Search results for "controlled study"
showing 10 items of 134 documents
Saccharomyces boulardii to Prevent Antibiotic-Associated Diarrhea: A Randomized, Double-Masked, Placebo-Controlled Trial.
2015
Antibiotic-associated diarrhea is an important clinical problem, associated with morbidity, mortality and healthcare costs. Our randomized, placebo controlled multicenter trial do not support the efficacy of Saccharomyces boulardii in the prevention of antibiotic-associated diarrhea.
Randomized placebo-controlled trial comparing desloratadine and montelukast in monotherapy and desloratadine plus montelukast in combined therapy for…
2004
BACKGROUND: H 1 -receptor antagonists are considered to be particularly effective in reducing pruritus, and they are therefore recommended as first-line treatment in patients with chronic idiopathic urticaria (CIU). Recently, antileukotriene receptors have been used in patients with CIU, either administered as monotherapy or combined with H 1 -receptor antagonists. OBJECTIVE: We compared the clinical efficacy of 5 mg of desloratadine administered once daily either as monotherapy or combined with a leukotriene antagonist, 10 mg of montelukast daily, and 10 mg of montelukast administered daily as monotherapy for the treatment of patients affected by CIU with placebo. METHODS: One hundred sixt…
Tacrolimus Monotherapy Without Steroids After Liver Transplantation – A Prospective Randomized Double-Blinded Placebo-Controlled Trial
2007
Early steroid withdrawal after liver transplantation (LT) is desirable in order to reduce steroid side effects. Between February 2000 and August 2004, 110 patients after LT were included in this prospective, randomized, double-blind, placebo-controlled trial. Randomization was performed before LT. In all patients, tacrolimus was used without induction therapy. All patients received methylprednisolon for 14 days, thereafter a double-blinded medication containing either placebo (n = 56) or methylprednisolon (n = 54) for 6 months, which was completely stopped thereafter. End points were patient and graft survival, acute and chronic rejection, and incidence of steroid side effects during the fi…
A prospective, double-blind, placebo-controlled trial to establish a safe gluten threshold for patients with celiac disease
2007
BACKGROUND: Treatment of celiac disease (CD) is based on the avoidance of gluten-containing food. However, it is not known whether trace amounts of gluten are harmful to treated patients. OBJECTIVE: The objective was to establish the safety threshold of prolonged exposure to trace amounts of gluten (ie, contaminating gluten). DESIGN: This was a multicenter, double-blind, placebo-controlled, randomized trial in 49 adults with biopsy-proven CD who were being treated with a gluten-free diet (GFD) for > or =2 y. The background daily gluten intake was maintained at < 5 mg. After a baseline evaluation (t0), patients were assigned to ingest daily for 90 d a capsule containing 0, 10, or 50 mg glute…
Desmopressin in the Treatment of Nocturia: A Double-Blind, Placebo-Controlled Study
2007
Objectives: To investigate efficacy, safety, and impact on quality of sleep of desmopressin in the treatment of nocturia. Methods: Adults aged >= 18 yr with nocturia (>= 2 voids/night) received desmopressin tablets (0.1, 0.2, or 0.4 mg) during a 3-wk dose-titration period. Patients should show sufficient response during the dose-titration period (>= 20% reduction in nocturnal diuresis) and a return of nocturnal diuresis to >= 80% of baseline levels during washout. Eligible patients then entered a 3-wk double-blind treatment period and received either desmopressin or placebo. Results: 127 patients were randomised to either desmopressin (n = 61) or placebo (n = 66). Twenty (33%) desmopressin-…
Autologous whole blood injections to patients with chronic urticaria and a positive autologous serum skin test: a placebo-controlled trial.
2005
<i>Background:</i> Patients with chronic urticaria (CU) frequently exhibit positive skin test reactions to autologous serum (ASST). Therapies aimed at inducing tolerance to circulating histamine-releasing factors in ASST+ CU patients, e.g. by treatment with autologous whole blood (AWB), have not yet been tested. <i>Objective:</i> To test whether ASST+ CU patients can benefit from repeated low-dose intramuscular injections of AWB. <i>Methods:</i> We characterized CU severity and duration, anti-Fc<sub>&#917;</sub>RI and anti-IgE expression, use of antihistamines, and quality of life in 56 CU patients (ASST+: 35, ASST–: 21) and assessed the t…
Randomised placebo-controlled trial of moclobemide, cognitive–behavioural therapy and their combination in panic disorder with agoraphobia
1999
BackgroundIn the treatment of panic disorder with agoraphobia, the efficacy of pharmacological, psychological and combined treatments has been established. Unanswered questions concern the relative efficacy of such treatments.AimsTo demonstrate that moclobemide and cognitive–behavioural therapy (CBT) are effective singly and more effective in combination.MethodFifty-five patients were randomly assigned to an eight-week treatment of: moclobemide plus CBT; moclobemide plus clinical management (‘psychological placebo’); placebo plus CBT; or placebo plus clinical management.ResultsComparisons between treatments revealed strong effects for CBT. Moclobemide with clinical management was not superi…
Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial
2012
BACKGROUND: Some patients with severe asthma have recurrent asthma exacerbations associated with eosinophilic airway inflammation. Early studies suggest that inhibition of eosinophilic airway inflammation with mepolizumab-a monoclonal antibody against interleukin 5-is associated with a reduced risk of exacerbations. We aimed to establish efficacy, safety, and patient characteristics associated with the response to mepolizumab. METHODS: We undertook a multicentre, double-blind, placebo-controlled trial at 81 centres in 13 countries between Nov 9, 2009, and Dec 5, 2011. Eligible patients were aged 12-74 years, had a history of recurrent severe asthma exacerbations, and had signs of eosinophil…
Repetitive low-energy shock wave treatment for chronic lateral epicondylitis in tennis players.
2004
Background There is conflicting evidence regarding extracorporeal shock wave treatment for chronic tennis elbow. Hypothesis Treatment with repetitive low-energy extracorporeal shock wave treatment is superior to repetitive placebo extracorporeal shock wave treatment. Methods Seventy-eight patients enrolled in a placebo-controlled trial. All patients were tennis players with recalcitrant MRIconfirmed tennis elbow of at least 12 months’ duration. Patients were randomly assigned to receive either active low-energy extracorporeal shock wave treatment given weekly for 3 weeks (treatment group 1) or an identical placebo extracorporeal shock wave treatment (sham group 2). Main outcome measure was …
Effects of moclobemide on sexual performance and nocturnal erections in psychogenic erectile dysfunction
2001
Rationale and objectives: We tested the hypothesis that the selective reversible MAO-A inhibitor moclobemide has a specific therapeutic effect on erectile dysfunction independent of its antidepressive properties. Methods: In a double-blind placebo controlled study, 12 male outpatients suffering from psychogenic erectile dysfunction without any other psychiatric disorder were investigated. Based on comprehensive diagnosis before the beginning of the study, organic factors relevant for sexual function were excluded. The treatment period was 8 weeks. Half the patients received 450 mg moclobemide during the first week, and 600 mg afterwards; the others received placebo. Apart from assessment of…