Clinical Assessment of Efficacy of Omega 3 in Oral Submucous Fibrosis Patients - A Randomized Controlled Trial.

BACKGROUND: Oral submucous fibrosis (OSMF) is a chronic, potentially malignant condition affecting the oral cavity. Omega 3 has shown innumerable health benefits in yesteryears. So, the aim of the study was to evaluate the efficacy of Omega 3 in the medical management of this disease. METHODS: A randomized controlled trial was designed and 48 clinically confirmed patients of OSMF (24 in each group) completed the study. Patients of both the groups were given biweekly intralesional injections of dexamethasone 1.5ml, hyaluronidase 1500 IU mixed with lignocaine for 6 weeks. Additionally, group A received a placebo (lactose capsule) for 3 months while group B received 1gm of omega 3 (flaxseed oil) three times daily continuously for 3 months. Patients were followed every month for 3 months and then, after 6 months and one year. RESULTS: During the first two months, improvement was observed in both the groups independently but intergroup comparison showed no significant difference. However, after 3 months statistically significant (p<0.05) improvement among all three clinical parameters i.e. inter-incisal distance (mean improvement in group A = 3.79±1.07mm and group B = 6.58±1.24mm, p=0.019), tongue protrusion (mean improvement in group A = 1.87±1.54mm and group B = 4.62±1.78mm, p=0.044) and cheek flexibility (mean improvement in group A = 2.08±1.38mm and group B = 3.50±1.84mm, p=0.035) was observed in group B when compared to group A. In contrast, statistically significant improvement in burning sensation was observed after one month itself in group B when compared to group A (mean drop in group A = 2.5±0.78 points and group B = 6.0±1.144 points, p<0.05). CONCLUSION: Omega 3 in conjunction with intralesional injections is an effective therapy when compared to intralesional injections alone in treatment of patients with OSMF (grade II and III) with no side effects.

Omega 3: a novel treatment agent in oral submucous fibrosis: a pilot study.

BACKGROUND: Oral submucous fibrosis (OSF) is a chronic debilitating disease and a premalignant condition of the oral cavity. It is well known for its impervious nature to medical therapy. Omega-3 polyunsaturated fatty acids have been reported to have anti-inflammatory properties. However, its role in OSF is still not known. This preliminary study assessed the efficacy of systemic omega 3 in this disease. METHODS: A randomized single-blinded controlled trial was designed, and a total of 10 clinically confirmed adult patients with OSF were included in the study. Group A was given biweekly intralesional injections of dexamethasone 1.5 ml and hyaluronidase 1500 IU mixed with lignocaine for 6 weeks and a placebo for 3 months. Group B was also given similar intralesional injections but with 1 gm of omega 3 three times daily continuously for 3 months. Patients were followed every month for 3 months and then after 6 months. RESULTS: Significant improvement was noted among all clinical parameters (interincisal distance, tongue protrusion, cheek flexibility, and visual analogue scale) in both the groups. Intergroup comparison showed significant reduction in burning sensation in group B; that is, P value was 0.005, while improvement in rest of the three clinical features was not statistically significant. CONCLUSION: Omega 3 can be used as an adjunctive treatment option in patients with OSF to reduce subjective symptoms. More studies should be conducted with a larger sample size to study the effect of omega 3 in patients with OSF.