Search results for "PLACEBO"
showing 10 items of 704 documents
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…
Response to treatment in minor and major depression: results of a double-blind comparative study with paroxetine and maprotiline.
1997
Several concepts of minor depression in the sense of acute but less severe symptomatology than major depression have been proposed in the literature, but currently none of them is generally accepted. For the treatment of these conditions, only few recommendations based on empirical data are available. We conducted a randomized double-blind multicentre study in depressed outpatients comparing paroxetine and maprotiline in both patients with minor (n = 245) and major depression (n = 298). For the diagnosis, Research Diagnostic Criteria were used in a modified version. Two response criteria were applied: a reduction of 50% or more in total HAMD-17 scores from baseline (criterion 1), and a redu…
Effects of Kinesio® Tape in low back muscle fatigue: randomized, controlled, doubled-blinded clinical trial on healthy subjects.
2013
BACKGROUND: Muscle fatigue of the trunk extensor musculature plays a considerable role in chronic low back pain (LBP). The underlying physiology of fatigue is complex and not fully understood. The Kinesio Taping (KT) supports damaged structures while allowing mobility and at the same time may influence some of the mechanisms associated with muscle fatigue such as blood flow and proprioception. OBJECTIVE: The aim of this study is to determine the influence of KT on the resistance to fatigue of the lumbar extensor musculature in a sample of young healthy subjects. METHODS: A randomized, controlled, doubled-blinded clinical trial was conducted. Ninety nine healthy subjects were randomized in t…
Endogenous opioid peptide responses to opioid and anti-inflammatory medications following eccentric exercise-induced muscle damage.
2009
To determine the effects of Vicoprofen, Ibuprofen, and a placebo on the responses of endogenous opioid peptides following eccentric exercise-induced muscle damage 36 healthy men (age: 22.8 years; height: 178.8+/-6.2cm; body mass: 78.9+/-13.7kg; body fat: 15.8+/-6.5%) volunteered to participate in the study. Each participant was evaluated for pain 24h post and randomly assigned to an experimental group: VIC (Vicoprofen), IBU (Ibuprofen), or P (placebo). Medication was given four times daily (i.e., VIC (hydrocodone bitartrate 7.5mg with Ibuprofen 200mg) and IBU 200mg). Blood was obtained at rest and at 0, 24, 48, 72, 96 and 120h following the eccentric exercise damage protocol. No significant…
Effect of Corticosteroids on Facial Function after Cerebellopontine Angle Tumor Removal: A Double-Blind Study versus Placebo
2015
The aim of this study was to assess the effect of corticosteroids administered intra- and postoperatively on the occurrence of facial palsy after a cerebellopontine angle (CPA) tumor resection, and to investigate pre- and intraoperative prognostic factors. A multicenter, prospective, randomized, double-blind and versus-placebo study was conducted between 2006 and 2010. Three hundred and ten patients operated on for a CPA tumor (96% vestibular schwannomas, 4% miscellaneous) were included by five participating centers. The population was stratified into patients with small (≤15 mm CPA on axial MRI views) and large tumors. In each group, patients were randomized to receive corticosteroid (1 mg…
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 …
Omalizumab in patients with symptomatic chronic idiopathic/spontaneous urticaria despite standard combination therapy
2013
Patients with chronic idiopathic urticaria/chronic spontaneous urticaria (CIU/CSU) often continue to experience symptoms despite receiving standard-of-care therapy with H1-antihistamines along with 1 or more add-on therapies.We sought to evaluate the safety and efficacy of 24 weeks of treatment with omalizumab in patients with persistent CIU/CSU despite treatment with H₁-antihistamines at up to 4 times the approved dose plus H₂-antihistamines, leukotriene receptor antagonists, or both.In this phase III study patients were randomized to receive 6 subcutaneous injections at 4-week intervals of either 300 mg of omalizumab or placebo, followed by a 16-week observation period. The primary object…
Effect of omalizumab on angioedema in H1-antihistamine-resistant chronic spontaneous urticaria patients: results from X-ACT, a randomized controlled …
2016
Background Chronic spontaneous urticaria (CSU) severely impacts quality of life (QoL), especially in patients with wheals and angioedema. Omalizumab is approved as add-on therapy for CSU patients; however, its effect on patients who are double-positive for wheals and angioedema has not been systematically studied. Objective The primary objective was to evaluate the efficacy of omalizumab vs placebo at week 28 using the Chronic Urticaria Quality of Life (CU-Q2oL) questionnaire. Number of angioedema-burdened days, time interval between successive angioedema episodes, disease activity, angioedema-specific and overall QoL impairment were secondary objectives. Methods X-ACT was a phase III, rand…
Efficacy and safety of omalizumab in patients with chronic urticaria who exhibit IgE against thyroperoxidase
2011
Background A subgroup of patients with chronic spontaneous urticaria (CU) exhibits IgE antibodies directed against autoantigens, such as thyroperoxidase (TPO). We conducted this study to investigate whether such patients with CU with IgE against TPO benefit from treatment with omalizumab, a humanized anti-IgE mAb licensed for the treatment of severe persistent allergic (IgE-mediated) asthma. Objectives We sought to assess the efficacy of omalizumab treatment in patients with CU with IgE autoantibodies against TPO. Methods In this multicenter, randomized, double-blind, placebo-controlled study patients with CU (male/female, 18-70 years of age) with IgE autoantibodies against TPO who had pers…