Pfaffenrath Volker, Diener Hans-Christoph, Pageler Lutz, Peil Hubertus, Aicher Bernhard
Neurological Practice, Leopoldstrasse 59, Munich, Germany.
Headache. 2009 May;49(5):638-45. doi: 10.1111/j.1526-4610.2009.01402.x.
To compare the superior efficacy of the fixed combination of acetylsalicylic acid, paracetamol, and caffeine over the single substances, which was observed in the randomized, double-blind phase of the clinical trial, with the efficacy of the respective usual nonprescription medication taken by the patients in the open-label pre-phase of the same study.
The "Thomapyrin Study" showed significant superiority of the fixed combination containing acetylsalicylic acid, paracetamol, and caffeine over the combination without caffeine, the single preparations, and placebo in the treatment of headache.
Prior to the randomized treatment phase, a headache episode treated with the patient's usual nonprescription medication was recorded (open-label pre-phase). Patients assessed their pain intensity on a 100-mm visual analog scale. For the 1734 patients included in the efficacy analysis, we compared the time course of the pain intensity difference (PID) to baseline after the patients took their usual medication with the time course of the PID after intake of the randomized study medication.
Time course of PID after intake of the patient's usual medication was very similar to the time course of PID after intake of the randomized study medication. After 2 hours, pain reduction was on average 43.0, 38.2, 38.1, and 37.7 mm as assessed on the visual analog scale in the group of patients who took their usual triple combination containing acetylsalicylic acid, paracetamol, and caffeine, the single agents acetylsalicylic acid, paracetamol, and ibuprofen, respectively, in the open-label phase. The corresponding mean pain reduction was 44.7, 40.7, and 39.5 mm in patients allocated to the triple combination containing acetylsalicylic acid, paracetamol, and caffeine, the single agents acetylsalicylic acid, and paracetamol, respectively, in the randomized, double-blind phase.
比较乙酰水杨酸、对乙酰氨基酚和咖啡因的固定组合相对于单一药物的优越疗效，该优越疗效在临床试验的随机、双盲阶段已被观察到，同时将其与同一研究开放标签预阶段患者服用的各自常用非处方药的疗效进行比较。
“托马匹林研究”表明，含有乙酰水杨酸、对乙酰氨基酚和咖啡因的固定组合在治疗头痛方面比不含咖啡因的组合、单一制剂和安慰剂具有显著优越性。
在随机治疗阶段之前，记录一次用患者常用非处方药治疗的头痛发作（开放标签预阶段）。患者在100毫米视觉模拟量表上评估疼痛强度。对于纳入疗效分析的1734名患者，我们将患者服用常用药物后疼痛强度差异（PID）与基线的时间进程与摄入随机研究药物后PID的时间进程进行了比较。
患者服用常用药物后PID的时间进程与摄入随机研究药物后PID的时间进程非常相似。2小时后，在开放标签阶段服用含乙酰水杨酸、对乙酰氨基酚和咖啡因的常用三联组合、单一药物乙酰水杨酸、对乙酰氨基酚和布洛芬的患者组中，根据视觉模拟量表评估，疼痛减轻平均分别为43.0、38.2、38.1和37.7毫米。在随机双盲阶段，分配到含乙酰水杨酸、对乙酰氨基酚和咖啡因的三联组合、单一药物乙酰水杨酸和对乙酰氨基酚的患者中，相应的平均疼痛减轻分别为44.7、40.7和39.5毫米。
