Open-label comparative study of the efficacy of sodium valproate and topiramate as prophylactic therapy for migraine in adults

Abstract

Background: Migraine is a most common and highly prevalent neurologic disorder characterized by recurrent moderate-to-severe headaches often in association with a number of autonomic nervous system symptoms. Sodium valproate and topiramate are the two newer antiepileptic agents which are commonly prescribed for the migraine prophylaxis in India. Aims and Objectives: The aims of the study were as follows: (1) To compare the efficacy of sodium valproate 15–30 mg/kg/day and topiramate 2–3 mg/kg/day as prophylactic therapy for migraine in adults and (2) to study cost-effectiveness and safety profile of sodium valproate and topiramate. Materials and Methods: It is an open-label comparative study; 100 migraine patients of age group between 20 years and 50 years of both sexes were enrolled in the present study according to the inclusion criteria. Patients were diagnosed as migraine as per the International Criteria For Headache Disorders-3. Before starting treatment and after diagnosis, investigations have done, that is, complete blood picture, liver function test, renal function test, random blood sugar, and thyroid profile. Randomization was done by choosing every alternate patient and study drugs were prescribed. One hundred patients were divided into two groups, Group-A: 50 patients administered Tab. sodium valproate 500 mg twice daily orally and Group-B: 50 patients administered Tab. topiramate 150 mg once daily orally for a period of 6 months. Results: In Group-A, the severity of pain value before starting treatment was 6.440 ± 2.130 which is reduced to 1.820 ± 1.024 at the end of the treatment which was statistically significant (P < 0.0001) and the frequency of headache value before starting treatment was 4.220 ± 1.298 which is reduced to 1.320 ± 0.7407 at the end of the treatment, P < 0.0001 which was statistically significant. In Group-B, the severity of pain value before starting treatment was 6.200 ± 2.119 which is reduced to 1.840 ± 0.9765 after starting treatment which was statistically significant (P < 0.0001) and the frequency of headache value before starting treatment was 4.300 ± 1.199 which is reduced to 1.340 ± 0.6884 after starting treatment, P < 0.0001 which was statistically significant. In between the two groups severity of migraine pain and headache frequencies the P value was statistically significant. Conclusion: The results of the present study demonstrated that both sodium valproate and topiramate were well tolerated, having similar efficacy in reducing the severity of the pain, headache frequencies, and improving the quality of life. Sodium valproate is preferred because of cost-effectiveness.