Safety of a patented special butterbur root extract for migraine prevention

Headache. 2003 Jan;43(1):76-8. doi: 10.1046/j.1526-4610.2003.03015.x.


Objective: To report on the safety of a patented special butterbur root extract used for migraine prevention.

Background: Two placebo-controlled clinical trials have been conducted supporting the beneficial use in humans.

Methods: Results from acute, subchronic and chronic animal toxicity studies as well as from mutagenicity studies are reported. Safety data gained from clinical trials, postmarketing surveillance studies and pharmacovigilance are evaluated and discussed.

Conclusion: The patented special butterbur root extract is safe for the treatment in humans.

Publication types

  • Clinical Trial
  • Controlled Clinical Trial

MeSH terms

  • Adolescent
  • Animals
  • Child
  • Europe
  • Humans
  • Migraine Disorders / prevention & control*
  • Patents as Topic*
  • Petasites*
  • Phytotherapy* / adverse effects
  • Plant Extracts / adverse effects
  • Plant Extracts / therapeutic use*
  • Plant Extracts / toxicity
  • Plant Preparations / adverse effects
  • Plant Preparations / therapeutic use
  • Product Surveillance, Postmarketing / statistics & numerical data
  • Rats
  • Rats, Wistar
  • Risk Factors


  • Plant Extracts
  • Plant Preparations