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Scientific Papers on Alternative Migraine Treatment

Efficacy of Ginkgolide B in the prophylaxis of migraine with aura

D'Andrea G, Bussone G, Allais G, Aguggia M, D'Onofrio F, Maggio M, Moschiano F, Saracco MG, Terzi MG, Petretta V, Benedetto C.
Headache and Cerebrovascular Center, Villa Margherita Neurology Clinic, Arcugnano, 36057, Vicenza, Italy. giovidavi@virgilio.it
Neurol Sci. 2009 May;30 Suppl 1:S121-4.

In a multicentric, open, preliminary trial, we evaluated the use of Ginkgolide B, a herbal constituent extract from Ginkgo biloba tree leaves, in the prophylactic treatment of migraine with aura (MA). Fifty women suffering from migraine with typical aura, or migraine aura without headache, diagnosed according to International Headache Society criteria, entered a six-month study. They underwent a two month run-in period free of prophylactic drugs, followed by a four month treatment period (subdivided into two bimesters, TI and TII) with a combination of 60 mg ginkgo biloba terpenes phytosome, 11 mg coenzyme Q 10, and 8.7 mg vitamin B2 (Migrasoll), administered twice daily. A detailed diary reporting neurological symptoms, duration, and frequency of MA was compiled by patients throughout the trial. The number of MA significantly decreased during treatment (from 3.7 +/- 2.2 in the run-in period, to 2.0 +/- 1.9 during TI and to 1.2 +/- 1.6 during TII; Anova for repeated measures: P < 0.0001). There was also a statistically significant decrease in the average MA duration, which was 40.4 +/- 19.4 min during run-in, 28.2 +/- 19.9 during TI, and 17.6 +/- 20.6 during TII. Total disappearance of MA was observed in 11.1% patients during TI and in 42.2% of patients during T2. No serious adverse event was provoked by Migrasoll administration. Ginkgolide B is effective in reducing MA frequency and duration. The effect is clearly evident in the first bimester of treatment and is further enhanced during the second.
PMID: 19415441 [PubMed - indexed for MEDLINE]

Riboflavin prophylaxis in pediatric and adolescent migraine

Condò M, Posar A, Arbizzani A, Parmeggiani A.
Department of Neurological Sciences, University of Bologna, Bologna, Italy.
J Headache Pain. 2009 Oct;10(5):361-5. Epub 2009 Aug 1.

Migraine is a common disorder in childhood and adolescence. Studies on adults show the effectiveness and tolerability of riboflavin in migraine prevention, while data on children are scarce. This retrospective study reports on our experience of using riboflavin for migraine prophylaxis in 41 pediatric and adolescent patients, who received 200 or 400 mg/day single oral dose of riboflavin for 3, 4 or 6 months. Attack frequency and intensity decreased (P < 0.01) during treatment, and these results were confirmed during the follow-up. A large number of patients (77.1%) reported that abortive drugs were effective for controlling ictal events. During the follow-up, 68.4% of cases had a 50% or greater reduction in frequency of attacks and 21.0% in intensity. Two patients had vomiting and increased appetite, respectively, most likely for causes unrelated to the use of riboflavin. In conclusion, riboflavin seems to be a well-tolerated, effective, and low-cost prophylactic treatment in children and adolescents suffering from migraine.
PMID: 19649688 [PubMed - indexed for MEDLINE]
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A randomized double-blind placebo-controlled trial of thioctic acid in migraine prophylaxis

Magis D, Ambrosini A, Sándor P, Jacquy J, Laloux P, Schoenen J.
Headache Research Unit, Neurology Department, University of Liège, Liège, Belgium.
Headache. 2007 Jan;47(1):52-7.

BACKGROUND: Impaired mitochondrial phosphorylation potential may play a role in migraine pathogenesis. Metabolic enhancers, such as riboflavin or coenzyme Q, are effective in migraine prophylaxis and quasi-devoid of adverse effects. Thioctic acid (-lipoic acid) is another substance known to enhance energy metabolism in mitochondria and to be beneficial in diabetic neuropathy. OBJECTIVE: After an open pilot study suggesting its therapeutic antimigraine potentials, we embarked therefore in a randomized controlled trial of thioctic acid (Thioctacid) in migraine prophylaxis steered by the Belgian Headache Society. METHODS: Five Belgian centers recruited 54 migraineurs (43 migraine without aura, 11 with aura; mean age 38 +/- 8 years; 7 males). After a 1-month single-blinded run-in period, 44 patients received either placebo (n = 18) or thioctic acid 600 mg p.o./day (n = 26) for 3 months. RESULTS: Statistical analysis was carried out on an intention-to-treat basis. Monthly attack frequency tended to be reduced between run-in and the 3rd month of treatment in the thioctic acid group compared to placebo (P= .06). The proportion of 50% responders was not significantly different between thioctic acid (30.8%) and placebo (27.8%). Within-group analyses showed a significant reduction of attack frequency (P= .005), headache days (P= .009), and headache severity (P= .03) in patients treated with thioctic acid for 3 months, while these outcome measures remained unchanged in the placebo group. No adverse effects were reported. For logistical reasons this trial was interrupted before the planned 80 patients were enrolled. CONCLUSION: Albeit underpowered, this study tends to indicate that thioctic acid may be beneficial in migraine prophylaxis. Before any firm conclusion can be drawn, however, a large multicenter trial is necessary.
PMID: 17355494 [PubMed - indexed for MEDLINE]
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Petasites hybridus root (butterbur) is an effective preventive treatment for migraine

Lipton RB, Göbel H, Einhäupl KM, Wilks K, Mauskop A.
Department of Neurology, Albert Einstein College of Medicine, 1165 Morris Park Ave., Rousso Bldg., Rm. 332, Bronx, NY 10461, USA. rlipton@aecom.yu.edu
Neurology. 2004 Dec 28;63(12):2240-4.

OBJECTIVE: To evaluate the clinical efficacy of a standardized special root extract from the plant Petasites hybridus as a preventive therapy for migraine. METHODS: This is a three-arm, parallel-group, randomized trial comparing Petasites extract 75 mg bid, Petasites extract 50 mg bid, or placebo bid in 245 patients with migraine. Eligible patients met International Headache Society criteria for migraine, were ages 18 to 65, and had at least two to six attacks per month over the preceding 3 months. The main outcome measure was the decrease in migraine attack frequency per month calculated as percentage change from baseline over a 4-month treatment period. RESULTS: Over 4 months of treatment, in the per-protocol analysis, migraine attack frequency was reduced by 48% for Petasites extract 75 mg bid (P = 0.0012 vs placebo), 36% for Petasites extract 50 mg bid (p = 0.127 vs placebo), and 26% for the placebo group. The proportion of patients with a > or =50% reduction in attack frequency after 4 months was 68% for patients in the Petasites extract 75-mg arm and 49% for the placebo arm (P < 0.05). Results were also significant in favor of Petasites 75 mg at 1, 2, and 3 months based on this endpoint. The most frequently reported adverse reactions considered possibly related to treatment were mild gastrointestinal events, predominantly burping. CONCLUSIONS: Petasites extract 75 mg bid is more effective than placebo and is well tolerated as a preventive therapy for migraine. Petasites 50 mg PO bid was not significantly more effective than placebo on the primary study endpoints.
PMID: 15623680 [PubMed - indexed for MEDLINE]
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Coenzyme Q10 deficiency and response to supplementation in pediatric and adolescent migraine

Hershey AD, Powers SW, Vockell AL, Lecates SL, Ellinor PL, Segers A, Burdine D, Manning P, Kabbouche MA.
Division of Neurology, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Cincinnati, OH 45229, USA.
Headache. 2007 Jan;47(1):73-80.

BACKGROUND: Coenzyme Q10 (CoQ10) has been suggested to be effective in the prevention of migraine, and levels can be quantified with standardized reference ranges. OBJECTIVE: This study documents the prevalence of CoQ10 deficiency in migraine headache and examines the potential effectiveness of supplementation. METHODS: We assessed patients attending a tertiary care center with frequent headaches for CoQ10 deficiency. We recommended patients with low CoQ10 levels begin supplementation with CoQ10 as part of their multidisciplinary treatment plan. We assessed response to treatment including correction of CoQ10 deficiency, overall headache improvement, and headache disability. RESULTS: CoQ10 was measured in 1550 patients (mean age 13.3 +/- 3.5, range 3 to 22 years). The mean total CoQ10 level was 0.60 +/- 0.20 microg/mL (range 0.21 to 1.77 microg/mL). Of these patients, 32.9% were below the reference range. Patients with low CoQ10 were recommended to start 1 to 3 mg/kg per day of CoQ10 in liquid gel capsule formulation. In a subset of patients who returned for timely follow-up (mean, 97 days), the total CoQ10 level improved to 1.20 +/- 0.59 microg/mL (P < .0001), while the headache frequency improved from 19.2 +/- 10.0 to 12.5 +/- 10.8 (P < .001) and headache disability assessed with PedMIDAS improved from 47.4 +/- 50.6 to 22.8 +/- 30.6 (P < .001). CONCLUSIONS: Deficiency of CoQ10 may be common in pediatric and adolescent migraine. Determination of deficiency and consequent supplementation may result in clinical improvement. Further analysis involving more scientifically rigorous methodology will be required to confirm this observation.
PMID: 17355497 [PubMed - indexed for MEDLINE]
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Efficacy of coenzyme Q10 in migraine prophylaxis: a randomized controlled trial

Sándor PS, Di Clemente L, Coppola G, Saenger U, Fumal A, Magis D, Seidel L, Agosti RM, Schoenen J.
Headache and Pain Unit, Neurology Department, University Hospital Zurich, Frauenklinikstrasse 26, 8091 Zurich, Switzerland.
Neurology. 2005 Feb 22;64(4):713-5.

Riboflavin, which improves energy metabolism similarly to coenzyme Q10 (CoQ10), is effective in migraine prophylaxis. We compared CoQ10 (3 x 100 mg/day) and placebo in 42 migraine patients in a double-blind, randomized, placebo-controlled trial. CoQ10 was superior to placebo for attack-frequency, headache-days and days-with-nausea in the third treatment month and well tolerated; 50%-responder-rate for attack frequency was 14.4% for placebo and 47.6% for CoQ10 (number-needed-to-treat: 3). CoQ10 is efficacious and well tolerated.
PMID: 15728298 [PubMed - indexed for MEDLINE]
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The effects of magnesium prophylaxis in migraine without aura

Köseoglu E, Talaslioglu A, Gönül AS, Kula M.
Erciyes University, Medicine Faculty, Neurology Department, Kayseri, Turkey. emelk@erciyes.edu.tr
Magnes Res. 2008 Jun;21(2):101-8.

There are inconsistent findings about the efficacy of magnesium in the prophylaxis of migraine attacks and there is no study of magnesium prophylaxis focused on migraine subtypes without aura. In this double blind, randomized, placebo controlled study; we tried to evaluate the prophylactic effects of oral magnesium in migraine patients without aura. The prophylactic effects of 600 mg/day oral magnesium citrate supplementation were assessed by means of clinical evaluation, visual evoked potential and statistical parametric mapping of brain single photon emission computerized tomography before and after a 3 month treatment period. The results of 30 patients with migraine without aura (20-55 years old with 2-5 migraine attacks per month) on magnesium treatment were compared with those of 10 patients with similar properties on placebo treatment. Migraine attack frequency, severity and P1 amplitude in visual evoked potential examination decreased after magnesium treatment with respect to pretreatment values (P < 0.001). In a comparison of the effects of magnesium treatment with those of placebo, post/pretreatment ratios of migraine attack frequency, severity and P1 amplitude in Mg treatment group were found to be significantly lower than those in placebo treatment group (attack frequency P = 0.005, attack severity P < 0.001, P1 amplitude P < 0.05). Cortical blood flow in inferolateral frontal (P < 0.001), inferolateral temporal (P = 0.001) and insular regions (P< 0.01) increased significantly after magnesium treatment with respect to the pretreatment; while such significant changes of cortical blood flow were not observed with placebo treatment. These results have made us think that magnesium is a beneficial agent in prophylaxis of migraine without aura and might work with both vascular and neurogenic mechanisms.
PMID: 18705538 [PubMed - indexed for MEDLINE]
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Role of magnesium in the pathogenesis and treatment of migraine

Sun-Edelstein C, Mauskop A.
The New York Headache Center, New York, NY 10021, USA. drsun@nyheadache.com
Expert Rev Neurother. 2009 Mar;9(3):369-79.

Magnesium is an important intracellular element that is involved in numerous cellular functions. Deficiencies in magnesium may play an important role in the pathogenesis of migraine headaches by promoting cortical spreading depression, alteration of neurotransmitter release and the hyperaggregation of platelets. Given this multifaceted role of magnesium in migraine, the use of magnesium in both acute and preventive headache treatment has been researched as a potentially simple, inexpensive, safe and well-tolerated option. Studies have shown that preventive treatment with oral magnesium and acute headache treatment with intravenous magnesium may be effective, particularly in certain subsets of patients. In this review, the pathogenesis of migraine will be discussed, with an emphasis on the role of magnesium. Studies on the use of intravenous and oral magnesium in migraine treatment will be discussed and recommendations will be made regarding the use of magnesium in treating migraine headaches.
PMID: 19271946 [PubMed - indexed for MEDLINE]
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Efficacy and safety of 6.25 mg t.i.d. feverfew CO2-extract (MIG-99) in migraine prevention--a randomized, double-blind, multicentre, placebo-controlled study

Diener HC, Pfaffenrath V, Schnitker J, Friede M, Henneicke-von Zepelin HH.
Neurologische Universitätsklinik, Essen, Germany. h.diener@uni-essen.de
Cephalalgia. 2005 Nov;25(11):1031-41.

The efficacy and tolerability of a CO(2)-extract of feverfew (MIG-99, 6.25 mg t.i.d.) for migraine prevention were investigated in a randomized, double-blind, placebo-controlled, multicentre, parallel-group study. Patients (N = 170 intention-to-treat; MIG-99, N = 89; placebo, N = 81) suffering from migraine according to International Headache Society criteria were treated for 16 weeks after a 4-week baseline period. The primary endpoint was the average number of migraine attacks per 28 days during the treatment months 2 and 3 compared with baseline. Safety parameters included adverse events, laboratory parameters, vital signs and physical examination. The migraine frequency decreased from 4.76 by 1.9 attacks per month in the MIG-99 group and by 1.3 attacks in the placebo group (P = 0.0456). Logistic regression of responder rates showed an odds ratio of 3.4 in favour of MIG-99 (P = 0.0049). Adverse events possibly related to study medication were 9/107 (8.4%) with MIG-99 and 11/108 (10.2%) with placebo (P = 0.654). MIG-99 is effective and shows a favourable benefit-risk ratio.
PMID: 16232154 [PubMed - indexed for MEDLINE]