Search results for "PLACEBO"
showing 10 items of 704 documents
Pharmacologic management of neuropathic pain: Evidence-based recommendations
2007
Patients with neuropathic pain (NP) are challenging to manage and evidence-based clinical recommendations for pharmacologic management are needed. Systematic literature reviews, randomized clinical trials, and existing guidelines were evaluated at a consensus meeting. Medications were considered for recommendation if their efficacy was supported by at least one methodologically-sound, randomized clinical trial (RCT) demonstrating superiority to placebo or a relevant comparison treatment. Recommendations were based on the amount and consistency of evidence, degree of efficacy, safety, and clinical experience of the authors. Available RCTs typically evaluated chronic NP of moderate to severe …
Local Treatment of Urogenital Atrophy with an Estradiol-Releasing Vaginal Ring: A Comparative and a Placebo-Controlled Multicenter Study
1999
Local estrogen substitution has been shown to be more appropriate than any systemic application for the treatment of urogenital symptoms of hormone defiency. The efficacy, safety and acceptability of a new low-dose drug delivery system consisting of an estradiol-releasing silicone vaginal ring was studied in two multicenter trials. In an open-label comparative trial a total of 219 postmenopausal women were randomized to the estradiol-releasing vaginal ring or to estriol suppositories. In terms of efficacy both treatment arms were shown to be equivalent; however, significantly higher rates of acceptability were found for the vaginal ring. In a double-blinded placebo-controlled study a total …
Suspected Nonceliac Gluten Sensitivity Confirmed in Few Patients After Gluten Challenge in Double-Blind, Placebo-Controlled Trials
2017
A double-blind, placebo-controlled, gluten challenge has been proposed to confirm a diagnosis of non-celiac gluten sensitivity (NCGS) in patients without celiac disease who respond to a gluten-free diet. To determine the accuracy of this approach, we analyzed data from 10 double-blind, placebo-controlled, gluten challenge trials, comprising 1312 adults. The studies varied in the duration of the challenge (ranging from 1 day to 6 weeks), daily doses for the gluten challenge (ranging from 2 g to 52 g; 3 studies administered less than 8 g/day), and composition of the placebo (gluten-free products, xylose, whey protein, rice, or corn starch containing fermentable carbohydrates). Most of the stu…
Influence of gender on cytokine induced depression and treatment
2021
Abstract Background Cytokine treatment with Interferon-alpha (IFN-α) represents a clinical model of immune associated depression, but it remains unclear if it is of the same entity as major depressive disorder (MDD). The study focuses on possible gender differences in IFN-α induced depression and effects of a pre-emptive antidepressant treatment. Methods Data from 181 patients with chronic hepatitis C infection (cHC) without history of mental illnesses undergoing treatment with IFN-α 2a and ribavirin were re-analyzed for gender effects. Patients with a pre-emptive antidepressant therapy with Escitalopram (n = 90, verum group) to prevent IFN-induced depression were compared to patients who r…
Genistein and endothelial function in postmenopausal women with metabolic syndrome
2013
BackgroundPrevious data have suggested that genistein could exert beneficial effects on endothelial function and on predictors of cardiovascular risk in healthy postmenopausal women. In a randomized clinical trial, we studied the effects of genistein on endothelial function in postmenopausal women with metabolic syndrome (MS). MethodsTwenty postmenopausal women with MS, according to modified NCEP-ATP III criteria were randomly assigned to receive placebo or genistein (54mg/day) for 6months, along with a Mediterranean-style diet. Postmenopausal women without MS (n=15), served as controls. The primary goal was the assessment of endothelial function by flow-mediated vasodilation (FMD) of brach…
Intraoperative wound instillation of ropivacaine extraperitoneally subfascially fails to provide analgesia after remifentanil–isoflurane for abdomina…
2005
Summary Background Intraoperative local anaesthetic wound instillation has been shown previously to provide analgesia after abdominal surgery. This pain relief may be important, if remifentanil is used for general anaesthesia, because the rapid offset of action may mean that there is not enough analgesia at the end of surgery and in the recovery period. The aim of this randomized, placebo-controlled, double-blind study was to evaluate the analgesic efficacy of preventative wound instillation of ropivacaine after abdominal hysterectomy (AH). We hypothesized that this approach will significantly reduce postoperative morphine consumption. Patients and methods After ethics approval, 40 patients…
Hyaluronan for knee osteoarthritis: an updated meta-analysis of trials with low risk of bias
2015
International audience; Background The effectiveness of intra-articular hyaluronic acid (IAHA) injection for knee osteoarthritis (KOA) is debated.Objectives To evaluate the effect of IAHA for patients with KOA by analysing data from trials of IAHA versus placebo with low risk of bias, to provide the highest level of evidence.Methods A systematic review and meta-analysis was conducted. Randomised controlled trials (RCTs) with a low risk of bias (adequate randomisation and concealment and double-blind design) that investigated IAHA versus placebo (saline solution) injection were eligible. The primary efficacy measure was pain intensity and secondary outcome function at 3 months. The treatment…
Psychophysical and electrofunctional contrast sensitivity in cataractous patients treated with bendazac-lysine salt
1990
The clinical progression of the cataract may be influenced by drugs which reduce the denaturation of lens proteins. One of the most promising drugs is the bendazac-lysine salt. The drug was used in a double-blind study of a group of patients with initial cortical cataract in order to evaluate the changes in visual acuity and contrast sensitivity by means of a psychophysical and an electrophysiological method. After 6 months of treatment with bendazac the mean values of visual acuity showed a statistically significant increase in respect to baseline values, as well as an improvement of the threshold of contrast for most spatial frequencies. In the eyes treated with placebo there was no stati…
OARSI/OMERACT Initiative to Define States of Severity and Indication for Joint Replacement in Hip and Knee Osteoarthritis. An OMERACT 10 Special Inte…
2011
Objective.To define pain and physical function cutpoints that would, coupled with structural severity, define a surrogate measure of “need for joint replacement surgery,” for use as an outcome measure for potential structure-modifying interventions for osteoarthritis (OA).Methods.New scores were developed for pain and physical function in knee and hip OA. A cross-sectional international study in 1909 patients was conducted to define data-driven cutpoints corresponding to the orthopedic surgeons’ indication for joint replacement. A post hoc analysis of 8 randomized clinical trials (1379 patients) evaluated the prevalence and validity of cutpoints, among patients with symptomatic hip/knee OA.…
Treatment with human umbilical cord-derived mesenchymal stem cells for COVID-19 patients with lung damage: a randomised, double-blind, placebo-contro…
2020
AbstractBACKGROUNDTreatment of severe Corona Virus Disease 2019 (COVID-19) is challenging. We performed a phase 2 trial to assess the efficacy and safety of human umbilical cord-mesenchymal stem cells (UC-MSCs) to treat severe COVID-19 patients with lung damage, based on our phase 1 data.METHODSIn this randomized, double-blind, and placebo-controlled trial, we recruited 101 severe COVID-19 patients with lung damage. They were randomly assigned to receive either UC-MSCs (4 × 107 cells per infusion) or placebo on day 0, 3, and 6. The primary endpoint was an altered proportion of whole lung lesion volumes from baseline to day 28. Other imaging outcomes, 6-minute walk test, maximum vital capaci…