PMID- 34788454
OWN - NLM
STAT- MEDLINE
DCOM- 20220317
LR  - 20220317
IS  - 1550-9109 (Electronic)
IS  - 0161-8105 (Linking)
VI  - 45
IP  - 2
DP  - 2022 Feb 14
TI  - Zao Ren An Shen capsule for insomnia: a double-blind, randomized, 
      placebo-controlled trial.
LID - zsab266 [pii]
LID - 10.1093/sleep/zsab266 [doi]
AB  - 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).
CI  - (c) Sleep Research Society 2021. Published by Oxford University Press on behalf of 
      the Sleep Research Society. All rights reserved. For permissions, please email: 
      journals.permissions@oup.com.
FAU - Birling, Yoann
AU  - Birling Y
AUID- ORCID: 0000-0003-1478-6705
AD  - NICM Health Research Institute, Western Sydney University, Penrith, NSW, 
      Australia.
FAU - Zhu, Xiaoshu
AU  - Zhu X
AD  - NICM Health Research Institute, Western Sydney University, Penrith, NSW, 
      Australia.
AD  - School of Health Sciences, NICM Health Research Institute, Western Sydney 
      University, Penrith, NSW, Australia.
FAU - Avard, Nicole
AU  - Avard N
AD  - NICM Health Research Institute, Western Sydney University, Westmead, NSW, 
      Australia.
FAU - Tannous, Caterina
AU  - Tannous C
AD  - School of Health Sciences, Western Sydney University, Penrith, NSW, Australia.
FAU - Fahey, Paul P
AU  - Fahey PP
AD  - School of Health Sciences, Western Sydney University, Penrith, NSW, Australia.
FAU - Sarris, Jerome
AU  - Sarris J
AD  - NICM Health Research Institute, Western Sydney University, Penrith, NSW, 
      Australia.
AD  - The Florey Institute of Neuroscience and Mental Health and Professional Unit, The 
      Melbourne Clinic, Department of Psychiatry, University of Melbourne, Melbourne, 
      VIC, Australia.
FAU - Bensoussan, Alan
AU  - Bensoussan A
AD  - NICM Health Research Institute, Western Sydney University, Penrith, NSW, 
      Australia.
LA  - eng
SI  - ANZCTR/ACTRN12619000140156
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Sleep
JT  - Sleep
JID - 7809084
SB  - IM
MH  - Double-Blind Method
MH  - Fatigue
MH  - Humans
MH  - Quality of Life
MH  - Sleep
MH  - *Sleep Initiation and Maintenance Disorders/drug therapy
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Chinese medicine
OT  - ZRAS
OT  - herbal medicine
OT  - insomnia
OT  - sleep
OT  - trial
EDAT- 2021/11/18 06:00
MHDA- 2022/03/18 06:00
CRDT- 2021/11/17 17:30
PHST- 2021/09/14 00:00 [received]
PHST- 2021/10/22 00:00 [revised]
PHST- 2021/11/18 06:00 [pubmed]
PHST- 2022/03/18 06:00 [medline]
PHST- 2021/11/17 17:30 [entrez]
AID - 6425938 [pii]
AID - 10.1093/sleep/zsab266 [doi]
PST - ppublish
SO  - Sleep. 2022 Feb 14;45(2):zsab266. doi: 10.1093/sleep/zsab266.