Avaliação da eficácia do pindolol na redução das crises de dor em pacientes diagnosticado com migrânea: um ensaio clínico randomizado controlado.

Abstract

Introduction: migraine is a primary headache disorder which affects 12% of worldwide population, mainly caucasian young women. The pain crises may be mild or intense, affecting the patients’ quality of life. These events can be minimized by the adoption of proper prophylactic measures, including effective drugs, such as beta blockers. Purpose: to evaluate the effectiveness of pindolol in the prevention of migraine crises. Methods: randomized, double-blind, controlled trial, whose studied individuals have been allocated into two groups by the drawing of alpha-numeric codes which have been generated by a computer program. The trial has been performed at the Neurology ambulatory of the Hospital Universitário Alcides Carneiro (HUAC), during the period between August of 2012 and August of 2014. Participants: from 175 selected patients, 80 has been diagnosed with migraine and fulfilled the inclusion criteria. Intervention: 30 days of non-pharmacological treatment and abortive therapy associated to pindolol or microcrystalline cellulose (CMC) followed by revaluation by the end of the medication. Primary outcome: pain intensity improvement equal or superior to 50%, assessed by the Visual Analog Scale. Secondary outcome: duration measured in hours and number of the crises improvement and patients’ satisfaction with the treatment, analyzed by the Likert Questionnaire. Results:40 patients have been initially randomized into the control and experimental groups, but, after some follow-up losses, this number has been reduced to 28 patients in each group. Statistical differences between both groups have not been found in relation to pain intensity, the number of the crises and its duration per month. However, it has been observed improvement of the parameters when assessed inside the same group before and after the intervention (p<0,05). From the whole sample, 58,98% have not been presented equal or superior to 50% pain improvement. Considering the experimental group, this percentage reached 64,9%. Only two patients have abandoned the trial due to side effects. Conclusion: this present trial points the lack of superiority of pindolol associated to abortive therapy and non-pharmacological measures in relation to these latest two combination in preventing migraine crises. Nonetheless, more studies are required to determine this drug prophylactic effectiveness. This trial has been registered in the REBEC (Brazilian Trial Register) Platform, under the Trial Universal Number U1111- 1131-2299. This project has been financed by own resources. No conflict interests declared.