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1.
Network meta-analysis and trial sequential analysis for atrial fibrillation patients receiving PCI or with ACS.
Yang, SM, Huang, CJ, Chen, CH, Yu, WC, Sung, SH, Guo, CY, Chuang, SY, Cheng, HM, Chiang, CE
Journal of the Chinese Medical Association : JCMA. 2022;(1):59-66
Abstract
BACKGROUND In patients with atrial fibrillation (AF) and acute coronary syndrome (ACS) or undergoing percutaneous coronary intervention (PCI), choosing the most appropriate antithrombotic treatment remains a dilemma. We aimed to compare the relative efficacy and safety outcomes of antithrombotic drugs in patients with AF after undergoing PCI or ACS. METHODS Randomized controlled trials were systematically searched on PubMed, EMBASE, and the Cochrane Library. Five studies (11,532 patients) were included in the network meta-analysis. Trial sequential analysis (TSA) was performed to assess the reliability and conclusiveness of the meta-analysis comparing the dual antithrombotic therapy strategies with the triple antithrombotic therapy strategy. RESULTS Compared with vitamin K antagonist + dual antiplatelet therapy, novel oral anticoagulant (NOAC) + P2Y12 inhibitor was associated with a significantly better trial-defined primary safety outcome (odds ratio: 0.53; 95% CI, 0.31-0.90) and the lowest probability of thrombolysis in myocardial infarction major bleeding and intracranial hemorrhage using the cumulative ranking technique. In patients omitting aspirin, TSA demonstrated conclusive evidence with significant decreases in all safety outcomes and inconclusive evidence with a nonsignificant increase in in-stent thrombosis (risk ratio: 1.32; TSA-adjusted 95% CI, 0.54-3.24) and myocardial infarction (risk ratio: 1.19; TSA-adjusted 95% CI, 0.84-1.68). CONCLUSIONS In patients with AF receiving PCI or with ACS, NOAC + P2Y12 inhibitor was associated with the lowest bleeding risk but resulted in a statistically nonsignificant, numerically greater risk for stent thrombosis and myocardial infarction, suggesting that triple antithrombotic therapy should still be an option for certain patients at a high risk of stent thrombosis or myocardial infarction.
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2.
Pivotal clinical trials, meta-analyses and current guidelines in the treatment of hyperkalemia.
Bianchi, S, Regolisti, G
Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association. 2019;(Suppl 3):iii51-iii61
Abstract
Hyperkalemia (HK) is the most common electrolyte disturbance observed in patients with advanced stages of chronic kidney disease (CKD), is a potentially life-threatening clinical condition due to an increased risk of fatal arrhythmias, and strongly impacts the quality of life and prognosis of CKD patients. Moreover, while renin-angiotensin-aldosterone system inhibitors (RAASIs) represent the most cardio-nephro-protective drugs used in clinical practice, the treatment with these drugs per se increases serum potassium (sK) values, particularly when heart failure and diabetes mellitus coexist. In fact, the onset or recurrence of HK is frequently associated with not starting, down-titrating or withdrawing RAASIs, and is an indication to begin renal replacement treatment in end-stage renal disease. Current strategies aimed at preventing and treating chronic HK are still unsatisfactory, as evidenced by the relatively high prevalence of HK also in patients under stable nephrology care, and even in the ideal setting of randomized clinical trials. Indeed, dietary potassium restriction, the use of sodium bicarbonate or diuretics, the withdrawal or down-titration of RAASIs, or the administration of old potassium binders, namely sodium polystyrene sulphonate and calcium polystyrene sulphonate, have limited efficacy and are poorly tolerated; therefore, these strategies are not suitable for long-term control of sK. As such, there is an important unmet need for novel therapeutic options for the chronic management of patients at risk for HK. The development of new potassium binders may change the treatment landscape in the near future. This review summarizes the current evidence on the treatment of chronic HK in cardio-renal patients.
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3.
Full-Endoscopic Procedures Versus Traditional Discectomy Surgery for Discectomy: A Systematic Review and Meta-analysis of Current Global Clinical Trials.
Li, XC, Zhong, CF, Deng, GB, Liang, RW, Huang, CM
Pain physician. 2016;(3):103-18
Abstract
BACKGROUND Traditional discectomy surgery (TDS) provides good or excellent results in clinical surgical discectomy but may induce neural adhesion, spinal structural damage, instability, and other complications. The potential advantages of full-endoscopic (FE) procedures over standard TDS include less blood loss, less postoperative pain, shorter hospitalization, and an earlier return to work. However, more evidence is needed to support this new technology in clinical applications. OBJECTIVE The aim of this systematic review and meta-analysis was to compare the safety and efficacy of FE and TDS. STUDY DESIGN Comprehensive systematic review and meta-analysis of the literature. METHODS Electronic databases, including PubMed, EMBASE, SinoMed, and Cochrane Library, were searched to identify clinical therapeutic trials comparing FE to TDS for discectomy. RESULTS Six trials comprising 730 patients were included, and the overall quality of the literature was moderate, including 4 Grade I levels of evidence (4 randomized controlled trials, [RCTs]) and 2 Grade II levels (2 non-RCTs). The pooled data revealed no difference in reoperation rates between FE and TDS (P = 0.94), but the complication rate was significantly lower in the FE group (3.86%) than in the TDS group (11.4%). Perioperative parameters (operation time, blood loss, hospitalization time, and return to work days) were significantly lower in the FE group (P < 0.05 for all groups using either score). Postoperative pain and neurology score assessments were conducted at 4 different time points at 3 months, 6 months, 12 months, and 24 months. Significant differences were detected in the following: lumbar North American Spine Society (NASS) pain at 6 months (P = 0.008); cervical NASS neurology at 6 months (P = 0.03); visual analog scale (VAS) score in leg at 3 months (P < 0.001); VAS score in arm at 24 months (P = 0.002); VAS score in neck at 3 months, 6 months, and 12 months after therapy (P = 0.003, P = 0.004, P = 0.01); and VAS score in neck at 3 months and 6 months (P = 0.01, P = 0.004). Moreover, the pooled data revealed no statistically significant differences in improvements in the Oswestry disability index (ODI), instability (X-ray), and Hilibrand criteria (P > 0.05 for all groups). LIMITATIONS Only 6 studies were included, 4 of which had the same authors. Between-study heterogeneity due to differences in socioeconomic factors, nutrition, and matching criteria is difficult to avoid. CONCLUSIONS Based on this meta-analysis of 24 months of clinical results, we conclude that the FE procedure is as effective as TDS but has the additional benefits of lower complication rates and superior perioperative parameters. In addition, patients may experience less pain with FE techniques due to a smaller incision and less operative injury. However, large-volume, well-designed RCTs with extensive follow-up are needed to confirm and update the findings of this analysis.
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4.
Homocysteine and vascular disease: review of published results of the homocysteine-lowering trials.
Clarke, R, Halsey, J, Bennett, D, Lewington, S
Journal of inherited metabolic disease. 2011;(1):83-91
Abstract
Moderately elevated homocysteine levels have been associated with a higher risk of cardiovascular disease in observational studies, but whether these associations are causal is uncertain. Randomized trials of dietary supplementation with B vitamins were set up to assess whether lowering homocysteine levels could reduce the risk of vascular disease. This review is based on a meta-analysis of published results of eight homocysteine-lowering trials for preventing vascular disease. The eight trials comprised a total of 37,485 individuals and provided comparisons of the effects of B vitamins on 5,074 coronary heart disease (CHD) events, 1,483 stroke events, 2,692 incident cancer events, and 5,128 deaths. Our meta-analysis assessed the effects of lowering homocysteine levels by about 25% for about 5 years. Allocation to B vitamins had no beneficial effects on any cardiovascular events, with hazard ratios (95% confidence intervals) of 1.01 (0.96-1.07) for CHD and 0.96 (0.87-1.07) for stroke. Moreover, allocation to B vitamins had no significant adverse effects on cancer [1.08 (0.99-1.17)], or for death from any cause [1.02 (0.97-1.07)]. Thus, supplementation with B vitamins had no statistically significant effects on the risks of cardiovascular events, total mortality rates, or cancer. A meta-analysis based on individual participant data from all available trials will assess the effects of lowering homocysteine levels on a broader range of outcomes, overall and in all relevant subgroups. However, available evidence does not support the routine use of B vitamins to prevent cardiovascular disease.
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5.
Systematic review and meta-analysis of cannabis treatment for chronic pain.
Martín-Sánchez, E, Furukawa, TA, Taylor, J, Martin, JL
Pain medicine (Malden, Mass.). 2009;(8):1353-68
Abstract
SETTING Cannabis preparations have been used as a remedy for thousands of years in traditional medicine. Clinical use of cannabinoid substances is restricted, due to legal and ethical reasons, as well as limited evidence showing benefits. OBJECTIVE To assess the efficacy and harms of cannabis preparations in the treatment of chronic pain. DESIGN Systematic review and meta-analysis of double-blind randomized controlled trials that compared any cannabis preparation to placebo among subjects with chronic pain. An electronic search was made in Medline/Pubmed, Embase, and The Cochrane Controlled Trials Register (TRIALS CENTRAL) of all literature published until February 2008, as well as specific web pages devoted to cannabis. Studies were cross-checked, selected, and assessed. RESULTS Eighteen trials were included. The efficacy analysis (visual analog scales) displayed a difference in standardized means in favor of the cannabis arm of -0.61 (-0.84 to -0.37), with statistical homogeneity (I(2) = 0.0%; P = 0.50). For the analysis of harms, the following Odds Ratios (OR) and number needed to harm (NNH) were obtained: for events linked to alterations to perception, OR: 4.51 (3.05-6.66), NNH: 7 (6-9); for events affecting motor function, 3.93 (2.83-5.47), NNH: 5 (4-6); for events that altered cognitive function, 4.46 (2.37-8.37), NNH: 8 (6-12). CONCLUSIONS Currently available evidence suggests that cannabis treatment is moderately efficacious for treatment of chronic pain, but beneficial effects may be partially (or completely) offset by potentially serious harms. More evidence from larger, well-designed trials is needed to clarify the true balance of benefits to harms.
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6.
Diagnostic accuracy of beta-methyl-p-[123I]-iodophenyl-pentadecanoic acid (BMIPP) imaging: a meta-analysis.
Inaba, Y, Bergmann, SR
Journal of nuclear cardiology : official publication of the American Society of Nuclear Cardiology. 2008;(3):345-52
Abstract
BACKGROUND beta-Methyl-p-[(123)I]-iodophenyl-pentadecanoic acid (BMIPP) imaging has been used extensively to detect coronary artery disease (CAD), primarily in Japan. However, the reported sensitivity and specificity vary considerably from study to study. This meta-analysis was conducted to summarize the evidence for the diagnostic accuracy of resting BMIPP imaging in the detection of CAD. METHODS AND RESULTS A MEDLINE search of the literature published through the end of 2006 was performed. Seven studies (528 patients) met the inclusion criteria. Using random-effects models, the overall sensitivity and specificity to detect CAD were 78% (95% confidence interval, 73% to 81%) and 84% (95% confidence interval, 77% to 89%), respectively. A significant threshold effect was identified among studies, which was expected given the between-study variability in study methodology. A summary receiver-operating characteristic curve yielded an asymmetric curve with an area under the curve of 0.91 (SE, 0.020), indicating excellent diagnostic performance. CONCLUSIONS Imaging with BMIPP at rest exhibits a moderate sensitivity and high specificity to detect CAD in patients with a high prevalence of CAD. Thus, this tracer may be of great value for patients with acute chest pain and those with relative contraindications to exercise or pharmacologic stress myocardial perfusion imaging (MPI).
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7.
Nebulized furosemide for the management of dyspnea: does the evidence support its use?
Newton, PJ, Davidson, PM, Macdonald, P, Ollerton, R, Krum, H
Journal of pain and symptom management. 2008;(4):424-41
Abstract
Dyspnea is a common and distressing symptom associated with multiple chronic illnesses and high levels of burden for individuals, their families and health care systems. The subjective nature dyspnea and a poor understanding of pathophysiological mechanisms challenge the clinician in developing management plans. Nebulized furosemide has been identified as a novel approach to dyspnea management. This review summarizes published studies, both clinical and experimental, reporting the use of nebulized furosemide. The search criteria yielded 42 articles published in the period 1988 to 2004. Although nebulized furosemide appeared to have a positive influence on dyspnea and physiological measurements, caution must be taken with the results primarily coming from small-scale clinical trials or observation trials. Despite the limitations of the studies reported, given the range of conditions reporting effectiveness of nebulized furosemide, further investigation of this potential novel treatment of dyspnea is warranted.
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8.
Soft drinks and weight gain: how strong is the link?
Wolff, E, Dansinger, ML
Medscape journal of medicine. 2008;(8):189
Abstract
CONTEXT Soft drink consumption in the United States has tripled in recent decades, paralleling the dramatic increases in obesity prevalence. The purpose of this clinical review is to evaluate the extent to which current scientific evidence supports a causal link between sugar-sweetened soft drink consumption and weight gain. EVIDENCE ACQUISITION MEDLINE search of articles published in all languages between 1966 and December 2006 containing key words or medical subheadings, such as "soft drinks" and "weight." Additional articles were obtained by reviewing references of retrieved articles, including a recent systematic review. All reports with cross-sectional, prospective cohort, or clinical trial data in humans were considered. EVIDENCE SYNTHESIS Six of 15 cross-sectional and 6 of 10 prospective cohort studies identified statistically significant associations between soft drink consumption and increased body weight. There were 5 clinical trials; the two that involved adolescents indicated that efforts to reduce sugar-sweetened soft drinks slowed weight gain. In adults, 3 small experimental studies suggested that consumption of sugar-sweetened soft drinks caused weight gain; however, no trial in adults was longer than 10 weeks or included more than 41 participants. No trial reported the effects on lipids. CONCLUSIONS Although observational studies support the hypothesis that sugar-sweetened soft drinks cause weight gain, a paucity of hypothesis-confirming clinical trial data has left the issue open to debate. Given the magnitude of the public health concern, larger and longer intervention trials should be considered to clarify the specific effects of sugar-sweetened soft drinks on body weight and other cardiovascular risk factors.
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9.
In search of the magic nutraceutical: problems with current approaches.
Heyland, DK
The Journal of nutrition. 2001;(9 Suppl):2591S-5S
Abstract
Over the last few decades, substrates with immune-modulating properties have been identified in all groups of micro- and macronutrients. Numerous experimental studies have focused on evaluating these substances, either alone or in combination. After hundreds of experiments, no clear, consistent signal exists that any of these agents result in significant treatment benefits in critically ill patients. The current approach to establishing the efficacy of nutritional interventions suffers from several limitations. First, the majority of studies focus on surrogate or substitute end points rather than clinically important end points. Second, the majority of clinical studies are small, and as such are underpowered to detect a significant treatment effect on clinically important end points. Third, the methodological quality of individual randomized trials varies. Methodological limitations, prevalent in nutrition studies, limit the strength of clinical inference that can be made from study results. High quality studies have been shown to differ significantly from low quality studies in their estimation of treatment effect. Fourth, the generalizability of single-site studies is limited. Finally, studies sponsored solely by industry are considered to be less believable than studies conducted under the auspices of peer-review agencies. Future evaluations must be done in the context of large, multicenter, well-designed, randomized trials focusing on clinically important end points that are sponsored from a variety of sources (including peer-reviewed agencies). Although such trials are costly, they are feasible and are much more likely to be believable and generalizable than the current approach.
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10.
Clinical and angiographic factors associated with asymptomatic restenosis after percutaneous coronary intervention.
Ruygrok, PN, Webster, MW, de Valk, V, van Es, GA, Ormiston, JA, Morel, MA, Serruys, PW
Circulation. 2001;(19):2289-94
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Abstract
BACKGROUND Angiographic restenosis after percutaneous coronary interventional procedures is more common than recurrent angina. Clinical and angiographic factors associated with asymptomatic versus symptomatic restenosis after percutaneous coronary intervention were compared. METHODS AND RESULTS All patients with angiographic restenosis from the BENESTENT I, BENESTENT II pilot, BENESTENT II, MUSIC, WEST 1, DUET, FINESS 2, FLARE, SOPHOS, and ROSE studies were analyzed. Multivariate analysis evaluated 46 clinical and angiographic variables, comparing those with and without angina. The 10 studies recruited 2690 patients who underwent percutaneous revascularization and 6-month follow-up angiography (86% of those eligible). Restenosis (≥50% diameter stenosis) occurred in 607 patients and was clinically silent in 335 (55%). Male sex (P=0.008), absence of antianginal therapy with nitrates (P=0.0002) and calcium channel blockers (P=0.02) at 6 months, greater reference diameter after the procedure (P=0.04), greater reference diameter at follow-up (P=0.004), and lesser lesion severity (percent stenosis) at 6 months (P=0.0004) were univariate predictors of asymptomatic restenosis. By multivariate analysis, only male sex (P=0.04), greater reference diameter at follow-up (P=0.002), and lesser lesion severity at 6 months (P=0.0001) were associated with restenosis without angina. CONCLUSIONS Approximately half of patients with angiographic restenosis have no symptoms. The only multivariate predictors of silent restenosis at 6 months were male sex, greater reference diameter at follow-up, and lesser lesion severity on follow-up angiography.