Tehran University Medical Journal (Feb 2024)
Investigating the effectiveness of Sodae herbal capsule on migraine headaches and comparing it with sodium valproate
Abstract
Background: One of the first-line treatments to prevent migraine attacks is Sodium Valproate. "Booali Daroo" pharmaceutical company has made a herbal capsule called Sodae based on traditional Iranian medicine. The aim of this study is to compare the effect of Sodae and Sodium Valproate on migraine headaches. Methods: This two-center, double-blind, randomized clinical trial was conducted between December 2021 and July 2022 in the cities of Kermanshah and Hamadan. In this study, 76 migraine patients were randomly divided into two groups. One group received routine medication with Soda capsules and the other group received routine medication with Valproate capsules. Tow group were examined and followed up for three months. Data related to demographic and clinical information of patients were collected and entered into SPSS software version 25. Data analysis was done with a significance level of 0.05. Results: Overall, 76 patients assessed (36 in the Sodae group and 40 in the Valproate group). The reduction of headache indicators was not significant between the two groups; in such a way that: the frequency (7.49±6.1 vs. 5.75±4.5, P=0.183), the severity (5.66±1.6 vs. 6.34±1.8, P=0.089), the duration of attacks (23.48±30.5 vs. 32.35±32.6, P=0.069), and the Migraine Disability Assessment Score (53.94±77.3 vs. 95.94±104.2, P=0.061) respectively in Valproate and Sodae. Examining different classes of MIDAS score showed that at the end of the study compared to the beginning of the study, the number of people with severe disability decreased significantly and their disability changed from severe disability to lower degrees of disability (P<0.05). The frequency of side effects was not significantly different between the two groups (12 patients (35%) in Sodae versus 21 patients (55%) in Valproate, P=0.090). Conclusion: In terms of frequency, intensity and duration of migraine headaches as well as side effects, there was no significant difference between Sodium Valproate and Sodae groups.
