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.

Purified dry extract of Paullinia cupana (guaraná) (PC-18) for chemotherapy-related fatigue in patients with solid tumors: an early discontinuation study.

PURPOSE: Paullinia cupana (guaraná) is an Amazonian plant that has been previously shown to be effective in treating chemotherapy-related fatigue (CRF) in patients with breast cancer. We aimed to evaluate the efficacy of a purified dry extract of P. cupana (PC-18) in patients with various solid tumors treated with chemotherapy. METHODS: We included 40 patients with solid tumors who showed increases in their Brief Fatigue Inventory (BFI) questionnaire scores after 1 week of systemic chemotherapy. PC-18 was administered at 37.5 mg by mouth two times per day (PO bid), starting after 1 week of chemotherapy, for 3 weeks (induction phase). Patients who had an improvement in or stabilization of their BFI scores were randomized to receive either PC-18 at the same dose or placebo for the following 3 weeks (maintenance phase). RESULTS: After PC-18 treatment, the BFI fatigue scores improved or stabilized in 36 out of the 40 patients (mean BFI score difference = 2.503; 95% confidence interval: 1.716-3.375, p = .0002). Three weeks after randomization (16 patients on PC-18 and 17 on placebo), we observed no significant differences in the BFI, Functional Assessment of Chronic Illness Therapy, Hospital Anxiety and Depression Scale, and Pittsburgh Sleep Quality Index scores between patients randomized to PC-18 versus placebo. CONCLUSIONS: We conclude that the PC-18 extract may be effective for the treatment of CRF in patients with a variety of solid tumors. A conditioning effect, which was observed in patients who had a beneficial effect of PC-18 on CRF, may explain the better than expected fatigue scores of the placebo-treated patients.

Paullinia cupana for control of hot flashes in breast cancer patients: a pilot study.

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.

Expression of CK-19, galectin-3 and HBME-1 in the differentiation of thyroid lesions: systematic review and diagnostic meta-analysis.

BACKGROUND: To distinguish between malignant and benign lesions of the thyroid gland histological demonstration is often required since the fine-needle aspiration biopsy method applied pre-operatively has some limitations. In an attempt to improve diagnostic accuracy, markers using immunocytochemistry and immunohistochemistry techniques have been studied, mainly cytokeratin-19 (CK-19), galectin-3 (Gal-3) and Hector Battifora mesothelial-1 (HBME-1). However, current results remain controversial. The aim of the present article was to establish the diagnostic accuracy of CK-19, Gal-3 and HBME-1 markers, as well as their associations, in the differentiation of malignant and benign thyroid lesions. METHODS: A systematic review of published articles on MEDLINE and The Cochrane Library was performed. After establishing inclusion and exclusion criteria, 66 articles were selected. The technique of meta-analysis of diagnostic accuracy was employed and global values of sensitivity, specificity, area under the summary ROC curve, and diagnostic odds ratio (dOR) were calculated. RESULTS: For the immunohistochemistry technique, the positivity of CK-19 for the diagnosis of malignant thyroid lesions demonstrated global sensitivity of 81% and specificity of 73%; for Gal-3, sensitivity of 82% and specificity of 81%; and for HBME-1, sensitivity of 77% and specificity of 83%. The association of the three markers determined sensitivity of 85%, specificity of 97%, and diagnostic odds ratio of 95.1. Similar results were also found for the immunocytochemistry assay. CONCLUSION: This meta-analysis demonstrated that the three immunomarkers studied are accurate in pre- and postoperative diagnosis of benign and malignant thyroid lesions. Nevertheless, the search for other molecular markers must continue in order to enhance this diagnostic accuracy since the results found still show a persistency of false-negative and false-positive tests. VIRTUAL SLIDES: Http://www.diagnosticpathology.diagnomx.eu/vs/3436263067345159.