A Double-Blind Placebo-Controlled Pilot Study of Sublingual Feverfew and Ginger (LipiGesic® M) in the Treatment of Migraine

Roger K. Cady, MD, Jerome Goldstein, MD, Robert Nett, MD, Russell Mitchell, M.E. Beach, BS LPN, CCRP; Rebecca Browning, BS Headache Care Center, Springfield, MO

BACKGROUND

Therapeutic needs of migraineurs vary considerably from patient to patient and even attack to attack. Some attacks require high-end therapy, while other attacks have treatment needs that are less immediate. While triptans are considered the “gold standard” of migraine therapy, they do have limitations and many patients are seeking other therapeutic alternatives. In 2005, an open-label study of feverfew/ginger suggested efficacy for attacks of migraine treated early during the mild headache phase of the attack.*

PRIMARY OBJECTIVE

To assess the efficacy of sublingually administered preparation of feverfew/ginger in providing relief of headache and associated symptoms in acute migraine when administered early in the process of migraine.

SECONDARY OBJECTIVES

  1. Evaluate persistent or recurrent headache 2 – 24 hours following treatment
  2. Assess adverse events
  3. Compare Patient Perception of Migraine Questionnaire scores between active therapy and placebo

METHOD OF STUDY

The double-blind, placebo-controlled, randomized s tudy was approved by an independent investigational review board and was conducted at three headache specialty centers in the United States.

Sixty subjects,** ages 12 – 60, who met International Headache Society (IHS) diagnostic criteria (1988) for migraine without aura (IHS 1.1) or migraine with aura (IHS 1.2) were enrolled in the study. The subjects had a history of migraine for greater than 1 year with an attack frequency between 2 – 6 attacks per month over the previous 3 months. Seventy-five percent of the reported attacks began with mild headache that could be differentiated between migraine and non-migraine.

Eligible subjects were encouraged, but not required, to treat migraine at the onset of attack during the mild pain phase with LipiGesic M. One treatment consisted of two 3ml LipiGesic M doses administered sublingually 5 minutes apart. A second treatment could be taken if needed for persistent or recurrent pain between 1 and 24 hours. Subjects recorded response to treatment in diaries.

RESULTS

  • Of all subjects treating across the range of headache severity (1-3) with sublingual feverfew/ ginger, 32% reported being pain-free at 2 hours post-dose compared to 16% utilizing placebo (P = .02).
  • At 2 hours post-dose, the percentage of attacks that was rated as no pain or mild pain was 64% for sublingual feverfew/ginger compared to 39% for placebo.
  • At 2 hours post-dose, there was a statistically significant difference in associated migraine symptoms and headache characteristics between active and placebo groups.
  • This included statistical superiority for feverfew/ginger over placebo in eliminating the pulsating character of the headache (P = .007), the worsening of headache with activity (0.015), and the presence of light sensitivity (0.001), sound sensitivity (0.003), and nausea (P=.002).
  • Evaluation of subjects’ responses on the Patient Perception of Migraine Questionnaire (PPMQ-R) revealed statistical superiority for feverfew/ginger over placebo in total score (efficacy + functionality + ease of use) (P = .30), efficacy (P = .04), and functionality (P = .02).
  • Sublingual feverfew/ginger was well tolerated in this study. Adverse events were mild, similar to the placebo group with the exception of oral numbness.

CONCLUSIONS

Sublingual feverfew/ginger appears safe and effective as a first-line abortive treatment for a population of migraineurs who frequently experience mild headache prior to the onset of moderate to severe headache. It appears to be well tolerated and has no known contraindications with other acute treatments for migraine.

This study was funded by PuraMed BioScience Corporation.

* Cady RK, Goldstein J, Nett R, et al. A Double-Blind Placebo-Controlled Pilot study of Sublingual Feverfew and Ginger (LipiGesic™M) in the Treatment of Migraine. Headache. 2011;0017-8748.
** Fifty-nine subjects provided data for analysis. One subject withdrew because of pregnancy.

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