Comparing Zonisamide With Sodium Valproate in the Management of Migraine Headaches: Double-Blind Randomized Clinical Trial of Efficacy and Safety

比较唑尼沙胺与丙戊酸钠治疗偏头痛的疗效和安全性:一项双盲随机临床试验

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Abstract

BACKGROUND: Migraine is one of the most debilitating medical conditions and has a high socioeconomic burden. As conventional therapeutic methods do not entirely alleviate the symptoms, new alternatives are being considered. OBJECTIVES: This study evaluates the efficacy and safety of zonisamide compared with sodium valproate in the management of migraine headaches. PATIENTS AND METHODS: In the current double-blind, parallel, randomized, controlled trial, 96 patients with a migraine diagnosis based on the international headache society (HIS) criteria were selected. They were divided randomly into two groups; the case group was given zonisamide, and sodium valproate was given to a control group. In addition to the side effects of the drugs, the severity, duration, and frequency of migraine attacks were evaluated at baseline and at three months. RESULTS: The 96 selected patients were divided randomly into two treatment groups (zonisamide n = 48, sodium valproate n = 48). Seven patients were excluded from analysis because of early dropout, leaving 89 (n = 45; n = 44) patients for analysis. While using zonisamide, six (13%) patients complained of fatigue, and two (4%) patients encountered noticeable appetite and weight loss. In the control group, five (11%) patients reported dizziness, and four (9%) patients faced obvious appetite and weight gain. Both drugs were considerably efficient in reducing further attacks. There was no statistically significant correlation between frequency or severity of migraine attacks and the drug used for treatment in three months of follow-up. CONCLUSIONS: Both medications are effective in reducing migraine attacks. It will be important to consider the drugs' adverse effects and availability and patients' medical and socioeconomic condition to select the appropriate treatment.

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