{"title":"低剂量心得安与阿米替林预防偏头痛：一项评估疗效、安全性和成本效益的随机对照试验。","authors":"Vandana Roy, Nasra Banu, Girish Gulab Meshram, Debashish Chowdhury","doi":"10.1007/s40261-025-01481-4","DOIUrl":null,"url":null,"abstract":"<p><strong>Background and objectives: </strong>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.</p><p><strong>Methods: </strong>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]).</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Trial registration number: </strong>Clinical Trial Registry-India (Date: 27 October 2020; registration no.: CTRI/2020/01/022972).</p>","PeriodicalId":10402,"journal":{"name":"Clinical Drug Investigation","volume":" ","pages":"781-791"},"PeriodicalIF":2.7000,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Low-Dose Propranolol versus Amitriptyline for Episodic Migraine Prophylaxis: A Randomized Controlled Trial Assessing Efficacy, Safety, and Cost-Effectiveness.\",\"authors\":\"Vandana Roy, Nasra Banu, Girish Gulab Meshram, Debashish Chowdhury\",\"doi\":\"10.1007/s40261-025-01481-4\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background and objectives: </strong>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.</p><p><strong>Methods: </strong>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]).</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Trial registration number: </strong>Clinical Trial Registry-India (Date: 27 October 2020; registration no.: CTRI/2020/01/022972).</p>\",\"PeriodicalId\":10402,\"journal\":{\"name\":\"Clinical Drug Investigation\",\"volume\":\" \",\"pages\":\"781-791\"},\"PeriodicalIF\":2.7000,\"publicationDate\":\"2025-10-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical Drug Investigation\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s40261-025-01481-4\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/9/11 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Drug Investigation","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s40261-025-01481-4","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/9/11 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
Low-Dose Propranolol versus Amitriptyline for Episodic Migraine Prophylaxis: A Randomized Controlled Trial Assessing Efficacy, Safety, and Cost-Effectiveness.
Background and objectives: 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.
Methods: 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]).
Results: 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.
Conclusions: 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.
期刊介绍：
Clinical Drug Investigation provides rapid publication of original research covering all phases of clinical drug development and therapeutic use of drugs. The Journal includes:
-Clinical trials, outcomes research, clinical pharmacoeconomic studies and pharmacoepidemiology studies with a strong link to optimum prescribing practice for a drug or group of drugs.
-Clinical pharmacodynamic and clinical pharmacokinetic studies with a strong link to clinical practice.
-Pharmacodynamic and pharmacokinetic studies in healthy volunteers in which significant implications for clinical prescribing are discussed.
-Studies focusing on the application of drug delivery technology in healthcare.
-Short communications and case study reports that meet the above criteria will also be considered.
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