Cardiac rehabilitation of Baduanjin exercise in coronary heart disease after PCI: A protocol for systematic review and meta-analysis of randomized controlled trials

Background:Percutaneous coronary intervention (PCI) is an effective revascularization strategy in patients with coronary heart disease (CHD). However, recent studies had indicated that postPCI patients usually suffer from a low-quality life. Cardiac rehabilitation (CR) has been recommended by numerous guidelines in the clinic for these patients. And Baduanjin exercise can significantly benefit patients with CHD. Regrettably, the effect of Baduanjin exercise on postPCI patients is still not clear. Therefore, this systematic review and meta-analysis protocol is planned to explore the effect of Baduanjin exercise in patients with CHD who have undergone PCI.Methods:PubMed, Excerpta Medica Database, Cochrane Library, Web of Science, Wanfang Database, SINOMED, China Science and Technology Journal Database, and China National Knowledge Infrastructure will be searched for appropriate articles from respective inceptions until December 1th, 2020. Two reviewers will independently conduct article selection, data collection, and risk of bias evaluation. Disagreements will be resolved first by discussion and then by consulting a third author for arbitration. The primary outcome will include left ventricular ejection fraction. And the change in the scores on the Seattle Angina Questionnaire, SF-36 health survey scale, Zung Self-rating Anxiety scale and self-rating depression scale will be used as the secondary outcomes. RevMan 5.3 will be used for meta-analysis.Results:This systematic review and meta-analysis will explore whether Baduanjin exercise is an effective intervention in postPCI patients.Conclusion:This systematic review and meta-analysis will provide convincing evidence of Baduanjin exercise that specifically focuses on CR of Baduanjin exercise on CHD after PCI.Registration number:INPLASY202130065.     

Coronary revascularization for heart failure with coronary artery disease: A systematic review and meta-analysis of randomized trials

Aims

Coronary artery disease (CAD) is a common cause of heart failure (HF). Whether coronary revascularization improves outcomes in patients with HF receiving guideline-recommended pharmacological therapy (GRPT) remains uncertain; therefore, we conducted a systematic review and meta-analysis of relevant randomized controlled trials (RCTs).

Methods and results

We searched in public databases for RCTs published between 1 January 2001 and 22 November 2022, investigating the effects of coronary revascularization on morbidity and mortality in patients with chronic HF due to CAD. All-cause mortality was the primary outcome. We included five RCTs that enrolled, altogether, 2842 patients (most aged <65 years; 85% men; 67% with left ventricular ejection fraction ≤35%). Overall, compared to medical therapy alone, coronary revascularization was associated with a lower risk of all-cause mortality (hazard ratio [HR] 0.88, 95% confidence interval [CI] 0.79–0.99; p = 0.0278) and cardiovascular mortality (HR 0.80, 95% CI 0.70–0.93; p = 0.0024) but not the composite of hospitalization for HF or all-cause mortality (HR 0.87, 95% CI 0.74–1.01; p = 0.0728). There were insufficient data to show whether the effects of coronary artery bypass graft surgery or percutaneous coronary intervention were similar or differed.

Conclusions

For patients with chronic HF and CAD enrolled in RCTs, the effect of coronary revascularization on all-cause mortality was statistically significant but neither substantial (HR 0.88) nor robust (upper 95% CI close to 1.0). RCTs were not blinded, which may bias reporting of the cause-specific reasons for hospitalization and mortality. Further trials are required to determine which patients with HF and CAD obtain a substantial benefit from coronary revascularization by either coronary artery bypass graft surgery or percutaneous coronary intervention.     

Ultrafiltration for acute decompensated heart failure: A systematic review and meta-analysis of randomized controlled trials

Background

Current clinical guidelines recommend ultrafiltration (UF) for patients with acute decompensated heart failure (ADHF) who are unresponsive or resistant to diuretics. We systematically reviewed the latest randomized evidence on the efficacy and safety of UF in ADHF.

Methods

MEDLINE, EMBASE and the Cochrane database were searched in January 2013 for eligible randomized controlled trials (RCTs) evaluating UF in patients with ADHF. A Mantel–Haenszel random-effects model was used to calculate mean differences (MDs) and odds ratios (ORs) for continuous and dichotomous data, respectively, with 95% confidence intervals (CIs).

Results

Data of 12 studies (n = 659) were meta-analyzed; follow-up duration ranged from 36 h to 12 months. Compared to control, treatment of UF was associated with significant fluid removal (MD 1.28, 95% CI 0.43 to 2.12, P = 0.003) and weight loss (MD 1.23, 95% CI 0.03 to 2.44, P = 0.04), with no significant effects on all-cause mortality (OR 1.08, 95% CI 0.63 to 1.86, P = 0.77) or all-cause rehospitalization (OR 0.89, 95% CI 0.39 to 2.00, P = 0.77). No significant differences were observed in the analyses of change in serum creatinine or unscheduled medical care; analysis of adverse effects was inconclusive since only one study provided usable data.

Conclusions

For patients with ADHF, UF is effective in reducing fluid retention and body weight, with no significant benefits in mortality or rehospitalization. The current limited randomized evidence highlights the need for further well-conducted randomized studies of adequate power to establish the role of UF in ADHF patients for whom conventional HF treatment is unsuccessful or contraindicated.     

Intramyocardial autologous bone marrow cell transplantation for ischemic heart disease: A systematic review and meta-analysis of randomized controlled trials

Objective

This study was undertaken to evaluate the efficacy of intramyocardial bone marrow cell (BMC) transplant therapy for ischemic heart disease (IHD).

Methods

The PubMed, Embase, and Cochrane Library databases through October 2013 were searched for randomized clinical trials (RCTs) of intramyocardial BMCs to treat IHD. The primary endpoint was change in left ventricular ejection fraction (LVEF). Secondary endpoints were changes in left ventricular end-systolic volume (LVESV) and left ventricular end-diastolic volume (LVEDV). Weighted mean differences for the changes were estimated with a random-effects model.

Results

Eleven RCTs with 492 participants were included. Intramyocardial BMC transplantation increased LVEF (4.91%; 95% confidence interval [CI] 2.84%–6.99%; P < 0.00001), reduced LVESV (10.66 mL; 95% CI, −18.92 mL to −2.41 mL; P = 0.01), and showed a trend toward decreased LVEDV (−7.82 mL; 95% CI, −16.36 mL–0.71 mL; P = 0.07). Patients suitable for revascularization with coronary artery bypass grafting had greater improvement in LVEF (7.60%; 95% CI, 4.74%–10.46%, P < 0.00001) than those unsuitable for revascularization (3.76%; 95% CI, 2.20%–5.32%; P < 0.00001). LVEDV reduction was also more significant in revascularizable IHD (−16.51 mL; 95% CI, −22.05 mL to −10.07 mL; P < 0.00001) than non-revascularizable IHD (−0.89 mL; 95% CI, −8.44 mL–6.66 mL; P = 0.82).

Conclusion

Intramyocardial BMC injection contributes to improvement in left ventricular dysfunction and reduction in left ventricular volume. Patients with revascularizable IHD may benefit more from this therapy.     

Exercise therapy in patients with constipation: a systematic review and meta-analysis of randomized controlled trials

Background: Exercise therapy has shown significant efficacy as a means of treating various intestinal diseases, but its role in the treatment of constipation is still unclear. The purpose of this study was thus to analyze the effects of exercise on constipation by means of a systematic review and meta-analysis.

Methods: PubMed, Web of Science, EMBASE, Cochrane Library and three Chinese databases [Wanfang Database, Chinese Biomedical Literature (CBM) and China National Knowledge Infrastructure (CNKI)] were searched for relevant studies published through June 2018. Eligible studies were selected in accordance with the PRISMA statement. The main results of interest were changes in gastrointestinal symptoms.

Results: A total of nine randomized controlled trials involving 680 participants were included. Eight studies involved aerobic exercise and only one study involved anaerobic exercise. The aerobic exercises included were Qigong, walking and physical movement. The results of this systematic review and meta-analysis indicated that exercise had significant benefits as a means of improving the symptoms of constipation patients [relative risk (RR)?=?1.97; 95% CI: 1.19, 3.27; p?=?.009; I²=91.3%]. Subgroup analyses showed that aerobic exercise (RR = 2.42; 95% CI: 1.34, 4.36; p?=?.000; I²=88%) similarly had a positive effect on constipation. However, these results were associated with a high risk of bias.

Conclusion: Our results suggest that exercise may be a feasible and effective treatment option for patients with constipation. However, due to methodological shortcomings, the real effect of this intervention cannot be definitively determined. Researchers should, therefore, design more rigorous studies in order to evaluate the effect of exercise on constipation.     

Bortezomib for patients with previously untreated multiple myeloma: a systematic review and meta-analysis of randomized controlled trials

Multiple myeloma (MM) is an incurable disease with a poor survival, which has not been affected even by high-dose chemotherapy. This systematic review was performed to assess the efficacy and safety of the novel agent bortezomib for patients with previously untreated MM. We systematically searched biomedical literature databases and identified randomized controlled trials (RCTs) comparing bortezomib with placebo, no bortezomib, or other active agents for patients with previously untreated MM. Overall survival (OS), reported as hazard ratio (HR) with 95 % confidence interval (CI), was the primary outcome measure. The secondary outcomes included time to progression (TTP), progression-free survival (PFS), and response rates. Five RCTs involving 2,728 patients were included. Three trials compared bortezomib with no bortezomib, and two compared bortezomib with other active agents (vincristine ± adriamycin-based chemotherapy). All included RCTs had methodological shortcomings, including no or unclear allocation concealment and blinding. Compared with no bortezomib or vincristine-based chemotherapy, the bortezomib-based regimen significantly improved the OS of patients with previously untreated MM. HR was 0.71 (95 % CI 0.55–0.93) and 0.77 (95 % CI 0.60–0.99), respectively. However, when compared with the vincristine + adriamycin-based regimen, the OS was similar (HR?=?0.87, 95 % CI 0.57–1.33). TTP, PFS, and response rates were also improved in patients receiving bortezomib-based regimen. However, the risk of peripheral neuropathy was found to be significantly higher. In summary, bortezomib appears to improve survival and response rates of patients with previously untreated MM in spite of higher risk of peripheral neuropathy.     

Larazotide acetate for treatment of celiac disease: A systematic review and meta-analysis of randomized controlled trials

PurposeThe standard of care for treatment of celiac disease (CD) is a stringent lifetime gluten-free diet (GFD). Larazotide acetate (AT-1001) is an anti-zonulin which functions as a gut permeability regulator for treatment of CD. We endeavored to conduct a systematic review and meta-analysis of all randomized controlled trials (RCTs) which studied the efficacy and safety of AT-1001 in patients with CD.MethodsWe examined four databases from inception to 20-August-2020. We pooled continuous outcomes as mean difference and dichotomous outcomes as risk ratio with 95% confidence interval under the fixed-effects meta-analysis model.ResultsFour RCTs met our eligibility criteria, comprising 626 patients (AT-1001, n=465, placebo, n=161). Three and two RCTs reported outcomes of patients undergoing gluten challenge (intake of 2.4–2.7 grams of gluten/day) and GFD, respectively. For change in lactulose-to-mannitol ratio, the endpoint did not significantly differ between AT-1001 and placebo groups, irrespective of the gluten status. Subgroup analysis of patients undergoing gluten challenge showed AT-1001 treatment (compared with placebo) significantly correlated with better symptomatic improvement in the two endpoints of change in total gastrointestinal symptom rating scale (total GSRS) and CD-specific GSRS (CD-GSRS). However, no significant difference was noted among patients undergoing GFD for the abovementioned two efficacy endpoints. Compared with placebo, AT-1001 favorably reduced the adverse event (AE) of gluten-related diarrhea in patients who underwent gluten challenge. Other AEs were comparable between both AT-1001 and placebo groups.ConclusionsAT-1001 is largely well-endured and seems somehow superior to placebo in alleviating gastrointestinal symptoms among CD patients undergoing gluten challenge. Nevertheless, additional RCTs are warranted to validate these findings.     

Effects of dapagliflozin in patients with nonalcoholic fatty liver disease: A systematic review and meta-analysis of randomized controlled trials

BackgroundDapagliflozin as a treatment option in patients with nonalcoholic fatty liver disease (NAFLD) has received increasing attention, however, the efficacy and safety of dapagliflozin for NAFLD has not been well assessed. This meta-analysis aimed to summarize these RCTs and evaluate the efficacy of dapagliflozin for patients with NAFLD.MethodsThe PubMed, Embase, Web of Science, and Cochrane Library databases were searched for RCTs comparing dapagliflozin with placebo or active comparator in patients with NAFLD from inception to Oct 2021.ResultsWe included seven trials with 390 randomized participants in total. Compared to the placebo or control group, dapagliflozin could reduce the levels of alanine aminotransferase(ALT) (WMD: -6.62U/L; 95%CI: -12.66,-0.58; p = 0.03) and aspartate aminotransaminase(AST) (WMD: -4.20U/L; 95%CI: -7.92,-0.47; p = 0.03). However, dapagliflozin produced a non-significant decrease in gamma-glutamyl transferase (GGT) levels (WMD: -7.28U/L; 95%CI: -16.26,1.71; p = 0.11). Additionally, we showed that dapagliflozin significantly affect Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) (WMD: -0.88; 95%CI: -1.43,-0.33; p = 0.002). Metabolic outcomes, such as bodyweight (WMD: -3.79 Kg; 95%CI: -4.63,-2.95; p < 0.00001), body mass index (BMI) (WMD: -1.33 Kg/m²; 95%CI: -2.37,-0.28; p = 0.01), low-density lipoprotein cholesterol (LDL-C) (WMD: -2.66 mg/dL; 95%CI: -3.99,-1.32; p < 0.00001) and triglycerides (TG) (WMD: -16.77 mg/dL; 95%CI: -31.93,-1.61; p = 0.03) were also reduced. Meanwhile, we found that dapagliflozin increased total cholesterol (TC) (WMD: 9.77 mg/dL; 95%CI: 1.58,17.97; p = 0.02). There was no significant difference in the incidence of total adverse events between the dapagliflozin group and the control group (RR = 0.96; 95%CI: 0.60,1.54; p = 0.86).ConclusionOur results suggest that dapagliflozin effectively improves liver function parameters and metabolic outcomes among patients with NAFLD. At the same time, treatment with dapagliflozin may increase total cholesterol.     

Drug-eluting balloons for coronary artery disease: A meta-analysis of randomized controlled trials

Background

Drug-eluting balloons (DEB) are attractive new alternatives to drug-eluting stents (DES) for percutaneous coronary interventions. We aimed to systematically review the efficacy and safety of DEB in the treatment of coronary artery disease (CAD).

Methods

MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL) were searched in December 2011 for eligible randomized controlled trials. Primary outcomes were target lesion revascularization (TLR), major adverse cardiac events (MACE) and mortality. Secondary outcomes were late lumen loss, minimal lumen diameter and binary restenosis.

Results

Five studies involving 349 patients were included. Compared to controls, DEB improved angiographic measures with no significant effect on clinical outcomes in the overall CAD population. There is clear superiority of DEB in patients with in-stent restenosis in TLR (OR 0.17, 95% CI 0.07 to 0.38, p < 0.0001, I² = 0%), MACE (OR 0.22, 95% CI 0.10 to 0.51, p = 0.0005, I² = 13%), late lumen loss (in-stent: MD − 0.51, 95% CI − 0.73 to − 0.28, p < 0.00001, I² = 60%; in-segment: MD − 0.51, 95% CI − 0.77 to − 0.24, p = 0.0002, I² = 72%;), minimal lumen diameter (in-stent: MD 0.49, 95% CI 0.05 to 0.93, p = 0.03, I² = 85%; in-segment: MD 0.49, 95% CI 0.13 to 0.86, p = 0.008, I² = 79%) and binary restenosis (in-stent: OR 0.15, 95% CI 0.05 to 0.47, p = 0.001, I² = 37%; in-segment: OR 0.11, 95% CI 0.05 to 0.27, p < 0.00001, I² = 17%).

Conclusions

Our findings support the current recommendation of using DEB in in-stent restenosis. Large, well-conducted trials are essential in determining the application of DEB in other lesion types as well as exploring device-specific efficacy and safety profiles.     

Corticosteroid therapy for COVID-19: A systematic review and meta-analysis of randomized controlled trials

Background:Corticosteroid treatment is an effective and common therapeutic strategy for various inflammatory lung pathologies and may be an effective treatment for coronavirus disease 2019 (COVID-19). The purpose of this systematic review and meta-analysis of current literature was to investigate the clinical outcomes associated with corticosteroid treatment of COVID-19.Methods:We systematically searched PubMed, medRxiv, Web of Science, and Scopus databases through March 10, 2021 to identify randomized controlled trials (RCTs) that evaluated the effects of corticosteroid therapies for COVID-19 treatment. Outcomes of interest were mortality, need for mechanical ventilation, serious adverse events (SAEs), and superinfection.Results:A total of 7737 patients from 8 RCTs were included in the quantitative meta-analysis, of which 2795 (36.1%) patients received corticosteroids plus standard of care (SOC) while 4942 (63.9%) patients received placebo and/or SOC alone. The odds of mortality were significantly lower in patients that received corticosteroids as compared to SOC (odds ratio [OR] = 0.85 [95% CI: 0.76; 0.95], P = .003). Corticosteroid treatment reduced the odds of a need for mechanical ventilation as compared to SOC (OR = 0.76 [95% CI: 0.59; 0.97], P = .030). There was no significant difference between the corticosteroid and SOC groups with regards to SAEs and superinfections.Conclusion:Corticosteroid treatment can reduce the odds for mortality and the need for mechanical ventilation in severe COVID-19 patients.     

Effects of statins on stroke prevention in patients with and without coronary heart disease: a meta-analysis of randomized controlled trials

PURPOSE: To assess if lipid-lowering interventions (statins, fibrates, resins, n-3 fatty acids, diet) prevent nonfatal and fatal strokes in patients with and without coronary heart disease. METHODS: We systematically searched the literature up to August 2002 to retrieve all randomized controlled trials of lipid-lowering interventions that reported nonfatal and fatal stroke and mortality data. The search yielded 65 trials with 200,607 patients for a meta-analysis to determine whether treatment effects differed between types of lipid-lowering interventions and between patient samples with and without coronary heart disease. RESULTS: The risk ratio for nonfatal and fatal stroke for statins as compared with control interventions was 0.82 (95% confidence interval [CI]: 0.76 to 0.90). The corresponding risk ratios for statins as compared with control were 0.75 (95% CI: 0.65 to 0.87) for patients with coronary heart disease and 0.77 (95% CI: 0.62 to 0.95) for those without coronary heart disease. The confidence intervals of risk ratios for nonfatal and fatal stroke associated with fibrates, resins, n-3 fatty acids, and diet all included 1, as did the confidence intervals for these interventions in patients with and without coronary heart disease. Weighted meta-regression analysis suggested a stronger association of stroke reduction with statin treatment than with the extent of cholesterol reduction. CONCLUSION: This meta-analysis suggests that statins reduce the incidence of stroke in patients with and without coronary heart disease.     

N-3 polyunsaturated fatty acids in coronary heart disease: a meta-analysis of randomized controlled trials

PURPOSE: Observational studies have shown an inconsistent association between n-3 polyunsaturated fatty acids and the risk of coronary heart disease. We investigated the effects of dietary and non-dietary (supplemental) intake of n-3 polyunsaturated fatty acids on coronary heart disease. SUBJECTS AND METHODS: We searched the literature to identify randomized controlled trials that compared dietary or non-dietary intake of n-3 polyunsaturated fatty acids with a control diet or placebo in patients with coronary heart disease. Studies had to have at least 6 months of follow-up data, and to have reported clinical endpoint data. We identified 11 trials, published between 1966 and 1999, which included 7951 patients in the intervention and 7855 patients in the control groups. RESULTS: The risk ratio of nonfatal myocardial infarction in patients who were on n-3 polyunsaturated fatty acid-enriched diets compared with control diets or placebo was 0.8 (95% confidence interval [CI]: 0.5 to 1.2, P = 0.16; Breslow-Day test for heterogeneity, P = 0.01), and the risk ratio of fatal myocardial infarction was 0.7 (95% CI: 0.6 to 0.8, P <0.001; heterogeneity P >0.20). In 5 trials, sudden death was associated with a risk ratio of 0.7 (95% CI: 0.6 to 0.9, P <0.01; heterogeneity P >0.20), whereas the risk ratio of overall mortality was 0.8 (95% CI: 0.7 to 0.9, P <0.001; heterogeneity P >0.20). There was no difference in summary estimates between dietary and non-dietary interventions of n-3 polyunsaturated fatty acids for all endpoints. CONCLUSION: This meta-analysis suggests that dietary and non-dietary intake of n-3 polyunsaturated fatty acids reduces overall mortality, mortality due to myocardial infarction, and sudden death in patients with coronary heart disease.