Samira Khani1, Seyed Amir Hejazi1, Mehdi Yaghoubi2, Ehsan Sharifipour3. 1. Department of Neurology, Neurosciences Research Center (NSRC), Qom University of Medical Sciences, Shahid-Beheshti hospital, Shahid-Beheshti street, Qom, Iran. 2. Cellular and Molecular Research Center, Qom University of Medical Sciences, Qom, Iran. 3. Department of Neurology, Neurosciences Research Center (NSRC), Qom University of Medical Sciences, Shahid-Beheshti hospital, Shahid-Beheshti street, Qom, Iran. Sharifipour.e@gmail.com.
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.
RCT Entities:
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 migrainepatients 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.