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Biomedical subjects

S Palomba

Publications and source records attributed to S Palomba.

At least 37 records · Page 2Linked to original sources

Effectiveness of short-term administration of tibolone plus gonadotropin-releasing hormone analogue on the surgical outcome of laparoscopic myomectomy.

OBJECTIVE: To evaluate whether administration of tibolone changes the effectiveness of GnRH analogue administered before laparoscopic myomectomy. DESIGN: Prospective, randomized, open, placebo-controlled clinical trial. SETTING: Department of Gynecology and Obstetrics, University of Naples Federico II, Naples, Italy. PATIENT(S): 66 women with symptomatic uterine leiomyomas. INTERVENTION(S): Treatment for 2 months with leuprolide acetate and iron tablets, plus tibolone (group A) or placebo tablets (group B); or with leuprolide acetate and iron tablets (group C). MAIN OUTCOME MEASURE(S): Laparoscopic myomectomy at the end of treatment. Operative time and blood loss during surgery were recorded. Uterine volume, volume and number of uterine leiomyomas, volume and echogenicity of the largest uterine leiomyomas, hematologic data, and myoma-related symptoms were evaluated at baseline and 1 week before and after surgery. RESULT(S): Uterine and leiomyomata volume and myoma-related symptoms were significantly reduced and hematologic variables improved significantly in groups A and B, compared with baseline values and with group C. Operative time and blood loss were significantly less in groups A and B than in group C. After surgery, hematologic variables were significantly worse in group C compared with groups A and B. During the study no significant difference was detected between groups A and B. CONCLUSIONS: Administration of tibolone administration in patients treated with GnRH analogue before laparoscopic myomectomy does not change the effectiveness of the analogue administered alone.

Adult↗

Use of leuprolide acetate plus tibolone in the treatment of severe premenstrual syndrome.

OBJECTIVE: To evaluate the effectiveness of GnRH agonist (GnRH-a) plus tibolone in the treatment of severe premenstrual syndrome (PMS). DESIGN: Prospective, double-blind, placebo-controlled clinical trial. SETTING: Department of Obstetrics and Gynecology, University of Naples Federico II, Naples, Italy. PATIENT(S); Thirty patients affected by severe PMS, aged 23-29 years (mean age +/- SD, 25.3 +/- 2.9 years). INTERVENTION(S): Treatment for two cycles with leuprolide acetate depot (3.75 mg IM for 28 days) in association with tibolone (2.5 mg/d orally) or placebo (1 tablet per day orally). MAIN OUTCOME MEASURE(S): The mean severity of each symptom and sign of PMS was evaluated using a visual analog scale during the last 7 days of each treatment cycle in comparison with the last 7 days of the cycle before treatment. RESULT(S): Mean scores for each of the adverse psychological/physical and positive psychological symptoms were significantly improved during treatment. No statistically significant difference was detected between patients treated with tibolone and placebo. A significantly lower number of hot flushes per day was observed in groups treated with GnRH-a and tibolone in comparison with GnRH-a and placebo. CONCLUSION(S): Tibolone administered in association with GnRH-a does not reduce the therapeutic effect of GnRH-a in women affected by PMS. Tibolone used in association with GnRH-a may provide long-term medical treatment for women with PMS.

Adult↗

Effects of raloxifene treatment on uterine leiomyomas in postmenopausal women.

OBJECTIVE: To evaluate the effects of raloxifene administration on uterine and uterine leiomyoma sizes in postmenopausal women. DESIGN: Prospective randomized, double-blind, placebo-controlled clinical trial. SETTING: Department of Gynecology, Obstetrics, and Pathophysiology of Human Reproduction, University of Naples "Federico II", Italy. PATIENT(S): Seventy spontaneous postmenopausal women affected by uterine leiomyomas. INTERVENTION(S): Twelve cycles (of 28 days each) of treatment with raloxifene (60 mg daily per os) or placebo. MAIN OUTCOME MEASURE(S): At entry and at every 3 cycles, uterine and uterine leiomyoma dimensions were measured by means of transvaginal ultrasound. The difference between uterine and leiomyoma volumes (Delta size) was calculated in all subjects. The characteristics of uterine bleeding and the side effects of the treatments were assessed using a daily diary. RESULT(S): After 6, 9, and 12 cycles of therapy, in subjects treated with raloxifene, the mean uterine and uterine leiomyoma size were significantly decreased, and the mean Delta size significantly increased in comparison with basal values and the placebo group. No significant differences in uterine bleeding were detected between the two groups. CONCLUSION(S): In postmenopausal women raloxifene appears to act selectively on uterine leiomyomas, reducing their size.

Double-Blind Method↗

Laparoscopic Burch colposuspension: a randomized controlled trial comparing two transperitoneal surgical techniques.

OBJECTIVE: To compare the effectiveness of two transperitoneal laparoscopic Burch procedures. METHODS: The sample size required was 30 subjects per group to detect a statistically significant estimated difference of 15% between two surgical procedures with an alpha = 0.05 and a power of 0.7. Sixty women affected by genuine stress incontinence (GSI) were enrolled and randomly assigned to two groups of 30 women each. All women were treated with the transperitoneal laparoscopic Burch procedure using nonabsorbable sutures (group A) or Prolene mesh (Ethicon, Somerville, NJ) fixed with tacks or staples (group B). The failure rate was defined subjectively and objectively. The subjective evaluation was performed by asking the women to rate their urine loss on a visual analog scale. The objective evaluation was a clinical evaluation using multichannel urodynamic studies. RESULTS: The subjective failure rate was not significantly different between the two groups at 3 months (0% for both groups), 6 months (3.7% versus 3.8% for groups A and B, respectively), and 12 months (7.4% versus 15.4% for groups A and B, respectively) after surgery. At 3 months (3.7% versus 3.8% for groups A and B, respectively) and 6 months (7.4% versus 15.4% for groups A and B, respectively) follow-up, the objective failure rate was not significantly different between the two groups. However, at 12 months after the surgical procedure, the objective failure rate was significantly lower in group A than in group B (11.1% versus 26.9%, respectively; P <.05). CONCLUSION: Transperitoneal laparoscopic Burch colposuspension performed using sutures was more effective than the mesh technique.

Colposcopy↗

Transdermal hormone replacement therapy in postmenopausal women with uterine leiomyomas.

OBJECTIVE: To evaluate the effects of transdermal hormone replacement therapy (HRT) on uterine and leiomyoma size and on uterine bleeding patterns in postmenopausal women with uterine leiomyomas. METHODS: The required sample size was calculated to be 30 subjects per group to detect an effect on the size of one standard deviation (SD) with an alpha value of 0.05 (two-sided) and a power 1 - delta = 0.8. At the end of the study, the power analysis showed a value of beta = 0.826. Seventy postmenopausal women with uterine leiomyomas were enrolled and treated for 12 cycles of 28 days each with transdermal 17 beta-estradiol (E(2)) patches plus oral medroxyprogesterone acetate continuously added (group A) or with calcium carbonate (group B). At entry and every three cycles, uterine and leiomyoma dimensions were measured by transvaginal ultrasonography. To evaluate the effect of transdermal HRT on the characteristics of uterine bleeding, 35 healthy postmenopausal women without uterine leiomyomas (group C) were enrolled and treated with the same regimen as group A. A daily diary was used to record the abnormal uterine bleeding episodes, and a rank scale was used to assess the severity of bleeding. RESULTS: There were no significant changes in mean uterine or leiomyoma size between groups A and B, or in each group compared with basal values. No significant difference was detected between groups A and C in uterine bleeding patterns. CONCLUSION: Transdermal HRT did not increase the size of uterine leiomyomas or affect uterine bleeding patterns in postmenopausal women.

Administration, Cutaneous↗

Conscious sedation versus general anaesthesia for minilaparoscopic gamete intra-Fallopian transfer: a prospective randomized study.

BACKGROUND: Gamete intra-Fallopian transfer (GIFT) is a successful technique for infertile women, and is performed almost exclusively by laparoscopy under general anaesthesia. METHODS: We performed a prospective randomized study of 67 infertile patients to assess the efficacy of minilaparoscopic GIFT under conscious sedation/local anaesthesia (group A) compared with general anaesthesia (group B). Operative and discharge times and pregnancy outcome were evaluated in both groups. RESULTS: Operative time was similar in both groups. The rate of patients discharged 2 h after surgery was significantly higher in group A. The necessity for postoperative analgesics was significantly higher in group B. No significant differences were noted between the two study groups in terms of pregnancy outcome. CONCLUSIONS: Conscious sedation and local anaesthesia will allow us to perform an outpatient minilaparoscopic GIFT without the need for general anaesthesia. The simplicity of the method, and the quicker discharge time in comparison with general anaesthesia, offer a detectable benefit for patients.

Adult↗

Growth hormone secretion after baclofen administration in different phases of the menstrual cycle in healthy women.

AIM: The aim of this study was to investigate the effect of baclofen administration on growth hormone (GH) secretion during different phases of the menstrual cycle. METHODS: Twelve healthy women (33.6 +/- (SD) 2.8 years; range 23-40 years) with regular menstrual cycles were enrolled. The phases of the menstrual cycle were determined using transvaginal ultrasonography (TV-US) and detecting hormonal serum levels. Plasma GH levels were evaluated during the early follicular, periovulatory and luteal phases of the cycle before and after the baclofen challenge test. RESULTS: After acute baclofen administration, GH levels increased significantly (p < 0.001) compared to basal values during the periovulatory and luteal phases, while no significant variation was detected during the early follicular phase. In addition, plasma GH levels resulted significantly (p < 0.001) higher during the luteal phase than during the periovulatory phase. CONCLUSION: Acute baclofen administration induces a significant increase in plasma GH levels in healthy females during the periovulatory and luteal phases, but not during the early follicular phase. These data suggest a modulator role of plasma sex steroids levels on GH release induced by baclofen.

Administration, Oral↗

[Effect of estriol treatment per vaginam before Burch culposuspension].

BACKGROUND: To assess the effect of estriol treatment per vaginam before Burch culposuspension in postmenopausal women with stress urinary incontinence (IUS). METHODS DESIGN: prospective randomised study. SETTING: Department of Gynaecology, Obstetrics and Physiopathology of Human Reproduction-Medical School-University of Naples Federico II . PATIENTS: twenty women in postmenopause at least from five years with a urogenital symptomatology due to IUS. INTERVENTIONS: women were randomised into one of two groups (treated or control) and they were submitted to an evaluation of vulva and vagina trophism. All the women were submitted to a urodynamic examination and to a transvaginal ultrasonography with evaluation of pubis-bladder neck distance, bladder and proximal urethra position, before treatment, one week before the operation and after six months from the same operation. EVALUATIONS: subjective symptomatology and urodynamic parameters between treated and control groups before and after operation. RESULTS: After 12 weeks of treatment, a significant improvement of subjective symptomatology and a not significant improvement of all the urodynamic parameters in the treated group in comparison with the control group have been demonstrated, while any anatomic alteration compared with the basal hasn t been observed. After six months from the operation in all the women a significant reduction of subjective quantity of urine lost after a strain has been demonstrated and significant variations of urodynamic parameters without significant differences between treated group and control group were also observed. CONCLUSIONS: The estriol treatment per vaginam is not so effective on the result of Burch culposuspension in postmenopausal women with IUS.

Administration, Intravaginal↗

Using complete breastfeeding and lactational amenorrhoea as birth spacing methods.

The aim of this study was to evaluate the effectiveness of lactational amenorrhoea and to determine the relationship between extended breastfeeding and the return of fertility. Breastfeeding pattern, basal body temperature, cervical mucus, salivary ferning, vaginal blood discharge, frequency of sexual intercourse, and the presence of ovulation in the first cycle after the resumption of menses with ultrasonography were evaluated in 40 women. All subjects completed the study with only one case of incomplete breastfeeding. No pregnancies were observed. The mean number of feeding sessions and mean interval between sessions decreased significantly (p <0.01) during the first six months postpartum (7.5 +/- 1.3 after 60 days postpartum vs. 5.7 +/- 2.1 after 180 days, and 3.6 +/- 0.8 vs. 5.1 +/- 0.9, respectively). Eight women (20%) menstruated before weaning, but none had an adequate thermal shift, while 32 (80%) had their first vaginal bleeding after weaning with 12 (37.5%) registering an adequate thermal shift. Both basal body temperature and salivary ferning proved to be suggestive of ovarian activity, while mucus characteristics were not reliable in identifying fertile periods. Our study showed that breastfeeding associated with lactational amenorrhoea proved to be a good method of postpartum fertility control. Since the importance of supplementation is still debated, it is recommended that a "complete" breastfeeding program be used.

Adult↗

The importance of user compliance on the effectiveness of natural family planning programs.

Nowadays, there is an increasing interest in natural family planning methods. The biological basis for the application of natural family planning methods is the recognition of ovulation and, more extensively, of the fertile period. Several studies in the past decade have shown the efficacy of these methods and that the main cause of failure was either a conscious departure from the rules of the method or erroneous application of the method. Another problem affecting natural family planning that has been highlighted is the relatively high discontinuation rate. These features are probably due to low compliance in applying the natural family planning rules, which may be too demanding for a number of couples. In this review, there are comments on the application of natural family planning methods, the discontinuation rates and the failure of the method due to mistakes in the studies carried out in the past 15 years. Steps that can be taken to limit mistakes and discontinuity are also addressed.

Family Planning Services↗

Effects of postmenopausal hypoestrogenism on skin collagen.

OBJECTIVE: The aim of our study was to evaluate the effect of aging and postmenopausal hypoestrogenism on skin collagen content. METHODS: Thirty-two women (mean age 48.78 +/- 9.86; year +/- S.D., range 28-68), 14 in premenopause and 18 in postmenopause, underwent skin biopsies performed during laparotomic operation. The amount of collagen type I, III and type III/type I ratio was evaluated by immunohistochemistry and computerised image analysis, and was related to age and years of postmenopause. RESULTS: In the postmenopausal patients, a significant (P < 0.01) decrease of percentage of skin collagen type I, type III and type III/type I ratio was observed in comparison to premenopausal women. The percentages of collagen type I, type III and type III/I ratio of all patients studied was significantly (P < 0.01) correlated with chronological age (r = 0.88, 0.89 and 0.61, respectively). Considering only postmenopausal subjects, the correlation with chronological age was significant (P < 0.01) for collagen type I and type III of postmenopausal women (r = 0.59, r = 0.64, respectively), but not for the type III/I ratio (r = 0.37, P = 0.131). The percentages of collagen type I, type III and type III/I ratio of postmenopausal women showed a significant (P < 0.01) inverse correlation with years of postmenopause (r = 0.76, 0.73 and 0.73, respectively). CONCLUSIONS: Our data suggest that the decrease of skin collagen is an estrogen-related phenomenon.

Adult↗

Hypogonadotropic hypogonadism in obese women after biliopancreatic diversion.

OBJECTIVE: To evaluate a particular form of weight-related amenorrhea occurring in severely obese patients after biliopancreatic diversion, a surgical procedure designed to cause weight loss. DESIGN: Prospective, open, controlled clinical trial. SETTING: Department of Gynecology and Obstetrics, University of Naples "Federico II", Naples, Italy. The surgical procedures were performed in various hospitals in the Naples metropolitan area. PATIENT(S): Eight severely obese women (mean [+/-SD] age, 26.9+/-5.3 years) who underwent biliopancreatic diversion (group A) and eight healthy women of normal weight (mean [+/-SD] age, 25.8+/-5.6 years) (group B). INTERVENTION(S): Biliopancreatic diversion, hormonal evaluation, and LH pulsatility evaluation. MAIN OUTCOME MEASURE(S): Weight parameters, hormone levels, and LH pulsatility amplitude and frequency before surgery and at the onset of amenorrhea after surgery, and the response of LH pulsatility to the infusion of naloxone at the onset of amenorrhea. RESULT(S): All patients lost weight after surgery and became amenorrheic after 3 months, when they had lost 25% of their basal weight but were still obese. The hormonal picture at that time was one of hypothalamic amenorrhea with significantly reduced LH pulsatility frequency and amplitude. The alterations in LH pulsatility were not modified by naloxone infusion. CONCLUSION(S): Obese patients who undergo dramatic weight loss may be affected by hypothalamic amenorrhea when still obese. Endogenous opioid activity does not play a significant role in this kind of hypogonadotropic hypogonadism.

Adult↗

Efficacy of methods for determining ovulation in a natural family planning program.

OBJECTIVE: To evaluate the efficacy in ovulation detection of methods used in natural family planning in comparison with pelvic ultrasonography. DESIGN: Prospective analysis of ovulation detection by natural family planning methods and ultrasonography. SETTING: Natural family planning clinic, Department of Obstetrics and Gynecology, University of Naples "Federico II". PATIENT(S): Forty healthy women who were highly motivated to use natural family planning. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Transvaginal ultrasonographic findings, urinary LH levels, salivary beta-glucuronidase activity, salivary ferning levels and characteristics of cervical mucus, and BBT. RESULT(S): Urinary LH level determination yielded a 100% correlation with the simultaneous ultrasonographic diagnosis of ovulation. Mucus sensations and characteristics yielded a 48.3% correlation when simultaneously evaluated with ovulation. Beta-glucuronidase levels yielded a 27.7% correlation. The salivary ferning test had a 36.8% ovulation-detection rate the day of ovulation, but 58.7% of results were uninterpretable. Body temperature measurements yielded a 30.4% correlation with the simultaneous ultrasonographic diagnosis of ovulation. CONCLUSION(S): Measuring urinary LH levels is an excellent method for determining ovulation. Although variations in mucus characteristics and basal body temperature correlate somewhat with ovulation, the length of the fertile period is overestimated with these methods. The salivary ferning test and measurement of beta-glucuronidase levels are not good methods for home ovulation testing.

Adult↗

Long-term administration of tibolone plus gonadotropin-releasing hormone agonist for the treatment of uterine leiomyomas: effectiveness and effects on vasomotor symptoms, bone mass, and lipid profiles.

OBJECTIVE: To evaluate the effects of long-term administration of GnRH agonist (GnRH-a) plus tibolone for uterine leiomyomatosis. DESIGN: Prospective open clinical trial. SETTING: Department of Gynecology, Obstetrics and Pathophysiology of Human Reproduction, University of Naples "Federico II", Naples, Italy. PATIENT(S): Twenty-five subjects with symptomatic uterine leiomyomas. INTERVENTION(S): Treatment for 2 years with leuprolide acetate (3.75 mg IM every 28 days) and tibolone (2.5 mg/d per os). MAIN OUTCOME MEASURE(S): Uterine and uterine leiomyoma sizes, endometrial thickness, lumbar spine bone mineral density (BMD), bone metabolism, lipid profile, myoma-related symptoms at baseline and every 6 months. Hot flashes and vaginal bleeding episodes recorded in a daily symptom diary. RESULT(S): After 6 months of treatment, a significant reduction was observed in uterine and leiomyoma volumes and myoma-related symptoms compared with baseline values. No significant change was observed in bone turnover, lumbar BMD, or serum total cholesterol, low-density lipoprotein cholesterol, or triglyceride levels. High-density lipoprotein cholesterol values were significantly lower than baseline values after 6 months of treatment but not after 18 months of therapy. A low mean number of hot flashes per day was observed. CONCLUSION(S): Long-term administration of GnRH-a plus tibolone reduces hot flashes and prevents bone loss without changing the lipid profile.

Adult↗

A clinical trial of the effects of tibolone administered with gonadotropin-releasing hormone analogues for the treatment of uterine leiomyomata.

OBJECTIVE: To evaluate the effects of tibolone therapy in association with GnRH-a on uterine leiomyomata, on climacteric-like symptoms, on bone metabolism, and on the lipid profile. DESIGN: A prospective, randomized, double-blind, placebo-controlled, clinical trial. SETTING: Department of Gynecology and Obstetrics, University of Naples "Federico II," Naples, Italy. PATIENT(S): Fifty women with symptomatic uterine leiomyomata. INTERVENTION(S): Six months of treatment with leuprolide acetate (3.75 mg every 28 days IM) combined with daily placebo tablets (group A) or with 2.5-mg of tibolone per os (group B). MAIN OUTCOME MEASURE(S): Uterine and uterine leiomyomata sizes, lumbar spine bone mineral density, biochemical markers of bone metabolism, lipid profile, and myoma-related symptoms were measured at baseline and after 6 months of treatment. Daily symptom diary in which hot flushes and vaginal bleeding episodes were recorded. RESULT(S): No differences between the 2 groups in uterine and uterine leiomyomata size and myoma-related symptoms were detected. After 6 months of treatment, there were statistically significant changes from baseline in bone mineral density and in biochemical markers of bone metabolism in group A but not in group B. Vasomotor symptoms were significantly lower in group B than in group A. There was a statistically significant increase (P<.01) in serum total cholesterol, high-density lipoprotein cholesterol, and triglycerides in group A after 6 months of treatment in comparison with baseline values. The difference in serum total cholesterol and triglyceride levels after 6 months of treatment in group B was not statistically significant in comparison with baseline values, but was statistically significant in comparison with group A values (P<.01). In group B, levels of high-density lipoprotein cholesterol were significantly lower after 6 months of therapy in comparison with baseline values and in comparison with group A values (P<.01). There were no statistically significant changes at baseline and after 6 months of treatment in the level of low-density lipoprotein cholesterol in either group. CONCLUSION(S): Administration of tibolone in association with GnRH-a reduces vasomotor symptoms and prevents bone loss, without compromising the therapeutic efficacy of GnRH-a alone.

Adult↗

Ultrasonographic measurement of endometrial thickness during hormonal replacement therapy in postmenopausal women.

The objective of this study was to measure endometrial thickness by transvaginal ultrasonography during two regimens of hormonal replacement therapy (HRT) in postmenopausal women and to compare these data with endometrial histology. Transvaginal ultrasonographic evaluation of endometrial thickness and endometrial biopsy were performed in 80 postmenopausal women before and after 6 months of HRT (between the 24th and the 28th day of the cycle). The group was randomized so that 40 women (Group A) were treated with a continuous sequential regimen consisting of 5 micrograms/day of estradiol continuously and 5 mg/day of medrogestone from the 17th to the 28th day of the cycle; and 40 women (Group B) were given continuous administration of 50 micrograms/day estradiol and 5 mg/day medrogestone. Prior to therapy, there was no significant difference in mean endometrial thickness between the groups. After 6 months of therapy, endometrial thickness was significantly increased in comparison with basal values in both groups. The mean value was significantly higher (p < 0.001) in Group A (8.5 +/- 3.7 mm) than in Group B (3.6 +/- 1.3 mm). In Group A, endometrial thickness was < or = 4 mm in 16.7% of patients and < or = 8 mm in 69.5% of patients. In Group B, 91% of patients had an endometrium of < or = 4 mm. In both groups, the thickness of the atrophic endometrium was less than that of the other histological types of endometrium (4.1 +/- 0.3 mm for Group A and 3.5 +/- 1.2 mm for Group B). In Group A, the difference in mean endometrial thickness between the proliferative and secretory endometrium was not statistically significant. In both groups, the transvaginal ultrasonographic measurement of endometrial thickness of < or = 4 mm had a high sensitivity for detecting atrophic endometrium (83.3% for Group A and 93.7% for Group B).

Biopsy, Needle↗

Gonadotropin-releasing hormone agonists administration in polycystic ovary syndrome. Effects on bone mass.

Women with amenorrhea and polycystic ovaries (PCO) seem to present a relative degree of protection against bone loss caused by hypoestrogenism. We treated 20 patients affected by polycystic ovary syndrome (PCOS) with a gonadotropin-releasing hormone agonist (GnRH-a) for 6 months. After treatment mean bone mineral density (BMD) significantly decreased. We concluded that patients with PCOS have to be considered at risk of developing osteopenia when treated with GnRH-a. The relative protection against osteoporosis, that is present in amenorrheic patients with PCO, might be attributed to the characteristics of amenorrhea in these patients.

Acne Vulgaris↗