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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.
AuthorsXu He, Ruihuan Zhang, Zhe Li, Zhen Yao, Xiaoxia Xie, Ruoxue Bai, Lan Li, Xu Zhang, Sha Zhang, Yan Shen, Shaowei Li, Zhenliang Hui, Rongrong Liu, Jun Chen
JournalJournal of pineal research (J Pineal Res) Vol. 73 Issue 4 Pg. e12832 (Nov 2022) ISSN: 1600-079X [Electronic] England
PMID36073608 (Publication Type: Randomized Controlled Trial, Journal Article)
Copyright© 2022 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
Chemical References
  • Antidepressive Agents
  • Melatonin
  • Paroxetine
  • Powders
  • Tablets
  • Drugs, Chinese Herbal
Topics
  • Humans
  • Antidepressive Agents (therapeutic use)
  • Circadian Rhythm (physiology)
  • Depressive Disorder, Major (drug therapy)
  • Melatonin (metabolism)
  • Paroxetine (therapeutic use)
  • Powders (therapeutic use)
  • Sleep (physiology)
  • Tablets (therapeutic use)
  • Drugs, Chinese Herbal (therapeutic use)

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