Oral magnesium oxide prophylaxis of frequent migrainous headache in children: a randomized, double-blind, placebo-controlled trial
Wang F, Van Den Eeden SK, Ackerson LM, Salk SE, Reince RH, Elin RJ
Headache · 99 citas
Etiquetas de revisión
Financiación no declaradaDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación no declarada
Publicación
- Publicado
- 2003-06-01 · Headache · vol. 43 · número 6 · págs. 601–610
- Editorial
- Wiley
- Citado
- 235 citas · más que el 91% de estudios similares · 3.1× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 48 trabajos
- Acceso
- De pago
- Áreas de investigación
- Migraine and Headache Studies · Magnesium in Health and Disease · Traumatic Brain Injury Research
- Palabras clave
- magnesium oxide, migraine prophylaxis, pediatric migraine, headache frequency, headache severity, children and adolescents, complementary therapy
- MeSH
- humans, recurrence, magnesium oxide, treatment outcome, administration, oral, double-blind method, adolescent, child, child, preschool, female, male, migraine disorders
6 autores
- Fong Wang🇺🇸Kaiser Permanente; Kaiser Permanente Hayward Medical Center
- Stephen K. Van Den Eeden🇺🇸Kaiser Permanente
- Lynn Ackerson🇺🇸Kaiser Permanente
- Susan E. Salk🇺🇸Kaiser Permanente
- Robyn H. Reince🇺🇸Kaiser Permanente; Kaiser Permanente Hayward Medical Center
- Ronald J. Elin🇺🇸University of Louisville
Resumen
El texto original del estudio, en el idioma en que se publicó.
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 placebo in preventing frequent migrainous headache in children, but treatment with the active agent did lead to a significant reduction in headache days. Larger trials involving this safe, appealing complementary therapy are needed.
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