Effectiveness randomized clinical

Randomized, controlled clinical trials reduce bias and variability by a process of selection, randomization and standardization of treatment, and often take place under artificial conditions isolated from those of routine clinical practice (Freemande et al, 1993 Simon et al, 1995b). Yet it is the uncontrolled interactions of a dmg technology with patients, health-care workers and the system of health care that ultimately lead to much of the variability in outcomes and expenditures in clinical practice. Thus the value of RCTs in evaluating cost-effectiveness in clinical practice maybe limited (Reeder, 1995 Simon et al, 1995b Hotopf et al, 1996). 

For any intervention intended to impact favorably upon human health, it is important to evaluate its safety and efficacy in order to demonstrate that it does not cause harm and it does provide the expected benefit. The gold standard method for evaluating any intervention, whether it be a botanical product, dietary supplement, drug, medical device or medical procedure, is the randomized, clinical trial (RCT). A clinical trial is a type of experiment conducted in human subjects where the effects of at least two interventions are compared. Often, the clinical trial takes the form of an active treatment compared to an inactive control or placebo. 

MILLER ERR, APPEL L J, RISBY T H (1998) Effect of dietary patterns on measures of lipid peroxidation results from a randomized clinical trial, Circulation, 98, 2390-95. 

IA, condition with evidence and/or general agreement that a procedure or treatment is useful and effective, based on data from multiple randomized clinical trials IB, condition with evidence and/or general agreement that a procedure or treatment is useful and effective-based on data from a single randomized trial or nonrandomized studies. 

Treatment Effect in Randomized Clinical Trials A Meta-Analytic Evaluation, Depression and Anxiety 19 (2004) 10-19 Leo, Jonathan, Academic Freedom and Controversy over the Publication of Factually Correct, Publicly Available Information (2009) http //online.wsj.com/public/resources/documents/leo statement for WSJ.htm[25/o4/2009 17 56 46]... 

Dowsett M, Bundred NJ, Decensi A, Sainsbury RC, Lu Y, Hills MJ, et al. (2001) Effect of raloxifene on breast cancer cell Ki67 and apoptosis a double-blind, lacebo-controlled, randomized clinical trial in postmenopausal patients. Can Epidemiol Biomar Prev 10 961-966... 

New SERMS are in different development stages. Lasoftmfene has been shown to have positive effects on bone and lipid metabolism without negative impact on uterine growth (Ke et al. 1998). There is a large-sample, prospective, randomized clinical trial in progress in which breast cancer, together with fracture prevention, is one of the main outcomes. 

McTiernan A, Rajan KB, Ulrich CM et al. (2004) Effect of exercise on serum estrogens in postmenopausal women a 12-month randomized clinical trial. Cancer Res 64 2923-2928... 

Andersson et al. (2002) have shown in a randomized clinical trial that raloxifene does not affect insulin sensitivity or glycemic control in postmenopausal women with type-2 diabetes mellitus. It has favorable or neutral effects on selected surrogate markers of cardiovascular risk while decreasing hyperan-drogenicity in these patients. 

Haskell SG, Richardson E (2004) The effect of raloxifene on cognitive function in postmenopausal women a randomized clinical trial. Conn Med 68 355-358... 

Hayachi, K. and Walker, A.M. (1996). Japanese and American reports of randomized trials Difference in the reporting of adverse effects. Controlled Clinical Trials 17 99-110... 

A 5 year randomized clinical trial in the United States found that in spite of the availability of hypertensive medication, awareness promotions, and guidelines, only a third of all the hypertensive patients have their blood pressure under effective control due to noncompUance in medication. More tailored behavioral management intervention may help to improve compliance and achieve better control. 

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