Avaliação do efeito terapêutico da Aroeira-do-sertão (Myracrodruon urundeuva Allemão) na gastropatia reativa induzida por anti-inflamatórios não esteróides

Abstract

This clinical trial evaluated the gastroprotective effect of the Myracrodruon urundeuva Allemão (Aroeira-do-sertão) in face of the reactive gastropathy (RG) due to the oral usage of low-dose (100 mg/day) of aspirin (acetyl salicylic acid – ASA). The Myracrodruon urundeuva Allemão, is a native plant of the Brazilian Northeast, used in popular medicine, as infusions or decoctos of its trunk bark, for dermatologic, respiratory, gastrointestinal and gynecologic disorders. Its hydroalcoholic and aqueous extracts were submitted to pre-clinical pharmacologic assays which showed anti-inflammatory, analgesic, healing, anti-ulcer, antihistaminic and antibradicininic effects. As well, preliminary clinical assays showed its therapeutic effects to peptic ulcers and to cervicitis. The RG due to ASA, which is identifiable and classifiable endoscopically, were chosen as gastroduodenal lesions model. It was employed the Aroeira-do-sertão elixir, obtained from burgeons of the young plant. The study was prospective, randomized, double-blind and placebo comparative and evaluated the occurrence of RG due to ASA in 2 groups of participants treated for 4 weeks, respectively with: ASA and Aroeira Elixir (Aroeira Group) and ASA and Placebo (Placebo Group). Before treatments (pre-study), the participants, from both sexes, with 21 to 65 years old, showed gastroduodenal normality by upper digestive endoscopy (UDE); answered a digestive signs and symptoms questionnaire, with frequency and intensity scores, and submitted to laboratory tests (CBC, Glucose, Creatinine, AST, ALT, PT and PTT). Twelve participants were included in the Aroeira Group and 11 in the Placebo Group. After 4 weeks of treatment, new UDEs were performed, the symptomatic questionnaire was reapplied and the laboratory tests were repeated (post-study). The post-studies UDEs showed ASA RG in 100% of the Aroeira Group participants and in 82% of the Placebo Group participants (p = 0.2160). The pre and post-study questionnaires analysis showed no significant clinical variations in the intragroup comparison (Aroeira Group, p = 0.2907; Placebo Group, p = 0.8880) or in the intergroup comparison (Pre-study, p = 0.7951 vs Post-study, p = 0.6809). The laboratory tests showed a few statistically significant variations in the intragroups comparisons of CBC parameters, which, however, stayed within the normal range values. As well, there were discrete elevations of the medium glucose dosages (alterations justifiable by the profile of the participants’ population). However, these data were not statistically significant in the pre and post-study variations comparisons. All the other laboratory parameters stayed within the normal range values and did not show statistically significant variations in the pre and post-study comparisons. In conclusion, this study demonstrated that the Myracrodruon urundeuva Allemão, in the formulation studied, do not offer gastroprotection to the lesions resulting by the oral ASA usage, but neither it was associated to adverse gastrointestinal events nor to toxic hematologic or biochemical effects. In relation to the low-dose ASA therapy, the study demonstrated a high incidence of oligosymptomatic RG during the initial weeks of treatment.