Colchicine as a therapeutic drug in the management of oral submucous fibrosis - A randomized clinical study

Abstract

Aim: The present study was planned to clinically determine the effectiveness of colchicine as a monotherapy in oral submucous fibrosis (OSMF) patients. Materials and Methods: Thirty OSMF patients were enrolled in the study and randomly divided into two groups by permuted-block randomization. Group A: Patients were treated with 0.5 mg colchicine (Goutnil) tablets twice daily for 3 months. Whereas, in Group B, intralesional injection of dexamethasone 2 mL, hyaluronidase 1,500 IU with 2 mL lignocaine HCl biweekly for 4–6 weeks were given. For all the individuals, baseline parameters like mouth opening, buccal mucosal flexibility, burning sensation, and tongue protrusion were recorded and reassessment was done at 1, 3, and 6 months followed by statistical analysis. Results: A significant decrease in the Visual Analogue Scale (VAS) score for severity of burning sensation was observed in Group A whereas mouth opening and tongue protrusion were higher in Group B patients. Statistically significant differences in the buccal mucosal flexibility were appreciable in the intragroup comparisons of both the groups from baseline to 6-month follow-up. Conclusion: Colchicine can be suggested as an adjuvant drug for reducing the burning sensation for the OSMF patients in whom steroids are contraindicated.