Efficacy and Safety of Jiawei Suanzaoren Decoction Combined with Lorazepam for Chronic Insomnia: A Parallel-Group Randomized Controlled Trial

Ming-Fen Song; Li-Qiong Chen; Qiong-Yan Shao; Lin-Lin Hu; Wen-Juan Liu; Yong-Hua Zhang

doi:10.1155/2020/3450989

Efficacy and Safety of Jiawei Suanzaoren Decoction Combined with Lorazepam for Chronic Insomnia: A Parallel-Group Randomized Controlled Trial

Evid Based Complement Alternat Med. 2020 Feb 8:2020:3450989. doi: 10.1155/2020/3450989. eCollection 2020.

Authors

Ming-Fen Song^{1

2}, Li-Qiong Chen², Qiong-Yan Shao², Lin-Lin Hu³, Wen-Juan Liu³, Yong-Hua Zhang^{2

4}

Affiliations

¹ Molecular Biology Laboratory, Hangzhou Seventh People's Hospital, Hangzhou, Zhejiang, China.
² Hangzhou Hospital of Traditional Chinese Medicine, Guang Xing Hospital Affiliated to Zhejiang Chinese Medical University, Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China.
³ Department of Psychosomatic Disorders, Hangzhou Seventh People's Hospital, Hangzhou, Zhejiang, China.
⁴ Department of Internal Neurology, Hangzhou Hospital of Traditional Chinese Medicine, Hangzhou, Zhejiang, China.

Abstract

Background: Chronic insomnia is a major public health problem, but there are limited effective therapies. Jiawei Suanzaoren Decoction (JW-SZRD) has been used as an alternative option for treating insomnia. This study aimed to investigate the long-term efficacy and safety of JW-SZRD in combination with lorazepam for chronic insomnia.

Methods: A total of 207 participants were analyzed in this study. The treatment group (TG) received JW-SZRD and lorazepam orally, and the control group (CG) received lorazepam alone. The Insomnia Severity Index (ISI), the Self-Rating Depression Scale (SDS), the Self-Rating Anxiety Scale (SAS), and the Somatic Self-rating Scale (SSS) were evaluated at baseline, weeks 4, 8, and 12. The MOS 36-item Short Form Health Survey (SF-36) was assessed at baseline and week 12. Adverse effects (AEs) were evaluated by the Treatment Emergent Symptom Scale (TESS).

Results: Both TG and CG showed obvious improvements in the sleep onset latency (SOL) (P=0.001 and 0.005) and total sleep time (TST) (P=0.001 and 0.005) and total sleep time (TST) (P=0.001 and 0.005) and total sleep time (TST) (P=0.001 and 0.005) and total sleep time (TST) (P=0.001 and 0.005) and total sleep time (TST) (P=0.001 and 0.005) and total sleep time (TST) (d = 1.28). The ISI reduction rate in TG was higher than that in CG at weeks 4, 8, and 12 (P=0.001 and 0.005) and total sleep time (TST) (P=0.001 and 0.005) and total sleep time (TST) (P=0.001 and 0.005) and total sleep time (TST) (P=0.001 and 0.005) and total sleep time (TST) (P=0.001 and 0.005) and total sleep time (TST) (P=0.001 and 0.005) and total sleep time (TST) (.

Conclusion: The combination of JW-SZRD with lorazepam can significantly improve sleep quality with fewer AEs. It is an effective treatment and superior to lorazepam alone for chronic insomnia.