Nigella Sativa 100% Topical Oil is an Effective Therapeutic and Prophylactic Agent in Treatment of Recurrent Aphthous Ulcer (RAU) (Single blind placebo controlled therapeutic study)

Background: Recurrent aphthous ulcer (RAU) is a common oral disease without well known etiology. The disease is treated by a variety of agents for palliative, prophylactic, and curative purposes. Nigella sativa has been used in the treatment of many medical and skin diseases, and it contains several active ingredients in significant amounts and potential values; it contains fixed oil, sterols, volatile oil and others. Objective: To assess the therapeutic, prophylactic efficacy and safety of topical 100% nigella sativa oil in the management of patients with RAU. Patients Methods: This is a single blind placebo controlled therapeutic study where 40 patients with early onset oral aphthosis were recruited in this work those who attended Baghdad Teaching Hospital- Department of Dermatology between April 2005- April 2006. Patients were divided randomly into two groups, Group A (20 patients) were instructed to use 100% Nigella Sativa topical oil twice daily. While Group B (20 patients) were instructed to use placebo (distilled water mouthwash), 5 ml twice daily. A short term assessment of each patient of both groups was done to evaluate the therapeutic effect of the drug by using oral clinical manifestation index (OCMI), mean size of the largest diameter of ulcers. A long term assessment was done for each patient to evaluate the prophylactic effect of the drug by using OCMI before, after 1, 2 and 3 months of therapy. Results: The patients included in this study were 19 (47.5%) males and 21 (52.5%) females, with female to male ratio was 1.1:1. Their ages ranged between 20-60( 29.6 ± 9.6) years. The mean of OCMI in Group A started to decline directly after 4 days of therapy and to its lower level after 8 days of therapy, and it was statistically significant (P value 0.05). The change in the mean of OCMI of Group B after 4 and 8 days of therapy was also statistically significant (P value 0.05). The response rate (percentage of change in the mean) after 4 days of therapy in Group A was 10.23 % and in Group B was 6.44%, while the response rate after 8 days of therapy in group A was 60.60 % and in group B was 44.98%. The difference in the response rates after 4 and 8 days between Groups A and B was statistically significant (P value 0.05). The mean size of ulcers in Group A started to decline directly after 4 days of therapy and to its lower level after 8 days of therapy, and it was statistically significant (P value 0.05). The change in the mean size of ulcers of Group B after 4 and 8 days of therapy was also statistically significant (P value 0.05). The response rate after 4 days of therapy in Group A was 39.65 % and in Group B was 15.08 %, while the response rate after 8 days of therapy in Group A was 78.57 % and in Group B was 55.36%. The difference in the response rates after 4 and 8 days between Groups A and B was statistically significant (P value 0.05). So, the therapeutic action of 100% nigella sativa oil was statistically significant drug more effective than placebo. No significant side effects were noticed. Topical Nigella Sativa oil 100% showed significant prophylactic efficacy after 1 and 2 months from starting the therapy in comparison to placebo and no significant effect was noticed after 3 months. Conclusion: Topical nigella sativa oil 100% is a new, safe effective therapeutic and prophylactic remedy in management of RAU. The mechanism of action of nigella sativa in treatment of RAU cannot be clearly understood, but probable mechanisms of action of Nigella Sativa may be through its antimicrobial, immunomodulator and antioxidant actions.