scholarly journals Is the SMART approach better than other treatment approaches for prevention of asthma exacerbations? A meta-analysis

2016 ◽  
Vol 71 (4) ◽  
Author(s):  
R. Agarwal ◽  
A. Khan ◽  
A.N. Aggarwal ◽  
D. Gupta
Keyword(s):  
Adverse Events ◽  
Inhaled Corticosteroids ◽  
Meta Analysis ◽  
Group Versus ◽  
Medical Intervention ◽  
Fixed Dose ◽  
Control Group ◽  
Severe Exacerbation ◽  
Asthma Exacerbations ◽  
Statistical Heterogeneity

Background and Aims. The combination of inhaled corticosteroids (ICS) and long-acting β2 agonists (LABA) has been used as a single inhaler both for maintenance and reliever therapy in asthma, the SMART approach. The administration of additional CS with each reliever inhalation in response to symptoms is expected to provide better control of airway inflammation. The aim of this meta-analysis was to evaluate the efficacy and safety of the SMART approach versus other approaches in the management of asthma in preventing asthma exacerbations. Methods. We searched the MEDLINE and EMBASE databases for studies that have reported exacerbations in the SMART group versus the control group. We calculated the odds ratio (OR) and 95% confidence intervals (CI) to assess the exacerbations in the two groups and pooled the results using a random-effects model. Results. Our search yielded eight studies. The use of SMART approach compared to fixed-dose ICS-LABA combination significantly decreased the odds of a severe exacerbation (OR 0.65; 95% CI, 0.53-0.80) and severe exacerbation requiring hospitalization/ER treatment (OR 0.69; 95% CI, 058- 0.83). The use of SMART approach compared to fixed-dose ICS also significantly decreased the odds of a severe exacerbation (OR 0.52; 95% CI, 0.45-0.61) and severe exacerbation requiring medical intervention (OR 0.52; 95% CI, 0.42-0.65). The occurrence of adverse events was similar in the two groups. There was some evidence of statistical heterogeneity. Conclusions. The SMART approach using formoterol- budesonide is superior in preventing exacerbations when compared to traditional therapy with fixed dose ICS or ICS-LABA combination without any increase in adverse events.

scholarly journals Efficacy and safety of IL-6 inhibitors in patients with COVID-19 pneumonia: a systematic review and meta-analysis of multicentre, randomized trials

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Alessandro Belletti ◽  
Corrado Campochiaro ◽  
Marilena Marmiere ◽  
Valery Likhvantsev ◽  
Andrey Yavorovskiy ◽  
...  
Keyword(s):  
Adverse Events ◽  
Randomized Trials ◽  
Primary Outcome ◽  
Meta Analysis ◽  
Group Versus ◽  
Control Group ◽  
Open Label ◽  
Secondary Infections ◽  
All Cause Mortality

Abstract Purpose COVID-19 is characterized by dysregulated immune response, respiratory failure and a relevant mortality rate among hospitalized patients. Interleukin-6 (IL-6) is involved in COVID-19-associated cytokine storm, and several trials investigated whether its inhibition could improve patients’ outcome. We performed a meta-analysis of randomized trials (RCT) to test this hypothesis. Materials and methods Two independent investigators searched PubMed, Scopus, ClnicalTrials.gov and medRxiv up to September 1st, 2021. Inclusion criteria were: administration of tocilizumab or sarilumab; COVID-19 adult patients with pneumonia; and being a RCT. Primary outcome was mortality at the longest follow-up. Secondary outcomes included intubation rate and incidence of adverse events. Two independent investigators extracted data from eligible trials. Results Of the 763 studies assessed, 15 RCTs were included (9,320 patients), all were multicentre, and the majority open-label vs standard treatment. IL-6 inhibitors were associated with reduced all-cause mortality at the longest follow-up (1315/5,380 [24.4%] in the IL-6 inhibitors group versus 1080/3,814 [28.3%] in the control group, RR = 0.90; 95% CI 0.84 to 0.96; p for effect = 0.003, I2 = 0%, with 13 studies included), with reduction in 28/30-day mortality and intubation rates, and with no increase in adverse events and secondary infections. Conclusion IL-6 inhibitors reduced longest follow-up mortality and intubation in COVID-19 patients. Findings need to be confirmed in high-quality RCTs.

scholarly journals Coenzyme Q10 supplementation for prophylaxis in adult patients with migraine—a meta-analysis

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e039358
Author(s):  
Suhairul Sazali ◽  
Salziyan Badrin ◽  
Mohd Noor Norhayati ◽  
Nur Suhaila Idris
Keyword(s):  
Random Effects ◽  
Coenzyme Q10 ◽  
Migraine Headache ◽  
Meta Analysis ◽  
Adult Patients ◽  
Control Group ◽  
Cochrane Central Register ◽  
Statistical Heterogeneity ◽  
Coq10 Supplementation ◽  
The Impact

ObjectiveTo determine the effects of coenzyme Q10 (CoQ10) for reduction in the severity, frequency of migraine attacks and duration of headache in adult patients with migraine.DesignSystematic review and meta-analysis.Data sourcesCochrane Central Register of Controlled Trials, CENTRAL, MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Psychological Information Database (PsycINFO) from inception till December 2019.Study selectionAll randomised control trials comparing CoQ10 with placebo or used as an adjunct treatment included in this meta-analysis. Cross-over designs and controlled clinical trials were excluded.Data synthesisHeterogeneity at face value by comparing populations, settings, interventions and outcomes were measured and statistical heterogeneity was assessed by means of the I2 statistic. The treatment effect for dichotomous outcomes were using risk ratios and risk difference, and for continuous outcomes, mean differences (MDs) or standardised mean difference; both with 95% CIs were used. Subgroup analyses were carried out for dosage of CoQ10 and if CoQ10 combined with another supplementation. Sensitivity analysis was used to investigate the impact risk of bias for sequence generation and allocation concealment of included studies.ResultsSix studies with a total of 371 participants were included in the meta-analysis. There is no statistically significant reduction in severity of migraine headache with CoQ10 supplementation. CoQ10 supplementation reduced the duration of headache attacks compared with the control group (MD: −0.19; 95% CI: −0.27 to −0.11; random effects; I2 statistic=0%; p<0.00001). CoQ10 usage reduced the frequency of migraine headache compared with the control group (MD: −1.52; 95% CI: −2.40 to −0.65; random effects; I2 statistic=0%; p<0.001).ConclusionCoQ10 appears to have beneficial effects in reducing duration and frequency of migraine attack.PROSPERO registration numberCRD42019126127.

Pharmacological Treatment of Osteoporosis in Elderly People: A Systematic Review and Meta-Analysis

Gerontology ◽  
2021 ◽  
pp. 1-11
Author(s):  
Qin-Yi Wang ◽  
Na Ding ◽  
Yi-He Dong ◽  
Zhang-Xin Wen ◽  
Rong Chen ◽  
...  
Keyword(s):  
Adverse Events ◽  
Elderly Patients ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Anabolic Agents ◽  
Double Blind ◽  
Antiresorptive Agents ◽  
Statistical Heterogeneity ◽  
Post Hoc

<b><i>Background:</i></b> The evidence supporting the use of antiresorptive and anabolic agents for fracture prevention in elderly patients is still inconclusive. Whether it is too late to alter the course of the disease in this age-group has remained uncertain. <b><i>Objectives:</i></b> The objective of this study was to determine the efficacy and safety of antiresorptive and anabolic agents in elderly patients. <b><i>Methods:</i></b> PubMed, Web of Science, MEDLINE, and the Cochrane Central Register of Controlled Trials were searched for randomized controlled trials (RCTs) and post hoc analyses of RCTs reporting efficacy outcomes or adverse events of antiresorptive and anabolic agents in elderly patients. Statistical heterogeneity was assessed with the Cochran <i>Q</i> χ<sup>2</sup> test and <i>I</i><sup>2</sup> statistic. All results were expressed as relative risk (RR) with 95% confidence intervals (CIs). <b><i>Results:</i></b> The meta-analysis included 1 RCT and 11 post hoc analyses of data from 10 double-blind placebo-controlled RCTs. Antiresorptive therapy significantly reduced the pooled incidence of vertebral fractures (RR = 0.43; 95% CI = 0.35–0.53; and <i>p</i> &#x3c; 0.001). It was also associated with lower risk of nonvertebral and hip fractures (RR = 0.84; 95% CI = 0.74–0.96; and <i>p</i> = 0.009 and RR = 0.75; 95% CI = 0.58–0.97; and <i>p</i> = 0.028, respectively). For any adverse events, no difference was observed between antiresorptive agents and placebo groups (RR = 1.01; 95% CI = 1.00–1.02; and <i>p</i> = 0.23). <b><i>Conclusions:</i></b> Both antiresorptive and anabolic agents represented potentially important osteoporosis treatments, showing significant effects on reducing vertebral, nonvertebral, or hip fracture risk, and were well-tolerated by elderly patients. Even in the elderly, maybe it is not too late to alter the course of the disease.

scholarly journals Effectiveness of Body Psychotherapy. A Systematic Review and Meta-Analysis

2021 ◽  
Vol 12 ◽  
Author(s):  
Sophie Rosendahl ◽  
Heribert Sattel ◽  
Claas Lahmann
Keyword(s):  
Wide Spectrum ◽  
Meta Analysis ◽  
Control Group ◽  
Medium Effects ◽  
Body Psychotherapy ◽  
Randomized Controlled ◽  
Statistical Heterogeneity ◽  
Degree Of Control ◽  
Established Treatment ◽  
Significant Statistical Heterogeneity

Despite the growing relevance and applicability of elements based on and derived from the embodied mind paradigm, body psychotherapy (BPT) appears not to be a well-established treatment option. This might be due to a lack of proof for its efficacy. We searched electronic databases (Pubmed MEDLINE, PsycInfo, and PSYNDEX) for randomized controlled trials (RCTs) examining predefined BPT interventions. A total of 2,180 references were screened, of which 113 studies were scrutinized in detail and 18 RCTs finally included. The observed effect size (ES) demonstrated medium effects of BPT on primary outcomes psychopathology and psychological distress. In case of significant statistical heterogeneity, exploratory subgroup analyses revealed diagnosis and the degree of control group activity as noteworthy moderators. For secondary outcomes, evidence was scarce, and an improvement could be demonstrated only for coping abilities. The identified evidence indicates that BPT is beneficial for a wide spectrum of psychic suffering. There is a strong need for high-quality studies with bigger samples and for well-defined diagnostic entities to underpin its effectiveness.

scholarly journals Nervous and Muscular Adverse Events after COVID-19 Vaccination: A Systematic Review and Meta-Analysis of Clinical Trials

Vaccines ◽  
2021 ◽  
Vol 9 (8) ◽  
pp. 939
Author(s):  
Jiaxin Chen ◽  
Yuangui Cai ◽  
Yicong Chen ◽  
Anthony P. Williams ◽  
Yifang Gao ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Adverse Events ◽  
Fixed Effects ◽  
Meta Analysis ◽  
Phase 1 ◽  
Cochrane Library ◽  
Categorical Variables ◽  
Control Group ◽  
Open Label

Background: Nervous and muscular adverse events (NMAEs) have garnered considerable attention after the vaccination against coronavirus disease (COVID-19). However, the incidences of NMAEs remain unclear. We aimed to calculate the pooled event rate of NMAEs after COVID-19 vaccination. Methods: A systematic review and meta-analysis of clinical trials on the incidences of NMAEs after COVID-19 vaccination was conducted. The PubMed, Medline, Embase, Cochrane Library, and Chinese National Knowledge Infrastructure databases were searched from inception to 2 June 2021. Two independent reviewers selected the study and extracted the data. Categorical variables were analyzed using Pearson’s chi-square test. The pooled odds ratio (OR) with the corresponding 95% confidence intervals (CIs) were estimated and generated with random or fixed effects models. The protocol of the present study was registered on PROSPERO (CRD42021240450). Results: In 15 phase 1/2 trials, NMAEs occurred in 29.2% vs. 21.6% (p < 0.001) vaccinated participants and controls. Headache and myalgia accounted for 98.2% and 97.7%, and their incidences were 16.4% vs. 13.9% (OR = 1.97, 95% CI = 1.28–3.06, p = 0.002) and 16.0% vs. 7.9% (OR = 3.31, 95% CI = 2.05–5.35, p < 0.001) in the vaccine and control groups, respectively. Headache and myalgia were more frequent in the newly licensed vaccines (OR = 1.97, 95% CI = 1.28–3.06, p = 0.02 and OR = 3.31, 95% CI = 2.05–5.35, p < 0.001) and younger adults (OR = 1.40, 95% CI = 1.12–1.75, p = 0.003 and OR = 1.54, 95% CI = 1.20–1.96, p < 0.001). In four open-label trials, the incidences of headache, myalgia, and unsolicited NMAEs were 38.7%, 27.4%, and 1.5%. Following vaccination in phase 3 trials, headache and myalgia were still common with a rate of 29.5% and 19.2%, although the unsolicited NMAEs with incidence rates of ≤ 0.7% were not different from the control group in each study. Conclusions: Following the vaccination, NMAEs are common of which headache and myalgia comprised a considerable measure, although life-threatening unsolicited events are rare. NMAEs should be continuously monitored during the ongoing global COVID-19 vaccination program.

scholarly journals Oral immunotherapy for IgE-mediated cow’s milk allergy in children: a systematic review and meta-analysis

2021 ◽  
Author(s):  
Lujing Tang ◽  
Yu Yu ◽  
Xiangyuan Pu ◽  
Jie Chen
Keyword(s):  
Meta Analysis ◽  
Oral Immunotherapy ◽  
Cow’S Milk Allergy ◽  
Cow’S Milk ◽  
Control Group ◽  
Milk Allergy ◽  
Cow's Milk ◽  
Cow's Milk Allergy ◽  
Statistical Heterogeneity ◽  
Ige Mediated

Background: Cow’s milk allergy(CMA) is the most common allergy in infants that decreases the quality of life of patients and their families. Standard treatment for CMA is the strict avoidance of milk, new treatment strategies such as oral immunotherapy (OIT) have been sought for patients with CMA . We aimed to assess the clinical efficacy and safety of OIT in the treatment of children with IgE-mediated cow’s milk allergy (IMCMA). Methods: We searched all randomized controlled trials (RCTs) in which OIT is used to treat children with IMCMA from 5 international electronic databases. We estimated a pooled relative ratio (RR) for each outcome using a Mantel-Haenzel fixed-effect model if statistical heterogeneity was low. Results: Eleven studies were chosen for meta-analysis, including a total of 469 children (242 OIT, 227 control). 176 patients (72.7%) in the OIT were desensitized compared to 49 patients in the control group (RR 7.35, 95%CI 2.82-19.13, p<0.0001). The desensitization effect of OIT was particularly significant in children over 3 years old (RR 18.05, 95%CI 6.48-50.26, p<0.00001). Although adverse effects were common, they usually involved mild reactions, but epinephrine use was more common in the OIT group (RR 7.69, 95%CI 2.16-27.33, p<0.002). Conclusion: OIT can lead to desensitization in the majority of individuals with IMCMA, especially in patients over 3-years old. A major problem of OIT is the frequency of adverse events, although most are mild. OIT may be an alternative treatment in the future.

Triple therapy in uncontrolled asthma: a network meta-analysis of Phase III studies

2021 ◽  
pp. 2004233
Author(s):  
Paola Rogliani ◽  
Beatrice Ludovica Ritondo ◽  
Luigino Calzetta
Keyword(s):  
Meta Analysis ◽  
Phase Iii ◽  
Fixed Dose ◽  
High Dose ◽  
Severe Exacerbation ◽  
Triple Combination ◽  
Combination Therapies ◽  
Uncontrolled Asthma ◽  
Long Acting ◽  
The Impact

Conflicting evidence is currently available concerning the impact on asthma exacerbation of triple inhaled corticosteroid (ICS), long-acting β2-adrenoceptor agonist (LABA), and long-acting muscarinic receptor antagonist (LAMA) fixed-dose combination (FDC). Since meta-analyses allow settling controversies of apparently inconsistent results, we performed a network meta-analysis of Phase III randomised controlled trials including 9535 patients to assess the effect of ICS/LABA/LAMA combinations in uncontrolled asthma. Triple combination therapies with an ICS administered at high dose (HD) were more effective (p<0.05) than medium dose (MD) ICS/LABA/LAMA FDC and both MD and HD ICS/LABA FDCs against moderate to severe exacerbation (relative risk [RR] from 0.61 to 0.80) and increasing trough forced expiratory volume in the 1st second (mL from +33 to +114). Triple combination therapies including HD ICS were superior (p<0.05) than MD ICS/LABA/LAMA FDC in preventing severe exacerbation (RR from 0.46 to 0.65), but not with respect to moderate exacerbation (p>0.05). Triple combination therapies were equally effective on asthma control, with no safety concerns. This quantitative synthesis suggests that ICS/LABA/LAMA FDCs are effective and safe in uncontrolled asthma, and that the dose of ICS in the combination represents the discriminating factor to treat patients with a history of moderate or severe exacerbation.

scholarly journals Effect of Maternal Postpartum and Infant Intermittent Vitamin D Supplementation on Infant Vitamin D Status: A Systematic Review and Meta-Analysis of Trials (P11-089-19)

2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
Karen O'Callaghan ◽  
Mahgol Taghivand ◽  
Anna Zuchniak ◽  
Akpevwe Onoyovwi ◽  
Jill Korsiak ◽  
...  
Keyword(s):  
Vitamin D ◽  
Meta Analysis ◽  
Vitamin D Supplementation ◽  
Small Sample ◽  
Risk Of Bias ◽  
World Health ◽  
Control Group ◽  
Cochrane Central Register ◽  
Vitamin D Status ◽  
Statistical Heterogeneity

Abstract Objectives To determine the response of infant (≤ 1 year) circulating 25-hydroxyvitamin D (25(OH)D) to maternal postpartum or infant intermittent vitamin D supplementation in comparison to current recommendations of direct daily oral infant supplementation (400 IU/d). Methods MEDLINE, MEDLINE In-Process, Embase, the Cochrane Database of Systematic Reviews, and the Cochrane Central Register of Controlled Trials were searched up to December 4th 2018. A systematic search of online trial registries for unpublished, ongoing, or planned trials was also completed. Risk of bias was assessed using the Cochrane Risk Assessment Tool. Meta-analysis was limited to trials with a control group of infants receiving 400 IU vitamin D/d. A weighted mean difference (WMD) and 95% confidence interval (CI) was generated using infant 25(OH)D as a continuous outcome. Random-effects models accounted for within- and between-study variability. Statistical heterogeneity was quantified with the I2 statistic. Results A total of 28 trials were included, representing data from all 6 World Health Organization world regions. Of the 25 trials that specified a calciferol form, the majority (88%) employed vitamin D3. Six trials (21%) had an overall low risk of bias. Six trials qualified for meta-analysis, stratified by maternal (n = 4) and infant (n = 2) administration. Maternal supplementation resulted in a modestly lower infant vitamin D status than daily infant supplementation (WMD =-7.3 nmol/L; 95% CI: -14.0 to -0.6; I2 = 37%, P = 0.17). Comparison of infant intermittent bolus dosing to daily supplementation was limited by a small sample size and substantial heterogeneity, resulting in a wide CI (WMD = 10.2 nmol/L; 95% CI: -42.9 to 63.3; I2 = 96%, P < 0.001). Safety outcomes, including effects on calcium homeostasis, were inconsistently reported. Four ongoing trials were identified as potential contributors to future reviews. Conclusions Evidence to support the use of specific alternative maternal or infant regimens to substitute for current daily infant vitamin D supplementation is weak and inconsistent. Dose-ranging, adequately powered trials are required to establish the efficacy and safety of feasible alternative strategies to prevent infant vitamin D deficiency Funding Sources SickKids C-GCH Growth and Development Fellowship.

Corticosteroid as an Adjunct in the Treatment of Endobronchial Tuberculosis: A Systematic Review & Meta-analysis

2020 ◽  
Vol 16 (1) ◽  
pp. 53-60
Author(s):  
Nihar R. Mishra ◽  
Manoj K. Panigrahi ◽  
Girish C. Bhatt ◽  
Rashmi R. Das
Keyword(s):  
Adverse Events ◽  
Meta Analysis ◽  
Intervention Group ◽  
Oral Prednisolone ◽  
Oral Steroid ◽  
Control Group ◽  
Eligibility Criteria ◽  
Steroid Group ◽  
Significant Difference ◽  
Endobronchial Tuberculosis

Background: Corticosteroid exerts anti-inflammatory action and can prevent tissue damage resulting from various causes. Studies have shown that corticosteroids may prevent the damaging effect of tuberculosis (TB) in various organs, but there is no published meta-analysis specifically looking for the effect of corticosteroid in endobronchial TB. Objective: To synthesize the evidence regarding the usefulness of corticosteroid in endo-bronchial TB. Methods: A comprehensive search was performed of the major electronic databases till 30th November 2018. Randomized trials comparing treatment with corticosteroid as an adjunct to antitubercular drugs (ATT) versus placebo/no treatment in endobronchial TB were included. Three authors independently applied eligibility criteria, assessed the studies for methodological quality, and extracted data. The review is registered at PROSPERO database [CRD42016047063]. Results: Out of 525 search results, 4 trials including 205 patients (151 children) were eligible for inclusion. Oral prednisolone was used in various dose schedules. Rifampicin containing ATT regimen was used in 3 trials. The bronchoscopy findings showed no significant improvement at 1 month (effect size could not be calculated due to 0 event in the intervention group, p = 0.05), 2 months (RR 1.26, 95% CI 0.89 to 1.8), and at completion of ATT (RR 0.63, 95% CI 0.1 to 4.14) in steroid-treated group compared to the control group. The need for repeat bronchoscopy was significantly decreased in the steroid group (RR 0.13, 95% CI 0.02 to 0.9). Among the adverse events, the infection rate was significantly lesser in the steroid group (RR 0.53, 95% CI 0.29 to 0.97); but other adverse events (mortality, hypertension, and abdominal distension) showed no significant difference between the two groups. The GRADE evidence generated was of very low quality. Conclusions: The present meta-analysis showed that oral steroid does not help patients with endobronchial tuberculosis. However, the quality of evidence was very low. Future trials with robust design and a larger sample size would be required to provide any firm recommendation regarding the use of oral prednisolone in endobronchial tuberculosis.

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