Concurrent sodium valproate-magnesium therapy in the prevention of migraine headaches

Migraine as a primary headache disorder with substantial pain is included in the 20 most disabling diseases according to the World Health Organization.

Lifestyle management, acute treatment, and preventive treatment are three approaches to treat migraine. 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 medication-overuse headaches.

Sodium valproate is one of the FDA-approved antiepileptic drugs (AEDs) for the prevention of migraine.

Although there has been existing evidence on the effectiveness of magnesium in migraine prophylaxis, no study has evaluated magnesium potency in increasing sodium valproate efficacy in combination therapy of migraine. The current study was the first attempt to compare the efficacy of combination therapy of magnesium and sodium valproate with each treatment alone in migraine prophylaxis.

Key Summary:

· The results of the present study revealed that combination treatment with a low dose of sodium valproate and magnesium has desired efficacy in the reduction of migraine frequency, severity, duration of attacks, and number of utilized painkillers. Considering these promising results, it also indicated that by the addition of magnesium to valproate, sodium valproate unchanged low dose improves its efficacy.

Consequently, the development of a new combination drug (Magnesium Valproate) in this manner, can be a more potent and safe therapy for migraine prophylaxis.

The obtained results of the present study indicated that valproate was significantly more effective than magnesium in the reduction of migraine frequency and severity, duration of attacks, painkiller number, and MIDAS and HIT scores.

The findings of the present clinical study also confirmed this idea and indicated that a combination of magnesium and low-dose valproate (200 mg) have appropriate efficacy in migraine prophylaxis without any reported exacerbation of side effects.

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Abstract

Objective

This 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 methods

This 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 sodium valproate, group B magnesium with sodium valproate, and group C 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.

Results

The obtained results revealed a significant reduction in all migraine characteristics in all groups compared to those reported for the baseline. Intragroup data analysis indicated that there was no statistically significant difference in headache frequency between groups A and B in the third month; nevertheless, three other parameters showed a significant reduction in group B, compared to those reported for group A in the third month. On the other hand, group C could not effectively reduce measured parameters in the patients, compared to groups A and B after 3 months. Furthermore, the MIDAS and HIT-6 scores significantly diminished in groups A, B, and C compared to those reported at the baseline, and these changes were more significant in groups A and B than in group C.

Conclusion

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.

Glossary:

The Migraine Disability Assessment (MIDAS) and Headache Impact Test-6 (HIT-6) scores