scholarly journals Adverse events of exercise therapy in randomised controlled trials: a systematic review and meta-analysis

2019 ◽  
Vol 54 (18) ◽  
pp. 1073-1080 ◽  
Author(s):  
Andre Niemeijer ◽  
Hans Lund ◽  
Signe Nilssen Stafne ◽  
Thomas Ipsen ◽  
Cathrine Luhaäär Goldschmidt ◽  
...  
Keyword(s):  
Systematic Review ◽  
Relative Risk ◽  
Adverse Events ◽  
Exercise Therapy ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Control Group ◽  
Controlled Trials ◽  
Serious Adverse Events ◽  
Randomised Controlled

ObjectiveTo evaluate the relative risk (RR) of serious and non-serious adverse events in patients treated with exercise therapy compared with those in a non-exercising control group.DesignSystematic review and meta-analysis.Data sourcesPrimary studies were identified based on The Cochrane Database of Systematic Reviews investigating the effect of exercise therapy.Eligibility criteriaAt least two of the authors independently evaluated all identified reviews and primary studies. Randomised controlled trials were included if they compared any exercise therapy intervention with a non-exercising control. Two authors independently extracted data. The RR of serious and non-serious adverse events was estimated separately.Results180 Cochrane reviews were included and from these, 773 primary studies were identified. Of these, 378 studies (n=38 368 participants) reported serious adverse events and 375 studies (n=38 517 participants) reported non-serious adverse events. We found no increase in risk of serious adverse events (RR=0.96 (95%CI 0.90 to 1.02, I2: 0.0%) due to exercise therapy. There was, however, an increase in non-serious adverse events (RR=1.19 (95%CI 1.09 to 1.30, I2: 0.0%). The number needed to treat for an additional harmful outcome for non-serious adverse events was 6 [95%CI 4 to 11).ConclusionParticipating in an exercise intervention increased the relative risk of non-serious adverse events, but not of serious adverse events. Exercise therapy may therefore be recommended as a relatively safe intervention.PROSPERO registration numberCRD42014014819.

scholarly journals Intra-arterial anaesthetics for pain control in arterial embolisation procedures: a systematic review and meta-analysis

2021 ◽  
Vol 4 (1) ◽  
Author(s):  
Taha Hanif Shiwani ◽  
Hunain Shiwani
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Cohort Studies ◽  
Pain Control ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Serious Adverse Events ◽  
Arterial Embolisation ◽  
Randomised Controlled

Abstract Purpose A systematic review to determine the effectiveness of intra-arterial anaesthetics on post- operative pain and opioid analgesia requirements in arterial embolisation procedures. Materials and methods A systematic review of the literature was performed (Embase, PubMed, MEDLINE and the Cochrane Library) from inception to 10th August 2020. Randomised controlled trials (RCTs) and cohort studies that utilised intra-arterial anaesthesia during an embolisation procedure for the purposes of pain control were included. Eligibility was assessed by two investigators independently. Results Eight hundred fifty-nine candidate articles were identified, and 9 studies met the inclusion criteria (6 RCTs and 3 retrospective cohort studies). Four studies were of hepatic chemoembolisation and 5 were of uterine artery embolisation. Five hundred twenty-nine patients were treated in total. All studies used lidocaine as the anaesthetic with doses ranging from 20 to 200 mg, and the anaesthetic was delivered varyingly before, during or after embolisation. Pain intensity was converted to a numeric scale from 0 to 10, and opioid doses were converted to milligram morphine equivalent doses. A random-effects meta-analysis model was used to analyse the results of RCTs, and the results of cohort studies were summarised with a narrative synthesis. The meta-analyses suggested that pain scores were reduced by a mean of 1.02 (95% CI − 2.34 to 0.30; p = 0.13) and opioid doses were reduced by a mean of 7.35 mg (95% CI, − 14.77, 0.06; p = 0.05) in the intervention group however neither finding was statistically significant. No serious adverse events were reported. Conclusion Intra-arterial anaesthetic may slightly reduce pain intensity and post-operative opioid consumption following embolisation, however the results are not statistically significant. There is very limited data available on the effect of anaesthetic on length of hospital admission. Whilst no serious adverse events were reported, there are some concerns regarding the effect of lidocaine on the technical success of embolisation procedures that preclude our recommendation for routine use in embolisation procedures. High quality randomised controlled trials are required to elucidate the dose-response effect of lidocaine on opioid consumption and pain following embolisation, particularly in the first few hours post-operatively, as well as effects on duration of hospital stay.

scholarly journals Efficacy and safety of omalizumab in chronic rhinosinusitis with nasal polyps: a systematic review and meta-analysis of randomised controlled trials

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e047344
Author(s):  
Qingwu Wu ◽  
Lianxiong Yuan ◽  
Huijun Qiu ◽  
Xinyue Wang ◽  
Xuekun Huang ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Chronic Rhinosinusitis ◽  
Randomised Controlled Trials ◽  
Nasal Polyps ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomised Controlled

ObjectivesTo assess the efficacy and safety of omalizumab for chronic rhinosinusitis with nasal polyps (CRSwNP) and to identify evidence gaps that will guide future research on omalizumab for CRSwNP.DesignSystematic review and meta-analysis.Data sourcesA comprehensive search was performed in PubMed, Embase, Web of Science and the Cochrane Library on 13 October 2020.Eligibility criteriaRandomised controlled trials (RCTs) comparing omalizumab with placebo, given for at least 16 weeks in adult patients with CRSwNP.Data extraction and synthesisTwo independent authors screened search results, extracted data and assessed studies using the Cochrane risk of bias tool. Data were pooled using the inverse-variance method and expressed as mean differences (MDs) with 95% CIs. Heterogeneity was assessed by the χ2 test and the I2 statistic.ResultsA total of four RCTs involving 303 participants were identified. When comparing omalizumab to placebo, there was a significant difference in Nasal Polyps Score (MD=−1.20; 95% CI −1.48 to −0.92), Nasal Congestion Score (MD=−0.67; 95% CI −0.86 to −0.48), Sino-Nasal Outcome Test-22 (MD=−15.62; 95% CI −19.79 to −11.45), Total Nasal Symptom Score (MD=−1.84; 95% CI −2.43 to −1.25) and reduced need for surgery (risk ratio (RR)=5.61; 95% CI 1.99 to 15.81). Furthermore, there was no difference in the risk of serious adverse events ((RR=1.40; 95% CI 0.29 to 6.80), adverse events (RR=0.83; 95% CI 0.60 to 1.15) and rescue systemic corticosteroid (RR=0.52; 95% CI 0.17 to 1.61).ConclusionsThis was the first meta-analysis that identified omalizumab significantly improved endoscopic, clinical and patient-reported outcomes in adults with moderate to severe CRSwNP and it was safe and well tolerated.PROSPERO registration numberCRD42020207639.

scholarly journals Efficacy and safety of pirfenidone in the treatment of idiopathic pulmonary fibrosis patients: a systematic review and meta-analysis of randomised controlled trials

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e050004
Author(s):  
Wenjuan Wu ◽  
Lingxiao Qiu ◽  
Jizhen Wu ◽  
Xueya Liu ◽  
Guojun Zhang
Keyword(s):  
Systematic Review ◽  
Idiopathic Pulmonary Fibrosis ◽  
Pulmonary Fibrosis ◽  
Adverse Events ◽  
Acute Exacerbation ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomised Controlled

ObjectivesIdiopathic pulmonary fibrosis (IPF) has been defined as a distinctive type of chronic fibrotic disease, characterised by a progressive decline in lung function and a common histological pattern of interstitial pneumonia. To analyse the efficacy and safety of pirfenidone in the treatment of IPF, a systematic review and meta-analysis was performed.DesignThis is a meta-analysis study.ParticipantsPatients were diagnosed as IPF.InterventionsUse of pirfenidone.Primary and secondary outcomeProgression-free survival (PFS), acute exacerbation and worsening of IPF and Impact on adverse events.MeasuresThe inverse variance method for the random-effects model was used to summarise the dichotomous outcomes, risk ratios and 95% CIs.ResultsA total of 9 randomised controlled trials with 1011 participants receiving pirfenidone and 912 controls receiving placebo were summarised. The pooled result suggested a statistically significant difference inall-cause mortality after pirfenidone use, with a summarised relative ratio of 0.51 (p<0.01). Longer PFS was observed in patients receiving pirfenidone compared with those who were given placebo (p<0.01). The IPF groups presented a high incidence of adverse events with a pooled relative ratio of 3.89 (p<0.01).ConclusionsPirfenidone can provide survival benefit for patients with IPF. Pirfenidone treatment was also associated with a longer PFS, a lower incidence of acute exacerbation and worsening of IPF.

scholarly journals Respiratory syncytial virus prophylaxis for prevention of recurrent childhood wheeze and asthma: a systematic review

2020 ◽  
Vol 9 (1) ◽  
Author(s):  
Lauren Alexandra Quinn ◽  
Michael D. Shields ◽  
Ian Sinha ◽  
Helen E. Groves
Keyword(s):  
Systematic Review ◽  
Monoclonal Antibody ◽  
Relative Risk ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Group Analysis ◽  
Controlled Trials ◽  
Recurrent Wheeze ◽  
Syncytial Virus ◽  
Randomised Controlled

Abstract Background Acute bronchiolitis caused by respiratory syncytial virus (RSV) has been associated with greater risk of recurrent wheezing and asthma. However, it is unclear whether this association is causal. RSV-specific monoclonal antibodies have been shown to reduce RSV-related hospitalisations in high-risk infants, but the longer-term follow-up has given conflicting evidence for prevention of recurrent wheeze or asthma. Objective We performed a systematic review and meta-analysis to determine whether monoclonal antibody prophylaxis against RSV bronchiolitis reduces the risk of subsequent recurrent wheeze or asthma. If so, this may support the hypothesis of causality. Methods Studies were identified via an online database search using Embase, MEDLINE, PubMed, Web of Science and the Cochrane Library. Manufacturers of monoclonal antibodies were contacted directly for unpublished data. The intervention of interest was RSV monoclonal antibody prophylaxis, and the primary outcome measure was recurrent wheeze and/or asthma. Studies were screened according to inclusion/exclusion criteria. Included studies were evaluated for quality and assessed for bias independently by 3 reviewers using the ‘Grading of Recommendations Assessment, Development and Evaluation’ (GRADE) approach. Results were extracted into 2 × 2 outcome tables and a meta-analysis carried out producing forest plots based on relative risk. Heterogeneity was assessed using the I2 statistic. Results The search identified 141 articles, which, after screening, resulted in eight studies (2 randomised controlled trials), thus including 11,195 infants in the meta-analysis. The overall result demonstrated a non-statistically significant reduction in relative risk of developing recurrent wheeze or asthma (RR 0.60; 95% CI 0.31 to 1.16). Study quality was generally low with evidence of publication bias and statistical heterogeneity. However, sub-group analysis excluding studies deemed to be ‘very low’ quality showed a relative risk of 0.42 (95% CI 0.22 to 0.80, p = 0.008). A further sub-group analysis for infants aged 32 to < 36 weeks showed a statistically significant relative risk of 0.35 (95% CI 0.14 to 0.86, p = 0.02). Discussion We did not identify an overall statistically significant benefit. However, our two sub-group analyses did find statistically significant benefits of monoclonal antibody therapy on the risk of recurrent wheeze and asthma. The main limitation of this study is the lack of high-quality randomised controlled trials, highlighting the need for more research in this field.

scholarly journals Respiratory syncytial virus prophylaxis for prevention of recurrent childhood wheeze and asthma: a systematic review

2020 ◽  
Author(s):  
Lauren Quinn ◽  
Michael D Shields ◽  
Ian Sinha ◽  
Helen E Groves
Keyword(s):  
Systematic Review ◽  
Monoclonal Antibody ◽  
Relative Risk ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Group Analysis ◽  
Controlled Trials ◽  
Recurrent Wheeze ◽  
Syncytial Virus ◽  
Randomised Controlled

Abstract Background Acute bronchiolitis caused by Respiratory Syncytial Virus (RSV) has been associated with greater risk of recurrent wheezing and asthma. However, it is unclear whether this association is causal. RSV-specific monoclonal antibodies have been shown to reduce RSV-related hospitalisations in high-risk infants, but the longer term follow-up has given conflicting evidence for prevention of recurrent wheeze or asthma.Objective We performed a systematic review and meta-analysis to determine whether monoclonal antibody prophylaxis against RSV-bronchiolitis reduces the risk of subsequent recurrent wheeze or asthma. If so, this may support the hypothesis of causality.Methods Studies were identified via an online database search. Manufacturers of monoclonal antibodies were contacted directly for unpublished data. The intervention of interest was RSV monoclonal antibody prophylaxis and the primary outcome measure was recurrent wheeze and/or asthma. Studies were screened according to inclusion/exclusion criteria. Included studies were evaluated for quality and assessed for bias independently by 3 reviewers using the ‘Grading of Recommendations Assessment, Development and Evaluation’ (GRADE) approach. Results were extracted into 2 × 2 outcome tables and a meta-analysis carried out producing forest plots based on relative risk. Heterogeneity was assessed using the I2 statistic.Results 11,195 infants were included in the meta-analysis, consisting of eight studies (2 randomised controlled trials). The overall result demonstrated a non-statistically significant reduction in relative risk of developing recurrent wheeze or asthma (RR 0.60; 95% CI 0.31 to 1.16). Study quality was generally low with evidence of publication bias and statistical heterogeneity. Sub-group analysis excluding studies deemed to be ‘very low’ quality showed a relative risk of 0.42 (95% CI: 0.22 to 0.80, p = 0.008). A further sub-group analysis for infants aged 32 to < 36 weeks showed a statistically significant relative risk of 0.35 (95% CI: 0.14 to 0.86, p = 0.02).Discussion We did not identify an overall statistically significant benefit. However, our two subgroup analyses did find statistically significant benefits of monoclonal antibody therapy on the risk of recurrent wheeze and asthma. The main limitation of this study is the lack of high quality randomised controlled trials, highlighting the need for more research in this field.

scholarly journals Comparative Effectiveness of Pharmacological Interventions for Covid-19: A Systematic Review and Network Meta-Analysis

2021 ◽  
Vol 12 ◽  
Author(s):  
Franco De Crescenzo ◽  
Laura Amato ◽  
Fabio Cruciani ◽  
Luke P Moynihan ◽  
Gian Loreto D’Alò ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Pharmacological Intervention ◽  
Pharmacological Interventions ◽  
Serious Adverse Events ◽  
All Cause Mortality ◽  
Randomised Controlled

Background: Several pharmacological interventions are now under investigation for the treatment of Covid-19, and the evidence is evolving rapidly. Our aim is to assess the comparative efficacy and safety of these drugs.Methods and Findings: We performed a systematic review and network meta-analysis searching Medline, Pubmed, Embase, Cochrane Covid-19 register, international trial registers, medRxiv, bioRxiv, and arXiv up to December 10, 2020. We included all randomised controlled trials (RCTs) comparing any pharmacological intervention for Covid-19 against any drugs, placebo or standard care (SC). Data extracted from published reports were assessed for risk of bias in accordance with the Cochrane tool, and using the GRADE framework. Primary outcomes were all-cause mortality, adverse events (AEs) and serious adverse events (SAEs). We estimated summary risk ratio (RR) using pairwise and network meta-analysis with random effects (Prospero, number CRD42020176914). We performed a systematic review and network meta-analysis searching Medline, Pubmed, Embase, Cochrane Covid-19 register, international trial registers, medRxiv, bioRxiv, and arXiv up to December 10, 2020. We included all randomised controlled trials (RCTs) comparing any pharmacological intervention for Covid-19 against any drugs, placebo or standard care (SC). Data extracted from published reports were assessed for risk of bias in accordance with the Cochrane tool, and using the GRADE framework. Primary outcomes were all-cause mortality, adverse events (AEs) and serious adverse events (SAEs). We estimated summary risk ratio (RR) using pairwise and network meta-analysis with random effects (Prospero, number CRD42020176914). We included 96 RCTs, comprising of 34,501 patients. The network meta-analysis showed in terms of all-cause mortality, when compared to SC or placebo, only corticosteroids significantly reduced the mortality rate (RR 0.90, 95%CI 0.83, 0.97; moderate certainty of evidence). Corticosteroids significantly reduced the mortality rate also when compared to hydroxychloroquine (RR 0.83, 95%CI 0.74, 0.94; moderate certainty of evidence). Remdesivir proved to be better in terms of SAEs when compared to SC or placebo (RR 0.75, 95%CI 0.63, 0.89; high certainty of evidence) and plasma (RR 0.57, 95%CI 0.34, 0.94; high certainty of evidence). The combination of lopinavir and ritonavir proved to reduce SAEs when compared to plasma (RR 0.49, 95%CI 0.25, 0.95; high certainty of evidence). Most of the RCTs were at unclear risk of bias (42 of 96), one third were at high risk of bias (34 of 96) and 20 were at low risk of bias. Certainty of evidence ranged from high to very low.Conclusion: At present, corticosteroids reduced all-cause mortality in patients with Covid-19, with a moderate certainty of evidence. Remdesivir appeared to be a safer option than SC or placebo, while plasma was associated with safety concerns. These preliminary evidence-based observations should guide clinical practice until more data are made public.

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