AIM: Oral submucous fibrosis (OSMF) is a high-risk premalignant condition predominantly seen in the Indian subcontinent. The aim of the present study was to evaluate the efficacy of oxitard capsules in the management of OSMF. MATERIALS AND METHODS: Total of 120 subjects with clinico-pathologically diagnosed OSMF were included in the study and divided equally in 2 groups; Group A (oxitard group) and Group B (placebo group). Group A was administered 2 oxitard capsules twice daily and Group B was given placebo tablets twice daily, for 3 months. Evaluation for different clinical parameters was done at regular intervals and data was analyzed using the Student's paired t test and Chi-square test. P < 0.001 was considered to be statistically significant. RESULTS: Clinical improvements in mouth-opening and tongue protrusion were significant in the Group A (P < 0.001). Subjective symptoms of burning sensation (P = 0.0001), pain associated with the lesion (P = 0.000), difficulty in swallowing (P = 0.0003) and speech (P = 0.0005) also significantly improved in the Group A. There was a mild to moderate decrease in the size of the lesion. CONCLUSION: Though there is no definitive treatment for the condition; however, oxitard capsules can bring about significant clinical improvements in the symptoms like mouth-opening, tongue protrusion, burning sensation, difficulty in swallowing and speech and pain associated with the lesion, thereby improving the quality of life of the affected individuals.
RCT Entities:
AIM: Oral submucous fibrosis (OSMF) is a high-risk premalignant condition predominantly seen in the Indian subcontinent. The aim of the present study was to evaluate the efficacy of oxitard capsules in the management of OSMF. MATERIALS AND METHODS: Total of 120 subjects with clinico-pathologically diagnosed OSMF were included in the study and divided equally in 2 groups; Group A (oxitard group) and Group B (placebo group). Group A was administered 2 oxitard capsules twice daily and Group B was given placebo tablets twice daily, for 3 months. Evaluation for different clinical parameters was done at regular intervals and data was analyzed using the Student's paired t test and Chi-square test. P < 0.001 was considered to be statistically significant. RESULTS: Clinical improvements in mouth-opening and tongue protrusion were significant in the Group A (P < 0.001). Subjective symptoms of burning sensation (P = 0.0001), pain associated with the lesion (P = 0.000), difficulty in swallowing (P = 0.0003) and speech (P = 0.0005) also significantly improved in the Group A. There was a mild to moderate decrease in the size of the lesion. CONCLUSION: Though there is no definitive treatment for the condition; however, oxitard capsules can bring about significant clinical improvements in the symptoms like mouth-opening, tongue protrusion, burning sensation, difficulty in swallowing and speech and pain associated with the lesion, thereby improving the quality of life of the affected individuals.