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- Chen, XK, et al.
(författare)
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Feasibility and Preliminary Effects of the BESMILE-HF Program on Chronic Heart Failure Patients: A Pilot Randomized Controlled Trial
- 2021
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Ingår i: Frontiers in cardiovascular medicine. - : Frontiers Media SA. - 2297-055X. ; 8, s. 715207-
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Tidskriftsartikel (refereegranskat)abstract
- Aims: The Baduanjin Eight-Silken-Movements wIth Self-Efficacy building for Heart Failure (BESMILE-HF) program is a contextually adapted cardiac rehabilitation program. It uses a traditional Chinese exercise, Baduanjin, to solve the unmet demand of exercise-based cardiac rehabilitation programs due to their scarcity and unaffordability in China. This pilot study assesses BESMILE-HF's feasibility and preliminary effects.Methods: Eighteen patients with chronic heart failure were included: 8 in a BESMILE-HF group (age: 67 ± 5 years, EF: 40.4 ± 13.6%) and 10 in a control group (age: 70 ± 13 years, EF: 42.9 ± 12.5%). Both received the usual medications, with the intervention group receiving additionally the BESMILE-HF program for 6 weeks. Feasibility was explored by participants' involvement in the intended intervention. Clinical outcome assessments were conducted at baseline and post-intervention, while adverse events were captured throughout the study period.Results: The BESMILE-HF program was well-received by patients, and adherence to the intervention was good. The intervention group completed all required home exercises and total home-practice time was correlated with baseline self-efficacy (r = 0.831, p = 0.011). Moreover, after 6 weeks, self-efficacy increased in the BESMILE-HF group (p = 0.028) and the change was higher than in the control [mean difference (MD): 3.2; 95% confidence interval (CI) 0.6–5.9, p = 0.004]. For the exercise capacity, the control group demonstrated a significant decline in peak oxygen consumption (p =0.018) whereas, the BESMILE-HF group maintained their exercise capacity (p = 0.063). Although the between-group difference was not statistically significance, there was clear clinical improvement in the BESMILE-HF group (1.5 mL/kg/min, 95% CI, −0.3 to 3.2 vs. minimal clinically important difference of 1 mL/kg/min). Throughout the study period, no adverse events related to the intervention were captured.Conclusions: BESMILE-HF is feasible for patients with chronic heart failure in Chinese settings. A larger sample size and a longer follow-up period is needed to confirm its benefit on clinical outcomes.Clinical Trial Registration:ClinicalTrials.gov: NCT03180320.
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- Chen, XK, et al.
(författare)
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Tai Chi and Qigong Practices for Chronic Heart Failure: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
- 2020
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Ingår i: Evidence-based complementary and alternative medicine : eCAM. - : Hindawi Limited. - 1741-427X .- 1741-4288. ; 2020, s. 2034625-
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Tidskriftsartikel (refereegranskat)abstract
- Background. Several randomized controlled trials (RCTs) have assessed the role of Tai Chi and Qigong Practices (TQPs) in managing chronic heart failure (CHF). They have included broad variations in comparators, sample sizes, and results. This study evaluates existing RCTs for evidence of TQPs rehabilitation effects for CHF. Methods. Both English and Chinese databases were searched from their inception to October 23, 2019. RCTs were included if they compared the addition of TQPs into routine managements (RMs) to RMs alone or compared TQPs to general exercise, with RMs as a consistent cointervention in both groups. Data were screened and extracted independently using predesigned forms. RCT quality was assessed with the Cochrane tool. The primary outcomes were peak oxygen consumption (VO2peak), 6-minute walking distance (6MWD), and Minnesota Living with Heart Failure Questionnaire (MLHFQ). Mean differences (MDs) and 95% confidence intervals (CIs) were calculated, and heterogeneity was assessed with an I2 statistic. Results. A total of 33 RCTs with 2,465 patients were included in the systematic review. Compared to the RMs alone, TQPs plus RMs improved VO2peak (MD: 1.24 mL/kg/min, 95% CI, 0.91 to 1.57; I2 = 0%), 6MWD (MD: 59.63 meters, 95% CI, 43.35 to 75.90 I2 = 88%), and MLHFQ (MD: −8.63 scores; 95% CI, −10.60 to -6.67; I2 = 94%). Compared to general exercise, superior improvements were found in the TQP group; they were significant in MLHFQ (MD: −9.18 scores; 95% CI, −17.95 to −0.41; I2 = 86%), but not in VO2peak or 6MWD. Evidence was also found of TQPs’ safety and high adherence. Conclusions. Considering that there are low costs, multiple physical benefits, and no equipment required, TQPs are a promising rehabilitation therapy, as an adjunct to routine pharmacotherapies or as an alternative to conventional exercises, especially in home-based settings.
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- Chen, XK, et al.
(författare)
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Traditional Baduanjin exercise through the eyes of patients with chronic heart failure: A qualitative content analysis study
- 2023
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Ingår i: Frontiers in cardiovascular medicine. - : Frontiers Media SA. - 2297-055X. ; 9, s. 1049036-
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Tidskriftsartikel (refereegranskat)abstract
- Baduanjin (eight silken movements) is a traditional Chinese exercise that can be used as cardiac rehabilitation therapy for patients with chronic heart failure (CHF) especially when other forms of rehabilitation are scarce or unaffordable. This study explores the experiences of Chinese patients with CHF who undertook Baduanjin exercise at home as part of a pilot trial in Guangzhou, China.MethodsWe conducted seven qualitative interviews with participants who had participated in the intervention arm of a pilot randomized controlled trial (RCT) (n = 8). For data collection, we used a semi-structured interview guide with both open-ended, and follow-up questions. We audio recorded the interviews, transcribed them verbatim, and then analyzed them with content analysis.ResultsParticipants’ experiences of doing Baduanjin were classified into three categories: (1) improving practice (2) factors facilitating good exercise adherence, and (3) feeling good. Participants reported that the exercises were easy but that the correct Baduanjin execution and coordination between the mind, movements, and breathing were only achievable through practice. In addition, the training benefits which they perceived were the predominant motivation for patients to keep practicing. Finally, trust in Baduanjin, personal attitudes toward health, flexibility in practice times, as well as social support helped the participants to achieve good adherence to home-based training.ConclusionThis study’s findings indicate that Baduanjin could be a cardiac rehabilitation exercise modality for patients with CHF in China, especially in a home-based setting.
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- Li, G, et al.
(författare)
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Developing a Core Outcome Set for Clinical Trials of Chinese Medicine for Hyperlipidemia
- 2022
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Ingår i: Frontiers in pharmacology. - : Frontiers Media SA. - 1663-9812. ; 13, s. 847101-
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Tidskriftsartikel (refereegranskat)abstract
- Background: Chinese medicine (CM) is widely used for treating hyperlipidemias, especially in China. However, the heterogeneity of outcomes measured and reported across trials exacerbates the obstacles of evidence synthesis and effectiveness comparison. In this study, we develop a core outcome set (COS) for CM clinical trials for hyperlipidemia (COS-CM-Hyperlipidemia) to tackle the outcome issues.Methods: We generated candidate outcomes through a systematic review of interventional and observational studies of Chinese medicine for hyperlipidemias. The comprehensive search strategy was employed. Study selection and data collection were independently done by two researchers. We searched clinical trial registry platform to supplement the outcomes list extracted by systematic review. Then, we conducted a three-round Delphi survey. The stakeholders were hyperlipidemia patients, clinicians or researchers, in either CM/integrated Chinese or Western medicine, clinical pharmacy, clinical epidemiology or statisticians, or editors of important relevant journals and an ethicist. They used a 9-point Likert scale to determine how important they felt each outcome was in determining treatment success. A consensus meeting was held to confirm the final COS, based on the Delphi survey results.Results: We identified a total of 433 outcomes from 3,547 articles, and 28 outcomes from 367 registered trials. After standardization, we selected 71 outcomes to develop a preliminary outcome list for further consensus. After three Delphi survey rounds and one consensus meeting, the most important outcomes were determined for COS-CM-Hyperlipidemia. It included cardiovascular events, low-density lipoprotein cholesterol, risk of cardiovascular disease, total cholesterol, carotid intima-media thickness, high-density lipoprotein cholesterol, triglycerides, cerebrovascular events, adverse drug reactions and patient-reported symptoms.Conclusion: COS-CM-Hyperlipidemia may improve outcome reporting consistency in clinical trials. Further work is needed to explore the optimal methods for measuring these outcomes.Registration: The Core Outcome Measures in Effectiveness Trials Initiative (COMET): http://www.cometinitiative.org/studies/details/983. Registered on 25 April 2017.
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- Li, G, et al.
(författare)
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Outcome Reporting Variability in Trials of Chinese Medicine for Hyperlipidemia: A Systematic Review for Developing a Core Outcome Set
- 2021
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Ingår i: Evidence-based complementary and alternative medicine : eCAM. - : Hindawi Limited. - 1741-427X .- 1741-4288. ; 2021, s. 8822215-
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Tidskriftsartikel (refereegranskat)abstract
- Introduction. Hyperlipidemia is an underlying process behind cardiovascular disease. Chinese medicine (CM) may be effective in treating hyperlipidemia, but there is a lack of studies with high methodological quality. A major reason for this is heterogeneity in outcome reporting. Therefore, this study explores the degree of outcome reporting variation in CM trials for hyperlipidemia. It then generates a list of potentially important outcomes for developing a core outcome set (COS). Methods. A systematic review of literature focusing on studies of CM for hyperlipidemia was conducted. Outcomes were listed verbatim and grouped into 8 domains. Outcome frequency and definition uniformity were analyzed. Results. 3,702 studies and 452 individual outcomes were identified. These outcomes were reported 27,328 times, of which 1.6% were reported as primary outcomes, and 13.3% were defined. The most frequent outcome was total triglyceride, represented in 86.7% of the studies, followed by total cholesterol (86.0%), total effective rate (75.1%), high-density lipoprotein cholesterol (73.2%), and low-density lipoprotein cholesterol (60.5%). However, 43.6% of outcomes were reported only once. The largest outcome domain was “pathological or pathophysiological outcomes,” which included 67.0% of outcomes. Of the “response rate related outcomes” domain, total effective rate was the most frequently reported outcome (n = 2,780), and 95.3% of the studies gave a clear definition. However, these definitions were often contradictory. Only 10 papers reported cardiovascular events, 3 of which referred to them as primary outcomes. Moreover, ten patient-reported outcomes were reported in the retrieved literature 19 times in total. The majority of the outcomes did not report measurement instruments (MIs) (269/453, 59.4%). MIs of the surrogate outcomes were reported more frequently. Conclusion. Outcome reporting in CM trials for hyperlipidemia is inconsistent and ill-defined, creating barriers to data synthesis and comparison. Thus, we propose and are developing a COS for CM trials for hyperlipidemia.
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- Mao, W, et al.
(författare)
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Bupi Yishen Formula Versus Losartan for Non-Diabetic Stage 4 Chronic Kidney Disease: A Randomized Controlled Trial
- 2021
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Ingår i: Frontiers in pharmacology. - : Frontiers Media SA. - 1663-9812. ; 11, s. 627185-
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Tidskriftsartikel (refereegranskat)abstract
- Chinese herbal medicine (CHM) might have benefits in patients with non-diabetic chronic kidney disease (CKD), but there is a lack of high-quality evidence, especially in CKD4. This study aimed to assess the efficacy and safety of Bupi Yishen Formula (BYF) vs. losartan in patients with non-diabetic CKD4. This trial was a multicenter, double-blind, double-dummy, randomized controlled trial that was carried out from 11-08-2011 to 07-20-2015. Patients were assigned (1:1) to receive either BYF or losartan for 48 weeks. The primary outcome was the change in the slope of the estimated glomerular filtration rate (eGFR) over 48 weeks. The secondary outcomes were the composite of end-stage kidney disease, death, doubling of serum creatinine, stroke, and cardiovascular events. A total of 567 patients were randomized to BYF (n = 283) or losartan (n = 284); of these, 549 (97%) patients were included in the final analysis. The BYF group had a slower renal function decline particularly prior to 12 weeks over the 48-week duration (between-group mean difference of eGFR slopes: −2.25 ml/min/1.73 m2/year, 95% confidence interval [CI]: −4.03,−0.47), and a lower risk of composite outcome of death from any cause, doubling of serum creatinine level, end-stage kidney disease (ESKD), stroke, or cardiovascular events (adjusted hazard ratio = 0.61, 95%CI: 0.44,0.85). No significant between-group differences were observed in the incidence of adverse events. We conclude that BYF might have renoprotective effects among non-diabetic patients with CKD4 in the first 12 weeks and over 48 weeks, but longer follow-up is required to evaluate the long-term effects.Clinical Trial Registration:http://www.chictr.org.cn, identifier ChiCTR-TRC-10001518.
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