PMID- 33240190
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20201127
IS  - 1664-2295 (Print)
IS  - 1664-2295 (Electronic)
IS  - 1664-2295 (Linking)
VI  - 11
DP  - 2020
TI  - Self-Designed Ningxin Anshen Formula for Treatment of Post-ischemic Stroke 
      Insomnia: A Randomized Controlled Trial.
PG  - 537402
LID - 10.3389/fneur.2020.537402 [doi]
LID - 537402
AB  - This study aimed to assess the efficacy and safety of self-designed Ningxin 
      Anshen (NXAS) Formula for post-ischemic stroke insomnia of blood-deficient and 
      liver-heat syndrome. Ninety patients were randomized into NXAS group, Placebo 
      group and Zopiclone group. Patients in the NXAS group, Placebo group and 
      Zopiclone group were treated with Ningxin Anshen Formula, placebo and zopiclone 
      for 4 weeks, respectively. The scores of the Pittsburgh Sleep Quality Index 
      (PSQI), Insomnia Severity Index (ISI) and traditional Chinese Medicine (TCM) 
      Syndromes of self-designed scale and the number of adverse events (AEs) were 
      determined. Results showed that the overall effective rate in the NXAS group and 
      Placebo group was 76.67 and 30.00%, respectively, showing significant difference 
      (P < 0.01). There was no marked difference between Zopiclone group (80.00%) and 
      NXAS group. In both NXAS group and Zopiclone group, the scores of PSQI, ISI, and 
      TCM Syndromes of self-designed scale after 4-week treatment were significantly 
      different from those before treatment (P < 0.01). After 4-week treatment, the 
      scores of PSQI, ISI, and TCM Syndromes of self-designed score were comparable 
      between NXAS group and Zopiclone group (P > 0.05). Only one patient in the NXAS 
      group developed gastrointestinal discomfort, which resolved without treatment 
      discontinuation. In conclusion, self-designed NXAS Formula is effective and safe 
      and has little adverse effect in treating post-stroke insomnia of blood-deficient 
      and liver-heat syndrome.
CI  - Copyright (c) 2020 Dai, Li, Sun, Li and Xiong.
FAU - Dai, Ning
AU  - Dai N
AD  - College of Traditional Chinese Medicine, Beijing University of Traditional 
      Chinese Medicine (TCM), Beijing, China.
FAU - Li, Yuanyuan
AU  - Li Y
AD  - Department of Acupuncture and Moxibustion, Dongfang Hospital, Beijing University 
      of Traditional Chinese Medicine (TCM), Beijing, China.
FAU - Sun, Jing
AU  - Sun J
AD  - Department of Medical Neurology, Tongzhou District of Dongzhimen Hospital, 
      Beijing University of Traditional Chinese Medicine (TCM), Beijing, China.
FAU - Li, Feng
AU  - Li F
AD  - College of Traditional Chinese Medicine, Beijing University of Traditional 
      Chinese Medicine (TCM), Beijing, China.
FAU - Xiong, Hang
AU  - Xiong H
AD  - Department of Medical Neurology, Tongzhou District of Dongzhimen Hospital, 
      Beijing University of Traditional Chinese Medicine (TCM), Beijing, China.
LA  - eng
PT  - Journal Article
DEP - 20201109
PL  - Switzerland
TA  - Front Neurol
JT  - Frontiers in neurology
JID - 101546899
PMC - PMC7680871
OTO - NOTNLM
OT  - Insomnia Severity Index
OT  - Ningxin Anshen Formula
OT  - Pittsburgh Sleep Quality Index
OT  - post-stroke insomnia
OT  - randomized controlled trial
EDAT- 2020/11/27 06:00
MHDA- 2020/11/27 06:01
PMCR- 2020/11/09
CRDT- 2020/11/26 05:45
PHST- 2020/06/05 00:00 [received]
PHST- 2020/10/12 00:00 [accepted]
PHST- 2020/11/26 05:45 [entrez]
PHST- 2020/11/27 06:00 [pubmed]
PHST- 2020/11/27 06:01 [medline]
PHST- 2020/11/09 00:00 [pmc-release]
AID - 10.3389/fneur.2020.537402 [doi]
PST - epublish
SO  - Front Neurol. 2020 Nov 9;11:537402. doi: 10.3389/fneur.2020.537402. eCollection 
      2020.