Objective: To evaluate the clinical effectiveness and safety of Sanchi Tong Shu capsule in the treatment of common aural vertigo.
Method: A multi-center randomized controlled trial was designed to study 206 vertigo patients who were randomly allocated into one of the two groups. One group was treated with Sanchi Tong Shu capsule for 14 days, another group was treated with betahistine mesilate tablets for 14 days.
Result: The clinical effectiveness rates of the two groups were 84.86% and 90.92% respectively according to FAS analysis and 84.76%, 90.92% respectively according to PPS analysis. No statistic significance difference was found between the two groups (P > 0.05). After 14 days treatment, total DHI and all the subsection (including body, emotion and function) scores of the two groups were all decreased compared with treatment before (P < 0.01). Compared the difference value of the total DHI and subsection scores before and after treatment, the two groups have no difference (P > 0.05). The adverse effective rate of the two groups were 3.29% and 7.84% respectively and there was no statistic difference between the two groups (P > 0.05).
Conclusion: Sanchi Tong Shu capsule is a safe and effective drug for the treatment of common aural vertigo.