Volume 16, Issue 1, 1 December 2015, 8p
a
Migraine and Headache Clinic, Königstein im Taunus, Germany
b Department of Neurology, University Hospital Essen, Essen, Germany
c Weber & Weber GmbH & Co.KG, Clinical Research, Inning, Germany
b Department of Neurology, University Hospital Essen, Essen, Germany
c Weber & Weber GmbH & Co.KG, Clinical Research, Inning, Germany
Abstract
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. © 2015, Gaul et al.; licensee
Springer.
Author keywords
Migraine; Nutritional Supplement; Prevention
Indexed keywords
EMTREE drug terms: magnesium; placebo; riboflavin; ubidecarenone
EMTREE medical terms: adult; aged; Article; assessment
of humans; chromaturia; controlled study; diarrhea; diet
supplementation; double blind procedure; drug efficacy; drug safety;
female; head impact test questionnaire; headache; human; major clinical
study; male; micturition disorder; migraine; multicenter study; pain
intensity; priority journal; randomized controlled trial; treatment
duration
Chemicals and CAS Registry Numbers: magnesium, 7439-95-4; riboflavin, 83-88-5; ubidecarenone, 303-98-0
Drug tradename: dolovent,migravent.
