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.
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.
Pini
Luigi Alberto
LA
Centro Cefalee, Azienda Ospedaliera Universitaria, Modena, Italy.
Del Bene
Enrico
E
Zanchin
Giorgio
G
Sarchielli
Paola
P
Di Trapani
Girolamo
G
Prudenzano
Maria Pia
MP
LaPegna
Giovanni
G
Savi
Lidia
L
Di Loreto
Giorgio
G
Dionisio
Paolo
P
Granella
Franco
F
D000082:Acetaminophen / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D000368:Aged; D018712:Analgesics, Non-Narcotic / Q000627:therapeutic use*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D002110:Caffeine / Q000627:therapeutic use*; D000697:Central Nervous System Stimulants / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004341:Drug Evaluation; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007558:Italy / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D009288:Naproxen / Q000627:therapeutic use*; D010147:Pain Measurement; D017288:Pain Threshold / Q000187:drug effects; D012189:Retrospective Studies; D018781:Tension-Type Headache / Q000188:drug therapy*; D055815:Young Adult
D018712:Analgesics, Non-Narcotic; D000894:Anti-Inflammatory Agents, Non-Steroidal; D000697:Central Nervous System Stimulants; D000082:Acetaminophen; D002110:Caffeine; D009288:Naproxen