scholarly journals The impact of equol-producing status in modifying the effect of soya isoflavones on risk factors for CHD: a systematic review of randomised controlled trials

2016 ◽  
Vol 5 ◽  
Author(s):  
Rahel L. Birru ◽  
Vasudha Ahuja ◽  
Abhishek Vishnu ◽  
Rhobert W. Evans ◽  
Yoshihiro Miyamoto ◽  
...  
Keyword(s):  
Risk Factors ◽  
Randomised Controlled Trials ◽  
Statistical Power ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Ovid Medline ◽  
Central Register ◽  
Bacterial Action ◽  
Randomised Controlled ◽  
The Impact

AbstractRecent studies suggest that the ability to produce equol, a metabolite of the soya isoflavone daidzein, is beneficial to coronary health. Equol, generated by bacterial action on isoflavones in the human gut, is biologically more potent than dietary sources of isoflavones. Not all humans are equol producers. We investigated whether equol-producing status is favourably associated with risk factors for CHD following an intervention by dietary soya isoflavones. We systematically reviewed randomised controlled trials (RCT) that evaluated the effect of soya isoflavones on risk factors for CHD and that reported equol-producing status. We searched PubMed, EMBASE, Ovid Medline and the Cochrane Central Register for Controlled Trials published up to April 2015 and hand-searched bibliographies to identify the RCT. Characteristics of participants and outcomes measurements were extracted and qualitatively analysed. From a total of 1671 studies, we identified forty-two articles that satisfied our search criteria. The effects of equol on risk factors for CHD were mainly based on secondary analyses in these studies, thus with inadequate statistical power. Although fourteen out of the forty-two studies found that equol production after a soya isoflavone intervention significantly improved a range of risk factors including cholesterol and other lipids, inflammation and blood pressure variables, these results need further verification by sufficiently powered studies. The other twenty-eight studies primarily reported null results. RCT of equol, which has recently become available as a dietary supplement, on CHD and its risk factors are awaited.

Tafenoquine for primary and terminal prophylaxis of malaria in apparently healthy people: a systematic review

2019 ◽  
Vol 113 (10) ◽  
pp. 579-586 ◽  
Author(s):  
Chaturaka Rodrigo ◽  
Senaka Rajapakse ◽  
Sumadhya Deepika Fernando
Keyword(s):  
Randomised Controlled Trials ◽  
Dose Range ◽  
Primary Prophylaxis ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Time Restrictions ◽  
Central Register ◽  
Randomised Controlled ◽  
Malaria Episodes ◽  
Apparently Healthy

Abstract Primaquine was the only licenced antimalarial hypnozoiticidal drug available until recently. Now there is a newly approved alternative: tafenoquine. This review explores the efficacy of tafenoquine as a primary and terminal prophylactic agent in malaria. Multiple databases (Cochrane Central Register of Controlled Trials [CENTRAL], MEDLINE [PubMed], Embase [Ovid], Scopus, CINAHL [EBSCOhost] and LILACS) were searched for clinical randomised controlled trials that had used tafenoquine for prophylaxis without language or time restrictions. The last date of searching was 13 August 2018. For primary prophylaxis, tafenoquine reduced episodes of malaria compared with placebo, at a dose range from 50 mg weekly to 400 mg monthly in three trials conducted in Ghana, Kenya and Thailand. Two trials compared tafenoquine vs mefloquine, but malaria episodes were too few to reach a conclusion. For terminal prophylaxis, evidence from two trials suggest that tafenoquine may have equal or better efficacy compared with primaquine. All trials excluded pregnant participants or those with G6PD deficiency. Tafenoquine is effective for both primary and terminal prophylaxis. If used for primary prophylaxis it may continue to offer protection against vivax relapses after exposure has ended (as terminal prophylaxis).

scholarly journals Comparative efficacy and safety of different regimens of ranibizumab for neovascular age-related macular degeneration: a network meta-analysis of randomised controlled trials

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e040906
Author(s):  
Xinyu Zhao ◽  
Lihui Meng ◽  
Youxin Chen
Keyword(s):  
Adverse Events ◽  
Macular Degeneration ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Age Related Macular Degeneration ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Efficacy And Safety ◽  
Age Related ◽  
Randomised Controlled

ObjectiveTo give a comprehensive efficacy and safety ranking of different therapeutic regimens of ranibizumab for neovascular age-related macular degeneration (nAMD).DesignA systematic review and network meta-analysis.MethodsThe PubMed, Embase, Cochrane Central Register of Controlled Trials, and other clinical trial registries were searched up to 1 October 2019 to identify related randomised controlled trials (RCT) of different regimens of ranibizumab for nAMD. The primary efficacy outcome was the changes of best-corrected visual acuity (BCVA) at 1 year, the primary safety outcome was the incidence of severe ocular adverse events. Secondary outcomes such as changes of central retinal thickness (CRT) were evaluated. We estimated the standardised mean difference (SMD), ORs, 95% CIs, the surface under the cumulative ranking curves and the mean ranks for each outcome using network meta-analyses with random effects by Stata 14.0.ResultsWe identified 26 RCTs involving 10 821 patients with nAMD randomly assigned to 21 different therapeutic regimens of ranibizumab or sham treatment. Ranibizumab 0.5 mg (treat and extend, T&E) is most effective in terms of changes of BCVA (letters, SMD=21.41, 95% CI 19.86 to 22.95) and three or more lines of BCVA improvement (OR=2.83, 95% CI 1.27 to 4.38). However, it could not significantly reduce retreatment times compared with monthly injection (SMD=−0.94, 95% CI −2.26 to 0.39). Ranibizumab 0.5 mg (3+pro re nata)+non-steroidal anti-inflammatory drugs (NSAIDs) is most effective in reducing CRT and port delivery system of ranibizumab (100 mg/mL) could reduce the number of retreatment most significantly. All regimes have no more risk of severe ocular complications (including vitreous haemorrhage, rhegmatogenous retinal detachment, endophthalmitis, retinal tear and retinal pigment epithelium tear) or cardiocerebral vascular complications.ConclusionsRanibizumab 0.5 mg (T&E) is most effective in improving the visual outcome. The administration of topical NSAIDs could achieve additional efficacy in CRT reduction and visual improvement. Both interventions had acceptable risks of adverse events.

scholarly journals Recruiting hard-to-reach pregnant women at high psychosocial risk: strategies and costs from a randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Alice MacLachlan ◽  
Karen Crawford ◽  
Shona Shinwell ◽  
Catherine Nixon ◽  
Marion Henderson
Keyword(s):  
Pregnant Women ◽  
Randomised Controlled Trials ◽  
Social Care ◽  
Early Years ◽  
Controlled Trials ◽  
Recruitment Strategies ◽  
Recruitment Activities ◽  
Research Nurses ◽  
Randomised Controlled ◽  
The Impact

Abstract Background Recruiting participants to randomised controlled trials (RCTs) is often challenging, particularly when working with socially disadvantaged populations who are often termed ‘hard-to-reach’ in research. Here we report the recruitment strategies and costs for the Trial for Healthy Relationship Initiatives in the Very Early years (THRIVE), an RCT evaluating two group-based parenting interventions for pregnant women. Methods THRIVE aimed to recruit 500 pregnant women with additional health and social care needs in Scotland between 2014 and 2018. Three recruitment strategies were employed: (1) referrals from a health or social care practitioner or voluntary/community organisation (practitioner-led referral), (2) direct engagement with potential participants by research staff (researcher-led recruitment) and (3) self-referral in response to study advertising (self-referral). The number of referrals and recruited participants from each strategy is reported along with the overall cost of recruitment. The impact of recruitment activities and the changes in maternity policy/context on recruitment throughout the study are examined. Results THRIVE received 973 referrals: 684 (70%) from practitioners (mainly specialist and general midwives), 273 (28%) from research nurses and 16 (2%) self-referrals. The time spent in antenatal clinics by research nurses each month was positively correlated with the number of referrals received (r = 0.57; p < 0.001). Changes in maternity policies and contexts were reflected in the number of referrals received each month, with both positive and negative impacts throughout the trial. Overall, 50% of referred women were recruited to the trial. Women referred via self-referral, THRIVE research nurses and specialist midwives were most likely to go on to be recruited (81%, 58% and 57%, respectively). Key contributors to recruitment included engaging key groups of referrers, establishing a large flexible workforce to enable recruitment activities to adapt to changes in context throughout the study and identifying the most appropriate setting to engage with potential participants. The overall cost of recruitment was £377 per randomised participant. Conclusions Recruitment resulted from a combination of all three strategies. Our reflections on the successes and challenges of these strategies highlight the need for recruitment strategies to be flexible to adapt to complex interventions and real-world challenges. These findings will inform future research in similar hard-to-reach populations. Trial registration International Standard Randomised Controlled Trials Number Registry ISRCTN21656568. Retrospectively registered on 28 February 2014

Functional cortical changes associated with shoulder instability – a systematic review

2021 ◽  
pp. 175857322110190
Author(s):  
Morissa F Livett ◽  
Deborah Williams ◽  
Hayley Potter ◽  
Melinda Cairns
Keyword(s):  
Systematic Review ◽  
Joint Instability ◽  
Glenohumeral Joint ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Cortical Function ◽  
High Quality Research ◽  
Central Register ◽  
Rehabilitative Measures ◽  
Randomised Controlled

Background Glenohumeral joint instability is associated with structural deficits and/or alterations in sensory and motor processing; however, a proportion of patients with glenohumeral joint instability fail to respond to surgical and rehabilitative measures. This systematic review aimed to establish if functional cortical changes occur in patients with glenohumeral joint instability. Methods AMED, CINAHL, Cochrane Central Register of Controlled Trials, Embase, Medline, PEDro, Pubmed, PsychINFO and Scopus were searched from inception to 17 March 2021. Randomised controlled trials and non-randomised trials were included and quality was appraised using the Downs and Black tool. Results One thousand two hundred seventy-nine records were identified of which five were included in the review. All studies showed altered cortical function when comparing instability patients with healthy controls and included areas associated with higher cortical functions. Discussion The findings of this systematic review offer some insight as to why interventions addressing peripheral pathoanatomical factors in patients with glenohumeral joint instability may fail in some cases due to functional cortical changes. However, data are of moderate to high risk of bias. Further high-quality research is required to ascertain the degree of functional cortical changes associated with the type and duration of glenohumeral joint instability.

scholarly journals Fluid resuscitation in paediatric burns: how do we get it right? A systematic review of the evidence

2018 ◽  
Vol 104 (3) ◽  
pp. 280-285 ◽  
Author(s):  
Christopher Stutchfield ◽  
Anna Davies ◽  
Amber Young
Keyword(s):  
Systematic Review ◽  
Fluid Resuscitation ◽  
Primary Data ◽  
Controlled Trials ◽  
Burn Shock ◽  
Cochrane Central Register ◽  
Study Protocols ◽  
Central Register ◽  
Affect Patient Outcome ◽  
Randomised Controlled

BackgroundOptimal fluid resuscitation in children with major burns is crucial to prevent or minimise burn shock and prevent complications of over-resuscitation.ObjectivesTo identify studies using endpoints to guide fluid resuscitation in children with burns, review the range of reported endpoint targets and assess whether there is evidence that targeted endpoints impact on outcome.DesignSystematic review.MethodsMedline, Embase, Cinahl and the Cochrane Central Register of Controlled Trials databases were searched with no restrictions on study design or date. Search terms combined burns, fluid resuscitation, endpoints, goal-directed therapy and related synonyms. Studies reporting primary data regarding children with burns (<16 years) and targeting fluid resuscitation endpoints were included. Data were extracted using a proforma and the results were narratively reviewed.ResultsFollowing screening of 777 unique references, 7 studies fulfilled the inclusion criteria. Four studies were exclusively paediatric. Six studies used urine output (UO) as the primary endpoint. Of these, one set a minimum UO threshold, while the remainder targeted a range from 0.5–1.0 mL/kg/hour to 2–3 mL/kg/hour. No studies compared different UO targets. Heterogeneous study protocols and outcomes precluded comparison between the UO targets. One study targeted invasive haemodynamic variables, but this did not significantly affect patient outcome.ConclusionsFew studies have researched resuscitation endpoints for children with burns. Those that have done so have investigated heterogeneous endpoints and endpoint targets. There is a need for future randomised controlled trials to identify optimal endpoints with which to target fluid resuscitation in children with burns.

scholarly journals Effects of supplementation with carnosine and other histidine-containing dipeptides on chronic disease risk factors and outcomes: protocol for a systematic review of randomised controlled trials

BMJ Open ◽  
2018 ◽  
Vol 8 (3) ◽  
pp. e020623 ◽  
Author(s):  
Kirthi Menon ◽  
Aya Mousa ◽  
Barbora de Courten
Keyword(s):  
Risk Factors ◽  
Systematic Review ◽  
Chronic Disease ◽  
Chronic Diseases ◽  
Randomised Controlled Trials ◽  
Disease Risk ◽  
Primary Data ◽  
Controlled Trials ◽  
Chronic Disease Risk ◽  
Randomised Controlled

IntroductionAgeing of populations globally, coupled with the obesity epidemic, has resulted in the rising prevalence of chronic diseases including diabetes, cardiovascular diseases, cancers and neurodegenerative disorders. Prevention of risk factors that contribute to these diseases is key in managing the global burden of chronic diseases. Recent studies suggest that carnosine, a dipeptide with anti-inflammatory, antioxidative and antiglycating properties may have a role in the prevention of chronic diseases; however, no previous reviews have examined the effects of carnosine and other histidine-containing peptides (HCDs) on chronic disease risk factors and outcomes. We aim to conduct a comprehensive systematic review to examine the effects of supplementation with carnosine and other HCDs on chronic disease risk factors and outcomes and to identify relevant knowledge gaps.Methods and analysisElectronic databases including Medline, Cumulative Index of Nursing and Allied Health, Embase and all Evidence-Based Medicine will be systematically searched to identify randomised controlled trials (RCTs) and systematic reviews of RCTs, comparing supplementation with carnosine and/or other HCDs versus placebo, usual care or other pharmacological or non-pharmacological interventions. One reviewer will screen titles and abstracts for eligibility according to prespecified inclusion criteria, after which two independent reviewers will perform data extraction and quality appraisal. Meta-analyses, metaregression and subgroup analyses will be conducted where appropriate.Ethics and disseminationEthics approval is not required as this review does not involve primary data collection. This review will generate level-one evidence regarding the effects of carnosine supplementation on chronic disease risk factors and outcomes and will be disseminated through peer-reviewed publications and at conference meetings to inform future research on the efficacy of carnosine supplementation for the prevention of chronic diseases.PROSPERO registration numberCRD42017075354.

scholarly journals Efficacy of pharmacological therapies in patients with IBS with diarrhoea or mixed stool pattern: systematic review and network meta-analysis

Gut ◽  
2019 ◽  
Vol 69 (1) ◽  
pp. 74-82 ◽  
Author(s):  
Christopher J Black ◽  
Nicholas E Burr ◽  
Michael Camilleri ◽  
David L Earnest ◽  
Eamonn MM Quigley ◽  
...  
Keyword(s):  
Abdominal Pain ◽  
Meta Analysis ◽  
Composite Endpoint ◽  
Response To Therapy ◽  
Stool Consistency ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Once Daily ◽  
Central Register ◽  
Randomised Controlled

ObjectiveOver half of patients with IBS have either diarrhoea (IBS-D) or a mixed stool pattern (IBS-M). The relative efficacy of licenced pharmacological therapies is unclear in the absence of head-to-head trials. We conducted a network meta-analysis to resolve this uncertainty.DesignWe searched MEDLINE, Embase, Embase Classic, the Cochrane central register of controlled trials, and Clinicaltrials.gov through January 2019 to identify randomised controlled trials (RCTs) assessing the efficacy of licenced pharmacological therapies (alosetron, eluxadoline, ramosetron and rifaximin) in adults with IBS-D or IBS-M. Trials included in the analysis reported a dichotomous assessment of overall response to therapy, and data were pooled using a random effects model. Efficacy and safety of all pharmacological therapies were reported as a pooled relative risk with 95% CIs to summarise the effect of each comparison tested. Treatments were ranked according to their p score.ResultsWe identified 18 eligible RCTs (seven alosetron, five ramosetron, two rifaximin and four eluxadoline), containing 9844 patients. All were superior to placebo for the treatment of IBS-D or IBS-M at 12 weeks, according to the Food and Drug Administration (FDA)-recommended endpoint for trials in IBS. Alosetron 1 mg twice daily was ranked first for efficacy, based on the FDA-recommended composite endpoint of improvement in both abdominal pain and stool consistency, effect on global symptoms of IBS and effect on stool consistency. Ramosetron 2.5µg once daily was ranked first for effect on abdominal pain. Total numbers of adverse events were significantly greater with alosetron 1 mg twice daily and ramosetron 2.5µg once daily, compared with placebo. Rifaximin 550 mg three times daily ranked first for safety. Constipation was significantly more common with all drugs, except rifaximin 550 mg three times daily.ConclusionIn a network meta-analysis of RCTs of pharmacological therapies for IBS-D and IBS-M, we found all drugs to be superior to placebo, but alosetron and ramosetron appeared to be the most effective.

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