Efficacy of Petasites hybridus in migraine prophylaxis: the first real-world study

Background Petasites hybridus is a plant from the Asteraceae family used in migraine prophylaxis. Petasins and isopetasins, one of its constituents, act through antinociceptive, anti-CGRP, anti-inflammatory mechanisms and on calcium channels. Objective This study aimed to evaluate the therapeutic efficacy of Petasites hybridus in the prophylaxis of episodic migraine (EM) and chronic migraine (CM). Methods This was a single-center, retrospective, observational, uncontrolled, descriptive, and real-world study with 120 consecutive patients with EM or CM treated with Petasites hybridus . Results One hundred and twenty patients (72 with EM and 48 with CM) were treated with Petasites hybridus , whose mean age was 35.4 ± 12.4 years, ranging from 18 to 60 years. Before treatment, the average frequency of headache for EM and CM was 6.0 ± 2.7 and 26.3 ± 5.1 days per month, respectively. After 12 weeks, there was a reduction in the number of days with headache, both in the EM and CM, respectively, to 2.6 ± 2.9 and 12.7 ± 8.6 ( p < 0.0001). The reduction in headache attacks was greater than 50% in 59.2% of patients. There was a reduction in disability in both groups. Adverse events occurred in 28.3% of patients, including a bitter sensation in the mouth and/or eructation, lasting 6.4 ± 2.7 days and ranging from 2 to 14 days. Conclusion Petasites hybridus was well tolerated and reduced the number of headache days per month by ≥50% in 60% of migraine patients within the first 12 weeks, providing a reduction in the degree of disability. Furthermore, Petasites hybridus (Petamig ® ) is free of pyrrolizidine alkaloids, making it appropriate and safe for prescription to patients.