48.6% black. Blood pressure levels and body mass index were similar in both groups. The analysis of the KMI and their variables comparision betwen groups (S and M) at time 0 and 1 was p=0.235 and p=0.406 respectively. Conclusions: Cinnarizine was similar to placebo for recipe of climacteric symptoms evaluated by KMI. There was significant improvement of symptom vertigo in patients treated with cinnarizine.

Introdução: O tratamento hormonal para amenizar sintomas do climatério é bem conhecido, mas nem sempre pode ser indicado para grande parte das mulheres. Por estes motivos, tem-se testado várias opções de tratamento não hormonal, cujos resultados nem sempre são satisfatórios e conclusivos. Objetivo: Avaliar a eficácia da cinarizina no tratamento dos sintomas climatéricos. Casuística e método: Foram estudadas prospectivamente 62 mulheres climatéricas sintomáticas com predomínio de ondas de calor que preencheram os critérios de inclusão e exclusão com idade variando de 45 a 60 anos, as quais foram avaliadas pelo Índice Menopausal de Kupperman (IMK), e atendidas no Setor de Ginecologia Endócrina e Climatério do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo. Foram divididas aleatoriamente em dois grupos: S com 27 pacientes (25 mg de Cinarizina a cada 12 hs, v.o., por 6 meses) e M com 35 pacientes (1 comprimido de placebo a cada 12hs, v.o., por 6 meses). Resultados: No grupo S a média etária foi 53,9 anos; 51,9% brancas e 48,1% negras; e no grupo M a média etária foi de 54,7 anos; 51,4% brancas e 48,6% negras. Os níveis pressóricos e o índice de massa corpórea foram semelhantes, entre os grupos. A análise do IMK e suas variantes comparativamente nos grupos S e M nos tempos 0 e 1 foi p=0,235 e p=0,406, respectivamente. Conclusões: A cinarizina foi semelhante ao placebo no alívio dos sintomas do climatério avaliados pelo IMK. Houve melhora significante do sintoma vertigem nas pacientes que receberam cinarizina. / Introduction: The hormonal treatment for relief of climateric symptoms is well-known but most women can not be treated with homones. For this reason several treatments without hormones has been evaluated with no conclusive results yet. Objective: Evaluate the efficacy of cinnarizine in the treatment of climacteric symptoms. Casuistry and Method: Were prospectively studied 62 symptomatic climacteric women with prevalence of hot flashes who met the inclusion and exclusion criteria aged from 45 to 60 years, evaluated by Kupperman\'s Menopause Index (KMI) attended at the Sector of Endocrinology Gynecology and Climacteric from the Medical School of the Hospital das Clinicas of the University of São Paulo. The subjects were divided alleatory in two: 27 patients Group S (Cinnarizine 25mg every 12h) and Group M with 35 (1 Placebo each 12h). Results: In group S the mean age was 53.9 years; 51.9% white and 48.1% black; and in group M the mean age was 54.7 years; 51.4% white and 48.6% black. Blood pressure levels and body mass index were similar in both groups. The analysis of the KMI and their variables comparision betwen groups (S and M) at time 0 and 1 was p=0.235 and p=0.406 respectively. Conclusions: Cinnarizine was similar to placebo for recipe of climacteric symptoms evaluated by KMI. There was significant improvement of symptom vertigo in patients treated with cinnarizine.

本研究では，アクセプタンス&コミットメント・セラピーによる健康関連の生活の質の向上と更年期症状の重症度への効果を検討した。質問紙調査ならびに前後比較試験と一事例の実験デザインの3つの研究により検討した。その結果，ACTによる介入が健康関連の生活の質を向上させ，更年期症状の重症度を低減させる可能性が示された。本研究により更年期症状への介入の新たな選択肢を提示するとともに，ACTの適用範囲を広げることなった。 / 博士(心理学) / Doctor of Philosophy in Psychology / 同志社大学 / Doshisha University