Nigella sativa in Comparison to Steroids in Managing Oral Submucous Fibrosis

Abstract

Background: Nigella sativa (N. sativa), a natural herb, commonly known as Black seed or Kalonji, has a prolonged medicinal history of more than 2000 years. Oral submucous fibrosis (OSMF) is a chronic inflammatory disorder, which is mostly treated with steroids. This clinical trial was conducted to assess the effectiveness of N. sativa oil in comparison to steroids for treating OSMF. Methods: This randomized clinical trial consisted of n=39 clinically diagnosed OSMF patients aged 18 years and above. Patients were divided through randomization into two groups. Group 1 was prescribed steroid lotion while Group 2 was given N. sativa oil (Cold-pressed) to be applied on the buccal mucosa for three months along with physiotherapy. Mann-Whitney U Test while the Wilcoxon Rank sum test were applied. A p-value of less than 0.05 was considered statistically significant. Results: Thirty patients (aged 35.33±2.07) completed the trial in which the majority were males (n=28, 93.30%) and were from Urdu-speaking communities [22 (73.30%)]. Most of the patients (n= 18, 60%) were consuming a combination of Pan and Areca Nut (Chaliya), 04 (13.3%) were consuming only areca nut while 03 (10%) used Gutkha as a habit. In this trial, N. sativa was found to be equally effective as compared to steroids in reducing pain and improving the interincisal mouth opening (IIMO) (p-value >0.05%). Conclusion: N. sativa can be used as an effective treatment option for reducing pain or burning and increasing interincisal mouth opening in patients with OSMF without producing any side effects. Keywords: Nigella sativa; Oral Submucous Fibrosis; Steroids; Head and Neck Squamous Cell Carcinoma.