Evaluation of the effectiveness of oral Pirfenidone in the treatment of oral submucous fibrosis: A non-randomised pilot clinical trial.

Background: Oral submucous fibrosis (OSMF) is a potentially malignant disorder with a high rate of malignant transformation. Pirfenidone is an anti-fibrotic drug currently used in the treatment of idiopathic lung fibrosis (ILF). As both ILF and OSMF are mediated through transforming growth factor-beta, Pirfenidone could be beneficial in treating early stages of OSMF.

Objectives: To evaluate the effectiveness of oral Pirfenidone in increasing the mouth opening, reducing fibrosis and burning sensation.

Settings and design: A single-arm prospective clinical trial conducted in the Department of Oral Medicine and Radiology, at a recognised dental college.

Materials and methods: Eleven subjects of either sex, of 21-55 years diagnosed with OSMF Stage 2 according to Chandramani More et al. classification, were recruited for the study and prescribed Pirfenidone 200 mg, 1 tablet TID with meals for 1 week, and later 2 tablets TID with meals for 5 weeks. The patients were monitored for adverse effects, and treatment response was assessed as unit of improvement. Data were analysed using SPSS; parametric tests such as ANOVA followed by post hoc test and non-parametric tests such as Friedman's followed by Wilcoxon signed rank test were applied with significance at P < 0.05.

Results: 60% of the patients showed +1 unit of improvement with no serious adverse effect.

Conclusions: The patient-related clinical outcomes were quite significant showing the effectiveness of Pirfenidone as a promising adjuvant therapy in the management of OSMF.