Clinical safety evaluation of a tea containing Cissampelos sympodialis in healthy volunteers

ABSTRACTCissampelos sympodialis Eichler, Menispermaceae, is widely used by Indian tribes and folk medicine to treat various inflammatory disorders, including asthma. Clinical toxicological trials were made with the tea of C. sympodialis, a medicinal plant. The study took place at Lauro Wanderley Hospital/UFPB-PB, where seventeen healthy volunteers were chosen, among those six men and eleven women who orally ingested, during four weeks uninterruptedly, 150 ml of the tea, once a day. Before the first ingestion and after the last one, the participants were subjected to clinical and laboratorial tests for their overall conditions in order to analyze the toxicity of the plant. The results demonstrated that the volunteers neither experience clinical nor laboratorial alterations, as well as no significant adverse effects, apart from little change detected in their hematological tests. Nevertheless, none demonstrated any pathological conditions, just alterations of the normal human being physiology. Therefore, it is concluded that these data complement that obtained during pre-clinical studies and confirm a low toxicity of this plant.

Toxicidade Aguda em Ratos Wistar Tratados com o Extrato Etanólico de Dioclea grandiflora Mart. Ex Benth (Fabaceae) (EEDg) / Acute Toxicity of Dioclea grandiflora Mart. Ex Benth (Fabaceae) Ethanolic Extract in Wistar Rats

Introdução: A Dioclea grandiflora, conhecido como Mucunã de caroço,atua sobre o Sistema Nervoso Central, doenças da próstata e pedrasnos rins. Objetivo: Realizar estudo toxicológico não clínico agudo, emratos, com base na Instrução Normativa nº4, de 18 de junho de 2014da Agência Nacional de Vigilância Sanitária (ANVISA). Material eMétodos: Foram utilizados ratos Wistar, ambos os sexos, dose 2000mg/kg, via oral, do extrato etanólico bruto de Dioclea grandifloraadministrado a um grupo tratado e um grupo controle (veículo). Apósa administração, os parâmetros de comportamento foi observado por30, 60, 90, 120, 180 e 240 minutos, consumo de ração e água,parâmetros hematológicos e bioquímicos. O número de sobreviventescontabilizados para determinar a DL50. Resultados: Houve aumentoestatisticamente significativo no consumo de água (Controle:160,4±5,85; Tratado: 201,3±8,55) e ração das fêmeas (Controle:95,98±3,02; Tratado: 113,1±2,42) e aumento estatisticamentesignificativo no consumo de água (Controle: 236,7±6,43; Tratado:267,5±8,72) e ração dos machos (Controle: 152,4±2,51; Tratado:177,64,15). Aumento estatisticamente significativo na albumina dosmachos (Controle: 3,2±0,08; Tratado: 3,6±0,08), nas fêmeas reduziuestatisticamente significativo a fosfatase alcalina (Controle:198,5±18,81; Tratado: 99,97±16,02) , proteína total (Controle:7,85±0,09; Tratado: 6,85±0,24) e globulinas (Controle: 4,28±0,14;Tratado: 3,27±0,27). Diminuiu estatisticamente significativo o númerode hemácias nas fêmeas (Controle: 10,18±0,28; Tratado: 9,62±0,18).Conclusão: De acordo com os resultados a DL50 foi superior à dosetestada, porém são necessários estudos toxicológicos de longa duraçãopara atestar a segurança de seu uso...

Introduction: Dioclea grandiflora, known as Mucunã de caroço, acts onthe central nervous system, and against prostate disease and kidneystones. Objective: To perform a nonclinical acute toxicology study inrats following the Normative Instruction #4 as of June 18th 2014 of theNational Health Surveillance Agency (ANVISA). Material and Methods:Wistar rats of both sexes were used in the study. A dose of 2000 mg/kg of Dioclea grandiflora ethanolic extract was administered orally tothe test group. A control group using only the vehicle was also included.Then behavioral parameters were monitored for 30, 60, 90, 120, 180,and 240 minutes after feed and water intake, along with hematologicaland biochemical parameters. The number of survivors was recordedto determine the LD50. Results: There was a statistically significantincrease in water (Control: 160.4 ± 5.85; Treated: 201.3 ± 8.55), andfeed intake (Control: 95.98 ± 3.02; Treated: 113.1 ± 2.42) for femalerats; and a statistically significant increase in water (Control: 236.7 ±6.43; Treated: 267.5 ± 8.72) and feed intake (Control: 152.4 ± 2.51;Treated: 177.6 ± 4.15) for males. A statistically significant increase inalbumin levels was observed for males (Control: 3.2 ± 0.08; Treated:3.6 ± 0.08), and a decrease in alkaline phosphatase (Control: 198.5 ±18.81; Treated: 99.97 ± 16.02), total protein (Control: 7.85 ± 0.09;Treated: 6.85 ± 0.24) and globulin (Control: 4.28 ± 0.14; Treated: 3.27± 0.27) was found for females. Also, in females the number of redblood cells was found to be significantly reduced (Control: 10.18 ±0.28; Treated: 9.62 ± 0.18). Conclusion: According to the results, theLD50 value found was higher than that of the tested dose. Howeverlong-term toxicology studies are needed to further prove the safetyof the extract...

Atualizações e Perspectivas na Miastenia gravis / Updates and Perspectives on myasthenia gravis

Este estudo teve como objetivo uma buscabibliográfica sobre a Miastenia gravis (MG). Metodologia: Apesquisa bibliográfica foi realizada nas bases de dadoseletrônicos Pubmed, Science Direct, Scielo e Bireme dosúltimos dez anos, além de outros artigos que apresentavamextrema relevância histórica. Resultados: MG é uma doençaauto-imune caracterizada por fraqueza muscular, cujapatogenia está relacionada com a destruição da transmissãoneuromuscular por diferentes mecanismos, como diminuiçãodos receptores nicotínicos de acetilcolina, destruição dasproteínas envolvidas com a formação neuromuscular ou pelaatuação de anticorpos contra uma proteína quinase específicado músculo (MUSK). O tratamento atual da MG se baseia nautilização de inibidores da acetilcolinesterase, corticosteróides,timectomia, imunosupressores, imunoglobulinaintravenosa e plasmaferese. A identificação precoce da MGe de seus fatores precipitantes torna esta patologia maisacessível a novas modalidades de tratamento, comoanticorpos monoclonais, prolactina, tracolimus e crotamina.Conclusão: O melhor conhecimento acerca de seusmecanismos moleculares tem proporcionado o desenvolvimentode novas opções terapêuticas, necessárias paraamenizar crises severas, levando a um prognósticoadequado. Novas descobertas poderão contribuir para aqualidade de vida dos pacientes, ocasionando remissão dadoença e não apenas amenizando os seus sintomas...

This study aimed to a search the literature onmyasthenia gravis (MG). Methodology: Literature search wasconducted in the electronic databases PubMed, ScienceDirect, Scielo and Bireme, in the last ten years, and otherarticles that had extreme historical importance were alsoincluded. Results: MG is an autoimmune diseasecharacterized by muscle weakness, whose pathogenesisis related to the destruction of neuromuscular transmissionby different mechanisms, such as decreased nicotinicacetylcholine receptors, destruction of proteins involved inthe neuromuscular formation or the activity of antibodies ona specific muscle protein kinase (MUSK). The current treatmentof MG is based on the use of acetylcholinesterase inhibitors,corticosteroids, thymectomy, immunosuppressants,intravenous immunoglobulin and plasmapheresis. Earlyidentification of MG and its precipitating factors make thisdisease more accessible to new treatment modalities suchas monoclonal antibodies, prolactin, and tacrolimus crotamine.Conclusion: A better knowledge about molecular mechanismshas provided the development of new therapeutic optionsnecessary to alleviate severe crises, leading to a properprognosis. New findings may contribute to the quality of lifeof patients, resulting in remission of the disease and not justin relieving its symptoms...