Randomised Controlled Trial to Compare Safety and Efficacy of Propranolol with Flunarizine in Adult Patients Suffering from Migraine as Prophylactic Drugs

Background: Migraine is a primary neurovascular headache disorder characterize bymoderate to severe headaches, most often unilateral and generally associated withnausea and increased sensitivity to light and sound. Several factors can trigger migraineare probable contributing factors while others are possible or unproven such as: stress,hormonal changes, skipped meal, smoking, odour etc. Propranolol (non selective betablocker) is the most common and one of the most effective first line medication usedfor migraine prophylaxis. Flunarizine (Calcium channel blocker) is acknowledged innumerous countries and included in numerous national guidelines for prophylaxis ofmigraine. We therefore intended to carry out this study and produce more data tosupport the choice of a medication for migraine prophylaxis that is both more effectiveand has a better safety profile. Aim: The aim of our study was to compare safety andefficacy of propranolol with flunarizine in adult patients suffering from migraine asprophylactic drugs.Objectives: 1) To evaluate safety and efficacy of propranolol.2) Toevaluate safety and efficacy of flunarizine.Material and Methods: This comparative,prospective, randomized, and academic interventional study was conducted inDepartment of Pharmacology and Department of Neurology at Dr. R.P.G.M.C. Kangraat Tanda, Himachal Pradesh in India. For this study total 78 patients of migraine wereaccessed for eligibility. After excluding 2 a total of 76 patients of aged 18-65 years,satisfying the eligibility criteria were randomized into 2 groups to receive either theTablet Propranolol 40 mg per day for first 5 days then 40 mg twice a day for 2 monthsor Tablet Flunarizine 10 mg per day for 2 months. A general evaluation, and physicalexamination, routine investigations were performed on the first visit and repeated afterevery one month of treatment for next 2 months. Patient also assessed with VAS(Visual Analogue Scale) for headache intensity 1 (mild) to 10 (excruciating), to checkextent of a patient’s disease. Results: 89.2% of the participants in Group A and 52.8%of the study participants in Group B belonged to age group 18-40 years. In Group A,dizziness (n = 20) was the most common adverse effect associated with propranolol,while in Group B; tiredness (n = 3) and weight gain (n = 3) were the most commonadverse effects associated with flunarizine. There was statistically significant increasein BMI after 2 months among patients who were in Group B than those who were inGroup A (p=0.045).There was statistically significant difference in the mean (SD)Heart Rate value of participants in Group A (75.65± 5.1) and Group B (80.14 ± 5.9) atthe end of 2nd month (p=0.001). Also, there was statistically significant improvementin headache frequency (p=0.01) headache intensity (p=0.004) and headache duration(p=0.04) in Group A as compare to Group B.Conclusion: Flunarizine was associatedORGINAL ARTICLE OPEN ACCESSAbhishek Garget al.,Randomised Controlled Trial to Compare Safety and Efficacy of Propranolol withFlunarizine in Adult Patients Suffering from Migraine as Prophylactic Drugs. Int. J Med. Pharm. Res., 5(5):303‐319, 2024304with less adverse effects and Propranolol was associated with low headache frequency,headache intensity and headache duration as compared to flunarizine group.