PREvention of VENous Thromboembolism in Hemorrhagic Stroke Patients – PREVENTIHS Study: A Randomized Controlled Trial and a Systematic Review and Meta-Analysis

2020 ◽  
pp. 1-10
Author(s):  
Maurizio Paciaroni ◽  
Giancarlo Agnelli ◽  
Andrea Alberti ◽  
Cecilia Becattini ◽  
Francesco Guercini ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Randomized Clinical Trials ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Recruitment Rate ◽  
Control Group ◽  
Level Of Evidence ◽  
Hematoma Enlargement ◽  
Number Of Patients ◽  
Enoxaparin Group

<b><i>Background:</i></b> In this randomized trial, currently utilized standard treatments were compared with enoxaparin for the prevention of venous thromboembolism (VTE) in patients with intracerebral hemorrhage (ICH). <b><i>Methods:</i></b> Enoxaparin (0.4 mg daily for 10 days) was started after 72 h from the onset of ICH. The primary outcome was symptomatic or asymptomatic deep venous thrombosis as assessed by ultrasound at the end of study treatment. The safety of enoxaparin was also assessed. We included the results of this study in a meta-analysis of all relevant studies comparing anticoagulants with standard treatments or placebo. <b><i>Results:</i></b> PREVENTIHS was prematurely stopped after the randomization of 73 patients, due to the low recruitment rate. The prevalence of any VTE at 10 days was 15.8% in the enoxaparin group and 20.0% in the control group (RR 0.79 [95% CI 0.29–2.12]); 2.6% of enoxaparin and 8.6% of standard therapy patients had severe bleedings (RR 0.31 [95% CI 0.03–2.82]). When these results were meta-analyzed with the results of the selected studies (4,609 patients; 194 from randomized trials), anticoagulants were associated with a nonsignificant reduction in any VTE (OR 0.81; 95% CI 0.43–1.51), in pulmonary embolism (OR 0.53; 95% CI, 0.17–1.60), and in mortality (OR 0.85; 95% CI 0.64–1.12) without increase in hematoma enlargement (OR 0.97; 95% CI, 0.31–3.04). <b><i>Conclusions:</i></b> In patients with acute ICH, the use of anticoagulants to prevent VTE was safe but the overall level of evidence was low due to the low number of patients included in randomized clinical trials.

scholarly journals Percutaneous surgery in the treatment of Haglund syndrome

2020 ◽  
Vol 14 (3) ◽  
pp. 285-292
Author(s):  
Marília Gomes ◽  
Gabriel Monteiro ◽  
José Arteiro Neto
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Minimally Invasive ◽  
Success Rate ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Percutaneous Surgery ◽  
Level Of Evidence ◽  
Number Of Patients ◽  
The Mean

Objective: The present study aimed to verify the state of the art of minimally invasive percutaneous surgical treatment for Haglund syndrome. Methods: This systematic review of the literature was based on a bibliographic survey in the PubMed, Medline and Embase databases. The descriptors "Haglund syndrome", "Haglund", "Achilles", "Minimally invasive", "Percutaneous surgery" and "Osteotomy" were used, in addition to the filters "Randomized Controlled Trial", "Randomized Clinical Trial", "Meta-Analysis", "Systematic Reviews", "Reviews", and "Clinical Trial". Results: A total of 37 articles were included. The total number of patients with Haglund syndrome treated in the included studies was 831 and 920. The mean patient age was 46.6 years (range, 28.7 to 61) and 58% were men. A higher success rate and a lower rate of complications were reported in men, and physically active patients had better treatment results. The mean success rate for minimally invasive percutaneous procedures was 83.4% (range 66 to 100%). Overall patient satisfaction was 77.5% (range 60 to 95%) and the complication rate was 6.3% (range 0 to 23%). Conclusion: Despite a lack of studies with the recommended evidence level, minimally invasive and percutaneous surgical treatments seem to be a good option for patients with Haglund syndrome when conservative treatment fails. Level of Evidence III; Therapeutic Studies; Systematic Review of Level III Studies.

A Systematic Review and Meta-Analysis about the Effect of Bisphosphonates on the Risk of Skeletal-Related Event in Men with Prostate Cancer

2020 ◽  
Vol 20 (13) ◽  
pp. 1604-1612
Author(s):  
Congcong Wu ◽  
Hua Jiang ◽  
Jianghua Chen
Keyword(s):  
Prostate Cancer ◽  
Fixed Effects ◽  
Data Extraction ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Control Group ◽  
Fixed Effects Model ◽  
Related Event ◽  
Mineral Density ◽  
Skeletal Related Event

Background: Although the adjuvant therapy of bisphosphonates in prostate cancer is effective in improving bone mineral density, it is still uncertain whether bisphosphonates could decrease the risk of Skeletal- Related Event (SRE) in patients with prostate cancer. We reviewed and analyzed the effect of different types of bisphosphonates on the risk of SRE, defined as pathological fracture, spinal cord compression, radiation therapy to the bone, surgery to bone, hypercalcemia, bone pain, or death as a result of prostate cancer. Methods: A systemic literature search was conducted on PubMed and related bibliographies. The emphasis during data extraction was laid on the Hazard Ratio (HR) and the corresponding 95% Confidence Interval (CI) from every eligible Randomized Controlled Trial (RCT). HR was pooled with the fixed effects model, and preplanned subgroup analyses were performed. Results: 5 RCTs (n = 4651) were included and analyzed finally after screening 51 articles. The meta-analysis of all participants showed no significant decrease in the risk of SRE when adding bisphosphonates to control group (HR = 0.968, 95% CI = 0.874 - 1.072, p = 0.536) with low heterogeneity (I2 = 0.0% (d.f. = 4) p = 0.679). There was no significant improvement on SRE neither in the subgroups with Metastases (M1) or Castration-Sensitive Prostate Cancer (CSPC) (respectively HR = 0.968, 95% CI = 0.874 - 1.072, p = 0.536, I2 = 0.0% (d.f. = 4) p = 0.679; HR = 0.954, 95% CI = 0.837 - 1.088, p = 0.484, I2 = 0.0% (d.f. = 3) p = 0.534). Conclusion: Our study demonstrated that bisphosphonates could not statistically significantly reduce the risk of SRE in patients with prostate cancer, neither in the subgroups with M1 or CSPC.

scholarly journals Sofosbuvir with daclatasvir and the outcomes of patients with COVID-19: a systematic review and meta-analysis with GRADE assessment

2021 ◽  
pp. postgradmedj-2021-140287
Author(s):  
Ahmad Fariz Malvi Zamzam Zein ◽  
Catur Setiya Sulistiyana ◽  
Wilson Matthew Raffaello ◽  
Arief Wibowo ◽  
Raymond Pranata
Keyword(s):  
Systematic Review ◽  
Absolute Risk ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Invasive Mechanical Ventilation ◽  
Intervention Group ◽  
Control Group ◽  
Reduce Mortality Rate ◽  
Icu Admission ◽  
Clinical Recovery

PurposeThis systematic review and meta-analysis aimed to evaluate the effect of sofosbuvir/daclatasvir (SOF/DCV) on mortality, the need for intensive care unit (ICU) admission or invasive mechanical ventilation (IMV) and clinical recovery in patients with COVID-19.MethodsWe performed a systematic literature search through the PubMed, Scopus and Embase from the inception of databases until 6 April 2021. The intervention group was SOF/DCV, and the control group was standard of care. The primary outcome was mortality, defined as clinically validated death. The secondary outcomes were (1) the need for ICU admission or IMV and (2) clinical recovery. The pooled effect estimates were reported as risk ratios (RRs).ResultsThere were four studies with a total of 231 patients in this meta-analysis. Three studies were randomised controlled trial, and one study was non-randomised. SOF/DCV was associated with lower mortality (RR: 0.31 (0.12, 0.78); p=0.013; I2: 0%) and reduced need for ICU admission or IMV (RR: 0.35 (0.18, 0.69); p=0.002; I2: 0%). Clinical recovery was achieved more frequently in the SOF/DCV (RR: 1.20 (1.04, 1.37); p=0.011; I2: 21.1%). There was a moderate certainty of evidence for mortality and need for ICU/IMV outcome, and a low certainty of evidence for clinical recovery. The absolute risk reductions were 140 fewer per 1000 for mortality and 186 fewer per 1000 for the need for ICU/IMV. The increase in clinical recovery was 146 more per 1000.ConclusionSOF/DCV may reduce mortality rate and need for ICU/IMV in patients with COVID-19 while increasing the chance for clinical recovery.Protocol registrationPROSPERO: CRD42021247510.

scholarly journals A Collaborative Deprescribing Intervention in a Subacute Medical Outpatient Clinic: A Pilot Randomized Controlled Trial

Metabolites ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. 204
Author(s):  
Anissa Aharaz ◽  
Jens Henning Rasmussen ◽  
Helle Bach Ølgaard McNulty ◽  
Arne Cyron ◽  
Pia Keinicke Fabricius ◽  
...  
Keyword(s):  
Pilot Study ◽  
Controlled Trial ◽  
Inappropriate Medication ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Patient Interviews ◽  
Number Of Patients ◽  
Multimorbid Patients ◽  
And Control

Medication deprescribing is essential to prevent inappropriate medication use in multimorbid patients. However, experience of deprescribing in Danish Subacute Medical Outpatient Clinics (SMOCs) is limited. The objective of our pilot study was to evaluate the feasibility and sustainability of a collaborative deprescribing intervention by a pharmacist and a physician to multimorbid patients in a SMOC. A randomized controlled pilot study was conducted, with phone follow-up at 30 and 365+ days. A senior pharmacist performed a systematic deprescribing intervention using the Screening Tool of Older Persons’ potentially inappropriate Prescriptions (STOPP) criteria, the Danish deprescribing list, and patient interviews. A senior physician received the proposed recommendations and decided which should be implemented. The main outcome was the number of patients having ≥1 medication where deprescribing status was sustained 30 days after inclusion. Out of 76 eligible patients, 72 (95%) were included and 67 (93%) completed the study (57% male; mean age 73 years; mean number of 10 prescribed medications). Nineteen patients (56%) in the intervention group and four (12%) in the control group had ≥1 medication where deprescribing status was sustained 30 days after inclusion (p = 0.015). In total, 37 medications were deprescribed in the intervention group and five in the control group. At 365+ days after inclusion, 97% and 100% of the deprescribed medications were sustained in the intervention and control groups, respectively. The three most frequently deprescribed medication groups were analgesics, cardiovascular, and gastrointestinal medications. In conclusion, a collaborative deprescribing intervention for multimorbid patients was feasible and resulted in sustainable deprescribing of medication in a SMOC.

scholarly journals Feasibility Aspects of Exploring Exercise-Induced Neuroplasticity in Parkinson’s Disease: A Pilot Randomized Controlled Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-12 ◽  
Author(s):  
Hanna Johansson ◽  
Malin Freidle ◽  
Urban Ekman ◽  
Ellika Schalling ◽  
Breiffni Leavy ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Dual Task ◽  
Trial Design ◽  
Controlled Trial ◽  
Recruitment Rate ◽  
Blood Sampling ◽  
Assessment Process ◽  
Control Group ◽  
Exercise Induced

Background. Recent studies indicate that exercise can induce neuroplastic changes in people with Parkinson’s disease (PwPD). Reports of feasibility outcomes from existing pilot trials however are, of date, insufficient to enable replication by others in larger definitive trials. Objective. To evaluate trial design for a definitive trial by exploring process and scientific feasibility. Methods. The trial design was a parallel-group RCT pilot with a 1 : 1 allocation ratio to either HiBalance or an active control group (HiCommunication). Both groups received one-hour sessions twice weekly, plus home exercises weekly, for 10 weeks. Participants with mild-to-moderate Parkinson’s disease (PD) were recruited via advertisement. Assessment included physical performance, structural and functional MRI, blood sampling, neuropsychological assessment, and speech/voice assessment. Process and scientific feasibility were monitored throughout the study. Process feasibility involved recruitment, participant acceptability of assessments and interventions, assessment procedures (focus on imaging, blood sampling, and dual-task gait analysis), and blinding procedures. Scientific feasibility involved trends in outcome response and safety during group training and home exercises. Data are presented in median, minimum, and maximum values. Changes from pre- to postintervention are reported descriptively. Results. Thirteen participants were included (4 women, mean age 69.7 years), with a recruitment rate of 31%. Attendance rates and follow-up questionnaires indicated that both groups were acceptable to participate. Image quality was acceptable; however, diplopia and/or sleepiness were observed in several participants during MRI. With regard to dual-task gait performance, there appeared to be a ceiling effect of the cognitive tasks with seven participants scoring all correct answers at pretest. Blinding of group allocation was successful for one assessor but was broken for half of participants for the other. Conclusions. The overall trial design proved feasible to perform, but further strengthening ahead of the definitive RCT is recommended, specifically with respect to MRI setup, cognitive dual-tasks during gait, and blinding procedures. This trial is registered with NCT03213873.

scholarly journals The Use of a Synthetic Cartilage Implant for Hallux Rigidus

2018 ◽  
Vol 3 (3) ◽  
pp. 2473011418S0045
Author(s):  
Niall Smyth ◽  
Jonathan Kaplan ◽  
Amiethab Aiyer
Keyword(s):  
Polyvinyl Alcohol ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Hallux Rigidus ◽  
Reference List ◽  
Great Toe ◽  
Level Of Evidence ◽  
High Level ◽  
Ability Measure

Category: Other Introduction/Purpose: Hallux rigidus is one of the most common pathologies afflicting the foot. Various joint salvage techniques have been described with a multitude of different implants. Recently, a synthetic cartilage implant composed of polyvinyl alcohol (PVA) received FDA premarket approval for treatment of arthritis of the great toe and has been used in over 4,000 cases. The purpose of this study was to systematically review the clinical evidence supporting the use of a PVA implant in hallux rigidus. Methods: A systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA). Using the terms “cartiva OR polyvinyl alcohol OR synthetic cartilage OR hemiarthroplasty AND hallux rigidus OR great toe arthritis OR first toe arthritis “ we searched the PubMed/Medline database in December 2017. In addition, the reference list of publications were scanned for further relevant studies. Results: 4 studies met the inclusion criteria, all of which were derived from a single randomized controlled trial. At short-term follow-up (2 years), patients undergoing placement of a PVA implant had significant improvement in Foot and Ankle Ability Measure (FAAM) sports and activity of daily living, as well as VAS pain scores. The outcomes of the surgery were found to be noninferior compared to arthrodesis. At intermediate follow-up (5 years), the improvement in clinical outcomes persisted and implant survivorship was 96%. Conclusion: There are limited studies available detailing the outcomes of a PVA implant for hallux rigidus, however the results that are available demonstrate a high level of evidence. There are no long-term publications assessing the outcomes of a PVA implant for hallux rigidus.

scholarly journals Systematic Review and Meta-Analysis of 16 Randomized Clinical Trials of Radix Astragali and Its Prescriptions for Diabetic Retinopathy

2013 ◽  
Vol 2013 ◽  
pp. 1-13 ◽  
Author(s):  
Lin Cheng ◽  
Gai Zhang ◽  
Yi Zhou ◽  
Xuejing Lu ◽  
Fuwen Zhang ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Diabetic Retinopathy ◽  
Methodological Quality ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Plasma Viscosity ◽  
Control Group ◽  
Radix Astragali ◽  
Manual Search ◽  
Computer Based

Objective. To evaluate the efficacy and safety of radix astragali and its prescriptions for diabetic retinopathy.Methods. A computer-based online and manual search was conducted for randomized controlled trials addressing radix astragali and its prescriptions for diabetic retinopathy.Results. 16 RCTs involving 977 subjects and 1586 eyes were identified. Meta-analysis indicated that the effect of radix astragali and its prescriptions in improving visual acuity and fundus manifestations, lowering FBG, TG, plasma viscosity, and RAI, was superior to that of control group (WMD or OR 0.20, 0.27, −0.26, −0.36, −0.93, −1.27; 95% CI [0.09, 0.30], [0.17, 0.40], [−0.51, 0.00], [−0.60, −0.12], [−1.67, −0.20], [−2.35, −0.19];P<0.05, resp.). In contrary, the efficacy of radix astragali and its prescriptions was not superior to those of control group in descending HbA1C and TC with WMD 0.45, −0.96 and 95% CI [−1.00, 1.90], [−2.19, 0.27],P>0.05, respectively. GRADE software suggested that the studies were of low methodological quality.Conclusion. Radix astragali and its prescriptions were superior to other treatments for diabetic retinopathy in terms of improving visual acuity and fundus manifestations, reducing FBG, TG, RAI, and plasma viscosity. The evaluated studies were of low methodological quality, indicating that the previous findings should be read with care.

scholarly journals USE OF FLUNARIZINE AS A PREVENTIVE FOR VESTIBULAR MIGRAINE CRISES IN COMPARISON WITH OTHER DRUGS: SYSTEMATIC LITERATURE REVIEW

2021 ◽  
Author(s):  
Lara Estupina Braghieri ◽  
Paula Lopes ◽  
Osmar Person ◽  
Fernando Junior ◽  
Priscila Bogar
Keyword(s):  
Literature Review ◽  
Systematic Literature Review ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Vestibular Migraine ◽  
Moderate Degree ◽  
Level Of Evidence ◽  
Grade Method ◽  
Episodic Vertigo ◽  
Preventive Drug

INTRODUCTION: Vestibular migraine is the main cause of episodic vertigo and the second most common cause of dizziness in adults. Treatment for vestibular migraine encompasses the prevention of crises and the control of acute symptoms. Flunarizine works by preventing the contraction of labyrinthine vessels and altering blood flow, thus preventing symptoms. Due to the high prevalence of the disease, its negative impacts on individual health and increased expenditure on public health, preventive pharmacological and non-pharmacological treatment must be implemented early. PURPOSE: To evaluate the efficacy of Flunarizine as a preventive for migraine and vestibular crises compared to other preventive drugs. MATERIAL AND METHODS: Scientific articles were searched in the databases using the terms (vestibular migraine OR migrainous vertigo) AND (flunarizine) AND (prophylaxis). Subsequently, a systematic literature review and meta-analysis was performed, including 3 randomized clinical trials comparing flunarizine and other preventive drugs in terms of efficacy and safety for preventing migraine vertigo attacks. The studies were analyzed using a ROB table, analysis using the GRADE method and meta-analysis. RESULTS: Qualitatively, the analysis showed that flunariniza was positive for decreasing the frequency of vertigo in cases of vestibular migraine, with a moderate degree of evidence, a relative risk of 0.34 and a confidence interval of 0.15 to 0.76. CONCLUSIONS: There are few studies available in the scientific literature on the use of flunarizine in vestibular migraine, many of which are heterogeneous among themselves, mainly in the way of evaluating and monitoring patients, carried out mainly through subjective methods. The meta-analysis showed a positive result for flunarizine as a preventive drug for the studied population. Furthermore, in all the studies analyzed, no serious side effects resulting from the use of the medication were reported, which makes it safe for patients to use. Flunarizine is a good drug for the prevention of vestibular migraine, especially in reducing the number of attacks, with a good level of evidence.

scholarly journals EFFICACY OF SPIRULINA FOR ALLERGIC RHINITIS

2021 ◽  
Author(s):  
Iury Gomes Batista ◽  
Osmar Cleyton Person ◽  
Fernando Veiga Angelico Junior ◽  
Priscila Bogar
Keyword(s):  
Clinical Trials ◽  
Allergic Rhinitis ◽  
Randomized Clinical Trials ◽  
Nasal Congestion ◽  
Control Group ◽  
Cochrane Central Register ◽  
Level Of Evidence ◽  
Runny Nose ◽  
Trial Quality ◽  
Central Register

Introduction: Allergic rhinitis is a condition of high prevalence in the population and widely studied, with several treatments being consecrated for its control. Spirulina is a dietary supplement that modulates immune function, and has been shown to modulate the inflammatory response of allergic rhinitis. Purpose: To evaluate spirulina in the treatment and control of allergic rhinitis. Material and Methods: This is a systematic review of randomized clinical trials. Searches were performed for randomized clinical trials relating spirulina to allergic rhinitis in five electronic databases: Cochrane - Central Register of Controlled Trials - CENTRAL (2021), PUBMED (1966-2021), EMBASE (1974-2021), LILACS (1982-2021) AND SCOPUS (2021). Two investigators independently extracted data and assessed trial quality. Results: Two clinical trials involving a total of 215 patients were included. Both studies assessed the efficacy of spirulina in improving allergic rhinitis as the primary outcome. The first study described a significant reduction in runny nose, nasal congestion and itching over time of medication use (p 0.001) and in the second study the prevalence of rhinorrhea (P = 0.021), nasal congestion or obstruction (P = 0.039) and decreased smell (P = 0.030) were significantly less in the experimental group than in the control group. Conclusions: The included studies were in favor of the use of spirrulina. However, the level of evidence is very low and limited. We should have caution due to the small number of clinical trials and participants in these studies. It is recommended to carry out new RCTs following the CONSORT standardization.

scholarly journals Design and analysis of a clinical trial using previous trials as historical control

2019 ◽  
Vol 16 (5) ◽  
pp. 531-538 ◽  
Author(s):  
David Alan Schoenfeld ◽  
Dianne M Finkelstein ◽  
Eric Macklin ◽  
Neta Zach ◽  
David L Ennist ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Amyotrophic Lateral Sclerosis ◽  
Sample Size ◽  
Standard Error ◽  
Controlled Trial ◽  
Sample Size Calculation ◽  
Control Group ◽  
Controlled Trials ◽  
Number Of Patients ◽  
Lateral Sclerosis

Background/AimsFor single arm trials, a treatment is evaluated by comparing an outcome estimate to historically reported outcome estimates. Such a historically controlled trial is often analyzed as if the estimates from previous trials were known without variation and there is no trial-to-trial variation in their estimands. We develop a test of treatment efficacy and sample size calculation for historically controlled trials that considers these sources of variation.MethodsWe fit a Bayesian hierarchical model, providing a sample from the posterior predictive distribution of the outcome estimand of a new trial, which, along with the standard error of the estimate, can be used to calculate the probability that the estimate exceeds a threshold. We then calculate criteria for statistical significance as a function of the standard error of the new trial and calculate sample size as a function of difference to be detected. We apply these methods to clinical trials for amyotrophic lateral sclerosis using data from the placebo groups of 16 trials.ResultsWe find that when attempting to detect the small to moderate effect sizes usually assumed in amyotrophic lateral sclerosis clinical trials, historically controlled trials would require a greater total number of patients than concurrently controlled trials, and only when an effect size is extraordinarily large is a historically controlled trial a reasonable alternative. We also show that utilizing patient level data for the prognostic covariates can reduce the sample size required for a historically controlled trial.ConclusionThis article quantifies when historically controlled trials would not provide any sample size advantage, despite dispensing with a control group.

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