Kubitzek Florian, Ziegler Gabrielle, Gold Morris S, Liu Jiun-Min H, Ionescu Elisabeta
Principal Investigator, Member of German Society of Pain Therapy (STK), Leopoldstr. 33, 80802, München, Germany.
Eur J Pain. 2003;7(2):155-62. doi: 10.1016/S1090-3801(02)00094-0.
Several clinical trials have demonstrated that low doses of non-steroidal anti-inflammatory drugs relieve episodic tension-type headache (ETH).
The aims of this placebo-controlled study were to determine whether single doses of diclofenac-K 12.5 and 25mg effectively relieve ETH in adults and to compare it to ibuprofen 400mg.
A single-dose multicentre, randomised, double-blind, double-dummy, clinical trial was conducted at 22 primary care centres in Germany. All subjects had a history of ETH according to the classification of the International Headache Society. Of 684 subjects randomised, 620 used the study drugs for an episode of tension headache occurring within one month after enrolment: diclofenac-K 12.5mg (n=160), diclofenac-K 25mg (n=156), ibuprofen 400mg (n=151) and placebo (n=153). The primary efficacy variable was total pain relief, calculated as the time-weighted sum of the pain relief assessments from baseline to the 3h evaluation time (TOTPAR-3).
For TOTPAR-3, all active treatments were superior to placebo; no statistically significant difference between the three active treatments could be detected. A similar pattern was also observed with regard to TOTPAR-6 (6h evaluation time), > or =50%maxTOTPAR at 3 and 6h, weighted pain intensity difference at 3 and 6h (SPID-3; SPID-6), percentage of patients with complete headache relief at 2h, end of study global evaluation and time to rescue medication. The number-needed-to-treat (NNT) at 6h was 4.5 (2.9-9.2) in the ibuprofen 400mg group, 4.0 (2.8-7.3) in the diclofenac-K 12.5mg group and 3.9 (2.7-7.1) in the diclofenac-K 25mg group. These differences were not statistically significant.
Diclofenac-K, administered as single doses of 12.5 and 25mg effectively relieves ETH and is comparable to ibuprofen 400mg.
多项临床试验表明，低剂量非甾体抗炎药可缓解发作性紧张型头痛（ETH）。
本安慰剂对照研究旨在确定单次服用12.5毫克和25毫克双氯芬酸钾是否能有效缓解成人的ETH，并将其与400毫克布洛芬进行比较。
在德国22个初级保健中心进行了一项单剂量多中心、随机、双盲、双模拟临床试验。根据国际头痛协会的分类，所有受试者均有ETH病史。在684名随机分组的受试者中，620人在入组后一个月内使用研究药物治疗一次紧张性头痛发作：双氯芬酸钾12.5毫克（n = 160）、双氯芬酸钾25毫克（n = 156）、布洛芬400毫克（n = 151）和安慰剂（n = 153）。主要疗效变量为总疼痛缓解，计算方法为从基线到3小时评估时间（TOTPAR - 3）的疼痛缓解评估的时间加权总和。
对于TOTPAR - 3，所有活性治疗均优于安慰剂；三种活性治疗之间未检测到统计学上的显著差异。在TOTPAR - 6（6小时评估时间）、3小时和6小时时≥50%最大TOTPAR、3小时和6小时时的加权疼痛强度差异（SPID - 3；SPID - 6）、2小时时完全缓解头痛的患者百分比、研究结束时的总体评估以及使用急救药物的时间方面也观察到类似模式。布洛芬400毫克组6小时时的需治疗人数（NNT）为4.5（2.9 - 9.2），双氯芬酸钾12.5毫克组为4.0（2.8 - 7.3），双氯芬酸钾25毫克组为3.9（2.7 - 7.1）。这些差异无统计学意义。
单次服用12.5毫克和25毫克双氯芬酸钾能有效缓解ETH，且与400毫克布洛芬相当。
