Estudo clínico de segurança não controlado do uso de drogas vegetais em pacientes atendidos em um ambulatório público de fitoterapia
Nenhuma Miniatura disponível
Data
2020-03-02
Autores
Título da Revista
ISSN da Revista
Título de Volume
Editor
Universidade Federal de Goiás
Resumo
Introduction: The use of medicinal plants has been increasing worldwide, so as the reports of adverse events (AE) related to them. The World Health Organization Toxicity Grading Scale for Determining the Severity of Adverse Events (WHO-TGS) establishes the toxicity criteria for laboratory tests in clinical trials with humans, allowing to evaluate the safety of a treatment. Additionally, the Naranjo Algorithm establishes the causal relationship between the observed AE and the product under investigation. Main objective: To verify the safety of the use of 12 medicinal plants in subjects attended at a phytotherapy outpatient clinic of the Unified Health System, using the WHO-TGS and the Naranjo Algorithm. Methodology: This is an open and prospective uncontrolled "before and after" clinical study. The selected participants were submitted to laboratory tests before and after 30 days of use of the prescribed medicinal plants. The results were analyzed according to WHO-TGS. The medicinal plants were suspended for 30 days in those who presented laboratory alterations indicative of toxicity, the exams were repeated, and the results analyzed. The observed AE had their causality established through the Naranjo Algorithm. Results and discussion: There was a higher prevalence of female individuals, mean age of 46 years, graduated level, who sought the health service to treat depression and anxiety. The majority of them are non-users of tobacco and illicit drugs, while half regularly consume alcoholic beverages, and are characterized mainly by the daily use of medicinal plants, plant drugs and herbal medicines for therapeutic purposes. 42 subjects were selected to use the medicinal plants prescribed for 30 days, of which 17 (40.5%) did not present AE, whereas 25 (59.5%) presented Grade 1 toxicity (GT1) AE, mainly the increase in amylase concentration (n=9). After the suspension of the medicinal plants use, 14 participants continued to present GT1 AE, mainly hypomagnesemia and hematuria. The Naranjo Algorithm established a possible causal relationship between hyperamylasemia; hypomagnesemia; hematuria; AST, ALT and GGT increase; hyperglycemia; hypocalcemia; hypercalcemia; thrombocytopenia; prothrombin time elevation; proteinuria and the medicinal plants used. Conclusions: The results obtained revealed the socio-demographic, clinical, life habits and pharmacotherapeutic profile of the participants. They demonstrated the occurrence of AE after the use of Bauhinia forficata, Curcuma longa, Cynara scolymus, Equisetum arvense, Erythrina mulungu, Matricaria chamomilla, Melissa officinalis, Passiflora edulis, Phyllanthus niruri e Zingiber officinale, evidencing a possible causal relationship to the use of these medicinal plants. Such relationship corresponds to a low level of probability of occurrence of an AE by the products under investigation, that is, it demonstrates safety in the use of these medicinal plants, in the experimental conditions employed.
Descrição
Citação
CIRILO, H. N. C. Estudo clínico de segurança não controlado do uso de drogas vegetais em pacientes atendidos em um ambulatório público de fitoterapia. 2020. 280 f. Tese (Doutorado em Ciências Farmacêuticas) - Universidade Federal de Goiás,Goiânia, 2020.