Efficacy of Combined Topiramate and Nortriptyline Over Monotherapy of Topiramate or Nortriptyline for Migraine Prophylaxis

Abstract

Introduction: Migraine is a chronic disabling disease that often requires prophylaxis to achieve control over the frequency, duration, and intensity of headaches. Different single or combination drugs are used for prophylaxis. Aims of the Study: This study aimed to evaluate the efficacy of combined of Topiramate plus Nortriptyline and monotherapy of Topiramate or Nortriptyline for migraine prophylaxis. Methods & Materials: A one-year, Randomized Controlled Trial was done at Department of Pharmacology and Therapeutics, Dhaka Medical College, Dhaka, Bangladesh. A total of 63 migraine patients were enrolled by block random sampling block of 9, 1:1:1 design. The patients were divided into three groups. In Group A, 21 patients were treated with Topiramate, in Group B, 21 patients were treated with Nortriptyline and in Group C, 21 patients were treated with Topiramate plus Nortriptyline. Result: After 3 months of treatment, frequency of headache reduced from median (IQR) 6.0 (2.5-11.0) to 0.0(0.0-1.0) in Group A, 12.0 (6.0-16.0) to in Group B and 6.0(3.5-12.00 to 0.0(0.0-0.0) in Group C. Duration of headache reduced from median (IQR) 6.0 (5.5-12.0) to 6.0(4.0-10.0) in Group A, 4.0(3.5-8.0) in Group B and 6.0 (4.0-12.0) to 5.0(3.0-10.0) in Group C. Intensity of Headache (Visual Analogue Scale score) reduced from median (IQR) 8.0 (7.0-9.0) to 3.0(2.0-3.5) in Group A, from 8.0(7.0-9.0) to 3.0(2.0-4.0) in Group B and 8.0(7.0-9.0) to 2.0(2.0-3.0) in Group C. Conclusion: The combined Topiramate plus Nortriptyline in the headache treatment compared to monotherapy of topiramate or nortriptyline group, the frequency, duration, severity of the headache and HIT-6 score, all were reduced most by the combined group.