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

Authors

  • Roger K. Cady MD,

    Corresponding authorSearch for more papers by this author
  • Jerome Goldstein MD,

    1. From the Headache Care Center, Springfield, MO, USA (R.K. Cady); San Francisco Headache Clinic, San Francisco, CA, USA (J. Goldstein); Texas Headache Associates, San Antonio, TX, USA (R. Nett); PuraMed BioScience, Inc., Schofield, WI, USA (R. Mitchell); Clinvest/A Division of Banyan Group, Inc., Springfield, MO, USA (M.E. Beach and R. Browning).
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  • Robert Nett MD,

    1. From the Headache Care Center, Springfield, MO, USA (R.K. Cady); San Francisco Headache Clinic, San Francisco, CA, USA (J. Goldstein); Texas Headache Associates, San Antonio, TX, USA (R. Nett); PuraMed BioScience, Inc., Schofield, WI, USA (R. Mitchell); Clinvest/A Division of Banyan Group, Inc., Springfield, MO, USA (M.E. Beach and R. Browning).
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  • Russell Mitchell,

    1. From the Headache Care Center, Springfield, MO, USA (R.K. Cady); San Francisco Headache Clinic, San Francisco, CA, USA (J. Goldstein); Texas Headache Associates, San Antonio, TX, USA (R. Nett); PuraMed BioScience, Inc., Schofield, WI, USA (R. Mitchell); Clinvest/A Division of Banyan Group, Inc., Springfield, MO, USA (M.E. Beach and R. Browning).
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  • M.E. Beach BS, LPN, CCRP,

    1. From the Headache Care Center, Springfield, MO, USA (R.K. Cady); San Francisco Headache Clinic, San Francisco, CA, USA (J. Goldstein); Texas Headache Associates, San Antonio, TX, USA (R. Nett); PuraMed BioScience, Inc., Schofield, WI, USA (R. Mitchell); Clinvest/A Division of Banyan Group, Inc., Springfield, MO, USA (M.E. Beach and R. Browning).
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  • Rebecca Browning BS

    1. From the Headache Care Center, Springfield, MO, USA (R.K. Cady); San Francisco Headache Clinic, San Francisco, CA, USA (J. Goldstein); Texas Headache Associates, San Antonio, TX, USA (R. Nett); PuraMed BioScience, Inc., Schofield, WI, USA (R. Mitchell); Clinvest/A Division of Banyan Group, Inc., Springfield, MO, USA (M.E. Beach and R. Browning).
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  • Conflict of Interest: Dr. Roger Cady has served as a consultant for GlaxoSmithKline, Merck, Ortho-McNeil and received research grants from Allergan, Endo Pharmaceuticals, GlaxoSmithKline, Merck, PuraMed Bioscience and Wyeth. Dr. Jerome Goldstein has served as a consultant and/or served on advisory boards for multiple pharmaceutical companies. Dr. Robert Nett has served as a consultant and/or served on advisory boards for multiple pharmaceutical companies. Mr. Russell Mitchell is Chairman/CEO and stockholder in PuraMed BioScience, Inc. Ms. M.E. Beach and Ms. Rebecca Browning have nothing to disclose.

  • Financial support: Research study provided by a grant from PuraMed Bioscience.

R.K. Cady, Headache Care Center, 3805 S. Kansas Expressway, Springfield, MO 65807, USA.

Abstract

(Headache 2011;51:1078-1086)

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.

Methods/Materials.— In this multi-center pilot study, 60 patients treated 221 attacks of migraine with sublingual feverfew/ginger or placebo. All subjects met International Headache Society criteria for migraine with or without aura, experiencing 2-6 attacks of migraine per month within the previous 3 months. Subjects had <15 headache days per month and were not experiencing medication overuse headache. Inclusion required that subjects were able to identify a period of mild headache in at least 75% of attacks. Subjects were required to be able to distinguish migraine from non-migraine headache. Subjects were randomized 3:1 to receive either sublingual feverfew/ginger or a matching placebo and were instructed but not required to treat with study medication at the earliest recognition of migraine.

Results.— Sixty subjects treated 208 evaluable attacks of migraine over a 1-month period; 45 subjects treated 163 attacks with sublingual feverfew/ginger and 15 subjects treated 58 attacks with a sublingual placebo preparation. Evaluable diaries were completed for 151 attacks of migraine in the population using feverfew/ginger and 57 attacks for those attacks treated with placebo. At 2 hours, 32% of subjects receiving active medication and 16% of subjects receiving placebo were pain-free (P = .02). At 2 hours, 63% of subjects receiving feverfew/ginger found pain relief (pain-free or mild headache) vs 39% for placebo (P = .002). Pain level differences on a 4-point pain scale for those receiving feverfew/ginger vs placebo were −0.24 vs −0.04 respectively (P = .006). Feverfew/ginger was generally well tolerated with oral numbness and nausea being the most frequently occurring adverse event.

Conclusion.— 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.

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