Propranolol vs flunarizine vs flunarizine plus propranolol in migraine without aura prophylaxis. a double-blind trial

Abstract

-Fourty-five migraine without aura patients underwent a parallel double-blind trial aiming the comparison of the effects of propranolol 60 mg/day to flunarizine 10 mg/day and to propranolol 60 mg/day plus flunarizine 10 mg/day simultaneously. There were 3 groups, each one with 15 patients. After a 20-day-baseline period, each group received one kind of treatment during 120 days. Migraine index on propranolol was 23.4*. on flunarizine 18.7* and on both drugs 14.4*, mean frequency of attacks on propranolol was 1.26**, on flunarizine 1.2** and on both drugs 1.13** (*p<0.05, ** p < 0.01 compared to baseline) and global evaluation was reduced with all forms of treatment. It was not found statistical differences between groups, nevertheless there was a trend in the group using two drugs reaching lower values in migraine index, frequency of attacks and global evaluation. In individuals using flunarizine (alone or associated with propranolol) the therapeutic effect was largely maintained up to 45 days after drug withdrawal.KEY WORDS: migraine trial, propranolol and migraine, flunarizine and migraine, migraine and polytheraphy.Ensaio duplo-cego comparando propranolol, flunarizina e flunarizina associada ao propranolol na profilaxia da migrânea sem aura RESUMO -Quarenta e cinco pacientes com migrânea sem aura submeteram-se a ensaio paralelo e duplo-cego visando comparar os efeitos de propranolol (PPN), flunarizina (FNZ) e uso associado de propranolol mais flunarizina. Foram divididos em três grupos de 15 indivíduos. Após período preliminar de 20 dias sem a administração de qualquer droga, um grupo recebeu PPN 60 mg/dia, outro grupo FNZ 10 mg/dia, e o terceiro grupo PPN 60 mg/dia associado à FNZ 10 mg/dia. O tempo de tratamento foi 120 dias. O índice de dor no grupo sob PPN passou de 39,3 para 23,4 (p<0,05) no grupo sob FNZ de 33,7 para 18,7 (p<0,05) e no grupo recebendo ambas as drogas de 33,5 para 14,4 (p<0,05). Não houve diferenças entre os índices de dor dos três grupos após o tratamento. A frequência de crises no grupo sob PPN passou de 2,8 para 1,26 (p<0,01) no grupo sob FNZ de 2,6 para 1,2 (p<0,01) e no grupo recebendo ambas as drogas de 2,9 para 1,13 (p<0,01). Não houve diferenças entre as frequências de crises dos três grupos após o tratamento. Foram confirmadas as eficácias dessas drogas na profilaxia da migrânea sem aura. A associação das drogas não logrou benefício ulterior no que concerne à diminuição dos índices de dor ou da frequência de crises. Entretanto, na avaliação global por parte do paciente, os melhores resultados estavam entre os que usaram duas drogas. Nos grupos que usaram FNZ (isolada ou associada ao PPN), as melhoras alcançadas persistiram mesmo após 45 dias da retirada dos fármacos.PALAVRAS CHAVE: migrânea, propranolol na migrânea, flunarizina na migrânea, migrânea e politerapia.

Rizatriptan versus rizatriptan plus rofecoxib versus rizatriptan plus tolfenamic acid in the acute treatment of migraine

“…Targeting it, when treating the patient, does represent a potential way of achieving better results. Attempts to increase efficacy and achieve patient's expectations can also represent the difference between being effective or keep the adherence in a patient's treatment [28-30]. Further controlled studies are warranted to confirm these observations.…”

Development and validation of a HPTLC method for simultaneous quantitation of flunarizine dihydrochloride and propranolol hydrochloride in capsule dosage form

“…PRO is official in Indian Pharmacopoeia (IP)[2]. FLU and PRO are used in combination for migraine prophylaxis[34]. Literature survey reveals that various analytical methods like UV[56], HPLC[789101112], HPTLC[13], and GC[14] are reported for the individual drugs and in combination with others and one paper on UV using methanol as solvent for simultaneous estimation of FLU and PRO[15].…”

Controversies in migraine: monotherapy

“…In one study, the combination of propranolol and fluoxetine was superior to monotherapy with one of the two compounds [20], but without significant difference at statistical analysis. No difference in efficacy was evident in other two controlled studies: low doses of propranolol and propranolol ?…”