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1.
BMJ Open ; 8(2): e018052, 2018 02 14.
Article in English | MEDLINE | ID: mdl-29444778

ABSTRACT

INTRODUCTION: Coronary artery disease (CAD) not amenable to revascularisation indicates that the coronary arteries have severe diffuse lesions or calcifications, or that CAD is complicated with severe multiple-organ disease. Currently, Western medicines available for the treatment of CAD not amenable to revascularisation are limited. Shexiang Baoxin Pill (SBP), a type of Chinese patent medicine, has been widely used to treat CAD in China for many years. Previous studies have shown that long-term administration of SBP (1-2 pills three times daily, for at least 6 months) for treatment of CAD is effective and safe, with a significant, long-term effect. This study aims to evaluate the efficacy and safety of SBP in patients with CAD not amenable to revascularisation. METHODS AND ANALYSIS: This is a multicentre, randomised, double-blinded, placebo-controlled clinical trial. A total of 440 participants will be randomly allocated to two groups: the intervention group and the placebo group. Based on conventional treatment with Western medicine, the intervention group will be treated with SBP and the placebo group will be treated with SBP placebo. The primary outcomes include major adverse cardiovascular events (including angina, acute myocardial infarction, pulmonary embolism and aortic dissection). The secondary outcomes include C reactive protein, B-type natriuretic peptide, ECG, echocardiographic parameters (ejection fraction percentage and the E/A ratio) and hospital readmission rates due to CAD. Assessments will be performed at baseline (before randomisation) and at 24 weeks after randomisation. ETHICS AND DISSEMINATION: The protocol has been approved by the Research Ethics Committee of Guang'anmen Hospital, China Academy of Chinese Medical Sciences in Beijing, China (reference: 2016-129-KY-01). The results of this study will be published in a peer-reviewed journal and will be used as a basis for a multisite trial. TRIAL REGISTRATION NUMBER: NCT03072121; Pre-results.


Subject(s)
Angina Pectoris/prevention & control , Aortic Dissection/prevention & control , Coronary Artery Disease/drug therapy , Coronary Vessels/pathology , Drugs, Chinese Herbal/therapeutic use , Myocardial Infarction/prevention & control , Pulmonary Embolism/prevention & control , Aged , Aortic Dissection/etiology , Angina Pectoris/etiology , C-Reactive Protein/metabolism , Coronary Artery Disease/complications , Double-Blind Method , Drugs, Chinese Herbal/pharmacology , Electrocardiography , Female , Humans , Male , Middle Aged , Myocardial Infarction/etiology , Natriuretic Peptide, Brain/metabolism , Patient Readmission , Percutaneous Coronary Intervention , Pulmonary Embolism/etiology , Research Design , Treatment Outcome
2.
Cochrane Database Syst Rev ; 8: CD006612, 2017 08 17.
Article in English | MEDLINE | ID: mdl-28816346

ABSTRACT

BACKGROUND: Cardiovascular disease, which includes coronary artery disease, stroke and peripheral vascular disease, is a leading cause of death worldwide. Homocysteine is an amino acid with biological functions in methionine metabolism. A postulated risk factor for cardiovascular disease is an elevated circulating total homocysteine level. The impact of homocysteine-lowering interventions, given to patients in the form of vitamins B6, B9 or B12 supplements, on cardiovascular events has been investigated. This is an update of a review previously published in 2009, 2013, and 2015. OBJECTIVES: To determine whether homocysteine-lowering interventions, provided to patients with and without pre-existing cardiovascular disease are effective in preventing cardiovascular events, as well as reducing all-cause mortality, and to evaluate their safety. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL 2017, Issue 5), MEDLINE (1946 to 1 June 2017), Embase (1980 to 2017 week 22) and LILACS (1986 to 1 June 2017). We also searched Web of Science (1970 to 1 June 2017). We handsearched the reference lists of included papers. We also contacted researchers in the field. There was no language restriction in the search. SELECTION CRITERIA: We included randomised controlled trials assessing the effects of homocysteine-lowering interventions for preventing cardiovascular events with a follow-up period of one year or longer. We considered myocardial infarction and stroke as the primary outcomes. We excluded studies in patients with end-stage renal disease. DATA COLLECTION AND ANALYSIS: We performed study selection, 'Risk of bias' assessment and data extraction in duplicate. We estimated risk ratios (RR) for dichotomous outcomes. We calculated the number needed to treat for an additional beneficial outcome (NNTB). We measured statistical heterogeneity using the I2 statistic. We used a random-effects model. We conducted trial sequential analyses, Bayes factor, and fragility indices where appropriate. MAIN RESULTS: In this third update, we identified three new randomised controlled trials, for a total of 15 randomised controlled trials involving 71,422 participants. Nine trials (60%) had low risk of bias, length of follow-up ranged from one to 7.3 years. Compared with placebo, there were no differences in effects of homocysteine-lowering interventions on myocardial infarction (homocysteine-lowering = 7.1% versus placebo = 6.0%; RR 1.02, 95% confidence interval (CI) 0.95 to 1.10, I2 = 0%, 12 trials; N = 46,699; Bayes factor 1.04, high-quality evidence), death from any cause (homocysteine-lowering = 11.7% versus placebo = 12.3%, RR 1.01, 95% CI 0.96 to 1.06, I2 = 0%, 11 trials, N = 44,817; Bayes factor = 1.05, high-quality evidence), or serious adverse events (homocysteine-lowering = 8.3% versus comparator = 8.5%, RR 1.07, 95% CI 1.00 to 1.14, I2 = 0%, eight trials, N = 35,788; high-quality evidence). Compared with placebo, homocysteine-lowering interventions were associated with reduced stroke outcome (homocysteine-lowering = 4.3% versus comparator = 5.1%, RR 0.90, 95% CI 0.82 to 0.99, I2 = 8%, 10 trials, N = 44,224; high-quality evidence). Compared with low doses, there were uncertain effects of high doses of homocysteine-lowering interventions on stroke (high = 10.8% versus low = 11.2%, RR 0.90, 95% CI 0.66 to 1.22, I2 = 72%, two trials, N = 3929; very low-quality evidence).We found no evidence of publication bias. AUTHORS' CONCLUSIONS: In this third update of the Cochrane review, there were no differences in effects of homocysteine-lowering interventions in the form of supplements of vitamins B6, B9 or B12 given alone or in combination comparing with placebo on myocardial infarction, death from any cause or adverse events. In terms of stroke, this review found a small difference in effect favouring to homocysteine-lowering interventions in the form of supplements of vitamins B6, B9 or B12 given alone or in combination comparing with placebo.There were uncertain effects of enalapril plus folic acid compared with enalapril on stroke; approximately 143 (95% CI 85 to 428) people would need to be treated for 5.4 years to prevent 1 stroke, this evidence emerged from one mega-trial.Trial sequential analyses showed that additional trials are unlikely to increase the certainty about the findings of this issue regarding homocysteine-lowering interventions versus placebo. There is a need for additional trials comparing homocysteine-lowering interventions combined with antihypertensive medication versus antihypertensive medication, and homocysteine-lowering interventions at high doses versus homocysteine-lowering interventions at low doses. Potential trials should be large and co-operative.


Subject(s)
Cardiovascular Diseases/prevention & control , Hyperhomocysteinemia/therapy , Vitamin B Complex/therapeutic use , Angina Pectoris/prevention & control , Cardiovascular Diseases/etiology , Cause of Death , Folic Acid/therapeutic use , Humans , Hyperhomocysteinemia/complications , Myocardial Infarction/epidemiology , Myocardial Infarction/prevention & control , Randomized Controlled Trials as Topic , Risk Factors , Stroke/epidemiology , Stroke/prevention & control , Vitamin B 12/therapeutic use , Vitamin B 6/therapeutic use
3.
JAMA Cardiol ; 2(6): 608-616, 2017 06 01.
Article in English | MEDLINE | ID: mdl-28384800

ABSTRACT

Importance: Cohort studies have reported increased incidence of cardiovascular disease (CVD) among individuals with low vitamin D status. To date, randomized clinical trials of vitamin D supplementation have not found an effect, possibly because of using too low a dose of vitamin D. Objective: To examine whether monthly high-dose vitamin D supplementation prevents CVD in the general population. Design, Setting, and Participants: The Vitamin D Assessment Study is a randomized, double-blind, placebo-controlled trial that recruited participants mostly from family practices in Auckland, New Zealand, from April 5, 2011, through November 6, 2012, with follow-up until July 2015. Participants were community-resident adults aged 50 to 84 years. Of 47 905 adults invited from family practices and 163 from community groups, 5110 participants were randomized to receive vitamin D3 (n = 2558) or placebo (n = 2552). Two participants retracted consent, and all others (n = 5108) were included in the primary analysis. Interventions: Oral vitamin D3 in an initial dose of 200 000 IU, followed a month later by monthly doses of 100 000 IU, or placebo for a median of 3.3 years (range, 2.5-4.2 years). Main Outcomes and Measures: The primary outcome was the number of participants with incident CVD and death, including a prespecified subgroup analysis in participants with vitamin D deficiency (baseline deseasonalized 25-hydroxyvitamin D [25(OH)D] levels <20 ng/mL). Secondary outcomes were myocardial infarction, angina, heart failure, hypertension, arrhythmias, arteriosclerosis, stroke, and venous thrombosis. Results: Of the 5108 participants included in the analysis, the mean (SD) age was 65.9 (8.3) years, 2969 (58.1%) were male, and 4253 (83.3%) were of European or other ethnicity, with the remainder being Polynesian or South Asian. Mean (SD) baseline deseasonalized 25(OH)D concentration was 26.5 (9.0) ng/mL, with 1270 participants (24.9%) being vitamin D deficient. In a random sample of 438 participants, the mean follow-up 25(OH)D level was greater than 20 ng/mL higher in the vitamin D group than in the placebo group. The primary outcome of CVD occurred in 303 participants (11.8%) in the vitamin D group and 293 participants (11.5%) in the placebo group, yielding an adjusted hazard ratio of 1.02 (95% CI, 0.87-1.20). Similar results were seen for participants with baseline vitamin D deficiency and for secondary outcomes. Conclusions and Relevance: Monthly high-dose vitamin D supplementation does not prevent CVD. This result does not support the use of monthly vitamin D supplementation for this purpose. The effects of daily or weekly dosing require further study. Trial Registration: clinicaltrials.gov Identifier: ACTRN12611000402943.


Subject(s)
Cardiovascular Diseases/prevention & control , Cholecalciferol/administration & dosage , Vitamin D Deficiency/drug therapy , Vitamins/administration & dosage , Aged , Aged, 80 and over , Angina Pectoris/epidemiology , Angina Pectoris/prevention & control , Arrhythmias, Cardiac/epidemiology , Arrhythmias, Cardiac/prevention & control , Arteriosclerosis/epidemiology , Arteriosclerosis/prevention & control , Cardiovascular Diseases/epidemiology , Cardiovascular Diseases/mortality , Cholecalciferol/therapeutic use , Dietary Supplements , Double-Blind Method , Female , Heart Failure/epidemiology , Heart Failure/prevention & control , Humans , Hypertension/epidemiology , Hypertension/prevention & control , Male , Middle Aged , Myocardial Infarction/epidemiology , Myocardial Infarction/prevention & control , New Zealand , Proportional Hazards Models , Stroke/epidemiology , Stroke/prevention & control , Venous Thrombosis/epidemiology , Venous Thrombosis/prevention & control , Vitamin D Deficiency/epidemiology , Vitamins/therapeutic use
4.
Cochrane Database Syst Rev ; (5): CD010237, 2015 May 21.
Article in English | MEDLINE | ID: mdl-25994229

ABSTRACT

BACKGROUND: Percutaneous coronary intervention (PCI) is a standard treatment for coronary heart disease (CHD). Restenosis, defined as a 50% reduction in luminal diameter at six months after PCI, indicates a need for revascularisation. Restenosis has proven to be a major drawback to PCI. Tong-xin-luo is one of the prophylactic strategies for cardiovascular events in patients after PCI that is widely used in China, but its efficacy and safety have not been systematically evaluated. OBJECTIVES: To systematically assess the efficacy and safety of Tong-xin-luo capsules in preventing cardiovascular events after PCI in patients with CHD. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials in The Cochrane Library, MEDLINE (OVID), EMBASE (OVID), WanFang, Chinese Biomedical Database, Chinese Medical Current Contents, and China National Knowledge Infrastructure from their inception to June 2014. We also searched other resources, including ongoing trials and research registries. We applied no language restrictions. SELECTION CRITERIA: Randomised controlled trials of participants with CHD after PCI were included. Participants in the intervention group received Tong-xin-luo capsules for at least three months. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed the risk of bias. Any disagreements were resolved by discussion with a third review author. The primary outcomes included occurrence of angiographic restenosis and adverse events; the secondary outcomes included myocardial infarction, heart failure, angina, all cause mortality, mortality due to any cardiovascular event, use of revascularisation, patient acceptability, quality of life and cost-effectiveness. Dichotomous data were measured with risk ratios (RRs) with 95% confidence intervals (CIs). MAIN RESULTS: Sixteen studies involving 1063 participants were identified. The risk of bias for fifteen studies was high and along with imprecision and possible publication bias, this lowered our confidence in the results. There was low quality evidence that Tong-xi-luo reduced the rates of angiographic restenosis (RR 0.16, 95% CI 0.07 to 0.34), myocardial infarction (RR 0.32, 95% CI 0.16 to 0.66), heart failure (RR 0.26, 95% CI 0.11 to 0.62), and use of revascularisation (RR 0.26, 95% CI 0.15 to 0.45). There was very low quality evidence for the effect of Tong-xin-luo on all-cause mortality (RR 0.38, 95% CI 0.06 to 2.56), angina (RR 0.24, 95% CI 0.17 to 0.34) and death due to any cardiovascular event (RR 0.31, 95% CI 0.08 to 1.12). Adverse events were seldom reported, and included gastrointestinal reactions and nausea. AUTHORS' CONCLUSIONS: The addition of Tong-xin-luo to conventional Western medicine may possibly prevent restenosis and recurrence of cardiovascular events in patients with CHD after PCI. However, the data are limited by publication bias and high risk of bias for included studies. Further high-quality trials are required to evaluate the potential effects of this intervention.


Subject(s)
Coronary Disease/drug therapy , Coronary Restenosis/prevention & control , Drugs, Chinese Herbal/therapeutic use , Percutaneous Coronary Intervention , Secondary Prevention/methods , Angina Pectoris/prevention & control , Capsules , Cause of Death , Heart Failure/prevention & control , Humans , Myocardial Infarction/prevention & control , Randomized Controlled Trials as Topic , Treatment Outcome
5.
Cochrane Database Syst Rev ; 1: CD006612, 2015 Jan 15.
Article in English | MEDLINE | ID: mdl-25590290

ABSTRACT

BACKGROUND: Cardiovascular disease, which includes coronary artery disease, stroke and congestive heart failure, is a leading cause of death worldwide. Homocysteine is an amino acid with biological functions in methionine metabolism. A postulated risk factor is an elevated circulating total homocysteine level, which is associated with cardiovascular events. The impact of homocysteine-lowering interventions, given to patients in the form of vitamins B6, B9 or B12 supplements, on cardiovascular events. This is an update of a review previously published in 2009 and 2013. OBJECTIVES: To determine whether homocysteine-lowering interventions, provided in patients with and without pre-existing cardiovascular disease are effective in preventing cardiovascular events, as well as all-cause mortality and evaluate their safety. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL 2014, Issue 1), MEDLINE (1950 to January week 5 2014), EMBASE (1980 to 2014 week 6) and LILACS (1986 to February 2014). We also searched Web of Science (1970 to 7 February 2014). We handsearched the reference lists of included papers. We also contacted researchers in the field. There was no language restriction in the search. SELECTION CRITERIA: We included randomised controlled trials assessing the effects of homocysteine-lowering interventions for preventing cardiovascular events with a follow-up period of one year or longer. We considered myocardial infarction and stroke as the primary outcomes. We excluded studies in patients with end-stage renal disease. DATA COLLECTION AND ANALYSIS: We performed study selection, 'Risk of bias' assessment and data extraction in duplicate. We estimated risk ratios (RR) for dichotomous outcomes. We measured statistical heterogeneity using the I(2) statistic. We used a random-effects model. MAIN RESULTS: In this second updated Cochrane Review, we identified no new randomised controlled trials. Therefore, this new version includes 12 randomised controlled trials involving 47,429 participants. In general terms, 75% (9/12) trials had a low risk of bias. Homocysteine-lowering interventions compared with placebo did not significantly affect non-fatal or fatal myocardial infarction (1743/23,590 (7.38%) versus 1247/20,190 (6.17%); RR 1.02, 95% confidence interval (CI) 0.95 to 1.10, I(2) = 0%, high quality evidence), stroke (968/22,348 (4.33%) versus 974/18,957 (5.13%); RR 0.91, 95% CI 0.82 to 1.0, I(2) = 11%, high quality evidence) or death from any cause (2784/22,648 (12.29%) versus 2502/19,250 (10.64%); RR 1.01, 95% CI 0.96 to 1.07, I(2) = 6%, high quality evidence). Homocysteine-lowering interventions compared with placebo did not significantly affect serious adverse events (cancer) (1558/18,130 (8.59%) versus 1334/14,739 (9.05%); RR 1.06, 95% CI 0.98 to 1.13; I(2) = 0%, high quality evidence). AUTHORS' CONCLUSIONS: This second update of this Cochrane Review found no evidence to suggest that homocysteine-lowering interventions in the form of supplements of vitamins B6, B9 or B12 given alone or in combination should be used for preventing cardiovascular events. Furthermore, there is no evidence to suggest that homocysteine-lowering interventions are associated with an increased risk of cancer.


Subject(s)
Cardiovascular Diseases/prevention & control , Hyperhomocysteinemia/therapy , Vitamin B Complex/therapeutic use , Angina Pectoris/prevention & control , Cardiovascular Diseases/etiology , Humans , Hyperhomocysteinemia/complications , Myocardial Infarction/prevention & control , Randomized Controlled Trials as Topic , Risk Factors , Stroke/prevention & control
6.
Forsch Komplementmed ; 21(6): 351-9, 2014.
Article in English | MEDLINE | ID: mdl-25592946

ABSTRACT

BACKGROUND: Coronary artery bypass grafting (CABG) is widely used in the treatment of coronary artery disease. A multicenter, double-blind, randomized, controlled clinical trial was designed to evaluate the efficacy and safety of Huxin Formula post CABG. PATIENTS AND METHODS: 270 inpatients with coronary heart disease participated in this study. CABG patients in the control group were treated with placebo, while patients in the experimental group were treated with Huxin Formula 1 week after the surgery. All patients were treated for 6 months and followed up for another 6 months. The main outcomes (death, nonfatal myocardial infarction, repeat revascularization, and readmission) were assessed 360 days after treatment, and secondary outcomes (frequency and scores of angina pectoris, etc.) were assessed 0, 90, 180, 270, and 360 days after treatment. RESULTS: Our results showed no significant difference between the 2 groups for the primary endpoints. In patients with cardiac function class II (New York Heart Association), the score of angina pectoris was significantly lower (3.88 ± 3.86 vs. 5.45 ± 3.59) and the frequency of angina pectoris attacks was less (0.96 ± 1.01 vs. 1.36 ± 0.94) after 90 days of treatment with Huxin Formula compared to placebo (p < 0.05). In patients with 3 coronary vessel lesions, the cardiac function class (1.14 ± 0.35 vs. 1.05 ± 0.21) after 360 days was significantly higher in the control group compared to the treatment group (p < 0.05). There were no obvious adverse reactions. CONCLUSION: Huxin Formula may improve cardiac function of patients with 3 coronary vessel lesions and relieve symptoms of patients with cardiac function class II but failed to show superiority in primary outcomes.


Subject(s)
Angina Pectoris/prevention & control , Coronary Artery Bypass , Drugs, Chinese Herbal/pharmacology , Heart/drug effects , Aged , Drugs, Chinese Herbal/administration & dosage , Female , Heart Diseases/drug therapy , Humans , Male , Middle Aged , Postoperative Period , Treatment Outcome
11.
JAMA ; 309(12): 1241-50, 2013 Mar 27.
Article in English | MEDLINE | ID: mdl-23532240

ABSTRACT

IMPORTANCE: Chelation therapy with disodium EDTA has been used for more than 50 years to treat atherosclerosis without proof of efficacy. OBJECTIVE: To determine if an EDTA-based chelation regimen reduces cardiovascular events. DESIGN, SETTING, AND PARTICIPANTS: Double-blind, placebo-controlled, 2 × 2 factorial randomized trial enrolling 1708 patients aged 50 years or older who had experienced a myocardial infarction (MI) at least 6 weeks prior and had serum creatinine levels of 2.0 mg/dL or less. Participants were recruited at 134 US and Canadian sites. Enrollment began in September 2003 and follow-up took place until October 2011 (median, 55 months). Two hundred eighty-nine patients (17% of total; n=115 in the EDTA group and n=174 in the placebo group) withdrew consent during the trial. INTERVENTIONS: Patients were randomized to receive 40 infusions of a 500-mL chelation solution (3 g of disodium EDTA, 7 g of ascorbate, B vitamins, electrolytes, procaine, and heparin) (n=839) vs placebo (n=869) and an oral vitamin-mineral regimen vs an oral placebo. Infusions were administered weekly for 30 weeks, followed by 10 infusions 2 to 8 weeks apart. Fifteen percent discontinued infusions (n=38 [16%] in the chelation group and n=41 [15%] in the placebo group) because of adverse events. MAIN OUTCOME MEASURES: The prespecified primary end point was a composite of total mortality, recurrent MI, stroke, coronary revascularization, or hospitalization for angina. This report describes the intention-to-treat comparison of EDTA chelation vs placebo. To account for multiple interim analyses, the significance threshold required at the final analysis was P = .036. RESULTS: Qualifying previous MIs occurred a median of 4.6 years before enrollment. Median age was 65 years, 18% were female, 9% were nonwhite, and 31% were diabetic. The primary end point occurred in 222 (26%) of the chelation group and 261 (30%) of the placebo group (hazard ratio [HR], 0.82 [95% CI, 0.69-0.99]; P = .035). There was no effect on total mortality (chelation: 87 deaths [10%]; placebo, 93 deaths [11%]; HR, 0.93 [95% CI, 0.70-1.25]; P = .64), but the study was not powered for this comparison. The effect of EDTA chelation on the components of the primary end point other than death was of similar magnitude as its overall effect (MI: chelation, 6%; placebo, 8%; HR, 0.77 [95% CI, 0.54-1.11]; stroke: chelation, 1.2%; placebo, 1.5%; HR, 0.77 [95% CI, 0.34-1.76]; coronary revascularization: chelation, 15%; placebo, 18%; HR, 0.81 [95% CI, 0.64-1.02]; hospitalization for angina: chelation, 1.6%; placebo, 2.1%; HR, 0.72 [95% CI, 0.35-1.47]). Sensitivity analyses examining the effect of patient dropout and treatment adherence did not alter the results. CONCLUSIONS AND RELEVANCE: Among stable patients with a history of MI, use of an intravenous chelation regimen with disodium EDTA, compared with placebo, modestly reduced the risk of adverse cardiovascular outcomes, many of which were revascularization procedures. These results provide evidence to guide further research but are not sufficient to support the routine use of chelation therapy for treatment of patients who have had an MI. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00044213.


Subject(s)
Angina Pectoris/prevention & control , Chelating Agents/therapeutic use , Edetic Acid/therapeutic use , Myocardial Infarction/prevention & control , Stroke/prevention & control , Aged , Atherosclerosis/complications , Atherosclerosis/drug therapy , Double-Blind Method , Female , Hospitalization/statistics & numerical data , Humans , Infusions, Intravenous , Male , Middle Aged , Myocardial Infarction/mortality , Percutaneous Coronary Intervention , Recurrence , Risk , Treatment Outcome
14.
Cochrane Database Syst Rev ; (1): CD006612, 2013 Jan 31.
Article in English | MEDLINE | ID: mdl-23440809

ABSTRACT

BACKGROUND: Cardiovascular disease (including coronary artery disease, stroke and congestive heart failure), is a leading cause of death worldwide. Homocysteine is an amino acid with biological functions in methionine metabolism. A postulated risk factor is elevated circulating total homocysteine levels, which are associated with cardiovascular events. This is an update of a review previously published in 2009. OBJECTIVES: To assess the clinical effectiveness of homocysteine-lowering interventions in people with or without pre-existing cardiovascular disease. SEARCH METHODS: We searched The Cochrane Central Register of Controlled Trials (CENTRAL) on The Cochrane Library (2012, Issue 2), MEDLINE (1950 to Feb week 2 2012), EMBASE (1980 to 2012 week 07), and LILACS (1986 to February 2012). We also searched ISI Web of Science (1970 to February 2012). We handsearched the reference lists of included papers. We also contacted researchers in the field. There was no language restriction in the search. SELECTION CRITERIA: We included randomised controlled trials assessing the effects of homocysteine-lowering interventions for preventing cardiovascular events with a follow-up period of one year or longer. We considered myocardial infarction and stroke as the primary outcomes. We excluded studies in patients with end-stage renal disease. DATA COLLECTION AND ANALYSIS: We performed study selection, 'Risk of bias' assessment and data extraction in duplicate. We estimated risk ratios (RR) for dichotomous outcomes. We measured statistical heterogeneity using I(2). We used a random-effects model. MAIN RESULTS: In this updated systematic review, we identified four new randomised trials, resulting in a total of 12 randomised controlled trials involving 47,429 participants. In general terms, the trials had a low risk of bias. Homocysteine-lowering interventions compared with placebo did not significantly affect non-fatal or fatal myocardial infarction (pooled RR 1.02, 95% CI 0.95 to 1.10, I(2) = 0%), stroke (pooled RR 0.91, 95% CI 0.82 to 1.0, I(2) = 11%) or death by any cause (pooled RR 1.01 (95% CI 0.96 to 1.07, I(2): 6%)). Homocysteine-lowering interventions compared with placebo did not significantly affect serious adverse events (cancer) (1 RR 1.06, 95% CI 0.98 to 1.13; I(2) = 0%). AUTHORS' CONCLUSIONS: This updated Cochrane review found no evidence to suggest that homocysteine-lowering interventions in the form of supplements of vitamins B6, B9 or B12 given alone or in combination should be used for preventing cardiovascular events. Furthermore, there is no evidence suggesting that homocysteine-lowering interventions are associated with an increased risk of cancer.


Subject(s)
Cardiovascular Diseases/prevention & control , Hyperhomocysteinemia/therapy , Vitamin B Complex/therapeutic use , Angina Pectoris/prevention & control , Cardiovascular Diseases/etiology , Humans , Hyperhomocysteinemia/complications , Myocardial Infarction/prevention & control , Randomized Controlled Trials as Topic , Risk Factors , Stroke/prevention & control
15.
Ann Intern Med ; 159(12): 797-805, 2013 Dec 17.
Article in English | MEDLINE | ID: mdl-24490264

ABSTRACT

BACKGROUND: Whether high-dose multivitamins are effective for secondary prevention of atherosclerotic disease is unknown. OBJECTIVE: To assess whether oral multivitamins reduce cardiovascular events and are safe. DESIGN: Double-blind, placebo-controlled, 2 x 2 factorial, multicenter, randomized trial. (ClinicalTrials.gov: NCT00044213) SETTING: 134 U.S. and Canadian academic and clinical sites. PATIENTS: 1708 patients aged 50 years or older who had myocardial infarction (MI) at least 6 weeks earlier and had serum creatinine levels of 176.8 mol/L (2.0 mg/dL) or less. INTERVENTION: Patients were randomly assigned to an oral, 28-component, high-dose multivitamin and multimineral mixture or placebo. MEASUREMENTS: The primary end point was time to total death, recurrent MI, stroke, coronary revascularization, or hospitalization for angina. RESULTS: The median age was 65 years, and 18% of patients were women. The qualifying MI occurred a median of 4.6 years (interquartile range [IQR], 1.6 to 9.2 years) before enrollment. Median follow-up was 55 months (IQR, 26 to 60 months). Patients received vitamins for a median of 31 months (IQR, 13 to 59 months) in the vitamin group and 35 months (IQR, 13 to 60 months) in the placebo group (P = 0.65). Totals of 645 (76%) and 646 (76%) patients in the vitamin and placebo groups, respectively, completed at least 1 year of oral therapy (P = 0.98), and 400 (47%) and 426 (50%) patients, respectively, completed at least 3 years (P = 0.23). Totals of 394 (46%) and 390 (46%) patients in the vitamin and placebo groups, respectively, discontinued the vitamin regimen (P = 0.67), and 17% of patients withdrew from the study. The primary end point occurred in 230 (27%) patients in the vitamin group and 253 (30%) in the placebo group (hazard ratio, 0.89 [95% CI, 0.75 to 1.07]; P = 0.21). No evidence suggested harm from vitamin therapy in any category of adverse events. LIMITATION: There was considerable nonadherence and withdrawal, limiting the ability to draw firm conclusions (particularly about safety). CONCLUSION: High-dose oral multivitamins and multiminerals did not statistically significantly reduce cardiovascular events in patients after MI who received standard medications. However, this conclusion is tempered by the nonadherence rate. PRIMARY FUNDING SOURCE: National Institutes of Health.


Subject(s)
Cardiovascular Diseases/prevention & control , Dietary Supplements , Minerals/therapeutic use , Myocardial Infarction/complications , Vitamins/therapeutic use , Administration, Oral , Aged , Angina Pectoris/prevention & control , Cause of Death , Coronary Artery Disease/complications , Coronary Artery Disease/prevention & control , Dietary Supplements/adverse effects , Double-Blind Method , Female , Humans , Infusions, Intravenous , Male , Medication Adherence , Middle Aged , Minerals/administration & dosage , Minerals/adverse effects , Myocardial Infarction/prevention & control , Patient Dropouts , Secondary Prevention , Stroke/prevention & control , Vitamins/administration & dosage , Vitamins/adverse effects
17.
Herz ; 37(1): 85-96, 2012 Feb.
Article in German | MEDLINE | ID: mdl-22331062

ABSTRACT

The main treatment goals of conservative treatment of patients with stable coronary heart disease are prevention of symptoms, prevention of myocardial infarction, and heart failure and reduction of mortality. Lifestyle changes (smoking cessation, physical activity) are essential to reduce risk factors. For symptomatic treatment and prevention of angina pectoris, beta-blockers, calcium channel blockers, nitrates, I((f)) (funny channel) blockers and ranolazine are effective. Cornerstones of pharmacological prevention are drugs with prognostic effects, specifically aspirin and statins, as well as treatment of co-existing disorders such as hypertension and diabetes.


Subject(s)
Coronary Disease/rehabilitation , Acetanilides/adverse effects , Acetanilides/therapeutic use , Adrenergic beta-Antagonists/adverse effects , Adrenergic beta-Antagonists/therapeutic use , Angina Pectoris/prevention & control , Calcium Channel Blockers/adverse effects , Calcium Channel Blockers/therapeutic use , Combined Modality Therapy , Coronary Disease/diagnosis , Drug Incompatibility , Enzyme Inhibitors/adverse effects , Enzyme Inhibitors/therapeutic use , Heart Failure/diagnosis , Heart Failure/prevention & control , Heart Rate/drug effects , Humans , Life Style , Myocardial Infarction/diagnosis , Myocardial Infarction/prevention & control , Myocardial Revascularization , Nitrates/adverse effects , Nitrates/therapeutic use , Piperazines/adverse effects , Piperazines/therapeutic use , Ranolazine , Treatment Outcome
19.
REME rev. min. enferm ; 14(4): 577-586, out.-dez. 2010.
Article in Portuguese | LILACS, BDENF - Nursing | ID: lil-590338

ABSTRACT

Uma das atribuições do enfermeiro é prestar assistência global ao paciente, com vista à promoção e à recuperação da saúde nas esferas física, mental e emocional. No tratamento da angina estável, essa abordagem é essencial. Sua terapêutica requer um cuidado amplo e contínuo na busca da estabilidade clínica e da melhora da qualidade de vidado paciente. A inserção da acupuntura, que reduz o estresse, a ansiedade e aumenta o bem-estar físico e emocional, é uma alternativa. Pesquisas científicas demonstram que sua ação no organismo induz a liberação de neurotransmissores que atuam no tônus vascular e nas doenças cardiovasculares, como a angina pectóris. O objetivo com este estudo foi identificar as relações da acupuntura com os cuidados do enfermeiro-acupunturista ao paciente com angina estável,buscando uma correlação entre o tratamento tradicional e complementar para essa patologia. Espera-se, também,contribuir para a reflexão dos profissionais de saúde, em especial do enfermeiro-acupunturista, sobre as novas perspectivas de tratamento da angina estável. Trata-se de uma revisão teórica realizada em bancos de dados do BVS,LILACS, SCIELO, BIREME e MEDLINE, com quinze artigos, sete livros, uma tese, quatro manuais e uma resolução. Em face dos resultados obtidos e da abordagem terapêutica integral da acupuntura, foi possível associá-la aos cuidados do enfermeiro no campo da integralidade da atenção. A inserção da acupuntura nos cuidados do enfermeiro requer capacitação para sua aplicação.


One of the nurse’s attributions is to give global assistance to the patient, having in mind the promotion and recovery of their physical, mental and emotional health. This approach is essential when treating stable angina pectoris. Its therapeutic requires a wide and continuous care that aims to maintain clinical stability and improve the patient’s quality of life. An alternative is the use of acupuncture to reduce stress and anxiety and to increase emotional and physical well being. Scientific researches demonstrate that this therapy encourages the release of neurotransmitters that act in the vascular tone and cardiovascular illnesses such as angina pectoris. This study tries to identify the relationship between the acupuncture practiced by an acupuncturist nurse and the patient with stable angina and attempts an association between the traditional and complementary treatments to this pathology. It also aims to make a contribution to the discussion and reflection of health professionals specially the acupuncturist nurses, about the perspectives of the new treatment to the stable angina. It is a theoretical review paper performed on BVS, LILACS, SCIELO, BIREME and MEDLINE,with fifteen articles, seven books, a thesis, four manuals and a resolution. According to the obtained results and the acupuncture integral therapeutic approach, it was possible to associate this treatment to the nursing care in the field of the integral medical care. Introducing acupuncture therapy into the nursing care requires qualification.


Una de las atribuciones del enfermero es ofrecer atención integral al paciente con el objeto de promover y recuperar su salud física, mental y emocional. Tal enfoque es esencial en el tratamiento de la angina estable. Su terapéutica exige cuidados amplios y continuos con miras a mantener la estabilidad clínica y mejorar la calidad de vida del paciente.La inserción de la acupuntura, que disminuye el estrés y la ansiedad y aumenta el bienestar físico y emocional, es una alternativa. Investigaciones científicas demuestran que su acción sobre el organismo induce a la liberación deneurotransmisores que actúan en el sistema cardiovascular y en enfermedades como la angina de pecho. El objetivo de este trabajo ha sido identificar las relaciones de la acupuntura con los cuidados del enfermero acupuntor al pacientecon angina estable, buscando la relación entre el tratamiento tradicional y el complementario para esta patología.Además, se espera contribuir a la reflexión de los profesionales de salud, en especial del enfermero acupuntor, sobre las nuevas perspectivas del tratamiento de la angina estable. Se trata de una revisión teórica de quince artículos, siete libros, una tesina, cuatro manuales y una resolución realizada en bancos de datos de BVS, LILACS, SCIELO, BIREME y MEDLINE. Como consecuencia de los resultados obtenidos y del enfoque terapéutico integral de la acupuntura, se laha podido asociar a los cuidados del enfermero en el campo de la integralidad de la atención. Se requiere capacitación para aplicar la acupuntura dentro de los cuidados del enfermero.


Subject(s)
Humans , Angina Pectoris/nursing , Angina Pectoris/prevention & control , Comprehensive Health Care , Nursing Care , Acupuncture Therapy/nursing , Complementary Therapies
20.
Vasc Health Risk Manag ; 6: 749-74, 2010 Sep 07.
Article in English | MEDLINE | ID: mdl-20859545

ABSTRACT

The objectives in treating angina are relief of pain and prevention of disease progression through risk reduction. Mechanisms, indications, clinical forms, doses, and side effects of the traditional antianginal agents - nitrates, ß-blockers, and calcium channel blockers - are reviewed. A number of patients have contraindications or remain unrelieved from anginal discomfort with these drugs. Among newer alternatives, ranolazine, recently approved in the United States, indirectly prevents the intracellular calcium overload involved in cardiac ischemia and is a welcome addition to available treatments. None, however, are disease-modifying agents. Two options for refractory angina, enhanced external counterpulsation and spinal cord stimulation (SCS), are presented in detail. They are both well-studied and are effective means of treating at least some patients with this perplexing form of angina. Traditional modifiable risk factors for coronary artery disease (CAD) - smoking, hypertension, dyslipidemia, diabetes, and obesity - account for most of the population-attributable risk. Individual therapy of high-risk patients differs from population-wide efforts to prevent risk factors from appearing or reducing their severity, in order to lower the national burden of disease. Current American College of Cardiology/American Heart Association guidelines to lower risk in patients with chronic angina are reviewed. The Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial showed that in patients with stable angina, optimal medical therapy alone and percutaneous coronary intervention (PCI) with medical therapy were equal in preventing myocardial infarction and death. The integration of COURAGE results into current practice is discussed. For patients who are unstable, with very high risk, with left main coronary artery lesions, in whom medical therapy fails, and in those with acute coronary syndromes, PCI is indicated. Asymptomatic patients with CAD and those with stable angina may defer intervention without additional risk to see if they will improve on optimum medical therapy. For many patients, coronary artery bypass surgery offers the best opportunity for relieving angina, reducing the need for additional revascularization procedures and improving survival. Optimal medical therapy, percutaneous coronary intervention, and surgery are not competing therapies, but are complementary and form a continuum, each filling an important evidence-based need in modern comprehensive management.


Subject(s)
Angina Pectoris/therapy , Myocardial Revascularization , Vasodilator Agents/therapeutic use , Adrenergic beta-Antagonists/adverse effects , Adrenergic beta-Antagonists/therapeutic use , Angina Pectoris/drug therapy , Angina Pectoris/prevention & control , Angina Pectoris/surgery , Calcium Channel Blockers/therapeutic use , Female , Health Behavior , Humans , Male , Nitrates/therapeutic use , Primary Prevention , Risk Factors , Treatment Failure
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