Danish Headache Center and Department of Neurology, University of Copenhagen, Rigshospitalet Glostrup, Copenhagen, Denmark.
Danish Headache Center, Department of Neurology N39, Rigshospitalet Glostrup, University of Copenhagen, Valdemar Hansens vej 5, DK-2600, Glostrup, Denmark.
J Headache Pain. 2018 Aug 17;19(1):71. doi: 10.1186/s10194-018-0890-y.
Previous studies indicate that sumatriptan is not effective when second messenger levels are high as after cilostazol provocation. Therefore, we have conducted the present study, where sumatriptan is administrated as pretreatment before cAMP increases due to cilostazol intake. Our hypothesis was that pretreatment with sumatriptan would have a significant effect against cilostazol induced headache in healthy volunteers.
In a double-blind, randomized, crossover design, 30 healthy volunteers of both sexes received cilostazol 200 mg on two separate days, each day preceded by oral sumatriptan (2 × 50 mg) or placebo. Headache response and accompanying symptoms were registered in a questionnaire by the participants themselves.
Cilostazol induced a mild to moderate headache in all but 3 participants (Range 0-7 on Numerical Rating Scale). There was no significant difference in headache score 2 h (p = 0.67) or 4 h (p = 0.1) after treatment between the 2 days. Median peak headache score was 1.5 (range 0-5) on the sumatriptan day and 2 (range 0-7) on the placebo day (p = 0.26).
Pre-treatment with sumatriptan prevents cilostazol induced headache from developing. However, the placebo group did not develop enough headache to get statistical significant results. The cilostazol pre-treatment model is valuable for experimental headache research and perhaps for testing drugs with another mechanism of action.
ClinicalTrials.gov Identifier: NCT03156920 .
先前的研究表明，在环磷腺苷水平升高（如在用西洛他唑激发后）时，舒马曲坦无效。因此，我们进行了本研究，在西洛他唑引起 cAMP 增加之前给予舒马曲坦作为预处理。我们的假设是，舒马曲坦预处理对健康志愿者的西洛他唑引起的头痛会有显著的效果。
在一项双盲、随机、交叉设计的研究中，30 名健康的男女志愿者在两天内分别服用西洛他唑 200mg，每天之前口服舒马曲坦（2×50mg）或安慰剂。参与者本人通过问卷记录头痛反应和伴随症状。
西洛他唑引起所有参与者（除 3 名外）轻度至中度头痛（数字评分量表范围 0-7）。在治疗后 2 小时（p=0.67）或 4 小时（p=0.1），2 天之间的头痛评分无显著差异。舒马曲坦日的头痛评分中位数为 1.5（范围 0-5），安慰剂日为 2（范围 0-7）（p=0.26）。
舒马曲坦预处理可预防西洛他唑引起的头痛发作。然而，安慰剂组没有出现足够的头痛，无法得出统计学上显著的结果。西洛他唑预处理模型对于实验性头痛研究有价值，或许对于测试具有另一种作用机制的药物也有价值。
ClinicalTrials.gov 标识符：NCT03156920。
