title: 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.
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.
authors.affiliation: Centro Cefalee, Azienda Ospedaliera Universitaria, Modena, Italy.
authors.forename: Luigi Alberto
authors.initials: LA
authors.lastname: Pini
authors.forename: Enrico
authors.initials: E
authors.lastname: Del Bene
authors.forename: Giorgio
authors.initials: G
authors.lastname: Zanchin
authors.forename: Paola
authors.initials: P
authors.lastname: Sarchielli
authors.forename: Girolamo
authors.initials: G
authors.lastname: Di Trapani
authors.forename: Maria Pia
authors.initials: MP
authors.lastname: Prudenzano
authors.forename: Giovanni
authors.initials: G
authors.lastname: LaPegna
authors.forename: Lidia
authors.initials: L
authors.lastname: Savi
authors.forename: Giorgio
authors.initials: G
authors.lastname: Di Loreto
authors.forename: Paolo
authors.initials: P
authors.lastname: Dionisio
authors.forename: Franco
authors.initials: F
authors.lastname: Granella
mesh_terms: 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
chemical_list: D018712:Analgesics, Non-Narcotic; D000894:Anti-Inflammatory Agents, Non-Steroidal; D000697:Central Nervous System Stimulants; D000082:Acetaminophen; D002110:Caffeine; D009288:Naproxen