Randomised controlled trials

BACKGROUND: The presence of mental health conditions is pervasive in patients who experienced acute myocardial infarction (AMI), significantly disrupting their recovery. Providing timely and easily accessible psychological interventions using virtual reality-based cognitive-behavioural therapy (VR-CBT) could potentially improve both acute and long-term symptoms affecting their mental health. AIMS: We aim to examine the effectiveness of VR-CBT on anxiety symptoms in patients with AMI who were admitted to the intensive care unit (ICU) during the acute stage of their illness...

OBJECTIVE: Post-endodontic pain (PEP) after endodontic treatment (ET) might be reduced by adding cortisone to the composition of root canal sealer (RCS). This study aimed to test this hypothesis using grade A methodology. METHODS: A multicentric prospective randomised controlled clinical trial was performed in general practice. Adult patients with an indication of ET in a molar or premolar performed in one session were included be-tween 2021 and 2022 in 15 centres...

BACKGROUND: Data on cost-effectiveness of first-line infliximab in paediatric patients with Crohn's disease are limited. Since biologics are increasingly prescribed and accompanied by high costs, this knowledge gap needs to be addressed. AIM: To investigate the cost-effectiveness of first-line infliximab compared to conventional treatment in children with moderate-to-severe Crohn's disease. METHODS: We included patients from the Top-down Infliximab Study in Kids with Crohn's disease randomised controlled trial...

BACKGROUND AND OBJECTIVE: Immune checkpoint inhibitors (ICIs) and antibody-drug conjugates (ADCs) herald a transformative era in metastatic renal cell carcinoma (RCC) and transitional cell carcinoma (TCC) treatment, amid acknowledged sex-based disparities in these cancers. We conducted a systematic review and network meta-analysis (NMA) to identify sex-specific differences in the efficacy of ICI/ADC monotherapy or combination therapies for RCC and TCC survival, in metastatic and adjuvant settings...

BACKGROUND AND OBJECTIVE: Several bacterial immunisations have been developed to reduce the socioeconomic burden of urinary tract infections (UTIs) and the use of prophylactic antibiotics in the management of recurrent UTIs (rUTIs). This systematic review evaluates the effectiveness of vaccinations in preventing rUTIs. METHODS: Medline, Embase, and Web of Science were searched from inception to December 2023. Data were collected from cohort studies with a comparator arm and randomised controlled trials (RCTs) investigating vaccination efficacy in adult rUTI patients according to predefined selection criteria (PROSPERO registration: CRD42022356662)...

The systematic review aims to answer the PICOS question: "Are the autologous platelet concentrates (APCs) an effective strategy in prevention and/or treatment of patients at risk of/affected by medication-related osteonecrosis of the jaws (MRONJ)?". A literature search was conducted via PubMed, MEDLINE, EMBASE, and CINAHL (January 2006 - September 2023). 30 articles were included, evaluating preventive (n = 8*) and treatment strategies (n = 23*). The risk of bias and quality of studies were assessed utilising ROB-2, ROBIN-1 and GRADE criteria...

INTRODUCTION: This study will explore the effectiveness of fish skin grafts (FSG) in ulcer healing in diabetic foot disease compared to standard of care (SOC). METHODS: The systematic review and meta-analysis were performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) standard. The electronic databases of PubMed, EMBASE, and Web of Science (WoS) internet were searched for the outcome rate of complete ulcer healing. The risk of bias assessment was conducted using the tool recommended by the Cochrane Collaboration...

BACKGROUND: In the UK, smoking prevalence in people with depression (34%) and anxiety (29%) is more than double that of the general population (13%). People who stop smoking improve their mental health with comparable effect sizes found for antidepressants. In England, online psychological therapy is a standard treatment for depression and anxiety. Online therapy is an acceptable setting for smoking cessation support; however, integrated smoking and mental health support is not available...

BACKGROUND: Dietary advice and medical treatments are recommended to patients with irritable bowel syndrome (IBS). Studies have not yet compared the efficacy of dietary treatment with pharmacological treatment targeting the predominant IBS symptom. We therefore aimed to compare the effects of two restrictive dietary treatment options versus optimised medical treatment in people with IBS. METHODS: This single-centre, single-blind, randomised controlled trial was conducted in a specialised outpatient clinic at the Sahlgrenska University Hospital, Gothenburg, Sweden...

BACKGROUND: Vitamin A plays a key role in lung development, but there is no consensus regarding the optimal vitamin A dose and administration route in extremely low birthweight (ELBW) infants. We aimed to assess whether early postnatal additional high-dose fat-soluble enteral vitamin A supplementation versus placebo would lower the rate of moderate or severe bronchopulmonary dysplasia or death in ELBW infants receiving recommended basic enteral vitamin A supplementation. METHODS: This prospective, multicentre, randomised, parallel-group, double-blind, placebo-controlled, investigator-initiated phase 3 trial conducted at 29 neonatal intensive care units in Austria and Germany assessed early high-dose enteral vitamin A supplementation (5000 international units [IU]/kg per day) or placebo (peanut oil) for 28 days in ELBW infants...

BACKGROUND: The highest priority uncertainty for people with symptomatic cerebral cavernous malformation is whether to have medical management and surgery or medical management alone. We conducted a pilot phase randomised controlled trial to assess the feasibility of addressing this uncertainty in a definitive trial. METHODS: The CARE pilot trial was a prospective, randomised, open-label, assessor-blinded, parallel-group trial at neuroscience centres in the UK and Ireland...

BACKGROUND: Midwives provide counselling for birth plans (BPs) to women during prenatal care; however, the impact of individualised BP counselling interventions based on shared decision-making (SDM) regarding women's preferences is unknown. METHODS: This randomised cluster trial included four primary healthcare units. Midwives provided BP counselling based on SDM to women in the intervention group (IG) during prenatal care along with a handout about evidence-based recommendations...

INTRODUCTION: In the first randomised controlled trial of a dementia training and support intervention in UK homecare agencies, we aimed to assess: acceptability of our co-designed, manualised training, delivered by non-clinical facilitators; outcome completion feasibility; and costs for a future trial. METHODS: This cluster-randomised (2:1) single-blind, feasibility trial involved English homecare agencies. Intervention arm agency staff were offered group videocall sessions: 6 over 3 months, then monthly for 3 months (NIDUS-professional)...

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INTRODUCTION: Subjective cognitive decline means a decline in the subjective perception of self-cognitive function, which is likely to evolve into mild cognitive impairment and dementia. The number of elderly with subjective cognitive decline has increased, bringing huge burdens and challenges to caregivers and society. With the increase in research on art therapies, some of them have gradually been proven to be effective for cognitive function. Therefore, this study aims to summarise the evidence and identify the best art therapy for elderly with subjective cognitive decline...

INTRODUCTION: With increasing life expectancy of older adult population, maintaining independence and well-being in later years is of paramount importance. This study aims to investigate the impact of three distinct interventions: cognitive training, resistance training and a combination of both, compared with an inactive control group, on cognitive performance, mobility and quality of life in adults aged ≥65 years. METHODS AND ANALYSIS: This trial will investigate healthy older adults aged ≥65 years living independently without cognitive impairments...

BACKGROUND: Blurred work-non-work boundaries can have negative effects on mental health, including sleep. OBJECTIVES: In a randomised control trial, we aimed to assess the effectiveness of an online recovery training programme designed to improve symptoms of insomnia in a working population exposed to blurred boundaries. METHODS: 128 participants with severe insomnia symptoms (Insomnia Severity Index ≥15) and working under blurred work and non-work conditions (segmentation supplies <2...

INTRODUCTION: For patients with drug-resistant epilepsy (DRE) who are not suitable for surgical resection, neuromodulation with vagus nerve stimulation (VNS) is an established approach. However, there is limited evidence of seizure reduction when replacing traditional VNS (tVNS) device with a cardiac-based one (cbVNS). This meta-analysis compares the seizure reduction achieved by replacing tVNS with cbVNS in a population with DRE. METHODS: We systematically searched PubMed, Embase, and Cochrane Central following PRISMA guidelines...

BACKGROUND: Numerous interventions for pressure injury prevention have been developed, including care bundles. OBJECTIVE: To systematically review the effectiveness of pressure injury prevention care bundles on pressure injury prevalence, incidence, and hospital-acquired pressure injury rate in hospitalised patients. DATA SOURCES: The Medical Literature Analysis and Retrieval System Online (via PubMed), the Cumulative Index to Nursing and Allied Health Literature, EMBASE, Scopus, the Cochrane Library and two registries were searched (from 2009 to September 2023)...

BACKGROUND: The World Health Organization recommends universal iron supplementation for children aged 6-23 months in countries where anaemia is seen in over 40% of the population. Conventional ferrous salts have low efficacy due to low oral absorption in children with inflammation. Haem iron is more bioavailable, and its absorption may not be decreased by inflammation. This study aims to compare daily supplementation with haem iron versus ferrous sulphate on haemoglobin concentration and serum ferritin concentration after 12 weeks of supplementation...