Efficacy of low-dose Topiramate in Migraine Prophylaxis

Muhammad Abdul Momen Khan, Mohammad Bahadur Ali Miah, M. Shahidullah, Md. Rafiqul Islam, Subash Kanti Day, J. Ferdous, Md Amir Hossain
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Abstract

Background: Anticonvulsants are now commonly used for migraine prophylaxis, among them topiramate, one of the newer anticonvulsants, recently has been demonstrated to be effective as mono-therapy for migraine prophylaxis. Objectives: To observe the efficacy and safety of low dose topiramate in migraine prophylaxis. Methods: This prospective trial was carried out in the Out Patient Department (OPD) & Headache Clinic, Department of Neurology, Bangabandhu Sheikh Mujib Medical University, Dhaka. Total 60 patients around the age range of 18 to 50 years diagnosed as migraine (with aura or without aura) according to ICHD-3 criteria, were recruited as the study population. Total 60 patients were administered by Tab.Topiramate 50 mg/ day. Out of them, total 47 patients had completed the study due to drop out of 13 patients. During trial, three follow up visits were taken, 1st follow up after 4 weeks of baseline information (Before starting prophylactic medication), 2nd follow up after 4 weeks of treatment, 3rd follow up after 8 weeks of treatment. Efficacy of treatment was measured by headache frequency, duration and severity as measured by the VAS. Effectiveness was assessed by comparing baseline & on-treatment migraine status. Results: The mean (SD) age of patients were found 29.72 (9.58) years. Female sex was predominant. The mean (SD) value of frequency of migraine at baseline level with 1st and 2nd follow up were statistically significant [Baseline 9.28 (2.39) vs. 1st FU 7.55 (3.07), p=0.001; Baseline 9.28 (2.39) vs. 2nd FU 4.72 (2.80), p<0.001]. Duration of each episode of migraine ,comparing the mean (SD) value of duration of migraine of baseline level with 1st and 2nd follow up were statistically significant [Baseline 10.85 (5.26) vs. 1st FU 8.06 (4.11) hr, p<0.001; Baseline 10.85 (5.26) vs. 2nd FU 5.53 (2.98) hr, p<0.001]. According to severity of migraine based on VAS in base line period all patients had experienced moderate & severe headache but in 1st follow up, few patients had experienced mild headache from moderate headache, few patients had experienced moderate headache from severe headache & in 2nd follow up, patients had better condition and had experienced mild and moderate headache, no patient had experienced severe headache. In this study, 23.4% patients developed adverse effects. Among the adverse effects, 8.5% develop dizziness, 6.3% drowsiness, 4.2% anorexia & blurring of vision. Conclusion: The present study suggest that low dose topiramate are effective for migraine prophylaxis in reduction of frequency, severity and duration of migraine headache . Bangladesh Journal of Neuroscience 2015; Vol. 31 (2): 70-75
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低剂量托吡酯预防偏头痛的疗效
背景:抗惊厥药物现在普遍用于偏头痛预防,其中托吡酯,一种较新的抗惊厥药物,最近已被证明是有效的偏头痛预防的单一治疗。目的:观察低剂量托吡酯预防偏头痛的疗效和安全性。方法:本前瞻性试验在达卡班班杜谢赫穆吉布医科大学神经内科门诊及头痛门诊进行。根据ICHD-3标准,共招募60例年龄在18至50岁之间诊断为偏头痛(有先兆或无先兆)的患者作为研究人群。60例患者采用Tab治疗。托吡酯50毫克/天。其中有13名患者退出,共有47名患者完成了研究。试验期间进行3次随访,第1次随访于4周后基线信息(开始预防性用药前),第2次随访于4周后,第3次随访于8周后。通过VAS测量的头痛频率、持续时间和严重程度来衡量治疗效果。通过比较基线和治疗期间偏头痛状态来评估有效性。结果:患者平均(SD)年龄为29.72(9.58)岁。女性占主导地位。第一次和第二次随访时基线水平偏头痛频次的平均(SD)值具有统计学意义[基线9.28(2.39)比第一次随访7.55 (3.07),p=0.001;基线9.28 (2.39)vs.第二FU 4.72 (2.80), p<0.001]。每次偏头痛发作的持续时间,与第一次和第二次随访相比,基线水平偏头痛持续时间的平均值(SD)值具有统计学意义[基线10.85(5.26)比第一次随访8.06 (4.11)hr, p<0.001;基线10.85(5.26)比第二次FU 5.53(2.98)小时,p<0.001]。根据基线期偏头痛的VAS严重程度,所有患者均出现中度和重度头痛,但在第一次随访中,中度头痛转为轻度头痛的患者较少,重度头痛转为中度头痛的患者较少;第二次随访时,患者病情好转,出现轻度和中度头痛,无患者出现重度头痛。在本研究中,23.4%的患者出现了不良反应。在不良反应中,8.5%为头晕,6.3%为嗜睡,4.2%为厌食和视力模糊。结论:低剂量托吡酯可有效预防偏头痛,降低偏头痛发生频率、严重程度和持续时间。孟加拉国神经科学杂志2015;Vol. 31 (2): 70-75
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