Efficacy and safety of an ethanolic solution of peppermint oil for patients with episodic tension type headache: EUMINZ® a randomized controlled trial
27 September 2017 (online)
Tension-type headache is the most prevalent type of headache across all age groups worldwide . The tension relieving and analgesic effects of topically applied peppermint oil and its major components terpenes, menthol, menthone, isomenthone, menthyl acetate and cineol probably result from an increased sensitivity for cold, mediated by Ca2+-antagonistic action of I-menthol and consecutively a reduction of pain stimuli transmission [2, 3].
A prospective, randomized, double-blind and placebo-controlled clinical phase IV trial had been performed to assess efficacy and safety of a 10% ethanolic solution of peppermint oil for topical use compared to placebo in patients with episodic tension-type headache. 211 study participants were randomly allocated within a parallel-group design. As primary endpoint the pain-free rate at 120 min after start of the treatment had been measured on a Verbal Pain Rating Scale (VPRS).
Whereas the primary endpoint defined as VPRS responder rate in the first documented headache episode could not be met (p = 0.1006; 1-sided, non-parametric Fisher's exact test), the difference in VAS (Visual Analogue Scale) and SPID (Sum of Pain Intensity Difference) for all episodic headache episodes (eHEs) was more pronounced and in favor of verum treatment (p = 0.0088). Subgroup analysis for VPRS and VAS SPID over all eHEs showed results in favor of verum in female patients, patients of both sexes using concomitant pain medication and those compliant to the recommended application schedule.
Topical application of peppermint oil should be considered as effective and safe treatment option for patients suffering from episodic tension type headache. Bearing in mind the risks and long term side effects of analgesics the EUMINZ® trial has generated clinical evidence for an effective and safe treatment approach.
This work was funded by MCM Klosterfrau Vertriebsgesellschaft mbH, Gereonsmühlengasse 1 – 11, 50670 Köln, Germany.
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