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 use of adjuvant chemotherapy for treating patients with operable breast cancer remains a worldwide controversy. Using the data from published randomized control trials with a minimum two-year follow-up, pooled estimates of relapse-free survival rates and overall survival rates were calculated. Relapse-free survival rates were improved by 12.5% (95% confidence interval [CI] +/- 4.5%) at three years and by 8% (CI +/- 6%) at five years, with studies using multiple agents showing a greater effect. A significant advantage was also present in overall survival rates at three years, but only for studies involving multiple agents (4% +/- 3.5%). Results from combining data for other types of trials were inconclusive. The use of this method is presented to illustrate its value as an explicit and systematic one for combining data from several randomized control trials in assessing a therapeutic controversy.

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.

Four hundred sixty-seven patients with symptomatic upper urinary tract calculi underwent extracorporeal shock-wave lithotripsy (ESWL) at The New York Hospital-Cornell Medical Center during the first year. Ninety-five percent of stones were completely treated with one ESWL session. An analysis of 300 treatments revealed that the overall stone-free rate (success) three months after treatment was 75%. The stone-free rate for patients with renal pelvic calculi less than or equal to 20 mm in diameter was 91%. Individual patient stone-free rates depended on stone size (burden), position, composition, and quality of disintegration. Two percent of treatments failed to disintegrate the targeted stone. Complications were minimal. Seven percent of treatments were followed by a secondary endoscopic procedure to facilitate complete stone passage, and 23% of treatments were preceded by cystoscopy with ureteral stent placement of manipulation of stones. Combined therapy utilizing percutaneous surgery or multiple sequential ESWL treatments is necessary for complex stones, and ureteroscopy or basket extraction remains the treatment of choice for distal ureteral calculi.

Since the treatment of chancroid was reviewed in 1982, the results of subsequent treatment trials have offered the clinician additional therapeutic choices as well as shorter courses of therapy. Erythromycin (500 mg four times a day for seven days) provides consistently effective treatment for cases acquired throughout the world, although erythromycin-resistant strains have been isolated in Singapore. Sulfamethoxazole and trimethoprim (800 mg/160 mg orally twice a day for seven days), ceftriaxone (250 mg intramuscularly one time), and amoxicillin/clavulanic acid (500 mg/125 mg orally three times a day for seven days) are also efficacious. There is, however, significant geographic variability in the susceptibility of Haemophilus ducreyi to sulfamethoxazole and trimethoprim, suggesting this combination may become increasingly less effective, and a lack of in-depth experience in the treatment of chancroid with ceftriaxone and amoxicillin/clavulanic acid.

Tetracycline hydrochloride, 500 mg orally four times a day for seven days, remains the treatment of choice for C trachomatis infections in men and nonpregnant women. Either erythromycin, 500 mg orally four times daily for seven days, or an equivalent dosage of another erythromycin product is an alternative treatment for patients who cannot tolerate tetracycline and for pregnant women. These two treatment regimens can be generalized to include nongonococcal urethritis and mucopurulent cervicitis. However, other treatment regimens that are effective against C trachomatis may not be effective for treating nongonococcal urethritis or mucopurulent cervicitis not caused by C trachomatis. The optimal treatment for pregnant women with C trachomatis infections and women with acute PID has not been established. Additional treatment trials with both groups of patients are needed to determine the effectiveness of antimicrobial agents in addition to those currently used, to establish the appropriate dose of each antimicrobial agent, and to clarify the appropriate duration of treatment. All individuals who are sexual partners of patients with nongonococcal urethritis, mucopurulent cervicitis, and acute PID (within the 30 days prior to onset of their symptoms or time of positive clinical evaluation findings) should be examined for sexually transmitted disease and treated promptly with a regimen effective against uncomplicated gonorrhea and chlamydial infections. Prompt treatment of sexual partners reduces the rate of treatment failure due to reinfection, reduces the transmission of infection, and reduces the frequency of occurrence of adverse sequelae of infection.

In a cross-over design, three interventions were tested for their impact on the rate of use of 12 commonly ordered blood tests and roentgenograms among internists in a health maintenance organization. Overall use fell by 14.2% in a 16-week period during which physicians received confidential feedback on their individual rates of use compared with peers (cost feedback). Eleven of 12 tests showed some decrease. Similar feedback on rates of abnormal test results (yield feedback) and a program of test-specific education failed to show a consistent effect. Variability in rates of test use among physicians, as measured by the coefficient of variation, fell by 8.3% with cost feedback, by 1.3% with yield feedback, and by 2.3% with education, but these changes were inconsistent across tests.

In a randomized double-blind study (N = 562), a traditional treatment schedule, starting antihypertensive treatment in elderly hypertensive patients (60 to 75 years old) with 25 mg of hydrochlorothiazide once daily and doubling the dose if a satisfactory response was not achieved, was compared with antihypertensive treatment of 100 mg of metoprolol once daily, adding 12.5 mg of hydrochlorothiazide for patients whose response was not satisfactorialy achieved with metoprolol alone. Systolic and diastolic blood pressure was significantly reduced with both regimens. The frequency rates of responders (diastolic blood pressure, less than or equal to 95 mm Hg) in the metoprolol group and the hydrochlorothiazide group were 50% and 47% after four weeks and 65% and 61% after eight weeks, respectively. There were no significant differences in total symptom score or single symptoms between the regimens, but significantly more patients had hypokalemia and hyperuricemia with the hydrochlorothiazide regimen. Thus, we conclude that beginning antihypertensive treatment with 100 mg of metoprolol once daily and adding a small dose of hydrochlorothiazide (12.5 mg) in patients whose response is not satisfactory with metoprolol alone appears to be effective and safe in elderly hypertensive patients.

In a prospective randomized study, contamination rates of disposable pressure transducers changed every two days (n = 81) were compared with those changed at four (n = 26) or eight days (n = 50); the mean daily incidence of contamination was 3% for each group. After four days of use, the cumulative prevalences of contamination were similar. However, after eight days, the cumulative prevalence was significantly higher in transducers used without change (6.9%) than in those changed every two days (2.9%). Gram-negative bacilli were present in 63% of contaminated transducers; over half were from the patients' own flora. The only definite transducer-related bacteremia occurred on a day of initial contamination and should have been unaffected by the interval of change. Routine use of disposable transducers can be safely extended to four days, even in a busy intensive care unit.

Loperamide hydrochloride was compared with bismuth subsalicylate for the treatment of acute nondysenteric travelers' diarrhea in 219 students visiting seven countries in Latin America. Subjects whose condition was not improved with therapy could elect to take trimethoprim-sulfamethoxazole. Persons receiving loperamide passed fewer unformed stools when compared with the bismuth subsalicylate group during the first four hours of therapy, from four to 24 hours, and from 24 to 48 hours after therapy was initiated. Among subjects with disease due to enterotoxigenic Escherichia coli, Shigella sp, other pathogens, and unknown agents, fewer unformed stools were passed by the loperamide-treated subjects than the bismuth subsalicylate-treated subjects for all time periods studied. No significant prolongation of disease was seen in subjects with shigellosis treated with loperamide. Eight of the loperamide-treated subjects experienced constipation compared with one in the bismuth subsalicylate-treated group; otherwise, there was no difference in minor side effects experienced between both treatment groups. We conclude that loperamide is a safe and effective alternative to bismuth subsalicylate for the treatment of nondysenteric travelers' diarrhea.

We conducted a double-blind, placebo-controlled, crossover study of the effectiveness of amitriptyline and fluphenazine in alleviating the pain of diabetic peripheral neuropathy in six diabetic patients. Pain was evaluated by the patients with a graphic rating scale. A placebo response was found, but no additional effect of amitriptyline and fluphenazine was seen. Although the statistical power of this study was low, these data, when combined with a reevaluation of previous trials of amitriptyline and fluphenazine in the treatment of painful diabetic neuropathy, indicate that there is no justification for the use of these agents in the treatment of painful neuropathy outside of large, controlled clinical trials. Depression as a possible cause of this condition should not go unnoted or untreated.

Improved perinatal outcome is associated with the prevention of hyperglycemia during pregnancy in diabetic women. To determine whether the method of insulin administration influences the degree of diabetic control obtained, we randomized 22 pregnant diabetic women to intensive conventional insulin therapy (N = 11) and insulin pump therapy (N = 11). Frequent outpatient visits; home glucose monitoring, at least six times daily; and frequent telephone contact were offered to all subjects. Patients were hospitalized in the inpatient clinical research center each trimester for a 24-hour metabolic profile. There were no differences between the two treatment groups with respect to outpatient mean glucose levels, symptomatic hypoglycemia, or glycosylated hemoglobin levels, or with respect to inpatient mean glucose level, glycemic excursions, chemical hypoglycemia, or hyperglycemia. Excellent metabolic control was achieved with both treatment methods.