Betamethasone oral mini-pulse therapy compared with topical triamcinolone acetonide (0.1%) paste in oral lichen planus: A randomized comparative study

Abstract

Betamethasone oral mini-pulse (OMP) therapy has been used effectively and safely in vitiligo, alopecia areata, and lichen planus. We sought to evaluate the efficacy and safety of betamethasone OMP in patients with symptomatic moderate to severe oral lichen planus and to compare it with topical triamcinolone acetonide. In all, 49 patients with moderate to severe oral lichen planus were randomly allocated to receive either OMP comprising 5 mg of betamethasone orally on 2 consecutive days per week (group A) or triamcinolone acetonide (0.1%) paste application thrice daily (group B), for 3 months followed by stepwise tapering during the next 3 months. Treatment response was assessed by the change in the score, which was based on the number of sites involved and the area affected. The changes in the symptoms and side effects were also recorded. Patients were followed up after treatment for 3 months to look for relapse. In all, 23 of 25 patients in group A and 23 of 24 patients in group B completed the study. Good to excellent response was seen in 17 of 25 (68.0%) patients in group A as compared with 16 of 24 (66.0%) in group B at 6 months. Symptom-free state was achieved in 13 of 25 (52%) patients in group A and 12 of 24 (50%) in group B. The difference in the mean scores within each group was statistically significant from the fourth week onward in group A and eighth week onward in group B, whereas in patients with erosive disease it was second and twelfth week onward, respectively. The difference in the treatment response between the two groups was statistically significant only at week 24 when reduction in severity score was more in triamcinolone group. Side effects were seen in 14 (56%) patients in group A and 6 (25%) patients in group B, which were mild and reversible. Relapse occurred in 9 of 23 (39.1%) patients in group A after 13.78 +/- 6.96 weeks as compared with 5 of 23 (21.7%) in group B after 19.20 +/- 1.79 weeks. The study was not blinded and the change in the quality of life with treatment was not measured. Betamethasone OMP improves the clinical outcome in patients with moderate to severe oral lichen planus. When compared with topical triamcinolone acetonide it is equally effective but the response is earlier, especially in erosive disease. It may be a useful and convenient alternative either as a monotherapy or to achieve rapid symptomatic relief during periods of exacerbations.