[Cancers and contraceptive pill: the CNGOF, the FNCGM and the SFG answer the CIRC].
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Biomedical subjects
Publications and source records attributed to D Serfaty.
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OBJECTIVES: To evaluate rates of continuation with hormone replacement therapy (HRT) at 2 years in 2 cohorts of female patients, one of which was treated with a set combination of oral oestradiol valerate and medroxyprogesterone acetate and the other with percutaneous 17 beta-oestradiol gel combined with an oral progestogen selected by the prescribing doctor. PATIENTS AND METHODS: A prospective, randomised, open study, including 885 patients followed for 2 years whose 477 were in the oral HRT cohort and 408 were in the dermal cohort. Randomisation was done by group with prescription of the selected HRT for the cohort. The 2 treatment groups were compared using chi(2) tests and Fisher's exact test for qualitative variables, Student's t test or Wilcoxon's test for qualitative variables and Kaplan-Meier survival curves for continuation of HRT, with comparisons using the log-rank test. The prognostic value of baseline parameters on subsequent continuation of HRT was studied using the Cox model (Wald test, odds ratio). RESULTS; Among the 885 treated patients, 711 received the HRT assigned to their cohort (382 in the oral HRT cohort, 329 in the dermal HRT cohort). After 2 years, 77.9% of the patients in the oral HRT cohort and 73.4% of the patients in the dermal HRT cohort were continuing to take their prescribed HRT (P = 0. 076): 37.9% of patients in the oral HRT cohort and 20.2% of patients in the dermal HRT cohort (P < 0.001) continued taking their treatment without any modification. CONCLUSION: Although there was no significant difference in the level of compliance in the 2 groups, it is nonetheless worth noting that the HRT compliance with a sequential fixed estroprogestogen combination was, in this trial, at least equal to that with the free combination of a transdermal estrogen and a progestogen whose nature, dosage and sequence duration are selected by the prescriber. On the other hand, treatment modifications occurred more frequently in the cutaneous HRT group, which is logical as free combination affords to adapt the treatment to each patient.
OBJECTIVE: To study the impact of an original education program on compliance to hormone replacement therapy (HRT) in post-menopausal women. METHODS: Data were obtained from 1,192 post-menopausal women (age: 53 +/- 5 years) included in the study with an onset less than six months: E2 gel (n = 791) or patch (n = 401) + progestins, and randomized in either educational program (Ep = 600) or regular verbal counselling (VC = 592). A patient is considered bad compliant with HRT when she prematurely stopped the study, whatever the reason of the cessation. The groups EP and VC are homogeneous for the age distribution, the HRT regimen, the date of onset and the climateric symptoms scores. RESULTS: There is a significant difference between EP and VC groups in compliance, respectively 86 and 81% (p < 0.027). This difference is partially explained by the significant improvement in the patch subgroups (EP: 86% versus VC: 77%, p = 0.028). The trend observed in the gel group is not significant (EP: 85% and VC: 82%) due to the high level of compliance usually noticed in women treated with the gel and the verbal counselling. The significative difference in the compliance observed during the verbal counselling between the continuous (76%) and the sequential (86%, p = 0.001) HRT regimen disappears with the educational program (continuous: 84% and sequential: 87%, NS). CONCLUSION: This first large study on the HRT compliance in France, using a patient educational material, validates its efficacy to reach a better compliance than with regular verbal counselling. Even though in the daily practice, about 40% of the patients discontinue the treatment during the first year, 81% of the women followed in this study continue to receive the HRT after nine months of use. The original educational program of the COMET study improves significatively this high compliance (+ 5% from the verbal counselling). Thus, the combination of the doctor verbal counselling and an educational material is desirable to obtain a good compliance with HRT.
OBJECTIVE: The Protectaid sponge (Gefar Pharma, Switzerland) is a new feminine barrier contraceptive method containing three low-dose spermicidal agents. In order to evaluate its efficacy and safety profiles, an international, multicenter study has been conducted in four countries. METHODS: Healthy, presumably fertile and sexually active women were enrolled in this study and were followed at 15 days, 3, 6, 9 and 12 months. Contraceptive efficacy was assessed by a pregnancy test, while safety was evaluated by performing gynecological examinations as well as reporting adverse events. The 'acceptability' of the sponge by the women was assessed through a standard questionnaire. RESULTS: A total of 129 women were enrolled in the study, generating 1182 cycles of use of the sponge. The overall efficacy rate was 77%, with no significant influence of age or parity. Acceptability was high, with 85% of subjects being symptom- or problem-free while using the sponge. Finally, the safety profile was very good, with no clinically significant evidence of local or systemic adverse reactions. CONCLUSION: The new Protectaid sponge is a safe and effective non-hormonal contraceptive method for women.
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The most important beneficial effect of modern contraception is that it has promoted the concept of birth control as a fundamental right of women from the viewpoint of equality between men and women. This right will lead to further rights for women, in particular, that of a free choice in respect of their sex lives, their method of procreation and, in more general terms, their way of life and their legitimate place in society.
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OBJECTIVE: To compare the cycle control and tolerability of two oral contraceptives containing 20 micrograms ethinylestradiol and either 150 micrograms desogestrel or 75 micrograms gestodene. METHODS: A randomized, multicenter study was conducted in which 1016 healthy adult women received the desogestrel (n = 509) or the gestodene (n = 507) preparation for six treatment cycles. RESULTS: No significant differences in bleeding patterns were detected between the two treatments. The incidence and duration of irregular bleeding decreased markedly, and to a similar extent, during each treatment. The occurrence of irregular bleeding per cycle decreased from 24.6 to 9.4% in the desogestrel group and from 19.7 to 8.6% in the gestodene group. Its duration fell from 1.1 to 0.2 days and from 0.9 to 0.3 days, respectively. There was a consistently low incidence of amenorrhea (1.0-2.8%). There were no significant differences between treatments for the incidence, intensity or emergence of dysmenorrhea. During both treatments, the incidence of premenstrual syndrome and complaints such as breast tenderness, nausea and headache dropped markedly. CONCLUSION: Ultra low-dose oral contraceptives containing desogestrel or gestodene offer equivalent, good cycle control and improvements in dysmenorrhea and premenstrual syndrome and have similar, excellent tolerability profiles.
Chlamydia trachomatis is a primary cause of acute or silent salpingitis leading to infertility and ectopic pregnancy. The C. trachomatis epidemic, undiscovered in most cases, spreads, mostly in adolescents, during the years following the onset of sexual activity. As opposed to gonococcal infection which has greatly decreased, C. trachomatis cervical and urethral infection is commun in young occidentals. More then 30 different studies covering 200-12000 subjects screened in family planning centers, college women and men, students and military recruits in different parts of the USA, in Scandinavian countries and France, indicate a prevalence of 5-20% (mean 10%) in apparently healthy young females < 25 years and 5-10% in males. Female prevalence is strongly related to age, being highest (5-20%) in women < 20 years old. Several cost-benefit analysis show that the total cost of the general screening in young populations, which can easily be carried out for women in family planning centers, could save twice the cost of treatment for pelvic inflammatory disease caused by C. trachomatis and six times the total cost of C. trachomatis epidemics if late sequelae are taken into account (tubal infertility treatment, ectopic pregnancy). In France, screening should save 12 to 48 millions French francs each year, depending of the cost of detection. The final benefit of detection should be the eradication of the epidemic as obtained to date in Scandinavian countries.
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UNLABELLED: Premenstrual syndrome (PMS) constitutes a real health problem in France. Its etiology is still poorly understood. A national multicenter study has recently been devoted to this problem. The results are reported here. STUDY OBJECTIVES: to improve awareness of the epidemiology of PMS and evaluate the therapeutic activity, on an open-label basis, of a micronized purified flavonoid fraction (Daflon 500 mg). METHODS: the features of PMS were determined prior to the commencement of any treatment by using a daily self-assessment diary consisting of 24 items. The same diary was used for the 3 cycles during which patients were treated with Daflon 500 mg at the dose of 2 tabs/day without interruption. Weight and circumferential measurements were noted at least twice per cycle. Monitoring included telephone contact after one cycle and a final clinical evaluation after 3 cycles under treatment. RESULTS: of the 1,908 women selected by 887 gynecologists throughout the country, 1,724 contributed to the epidemiological study. It was confirmed that problems related to PMS were significant in 35% of cases and led to time off work in 7.4% of cases. One thousand four hundred and seventy three women completed the therapeutic trial. PMS disappeared completely in 37,4% of patients. The duration of PMS decreased on average by 2.6 days (p < 0.0001). Symptoms of congestion gradually lessened in terms of both frequency and severity by about 60%, the same applying to weight gain (-29% in comparison with the pre-treatment cycle). The safety/acceptability of Daflon 500 mg was considered to be very good by both patients and gynecologists. CONCLUSION: the diagnosis and management of PMS require precise evaluation. This study, the results of which require confirmation, justifies the inclusion of Daflon 500 mg among potential treatments offered to women suffering from PMS with a congestive component.
Chlamydia trachomatis is a primary cause of acute or silent salpingitis leading to infertility and ectopic pregnancy. The C. trachomatis epidemic, undiscovered in most cases, spreads, mostly in adolescents, during the years following the onset of sexual activity. As opposed to gonococcal infection which has greatly decreased, C. trachomatis cervical and urethral infection is common in young occidentals. More then 30 different studies covering 200-12,000 subjects screened in family planning centers, college women and men, students and military recruits in different parts of the USA, in Scandinavian countries and France, indicate a prevalence of 5-20% (mean 10%) in apparently healthy young females < 25 years and 5-10% in males. Female prevalence is strongly related to age, being highest (15-20%) in women < 20 years old. Several cost-benefit analyses show that the total cost of the general screening in young populations, which can easily be carried out for women in family planning centers, could save twice the cost of treatment for pelvic inflammatory disease caused by C. trachomatis and six times the total cost of C. trachomatis epidemics if late sequelae are taken into account (tubal infertility treatment, ectopic pregnancy). There is a debate among authors concerning the relative merits of total screening versus selective screening in family planning centers, the most common opinion being to do a total screening of women < 20 years old and selective screening of women 20-30 years of age with at least one risk factor, the most common risk factors being more than one partner in a year, purulent, cervical discharge, failure to use condoms and use of a contraceptive pill. Although the data clearly show that C. trachomatis screening is cost-effective, conducting of the diagnostic laboratory tests used in such screening programs should be carefully evaluated relative to cost, feasibility, specificity and sensitivity and should be adapted to the presumed prevalence in screened populations.
Vaginal contraception (condom, diaphragm and spermicide in pessary, tablet, jelly, cream, or sponge form) have been little used in France and generally in Europe since the advent of modern contraception with "the pill" and the intrauterine contraceptive device. The former methods, when properly used, are nevertheless both effective and useful, at least as interim measures. In addition, the protection they afford against sexually transmitted diseases and, for the condom, against HIV, is not negligible. Finally, the "barrier" methods of contraception such as the diaphragm and the condom afford significant protection against cancer of the cervix. The intrauterine contraceptive device (IUCD), used in France by 14% of women between 15 and 49 years of age and by 90 million women throughout the world for whom it is the main reversible means of contraception, have a mechanism of action that is still not fully understood. Most IUCD now used are made of copper. There are also diffusion IUCD based on progesterone or a synthetic progestational hormone which are useful in case of anaemia, menorrhagia or dysmenorrhea.
RU 486 is the code name for mifepristone, a 19-norsteroid first synthesized in 1980. Its chemical structure is similar to progesterone and progesterone derivatives. The difference lies in an 11 beta ring substitution which results in high affinity for progesterone and cortisol receptors. Once linked to the receptor, RU 486 temporarily blocks the action of the corresponding hormone. In vitro and in vivo, RU 486 has a powerful anti-progesterone and anti-glucocorticoid effect and a less powerful but nevertheless important anti-androgen effect. The essential clinical application for RU 486 involves its anti-progesterone effect, currently used in several indications including voluntary pregnancy termination and preparation for the prostaglandin action used to induce labour in interrupted pregnancies. Potential indications have been suggested for preparing the cervix for endo-uterine manoeuvres, induction of labour in term pregnancy and contraception. Other potential indications in gynaecology include breast cancer, endometriosis and uterine fibroma. Meningioma and Cushing's syndrome would be further indications. How far will we go with RU 486? All will depend on the social and economic resistance to the drug and to an even greater extent on ethical considerations. The strength of the anti-RU 486 lobby may well dampen the development of non-contraception indications for this effective anti-progesterone agent.
The European Society of Contraception developed a survey to examine birth control methods in the 12 countries++ of the European Community. Responses to those questions relating to prescribing++ practices of oral contraceptives (OCs) are presented herein. The survey was sent to 400 physicians. One hundred two responded, most from France, Belgium, and the United Kingdom. The responses revealed that the most popular OCs are modern combined formulations containing low doses of ethinyl estradiol and progestogens such as norgestimate, desogestrel, gestodene, and levonorgestrel. More than half of physicians prescribe a particular formulation because of its tolerability and 20% because of its hormonal content. More than 90% prescribe OCs to healthy, nonsmoking women over 40. However, three fourths will not prescribe OCs to smokers over 35. Half of physicians recommend mammography for their older OC patients. Half also recommend cholesterol screening, but 8% only for women over 30. Most physicians are no longer reluctant to prescribe OCs to their diabetic patients: 61% prescribe OCs for women with non-insulin-dependent diabetes, 56% for those with insulin-dependent diabetes, and 85% for those with a history of gestational diabetes. Despite recent studies showing no relation between past OC use and cardiovascular disease, 42% of physicians said that their greatest OC-related health concern is cardiovascular disease. One third cited noncompliance as their greatest concern. These results reveal inhomogeneous prescribing practices for OCs among European physicians. ¿Over-screening¿--not prescribing the pill because of perceived (but not necessarily real) health risks--may be depriving many women of the contraceptive and noncontraceptive benefits of OCs. Complete and accurate information--as promoted by the European Society of Contraception--is one way to combat such overscreening.
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