Efficacy of Trans Retinoic Acid in the treatment of Oral Submucous Fibrosis- A Comprehensive Study
Background and Objectives- OSMF is a premalignant disorder that primarily affects people in the Indian subcontinent. It causes the oral soft tissues to become increasingly juxtaepithelial fibrosis-prone, which eventually makes it impossible to open the mouth. The objectives of the study was to assess the efficacy of TRA in treatment of OSMF, its side effects and quality of life in patients. Methods- It was a monocentric single blind study conducted in Department of OtoRhinoLaryngology in Tertiary care centre for a period of 1 year. In order to assess the effectiveness of trans RA in the treatment of OSMF, a premalignant condition in the oral cavity, we have undertaken a study to determine the quality of life in patients with Grade I and Grade II OSMF and to determine the efficacy of tretinoin (a vitamin A supplement) in the form of soft gel capsules containing trans RA. In total, 40 patients with OSMF who were classified as Grade I and II by Khanna and Andrade in 19957 were included in the study. Two groups of twenty patients each, 1 and 2, were randomly selected from among these patients. Results- It was seen the burning sensation in test groups shows a decreasing trends as the efficacy of TRA increases as the time of follow up progresses and it was statistically significant (p<0.05). The result of this study showed an improvement in the mouth opening of the patients of test Group with a significant decrease in the burning sensation as compared to the control group. the major side effects seen during the follow up period for test group was headache seen in 64% of patients and it was significant (p<0.05), followed by nausea and vomiting in 50%, dizziness and rashes were also seen in patients who were continuously taking the medication for 6 months.; The quality of life significantly improved due to better mouth opening and decrease in burning sensation. None of the patients showed relapse after the discontinuation of the drug. Conclusion- This baseline study provides opportunities for additional research on the systemic use of all RA forms available for treating OSMF as well as on the use of medication in a formulation that can be injected locally into fibrous bands to validate the above findings.