Estudo de toxicologia clínica e eficácia terapêutica do fitomedicamento melagrião

Abstract

The expectorant Melagrião® is a phytotherapic medicine composed of six medicinal plants with known action in the respiratory tract: Mikania glomerata, Cephaelis ipecacuanha, Aconitum napellus, Polygala senega, Myroxylon balsamum and Nasturtium officinale. The aim of this study was to evaluate the safety, the genotoxic potential of Melagrião® in healthy volunteers and its efficacy in patients with clinical diagnosis of acute bronchitis. This study contemplated two clinical protocols. Protocol A evaluated the Clinical Toxicology and safety of Melagrião® and consisted of a double-blind, placebo-controlled, randomized, parallel, with 46 adults subjects, randomly divided into two groups: Placebo and Melagrião®, each consisting of 28 and 18 volunteers, respectively. The subjects were treated for 28 uninterrupted days with 120 mL of Melagrião® or Placebo, divided into four daily doses. Clinical and laboratory evaluations were performed in the pre-study, during the treatment period and after the end of the study. The genotoxicity of Melagrião®, was investigated through the comet assay. The mean age of the subjects was 19.37 ± 17.36 years for the Melagrião® group and 24.70 ± 23.50 for the placebo group. The hematological, hepatic, renal and metabolic functions were analyzed before, during (7th, 14th and 28th day) and 7 days after the study through laboratory findings, which did not evidence signs of toxicity. Headache, vomiting, abdominal pain, dry cough, drowsiness, diarrhea, flatulence, heartburn and insomnia were the found adverse events attributed to both groups. No damage was observed (p >0.05) in peripheral lymphocytes of the subjects treated with Melagrião® by the comet assay. The clinical toxicology and genotoxicity studies showed no toxicity in the volunteers treated with Melagrião® for 28 uninterrupted days. Protocol B consisted of a double-blind, randomized and parallel study with 86 patients, randomly divided into two groups: Melagrião® (n = 43) or bromhexine (n = 43). They were all treated for 7 consecutive days using the recommended dosage according to the treatment group and age. Clinical and laboratory evaluations were performed in the pre-study and only clinical evaluation was performed on the seventh day. The mean age of the subjects was 19.37 ± 17.36 years for the Melagrião® group and 24.70 ± 23.50 for bromhexine group. Results of Protocol B show equivalence between the formulations tested, not being evident clinical and statistical differences within the parameters evaluated, and therefore the phytomedication Melagrião® effective in treating acute bronchitis. Abdominal pain and fever were the found adverse events attributed to both groups. The Melagrião® demonstrated safety in therapeutic dose, genotoxic negative character and effective in improving the signs and symptoms of acute bronchitis.