Xarope de cumaru como terapia complementar na asma persistente leve

Abstract

Amburana cearensis is a medicinal plant common to the Brazilian Northeastern and empirically used as bronchodilatador in respiratory tract diseases including asthma. A clinical trial double blind, placebo-controlled, randomized, parallel analyzed in the Unit of Clinical Pharmacology, Ceara, Brazil, the therapeutic efficacy of Cumaru syroup as complementar therapy in patients with mild asthma on regular treatment with inhaled corticosteroids. The study had three phases, pre, treatment and post treatment. The patients were included in the study based on clinical history, physical examination and laboratory test and were randomized into group that received Cumaru syrup and the placebo group who received the placebo and both groups consisting of 21 patients who ingested the syrup in the dose 15 mL three times daily for a period of 15 consecutive days. The study had as primary outcome the change in quality of life assessed by questionnaire of quality of life in asthma - with standardized activities - AQLQ (S) distributed in four areas: symptoms, activity limitation, emotional function and environmental stimuli and secondary outcome evaluation made by pulmonary function tests and safety of the formulation under investigation by laboratory tests in the pre-treatment and the first day after completion of treatment for 15 days with the syrup. All patients were from the city of Fortaleza, with 96% belonging to the female and The level of education was the least complete basic education represented 54% of the sample. The pre-study showed no statistically significant differences between groups regarding gender, IMC, FEV1, PEF, use of rescue medication, overall quality score measured by the AQLQ(S) and the presence of hypertension (p> 0.05), however there was statistically significant difference in mean age, where the placebo group showed significantly lower results (37,238 ± 10,319) than the group Cumaru (46,619 ± 10,351). The improvement in quality of life was statistically significant in group Cumaru when compared to the placebo group both in terms of global and for each domain: symptoms, activity limitation, environmental exposure and emotional function measured by the AQLQ(S) (p <0.05). Cumaru group in the proportion of patients with global improvement of quality of life was significantly higher (61.90%) that seen in the placebo group (9.52%), with relative risk of 6500. The FVC, FEV1, for FEV1 / FVC and FEF 25-75% of FVC did not suffer significant changes in both groups (p> 0.05) in any of the stages studied. The Cumaru syrup was well tolerated by patients and adverse events did not show any clinical relevance. The haematological and biochemical analysis of patients in both groups showed no statistically significant differences between them in any of the stages studied. Cumaru syrup was well tolerated by patients and adverse effects observed were equivalent to those in the placebo group. It is concluded that the administration of 45mL/day of Cumaru syrup during 15 days as complementary therapy provided significant improvement in quality of life, without causing systemic toxicity but has not modified the spirometric parameters representing a safe alternative for the treatment of asthma.