A comparison of transdermal over-the-counter lidocaine 3.6% menthol 1.25%, Rx lidocaine 5% and placebo for back pain and arthritis

Abstract

Aim: Transdermal lidocaine therapy has become a gold standard as part of a treatment regimen for patients who suffer from localized pain. We compared transdermal patches: over-the-counter (OTC) lidocaine 3.6% combined with menthol 1.25%, prescription lidocaine 5% (Rx) and placebo. Methods: In a double-blind, placebo-controlled trial, 87 patients were randomized to: OTC, Rx or placebo. Results: OTC met primary end points of noninferiority compared with Rx for efficacy, side effects and quality of life. Versus placebo, OTC proved superiority for efficacy, general activity and normal work. Side effects were similar. Conclusion: It is theorized that menthol's ability to increase skin permeability facilitated more efficient drug delivery to the site of pain causing higher than expected efficacy. Decreased cost and resource utilization could benefit patients and payers.