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The Cochrane Database of Systematic... Dec 2015Sudden cardiac death (SCD) is one of the main causes of cardiac death. There are two main strategies to prevent it: managing cardiovascular risk factors and reducing the... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Sudden cardiac death (SCD) is one of the main causes of cardiac death. There are two main strategies to prevent it: managing cardiovascular risk factors and reducing the risk of ventricular arrhythmias. Implantable cardiac defibrillators (ICDs) constitute the standard therapy for both primary and secondary prevention; however, they are not widely available in settings with limited resources. The antiarrhythmic amiodarone has been proposed as an alternative to ICD.
OBJECTIVES
To evaluate the effectiveness of amiodarone for primary or secondary prevention in SCD compared with placebo or no intervention or any other antiarrhythmic drugs in participants at high risk (primary prevention) or who have recovered from a cardiac arrest or a syncope due to Ventricular Tachycardia/Ventricular Fibrillation, or VT/VF (secondary prevention).
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (OVID), EMBASE (OVID), CINAHL (EBSCO) and LILACS on 26 March 2015. We reviewed reference lists of included studies and selected reviews on the topic, contacted authors of included studies, screened relevant meetings and searched in registers for ongoing trials. We applied no language restrictions.
SELECTION CRITERIA
Randomised and quasi-randomised trials assessing the efficacy of amiodarone versus placebo, no intervention, or other antiarrhythmics in adults. For primary prevention we considered participants at high risk for SCD. For secondary prevention we considered participants recovered from cardiac arrest or syncope due to ventricular arrhythmias.
DATA COLLECTION AND ANALYSIS
Two authors independently assessed the trials for inclusion and extracted relevant data. We contacted trial authors for missing data. We performed meta-analyses using a random-effects model. We calculated risk ratios (RR) for dichotomous outcomes with 95% confidence intervals (CIs). Three studies included more than one comparison.
MAIN RESULTS
We included 24 studies (9,997 participants). Seventeen studies evaluated amiodarone for primary prevention and six for secondary prevention. Only three studies used an ICD concomitantly with amiodarone for the comparison (all of them for secondary prevention).For primary prevention, amiodarone compared to placebo or no intervention (17 studies, 8383 participants) reduced SCD (RR 0.76; 95% CI 0.66 to 0.88), cardiac mortality (RR 0.86; 95% CI 0.77 to 0.96) and all-cause mortality (RR 0.88; 95% CI 0.78 to 1.00). The quality of the evidence was low.Compared to other antiarrhythmics (three studies, 540 participants), amiodarone reduced SCD (RR 0.44; 95% CI 0.19 to 1.00), cardiac mortality (RR 0.41; 95% CI 0.20 to 0.86) and all-cause mortality (RR 0.37; 95% CI 0.18 to 0.76). The quality of the evidence was moderate.For secondary prevention, amiodarone compared to placebo or no intervention (two studies, 440 participants) appeared to increase the risk of SCD (RR 4.32; 95% CI 0.87 to 21.49) and all-cause mortality (RR 3.05; 1.33 to 7.01). However, the quality of the evidence was very low. Compared to other antiarrhythmics (four studies, 839 participants) amiodarone appeared to increase the risk of SCD (RR 1.40; 95% CI 0.56 to 3.52; very low quality of evidence), but there was no effect in all-cause mortality (RR 1.03; 95% CI 0.75 to 1.42; low quality evidence).Amiodarone was associated with an increase in pulmonary and thyroid adverse events.
AUTHORS' CONCLUSIONS
There is low to moderate quality evidence that amiodarone reduces SCD, cardiac and all-cause mortality when compared to placebo or no intervention for primary prevention, and its effects are superior to other antiarrhythmics.It is uncertain if amiodarone reduces or increases SCD and mortality for secondary prevention because the quality of the evidence was very low.
Topics: Adult; Amiodarone; Anti-Arrhythmia Agents; Cause of Death; Death, Sudden, Cardiac; Humans; Primary Prevention; Randomized Controlled Trials as Topic; Secondary Prevention; Vasodilator Agents
PubMed: 26646017
DOI: 10.1002/14651858.CD008093.pub2 -
Cureus Sep 2023Paroxysmal supraventricular arrhythmias are a group of common rhythm disturbances that are often prevalent, frequently recurrent, sporadic, and life-threatening. These... (Review)
Review
Paroxysmal supraventricular arrhythmias are a group of common rhythm disturbances that are often prevalent, frequently recurrent, sporadic, and life-threatening. These arrhythmias are precipitated by factors such as age, sex, and associated comorbidities. Typically, patients with paroxysmal arrhythmias are asymptomatic during evaluation, and the condition is often detected incidentally. Symptoms associated with these arrhythmias include palpitations, fatigue, light-headedness, chest discomfort, dyspnea, presyncope, and, less commonly, polyuria and serious psychological distress. In terms of treatment, common modalities include antiarrhythmic drug therapy and catheter ablation. When selecting drug therapy, factors such as comorbidities, patient-specific modifiers, preferences, follow-up frequency, and cost-effectiveness are taken into account. For long-term treatment, calcium channel blockers are often used instead of adenosine, while adenosine is preferred for acute attacks due to its higher efficacy. Comparatively, adenosine and verapamil are commonly used drugs in the emergency setting to treat paroxysmal supraventricular tachycardia (PSVT). Adenosine exhibits a faster onset of action, but adverse effects occur more commonly, whereas verapamil has a slower onset of action and a lower incidence of adverse effects. We searched for articles from PubMed, PubMed Central (PMC), and Science Direct, and these articles were reviewed systematically. After applying the search strategy to these databases, 195 articles were identified. Fourteen of these were finalized for review. The efficacy of adenosine versus verapamil in terminating acute attacks of PSVT is reviewed in our article.
PubMed: 37885520
DOI: 10.7759/cureus.45946 -
Academic Emergency Medicine : Official... Apr 2022Ruptured abdominal aortic aneurysm (rAAA) is a life-threatening condition, and rapid diagnosis is necessary to facilitate early surgical intervention. We sought to... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
Ruptured abdominal aortic aneurysm (rAAA) is a life-threatening condition, and rapid diagnosis is necessary to facilitate early surgical intervention. We sought to evaluate the accuracy of presenting symptoms, physical examination signs, computed tomography with angiography (CTA), and point-of-care ultrasound (PoCUS) for diagnosis of rAAA.
METHODS
We searched six databases from inception through April 2021. We included studies investigating the accuracy of any of the above tests for diagnosis of rAAA. The primary reference standard used in all studies was intraoperative diagnosis or death from rAAA. Because PoCUS cannot detect rupture, we secondarily assessed its accuracy for the diagnosis of AAA, using the reference standard of intraoperative or CTA diagnosis. We used GRADE to assess certainty in estimates.
RESULTS
We included 20 studies (2,077 patients), with 11 of these evaluating signs and symptoms, seven evaluating CTA, and five evaluating PoCUS. Pooled sensitivities of abdominal pain, back pain, and syncope for rAAA were 61.7%, 53.6%, and 27.8%, respectively (low certainty). Pooled sensitivity of hypotension and pulsatile abdominal mass were 30.9% and 47.1%, respectively (low certainty). CTA had a sensitivity of 91.4% and specificity of 93.6% for diagnosis of rAAA (moderate certainty). In our secondary analysis, PoCUS had a sensitivity of 97.8% and specificity of 97.0% for diagnosing AAA in patients suspected of having rAAA (moderate certainty).
CONCLUSIONS
Classic clinical symptoms associated with rAAA have poor sensitivity, and their absence does not rule out the condition. CTA has reasonable accuracy, but misses some cases of rAAA. PoCUS is a valuable tool that can help guide the need for urgent transfer to a vascular center in patients suspected of having rAAA.
Topics: Aortic Aneurysm, Abdominal; Aortic Rupture; Humans; Physical Examination; Tomography, X-Ray Computed; Ultrasonography
PubMed: 35220634
DOI: 10.1111/acem.14475 -
Frontiers in Oncology 2022Traditionally, early phase clinical trials in oncology have been performed in patients based on safety risk-benefit assessment. Therapeutic transition to immuno-oncology...
AIM
Traditionally, early phase clinical trials in oncology have been performed in patients based on safety risk-benefit assessment. Therapeutic transition to immuno-oncology may open new opportunities for studies in healthy volunteers, which are conducted faster and are less susceptible to confounders. Aim of this study was to investigate to what extent this approach is utilized and whether pharmacodynamic endpoints are evaluated in these early phase trials. We conducted a comprehensive review of clinical trials with healthy volunteers using immunotherapies potentially relevant for oncology.
METHODS
Literature searches according to PRISMA guidelines and after registration in PROSPERO were conducted in PubMed, Embase, Web of Science and Cochrane databases with the cut-off date 20 October 2020, using search terms of relevant targets in immuno-oncology. Articles describing clinical trials with immunotherapeutics in healthy volunteers with a mechanism relevant for oncology were included. "Immunotherapeutic" was defined as compounds exhibiting effects through immunological targets. Data including study design and endpoints were extracted, with specific attention to pharmacodynamic endpoints and safety.
RESULTS
In total, we found 38 relevant immunotherapeutic compounds tested in HVs, with 86% of studies investigating safety, 82% investigating the pharmacokinetics (PK) and 57% including at least one pharmacodynamic (PD) endpoint. Most of the observed adverse events (AEs) were Grade 1 and 2, consisting mostly of gastrointestinal, cutaneous and flu-like symptoms. Severe AEs were leukopenia, asthenia, syncope, headache, flu-like reaction and liver enzymes increase. PD endpoints investigated comprised of cytokines, immune and inflammatory biomarkers, cell counts, phenotyping circulating immune cells and challenge assays.
DISCUSSION
Healthy volunteer studies with immuno-oncology compounds have been performed, although not to a large extent. The integration of healthy volunteers in well-designed proof-of-mechanism oriented drug development programs has advantages and could be pursued more in the future, since integrative clinical trial protocols may facilitate early dose selection and prevent cancer patients to be exposed to non-therapeutic dosing regimens.
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=210861, identifier CRD42020210861.
PubMed: 36106110
DOI: 10.3389/fonc.2022.954806 -
Medicine Jul 2016Inconsistent results have been reported about the risk stratification of patients with Brugada syndrome. We have summarized the evidence regarding the strength of... (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION
Inconsistent results have been reported about the risk stratification of patients with Brugada syndrome. We have summarized the evidence regarding the strength of association between 6 risk factors (family history of sudden cardiac death [SCD] or syncope, inducible ventricular arrhythmias on electrophysiology study [EPS], spontaneous type 1 Brugada electrocardiogram [ECG], male sex, family history of SCD, and sodium voltage-gated channel alpha subunit 5 [SCN5A] gene mutation) and subsequent cardiac events in Brugada syndrome patients.
METHODS
Pubmed, Ovid, Embase, and the Cochrane Library were searched for studies published between January 1992 and March 2016. Only prospective studies (27 studies, 4494 patients) that reported estimates with 95% confidence intervals (CIs) of cardiac events for the 6 risk factors were included.
RESULTS
Family history of SCD or syncope (risk ratio [RR] 4.97, 95% CI 3.96-6.23, P < 0.001), inducible ventricular arrhythmia on EPS (RR 3.56, 95% CI 1.30-9.74, P = 0.01), and spontaneous type 1 Brugada ECG (RR 4.07, 95% CI 2.23-7.41, P < 0.001) were associated with an increased risk of future cardiac events. Spontaneous type 1 Brugada ECG was associated with an elevated risk of future cardiac events in patients without a family history of SCD.
CONCLUSIONS
Inducible ventricular arrhythmias on EPS, spontaneous type 1 Brugada ECG, and family history of SCD or syncope indicate a high risk of future cardiac events in patients with Brugada syndrome. Spontaneous type 1 Brugada ECG significantly increased the risk of future cardiac events in patients without family history of SCD.
Topics: Brugada Syndrome; Electrocardiography; Genetic Predisposition to Disease; Humans; Mutation; NAV1.5 Voltage-Gated Sodium Channel; Risk Assessment; Risk Factors; Sex Factors; Syncope; Ventricular Fibrillation
PubMed: 27472692
DOI: 10.1097/MD.0000000000004214 -
International Journal of Cardiology.... Mar 2021Initial orthostatic hypotension is a clinically relevant syndrome in older adults which has been associated with symptoms of orthostatic intolerance. The aim of this... (Review)
Review
BACKGROUND
Initial orthostatic hypotension is a clinically relevant syndrome in older adults which has been associated with symptoms of orthostatic intolerance. The aim of this systematic review was to determine the prevalence of orthostatic intolerance symptoms in older adults with initial orthostatic hypotension.
METHODS
MEDLINE (from 1946), EMBASE (from 1974) and Cochrane were searched to December 6th 2019 using the terms "initial orthostatic hypotension", "postural hypotension" and "older adults". Study selection involved the following criteria: published in English; mean or median age 65 years and diagnosis of initial orthostatic hypotension encompassed a decrease in systolic blood pressure by ≥ 40 mmHg and/or diastolic blood pressure by ≥ 20 mmHg within a maximum of 1 min following a postural change.
RESULTS
Of 8311 articles, 12 articles reporting initial orthostatic hypotension prevalence in 3446 participants with a mean age of 75 (6 SD) years (56.5% female) were included. Five initial orthostatic hypotension definition variations were utilised and symptoms were reported in six articles (968 participants, mean age 73.4 (6.1 SD) years, 56% female). The prevalence of symptoms in older adults with initial orthostatic hypotension ranged from 24 to 100% and was dependent on variations in timing or the inclusion of symptoms in the initial orthostatic hypotension definition.
CONCLUSIONS
Where orthostatic intolerance symptoms were reported, a large proportion of older adults with a diagnosis of initial orthostatic hypotension were symptomatic. However, the literature on initial orthostatic hypotension and orthostatic intolerance symptoms is scarce and a variety of definitions of initial orthostatic hypotension are utilised.
PubMed: 33884364
DOI: 10.1016/j.ijchy.2020.100071 -
JMIR MHealth and UHealth Apr 2021Atrial fibrillation (AF) is the most common arrhythmia, and its prevalence is increasing. Early diagnosis is important to reduce the risk of stroke. Mobile health... (Review)
Review
BACKGROUND
Atrial fibrillation (AF) is the most common arrhythmia, and its prevalence is increasing. Early diagnosis is important to reduce the risk of stroke. Mobile health (mHealth) devices, such as single-lead electrocardiogram (ECG) devices, have been introduced to the worldwide consumer market over the past decade. Recent studies have assessed the usability of these devices for detection of AF, but it remains unclear if the use of mHealth devices leads to a higher AF detection rate.
OBJECTIVE
The goal of the research was to conduct a systematic review of the diagnostic detection rate of AF by mHealth devices compared with traditional outpatient follow-up. Study participants were aged 16 years or older and had an increased risk for an arrhythmia and an indication for ECG follow-up-for instance, after catheter ablation or presentation to the emergency department with palpitations or (near) syncope. The intervention was the use of an mHealth device, defined as a novel device for the diagnosis of rhythm disturbances, either a handheld electronic device or a patch-like device worn on the patient's chest. Control was standard (traditional) outpatient care, defined as follow-up via general practitioner or regular outpatient clinic visits with a standard 12-lead ECG or Holter monitoring. The main outcome measures were the odds ratio (OR) of AF detection rates.
METHODS
Two reviewers screened the search results, extracted data, and performed a risk of bias assessment. A heterogeneity analysis was performed, forest plot made to summarize the results of the individual studies, and albatross plot made to allow the P values to be interpreted in the context of the study sample size.
RESULTS
A total of 3384 articles were identified after a database search, and 14 studies with a 4617 study participants were selected. All studies but one showed a higher AF detection rate in the mHealth group compared with the control group (OR 1.00-35.71), with all RCTs showing statistically significant increases of AF detection (OR 1.54-19.16). Statistical heterogeneity between studies was considerable, with a Q of 34.1 and an I of 61.9, and therefore it was decided to not pool the results into a meta-analysis.
CONCLUSIONS
Although the results of 13 of 14 studies support the effectiveness of mHealth interventions compared with standard care, study results could not be pooled due to considerable clinical and statistical heterogeneity. However, smartphone-connectable ECG devices provide patients with the ability to document a rhythm disturbance more easily than with standard care, which may increase empowerment and engagement with regard to their illness. Clinicians must beware of overdiagnosis of AF, as it is not yet clear when an mHealth-detected episode of AF must be deemed significant.
Topics: Adolescent; Atrial Fibrillation; Cost-Benefit Analysis; Electrocardiography; Humans; Stroke; Telemedicine
PubMed: 33908885
DOI: 10.2196/26161 -
Integrative Medicine Research Jun 2024Post-viral olfactory dysfunction (PVOD) is the common symptoms of long COVID, lacking of effective treatments. Traditional Chinese medicine (TCM) is claimed to be... (Review)
Review
BACKGROUND
Post-viral olfactory dysfunction (PVOD) is the common symptoms of long COVID, lacking of effective treatments. Traditional Chinese medicine (TCM) is claimed to be effective in treating olfactory dysfunction, but the evidence has not yet been critically appraised. We conducted a systematic review to evaluate the effectiveness and safety of TCM for PVOD.
METHODS
We searched eight databases to identified clinical controlled studies about TCM for PVOD. The Cochrane risk of bias tools and GRADE were used to evaluate the quality of evidence. Risk ratio (RR), mean differences (MD), and 95 % confidence interval (CI), were used for effect estimation and RevMan 5.4.1 was used for data analysis.
RESULTS
Six randomized controlled trials (RCTs) (545 participants), two non-randomized controlled trials (non-RCTs) (112 participants), and one retrospective cohort study (30 participants) were included. The overall quality of included studies was low. Acupuncture ( = 8) and acupoint injection ( = 3) were the mainly used TCM therapies. Five RCTs showed a better effect in TCM group. Four trials used acupuncture, and three trials used acupoint injection. The results of two non-RCTs and one cohort study were not statistically significant. Two trials reported mild to moderate adverse events (pain and brief syncope caused by acupuncture or acupoint injection).
CONCLUSIONS
Limited evidence focus on acupuncture and acupoint injection for PVOD and suggests that acupuncture and acupoint injection may be effective in improving PVOD. More well-designed trials should focus on acupuncture to confirm the benefit.
PROTOCOL REGISTRATION
The protocol of this review was registered at PROSPERO: CRD42022366776.
PubMed: 38831890
DOI: 10.1016/j.imr.2024.101045 -
The Cochrane Database of Systematic... Aug 2018Short-stay units are hospital units that provide short-term care for selected patients. Studies have indicated that short-stay units might reduce admission rates, time... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Short-stay units are hospital units that provide short-term care for selected patients. Studies have indicated that short-stay units might reduce admission rates, time of hospital stays, hospital readmissions and expenditure without compromising the quality of care. Short-stay units are often defined by a target patient category, a target function, and a target time frame. Hypothetically, short-stay units could be established as part of any department, but this review focuses on short-stay units that provide care for participants with internal medicine diseases and conditions.
OBJECTIVES
To assess beneficial and harmful effects of short-stay unit hospitalisation compared with usual care in people with internal medicine diseases and conditions.
SEARCH METHODS
We searched CENTRAL, MEDLINE, Embase, three other databases and two trials registers up to 13 December 2017 together with reference checking, citation searching and contact with study authors to identify additional studies. We also searched several grey literature sources and performed a forward citation search for included studies.
SELECTION CRITERIA
We included randomised trials and cluster-randomised trials, comparing hospitalisation in a short-stay unit with usual care (hospitalisation in a traditional hospital ward or other services). We defined a short-stay unit to be a hospital ward where the targeted length of stay in hospital for patients was five days or less. We included both multipurpose and specialised short-stay units. Participants were adults admitted to hospital with an internal medicine disease or condition. We excluded surgical, obstetric, psychiatric, gynaecological, and ambulatory participants. Trials were included irrespective of publication status, date, and language.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane. Two review authors independently extracted data and assessed the risk of bias of each included trial. We measured intervention effect sizes by meta-analyses for two primary outcomes, mortality and serious adverse events, and one secondary outcome, hospital readmission. We narratively reported the following important outcomes: quality of life, activities of daily living, non-serious adverse events, and costs. We used risk ratio differences of 15% for mortality and of 20% for serious adverse events for minimal relevant clinical consideration. We rated the certainty of the evidence and the strength of recommendations of the outcomes using the GRADE approach.
MAIN RESULTS
We included 19 records reporting on 14 randomised trials with a total of 2872 participants. One trial was ongoing. Thirteen trials evaluated short-stay unit hospitalisation for six specific conditions (acute decompensated heart failure (one trial), asthma (one trial), atrial fibrillation (one trial), chest pain (seven trials), syncope (two trials), and transient ischaemic attack (one trial)) and one trial investigated participants presenting with miscellaneous internal medicine disease and conditions. The components of the intervention differed among the trials as dictated by the trial participants' condition. All included trials were at high risk of bias.The certainty of the evidence for all outcomes was very low. Consequently, it is uncertain whether hospitalisation in short-stay units compared with usual care reduces mortality (risk ratio (RR) 0.73, 95% confidence interval (CI) 0.47 to 1.15) 5 trials (seven additional trials reporting on 1299 participants reported no deaths in either group)); serious adverse events (RR 0.95, 95% CI 0.59 to 1.54; 7 trials (one additional trial with 108 participants reported no serious adverse events in either group)), and hospital readmission (RR 0.80, 95% CI 0.54 to 1.19, 8 trials (one additional trial with 424 participants did not report results for participants)). There was not enough information to confirm or refute that short-stay unit hospitalisation had relevant effects on quality of life, activities of daily living, non-serious adverse events, and costs.
AUTHORS' CONCLUSIONS
Overall, the quantity and the certainty of the evidence was very low. Consequently, it is uncertain whether there are any beneficial or harmful effects of short-stay unit hospitalisation for adults with internal medicine diseases and conditions - more trials comparing the effects of short-stay units with usual care are needed. Such trials ought to be conducted with low risk of bias and low risks of random errors to improve the overall confidence in the evidence.
Topics: Activities of Daily Living; Adult; Asthma; Atrial Fibrillation; Chest Pain; Heart Failure; Hospital Mortality; Hospital Units; Humans; Internal Medicine; Ischemic Attack, Transient; Length of Stay; Patient Readmission; Quality of Life; Randomized Controlled Trials as Topic; Syncope; Time Factors
PubMed: 30102428
DOI: 10.1002/14651858.CD012370.pub2 -
Seizure Oct 2018Transient loss of consciousness (TLOC) is a common presentation in primary care. Over 90% of these are due to epileptic seizures (ES), syncope, or psychogenic... (Review)
Review
BACKGROUND
Transient loss of consciousness (TLOC) is a common presentation in primary care. Over 90% of these are due to epileptic seizures (ES), syncope, or psychogenic non-epileptic seizures (PNES). Misdiagnosis rates are as high as 30%.
METHODS
Systematic review of inter-ictal clinical criteria to aid differential diagnosis of TLOC. We searched Medline, EMBASE, CINAHL and PsycInfo databases, as well as relevant grey literature depositories and citations of relevant reviews and guidelines for studies giving sensitivity and specificity of inter-ictal clinical characteristics used to differentiate between causes of TLOC. Two independent reviewers selected studies for inclusion and performed critical appraisal of included articles. We performed a narrative synthesis of included studies.
RESULTS
Of 1023 results, 16 papers were included. Two compared syncope, ES, and PNES; all others compared ES and PNES. All were at significant risk of bias in at least one domain. 6 studied patient symptoms, 6 medical and social history, 3 witness reports and 1 examination findings. No individual criterion differentiated between diagnoses with high sensitivity and specificity.
CONCLUSIONS
There is a lack of validated diagnostic criteria to help clinicians assessing patients in primary or emergency care settings to discriminate between common causes of TLOC. Performance may be improved by combining sets of criteria in a clinical decision rule, but no such rule has been validated prospectively against gold-standard diagnostic criteria.
Topics: Databases, Factual; Diagnosis, Differential; Electroencephalography; Epilepsy; Humans; Syncope; Unconsciousness
PubMed: 30145472
DOI: 10.1016/j.seizure.2018.08.012