AI Article Synopsis
- The paper examines the methods used in prophylactic drug trials for migraine, focusing on a study of ferrum quartz in 33 patients.
- It discusses definitions of migraines, the relationship between headache types, and presents a headache diary to differentiate between internal headaches and migraine attacks.
- A statistical model highlights the greater variability between patients compared to within patients, suggesting challenges in achieving power with a non-crossover trial design; it also indicates that longer treatment periods require fewer participants.
Article Abstract
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.
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| http://dx.doi.org/10.1046/j.1468-2982.1981.0103127.x | DOI Listing |
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