Curcumin mucoadhesive gel in management of osmf: a clinical and histopathological study

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 oral submucous fibrosis but none have proved curative or reduced the morbidity significantly. Very few researches have shown the efficacy of curcumin as targeted local drug delivery in oral submucous fibrosis. Hence the study was planned. In vitro & in vivo studies suggested curcumin as an anticancer, antioxidant & anti-inflammatory agent. Thus based on this literature survey the study was
undertaken.
Aim: To evaluate the efficacy of 10% curcumin mucoadhesive gel for the treatment of clinical stage 2 OSMF patients.
Study design & Sample size: This is an in-vivo single arm clinical study. The study sample included a total of 50 clinical stage 2 OSMF patients with clinically & histopathologically confirmed diagnosis.
Materials & methods: Patients were given 10% curcumin mucoadhesive gel and were instructed to apply topically two times per day making a daily dose of 1 gram. The primary outcome measures were to note the subjective symptoms and objective parameters. Subjective & objective parameters were entered as scores in the proforma. All measurements were taken by the same examiner to avoid observer variability. These parameters were analyzed at baseline, 15th day, 30th day, 45th day, 60th day & 75th day, 90th day, 4th month, 5th month and 6th month. Patients were also evaluated histopathologically after 6months.
Statistical analysis: The data collected were tabulated and analysed. The difference in scores at 15th day, 30th day, 45th day, 60th day, 75th day, 90th day, 4th month, 5th month and 6th month were compared by paired t test. ‘p’ value of 0.05 or less was utilized for statistical significance.
Results: Patients showed statistically significant improvement in all the subjective signs & symptoms, clinical staging & histopathological grading with p value of < 0.05.
Conclusion: It is evident from the study that curcumin holds good promise in the treatment of OSMF.