Efficacy of a Combination of Tanacetum parthenium, 5-Hydroxy Tryptophan and Magnesium (Aurastop) in Episodic Migraine Prevention: A Multicentric Observational Study

摘要

Objective: To verify the efficacy and safety of the new combination of Tanacetum parthenium 150 mg, 5-hydrossitriptophan (5-HTTP) 20 mg and magnesium 185 mg (Aurastop) in the prophylactic treatment of episodic migraine without aura (MO). Methods: Eighty patients suffering from MO for at least 6 months with a monthly frequency of 3 to 8 attacks and 4 to12 headache days, were enrolled in this open study and treated with Aurastop twice daily per os for 3 months. The reduction of headache days per month was assessed as the primary end-point, while the secondary end-points were: 1) reducti on of the number of MO attacks; 2) reduction of intensity of the pain; 3) reduction of acute treatment drug intake; 4) subjective change of pain intensity. Results: All the parameters significantly improved at the end of the observational period of treatment with Aurastop. In more detail: a significant reduction of the number of headache days (from 9.1 ± 2.0 before treatment to 3.2 ± 1.8 post treatment, p < 0.001); number of attacks per month (from 6.0 ± 1.2 to 2.4 ± 1.1, p < 0.001); pain intensity (in a visual analogical scale [VAS]: from 7 ± 1.0 to 3.2 ± 0.7, p < 0.001); number of drug doses for acute treatment (triptans, simple analgesics or in combination) assumed by each subject per month (from 9.5 ± 1.8 to 2.2 ± 1.1, p < 0.001). No serious adverse events were observed. Conclusion: Albeit obtained with the limitation of open-trials, our findings suggest that AURASTOP is a promising approach for migraine prevention; further investigations are required to confirm the safety and efficacy of this treatment.