Anne H. Coulson

Randomised controlled trial of prophylactic antibiotics before insertion of intrauterine devices

Summary Background The value of antibiotic prophylaxis before insertion of an intrauterine device (IUD) remains uncertain. We undertook a triple-masked, randomised, placebo-controlled trial to find out whether such prophylaxis reduces the rate of IUD removal within 90 days. Methods 11 clinic sites in southern California enrolled women who requested IUD insertion and were at low risk of sexually transmitted infection according to self-reported medical history. We randomly assigned 1985 participants either 500 mg azithromycin or placebo capsules of identical appearance taken about 1 h before insertion of a Copper T 380A IUD. 118 women did not have an IUD inserted. We followed up 1833 of the remaining 1867 (98%) participants for at least 90 days after insertion. Findings The rate of IUD removal for any reason other than partial expulsion was 3·8% (35/918) in the antibiotic group and 3·4% (31/915) in the placebo group (relative risk 1·1 [95% Cl 0·7–1·8]). The two treatment groups sought medical attention with equal frequency (mean 38 visits per 100 women). During the 90 days after IUD insertion, only one woman from each assignment group had salpingitis, as defined by established criteria. Interpretation Prophylaxis with azithromycin did not affect the likelihood that a woman would retain her IUD at 90 days or the frequency of postinsertion medical attention. In appropriately screened women, the risk of upper-genitaltract infection is negligible after IUD insertion, with or without the administration of prophylactic antibiotics.

Effects of various factors on systolic and diastolic blood pressure in the Los Angeles heart study

Abstract Higher systolic blood pressures were found among similar age groups measured in 1962 compared to those found in 1950 in the Los Angeles Heart Study. Analyses were performed to insure that these differences were real and not due to measurement differences or to self selection. Covariance analyses indicated that higher blood pressures occurred among subjects who reported that they had not eaten for 2 hr or more or for 5 hr or more prior to examination as well as among non-smokers, alcohol users, and non-salt adders. The magnitude of the differences associated with these factors is probably not of clinical significance. None of these factors explain the existing differences in blood pressures between these two examination periods. Thus, the differences observed are consistent with the hypothesis of a healthier population, age for age, entering the study in 1950 compared to the survivors examined in 1962.

The UCLA population studies of CORD: X. A cohort study of changes in respiratory function associated with chronic exposure to SOx, NOx, and hydrocarbons

Two never-smoking cohorts in Southern California, one in Lancaster (N = 2340) exposed only to moderate levels of oxidants and the other in Long Beach (N = 1326) exposed to high levels of SOx, NO2, hydrocarbons and particulates completed spirometry and the single-breath nitrogen test five to six years apart. Forty-seven percent and 45 percent of the participants were retested. Mean results at baseline for those tested and not retested were similar. Loss to follow-up was primarily due to moving (39 percent and 47 percent). Every difference of consequence indicated greater deterioration in lung function in Long Beach. The level of significance of the difference was greatest, even in the youngest age groups, for delta N2(750-1250), suggesting that the earliest site of impairment may occur in the small airways. Greater deterioration in spirometric parameters was observed in every age group in Long Beach females above seven years of age at baseline and in Long Beach males above 15 years of age, suggesting that chronic exposure to the pollutant mix occurring in Long Beach ultimately adversely affects the large airways as well as small airways.

The differential effect of serum cholesterol, blood pressure and weight on the incidence of myocardial infarction and angina pectoris

Abstract The results of 15 yr of follow-up of white males at risk in the Los Angeles Heart Study are reported. The total number of new cases of coronary heart disease is divided into 2 groups: (i) persons who were diagnosed myocardial infarction, or sudden death (MI), and (ii) persons who were diagnosed as angina pectoris (AP). The risk factors studied were age, serum cholesterol level, blood pressure and wt. index. Two techniques of analysis, the classical method and discriminant function analysis, are used and compared. In both methods of data analysis high serum cholesterol is clearly associated with the development of MI. None of the 3 factors studied had an appreciable influence on AP.

MORTALITY AND WATER-HARDNESS: IN THREE MATCHED COMMUNITIES IN LOS ANGELES

Abstract Three Los Angeles communities supplied by water of different hardnesses— Reseda, Burbank, and Downey—have been matched for age, sex, race, income, socioeconomic status, and stability using 1970 census data. Age and sex adjusted death-rates in these three communities from six types of heart-disease and from malignant neoplasms and infant and neonatal mortality have been compared with each other and with the corresponding rates for L.A. County and the United States. Mortality from malignant neoplasms was used as a control for confounding variables. No consistent association was found between deaths from heart disease, infant mortality, or neonatal mortality on the one hand and degree of water hardness on the other.

Breakage and acceptability of a polyurethane condom: a randomized, controlled study.

CONTEXT Although the first commercial polyurethane condom was approved for use several years ago, no U.S. clinical trial has compared its performance to that of the latex condom. METHODS In a masked crossover study, 360 couples were randomized to use three polyurethane condoms and three latex condoms. After each use, couples recorded condom breaks, condom slips and other aspects of performance. At completion of the study, couples compared the sensitivity, ease of use, fit and lubrication of the two types of condoms. RESULTS The clinical breakage rate of the polyurethane condom was 7.2%, compared with 1.1% for the latex condom (relative risk of 6.6, 95% confidence interval of 3.5-12.3). The complete slippage rate (combining incidents during intercourse and withdrawal) of the polyurethane condom was 3.6%, compared with 0.6% for the latex condom (relative risk of 6.0, 95% confidence interval of 2.6-14.2). Most male users preferred the sensitivity provided by the polyurethane condom to that of the latex condom. CONCLUSIONS The clinical breakage rate of the polyurethane condom is significantly higher than that of the latex condom. However, nearly half of the users preferred the polyurethane condom, which provides an option for couples who have rejected conventional condoms or who cannot use latex products.

Effect of prophylactic antibiotics on morbidity associated with IUD insertion: Results of a pilot randomized controlled trial

The efficacy of administering an antibiotic prior to IUD insertion to reduce the risk of introducing an upper genital tract infection during the procedure has not yet been established. Two double-blind randomized studies conducted in Africa comparing a 200 mg prophylactic dose of doxycycline with a placebo did not conclusively identify a reduced risk of post-insertion pelvic inflammatory disease (PID). A clinical trial of comparable design is currently under way in the US. This multi-site trial will evaluate whether use of an antibiotic prior to insertion reduces the risk of IUD removal for all medical reasons, including upper genital tract infection, within the first three months after insertion. This paper reports on the pilot phase of this study, which was designed to test the protocols and data collection instruments in advance of the full-scale clinical trial. A total of 447 prospective IUD (TCu-380A) users were randomly assigned to receive either a 200 mg dose of doxycycline or a placebo one hour before IUD insertion. 3.6% (8/219) of participants who received the antibiotic had the device removed for medical reasons (infection, bleeding, cramping, etc.) within three months post-insertion compared to 4.5% (10/223) of participants who received the placebo. This reduction in the removal rate was not statistically significant given the limited size of the pilot study (RR = 0.81; 95% CI 0.28-2.29). Only two subjects, one from each treatment group, met the diagnostic criteria for acute PID. The overall three-month retention rate was 91.8% for the antibiotic group and 89.7% for the placebo group.(ABSTRACT TRUNCATED AT 250 WORDS)

The UCLA population studies of chronic obstructive respiratory disease. II. Determination of reliability and estimation of sensitivity and specificity.

Abstract A probability sample of 218 adults tested at a mobile lung function (field) laboratory was retested at a UCLA reference laboratory. Results in the two laboratories were compared for (i) numerical correlation, (ii) variability, and (iii) agreement in disease classification. FEV 1 and FVC showed good agreement between laboratories. Plethysmography showed good agreement and moderate correlation. SBNT showed poor correlation, high variability, but good agreement. Test subjects were classified by two respiratory specialists as having or not having chronic obstructive respiratory disease. Individuals thus diagnosed were considered to be true positives and the results of each of the tests, groups of tests, and all tests in each laboratory were evaluated, using these criteria, for their estimated sensitivity and specificity: (i) FEV 1 , FVC , and plethysmography were estimated to be specific but relatively insensitive; (ii) FEF 25–75% was less specific but more sensitive; (iii) the flow-volume curve had the highest sensitivity and reasonable specificity; (iv) closing volume showed reasonable sensitivity and specificity but was not reliable. Determination of specificity may have been confounded by the presence of disease too early to diagnose clinically. The disparity in classification between the two laboratories was no greater than that between the two physicians. Field screening using spirometry, SBNT, and body plethysmography is apparently comparable to comprehensive diagnostic procedures in a clinic setting.

HLA types and immunity in multiple sclerosis.

HLA types and levels of humoral and cell-mediated immune responses to several antigens were studied in a large group of patients with multiple sclerosis, and in controls. Patients were more likely than controls to have the DKw2 antigen. They had higher mean antibody titers to measles but not to cytomegalovirus, herpes 1, or herpes 2, and had less competent cell-mediated responses. Antibody titers to measles were lower and cell-mediated immune responses were more effective in patients with the DRw2 antigen than in patients without it. This apparent specificity for measles suggests that the etiology of multiple sclerosis is related to the immune response to measles or related viruses.

Sensitivity and Specificity of Serum Δ9-Tetrahydrocannabinol and 11-nor-9-carboxy-Δ9-Tetrahydrocannabinol by Radioimmunoassay in Identifying Habitual Daily Smokers of Marijuana

†Supported by NIDA Grant No. RO1-DA-03018 and by the United States Public Health Service CRC Grant No. RR-00865 from the National Institutes of Health.