Use of Topical Non-Steroidal Anti-Inflammatory Drugs to Reduce Pain in Oral Lichen Planus and Oral Lichenoid Lesions

Abstract

Background: Lichen Planus (LP) is a chronic inflammatory disorder demonstrating some immune pathology. It is a cell-mediated immune condition of an unknown etiology. Oral Lichenoid Lesions (OLL) has been viewed both as a separate condition from OLP and as a variation of OLP. Available treatments for OLP are not curative and many of them have potentially significant side effects. Although topical Steroids are considered the first line of treatment, a recent systematic review found that there was no evidence shows that one steroid is more effective than another. Objective: The aim of this study was to conduct a crossover clinical trial to examine the efficacy of a topical non-steroidal anti-inflammatory agent (ibuprofen) over placebo in reducing pain in patients with Oral Lichen planus (OLP) and Oral Lichenoid Lesions (OLL). Methods: A four-week randomized, double-blind, cross-over, placebo-controlled trial was planned. Potential participants who had symptomatic forms of OLP and OLL with pain levels equal to or greater than 3 out 10 on a 10cm Visual Analog Scale (VAS) were screened through the Oral Medicine patient registry at the University of Washington. Based on a coin toss, Placebo (drug A) was chosen for the first block of two participants. At first visits the participants received two bottles; each bottle had an individual label marked either “A” or “B” for active medication and placebo respectively. The coding which identified the contents of A and B was sealed by the pharmacy and was kept with one of the committee members as well as with the pharmacy. One of the bottles contained the suspension of the topical NSAID (100 mg per 5 ml concentration of ibuprofen). Another placebo suspension was also compounded with the same taste but without the active ingredient. The participants were asked to record their baseline score of spontaneous pain on a horizontal 10 cm VAS before commencing the use of the provided rinses. Subjects were asked to record their pain level also at day 4 and day 7. All participants were instructed to use the first suspension four times a day for 7 days. The primary study endpoint was the change in pain severity score from Baseline to day 4 and day7. Results: At baseline, the participants using the bottle B first (active drug) reported a mean score of 50.8 16.6 on the VAS. Those who used the bottle A (Placebo arm) first reported a mean VAS score of 55.9 19.23. A t-test comparing mean scores showed that the mean pain level at baseline for both groups was not significantly different (P=.144). VAS scores for the placebo drug decreased by a mean of 6.4mm from baseline to the end of the drug use (49.3mm to 42.9mm). For the active drug, the VAS scored decreased by 12.3mm (56.3mm to 44.0mm). A paired samples t-test showed near significance (P=0.096) was observed for the active medication (bottle B) between days 0 and 7. Linear regression showed that the percent change from days 0 to 7 for the active medication group was near-significant (p=.108), even when controlling for both order and the baseline VAS score. Conclusion: Our results tend to support the validity of an approach to the treatment of inflammatory conditions of the oral cavity, based on using topical NSAIDs According to the findings of the present study, topical NSAIDs may help to reduce pain caused by OLP and OLLs.