Efficacy of combination curcumin therapy in oral submucous fibrosis - 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. Shankar and co authors have reviewed the most common mucosal diseases and identified the current treatment approaches systemically and locally. Systemic bioavailability of curcumin is less. Local drug delivery may provide a more targeted and efficient drug-delivery option than systemic delivery for diseases of the oral mucosa. Oral diseases can be effectively treated by systemic and local therapeutic approaches, due to the ease of the oral cavity accessibility
Very few researches have shown the efficacy of curcumin as combination of systemic and targeted local drug delivery in oral submucous fibrosis. Hence the study was planned.
Aim: The aim of the study was to evaluate the efficacy of curcumin 250 mg capsules and 5% curcumin mucoadhesive gel in 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 curcumin 250 mg capsules and were instructed to take 2 capsules per day and 5% 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 6 months.
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 subjective symptoms and objective parameters, clinical staging & histopathological grading with p value of < 0.05.
Conclusion: It is evident from the study that curcumin combination therapy holds good promise in the treatment of OSMF.