A study of efficacy of Nigella sativa in treatment of Meniere's disease: A randomized, placebo controlled clinical trial

PURPOSE: Meniere's disease (MD), first introduced by Prosper Meniere, is characterized mainly by vertigo, tinnitus, aural fullness and sensorineural hearing loss. Though the exact pathophysiology of MD is unknown, immunologic and inflammatory interactions are possible underlying mechanisms involved in MD. This study is aimed to investigate the immunomodulatory and anti-inflammatory effect of Nigella sativa on MD as a therapeutic agent. METHODS: We divided 40 patients with definite MD into two groups of 20 cases. The study group received 1 g of Nigella sativa oil daily for three months and the control group received a placebo. Changes in hearing, tinnitus and vertigo were estimated by pure tone audiometry, tinnitus handicap inventory questionnaire and dizziness handicap inventory questionnaire, respectively. RESULTS: At the end of the study we did not observe any significant improvement in study's group hearing threshold, tinnitus and vertigo compared to the control group. CONCLUSIONS: In this study, statistical analysis showed that Nigella sativa failed to improve signs and symptoms of MD. However, further investigations with a larger study population are needed to ascertain the current conclusion.