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.