Effectiveness of the Association N-Palmitoylethanolamine and Transpolydatin in the Treatment of Primary Dysmenorrhea.

STUDY OBJECTIVE: To evaluate the effectiveness and safety of the combination of N-palmitoylethanolamine (PEA) and transpolydatin vs placebo in the treatment of primary dysmenorrhea in adolescents and young women. DESIGN, SETTING, AND PARTICIPANTS: Randomized treatment and follow-up of 220 cases of primary dysmenorrhea in the Department of Medicine and Health Sciences, Institute of Gynecology and Obstetrics, University of Molise, Italy. METHODS: Between February 2013 and February 2014, we treated 220 young women aged 16 to 24 years who had primary dysmenorrhea: 110 patients were treated with the oral combination of PEA-transpolydatin: 400 mg + 40 mg (1 tablet a day for 10 days from the 24th day of cycle) and 110 patients with placebo (1 tablet a day for 10 days from the 24th day of cycle). A follow-up was performed after treatment, and all girls were seen at this time. A 10-point visual analog scale was used to measure the improvement of pelvic pain. For categorical variables, the χ(2) test and analysis of variance were performed to value the significance of differences between groups. A value of P < .05 was considered statistically significant. RESULTS: An improvement of pelvic pain was seen in 98.18% (95% confidence interval 97.64% to 98.60%) of cases in group 1 vs 56.36% (95% confidence interval 48.62% to 63.81%) in group 2 (P < .001). The combination of PEA and transpolydatin was more effective than placebo (P < .001). CONCLUSION: The combination of PEA and transpolydatin shows promise as a valid adjuvant therapy in the medical treatment of primary dysmenorrhea in adolescents and young women.

A randomized controlled trial comparing three single-incision minislings for stress urinary incontinence.

INTRODUCTION AND HYPOTHESIS: Studies have observed a significant heterogeneity in efficacy data for single-incision minislings (SIMS) as surgical treatment for female urinary incontinence (UI). Our study aim was to test the hypothesis that different vaginal kits for SIMS have different long-term outcomes. METHODS: One hundred and twenty women with stress (SUI) or mixed (MUI) UI were enrolled in a multicenter randomized clinical trial (registration number NCT00751088) and treated with three different SIMS (Ajust, MiniArc, or TVT Secur System). Duration of follow-up was at least 24 months from surgery. The primary outcome was the subjective cure rate at 24 months from surgery; secondary outcomes were rates of total failure and reoperations for UI. RESULTS: At study end, no difference was detected between groups in terms of total subjective cure rate [21 (52.5%) vs. 26 (65.0%) vs. 21 (52.5%), in Ajust, MiniArc, and TVT Secur System group, respectively; P = 0.412] or in terms of total failure rate [24 (60.0%) vs. 22 (55.0 %) vs. 27 (67.5 %), in Ajust, MiniArc, and TVT Secur System group, respectively; P = 0.432]. The proportion of patients who received a second surgery for UI was also not significantly different between groups [13 (32.5%) vs. 10 (25.0%) vs. 13 (32.5%), in Ajust, MiniArc, and TVT Secur System, respectively; P = 0.831]. CONCLUSION: The long-term efficacy of SIMS does not differ between the vaginal kits examined.

Single-incision mini-slings versus retropubic tension-free vaginal tapes: a multicenter clinical trial.

STUDY OBJECTIVE: To compare single-incision mini-slings (SIMSs) and retropubic tension-free vaginal tape (r-TVT) in terms of the long-term efficacy and safety for the treatment of female stress (SUI) or mixed urinary incontinence (MUI). DESIGN: Prospective multicenter cohort trial (registration number NCT00751088) (Canadian Task Force II). SETTINGS: Department of Obstetrics and Gynecology, Italy. PATIENTS: Two hundred-forty women with SUI/MUI. INTERVENTIONS: SIMS or r-TVT. MEASUREMENTS AND MAIN RESULTS: The operative time and the use of analgesic tablets were significantly (p < .001) higher and lower, respectively, in the r-TVT group versus the SIMS group. After 24 months of follow-up, no difference between the study arms was observed in terms of the complication rate (30/120 [25%] vs 19/120 [15.8%] for the r-TVT and SIMS arms, respectively; relative risk = 1.58; 95% confidence interval, 0.94-2.65; p = .083), whereas the subjective cure rate was significantly lower in the SIMS arm than in the r-TVT arm (57/103 [55.3%] vs 89/106 [84.0%] for the r-TVT and SIMS arms, respectively; relative risk = 0.66; 95% confidence interval, 0.54-0.80]; p < .001). The proportion of retreated patients for SUI/MUI was significantly higher in the SIMS arm than in the r-TVT arm (37/103 [34.9%] vs 12/106 [11.3%] for SIMS and r-TVT arm, respectively; p < .001). CONCLUSION: SIMS has no advantage in terms of safety over r-TVT and was found to be less effective than r-TVT. Thus, its use in the clinical practice should be questioned.

Vulvo-vaginitis in prepubertal girls: new ways of administering old drugs.

STUDY OBJECTIVE: To evaluate the effectiveness and safety of local vs systemic antibiotic treatment in the management of recurrent vulvovaginitis in children. DESIGN: Randomized treatment and follow-up of 90 cases of persistent vulvovaginitis. SETTING: The Department of Medicine and Health Sciences, Institute of Gynecology and Obstetrics, University of Molise, Italy. METHODS: Between January 2009 and December 2012, 90 prepubertal girls (Tanner Stage I) aged 6-12 years, with recurrent discharge not responding to common hygienic measures and not suspected of being sexually abused, were treated, 45 patients with oral antibiotic treatment (group 1) and 45 patients with a local antibiotic treatment (group 2). Vaginal cultures were prepared before treatment and follow-ups were made after 3 months. RESULTS: Bacterial pathogens were isolated in vaginal secretions of 84/90 (93%) girls. There were 6 girls receiving antibiotic treatment who had persistent discharge and repetitive isolations of Escherichia coli. Administration type was selected at random. Symptoms and signs were resolved in all girls, but we observed 1 recurrence (2.22%) in group 2 vs 6 recurrences (13.33%) in group 1 (P = .049). In group 1 we observed 3 cases (6.67%) of gastro-intestinal side effects vs no cases in group 2 (P = .079). CONCLUSION: Topical medication based on netilmicin, associated with Benzalkonium-Chloride, showed a clinical and microbiological effectiveness in first-line treatment of bacterial vulvovaginitis in children, comparable to conventional drugs; so local treatment may be a good alternative to systemic treatment decreasing the use of oral antibiotics in young people and related risks of bacterial resistances.

A randomized controlled trial comparing three vaginal kits of single-incision mini-slings for stress urinary incontinence: surgical data.

OBJECTIVE: Single-incision mini-slings (SIMS) are new minimally invasive devices used for female stress urinary incontinence (SUI). To date, several SIMS are available, but few and uncontrolled comparative data have assessed their safety and feasibility. The aim of the present clinical study was to compare three different SIMS in an ambulatory setting. STUDY DESIGN: One hundred and twenty patients with SUI were randomized to receive three SIMS: Ajust, MiniArc, and TVT Secur System. Surgical data were compared. RESULTS: Significantly (P<0.05) lower surgical difficulty and higher patient satisfaction were detected in the MiniArc group when compared to the Ajust and TVT Secur System groups. A significantly (P<0.05) higher feasibility under local anesthesia and in ambulatory setting was also detected for the MiniArc group. The overall complication rate was significantly (P<0.05) lower in the MiniArc group than in the TVT Secur System group. CONCLUSIONS: MiniArc is simpler to insert under local anesthesia and in an ambulatory setting. It is safer than the TVT Secur System, and is related to higher patient satisfaction.

Metformin reduces risk of ovarian hyperstimulation syndrome in patients with polycystic ovary syndrome during gonadotropin-stimulated in vitro fertilization cycles: a randomized, controlled trial.

OBJECTIVE: To test whether metformin administration reduces the incidence of ovarian hyperstimulation syndrome (OHSS) in infertile high-risk patients with polycystic ovary syndrome (PCOS) who have been treated with gonadotropins for IVF. DESIGN: Parallel, randomized, double-blind, placebo-controlled clinical trial. SETTING: Academic departments, general hospital, and IVF centers. PATIENT(S): One hundred twenty patients with PCOS at high risk for OHSS. INTERVENTION(S): Gonadotropins ovarian stimulation for IVF and metformin (500 mg three times daily) or placebo tablets (three times daily). MAIN OUTCOME MEASURE(S): The primary end point of the current clinical trial was the rate of OHSS. Anthropometric and reproductive data were evaluated. RESULT(S): The total OHSS and cancellation rates were significantly reduced in patients treated with metformin. The relative risk for OHSS was of 0.28 (95% confidence interval, 0.11-0.67). With metformin the stimulation length and the total amount of gonadotropins used were significantly increased, whereas the peak E(2) levels were significantly reduced. CONCLUSION(S): In patients with PCOS who are at high risk for OHSS and who have been stimulated with gonadotropins for IVF cycles, metformin reduces the risk of OHSS by modulating the ovarian response to the stimulation. REGISTRATION ID NUMBER FROM CLINICALTRIALS.GOV: NCT01233206.

Trisomy 1q42-qter associated with monosomy 6q27-qter: a case report.

PURPOSE: Partial trisomy 1q42-qter is a rare chromosomal aberration. Most cases arise from de novo unbalanced translocations or from unbalanced inheritance of parental balanced rearrangements. METHODS: Descriptive case report. RESULTS: A 4-year-old boy had shown an increased neck translucency at the fetal ultrasound examination performed at the 11th week of gestation. Amniocentesis, performed at the 18th week of gestation, did not demonstrate any genetic abnormality. A second fetal ultrasound examination, carried out at the 35th week of gestation, showed congenital clubfeet and hydrocephalus. At birth, clinical examination revealed congenital bilateral ventriculomegaly, bilateral congenital equinovarus clubfeet, low-set ears, plagiocephaly, micrognathia, hypertelorism, prominent forehead, broad nasal bridge, hypertonic syndrome, and inguinal hernia. Ophthalmologic consultation showed the presence of optic pit in his left eye. Genetic counseling was performed. Chromosome analysis demonstrated a partial trisomy 1q42.2-qter associated with a partial monosomy 6q27-qter. Moreover, deletions of the distal region on the long arm of chromosome 6 are frequently associated with both ocular abnormalities and several solid tumor types. Moderate mental and psychomotor retardation has occurred. CONCLUSIONS: This case emphasizes the importance of scheduling a screening test for eye diseases and tumor in these patients.

Laparoscopic surgery vs laparotomy for early stage endometrial cancer: long-term data of a randomized controlled trial.

OBJECTIVE: The purpose of the study was to compare the long-term safety and efficacy of laparoscopic surgery and laparotomy approaches to early stage endometrial cancer. STUDY DESIGN: This was a prospective long-term extension study of a randomized controlled study that included 84 patients with clinical stage I endometrial cancer (laparoscopic surgery group, 40 women; laparotomy group, 38 women). Safety and efficacy data were evaluated and analyzed by the intention-to-treat principle. RESULTS: After a follow-up period of 78 months (interquartile range, 7; range, 19-84 months) and 79 months (interquartile range, 6; range, 22-84 months) for laparoscopic surgery and laparotomy groups, respectively, no difference in the cumulative recurrence rates (8/40 [20.0%] and 7/38 [18.4%]; P = .860) and deaths (7/40 [17.5%] and 6/38 [15.8%] patients; P = .839) was detected between groups. No significant differences in overall (P = .535) and disease-free (P = .512) survival were observed. CONCLUSION: The laparoscopic surgery approach to early stage endometrial cancer is as safe and effective a procedure as the laparotomy approach.

Effectiveness of risedronate in osteoporotic postmenopausal women with inflammatory bowel disease: a prospective, parallel, open-label, two-year extension study.

OBJECTIVE: To evaluate long-term efficacy of risedronate in osteoporotic postmenopausal patients with inflammatory bowel disease (IBD). DESIGN: A prospective, parallel, open-label, 2-year extension study of a randomized, double-blind, 1-year clinical trial. Eighty-one osteoporotic postmenopausal women with IBD were treated with risedronate (n = 40) or placebo (n = 41). Bone mineral density (BMD), biochemical bone turnover markers, and vertebral and nonvertebral fractures were assessed throughout the study. Data were analyzed using the intent-to-treat principle. RESULTS: Significant (P < 0.05) differences were observed between risedronate and placebo groups at 1-, 2-, and 3-year follow-up visits in bone turnover markers and in lumbar spine, trochanter, and femoral neck BMD. In participants treated with risedronate, the percentage of changes from baseline in bone turnover markers and in lumbar spine, trochanter, and femoral neck BMD were significantly (P < 0.05) higher at 2- and 3-year follow-up in comparison with baseline and 1-year follow-up, with a significant (P < 0.05) difference between the 2- and 3-year follow-up visits. At the end of the study, the cumulative risk of vertebral and nonvertebral fractures was significantly (P < 0.05) lower in the risedronate group than in the placebo group. The relative risk for new vertebral fractures was 0.456 (95% CI: 0.134-1.559, P = 0.211) and 0.296 (95% CI: 0.121-0.721, P = 0.007) and was 0.209 (95% CI: 0.023-1.867, P = 0.161) and 0.137 (95% CI: 0.030-0.620, P = 0.010), respectively, for new nonvertebral fractures after 2 and 3 years of risedronate treatment. CONCLUSIONS: In postmenopausal osteoporotic women with IBD, long-term treatment with risedronate is effective in increasing BMD and reducing vertebral and nonvertebral fracture risk.

Presurgical assessment of intraabdominal visceral fat in obese patients with early-stage endometrial cancer treated with laparoscopic approach: relationships with early laparotomic conversions.

STUDY OBJECTIVE: To evaluate the relationship between intraabdominal visceral fat (IVF) and early conversion from laparoscopy to laparotomy in obese patients. DESIGN: Prospective study (Canadian Task Force classification II-2). SETTING: Department of obstetrics and gynecology, University "Magna Graecia" of Catanzaro. PATIENTS: One hundred fifty-one obese patients with endometrial cancer and laparoscopic surgery. INTERVENTIONS: Laparoscopic treatment for early-stage endometrial cancer. MEASUREMENT AND MAIN RESULTS: In all patients, demographic, anthropometric (including body mass index, waist-to-hip ratio, and waist circumference), and IVF assessments (using ultrasonography [IVF-USG, cm] and computed tomography [IVF-CT, cm(2)]), were evaluated. In 122 patients (122/151, 80.8%), the laparoscopies were successfully completed (group A), whereas 29 patients (29/151, 19.2%) had a laparotomic conversion. Specifically, in 19 (19/29, 65.5%) and in 10 patients (10/29, 34.5%) the conversion was early (group B1) and late (group B2), respectively. A significant (p <.05) difference in surgical stage IC and in postoperative complications rate was detected between group A and groups B1 and B2, without difference between these 2 last groups. IVF-USG and IVF-CT were significantly (p <.01) higher in group B1 in comparison with groups A and B2, without difference between these 2 last groups. A strong and significant (p <.001) association between IVF-USG and IVF-CT was detected in all groups by Spearman bivariate correlation (r = 0.78, 0.918, and 0.978 for group A, B1, and B2, respectively). Multivariate analysis showed the IVF-CT as the main predictor for early laparotomic conversion (OR 2.184; 95% CI 1.227-3.886). CONCLUSIONS: Intraabdominal visceral fat is a predictor for early laparotomic conversion in obese patients with endometrial cancer. Further studies are necessary to assess the efficacy of the IVF evaluation for reducing the laparotomic conversion risk in obese women undergoing laparoscopic surgery for gynecologic malignancy.

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.

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.

Laparoscopic colposuspension using sutures or prolene meshes: a 3-year follow-up.

OBJECTIVE(S): To compare the long-term effectiveness of two different laparoscopic colposuspension procedures. STUDY DESIGN: Sixty women affected by genuine stress incontinence (GSI) were enrolled in a prospective randomized controlled trial (RCT) and treated by transperitoneal laparoscopic colposuspension using nonabsorbable sutures (group A) or prolene mesh fixed with tackers or staplers (group B). In each group the subjective and objective failure rates were evaluated at 12, 24, and 36 months after surgery. For the subjective evaluation patients were asked whether they had experienced urine leakage and any urine loss they reported was recorded on a visual analogue scale (VAS). The objective evaluation was performed by means of a clinical examination and multichannel urodynamic studies. The data were analyzed by the intention-to-treat method. RESULTS: The subjective failure rate was significantly (P < 0.05) lower in group A than in group B at 12 months (3.3% versus 13.3%, respectively), 24 months (20.0% versus 36.7%, respectively), and 36 months (33.3% versus 53.3%, respectively) after surgery. The objective failure rate also differed significantly (P < 0.05) between the two groups after 12 (10.7% versus 25.0% for group A and group B, respectively), 24 (29.6% versus 57.7%, respectively), and 36 (42.3% versus 61.5%, respectively) months of follow-up. CONCLUSION(S): Laparoscopic colposuspension performed with sutures is more effective than laparoscopic colposuspension accomplished with the use of prolene meshes in the long term, and the use of prolene meshes should be avoided in treatment of GSI.

Long-term effectiveness and safety of GnRH agonist plus raloxifene administration in women with uterine leiomyomas.

BACKGROUND: Our aim was to evaluate the long-term effectiveness and safety of GnRH agonist plus raloxifene administration in women with symptomatic uterine leiomyomas. METHODS: Fifty pre-menopausal women with uterine leiomyomas were treated with leuprolide acetate depot at dose of 3.75 mg/28 days and raloxifene hydrochloride at 60 mg/day for 18 cycles. At admission and after each six cycles of treatment, bone mineral density (BMD), uterine, leiomyoma and non-leiomyoma dimensions, serum bone metabolism markers, lipid, glucose and insulin levels were evaluated. Leiomyoma-related and climacteric-like symptoms were assessed using a daily diary. RESULTS: Throughout the study, no significant change in BMD or in any bone metabolism markers was observed. A significant decrease in uterine, leiomyoma and non-leiomyoma sizes was detected in comparison with baseline already after 6 months. No other significant change was observed at the successive follow-up visits. No significant change in lipid and glucose profile was detected throughout the study. The treatments were well tolerated. All treatment withdrawals (16%, eight out of 50) were due to lack of compliance, and none to drug-related adverse experiences. CONCLUSION: GnRH agonist plus raloxifene administration is an effective and safe treatment for pre-menopausal women with uterine leiomyomas.

Long-term effectiveness of presacral neurectomy for the treatment of severe dysmenorrhea due to endometriosis.

STUDY OBJECTIVE: To assess the long-term effectiveness of presacral neurectomy (PSN) in women with severe dysmenorrhea due to endometriosis treated with conservative laparoscopic surgical intervention. DESIGN: Randomized, controlled trial (Canadian Task Force classification I). SETTING: University-affiliated department of obstetrics and gynecology. PATIENTS: One hundred forty-one sexually active women of reproductive age. INTERVENTION: Conservative laparoscopic surgery without (group A) or with (group B) PSN. MEASUREMENTS AND MAIN RESULTS: At entry and 24-months after surgical procedures, cure rates; frequency and severity of dysmenorrhea, dyspareunia, and chronic pelvic pain; and quality of life were evaluated. At follow-up visit, the cure rate was significantly (P<0.05) higher in group B (83.3%) than in group A (53.3%). The frequency and severity of dysmenorrhea, dyspareunia, and chronic pelvic pain were significantly (P<0.05) lower in both groups compared with baseline values, and only severity was significantly (P<0.05) lower in group B. A significant (P<0.05) improvement in quality of life was observed after surgery in both groups and was significantly (P<0.05) increased in group B compared with group A. CONCLUSION: PSN improves long-term cure rates and quality of life in women treated with conservative laparoscopic surgery for severe dysmenorrhea due to endometriosis.

Lipid, glucose and homocysteine metabolism in women treated with a GnRH agonist with or without raloxifene.

BACKGROUND: Although GnRH analogues are widely used to treat a variety of sex hormone-related diseases, little is known about their effect on metabolism. Therefore, we have evaluated the effect of a GnRH analogue, administered with or without raloxifene, on serum levels of lipoproteins, glucose, insulin and homocysteine (Hcy). METHODS: One hundred premenopausal women with symptomatic uterine leiomyomas were initially enrolled and randomized to receive 3.75 mg/28 days leuprolide acetate depot associated with 60 mg/day raloxifene hydrochloride (group A) or 1 placebo tablet/day (group B) for six cycles of 28 days. At entry and at cycle 6, subjects underwent anthropometric measurements, including body mass index and waist-to-hip ratio measurements, and blood chemistry assays for serum total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG), glucose, insulin, Hcy, vitamin B(12) and folate concentrations. Insulin resistance was evaluated with the homeostasis model assessment (HOMA) score. RESULTS: Baseline parameters were similar in the two groups. At cycle 6, TC, HDL-C, LDL-C and TG levels were significantly increased (P < 0.05) in group B. In group A, LDL-C levels were unchanged, and TC, HDL-C and TG levels were increased (P < 0.05). Serum TC and LDL-C levels differed (P < 0.05) between the groups. Glucose levels were unchanged between and within groups, whereas insulin levels and HOMA scores increased (P < 0.05) versus baseline in group B. Post-treatment Hcy levels were higher (P < 0.05) versus baseline in group B; they were unchanged in group A. Serum vitamin B(12) and folate concentrations were unchanged in both groups. CONCLUSIONS: GnRH analogues alter serum lipoprotein and Hcy levels and increase insulin resistance. These acute metabolic changes may be prevented or reduced by raloxifene.

Effect of tibolone on breast symptoms resulting from postmenopausal hormone replacement therapy.

OBJECTIVE: To evaluate the incidence of breast symptoms in a population treated with various hormone replacement therapy (HRT) regimens and to detect the variations in breast symptomatology after HRT changing to tibolone administration. METHODS: This prospective placebo-controlled clinical trial was conducted on healthy women on HRT reporting breast symptoms. A questionnaire was given to each woman to detect breast symptomatology. Breast tenderness and mastalgia were evaluated using a visual analogue scale (VAS). According to the choice of the each woman with breast symptoms, the HRT was changed to tibolone (2.5 mg/day per os) or to calcium carbonate (1 tab/day, placebo group). The duration of treatment was of 12 months. After 6 and 12 months breast symptomatology was re-evaluated. RESULTS: Among the 600 screened women, 64 (10.7%) were suffering from breast symptomatology. After 6 and 12 months of treatment with tibolone or placebo, mean VAS score for breast tenderness and for mastalgia resulted significantly (P<0.05) decreased, without differences between groups, in comparison with basal value. Only one woman had no improvement from the breast symptoms with tibolone administration. CONCLUSIONS: Shifting from classical HRT to tibolone is followed by a significant reduction of breast symptomatology in postmenopausal women with breast complaints similar to that obtained with treatment withdrawal.

Effectiveness of presacral neurectomy in women with severe dysmenorrhea caused by endometriosis who were treated with laparoscopic conservative surgery: a 1-year prospective randomized double-blind controlled trial.

OBJECTIVE: The purpose of this study was to assess the effectiveness of presacral neurectomy in women with severe dysmenorrhea caused by endometriosis that was treated with conservative surgical intervention. STUDY DESIGN: One hundred forty-one sexually active women of fertile age with chronic severe dysmenorrhea caused by endometriosis were treated with conservative laparoscopic surgery. Patients were assigned randomly to not receive (group A) or receive (group B) presacral neurectomy. At 6 and 12 months after the surgical procedures, the cure rate was evaluated in each patient. The frequency and severity of dysmenorrhea, dyspareunia, and chronic pelvic pain were also evaluated at the same time intervals. RESULTS: The cure rate was significantly higher in group B compared with group A at a follow-up examination at 6 months (87.3% vs 60.3%) and 12 months (85.7% vs 57.1%). At follow-up visits, the frequency and severity of dysmenorrhea, dyspareunia, and chronic pelvic pain were significantly lower in both groups compared with baseline values; in particular, significantly lower values were observed in group B versus group A for the severity. CONCLUSION: Presacral neurectomy improves the cure rate in women who are treated with conservative laparoscopic surgery for severe dysmenorrhea caused by endometriosis.