The Effect of Treatment with an Herbal Formulation of Salvia hydrangea, Citrus aurantium, Lipia citriodora, and Elm Bark on the Intensity of Tinnitus: A Clinical Trial

Abstract

Background: Tinnitus is a symptom of an underlying medical condition that is associated with hearing loss in humans. It is a subjective disease where patients hear voices that others cannot hear. Increase in noise pollution, growing development of communication devices, and the long-ranging 8-year war in our country have further accelerated the spread of this disorder. Given that no definitive medical or surgical treatment has been confirmed for this condition, new research to improve treatment options is urgent. Aim: The purpose of this study was to assess the effect of a formulation prepared from Salvia hydrangea , Citrus aurantium , Lipia Citriodora , and elm bark on the status of tinnitus. Methods: In this single-blind clinical trial, 144 patients with tinnitus were selected based on pre-defined inclusion criteria and then randomly divided into 3 groups: herbal formulation, cinnarizine, and placebo groups, where the frequency and intensity of tinnitus was measured based on the Tinnitus Handicap Inventory (THI) and Visual Analogue Scale (VAS) criteria before and on 28 and 56 days post treatment. Data were analyzed by the statistical software SPSS version 16, repeated measurement, one-way, and X2 for comparison within and among groups, with the significance level set at p < 0.05. Results: comparably, tinnitus based on THI criteria differed among the 3 groups on 28 and 56 days of intervention, where the difference was statistically significant (p < 0.05). This difference was more significant between the cinnarizine and placebo groups. The mean severity of tinnitus, based on the VAS score, differed among the three groups on 28 and 56 days after intervention, although the difference was not statistically significant. Conclusion: Herbal formulation was effective on tinnitus alleviation, but its effect was not superior to that of conventionally used chemical drug cinnarizine.