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

Raimundo Pereira Silva-Néto^*

• Federal University of the Parnaíba Delta, Parnaíba, Brazil

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. Conclusions: 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.