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Background: There is a need for effective, well tolerated and affordable drug for chronic migraine prophylaxis in low socioeconomic countries.
Objective: To study the efficacy and safety of propranolol and sodium valproate (a food and drug administration approved and widely used treatment for prevention of migraine) as a prophylactic treatment in chronic migraine (CM) patients and to compare their efficacy and safety to each other.
Methods: In this single center, open labeled clinical trial, 40 patients with CM were subdivided into two group: group 1 (n=20) treated with propranolol and group 2 (n=20) treated with sodium valproate. Patients maintained headache diaries over a 1-month baseline period and a 6- month active study period. The evaluation of the treatment was done after 3 and 6 months of the initiation of the treatment. The efficacy measures were evaluation of monthly attacks frequency and attacks severity using VAS of pain (visual analogue scale. Disability and impact of migraine were evaluated using Migraine assessment disability scale (MIDAS) and Headache Impact Test (HIT-6). Throughout the study, patients were monitored for any symptoms or signs of adverse effects.
Results: Of 40 patients participated in this study (mean age, 33.48; females 72.5%). At the 6th month, the study was completed by 27 patients (propranolol; n=14 and sodium valproate; n=13). Between 55 and 62% of both groups reported more than 50% reduction in monthly attacks frequency. In both groups, there was significant reduction of VAS of pain scores. Both groups showed significant improvement of HIT-6 and MIDAS scores. Before the start of treatment, 85% to 100% of patients in both groups had severe MIDAS and HIT-6 scores. At the end of the study, only 35.7% of propranolol group and 30.8 of sodium valproate group showed severe MIDAS scores and 50% of propranolol group and 40% of sodium valproate group reported severe HIT-6 scores. 55% (n=11) of patients in propranolol reported AEs related to treatment compared to 75% (n=15) in the sodium valproate group. A higher proportion of patients discontinued the treatment because of AEs in Na valproate group compared to sodium valproate group with no statistically significant difference in between (20% vs. 5%, respectively).
Conclusions: Propranolol and sodium valproate demonstrated similar efficacy and tolerability in the prophylactic treatment of CM.
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