Paullinia cupana para o controle de fogachos em pacientes com câncer de mama: um estudo piloto / Paullinia cupana for control of hot flashes in breast cancer patients: a pilot study

OBJETIVO: Avaliar se a Paullinia cupana diminui o número e a gravidade dos fogachos em mulheres após diagnóstico de câncer de mama. MÉTODOS: Estudo piloto prospectivo fase II realizado com mulheres que sobreviveram ao câncer de mama, que completaram o tratamento pelo menos 3 meses antes e que apresentavam ao menos 14 episódios de fogachos por semana. Utilizando o desenho de Simon para que a primeira etapa fosse considerada positiva, ao menos 9 de 15 mulheres deveriam ter a gravidade dos fogachos diminuída em pelo menos 50%. As pacientes receberam 50mg do extrato seco de Guaraná oralmente 2 vezes por dia por 6 semanas. Foram avaliadas, a gravidade e a frequência dos fogachos. RESULTADOS: Dezoito pacientes iniciaram o tratamento com Paullinia cupana e 15 completaram o estudo. Três pacientes deixaram o estudo imediatamente após iniciarem o tratamento em razão de dificuldade na participação e não adesão. Das 15 pacientes que completaram o estudo, 10 obtiveram diminuição de mais de 50% dos índices de gravidade de fogachos. Durante as 6 semanas de tratamento, diminuições estatisticamente significativas foram observadas tanto no número de fogachos (p=0,0009), quanto nos índices de gravidade (p<0,0001). Paullinia cupana foi bem tolerada, e não houve relato de toxicidade como causa de saída do estudo. CONCLUSÕES: Paullinia cupana pareceu promissora para o controle de fogachos. Estudos mais extensivos são necessários.

OBJECTIVE: To evaluated whether Paullinia cupana decrease number and severity of hot flashes in breast cancer survivors. METHODS: This was a prospective phase II pilot study. We studied female breast cancer survivors who had completed the cancer treatment 3 months previously and who were experiencing at least 14 hot flashes per week. At least 9 of the 15 patients were required to have a decrease of at least 50% in hot flash severity score in keeping with the Simon Design. Patients received 50mg of dry extract of Paullinia cupana orally twice a day for 6 weeks. We assessed both frequency and severity of hot flashes. RESULTS: A total of 18 patients started the Paullinia cupana treatment, and 15 completed the study. Three patients left the study immediately after starting the treatment because of personal difficulties in participation or noncompliance. Of the 15 patients who completed the study 10 had a decrease of more than 50% in hot flash severity scores. During the 6 weeks of treatment, statistically significant decreases were seen in both numbers of hot flashes (p=0.0009) and severity scores (p<0.0001). Paullinia cupana was well tolerated, and there were no instances of discontinuation because of toxicity. CONCLUSIONS: Paullinia cupana appears promising for controlling hot flashes. More extensive studies seem warranted.

Evaluation of core and surface body temperatures, prevalence, onset, duration and severity of hot flashes in men after bilateral orchidectomy for prostate cancer

OBJECTIVE: To assess the prevalence, onset, duration and severity of hot flashes in men after bilateral orchidectomies (BO) for prostate cancer, to evaluate body temperature changes during hot flashes and to determine whether an elevated temperature within a few days after BO can be caused by deprivation of androgen. MATERIALS AND METHODS: Patients (n = 101) were questioned about the characteristics of their hot flashes after BO for prostate cancer. A subgroup of these men (n = 17) were instructed to record their oral and forehead temperatures during and at fixed intervals between hot flashes daily for 4 weeks. RESULTS: The mean age was 71.6 years, mean follow-up after BO was 33.2 months. Hot flashes were reported by 87 men (86 percent) with previous spontaneous remission in 9 (10 percent). The median time between BO and the onset of hot flashes was 21 days (range 1-730), median number of hot flashes 3 per day (range 1-20), and median duration was 120 seconds (range 5 to 1800). There was no significant difference between median oral (36.4º C) and forehead (36.0º C) temperature in the normal state, but during hot flashes the median forehead temperature (37.0º C) was higher than the oral temperature (36.5º C) (p = 0.0004). Both median oral and forehead temperatures were higher during hot flashes (36.5º C and 37.0º C) than in the normal state (36.4º C and 36.0º C, respectively) (p < 0.0001). During hot flashes, the oral temperature was 38º C to 40º C in only 3.2 percent of 593 readings in 17 patients. CONCLUSIONS: The median oral and forehead temperatures are higher during hot flashes than in normal periods. Oral temperature elevation > 38º C within days after a BO is unlikely to be the result of androgen deprivation alone.

Fatores associados à intensidade das ondas de calor em mulheres em climatério / Factors associated with the intensity of hot flashes in climacteric women

OBJETIVO: Identificar os fatores associados à intensidade das ondas de calor em mulheres climatéricas em Campinas, São Paulo. MÉTODOS: Análise secundária de banco de dados de estudo descritivo de coorte transversal, de base populacional. Foram selecionadas 334 mulheres com ondas de calor, por amostragem, entre 45-60 anos. Os dados foram coletados por meio de entrevistas domiciliares, com questionários estruturados e pré-testados, fornecidos pela Fundação Internacional de Saúde/Sociedade Internacional de Menopausa, Sociedade Norte-Americana de Menopausa, e adaptados pelos autores, e a intensidade das ondas de calor mensurada por meio do índice circulatório. Avaliou-se a idade, uso de métodos anticoncepcionais, terapia hormonal, laqueadura tubária, índice de massa corpórea, estado menopausal, tempo de menopausa, antecedente de histerectomia, ooforectomia bilateral e tabagismo. Calculou-se a mediana e as freqüências absolutas e relativas, de acordo com o tipo de variável. A medida de associação foi a razão de prevalência (RP). Realizou-se análise bivariada e de regressão múltipla para identificação dos fatores associados à intensidade das ondas de calor, com intervalo de confiança de 95 por cento (IC 95 por cento). RESULTADOS: Mulheres com tempo de menopausa superior a 61 meses (RP: 0,59; IC 95 por cento: 0,39-0,88) apresentaram chance significativamente menor de referir ondas de calor intensas enquanto o antecedente de ooforectomia bilateral (RP: 1,95; IC 95 por cento: 1,08-3,50) associou-se significativamente à intensidade das ondas de calor. CONCLUSÃO: Os fatores associados às ondas de calor de maior intensidade, tempo de menopausa e ooforectomia bilateral sugerem o hipoestrogenismo como causa comum para as ondas de calor intensas. Mulheres com esses fatores devem receber atenção especializada, minimizando as repercussões negativas das ondas de calor.

OBJECTIVE: To identify factors associated with the intensity of hot flashes in 334 climacteric women living in Campinas, São Paulo, Brasil. METHODS: Secondary analysis of a data bank of a descriptive cross-sectional population-based study. Selection of 334 women reporting hot flashes aged 45-60 years was carried out through cluster sampling. Data were collected by home interviews using a structured, pre-tested questionnaire provided by the International Health Foundation/International Menopause Society and by the North American Menopause Society and adapted by the authors. Intensity of hot flashes was measured using the circulatory index. The variables analyzed were age, use of contraceptive methods and hormonal therapy, tubal ligation, body mass index, menopausal status, time since menopause, hysterectomy, bilateral oophorectomy and smoking. Statistical analysis was performed by using the median, absolute and relative frequencies according to the type of variable. The prevalence ratio (PR) was used to measure association. Bivariate analysis and multiple logistic regression with a 95 percent confidence interval (95 percent CI) were used to identify the factors associated with the intensity of hot flashes. RESULTS: Women with time since menopause of over 61 months (PR: 0.59; IC 95 percent: 0.39-0.88) had a significantly lower chance of presenting intense hot flashes while the antecedent of bilateral oophorectomy (PR: 1.95; IC 95 percent: 1.08-3.50) was significantly associated with the intensity of hot flashes. CONCLUSION: Both factors, time since menopause and bilateral oophorectomy, suggest hypoestrogenism as a common cause of more intense hot flashes. Women with these factors should receive specialized care to minimize the negative effects of hot flashes.