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

Journal of Headache and Pain

Volumn 9, Issue 6, 2008, Pages 367-373

  Pini, Luigi Alberto ^a   Del Bene, Enrico ^b   Zanchin, Giorgio ^c   Sarchielli, Paola ^d   Di Trapani, Girolamo ^e   Prudenzano, Maria Pia ^f   LaPegna, Giovanni ^g   Savi, Lidia ^h   Di Loreto, Giorgio ⁱ   Dionisio, Paolo ⁱ   Granella, Franco ^j  

^a Azienda Ospedaliera di Modena   (Italy)

^b CAREGGI UNIVERSITY HOSPITAL   (Italy)

^c UNIVERSITY HOSPITAL OF PADOVA   (Italy)

^d POLICLINICO MONTELUCE   (Italy)

^e FONDAZIONE POLICLINICO UNIVERSITARIO A GEMELLI IRCCS   (Italy)

^f POLICLINICO   (Italy)

^g Azienda USL 2   (Italy)

^h MOLINETTE HOSPITAL   (Italy)

ⁱ Università Politecnica delle Marche ACRAF Gruppo Angelini   (Italy)

^j UNIVERSITY OF PARMA   (Italy)

more..

Author keywords

Acute treatment; Caffeine; Naproxen sodium; Paracetamol; Paracetamol caffeine combination; Tension type headache

Indexed keywords

ANALGESIC AGENT; CAFFEINE PLUS PARACETAMOL; NAPROXEN; PLACEBO; SYNFLEX FORTE; TACHIHAF; UNCLASSIFIED DRUG;

ABDOMINAL PAIN; ADULT; AGED; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIZZINESS; DOUBLE BLIND PROCEDURE; DROWSINESS; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DYSPEPSIA; FATIGUE; FEMALE; HEART PALPITATION; HUMAN; INSOMNIA; ITALY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; NERVOUSNESS; OUTCOME ASSESSMENT; PAIN ASSESSMENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; TENSION HEADACHE; VOMITING;

EID: 56549110163     PISSN: 11292369     EISSN: 11292377     Source Type: Journal    
DOI: 10.1007/s10194-008-0071-5     Document Type: Article

References (27)

1. Stovner L, Hagen K, Jensen R et al (2007) The global burden of headache: a documentation of headache prevalence and disability worldwide. Cephalalgia 27:193-210
2. Lyngberg AC, Rasmussen BK, Jørgensen T et al (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. Rasmussen BK, Jensen R, Olesen J (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, Rasmussen BK, Jensen R et al (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. Schwartz BS, Stewart WF, Simon D et al (1998) Epidemiology of tension-type headache. JAMA 279:381-383
6. Lenaerts ME (2006) Burden of tension-type headache. Curr Pain Headache Rep 10:459-466
7. Verhagen AP, Damen L, Berger MY (2006) Is any one analgesic superior for episodic tension-type headache? J Fam Pract 55:1064-1072
8. Tfelt-Hansen P (2007) Acute pharmacotherapy of migraine, tension-type headache, and cluster headache. J Headache Pain 8:127-134
9. Ward N, Whitney C, Avery D et al (1991) The analgesic effects of caffeine in headache. Pain 44:151-155
10. Migliardi JR, Armellino JJ, Friedman M et al (1994) Caffeine as an analgesic adjuvant in tension headache. Clin Pharmacol Ther 56:576-586
11. Miller DS, Talbot CA, Simpson W et al (1987) A comparison of naproxen sodium, acetaminophen and placebo in the treatment of muscle contraction headache. Headache 27:392-396
12. Lange R, Lentz R (1995) Comparison ketoproten, ibuprofen and naproxen sodium in the treatment of tension-type headache. Drugs Exp Clin Res 21:89-96
13. Prior MJ, Cooper KM, May LG et al (2002) Efficacy and safety of acetaminophen and naproxen in the treatment of tension-type headache. A randomized, double-blind, placebo-controlled trial. Cephalalgia 22:740-748
14. Headache Classification Subcommittee of the International Headache Society (2004) The International Classification of Headache Disorders, 2nd edn. Cephalalgia 24(Suppl 1):1-160
15. International Headache Society Committee on Clinical Trials (1995) Guidelines for trials of drug treatments in tension-type headache (1st edn). Cephalalgia 15:165-179
16. Piaggio G, Elbourne DR, Altman DG et al (2006) Reporting of noninferiority and equivalence randomized trials. An extension of the CONSORT statement. JAMA 295:1152-1160
17. Piletta P, Porchet HC, Dayer P (1991) Central analgesic effect of acetaminophen but not of aspirin. Clin Pharmacol Ther 49:350-354
18. Pini LA, Vitale G, Ottani A et al (1997) Naloxone-reversible antinociception by paracetamol in the rat. J Pharmacol Exp Ther 280:934-940
19. Sandrini M, Romualdi P, Capobianco A et al (2001) The effect of paracetamol on nociception and dynorphin A levels in the rat brain. Neuropeptides 35:110-116
20. Botting RM (2000) Mechanism of action of acetaminophen: Is there a cyclooxygenase 3? Clin Infect Dis 31(suppl 5):S202-S210
21. Daly JW, Bruns RF, Snyder SH (1981) Adenosine receptors in the central nervous system: Relationship to the central actions of methylxanthines. Life Sci 28:2083-2097
22. Galloway MP, Roth RH (1983) Neuropharmacology of 3-isobutylmethylxanthine: Effects on central noradrenergic systems in vivo. J Pharmacol Exp Ther 227:1-8
23. Sawynok J, Yaksh TL (1993) Caffeine as an analgesic adjuvant: A review of pharmacology and mechanisms of action. Pharmacol Rev 45:43-85
24. Onrot J, Shaheen O, Biaggioni I et al (1986) Reduction of liver plasma flow by caffeine and theophylline. Clin Pharmacol Ther 40:506-510
25. Iqbal N, Ahmad B, Janbaz KH et al (1995) The effect of caffeine on the pharmacokinetics of acetaminophen in man. Biopharm Drug Dispos 16:481-487
26. Laska EM, Sunshine A, Mueller F et al (1984) Caffeine as an analgesic adjuvant. JAMA 251:1711-1718
27. Schoenen J, Wang W (1997) Tension-type headache. In: Goadsby PJ, Silberstein SD (eds) Headache. Butterworth-Heinemann, Boston, pp 177-200