EFFICACY OF CURCUMIN IN ORAL SUBMUCOUS FIBROSIS – A RANDOMIZED CONTROLLED CLINICAL TRIAL

Introduction: Oral submucous fibrosis (OSMF) is a potentially malignant disorder carrying a high risk of malignant transformation. A wide range of treatment modalities have been proposed for OSMF but none have proved curative or reduced the morbidity significantly. In-vitro and in-vivo studies suggested curcumin as an anticancer, antioxidant and anti-inflammatory agent. Thus based on this literature survey the study was undertaken. Aim: To evaluate the efficacy of curcumin for the treatment of clinical stage 2 OSMF patients and to compare it with patients receiving placebo drugs. Study Design and Sample Size: A randomized single blinded placebo controlled clinical trial was conducted in 100 clinical stage 2 OSMF patients with clinically and histopathologically confirmed diagnosis. Materials and Methods: 100 clinical stage 2 patients selected for the study were divided into 2 groups with 50 patients each. Group 1 patients were given placebo capsules. Group 2 patients were given curcumin capsules of 500 mg. The primary outcome measures were to note the subjective symptoms and objective parameters. These parameters were analyzed at baseline and 6^th month. Patients were also evaluated histopathologically after 6 months. ANOVA, students t test and p value were utilized for statistical inferences. Results: Patients in group 2 showed statistically significant improvement in all the subjective signs and symptoms and histopathological changes with p value of < 0.001 when compared with group 1 patients. Conclusion: It is evident from the study that curcumin holds good promise in the treatment of OSMF.