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Chinese herbal medicine for vascular cognitive impairment in cerebral small vessel disease: A protocol for systematic review and meta-analysis of randomized controlled trials
BACKGROUND: Cerebral small vessel disease (CSVD) is the most common etiology of vascular cognitive impairment (VCI). VCI in CSVD (CSVD-VCI) shows a progressive course with multiple stages and is also associated with dysfunctions such as gait, emotional and behavioral, and urinary disturbances, which...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Lippincott Williams & Wilkins
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7535689/ https://www.ncbi.nlm.nih.gov/pubmed/33019432 http://dx.doi.org/10.1097/MD.0000000000022455 |
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author | Zhang, Xinyang Liu, Xuemei Xia, Ruyu Li, Nannan Liao, Xing Chen, Zhigang |
author_facet | Zhang, Xinyang Liu, Xuemei Xia, Ruyu Li, Nannan Liao, Xing Chen, Zhigang |
author_sort | Zhang, Xinyang |
collection | PubMed |
description | BACKGROUND: Cerebral small vessel disease (CSVD) is the most common etiology of vascular cognitive impairment (VCI). VCI in CSVD (CSVD-VCI) shows a progressive course with multiple stages and is also associated with dysfunctions such as gait, emotional and behavioral, and urinary disturbances, which seriously affect the life quality of elderly people. In mainland China, Chinese herbal medicine (CHM) is clinically used for CSVD-VCI and presenting positive efficacy, but the evidence revealed in relevant clinical trials has not been systematically evaluated. The purpose of this study is to assess the current evidence available for the clinical efficacy and safety of CHM for CSVD-VCI. METHODS: A literature search of published RCTs up to April 30, 2020, has been conducted in the following 7 electronic databases: PubMed, Embase, the Cochrane Library, Chinese National Knowledge Infrastructure Database (CNKI), Chinese Science and Technology Journals Database (VIP), Wanfang Database, and Chinese Biomedical Literature Service System (SinoMed). For unpublished studies, 2 clinical trial online registration websites will be searched: ClinicalTrials.gov and Chinese Clinical Trial Registry (ChiCTR). Only randomized controlled trials (RCTs) using CHM in the treatment of patients with CSVD-VCI, which compares CHM with no treatment, placebo, or other conventional treatments, will be included in this systematic review. Primary outcomes will be set as acknowledged scales measuring cognitive function. Secondary outcomes will involve activities of daily living, behavioral, and psychological symptoms, global performance of dementia, neurological function, biological markers of endothelial dysfunction, the clinical effective rate, and adverse events. After screening studies and extracting data, the Cochrane Collaborations tool for assessing risk of bias will be applied to assess the methodological quality of included RCTs. Review Manager Version 5.3 software will be used for data synthesis and statistical analysis. Subgroup analyses, sensitivity analyses, and meta-regression will be conducted to detect potential sources of heterogeneity. The funnel plot and Eggers test will be developed to evaluate publication bias, if available. We will perform the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system to appraise the quality of evidence. RESULTS: Evidence exhibited in this systematic review will provide practical references in the field of CHM treating CSVD-VCI. Moreover, our detailed appraisals of methodological deficiencies of relevant RCTs will offer helpful advice for researchers who are designing trials of CHMs in the treatment of CSVD-VCI. CONCLUSION: The conclusion about the clinical efficacy and safety of CHM for CSVD-VCI will be provided for clinical plans, decisions, and policy developments in the full version of this systematic review. SYSTEMATIC REVIEW REGISTRATION: INPLASY202080120. |
format | Online Article Text |
id | pubmed-7535689 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Lippincott Williams & Wilkins |
record_format | MEDLINE/PubMed |
spelling | pubmed-75356892020-10-14 Chinese herbal medicine for vascular cognitive impairment in cerebral small vessel disease: A protocol for systematic review and meta-analysis of randomized controlled trials Zhang, Xinyang Liu, Xuemei Xia, Ruyu Li, Nannan Liao, Xing Chen, Zhigang Medicine (Baltimore) 3800 BACKGROUND: Cerebral small vessel disease (CSVD) is the most common etiology of vascular cognitive impairment (VCI). VCI in CSVD (CSVD-VCI) shows a progressive course with multiple stages and is also associated with dysfunctions such as gait, emotional and behavioral, and urinary disturbances, which seriously affect the life quality of elderly people. In mainland China, Chinese herbal medicine (CHM) is clinically used for CSVD-VCI and presenting positive efficacy, but the evidence revealed in relevant clinical trials has not been systematically evaluated. The purpose of this study is to assess the current evidence available for the clinical efficacy and safety of CHM for CSVD-VCI. METHODS: A literature search of published RCTs up to April 30, 2020, has been conducted in the following 7 electronic databases: PubMed, Embase, the Cochrane Library, Chinese National Knowledge Infrastructure Database (CNKI), Chinese Science and Technology Journals Database (VIP), Wanfang Database, and Chinese Biomedical Literature Service System (SinoMed). For unpublished studies, 2 clinical trial online registration websites will be searched: ClinicalTrials.gov and Chinese Clinical Trial Registry (ChiCTR). Only randomized controlled trials (RCTs) using CHM in the treatment of patients with CSVD-VCI, which compares CHM with no treatment, placebo, or other conventional treatments, will be included in this systematic review. Primary outcomes will be set as acknowledged scales measuring cognitive function. Secondary outcomes will involve activities of daily living, behavioral, and psychological symptoms, global performance of dementia, neurological function, biological markers of endothelial dysfunction, the clinical effective rate, and adverse events. After screening studies and extracting data, the Cochrane Collaborations tool for assessing risk of bias will be applied to assess the methodological quality of included RCTs. Review Manager Version 5.3 software will be used for data synthesis and statistical analysis. Subgroup analyses, sensitivity analyses, and meta-regression will be conducted to detect potential sources of heterogeneity. The funnel plot and Eggers test will be developed to evaluate publication bias, if available. We will perform the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system to appraise the quality of evidence. RESULTS: Evidence exhibited in this systematic review will provide practical references in the field of CHM treating CSVD-VCI. Moreover, our detailed appraisals of methodological deficiencies of relevant RCTs will offer helpful advice for researchers who are designing trials of CHMs in the treatment of CSVD-VCI. CONCLUSION: The conclusion about the clinical efficacy and safety of CHM for CSVD-VCI will be provided for clinical plans, decisions, and policy developments in the full version of this systematic review. SYSTEMATIC REVIEW REGISTRATION: INPLASY202080120. Lippincott Williams & Wilkins 2020-10-02 /pmc/articles/PMC7535689/ /pubmed/33019432 http://dx.doi.org/10.1097/MD.0000000000022455 Text en Copyright © 2020 the Author(s). Published by Wolters Kluwer Health, Inc. http://creativecommons.org/licenses/by/4.0 This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. http://creativecommons.org/licenses/by/4.0 |
spellingShingle | 3800 Zhang, Xinyang Liu, Xuemei Xia, Ruyu Li, Nannan Liao, Xing Chen, Zhigang Chinese herbal medicine for vascular cognitive impairment in cerebral small vessel disease: A protocol for systematic review and meta-analysis of randomized controlled trials |
title | Chinese herbal medicine for vascular cognitive impairment in cerebral small vessel disease: A protocol for systematic review and meta-analysis of randomized controlled trials |
title_full | Chinese herbal medicine for vascular cognitive impairment in cerebral small vessel disease: A protocol for systematic review and meta-analysis of randomized controlled trials |
title_fullStr | Chinese herbal medicine for vascular cognitive impairment in cerebral small vessel disease: A protocol for systematic review and meta-analysis of randomized controlled trials |
title_full_unstemmed | Chinese herbal medicine for vascular cognitive impairment in cerebral small vessel disease: A protocol for systematic review and meta-analysis of randomized controlled trials |
title_short | Chinese herbal medicine for vascular cognitive impairment in cerebral small vessel disease: A protocol for systematic review and meta-analysis of randomized controlled trials |
title_sort | chinese herbal medicine for vascular cognitive impairment in cerebral small vessel disease: a protocol for systematic review and meta-analysis of randomized controlled trials |
topic | 3800 |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7535689/ https://www.ncbi.nlm.nih.gov/pubmed/33019432 http://dx.doi.org/10.1097/MD.0000000000022455 |
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