Improvement of migraine symptoms with a proprietary supplement containing riboflavin, magnesium and Q10

Summary

This randomized, double-blind, placebo-controlled multicenter trial investigated the effectiveness of a proprietary nutritional supplement (Migravent®/Dolovent®) composed of magnesium (600 mg), riboflavin (400 mg), and coenzyme Q10 (150 mg), along with low-dose multivitamins, in the prevention of migraines. The study addressed the increasing interest in non-pharmacologic migraine treatments, especially among patients seeking alternatives to conventional drugs due to side effects or contraindications.

Study Design and Participants

A total of 130 adult migraine patients aged 18–65 were recruited from 12 neurology centers across Germany. Inclusion criteria required a diagnosis of migraine (with or without aura) based on ICHD-II criteria, a history of at least three migraine attacks per month, and no use of preventive migraine treatments in the previous three months. After a 4-week baseline period, 130 patients were randomized to receive either the supplement or a placebo for 3 months.

Patients recorded their migraine days, pain intensity, and medication use in an online diary. The primary endpoint was the reduction in the number of migraine days. Secondary outcomes included maximum pain intensity, changes in HIT-6 scores (a validated migraine impact questionnaire), and patient self-reports of treatment efficacy.

Key Findings

1. Reduction in Migraine Days

Baseline migraine frequency averaged 6.2 days/month for both groups.

After 3 months, migraine days decreased to 4.4 days in the supplement group and 5.2 days in the placebo group, yielding a net reduction of 1.8 vs. 1.0 days, respectively.

This difference, while clinically relevant, did not reach statistical significance (p = 0.23).

2. Migraine Pain Intensity

Mean pain intensity on a 3-point scale dropped from 2.71 to 2.47 in the supplement group and from 2.70 to 2.64 in the placebo group.

This reduction was statistically significant in favor of the supplement (p = 0.03).

The percentage of patients with mild pain increased to 7.3% (vs. 1.8% in placebo), and those with severe pain dropped to 52.7% (vs. 64.9% in placebo).

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3. HIT-6 Scores

The supplement group’s average HIT-6 score dropped by 4.8 points (from 61.9 to 57.1), compared to a 2-pointdrop in the placebo group (from 61.9 to 59.9).

This difference was statistically significant (p = 0.01).

The observed reduction aligns with the minimally important change (MIC) threshold (−2.5 to −5.5), confirming clinical relevance.

4. Patient Evaluation of Efficacy

Patients rated the supplement’s efficacy significantly better than placebo (p = 0.01).

18.2% rated the supplement as “very good” vs. 0% in the placebo group.

29.1% of supplement users rated efficacy as “poor,” compared to 43.9% in the placebo group.

5. Safety and Tolerability

No serious adverse events occurred in either group.

Adverse reactions were higher in the supplement group (23.8%) vs. placebo (4.8%).

Most common were gastrointestinal symptoms (mainly diarrhea) and chromaturia (urine discoloration from riboflavin).

All adverse effects resolved before study completion.

Discussion and Interpretation

Although the primary endpoint (migraine day reduction) did not achieve statistical significance, the observed reduction of 1.8 days is considered clinically meaningful and comparable to established prophylactic drugs.

For example, a comparable trial using topiramate 100 mg/day reduced migraine days by 1.8 (vs. 1.1 with placebo) but reached significance due to a larger sample size (n = 139 vs. n = 55 here), suggesting that this trial might have been underpowered.

Secondary outcomes—especially reductions in pain intensity, HIT-6 scores, and patient satisfaction—were statistically and clinically significant, indicating the supplement’s potential benefit for improving migraine-related quality of life.

The study’s strengths include its double-blind, placebo-controlled design, multicenter recruitment, and use of validated tools (HIT-6, electronic diaries). One limitation noted was the potential for unblinding due to chromaturia, although patients were warned of this effect to reduce bias. The authors also acknowledge that the study was not powered to detect modest changes in migraine days.

Conclusion

While the supplement failed to significantly reduce the number of migraine days, it significantly improved secondary outcomes, including pain severity, quality of life, and subjective efficacy. Given its favorable safety profile and tolerability, this combination of magnesium, riboflavin, and coenzyme Q10 represents a promising non-pharmacological option for migraine prevention, particularly for patients seeking alternative or adjunctive therapies.

For full details, refer to the original article: https://pubmed.ncbi.nlm.nih.gov/25916335/