scholarly journals Efficacy and safety of vasopressin and terlipressin in preterm neonates: a protocol for a systematic review

2021 ◽  
Vol 5 (1) ◽  
pp. e001067
Author(s):  
Abdulrahman Salim Alsaadi ◽  
Katelyn Sushko ◽  
Vivian Bui ◽  
John Van Den Anker ◽  
Abdul Razak ◽  
...  

BackgroundThe use of vasoactive agents like arginine vasopressin (AVP) and terlipressin to treat hypotension or persistent pulmonary hypertension in critically ill preterm neonates is increasing. Therefore, a systematic review of the available data on dosing, efficacy and safety of AVP and terlipressin in this patient population appears beneficial.MethodsWe will conduct a systematic review of the available evidence on the use of AVP and terlipressin for the treatment of hypotension or persistent pulmonary hypertension in preterm neonates. We will search Ovid MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, Web of Science and Google Scholar from inception to March 2021. Two reviewers will independently screen titles and abstracts, review the full text of eligible studies, extract data, assess the risk of bias and judge the certainty of the evidence. Our primary outcome will be an (1) improvement of end-organ perfusion after initiation of AVP or terlipressin and (2) mortality prior to discharge. Our secondary outcomes will include (1) major neurosensory abnormality and (2) the occurrence of adverse events.DiscussionThe currently available evidence on the efficacy and safety of AVP and terlipressin in preterm neonates is limited. Yet, evidence on the pharmacology of these drugs and the pathophysiology of vasoplegic shock support the biological plausibility for their clinical effectiveness in this population. Therefore, we aim to address this gap concerning the use of vasopressin and terlipressin among critically ill preterm neonates.Trial registrationThis protocol has been submitted for registration to the international database of prospectively registered systematic reviews (PROSPERO, awaiting registration number).

2021 ◽  
Vol 5 (1) ◽  
pp. e001200
Author(s):  
Katelyn Sushko ◽  
Nada Al-Rawahi ◽  
Kristi Watterberg ◽  
John Van Den Anker ◽  
Catherine Litalien ◽  
...  

BackgroundImpaired adrenal function is a well-described entity in critically ill term and preterm neonates with systemic hypotension. The standard treatment for neonatal hypotension includes volume expanders and vasopressors. Recent evidence supports the use of glucocorticoids for the primary or rescue treatment of neonatal hypotension associated with impaired adrenal function. However, inconsistency regarding the prescribed dosing regimen to provide the best balance between efficacy and safety in this vulnerable population remains an area of concern.MethodsWe will conduct a systematic review and meta-analysis to evaluate low-dosing compared with high-dosing regimens of hydrocortisone for the treatment of hypotension in critically ill term, preterm and very low birth weight neonates. Ovid MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and Web of Science will be searched from inception to November 2021. Study screening and selection will be completed as per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guideline. Our primary outcomes will be (1) an improvement in end-organ perfusion, defined as an increase in blood pressure along with an increase in urine output or a reduction in serum lactate and (2) mortality prior to discharge. Our secondary outcomes will be the development of (1) major neurosensory abnormality, (2) bronchopulmonary dysplasia and (3) the occurrence of adverse events.DiscussionHydrocortisone may be beneficial in the treatment of hypotension associated with impaired adrenal function among critically ill neonates. However, its optimal dosing to balance desired efficacy with the risk of adverse events is yet to be determined. Our systematic review and meta-analysis aims to address this evidence gap, providing valuable knowledge for a large audience, including guideline developers, policy-makers and clinicians.PROSPERO registration numberThis protocol is submitted for registration to the international database of prospectively registered systematic reviews (PROSPERO, awaiting registration number).


2019 ◽  
Vol 13 (1) ◽  
pp. 32-44
Author(s):  
Nigel Ashworth ◽  
Henry Aidoo ◽  
Alexander Doroshenko ◽  
David Antle ◽  
Charl Els ◽  
...  

Objective:Botulinum Toxin (BTX) has become a widely used treatment in several dystonic conditions, but the evidence for its efficacy has largely come from open trials and expert opinion. This systematic review examined the efficacy and safety of BTX in the treatment of Focal Hand Dystonia (FHD) in Randomized Controlled Trials (RCTs).Methods:We searched Ovid MEDLINE, EMBASE, Cochrane Database of Systematic Reviews (CDSR), Database of Abstracts of Reviews of Effects (DARE), Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL, SPORT Discus, SCOPUS, Web of Science, PEDro, ClinicalTrials.gov, and the International Clinical Trials Registry Platform (ICTRP) for randomized, placebo-controlled trials on the use of BTX for FHD.Results:Of 1,116 publications retrieved from the databases searched, three publications were included. The evidence identified pertains to focal task-specific hand dystonias. Sixty-nine participants were involved in the three RCTs with a mean duration of symptoms of 7.5 years. Participants were assessed using a combination of self-reported and functional performance outcome measures following injections of BTX subtype A (BTX-A) or placebo. The Oxford Quality Scale was used to assess the included studies, and the three studies each scored 3/5 or above. The included studies reported no adverse events with BTX-A use, other than muscle weakness and pain at the injection sites.Conclusion:The number of participants included in these three trials is too small to draw dependable conclusions about the efficacy and safety of BTX-A for FHD. There is currently not enough evidence to recommend the routine use of BTX-A for FHD.


2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Najmeh Seifi ◽  
Ali Jafarzadeh Esfahani ◽  
Alireza Sedaghat ◽  
Reza Rezvani ◽  
Majid Khadem-Rezaiyan ◽  
...  

Abstract Purpose The objective of this systematic review was to evaluate the effect of pre-, pro-, and synbiotics on feeding tolerance of enterally fed critically ill adult patients. Methods MEDLINE, Science Direct, Web of Knowledge, and the Cochrane Central Register of Controlled Trials were searched up to November 2019. English language randomized controlled trials reporting the effect of pre, pro or synbiotics on the feeding tolerance of enterally fed critically ill adult patients were included. Results Overall, 15 papers were selected for review. Among six studies reporting the energy intake, only two studies showed significantly higher energy intake in the prebiotic-receiving groups. Among four RCTs reporting frequency or time to achieve the target calorie, only one found a significant effect of probiotics to reduce the time to achieve a target dose of calorie. About the prevalence or duration of diarrhea, 7 out of 12 RCTs reported a beneficial effect. All but one study found no beneficial effects for gut microbiota manipulation on clinical endpoints including length of stay (LOS) in hospital and intensive care unit (ICU). Conclusion It should be noticed that the heterogeneity in study designs, product format, and ICU patient populations makes it difficult to draw any general conclusion. Overall, it seems that pre, pro, or synbiotics have no significant beneficial effect on feeding tolerance and clinical endpoints in critically ill adults, but they may reduce the prevalence or duration of diarrhea.


BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e042597
Author(s):  
Xinyuan Liu ◽  
Qing Yang ◽  
Zhongning He ◽  
Shukun Yao

IntroductionFunctional constipation (FC) is a common digestive system disease, with an uptrend in morbidity and mortality, resulting in huge social and economic losses. Although the guidelines recommend lifestyle intervention as a first-line treatment, lifestyle intervention is not widely used in clinic. Inulin can be used as the basic material of functional food. Clinical studies have shown that inulin supplementation is associated with increased frequency of bowel movements, but has certain side effects. Therefore, the efficacy and safety of inulin in the treatment of FC need to be further evaluated.Methods and analysisWe will search Medline, Web of Science, Embase, China National Knowledge Infrastructure Database, Wanfang Database and China Biomedical Literature Database. We will also search the China Clinical Trial Registry, the Cochrane Central Register of Controlled Trials and related conference summaries. This systematic review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. RevMan V.5.3.5 will be used for analysis.Ethics and disseminationThis systematic review will evaluate the efficacy and safety of inulin supplementation for the treatment of FC. All included data will be obtained from published articles, there is no need for the ethical approval, and it will be published in a peer-reviewed journal. Due to lack of a new systematic review in this field, this study will combine relevant randomised controlled trials to better explore the evidence of inulin supplementation in the treatment of FC and guide clinical practice and clinical research.PROSPERO registration numberCRD42020189234.


2022 ◽  
pp. 019459982110677
Author(s):  
Firas Sbeih ◽  
Malek H. Bouzaher ◽  
Swathi Appachi ◽  
Seth Schwartz ◽  
Michael S. Cohen ◽  
...  

Objective To systematically review the literature to determine safety of cochlear implantation in pediatric patients 12 months and younger. Data Source Ovid MEDLINE, EMBASE, CINAHL, and Cochrane Central Register of Controlled Trials (CENTRAL) databases were searched from inception to March 20, 2021. Review Methods Studies that involved patients 12 months and younger with report of intraoperative or postoperative complication outcomes were included. Studies selected were reviewed for complications, explants, readmissions, and prolonged hospitalizations. Two independent reviewers screened all studies that were selected for the systematic review and meta-analysis. All studies included were assessed for quality and risk of bias. Results The literature search yielded 269 studies, of which 53 studies underwent full-text screening, and 18 studies were selected for the systematic review and meta-analysis. A total of 449 patients and 625 cochlear implants were assessed. Across all included studies, major complications were noted in 3.1% of patients (95% CI, 0.8-7.1) and 2.3% of cochlear implantations (95% CI, 0.6-5.2), whereas minor complications were noted in 2.4% of patients (95% CI, 0.4-6.0) and 1.8% of cochlear implantations (95% CI, 0.4-4.3). There were no anesthetic complications reported across all included studies. Conclusion The results of this systematic review and meta-analysis suggest that cochlear implantation in patients 12 months and younger is safe with similar rates of complications to older cohorts.


2019 ◽  
Vol 8 (1) ◽  
Author(s):  
James D. Millard ◽  
Elizabeth A. Mackay ◽  
Laura J. Bonnett ◽  
Geraint R. Davies

Abstract Background Pyrazinamide (PZA) is a key component of current and future regimens for tuberculosis (TB). Inclusion of PZA at higher doses and for longer durations may improve efficacy outcomes but must be balanced against the potential for worse safety outcomes. Methods We will search for randomised and quasi-randomised clinical trials in adult participants with and without the inclusion of PZA in TB treatment regimens in the Cochrane infectious diseases group’s trials register, Cochrane central register of controlled trials (CENTRAL), MEDLINE, EMBASE, LILACS, the metaRegister of Controlled Trials (mRCT) and the World Health Organization (WHO) international clinical trials registry platform. One author will screen abstracts and remove ineligible studies (10% of which will be double-screened by a second author). Two authors will review full texts for inclusion. Safety and efficacy data will be extracted to pre-piloted forms by one author (10% of which will be double-extracted by a second author). The Cochrane risk of bias tool will be used to assess study quality. The study has three objectives: the association of (1) inclusion, (2) dose and (3) duration of PZA with efficacy and safety outcomes. Risk ratios as relative measures of effect for direct comparisons within trials (all objectives) and proportions as absolute measures of effect for indirect comparisons across trials (for objectives 2 and 3) will be calculated. If there is insufficient data for direct comparisons within trials for objective 1, indirect comparisons between trials will be performed. Measures of effect will be pooled, with corresponding 95% confidence intervals and p values. Meta-analysis will be performed using the generalised inverse variance method for fixed effects models (FEM) or the DerSimonian-Laird method for random effects models (REM). For indirect comparisons, meta-regression for absolute measures against dose and duration data will be performed. Heterogeneity will be quantified through the I2-statistic for direct comparisons and the τ2 statistic for indirect comparisons using meta-regression. Discussion The current use of PZA for TB is based on over 60 years of clinical trial data, but this has never been synthesised to guide rationale use in future regimens and clinical trials. Systematic review registration: International Prospective Register of Systematic Reviews (PROSPERO) CRD42019138735


2020 ◽  
Vol 96 (8) ◽  
pp. 563-570
Author(s):  
Rosie L Latimer ◽  
Hannah S Shilling ◽  
Lenka A Vodstrcil ◽  
Dorothy A Machalek ◽  
Christopher K Fairley ◽  
...  

ObjectiveTo systematically review and appraise published data, to determine the prevalence of Mycoplasma genitalium (MG) in men who have sex with men (MSM) tested at each anatomical site, that is, at the urethra, rectum and/or pharynx.DesignSystematic review and meta-analysis.Data sourcesOvid Medline, PubMed, Embase were searched for articles from 1st January 1981 (the year MG was first identified) to 1st June 2018.Review methodsStudies were eligible for inclusion if they reported MG prevalence in MSM tested at the urethra, rectum and/or pharynx, in at least 50 MSM, using nucleic acid amplification testing. Data were extracted by anatomical site, symptom and HIV status. Summary estimates (95% CIs) were calculated using random-effects meta-analysis. Subgroup analyses were performed to assess heterogeneity between studies.ResultsForty-six studies met inclusion criteria, with 34 reporting estimates of MG prevalence at the urethra (13 753 samples), 25 at the rectum (8629 samples) and 7 at the pharynx (1871 samples). MG prevalence was 5.0% (95% CI 3.5 to 6.8; I2=94.0) at the urethra; 6.2% (95% CI 4.6 to 8.1; I2=88.1) at the rectum and 1.0% (95% CI 0.0 to 5.1; I2=96.0) at the pharynx. The prevalence of MG was significantly higher at urethral and rectal sites in symptomatic versus asymptomatic MSM (7.1% vs 2.2%, p<0.001; and 16.1% vs 7.5%, p=0.039, respectively). MG prevalence at the urethra was significantly higher in HIV-positive compared with HIV-negative MSM (7.0% vs 3.4%, p=0.006).ConclusionMG was common in MSM, particularly at urethral and rectal sites (5% to 6%). MG was more commonly detected in symptomatic men at both sites, and more common in HIV-positive men at the urethra. MG was uncommonly detected in the pharynx. Site-specific estimates are similar to those for chlamydia and will be helpful in informing testing practices in MSM.PROSPERO registration numberCRD42017058326.


BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e030713 ◽  
Author(s):  
Dacheng Li ◽  
Li Zhu ◽  
Daming Liu

IntroductionRefractory gastro-oesophageal reflux disease (rGORD) is a common disease, affecting patients’ quality of life. Since conventional medicines have limitations, like low effective rates and adverse events, acupuncture may be a promising therapy for rGORD. While no related systematic review has been published, the present study is designed to evaluate the efficacy and safety of acupuncture for rGORD.Methods and analysisPubMed, the Cochrane Central Register of Controlled Trials and Chinese electronic databases, including China National Knowledge Infrastructure, Wan Fang database, VIP, SinoMed and the Chinese Clinical Trial Registry, will be searched from establishment of the database to 31 August 2019. There will be no limitations on language, and all articles will be screened and collected by two reviewers independently. RevMan V.5.3.5 software will be used for meta-analysis, and the conduction of study will refer to the Cochrane Handbook for Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol guidelines. The efficacy and safety of acupuncture for rGORD will be evaluated based on outcomes, including global symptom improvement, oesophageal sphincter function test measured by high-resolution manometry, quality of life, recurrence rate and adverse events.Ethics and disseminationThere is no necessity for this study to acquire an ethical approval, and this review will be disseminated in a peer-reviewed journal or conference presentation.Trial registration numberCRD42018111912.


BMJ Open ◽  
2018 ◽  
Vol 8 (9) ◽  
pp. e023097 ◽  
Author(s):  
Amy R Mulick ◽  
Victoria Allen ◽  
Hywel C Williams ◽  
Douglas J C Grindlay ◽  
Neil Pearce ◽  
...  

IntroductionAtopic dermatitis is a complex disease with differing clinical presentations. Many attempts have been made to identify uniform subtypes, or phenotypes, of atopic dermatitis in order to identify different aetiologies, improve diagnosis, estimate more accurate clinical prognoses, inform treatment andmanagement or predict treatment efficacy andeffectiveness. However, no consensus yet exists on exactly what defines these phenotypes or how many there are and whether they are genuine or statistical artefacts. This review aims to identify previously reported phenotypes of atopic dermatitis, the features used to define them and any characteristics or clinical outcomes significantly associated with them.Methods and analysisWe will search Ovid Embase, Ovid MEDLINE and Web of Science from inception to the latest available date at the time of the search for studies attempting to classify atopic dermatitis in humans using any cross-sectional or longitudinal epidemiological or interventional design. Primary outcomes are atopic dermatitis phenotypes, features used to define them and characteristics associated with them in subsequent analyses. A secondary outcome is the methodological approach used to derive them. Two reviewers will independently screen titles and abstracts for inclusion, extract data and assess study quality. We will present the results of this review descriptively and with frequencies where possible.Ethics and disseminationEthical approval is not required for this study as it is a systematic review. We will report results from this systematic review in a peer-reviewed journal. The main value of this study will be to inform further research.PROSPERO registration numberCRD42018087500


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