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Study on the clinical assessment of integrated rehabilitation of Traditional Chinese Medicine and western medication for acute myocardial infarction.

ABSTRACT: OBJECTIVE:This trial aims to evaluate the efficacy and safety of the Baduanjin exercise in patients with acute myocardial infarction (AMI). METHODS:A single-center, open, randomized controlled clinical trial will be conducted to evaluate the effectiveness of the Baduanjin exercise on the rehabilitation of AMI patients. It plans to enroll 64 patients. Patients will be divided evenly into 2 groups using a random number table method. There will be 32 cases in each group. Patients in the experimental group will be treated with standardized drug therapy combined with Baduanjin exercise, while patients in the control group will be treated with standardized drug therapy combined with routine exercise. The primary outcome is the peak oxygen consumption (Peak VO2) during cardiopulmonary exercise test (CPET). The secondary outcomes include CPET, echocardiography, Seattle angina pectoris scale, hospital depression and anxiety scale, Pittsburgh Sleep Quality Index scale, scores of 4 examinations, and diagnostic methods of traditional Chinese medicine and composite endpoint events, etc. DISCUSSION:: This study will be the first to evaluate the effect of the Baduanjin exercise on the Peak VO2 in patients with AMI. STUDY REGISTRATION:This study has been registered on the Chinese Clinical Trial Registry (No: ChiCTR1800016209, protocol version 1.2).

SUBMITTER: Zhao Z

PROVIDER: S-EPMC7447369 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Study on the clinical assessment of integrated rehabilitation of Traditional Chinese Medicine and western medication for acute myocardial infarction.

Zhao Zhiqiang Z Wang Xianliang X Wang Shuai S Zhou Ruijuan R Liu Yu Y Su Lishuo L Li Chenyu C Lin Shanshan S Liu Hua H Zhao Lindan L Mao Jingyuan J

Medicine 20200801 34

<h4>Objective</h4>This trial aims to evaluate the efficacy and safety of the Baduanjin exercise in patients with acute myocardial infarction (AMI).<h4>Methods</h4>A single-center, open, randomized controlled clinical trial will be conducted to evaluate the effectiveness of the Baduanjin exercise on the rehabilitation of AMI patients. It plans to enroll 64 patients. Patients will be divided evenly into 2 groups using a random number table method. There will be 32 cases in each group. Patients in ...[more]

PMID: 32846768

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Project description:ObjectiveIntegrated therapy of traditional Chinese medicine (TCM) and Western medicine (WM) has gradually been applied to the treatment of rheumatoid arthritis (RA). Recently published studies have provided a wealth of data and information about the effectiveness of combination treatments, but high-quality evidence-based meta-analysis on this issue is not available yet. This study was conducted to compare and evaluate the efficacy and safety of the integrated therapy for RA.MethodsPubMed, EMBASE, and the Cochrane Library were searched up to January 2020. Randomized controlled trials (RCTs) that compared the efficacy and safety of integrative TCM-WM with WM alone for RA were included. The outcome measures contained therapeutic effects (TEs), tender joint count (TJC), swollen joint count (SJC), duration of morning stiffness (DMS), grip strength (GS), disease activity score in 28 joints (DAS28), rheumatoid factor (RF), anti-cyclic peptide containing citrulline (anti-CCP), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and adverse events (AEs) to assess the efficacy and safety of different treatments.ResultsA total of 20 RCTs with 2269 patients met the inclusion criteria. TCM used in these studies included Chinese herbal decoctions and tablets or capsules made from herbs and their extracts, while WM included disease-modifying antirheumatic drugs (DMARDs), nonsteroidal anti-inflammatory drugs (NSAIDs), and glucocorticoids (GC). Compared with patients receiving WM treatment alone, patients with integrative TCM-WM treatment showed better TEs (OR = 3.03, 95% CI [2.36, 3.88]). The integrative treatment group showed reductions in TJC (MD = -1.17, 95% CI [-2.12, -0.21]), SJC (MD = -0.87, 95% CI [-1.85, 0.10]), DMS (SMD = -0.69, 95% CI [-0.98, -0.41]), DAS28 (MD = -0.43, 95% CI [-0.57, -0.29]), RF (SMD = -0.59, 95% CI [-0.91, -0.27]), anti-CCP (SMD = -0.21, 95% CI [-0.36, -0.06]), ESR (MD = -8.36, 95% CI [-12.60, -4.12]), and CRP (MD = -6.73, 95% CI [-9.38, -4.08]), and increment in GS (SMD = 0.12, 95% CI [-0.63, 0.87]). AEs, especially gastrointestinal disorders, abnormal liver function, leukopenia, skin allergies and rashes, headaches and dizziness, and alopecia, significantly decreased (OR = 0.37, 95% CI [0.29, 0.47]) in the integrative treatment group.ConclusionsThe findings of this meta-analysis indicate that integrative TCM-WM could obtain effective and safe results in the treatment of RA. Using TCM as an adjunctive therapy in RA has great prospects for further development.

Project description:ObjectiveTraditional Chinese exercises (TCE) are excellent cardiac rehabilitation (CR) training that can effectively improve cardiorespiratory fitness. However, there is no published meta-analysis of TCE on CR in patients with myocardial infarction (MI). Therefore, this study aimed to provide a comprehensive evaluation from multiple perspectives.MethodsThis meta-analysis is based on the Cochrane Handbook of Systematic Reviews. Eight databases were searched from the date of database construction to March 15, 2023. Two investigators independently screened the literature and assessed their quality. The meta-analysis was performed with RevMan5.4 software.ResultsA total of 21 articles involving 1,890 patients were included. N-terminal pro-brain natriuretic peptide (NT-proBNP) in the TCE group were lower than the control group (MD = -96.34, 95%CI: -140.69 ∼-51.98, P < 0.00001, I2 = 96%), the left ventricular ejection fraction (LVEF) in the TCE group was higher than the control group (MD = 4.58, 95%CI: 3.28-5.88, P < 0.00001, I2 = 79%), the left ventricular end diastolic dimension (LVDD) in TCE group was lower than the control group (MD = -3.83, 95%CI: -5.27 ∼-2.38, P < 0.00001, I2 = 94%), the left ventricular end systolic diameter (LVESD) in TCE group was lower than the control group (MD = -2.17, 95%CI: -4.10 ∼-0.24, P < 0.00001, I2 = 96%), The 6-minute walk test (6MWT) in the TCE group was higher than the control group (MD = 69.60, 95%CI: 34.59-104.60, P < 0.00001, I2 = 99%), the oxygen uptake (VO2) in the TCE group was higher than the control group (MD = 4.38, 95%CI: 2.25-6.51, P < 0.00001, I2 = 94%), the 36-item short form survey (SF-36) in the TCE group was higher than the control group (MD = 13.34, 95%CI: 9.25-17.42, P = 0.008, I2 = 75%), the Hamilton Anxiety Scale (HAMA) in the TCE group was lower than the control group (MD = -4.34, 95%CI: -5.18 ∼-3.50, P = 1.00, I2 = 0%), the Hamilton Depression Scale (HAMD) in the TCE group was lower than the control group (MD = -3.48, 95%CI: -5.35 ∼-1.61, P = 0.0002, I2 = 88%), the incidence of major adverse cardiac events (MACEs) in the TCE group was lower than the control group (RR = 0.31, 95%CI: 0.20-0.47, P = 0.52, I2 = 0%). Subgroup analysis revealed differences in TCE types could be a potential source of heterogeneity.ConclusionMI patients who used TCE have not only notable improvements in cardiopulmonary function, physical function, quality of life, and emotions but also reduced the incidence of MACEs. Tai Chi might be more efficient than Ba Duan Jin.Systematic review registrationhttps://www.crd.york.ac.uk/PROSPERO/, identifier CRD42023408675.

Project description:IntroductionMyocardial infarction (MI) is the most dangerous complication in patients with coronary heart disease. In China, there is an increasing number of randomised controlled trials (RCTs) of traditional Chinese medicine (TCM) for treating MI. However, the inconsistency of outcome reporting means that a large number of clinical trials cannot be included in systematic reviews to provide the best evidence for clinical practice. The aim of this study is to develop a core outcome set (COS) for future TCM clinical trials of MI, which may improve the consistency of outcome reporting and facilitate the synthesis of data across studies in systematic reviews.Methods and analysisWe will conduct a systematic review of MI clinical trials with any intervention. Semistructured interviews will be conducted to obtain the perspectives of patients with MI. The outcomes from the systematic review and semistructured interviews will be grouped and used to develop a questionnaire. The questionnaire will be developed as a supplement for the TCM syndromes of MI and will be constructed from the results of a systematic review, existing medical records and a cross-sectional study. Then two rounds of the Delphi survey will be conducted with different stakeholders (TCM experts and Western medicine experts in cardiovascular disease, methodologists, magazine editors and patients) to determine the importance of the outcomes. Only the TCM experts will need to response to the questionnaire for core TCM syndromes. A face-to-face consensus meeting will be conducted to create a final COS and recommend measurement time for each outcome.Ethics and disseminationThis project has been approved by the Ethics Committee of Dongzhimen Hospital, Beijing University of Chinese Medicine. The final COS will be published and freely available.Trial registration numberThis study is registered with the Core Outcome Measures in Effectiveness Trials database as study 1243 (available at: http://www.comet-initiative.org/studies/details/1243).

Project description:Objectives: We intend to conduct a meta-analysis on the systematic evaluation of traditional Chinese medicine (TCM) in the treatment of ventricular remodeling following acute myocardial infarction (AMI). Our findings may provide certain references for the clinical treatment of ventricular remodeling. Methods: A systematic literature search was conducted in PubMed, Web of Science, Cochrane Library, Embase, CNKI, Wanfang Data, CQVIP, and CBM before 20 July 2020. Data were analyzed using a random/fixed-effect model. Primary outcomes included the effectiveness and TCM syndrome score (TCMSS). Secondary outcomes included 1) echocardiography data, including the left ventricular end-diastolic diameter (LVEDD), left ventricular end-systolic diameter (LVESD), left ventricular end-diastolic volume index (LVEDVi), left ventricular end-systolic volume index (LVESVi), left ventricular end-diastolic volume (LVEDV), left ventricular end-systolic volume (LVESV), interventricular septum thickness (IVST), left ventricular posterior wall thickness (LVPWT), left ventricular ejection fraction (LVEF), E/A, stroke volume (SV), and wall motion score (WMS); 2) serum indicators, including the B-type natriuretic peptide (BNP) or N-terminal pro-B-type natriuretic peptide (NT-proBNP), and C-reactive protein (CRP) or high sensitivity CRP (hs-CRP); (3) major adverse cardiovascular events (MACE) and other adverse events Results: Forty RCTs involving 3,659 subjects were recruited. Our findings proved that a combination of TCM or TCM preparations with conventional Western medicine for preventing and reversing ventricular remodeling at post-AMI could remarkably enhance the total effectiveness and reduced TCMSS. Moreover, myocardial functions (LVEF, E/A, and SV), ventricular remodeling (LVEDVi, LVESVi, LVEDV, LVESV, LVEDD, LVESD, LVPWT, and WMS), serum levels of BNP and CRP, and MACE were significantly improved by the combination of TCM or TCM preparations with conventional Western medicine. Nevertheless, IVST and the incidence of other adverse events were comparable between control and experimental groups Conclusion: The combination of TCM or TCM preparations and conventional Western medicine can alleviate the process of ventricular remodeling, enhance cardiac function, and reduce the incidence of MACE in AMI patients.

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Study on the clinical assessment of integrated rehabilitation of Traditional Chinese Medicine and western medication for acute myocardial infarction.

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Study on the clinical assessment of integrated rehabilitation of Traditional Chinese Medicine and western medication for acute myocardial infarction.

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