title: The onset of action and the analgesic efficacy of Saridon (a propyphenazone/paracetamol/ caffeine combination) in comparison with paracetamol, ibuprofen, aspirin and placebo (pooled statistical analysis).
abstract: The objective was to evaluate the onset of action, analgesic efficacy and tolerability of Saridon*, a propyphenazone 150 mg/paracetamol 250 mg/caffeine 50 mg combination, in comparison with paracetamol 500 mg, aspirin 500 mg, ibuprofen 200 mg and placebo, by a pooled statistical analysis of eight studies. Out of 500 generally healthy patients (55.2% men, 44.8% women), average age 43.5 years, 329 (65.8%) had moderate and 171 (34.2%) severe acute dentoalveolar pain. More Saridon-treated patients reported 'pain gone/partly gone' and less 'pain unchanged or worse' compared with paracetamol, aspirin and placebo 30min (p = 0.009, p < 0.001, p = 0.001, respectively) and 60 min after dosing (p < 0.0001 for all). The difference with ibuprofen was observed 60 min after dosing (p < 0.01). Pain intensity differences 30 min and 60 min after dosing infer that Saridon has a faster onset of action than all of the other medications that it was compared with (ibuprofen at only 60 min after dosing). Total pain relief scores four hours after dosing were higher in the Saridon group compared with the paracetamol, ibuprofen, placebo (p < 0.0001 for all) and aspirin groups (p < 0.01). At the end of the study, patients assessed Saridon as more efficacious than the other study medications (p < 0.0001 for all). No serious adverse events were observed with any of the drugs studied. All medications were well tolerated. Twenty patients (4.0%) reported adverse events with no significant differences between groups. The most common adverse events were gastrointestinal disorders, followed by nervous system, skin, subcutaneous tissue, respiratory, cardiac and general disorders. Saridon is an effective analgesic that combines the advantage of fast onset and effective analgesia as compared with paracetamol alone, ibuprofen, aspirin or placebo. The results of this pooled analysis of eight studies should be confirmed in a double-blind study, since seven of the studies included in this analysis were single blind.
authors: Oral and Maxillofacial Surgery Cranial Pain Research, Tucson, Arizona, USA.
authors: Theodore A
authors: TA
authors: Kiersch
authors: Milos R
authors: MR
authors: Minić
mesh_terms: D000328:Adult; D000983:Antipyrine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D001241:Aspirin / Q000627:therapeutic use*; D002110:Caffeine / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007052:Ibuprofen / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement / Q000187:drug effects; D010615:Phenacetin / Q000009:adverse effects / Q000627:therapeutic use*; D015990:Placebo Effect; D011728:Pyridones / Q000009:adverse effects / Q000627:therapeutic use*; D016037:Single-Blind Method; D014098:Toothache / Q000188:drug therapy*
chemical_list: D004338:Drug Combinations; D011728:Pyridones; D002110:Caffeine; C019552:Saridon; D010615:Phenacetin; D001241:Aspirin; D000983:Antipyrine; D007052:Ibuprofen