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Автор Pfaffenrath, V
Автор Wessely, P
Автор Meyer, C
Автор Isler, HR
Автор Evers, S
Автор Grotemeyer, KH
Автор Taneri, Z
Автор Soyka, D
Автор G”bel, H
Автор Fischer, M
Дата выпуска 1996
dc.description The migraine prophylactic effect of 10 mmol magnesium twice-daily has been evaluated in a multicentre, prospective, randomized, double-blind, placebo-controlled study. Patients with two to six migraine attacks per month without aura, and history of migraine of at least 2 years, were included. A 4-week baseline period without medication was followed by 12 weeks of treatment with magnesium or placebo. The primary efficacy end-point was a reduction of at least 50% in intensity or duration of migraine attacks in hours at the end of the 12 weeks of treatment compared to baseline. With a calculated total sample size of 150 patients, an interim analysis was planned after completing treatment of at least 60 patients, which in fact was performed with 69 patients (64F, 5M), aged 18–64 years. Of these, 35 had received magnesium and 34 placebo. The number of responders was 1 in each group (28.6% under magnesium and 29.4% under placebo). As determined in the study protocol, this was a major reason to discontinue the trial. With regard to the number of migraine days or migraine attacks there was no benefit with magnesium compared to placebo. There were no centre-specific differences, and the final assessments of treatment efficacy by the doctor and patient were largely equivocal. With respect to tolerability and safety, 45.7% of patients in the magnesium group reported primarily mild adverse events like soft stool and diarrhoea in contrast to 23.5% in the placebo group.
Издатель SAGE Publications
Тема Efficacy
Тема magnesium
Тема migraine prophylaxis
Тема safety
Тема tolerability
Название Magnesium in the Prophylaxis of Migraine—a Double-Blind, Placebo-Controlled Study
Тип other
DOI 10.1046/j.1468-2982.1996.1606436.x
Electronic ISSN 1468-2982
Print ISSN 0333-1024
Журнал Cephalalgia
Том 16
Первая страница 436
Последняя страница 440
Аффилиация Pfaffenrath, V, 1 Neurological Practice, Munich, Germany;
Аффилиация Wessely, P, 2 Department of Neurology, University of Vienna, Austria;
Аффилиация Meyer, C, 3 Neurological Practice, Baden;
Аффилиация Isler, HR, 4 Department of Neurology, University of Zrich, Switzerland;
Аффилиация Evers, S, 5 Department of Neurology, University of Mnster;
Аффилиация Grotemeyer, KH, 6 Clinic for Psychosomatics and Neurology, Duisburg;
Аффилиация Taneri, Z, 6 Clinic for Psychosomatics and Neurology, Duisburg;
Аффилиация Soyka, D, 7 Department of Neurology, University of Kiel;
Аффилиация G”bel, H, 7 Department of Neurology, University of Kiel;
Аффилиация Fischer, M, 8 Institute for Numerical Statistics, Cologne, Germany
Выпуск 6
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