Open Label Prospective Experience of Supplementation with a Fixed Combination of Magnesium, Vitamin B2, Feverfew, Andrographis Paniculata and Coenzyme Q10 for Episodic Migraine Prophylaxis

Vikelis, Michail; Dermitzakis, Emmanouil V.; Vlachos, George S.; Soldatos, Panagiotis; Spingos, Konstantinos C.; Litsardopoulos, Pantelis; Kararizou, Evangelia; Argyriou, Andreas A.

doi:10.3390/jcm10010067

Open AccessArticle

Open Label Prospective Experience of Supplementation with a Fixed Combination of Magnesium, Vitamin B2, Feverfew, Andrographis Paniculata and Coenzyme Q10 for Episodic Migraine Prophylaxis

by

Michail Vikelis

^1,2,3,*

,

Emmanouil V. Dermitzakis

⁴

,

George S. Vlachos

¹

,

Panagiotis Soldatos

⁵,

Konstantinos C. Spingos

⁶,

Pantelis Litsardopoulos

⁷,

Evangelia Kararizou

³ and

Andreas A. Argyriou

⁷

¹

Headache Clinic, Mediterraneo Hospital, 16675 Glyfada, Greece

²

Glyfada Headache Clinic, 16675 Glyfada, Greece

³

Headache Outpatient Clinic, 1st Department of Neurology, National and Kapodistrian University of Athens, 11528 Athens, Greece

⁴

Department of Neurology, “Geniki Kliniki” Euromedica, 54645 Thessaloniki, Greece

⁵

Private Practice, 24131 Kalamata, Greece

⁶

Corfu Headache Clinic, 49131 Corfu, Greece

⁷

Headache Outpatient Clinic, Neurology Department of the Saint Andrew’s State General Hospital of Patras, 26335 Patras, Greece

^*

Author to whom correspondence should be addressed.

J. Clin. Med. 2021, 10(1), 67; https://doi.org/10.3390/jcm10010067

Submission received: 9 December 2020 / Revised: 17 December 2020 / Accepted: 23 December 2020 / Published: 27 December 2020

(This article belongs to the Special Issue New Trends and Advances in Treatment Headache Disorders)

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Abstract

Background: To investigate the efficacy and safety of supplementation with a fixed combination of magnesium, vitamin B2, feverfew, andrographis paniculata and coenzyme Q10 in episodic migraine (EM) prevention. Methods: A pilot, single-arm, open-label study was conducted. After a one-month baseline period, the above-described supplementation was introduced in 113 EM Greek patients, who were prospectively followed-up for three months. The primary endpoint was the change in monthly migraine days between baseline period (BSL) and the third month of supplementation (T3). Secondary endpoints included changes in mean intensity of migraine and in days with use of acute migraine medications. Changes in scores of Migraine Disability Assessment questionnaire (MIDAS), Headache Impact Test-6 (HIT-6), Migraine Therapy Assessment questionnaire (MTAQ), Migraine-Specific Quality-of-life questionnaire (MSQ-QOL), Hospital Anxiety and Depression Scale (HADS) were also evaluated. Those with ≥50% reduction in monthly migraine days at T3, compared to BSL were considered supplementation-responders. Results: The mean number of migraine days was significantly decreased between BSL and T3 (9.4 ± 3.7 vs. 6.1 ± 3.5; p < 0.001). Likewise, days with peak headache intensity of >4/10 (5.7 ± 3.4 vs. 4.9 ± 3.1; p < 0.001) as well as days using acute headache medications per month (8.9 ± 3.6 vs. 5.7 ± 3.4; p < 0.001) were significantly reduced. At T3, 64 patients (56.6%) were classified as responders. The beneficial effect of supplementation was also associated with significant changes in HIT-6, MIDAS, MTAQ and MSQ-QOL scores. There were no safety concerns. Conclusions: The supplementation we have tested appears to be an effective and well-tolerated preventive approach against EM. A randomized, placebo-controlled study is needed to confirm our results.

Keywords: episodic migraine; prevention; nutraceuticals; magnesium; vitamin B2; feverfew; coenzyme Q10

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MDPI and ACS Style

Vikelis, M.; Dermitzakis, E.V.; Vlachos, G.S.; Soldatos, P.; Spingos, K.C.; Litsardopoulos, P.; Kararizou, E.; Argyriou, A.A. Open Label Prospective Experience of Supplementation with a Fixed Combination of Magnesium, Vitamin B2, Feverfew, Andrographis Paniculata and Coenzyme Q10 for Episodic Migraine Prophylaxis. J. Clin. Med. 2021, 10, 67. https://doi.org/10.3390/jcm10010067

AMA Style

Vikelis M, Dermitzakis EV, Vlachos GS, Soldatos P, Spingos KC, Litsardopoulos P, Kararizou E, Argyriou AA. Open Label Prospective Experience of Supplementation with a Fixed Combination of Magnesium, Vitamin B2, Feverfew, Andrographis Paniculata and Coenzyme Q10 for Episodic Migraine Prophylaxis. Journal of Clinical Medicine. 2021; 10(1):67. https://doi.org/10.3390/jcm10010067

Chicago/Turabian Style

Vikelis, Michail, Emmanouil V. Dermitzakis, George S. Vlachos, Panagiotis Soldatos, Konstantinos C. Spingos, Pantelis Litsardopoulos, Evangelia Kararizou, and Andreas A. Argyriou. 2021. "Open Label Prospective Experience of Supplementation with a Fixed Combination of Magnesium, Vitamin B2, Feverfew, Andrographis Paniculata and Coenzyme Q10 for Episodic Migraine Prophylaxis" Journal of Clinical Medicine 10, no. 1: 67. https://doi.org/10.3390/jcm10010067

APA Style

Vikelis, M., Dermitzakis, E. V., Vlachos, G. S., Soldatos, P., Spingos, K. C., Litsardopoulos, P., Kararizou, E., & Argyriou, A. A. (2021). Open Label Prospective Experience of Supplementation with a Fixed Combination of Magnesium, Vitamin B2, Feverfew, Andrographis Paniculata and Coenzyme Q10 for Episodic Migraine Prophylaxis. Journal of Clinical Medicine, 10(1), 67. https://doi.org/10.3390/jcm10010067

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Open Label Prospective Experience of Supplementation with a Fixed Combination of Magnesium, Vitamin B2, Feverfew, Andrographis Paniculata and Coenzyme Q10 for Episodic Migraine Prophylaxis

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