Randomised controlled trials

BACKGROUND: Few interventions for food addiction (FA) report on dietary intake variables. The present study comprised a three-arm randomised controlled trial in adults with symptoms of FA. The aim was to evaluate dietary intake, sleep and physical activity resulting from a dietitian-led telehealth intervention at 3 months. METHODS: Adults with ≥3 symptoms of FA and a body mass index > 18.5 kg/m2 were recruited. Dietary intake including energy, nutrients and diet quality were assessed by a validated food frequency questionnaire in addition to sleep quality and physical activity (total min) and compared between groups and over time...

PURPOSE: Management of massive rotator cuff tears (MRCTs) remains debated, and various arthroscopic and open techniques have been described for their management. Nevertheless, the optimal strategy remains unclear. The present study evaluated the clinical results in patients managed arthroscopically for MRCTs augmented with the long head biceps tendon (LHBT) at a minimum 1-year follow-up, considering different type of tears, demographic data and number of torn tendons. METHODS: Patients treated in a secondary referral centre from January 2021 to April 2022 were enroled prospectively...

INTRODUCTION: Intranasal corticosteroids (INCs) are the first line of therapy for chronic sinonasal conditions such as rhinitis and rhinosinusitis. Among these, one of the most frequently used is beclomethasone dipropionate (BDP). Over the years many studies have evaluated the efficacy of BDP as part of therapy for chronic rhinosinusitis (CRS) and allergic rhinitis (AR) along with nasal washes, which seems to be very well tolerated. OBJECTIVE: To analyse the data in the literature regarding the various therapeutic regimens of BDP in different sinonasal disease and their efficacy and tolerability...

BACKGROUND: Physical activity (PA) has multiple benefits for older adults (≥70 years old). Despite this many older adults do not undertake the World Health Organisation guideline recommended amount of PA. This systematic review examines barriers and motivators to PA in adults aged ≥70 years. METHODS: We analysed the quantitative literature, including observational studies and baseline data from randomised controlled trials. Studies examining specific diseases (e...

Patients with long-term disease experience low resilience, emphasising the importance of psychological interventions to improve resilience. However, there is no comprehensive evidence on the efficacy of resilience-related psychological interventions (RRPIs) in this population. Therefore, we performed a meta-analysis to evaluate and extend knowledge from previous meta-analyses on the efficacy of RRPIs on resilience, stress, anxiety, depression and quality of life among patients with long-term disease. Cochrane Library, Embase, Ovid-MEDLINE, PubMed, Scopus, Web of Science and CINAHL electronic databases were searched until 3 February 2023...

AIMS: Community treatment orders have been introduced in many jurisdictions with increasing use over time. We conducted a rapid umbrella review to synthesise the quantitative and qualitative evidence from systematic reviews and/or meta-analyses of their potential harms and benefits. METHODS: A systematic search of Medline, PubMed, Embase and PsycINFO for relevant systematic reviews and/or meta-analyses. Where available, participants on community treatment orders were compared with controls receiving voluntary psychiatric treatment...

Responsive feeding serves as an important protective factor for infant growth and overall health development. This study based on self-determination theory (SDT) aimed to assess the effects of a responsive breastfeeding (RBF) intervention programme on maternal breastfeeding and infant growth and development. A total of 110 mother-infant pairs were recruited and randomly divided into an intervention group (n = 55) and a control group (n = 55). The primary outcomes were breastfeeding motivation score, breastfeeding self-efficacy (BSE) and exclusive breastfeeding rate; the secondary outcomes were infant physical development at 6 weeks and 3 months...

BACKGROUND: Given the high rates of common mental disorders and limited resources, task-shifting psychosocial interventions are needed to provide adequate care. One such intervention developed by the World Health Organization is Problem Management Plus (PM+). AIMS: This review maps the evidence regarding the extent of application and usefulness of the PM+ intervention, i.e. adaptability, feasibility, effectiveness and scalability, since it was introduced in 2016...

BACKGROUND: To illustrate how (standardised) effect sizes (ES) vary based on calculation method and to provide considerations for improved reporting. METHODS: Data from three trials of tanezumab in subjects with osteoarthritis were analyzed. ES of tanezumab versus comparator for WOMAC Pain (outcome) was defined as least squares difference between means (mixed model for repeated measures analysis) divided by a pooled standard deviation (SD) of outcome scores. Three approaches to computing the SD were evaluated: Baseline (the pooled SD of WOMAC Pain values at baseline [pooled across treatments]); Endpoint (the pooled SD of these values at the time primary endpoints were assessed); and Median (the median pooled SD of these values based on the pooled SDs across available timepoints)...

BACKGROUND: Raspberry leaf use during pregnancy in Australia is widespread. There has been little research exploring the potential beneficial or harmful effects of raspberry leaf on pregnancy, labour, and birth. More research is needed to appropriately inform childbearing women and maternity healthcare professionals on the effects of raspberry leaf so that women can make informed choices. METHODS: This study aimed to determine associations between raspberry leaf use in pregnancy and augmentation of labour and other secondary outcomes...

BACKGROUND: The stalling global progress in malaria control highlights the need for novel tools for malaria elimination, including transmission-blocking vaccines. Transmission-blocking vaccines aim to induce human antibodies that block parasite development in the mosquito and mosquitoes becoming infectious. The Pfs48/45 protein is a leading Plasmodium falciparum transmission-blocking vaccine candidate. The R0.6C fusion protein, consisting of Pfs48/45 domain 3 (6C) and the N-terminal region of P...

The study was aimed to investigate the positive impact of bicarbonate Ringer's solution on postoperative outcomes in patients who underwent laparoscopic right hemihepatectomy. Patients in the two groups were infused with lactated Ringer's solution (LRS, n = 38) and the bicarbonate Ringer's solution (BRS, n = 38) at a rate of 5 ml·kg-1 ·h-1 . The stroke volume was monitored and 200 ml of hydroxyethyl starch with 130/0.4 sodium chloride injection (Hes) of a bolus was given in the first 5-10 min...

DESIGN: This study is a randomised, placebo-controlled, triple-arm, phase IIA clinical trial with double masking which investigates the effectiveness and safety of Cannabidiol (CBD) as an analgesic for acute dental pain. The intervention drug, Epidiolex is an FDA-approved CBD oral solution (100 mg/ml) derived from the cannabis plant. The psychoactive ingredient tetrahydrocannabinol (THC) is not included. The maximum recommended daily dose of Epidiolex is 20 mg/kg. 64 patients with moderate-severe odontogenic pain participated in the study and REDCap software was utilised to randomly assign participants into groups: CBD10 (10 mg/kg), CBD20 (20 mg/kg) and placebo...

The immune mechanisms mediating COVID-19 vaccine attenuation of COVID-19 remain undescribed. We conducted comprehensive analyses detailing immune responses to SARS-CoV-2 virus in blood post-vaccination with ChAdOx1 nCoV-19 or a placebo. Samples from randomised placebo-controlled trials (NCT04324606 and NCT04400838) were taken at baseline, onset of COVID-19-like symptoms, and 7 days later, confirming COVID-19 using nucleic amplification test (NAAT test) via real-time PCR (RT-PCR). Serum cytokines were measured with multiplexed immunoassays...

Optimal pain relief in day-case surgery is imperative to patient comfort and timely discharge from hospital. Short-acting opioids are commonly used for analgesia in modern anaesthesia, allowing rapid recovery after surgery. Plasma concentration fluctuations from repeated dosing of short-acting opioids can cause patients to oscillate between analgesia with potential adverse effects, and inadequate analgesia requiring rescue dosing. Methadone's unique pharmacology may offer effective and sustained analgesia with less opioid consumption, potentially reducing adverse effects...

OBJECTIVE: Caffeine is widely used in preterm infants to prevent or treat apnoea of prematurity. Adverse gastrointestinal effects of caffeine have not been thoroughly researched in preterm infants. With this systematic review and meta-analysis, we aim to summarise the results of trials on the gastrointestinal effects of caffeine in preterm infants. DESIGN: We searched MEDLINE, Web of Science, Scopus and ClinicalTrials.gov up to 21 April 2023. We included randomised controlled trials assessing caffeine versus placebo in preterm neonates and reporting gastrointestinal side effects...

BACKGROUND: Stereotactic Ablative Radiotherapy (SABR) for the treatment of oligometastatic disease can improve survival and delay the requirement for systemic therapy. The benefits of SABR in oligoprogressive disease are less well-defined. Here, we evaluate the available evidence investigating the efficacy of SABR in the treatment of oligoprogressive disease. METHODS: A systematic review was carried out following PRISMA guidelines. Medline and Embase databases were searched using the terms "stereotactic radiotherapy" OR "SABR" OR "Stereotactic Ablative Body Radiotherapy" OR "SBRT" OR "SRT" AND "oligoprogression" in May 2022, June 2023, and February 2024...

INTRODUCTION: Improving dietary patterns using medical nutrition therapy delivered via telehealth could make an effective contribution to reducing cardiovascular disease burden in rural Australia. However, it is important that medical nutrition therapy programmes are developed in collaboration with rural stakeholders, to increase feasibility for the rural context and the likelihood of successful implementation. The aim of this study was to evaluate the preliminary feasibility outcomes of integration (implementation), practicality, acceptability, demand, and preliminary effectiveness at the 3-month timepoint of the Healthy Rural Hearts randomised control trial...

Chewing gum reduces the duration of postoperative ileus and early recovery of bowel function following elective abdominal surgery. However, its role has not been studied in cases of gastroduodenal perforation peritonitis, prompting us to conduct this study. Patients were randomised into two groups, 39 patients received chewing gum (study group) and 43 patients were in the control group. Sensation of hunger, appearance of first bowel sound, and passages of flatus and faeces were significantly early in the study group; their hospital stay was also shorter...

BACKGROUND: Migraine is the second most common prevalent disorder worldwide and is a top cause of disability with a substantial economic burden. Many preventive migraine medications have notable side effects that affect different body organs. METHOD: We systematically searched for published randomised controlled trials (RCTs) using terms for migraine/headache and preventive medications. Using eligibility criteria, two reviewers independently assessed the articles...