Search results for "double-blind method"
showing 10 items of 631 documents
Tauroursodeoxycholic acid in the treatment of patients with amyotrophic lateral sclerosis
2015
Background and purpose: Tauroursodeoxycholic acid (TUDCA) is a hydrophilic bile acid that is produced in the liver and used for treatment of chronic cholestatic liver diseases. Experimental studies suggest that TUDCA may have cytoprotective and anti-apoptotic action, with potential neuroprotective activity. A proof of principle approach was adopted to provide preliminary data regarding the efficacy and tolerability of TUDCA in a series of patients with amyotrophic lateral sclerosis (ALS). Methods: As a proof of principle, using a double-blind placebo controlled design, 34 ALS patients under treatment with riluzole who were randomized to placebo or TUDCA (1 g twice daily for 54 weeks) were e…
Topical azithromycin for the prevention of Lyme borreliosis: a randomised, placebo-controlled, phase 3 efficacy trial
2017
Summary Background Lyme borreliosis develops in 1–5% of individuals bitten by ticks, but with a diagnostic gap affecting up to 30% of patients, a broadly applicable pharmacological prevention strategy is needed. Topical azithromycin effectively eradicated Borrelia burgdorferi sensu lato from the skin in preclinical studies. We assessed its efficacy in human beings. Methods In this randomised, double-blind, placebo-controlled, multicentre trial done in 28 study sites in Germany and Austria, adults were equally assigned to receive topical 10% azithromycin or placebo twice daily for 3 consecutive days, within 72 h of a tick bite being confirmed. Randomisation numbers, which were stratified by …
Effects of a vestibular physiotherapy protocol on adults with intellectual disability in the prevention of falls: A multi-centre clinical trial
2018
Background Balance alterations are one of the main problems in people with intellectual disabilities (ID), increasing their risk of falls and impacting their life. Aims To describe a vestibular rehabilitation programme (VRP) and evaluate its effects on the ability to maintain balance and risk of suffering a fall. Methods Forty-seven adults with mild to moderate ID were randomly assigned to two groups: a control group (CG, N = 24), which performed a general physical exercise only, and an experimental group (EG, N = 23) which also completed a VRP. The variables, used pre- and post-training and 1 month after the intervention, were as follows: Center of Pressure Displacement, Berg Scale, Timed …
Meta-analysis
2012
Treatment of the pain caused by chronic pancreatitis (CP) is not standardized. Knowledge of the response to placebo in this setting may aid the design of future trials. We aimed at investigating the placebo effect on abdominal pain remission rates in patients with CP.MEDLINE, EMBASE, and Scopus were searched, and randomized placebo-controlled trials in CP providing data on abdominal pain remission rates in placebo arms were included. Pooled estimates of the placebo rate were calculated using random-effects logistic regression analysis. Stratum-specific rates for different patients and study-level covariates were calculated to account for heterogeneity.Seven randomized controlled trials (202…
Safety and Ergogenic Properties of Combined Aminophylline and Ambrisentan in Hypoxia.
2017
We hypothesized that concomitant pharmacological inhibition of the endothelin and adenosine pathway is safe and improves exercise performance in hypoxic humans, via a mechanism that does not involve augmentation of blood oxygenation. To test this hypothesis, we established safety and drug interactions for aminophylline (500 mg) plus ambrisentan (5 mg) in normoxic volunteers. Subsequently, a placebo‐controlled study was employed to test the combination in healthy resting and exercising volunteers at simulated altitude (4,267 m). No serious adverse events occurred. Drug interaction was minimal or absent. Aminophylline alleviated hypoxia‐induced headaches. Aminophylline, ambrisentan, and their…
Impact of a non-attentively perceived odour on subsequent food choices
2014
International audience; Current research in psychology suggests that unconscious processes influence a significant proportion of choices and decisions. To study the impact of a non-attentively perceived odour on food choices, we used a priming paradigm. We had previously shown that non-attentively perceived fruity odours could impact food choice intentions (on a menu card), guiding participants toward items containing more fruit and/or vegetables. The present study was designed to extend these findings, in a real-life consumption setting. One hundred and fifteen participants took part in this study, and were assigned randomly to either a control or a scented condition. On arrival in the lab…
Fluvoxamine or placebo in the treatment of panic disorder and relationship to blood concentrations of fluvoxamine.
1998
A six-week double-blind placebo-controlled trial of fluvoxamine was undertaken in 46 patients suffering from panic disorder with or without agoraphobia diagnosed by DSM-III-R guidelines. Average daily dosage of fluvoxamine was 160 mg, with a highest permitted dose of 300 mg/day. Weekly evaluation included a diary in which the number, severity, and duration of full-blown and limited panic attacks and the duration and severity of anticipating fear, CAS, GAS, CGI, HAM-D, adverse effects and the number of capsules not taken were noted. Fluvoxamine was not significantly superior to placebo with regard to the main outcome criterion, i.e., the reduction in the number of panic attacks, but it was s…
Comparison of Ondansetron versus Clonidine efficacy for prevention of postoperative pain, nausea and vomiting after orthognathic surgeries : a triple…
2018
Background The aim of this randomized controlled triple blind trial was to compare the efficacy of clonidine with dexamethasone versus ondansetron with dexamethasone for postoperative pain, nausea and vomiting prevention in orthognathic surgery patients. Material and Methods In this clinical trial study, 30 consecutive patients with skeletal class III deformities were candidates for orthognathic surgery in Qaem hospital, Mashhad University of medical sciences, Mashhad, Iran from March to November 2017. These subjects were randomly assigned to two equal number groups, ondansetron or clonidine. Patients received either oral ondansetron 8mg or oral clonidine 150μg as premedication, 1 hour befo…
A double-blind, randomized, multicenter, Italian study of frovatriptan versus almotriptan for the acute treatment of migraine
2011
The objective of this study was to evaluate patients’ satisfaction with acute treatment of migraine with frovatriptan or almotriptan by preference questionnaire. One hundred and thirty three subjects with a history of migraine with or without aura (IHS 2004 criteria), with at least one migraine attack in the preceding 6 months, were enrolled and randomized to frovatriptan 2.5 mg or almotriptan 12.5 mg, treating 1–3 attacks. The study had a multicenter, randomized, double blind, cross-over design, with treatment periods lasting <3 months. At study end patients assigned preference to one of the treatments using a questionnaire with a score from 0 to 5 (primary endpoint). Secondary endpoints w…
Clinical evaluation of antiseptic mouth rinses to reduce salivary load of SARS-CoV-2
2021
AbstractMost public health measures to contain the COVID-19 pandemic are based on preventing the pathogen spread, and the use of oral antiseptics has been proposed as a strategy to reduce transmission risk. The aim of this manuscript is to test the efficacy of mouthwashes to reduce salivary viral load in vivo. This is a multi-centre, blinded, parallel-group, placebo-controlled randomised clinical trial that tests the effect of four mouthwashes (cetylpyridinium chloride, chlorhexidine, povidone-iodine and hydrogen peroxide) in SARS-CoV-2 salivary load measured by qPCR at baseline and 30, 60 and 120 min after the mouthrinse. A fifth group of patients used distilled water mouthrinse as a contr…