Togha Mansoureh, Rahmat Jirde Masoud, Nilavari Kiafar, Ashrafian Hosein, Razeghi Soodeh, Kohan Leila
Department of Neurology, Medical Sciences/University of Tehran, Sina Hospital, Imam Khomeini St, 11367-46911, Tehran Islamic Republic of Iran.
J Headache Pain. 2008 Apr;9(2):77-82. doi: 10.1007/s10194-008-0013-2. Epub 2008 Feb 20.
This was a double-blind clinical trial designed to assess the efficacy and safety of the cinnarizine (CIN) in patients with migraine who were refractory to propranolol and tricyclic antidepressants in comparison with sodium valproate (SV) to investigate whether CIN could be at least as effective as SV. A total of 125 patients were treated in a treatment period of 12 weeks. All patients had at least one intake of trial medication and 2-week post baseline efficacy observation which all were included in the ITT analysis. Of the 125 subjects treated, 46 discontinued prematurely: 25 from the CIN and 21 from the SV group. The main reasons for premature discontinuation were: lost to follow up (25/46, 63.2%), insufficient response (16/46, 20%), and adverse events (5/46, 12.8%). No statistically significant inter-group differences in the number of discontinuation was observed (p > 0.05). In both groups, number of attacks, intensity, and duration of attacks significantly decreased (p < 0.05). No statistically significant inter-group differences were observed regarding the mean number of attacks, duration, and intensity of migraine attacks for any of the time intervals analysed, except for the mean reduction of third and fourth visits intensity from baseline which were significantly different in two groups (p < 0.05), with the CIN group showing more reduction. Analysis of the number of responders showed that in the CIN group 61.2% subjects were responders, and 63.8% in the SV group. No statistically significant differences between the treatment groups were found for any of the secondary parameters. Overall 26 subjects reported one or more adverse events during the study period: 13 subjects in each group. Five subjects discontinued prematurely due to adverse events; two in the CIN group with significant weight gain, and 3 in the SV group with significant weight gain and severe tremor. These results suggest that CIN is an effective and safe prophylactic agent even in severe migraine headache.
这是一项双盲临床试验，旨在评估桂利嗪（CIN）在对普萘洛尔和三环类抗抑郁药难治的偏头痛患者中的疗效和安全性，并与丙戊酸钠（SV）进行比较，以研究CIN是否至少与SV一样有效。在12周的治疗期内共治疗了125例患者。所有患者至少服用一次试验药物，并进行2周的基线后疗效观察，所有这些均纳入意向性分析。在接受治疗的125名受试者中，46例提前停药：25例来自CIN组，21例来自SV组。提前停药的主要原因是：失访（25/46，63.2%）、反应不足（16/46，20%）和不良事件（5/46，12.8%）。停药数量在组间未观察到统计学显著差异（p>0.05）。两组的发作次数、强度和发作持续时间均显著减少（p<0.05）。在分析的任何时间间隔内，偏头痛发作的平均次数、持续时间和强度在组间未观察到统计学显著差异，但从基线开始第三次和第四次就诊时强度的平均降低在两组中显著不同（p<0.05），CIN组降低更多。对反应者数量的分析表明，CIN组61.2%的受试者为反应者，SV组为63.8%。治疗组之间在任何次要参数上均未发现统计学显著差异。总体而言，26名受试者在研究期间报告了一种或多种不良事件：每组13名受试者。5名受试者因不良事件提前停药；CIN组2名出现显著体重增加，SV组3名出现显著体重增加和严重震颤。这些结果表明，即使在严重偏头痛性头痛中，CIN也是一种有效且安全的预防药物。
