Open Label Prospective Experience of Supplementation with a Fixed Combination of Magnesium, Vitamin B2, Feverfew, Andrographis Paniculata and Coenzyme Q10 for Episodic Migraine Prophylaxis
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 p...
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MDPI AG
2020-12-01
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| Series: | Journal of Clinical Medicine |
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| Online Access: | https://www.mdpi.com/2077-0383/10/1/67 |
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| author | Michail Vikelis Emmanouil V. Dermitzakis George S. Vlachos Panagiotis Soldatos Konstantinos C. Spingos Pantelis Litsardopoulos Evangelia Kararizou Andreas A. Argyriou |
| author_facet | Michail Vikelis Emmanouil V. Dermitzakis George S. Vlachos Panagiotis Soldatos Konstantinos C. Spingos Pantelis Litsardopoulos Evangelia Kararizou Andreas A. Argyriou |
| author_sort | Michail Vikelis |
| collection | DOAJ |
| description | 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; <i>p</i> < 0.001). Likewise, days with peak headache intensity of >4/10 (5.7 ± 3.4 vs. 4.9 ± 3.1; <i>p</i> < 0.001) as well as days using acute headache medications per month (8.9 ± 3.6 vs. 5.7 ± 3.4; <i>p</i> < 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. |
| first_indexed | 2024-03-10T13:44:40Z |
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| institution | Directory Open Access Journal |
| issn | 2077-0383 |
| language | English |
| last_indexed | 2024-03-10T13:44:40Z |
| publishDate | 2020-12-01 |
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| spelling | doaj.art-8c561587ac1e4f2eb9a84751c6f9855f2023-11-21T02:43:40ZengMDPI AGJournal of Clinical Medicine2077-03832020-12-011016710.3390/jcm10010067Open Label Prospective Experience of Supplementation with a Fixed Combination of Magnesium, Vitamin B2, Feverfew, Andrographis Paniculata and Coenzyme Q10 for Episodic Migraine ProphylaxisMichail Vikelis0Emmanouil V. Dermitzakis1George S. Vlachos2Panagiotis Soldatos3Konstantinos C. Spingos4Pantelis Litsardopoulos5Evangelia Kararizou6Andreas A. Argyriou7Headache Clinic, Mediterraneo Hospital, 16675 Glyfada, GreeceDepartment of Neurology, “Geniki Kliniki” Euromedica, 54645 Thessaloniki, GreeceHeadache Clinic, Mediterraneo Hospital, 16675 Glyfada, GreecePrivate Practice, 24131 Kalamata, GreeceCorfu Headache Clinic, 49131 Corfu, GreeceHeadache Outpatient Clinic, Neurology Department of the Saint Andrew’s State General Hospital of Patras, 26335 Patras, GreeceHeadache Outpatient Clinic, 1st Department of Neurology, National and Kapodistrian University of Athens, 11528 Athens, GreeceHeadache Outpatient Clinic, Neurology Department of the Saint Andrew’s State General Hospital of Patras, 26335 Patras, GreeceBackground: 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; <i>p</i> < 0.001). Likewise, days with peak headache intensity of >4/10 (5.7 ± 3.4 vs. 4.9 ± 3.1; <i>p</i> < 0.001) as well as days using acute headache medications per month (8.9 ± 3.6 vs. 5.7 ± 3.4; <i>p</i> < 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.https://www.mdpi.com/2077-0383/10/1/67episodic migrainepreventionnutraceuticalsmagnesiumvitamin B2feverfew |
| spellingShingle | Michail Vikelis Emmanouil V. Dermitzakis George S. Vlachos Panagiotis Soldatos Konstantinos C. Spingos Pantelis Litsardopoulos Evangelia Kararizou Andreas A. Argyriou 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 episodic migraine prevention nutraceuticals magnesium vitamin B2 feverfew |
| title | Open Label Prospective Experience of Supplementation with a Fixed Combination of Magnesium, Vitamin B2, Feverfew, Andrographis Paniculata and Coenzyme Q10 for Episodic Migraine Prophylaxis |
| title_full | Open Label Prospective Experience of Supplementation with a Fixed Combination of Magnesium, Vitamin B2, Feverfew, Andrographis Paniculata and Coenzyme Q10 for Episodic Migraine Prophylaxis |
| title_fullStr | Open Label Prospective Experience of Supplementation with a Fixed Combination of Magnesium, Vitamin B2, Feverfew, Andrographis Paniculata and Coenzyme Q10 for Episodic Migraine Prophylaxis |
| title_full_unstemmed | Open Label Prospective Experience of Supplementation with a Fixed Combination of Magnesium, Vitamin B2, Feverfew, Andrographis Paniculata and Coenzyme Q10 for Episodic Migraine Prophylaxis |
| title_short | Open Label Prospective Experience of Supplementation with a Fixed Combination of Magnesium, Vitamin B2, Feverfew, Andrographis Paniculata and Coenzyme Q10 for Episodic Migraine Prophylaxis |
| title_sort | open label prospective experience of supplementation with a fixed combination of magnesium vitamin b2 feverfew andrographis paniculata and coenzyme q10 for episodic migraine prophylaxis |
| topic | episodic migraine prevention nutraceuticals magnesium vitamin B2 feverfew |
| url | https://www.mdpi.com/2077-0383/10/1/67 |
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