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Biomedical subjects

Tiziana Russo

Publications and source records attributed to Tiziana Russo.

At least 19 recordsLinked to original sources

Effects of metformin and clomiphene citrate on ovarian vascularity in patients with polycystic ovary syndrome.

OBJECTIVE: To evaluate the effects of metformin and of clomiphene citrate (CC) on the ovarian blood perfusion and on perifollicular and peri-corpus luteum (CL) vascularity in anovulatory women with polycystic ovary syndrome (PCOS). DESIGN: Prospective cohort study. SETTING: University "Magna Graecia" of Catanzaro. PATIENT(S): Forty anovulatory nonobese patients with PCOS who ovulated under treatment with metformin (850 mg twice daily) plus placebo (metformin group) and 38 under placebo plus CC (150 mg for 5 days; CC group). Another 30 healthy normal cycled women (control group). INTERVENTION(S): Serial transvaginal ultrasonographic examinations. MAIN OUTCOME MEASURE(S): Ovary artery blood flow impedance, dimensions, and vascularization of the dominant follicle and of the CL. RESULT(S): No difference was observed in all parameters in metformin ovulating cycles in comparison with healthy controls. In CC ovulating cycles, ovarian artery impedance, and perifollicular and peri-CL vascularization the results were significantly different from the metformin and control groups. After grouping the stimulated cycles for reproductive outcomes, perifollicular vascularization alone ended up being significantly lower only in CC-stimulated cycles with unfavorable outcome. CONCLUSION(S): In patients with PCOS who ovulate under treatment with metformin, the ovarian blood flows are similar to those observed in healthy women, whereas CC administration reduces the ovarian and, specifically, the perifollicular vascularization.

Adult↗

Uterine effects of clomiphene citrate in women with polycystic ovary syndrome: a prospective controlled study.

BACKGROUND: Previous data on the efficacy of clomiphene citrate, the most commonly used drug for treating anovulatory infertility in patients with polycystic ovary syndrome (PCOS), have shown a discrepancy between ovulation and pregnancy rates. In the present subanalysis (of a larger previously published randomized controlled trial), the effect of clomiphene citrate on several ultrasonographic markers of uterine receptivity in PCOS patients who ovulated under treatment was studied. METHODS: Thirty-three PCOS women who ovulated under 150 mg daily clomiphene citrate and 33 healthy controls were studied. Uterine, subendometrial and endometrial blood flows, endometrial thickness and pattern were assessed using serial ultrasonographic assessments. The data were analysed before and after grouping the clomiphene citrate-stimulated ovulatory cycles for reproductive outcome [unfavourable (ovulation alone or early pregnancy loss) or favourable outcome (clinical pregnancy and/or live birth)]. RESULTS: Both before and during treatment, uterine vascularity assessed at all sites was significantly lower in the PCOS group than in controls. Endometrial thickness and pattern were impaired in the PCOS group under clomiphene citrate treatment. A significant difference in all ultrasonographic parameters was observed between cycles ending in unfavourable versus those ended in favourable outcome. CONCLUSIONS: Clomiphene citrate administration alters several surrogate ultrasonographic parameters of uterine receptivity, and this effect could be crucial for its efficacy.

Adult↗

Cardiopulmonary impairment in young women with polycystic ovary syndrome.

CONTEXT: Insulin resistance is a feature of polycystic ovary syndrome (PCOS), and it is related to mitochondrial function, particularly with maximal oxygen consumption (VO(2max)). At the moment, no evaluation of cardiopulmonary functional capacity in young patients with PCOS has been performed. OBJECTIVE: Our objective was to assess cardiopulmonary functional capacity in young PCOS overweight patients. DESIGN AND SETTING: We conducted a prospective baseline-controlled clinical study at University Federico II of Naples, School of Medicine (Naples, Italy). PATIENTS: Forty-five PCOS patients were matched with 45 healthy women for age (mean +/- sd, 21.3 +/- 2.0 vs. 21.6 +/- 1.9 yr, respectively) and body mass index (29.4 +/- 3.6 vs. 29.0 +/- 3.4 kg/m(2), respectively). MEAN OUTCOME MEASURES: We assessed hormonal and metabolic pattern and functional capacity by cardiopulmonary exercise testing to evaluate maximal oxygen consumption (VO(2max)), oxygen consumption at anaerobic threshold (VO(2AT)), and the maximal workload at peak exercise. RESULTS: VO(2max) (17.0 +/- 3.7 vs. 26.8 +/- 3.5 ml/kg.min), oxygen consumption at anaerobic threshold (13.9 +/- 3.0 vs. 21.2 +/- 3.8 ml/kg.min), and maximal workload at peak exercise (101.3 +/- 25.2 vs. 135 +/- 22.6 W) were significantly (P < 0.001) reduced in PCOS subjects compared with healthy women. The multiple linear regression analysis showed that only homeostasis model assessment appears to have a strong negative linear relation with VO(2max) in PCOS. No relation was found in controls. CONCLUSIONS: Our data demonstrate a reduced cardiopulmonary functional capacity in young PCOS patients.

Adult↗

Laparoscopic uterine nerve ablation versus vaginal uterosacral ligament resection in postmenopausal women with intractable midline chronic pelvic pain: a randomized study.

OBJECTIVE: To assess and compare the laparoscopic uterine nerve ablation (LUNA) and the vaginal uterosacral ligament resection (VUSR) in postmenopausal women with chronic pelvic pain (CPP). STUDY DESIGN: Eighty postmenopausal women with intractable and severe midline CPP were randomized to undergo LUNA or VUSR. Costs of two surgical procedures were assesses. Cure rate, severity of CPP, and deep dyspareunia were also evaluated after 6 and 12 months from surgery. RESULTS: The mean cost of LUNA resulted significantly higher in comparison with VURS (2078+/-637 versus 1497+/-297, P<0.001). The cure rate was not significantly different between the two groups at 6 (33/40, 82.5% versus 35/40, 87.5% for groups A and B, respectively; P=0.530; RR 0.94, 95% CI 0.78-1.13), and 12 months (27/36, 75.0% versus 28/38, 73.7%, for groups A and B, respectively; P=0.901; RR 0.90, 95% CI 0.78-1.33) of follow-up. At same times, a significant (P<0.01) decrease in severity of CPP and deep dyspareunia was observed in both groups with no difference between them. CONCLUSIONS: Both LUNA and VUSR are equally effective surgical treatments in postmenopausal women with central CPP but VUNR is significantly cheaper than LUNA.

Colpotomy↗

Metformin hydrochloride and recurrent miscarriage in a woman with polycystic ovary syndrome.

OBJECTIVE: To report the effect of metformin treatment on a patient with recurrent miscarriage (RM) and polycystic ovary syndrome (PCOS). DESIGN: Case report. SETTING: University department of obstetrics and gynecology, Italy. PATIENT(S): A woman complaining of RM who had PCOS and insulin resistance. INTERVENTION(S): Clinical, biochemical, and instrumental assessments. MAIN OUTCOME MEASURE(S): Administration of metformin hydrochloride before and throughout pregnancy. RESULT(S): After 3 months of treatment, the patient became pregnant. The pregnancy had a physiologic development, and at 39 weeks of gestation, the patient spontaneously delivered a healthy infant. CONCLUSION(S): Metformin has shown to be effective in an insulin-resistant PCOS woman with RM.

Abortion, Habitual↗

Efficacy of laparoscopic ovarian diathermy in clomiphene citrate-resistant women with polycystic ovary syndrome: relationships with chronological and ovarian age.

BACKGROUND: Laparoscopic ovarian diathermy (LOD) has been used successfully as a first-, second- and third-line treatment for ovulation induction in women with polycystic ovary syndrome (PCOS). However, little is known about the predictors for LOD efficacy. The aim of the present study was to evaluate reproductive outcomes in clomiphene citrate (CC)-resistant PCOS patients treated with LOD according to ovarian and chronological age. METHOD: A total of 60 non-obese, primary infertile, CC-resistant women with PCOS were enrolled and treated with LOD. During the following 6 months, all patients underwent ovulation monitoring and timed intercourse. If spontaneous ovulation did not occur within 3 months from surgery, CC (100 mg/day) was administered for 5 days from day 3 of the remaining cycles. The ovulation, abortion and pregnancy rates were assessed and analyzed with patients categorized according to chronological age (group A, <25 years; group B, 25-30 years; group C, 30-35 years; group D, >35 years) and ovarian age (group 1, follicle stimulating hormone (FSH) < 10 mIU/ml; group 2, FSH > 10 mIU/ml). RESULTS: At the end of the study, total ovulation, pregnancy and abortion rates were 57.1, 13.0 and 18.2%, respectively. No difference in all reproductive outcomes was observed between groups A, B and C, whereas the efficacy of LOD was significantly lower in group D. A significant difference in all clinical endpoints was detected between groups 1 and 2. CONCLUSIONS: Our data show that chronological age >35 years and basal FSH value > 10 mIU/ml are related to poor reproductive prognosis in CC-resistant PCOS patients treated with LOD.

Abortion, Spontaneous↗

Use of oral contraceptives in infertile patients: A descriptive review.

In the past and currently, there are several applications of oral contraceptives (OCs) in the field of infertility. The aim of the present descriptive review is to analyze the old and new uses of OCs in infertile patients undergoing simple or multiple ovulation-induction programs. Available data seem to indicate that OCs given before treatment could be effective in patients who are resistant to clomiphene citrate and in poor responders. In addition, the use of OCs is useful for scheduling in vitro fertilization programs downregulated with gonadotropin-releasing hormone-antagonists.

Anovulation↗

Clinical use of the perifollicular vascularity assessment in IVF cycles: a pilot study.

BACKGROUND: In Italy, a recent law has imposed a ban on the fertilization of more than three oocytes at one time, and all resulting embryos produced must be transferred simultaneously. The aim of the present controlled study was to assess the clinical feasibility and efficacy of the perifollicular vascularity assessment for oocyte selection in IVF cycles. METHODS: Fifty-four young primary infertile non-obese women (27 cases and 27 age- and BMI-matched controls) underwent IVF cycles. The choice of the oocytes to fertilize was performed according to perifollicular vascularization in the experimental group, whereas in the control group, the standard morphologic criteria alone were used. The dose of gonadotrophins used, the dominant follicles obtained, the duration of the ovarian stimulation, the number of oocytes retrieved, the number/quality of oocytes fertilized and of cleaved embryos, cycle cancellation, implantation, clinical pregnancy, ongoing pregnancy, multiple pregnancies and ovarian hyperstimulation syndrome rates were assessed in each group. RESULTS: The assessment of perifollicular vascularity was feasible in 88.9% of cases. No difference between groups was detected in any parameter evaluated. CONCLUSION: Power Doppler assessment of perifollicular vascularity seems to have no clinical utility for oocyte selection in IVF cycles for young infertile women.

Adult↗

Uterine effects of metformin administration in anovulatory women with polycystic ovary syndrome.

BACKGROUND: Metformin has been shown to improve fertility in anovulatory patients with polycystic ovary syndrome (PCOS), inducing not only a high ovulation and pregnancy rate but also reducing the incidence of miscarriages. The aim of the present study was to evaluate the uterine effects of metformin in patients with PCOS who ovulated under metformin. METHODS: Thirty-seven non-obese primary infertile anovulatory patients with PCOS and another 30 age- and body mass index-matched healthy women (control group) were studied. PCOS patients were treated with metformin (850 mg twice daily) for 6 months, whereas the control group did not receive any treatment. In these PCOS patients who ovulated whilst under metformin treatment (PCOS group) and in controls, uterine, sub-endometrial and endometrial blood flow, and endometrial thickness and pattern were evaluated using serial ultrasonographic assessments. RESULTS: Before treatment, uterine, sub-endometrial and endometrial blood flows were significantly lower in patients with PCOS than in the control group. All indexes of uterine vascularization were significantly improved in the PCOS group with metformin treatment and were not different from the controls. Nor was any difference in endometrial thickness and pattern detected between PCOS and control groups. After grouping the data of PCOS patients who ovulated under metformin for cycles with favourable/unfavourable reproductive outcome, no difference in any parameter was observed. CONCLUSIONS: Metformin improves all surrogate markers of endometrial receptivity in PCOS patients, without difference between patients who had favourable or unfavourable reproductive outcome.

Adult↗

Improvement in endothelial structure and function after metformin treatment in young normal-weight women with polycystic ovary syndrome: results of a 6-month study.

CONTEXT: Recent data indicate that women affected by the polycystic ovary syndrome (PCOS) are at greater risk for cardiovascular disease and that metformin may improve the metabolic alterations in these patients. OBJECTIVE: The objective of this study was to evaluate the effects of 6 months of metformin administration on endothelial structure and function in women with PCOS. DESIGN: This was a prospective, baseline-controlled, clinical study. SETTING: The study was performed at University Federico II (Naples, Italy). PATIENTS: Thirty young normal-weight women with PCOS without additional metabolic or cardiovascular diseases were studied. INTERVENTIONS: Metformin (850 mg daily) was administered for 6 months. MEAN OUTCOME MEASURES: The main outcome measures were complete hormonal profile, including total testosterone, SHBG, dehydroepiandrosterone sulfate, prolactin, and gonadotropin levels; serum insulin and glucose levels during a 75-g 2-h oral glucose tolerance test; plasma endothelin-1 concentrations (picomoles per liter +/- sd); serum lipid profile; brachial artery baseline diameter (millimeters +/- sd), diameter after reactive hyperemia (millimeters +/- sd), and flow-mediated dilation (percentage +/- sd); and the intima media thickness (millimeters +/- sd) on both common carotid arteries. RESULTS: After treatment, SHBG levels and the free androgen index changed significantly (P < 0.001). High-density lipoproteins and the area under curve for glucose/area under curve for insulin ratio also significantly (P < 0.001) increased, whereas low-density lipoproteins and plasma endothelin-1 levels were significantly (P < 0.001) reduced. No other change was found in any of the biochemical parameters evaluated. A significant difference was observed in brachial artery baseline diameter (3.24 +/- 0.30 vs. 3.0 +/- 0.30), flow-mediated dilation (14.30 +/- 1.90 vs. 15.70 +/- 1.50) (P < 0.01, each), diameter after reactive hyperemia (3.70 +/- 0.30 vs. 3.55 +/- 0.10) (P < 0.05), and intima media thickness (0.53 +/- 0.09 vs. 0.40 +/- 0.07) (P < 0.001) after metformin treatment in comparison with baseline values. CONCLUSIONS: A 6-month course of metformin improves endothelial structure and function in young, normal-weight women with PCOS.

Area Under Curve↗

A randomized controlled trial evaluating metformin pre-treatment and co-administration in non-obese insulin-resistant women with polycystic ovary syndrome treated with controlled ovarian stimulation plus timed intercourse or intrauterine insemination.

BACKGROUND: There are few data in the literature regarding the utility of metfomin before and during gonadotrophin administration in women with polycystic ovary syndrome (PCOS). The aim of the present study was to assess the effect of the pre-treatment and co-administration of metformin in infertile PCOS women treated with controlled ovarian stimulation (COS) followed by timed intercourse (TI) or intrauterine insemination (IUI). METHODS: Seventy insulin-resistant primary infertile women with PCOS were randomized to receive metformin cloridrate (850 mg twice daily; group A) or placebo tablets (two tablets daily; group B) for 3 months. Three trials of COS using highly purified urinary FSH (hpFSH) plus TI/IUI were performed. Number of ampoules of gonadotrophin used, duration of the ovarian stimulation, cycle cancellation, ovulation, pregnancy, abortion, live birth, mono-ovulatory cycles, multiple pregnancies and ovarian hyperstimulation syndrome (OHSS) rates were assessed. RESULTS: No difference between groups was detected in ovulation, cycle cancellation, pregnancy, abortion, live birth, multiple pregnancies and OHSS rates. The mono-ovulatory cycle rates were significantly (P = 0.002) more frequent in group A than in group B, whereas the days of stimulation for non-cancelled cycles and the number of vials of gonadotrophins used were significantly (P < 0.001) higher in group A than in group B. CONCLUSION: In insulin-resistant women with PCOS, metformin pre-treatment and co-administration with hpFSH increases the mono-ovulatory cycles.

Adult↗

Efficacy of risedronate administration in osteoporotic postmenopausal women affected by inflammatory bowel disease.

Patients with inflammatory bowel disease (IBD) have frequently a bone mineral density (BMD) significantly lower than age-matched healthy subjects. The low BMD observed in IBD patients is related also to a higher incidence of bone fractures. In this prospective randomized study we evaluated the effect of 1-year risedronate administration on bone mass and turnover, and on vertebral fractures in osteoporotic postmenopausal women with IBD in remission. Ninety osteoporotic postmenopausal women were randomized to receive oral risedronate 35 mg/week (risedronate group) or placebo tablets (placebo group; one tab/week). The duration of treatment was 12 months. At entry and after treatment, lumbar spine and hip BMD, and serum osteocalcin (OC) and urinary deoxypyridinoline/creatinine ratio (DPD-Cr) levels were evaluated. Vertebral fractures were assessed from thoracic and lumbar lateral and anterior-posterior spinal radiographs taken at baseline, and from lateral spinal radiographs taken at the end of the study. At study entry, no difference between groups was also detected in BMD and in bone turnover markers. At the end of the study, lumbar spine, trochanter and femoral neck BMD was significantly ( p <0.05) higher in comparison with baseline in the risedronate group, whereas a significant ( p <0.05) decrease was observed in the placebo group. For the same visit, a significant ( p <0.05) difference in lumbar spine, trochanter and femoral neck BMD was detected between groups. After 12-month follow-up, serum OC and urinary DPD-Cr levels were significantly ( p <0.05) lower and higher in comparison with basal values in risedronate and placebo group, respectively. At the same time, a significant ( p <0.05) difference in serum OC and urinary DPD-Cr levels was observed between groups. Throughout the study, the incidence of vertebral fractures was significantly ( p <0.05) lower in the risedronate group than in the placebo group (12.5% vs 34.1%). The relative risk (RR) to develop a new vertebral fracture after 1 year of risedronate administration was of 0.36 (95% confidence interval, 0.14-0.85). In conclusion, risedronate administration is an effective anti-osteoporotic treatment in osteoporotic postmenopausal women with IBD in remission.

Bone Density↗

Prospective parallel randomized, double-blind, double-dummy controlled clinical trial comparing clomiphene citrate and metformin as the first-line treatment for ovulation induction in nonobese anovulatory women with polycystic ovary syndrome.

CONTEXT: Although metformin has been shown to be effective in the treatment of anovulation in women with polycystic ovary syndrome (PCOS), clomiphene citrate (CC) is still considered to be the first-line drug to induce ovulation in these patients. OBJECTIVE: The goal of this study was to compare the effectiveness of metformin and CC administration as a first-line treatment in anovulatory women with PCOS. DESIGN: We describe a prospective parallel randomized, double-blind, double-dummy controlled clinical trial. SETTING: The study was conducted at the University "Magna Graecia" of Catanzaro, Catanzaro, Italy. PATIENTS: One hundred nonobese primary infertile anovulatory women with PCOS participated. INTERVENTIONS: We administered metformin cloridrate (850 mg twice daily) plus placebo (group A) or placebo plus CC (150 mg for 5 d from the third day of a progesterone withdrawal bleeding) (group B) for 6 months each. MEAN OUTCOME MEASURES: The main outcome measures were ovulation, pregnancy, abortion, and live-birth rates. RESULTS: The subjects of groups A (n = 45) and B (n = 47) were studied for a total of 205 and 221 cycles, respectively. The ovulation rate was not statistically different between either treatment group (62.9 vs. 67.0%, P = 0.38), whereas the pregnancy rate was significantly higher in group A than group B (15.1 vs. 7.2%, P = 0.009). The difference found between groups A and B regarding the abortion rate was significant (9.7 vs. 37.5%, P = 0.045), whereas a positive trend was observed for the live-birth rate (83.9 vs. 56.3%, P = 0.07). The cumulative pregnancy rate was significantly higher in group A than group B (68.9 vs. 34.0%, P < 0.001). CONCLUSIONS: Six-month metformin administration is significantly more effective than six-cycle CC treatment in improving fertility in anovulatory nonobese PCOS women.

Adult↗

BsmI vitamin D receptor genotypes influence the efficacy of antiresorptive treatments in postmenopausal osteoporotic women. A 1-year multicenter, randomized and controlled trial.

Vitamin D receptor (VDR) gene polymorphisms could be considered one of the factors influencing the efficacy of the anti-osteoporotic treatments. In this multicenter, prospective, randomized and controlled trial we evaluated whether BsmI vitamin D receptor (VDR) genotypes influence the efficacy of antiresorptive treatment regimes (administered alone or in combination) in postmenopausal osteoporotic women. Using restriction endonuclease, we identified the BsmI VDR polymorphism in 1,100 postmenopausal women with osteoporosis. The women were randomized, taking account of genotype, into five treatment groups: (1) alendronate (Aln, 10 mg/day) plus raloxifene (Rlx, 60 mg/day); (2) Aln plus hormone replacement therapy (HRT, 0.625 mg/day conjugated equine estrogens plus 2.5 mg/day medroxyprogesterone acetate); (3) Aln alone; (4) HRT alone; and (5) Rlx alone. Lumbar-spine bone mineral density (BMD) and bone turnover markers were measured at study entry and after 1 year of treatment. Using the general linear model (GLM) repeated-measures procedure, the means of BMD and bone turnover markers significantly differed from baseline after a period of treatment. In particular, the mean change from baseline for BMD was -0.034 (95% confidence interval [CI]: -0.037 to -0.031, P <0.001); for serum osteocalcin (OC) it was 1.369 (95% CI: 1.289 to 1.448, P <0.001); and for urinary deoxypyridinoline (DPD) it was 1.322 (95% CI: 1.242 to 1.401, P <0.001), indicating a considerable variation before and after treatment of these indicators. In all three cases these effects appeared significantly influenced by treatments, genotypes, and the treatments*genotypes interaction term (P <0.001 each, except for the BMD and genotype effect with P =0.02), and not by the investigational centers involved in the study. In conclusion, in postmenopausal osteoporotic women, BsmI VDR genotypes influence the efficacy of antiresorptive drugs particularly when used in combination.

Administration, Oral↗

A prospective randomized comparison between laparoscopic and laparotomic approaches in women with early stage endometrial cancer: a focus on the quality of life.

OBJECTIVE: This study was undertaken to compare the quality of life (QoL) in women with early stage endometrial cancer treated with 2 different surgical approaches. STUDY DESIGN: Eighty-four women with clinical stage I endometrial cancer were enrolled in a prospective randomized controlled trial design and treated with laparoscopic or laparotomic approach. Another 40 women matched for demographic characteristics were studied as controls. In patients, before and after surgery, and in their matched controls, QoL was evaluated by using the Short-Form Healthy Survey (SF-36) and the climacteric symptoms using the Kupperman Index (KI). RESULTS: After randomization, no difference was detected in data recorded between the groups. At entry, QoL was similar in both treatment groups but significantly (P < .05) worse in comparison with controls. Throughout the study, QoL was significantly (P < .05) higher in laparoscopic group versus laparotomic group. After KI adjustment our data did not change. CONCLUSION: In early stage endometrial cancer, the laparoscopic approach provides significant benefits compared with laparotomy in terms of QoL.

Endometrial Neoplasms↗

Leuprolide acetate treatment with and without coadministration of tibolone in premenopausal women with menstrual cycle-related irritable bowel syndrome.

OBJECTIVE: To evaluate the effectiveness of gonadotropin-releasing hormone agonists (GnRH-a) with or without coadministration of tibolone in women with menstrual cycle-related irritable bowel syndrome (IBS). DESIGN: Prospective, randomized, placebo-controlled clinical trial. SETTING: Universities of Catanzaro and Naples. PATIENT(S): One hundred twenty young premenopausal women with menstrual cycle-related IBS (Rome II criteria). INTERVENTION(S): Administration of leuprolide acetate depot (LAD, 11.25 mg IM/3 months) plus tibolone (group A), LAD plus placebo tablets (group B), and injection of a placebo solution plus placebo tablets (group C). MAIN OUTCOME MEASURE(S): Severity of bowel symptoms or signs of IBS and quality of life (QoL), at baseline and after 6 months of treatment. RESULT(S): In all groups, the mean scores for each symptom or sign of IBS and for QoL were significantly improved after treatment. A significant difference was observed between group C and groups A and B. No difference between these last groups was detected in symptoms or signs of IBS. The QoL scores were significantly higher in group A than in group B. CONCLUSION(S): Gondotropin-releasing hormone agonist administration is effective in women with menstrual cycle-related IBS. The addition of tibolone does not reduce effectiveness compared with agonist alone and increases QoL.

Adult↗

Antiproliferative and proapoptotic effects of raloxifene on uterine leiomyomas in postmenopausal women.

OBJECTIVE: To study the cell effects of raloxifene on uterine and leiomyoma tissue in postmenopausal women. DESIGN: Prospective, randomized, double-blind, placebo-controlled study. SETTING: Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro, Italy. PATIENT(S): Forty postmenopausal women affected by uterine leiomyomas and selected for hysterectomy. INTERVENTION(S): Treatment for three cycles of 28 days with raloxifene at a dose of 180 mg/day orally (raloxifene group) or placebo tablets (3 tablets/day orally) (placebo group). MAIN OUTCOME MEASURE(S): Uterine and leiomyoma dimensions were measured in each subject at entry and before surgery. On leiomyomas and homologous myometrium the proliferating cell nuclear antigen (PCNA)-positive cells/total cells (PCNA/TC) and the Bcl-2-positive cells/Bax-positive cells (Bcl-2/Bax) ratios (%), as proliferation and apoptotic indexes, respectively, were measured. RESULT(S): After treatment, uterine and leiomyoma sizes were significantly changed in comparison with baseline and the placebo group. PCNA/TC and Bcl-2/Bax ratios were significantly higher in leiomyomas than in homologous myometrium. A significant difference was detected in PCNA/TC between the myometrium of the raloxifene and control groups, whereas no difference was observed in the Bcl-2/Bax ratio. A significant difference in PCNA/TC and Bcl-2/Bax ratios was detected in leiomyoma tissue between the raloxifene group and controls. CONCLUSION(S): In postmenopausal women, raloxifene administration reduces uterine leiomyomas by exerting a cell antiproliferative and proapoptotic action.

Apoptosis↗