Effectiveness of Xiaoyao capsule on sleep disorders and mood disturbance in patients in recovery from coronavirus disease 2019: a randomized controlled trial.

Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan Pub Date : 2023-04-01 DOI:10.19852/j.cnki.jtcm.2023.02.005

Yang Cunqing, Lian Fengmei, Yang Guiping, Huang Yufeng, Zhang Shuangbin, Wang Jianghua, Zhou Jing, Guo Dongqing, Shen Chuanyun, Y E Tiansong, F U Aojie, L I Xiaoli, Chen Le, Zhang Huifeng, T U Qiyin, Wang Ying, Yang Wenzhe, Tong Xiaolin, B A Yuanming

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Abstract

Objective: To study the efficacy of Xiaoyao capsule in improving the clinical symptoms of sleep and mood disorders during recovery from coronavirus disease 2019 (COVID-19).

Methods: The study cohort comprised 200 patients with sleep and mood disorders during recovery from COVID-19. Patients were randomized into the control group and the experimental group in a 1:1 ratio by blocked randomization. The patients received either Xiaoyao capsule (experimental group) or a placebo Xiaoyao capsule (control group) for 2 weeks. The improvements in the Traditional Chinese Medicine (TCM) syndrome scales, total effective rates, and disappearance rates of irritability, anxiety, and poor sleep were compared between the two groups.

Results: The TCM syndrome pattern scales, total effective rates, and disappearance rates of irritability, anxiety, and poor sleep did not significantly differ between the experimental group versus the control group in the full analysis set and the per protocol set after 1 and 2 weeks of treatment ( > 0.05).

Conclusions: Xiaoyao capsule do not significantly improve the clinical symptoms of sleep and mood disorders in patients in recovery from COVID-19.

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逍遥胶囊治疗2019冠状病毒病恢复期患者睡眠障碍和情绪障碍的随机对照试验

目的:研究逍遥胶囊改善新冠肺炎恢复期睡眠和情绪障碍临床症状的疗效。方法:研究队列包括200例在COVID-19康复期间出现睡眠和情绪障碍的患者。采用阻断随机法将患者按1:1的比例随机分为对照组和实验组。患者分别服用逍遥胶囊(实验组)或安慰剂逍遥胶囊(对照组)，疗程2周。比较两组在中医证候量表、总有效率、烦躁、焦虑、睡眠不良症状消失率等方面的改善情况。结果:治疗1周、2周后，实验组与对照组的中医证型量表、总有效率、烦躁、焦虑、睡眠不良消失率在全分析集和每方案集上均无显著差异(> 0.05)。结论:逍遥胶囊对新冠肺炎恢复期患者睡眠和情绪障碍的临床症状无明显改善作用。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan

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