Sini powder with paroxetine ameliorates major depressive disorder by modulating circadian rhythm: A randomized, double‐blind, placebo‐controlled trial

Abstract

Circadian rhythm disorder is a significant risk factor for mental diseases, and the recovery of circadian rhythm function has gradually become a signal of effective antidepressant therapy. Sini powder (SNP) is a classical, traditional Chinese formula for depression treatment. However, few clinical reports have been recorded. This randomized, double-blinded, controlled trial (ChiCTR1900022700) aimed to explore the efficacy of SNP on depression via regulating circadian rhythm. In total, 36 patients with major depressive disorder (MDD) were enrolled for 4-weeks medication and 6-weeks follow-up. HAMD-24 score and circadian rhythm index, including dim light melatonin onset (DLMO) and phase angle difference (PAD), were included in the assessment. DLMO and PAD were statistically significant in the SNP group after 4 weeks of treatment (p < .05) and with greater improvement in DLMO (p = .03). In addition, DLMO and the HAMD-24 score showed a positive correlation (p < .05); the HAMD-24 score degree decreased significantly over time (p < .001). Similarly, interaction effects were shown significantly between group and time (p = .049). The duration of SNP supplementation was relatively short, and the sample size was relatively small. SNP granules combined with paroxetine tablets have definite efficacy in improving the circadian rhythms of MDD patients, reflecting the therapeutic advantages of traditional Chinese medicine as antidepressants.

Research Progress on the Pharmacodynamic Mechanisms of Sini Powder against Depression from the Perspective of the Central Nervous System

“…Chaihu (CH, Radix Bupleuri), Zhishi (ZS, Aurantii Fructus Immaturus), Baishao (BS, Paeoniae Radix Alba), and Gancao (GC, Licorice) are included in SNP [21]. Multiple clinical trials demonstrated that SNP can effectively modulate the circadian rhythms of depression patients [22], demonstrating therapeutic effects on several types of depression, including diabetes with depression [23], functional dyspepsia with depression [24], and post-stroke depression [25]. Animal experiments proved that SNP can regulate the hypothalamicpituitary-adrenal (HPA) axis, and a single pretreatment extract can relieve the increases in serum corticosterone (CORT) and plasma corticotropin-releasing hormone (CRH) levels induced by acute stress, as well as elevating the mRNA expression of the hippocampal glucocorticoid receptor to combat depression [26].…”