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Randomized Controlled Trial
. 2008 Dec;9(6):367-73.
doi: 10.1007/s10194-008-0071-5. Epub 2008 Sep 25.

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

Luigi Alberto Pini  1 , Enrico Del Bene, Giorgio Zanchin, Paola Sarchielli, Girolamo Di Trapani, Maria Pia Prudenzano, Giovanni LaPegna, Lidia Savi, Giorgio Di Loreto, Paolo Dionisio, Franco Granella
Affiliations
Randomized Controlled Trial

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

Luigi Alberto Pini et al. J Headache Pain. 2008 Dec.

Abstract

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.

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Figures

Fig. 1
Fig. 1
Time course of the mean pain intensity difference (PID) for the three investigational treatments (intention-to-treat dataset, n = 91). PCF paracetamol 1,000 mg + caffeine 130 mg; NAP naproxen sodium 550 mg, PLA placebo
Fig. 2
Fig. 2
Time course of total pain relief (TOTPAR) for the three investigational treatments (intention-to-treat dataset, n = 81). PCF paracetamol 1,000 mg + caffeine 130 mg, NAP naproxen sodium 550 mg, PLA placebo
See this image and copyright information in PMC

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