The changing scene--an unnecessary pill crisis.
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A number of case-control studies published in 1995/1996 have shown an apparent increase in the risk of venous thromboembolism (VTE) associated with the use of third-generation oral contraceptives (OC). However, it was discussed very early on that these studies were subject to a number of biases or residual confounding that would have increased the risk estimates for third-generation OC while lowering those for second-generation preparations. Six new studies or analyses were performed trying to take into account many of the methodological problems that were discussed for the initial studies: Two population-based database analyses in the UK and Germany, a new analysis of the General Practice Registry database (GPRD) in the UK, an analysis of a new database of the Transnational study, a re-analysis of the original Transnational study with a new technique, and a population-based study in Denmark. These studies could not confirm a higher VTE risk in users of third-generation OC compared with those using second-generation OC. Data on the risk of arterial thromboembolism (ischaemic stroke and myocardial infarction) show no such difference between generations of OC, with a statistically significant reduction in the risk of acute myocardial infarction from first- to third-generation preparations in one major study. Some of the investigators concluded that there is very likely no increased risk of arterial thromboembolism associated with the use of low-dose oestrogen OC in young women who are properly screened for cardiovascular risk factors or for such conditions. These findings should be taken into account when interpreting the results of studies on the risk of VTE in women taking combined OC. (+info)
Conclusions: the relative safety of modern oral contraceptives.
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Published data on the relative safety of second and third generation oral contraceptives (OCs) is critically assessed. The original four studies published in 1995/1996 and their conclusions are examined in detail, including comments made by other investigators. Each study has advantages and flaws which are balanced in detail. Newer studies are then examined in the same manner. All recent papers indicate an equivalence of safety of second and third generation OCs, as the effects of various confounders and biases have been identified and analysed. We conclude that absolute risks are minor with both generations and that no reasons now exist to indicate any differences in their overall safety. We analyse finally how the pill crisis arose, and make suggestions about future reporting on OC safety. (+info)
A systematic review of drug induced ocular reactions in diabetes.
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AIMS: To conduct a systematic review of drug induced adverse ocular effects in diabetes to determine if this approach identified any previously unrecognised adverse drug effects; to make a preliminary assessment of the feasibility of this approach in identifying adverse drug reactions; and to assess the current accessibility of this information to prescribing physicians. METHODS: Literature search of online biomedical databases. The search strategy linked eye disorders with adverse drug reactions and diabetes. Source journals were classified as medical, pharmaceutical, diabetes related, or ophthalmological. It was determined whether the reactions identified were recorded in drug datasheets and the British National Formulary. RESULTS: 63 references fulfilled the selection criteria, of which 45 were considered to be relevant to the study. The majority of these were case reports but cross sectional surveys, case-control and cohort studies, and review articles were also identified. 61% of the reactions were not recorded in the British National Formulary and 41% were not recorded in the datasheets. 55% appeared in specialist ophthalmology journals. CONCLUSIONS: This is a feasible approach to the identification of adverse drug reactions. Adverse reactions not listed in the most commonly used reference sources were found. The majority were published in specialist ophthalmology journals which might not be seen by prescribing physicians. (+info)
Screening before and during the use of oral contraceptives and hormone replacement therapy. The ESHRE Capri Workshop Group.
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Most users of oral contraceptives (OC), and many users of hormone replacement therapy (HRT) are apparently healthy, using a preparation for preventative purposes. It is understandable, therefore, that many clinicians feel that they should screen women using these preparations for hidden disease. Sometimes this has resulted in women being subjected to a variety of procedures. This medicalization of the provision of care can inhibit women from availing themselves of these services. All screening programmes must have evidence that: early detection will affect the natural history of the disease; the performance characteristics of the test must be known; the test should be cost-effective, acceptable to users and providers, should influence clinical decisions, and treatment should exist for abnormal results. The tests time to time suggested before and during the use of OC and HRT do not fulfill these needs. Whether any of the contraindications for OC use are present can be determined simply by taking a history and performing a physical examination including measurement of blood pressure. The same policy applies to the women who will start HRT. If facilities are available for screening mammography this test should be performed prior to starting HRT as the oestrogen can promote the growth of an existing subclinical breast cancer. It is not cost effective to perform an endometrial biopsy in women without abnormal genital bleeding prior to starting HRT. Routine measurement of bone density is also not cost effective or necessary since no current available agent reduces the risk of fractures in women with osteoporosis more than HRT. (+info)
Serum leptin concentrations during the menstrual cycle in normal-weight women: effects of an oral triphasic estrogen-progestin medication.
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OBJECTIVE: To investigate in normal-weight premenopausal women the relationship between circulating leptin and serum gonadotropins and gonadal steroids, during both spontaneous and pharmacologically induced menstrual cycles. DESIGN: Clinical longitudinal study. METHODS: Two groups of age-matched, normal-weight premenopausal volunteer women (groups I and II) were enrolled in this study. Women in group I were free of any hormonal treatment, while women in group II were taking a triphasic estrogen--progestin contraceptive preparation. Blood samples were collected daily in both groups after an overnight fast throughout a complete menstrual cycle. RESULTS: In the spontaneously cycling women, serum leptin concentration positively correlated with estradiol (P<0.03) and progesterone (P<0. 05) and was higher in the luteal than in the follicular phase (P<0. 05). However, a significant (P<0.03) short-lasting increase in circulating leptin was present in the late follicular phase of all subjects. In the women using hormonal contraception serum leptin remained unchanged throughout the cycle, along with constantly low values of circulating luteinizing hormone and follicle-stimulating hormone. CONCLUSIONS: In normal-weight premenopausal women serum leptin concentrations differ during the menstrual cycle in line with changes in gonadotropin and gonadal steroid concentrations, increasing in the luteal phase of the cycle after a peri-ovulatory peak. These findings suggest a permissive role for leptin with regard to the functioning of the corpus luteum. (+info)
Human papillomavirus testing for triage of women with cytologic evidence of low-grade squamous intraepithelial lesions: baseline data from a randomized trial. The Atypical Squamous Cells of Undetermined Significance/Low-Grade Squamous Intraepithelial Lesions Triage Study (ALTS) Group.
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BACKGROUND AND OBJECTIVE: Human papillomavirus (HPV) infections appear to be central to the development of cervical cancer. This study addresses the question of whether testing women who have low-grade squamous intraepithelial lesions (LSILs) of the uterine cervix for HPV DNA is useful as a triage strategy. METHODS: Four clinical centers in different areas of the United States participated in a randomized clinical trial of the use of HPV DNA testing in women with cytologic evidence of atypical squamous cells of undetermined significance (ASCUS) or LSIL. The study sample in this article consists only of women who had LSIL at enrollment. Within 6 months of an LSIL diagnosis (based on a Pap smear read by a community-based cytopathologist), women who were 18 years of age or older completed a standardized questionnaire and underwent a pelvic examination that included collection of cervical specimens for HPV DNA testing by Hybrid Capture II (HCII)(R) assay. RESULTS: Among the 642 women referred with LSIL who had analyzable test results, the mean chronologic age and age at first coitus were similar among the four clinical centers, despite the centers' ethnic and geographic diversity. Overall, HPV DNA was detected in cervical samples from 532 (82.9%) of the 642 women (95% confidence interval = 79.7%-85.7%). This high frequency of HPV positivity was confirmed by polymerase chain reaction (PCR) assays in a subset of 210 paired specimens tested by HCII and PCR (81.4% were positive by both methods). CONCLUSION: Because a very high percentage of women with an LSIL diagnosis from Pap smears are positive for HPV DNA by HCII testing, there is limited potential for this assay to direct decisions about the clinical management of women with LSIL. The role of HPV testing in the management of women with ASCUS is still under study. (+info)
Gallstone disease in Peruvian coastal natives and highland migrants.
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BACKGROUND: In a previous study, we found that gallstones were a common occurrence in the high altitude villages of the Peruvian Andes. AIMS: To determine if high altitude (> or = 1500 m) is a contributing risk factor for gallstone disease. METHODS: We conducted a cross sectional study in a periurban community in Lima, Peru, and compared the prevalence of gallstone disease between coastal natives, highland (Sierra) natives and Sierra natives who had migrated to the coast. We also compared the prevalence rates from this study with those from a previous study conducted at high altitude. We examined 1534 subjects >15 years of age for gallstone disease. Subjects were interviewed for the presence or absence of risk factors. RESULTS: Gallstone disease was more common in females (16.1 cases per 100, 95% CI 13.8-18.2) than in males (10.7 per 100, 95% CI 8.0-13.4). Females had a greater risk of gallstone disease, especially if they had used oral contraception and/or had four or more children. The age adjusted prevalence was not significantly different between coastal natives, Sierra migrants, and Andean villagers. The prevalence of gallstone disease was not associated with time since migration or with having native Sierra parents. After adjusting for other risk factors, Sierra natives who migrated to the coast had a lower prevalence of gallstone disease than coastal natives (odds ratio 0.74, 95% CI 0.58-0.94). CONCLUSIONS: This study indicates that high altitude is not a positive risk factor for gallstone disease and confirms that this disease is common in Peruvians, which may be attributable to Peruvian-Indian ethnicity. (+info)
A reminder that human behavior frequently refuses to conform to models created by researchers.(56/1279)