Avalia??o da efic?cia de produto homeop?tico contendo Momordica charantia 12CH no controle dos sintomas do trato urin?rio inferior, causados pela hiperplasia benigna da pr?stata: ensaio cl?nico

• Main Author: Esposito, Regina Carmen
• Other Authors: 25069144472
• Language: Portuguese
• Published: PROGRAMA DE P?S-GRADUA??O EM DESENVOLVIMENTO E INOVA??O TECNOL?GICA EM MEDICAMENTOS 2017
• Subjects: CNPQ::CIENCIAS DA SAUDE: DESENVOLVIMENTO E INOVA??O TECNOL?GICA EM MEDICAMENTOS; Homeopatia; Momordica charantia; Ensaio cl?nico; Hiperplasia prost?tica; Sintomas do trato urin?rio inferior; Linf?citos
• Online Access: https://repositorio.ufrn.br/jspui/handle/123456789/24519

Submitted by Automa??o e Estat?stica ([e-mail]) on 2017-12-12T19:38:30Z No. of bitstreams: 1 ReginaCarmenEsposito_TESE.pdf: 1609404 bytes, checksum: bbff08f10f8b71c6162cfba459bc5243 (MD5) === Approved for entry into archive by Arlan Eloi Leite Silva ([e-mail]) on 2017-12-14T19:40:52Z (GMT) No. of bitstreams: 1 ReginaCarmenEsposito_TESE.pdf: 1609404 bytes, checksum: bbff08f10f8b71c6162cfba459bc5243 (MD5) === Made available in DSpace on 2017-12-14T19:40:52Z (GMT). No. of bitstreams: 1 ReginaCarmenEsposito_TESE.pdf: 1609404 bytes, checksum: bbff08f10f8b71c6162cfba459bc5243 (MD5) Previous issue date: 2017-09-29 === O aumento benigno da pr?stata, mais conhecido como hiperplasia benigna da pr?stata (HBP), leva a sintomas do trato urin?rio inferior (STUI), que contribuem para diminuir a qualidade de vida dos homens acima da quarta d?cada. O mesmo vem sendo tratado, na sua maioria, por medicamentos alop?ticos do grupo dos inibidores da 5-alfa-redutase e/ou alfa-bloqueadores e/ou fitoter?picos. A literatura cient?fica apresenta uma escassez de ensaios cl?nicos randomizados, controlados com cegamento sobre a efic?cia de medicamentos homeop?ticos que j? tenham mat?ria m?dica para esta doen?a, bem como de novos rem?dios homeop?ticos. O presente estudo visou a avaliar a efic?cia do produto homeop?tico, contendo Momordica charantia 12CH, no controle dos STUI, devido ? HBP em ensaio cl?nico, randomizado, duplo cego e placebo controlado. Foram aleatorizados 81 pacientes em grupo A - Placebo e grupo B - Momordica charantia 12CH e avaliados a cada consulta pela anamnese, com o Escore Internacional de Sintomas Prost?ticos (IPSS), pelos exames de imagem com mensura??o do Volume Prost?tico (PV) e do Volume de Urina Residual P?s-esvaziamento (PVR) e laboratoriais pelo Ant?geno Prost?tico Espec?fico (PSA), Prote?na C Reativa quantitativa (PCR) e Interleucina-6 (IL-6). Em 72 amostras, foram realizados imunofenotipagem de linf?citos e subpopula??es por citometria de fluxo. Tanto a vari?vel principal (IPSS) quanto as vari?veis secund?rias (PSA, PV, PVR e PCR) e acess?rias (IL-6, linf?citos totais, linf?citos B, linf?citos T, linf?citos T helper, linf?citos T citot?xico e rela??o CD4/CD8 e c?lulas Natural Killer) n?o apresentaram signific?ncia estat?stica nas m?dias entre os grupos tratado e Placebo. Quanto ?s vari?veis de seguran?a, o uso da medica??o homeop?tica, pelos pacientes, n?o trouxe interfer?ncia durante os seis meses do experimento, seja na taxa de glicemia de jejum, seja nas dosagens de alanina aminotransferase, aspartato aminotransferase, fosfatase alcalina, bilirrubinas totais e fra??es e creatinina, usadas para avalia??o hep?tica e da fun??o renal respectivamente. A aus?ncia de infec??o urin?ria, confirmada pelo sum?rio de urina dos pacientes, predominou em ambos os grupos A e B durante todo o per?odo do ensaio cl?nico. Pode-se concluir que o tratamento com a Momordica charantia 12CH n?o apresentou diferen?a significativa para o placebo, quanto ? efic?cia no controle dos STUI, por HBP, por?m mostrou-se seguro. Pesquisas de alta qualidade, que permitam a prescri??o, a partir da individualiza??o dos sintomas e com diferentes dinamiza??es, devem ser realizadas, para possibilitar uma interpreta??o mais decisiva. === The benign enlargement of the prostate, better known as benign prostatic hyperplasia (BPH) results in symptoms of the lower urinary tract (LUTS) that contributes to lower quality of life of men over the fourth decade, and is mostly treated by allopathic drugs of the group of 5-alpha-reductase inhibitors and / or alpha-blockers, and / or phytotherapics. The scientific literature shows lack research from randomised and doubleblind clinical trials on the efficacy of homeopathic medicinal products that already have homeopathic medical materia and new homeopathic medicinal for BPH.The present study aimed to evaluate the effectiveness of the homeopathic product containing Momordica charantia 12CH in the LUTS control caused by BPH in a clinical, randomized, double-blind and placebo-controlled trial.A total of 81 patients were randomized to group A - Placebo and group B - Momordica charantia 12CH and evaluated at each visit by anamnesis with the International Prostate Symptom Score (IPSS), by imaging tests measured prostate volume (PV) and post-void residual (PVR) and laboratory tests for prostate specific antigen (PSA), quantitative C-reactive protein (CRP) and interleukin-6 (IL-6), and in 72 samples, lymphocyte and subpopulation immunophenotyping were performed by flow cytometry.Both the main variable (IPSS) and the secondary variables (PSA, PV, PVR and CRP) and accessory variables (IL-6, total lymphocytes, B lymphocytes, T lymphocytes, T helper cells, cytotoxic T lymphocytes and CD4 / CD8 ratio and Natural Killer cells) did not present statistical significance in the means between the groups treated and Placebo.About the safety variables, the use of homeopathic medication by the patients did not interfere during the six months of research, either in the fasting glucose level, as well as in the dosages of alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubins and fractions and creatinine levels used for hepatic evaluation and renal function respectively.The absence of urinary infection confirmed by urinalysis of patients predominated in both groups A and B throughout the clinical trial period. It can be concluded that treatment with Momordica charantia 12CH did not show a significant difference for placebo in the efficacy in the control of STUI by BPH, but it demostrated to be safe. High quality researchs, which allows prescription, from the individualization of symptoms and with different dynamizations, must be performed, to enable more decisiveinterpretation of its effectiveness.