Improvement of migraine symptoms with a proprietary supplement containing riboflavin, magnesium and Q10: a randomized, placebo-controlled, double-blind, multicenter trial.

BACKGROUND: Non-medical, non-pharmacological and pharmacological treatments are recommended for the prevention of migraine. The purpose of this randomized double-blind placebo controlled, multicenter trial was to evaluate the efficacy of a proprietary nutritional supplement containing a fixed combination of magnesium, riboflavin and Q10 as prophylactic treatment for migraine. METHODS: 130 adult migraineurs (age 18 - 65 years) with ≥ three migraine attacks per month were randomized into two treatment groups: dietary supplementation or placebo in a double-blind fashion. The treatment period was 3 months following a 4 week baseline period without prophylactic treatment. Patients were assessed before randomization and at the end of the 3-month-treatment-phase for days with migraine, migraine pain, burden of disease (HIT-6) and subjective evaluation of efficacy. RESULTS: Migraine days per month declined from 6.2 days during the baseline period to 4.4 days at the end of the treatment with the supplement and from 6.2.days to 5.2 days in the placebo group (p = 0.23 compared to placebo). The intensity of migraine pain was significantly reduced in the supplement group compared to placebo (p = 0.03). The sum score of the HIT-6 questionnaire was reduced by 4.8 points from 61.9 to 57.1 compared to 2 points in the placebo-group (p = 0.01). The evaluation of efficacy by the patient was better in the supplementation group compared to placebo (p = 0.01). CONCLUSIONS: Treatment with a proprietary supplement containing magnesium, riboflavin and Q10 (Migravent® in Germany, Dolovent® in USA) had an impact on migraine frequency which showed a trend towards statistical significance. Migraine symptoms and burden of disease, however, were statistically significantly reduced compared to placebo in patients with migraine attacks.

Differential and stereoselective in vitro cytotoxicity of eremophilane sesquiterpenes of Petasites hybridus rhizomes in rat hepatocytes.

We tested two CO (2) extracts of Petasites hybridus L. rhizomes, A (rich in furanoeremophilanes) and B (rich in petasins), for IN VITRO cytotoxicity in rat hepatocytes by means of the 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide (MTT) assay (EC (50) values of 0.64 mg/mL for A and 0.32 mg/mL for B). Eight eremophilane sesquiterpene lactones (SL) (1- 8) and one petasin (9) isolated from A were nontoxic or showed moderate cytotoxicity. The presence and type of the ester side chain most probably control the extent of cytotoxicity of the eremophilanolides. (8 R)-2-[(angeloyl)oxy]eremophil-7(11)-en-12,8-olide (1) damaged the hepatocytes most. The 8 α-stereoisomers of both 8-H epimeric couples of the 2-angeloyloxy- and 2-methacroyloxy-esters seem to be more cytotoxic (up to approx. 10-fold) than the corresponding 8 ß-H stereoisomers. Moreover, the results of the MTT assay depended on the cell density being more pronounced with both 8 α-stereoisomers. Further investigations were conducted to study the influence of the stereochemistry on cell respiration, energy metabolism, and membrane integrity [release of lactate dehydrogenase (LDH)] with both couples of the 2-angeloyloxy- and 2-methacroyloxy-esters. In the LDH-leakage assay, (8 R)-2-[(methacroyl)oxy]eremophil-7(11)-en-12,8-olide (2) was the most toxic eremophilane. The stereoselectivity of cell damage of some SL points to a specific, yet unidentified molecular cytotoxicity target.

Migraine prevention in children and adolescents: results of an open study with a special butterbur root extract.

OBJECTIVE: To explore the role of a special butterbur root extract for migraine prevention in children and adolescents with severe migraines. BACKGROUND: Two randomized and placebo-controlled trials with a total of 289 migraine patients have demonstrated the efficacy and safety of a special butterbur root extract in the reduction of migraine attacks in adults. We studied whether butterbur had the potential as an efficient and well-tolerated migraine preventive in children and adolescents. DESIGN/METHODS: 108 children and adolescents between the ages of 6 and 17 were included in a multicenter prospective open-label study. Participants suffered from migraines diagnosed according to IHS classifications for at least 1 year. Patients were treated with 50 to 150 mg of the butterbur root extract depending on age for a period of 4 months. Treatment progression was recorded in migraine journals especially designed for children and adolescents. RESULTS: 77% of all patients reported a reduction in the frequency of migraine attacks of at least 50%. Attack frequency was reduced by 63%. 91% of patients felt substantially or at least slightly improved after 4 months of treatment. About 90% of each, doctors and patients, reported well-being or even improved well-being. Undesired effects (7.4%) included mostly eructation. No serious adverse events occurred and no adverse event caused a premature termination. CONCLUSIONS: The results and low rate of adverse events in this open prospective migraine prevention study in children and adolescents are similar to the results of two multicenter placebo-controlled butterbur studies in adults. Butterbur root extract shows a potential as an effective and well-tolerated migraine prophylaxis also for children and teenagers.

Petasites hybridus (Butterbur root) extract in the treatment of asthma--an open trial.

The efficacy and tolerability of a butterbur root extract (Petadolex) for the treatment of asthma was analyzed in a prospective, non-randomized, open trial. Subjects included 64 adults and 16 children/adolescents treated for two months with the extract, followed by two months during which the intake of the extract was optional. Concomitant asthma medication was permitted. The number, duration, and severity of asthma attacks decreased, while peak flow, forced expiratory volume (FEV1), and all measured symptoms improved during therapy. In addition, more than 40 percent of patients using asthma medications at baseline reduced intake of these medications by the end of the study. This study suggests the Petasites hybridus extract Petadolex is an effective and safe therapy for the treatment of asthma.

Safety of a patented special butterbur root extract for migraine prevention.

OBJECTIVE: To report on the safety of a patented special butterbur root extract used for migraine prevention. BACKGROUND: Two placebo-controlled clinical trials have been conducted supporting the beneficial use in humans. METHODS: Results from acute, subchronic and chronic animal toxicity studies as well as from mutagenicity studies are reported. Safety data gained from clinical trials, postmarketing surveillance studies and pharmacovigilance are evaluated and discussed. CONCLUSION: The patented special butterbur root extract is safe for the treatment in humans.