Shoden Promotes Relief from Stress and Anxiety: A Randomized, Double-Blind, Placebo- Controlled Study on Healthy Subjects with High Stress Levels

Abstract

Background This randomized placebo-controlled study examined the effect of ashwagandha root and leaf extract 60mg (AE60) and 120 mg (AE120) (35% withanolide glycosides, Shoden) in physically healthy subjects with higher stress and anxiety. It is hypothesized that a low dose extract with higher withanolide glycosides would decrease cortisol and increase testosterone thereby reducing stress and anxiety. Methods This parallel arm study recruited 60 subjects with an allocation ratio of 1:1:1 (AE60:AE120: placebo) for 60 days. Subjects who fulfilled the DSM –IV Criteria for generalized anxiety disorder (GAD) with a HAMA score > 20, and morning serum cortisol > 25 mcg/dl were included in the study. The participants did not have depression symptoms and were screened using Montgomery-Asberg Depression Rating Scale.. The primary outcome measure was HAMA and the secondary measures were morning serum cortisol, testosterone, perceived stress scale (PSS), clinical global impressions scale (CGI), and patient’s global impression of change scale (PGIC). Results After 60 days, AE60 and AE120 significantly decreased HAMA by 59% (p < 0.0001) whereas placebo had a negligible increase of 0.83%. Morning serum cortisol decreased significantly in AE60 and AE120 by 66% and 67% (p < 0.0001) respectively, whereas the placebo had only a 2.22% change. Testosterone increased significantly by 22% and 33% (p < 0.0001) in AE60 and AE120, respectively, whereas placebo had a 4% increase in males. PSS significantly decreased by 53% and 62%, CGI- severity by 72% and 68%, and PGIC by 60% respectively for AE60 and AE120. Conclusion AE60 and AE120 were significantly better than placebo in reducing anxiety and stress. The hypothesis that low dose extracts with 35% withanolide glycosides reduces non-depression high anxiety and stress was met. AE60 and AE120 significantly reduced morning serum cortisol and increased total testosterone. Hence low dose Shoden may be recommended for reducing high stress and anxiety.