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To investigate efficacy and safety of a supplementation with a fixed combination of magnesium, vitamin B2, feverfew, andrographis paniculata and coenzyme Q10 (Vivinor®) in episodic migraine prevention, by an observational, prospective real-world study in 113 Greek patients with episodic migraine that were prospectively followed-up for three months. The primary endpoint was the change in monthly migraine days between baseline period (BL)and the third month of treatment (T3).
To investigate efficacy and safety of a supplementation with a fixed combination of magnesium, vitamin B2, feverfew, andrographis paniculata and coenzyme Q10 (Vivinor®) in episodic migraine prevention.
An observational, prospective real-world study. After a one-month baseline period, Vivinor® was introduced in 113 Greek patients with episodic migraine that were prospectively followed-up for three months. The primary endpoint was the change in monthly migraine days between baseline period (BL)and the third month of treatment (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), MSQ-QOL (Migraine-Specific Quality of life questionnaire), HADS (Hospital Anxiety and Depression Scale) were also evaluated. Those with ≥50% reduction in monthly migraine days during T3 compared to BL were considered Vivinor®-responders.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| magnesium, vitamin B2, feverfew, andrographis paniculata and coenzyme Q10 | Dietary Supplement | Supplementation per os |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in monthly migraine days | Change in monthly migraine days between baseline period (BL) and the third month of treatment (T3) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean intensity of migraine | Changes in mean intensity of migraine between baseline period (BL) and the third month of treatment (T3) | 3 months |
| days with use of acute migraine medications | Changes in days with use of acute migraine medications between baseline period (BL) and the third month of treatment (T3) |
| Measure | Description | Time Frame |
|---|---|---|
| Migraine responders | Those with ≥50% reduction in monthly migraine days during T3 compared to BL were considered Vivinor®-responders. | 3 months |
Inclusion Criteria:
Exclusion Criteria:
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adult patients with a documented history of episodic migraine with or without aura for more than the 12 months prior to screening, according to the criteria of the International Classification of Headaches Disorders-III (IHS, 2013)
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| Name | Affiliation | Role |
|---|---|---|
| Michail Michail, MD, MSc, PhD | Mediterraneo Hospital, Glyfada, Greece | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Corfu HC | Corfu | 49100 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22529203 | Background | Holland S, Silberstein SD, Freitag F, Dodick DW, Argoff C, Ashman E; Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Evidence-based guideline update: NSAIDs and other complementary treatments for episodic migraine prevention in adults: report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Neurology. 2012 Apr 24;78(17):1346-53. doi: 10.1212/WNL.0b013e3182535d0c. |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D008274 | Magnesium |
| D012256 | Riboflavin |
| C000713829 | feverfew extract |
| C000713167 | Andrographis paniculata extract |
| C024989 | coenzyme Q10 |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
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| 3 months |
| Migraine Disability Assessment questionnaire (MIDAS) | Changes in scores of Migraine Disability Assessment questionnaire (MIDAS) during T3 | 3 months |
| Headache Impact Test-6 (HIT-6) | Changes in Headache Impact Test-6 (HIT-6) during T3 | 3 months |
| Migraine Therapy Assessment questionnaire (MTAQ) | Changes in Migraine Therapy Assessment questionnaire (MTAQ) during T3 | 3 months |
| D009422 | Nervous System Diseases |
| D008670 |
| Metals |
| D005415 | Flavins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |