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 in tertiarycare hospital of North India. A total of 76 patients satisfying the eligibility criteria wererandomized into 2 groups to receive either the Tablet Propranolol 40 mg per day forfirst 5 days then 40 mg twice a day for 2 months or Tablet Flunarizine 10 mg per dayfor 2 months. A general evaluation, physical examination and routine investigationswere performed on the first visit and repeated after every one month of treatment fornext 2 months. Patient also assessed with VAS (Visual Analogue Scale) for headacheintensity 1 (mild) to 10 (excruciating), to check extent of a patient’s disease.Results:Group A (89.2%) and Group B (52.8%) patients were in age group of 18-40years. In Group A, dizziness (n = 20) was the most common adverse effect associatedwith propranolol, while in Group B; tiredness (n = 3) and weight gain (n = 3) were themost common adverse effects associated with flunarizine. There was statisticallysignificant increase in BMI after 2 months among patients who were in Group B than those who were in Group A (p=0.045). There was statistically significant difference inthe mean (SD) Heart Rate value of participants in Group A (75.65± 5.1) and Group B(80.14 ± 5.9) at the end of 2nd month (p=0.001).Also, there was statistically significant improvement in headache frequency (p=0.01) headache intensity (p=0.004) andheadache duration (p=0.04) in Group A as compare to Group B.Conclusion: Flunarizine was associated with fewer adverse effects and Propranololwas associated with low headache frequency, headache intensity and headache durationas compared to flunarizine group. Trial Registration: Clinical Trials Registry –India (CTRI) Number CTRI/2023/06/053593 [Registered on: 06/06/2023]