The effect of nut consumption on markers of inflammation and endothelial function: a systematic review and meta-analysis of randomised controlled trials

ObjectivesTo examine the effect of nut consumption on inflammatory biomarkers and endothelial function.DesignA systematic review and meta-analysis.Data sourcesMEDLINE, PubMed, Cumulative Index to Nursing and Allied Health Literature and Cochrane Central Register of Controlled Trials (all years to 13 January 2017).Eligibility criteriaRandomised controlled trials (with a duration of 3 weeks or more) or prospective cohort designs conducted in adults; studies assessing the effect of consumption of tree nuts or peanuts on C-reactive protein (CRP), adiponectin, tumour necrosis factor alpha, interleukin-6, intercellular adhesion molecule 1, vascular cell adhesion protein 1 and flow-mediated dilation (FMD).Data extraction and analysisRelevant data were extracted for summary tables and analyses by two independent researchers. Random effects meta-analyses were conducted to explore weighted mean differences (WMD) in change or final mean values for each outcome.ResultsA total of 32 studies (all randomised controlled trials) were included in the review. The effect of nut consumption on FMD was explored in nine strata from eight studies (involving 652 participants), with consumption of nuts resulting in significant improvements in FMD (WMD: 0.79%(95% CI 0.35 to 1.23)). Nut consumption resulted in small, non-significant differences in CRP (WMD: −0.01 mg/L (95% CI −0.06 to 0.03)) (26 strata from 25 studies), although sensitivity analyses suggest results for CRP may have been influenced by two individual studies. Small, non-significant differences were also found for other biomarkers of inflammation.ConclusionsThis systematic review and meta-analysis of the effects of nut consumption on inflammation and endothelial function found evidence for favourable effects on FMD, a measure of endothelial function. Non-significant changes in other biomarkers indicate a lack of consistent evidence for effects of nut consumption on inflammation. The findings of this analysis suggest a need for more research in this area, with a particular focus on randomised controlled trials.PROSPERO registration numberCRD42016045424.

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Safety of tranexamic acid in thrombotic adverse events and seizure in patients with haemorrhage: a protocol for a systematic review and meta-analysis

BMJ Open ◽

10.1136/bmjopen-2019-036020 ◽

2020 ◽

Vol 10 (6) ◽

pp. e036020

Author(s):

Shuhei Murao ◽

Hidekazu Nakata ◽

Kazuma Yamakawa

Keyword(s):

Systematic Review ◽

Adverse Events ◽

Tranexamic Acid ◽

Randomised Controlled Trials ◽

Meta Analysis ◽

Underlying Disease ◽

Sensitivity Analyses ◽

Controlled Trials ◽

Cochrane Central Register ◽

Randomised Controlled

IntroductionTranexamic acid (TXA) is a synthetic derivative of the amino acid lysine that inhibits fibrinolysis by blocking lysine-binding sites on plasminogen, which contribute to reduced bleeding, the need for transfusion and mortality. Although there is reliable evidence of the efficacy of TXA, its effects on other important outcomes, adverse events, including thrombotic events and seizure, remain uncertain.Methods and analysisWe will conduct a systematic review and meta-analysis of randomised controlled trials with the objective of evaluating the incidence of thrombotic adverse events and seizure and how the effect of TXA varies by dose and underlying disease. We will include patients with bleeding in any underlying disease. We will search MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials for randomised controlled trials. The planned date of our systematic search is 1 June 2020. We will follow the recommendations of the Cochrane Collaboration and the Preferred Reporting Items for Systematic Review and Meta-Analysis statement. Subgroup and sensitivity analyses will be performed to explore residual heterogeneity and inconsistency. Meta-regression analysis will be carried out to investigate the association between the incidence of adverse events and the TXA dose. The risk of systematic errors (bias) and random errors will be assessed and the overall quality of evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation approach.Ethics and disseminationThis study will not involve primary data collection, and formal ethics approval will therefore not be required. We aim to publish this systematic review in a peer-review journal.Trial registration numberUMIN000039611.

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Parathyroid hormone analogues for fracture healing: protocol for a systematic review and meta-analysis of randomised controlled trials

BMJ Open ◽

10.1136/bmjopen-2017-019291 ◽

2018 ◽

Vol 8 (1) ◽

pp. e019291 ◽

Cited By ~ 5

Author(s):

Shenghan Lou ◽

Houchen Lv ◽

Zhirui Li ◽

Peifu Tang ◽

Yansong Wang

Keyword(s):

Systematic Review ◽

Parathyroid Hormone ◽

Fracture Healing ◽

Randomised Controlled Trials ◽

Meta Analysis ◽

Sensitivity Analyses ◽

Published Data ◽

Controlled Trials ◽

Anabolic Effect ◽

Randomised Controlled

IntroductionFracture healing is a complex physiological process. Impaired healing will increase the need for care and cause serious complications. Thus, identifying strategies to accelerate the rate of healing, preventing delayed unions and non-unions, is essential. Parathyroid hormone (PTH) is a key systemic regulator of calcium and phosphate metabolism. It has been determined that intermittent administration of PTH and its analogue can exert anabolic effect on bone, increase bone mass and reduce bone loss, leading to an increase in bone formation. Owing to their anabolic effect, there is an increasing interest in its potential in promoting the process of fracture healing. However, in clinical studies, the results are in conflict. This objective of this study is to determine the role of PTH analogues for fracture healing in adults.Methods and analysisMEDLINE, EMBASE and Cochrane databases will be searched to identify all randomised controlled trials (RCTs) and quasi-RCTs that compare the different effects between PTH analogues and any other treatments in adults with any type of fracture. The primary outcome is the functional recovery. And the secondary outcomes are fracture union and adverse events. The meta-analysis will be performed using a random effects model. Heterogeneity will be assessed by the P values and I² statistic. And subgroup analyses and sensitivity analyses will be used to explore the heterogeneity. Risk of bias will be assessed using the Cochrane tool and the quality of evidence will be assessed using the Grading of Recommendations Assessment, Development and Evaluation approach.Ethics and disseminationEthical approval is not required because this proposed systematic review and meta-analysis is based on published data, without including confidential personal data or data on interventions on patients. The findings of this study will be published in a peer-reviewed journaland presented at a relevant conference.PROSPERO registration numberCRD42017062093.

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Lowering blood pressure after acute intracerebral haemorrhage: protocol for a systematic review and meta-analysis using individual patient data from randomised controlled trials participating in the Blood Pressure in Acute Stroke Collaboration (BASC)

BMJ Open ◽

10.1136/bmjopen-2019-030121 ◽

2019 ◽

Vol 9 (7) ◽

pp. e030121 ◽

Cited By ~ 3

Author(s):

Tom J Moullaali ◽

Xia Wang ◽

Lisa J Woodhouse ◽

Zhe Kang Law ◽

Candice Delcourt ◽

...

Keyword(s):

Systematic Review ◽

Blood Pressure ◽

Acute Stroke ◽

Intracerebral Haemorrhage ◽

Randomised Controlled Trials ◽

Meta Analysis ◽

Patient Data ◽

Controlled Trials ◽

Cochrane Central Register ◽

Randomised Controlled

IntroductionConflicting results from multiple randomised trials indicate that the methods and effects of blood pressure (BP) reduction after acute intracerebral haemorrhage (ICH) are complex. The Blood pressure in Acute Stroke Collaboration is an international collaboration, which aims to determine the optimal management of BP after acute stroke including ICH.Methods and analysisA systematic review will be undertaken according to the Preferred Reporting Items for Systematic review and Meta-Analysis of Individual Participant Data (IPD) guideline. A search of Cochrane Central Register of Controlled Trials, EMBASE and MEDLINE from inception will be conducted to identify randomised controlled trials of BP management in adults with acute spontaneous (non-traumatic) ICH enrolled within the first 7 days of symptom onset. Authors of studies that meet the inclusion criteria will be invited to share their IPD. The primary outcome will be functional outcome according to the modified Rankin Scale. Safety outcomes will be early neurological deterioration, symptomatic hypotension and serious adverse events. Secondary outcomes will include death and neuroradiological and haemodynamic variables. Meta-analyses of pooled IPD using the intention-to-treat dataset of included trials, including subgroup analyses to assess modification of the effects of BP lowering by time to treatment, treatment strategy and patient’s demographic, clinical and prestroke neuroradiological characteristics.Ethics and disseminationNo new patient data will be collected nor is there any deviation from the original purposes of each study where ethical approvals were granted; therefore, further ethical approval is not required. Results will be reported in international peer-reviewed journals.PROSPERO registration numberCRD42019141136.

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Effectiveness of complex multiple-risk lifestyle interventions in reducing symptoms of depression: a study protocol for a systematic review and meta-analysis of randomised controlled trials

BMJ Open ◽

10.1136/bmjopen-2018-026842 ◽

2019 ◽

Vol 9 (3) ◽

pp. e026842 ◽

Cited By ~ 1

Author(s):

Irene Gómez-Gómez ◽

Emma Motrico ◽

Patricia Moreno-Peral ◽

Alina Rigabert ◽

Sonia Conejo-Cerón ◽

...

Keyword(s):

Systematic Review ◽

Randomised Controlled Trials ◽

Meta Analysis ◽

Depression Symptoms ◽

Controlled Trials ◽

Cochrane Central Register ◽

Lifestyle Interventions ◽

Symptoms Of Depression ◽

Multiple Risk ◽

Randomised Controlled

IntroductionMany studies have explored the impact of lifestyle interventions on depression. However, little is known about the effectiveness of complex multiple-risk lifestyle interventions in reducing symptoms of depression. Our objective is to assess the effectiveness of complex multiple-risk lifestyle interventions in reducing depressive symptoms in the adult population by the acquisition of at least two healthy habits—healthy diet, physical activity and/or smoking cessation. For such purpose, a systematic review and meta-analysis of randomised controlled trials will be conducted.Method and analysisMEDLINE (through Ovid and PubMed), Scopus, Cochrane Central Register of Controlled Trials, Web of Science, PsycINFO, OpenGrey Register (System for Information on Grey Literature in Europe) and the International Clinical Trials Registry Platform will be searched for relevant articles. Additionally, a supplementary manual search will be performed using lists of references, references to expert authors and other systematic reviews and/or meta-analyses. Study selection, data extraction (target habits, country, target populations, conditions and statistical data to name a few) and assessment of the risk of bias will be performed separately by two independent researchers. The primary outcome measure will be the reduction of depression symptoms, as measured by validated instruments. We will calculate pooled standardised mean differences and 95% CIs using random-effect models. Heterogeneity, sensitivity and publication bias will be assessed, and sub-group analysis will be performed. Heterogeneity will be explored by random-effects meta-regression analysis.Ethics and disseminationEthical approval is not required for this study. The results of this systematic review and meta-analysis will be presented in relevant conferences and published in a peer-review journal. The findings of this study could have important clinical and scientific implications for the improvement of symptoms of depression.PROSPERO registration numberCRD42018100253; Pre-results.

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Benefits of probiotics in preterm neonates in low-income and medium-income countries: a systematic review of randomised controlled trials

BMJ Open ◽

10.1136/bmjopen-2017-017638 ◽

2017 ◽

Vol 7 (12) ◽

pp. e017638 ◽

Cited By ~ 31

Author(s):

Girish Deshpande ◽

Gayatri Jape ◽

Shripada Rao ◽

Sanjay Patole

Keyword(s):

Systematic Review ◽

Mortality Rate ◽

Low Income ◽

Randomised Controlled Trials ◽

Meta Analysis ◽

Preterm Neonates ◽

Controlled Trials ◽

Cochrane Central Register ◽

Mortality And Morbidity ◽

Randomised Controlled

ObjectiveAlthough there is an overall reduction in underfive mortality rate, the progress in reducing neonatal mortality rate has been very slow. Over the last 20 years, preterm births have steadily increased in low-income and medium-income countries (LMICs) particularly in sub-Saharan Africa and South Asia. Preterm birth is associated with increased mortality and morbidity, particularly in LMICs. Based on systematic reviews of randomised controlled trials (RCTs), many neonatal units in high-income countries have adopted probiotics as standard of care for preterm neonates. We aimed to systematically review the safety and efficacy of probiotics in reducing mortality and morbidity in preterm neonates in LMICs.DesignSystematic review and meta-analysis of RCTs.Data sourcesMedline, Embase, Cochrane Central Register of Controlled Trials, Cumulative Index of Nursing and Allied Health Literature and E-abstracts from Pediatric Academic Society meetings and other paediatric and neonatal conference proceedings were searched in January 2017.Eligibility criteriaRCTs comparing probiotics versus placebo/no probiotic in preterm neonates (gestation<37 weeks) conducted in LMICs.ResultsTotal 23 (n=4783) RCTs from 4 continents and 10 LMICs were eligible for inclusion in the meta-analysis using fixed effect model. The risk of necrotising enterocolitis (NEC greater than or equal to stage II) (risk ratio (RR) 0.46 (95% CI 0.34 to 0.61), P<0.00001, numbers needed to treat (NNT) 25 (95% CI 20 to 50)), late-onset sepsis (LOS) (RR 0.80 (95% CI 0.71 to 0.91), P=0.0009, NNT 25 (95% CI 17 to 100)) and all-cause mortality (RR 0.73 (95% CI 0.59 to 0.90), P=0.003, NNT 50 (95% CI 25 to 100)) were significantly lower in probiotic supplemented neonates. The results were significant on random effects model analysis and after excluding studies with high risk of bias. No significant adverse effects were reported.ConclusionProbiotics have significant potential to reduce mortality and morbidity (eg, NEC, LOS) in preterm neonates in LMICs.

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Impact of levothyroxine in women with positive thyroid antibodies on pregnancy outcomes: a systematic review and meta-analysis of randomised controlled trials

BMJ Open ◽

10.1136/bmjopen-2020-043751 ◽

2021 ◽

Vol 11 (2) ◽

pp. e043751

Author(s):

Lorraine Lau ◽

Jamie L Benham ◽

Patricia Lemieux ◽

Jennifer Yamamoto ◽

Lois E Donovan

Keyword(s):

Systematic Review ◽

Preterm Delivery ◽

Pregnancy Outcomes ◽

Randomised Controlled Trials ◽

Meta Analysis ◽

Risk Of Bias ◽

Controlled Trials ◽

Cochrane Central Register ◽

Significant Difference ◽

Randomised Controlled

ObjectiveTo evaluate the effect of levothyroxine therapy on pregnancy outcomes compared with placebo or no treatment in women without overt hypothyroidism with presence of thyroid peroxidase antibodies (TPOAb) and/or thyroglobulin antibodies (TgAb).DesignSystematic review and meta-analysis of randomised controlled trialsStudy eligibility criteriaPrespecified criteria for inclusion were: randomised trials of levothyroxine versus control (placebo or no treatment) among women with positive TPOAb or TgAb who were pregnant or considering conception.Data sourcesOvid MEDLINE, EMBASE, CINAHL, Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Trials were searched from 1980 to 5 November 2020.Outcome measuresPrespecified data elements were extracted and where appropriate, meta-analyses were conducted. Main outcomes include pregnancy achieved, miscarriage, preterm delivery and live birth.Risk of bias assessmentCochrane Risk of Bias Tool for Quality Assessment of Randomised Controlled Trials.ResultsFrom 3023 citations, 79 citations were identified for full-text review. Of these, six trials (total of 2263 women) were included for qualitative and quantitative analyses. Risk of bias was deemed low for only one trial. There was no significant difference in the relative risk (RR) of pregnancy achieved (RR 1.03; 95% CI 0.93 to 1.13), miscarriage (RR 0.93; 95% CI 0.76 to 1.14), preterm delivery (RR 0.66; 95% CI 0.39 to 1.10) or live births (RR 1.01; 95% CI 0.89 to 1.16) in thyroid autoimmune women treated with levothyroxine compared with controls. Sensitivity analyses of preterm birth identified study quality and timing of levothyroxine initiation as sources of heterogeneity.ConclusionsAmong pregnant women or women planning conception, with thyroid autoimmunity, there is a lack of evidence of benefit for levothyroxine use (moderate to high Grading of Recommendations, Assessment, Development and Evaluations). Recommendations to use levothyroxine in this setting need to be reconsidered.PROSPERO registration numberCRD42019130459.

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Exercise for premenstrual syndrome: a systematic review and meta-analysis of randomised controlled trials

BJGP Open ◽

10.3399/bjgpopen20x101032 ◽

2020 ◽

Vol 4 (3) ◽

pp. bjgpopen20X101032 ◽

Cited By ~ 1

Author(s):

Emma Pearce ◽

Kate Jolly ◽

Laura L Jones ◽

Gemma Matthewman ◽

Mandana Zanganeh ◽

...

Keyword(s):

Systematic Review ◽

Premenstrual Syndrome ◽

Randomised Controlled Trials ◽

Primary Outcome ◽

Meta Analysis ◽

Current Evidence ◽

Controlled Trials ◽

Cochrane Central Register ◽

Exercise Interventions ◽

Randomised Controlled

BackgroundExercise is recommended as a treatment for premenstrual syndrome (PMS) in clinical guidelines, but this is currently based on poor-quality trial evidence.AimTo systematically review the evidence for the effectiveness of exercise as a treatment for PMS.Design & settingThis systematic review searched eight major databases, including MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL), and two trial registries from inception until April 2019.MethodRandomised controlled trials (RCTs) comparing exercise interventions of a minimum of 8-weeks duration with non-exercise comparator groups in women with PMS were included. Mean change scores for any continuous PMS outcome measure were extracted from eligible trials and standardised mean differences (SMDs) were calculated where possible. Random-effects meta-analysis of the effect of exercise on global PMS symptoms was the primary outcome. Secondary analyses examined the effects of exercise on predetermined clusters of psychological, physical, and behavioural symptoms.ResultsA total of 436 non-duplicate returns were screened, with 15 RCTs eligible for inclusion (n = 717). Seven trials contributed data to the primary outcome meta-analysis (n = 265); participants randomised to an exercise intervention reported reduced global PMS symptom scores (SMD = -1.08; 95% confidence interval [CI] = -1.88 to -0.29) versus comparator, but with substantial heterogeneity (I2 = 87%). Secondary results for psychological (SMD = -1.67; 95% CI = -2.38 to -0.96), physical (SMD = -1.62; 95% CI = -2.41 to -0.83) and behavioural (SMD = -1.94; 95% CI = -2.45 to -1.44) symptom groupings displayed similar findings. Most trials (87%) were considered at high risk of bias.ConclusionBased on current evidence, exercise may be an effective treatment for PMS, but some uncertainty remains.

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Effect of Kangaroo Mother Care on Successful Breastfeeding: A Systematic Review and Meta-Analysis of Randomised Controlled Trials

Reviews on Recent Clinical Trials ◽

10.2174/1574887113666180924165844 ◽

2019 ◽

Vol 14 (1) ◽

pp. 31-40 ◽

Cited By ~ 3

Author(s):

Morteza Ghojazadeh ◽

Sakineh Hajebrahimi ◽

Fatemeh Pournaghi-Azar ◽

Mohammad Mohseni ◽

Naser Derakhshani ◽

...

Keyword(s):

Systematic Review ◽

Breast Feeding ◽

Randomised Controlled Trials ◽

Assessment Tool ◽

Meta Analysis ◽

Kangaroo Mother Care ◽

Risk Of Bias ◽

Controlled Trials ◽

Cochrane Central Register ◽

Randomised Controlled

Background & Aims: Evaluating the effect of Kangaroo Mother Care (KMC) on breastfeeding success shows conflicting results. Regarding the importance of breastfeeding and uncertainties about its effect, this study intended to conduct a systematic review and meta-analysis of randomised controlled trials on the effect of KMC on success of breastfeeding. </P><P> Methods: In this systematic review and meta-analysis study, required data were collected by searching the following keywords: breastfeeding, Breast-Feeding, “skin-to-skin”, “Kangaroo Mother Care”, randomized clinical trial. The following databases were searched: Google Scholar, PubMed, EMBASE, Scopus, and Cochrane Central Register of Controlled Trials. Two authors independently extracted the data. To estimate the Breast-Feeding outcome variables, CMA2 software was used. The risk of bias of studies was assessed with the criteria developed in the Cochrane Handbook. Results: Twenty articles were included. In the KMC and CNC groups, 1,432 and 1,410 neonates were examined. Breastfeeding success rate was higher in the KMC group within different time slots, however this difference was not statistically significant (RR=1.11(95CI, 0.93-1.34) and RR=1.13(95%CI, 0.92-1.34) based on the time slot and birth weight, respectively). The inter-groups differences in the mean scores of Infant Breast-Feeding Assessment Tool (IBFAT) were statistically significant (P<0.05). Breastfeeding was initiated very sooner in the KMC group, suggesting a statistically significant inter-groups difference -0.72(95%CI, from -0.92 to -0.53) (P<0.05). Majority of the studies had a high risk of bias. Conclusion: Findings indicated a superiority of KMC over CNC in terms of breastfeeding success. Assessment of the complications and costs of KMC implementation is recommended.

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Helicobacter pylorieradication treatment for gastric carcinoma prevention in asymptomatic or dyspeptic adults: systematic review and Bayesian meta-analysis of randomised controlled trials

BMJ Open ◽

10.1136/bmjopen-2018-026002 ◽

2019 ◽

Vol 9 (9) ◽

pp. e026002 ◽

Cited By ~ 1

Author(s):

Teruhiko Terasawa ◽

Chisato Hamashima ◽

Katsuaki Kato ◽

Isao Miyashiro ◽

Takaki Yoshikawa ◽

...

Keyword(s):

Systematic Review ◽

Gastric Carcinoma ◽

Randomised Controlled Trials ◽

Meta Analysis ◽

Eradication Therapy ◽

Sensitivity Analyses ◽

Controlled Trials ◽

H Pylori ◽

Randomised Controlled ◽

Carcinoma Risk

ObjectivesRecent meta-analyses of eradication therapy inHelicobacter pylori-infected adults reported significant reductions in gastric carcinoma risk. However, concerns about supporting unfocused screening and eradication programme in healthy, asymptomatic populations have arisen. We performed a systematic review and Bayesian meta-analysis to provide an accurate interpretation of randomised evidence on the preventive effectiveness of eradication therapy on gastric carcinoma risk.MethodsWe searched databases including PubMed, Cochrane Central and Embase for reference and citation tracking without language restrictions, from inception through 31 July 2018. Paired investigators independently selected randomised controlled trials (RCTs) comparing eradication therapy with placebo or no treatment for asymptomatic or dyspepticH. pylori-infected adults with no previous gastric carcinoma. The main outcome was gastric carcinoma incidence; secondary outcomes included gastric carcinoma-specific, non-gastric carcinoma and all-cause mortality.ResultsA total of 5 population-based and 2 outpatient care-based RCTs involving 7303 adults were eligible. Eradication algorithms were heterogeneous, and unsuccessful eradication and reinfection were frequently observed. A Bayesian meta-analysis with competing risk outcomes found low-certainty evidence that eradication therapy might be more likely than control to reduce gastric carcinoma risk (HR=0.65; 95% credible interval (CrI) 0.41 to 1.0;I2=11%). The CrIs included the null effects across the subgroup and sensitivity analyses, apart from those based on particular models that excluded two RCTs that enrolled subjects with specific histological findings only (HR=0.55; CrI 0.30 to 0.89;I2=14%). The uncertainty of the average 41% risk reduction in gastric carcinoma-specific mortality included a clinically important mortality risk increase (HR=0.59 favouring eradication therapy; CrI 0.25 to 1.20;I2=13%; low certainty).ConclusionsThere is insufficient evidence to support or refute the effectiveness of eradication therapy in preventing gastric carcinoma inH. pylori-infected, high-risk populations. Rigorously conducted large RCTs of healthy infected adults only would provide evidence of the true efficacy of successful eradication.PROSPERO registration number:CRD42014009245.

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