This study explores whether home BP self-determination can be used to assess the effect of treatment in patients with borderline hypertension. Sixteen untreated patients underwent a double-blind trial of propranolol hydrochloride (average dose, 105 mg), clonidine hydrochloride (0.24 mg), and placebo. Home BP readings decreased with both active compounds (-8/-5 with propranolol and -11/-7 with clonidine). During placebo, the readings increased to levels identical to untreated values. This study demonstrates that patients with borderline hypertension are consistently capable of detecting small average changes in home BP. It is also shown that sympatholytic monotherapy can be effectively used to lower the BP in such patients.

Patients with long-term indwelling urethral catheters are subject to acute and long-term complications of bacteriuria. To evaluate the common practice of short-course antibiotic therapy in such patients, we performed a randomized controlled trial of ten-day courses of cephalexin monohydrate repeated whenever a susceptible bacteriuria was present. We observed 17 cephalexin group patients for 545 patient-weeks (160 cephalexin courses) and 18 control group patients for 477 patient-weeks. Throughout the study, the groups were comparable in regard to incidence and prevalence of bacteriuria, number of bacterial strains per weekly urine specimen, incidence of febrile days, and incidence of obstructed catheters. In the cephalexin group, the frequency of fever during periods when antibiotics were being used was similar to that during periods when antibiotics were not being used. More cephalexin-resistant bacteria were isolated from cephalexin group patients. Routine treatment with cephalexin of asymptomatic long-term catheterized patients, even for susceptible organisms, does not seem to be warranted.

To illuminate the process of obtaining informed consent to research in a medically dependent population, we interviewed 156 patients and 37 physicians involved in research projects at four Veterans Administration hospitals. Most patients knew they were research subjects, had voluntarily consented, and knew the details of their medical treatment, but few understood the research well. Readability analysis indicated that consent forms required college-level education. Twenty-eight percent of patients were not aware of their participation in research although they had signed consent forms. No single act, omission, or personal attribute completely explains this unawareness, but it is associated with incomplete consent forms, the identity of the person explaining the research, the manner of the explanation, and, in some cases, grave illness.

Sixty-four climbers participated in a randomized clinical trial of acetazolamide prophylaxis for acute mountain sickness (AMS) during rapid, active ascent of MT Rainier. Twenty-nine (93.6%) of 31 climbers receiving acetazolamide and 25 (75.8%) of 33 receiving placebo attained the summit. Time spent ascending from sea level to the summit (4,394 m) averaged 33.5 hours (range, 23 to 48 hours). On the summit AMS was less common in climbers receiving acetazolamide, and they experienced less headache, nausea, drowsiness, shortness of breath, and dizziness and a greater sense of satisfaction and psychological well-being. Minute ventilation on the summit was significantly greater in subjects taking acetazolamide (24.9 +/- 2.0 L/min compared with 16.9 +/- 3.8 L/min). Expired vital capacity was also greater on the summit in the acetazolamide group (6.9 +/- 0.4 L compared with 5.8 +/- 0.4 L). We conclude that acetazolamide is effective in the prophylaxis of AMS for climbers attempting rapid, active ascent. Increased ventilation at altitude, producing an increased alveolar oxygen tension, may be related to the observed amelioration of symptoms.

To assess the adequacy of peer review for research on human subjects, identical research protocols in oncology and anesthesiology were submitted to 32 institutional review boards (IRBs) at major universities with medical colleges. Each of the protocols posed serious ethical issues, contained flaws in scientific design, and provided an incomplete consent form. Twenty-two IRBs participated in the investigation, which revealed (1) consistency in the nonapproval of the three protocols, (2) substantial inconsistency among IRBs in the reasons offered in support of similar decisions, and (3) substantial inconsistency in the application of ethical, methodological, and informed-consent standards for individual review boards. This evidence suggests that revision of the protocols to satisfy particular objections would result in approval of flawed investigations.

The risk of epithelial ovarian cancer in relation to the use of combination oral contraceptives was evaluated in a case-control study of women younger than 60 years. Combination oral contraceptives were used by 35 (26%) of 136 cases and 187 (35%) of 539 controls. The relative risk estimate for combination oral contraceptive use was 0.6 (95% confidence interval, 0.4 to 0.9). The reduction in risk appeared to persist for as long as ten years after use had ceased and to be greater for longer durations of use, but these results were not statistically significant. The findings were not explained by parity or by other identified potential confounding factors. The results suggest that the use of combination oral contraceptives protects against epithelial ovarian cancer.

One hundred fifteen subjects took part in a double-blind study comparing the efficacy and safety of 0.5% malathion lotion (Prioderm lotion) and the alcoholic vehicle of the lotion as pediculicides in the treatment of head lice. The subjects, with a mean age of 9 years, had long-standing lice infestations and at least 20 viable ova. The subjects were treated with the test preparation, which was allowed to remain on the hair for 12 hours. Ovicidal and pediculicidal efficacy for the malathion lotion was significant; overall clinical evaluation by the investigators showed a significant number of moderate to marked therapeutic responses to malathion lotion. Only one adverse reaction (in the malathion lotion group) was reported, the stinging of pyodermal lesions in reaction to the alcoholic vehicle. Other concomitant scalp diseases were unchanged or improved at the end of the study.

The influence of cimetidine hydrochloride (300 mg four times daily for seven days) on plasma ethanol concentrations and the subjective assessment of intoxication after a single oral dose of ethanol (0.8 g/kg) were investigated in a randomized double-blind placebo controlled study in six volunteers. Compared with the placebo, cimetidine produced a small increase in both the peak plasma ethanol level (from 146 +/- 5.2 to 163 +/- 7.6 mg/dL, mean +/- SEM) and th area under the ethanol concentration time curve (from 717 +/- 17 to 771 +/- 44 mg/dLXhr). In addition, using a visual analogue scale, subjects rated themselves more intoxicated at their peak of intoxication while receiving cimetidine. These results suggest that cimetidine has a small effect on the handling of ethanol in humans.

An open-label clinical trial was conducted to test the safety and efficacy of intravenous metoclopramide monohydrochloride in preventing chemotherapy-induced nausea and vomiting. Thirty-eight patients received a total of 83 assessable courses of chemotherapy with cisplatin alone or in combination with other cytotoxic agents. In 19 of 38 patients (50%) or 40 of 83 courses (48%), nausea or vomiting did not occur ("total protection") and in six of 38 patients (16%) or 19 of 83 courses (23%), emesis occurred one of two times ("major protection"). Thus, 25 of 38 patients (66%) receiving 59 of 83 courses (71%) of cisplatin-containing chemotherapy attained either total or major antiemetic protection with metoclopramide. In those patients who received multiple courses of chemotherapy, antiemetic protection afforded by metoclopramide remained unabated. At this dosage, the drug was well tolerated with minimal side effects. Intravenous metoclopramide is consistently effective in preventing emesis associated with cisplatin when used either alone or in combination with other cancer chemotherapy agents that are in themselves emetogenic.

Eighty-one healthy, sedentary men aged 30 to 55 years were randomly assigned to supervised running (n = 48) or to sedentary control groups (n = 33) and followed up in a one-year trial. Measurements of plasma lipoproteins, fitness, and percent body fat were made at three-month intervals. Results and conclusions from this study are (1) that cross-sectional studies of lipoprotein concentrations in exercisers may be biased by a self-selection effect, since study participants with initially higher high-density lipoprotein cholesterol (HDL-C) and lower triglyceride concentrations were more easily persuaded to run more miles; (2) that plasma concentrations of HDL-C and low-density lipoprotein cholesterol (LDL-C) generally did not begin to change until a threshold exercise level (ten miles run per week) was maintained for at least nine months; and (3) that fitness increased and percent body fat decreased sooner and at lower exercise levels than required for HDL-C and LDL-C concentration changes.