Abstract
ObjectiveThis study aimed to assess the efficacy of concurrent magnesium-sodium valproate therapy and compare it with either magnesium or sodium valproate alone in migraine prophylaxis.Materials and methodsThis randomized single-center double-blind parallel-group controlled clinical trial study was conducted on migraine patients within the age range of 18–65 years. The subjects with at least four monthly attacks were randomly assigned to group A (n = 82) sodium valproate, group B (n = 70) magnesium with sodium valproate, and group C (n = 70) magnesium. The patients passed a one-month baseline without prophylactic therapy and then received a 3-month treatment. The characteristics of migraine, including frequency, severity, duration of the attacks, and the number of painkillers taken per month, were monthly recorded in each visit. The Migraine Disability Assessment (MIDAS) and Headache Impact Test-6 (HIT-6) scores were recorded at the baseline and after 3 months of treatment in each group. Within- and between-group analyses were performed in this study.ResultsThe obtained results revealed a significant reduction in all migraine characteristics in all groups compared to those reported for the baseline (P < 0.001). Intragroup data analysis indicated that there was no statistically significant difference in headache frequency between groups A and B in the third month (P = 0.525); nevertheless, three other parameters showed a significant reduction in group B, compared to those reported for group A in the third month (P < 0.05). On the other hand, group C could not effectively reduce measured parameters in the patients, compared to groups A and B after 3 months (P < 0.001). Furthermore, the MIDAS and HIT-6 scores significantly diminished in groups A, B, and C compared to those reported at the baseline (P < 0.001), and these changes were more significant in groups A and B than in group C (P < 0.001).ConclusionThe obtained results of this study revealed that magnesium could enhance the antimigraine properties of sodium valproate in combination therapy and reduce the required valproate dose for migraine prophylaxis.
Highlights
Migraine as a primary headache disorder with substantial pain is included in the 20 most disabling diseases according to the World Health Organization [39]
The obtained results of this study revealed that magnesium could enhance the antimigraine properties of sodium valproate in combination therapy and reduce the required valproate dose for migraine prophylaxis
The current study compared the efficacy of sodium valproate, sodium valproate plus magnesium oxide, and magnesium oxide in the migraine prophylaxis of patients within the age range of 18–65 years
Summary
Migraine as a primary headache disorder with substantial pain is included in the 20 most disabling diseases according to the World Health Organization [39]. Epidemiologic studies have indicated that the prevalence of migraine is about 14% in Iran similar to or even higher than that reported worldwide [11]. Acute treatment, and preventive treatment are three approaches to treat migraine [44]. Prophylactic therapy for migraine is recommended in patients with four or more attacks per month, eight or more headache days a month, debilitating headaches, and medicationoveruse headaches [15]. A reduction in the frequency of headaches about 50% or more, reduced intensity, and improved response to symptomatic medication can be three outcomes of preventive therapy [28]. Beta-blockers, calcium-channel blockers, anticonvulsants, selective serotonin reuptake inhibitors, tricyclic antidepressants, and angiotensin blockers are some of the medications used for migraine prophylaxis. Botulinum toxin, flunarizine, vitamins, minerals, and herbal agents were suggested in many studies [14, 44]
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