The use of ibuprofen plus caffeine to treat tension-type headache.

Simple analgesics such as ibuprofen, aspirin, and acetaminophen have long been used in the treatment of tension-type headache. Studies of combination agents of aspirin with caffeine or acetaminophen with caffeine have also demonstrated efficacy as analgesic agents. Other evidence also suggests that caffeine may have an analgesic effect unto itself in the relief of pain. We undertook the direction of a multicenter, double-blind, placebo-controlled, parallel trial to assess the efficacy and safety of ibuprofen combined with caffeine in the treatment of tension-type headache. The study was designed to also verify the analgesic efficacy of caffeine and further assess the role of tension-type headache as a model for the study of pain.