Methodological aspects of prophylactic drug trials in migraine.
The purpose of this paper is to analyse methodological aspects of prophylactic drug trials in migraine. A study of ferrum quartz in 33 patients provided the necessary data base. Migraine definitions, relation between interval headache and migraine, and a number of other clinical problems are discussed. A headache diary is presented which to a certain extent allows a separation of internal headache and migraine attacks. Virtually all patients with frequent migraine attacks have interval headaches. A statistical model which allows a separation of time effects and treatment effects is presented. The inter-patient variability was much greater than intra-patient variability. This indicates that it will be difficult to obtain sufficient power with a non-crossover design. The relation between duration of treatment periods and the necessary number of patients is shown to be inversely related.
D000328:Adult; D000368:Aged; D002986:Clinical Trials as Topic / Q000379:methods*; D004311:Double-Blind Method; D005260:Female; D005290:Ferric Compounds / Q000627:therapeutic use*; D006801:Humans; D007501:Iron / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000517:prevention & control*; D012825:Silicon / Q000627:therapeutic use*; D017655:Silicon Compounds
D005290:Ferric Compounds; D017655:Silicon Compounds; C035272:ferrum quartz; D007501:Iron; D012825:Silicon