Charly Gaul, Hans-Christoph Diener, Ulrich Danesch
Journal: The journal of headache and pain 2015;16():516
PMID: 25916335
Migraine is a functional disorder of the brain. Non-medical, non-pharmacological and pharmacological treatments are recommended for the prevention of migraine. The aim of this study was to evaluate the efficacy of a proprietary nutritional supplement containing a fixed combination of magnesium, riboflavin and Q10 as prophylactic treatment for migraine. This study is a randomized double-blind placebo controlled, multicentre trial. The study enrolled 173 participants for the baseline phase of which 130 were randomised to one of the two groups; supplement (n=64) or placebo (n=66). Results show a reduction of migraine pain and burden of disease after 3 months of treatment with the supplement. Patients rated the efficacy of the treatment significantly superior to placebo. Furthermore, abdominal discomfort and diarrhoea due to high amounts of magnesium were the main adverse events associated with the supplement. Authors conclude that the nutritional supplement had a trend towards statistical significance in the reduction of migraine days, probably due to being underpowered. Migraine symptoms and burden of disease, however, were statistically significantly reduced compared to placebo. Healthcare practitioners could use the results of this study to consider supplementation with the studied nutrients when working with migraine patients.
BACKGROUND
Non-medical, non-pharmacological and pharmacological treatments are recommended for the prevention of migraine. The purpose of this randomized double-blind placebo controlled, multicenter trial was to evaluate the efficacy of a proprietary nutritional supplement containing a fixed combination of magnesium, riboflavin and Q10 as prophylactic treatment for migraine.
METHODS
130 adult migraineurs (age 18 - 65 years) with ≥ three migraine attacks per month were randomized into two treatment groups: dietary supplementation or placebo in a double-blind fashion. The treatment period was 3 months following a 4 week baseline period without prophylactic treatment. Patients were assessed before randomization and at the end of the 3-month-treatment-phase for days with migraine, migraine pain, burden of disease (HIT-6) and subjective evaluation of efficacy.
RESULTS
Migraine days per month declined from 6.2 days during the baseline period to 4.4 days at the end of the treatment with the supplement and from 6.2.days to 5.2 days in the placebo group (p = 0.23 compared to placebo). The intensity of migraine pain was significantly reduced in the supplement group compared to placebo (p = 0.03). The sum score of the HIT-6 questionnaire was reduced by 4.8 points from 61.9 to 57.1 compared to 2 points in the placebo-group (p = 0.01). The evaluation of efficacy by the patient was better in the supplementation group compared to placebo (p = 0.01).
CONCLUSIONS
Treatment with a proprietary supplement containing magnesium, riboflavin and Q10 (Migravent® in Germany, Dolovent® in USA) had an impact on migraine frequency which showed a trend towards statistical significance. Migraine symptoms and burden of disease, however, were statistically significantly reduced compared to placebo in patients with migraine attacks.
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