Petasites Hybridus (ButterburRoot) Extract is effective in the Prophylaxis of Migraines Results of a Randomized, Double-Blind Trial
This study examined the efficacy and tolerability of an extract of Petasites hybridus compared to placebo in a double-blind parallel-group trial of patients suffering from migraine headaches with and without aura, as classified by the IHS. After a 4-week run-in observation phase without any trial medication, 60 such patients received randomly either the Petasites preparation (50 mg.BID) or placebo for 12 weeks. A total of 33 patients were allocated to the
drug group and 27 patients to the placebo group. In all, 58 patients completed the study. The efficacy was evaluated by means of a headache diary in which the frequency, duration and intensity of migraine headache were assessed. The frequency of migraine attacks per 4 weeks from patient diaries was defined as the primary efficacy variable. In addition, migraine-associated symptoms,
use of analgesics, global assessment of efficacy as well as the occurrence of adverse events were assessed. Compared to placebo, Petasites hybridus significantly reduced the frequency of migraine attacks and days with migraine per month as well as the frequency of accompanying symptoms (p<0.05). Global asessment of efficacy was also significantly better for the active group (p<0.01). The duration and intensity of pain were also diminished, but these results were not statistically significant. Compared to baseline,
Petasites hybridus reduced the frequency of attacks by 46% after 4 weeks. 60% after 8 weeks and 50% after 12 weeks of treatment (placebo group: 24%, 17% and 10% respectively). No adverse drug reactions were reported in either the drug or placebo group. The efficacy and excellent tolerability of the Petasites hybridus extract observed in this study suggest that this plant
preparation can be of clinical benefit to migraine patients.