We conducted a controlled trial of the adoption of a group-practice model within an academic department of medicine. Ongoing randomization yielded similar groups of patients and residents. To determine the effect of the intervention on medicine-clinic operation, we monitored the hospital outpatient activity of 28 residents and 2299 patients during an 11-month study period. The group-practice clinics generated 20% more patient encounters per month than did the traditional, control clinics (328 vs 273 encounters), primarily because twice as many voluntary, overflow clinic sessions were scheduled (20.2 vs 9.7 sessions). Yet, because group-practice registration was decentralized, patients spent 15% less time in completing scheduled visits (93.2 vs 109.9 minutes). Regular utilizers of the group practices made 7% more scheduled clinic visits on average (3.27 vs 3.05 visits), but 39% fewer walk-in visits (0.14 vs 0.23 visits). Hospital-wide, continuity of care was not affected. We conclude that adoption of a group-practice model at our institution improved clinic productivity, enhanced patient flow, and decreased unscheduled clinic visits.

To determine the value of extracranial-intracranial arterial anastomosis (EC/IC bypass), we randomly allocated 1377 patients with symptomatic atherosclerosis of the internal carotid or middle cerebral arteries to medical care alone or to EC/IC bypass with continuing medical care. As previously reported, surgery did not reduce--or significantly increase--the risk of stroke. Functional status data collected during the trial provide new information. Six weeks following entry, surgical patients showed greater dysfunction in the following activities: fluency of speech, getting in and out of bed, sitting down and standing up, toileting, cutting food and pouring beverages, and dressing and undressing. At 4.5 months, surgical patients still exhibited greater dysfunction in toileting, with nonsignificant trends in several other activities. From six months onward, there were no significant differences between the groups. Thus, EC/IC bypass results in transient worsening of functional status beyond the immediate perioperative period.

A randomized, double-blind, placebo-controlled trial was conducted to examine the effect of calcium supplementation on blood pressure in normotensive black (n = 21) and white (n = 54) men, aged 19 to 52 years. After a four-week baseline period of weekly blood pressure measurement, subjects were randomly assigned within racial groups to either a treatment (calcium, 1500 mg/d) or placebo group for a 12-week period. During the experimental period, multiple blood pressure measurements were taken every two weeks in both the seated and supine positions, using a random baseline sphygmomanometer. A repeated-measures analysis of covariance yielded a modest but significantly lower seated mean arterial pressure in the treatment group compared with the control group, but no differences between the races. Results were similar for supine blood pressure. Calcium supplementation, in comparison with placebo, resulted in lower mean arterial pressure in normotensive white and black men during a 12-week period. The overall blood pressure-lowering effect was not correlated with the response of serum levels of total and ionized calcium, total inorganic phosphorus, or parathyroid hormone, or overnight urinary electrolyte values.

In a randomized controlled clinical trial, the effectiveness of emergency medical technician (EMT) use of automatic external defibrillators (AEDs) was compared with EMT use of standard defibrillators for patients in cardiac arrest. A total of 321 cardiac arrest patients were treated during the study: 116 were treated by EMTs using the AED (AUTO group), 158 were treated by EMTs using the standard defibrillators (standard group), and 47 were treated by EMTs using the standard defibrillator when they were assigned to use the AED. There was no significant differences in hospital admission or discharge rates between the AUTO group (54% admitted, 28% discharged) and the standard group (52% admitted, 23% discharged) for patients in ventricular fibrillation (VF), for patients in non-VF rhythms, or for all patients combined. The only significant difference observed was in the time from power ON to first shock: 1.1 minutes average AUTO group and 2.0 minutes average standard group. The treatment groups did not differ significantly in sensitivity for VF (78% AED, 76% standard), specificity for non-VF rhythms (100% AED, 95% standard), or rates of defibrillation to a non-VF rhythm (62% AED, 57% standard). We conclude that in clinical outcomes and device performance, AEDs are comparable with standard defibrillators and should be considered an acceptable alternative. Automatic external defibrillators appear to have advantages over standard defibrillators in training, skill retention, and faster operation. Such devices can make early defibrillation available for a much larger portion of the population. They are a major innovation for the prehospital care of cardiac arrest patients.

A four-year trial assessed whether less severe hypertensives could discontinue antihypertensive drug therapy, using nutritional means to control blood pressure. Randomization was to three groups: group 1--discontinue drug therapy and reduce overweight, excess salt, and alcohol; group 2--discontinue drug therapy, with no nutritional program; or group 3--continue drug therapy, with no nutritional program. In groups 1 and 2 patients resumed drug therapy if pressure rose to hypertensive levels. Loss of at least 4.5 kg (10 + lb) was maintained by 30% of group 1, with a group mean loss of 1.8 kg (4 lb); sodium intake fell 36% and modest alcohol intake reduction was reported. At four years, 39% in group 1 remained normotensive without drug therapy, compared with 5% in group 2. Study findings demonstrated that nutritional therapy may substitute for drugs in a sizable proportion of hypertensives or, if drugs are still needed, can lessen some unwanted biochemical effects of drug treatment.

Within 48 hours of arrival in Mexico, 182 US students participated in a study to compare the efficacy of two dosages of bismuth subsalicylate (262 mg per tablet) as a prophylactic agent against diarrhea. The students were randomly assigned to receive two tablets (high dose) or one tablet (low dose) of bismuth subsalicylate four times daily or a placebo four times daily during a three-week period. Among these completing the trial, diarrhea (four or more unformed stools in 24 hours or three in eight hours, plus one other symptom) occurred in seven (14%) of 51 receiving the high-dose regimen compared with 15 (24%) of 63 receiving the low-dose regimen and 23 (40%) of 58 in the placebo group. Protection rates were 65% for high-dose and 40% for low-dose bismuth subsalicylate. Diarrhea caused by enterotoxigenic Escherichia coli was found in one student receiving the high-dose regimen, in no students receiving the low-dose regimen, and in seven placebo-treated subjects. Bismuth subsalicylate was well tolerated; the most common side effects were blackening of tongues and stools. Bismuth subsalicylate use in both dosages was associated with tinnitus at a low, clinically insignificant frequency of 1.2 days per 100 days of treatment. The dosage of two tablets of bismuth subsalicylate four times daily (2.1 g/d) appears to be a safe and effective means of reducing the occurrence of travelers' diarrhea among persons at risk for periods up to three weeks.

This prospective randomized study was undertaken to determine the efficacy of antimicrobial therapy compared with no therapy for bacteriuria in elderly ambulatory nonhospitalized women. Sixty-one women (mean age, 85.8 years) with bacteriuria were in the no therapy control group and 63 women (mean age, 85.8 years) with bacteriuria were in the therapy group; none had symptoms of urinary tract infection. One short course of antimicrobial therapy achieved a cure rate of 68.3% (43 of 63 women cured) two weeks after treatment. During the six-month follow-up period, ten (16.4%) of 61 women in the no therapy group and five (7.9%) of 63 women in the therapy group developed symptomatic urinary tract infection. At the time of six-month follow-up, 19 (34.5%) of 55 women in the no therapy group and 35 (63.6%) of 55 women in the therapy group did not have bacteriuria. We conclude that for asymptomatic bacteriuria in elderly ambulatory nonhospitalized women, short-course antimicrobial therapy is effective at two-week follow-up and that antimicrobial therapy can eliminate bacteriuria in most of these women for at least a six-month period.

Intradermal human diploid cell rabies vaccine (ID HDCV) was licensed for preexposure use in the United States on May 30, 1986. We studied the safety and efficacy of this newly approved route and dose of administration. Serologic results were available from 112 (90%) of the 124 persons who participated in an HDCV low-dose preexposure study in which five different ID, intramuscular (IM), and subcutaneous primary immunization regimens were administered. Three 1.0-mL IM doses of vaccine resulted in titers similar to those from three 0.1-mL ID doses when compared 49 days, one year, and two years after primary immunization. Uniformly high postbooster titers occurred in all five groups when ID boosters were administered at one year or two years. Adverse reactions were similar following both ID and IM vaccination. Although ID HDCV can be a cost-effective substitute for IM vaccine, excessive use of unnecessary preexposure booster doses by any route may be inadvisable because of systemic allergic reactions. In addition, poor immune responses to HDCV have been documented in persons vaccinated in some developing countries. This may limit the use of low-dose regimens in some places.

Several prospective studies have demonstrated an association between low serum cholesterol level and subsequent mortality from cancer. This finding was explored in the large cohort (361,662) of men aged 35 to 57 years who were screened for possible randomization to the Multiple Risk Factor Intervention Trial. Mortality follow-up revealed a significant excess of cancer in the lowest decile of serum cholesterol level during the early years of follow-up, which attenuated over time. In contrast, the association between high serum cholesterol and coronary heart disease did not diminish during the average of seven years of follow-up. These findings are consistent with the inference that the association between low serum cholesterol level and cancer is at least in part due to an effect of preclinical cancer on serum cholesterol level. A subset of the cohort (12,866 men) participated in the randomized Multiple Risk Factor Intervention Trial protocol, which called for annual measurements of serum cholesterol level. Among the 150 of these men who died of cancer during the trial, cholesterol level fell 22.7 mg/dL (0.59 mmol/L) more than in the survivors over an equivalent period. These data are consistent with the foregoing inference.

Evidence is accruing that older individuals receive little attention for mental health problems and that any attention that is given is most often within the primary care setting. A randomized clinical trial was carried out at a primary care clinic of The Johns Hopkins University, Baltimore, testing the ability of feedback of the results of a screening instrument (the General Health Questionnaire) to increase awareness in clinicians of the emotional and psychological problems of their patients. This report contrasts those aged 65 years and older with younger patients. Detection and management of mental morbidity were lower for older individuals, but the feedback intervention increased the likelihood of attention to these problems. This was not true for younger patients. Detection was significantly higher for older patients when screening data were made available, as was management, although the latter difference was not statistically significant. There was evidence as well that the intervention moved clinicians to greater congruence with their older patients in the perception that current mental health problems existed. These findings have important implications for primary care.

To learn more about the metabolic effects of dietary fructose and sucrose, 12 type I and 12 type II diabetic subjects were fed three isocaloric (or isoenergic) diets for eight days each according to a randomized, crossover design. The three diets provided, respectively, 21% of the energy as fructose, 23% of the energy as sucrose, and almost all carbohydrate energy as starch. The fructose diet resulted in significantly lower one- and two-hour postprandial plasma glucose levels, overall mean plasma glucose levels, and urinary glucose excretion in both type I and type II subjects than did the starch diet. There were no significant differences between the sucrose and starch diets in any of the measures of glycemic control in either subject group. The fructose and sucrose diets did not significantly increase serum triglyceride values when compared with the starch diet, but both increased postprandial serum lactate levels. We conclude that short-term replacement of other carbohydrate sources in the diabetic diet with fructose will improve glycemic control, whereas replacement with sucrose will not aggravate glycemic control.

In a double-blind trial, 21 patients with severe plaque psoriasis were randomly assigned to receive oral cyclosporine, 14 mg/kg/d, or its vehicle. After four weeks of therapy the 11 cyclosporine recipients had the following response to treatment: two had total clearing and six improved markedly, two moderately, and one minimally; whereas ten vehicle-treated patients showed no change or minimal improvement. Vehicle-treated patients, after a switch to cyclosporine for four weeks, demonstrated impressive improvement similar to that seen in patients who initially received only cyclosporine. Moderate or marked improvement or total clearing was noted in 17 (81%) of 21 and 20 (95%) of 21 after one and four weeks of therapy, respectively. Mitotic figures and leukotriene B4 levels in lesions decreased 86% and 64%, respectively, after seven days of cyclosporine therapy. Mononuclear (including activated T cells) and polymorphonuclear leukocyte infiltrates were markedly reduced in lesions of all patients after seven days of cyclosporine therapy. These results suggest that psoriasis may have an immunologic basis mediated by activated T cells and/or other immune cells; if a long-term regimen with a favorable efficacy-side effect ratio can be determined, cyclosporine would be a significant advance in the treatment of psoriasis.

A proposed Food and Drug Administration program to require written information with prescription drugs could cost $500 million annually; the American Medical Association has implemented a similar, voluntary program costing more than $3 million. However, the educational impact of written drug information has not been studied. We evaluated one-page drug information sheets using an objective examination. The baseline score of 71 patients was 3.9 of 6.0. Patients tested before and one day after receiving the drug sheet improved their score by +1.4. In the second phase, patients randomized to receive the drug sheet improved their score after one month by +1.1; those not given the sheet had no improvement. Changes in attitudes and incidence of reported adverse effects seemed to be random and unrelated to the information sheet. Thus, a drug information sheet may be a useful adjunct to patient education.

Saturated fatty acids and cholesterol in the diet raise the plasma cholesterol concentration, and a reduction in these constituents is recommended widely. However, there is not general agreement as to which nutrients should replace saturated fatty acids. Several different substitute nutrients are possible. In this study, three cholesterol-lowering diets were compared in nine men living in a domiciliary. On a typical American diet at baseline, cholesterol levels were in the normal range. One replacement diet was high in polyunsaturated fatty acids (High Poly); another had 30% fat and corresponded to the American Heart Association's (AHA) recommended diet for the general public (AHA phase I); the third diet had 20% fat, equivalent to the AHA phase III diet for treatment of hypercholesterolemia. Compared with baseline levels, all diets caused similar reductions in total cholesterol and low-density lipoprotein cholesterol levels, but the High Poly and AHA phase III diets lowered the high-density lipoprotein cholesterol level more than the AHA phase I diet. Thus, for the limited number of patients in this study, the diet recommended for the general public appeared as effective for lowering of cholesterol levels as diets containing more polyunsaturates or more carbohydrates.

We compared verapamil and propranolol hydrochloride for monotherapy of hypertension. Verapamil lowered blood pressure (BP) more effectively than propranolol in black and white patients. Verapamil was equally effective in blacks and whites, whereas propranolol was more effective in whites. Heart rate was reduced by 6.0 beats per minute by verapamil, and by 13.6 beats per minute by propranolol. In blacks, verapamil lowered systolic BP 16.9 vs 8.1 mm Hg for propranolol; verapamil reduced diastolic BP 12.8 vs 8.6 mm Hg for propranolol. In whites, verapamil lowered systolic BP 19.0 vs 12.7 mm Hg for propranolol; verapamil reduced diastolic BP 16.7 vs 12.3 mm Hg for propranolol. Increases in systolic BP were observed in 22% and 3.4% of patients receiving propranolol and verapamil, respectively. The PR interval was increased from 163.5 to 174.9 ms for verapamil vs 160.3 to 164.4 ms for propranolol. Constipation (15%) and headaches (10%) were most frequent complaints for verapamil vs fatigue (18%) and dizziness (7%) for propranolol. Changes in blood biochemistry values were of small magnitude. We conclude that verapamil monotherapy is a safe and effective means of achieving BP control in patients with essential hypertension.

We conducted a controlled, blinded, multicenter study of disulfiram treatment of alcoholism in 605 men randomly assigned to 250 mg of disulfiram (202 men); 1 mg of disulfiram (204 men), a control for the threat of the disulfiram-ethanol reaction; or no disulfiram (199 men), a control for the counseling that all received. Bimonthly treatment assessments were done for one year. Relative/friend interviews and blood and urine ethanol analyses were used to corroborate patients' reports. There were no significant differences among the groups in total abstinence, time to first drink, employment, or social stability. Among the patients who drank and had a complete set of assessment interviews, those in the 250-mg disulfiram group reported significantly fewer drinking days (49.0 +/- 8.4) than those in the 1-mg (75.4 +/- 11.9) or the no-disulfiram (86.5 +/- 13.6) groups. There was a significant relationship between adherence to drug regimen and complete abstinence in all groups. We conclude that disulfiram may help reduce drinking frequency after relapse, but does not enhance counseling in aiding alcoholic patients to sustain continuous abstinence or delay the resumption of drinking.

The capacity of educational programs to improve physician performance remains doubtful despite many evaluative efforts. This is especially true for programs sponsored by the federal government. We tested the efficacy of an educational program conducted by Professional Standards Review Organizations in reducing the inappropriate use of x-ray pelvimetry. This procedure may cause harm to the fetus, and there is little evidence that it is efficacious. We randomly assigned 120 hospitals in six Professional Standards Review Organizations to study and control groups. Physicians with delivery privileges at each study hospital participated in an educational program that discussed acceptable indications for x-ray pelvimetry. Pelvimetry use was similar in study and control hospitals before the program. However, after the program, pelvimetry was performed by physicians at study hospitals less than one third as often as by physicians at control hospitals. We conclude that educational programs can improve physician performance substantially and that such programs can be effectively conducted by federally sponsored physician organizations.

To test whether ex-smokers become physically dependent on nicotine in gum, we entered eight ex-smokers who were using nicotine gum into a randomized, double-blind, placebo-substitution trial. When placebo was substituted, seven of the eight subjects were observed to have withdrawal symptoms and two relapsed to smoking or nicotine gum. This result suggests that physical dependence (ie, withdrawal) may be a cause of behavioral dependence on nicotine gum (ie, use of gum beyond the recommended period) and physicians should emphasize the need for gradual reduction of nicotine gum.

As part of a prospective, randomized, controlled study of the effectiveness of a geriatric consultation team, we examined compliance by the house staff with recommendations made by the team. Recommendations were formulated for 185 patients, aged 75 years or older, who were randomized into intervention (n = 92) and control (n = 93) groups. In the control group, only 27.1% of the actions that would have been recommended by the team were implemented independently by the house staff. Problems commonly neglected included polypharmacy, sensory impairment, confusion, and depression. In the intervention group, overall compliance was 71.7%. Highest compliance occurred for recommendations addressing instability and falls (95.0%) and discharge planning (94.3%). We conclude that a geriatric consultation team contributes substantial additional input into the care of older patients. Furthermore, relatively high compliance can be achieved with recommendations made by a geriatric consultation team, thereby overcoming the first barrier to the establishment of such a service.