Combination of Tanacethum Partenium, 5-Hydrossitriptophan (5-Http) and Magnesium in the Prophylaxis of Episodic Migraine without Aura (AURASTOP®) An Observational Study

Objective: The study aim is to verify whether treatment with a new combination of tanacethum partenium, 5-hydrossitriptophan (5-http) and magnesium (Aurastop®) reduces headache frequency and intensity in patients suffering from episodic migraine without aura when used in migraine prevention. Methods: Forty patients, suffering from migraine without aura for at least 6 months with monthly frequency of 3 to 8 crises and presence of headache of 4 to12 days, were enrolled in this open study and treated orally with Aurastop twice daily for 3 months. The primary endpoint was reduction of migraine frequency (headache days per month) over an observation period of 3 months. The secondary endpoint was a composite of monthly frequency and intensity of pain crises, analgesics use (number of medications) and subjective change of pain intensity. Results: All the parameters significantly improved at the end of treatment with Aurastop. We observed a significant reduction of the number of headache days (from 8.8 ± 2.0 before treatment to 2.7 ± 1.7 post treatment, p < 0.001), as well as of the number of attacks (from 5.0 ± 1.2 per month to 2.1 ± 0.9 per month, p < 0.001), of pain intensity (from Visual Analogic Scale [VAS] 6.9 ± 1.0 to 3.3 ± 1.5, p < 0.001), and of the number of analgesics assumed by each subject (from 8.5 ± 1.6 per month to 2.4 ± 1.5 per month, p < 0.001). No serious adverse events were observed. Conclusion: Though obtained in the setting of an open-trial, our findings suggest that the new combination of tanacethum partenium, 5-hydrossitriptophan (5-http) and magnesium (AURASTOP®) is a promising approach for migraine prevention and warrant further investigation to confirm the safety and efficacy of this treatment.