Tolerability and efficacy of a combination of paracetamol and caffeine in the treatment of tension-type headache: a randomised, double-blind, double-dummy, cross-over study versus placebo and naproxen sodium

被引:0
作者
Luigi Alberto Pini
Enrico Del Bene
Giorgio Zanchin
Paola Sarchielli
Girolamo Di Trapani
Maria Pia Prudenzano
Giovanni LaPegna
Lidia Savi
Giorgio Di Loreto
Paolo Dionisio
Franco Granella
机构
[1] Centro Cefalee,Direzione Medica Centrale
[2] Azienda Ospedaliera Universitaria,Dipartimento di Neuroscienze
[3] Centro Cefalee,undefined
[4] Azienda Ospedaliera Universitaria Careggi,undefined
[5] Azienda Ospedaliera Universitaria,undefined
[6] Policlinico Monteluce,undefined
[7] Università del Sacro Cuore,undefined
[8] Policlinico Gemelli,undefined
[9] Azienda Ospedaliera Policlinico Consorziale,undefined
[10] Azienda USL 2,undefined
[11] Ospedale S. Giovanni Battista Molinette,undefined
[12] Angelini Farmaceutici,undefined
[13] ACRAF SpA,undefined
[14] Università di Parma,undefined
来源
The Journal of Headache and Pain | 2008年 / 9卷
关键词
Tension-type headache; Acute treatment; Paracetamol; Caffeine; Paracetamol–caffeine combination; Naproxen sodium;
D O I
暂无
中图分类号
学科分类号
摘要
The main aim of this study was to confirm in an Italian population affected by tension-type headache (TTH) the good profile of safety and tolerability of the combination paracetamol 1,000 mg–caffeine 130 mg (PCF) observed in previous studies, by a comparison with naproxen sodium 550 mg (NAP) and placebo (PLA). A secondary objective was to assess the efficacy of PCF in the acute treatment of TTH. This was a multicentre, randomised, double-blind, double-dummy, crossover, placebo-controlled trial. Tolerability was assessed by recording adverse events by the patient in the 4-h post-dose treatment. To assess the efficacy, the sum of pain intensity differences (SPID) and the total pain relief (TOTPAR) were calculated. Comparing PCF and NAP and PCF and PLA for tolerability, the difference was nonsignificant but the result regarding noninferiority was inconclusive, whilst NAP was noninferior to PLA. As regards SPID and TOTPAR, both PCF and NAP were better than placebo (P < 0.05), but not significantly different from each other. In conclusion, PCF was well-tolerated and effective in the treatment of acute TTH.
引用
收藏
页码:367 / 373
页数:6
相关论文
共 63 条
  • [1] Stovner L(2007)The global burden of headache: a documentation of headache prevalence and disability worldwide Cephalalgia 27 193-210
  • [2] Hagen K(2005)Has the prevalence of migraine and tension-type headache changed over a 12-year period? A Danish population survey Eur J Epidemiol 20 243-249
  • [3] Jensen R(1992)Impact of headache on sickness absence and utilisation of medical services: a Danish population study J Epidemiol Community Health 46 443-446
  • [4] Lyngberg AC(2005)Secular changes in health care utilization and work absence for migraine and tension-type headache. A population based study J Epidemiol Com Health 20 1007-1014
  • [5] Rasmussen BK(1998)Epidemiology of tension-type headache JAMA 279 381-383
  • [6] Jørgensen T(2006)Burden of tension-type headache Curr Pain Headache Rep 10 459-466
  • [7] Rasmussen BK(2006)Is any one analgesic superior for episodic tension-type headache? J Fam Pract 55 1064-1072
  • [8] Jensen R(2007)Acute pharmacotherapy of migraine, tension-type headache, and cluster headache J Headache Pain 8 127-134
  • [9] Olesen J(1991)The analgesic effects of caffeine in headache Pain 44 151-155
  • [10] Lyngberg AC(1994)Caffeine as an analgesic adjuvant in tension headache Clin Pharmacol Ther 56 576-586