Comparison ketoprofen, ibuprofen and naproxen sodium in the treatment of tension-type headache.

The safety and efficacy of treatment of tension-type headache with either ketoprofen or ibuprofen and naproxen sodium were evaluated in a prospective, randomized, double-blind parallel-group-study in 345 subjects. All patients were valid for evaluation of efficacy and safety. Headache pain intensity and pain relief were measured on categorical verbal scales 30, 45, 60, 120, 180 and 240 min after ingestion of a single dose of 12.5 mg or 25 mg ketoprofen, 200 mg ibuprofen and 275 mg naproxen sodium. At no time in four hours observation the efficacy of the four treatments differed, neither in pain intensity difference nor in the pain relief scale. A statistical comparison test was performed only once analysing the primary efficacy variable, the sum of pain intensity differences. There was no statistically significant difference among all treatments in this respect. The results of this clearly indicate that ketoprofen in a dosage of 12.5 or 25 mg, compared to 200 mg ibuprofen and 275 mg naproxen sodium, is an effective and safe treatment in tension-type headache.