Randomized Controlled Trial Supplement

OBJECTIVE: his study aimed to systematically evaluate the clinical efficacy of gabapentin and pregabalin in the treatment of acute herpes zoster neuralgia, including pain control and the occurrence of adverse effects. METHOD: A systematic computerized search was conducted in October 2023 in PubMed, Embase, Web of Science, Cochrane Library, VIP, CNKI, and Wanfang databases. Data from randomized controlled trials comparing gabapentin analogs for the treatment of acute herpes zoster neuralgia were searched...

INTRODUCTION: Extracorporeal membrane oxygenation (ECMO) may act as a driver or propagator of systemic inflammation. In turn, cytokine release can modify thromboelastographic (TEG) tests which are commonly used for anticoagulation monitoring. In this context, antithrombin (AT) supplementation might further modify TEG. METHODS: This is a pre-specified sub-study of the "Randomized Controlled Trial of Antithrombin Supplementation During Extracorporeal Membrane Oxygenation" study (investigator-initiated, randomized, single-blind, two-arm trial) conducted in two Italian ECMO referral ICUs...

PURPOSE: A double-blind, placebo-controlled, randomized, proof-of-concept trial aimed to evaluate the efficacy and safety of VerbasnolTM [ Rehmannia glutinosa Libosch leaf-based extract (RGLE)] in females, with moderate to severe acne vulgaris. PARTICIPANTS AND METHODS: Twenty-two females aged 18 to 35 years having moderate to severe acne with Global Acne Grading System (GAGS) scores of 19 to 38 were included in the study and were randomized in a 1:1 ratio to receive either one capsule (100 mg/day) of RGLE or placebo orally after breakfast for 56 days...

Aim: To assess the effect of cashew nut flour on the hematological parameters of children living with HIV-AIDS. Method: A 32-week randomized, blind clinical trial conducted at a specialized outpatient clinic. Children aged 2-12 years were allocated to intervention groups (IGs) ( n  = 11) receiving 12 g/day of cashew nut flour and control groups (CGs) ( n  = 9) receiving 12 g/day of carboxymethyl cellulose. Parameters of erythrocytes, leukocytes, platelets, and lipid profiles were evaluated...

BACKGROUND: The beneficial effects of folate have been observed under different conditions, but the available evidence on inflammation and reduction of cardiovascular disease (CVD) in type 2 diabetes mellitus (T2DM) is limited. The study aimed to explore the effects of folate on inflammation and homocysteine amongst individuals with T2DM. METHODS: PubMed, Scopus, and Cochrane Library were used to search for evidence. A random-effect model meta-analysis through Review Manager (version 5...

BACKGROUND: Astaxanthin is the most prevalent carotenoid in the marine environment and is widely used as an additive in formulated aquafeeds. OBJECTIVES: A 60-day feeding trial was conducted to consider the effect of dietary nanoliposome-coated astaxanthin (NA) on haematological parameters, serum antioxidant activities and immune responses of rainbow trout, Oncorhynchus mykiss. METHODS: A total of 450 healthy fish weighing 31.00 ± 2...

Delaying oral Ca supplementation might benefit cows with low blood Ca concentrations at 4 d in milk (DIM), a time when reduced blood total Ca (tCa) is associated with negative health and production outcomes. To implement a targeted approach to manage subclinical hypocalcemia (SCH) at the herd level, it is important to identify which cows benefit from supplemental Ca. Therefore, our objective was to determine if SCH diagnosis at 2 DIM could inform decisions of oral Ca supplementation at 2 and 3 DIM based on milk yield and 4 DIM blood Ca concentration...

Although postpartum Ca supplementation strategies are often employed to prevent subclinical hypocalcemia in dairy cows, these strategies have produced a mix of beneficial, neutral, and detrimental results when assessing milk yield and subsequent disease outcomes. Because the mechanisms underlying these differing results are unknown, our objectives were to determine how common postpartum Ca supplementation strategies affect blood Ca concentrations and parathyroid hormone (PTH). We conducted a randomized controlled trial with 74 multiparous dairy cows on a commercial dairy in central New York...

BACKGROUND: The efficacy of Pegbelfermin (PGBF) in treating non-alcoholic steatohepatitis (NASH) remains controversial. Therefore, we conducted a dose-response meta-analysis to explore the effect and pattern of PGBF at different dosages and treatment durations on transaminase reduction in NASH patients. METHODS: We conducted searches on PubMed, Embase, Cochrane Library, Web of Science, and ClinicalTrials.gov, and supplemented the search with gray literature and manual searches...

BACKGROUND: Docosahexaenoic acid (DHA) plays a crucial role in the growth and functional development of the infant brain. However, the impact of additional DHA supplementation on neurodevelopment in infants remains controversial in randomized controlled trials. In this systematic review and meta-analysis, we aimed to investigate the effects of prenatal and postnatal DHA supplementation on neurodevelopment. METHODS: We systematically searched the MEDLINE, EMBASE, and Cochrane Library electronic databases using a predefined strategy until 8 February 2024...

AIM: To investigate the effect of cholecalciferol supplementation on hand grip strength, walking speed, and expression of vitamin D receptor (VDR), interleukine-6 (IL-6) and insulin-like growth factor-1 (IGF-1) in monocyte in pre-frail older adults. METHODS: We conducted a randomized double-blinded placebo-controlled clinical trial for 12 weeks, involving 120 pre-frail older adults who were randomized to the cholecalciferol group (cholecalciferol 4000 IU/day) or the placebo group...

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: Prior research has highlighted the synergistic impact of protein supplementation on muscle function post-exercise in adults; however, evidence supporting the combined effects were less robust and inconsistent on those with protein insufficiency. This investigation aims to explore efficacy of protein-enriched soup coupled with exercise on muscle health and metabolism in middle-aged and older adults with suboptimal protein intake. METHODS: An open-label, 12-week, randomized controlled trial involving participants with insufficient protein intake (<1...

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...

BACKGROUND: Recent clinical studies have yielded controversial results regarding the effect of probiotics on cognitive function in Alzheimer's disease (AD) or mild cognitive impairment (MCI) subjects. To clarify the efficacy of probiotics on cognition, we conducted a meta-analysis of randomized controlled trials (RCTs). METHODS: Instructions of the PRISMA 2020 statement were followed. Literature from the PubMed, Embase and Cochrane databases were systematically searched and manually screened for relevant published RCTs...

Malnutrition presents a significant risk to patients undergoing gastrointestinal surgery, with direct consequences on postoperative complication rates, recovery times, and mortality. Our systematic review, guided by PRISMA protocols, examined the impact of preoperative nutritional support on these surgical outcomes. We scrutinized publications from PubMed, Medline, Embase, and the Cochrane Library up to April 2023, including randomized controlled trials, cohort studies, and systematic reviews. The stringent selection process narrowed to 10 studies demonstrating the efficacy of preoperative nutritional support, from oral supplements to enteral and parenteral nutrition, in reducing postoperative complications and length of hospital stays while enhancing recovery rates...

BACKGROUND: Muscle mass is important for metastatic prostate cancer survival and quality of life (QoL). The backbone of treatment for men with metastatic castration sensitive prostate cancer (mCSPC) is androgen deprivation therapy (ADT) with an androgen signaling inhibitor. ADT is an effective cancer treatment, but it facilitates significant declines in muscle mass and adverse health outcomes important to mCSPC survivors, such as fatigue, and reductions in physical function, independence, insulin sensitivity, and QoL...

Carob (Ceratonia siliqua) supplements can increase sperm quality. This study aimed to summarize the available evidence about the effects of carob (Ceratonia siliqua) supplements on sperm quality and reproductive hormones in infertile men. Systematic searches of five databases were conducted from inception to October 20, with the last update on November 20, 2023. Randomized clinical trials (RCTs) that compared carob (Ceratonia siliqua) supplements with nonintervention control groups on infertile man. Risk of bias and certainty of evidence were assessed by the Cochrane risk of bias tool 2...

Cucurbita moschata (Butternut squash) seeds are a rich source of nutrition containing nutrients including iron, zinc, copper, calcium, potassium, and phosphorus. The aim of this study was to determine if Cucurbita Moschata squash seed paste improves zinc and iron status, anthropometric status, and dietary intake in preschool children. A pretest-posttest control group trial using cluster randomisation was conducted over 6 months. Four preschools were randomly assigned to receive 100 g of intervention or 100 g of a placebo as the control to enhance iron and zinc status...

INTRODUCTION: In light of the public health burden of the COVID-19 pandemic, boosting the safety and immunogenicity of COVID-19 vaccines is of great concern. Numerous Traditional Chinese medicine (TCM) preparations have shown to beneficially modulate immunity. Based on pilot experiments in mice that showed that supplementation with Huoxiang Suling Shuanghua Decoction (HSSD) significantly enhances serum anti-RBD IgG titers after inoculation with recombinant SARS-CoV-2 S-RBD protein, we conducted this randomized, double-blind, placebo-controlled clinical trial aimed to evaluate the potential immunogenicity boosting effect of oral HSSD after a third homologous immunization with Sinovac's CoronaVac SARS-CoV-2 (CVS) inactivated vaccine...