Management of oral submucous fibrosis by two different drug regimens: A comparative study

BACKGROUND: Oral Submucous Fibrosis (OSF) is a precancerous condition of the oral mucosa. Existing treatments give only temporary symptomatic relief. Colchicine is an ancient drug with anti-fibrotic and anti-inflammatory properties. We planned to study the effects of colchicine in the management of oral submucous fibrosis. MATERIALS AND METHODS: Fifty OSF patients were divided randomly into two groups and treated for 12 weeks. Group 1-Patients were administered tablet colchicine orally, 0.5 mg twice daily and 0.5 ml intralesional injection Hyaluronidase 1,500 IU into each buccal mucosa once a week. Group 2-Patients were administered 0.5 ml intralesional injection Hyaluronidase 1,500 IU and 0.5 ml intralesional injection Hydrocortisone acetate 25 mg/ml in each buccal mucosa once a week alternatively. Student's t test and analysis of variance (ANOVA) were used to compare pre and post treatment results. P<0.05 was considered as significant. RESULTS: Thirty-three percent in group 1 got relief from burning sensation in the second week. Inter group comparisons of increase in mouth opening and reduction in histological parameters indicated that group 1 patients responded better than group 2. CONCLUSION: These encouraging results should prompt further clinical trials with colchicine alone on a larger sample size to broaden the therapeutic usefulness of the drug in the management of OSF.