The American journal of medicine
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Randomized Controlled Trial Comparative Study Clinical Trial
Serum glucose levels during long-term observation of treated and untreated men with mild hypertension. The Oslo study.
Serum glucose levels, triglyceride levels, and body weight are reported from a controlled drug trial in men, aged 40 to 49, with uncomplicated mild hypertension. The drug treatment started with hydrochlorothiazide alone, and methyldopa was added when necessary. If side effects occurred, methyldopa was replaced by propranolol. ⋯ There was no difference in serum potassium levels in the different drug groups. The results indicate that moderate thiazide doses do not have significant effects on serum glucose levels in this age group. Propranolol in combination with thiazide seems to increase the level of serum glucose.
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Randomized Controlled Trial Clinical Trial
Monotherapy with labetalol in the treatment of mild hypertension: a double-blind study.
The antihypertensive effects of oral labetalol compared with placebo were evaluated in 74 mildly hypertensive patients (standing diastolic blood pressure 95 to 110 mm Hg) in a bicentric double-blind parallel group study. Following a four-week placebo phase, 36 patients were randomly assigned to receive labetalol and 38 to receive placebo. A five-week titration phase followed during which the dose of labetalol was increased weekly from 100 mg twice a day to 600 mg twice a day to achieve a standing diastolic blood pressure of less than 90 mm Hg and decreased 10 mm Hg or more from baseline. ⋯ Blood pressure overshoot did not occur when labetalol was abruptly discontinued. Not one labetalol-treated patient discontinued the study because of adverse experiences. Labetalol is a safe and effective treatment for patients with mild hypertension.
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Randomized Controlled Trial Clinical Trial
The randomized controlled clinical trial. Scientific and ethical bases.
Randomized controlled trials are increasingly accepted in principle but not always in practice, particularly for surgical therapies. Successful surgical randomized controlled trials demonstrate their feasibility, and reports of uncontrolled surgical trials now commonly bear a statement that a definitive answer requires a controlled trial. ⋯ With candor in informed consent, the equal chance not to get a trial treatment makes the randomized controlled trial the most ethical design. Thus, scientific, behavioral, and ethical cases support the randomized controlled trial as the optimal method for investigation of nearly all therapeutic innovations and as a requirement for publication.
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Randomized Controlled Trial Comparative Study Clinical Trial
Comparative clinical studies of ototoxicity and nephrotoxicity of amikacin and gentamicin.
A comparative study of the oto- and nephrotoxicity of amikacin and gentamicin was carried out prospectively. Twenty-six gentamicin-treated patients and 27 amikacin-treated patients were monitored for changes in auditory and renal function during and after therapy. Thirteen of those treated with gentamicin and 20 of those treated with amikacin underwent vestibular caloric testing which could be evaluated for evidence of toxicity. ⋯ In two gentamicin-treated patients (7.7%), ototoxicity developed (one auditory, one vestibular), and in two amikacin-treated patients (7.4%), auditory toxicity developed. Statistical analysis of oto- and nephrotoxicity and their risk factors was not attempted because of the small numbers of patients who could be evaluated. Additional patients are being studied.