Single-blind placebo trial

PORKKALA-SARATAHO E K, NYYSSONEN K M, KAIKKONEN J E, POULSEN H E, HAYN E M, SALONEN R M, SALONEN J T (1998) A randomized, single-blind, placebo controlled trial of the effects of 200 mg a-tocopherol on the oxidation resistance of atherogenic hpoproteins, American Journal of Clinical Nutrition, 68, 1034-41. 

P. Frohna, S. Milwee, J. Pinkett, T. Lee, K. Moore-Perry, J. Chou, and R. H. Ellison in Results from a Randomized, Single-Blind, Placebo-Controlled Trial of FG-4592, a Novel Hypoxia Inducible Factor Prolyl Hydroxylase Inhibitor, in CKD Anemia, Vol. 2007, American Society of Nephrology Renal Week, San Francisco, November 2-5, 2007, Abstract SU-PO806, as abstracted in N. Agarwal and J. T. Prchal, Semin. Hematol., 2008, 45, 267. 

There has been only one double-blind, placebo-controlled long-term trial of lithium as a treatment for bipolar disorder in adults with MR (Naylor et ah, 1974). In this study, 14 adults with borderline to severe MR and bipolar disorder were treated with lithium (with levels between 0.6 and 1.0 mEq/F) for 1 year. The number of weeks of illness was significantly lower in the treatment group. A year-long, single-blind, placebo-controlled trial of lithium in five persons with bipolar mood disorder and MR treatment resulted in re-... 

Depending on the purpose of a study there are several subtypes of placebo-controlled trials (see Fig. 5.3). One design makes use of a single-blind placebo lead-in period. The purposes of this pretrial period of up to 4 weeks are ... 

Psychiatric symptomatology was assessed by the BPRS, the CGI, and the SANS before trial entry, on the last day of the single-blind placebo phase, and weekly thereafter for 6 weeks. If treatment was discontinued before day 42, all efficacy assessments were completed at the time of dropout. 

Clonazepam is widely used for the treatment of sleep disturbances related to post-traumatic stress disorder, despite very limited published data supporting its use for this indication. In a randomized, single-blind, placebo-controlled, crossover trial of clonazepam 1 mg at bedtime for 1 week followed by 2 mg at bedtime for 1 week in six patients with combat-related post-traumatic stress disorder there were no statistically significant differences between clonazepam and placebo (4). Adverse effects of clonazepam were generally mild and essentially indiscernible from those attributed to placebo. Only one patient elected to continue taking clonazepam at the end of the trial. The small sample size was a significant limitation of the study. 

Meloxicam may be relatively safe when given to patients with NSAID-induced urticaria/angioedema (14,15). Of 148 NSAID-sensitive subjects with an unequivocal history of urticaria with or without angioe-dema, who were challenged with increasing oral doses of meloxicam (1-7 mg/day) in a single-blind placebo-controlled trial, only two had a positive test (urticaria in one and urticaria/angioedema in the other) both had chronic idiopathic urticaria (16). 

The effect of an aromatic innnction (Vaporub) was studied by the inhalation of a radioaerosol in a randomized, single-blinded, placebo-controlled crossover trial with 12 chronic bronchitics. It was found that after the application of 7.5 g of the product to the chest, removal of the tracheobronchial... 

Hampel H, Ewers M, Burger K, Annas P, Mortberg A, Bogstedt A, Frolich T, Moller HI, Kurz A, Basun H. Lithium trial in Alzheimer s disease a randomized, single-blind, placebo-controlled, multicenter 10-week study. J Clin Psychiatry 2009 70 (6) 922-31. 

Anistreplase has a considerably longer a half-life than streptokinase, ie, 90 min compared to 20 min (87,88). Moreover, it does not require prolonged infusion to achieve its thrombolytic effects. Anistreplase was found to be highly effective after a single intravenous dose of 30 units over a 5-min period compared to a 60-min infusion of 1.5 million units of streptokinase (89—94). In direct comparative studies, anistreplase was as effective as intracoronary (95,96) and intravenously (96—100) adrninistered streptokinase. In a randomized, double-blind, placebo-controUed study (AIMS trial) with 1004 patients given this modified enzyme, the 30-day mortaUty rate was 12.2% for patients receiving placebo, compared to 6.4% for patients who received 30 units of anistreplase intravenously within six hours of the onset of symptoms (101). 

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