Ensaio clínico randomizado e metanálise sobre a eficácia da buspirona e da carbamazepina no tratamento de prevenção de recaídas em pacientes com dependência alcoólica

Abstract

Background. Few studies have investigated the potential benefits of carbamazepine and buspirone in the treatment of the alcohol relapse prevention, and their overall effect on alcohol consumption remains unconcluded. Furthermore, the pharmacological treatments available are not successful in all the cases and these drugs can be a promissory strategy to treat some non responders groups of patients. Objective. We carried out two different studies to (1) evaluate the efficacy of carbamazepine and buspirone in the alcohol-dependent patients relapse prevention treatment; and to (2) perform a meta-analysis of previous studies comparing these drugs with placebo in the alcoholism treatment. Methods. (Study 1) We conducted a randomized, double-blind, placebo-controlled, parallel design, 26-week trial to compare the efficacy of t.i.d. administration of carbamazepine 200 mg, of buspirone 10 mg and of combined carbamazepine-buspirone with placebo in 36 alcohol-dependent adult male patients. (Study 2) All published placebo-controlled trials of carbamazepine or buspirone were examined, and when suitable, data was extracted for calculation of a mean effect size. Results of our clinical trial also were computed. Results. (Study 1) Both carbamazepine and carbamazepine-buspirone groups improved the alcohol dependence severity index compared with placebo or buspirone, but only at a trend level of significance (p=0,09). Placebo performed better than pharmacological groups in all other alcohol measures or survival analysis measures, but it was not found significant differences between groups. (Study 2) Meta-analysis showed both carbamazepine and buspirone were superior than placebo in reducing the number of drinks per drinking days. Carbamazepine use increased the relative risk of drop-out rates in 57%, while buspirone decreased the relative risk of drop-out rates. Buspirone was effective in decrease drinking days and reducing craving, alcohol dependence severity, and anxiety and depression symptoms. But it failed to support abstinence as well as to delay return to drinking. Conclusion. There is no evidence that carbamazepine or buspirone supports abstinence. Nevertheless, our data suggests they can be a useful and promising strategy preventing excessive drinking in alcoholics.