Cargando…

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

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...

Descripción completa

Detalles Bibliográficos
Autores principales: Ning, Houxu, Zhou, Hao, Ren, Jingru, Zhou, Gaiyan, Yang, Ning, Wang, Zhenfu, Yuan, Canxing, Tian, Zuojun, Chen, Juping, Shen, Lihua, Zheng, Huifen, Zhao, Yang, Wang, Haidong, Liu, Weiguo, Liu, Zhenguo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9373440/
https://www.ncbi.nlm.nih.gov/pubmed/35962349
http://dx.doi.org/10.1186/s12967-022-03551-z
_version_ 1784767597407895552
author Ning, Houxu
Zhou, Hao
Ren, Jingru
Zhou, Gaiyan
Yang, Ning
Wang, Zhenfu
Yuan, Canxing
Tian, Zuojun
Chen, Juping
Shen, Lihua
Zheng, Huifen
Zhao, Yang
Wang, Haidong
Liu, Weiguo
Liu, Zhenguo
author_facet Ning, Houxu
Zhou, Hao
Ren, Jingru
Zhou, Gaiyan
Yang, Ning
Wang, Zhenfu
Yuan, Canxing
Tian, Zuojun
Chen, Juping
Shen, Lihua
Zheng, Huifen
Zhao, Yang
Wang, Haidong
Liu, Weiguo
Liu, Zhenguo
author_sort Ning, Houxu
collection PubMed
description 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
format Online
Article
Text
id pubmed-9373440
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-93734402022-08-13 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 Ning, Houxu Zhou, Hao Ren, Jingru Zhou, Gaiyan Yang, Ning Wang, Zhenfu Yuan, Canxing Tian, Zuojun Chen, Juping Shen, Lihua Zheng, Huifen Zhao, Yang Wang, Haidong Liu, Weiguo Liu, Zhenguo J Transl Med Research 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 BioMed Central 2022-08-12 /pmc/articles/PMC9373440/ /pubmed/35962349 http://dx.doi.org/10.1186/s12967-022-03551-z Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Ning, Houxu
Zhou, Hao
Ren, Jingru
Zhou, Gaiyan
Yang, Ning
Wang, Zhenfu
Yuan, Canxing
Tian, Zuojun
Chen, Juping
Shen, Lihua
Zheng, Huifen
Zhao, Yang
Wang, Haidong
Liu, Weiguo
Liu, Zhenguo
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9373440/
https://www.ncbi.nlm.nih.gov/pubmed/35962349
http://dx.doi.org/10.1186/s12967-022-03551-z
work_keys_str_mv AT ninghouxu zishenpingchangranulescombinedwithpramipexoleintheimprovementofdepressivesymptomsinparkinsonsdiseaseaprospectivemulticenterrandomizeddoubleblindcontrolledclinicalstudy
AT zhouhao zishenpingchangranulescombinedwithpramipexoleintheimprovementofdepressivesymptomsinparkinsonsdiseaseaprospectivemulticenterrandomizeddoubleblindcontrolledclinicalstudy
AT renjingru zishenpingchangranulescombinedwithpramipexoleintheimprovementofdepressivesymptomsinparkinsonsdiseaseaprospectivemulticenterrandomizeddoubleblindcontrolledclinicalstudy
AT zhougaiyan zishenpingchangranulescombinedwithpramipexoleintheimprovementofdepressivesymptomsinparkinsonsdiseaseaprospectivemulticenterrandomizeddoubleblindcontrolledclinicalstudy
AT yangning zishenpingchangranulescombinedwithpramipexoleintheimprovementofdepressivesymptomsinparkinsonsdiseaseaprospectivemulticenterrandomizeddoubleblindcontrolledclinicalstudy
AT wangzhenfu zishenpingchangranulescombinedwithpramipexoleintheimprovementofdepressivesymptomsinparkinsonsdiseaseaprospectivemulticenterrandomizeddoubleblindcontrolledclinicalstudy
AT yuancanxing zishenpingchangranulescombinedwithpramipexoleintheimprovementofdepressivesymptomsinparkinsonsdiseaseaprospectivemulticenterrandomizeddoubleblindcontrolledclinicalstudy
AT tianzuojun zishenpingchangranulescombinedwithpramipexoleintheimprovementofdepressivesymptomsinparkinsonsdiseaseaprospectivemulticenterrandomizeddoubleblindcontrolledclinicalstudy
AT chenjuping zishenpingchangranulescombinedwithpramipexoleintheimprovementofdepressivesymptomsinparkinsonsdiseaseaprospectivemulticenterrandomizeddoubleblindcontrolledclinicalstudy
AT shenlihua zishenpingchangranulescombinedwithpramipexoleintheimprovementofdepressivesymptomsinparkinsonsdiseaseaprospectivemulticenterrandomizeddoubleblindcontrolledclinicalstudy
AT zhenghuifen zishenpingchangranulescombinedwithpramipexoleintheimprovementofdepressivesymptomsinparkinsonsdiseaseaprospectivemulticenterrandomizeddoubleblindcontrolledclinicalstudy
AT zhaoyang zishenpingchangranulescombinedwithpramipexoleintheimprovementofdepressivesymptomsinparkinsonsdiseaseaprospectivemulticenterrandomizeddoubleblindcontrolledclinicalstudy
AT wanghaidong zishenpingchangranulescombinedwithpramipexoleintheimprovementofdepressivesymptomsinparkinsonsdiseaseaprospectivemulticenterrandomizeddoubleblindcontrolledclinicalstudy
AT liuweiguo zishenpingchangranulescombinedwithpramipexoleintheimprovementofdepressivesymptomsinparkinsonsdiseaseaprospectivemulticenterrandomizeddoubleblindcontrolledclinicalstudy
AT liuzhenguo zishenpingchangranulescombinedwithpramipexoleintheimprovementofdepressivesymptomsinparkinsonsdiseaseaprospectivemulticenterrandomizeddoubleblindcontrolledclinicalstudy