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.