Roy Vandana, Banu Nasra, Meshram Girish Gulab, Chowdhury Debashish
Department of Pharmacology, Maulana Azad Medical College and Associated Hospitals, New Delhi, 110002, India.
Department of Neurology, Govind Ballabh Pant Institute of Postgraduate Medical Education and Research, New Delhi, 110002, India.
Clin Drug Investig. 2025 Sep 11. doi: 10.1007/s40261-025-01481-4.
Direct head-to-head evidence of propranolol and amitriptyline for migraine prophylaxis is limited. This clinical trial compared the efficacy, safety, and cost-effectiveness of low-dose propranolol versus amitriptyline for episodic migraine prophylaxis over a 3-month period.
This randomized, controlled, open-label, prospective, parallel, single-center trial was conducted at a tertiary care hospital in India. A total of 60 prophylaxis-naïve patients with episodic migraine were randomized 1:1 to receive either low-dose propranolol (80 mg/day) or amitriptyline (10 mg/day). The primary outcome was the improvement in the monthly headache frequency at 3 months from baseline, while the secondary outcomes included improvements from baseline in the proportions of patients achieving a ≥ 50% reduction in monthly headache days, headache severity, headache-induced disability, monthly rescue medication intake, quality of life, and cost-effectiveness (measured by the average cost-effectiveness ratio [ACER] and incremental cost-effectiveness ratio [ICER]).
At 3 months, propranolol showed a significantly greater reduction in monthly headache frequency compared with amitriptyline (- 3.67 ± 1.47 versus - 2.87 ± 1.36 days, P = 0.03). More patients in the propranolol group (60%) achieved a ≥ 50% reduction in monthly headache days compared with the amitriptyline group (43.33%) (P = 0.02). Propranolol also showed a greater reduction in monthly rescue medication intake (P = 0.01), but differences in headache severity, headache-induced disability, and quality of life were not significant. Both groups experienced mild adverse drug reactions. Cost-effectiveness analysis revealed propranolol had a higher ACER (US $5.44) and ICER (US $0.40/1% reduction) than amitriptyline.
In our trial, low-dose propranolol demonstrated superior efficacy to amitriptyline in episodic migraine prophylaxis. Both drugs were well tolerated. Our study suggests that amitriptyline was more cost-effective than propranolol.
Clinical Trial Registry-India (Date: 27 October 2020; registration no.: CTRI/2020/01/022972).
普萘洛尔和阿米替林用于偏头痛预防的直接对比证据有限。本临床试验比较了低剂量普萘洛尔与阿米替林在3个月期间预防发作性偏头痛的疗效、安全性和成本效益。
本随机、对照、开放标签、前瞻性、平行、单中心试验在印度一家三级护理医院进行。共有60例初治发作性偏头痛患者按1:1随机分组，分别接受低剂量普萘洛尔（80毫克/天）或阿米替林（10毫克/天）治疗。主要结局是3个月时每月头痛频率相对于基线的改善情况，次要结局包括从基线开始，每月头痛天数减少≥50%的患者比例、头痛严重程度、头痛所致残疾、每月急救药物摄入量、生活质量以及成本效益（通过平均成本效益比[ACER]和增量成本效益比[ICER]衡量）的改善情况。
3个月时，普萘洛尔组每月头痛频率的降低幅度显著大于阿米替林组（-3.67±1.47天对-2.87±1.36天，P = 0.03）。与阿米替林组（43.33%）相比，普萘洛尔组更多患者（60%）每月头痛天数减少≥50%（P = 0.02）。普萘洛尔组每月急救药物摄入量的减少幅度也更大（P = 0.01），但在头痛严重程度、头痛所致残疾和生活质量方面差异不显著。两组均出现轻度药物不良反应。成本效益分析显示，普萘洛尔的ACER（5.44美元）和ICER（每降低1%为0.40美元）高于阿米替林。
在我们的试验中，低剂量普萘洛尔在预防发作性偏头痛方面显示出优于阿米替林的疗效。两种药物耐受性均良好。我们的研究表明，阿米替林比普萘洛尔更具成本效益。
印度临床试验注册中心（日期：2020年10月27日；注册号：CTRI/2020/01/022972）
