The proprietary supplement containing feverfew, coenzyme Q10 and magnesium assessed could be beneficial and safe for the prevention of migraine in adult patients.

Migraine refers to neurological disorder associated with frequently incapacitating episodic headaches. The prevalence of migraine varies according to deviation in data in different countries. Migraine treatment includes acute treatment for reducing migraine attacks and prophylactic treatment for reducing frequency, duration and severity of attacks. According to the European Federation of Neurological Societies (EFNS) guideline, prophylactic treatment should be considered when the quality of life is severely impaired, when two or more attacks occur per month, when migraine attacks do not respond to acute therapy or in case of frequent, very long, or uncomfortable auras. Although a lot of treatment options are available, the patients prefer the non-pharmacological therapies (herbal formulations, vitamins and health supplements). One of the best studied herbal formulation is the use of feverfew (Tanacetum parthenium L.) that exhibits anti-migraine properties due to the presence of active component, parthenolide. It acts by multiple actions like vascular smooth muscle relaxation, inhibition of serotonin release from platelets and anti-inflammatory effects. Migraine results in mitochondrial energy deficiency in the brain and since coenzyme Q10 plays an important role in maintaining mitochondrial energy stores, it offers significant benefits in preventing the migraine. It acts by stimulating endothelial release of nitric oxide and has anti-inflammatory effects. Magnesium deficiency can also contribute to migraine development as it is involved in a multitude of biological processes, some of which being linked to migraine pathogenesis (ATP production and function, glucose metabolism, control of vascular tone). The American Academy of Neurology (AAN) and American Headache Society (AHS) guideline for migraine prevention in adults gave feverfew and magnesium a Level B recommendation and the EFNS guideline a Level C. The AAN/AHS and EFNS guidelines gave coenzyme Q10 a Level C recommendation. On the basis of above information, it can be hypothesized that all the three ingredients (feverfew, coenzyme Q10 and magnesium) can be helpful in migraine prevention and this study was conducted to estimate the efficacy of supplementation containing the same in migraine prevention.

Rationale behind the research:

Migraine patients seem to be dissatisfied with the existing conventional therapies for treatment of migraine due to their cost and side effects. Thus, this study was conducted to assess the benefits of a nutritional supplement in migraine patients.

Objective:

To assess the effectiveness and safety of supplement containing feverfew, coenzyme Q10 and magnesium in adults diagnosed with migraine according to the criteria of the International Headache Society.

Study outcome measures:

• Baseline characteristics: Gender, age, prevalence of migraine with and without aura, age at migraine onset and medical history of patients were studied at baseline
• Primary endpoints: The number of days with migraine headache during third month of supplementation
• Secondary endpoints: Reduction of at least 50% in the number of days with migraine headache, associated symptoms, quality of life (QVM), anxiety/depression (HADS), safety and compliance

Time Points: Baseline, 1st month, 2nd month and 3rd month.

Study outcomes

Baseline: There were no significant baseline differences between the groups.

• There was a significant reduction in the number of days with migraine headache during third month of supplementation compared to baseline phase (1.3 days ±1.5 versus 4.9 days ±2.6, p<0.0001; n=68 intention to treat; primary criterion) {Fig 1}

• A reduction of at least 50% in the number of days with migraine headache, 75% (51/68) after 3 months, with a progressive increase over the period of supplementation (63.2% [43/68] after 1 month and 70.6% [48/68] after 2 months) was observed in patients {Fig 2}

• There was a decrease in the proportion of patients with anxiety and depressive symptoms between baseline phase and third month of supplementation from 61.9% (39/63 patients with information available) to 35% (21/60) for depression and from 52.4% (33/63) to 30% (18/60) for anxiety
  

The study concluded that a proprietary supplement containing feverfew, coenzyme Q10 and magnesium could prove to be a functional therapy in migraine prophylaxis. Treatment with these supplements for 3 months generated significant results in migraine headache reduction by more than 3 days. The choice of this primary criterion is recommended by the International Headache Society. The patients were presented with frequent anxiety, usual characteristics of migraine and declined quality of life at baseline and after 3 months’ supplementation.  All parameters evaluated at baseline were significantly improved. Significant results were obtained at first month that rises at second and third month. These results were similar to that reported in trials performed with propranolol, divalproex sodium and topiramate. These conventional drugs suffer from severe adverse effects and due to this disadvantage, patients switch to other medications like nutraceuticals and herbal medicines. In this study, the safety of the combination of feverfew, coenzyme Q10 and magnesium was assessed and found to be safe and effective. Supplementation had a significant beneficial effect on pain and on the impact of headaches on life assessed with the HIT-6 questionnaire.