Zao Ren An Shen capsule for insomnia: a double-blind, randomized, placebo-controlled trial

Yoann Birling; Xiaoshu Zhu; Nicole Avard; Caterina Tannous; Paul P Fahey; Jerome Sarris; Alan Bensoussan

doi:10.1093/sleep/zsab266

Zao Ren An Shen capsule for insomnia: a double-blind, randomized, placebo-controlled trial

Sleep. 2022 Feb 14;45(2):zsab266. doi: 10.1093/sleep/zsab266.

Authors

Yoann Birling¹, Xiaoshu Zhu^{1

2}, Nicole Avard³, Caterina Tannous⁴, Paul P Fahey⁴, Jerome Sarris^{1

5}, Alan Bensoussan¹

Affiliations

¹ NICM Health Research Institute, Western Sydney University, Penrith, NSW, Australia.
² School of Health Sciences, NICM Health Research Institute, Western Sydney University, Penrith, NSW, Australia.
³ NICM Health Research Institute, Western Sydney University, Westmead, NSW, Australia.
⁴ School of Health Sciences, Western Sydney University, Penrith, NSW, Australia.
⁵ The Florey Institute of Neuroscience and Mental Health and Professional Unit, The Melbourne Clinic, Department of Psychiatry, University of Melbourne, Melbourne, VIC, Australia.

PMID: 34788454
DOI: 10.1093/sleep/zsab266

Abstract

Study objectives: The aim of this study was to test the efficacy and safety of Zao Ren An Shen (ZRAS) capsule, a Chinese herbal medicine product, for the treatment of insomnia.

Methods: We conducted a double-blind randomized placebo-controlled trial. After a one-week placebo run-in, a total of 85 people with insomnia were randomly allocated to receive ZRAS or placebo for 4 weeks. The primary outcomes were insomnia severity assessed with the Insomnia Severity Index (ISI) and the number of participants with adverse events (AEs). Secondary outcomes included objective and subjective sleep parameters, psychological status, fatigue level, quality of life, acceptability, and tolerability.

Results: A nonsignificant (p > .05) difference of 0.7 points in ISI in favor of ZRAS capsule was found at the end of the treatment. The number of participants with AEs was not significantly different (p > .05) between the two groups. Except for subjective sleep onset latency, which had a nonsignificant (p > .05) medium effect (Cohen's d = 0.5), the effects in secondary efficacy outcomes were all small (Cohen's d < .4) and nonsignificant (p > .05). The acceptability and tolerability were high in the active group.

Conclusions: ZRAS capsule is safe, acceptable, and tolerable, yet not more effective than placebo in the treatment of insomnia. As previous evidence showed that Chinese herbal medicine was effective for insomnia, these results may be explained by the dose of the product, which was lower than the dose generally used in the clinic.Registration: This clinical trial was registered in Australia New Zealand Clinical Trial Registry (registration number ACTRN12619000140156) under the name "Impact of Zao Ren An Shen (ZRAS) capsule on chronic insomnia patients' insomnia severity: A randomized-controlled trial" (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376730&isReview=true).

Keywords: Chinese medicine; ZRAS; herbal medicine; insomnia; sleep; trial.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Double-Blind Method
Fatigue
Humans
Quality of Life
Sleep
Sleep Initiation and Maintenance Disorders* / drug therapy
Treatment Outcome

Associated data

ANZCTR/ACTRN12619000140156