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The effect of a therapeutic regimen of Traditional Chinese Medicine rehabilitation for post-stroke cognitive impairment: study protocol for a randomized controlled trial.

ABSTRACT: Post-stroke cognitive impairment (PSCI) lessens quality of life, restricts the rehabilitation of stroke, and increases the social and economic burden stroke imposes on patients and their families. Therefore effective treatment is of paramount importance. However, the treatment of PSCI is very limited. The primary aim of this protocol is to propose a lower cost and more effective therapy, and to confirm the long-term effectiveness of a therapeutic regimen of Traditional Chinese Medicine (TCM) rehabilitation for PSCI.A prospective, multicenter, large sample, randomized controlled trial will be conducted. A total of 416 eligible patients will be recruited from seven inpatient and outpatient stroke rehabilitation units and randomly allocated into a therapeutic regimen of TCM rehabilitation group or cognitive training (CT) control group. The intervention period of both groups will last 12 weeks (30 minutes per day, five days per week). Primary and secondary outcomes will be measured at baseline, 12 weeks (at the end of the intervention), and 36 weeks (after the 24-week follow-up period).This protocol presents an objective design of a multicenter, large sample, randomized controlled trial that aims to put forward a lower cost and more effective therapy, and confirm the long-term effectiveness of a therapeutic regimen of TCM rehabilitation for PSCI through subjective and objective assessments, as well as highlight its economic advantages.This trial was registered with the Chinese Clinical Trial Registry (identifier: ChiCTR-TRC-14004872 ) on 23 June 2014.

SUBMITTER: Huang J

PROVIDER: S-EPMC4485558 | biostudies-literature | 2015 Jun

REPOSITORIES: biostudies-literature

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The effect of a therapeutic regimen of Traditional Chinese Medicine rehabilitation for post-stroke cognitive impairment: study protocol for a randomized controlled trial.

Huang Jia J Lin Zhengkun Z Wang Qin Q Liu Feiwen F Liu Jiao J Fang Yunhua Y Chen Shanjia S Zhou Xiaoxuan X Hong Wenjun W Wu Jinsong J Madrigal-Mora Natalia N Zheng Guohua G Yang Shanli S Tao Jing J Tao Jing J Chen Lidian L

Trials 20150616

<h4>Background</h4>Post-stroke cognitive impairment (PSCI) lessens quality of life, restricts the rehabilitation of stroke, and increases the social and economic burden stroke imposes on patients and their families. Therefore effective treatment is of paramount importance. However, the treatment of PSCI is very limited. The primary aim of this protocol is to propose a lower cost and more effective therapy, and to confirm the long-term effectiveness of a therapeutic regimen of Traditional Chinese ...[more]

PMID: 26077459

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Project description:Background: Post-stroke cognitive impairment (PSCI) affects more than one-third of stroke patients, and causes much greater harm to long-term function than the initial brain damage. No conventional Western medications have shown convincing clinical effectiveness for treating PSCI. Research shows that Traditional Chinese medicine (TCM) can improve cognitive function in patients. However, the clinical efficacy and safety remain controversial. The aim of this study was to examine the effectiveness and harmful effects of TCMs in the treatment of PSCI. Method: We searched seven databases and two clinical registration websites for randomized controlled trials (RCTs). The revised Cochrane risk of bias tool (RoB 2.0) was used to evaluate the methodological quality and RevMan 5.4 was used for data analysis. This study has been submitted to PROSPERO with registration number is CRD42020149299. Results: We included 34 studies in this review. The results of this study showed that TCM adjuvant therapy improved scores on the MoCA [MD = 2.55, 95% CI (1.56, 3.53), p < 0.00001; MD = 3.07, 95% CI (1.98, 4.17), p < 0.00001 at treatment duration of <3 and 3 months, respectively], MMSE [MD = 2.55, 95% CI (1.99, 3.10), p < 0.00001; MD = 2.53, 95% CI (1.59, 3.47), p < 0.00001; MD = 2.91, 95% CI (1.26, 4.56), p = 0.0006; MD = 3.11, 95% CI (-0.04, 6.27), p = 0.05 at treatment duration of <3, 3, 4, and 6 months, respectively], and BI [MD = 7.34, 95% CI (3.83, 10.85), p < 0.0001; MD = 8.98, 95% CI (4.76, 13.21), p < 0.0001 at treatment duration of <3 and 3 months, respectively] and reduced scores on the ADL (MD = -8.64, 95% CI (-9.83, -7.45), p < 0.00001; MD = -2.00, 95% CI (-2.94, -1.06), p < 0.0001 at treatment duration of 3 and 4 months, respectively], NIHSS [MD = -2.48, 95% CI (-4.97, 0.00), p = 0.05; MD = -3.81, 95% CI (-6.21, -1.40), p = 0.002 at treatment duration of <3 and 3 months, respectively], and CSS [MD = -2.47, 95% CI (-3.49, -1.45), p < 0.00001 at a treatment duration of 3 months]. No serious adverse reactions were observed. Conclusion: Despite the significant positive results, the present evidence supports, to a limited extent because of the methodological flaws and herbal heterogeneity, that TCM adjuvant therapy can be used for patients with PSCI. While, further rigorous RCTs are warranted to confirm the efficacy and safety of TCM. Systematic Review Registration: https://www.crd.york.ac.uk/prospero, identifier CRD42020149299.

Project description:Background and purposeRecently, there are a number of clinical studies on traditional Chinese medicine (TCM) for post-stroke sleep disorders (PSSDs). This study aimed to map the current clinical studies and identify gaps to inform future study agendas.MethodsPubMed, Embase, Cochrane Library, and Chinese databases, including SinoMed, CNKI, and Wanfang, were searched for clinical studies on PSSDs treated with TCM from their inception to September 2021. Evidence sources, number of studies, types of PSSDs, intervention categories, effectiveness, and quality assessment were graphically displayed.ResultsThe evidence map involved 810 clinical studies, of which the earliest report was dated back to 1993, and an advanced growth of the whole evidence was observed in 2012. Randomized controlled trials (RCTs) were the most common type of study design (78.15%), and post-stroke insomnia was the most common type of sleep disorders (65.80%). The benefits of Chinese herbal medicine (CHM) and acupuncture therapies for post-stroke insomnia have been widely reported in RCTs (81.60% and 75.38%, respectively). However, the benefits of CHM interventions were assessed using a global approach rather than being based on a specific formula, and the highest level of evidence supporting the effectiveness of acupuncture therapies was of low methodological quality. In addition, evidence from primary studies was insufficient in the areas of TCM for post-stroke sleep-related breathing disorders (SBDs) and Chinese mind-body exercises for post-stroke insomnia.ConclusionsPSSDs treated with TCM have been widely assessed in clinical studies. For better evidence translation, clinical trials on specific CHM interventions and high-quality systematic reviews on acupuncture for post-stroke insomnia should be conducted. For a better solution to clinical questions, TCM on SBDs after stroke and the benefits of Chinese mind-body exercises for post-stroke insomnia should be explored in future clinical studies.

Project description:BackgroundPost-stroke depression (PSD) is common in stroke survivors, with significantly negative effects and serious impairments in terms of personal and social functioning. While both pharmacological and traditional Chinese medicine (TCM) interventions have been administered for PSD, there is still uncertainty about the balance between these and what treatment strategy should be preferred in clinical practice. Therefore, we aim to compare and rank, describing the protocol of a systematic review and network meta-analysis (NMA), the commonly used TCM interventions for PSD.Methods and analysisWe will search CENTRAL (the Cochrane Central Register of Controlled Trials), CINAHL, Embase, PubMed, CBM and PsycINFO, the US National Institutes of Health and the World Health Organisation International Trials Registry Platform search portal from inception to November 2018. There will be no restrictions on language, publication year or publication type. Only randomized clinical trials (RCTs) accessing any TCM treatments against active comparator or other controls for PSD will be included. The primary outcomes will be efficacy (the total number of participants, declining more than 50% on the total score between baseline) and acceptability of treatment (dropout rate due to any cause). A Bayesian NMA will be performed to compare all relative outcome of different TCM interventions. we will conduct the network meta-regression meta-analyses of data on the sex ratio, the types of stroke and the treatment duration of TCM interventions. Potential explanations in extra subgroup analyses according to the results of heterogeneity and inconsistency will be explored, and sensitivity analyses will be conducted to assess the robustness of the findings.Trials registration numberPROSPERO CRD42018082400.ConclusionOur study will generate evidence for TCM in the treatment of PSD and help to reduce the uncertainty about the effectiveness of PSD management, which will encourage further suggestions for TCM clinical practice or guideline.

Project description:Objective: Vascular cognitive impairment (VCI) accounts for approximately 50%-70% of all dementia cases and poses a significant burden on existing medical systems. Identifying an optimal strategy for preventing VCI and developing efficient symptomatic treatments remains a significant challenge. Syndrome differentiation represents a fundamental approach for personalized diagnosis and treatment in Traditional Chinese Medicine (TCM) and aligns with the principles of precision medicine. The objective of this study was to elucidate the metabolic characteristics of VCI based on TCM syndrome differentiation, thus providing novel insights into the diagnosis and treatment of VCI. Methods: A 2-year cross-sectional cognitive survey was conducted in four communities in Beijing between September 2020 and November 2022. The syndrome differentiation of participants was based on the Kidney-Yang Deficiency Syndrome Scale (KYDSS), which was originally developed by Delphi expert consultation. The identification of serum metabolites was performed by Ultra performance liquid chromatography (UPLC) analysis coupled with an electrospray ionization quadruple time-of-flight mass spectrometer (ESI-QTOF MS). Multivariate, univariate, and pathway analyses were used to investigate metabolic changes. Logistic regression models were also used to construct metabolite panels that were capable of discerning distinct groups. Phospholipase A2 (PLA2) levels were measured by a commercial ELISA kit. Results: A total of 2,337 residents completed the survey, and the prevalence of VCI was 9.84%. Of the patients with VCI, those with Kidney-Yang deficiency syndrome (VCIS) accounted for 70.87% of cases and exhibited more severe cognitive impairments. A total of 80 participants were included in metabolomics study, including 30 with VCIS, 20 without Kidney-Yang deficiency syndrome (VCINS), and 30 healthy control participants (C). Ultimately, 45 differential metabolites were identified when comparing the VCIS group with group C, 65 differential metabolites between the VCINS group and group C, and 27 differential metabolites between the VCIS group and the VCINS group. The downregulation of phosphatidylethanolamine (PE), and phosphatidylcholine (PC) along with the upregulation of lysophosphatidylethanolamine (LPE), lysophosphatidylcholine (LPC), phosphatidic acid (PA) and phospholipase A2 (PLA2) can be considered as the general metabolic characteristics associated with VCI. Dysfunction of glycerophospholipids, particularly LPEs and PCs, was identified as a key metabolic characteristic of VCIS. In particular Glycerophospho-N-Arachidonoyl Ethanolamine (GP-NArE) was discovered for the first time in VCI patients and is considered to represent a potential biomarker for VCIS. The upregulation of PLA2 expression was implicated in the induction of alterations in glycerophospholipid metabolism in both VCIS and VCINS. Moreover, robust diagnostic models were established based on these metabolites, achieving high AUC values of 0.9322, 0.9550, and 0.9450, respectively. Conclusion: These findings contribute valuable information relating to the intricate relationship between metabolic disorders in VCI, neurodegeneration and vascular/neuroinflammation. Our findings also provide a TCM perspective for the precise diagnosis and treatment of VCI in the context of precision medicine.

Project description:BackgroundCognitive impairment is one of the common sequelae after stroke, which not only hinders the recovery of patients but also increases the financial burden on families. In the absence of effective therapeutic measures, acupuncture treatment has been widely used in China to treat post-stroke cognitive impairment (PSCI), but the specific efficacy is unclear. Therefore, this review aimed to evaluate the true efficacy of acupuncture treatment in patients with PSCI.MethodsWe searched eight databases [PubMed, Embase, Web of Science, Cochrane Central Register of Controlled Trials, China Biomedical Literature Database (CBM), China Science and Technology Journal (VIP) database, the China National Knowledge Infrastructure (CNKI) database, and Wan fang database] from the inception to May 2022 for randomized controlled trials (RCTs) related to acupuncture treatment combined with cognitive rehabilitation (CR) for PSCI. Two investigators independently used a pre-designed form to extract valid data from eligible RCTs. The risk of bias was assessed through tools provided by the Cochrane Collaboration. The meta-analysis was implemented through Rev Man software (version 5.4). The strength of the evidence obtained was evaluated using GRADE profiler software. Adverse events (AEs) were collected by reading the full text and used to evaluate the safety of acupuncture treatment.ResultsThirty-eight studies involving a total of 2,971 participants were included in this meta-analysis. Overall, the RCTs included in this meta-analysis were poor in methodological quality. The combined results showed that acupuncture treatment combined with CR showed significant superiority compared to CR alone in terms of improving cognitive function [Mean Difference (MD) = 3.94, 95% confidence intervals (CI): 3.16-4.72, P < 0.00001 (MMSE); MD = 3.30, 95%CI: 2.53-4.07, P < 0.00001 (MoCA); MD = 9.53, 95%CI: 5.61-13.45, P < 0.00001 (LOTCA)]. Furthermore, the combination of acupuncture treatment and CR significantly improved patients' self-care ability compared to CR alone [MD = 8.66, 95%CI: 5.85-11.47, P < 0.00001 (MBI); MD = 5.24, 95%CI: 3.90-6.57, P < 0.00001 (FIM)]. Meanwhile, subgroup analysis showed that MMSE scores were not sufficiently improved in the comparison of electro-acupuncture combined with CR versus CR alone (MD = 4.07, 95%CI: -0.45-8.60, P = 0.08). However, we also observed that electro-acupuncture combined with CR was superior to the use of CR alone in improving MoCA and MBI scores in patients with PSCI [MD = 2.17, 95%CI: 0.65-3.70, P = 0.005 (MoCA); MD = 1.74, 95%CI: 0.13-3.35, P = 0.03 (MBI)]. There was no significant difference in the occurrence of adverse events (AE) between acupuncture treatment combined with CR and CR alone (P > 0.05). The certainty of the evidence was rated low level because of flaws in the study design and considerable heterogeneity among the included studies.ConclusionThis review found that acupuncture treatment combined with CR may have a positive effect on improving cognitive function and self-care ability in PSCI patients. However, our findings should be treated with caution owing to the existence of methodological quality issues. High-quality studies are urgently required to validate our results in the future.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022338905, identifier: CRD42022338905.

Project description:BackgroundStroke is a condition with high morbidity and mortality, and 75% of stroke survivors lose their ability to work. Stroke is a burden to the family and society. The purpose of this study was to evaluate the effectiveness of Chinese herbal patent medicines in the treatment of patients after the acute phase of a stroke.MethodsWe searched the following databases through August 2016: PubMed, Embase, Cochrane library, China Knowledge Resource Integrated Database (CNKI), China Science Periodical Database (CSPD), and China Biology Medicine disc (CBMdisc) for studies that evaluated Chinese herbal patent medicines for post stroke recovery. A random-effect model was used to pool therapeutic effects of Chinese herbal patent medicines on stroke recovery. Network meta-analysis was used to rank the treatment for each Chinese herbal patent medicine.ResultsIn our meta-analysis, we evaluated 28 trials that included 2780 patients. Chinese herbal patent medicines were effective in promoting recovery after stroke (OR, 3.03; 95% CI: 2.53-3.64; P < .001). Chinese herbal patent medicines significantly improved neurological function defect scores when compared with the controls (standard mean difference [SMD], -0.89; 95% CI, -1.44 to -0.35; P = .001). Chinese herbal patent medicines significantly improved the Barthel index (SMD, 0.73; 95% CI, 0.53-0.94; P < .001) and the Fugl-Meyer assessment scores (SMD, 0.60; 95% CI, 0.34-0.86; P < .001). In the network analysis, MLC601, Shuxuetong, and BuchangNaoxintong were most likely to improve stroke recovery in patients without acupuncture. Additionally, Mailuoning, Xuesaitong, BuchangNaoxintong were the patented Chinese herbal medicines most likely to improve stroke recovery when combined with acupuncture.ConclusionsOur research suggests that the Chinese herbal patent medicines were effective for stroke recovery. The most effective treatments for stroke recovery were MLC601, Shuxuetong, and BuchangNaoxintong. However, to clarify the specific effective ingredients of Chinese herbal medicines, a well-designed study is warranted.

Dataset Information

The effect of a therapeutic regimen of Traditional Chinese Medicine rehabilitation for post-stroke cognitive impairment: study protocol for a randomized controlled trial.

Publications

The effect of a therapeutic regimen of Traditional Chinese Medicine rehabilitation for post-stroke cognitive impairment: study protocol for a randomized controlled trial.

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