Search results for "double-blind method"
showing 10 items of 631 documents
Erectile function in men with type 2 diabetes treated with dulaglutide: an exploratory analysis of the REWIND placebo-controlled randomised trial.
2021
Digital
Effects on α- and β-cell function of sequentially adding empagliflozin and linagliptin to therapy in people with type 2 diabetes previously receiving…
2017
Aims The aim of the study was to investigate the effect of sequential treatment escalation with empagliflozin and linagliptin on laboratory markers of alpha- and beta cell function in patients with type 2 diabetes mellitus (T2DM) insufficiently controlled on metformin monotherapy. Methods Forty-four patients with T2DM received 25 mg empagliflozin for a duration of one month in an open-label fashion (treatment period (TP 1). Thereafter, patients were randomised to a double-blind add-on therapy with linagliptin 5 mg or placebo (TP 2) for one additional month. Alpha- and beta cell function were assessed with a standardised liquid meal test (LMT) and an intravenous (iv.) glucose challenge. Effi…
Oral Magnesium Supplementation for Treating Glucose Metabolism Parameters in People with or at Risk of Diabetes: A Systematic Review and Meta-Analysi…
2021
There is a large and growing body of literature focusing on the use of oral magnesium (Mg) supplementation for improving glucose metabolism in people with or at risk of diabetes. We therefore aimed to investigate the effect of oral Mg supplementation on glucose and insulin-sensitivity parameters in participants with diabetes or at high risk of diabetes, compared with a placebo. Several databases were searched investigating the effect of oral Mg supplementation vs placebo in patients with diabetes or conditions at high risk of diabetes. Data were reported as standardized mean differences (SMDs) with their 95% confidence intervals (CIs) using follow-up data of glucose and insulin-sensitivity …
Effects of the dual sodium-glucose linked transporter inhibitor, licogliflozinvsplacebo or empagliflozin in patients with type 2 diabetes and heart f…
2020
Aims Explore the efficacy, safety and tolerability of the dual sodium-glucose cotransporter (SGLT) 1 and 2 inhibitor, licogliflozin in patients with type-2 diabetes mellitus (T2DM) and heart failure. Methods This multicentre, parallel-group phase IIA study randomized 125 patients with T2DM and heart failure (New York Heart Association II-IV; plasma N-terminal pro b-type natriuretic peptide [NT-proBNP] >300 pg/mL) to licogliflozin (2.5 mg, 10 mg, 50 mg) taken at bedtime, empagliflozin (25 mg) or placebo (44 patients completed the study). The primary endpoint was change from baseline in NT-proBNP after 12 weeks. Secondary endpoints included change from baseline in glycated haemoglobin, fas…
Metabolic effect of berberine-silymarin association: A meta-analysis of randomized, double-blind, placebo-controlled clinical trials.
2019
The aim of this study is to assess the impact of a combination of berberine and silymarin on serum lipids and fasting plasma glucose (FPG) through a systematic review of literature and meta-analysis of the available randomized, double-blind, placebo-controlled clinical trials (RCTs). A systematic literature search in SCOPUS, PubMed-Medline, ISI Web of Science, and Google Scholar databases was conducted up to October 2, 2018, in order to identify RCTs assessing changes in plasma concentrations of total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and FPG during treatment with berberine and silymarin in combina…
A single loading dose of clopidogrel causes dose-dependent improvement of endothelial dysfunction in patients with stable coronary artery disease: Re…
2006
Clinical studies have demonstrated beneficial effects for clopidogrel in patients with atherothrombotic disease. Recent in vitro studies identified stimulating effects of clopidogrel on endothelial cells, pointing towards mechanisms of action beyond the inhibition of platelet aggregation. We hypothesized that in vivo use of clopidogrel improves endothelial dysfunction in patients with coronary artery disease (CAD). Fifty-eight patients with CAD were randomly assigned to double-blinded oral administration of one single dose of clopidogrel 300 mg (C300) or 600 mg (C600), respectively. Endothelial function was assessed by measurement of flow-mediated dilation (FMD) of the brachial artery befor…
Budesonide/formoterol maintenance and reliever therapy: a new treatment approach for adult patients with asthma.
2007
An inhaled corticosteroid (ICS) or an ICS/long-acting beta(2)-agonist (LABA) combination plus short-acting beta(2)-agonist (SABA) as needed for symptom relief is recommended for persistent asthma. Additionally, budesonide/formoterol maintenance and reliever therapy (Symbicort SMART, AstraZeneca, Sweden) has been approved for adults in the European Union. This option is well tolerated and offers greater reductions in asthma exacerbations together with similar improvements in daily symptom control, at a lower overall steroid load, compared with fixed-dose ICS/LABA plus SABA.Two large clinical trials investigated the use of budesonide/formoterol as maintenance and reliever compared with medium…
Budesonide induces remission more effectively than prednisone in a controlled trial of patients with autoimmune hepatitis.
2010
Autoimmune hepatitis (AIH) is a chronic liver disease associated with cirrhosis and liver failure. Corticosteroid therapy induces long-term remission but has many side effects. We compared the effects of budesonide (a steroid that is rapidly metabolized, with low systemic exposure) and prednisone, both in combination with azathioprine.We performed a 6-month, prospective, double-blind, randomized, active-controlled, multicenter, phase IIb trial of patients with AIH without evidence of cirrhosis who were given budesonide (3 mg, three times daily or twice daily) or prednisone (40 mg/d, tapered to 10 mg/d); patients also received azathioprine (1-2 mg/kg/d). Treatment was followed by a 6-month, …
Regular versus as-needed budesonide and formoterol combination treatment for moderate asthma: A non-inferiority, randomised, double-blind clinical tr…
2015
Summary Background Treatment guidelines for patients with moderate persistent asthma recommend regular therapy with a combination of an inhaled corticosteroid and a longacting β 2 agonist plus as-needed rapid-acting bronchodilators. We investigated whether symptom-driven budesonide and formoterol combination therapy administered as needed would be as effective as regular treatment with this combination plus as-needed symptom-driven terbutaline for patients with moderate asthma. Methods In this non-inferiority randomised clinical trial, we recruited adult patients (18–65 years of age) with stable moderate persistent asthma, according to 2006 Global Initiative for Asthma guidelines. Patients …
Randomized, Double-Blind, Clinically Controlled Trial of Intranasal Calcitonin Treatment in Patients with Hip Fracture
2002
The objective of this study was to evaluate the short-term outcome of intranasal calcitonin treatment of elderly hip fracture patients on pain, bone loss, functional recovery, and length of hospital stay. In addition, we wanted to compare the effect of calcitonin with placebo on fusion of hip fractures treated with internal fixation using a screw or a nail. In a randomized, double-blind, clinically controlled trial, 260 independently living patients (aged 65 years or older) with acute hip fracture were randomly assigned to intranasal calcitonin 200 IU daily for 3 months or matching placebo nasal spray. Analyses were completed on an intention-to-treat basis. Three months after the operation,…