The fixed combination of acetylsalicyclic acid, paracetamol and caffeine is more effective than the monotherapies and dual combination for the treatment of headache

Aim of the Study: We investigated efficacy, safety, and tolerability of two tablets of the fixed combination of 250mg acetylsalicyclic acid (ASA) + 200mg paracetamol + 50mg caffeine compared with 2×250mg ASA + 200mg paracetamol, 2×500mg ASA, 2×500mg paracetamol, or 2×50mg caffeine, and placebo in a randomised, placebo-controlled, double-blind study in patients representative for subjects who are used to treat their tension-type headache or migraine attacks with non-prescription analgesics. Methods/Patients: 2336 outpatients were enrolled in 133 centres. Of these, 353 patients were withdrawn after the pre-phase e…