PMID- 35962349
OWN - NLM
STAT- MEDLINE
DCOM- 20220816
LR  - 20220907
IS  - 1479-5876 (Electronic)
IS  - 1479-5876 (Linking)
VI  - 20
IP  - 1
DP  - 2022 Aug 12
TI  - Zishen pingchan granules combined with pramipexole in the improvement of 
      depressive symptoms in Parkinson's disease: a prospective, multicenter, 
      randomized, double-blind, controlled clinical study.
PG  - 357
LID - 10.1186/s12967-022-03551-z [doi]
LID - 357
AB  - BACKGROUND AND OBJECTIVE: Zishen Pingchan granule (ZPG), a traditional Chinese 
      herbal recipe for treating Parkinson's disease (PD), is usually used as an add-on 
      drug with some antiparkinsonian drugs in China. The objectives of this study were 
      to evaluate the efficacy, safety, and tolerability of ZPG combined with 
      pramipexole in the treatment of depression in PD (dPD). METHODS: A 12-week, 
      multicenter, randomized, double-blind, and placebo-controlled study on ZPG was 
      performed on a total of 200 patients who were treated with pramipexole but still 
      had mild to moderate depressive symptoms. Patients were randomly divided into ZPG 
      (n = 100) or placebo (n = 100). The primary effective result was the mean change 
      from the baseline on the Hamilton Depression Scale 17 items (HAM-D-17) over 
      12 weeks and the clinical efficacy rate. Secondary endpoints were the mean change 
      from the baseline in the Geriatric Depression Scale (GDS-15), Unified Parkinson's 
      disease rating scale Part III (UPDRS III), Parkinson's quality of life scale 
      (PDQ-8), and Parkinson's disease sleep scale (PDSS-2) over 12 weeks. RESULTS: 
      After 12 weeks of treatment, ZPG significantly reduced the mean [95% confidence 
      interval] HAMD score vs. placebo (- 1.43 scores [- 2.50, - 0.36]; p = 0.009). The 
      clinical remission rate and responders of the ZPG group were higher than those of 
      the placebo (46.1% vs. 31.0%; p = 0.041; 34.8% vs. 18.4%; p = 0.014). A 
      significant improvement in the PDSS-2 score was also observed in the ZPG group 
      compared with that in the placebo group (- 3.56 scores [- 5.77, - 1.35]; 
      p = 0.002). A total of 7 patients (7.1%) in the ZPG group had mild adverse events 
      (AEs) vs 9 patients (9%) in the placebo group. No severe AEs were observed in 
      either group. The randomization and controlled clinical study revealed that ZPG 
      was effective, safe, and well-tolerated. CONCLUSION: ZPG combined with 
      pramipexole further reduced the depressive symptoms and improved the sleeping 
      quality of PD patients. Trial registration The protocol was retrospectively 
      registered at the Chinese Clinical Trial Registry, Unique identifier: 
      ChiCTR1800019942, date of registration: December 9, 2018; 
      http://www.chictr.org.cn/showproj.aspx?proj=30432.
CI  - (c) 2022. The Author(s).
FAU - Ning, Houxu
AU  - Ning H
AD  - Department of Chinese Medicine, The Affiliated Brain Hospital of Nanjing Medical 
      University, Nanjing, 210029, China.
AD  - Department of Neurology, Nanjing Hospital of Chinese Medicine, Nanjing University 
      of Chinese Medicine, Nanjing, 210022, China.
FAU - Zhou, Hao
AU  - Zhou H
AD  - Department of Neurology, The Affiliated Brain Hospital of Nanjing Medical 
      University, Nanjing, 210029, China.
FAU - Ren, Jingru
AU  - Ren J
AD  - Department of Neurology, The Affiliated Brain Hospital of Nanjing Medical 
      University, Nanjing, 210029, China.
FAU - Zhou, Gaiyan
AU  - Zhou G
AD  - Department of Neurology, The Affiliated Brain Hospital of Nanjing Medical 
      University, Nanjing, 210029, China.
FAU - Yang, Ning
AU  - Yang N
AD  - Department of Chinese Medicine, The Affiliated Brain Hospital of Nanjing Medical 
      University, Nanjing, 210029, China.
FAU - Wang, Zhenfu
AU  - Wang Z
AD  - Department of Neurology, Chinese PLA General Hospital, Beijing, 100036, China.
FAU - Yuan, Canxing
AU  - Yuan C
AD  - Department of Neurology, Longhua Hospital, Shanghai University of Traditional 
      Chinese Medicine, Shanghai, 200032, China.
FAU - Tian, Zuojun
AU  - Tian Z
AD  - Department of Neurology, the First Affiliated Hospital of Guangzhou Medical 
      University, Guangzhou Medical University, Guangzhou, 510000, China.
FAU - Chen, Juping
AU  - Chen J
AD  - Department of Neurology, Changshu Hospital of Traditional Chinese Medicine, 
      Changshu, 215500, China.
FAU - Shen, Lihua
AU  - Shen L
AD  - Department of Neurology, Affiliated Hospital of Nantong University, Nantong 
      University, Nantong, 226000, China.
FAU - Zheng, Huifen
AU  - Zheng H
AD  - Department of Neurology, Geriatric Hospital of Nanjing Medical University, 
      Nanjing Medical University, Nanjing, 210000, China.
FAU - Zhao, Yang
AU  - Zhao Y
AD  - Department of Neurology, Nanjing Hospital of Chinese Medicine, Nanjing University 
      of Chinese Medicine, Nanjing, 210022, China.
FAU - Wang, Haidong
AU  - Wang H
AD  - Department of Chinese Medicine, The Affiliated Brain Hospital of Nanjing Medical 
      University, Nanjing, 210029, China.
FAU - Liu, Weiguo
AU  - Liu W
AUID- ORCID: 0000-0001-5916-9837
AD  - Department of Neurology, The Affiliated Brain Hospital of Nanjing Medical 
      University, Nanjing, 210029, China. wgliunbh@sina.com.
FAU - Liu, Zhenguo
AU  - Liu Z
AD  - Department of Neurology, Xinhua Hospital, Shanghai Jiao Tong University School of 
      Medicine, Shanghai, 200092, China. zhenguoliu2011@aliyun.com.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20220812
PL  - England
TA  - J Transl Med
JT  - Journal of translational medicine
JID - 101190741
RN  - 0 (Benzothiazoles)
RN  - 83619PEU5T (Pramipexole)
SB  - IM
MH  - Aged
MH  - Benzothiazoles/adverse effects
MH  - Depression/complications/drug therapy
MH  - Double-Blind Method
MH  - Humans
MH  - *Parkinson Disease/complications/drug therapy
MH  - Pramipexole/therapeutic use
MH  - Prospective Studies
MH  - Quality of Life
MH  - Severity of Illness Index
MH  - Treatment Outcome
PMC - PMC9373440
OTO - NOTNLM
OT  - Depression in the Parkinson's disease
OT  - Pramipexole
OT  - Randomized controlled trial
OT  - Zishen Pingchan granules
COIS- The authors declare that they have no competing interests.
EDAT- 2022/08/13 06:00
MHDA- 2022/08/17 06:00
PMCR- 2022/08/12
CRDT- 2022/08/12 23:38
PHST- 2022/04/13 00:00 [received]
PHST- 2022/07/22 00:00 [accepted]
PHST- 2022/08/12 23:38 [entrez]
PHST- 2022/08/13 06:00 [pubmed]
PHST- 2022/08/17 06:00 [medline]
PHST- 2022/08/12 00:00 [pmc-release]
AID - 10.1186/s12967-022-03551-z [pii]
AID - 3551 [pii]
AID - 10.1186/s12967-022-03551-z [doi]
PST - epublish
SO  - J Transl Med. 2022 Aug 12;20(1):357. doi: 10.1186/s12967-022-03551-z.