Miconazole as adjuvant therapy for oral lichen planus: a double-blind randomized controlled trial

Abstract

Summary Background Topical steroids are the first choice for the treatment of oral lichen planus (OLP). Antifungal drugs are often employed together with them, to prevent secondary oral candidosis, although it has been suggested anecdotally that they can also be beneficial for OLP itself. Objectives To compare the effect of clobetasol propionate with and without a topical antifungal drug (miconazole) on the symptoms and extension of OLP. Methods A randomized, parallel, double‐blind trial was conducted at the Unit of Oral Medicine and Pathology of the University of Milan. Thirty‐five outpatients with histologically proven OLP were randomly assigned to receive either clobetasol propionate and miconazole, or clobetasol propionate and placebo for 6 weeks. Primary outcomes included symptoms and extension of lesions; adverse effects were also recorded. Results All the patients who concluded the study (30 of 35) showed clinical and subjective improvement within 3 weeks. The addition of miconazole did not affect in a significant way the signs and symptoms of OLP. No cases of clinical candidosis were seen in the patients taking miconazole, while one‐third (five of 15) of the placebo group were affected. Conclusions Although effective in preventing iatrogenic candidosis, the addition of miconazole to topical steroid treatment does not improve the efficacy of the therapy.

Medical Management of Oral Lichen Planus: A Systematic Review

“…Few studies [3,17,21,[24][25][26]33,37] found a statistically significant difference in clinical improvement favouring their respective active interventions when compared to placebo. No statistically significant clinical improvement in the intervention groups when compared to placebo was noted by few other studies [18,19,30]. Sawaarn has recorded the overall treatment response and not the clinical area [32].…”

“…There was no evidence of difference in mean pain score after treatment between active intervention & placebo in three trials [18,19,30]. A statistically significant reduction in mean pain score favouring the active intervention was seen in the remaining nine trials [3,17,21,[24][25][26]32,33,37].…”

“…Twelve trials compared an active intervention with placebo: cyclosporine [3], clobetasol & miconazole [19], curcuminoids as an adjunct to prednisone [18], pimecrolimus [17,24,33], aloe vera [21,30], hyaluronic acid [26], ignatia [25], lycopene [32] & MuGard [37]. There was no evidence of difference in mean pain score after treatment between active intervention & placebo in three trials [18,19,30].…”

“…[18] all the participants received a systemic steroid, and in another study [28] the experimental intervention was compared with intralesional steroid. Of the 29 trials using steroid as an active intervention, clobetasol was used in nine trials [4,7,10,11,19,22,23,27,35], triamcinolone in ten trials [4,5,[13][14][15][16]20,28,31,36], flucinolone in two trials [6,8], dexamethasone in two trials [29,34], prednisolone in one trial [18], fluticasone in one trial [9] & betamethasone in two trials [9,20]. Systemic prednisolone was used in one trial [18].…”

“…Clinical response was measured by eleven trials [6][7][8][9][10][14][15][16]21,27,30,31] using the clinical grading by Thongprasom 1992 consisting of a six-point ordinal scale, four trials [17,19,22,24] used a different clinical grading scale with scores 1 to 4. Tel Aviv San Francisco scale was used in one trial [32].…”