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PubMed1997

[Randomized clinical trials in the Ugeskrift for Laeger 1948-1995].

The Danish Medical Journal (Ugeskrift for Laeger) was handsearched for randomised and pseudorandomised clinical trials over the years 1948-1995. We found 665 trials of which 539 (81%) were classified as randomised; the randomisation method was not stated for 422 of them (78%) and was insufficiently described in the majority of the rest. This problem became worse with time (p = 0.01). In contrast to the international literature where the increase was more gradual and occurred several years later, the number of randomised trials increased markedly around 1973. This change is associated with the introduction of courses in clinical research methodology during the previous years. Since randomisation is the most important safeguard against bias, the method should be described in detail.

Clinical Trials as Topic↗
PubMed1990

Usefulness of a systemic hypertension in-hospital educational program.

The effects of an educational program on compliance and blood pressure (BP) control were assessed in 47 hypertensive patients hospitalized for nonhypertension-related diseases. Patients were randomized to receive either a questionnaire and an educational program (group I, 25) or questionnaire only (group II, 22). Baseline clinical characteristics, admission diagnoses and antihypertensive medications were similar between the groups. Antihypertensive medications used by patients before the trial were not changed. Eight weeks after the initial intervention, patients in group I showed a significant reduction in both systolic and diastolic BP (137/89 vs 154/98 mm Hg, p = 0.005 and 0.006, respectively) and improved compliance (96 vs 36%, p = 0.04), compared with patients in group II. An education program in patients with high BP is an effective method to improve compliance and BP control in the short-term.

Aged↗
PubMed2001

Is early invasive treatment of unstable coronary artery disease equally effective for both women and men? FRISC II Study Group Investigators.

BACKGROUND: The Fragmin and fast Revascularization during InStability in Coronary artery disease (FRISC II) trial compared the effectiveness of an early invasive versus a noninvasive strategy in terms of the incidence of death and myocardial infarction (MI) in patients with unstable coronary artery disease (CAD). OBJECTIVES: In this subanalysis, we sought to evaluate gender differences in the effect of these different strategies. METHODS: The patients (749 women and 1,708 men) were randomized to early invasive or noninvasive strategies. Coronary angiography was performed within the first 7 days in 96% and 10% of the invasive and noninvasive groups, respectively, and revascularization was performed within the first 10 days in 71% and 9% of the invasive and noninvasive groups, respectively. RESULTS: Women presenting with unstable CAD were older, but fewer had previous infarctions, left ventricular dysfunction and elevated troponin T levels. Women had fewer angiographic changes. There was no difference in MI or death at 12 months among women in the invasive and noninvasive groups (12.4% vs. 10.5%, respectively), in contrast to the favorable effect in the invasively treated group of men (9.6% vs. 15.8%, p < 0.001). In an interaction analysis, there was a different effect of the early invasive strategy for the two genders (p = 0.008). CONCLUSIONS: Women with symptoms and/or signs of unstable CAD are older, but still have less severe CAD and a better prognosis compared with men. In contrast to its beneficial effect in men, an early invasive strategy did not reduce the risk of future events among women. Further research is warranted to identify the most appropriate treatment strategy in women with unstable CAD.

Aged↗
PubMed1990

A randomized trial to improve compliance in urinary tract infection patients in the emergency department.

A randomized trial was used to evaluate two forms of a health belief model (HBM) intervention aimed at increasing compliance among 139 patients with urinary tract infections who presented to the emergency department. Patients who received an HBM clinical intervention administered in the ED, HBM telephone intervention two to four days after the ED visit, or both interventions were much more likely than control patients to both schedule and keep a follow-up referral appointment. Both the clinical and telephone interventions were designed to increase perceived susceptibility to complications of the urinary tract infection, seriousness of the complications, and benefits and costs of action. Other factors predicting compliance include age of the patient, urgency of the urinary tract infection as rated subjectively by the emergency physician, need for child care, whether transportation was available, and questioning the nurse about the referral appointment.

Acute Disease↗
PubMed1999

Two-state mixed renewal processes for chronic disease.

We develop a model based on a two-state mixed renewal process and propose its use for modelling disease activity in studies of chronic conditions. We specify Weibull forms for the conditional transition intensities to allow for time trends, and bivariate frailties to accommodate subject-to-subject variability in the disease process. Extensions of this model are considered for stratified analyses in which strata are defined by the number of past exacerbations. Data from a motivating study of chronic bronchitis are analysed to illustrate the methodology.

Anti-Infective Agents↗
PubMed1990

Multicenter study of recombinant human erythropoietin in correction of anemia in rheumatoid arthritis.

PURPOSE: To administer recombinant erythropoietin to patients with rheumatoid arthritis who had significant anemia, while monitoring hematologic and rheumatologic clinical responses as well as potential toxicity. PATIENTS AND METHODS: Seventeen patients with rheumatoid arthritis from five rheumatology care settings were studied. The patients had initial hematocrits of 34% or less and stable clinical status, and were not being treated with second-line drugs or corticosteroids. An 8-week randomized double-blind study involving various dosages of recombinant erythropoietin, as well as placebo, was followed by a 24-week open-label study in which dosage could be titrated to achieve a normal hematocrit. RESULTS: In the 8-week randomized study, four of 13 patients who received injections of recombinant erythropoietin showed a hematologic response, arbitrarily defined as at least a 6-unit increase in hematocrit. None of four placebo-treated patients showed a meaningful hematologic response. All 11 patients who completed the subsequent 24-week open-label study reached a normal hematocrit level at some time during the study, and 10 of 11 showed an increase of hematocrit 6 units or greater. At least one adjustment, i.e., an increase, decrease, or omission of the erythropoietin dosage, was required in all patients to maintain the hematocrit at a target range of 35% for women or 40% for men. Meaningful changes were not seen in patients' capacity to perform activities of daily living or pain levels during either the 8-week randomized study or the 24-week open-label study. No adverse effects were associated with recombinant erythropoietin therapy. CONCLUSION: Patients with rheumatoid arthritis showed excellent hematologic responses to recombinant erythropoietin, without toxicity, during careful monitoring for appropriate dosage adjustment, although a meaningful change in rheumatologic clinical status was not seen.

Activities of Daily Living↗
PubMed1990

M-mode echocardiography in patients with severe congestive heart failure. A subgroup analysis in the Cooperative North Scandinavian Enalapril Survival Study (CONSENSUS).

In the CONSENSUS study, M-mode echocardiography was used as an optional examination. All patients were in severe congestive heart failure [New York Heart Association (NYHA) functional class IV], and all patients had radiologically marked increased heart size. Of 253 patients, M-mode echocardiography was done at baseline in 105 patients. M-mode echocardiographic recordings from 70 patients were received, and of these, only 54 patients (77%) had recordings of acceptable quality for evaluation. At follow-up, M-mode echocardiography was done after 6 weeks, 6 months and 12 months. However, because of the high mortality and the premature cessation of the study, only a limited number of patients had M-mode echocardiographic registrations after greater than 6 weeks. All M-mode echocardiographic registrations were analysed by 2 investigators independently. Systolic time interval (STI) decreased from 0.58 to 0.48 (p less than 0.05) in the enalapril group after 6 weeks. In the placebo group, a small increase in STI from 0.54 to 0.56 (not significant) was seen after 6 weeks. The decrease in STI in the enalapril group was secondary to an increase in left ventricular ejection time. No significant change was seen in left ventricular and left atrial diameters at follow-up: this finding can be explained by a type 2 error. These findings indicate an increased STI in the enalapril-treated group, which could explain why enalapril treatment reduced mortality in the CONSENSUS study.

Aged↗
PubMed1990

Lack of immune response to mouse IgG in hemophilia A patients treated chronically with Monoclate, a monoclonal antibody affinity purified factor VIII preparation.

Hemophilia A is caused by factor VIII deficiency that historically has been treated with either a cryoprecipitate fraction of serum or factor VIII concentrate. Recently, the availability of affinity isolated factor VIII (Monoclate) has allowed for a highly purified preparation for the chronic therapy of hemophilia A. This factor VIII preparation contains a trace quantity (less than 50 ng/100 I. U.) of mouse IgG. Immunoassays for the measurement of human IgG, IgM and IgE anti-mouse IgG antibody (HAMA) were developed and used to measure HAMA levels in hemophilia A patients undergoing chronic therapy with Monoclate in three different clinical studies. Natural antibodies to mouse IgG were observed in patient sera prior to Monoclate infusion. Data is presented demonstrating that induction of HAMA upon Monoclate treatment does not occur. The low level of mouse IgG contained in Monoclate appears to be below the threshold of immunogenicity. Most importantly, clinical symptoms related to hypersensitivity or anaphylaxis were never observed in any patient undergoing chronic therapy with Monoclate in these clinical studies.

Adolescent↗
PubMed1990

Comparison of simvastatin and cholestyramine in the treatment of primary hypercholesterolaemia.

The effects of simvastatin, a competitive inhibitor of the enzyme 3-hydroxy-3-methylglutaryl-coenzyme A reductase, on plasma lipid levels were compared with those of the bile acid sequestrant cholestyramine in a randomized parallel study of 60 subjects with primary hypercholesterolaemia. After a 12-week direct comparison period 37 subjects with inadequate cholesterol reduction received a combination of both drugs and all subjects were followed for a further 40 weeks. Simvastatin was more effective than cholestyramine in lowering total and LDL cholesterol levels and the LDL/HDL ratio (-31.7% v. -19.7% [P less than 0.01], -41.0% v. -31.8% [P less than 0.05] and -46.7% v. -33.6% [P less than 0.01], respectively at Week 12). Only simvastatin significantly increased the HDL cholesterol concentration (+13.3% [P less than 0.01] v. +6.4%). Cholestyramine increased plasma triglyceride levels by 37.5% (P less than 0.01) whereas simvastatin caused a slight non-significant reduction. Combined therapy produced a further decrease in total and LDL cholesterol levels, and in the LDL/HDL ratio, which was sustained for the duration of the study. Simvastatin was better tolerated than cholestyramine (P less than 0.01), and combining the two drugs enhanced efficacy without increasing the frequency of side effects.

Adult↗
PubMed1990

Effects of simvastatin and cholestyramine in familial and nonfamilial hypercholesterolemia. Multicenter Group I.

Simvastatin, a potent inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A reductase, was compared with cholestyramine resin in a randomized open-label 12-week multicenter study of 251 high-risk patients with familial or nonfamilial hypercholesterolemia. Simvastatin, 20 mg and 40 mg daily, produced mean reductions in total cholesterol of 26% and 33%, respectively, and reductions in low-density lipoprotein cholesterol level of 32% and 40%. Cholestyramine resin, 4 to 12 g twice daily, reduced total cholesterol and low-density lipoprotein cholesterol levels 15% and 21%, respectively. High-density lipoprotein cholesterol levels were increased 8% to 10% by all treatments. Plasma triglyceride levels were moderately decreased by simvastatin treatment, while triglyceride levels increased with cholestyramine treatment. Simvastatin was better tolerated than cholestyramine, which had numerous gastrointestinal tract side effects. No patient had a serious drug-related adverse event.

Adult↗
PubMed1988

Multicenter comparison of glyburide and glipizide in the treatment of non-insulin-dependent diabetes mellitus.

A multicenter, randomized, open-label comparison of glyburide and glipizide was made in 109 patients with non-insulin-dependent diabetes mellitus whose fasting plasma glucose levels had been maintained at less than or equal to 140 mg/dl by tolbutamide, chlorpropamide, or glyburide. After an initial evaluation, patients entered a dose-adjustment phase to establish the optimal daily dose of the assigned drug--glyburide or glipizide--needed to maintain metabolic control. A second evaluation was made at the end of this phase. Patients then proceeded into the maintenance phase, which lasted approximately three months. A final evaluation was made upon completion of or withdrawal from the maintenance phase. Metabolic control was monitored by means of determinations of fasting plasma glucose and hemoglobin A1c. Comparative efficacy was assessed in relation to the doses of the respective drugs needed to maintain acceptable metabolic control. Safety was evaluated through reports of adverse effects as well as through laboratory tests and measurements of vital signs at each patient visit.

Blood Glucose↗
PubMed1989

Should male consorts of women with bacterial vaginosis be treated?

Nitroimidazoles have been shown to be the drugs of choice to treat women with bacterial vaginosis, but the recurrence rate is high. Some workers have suggested that the recurrence of symptoms may in fact be reinfection by male consorts, but no controlled studies have been undertaken to confirm this. In an international, multicentre, randomised, double blind trial, the recurrence rate was studied in 241 women with a clinical diagnosis of bacterial vaginosis. All women were treated with 2 g metronidazole twice at an interval of two days. The patients were randomly allocated to two groups, one contained 123 women, whose consorts were given the same dose of metronidazole, the other consisted of 118 women whose consorts were given inert but identical placebo tablets. The women were evaluated at weeks 1, 4, and 12 after treatment. At week 1, the cure rate was 97% (115/119) in women whose consorts had been treated and 98% (111/113) in the others. At week 4 bacterial vaginosis had recurred in 17% (19/112) of women whose consorts had been treated and in 13% (14/106) of those whose consorts had received placebo. At week 12 the recurrence rates were 21% (20/95) in women with treated consorts, and 16% (15/95) in the others. The differences in recurrence rates between the two groups of women were not significant. In conclusion, treating the sexual partners of women with bacterial vaginosis does not seem to increase the cure rate.

Adolescent↗