Assessment of the QoL in Italian menopausal women: comparison between HRT users and non-users.

OBJECTIVES: The aim of this cross-sectional study was to describe QoL in a large sample of women attending menopause centres and compare untreated postmenopausal women and matched HRT users by employing the Women's Health Questionnaire (WHQ) and two generic instruments, the SF-36 and the EQ-5D. METHODS: Overall, 2906 women were recruited by 64 menopause centres throughout Italy, of whom 2160 filled in the questionnaire (1093 on HRT and 1067 not on HRT; response rate: 74%). RESULTS: HRT users tended to be younger, healthier and with shorter menopause duration as opposed to non users, while no major socio-economic differences were present. At multivariate analysis, the presence of chronic diseases, low socio-economic status and living in Southern Italy represented the most important predictors of poor QoL. Furthermore, HRT users showed a lower probability of reporting problems in usual activities and pain/discomfort (EQ-5D), role limitations due to emotional problems (SF-36) and anxiety/fears (WHQ). HRT users also showed highly significant better outcomes in those areas that are more directly attributable to hormonal changes of mid age, namely vasomotor symptoms and sexual problems. CONCLUSIONS: Although QoL is mainly influenced by socio-economic and cultural factors, HRT has the potential for improving not only symptoms, but also more general aspects of physical and psychological well-being of symptomatic postmenopausal women.

Validation of Italian version of the Women's Health Questionnaire: assessment of quality of life of women from the general population and those attending menopause centers.

OBJECTIVES: The Women's Health Questionnaire has been developed and validated in Anglo-Saxon and Swedish populations. The purpose of this study was to evaluate the Italian version of the questionnaire to determine whether cross-cultural differences exist in the perception of quality of life, and to use it to compare the quality of life in women attending menopause centers with that of women in the general population. METHODS: An Italian version of the Women's Health Questionnaire (WHQ) was produced, using the forward-backward translation method to ensure conceptual equivalence, and approved by the originator. Women were recruited by random selection from the general population and from menopause centers, those taking hormone replacement therapy being ineligible. The questionnaire was completed anonymously at home and mailed to the co-ordinating center. Psychometric evaluation included tests of item convergent and discriminant validity, internal-consistency reliability, test-retest reliability, construct validity and the discriminative properties of the questionnaire. RESULTS: The completeness of the data was good, with missing-value rates consistently low for most items. Item-scale correlations, used to evaluate internal consistency, were also good and the scaling success rate, used to measure item discriminant validity, was high for all scales. Scale scores were reliable for seven out of nine scales and test-retest reliability was excellent. There were few significant differences between the two populations of women in most of the WHQ areas. A comparison of Italian data with published data on English women showed great similarity. CONCLUSION: The Italian version of the WHO is valid and reproducible. The subjective perception of the menopause and its related problems is similar in geographically and culturally different populations.

Cord plasma corticotropin-releasing factor-binding protein (CRF-BP) in term and preterm labour.

Corticotropin-releasing factor-binding protein (CRF-BP) in pregnant women is measurable in maternal and fetal plasma as well as in amniotic fluid. The concentration of CRF-BP in maternal plasma and amniotic fluid changes significantly at the time of parturition. The aim of the present study was to evaluate fetal plasma CRF-BP levels in women delivering at term or with preterm labour. CRF-BP levels were measured the in umbilical cord plasma of women subdivided into two groups: (1) healthy pregnant women throughout the last 5 weeks of pregnancy either (a) out of labour (n = 21) or (b) at delivery after spontaneous labour (n = 64); and (2) patients with preterm labour (a) gone to delivery (n = 12) or (b) responding to tocolysis (n = 10). In the group of healthy women at term, CRF-BP levels were also measured in maternal plasma. CRF-BP was measurable in all specimens of umbilical cord plasma. Mean values +/- SEM at 40 weeks (5.85 +/- 0.65 nmol/l) were significantly lower than those obtained at 37 (6.48 +/- 0.47 nmol/l) or 38 (6.95 +/- 1.16 nmol/l) weeks of pregnancy. Similarly, mean +/- SEM maternal plasma CRF-BP levels in women at term out of labour were lowest at 40 weeks (3.57 +/- 0.22 nmol/l). In these women, mean +/- SEM CRF-BP levels in cord plasma (37 weeks: 6.47 +/- 0.47; 38 weeks: 6.95 +/- 1.16; 40 weeks: 5.85 +/- 0.65 nmol/l) were significantly higher than in maternal plasma at the same gestational age (37 weeks: 4.29 +/- 0.2; 38 weeks: 4.35 +/- 0.205; 40 weeks: 3.57 +/- 0.22 nmol/l). Mean +/- SEM levels of cord blood collected at delivery at term (4.93 +/- 0.14 nmol/l) showed lower CRF-BP levels than in women out of labour (6.18 +/- 0.55 nmol/l). Patients with preterm labour, with delivery within 48 h, showed significantly lower levels of cord plasma CRF-BP (4.21 +/- 0.29 nmol/l) than women at term out of labour (6.18 +/- 0.55 nmol/l) and than those at term with labour (4.93 +/- 0.14 nmol/l). Cord plasma CRF-BP levels decreased in the last 5 weeks of pregnancy, similar to maternal plasma CRF-BP levels, the lowest values resulting in women at labour or with preterm labour, thus suggesting that changes of CRF-BP in cord plasma are associated with the events of parturition.

[Symptoms, life habits and risk factors in Italian menopause women]. / Sintomi, abitudini di vita e fattori di rischio nella donna italiana in menopausa.

Authors report selected demographic, clinical and behavioral characteristics and symptoms of 2181 post-menopausal women enrolled in the CIOM study (collaborazione inter-ospedaliera per la menopausa) in the period 1990-1994. A computerized clinical record was used which was filled by gynecologist during the first and subsequent visits. The study allows to better understand some epidemiological aspects of menopause in comparison with other national and international surveys. The results support the need of educational interventions, both for women and medical doctors, to promote healthy lifestyle and the use of hormonal replacement therapy to alleviate symptoms and to prevent post-menopausal diseases.

[Patterns of use of hormone replacement therapy in 2 Italian populations]. / Profilo d'uso della terapia ormonale sostitutiva in due popolazioni italiane.

We analysed the pattern of hormone replacement therapy (HRT) use, over the period 1990-92, in a random sample of 76,537 women (45-74 years old) resident in the province of Rome, and in 1994 among all women (45-74 years old) resident in the Umbria region; data were collected through the regional drug prescription monitoring systems. During the three-year period an estimated 3.8% of women were prescribed HRT, among these 42% received estrogen with concomitant progestin therapy. The prevalence of use increased from 1.5% in 1990 to 2.2% in 1992 mainly because of an increased use of skin patches. In the Umbria region, out of the 166,112 women, 2.1% received at least one estrogen prescription. The prevalence of use increased in younger age classes but is almost unchanged over the sixties.

[Prevention of cardiovascular risk in menopause women: role of ovarian hormones]. / La prevenzione del rischio cardiovascolare nella donna in menopausa: ruolo degli ormoni ovarici.

Women receiving estrogen replacement therapy after menopause have a reduced risk of cardiovascular and cerebrovascular mortality when compared to untreated controls. Estrogens are thought to protect women primarily through an effect on lipid metabolism. However estrogen-induced increase of HDL-cholesterol and decrease of total and LDL-cholesterol appear to account only in part for the protective effect of ovarian hormones. Direct effects of estrogens on the arterial wall appear to contribute to the over-all cardiovascular benefits.

Clinical and hormonal effects of ethinylestradiol combined with gestodene and desogestrel in young women with acne vulgaris.

The effect of gestodene 75 micrograms (GTD) versus desogestrel 150 micrograms (DSG) combined with 30 micrograms of ethinylestradiol (EE) on acne lesions and plasma androstenedione (A), total testosterone (T), sex hormone binding globulin (SHBG) and "free androgen index" (FAI) was evaluated in an open study on 19 patients aged 18-35 years affected with postpubertal or persistent non-severe acne vulgaris. The patients were randomly allocated into two groups receiving EE-GTD (n = 8) and EE-DSG (n = 11), 21 tablets per cycle for 9 consecutive cycles. Clinical and hormonal evaluations were made between days 17-21 in the cycle before treatment and between days 17-21 of the cycle 3, 6 and 9 of treatment. During treatment, acne improved in most patients, reaching at cycle 9 a low score (absent or minimal) in 62% of the cases in the GTD group (mean acne score = 1.25) and in 90% of the cases in the DSG group (mean acne score = 0.90). Before treatment, about 75% of the patients showed one or more signs of biochemical hyperandrogenism, including elevated FAI (57%), elevated A (15%), elevated total T (15%) and decreased SHBG (21%), and there was evidence of inverse correlation between SHBG and acne scores (p < 0.05). The echogenic texture of the ovaries was multifollicular in 55% of the cases. By the end of the third cycle of treatment, the hormonal changes observed in both groups included significant decreases, with normalization of individual elevated levels of T, and a 3-fold rise of the initial values of plasma SHBG, which showed a further gradual increase at cycle 9 of EE-DSG administration. At cycle 9, normalization of the echogenic ovarian texture was observed. Acne improvement under treatments with estrogen and progestin (EP) could be significantly correlated with the normalization of biochemical hyperandrogenism. In conclusion, the biochemical and clinical efficacy of EE-GTD and EE-DSG indicate that both these preparations can be a good choice in the therapy of acne vulgaris, with a non-significant better clinical result with EE-DSG.

PIP: At the Sacred Heart Catholic University in Rome, Italy, health researchers randomly allocated 19 nulligravidae aged 18-35 with either postpubertal or persistent non-severe acne vulgaris to receive either the combined oral contraceptive (OC) containing 30 mcg ethinyl estradiol (EE) and 75 mcg gestodene (GTD) (Minulet) or 30 mcg EE and 150 mcg desogestrel (DSG) (Marvelon). They aimed to evaluate the effect of GTD and DSG combined with low doses of EE on acne lesions and on hormone levels. The women used the OCs (21 tablets/cycle) for nine consecutive cycles. At baseline, about 75% of all patients had at least one sign of biochemical hyperandrogenism (57% for elevated free androgen index, 15% for elevated androstenedione, 15% for elevated total testosterone, and 21% for reduced sex hormone binding globulin [SHBG]). At baseline, the higher the acne score was, the lower the SHBG level was (p 0.05). The ovaries of 55% of the women had multiple follicles. Acne improved significantly in both groups (mean acne score, 2.9-0.9 for EE/DSG and 2.87-1.25 for EE/GTD; p 0.05). In fact, 62% of cases in the EE/GTD group and 90% of those in the EE/DSG group had either minimal or no acne lesions. Acne improvement during treatment was significantly associated with normalization of biochemical hyperandrogenism. At completion of the third cycle of treatment, both groups experienced significant decreases in hormones. Individual elevated levels of testosterone normalized. The initial values of plasma SHBG had increased 3-fold. SHBG increased gradually to cycle 9 of EE-DSG OC use. At completion of cycle 9, the echogenic ovarian texture returned to normal. These findings suggest that, since both OCs are biochemically and clinically effective, these OCs may be a good treatment for acne vulgaris.

Leuprorelin acetate depot vs danazol in the treatment of endometriosis: results of an open multicentre trial.

A national multicentre trial was organized in order to compare the efficacy and safety of leuprorelin acetate depot and danazol in the treatment of endometriosis. Sixty-seven patients with pelvic endometriosis of different severity at laparoscopy were included in the study and followed during the 24 weeks of treatment. Leuprorelin acetate depot 3.75 mg was injected every 24 days, while the daily dose of danazol was 600-800 mg. At the end of the study objective improvements induced by the two drugs were observed by a second laparoscopic examination. In addition, at regular intervals during the study semiquantitative evaluation of subjective symptoms were monitored. Scoring the final objective changes in the two patient groups revealed no significant difference, however the women treated with leuprorelin acetate depot registered significantly better control of pelvic pain. Due to its efficacy, tolerability and ease of use, leuprorelin acetate appears to be an excellent drug for the treatment of endometriosis.

Efficacy of leuprorelin acetate depot in symptomatic fibromatous uteri: the Italian Multicentre Trial.

A total of 110 nonmenopausal women (mean age 42.1 years) presenting with symptomatic uterine leiomyomata and/or fibromatous uteri have been enrolled in this trial to evaluate the efficacy of the depot formulation of leuprorelin acetate in decreasing uterine volume and minimizing menorrhagia, dysmenorrhoea and pressure over the bladder. All patients were treated with an intramuscular injection of leuprorelin acetate depot 3.75 mg every 4 weeks for 16 weeks. Clinical examinations and hormonal and ultrasound determinations were performed before, during and at the end of treatment. Appropriate follow-up is still ongoing for most patients. At the end of the treatment period, of 88 women with enlarged fibromatous uteri, 33 (37.5%) showed a decrease in uterine volume of greater than or equal to 50% of the original size, while nine (10.2%) remained with unchanged uterine volume. Of 80 fibromas measurable separately, 47 (52.8%) decreased by greater than 50% of the initial volume and 16 (18%) remained unchanged or even increased. During treatment, clinically advantageous effects were observed in the associated symptomatology, mainly in the production of amenorrhoea and restoration of normal haemoglobin levels. Most of the patients were affected by irregular menstrual blood loss with consequent anaemia that in 29 patients was expressed by low levels of haemoglobin (mean 9.2 g/dl; SD 1.5; range 4.5-11.8 g/dl). By the end of the treatment, only one patient still had moderate vaginal blood loss. Haemoglobin levels rose to a mean value of 11.8 g/dl (SD 1.3; range 8.5-14.1 g/dl). Three patients (2.7%) failed to complete the 16-week treatment protocol, because of headache (one patient) and increased blood pressure (two patients). As a result of the treatment, of the 107 patients who were candidates for surgery and who were included in this study, only nine (8.4%) required surgery during leuprorelin acetate treatment. Of these, four operations were vaginal excision of the submucous myomata protruding into the cervix during treatment, and in five hysterectomy performed because of persistence of symptoms. In most patients the achievement of amenorrhoea minimized the fear of surgical emergency, facilitating an increased awareness of their clinical condition. With the exception of the three patients who dropped out, side effects were mild in all patients, consisting mainly of hot flushes, which were easily tolerated. In the following 8-12 months, the regrowth of uterine volume to original size has been usual in most of the 82 patients now in follow-up.(ABSTRACT TRUNCATED AT 400 WORDS)

Enchancement of deficient pituitary response to luteinizing hormone releasing hormone in patients with primary amenorrhea.

Although the absence of pituitary response to the luteinizing hormone releasing hormone (LHRH) test has been considered proof of a lesion primarily localized at the pituitary level, the possibility exists that an absent pituitary response may represent only the effect of a chronic deficiency of hypothalamic secretion. To verify this hypothesis, 4 patients with primary amenorrhea, hypogonadotropic hypogonadism, and deficient or absent responses to a 25 mug LHRH rapid IV test were treated with 400 mug LHRH infused in 7 hours during each of 3 successive days. The finding that patients with deficient LH responses to a rapid LHRH test became normally responsive to a second equivalent test after a slow and prolonged treatment with the decapeptide suggests that, in these patients, besides a lesion at the pituitary level, a primary defect at the hypothalamic or higher centers may also be suspected.

[Gonadotropins]. / Gonadotropine

The clinical usefulness of plasma LH and FSH radioimmunoassays, both in basal and dynamic conditions, is briefly discussed. While occasional LH and FSH determinations may indicate only a serious gonad failure, at least when high values are found, dynamic studies before and after LH-RH i.v. injection may suggest a hypothalamic or pituitary lesion. In this regard the LH-RH test is presented as the most evident demonstration of the utility of gonadotropin radioimmunoassay. Different patterns of response are presented and their correlation with menstrual disorders is discussed in view of different distribution (Tab.1). Moreover, the AA. suggest a primary hypothalamic deficiency in LH-RH in the cases of "deficient" response that, being a constant finding in different days, became a "normal" response after 3 days therapy with LH-RH infusion and returned to basal levels 2 months later. Equally, an "exaggerated" response consistenly found in some patients with secondary amenorrhea, is suspected to be of hypothalamic origin since "normalization" may be obtained after a similar LH-RH treatment.