Evaluation of the efficacy of a polyurethane condom: results from a randomized, controlled clinical trial.

CONTEXT: Condoms made of latex are not comfortable or appropriate for all consumers. Polyurethane condoms may provide a needed alternative. METHODS: In a double-masked study, 805 monogamous couples were randomized to use either the polyurethane condom or the latex condom for six months. Couples recorded the frequency of intercourse, of condom use and of breakage and slippage throughout the trial in coital diaries and in detailed reports on the first five uses. Breakage and slippage rates were determined, and typical-use and consistent-use pregnancy rates were calculated using life-table analysis, adjusted for use of emergency contraception. RESULTS: The six-month pregnancy rate during typical use (adjusted for use of emergency contraception) was 4.8% for the polyurethane condom and 6.3% for the latex condom. Similarly adjusted pregnancy rates during consistent use over six completed menstrual cycles--2.4% for the polyurethane condom and 1.1% for the latex condom--did not differ significantly. Clinical failure rates (including breakage and slippage occurring during either intercourse or withdrawal) were 8.5% for the polyurethane condom and 1.6% for the latex condom. In general, male participants were more satisfied with the latex condom, and users of latex were significantly less likely to drop out of the study for condom-related reasons than were users of polyurethane. CONCLUSIONS: Although polyurethane and latex condoms provide equivalent levels of contraceptive protection, the polyurethane condom's higher frequency of breakage and slippage suggests that this condom may confer less protection from sexually transmitted infections than does the latex condom.

PIP: Latex condoms are neither comfortable nor appropriate for all condom users. In a double-blinded study, 805 monogamous heterosexual couples aged 18-45 years were randomized to use either a polyurethane condom or the Ramses Sensitol latex condom for 6 months. The polyurethane condom had specifications similar to those of the commercially available Avanti condom. While both condoms are 180 mm long, with an open end diameter of 33 mm, when laid flat, the polyurethane and latex condoms are 64 and 52 mm wide, respectively. Recruited from Los Angeles, California, study participants were of mean age 27 years; 66% non-Hispanic Whites, 16% Hispanic, 6% Black, and 6% Asian; and with an average of 15 years education. Approximately 75% of the men were circumcised, and according to participants' measurements, the erect penis averaged 131 mm in midshaft circumference and 159 mm in length. 89% were using condoms as their contraceptive method at the start of the study. The 6-month pregnancy rate during typical use, adjusted for the use of emergency contraception, was 4.8% for the polyurethane condom and 6.3% for the latex condom. Similarly adjusted pregnancy rates during consistent use over 6 completed menstrual cycles were 2.4% for the polyurethane condom and 1.1% for the latex condom. Clinical failure rates, including breakage and slippage occurring during either intercourse or withdrawal were 8.5% for the polyurethane condom and 1.6% for the latex condom. Male participants were generally more satisfied with the latex condom, and users of latex were significantly less likely to drop out of the study for condom-related reasons than were polyurethane condom users.

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.

PIP: The only nonsurgical method of male contraception marketed worldwide, the condom is also known to be highly effective against the sexual transmission of HIV and other diseases. Condoms, however, are underutilized compared to other methods. In 1994, the London International Group introduced the first male polyurethane condom in the US. This paper reports findings from a study comparing users' experience with polyurethane and latex condoms. The 360 couples who participated in the masked crossover study were randomized to use 3 polyurethane condoms and 3 latex condoms. After each use, couples recorded condom breaks, condom slips, and other aspects of performance. At the completion of the study, couples compared the sensitivity, ease of use, fit, and lubrication of the 2 types of condoms. The clinical breakage rates of the polyurethane and latex condoms were 7.2% and 1.1%, respectively. The complete slippage rates of the polyurethane and latex condoms were 3.6% and 0.6%, respectively. Most male users found the polyurethane condom to be more sensitive than the latex condom.

Heavy habitual marijuana smoking does not cause an accelerated decline in FEV1 with age.

To assess the possible role of daily smoking of marijuana in the development of chronic obstructive pulmonary disease (COPD), we evaluated the effect of habitual use of marijuana with or without tobacco on the age-related change in lung function (measured as FEV1) in comparison with the effect of nonsmoking and regular tobacco smoking. A convenience sample of 394 healthy young Caucasian adults (68% men; age: 33 +/- 6 yr; mean +/- SD) including, at study entry, 131 heavy, habitual smokers of marijuana alone, 112 smokers of marijuana plus tobacco, 65 regular smokers of tobacco alone, and 86 nonsmokers of either substance were recruited from the greater Los Angeles community. FEV1 was measured in all 394 participants at study entry and in 255 subjects (65 %) on up to six additional occasions at intervals of > or = 1 yr (1.7 +/- 1.1 yr) over a period of 8 yr. Random-effects models were used to estimate mean rates of decline in FEV1 and to compare these rates between smoking groups. Although men showed a significant effect of tobacco on FEV1 decline (p < 0.05), in neither men nor women was marijuana smoking associated with greater declines in FEV1 than was nonsmoking, nor was an additive effect of marijuana and tobacco noted, or a significant relationship found between the number of marijuana cigarettes smoked per day and the rate of decline in FEV1. We conclude that regular tobacco, but not marijuana, smoking is associated with greater annual rates of decline in lung function than is nonsmoking. These findings do not support an association between regular marijuana smoking and chronic COPD but do not exclude the possibility of other adverse respiratory effects.

Effect of prophylactic antibiotics on morbidity associated with IUD insertion: results of a pilot randomized controlled trial. IUD Study Group.

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: XI. Impact of air pollution and smoking on annual change in forced expiratory volume in one second.

We assessed the relative impact of residential exposure to community air pollution and habitual cigarette smoking on lung function by comparing the annualized rate of change in forced expiratory volume in 1 s (FEV1) in current, former, and never-smokers 25 to 59 yr of age residing in three demographically similar areas of the Southern California air basin who had been chronically exposed to (1) moderate levels of photochemical oxidants and very low levels of other pollutants (Lancaster); (2) very high levels of photochemical oxidants, sulfates, and particulate matter (Glendora); and (3) high levels of sulfates, oxides of nitrogen, and probably hydrocarbons (Long Beach), together with moderate levels of sulfur dioxide. Of the 621 to 763 nonsmokers, 317 to 479 former smokers and 472 to 691 continuing smokers residing in the three areas who were studied initially, 53 to 64, 49 to 59, and 43 to 54%, respectively, were retested. For male residents, area of residence and smoking category each had highly significant effects on FEV1 decline (two-way ANCOVA; p < 0.001) without significant interaction (p > 0.4). After adjustment for baseline FEV1, age, height, and a history of allergy, the mean decline in FEV1 attributable to living in Long Beach compared with living in Lancaster was 23.6 ml/yr, which was 71% of the rate of decline in FEV1 (33.3 ml/yr), attributable to smoking > 1 pack of cigarettes per day. For female residents, a significant interaction was noted between area and smoking (p < 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)

Effects of smoked substance abuse on nonspecific airway hyperresponsiveness.

Previous data suggest that regular tobacco smoking may lead to nonspecific airway hyperresponsiveness (AHR) independent of airway obstruction, possibly because of effects on bronchial inflammation or mucosal permeability. Little is known concerning the effects on AHR of other widely smoked substances besides tobacco such as marijuana or cocaine. The smoke of both marijuana and cocaine contains respiratory irritants that elicit cough and produce abnormalities in airway dynamics and bronchial mucosal histopathology in habitual smokers. Therefore, regular smoking of one or both of these illicit substances could cause AHR or augment the AHR associated with tobacco smoking. The present study examined the influence of habitual smoking of marijuana, cocaine, and/or tobacco on nonspecific AHR in 542 (456 male) healthy participants (mean age, 34.8 +/- 6.8 SD yr) in an ongoing cohort study of the pulmonary effects of habitual smoking of illicit substances. Subjects with a history of intravenous drug abuse, significant occupational exposures, asthma, or recent upper respiratory tract infection were excluded. Inhalation challenge studies were performed using solutions of diluent and methacholine chloride (1.25 to 25 mg/ml) aerosolized by a DeVilbiss no. 646 nebulizer attached to a breath-activated dosimeter inhaled by three to five inspiratory capacity breaths. Positive responses to methacholine were defined by > or = 20% or > or = 10% declines in FEV1 from the postdiluent control value after inhalation of each concentration of methacholine. Participants were categorized by smoking status (nonsmoking and smoking of marijuana, cocaine, and/or tobacco alone and in combination); most analyses were performed in men and women separately.(ABSTRACT TRUNCATED AT 250 WORDS)

Interrelationship between diarrhea and vitamin A deficiency: is vitamin A deficiency a risk factor for diarrhea?

A cross-sectional study, a follow-up study and an evaluation of impact of community-based distribution of vitamin A capsules (200,000 IU) were conducted in Omdurman (Sudan) between November, 1988, and March, 1989. In the cross-sectional survey 1441 children less than 5 years of age participated, which established the baseline values for plasma retinol-binding protein. During the follow-up period 290 cases of diarrhea occurred. Low concentrations of plasma retinol-binding protein (less than 1.85 mg/dl) proved to be a risk factor for diarrhea, especially in girls. The relative risk increased after the second year of life. Children who received vitamin A supplementation before commencement of the study had a lower incidence of diarrhea. The protective effect of vitamin A supplementation was greater in girls (relative risk, 0.297; 95% confidence interval, 0.240 to 0.368) than in boys (relative risk, 0.404; 95% confidence interval, 0.352 to 0.464).

Pulmonary status of habitual cocaine smokers.

We determined the prevalence of respiratory symptoms and lung dysfunction in a large sample of habitual smokers of freebase cocaine ("crack") alone and in combination with tobacco and/or marijuana. In addition, we compared these findings with those in an age- and race-matched sample of nonusers of crack who did or did not smoke tobacco and/or marijuana. A detailed respiratory and drug use questionnaire and a battery of lung function tests were administered to (1) a convenience sample of 202 habitual smokers of cocaine (cases) who denied intravenous drug abuse and (2) a reference sample of 99 nonusers of cocaine (control subjects). The cocaine smokers (85% black) included the following: 68 never-smokers of marijuana, of whom 43 currently smoked tobacco and 25 did not, and 134 ever-smokers of marijuana (42 current and 92 former), of whom 92 currently smoked tobacco and 42 did not. The control subjects (96% black) included the following: 69 never-smokers of marijuana, of whom 26 currently smoked tobacco and 43 did not, and 30 ever-smokers of marijuana (18 current and 12 former), of whom 21 currently smoked tobacco and 9 did not. Cases smoked an average of 6.5 g cocaine per week for a mean of 53 months. The median time of the most recent use of crack prior to study was 19 days (range less than 1 to 180 days). After controlling for the use of other smoked substances, frequent crack use was associated with: (1) a high prevalence of at least occasional occurrences of acute cardiorespiratory symptoms within 1 to 12 h after smoking cocaine (cough productive of black sputum [43.7%], hemoptysis [5.7%], chest pain [38.5%], usually worse with deep breathing, and cardiac palpitations [52.6%]) and (2) a mild but significant impairment in the diffusing capacity of the lung.(ABSTRACT TRUNCATED AT 250 WORDS)

A nebulizer chronolog to monitor compliance with inhaler use.

The Lung Health Study is a 10-center 5-year clinical trial sponsored by the National Heart, Lung, and Blood Institute to evaluate the effectiveness of early intervention in chronic obstructive pulmonary disease (COPD). The specific objectives of the trial are to determine whether the accelerated decline in lung function characteristic of COPD and morbidity due to COPD can be reduced by special intervention at a relatively early stage in the evolution of the disease. Special intervention consists of a smoking-cessation program and the use of an inhaled bronchodilator to suppress airway hyperreactivity. The use of the inhaler canister is monitored every 4 months by canister weighing and, at two of the 10 centers, by an electronic recording device, the Nebulizer Chronolog. Among trial participants assigned the latter device, results from the first 4 months of the study indicate that only 52% of trial participants who were uninformed as to the nature of the chronolog used their inhaler at least twice daily as measured by the chronolog, compared with 87% as determined by self-report. Satisfactory or good compliance was achieved by 52% of these subjects as measured by the chronolog compared with 85% as assessed by canister weighing. Eighteen percent of uninformed participants "dumped" their inhalers within a 3-hour time period, contributing to the inaccuracy of canister weights as an indicator of compliance. Feedback of information to the participants from the chronolog improved the level of compliance and eliminated the "dumping" phenomenon. We conclude that, when accurate determinations of compliance are important, as in a drug trial, objective medication monitors should be considered. Electronic monitoring of inhaler use can provide valuable feedback, which encourages improved compliance.

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.

Bone mineral content in postmenopausal women: comparison of omnivores and vegetarians.

This cross-sectional study of bone mineral content (BMC)/bone width (BW) (BMC/BW, cortical radius) was conducted in elderly, free-living Methodist omnivores (n = 146) and Seventh-day Adventist vegetarians (n = 144) in southern California. The purpose was to investigate relationships between BMC/BW and dietary factors (primarily vegetarianism and intakes of protein and calcium) and use of prescribed drugs. BMC was measured by single-photon absorptiometry. Dietary intakes during current and early periods of life were assessed by 24-h dietary recall and frequency methods. Information about drug use was obtained by interview. BMC/BW was not different in omnivores vs vegetarians. There were no significant relationships or trends between current or early dietary intakes and BMC/BW in either group. In multiple-regression analysis, age, weight, and use of estrogen and thiazide diuretics were predictive of 31% of the variability in BMC/BW in the total group.

No evidence for a role of alcohol or other psychoactive drugs in accelerating immunodeficiency in HIV-1-positive individuals. A report from the Multicenter AIDS Cohort Study.

In a multicenter cohort study of homosexual men, the proportion of seropositives at enrollment who developed the acquired immunodeficiency syndrome (AIDS) during the following 18 months ranged from 5.5% to 8.2% in 1597 alcohol drinkers vs 9.2% in 109 nondrinkers with no clear trend according to use, and from 6.3% to 9.6% for 1662 users vs 7.2% for 83 nonusers of psychoactive drugs prior to enrollment. Among seropositive men with low initial T helper lymphocyte counts, those who continued to use drugs showed no significantly higher 18-month risk of AIDS than nonusers (13% vs 10%); the corresponding risks were 13% and 15%, respectively, for continued heavier vs continued lighter consumption of alcohol. No other manifestations of immunodeficiency were positively associated with substance use prior to enrollment. Prior use was not associated with low mean T helper cell counts at enrollment, and continued drug or alcohol use after enrollment was not associated with greater subsequent decline in counts. As used in a large cohort of homosexual men, psychoactive substances did not enhance the progression of human immunodeficiency virus infection.

Mineral oil lubricants cause rapid deterioration of latex condoms.

As little as sixty seconds' exposure of commercial latex condoms to mineral oil, a common component of hand lotions and other lubricants used during sexual intercourse, caused approximately 90% decrease in the strength of the condoms, as measured by their burst volumes in the standard ISO (International Standards Organization) Air Burst Test. Burst pressures were also reduced, although less dramatically. Lubricants such as Vaseline Intensive Care and Johnson's Baby Oil, each containing mineral oil, also affected condom integrity. Five min. exposure of condoms to glycerol, a frequent component of hand lotions and 'personal lubricants', did not significantly affect burst volume or pressure. Aqueous nonoxynol-9 spermicide did not affect either burst index. The implications of these results for contraception and protection from sexually transmitted diseases, including AIDS, are discussed.

PIP: Prolonged exposure of latex goods to mineral oil has long been known to cause deterioration. In order to determine whether mineral oil-lubricated condoms were subject to breakage during the average duration of sexual intercourse, condoms lubricated with 7 common lubricants were subjected to International Standards Organization Air Burst Tests for periods ranging from 60 seconds to 1 hour. The lubricants used were: water, light mineral oil, Squibb Mineral Oil, Johnson's Baby Oil, Vaseline Intensive Care Lotion, glycerol, and an aqueous solution of the spermicidal agent nonoxynol-9. 2 lots of condoms were tested, one of 1-month old condoms and one of 9-months old condoms. The tests demonstrated that mineral oil damaged the latex condoms within 60 seconds. Interviews with 1275 American males indicated that Vaseline Intensive Care Lotion was used by 61%. Johnson's Baby Oil was the choice of over 1/2 of 145 British males. Johnson's Baby Oil is almost pure mineral oil, and Vaseline Intensive Care Lotion contains mineral oil. Mineral oil-lubricated condoms are risky; however, the nonoxynol gel-treated condom, recommended as an AIDS prevention measure, is water-based and therefore safe.

Are condom instructions readable? Results of a readability study.

The use of condoms has assumed a central position in the current strategy to prevent sexual transmission of the human immunodeficiency virus. The effectiveness of condoms in disease prophylaxis is dependent, to a degree, on their correct use. Condom manufacturers routinely include information on condom use either printed on the actual package or in an enclosed package insert. With the use of three readability formulas, the reading grade level was determined for 14 different sets of instructions included with 25 brands of condoms manufactured by 7 domestic and 1 overseas manufacturer. The readability formulas, when applied to instructions for condom use, estimated that, conservatively, 8 of the 14 instructions required at least reading at the level of a high school graduate and none required less than a 10th grade level. Clearly written instructions and simple concepts could assist current and future condom users in the correct use of condoms and improve the effectiveness of condoms in the prevention of AIDS and other sexually transmitted diseases.

The UCLA population studies of chronic obstructive respiratory disease. 9. Lung function changes associated with chronic exposure to photochemical oxidants; a cohort study among never-smokers.

Two cohorts of never-smoking residents of Los Angeles were studied on two occasions five years apart. One cohort (N = 1,099) lived in a community with moderate levels of photochemical pollution and low levels of other pollutants, and the second (N = 1,117) lived in a community with very high levels of photochemical oxidant and relatively high levels of sulfates and particulates. Studies included measurement of forced expiratory volumes and flow rates and single-breath nitrogen washout, as well as use of a standardized questionnaire. The data represent 47 percent of 2,340 and 58 percent of 1,935 residents, respectively, of the original community samples. Mean baseline spirometry and nitrogen washout for those who were and those who were not retested were similar, reflecting the fact that loss to follow-up was primarily due to changes of residence. In the more polluted area there were significantly worse lung function test results for both men and women at baseline and significantly more rapid deterioration at follow-up. Mean changes in nitrogen washout were significantly greater in the more polluted community for both sexes and for all age groups including children. Most of the spirometric test results showed significantly more rapid decline among adults in the more polluted community. These results are consistent with the hypothesis that chronic exposures to a mix of photochemical oxidants, sulfates and particulates are associated with increased loss of lung function, which is especially marked among tests that reflect function of the small airways.

Respiratory effects of cocaine "freebasing" among habitual users of marijuana with or without tobacco.

Use of cocaine by smoking its alkaline precursor ("freebasing") has become increasingly prevalent. Recent studies of small numbers of cocaine users suggest that freebasing frequently causes cough, dyspnea, and abnormalities in diffusing capacity (DCO), although these findings could have been due to concomitant use of other drugs. We therefore evaluated the relationship between cocaine use by freebasing and chronic respiratory symptoms and lung dysfunction in a large sample of habitual smokers of marijuana with or without tobacco who denied intravenous drug abuse. The findings suggested that, among habitual marijuana smokers, "moderate" cocaine smoking damaged both large and small airways, as reflected by functional changes that were independent of concomitant marijuana use and appeared to be synergistic with the effects of tobacco. On the other hand, no adverse influence of cocaine smoking on the pulmonary microcirculation was demonstrated in our sample of freebase users.