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- Title
Oral Magnesium Oxide Prophylaxis of Frequent Migrainous Headache in Children: A Randomized, Double-Blind, Placebo-Controlled Trial.
- Authors
Wang, Fong; Van Den Eeden, Stephen K.; Ackerson, Lynn M.; Salk, Susan E.; Reince, Robyn H.; Elin, Ronald J.
- Abstract
Objective.—To assess whether, in children, oral magnesium oxide reduces migrainous headache frequency, severity, and associated features compared to placebo. Background.—There is no single, safe, widely well-tolerated, and effective prophylactic treatment for all children and adolescents with frequent migrainous headache. Design.—Randomized, double-blind, placebo-controlled, parallel-group trial. Methods.—This study was conducted between June 1997 and January 2000 using 7 selected Northern California Kaiser Permanente sites. We recruited children of ages 3 to 17 years who reported a 4-week history of at least weekly, moderate-to-severe headache with a throbbing or pulsatile quality, associated anorexia/nausea, vomiting, photophobia, sonophobia, or relief with sleep, but no fever or evidence of infection. Subjects were randomly assigned to receive either magnesium oxide (9 mg/kg per day by mouth divided 3 times a day with food) (n = 58) or matching placebo (n = 60) for 16 weeks. The number of headache days (days with at least one headache) during each of eight 2-week intervals was chosen to be the primary outcome variable. Results.—Of those enrolled, 86 (73%) completed the study (42 received magnesium oxide and 44 placebo); 74 of 192 eligible subjects declined to participate. Baseline information on demographic factors, health status, and headache history was similar comparing the 2 groups. By intention-to-treat analysis, we found a statistically significant decrease over time in headache frequency in the magnesium oxide group (P = .0037) but not in the placebo group (P = .086), although the slopes of these 2 lines were not statistically significantly different from each other (P = .88). The group treated with magnesium oxide had significantly lower headache severity (P = .0029) relative to the placebo group. Conclusions.—This study does not unequivocally determine whether oral magnesium oxide is or is not superior to...
- Subjects
MIGRAINE in children; PLACEBOS; OXIDES; MAGNESIUM; ORAL drug administration; THERAPEUTICS
- Publication
Headache: The Journal of Head & Face Pain, 2003, Vol 43, Issue 6, p601
- ISSN
0017-8748
- Publication type
Article
- DOI
10.1046/j.1526-4610.2003.03102.x