Gelstat Migraine (sublingually administered feverfew and ginger compound) for acute treatment of migraine when administered during the mild pain phase

Med Sci Monit. 2005 Sep;11(9):PI65-9. Epub 2005 Aug 26.

Abstract

Background: Treatment of migraine headaches is often delayed due to assessing the potential severity of an evolving headache or anticipating unwanted consequences from prescription medication. Studies have demonstrated improved pain-free response when prescription treatments are taken during the mild headache phase of a migraine. This study was designed to evaluate the efficacy of an OTC product, GelStat Migraine, when taken in the early, mild pain phase of migraine.

Material/methods: An open-label study enrolling 30 subjects, male and female, with a one-year history of migraine meeting IHS diagnostic criteria with or without aura, 2-8 migraines per month and < or = 15 headache days per month. Inclusion required having migraines that consistently started at mild and worsened to moderate or severe, if untreated, in at least 75% of attacks. Subjects also had to be able to distinguish migraine from non-migraine headaches and reliably identify migraine early in the course of an attack. One headache was treated in the mild pain phase with GelStat Migraine, a combination of feverfew and ginger.

Results: 29 evaluable subjects completed the study, all treating at mild pain. Two hours after treatment, 48% were pain-free with 34% reporting a headache of only mild severity. 29% reported a recurrence within 24 hours. Side effects were minimal and not serious. 59% of subjects were satisfied with Gelstat Migraine therapy and 41% preferred GelStat Migraine or felt it was equal to their pre-study medication.

Conclusions: GelStat Migraine is effective as a first line abortive treatment for migraine when initiated early during the mild headache phase.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Sublingual
  • Adult
  • Aged
  • Analgesics / administration & dosage
  • Analgesics / therapeutic use*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Migraine Disorders / drug therapy*
  • Migraine Disorders / physiopathology
  • Nonprescription Drugs
  • Pain / drug therapy
  • Pain / physiopathology
  • Phytotherapy*
  • Tanacetum parthenium*
  • Zingiber officinale*

Substances

  • Analgesics
  • Nonprescription Drugs