Urine specimens from 134 women with acute, uncomplicated urinary tract infection at three medical centers were examined by the antibody-coated bacteria (ACB) assay. Patients with negative assays (suggesting bladder infection alone) were randomized to receive either a single 3-g oral dose of amoxicillin trihydrate or conventional ten-day courses of sulfa-methoxazole-trimethoprim or oral ampicillin sodium. Comparable results were obtained with the three regimens for ACG-negative infection: 90% eradication of the original organism with single-dose amoxicillin, 100% with sulfamethoxazole-trimethoprim, and 96% with ampicillin. The overall incidence of ACB positivity was 32.1%, ranging from 8% to 63% at the three institutions. This difference seemed to be related to the ease of access to medical care: women with easy access having low rates of ACB positivity and those with poor access having high rates.

Stage II or III breast carcinoma patients were assigned to one of three adjuvant chemotherapy groups after mastectomy. The efficacy of melphalan, vs cyclophosphamide, fluorouracil, and prednisone (CFP), vs CFP plus BCG vaccine was compared in 173 patients treated for five days every six weeks for the first postoperative year. Tumor size, unfavorable local signs, extent of axillary nodal involvement, menopausal status, and participating hospital were considered in assigning patients to treatment groups. The median follow-up time was 26 months; 24.2% of the patients were studied for more than three years. Recurrent disease occurred in 31.6% of the patients in the melphalan group and in 13.4% and 13.2% in the other two groups. Six patients died of metastatic tumor; three others died of other causes. A favorable significant difference exists for polychemotherapy in prolonging disease-free interval in our series.

From June 1973 to August 1977, three hundred thirty-seven patients with small cell carcinoma of the lung were included in randomized therapeutic trials. By February 1979, fifty-one patients (15%) had survived for 18 months, including 29 (9%) in clinical complete remission. Of the latter patients, readmitted for restaging, including bone marrow examination, peritoneoscopy, and bronchomediastinoscopy, residual tumor was found in four. Treatment was discontinued in the remaining patients; six subsequently had relapses, while three patients died, free of disease, of other causes. Sixteen patients are still alive and free of disease more than 19 to 50 months after the primary diagnosis; seven were treated with combination chemotherapy alone, including four who initially had distant metastatic disease. The remaining nine patients had regional disease and were treated with both chemotherapy and radiotherapy, including prophylactic brain irradiation in four patients. Long-term survival can be achieved in a small number of patients in all stages of small cell carcinoma with intensive combination chemotherapy.

A self-care book that guides patients in seeking home care or physician care for 63 medical problems was assessed in three randomly selected groups of families to determine the book's effect on the number of visits to physicians. The first group was given the book and an optional seminar on its use; the second group was identical to the first but each family was promised $50 if their visits to physicians dropped by one third; the third group was a control group (total, 699 families). The book had no significant effect on the number of physician's visits during six- and 12-month study periods even though one half of the families read most or all of the book, and more than one third used it for a specific medical problem. Large-scale distribution of this self-care book therefore did not result in significantly less dependence on physicians for treatment of acute medical problems.

Adverse reactions to cimetidine have been identified through the manufacturer's Worldwide Spontaneous Reporting System. Reactions not observed during clinical trials-mental confusion, interstitial nephritis, and potentiation of oral anticoagulants-were identified and added to the prescribing information for cimetidine while further studies were undertaken. The monitoring of the drug's adverse reaction profile is ongoing so that new types of reactions can be identified.

The comparative effectiveness of three comprehensive therapeutic programs was studied in 118 patients with mild to moderate acne vulgaris. A topical program of tretinoin, benzoyl peroxide, and water avoidance was found to be as effective as the more commonly employed program of systemic tetracycline therapy with topically applied tretinoin and better than a program using systemic tetracycline therapy with abradant cleansers. At 16 weeks of therapy for all groups, the degree of skin dryness correlated with lack of improvement. Skin dryness is established as an aggravating factor in both the pathogenesis and treatment of acne. The topical program was nonirritating, well accepted by patients, and less expensive than the other two regimens.

Fifty-nine patients referred for painful diabetic neuropathy of the lower extremities were evaluated for depression and response to antidepressant drug therapy in a double-blind controlled study. All patients were found to have substantial degrees of depression during psychiatric interview and by Kupfer-Detre test scores (8.1 +/- 0.6, as compared with control values of 4.0 to 4.3 +/- 0.2). Treatment with imipramine hydrochloride or amitriptyline hydrochloride resulted in complete remission of lower extremity pains in all patients in 10 +/- 2 weeks, with concomitant relief of depression and return of depression test scores to 3.8. These results suggest that the syndrome of painful diabetic neuropathy of the lower extremities represents a depressive equivalent in a large proportion of cases and that treatment with imipramine or amitriptyline is a successful mode of therapy for such persons.

In a double-blind, placebo-controlled study, 51 patients with recurrent herpes simplex labialis were treated with topical ether or placebo within 24 hours of onset of a lesion. There was no noteworthy difference between groups given ether and placebo in progression of lesions, healing time, duration or intensity of pain, and duration or quantity of virus excretion. The ether also failed to reduce appreciably lesion virus titer, even when lesions were cultured immediately after topical application. Despite these results, 75% of the patients receiving ether and 77% of those receiving placebo reported effective reduction of the severity and duration of lesions. The marked placebo effect in the treatment of recurrent herpes infection helps to emphasize the need for objective measurements and placebo-controlled studies.

The Aspirin Myocardial Infarction Study (AMIS) was a National Heart, Lung and Blood Institute-sponsored, multicenter, randomized, double-blind, and placebo-controlled trial designed to test whether the regular administration of aspirin to men and women who had experienced at least one documented myocardial infarction (MI) would result in a significant reduction in total mortality over a three-year period. Cause-specific mortality, nonfatal events, and side effects were also evaluated. Over a 13-month period, 4,524 persons between the ages of 30 and 69 years were randomized to either 1 g of aspirin per day (2,267 persons) or placebo (2,257 persons). High levels of patient compliance to study protocol were indicated by various measures. Total mortality during the entire follow-up period was 10.8% in the aspirin group and 9.7% in the placebo group. Three-year total mortality was 9.6% in the aspirin group and 8.8% in the placebo group. The percentage of definite nonfatal MI was 8.1% in the placebo group and 6.3% in the aspirin group. Coronary incidence (coronary heart disease mortality or definite nonfatal MI) was 14.1% in the aspirin group and 14.8% in the placebo group. Symptoms suggestive of peptic ulcer, gastritis, or erosion of gastric mucosa occurred in 23.7% of the aspirin group and 14.9% in the placebo group. Based on AMIS results, aspirin is not recommended for routine use in patients who have survived an MI.

The controversial conclusions of University Group Diabetes Program (UGDP) investigators are refuted by new findings uncovered by analyses of patient data obtained from the UGDP Coordinating Center and by critical review of data previously published by UGDP investigators and the Biometric Committee. These new findings (1) document a notable discrepancy in the sex ratio of cardiovascular (CV) death rates in placebo-treated subjects, (2) show that all excess CV mortality in tolbutamide-treated subjects was restricted to a relatively small group of poorly controlled diabetics, and (3) provide evidence that insulin was efficacious in reducing CV deaths. The anomalous sex ratio of CV deaths in UGDP placebo-treated subjects dictates the conclusion that the CV death rate in placebo-treated subjects was spuriously low, giving the false impression of increased death rates in the other treatment groups, thereby accounting for all of the controversial observations reported by UGDP investigators. For this reason UGDP conclusions based on comparison with placebo-treated subjects should not be extrapolated to the general diabetic population.