scholarly journals Efficacy and safety profile of statins in patients with cancer: a systematic review of randomised controlled trials

2020 ◽  
Vol 76 (12) ◽  
pp. 1639-1651
Author(s):  
John P. Thomas ◽  
Yoon K. Loke ◽  
Leo Alexandre

Abstract Purpose A growing body of preclinical and observational research suggests that statins have potential as a therapeutic strategy in patients with cancer. This systematic review of randomised controlled trials (RCTs) in patients with solid tumours aimed to determine the efficacy of statin therapy on mortality outcomes, their safety profile and the risk of bias of included studies. Methods Full-text articles comparing statin therapy versus control in solid tumours and reporting mortality outcomes were identified from Medline and Embase from conception to February 2020. A systematic review with qualitative (primarily) and quantitative synthesis was conducted. This systematic review was prospectively registered (Prospero registration CRD42018116364). Results Eleven trials of 2165 patients were included. Primary tumour sites investigated included lung, colorectal, gastro-oesophageal, pancreatic and liver. Most trials recruited patients with advanced malignancy and used sub-maximal statin doses for relatively short durations. Aside from one trial which demonstrated benefit with allocation to pravastatin 40 mg in hepatocellular carcinoma, the remaining ten trials did not demonstrate efficacy with statins. The pooled hazard ratio for all-cause mortality with allocation to pravastatin in patients with hepatocellular carcinoma in two trials was 0.69 (95% confidence interval CI 0.30–1.61). Study estimates were imprecise. There were no clinically important differences in statin-related adverse events between groups. Overall, included trials were deemed low risk of bias. Conclusion The trial evidence is not sufficiently robust to confirm or refute the efficacy and safety of statins in patients with solid malignant tumours. Study and patient characteristics may explain this uncertainty. The potential role of high-dose statins in adjuvant settings deserves further research.

2021 ◽  
Vol 5 (1) ◽  
pp. e001129
Author(s):  
Bill Stevenson ◽  
Wubshet Tesfaye ◽  
Julia Christenson ◽  
Cynthia Mathew ◽  
Solomon Abrha ◽  
...  

BackgroundHead lice infestation is a major public health problem around the globe. Its treatment is challenging due to product failures resulting from rapidly emerging resistance to existing treatments, incorrect treatment applications and misdiagnosis. Various head lice treatments with different mechanism of action have been developed and explored over the years, with limited report on systematic assessments of their efficacy and safety. This work aims to present a robust evidence summarising the interventions used in head lice.MethodThis is a systematic review and network meta-analysis which will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses statement for network meta-analyses. Selected databases, including PubMed, Embase, MEDLINE, Web of Science, CINAHL and Cochrane Central Register of Controlled Trials will be systematically searched for randomised controlled trials exploring head lice treatments. Searches will be limited to trials published in English from database inception till 2021. Grey literature will be identified through Open Grey, AHRQ, Grey Literature Report, Grey Matters, ClinicalTrials.gov, WHO International Clinical Trials Registry and International Standard Randomised Controlled Trials Number registry. Additional studies will be sought from reference lists of included studies. Study screening, selection, data extraction and assessment of methodological quality will be undertaken by two independent reviewers, with disagreements resolved via a third reviewer. The primary outcome measure is the relative risk of cure at 7 and 14 days postinitial treatment. Secondary outcome measures may include adverse drug events, ovicidal activity, treatment compliance and acceptability, and reinfestation. Information from direct and indirect evidence will be used to generate the effect sizes (relative risk) to compare the efficacy and safety of individual head lice treatments against a common comparator (placebo and/or permethrin). Risk of bias assessment will be undertaken by two independent reviewers using the Cochrane Risk of Bias tool and the certainty of evidence assessed using the Grading of Recommendations, Assessment, Development and Evaluations guideline for network meta-analysis. All quantitative analyses will be conducted using STATA V.16.DiscussionThe evidence generated from this systematic review and meta-analysis is intended for use in evidence-driven treatment of head lice infestations and will be instrumental in informing health professionals, public health practitioners and policy-makers.PROSPERO registration numberCRD42017073375.


BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e047344
Author(s):  
Qingwu Wu ◽  
Lianxiong Yuan ◽  
Huijun Qiu ◽  
Xinyue Wang ◽  
Xuekun Huang ◽  
...  

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.


BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e050004
Author(s):  
Wenjuan Wu ◽  
Lingxiao Qiu ◽  
Jizhen Wu ◽  
Xueya Liu ◽  
Guojun Zhang

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.


2021 ◽  
pp. 1-13
Author(s):  
Davide Papola ◽  
Giovanni Ostuzzi ◽  
Federico Tedeschi ◽  
Chiara Gastaldon ◽  
Marianna Purgato ◽  
...  

Background Psychotherapies are the treatment of choice for panic disorder, but which should be considered as first-line treatment is yet to be substantiated by evidence. Aims To examine the most effective and accepted psychotherapy for the acute phase of panic disorder with or without agoraphobia via a network meta-analysis. Method We conducted a systematic review and network meta-analysis of randomised controlled trials (RCTs) to examine the most effective and accepted psychotherapy for the acute phase of panic disorder. We searched MEDLINE, Embase, PsycInfo and CENTRAL, from inception to 1 Jan 2021 for RCTs. Cochrane and PRISMA guidelines were used. Pairwise and network meta-analyses were conducted using a random-effects model. Confidence in the evidence was assessed using Confidence in Network Meta-Analysis (CINeMA). The protocol was published in a peer-reviewed journal and in PROSPERO (CRD42020206258). Results We included 136 RCTs in the systematic review. Taking into consideration efficacy (7352 participants), acceptability (6862 participants) and the CINeMA confidence in evidence appraisal, the best interventions in comparison with treatment as usual (TAU) were cognitive–behavioural therapy (CBT) (for efficacy: standardised mean differences s.m.d. = −0.67, 95% CI −0.95 to −0.39; CINeMA: moderate; for acceptability: relative risk RR = 1.21, 95% CI −0.94 to 1.56; CINeMA: moderate) and short-term psychodynamic therapy (for efficacy: s.m.d. = −0.61, 95% CI −1.15 to −0.07; CINeMA: low; for acceptability: RR = 0.92, 95% CI 0.54–1.54; CINeMA: moderate). After removing RCTs at high risk of bias only CBT remained more efficacious than TAU. Conclusions CBT and short-term psychodynamic therapy are reasonable first-line choices. Studies with high risk of bias tend to inflate the overall efficacy of treatments. Results from this systematic review and network meta-analysis should inform clinicians and guidelines.


2016 ◽  
Vol 34 (2) ◽  
pp. 76-83 ◽  
Author(s):  
Yan Yang ◽  
Qinghui Que ◽  
Xiaode Ye ◽  
Guo hua Zheng

Background Manual acupuncture (MA) is commonly used as a treatment for migraine in China. However, its specific clinical effects have been challenged on the basis that some of its effects may relate to psychological or ‘placebo’ mechanisms. Objective To identify the effectiveness of verum MA compared with sham acupuncture for the treatment of migraine. Methods Eight electronic databases were searched for randomised controlled trials (RCTs) evaluating the effect of verum versus sham MA on migraine. The quality of included trials was assessed using the ‘risk of bias’ tool provided by the Cochrane Handbook for Systematic Review of Intervention. RevMan 5.2 software was used for data analysis. Results Ten trials with 997 participants were included. Most trials had high methodological quality and were at low risk of bias. Meta-analysis showed superior effects of verum MA over sham acupuncture on the total effective rate, reflected by a reduction in the ‘not effective’ rate (relative risk (RR) 0.24, 95% CI 0.15 to 0.38; p<0.0001, four trials) and a reduced recurrence rate (RR 0.47, 95% CI 0.28 to 0.81; p=0.006, two trials), but no significant differences in headache intensity, frequency or duration, accompanying symptoms and use of medication. No severe adverse events related to acupuncture occurred during treatment with either verum or sham MA. Conclusions Current clinical evidence suggests that verum acupuncture is superior to sham acupuncture in migraine, reflected by a higher total effective rate and decreased recurrence rate. Nevertheless, further large-scale RCTs with a rigorous design are required to confirm these findings in view of the relative paucity of eligible RCTs and small sample sizes of those included.


2020 ◽  
Author(s):  
Blair Ross Hamilton ◽  
Katherine Staines ◽  
George Kelley ◽  
Kristi Kelley ◽  
Wendy Kohrt ◽  
...  

Introduction: Exercise is a cost-effective, widely available intervention that has been reported to help maintain optimal bone mineral density (BMD) in men, however, consideration of exercise modality is needed if the aim is to promote skeletal health. A previous meta-analysis of randomised controlled trials observed a moderate benefit on femoral neck (FN) but no benefit on lumbar spine (LS) BMD. However, since that analysis more randomised controlled trials (RCTs) have been published and updated methods of meta-analysis have been developed and therefore an updated systematic review and meta-analysis is required. Methods and analysis: RCTs of &gt;24 weeks and published in English up to 01/05/20 will be retrieved by searching 3 electronic databases, cross referencing and expert review. The primary outcome measures will be changes in FN and LS BMD and lower limb BMD. Risk of bias for each study will be assessed using the Cochrane Risk of Bias instrument for RCTs, while the strength of evidence for each outcome will be assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) instrument. Standardised effect sizes will be calculated from each study and pooled using the inverse heterogeneity (IVhet) model. Trial Registration number: CRD42020180441.


BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e046599
Author(s):  
Diana Naehrig ◽  
Aaron Schokman ◽  
Jessica Kate Hughes ◽  
Ronald Epstein ◽  
Ian B Hickie ◽  
...  

ObjectivesClinician well-being has been recognised as an important pillar of healthcare. However, research mainly addresses mitigating the negative aspects of stress or burnout, rather than enabling positive aspects. With the added strain of a pandemic, identifying how best to maintain and support the well-being, satisfaction and flourishing of general practitioners (GPs) is now more important than ever.DesignSystematic review.Data sourcesWe searched MEDLINE, PsycINFO, Embase, CINAHL and Scopus from 2000 to 2020.Study selectionIntervention studies with more than 50% GPs in the sample evaluating self-reported well-being, satisfaction and related positive outcomes were included. The Cochrane Risk of Bias 2 tool was applied.ResultsWe retrieved 14 792 records, 94 studies underwent full-text review. We included 19 studies in total. Six randomised controlled trials, three non-randomised, controlled trials, eight non-controlled studies of individual or organisational interventions with a total of 1141 participants. There were two quasi-experimental articles evaluating health system policy change. Quantitative and qualitative positive outcomes were extracted and analysed. Individual mindfulness interventions were the most common (k=9) with medium to large within-group (0.37–1.05) and between-group (0.5–1.5) effect sizes for mindfulness outcomes, and small-to-medium effect sizes for other positive outcomes including resilience, compassion and empathy. Studies assessing other intervention foci or other positive outcomes (including well-being, satisfaction) were of limited size and quality.ConclusionsThere is remarkably little evidence on how to improve GPs well-being beyond using mindfulness interventions, particularly for interventions addressing organisational or system factors. This was further undermined by inconsistent reporting, and overall high risk of bias. We need to conduct research in this space with the same rigour with which we approach clinical intervention studies in patients.PROSPERO registration numberCRD42020164699.Funding sourceDr Diana Naehrig is funded through the Raymond Seidler PhD scholarship.


Sign in / Sign up

Export Citation Format

Share Document