A randomized controlled safety trial of the diaphragm and cellulose sulfate microbicide gel in sexually active women in Zimbabwe.

BACKGROUND: Cellulose sulfate (CS) is an antimicrobial and contraceptive agent. We assessed its safety when used alone or with the diaphragm in Harare, Zimbabwe. STUDY DESIGN: This was a randomized controlled safety trial with three arms: diaphragm with 6% CS gel vs. diaphragm with KY gel vs. CS gel alone. Participants were instructed to use their study products before every sex act for a period of 6 months. Safety end points were assessed monthly by questionnaires and urinanalysis and bimonthly by clinical examinations, colposcopy, wet mounts and gram stains. RESULTS: One hundred nineteen monogamous women were enrolled (28% HIV+) and 105 (88%) completed the study. No urinary tract infections were diagnosed during the study; 81.4% women had symptoms and/or signs of genital irritation considered at least possibly related to the gel or device, and 41.5% had changes in vaginal flora. There were no statistically significant differences between treatment groups in safety end points. All six women with deep epithelial disruption were diaphragm users, and all such findings were on the external genitalia. Of those, 4 had herpetic ulcers which were unrelated to products use. CONCLUSIONS: Cellulose sulfate appeared safe when used for 6 months alone or with a diaphragm.

Relationship between saliva and serum CA 125 in women with and without epithelial ovarian cancer.

OBJECTIVE: To determine the distribution of saliva CA 125 levels in women with and without ovarian cancer, and to determine whether there is a correlation between saliva and serum CA 125 levels in either group. METHODS: CA 125 levels were measured by immunoradiometric assay in the serum and saliva of 50 women with epithelial ovarian cancer known to have elevated serum CA 125 levels (above 35 U/mL) and in 50 women seen for benign gynecologic conditions. RESULTS: Serum and saliva CA 125 values followed a log-normal distribution in both groups. The medians for serum and saliva CA 125 levels in cancer patients were 578 and 1379 U/mL, respectively. In the benign group, the median CA 125 value was 11 U/mL in serum and 994 U/mL in saliva. The correlation between saliva and serum CA 125 levels was not statistically significant in either the cancer (r = 0.003) or the benign group (r = 0.025). CONCLUSION: There is no relationship between saliva and serum CA 125 levels in women with either epithelial ovarian cancer or benign gynecologic conditions.

Mouth and genital ulcerations in the community.

OBJECTIVE: To estimate the prevalence of mouth and genital ulceration in the community and its relationship to rheumatic diseases. METHODS: A house to house survey was carried out over a period of 18 months extending from September 1993 to February 1995, on 5,894 individuals utilizing detailed questionnaires on symptoms of musculoskeletal diseases and associated symptoms including history of mouth, genital ulcers, eye symptoms, and skin changes. After the initial phase, a 2nd phase was completed by trained nurses and paramedical staff, the purpose of which was to explore in detail, the history of those responding positively to any of the questions in phase one. The 3rd stage was conducted by general practitioners and rheumatologist to interview and examine those identified in phase 2 at King Fahad Hospital, Buraidah, Kingdom of Saudi Arabia. RESULTS: We identified 7 (0.1%) cases of genital ulceration, 43 (0.7%) cases of mouth ulceration, 263 (4.5%) cases of reddish eye or blurred vision, and 124 (2.1%) cases of skin rashes. Only 2 cases had both mouth and genital ulceration in addition to eye disease, skin rash and musculoskeletal pain. There was significant correlation between mouth ulcers and skin rash, eye symptoms, genital ulcerations, male sex, single status, weight loss and backpain. CONCLUSION: The vast majority of mouth and genital ulcers are not associated with a known rheumatic disease.

[Reproductive dysfunction and oncologic diseases in women employed in the rubber manufacturing industry]. / Narusheniia funktsii i onkologicheskie zabolevaniia reproduktivnoi sfery u zhenshchin - rabotnits rezinovogo proizvodstva.

The study covered analysis of reproductive function, incidence of chronical diseases and gynecologic malignancies in rubber female workers. Hazardous work conditions of rubber production were reported to afflict reproductive function promoting gynecologic diseases and to change the structure of oncologic morbidity. Female workers exposed to occupational hazards of rubber production show some long-term effects of the exposure such as reliably increased reproductive impairments. Mechanism of such impairments may be connected with endocrine disbalance especially with estrogen deficit. As a result of it the changed ratio breast/uterus and ovary cancers is found among female rubber workers in comparison with the general population.

Chemical exposures of women workers in the plastics industry with particular reference to breast cancer and reproductive hazards.

Despite concern about the harmful effects of substances contained in various plastic consumer products, little attention has focused on the more heavily exposed women working in the plastics industry. Through a review of the toxicology, industrial hygiene, and epidemiology literatures in conjunction with qualitative research, this article explores occupational exposures in producing plastics and health risks to workers, particularly women, who make up a large part of the workforce. The review demonstrates that workers are exposed to chemicals that have been identified as mammary carcinogens and endocrine disrupting chemicals, and that the work environment is heavily contaminated with dust and fumes. Consequently, plastics workers have a body burden that far exceeds that found in the general public. The nature of these exposures in the plastics industry places women at disproportionate risk, underlining the importance of gender. Measures for eliminating these exposures and the need for regulatory action are discussed.

Medical care of chronic psychiatric outpatients.

Chronic psychiatric patients often fail to receive adequate general medical care. In a study of 42 outpatients in a psychosocial rehabilitation program, 93 percent were found to have at least one problem warranting assessment, treatment, or follow-up. Minor gynecologic disease was the most common problem among women and gross dental disease among men. Only 11 percent of the men's and 26 percent of the women's problems were receiving appropriate care. Seventy-seven percent of the previously unrecognized problems were found just by routine physical examination and hematocrit determination. Medical care for chronic psychiatric patients would improve if psychiatric clinics provided simple medical screening and if therapists were aware of their patients' general health needs.

Nonoxynol-9 use, genital ulcers, and HIV infection in a cohort of sex workers.

OBJECTIVES: To measure the associations between use of nonoxynol-9 (N-9) and incidence of genital ulcers, and incident ulcers and HIV seroconversion. METHODS: In a study of barrier contraceptive use and HIV infection, 273 female sex workers used condoms and 100 mg N-9 suppositories, and recorded sexual activity on coital logs. Genital ulcers were diagnosed clinically at monthly clinic visits. HIV infection was diagnosed by ELISA and Western blot. We calculated ulcer incidence rates by level of N-9 use. A nested matched case-control analysis assessed the effect of ulcers on HIV acquisition. RESULTS: More frequent N-9 use was not associated with genital ulcers and may have been protective against the lesions. Ulceration was not a strong risk factor for HIV acquisition in this study (odds ratio 1.1; 95% confidence interval 0.3-3.5). CONCLUSIONS: Frequent use of N-9 can cause genital irritation and ulceration. Ulcers, in turn, may be risk factors for HIV acquisition. This study, however, did not find an association between N-9 use and ulcers, nor between ulcers and HIV. There is probably a threshold of N-9 use frequency or dose below which the risk of ulceration is minimal. Ulcers due to infectious causes may have been prevented by N-9 use in this cohort.

PIP: To determine whether nonoxynol-9 produces disruption of the genital epithelium and, in turn, places users of this spermicide at increased risk of human immunodeficiency virus (HIV), 273 seronegative female commercial sex workers in Cameroon were enrolled in a 12-month cohort study. Subjects were instructed to use condoms and 100 mg nonoxynol-9 suppositories at each act of intercourse and to maintain coital logs. The presence or absence of vaginal and cervical ulcers was recorded at monthly gynecologic examinations; HIV testing was performed every three months. Included in the final analysis were the 191 women with no cervical ulcers at baseline. Of these, 77 (40%) were classified as frequent (15 times/month) nonoxynol-9 users, 84 (44%) as intermediate (11-15 times/month) users, and 30 (16%) as infrequent (10 or fewer times/month) users. 40 women had evidence of cervical ulceration during the observation period and 18 developed vaginal ulcerations. Unexpectedly, nonoxynol-9 use was not associated with an increased risk of ulceration. The incidence rates for cervical and vaginal ulcers, respectively, were 2.7% and 0.6% among frequent users, 2.2% and 0.8% among intermediate users, and 9.0% and 3.0% among infrequent users. Of the 17 women who became infected with HIV during the study, 29% had experienced ulceration compared to a rate of 28% for matched controls (odds ratio, 1.1; 95% confidence interval, 0.3-3.5). It is speculated that nonoxynol-9 provides sufficient lubrication during intercourse to prevent epithelial trauma. It is further plausible that any ulcers caused by nonoxynol-9--as opposed to those of infectious etiology--lack the immunologic cell responses required to increase susceptibility to HIV.

A controlled trial of nonoxynol 9 film to reduce male-to-female transmission of sexually transmitted diseases.

BACKGROUND: Nonoxynol 9 is a proved spermicide, but whether it is also a microbicide is uncertain. A truly effective vaginal microbicide would reduce the susceptibility of women to sexually transmitted diseases, including infection with the human immunodeficiency virus (HIV). METHODS: We enrolled 1292 HIV-negative female sex workers in Cameroon and enrolled them in a double-blind, placebo-controlled study in which the participants were randomly assigned to use either a film containing 70 mg of nonoxynol 9 or a placebo film, inserted into the vagina before intercourse. All of the women were provided with latex condoms and were instructed to have their male sexual partners use them. At monthly follow-up visits, we examined the women with a colposcope for genital lesions, tested endocervical specimens for gonorrhea and chlamydia infection with DNA probes, tested for HIV infection, and treated the women for curable sexually transmitted diseases. RESULTS: The rates of HIV infection (cases per 100 woman-years) were 6.7 in the nonoxynol 9 group and 6.6 in the placebo group (rate ratio, 1.0; 95 percent confidence interval, 0.7 to 1.5). The rates of genital lesions were 42.2 cases per 100 woman-years in the nonoxynol 9 group and 33.5 in the placebo group (rate ratio, 1.3; 95 percent confidence interval, 1.0 to 1.6). The rates of gonorrhea were 33.3 and 31.1 cases per 100 woman-years in the nonoxynol 9 and placebo groups, respectively (rate ratio, 1.1; 95 percent confidence interval, 0.8 to 1.4). The corresponding rates of chlamydia infection in the nonoxynol 9 group and the placebo group were 20.6 and 22.2 per 100 woman-years (rate ratio, 0.9; 95 percent confidence interval, 0.7 to 1.3). The women reported that condoms were used during 90 percent of sexual acts. CONCLUSIONS: The use of a nonoxynol 9 vaginal film did not reduce the rate of new HIV, gonorrhea, or chlamydia infection in this group of sex workers who used condoms and received treatment for sexually transmitted diseases.

PIP: The potential of nonoxynol-9 to reduce women's susceptibility to sexually transmitted diseases (STDs) was investigated in a double-blind, placebo-controlled trial conducted among 1170 HIV-negative sex workers in Cameroon. Participants were randomly assigned to receive either a film containing 70 mg of nonoxynol-9 (n = 595) or a placebo film (n = 575). Women in both groups were provided with latex condoms for their male partners. At monthly follow-up visits during the 12-month study period, colposcopy was used to examine women for genital lesions, endocervical smears were tested for gonorrhea and chlamydia, HIV testing was performed, and curable STDs were treated. Nonoxynol-9 film failed to confer any additional protection against infection with HIV, gonorrhea, or chlamydia beyond that provided by condoms alone and STD treatment. The rates of genital lesions were 42.2 cases per 100 woman-years in the nonoxynol-9 group and 33.5 in the placebo group (rate ratio (RR), 1.3; 95% confidence interval (CI), 1.0-1.6). The majority of genital lesions in the nonoxynol-9 group were external. The rates of gonorrhea were 33.3 and 31.1 cases per 100 woman-years in the nonoxynol-9 and placebo groups, respectively (RR, 1.1; 95% CI, 0.8-1.4), while those of chlamydia were 20.6 and 22.2 cases per 100 woman-years, respectively (RR, 0.9; 95% CI, 0.7-1.3). Finally, there were 6.7 cases of HIV infection per 100 woman-years in the nonoxynol-9 group and 6.6 in the placebo group (RR, 1.0; 95% CI, 0.7-1.5). Condoms were used during 90% of sexual acts.

Behçet's disease: clinical study of Jordanian patients.

BACKGROUND: Behçet's disease is a chronic, recurrent, inflammatory disorder characterized by the triad of oral and genital ulcers and ocular lesions. The etiology is unknown. This is the first report giving details of the clinical manifestations of Behçet's disease in Jordanian patients. METHODS: Twenty patients with Behçet's disease were studied to determine the clinical pattern in the North of Jordan. The patients were seen in Princess Basma Teaching Hospital in North Jordan. They presented to various clinics and underwent full clinical examination. Data for each patient on all features of Behçet's disease were recorded on a standard form. A comparison was made between Behçet's disease in Jordan and other countries in the region. RESULTS: Of the 20 patients, 14 were men and six women, giving a ratio of 2.3:1. Their ages ranged from 14 to 58 years. All had mouth ulcers, 65% genital ulcers, 65% ocular involvement, 55% joint involvement, 35% skin lesions, 20% vascular lesions, and 5% gastrointestinal involvement. The oral ulcers were the first manifestation of the disease process in 70% of our patients. Skin lesions, genital ulcers, and involvement of the central nervous system and the pulmonary system were less frequent in our study. CONCLUSIONS: Although it is difficult to obtain figures as to the incidence and prevalence of Behçet's disease in Jordan, the clinical manifestations, with a few exceptions, are similar to those in other countries in the region.