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

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e043751
Author(s):  
Lorraine Lau ◽  
Jamie L Benham ◽  
Patricia Lemieux ◽  
Jennifer Yamamoto ◽  
Lois E Donovan

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.

2019 ◽  
Vol 14 (1) ◽  
pp. 31-40 ◽  
Author(s):  
Morteza Ghojazadeh ◽  
Sakineh Hajebrahimi ◽  
Fatemeh Pournaghi-Azar ◽  
Mohammad Mohseni ◽  
Naser Derakhshani ◽  
...  

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.


BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e034424 ◽  
Author(s):  
Carmen Martín-Gómez ◽  
Patricia Moreno-Peral ◽  
Juan A Bellón ◽  
Sonia Conejo Cerón ◽  
Henar Campos-Paino ◽  
...  

IntroductionThe prevalence of postpartum depression (PPD) is 17%, and the incidence is 12% worldwide. Adverse consequences for mothers and babies have been associated with this disease. To assess the effectiveness of psychological, psychoeducational and psychosocial interventions in preventing PPD, a systematic review and meta-analysis (SR/MA) will be conducted.Methods and analysisA SR/MA will be performed following the indications of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Studies will be identified through MEDLINE (Ovid and PubMed), PsycINFO, Web of Science, Scopus, CINAHL, Cochrane Central Register of Controlled Trials, OpenGrey, Australian New Zealand Clinical Trial Registry, ClinicalTrials.gov and evidencebasedtherapy.org from inception until 31 January 2020. Bridging searches will be also conducted until the review is completed. The selection criteria will be as follows: (1) subjects will be pregnant females or females who have given birth in the last 12 months and who were non-depressive at baseline; (2) psychological, psychoeducational and psychosocial interventions; (3) comparator will be usual care, attention control, waiting list or no intervention; (4) outcomes will be specific results on PPD; and (5) the design of the studies will be randomised controlled trials. No restrictions regarding the year of publication, the setting of the intervention or the language of publication will be considered. Pooled standardised mean differences and 95% CIs will be calculated. The risk of bias of the studies will be assessed through the Cochrane Collaboration risk of bias tool. Heterogeneity between the studies will be determined by the I2 and Cochran’s Q statistics. Sensitivity and subgroup analyses will also be performed. Publication bias will be checked with funnel plots and Egger’s test. Heterogeneity will be explored by random-effects meta-regression analysis.Ethics and disseminationThe ethical assessment was not required. The results will be presented at conferences and disseminated through publications.PROSPERO registration numberCRD42018109981.


PLoS Medicine ◽  
2021 ◽  
Vol 18 (11) ◽  
pp. e1003821
Author(s):  
Cini Bhanu ◽  
Danielle Nimmons ◽  
Irene Petersen ◽  
Mine Orlu ◽  
Daniel Davis ◽  
...  

Background Drug-induced orthostatic hypotension (OH) is common, and its resulting cerebral hypoperfusion is linked to adverse outcomes including falls, strokes, cognitive impairment, and increased mortality. The extent to which specific medications are associated with OH remains unclear. Methods and findings We conducted a systematic review and meta-analysis to evaluate the extent to which specific drug groups are associated with OH. EMBASE, MEDLINE, and Web of Science databases were searched from inception through 23 November 2020. Placebo-controlled randomised controlled trials (RCTs) on any drug reporting on OH as an adverse effect in adults (≥18 years) were eligible. Three authors extracted data on the drug, OH, dose, participant characteristics, and study setting. The revised Cochrane risk-of-bias tool for randomised trials (RoB 2) was used to appraise evidence. Summary odds ratios (ORs) were estimated for OH using fixed effects Mantel–Haenszel statistics. We conducted subgroup analysis on validity of OH measurement, drug dose, risk of bias, age, and comorbidity. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) tool was used to summarise the certainty of evidence. Of 36,940 citations, 69 eligible RCTs were included in the meta-analysis comprising 27,079 participants. Compared with placebo, beta-blockers and tricyclic antidepressants were associated with increased odds of OH (OR 7.76 [95% CI 2.51, 24.03]; OR 6.30 [95% CI 2.86, 13.91]). Alpha-blockers, antipsychotics, and SGLT-2 inhibitors were associated with up to 2-fold increased odds of OH, compared to placebo. There was no statistically significant difference in odds of OH with vasodilators (CCBs, ACE inhibitors/ARBs, SSRIs), compared to placebo. Limitations of this study are as follows: data limited to placebo-controlled studies, (excluding head-to-head trials), many RCTs excluded older participants; therefore results may be amplified in older patients in the clinical setting. The study protocol is publicly available on PROSPERO (CRD42020168697). Conclusions Medications prescribed for common conditions (including depression, diabetes, and lower urinary tract symptoms) were associated with significantly increased odds of OH. Drugs causing sympathetic inhibition were associated with significantly increased odds of OH, while most vasodilators were associated with small nonsignificant differences in odds of OH, compared to placebo. Drugs targeting multiple parts of the orthostatic blood pressure (BP) reflex pathway (e.g. sympathetic inhibition, vasodilation, cardio-inhibitory effects) may carry cumulative risk, suggesting that individuals with polypharmacy could benefit from postural BP monitoring.


2021 ◽  
pp. 146531252110560
Author(s):  
Nidhi P Parmar ◽  
Gabrielle L Thompson ◽  
Nikki E Atack ◽  
Anthony J Ireland ◽  
Martyn Sherriff ◽  
...  

Background: Decalcification and gingivitis caused by plaque accumulation around brackets are common iatrogenic effects of fixed appliances. The influence of conventional versus self-ligating bracket design on microbial colonisation is unknown. Objective: To assess the levels of microbial colonisation associated with conventional and self-ligating brackets. Search sources: Three databases were searched for publications from 2009 to 2021. Data selection: Randomised controlled trials comparing levels of microbial colonisation before and during treatment with conventional and self-ligating brackets were assessed independently and in duplicate. Data extraction: Data were extracted independently by two authors from the studies that fulfilled the inclusion criteria. Risk of bias assessments were made using the revised Cochrane risk of bias tool for randomized trials. The quality of the included studies was assessed using the Critical Appraisal Skills Programme Checklist. Results: A total of 11 randomised controlled trials were included in this systematic review. Six of the studies were found to be at low risk of bias and five presented with some concerns. The studies were considered moderate to high quality. Five trials reported no statistically significant difference in microbial colonisation between bracket types. The remaining studies showed mixed results, with some reporting increased colonisation of conventional brackets and others increased colonisation of self-ligating brackets. The heterogeneity of study methods and outcomes precluded meta-analysis. Conclusion: Of the 11 studies included in this systematic review, five found no differences in colonisation between conventional and self-ligating brackets. The remaining studies showed mixed results. The evidence is inconclusive regarding the association between bracket design and levels of microbial colonisation.


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.


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.


BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e030121 ◽  
Author(s):  
Tom J Moullaali ◽  
Xia Wang ◽  
Lisa J Woodhouse ◽  
Zhe Kang Law ◽  
Candice Delcourt ◽  
...  

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.


BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e026842 ◽  
Author(s):  
Irene Gómez-Gómez ◽  
Emma Motrico ◽  
Patricia Moreno-Peral ◽  
Alina Rigabert ◽  
Sonia Conejo-Cerón ◽  
...  

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.


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.


2020 ◽  
Vol 124 (7) ◽  
pp. 641-653 ◽  
Author(s):  
Elizabeth P. Neale ◽  
Vivienne Guan ◽  
Linda C. Tapsell ◽  
Yasmine C. Probst

AbstractType 2 diabetes mellitus is a chronic disease increasing in global prevalence. Although habitual consumption of walnuts is associated with reduced risk of CVD, there is inconsistent evidence for the impact of walnut consumption on markers of glycaemic control. This systematic review and meta-analysis aimed to examine the effect of walnut consumption on markers of blood glucose control. A systematic search of Medline, PubMed, CINAHL and Cochrane databases (to 2 March 2019) was conducted. Inclusion criteria were randomised controlled trials conducted with adults which assessed the effect of walnut consumption on fasting blood glucose and insulin, glycated Hb and homeostatic model assessment of insulin resistance. Random effects meta-analyses were conducted to assess the weighted mean differences (WMD) for each outcome. Risk of bias in studies was assessed using the Cochrane Risk of Bias tool 2.0. Sixteen studies providing eighteen effect sizes were included in the review. Consumption of walnuts did not result in significant changes in fasting blood glucose levels (WMD: 0·331 mg/dl; 95 % CI −0·817, 1·479) or other outcome measures. Studies were determined to have either ‘some concerns’ or be at ‘high risk’ of bias. There was no evidence of an effect of walnut consumption on markers of blood glucose control. These findings suggest that the known favourable effects of walnut intake on CVD are not mediated via improvements in glycaemic control. Given the high risk of bias observed in the current evidence base, there is a need for further high-quality randomised controlled trials.


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