The New England journal of medicine
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Randomized Controlled Trial Clinical Trial
Bias in treatment assignment in controlled clinical trials.
Controlled clinical trials of the treatment of acute myocardial infarction offer a unique opportunity for the study of the potential influence on outcome of bias in treatment assignment. A group of 145 papers was divided into those in which the randomization process was blinded (57 papers), those in which it may have been unblinded (45 papers), and those in which the controls were selected by a nonrandom process (43 papers). ⋯ Differences in case-fatality rates between treatment and control groups (P less than 0.05) were found in 8.8 per cent of the blinded-randomization studies, 24.4 per cent of the unblinded-randomization studies, and 58.1 per cent of the nonrandomized studies. These data emphasize the importance of keeping those who recruit patients for clinical trials from suspecting which treatment will be assigned to the patient under consideration.
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Randomized Controlled Trial Clinical Trial
Cimetidine and tranexamic acid in the treatment of acute upper-gastrointestinal-tract bleeding.
We studied the effects of tranexamic acid (an antifibrinolytic agent) and cimetidine on acute upper-gastrointestinal-tract bleeding in a double-blind randomized placebo-controlled trial in 775 patients with hematemesis or melena or both. Mortality was significantly reduced in patients receiving either tranexamic acid (mortality, 6.3 per cent) or cimetidine (7.7 per cent), as compared with patients receiving placebo (13.5 per cent) (P = 0.0092 for tranexamic acid vs. placebo, P = 0.045 for cimetidine vs. placebo). ⋯ The reduced mortality associated with tranexamic acid was detectable at both participating hospitals and in most of the main subgroups of patients classified according to site of bleeding. However, treatment with this agent was not associated with any decrease in the rate of rebleeding or the need for operation.
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Randomized Controlled Trial Clinical Trial
Aerosolized ribavirin treatment of infants with respiratory syncytial viral infection. A randomized double-blind study.
We evaluated a new antiviral agent, ribavirin, in the treatment of infants hospitalized with lower-respiratory-tract disease from respiratory syncytial virus. Ribavirin or placebo was administered to 33 infants in a double-blind manner by continuous aerosol for three to six days. Seventeen infants were treated with placebo, and 16 with ribavirin. ⋯ Viral shedding was also diminished in the treated groups as compared with the placebo group. No side effects or toxicity were associated with the aerosol therapy. Isolates of respiratory syncytial virus obtained from the infants over the course of therapy showed no change in sensitivity to ribavirin.
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Randomized Controlled Trial Clinical Trial
Deamino-8-D-arginine vasopressin shortens the bleeding time in uremia.
In a randomized double-blind cross-over trial we gave either 1-deamino-8-D-arginine vasopressin or placebo to 12 patients with uremia, hemorrhagic tendencies, and prolonged bleeding times. After vasopressin infusion, all patients had shortened bleeding times, with the effect lasting for at least four hours in most cases. Platelet count, platelet cyclic AMP levels, platelet retention on glass beads, plasma fibronectin, serum thromboxane B2 and residual prothrombin, hematocrit, and plasma osmolarity were unchanged after vasopressin. ⋯ The compound was given to nine additional patients with acute or chronic renal failure and prolonged bleeding times, before major surgery or renal biopsy. In these patients, shortening of the bleeding time was associated with normal hemostasis. Our findings indicate that 1-deamino-8-D-arginine vasopressin can be used for temporary correction of bleeding time and may prevent surgical bleeding in patients with uremia.
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Randomized Controlled Trial Clinical Trial
Behavioral treatment for the anticipatory nausea and vomiting induced by cancer chemotherapy.
The nausea and vomiting experienced by one in four cancer patients in anticipation of chemotherapy is probably a learned response to treatment. To determine whether behavioral approaches for altering learned responses might be useful treatments for these symptoms, we compared the effects of "systematic desensitization" (a behavioral treatment in which relaxation is learned as a response to situations in which patients have had anticipatory nausea and vomiting) with those of counseling and of no treatment. ⋯ Desensitized patients also reported significantly less severe anticipatory nausea (P less than 0.01) and vomiting (P less than 0.05) and a shorter duration of anticipatory nausea (P less than 0.01). We conclude that systematic desensitization appears to have an antiemetic effect in cancer patients who receive chemotherapy, and may be useful in the management of these problems.