1Pileje Laboratoire, 37 quai de Grenelle, 75015, 15 Paris cedex, France
1Pileje Laboratoire, 37 quai de Grenelle, 75015, 15 Paris cedex, France
1Pileje Laboratoire, 37 quai de Grenelle, 75015, 15 Paris cedex, France
2Centre d’Analysis et de Traitement de la Douleur, service de neurochirurgie, Hôpital Salengro, CHRU de Lille, 59037 Lille Cedex, France
Related Knowledge
Summary
Background
Migraine is a typical neurological dysfunction characterised by extreme episodic complications, that are steadily incapacitating. US authorities statistics point out that migraine impacts round one in seven People yearly [1]. European knowledge confirmed the imply prevalence of migraine amongst 170,000 adults to be 14.7% (8% in males and 17.6% in girls) [2]; in France, prevalence was reported to be between 12 to 21% within the Framig III examine [3].
Migraine therapy historically consists of acute remedy for aborting migraine assaults and prophylactic therapy for decreasing the frequency, period and severity of assaults. In accordance with the European Federation of Neurological Societies (EFNS) guideline, prophylactic therapy needs to be thought-about when the standard of life is severely impaired, when two or extra assaults happen per 30 days, when migraine assaults don’t reply to acute remedy or in case of frequent, very lengthy, or uncomfortable auras [4]. Regardless of the multitude of therapy choices out there, sufferers are sometimes dissatisfied resulting from failure of attaining optimum management and value of typical medication. As well as, a few of the current drugs are related to unacceptable adversarial results [5]. The necessity for efficient therapies with much less unwanted effects explains, not less than partly, the rising curiosity towards non-pharmacologic options for migraine prophylaxis, which embrace nutritional vitamins, minerals, and dietary supplements together with natural preparations.
The most effective-studied vegetation for migraine prophylaxis in adults is feverfew (Tanacetum parthenium L.). Antimigraine properties are attributed to its fundamental lively element, parthenolide, which has a number of actions together with vascular easy muscle leisure, inhibition of serotonin launch from platelets and anti inflammatory results [6, 7]. Efficacy of a feverfew monopreparation in migraine prevention was proven in a randomised double blind placebo-controlled medical examine [8]. Nevertheless, efficacy was not noticed in all research carried out with feverfew. This inconsistency in outcomes between research could possibly be as a result of variations within the focus and stability of parthenolides within the extracts examined [7].
Coenzyme Q10 has been hypothesized to be helpful in migraine prevention due to its vital position in sustaining mitochondrial vitality shops [6] and the proof that migraine ends in mitochondrial vitality deficiency within the mind [9–11]. It was additionally reported that coenzyme Q10 counteracts endothelial dysfunction by stimulating endothelial launch of nitric oxide and has anti-inflammatory results [6]. A examine performed in 1550 kids and adolescents with migraine confirmed that about one third of them had a coenzyme Q10 degree under the reference vary [12]. Supplementation of this subpopulation with coenzyme Q10 (1 to three mg/kg per day for 3 months) improved coenzyme Q10 degree, headache frequency and incapacity. In a double blind, randomised, placebo-controlled medical trial carried out in grownup sufferers with migraine [13], therapy with coenzyme Q10 (100 mg per os 3 times a day for 3 months) considerably decreased the frequency of migraine assaults.
There’s a massive physique of proof that factors to a state of magnesium deficiency in migraine victims that might contribute to migraine improvement [6, 14, 15]. Magnesium is concerned in a mess of organic processes, a few of which being linked to migraine pathogenesis (ATP manufacturing and performance, glucose metabolism, management of vascular tone) [7]. In a randomised placebo-controlled examine, supplementation with magnesium (600 mg per os each day for 3 months) considerably diminished the frequency of migraine assaults in grownup sufferers [16]. Efficacy of magnesium was additionally reported particularly in adults with migraine with out aura [17]. In kids, it was proven that pre-treatment with magnesium elevated the efficacy of acetaminophen and ibuprofen [18]. No helpful impact of magnesium for the prevention of migraine was additionally reported [19].
The American Academy of Neurology (AAN) and American Headache Society (AHS) guideline for migraine prevention in adults gave feverfew and magnesium a Degree B suggestion (most likely efficient and needs to be thought-about for prevention) [20] and the EFNS guideline a Degree C (possible efficacy) [4]. The AAN/AHS and EFNS tips gave coenzyme Q10 a Degree C suggestion.
Primarily based on this data, supplementation with these three components concurrently could be of profit for migraine victims. We performed an observational examine to evaluate a 3-month supplementation with a proprietary complement containing feverfew, coenzyme Q10 and magnesium (Antemig®) in adults identified with migraine based on the factors of the Worldwide Headache Society; the variety of days with migraine headache per 30 days was the first end result.
Strategies
Outcomes – “magnesium q10”
A complete of 132 sufferers have been screened by 20 GPs between January and December 2015. Thirty-four sufferers have been misplaced to follow-up throughout the baseline part (two GPs discontinued the examine [one died] resulting in the lack of 12 sufferers) and 23 sufferers have been excluded on V2 (Fig. (Fig.1).1). Due to this fact, 75 sufferers (Security Inhabitants) began supplementation on V2. Sixty-eight sufferers acquired not less than one dose of complement and have been assessed on V3 (ITT inhabitants) and 62 topics have been included within the PP inhabitants.
Dialogue
The outcomes of this observational examine counsel that the proprietary complement containing feverfew, coenzyme Q10 and magnesium could possibly be of curiosity for migraine prophylaxis. Therapy for 3 months considerably diminished the typical variety of days with migraine headache in grownup sufferers by greater than 3 days, the lower being progressive over the interval of supplementation and statistically important from first month. The selection of this main criterion is really helpful by the Worldwide Headache Society [25]. At baseline, members offered with the same old traits of migraine victims consulting GPs (i.e. primarily girls in center age); on common, that they had migraine headache for greater than 4 days per 30 days with frequent anxiousness as co-morbidity and deteriorated high quality of life as proven by the QVM questionnaire. After 3 months of supplementation, all parameters evaluated have been dramatically improved. With regard to the proportion of sufferers with a 50% discount within the variety of days with migraine headache, additionally a classical analysis criterion for prophylactic therapy of migraine, a major end result was noticed from first month and the proportion elevated progressively at 2 and three months. This commentary, which was additionally made for the first criterion, means that the dietary complement examined has a speedy onset of motion. Such a quick onset was beforehand reported within the randomised, double-blind, multicentre, placebo-controlled examine of Diener et al. [8] with a monopreparation of feverfew (MIG-99, 6.25 mg 3 times a day); on this examine, lower within the frequency of migraine assaults was important from the fifth week of therapy. Responder price in our examine was much like that reported in trials carried out with propranolol [26], divalproex sodium [27] and topiramate [28]. These typical medication have potential adversarial occasions, generally extreme in nature. For that reason, sufferers have a tendency to show to nutraceuticals and natural medicines for migraine aid. In our examine, the mixture of feverfew, coenzyme Q10 and magnesium was properly tolerated; solely 4 adversarial occasions of gentle severity have been reported in 4 sufferers. Feverfew, coenzyme Q10 and magnesium monopreparations haven’t been related to main security issues in earlier research; solely gentle and transient adversarial occasions, mostly gastro-intestinal complaints have been reported [5, 7, 20]. Now, tolerability and drug security is an element influencing compliance and maximization of compliance is one precept of preventive remedy [29]. A meta-analysis has proven that certainly one of six sufferers discontinue therapy with propranolol, which is the classical first-line drug for migraine prophylaxis [26]. In our examine, security was good.
The primary limitation of our examine is that it was an observational examine and was not randomised, double-blinded and placebo-controlled. Because of the placebo impact, generally excessive in migraine prophylactic therapy [30], the impact of supplementation could be overestimated. One other limitation is the relative modest dimension of the examine inhabitants.
Scientific trials carried out with feverfew, magnesium and coenzyme Q10 largely as single brokers have proven conflicting outcomes probably resulting from totally different dosages and formulations used [5, 6, 8, 12, 13, 16–19]. To our data, there is no such thing as a earlier report of a examine performed with a mix of feverfew, coenzyme Q10 and magnesium. A randomised medical trial carried out with a mix of feverfew, magnesium and riboflavin failed to point out a helpful impact over management (riboflavin); most likely as a result of round one third of sufferers within the two teams took concomitant prophylactic remedy throughout the examine (round 13% in our examine) [31]. In a current randomised double blind placebo-controlled medical trial carried out in 130 sufferers with a mix of 400 mg riboflavin, 600 mg magnesium and 150 mg coenzyme Q10 [32], the imply variety of days with migraine headache per 30 days declined by roughly 2 days after 3 months of therapy; though not statistically important, this discount was thought-about as clinically related. On this examine, supplementation had a major helpful impact on ache and on the affect of complications on life assessed with the HIT-6 questionnaire.
Conclusions
This observational examine performed in main care means that the proprietary complement containing feverfew, coenzyme Q10 and magnesium (Antemig®), on the dose of 1 pill per day for as much as 3 months, could possibly be efficient and properly tolerated for the prophylaxis of migraine in adults and deserves additional analysis; the outcomes must be confirmed in a randomised placebo-controlled medical trial. Supplementation with this formulation could possibly be notably helpful within the therapeutic armamentarium to satisfy the wants of sufferers affected by migraine; utilizing it along side typical therapies as a part of a multidisciplinary therapy plan is prone to lead to optimum responses.