Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2021 Apr 7;22(1):21.
doi: 10.1186/s10194-021-01234-6.

Comparative study of magnesium, sodium valproate, and concurrent magnesium-sodium valproate therapy in the prevention of migraine headaches: a randomized controlled double-blind trial

Samira Khani  1 , Seyed Amir Hejazi  1 , Mehdi Yaghoubi  2 , Ehsan Sharifipour  3
Affiliations
Randomized Controlled Trial

Comparative study of magnesium, sodium valproate, and concurrent magnesium-sodium valproate therapy in the prevention of migraine headaches: a randomized controlled double-blind trial

Samira Khani et al. J Headache Pain. .

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 (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.

Results: The 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).

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.

Keywords: Magnesium; Migraine; Prophylaxis; Sodium valproate.

PubMed Disclaimer

Conflict of interest statement

Non

Figures

Fig. 1
Fig. 1
CONSORT flow diagram of participants through the study
Fig. 2
Fig. 2
Migraine characteristics of the three groups in different treatment periods; *P values≤0.05 were considered statistically significant vs baseline [measured using sample (paired) t test]. A: Sodium Valproate; B: Sodium Valproate +Magnesium; C: Magnesium
Fig. 3
Fig. 3
Intra group comparison of duration, severity, number of attack and painkiller in different treatment periods
Fig. 4
Fig. 4
Comparison of MIDAS and HIT-6 score change between three treatment groups. MIDAS change, P value: (A Vs B = 0.023, A Vs C = 0.001, B Vs C < 0.001). HIT change, P value: (A Vs B = 0.999, A Vs C < 0.001, B Vs C < 0.001)
See this image and copyright information in PMC

References

    1. Altura BT, Altura BM. Withdrawal of magnesium causes vasospasm while elevated magnesium produces relaxation of tone in cerebral arteries. Neurosci Lett. 1980;20(3):323–327. doi: 10.1016/0304-3940(80)90168-8. - DOI - PubMed
    1. Assarzadegan, F., H. Tabesh, S.-M. Hosseini-Zijoud, A. D. Beale, A. Shoghli, M. G. Yazdi, B. Mansouri, O. Hesami, N. B. Moghadam and H. D. J. I. R. C. M. J. Kasmaei (2016). "Comparing zonisamide with sodium valproate in the management of migraine headaches: double-blind randomized clinical trial of efficacy and safety." 18(9) - PMC - PubMed
    1. Bigal, M. E., A. M. Rapoport, R. B. Lipton, S. J. Tepper, F. D. J. H. T. J. o. H. Sheftell and F. Pain (2003). "Assessment of migraine disability using the migraine disability assessment (MIDAS) questionnaire: a comparison of chronic migraine with episodic migraine." 43(4): 336–342 - PubMed
    1. Bostani, A., A. Rajabi, N. Moradian, N. Razazian and M. J. I. J. o. N. Rezaei (2013). "The effects of cinnarizine versus sodium valproate in migraine prophylaxis." 123(7): 487–493 - PubMed
    1. Canger, R. and L. J. C. D. I. Guidolin (2000). "Clinical Efficacy and Tolerability of Magnesium Valproate as Monotherapy in Patients with Generalised or Partial Epilepsy." 20(4): 215–221

Publication types