Headache as a model for assessing mild analgesic drugs.

A method for the evaluation of the efficacy of mild analgesic drugs in outpatients with nonmigrainous headache is described. During the 3-hour drug evaluation period, patients were required to record at hourly intervals their pain intensity using both a verbal rating and a visual analog scale, their pain relief, and the occurrance of side effects. The results obtained in six studies consisted of comparisons of reference compounds aspirin (1000 mg) and two analgesic combinations (containing aminophenazone, caffeine, and butalbital); test medications aspirin (500 mg), codeine (30 mg), proquazone (300 mg), and new formulations of the two analgesic combinations (aminophenazone replaced by propyphenazone); and, in every study, placebo. In a seventh study, the analgesic effects of three doses aspirin (250, 500, and 1000 mg) were compared with that of placebo. Every study was conducted under double-blind, complete crossover conditions, and between 24 and 36 patients were used in each study. Using parametric and nonparametric statistical analyses, the reference compounds and the majority of the test medications exhibited significant analgesic properties. Also, a highly significant dose--response effect was demonstrated for aspirin. It is concluded that the headache model is a practicable, reliable, and sensisive method for the evaluation of the effectiveness of mild analgesic drugs.

RCT Entities:   Population Interventions Outcomes