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Improvement of migraine symptoms with a proprietary supplement containing riboflavin, magnesium and Q10: a randomized, placebo-controlled, double-blind, multicenter trial.

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.

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  • Authors+Show Affiliations

    ,

    Migraine and Headache Clinic, Königstein im Taunus, Germany, c.gaul@migraene-klinik.de.

    , ,

    Source

    MeSH

    Adult
    Dietary Supplements
    Double-Blind Method
    Drug Combinations
    Female
    Germany
    Humans
    Magnesium
    Male
    Middle Aged
    Migraine Disorders
    Riboflavin
    Surveys and Questionnaires
    Treatment Outcome
    Ubiquinone
    Vitamins

    Pub Type(s)

    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    25916335

    Citation

    Gaul, Charly, et al. "Improvement of Migraine Symptoms With a Proprietary Supplement Containing Riboflavin, Magnesium and Q10: a Randomized, Placebo-controlled, Double-blind, Multicenter Trial." The Journal of Headache and Pain, vol. 16, 2015, p. 516.
    Gaul C, Diener HC, Danesch U, et al. Improvement of migraine symptoms with a proprietary supplement containing riboflavin, magnesium and Q10: a randomized, placebo-controlled, double-blind, multicenter trial. J Headache Pain. 2015;16:516.
    Gaul, C., Diener, H. C., & Danesch, U. (2015). Improvement of migraine symptoms with a proprietary supplement containing riboflavin, magnesium and Q10: a randomized, placebo-controlled, double-blind, multicenter trial. The Journal of Headache and Pain, 16, p. 516. doi:10.1186/s10194-015-0516-6.
    Gaul C, et al. Improvement of Migraine Symptoms With a Proprietary Supplement Containing Riboflavin, Magnesium and Q10: a Randomized, Placebo-controlled, Double-blind, Multicenter Trial. J Headache Pain. 2015;16:516. PubMed PMID: 25916335.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Improvement of migraine symptoms with a proprietary supplement containing riboflavin, magnesium and Q10: a randomized, placebo-controlled, double-blind, multicenter trial. AU - Gaul,Charly, AU - Diener,Hans-Christoph, AU - Danesch,Ulrich, AU - ,, Y1 - 2015/04/03/ PY - 2015/02/23/received PY - 2015/03/19/accepted PY - 2015/4/29/entrez PY - 2015/4/29/pubmed PY - 2015/12/15/medline SP - 516 EP - 516 JF - The journal of headache and pain JO - J Headache Pain VL - 16 N2 - 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. SN - 1129-2377 UR - https://www.unboundmedicine.com/medline/citation/25916335/full_citation L2 - https://thejournalofheadacheandpain.biomedcentral.com/articles/10.1186/s10194-015-0516-6 DB - PRIME DP - Unbound Medicine ER -