Clinical Studies

Study 82518

to evaluate the benefit of a
Migraine Blocking Blend

consisting of a high daily dose ofCoQ10, Riboflavin, Magnesium, Omega3 Oil, and a polyphenolic blend to determine effects of said supple mentation on symptoms of patients with migraine headaches.

Primary Objective

Efficacy Evaluation of a Migraine Blocking Blend in subjects diagnosed with episodic migraines, having two to eight migraine episodes per month and its impact on FREQUENCY of headache, SEVERITY of headache, and DURATION of headache.

BACKGROUND

A migraine is a chronic, episodic, and debilitating primary headache syndrome that affects about 15 to 20% of the world population.

  • A Migraineis a chronic, episodic, and debilitating primary headache syndrome that affects about15 to 20% of the world population. Migraines are generally classified as one of two main types.
  • The first type, migraine without aura (previously known as common migraine), affects about 15% of the population. In migraine without aura, the headache is usually unilateral, pulsating, and moderate to severe in intensity, and may last a few hours to 3 days. The headache may also be associated with nausea, vomiting, photophobia, and other symptoms.
  • The second type, migraine with aura (previously known as classic migraine), affects about 8% of the population. In migraine with aura, one or more auras, such as visual, somatosensory, and motor symptoms, development prior to the development of a migraine attack.
  • Migraine with aura and Migraine without aura co-occur in 13% of migraine sufferers.To evaluate the benefit of taking a product consisting of a high daily dose of CoQ10, Riboflavin, Magnesium, Omega3 Oil, and polyphenolic blend, a study was conducted to determine effects of said supplementation on symptoms of patients with common migraine headaches.

OVERVIEW

Overview of the study:

  • Study protocols were reviewed by independent Neurologist prior to study initiation.
  • Subjects with 2 to 8 migraine episodes per month with an interval of >48 hours between attacks, with or without migraine aura, and a maximum frequency of 15 migraine days per month.
  • Age Range: >18 to <50 years
  • Group 1 = Test Group; Group 2 = Placebo Group.
  • 80 participants: 86% were woman and 14% were male with a mean (±SD) age of 36.9 ± 12.2.
  • Product used is a high daily dose of CoQ10, Riboflavin,Magnesium, Omega3 Oil, and polyphenolic blend

Group 1

Migraine Blocking Blend contains the following: (DailyDose)

  • CoEnzymeQ10(CoQ10): 150mg
  • Riboflavin: 400mg
  • MagnesiumGlycinate: 400mg
  • VitaminD: 1000IU
  • Omega3OilBlend: 1140mg
  • PolyphenolicAntioxidantBlend: 50mg

Placebo contains the following: (DailyDose)

  • Starch: 1000mg
  • Vegetable Oil: 1140mg

SUMMARY OF RESULTS

  • Migraine supplement usage had the same level of effectiveness as prescription medications without major side effects.
  • Significant improvements were found in reduction of headache frequency, severity, and duration.
  • No significant difference was found for medication consumption (included over-the-counter medications, but no migraine prescriptions). This is likely due to the short duration of the study, which was not long enough to affect ingrained habits among migraine sufferers. As certain NSAIDS (ibuprofen, Advil, Motrin IB) may also cause abdominal pain, bleeding and other complications, these symptoms could not definitely be attributed to the study supplement.
  • Adverse effects, while common, were mild and of short effect.
    • 43 adverse events occurred during the study, 36 in group 1, and 7 in group 2 with patients reporting mild adverse events like constipation, stomach discomfort, soft stools, and diarrhea.
    • Events lasted between 1-3 days.
    • No individuals discontinued use of product due to adverse effects.

SIGNIFICANT RESULTS

Headache Frequency:

  • On day 56 Group 1 demonstrated a statistically significantly reduction of Headache Frequency with reduction of 26.5% with respect to baseline (Day 28) and a difference of -24.5% with respect to Group 2.
  • On day 112 Group 1 demonstrated a statistically significant reduction of Headache Frequency with a reduction of 22.6% with respect to baseline (Day 28) and a difference of -25.8% with respect to Group 2.
  • Excluding non-responders, results for Group 1 increased to 62% at day 56,71% at day 84, and 67% at day 112.

Conclusions: Test group experienced on average 1.5 fewer migraines per 28 days compared to base line. Placebo group experienced a slight decline (-0.5 migraines) in the first 28 days, but returned to baseline for the rest of the study period.

Headache Severity:

  • On day 56 Group 1 demonstrated a statistical significant reduction of Headache Severity with a reduction of33.3% with respect to baseline (Day 28).
  • On day 84 Group 1 demonstrated a statistical significant reduction of Headache Severity with a reduction of26.2% with respect to baseline (Day 28).
  • On day 112 Group 1 demonstrated a statistical significant reduction of Headache Severity with a reduction of 28.8% with respect to baseline.
  • Excluding non-responders, results for Group 1 increased to 64% at day 56, 73% at day 84, and 76% at day 112.


Conclusions: The test group experienced a reduction in self-reported headache severity -1.25 point on a 10 point scale (12.5% reduction) in the initial 28 days. This is an average of almost a full point reduction (10% reduction) compared to baseline over the entire length of the study. The placebo group experienced less than a 0.5 point reduction (5% reduction) over the entire length of the study.
Headache Duration:

  • On day 112 Group 1 demonstrated a statistical significant reduction of Duration of Headacheswith a reduction of 31.1% with respect to baseline(Day 28) and a difference of -23.4% with respect to Group 2.
  • Excluding non-responders, results for Group 1 increased to 76% at day 56, 75% at day 84, and 77% at day 112.

Conclusions: In conclusion, sufferers in our test group saw a significant decrease in both headache severity and headache duration. On average they experienced 12 fewer hours of migraines per 28-day period. In comparison, the placebo group experienced an average of only 3 fewer hours of migraines per 28-day period.

OVERALL CONCLUSION

Test product was effective in reducing overall symptoms of both severity and duration. Overall level of incident (frequency) was also reduced during the study, but not at the 95% significant level. The test product was overall a significant improvement in the health of the migraine sufferers. The therapy itself showed similar results to that of the common medications prescribed for prophylactic treatment of migraines.Anecdotally, 75% of the test subjects on the active test reached out at the conclusion of the study to identify where to continue purchase and use of the test product. Further studies are warranted to evaluate improvement of quality of life metrics, as well as longer duration to evaluate if total amount of NSAIDs are reduced as the subjects take the product.