A PILOT CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MAGNESIUM AND VITAMIN B6 SUSPENSION FOR THE TREATMENT OF MIGRAINE

Background: Migraine is a debilitating neurological disorder affecting approximately 12% of the global population, marked by severe headaches and associated symptoms. It contributes significantly to disability and is a significant component of the worldwide disease burden. Given its involvement in regulating serotonin function and vascular tone, Magnesium's role in migraine treatment has been investigated for its potential benefits in reducing migraine symptoms. Objective: This pilot clinical study aimed to evaluate the efficacy and safety of Megrim suspension, containing magnesium and vitamin B6, for the treatment of migraine. Methodology: In a 12-week, open-label, prospective pilot study, 50 patients aged 18-65 with migraine (with or without aura) were enrolled. Patients received 20 ml of Megrim suspension daily. Primary outcomes included mean migraine days, monthly migraine frequency, duration of daily migraines, severity (Visual Analog Scale), and Migraine Headache Index Score (MHIS). Secondary outcomes assessed the rate of recurrence and responder rate (≥50% reduction in migraine frequency). Results: After three months, there was a significant reduction in migraine days (8.65 ± 2.24 vs 5.29 ± 1.95, P<0.05), headache duration (6.38 ± 2.35 to 4.88 ± 2.50 hours/day, P<0.001), and severity (8.06 ± 1.53 vs 5.23 ± 1.72, P=0.003). The MHIS decreased significantly from 14.11± 6.24 to 7.70 ± 2.91 (P<0.001). Eighty-eight percent of patients were classified as responders, further reinforcing the safety and efficacy of the treatment. The treatment was well tolerated, with mild gastrointestinal discomfort reported by seven patients. Conclusion: Megrim suspension significantly reduces migraine days, duration, severity, and overall migraine burden, demonstrating its efficacy and safety as a therapeutic option for migraine management. Further research with larger samples and longer follow-up is warranted to confirm these findings and assess long-term benefits.