scholarly journals Clinical efficacy, safety and tolerability of aliskiren monotherapy: a protocol for an umbrella review

BMJ Open ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. e033448
Author(s):  
Qiyuan Zhao ◽  
Jiantong Shen ◽  
Jingya Lu ◽  
Fan Li ◽  
Qi Jiang ◽  
...  

IntroductionAliskiren is a newly developed medicine. As one of the effective renin–angiotensin–aldosterone system inhibitors, its role in lowering blood pressure has been recognised. However, its safety and tolerability still remain controversial. The aim of the paper is to systematically summarise the published studies about the clinical efficacy and side effects of aliskiren monotherapy.Methods and analysisA comprehensive review of PubMed, Embase and Cochrane Library databases published from inception until June 2019 will be conducted. The selected articles are meta-analyses that integrated the randomised controlled studies, which evaluated efficacy, safety and tolerability of aliskiren monotherapy. Two people will select eligible articles and extract data independently. Any disputes will be resolved by discussion or the arbitration of a third person. The quality of reporting evidence will be assessed using the AMSTAR 2 tool. Study selection process will be presented using a flowchart. We will re-analyse each outcome with the random effect methods if necessary. If possible, we will also calculate 95% prediction intervals for each random effect estimate, by using Egger’s test to evaluate if the reporting bias existed.Ethics and disseminationEthical approval is not required for the study, as we only collected data from available published materials. This umbrella review will be also submitted to a peer-reviewed journal for publication after completion.PROSPERO registration numberCRD42019142141.

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e043807
Author(s):  
Jiantong Shen ◽  
Wenming Feng ◽  
Yike Wang ◽  
Qiyuan Zhao ◽  
Billong Laura Flavorta ◽  
...  

IntroductionEfficacy of aliskiren combination therapy with other antihypertensive has been evaluated in the treatment of patients with hypertension in recent systematic reviews. However, most previous reviews only focused on one single health outcome or one setting, none of them made a full summary that assessed the impact of aliskiren combination treatment comprehensively. As such, this umbrella review based on systematic reviews and meta-analyses is aimed to synthesise the evidences on efficacy, safety and tolerability of aliskiren-based therapy for hypertension and related comorbid patients.Methods and analysisA comprehensive search of PubMed, EMBASE, Cochrane Library, CNKI published from inception to August 2020 will be conducted. The selected articles are systematic reviews which evaluated efficacy, safety and tolerability of aliskiren combination therapy. Two reviewers will screen eligible articles, extract data and evaluate quality independently. Any disputes will be resolved by discussion or the arbitration of a third person. The quality of reporting evidence will be assessed using the Assessment of Multiple Systematic Reviews V.2 tool tool. We will take a mixed-methods approach to synthesising the review literatures, reporting summary of findings tables and iteratively mapping the results.Ethics and disseminationEthical approval is not required for the study, as we would only collect data from available published materials. This umbrella review will be also submitted to a peer-reviewed journal for publication after completion.PROSPERO registration numberCRD42020192131.


BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e045899
Author(s):  
Ibrahim Almufarrij ◽  
Harvey Dillon ◽  
Kevin J Munro

IntroductionHearing aids are typically programmed using the individual’s audiometric thresholds. Developments in technology have resulted in a new category of direct-to-consumer devices, which are not programmed using the individual’s audiometric thresholds. This review aims to identify whether programming hearing aids using the individual’s audiogram-based prescription results in better outcomes for adults with hearing loss.Methods and analysisThe methods of this review are reported in line with Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines. On 23 August 2020, eight different databases were systematically searched without any restrictions: EMBASE, MEDLINE, PubMed, PsycINFO, Web of Science, Cochrane Library, Emcare and Academic Search Premier. To ensure that this review includes the most recent evidence, the searches will be repeated at the final write-up stage. The population of interest of this review will be adults with any degree or type of hearing loss. The studies should compare hearing aids programmed using an audiogram-based prescription (and verified in the real ear) with those not programmed on the basis of the individual’s audiogram. The primary outcome of interest is consumers’ listening preferences. Hearing-specific health-related quality of life, self-reported listening ability, speech intelligibility of words and sentences in quiet and noisy situations, sound quality ratings and adverse events are the secondary outcomes of interest. Both randomised and non-randomised controlled trials will be included. The quality of each individual study and the overall evidence will be assessed using Downs and Black’s checklist and the Grading of Recommendations, Assessment, Development and Evaluations tool, respectively.Ethics and disseminationWe will only retrieve and analyse data from published studies, so no ethical approval is required. The review findings will be published in a peer-reviewed journal and presented at scientific conferences.PROSPERO registration numberCRD42020197232.


2021 ◽  
Vol 7 (1) ◽  
pp. e000895
Author(s):  
Linda S Pescatello ◽  
Yin Wu ◽  
Simiao Gao ◽  
Jill Livingston ◽  
Bonny Bloodgood Sheppard ◽  
...  

ObjectiveTo compare the blood pressure (BP) effects of exercise alone (EXalone), medication alone (MEDSalone) and combined (EX+MEDScombined) among adults with hypertension.Data sourcesPubMed, Scopus, Cumulative Index to Nursing and Allied Health Literature, SPORTDiscus and the Cochrane Library.Eligibility criteriaRandomised controlled trails (RCTs) or meta-analyses (MAs) of controlled trials that: (1) involved healthy adults>18 year with hypertension; (2) investigated exercise and BP; (3) reported preintervention and postintervention BP and (4) were published in English. RCTs had an EX+MEDScombined arm; and an EXalone arm and/or an MEDSalone arm; and MAs performed moderator analyses.DesignA systematic network MA and meta-review with the evidence graded using the Physical Activity Guidelines for Americans Advisory Committee system.OutcomeThe BP response for EXalone, MEDSalone and EX+MEDScombined and compared with each other.ResultsTwelve RCTs qualified with 342 subjects (60% women) who were mostly physically inactive, middle-aged to older adults. There were 13 qualifying MAs with 28 468 participants (~50% women) who were mostly Caucasian or Asian. Most RCTs were aerobic (83.3%), while the MAs involved traditional (46%) and alternative (54%) exercise types. Strong evidence demonstrates EXalone, MEDSalone and EX+MEDScombined reduce BP and EX+MEDScombined elicit BP reductions less than the sum of their parts. Strong evidence indicates EX+MEDScombined potentiate the BP effects of MEDSalone. Although the evidence is stronger for alternative than traditional types of exercise, EXaloneelicits greater BP reductions than MEDSalone.ConclusionsThe combined BP effects of exercise and medications are not additive or synergistic, but when combined they bolster the antihypertensive effects of MEDSalone.PROSPERO registration numberThe protocol is registered at PROSPERO CRD42020181754.


Author(s):  
Alexandro Andrade ◽  
Thais Cristina Siqueira ◽  
Anderson D’Oliveira ◽  
Fábio Hech Dominski

The authors aimed to provide an overview of the evidence on the effects of exercise in people with Alzheimer’s disease through a comprehensive review of the existing systematic reviews and meta-analyses. A literature search was performed in CINAHL, Cochrane Library, EMBASE, PubMed, SPORTDiscus, Scopus, and Web of Science databases according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The AMSTAR-2-Tool was used for the quality assessment. Twenty-three reviews fulfilled the criteria. Most of the reviews investigated the effects of aerobic exercise on Alzheimer’s disease symptoms. The largest effects of exercise were seen in terms of improved cognition by multiple exercises. The majority of the reviews were rated as being of moderate quality and none were classified as having high quality. Exercise is an effective way to treat Alzheimer’s disease symptoms and has a low incidence of related adverse events. As most reviews were evaluated as low-moderate quality, caution is needed in the interpretation of the results.


BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e027778 ◽  
Author(s):  
Song Jin ◽  
Yi-Fan Li ◽  
Di Qin ◽  
Dan-Qing Luo ◽  
Hong Guo ◽  
...  

IntroductionNon-pharmacological treatments are used in the management of irritable bowel syndrome, and their effectiveness has been evaluated in multiple meta-analyses. The robustness of the results in the meta-analyses was not evaluated. We aimed to assess whether there is evidence of diverse biases in the meta-analyses and to identify the treatments without evidence of risk of bias.Methods and analysisWe will search MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Web of Science and CINAHL Plus for meta-analyses that evaluate the effectiveness of non-pharmacological treatments. The time of publication will be limited from inception to December 2018. The credibility of the meta-analyses will be evaluated by assessing between-study heterogeneity, small-study effect and excess significance bias. The between-study heterogeneity will be assessed using the Cochrane’s Q test, and the extent of the heterogeneity will be classified using the I2statistics. The existence of a small-study effect in a meta-analysis will be evaluated using the funnel plot method and confirmed by Egger’s test. Excess significance bias will be evaluated by comparing the expected number of clinical studies with positive findings with the observed number.Ethics and disseminationNo formal ethical approval is required since we will use publicly available data. We will disseminate the findings of the umbrella review through publication in a peer-reviewed journal and conference presentations.PROSPERO registration numberCRD42018111516.


2020 ◽  
Vol 2020 ◽  
pp. 1-9
Author(s):  
T. Paolucci ◽  
S. Sbardella ◽  
C. La Russa ◽  
F. Agostini ◽  
M. Mangone ◽  
...  

Parkinson disease (PD) is a chronic neurodegenerative condition that leads to progressive disability. PD-related reductions in muscle strength have been reported to be associated with lower functional performance and balance confidence with an increased risk of falls. Progressive resistance training (PRT) improves strength, balance, and functional abilities. This umbrella review examines the efficacy of PRT regarding muscular strength in PD patients. The PubMed, PEDro, Scopus, and Cochrane Library databases were searched from January 2009 to August 2019 for systematic reviews and meta-analyses conducted in English. The populations included had diagnoses of PD and consisted of males and females aged >18 years old. Outcomes measured were muscle strength and enhanced physical function. Eight papers (six systematic reviews and meta-analyses and two systematic reviews) were considered relevant for qualitative analysis. In six of the eight studies, the reported severity of PD was mild to moderate. Each study analyzed how PRT elicited positive effects on muscle strength in PD patients, suggesting 10 weeks on average of progressive resistance exercises for the upper and lower limbs two to three times per week. However, none of the studies considered the postworkout follow-up, and there was no detailed evidence about the value of PRT in preventing falls. The possibility of PRT exercises being effective for increasing muscle strength in patients with PD, but without comorbidities or severe disability, is discussed. Overall, this review suggests that PRT should be included in rehabilitation programs for PD patients, in combination with balance training for postural control and other types of exercise, in order to preserve cardiorespiratory fitness and improve endurance in daily life activities.


BMJ Open ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. e031951
Author(s):  
Liqun Li ◽  
Jinjing Tan ◽  
Lijian Liu ◽  
Jianfeng Li ◽  
Guangwen Chen ◽  
...  

ObjectiveSystematic reviews and meta-analyses have revealed the associations betweenH. pyloriinfection and various health outcomes. We aimed to evaluate the strength and breadth of evidence on the associations.DesignUmbrella review of systematic reviews and meta-analyses.SettingNo settings.ParticipantsNo patients involved.Data sourcesEmbase, PubMed, Web of Science, Cochrane Library Databases, CNKI, VIP database and Wangfang database from inception to February 1, 2019.Outcomes measuresDiverse diseases (such as cancer and ischaemic heart disease).ResultsSixty articles reporting 88 unique outcomes met the eligible criteria. 74 unique outcomes had nominal significance (p<0.05). Of the outcomes with significance, 61 had harmful associations and 13 had beneficial associations. Furthermore, 73% (64) of the outcomes exhibited significant heterogeneity . Of the these meta-analyses, 32 had moderate to high heterogeneity (I2=50%–75%) and 24 had high heterogeneity (I2>75%). Moreover, 20% exhibited publication bias (p<0.1). In addition, 97% of the methodological qualities were rated ‘critically low’. 36% of the evidence qualities of outcomes were rated ‘low’, 56% of the evidence qualities were rated ‘very low’ and 8% of the evidence qualities were rated ‘moderate’.H. pyloriinfection may be associated with an increased risk of five diseases and a decreased risk of irritable bowel syndrome.ConclusionAlthough 60 meta-analyses explored 88 unique outcomes, moderate quality evidence only existed for six outcomes with statistical significance.H. pyloriinfection may be associated with a decreased risk of irritable bowel syndrome and an increased risk of hypertriglyceridemia, chronic cholecystitis and cholelithiasis, gestational diabetes mellitus, gastric cancer and systemic sclerosis.Trial registrationCRD42019124680.


2020 ◽  
pp. bmjsrh-2019-200448
Author(s):  
Mia Schmidt-Hansen ◽  
Jonathan Lord ◽  
Elise Hasler ◽  
Sharon Cameron

BackgroundMedical abortion with mifepristone and misoprostol usually involves an interval of 36–48 hours between administering these drugs; however, it is possible that the clinical efficacy at early gestations may be maintained when the drugs are taken simultaneously. The objective of this systematic review was to determine the safety and effectiveness of simultaneous compared with interval administration of mifepristone and misoprostol for abortion up to 10+0 weeks’ gestation.MethodsWe searched Embase Classic, Embase; Ovid MEDLINE(R) including Daily, and Epub Ahead-of-Print, In-Process & Other Non-Indexed Citations; and Cochrane Library on 11 December 2019. We included randomised controlled trials (RCTs), published in English from 1985, comparing simultaneous to interval administration of mifepristone and misoprostol for early abortion. Risk of bias was assessed using the Cochrane Collaboration checklist for RCTs. Meta-analysis of risk ratios (RRs) using the Mantel-Haenszel method were performed. The quality of the evidence was assessed using GRADE.ResultsMeta-analyses of three RCTs (n=1280) showed no differences in ‘ongoing pregnancy’ (RR 1.78, 95% CI 0.38 to 8.36), ‘haemorrhage requiring transfusion or ≥500 mL blood loss’ (RR 0.11, 95% CI 0.01 to 2.03) and ‘incomplete abortion with the need for surgical intervention’ (RR 1.30, 95% CI 0.76 to 2.25) between the interventions. Individual study results showed no difference in patient satisfaction, or ‘need for repeat misoprostol’, although ‘time to onset of bleeding or cramping’ was longer after simultaneous than interval administration. The quality of evidence was very low to moderate.ConclusionThe published data support the use of simultaneous mifepristone and misoprostol for medical abortion up to 9+0 weeks in women who prefer this method of administration.


BMJ Open ◽  
2020 ◽  
Vol 10 (3) ◽  
pp. e035287
Author(s):  
Min Chen ◽  
Tai-Chun Tang ◽  
Tao-Hong He ◽  
Yong-Jun Du ◽  
Di Qin ◽  
...  

IntroductionThe prevalence of haemorrhoidal diseases was high in general population, and many treatments are proposed for the management of haemorrhoids. The treatments include conservative and surgical interventions; the credibility and strength of current evidence of their effectiveness are not comprehensively evaluated. We aim to evaluate the credibility of systematic reviews and meta-analyses that assess the effectiveness of the treatments for haemorrhoidal diseases through an umbrella review.Methods and analysisWe will search Ovid Medline, Embase, Cochrane library and Web of Science from inception to March 2020 without any language restriction. We will include meta-analyses that examine the effectiveness of treatments in the management of haemorrhoids. Two reviewers will independently screen the titles and abstracts of retrieved articles, and they will extract data from the included meta-analyses. For each meta-analysis, we will estimate the effect size of a treatment through the random-effect model and the fixed-effect model, and we will evaluate between-study heterogeneity (Cochrane’s Q and I2statistics) and small-study effect (Egger’s test); we will also estimate the evidence of excess significance bias. Evidence of each treatment will be graded according to prespecified criteria. Methodological quality of each meta-analysis will be evaluated by using Assessment of Multiple Systematic Reviews 2. The corrected cover area method will be used to assess the impact of overlap in reviews on the findings of the umbrella review.Ethics and disseminationWe will present the results of the umbrella review at conferences and publish the final report in a peer-reviewed journal. The umbrella review does not require ethical approval.PROSPERO registration numberCRD42019140702.


2019 ◽  
Vol 29 (Supplement_4) ◽  
Author(s):  
K Giannakou ◽  
E Constantinou ◽  
D Lamnisos

Abstract Background Gestational diabetes mellitus (GDM) is a common pregnancy complication, defined as glucose intolerance with onset or first recognition during pregnancy, in women without diabetes history during pregnancy. It is a major cause for adverse maternal and fetal outcomes and affects around 15% of all pregnancies. GDM is considered to be a risk factor for future metabolic conditions and cardiovascular disease. Methods An umbrella review was performed to identify systematic reviews and meta-analyses of randomized controlled trials for GDM prevention in order to summarize evidence and evaluate the validity of the interventions. We searched PubMed, the Cochrane library and ISI Web of Science from inception to March 2019. For each meta-analysis we estimated the summary effect size by random-effects and fixed-effects models, the 95% confidence interval, the 95% prediction interval, the between-study heterogeneity expressed by I2, evidence of small-study effects and evidence of excess significance bias. Results Six-teen eligible papers were identified providing data on 39 associations. Eighteen (46%) associations had nominally statistically significant findings at P &lt; 0.05, while only one (3%) remain significant at P &lt; 10-6 under the random-effects model. Eight (21%) associations had large or very large heterogeneity. Evidence for small-study effects and excess significance bias was found in 5 (13%) and 2 (5%) associations, respectively. Only one intervention presented robust evidence for a convincing association: prenatal exercise compared with no exercise (RR 0.62, 95% CI: 0.52-0.75). It was supported by &gt; 500 cases, 95% prediction intervals excluding the null, no large heterogeneity, small-study effects, or excess of significance. Conclusions Prenatal exercise shows the strongest consistent evidence. The findings from our study highlight the importance of patient education about lifestyle modifications to reduce risk of GDM. Key messages Prenatal exercise could lower the risk of GDM based on solid epidemiologic evidence. Obesity, pregnancy hypertension and other metabolic conditions could be prevented as well.


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