Randomized intervention trial

Hjalmarson A, Goldstein S, Fagerberg B, Wedel H, Waag-stein F, Kjekshus J et al. Effects of controlled-release metoprolol on total mortality, hospitalizations, and well-being in patients with heart failure the Metoprolol CR/XL Randomized Intervention Trial in congestive heart failure (MERIT-HF). MERIT-HF Study Group. JAMA 2000 283(10) 1295-302. 

Abbreviations-. BEST, beta-blocker evaluation survival trial CAPRICORN, caiveclilol postinfarct suivival control in left ventricular dysfunction C1B1S II, Cardiac Insufficiency Bisoprolol Study II COMET, Carvedilol or Metoprolol European Trial COPERNICUS, carvedilol prospective randomized cumulative survival HF, heart failure LVEF, left ventricular ejection fraction MDC, metoprolol in dilated cardiomyopathy MERIT-HF, metoprolol controlled-release randomized intervention trial in congestive heart failure fJYHA, New York Heart Association. 

Wikstrand J, Hjalmarson A, Waagstein F, et al. Dose of metoprolol CR/XL and clinical outcomes in patients with heart failure Analysis of the experience in metoprolol CR/XL randomized intervention trial in chronic heart failure (MERIT-HF). J Am Coll Cardiol 2002 40 491-498. 

MERIT-HF Study Group. Effect of metoprolol CR/XL in chronic heart failure Metoprolol CR/XL Randomized Intervention Trial in Congestive Heart Failure (MERIT-HF). Lancet 1999 353 2001-2007. 

Secondary prevention reinfarction Israeli nifedipine trial (SPRINT). A randomized intervention trial of nifedipine in patients with acute myocardial infarction. The Israeli Sprint Study Group. Eur Heart J 1988 9(4) 354-64. 

Fox KA, Poole-Wilson PA, Henderson RA, et al, for the Randomized Intervention Trial of unstable Angina (RITA) investigators. Interventional Versus Conservative Treatment for Patients With Unstable Angina or Non-ST-Elevation Myocardial Infarction the British Heart Foundation RITA 3 Randomised Trial. Randomized Intervention Trial of unstable Angina. Lancet 2002 360(9335) 743-51. 

An overall osteoprotective effect is associated with soy diets, the major active component being the isoflavones although the contribution (if any) of soy protein has to be clarified. The spine, rather than the femur, appears to be the most consistently protected bone site. The average daily intake in Japanese women is around 50 mg/day and appears to be sufficient to have a long-term protective effect on the spine. In non-Asian, postmenopausal women, the demonstrated effective dose is 80-90 mg/day. In future clinical studies, investigating the effect of isoflavones on bone metabolism, larger scale, randomized, controlled, intervention trials for longer time periods (1-3 years) will be necessary with a standardized source of soy protein/isoflavones and... 

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. 

Liu J, Ho Sc, Su Y, Chen W, Zhang C and Chen Y. 2009. Effect of long-term intervention of soy isoflavones on bone mineral density in women A meta-analysis of randomized controlled trials. Bone Doi 10.1016/j.bone.2008.12.020. 

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. 

RITA 2 Trial Participants. Coronary angioplasty versus medical therapy for angina The second Randomized Intervention Treatment of Angina trial. Lancer 1997 350 461. 

RITA Trial Participants. Coronary angioplasty vs. coronary artery bypass surgery the randomized intervention treatment of angina trial. Lancet 1993 341 573. 

The intracoronary route has also been used to deliver autologous MSCs. Chen et al. [108] recently reported the first randomized clinical trial of these cells in 69 patients who imderwent a primary percutaneous coronary intervention within 12 h after an AMI. Either MSCs or saline was injected into the target coronary artery. At 3-month follow-up, left ventricular perfusion and the LVEF had significantly improved in the treatment group. 

Whelton PK, Appel LJ, Espeland MA, Applegate WB, Ettinger WH Jr., Kostis JB et al. Sodium reduction and weight loss in the treatment of hypertension in older persons a randomized controlled trial of nonpharmacologic interventions in the elderly (TONE). TONE Collaborative Research Group. JAMA 1998 279(ll) 839-46. 

In conclusion, as summarized by Kupfer and Frank 12001), many randomized controlled trials have established that pharmacological and psychotherapy intervention provides excellent short-term benefit in terms of... 

McGorry, P.D., Yung, A.R., Phillips, LJ., et al. Randomized controlled trial of interventions designed to reduce the risk of progression to first-episode psychosis in clinical sample with subthreshold symptoms. Arch. Gen. Psvchiatrv 59(10), 921-928, 2002. 

Anton RF et al Combined pharmacotherapies and behavioral interventions for alcohol dependence The COMBINE study A randomized controlled trial. JAMA 2006 295 2003. [PMID 16670409]... 

Hanlon JT, Weinberger M, Samsa GP, et al. 1996. A randomized, controlled trial of a clinical pharmacist intervention to improve inappropriate prescribing in elderly outpatients with polypharmacy. Am J Med 100 428. 

Mehilli J, Kastrati A, Schuhlen H, et al. Randomized clinical trial of abciximab in diabetic patients undergoing elective percutaneous coronary interventions after treatment with a high loading dose of clopidogrel. Circulation 2004 I 10 3627-3635. 

Steinhubl SR, Berger PB, Mann JT III, et al. Early and sustained dual oral antiplatelet therapy following percutaneous coronary intervention a randomized controlled trial. JAMA 2002 288 241 1-2420. 

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