Govind Ballabh Pant Institute of Post Graduate Medical Education and Research, New Delhi, India.
All India Institute of Medical Sciences, New Delhi, India.
Cephalalgia. 2022 Apr;42(4-5):396-408. doi: 10.1177/03331024211047454. Epub 2021 Sep 27.
The aim of the TOP-PRO-study, a double-blind randomized controlled trial, was to assess the efficacy (non-inferiority) and tolerability of propranolol compared to topiramate for the prevention of chronic migraine.
Except for topiramate, oral preventive treatment for chronic migraine lacks credible evidence.
Chronic migraine patients aged above 18 years and less than 65 years of age, not on any preventive treatment were randomly allocated to receive topiramate (100 mg/day) or propranolol (160 mg/day). The primary efficacy outcome was the mean change in migraine days per 28 days at the end of 24 weeks from baseline. A mean difference of 1.5 days per four weeks was chosen as the cut-off delta value. Multiple secondary efficacy outcomes and treatment emergent adverse events were also assessed.
As against the planned sample size of 244, only 175 patients could be enrolled before the spread of the corona virus disease-2019 pandemic and enforcement of lockdown in India. Of the 175 randomized patients, 95 (topiramate 46 and propranolol 49) completed the trial. The mean change in migraine days was -5.3 ± 1.2 vs -7.3 ± 1.1 days (p = 0.226) for topiramate and propranolol groups respectively. Propranolol was found to be non-inferior and not superior to topiramate (point estimate of -1.99 with a 95% confidence interval of -5.23 to 1.25 days). Multiple secondary outcomes also did not differ between the two groups. Intention to treat analysis of 175 patients and per-protocol analysis of 95 patients yielded concordant results. There was no significant difference in the incidence of adverse events between the two groups.
Propranolol (160mg/day) was non-inferior, non-superior to topiramate (100mg/day) for the preventive treatment of chronic migraine and had a comparable tolerability profile.Trial Registration: Clinical Trials Registry-India CTRI/2019/05/018997).
TOP-PRO 研究是一项双盲随机对照试验，旨在评估普萘洛尔与托吡酯预防慢性偏头痛的疗效（非劣效性）和耐受性。
除托吡酯外，口服预防性治疗慢性偏头痛缺乏可靠证据。
年龄在 18 岁以上、65 岁以下、未接受任何预防性治疗的慢性偏头痛患者被随机分配接受托吡酯（100mg/天）或普萘洛尔（160mg/天）治疗。主要疗效终点为基线后 24 周内每 28 天偏头痛天数的平均变化。选择每周相差 1.5 天作为截断差值。还评估了多个次要疗效终点和治疗中出现的不良事件。
在冠状病毒病-2019 大流行传播和印度实施封锁之前，计划的样本量为 244 例，仅招募了 175 例患者。在随机分组的 175 例患者中，95 例（托吡酯 46 例，普萘洛尔 49 例）完成了试验。普萘洛尔组和托吡酯组的偏头痛天数平均变化分别为-5.3±1.2 天和-7.3±1.1 天（p=0.226）。普萘洛尔被证明非劣效且不比托吡酯优越（点估计值为-1.99，95%置信区间为-5.23 至 1.25 天）。两组之间的多个次要结局也没有差异。175 例患者的意向治疗分析和 95 例患者的方案分析得出了一致的结果。两组不良事件发生率无显著差异。
普萘洛尔（160mg/天）与托吡酯（100mg/天）预防慢性偏头痛的疗效非劣效，且耐受性相当。
印度临床试验注册处 CTRI/2019/05/018997）。
