Clinical trials controlled

It has been proposed that the development of the complications of diabetes mellitus may be linked to oxidative stress and therefore might be attenuated by antioxidants such as vitamin E. Furthermore, it is discussed that glucose-induced vascular dysfunction in diabetes can be reduced by vitamin E treatment due to the inactivation of PKC. Cardiovascular complications are among the leading causes of death in diabetics. In addition, a postulated protective effect of vitamin E (antioxidants) on fasting plasma glucose in type 2 diabetic patients is also mentioned but could not be confirmed in a recently published triple-blind, placebo-controlled clinical trial [3]. To our knowledge, up to now no clinical intervention trials have tested directly whether vitamin E can ameliorate the complication of diabetes. 

Kranzler HR, Wesson DR, Billot L Naltrexone depot for treatment of alcohol dependence a multicenter, randomized, placebo-controlled clinical trial. Alcohol Clin... 

Reoux JP, Saxon AJ, Malte CA, et al Divalproex sodium in alcohol withdrawal a randomized douhle-hlind placeho-controlled clinical trial. Alcohol Clin Exp Res 25 1324-1329,2001... 

Killen JD, Fortmann SP, Schatzberg AF, etal Nicotine patch and paroxetine for smoking cessation. J Consult Clin Psychol 68 883—889, 2000 Kornitzer M, Boutsen M, Dramaix M, et al Combined use of nicotine patch and gum in smoking cessation aplacebo-controlled clinical trial. Prev Med24 41 7,1995... 

Szeimies RM, Gerritsen MJ, Gupta G, Ortonne JP, Serresi S, Bichel J, Lee JH, Fox TL, Alomar A (2004) Imiquimod 5% cream for the treatment of actinic keratosis results from a phase III, randomized, double-blind, vehicle-controlled, clinical trial with histology. J Am Acad Dermatol 51 547-555... 

Kimbrough-Green CK, Griffiths CE, Finkel LJ, et al (1994) Topical retinoic acid (Tretinoin) for melasma in black patients-a vehicle controlled clinical trial. Arch Dermatol 130 727-733... 

Griffiths CE, Finkel LJ, Ditre CM, et al (1993) Topical tretinoin (retinoic acid) improves melasma a vehicle-controlled, clinical trial. Br J Dermatol 129 415-421... 

Highly selective COX-2 inhibitors - coxibs (rofecoxib, celecoxib, or less popular - valdecoxib, etoricoxib parecoxiband lumiracoxib) - were found to be well tolerated in a series of placebo-controlled clinical trials [8]. However, rofecoxib and valdecoxib have been withdrawn from the market because of an increased incidence... 

Data on antidepressant dmgs are available from a number of sources randomized, controlled clinical trials (RCTs) in both hospital and primary-care populations decision analytic models population-based naturalistic observational studies of usual... 

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). 

Tollefson GD, Sanger TM (1997). Negative symptoms a path analytic approach to a double blind, placebo controlled clinical trial with olanzapine. Am J Psychiatry 154,... 

The mean dietary intake of soy isoflavones in Asian populations consuming soy-based diets ranges from 20-40 mg isoflavones/day, with upper percentile consumer intakes of 70 mg/day (corresponding to around 1 mg/kg body weight). In the six month intervention studies in Western postmenopausal women, the effective dose for improved BMD was around 80-90 mg/day, while in the one year, randomized, double-blind, placebo controlled clinical trial, the effective dose was 54 mg/day. Overall, the dietary recommendation is to consume 50 mg isoflavones/day in combination with standard nutritional requirements for calcium and vitamin D. 

Clemens, J.A., Bulkley, G.B., Cameron, J.L., Milligan, F.L., Hutcheon, L., Horn, S.D. and MacGowan, S.W. (1991). Effect of xanthine oxidase inhibition with allopurinol on the incidence and severity of post-ERCP pancreatitis and hyper-amylasaemia in a prospective, randomized, double-blind, placebo-controlled clinical trial of 168 patients. Gastroenterology 100, A270. 

In randomized, controlled, clinical trials, calcium channel blockers were as effective as p-blockers at preventing ischemic symptoms. Calcium channel blockers are recommended as initial treatment in IHD when /3-blockers are contraindicated or not tolerated. In addition, CCBs may be used in combination with /3-blockers when initial treatment is unsuccessful. However, the combination of a (1-blocker with either verapamil or diltiazem should be used with extreme caution since all of these drugs decrease AV nodal conduction, increasing the risk for severe bradycardia or AV block when used together. If combination therapy is warranted, a long-acting dihydropyridine CCB is preferred. (3-Blockers will prevent reflex increases in sympathetic tone and heart rate with the use of calcium channel blockers with potent vasodilatory effects. 

In placebo-controlled clinical trials, alendronate, ibandronate, and risedronate increased bone mineral density by up to 5% to 8% in the lumbar spine and up to 3% to 5% in the hip.13-16 Additional data suggest that bone mineral density continues to increase with long-term therapy of 7 to 10 years.17,18... 

Interest in the role of HMG-CoA reductase inhibitors (statins) in the treatment of osteoporosis came from boneforming properties seen in animal studies. However, controlled clinical trials are needed. 

Jiang, R. H., Shu, L., Zhang, H. Y. et al. (2006). A phase II randomized double blind multi-centers and parallel control clinical trial for bupropion SR in the treatment of depressive disorders. Chinese Journal of New Drugs, 15(2), 128-31. 

Rush, A. J., Fava, M., Wisniewski, S. R. et al. (2004). Sequenced treatment alternatives to relieve depression (STAR D) rationale and design. Controlled Clinical Trials, 25(1), 119-42. 

Phase II investigates the compound s efficacy and safety in controlled clinical trials for a specific therapeutic indication. To eliminate as many competing factors as possible, Phase II trials are narrowly controlled. They are characterized as small—several hundred subjects with the indicated disease or symptoms—and are closely monitored. The control may be either a placebo study arm or an active control arm. The endpoint measured may be the clinical outcome of interest or a surrogate. Phase II trials may last for several months or even several years. Early pilot trials to evaluate safety and efficacy are called Phase Ila. Later trials, called Phase lib, are important tests of the compound s efficacy. These trials may constitute the pivotal trials used to establish the drug s safety and efficacy. At least one pivotal trial (most frequently a large, randomized Phase III study) is done. Only about one third of compounds entered into Phase II will begin Phase III studies [61],... 

The United States Pharmacopeial Convention, Inc. (USP) in 2000 issued the USP criteria for levels of evidence for botanical articles [117]. While issued for botanicals, the criteria have application to all therapeutic agents. The USP criteria rank evidence from I to IV, with Level I being the strongest. Within Level I, the randomized controlled clinical trial is ranked highest, followed by meta-analysis and epidemiological studies. Level II consists of the same designs, but with methodological flaws. Level III includes inconclusive studies, and Level IV is anecdotal evidence. 

Moore s idea of analysing the data that had been sent to the FDA seemed brilliant, and I proposed that we work on it together. So we began. Moore wrote to the FDA invoking the Freedom of Information Act and requested the medical and statistical reviews of every placebo-controlled clinical trial for the treatment of depression by what, at that time, were the six most widely used new-generation antidepressant drugs Prozac, Seroxat (Paxil in... 

There is yet another possibility. The general assumption is that the effect of a drug adds to the placebo effect, so that the total improvement that patients experience is the drug effect in addition to the placebo effect. This assumption is implicit in the design of placebo-controlled clinical trials, in which the drug effect is assessed as the difference between the response to the drug and the response to the placebo. Anne Harrington, an historian of science at Harvard University and the London School of Economics, calls it the oil-and-water hypothesis. 

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