The American journal of medicine
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Randomized Controlled Trial Clinical Trial
Long-term, nightly benzodiazepine treatment of injurious parasomnias and other disorders of disrupted nocturnal sleep in 170 adults.
To assess the efficacy, dose stability, safety, and abuse potential of long-term, nightly benzodiazepine treatment of chronic disorders of disrupted nocturnal sleep. ⋯ Long-term, nightly benzodiazepine treatment of injurious parasomnias and other disorders of disrupted nocturnal sleep resulted in sustained efficacy in most cases, with low risk of dosage tolerance, adverse effects, or abuse. Data from this study on the treatment of chronic, severe insomnia (a small subset of all insomnia) are not generalizable to the typical insomnia patient.
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Randomized Controlled Trial Clinical Trial
Addition of anticholinergic solution prolongs bronchodilator effect of beta 2 agonists in patients with chronic obstructive pulmonary disease.
A randomized, double-blind placebo-controlled clinical trial was designed to assess the safety, efficacy, and duration of the bronchodilation resulting from the addition of 500 micrograms of ipratropium bromide (Atrovent; Boehringer Ingelheim, CT) inhalation solution to standard small volume nebulizer treatments with 2.5 mg albuterol inhalation solution. A total of 195 patients (63% men, average age 64 years) with > 10 pack-year smoking histories and stable, moderate-to- severe chronic obstructive pulmonary disease (COPD; forced expiratory volume in 1 second [FEV1] 1.02 liter, 38.8% predicted) from eight university-affiliated chest clinics in seven U. S. cities were enrolled into the study. ⋯ Similar increases were seen in FVC and FEF25-75%. The peak improvements in FEV1 and FVC with the addition of ipratropium bromide to albuterol were maintained on test days 43 and 85. Considering the safety and efficacy profiles of this combination, the data would suggest that ipratropium bromide inhalation solution should be considered first-line therapy for those patients with COPD requiring small volume nebulizer treatments.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Nebulized bronchodilators for outpatient management of stable chronic obstructive pulmonary disease.
The bronchodilator efficacy, safety, and persistence of effect of the anticholinergic agent ipratropium bromide and the beta-adrenergic agonist albuterol, both given by nebulization, were compared in 223 patients with stable, severe chronic obstructive pulmonary disease (COPD). The study was a randomized, double-blind, parallel group trial conducted over 85 days. Patients took the study drugs (either 500 micrograms of ipratropium bromide or 2.5 mg of albuterol) three times daily on an outpatient basis throughout the study. ⋯ Patients receiving ipratropium bromide scored higher on a quality-of-life questionnaire evaluating dyspnea, fatigue, emotional function, and mastery. Side effects were relatively infrequent and generally mild for both study drugs. These results show that ipratropium bromide, given by nebulization, is safe and effective in the outpatient treatment of COPD.
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Randomized Controlled Trial Clinical Trial
Alpha sympathomimetic treatment of autonomic insufficiency with orthostatic hypotension.
In this double-blind study, the authors compared the safety and efficacy of the investigational oral agent midodrine, a specific alpha 1-sympathomimetic agent, with ephedrine, a nonspecific alpha- and beta-adrenergic receptor agonist. Eight patients (4 men and 4 women) with refractory orthostatic hypotension resulting from autonomic failure were studied. This study was based on the notion that neurogenic orthostatic hypotension results from attenuation of adrenergic nerve traffic and not from alpha-adrenergic receptor dysfunction. Although arteriolar vasoconstrictors seem to be appropriate therapeutic agents, their success has been limited, and the search for an ideal drug is ongoing. ⋯ Midodrine safely and effectively improved orthostatic hypotension caused by autonomic failure. Our data suggest that the ability to stand is improved better by midodrine than by ephedrine.
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Randomized Controlled Trial Clinical Trial
Combined therapy with estrogen and etidronate has an additive effect on bone mineral density in the hip and vertebrae: four-year randomized study.
Administration of estrogen or etidronate has been shown to increase bone mineral density in postmenopausal women. This 4-year, prospective, randomized study was carried out to monitor any added beneficial effect on bone mineral density when hormone-replacement therapy (HRT) was combined with etidronate. ⋯ This 4-year, prospective, randomized study in early postmenopausal women showed an additive effect of ICE and HRT on the bone mineral density in both vertebrae and the hip. Furthermore, the combined therapy prevented the occurrence of osteomalacia associated with etidronate. This is the first study to demonstrate the effects of etidronate in early postmenopausal women, and the additive beneficial effects of HRT and ICE on bone mineral density.