Pietro Affinito

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.

Effects of hormone replacement therapy on ocular function in postmenopause.

ObjectiveTo evaluate the effect of hormone replacement therapy on climacteric ocular complaints, lacrimal secretion, intraocular pressure (IOP), and corneal thickness. DesignA prospective, controlled, randomized study on 50 healthy women (mean age 53.4 ± 3.8 years) at least 1 year after spontaneous menopause. Twenty-five women (group A) were treated with transdermal 17&bgr;-estradiol (50 &mgr;g/day) and medroxyprogesterone acetate (10 mg/day) for 12 days per cycle. Twenty-five untreated women (group B) were used as a control group. All participants underwent eye examination at the beginning of the study and after 3 and 6 months of therapy to detect ocular diseases and to measure lachrymal secretion, IOP, and corneal thickness. ResultsNo significant differences were observed between the two groups at the beginning of the study. After 3 and 6 months of treatment, we observed a significant reduction in the percentage of women in group A affected by ocular symptoms and in the severity of symptomatology in comparison with baseline and with group B (P < 0.01). A significant increase of both basal and stimulated lachrymal secretion was observed after 3 months of therapy in group A in comparison with baseline (P < 0.01). There was a significant decrease of IOP (P < 0.01) after 3 months of therapy in group A (P < 0.01), and a slight, nonsignificant increase of corneal thickness was observed in group A at 3 and 6 months in comparison with basal values. ConclusionOur data suggest that hormone replacement therapy may exert a beneficial effect on ocular symptomatology, increase lachrymal secretion, reduce IOP, and increase corneal thickness.

Effects of hormonal replacement therapy in postmenopausal hypertensive patients

OBJECTIVE To evaluate the effect of hormonal replacement therapy (HRT) on blood pressure (BP) in postmenopausal hypertensive women. METHODS Sixty women affected by hypertension were enrolled and randomized in two groups of treatment: transdermal continuous HRT in a sequential regimen (group A) and placebo (group P). At baseline, after 3 and 6 months of treatment, the BP with standard sphygmomanometer and with 24-h ambulatory recording method was evaluated in two periods (from day 10 through day 16 of the cycle and from day 20 through day 27 of the cycle). At the same time, we also evaluated total cholesterol, LDL-c, HDL-c, triglycerides, and fibrinogen levels. RESULTS After 3 and 6 months of treatment, no significant variations of systolic and diastolic BP measured with standard sphygmomanometer were detected in both groups. On the contrary, in group A in comparison with basal values and group P, and without difference between the two phases of treatment, the 24-h recording showed a significant (P<0.05) decrease in BP. No significant variations were detected in group P versus baseline. In particular, we observed in group A at 3 months of treatment a significant (P<0.05) decrease only in daytime BP in comparison with basal values and group P, without difference between the two phases of treatment. Indeed, the decrease in daytime BP was significant (P<0.05) for both systolic and diastolic BP. At 3 and 6 months a significant (P<0.05) decrease in total cholesterol, LDL-c and fibrinogen levels was detected in group A versus baseline and group P. HDL-c and triglyceride concentrations showed no significant variations. CONCLUSIONS The transdermal HRT induces a significant reduction of BP values and a favorable metabolic action in postmenopausal hypertensive patients.

Endometrial hyperplasia: efficacy of a new treatment with a vaginal cream containing natural micronized progesterone.

Seventy-eight premenopausal women affected by benign endometrial hyperplasia (60 simple and 18 complex) were treated from the 10th to the 25th day of the menstrual cycle with a vaginal cream containing 100 mg of natural micronized progesterone in polyethylene glycol base. The treatment lasted 3 months in 58 patients and 6 in the other 16 patients. Four patients were lost from the study. We observed a total of 67 complete regressions (90.5%) of which 58 (78.3%) occurred in the first 3 months and 9 (11.5%) after 6 months of treatment. Simple hyperplasia showed a significantly higher response to treatment in comparison with the complex type (P < 0.001). The most frequent endometrial pattern detected in the patients in whom hyperplasia regressed was of a secretive type. Recurrence of hyperplasia occurred in 1 out of 58 (1.72%) patients at the 3rd month and in 3 out of 49 (6.1%) patients at the 6th month after treatment. There were no significant differences between the two hystological groups in the percentage of recurrence. During treatment we observed a significant reduction of the amount, duration and frequency of the menstrual bleeding. Minimal side-effects were observed. In conclusion, for its effectiveness and safety, vaginal administration of natural micronized progesterone seems to be an interesting approach to benign endometrial hyperplasia, particularly indicated in women also affected by metabolic disorders.

Effects of thyroxine therapy on bone metabolism in postmenopausal women with hypothyroidism

Objective. To evaluate whether thyroid stimulating hormone‐suppressive thyroxine replacement therapy increases bone loss in postmenopausal women.

Double-blind controlled trial of progesterone vaginal cream treatment for cyclical mastodynia in women with benign breast disease

The clinical effectiveness and safety of vaginal micronized progesterone treatment in mastodynia were evaluated in a double-blind placebo controlled study. Eighty regularly menstruating worn-’ en affected by severe cyclical mastodynia were randomly assigned to two groups of 40 patients. One group was treated for 6 cycles from the 19th to the 25th day of the cycle with 4 g of vaginal cream containing 2.5% natural progesterone. The other group was similarly treated with placebo. The treatment was preceded by a control cycle. All patients reported every day their breast pain on a 100 mm visual linear analogue scale (VAS). The response of breast tenderness and nodularity to treatment was assessed by clinical examination. Vaginal progesterone resulted significantly more efficacious than placebo in reducing mean ratings of breast pain on VAS and mean scores of breast tenderness to touch. Success of treatment, defined as reduction greater than 50% of basal mean score of breast pain on VAS, was achieved in the 64.9% of patients treated with progesterone and in the 22.2% of patients receiving placebo (p<0.01). Conversely, at the end of treatment, the improvement in breast nodularity showed a not statistically significant difference between the two groups. No major side-effects were detected.

Ultrasonographic endometrial monitoring during continuous -sequential hormonal replacement therapy regimen in postmenopausal women

OBJECTIVE To evaluate the endometrial thickness in different periods of a continuous-sequential HRT regimen and to correlate the ultrasonographic findings with the histological patterns. METHODS The study was structured in two phases. In the 1st phase, 37 postmenopausal women (group A) treated by at least 6 months with a conventional continuous-sequential hormonal replacement therapy (cs-HRT) regimen were enrolled. In all patients, the endometrial thickness was measured at the 7th, 14th, 21st and 25th day of the cycle using transvaginal ultrasonography (TV-USG). In the 2nd phase of the study, other 41 postmenopausal women (group B) were enrolled and treated with the same sc-HRT regimen. At entry and after six cycles of cs-HRT, an endometrial biopsy was performed. The endometrial pattern was related with endometrial thickness. Either the evaluations were performed immediately after progestogen withdrawal bleeding, as showed by 1st phase results. RESULTS The results of the 1st phase of the study showed a mean endometrial thickness significantly lower at 7th day of the cycle compared to 14th, 21st and 25th day (4.3+/-1.2 versus 6.6+/-2.9, 7.8+/-4.2 and 7.4+/-4.6 mm+/-SD, respectively). After six cycles of cs-HRT (2nd phase of the study), the mean endometrial thickness was significantly increased in comparison with basal values (4.2+/-1.5 versus 2.8+/-1.2 mm+/-SD; P<0.05). Endometrial biopsies showed 13 cases (39.4%) of atrophy and 20 cases (60.6%) of proliferative endometrium. Mean endometrial thickness in case of atrophy was lower than in presence of a proliferative endometrium (3.7+/-1.2 versus 4.4+/-1.4 mm+/-SD; not significant). Endometrial thickness was <4 mm in 16 cases (11 of atrophic and five of proliferative endometrium), between 4 and 5 mm in 15 cases (13 of proliferative and two of atrophic endometrium) and between 5 and 6 mm in two cases (either case of proliferative endometrium). CONCLUSIONS The best timing for monitoring endometrial thickness during cs-HRT regimens is the period immediately after withdrawal bleeding improving the reliability of the ultrasonographic exam to identify endometrial pathologies.

Heterotopic pregnancy in a woman without previous ovarian hyperstimulation: Ultrasound diagnosis and management

Heterotopic pregnancy (HT) in the absence of a previous ovarian hyperstimulation is a very rare condition. Transvaginal ultrasonography (TV) in the case of first trimester pelvic pain allows a high diagnostic reliability in the identification of HT and a successful conservative treatment by means of TV potassium chloride injection.

A new fluoride preparation for the prevention of postmenopausal osteoporosis: Calcium monofluorophosphate

Fifty-six postmenopausal women aged 52.4 +/- 6.7 years (SD) were treated for 12 months with L-glutamine calcium monofluorophosphate. Each patient received four tablets/day, providing a total dose of 20 mg of fluoride and 600 mg of elemental calcium. Bone mineral density was measured at baseline and after 6 and 12 months of treatment by dual photon absorptiometry of the distal forearm. At these times, serum levels of alkaline phosphatase and osteocalcin, and urinary concentrations of hydroxyproline and calcium, were also assayed. Results were compared with a control group of 50 untreated postmenopausal women with similar clinical characteristics. Forty-nine patients completed the study. Bone mineral density in the treated patients showed a significant increase after 6 months in comparison with both baseline (p < 0.01) and controls (p < 0.01). After 12 months no significant further increase in bone mineral density was detected. In the control group, a significant decrease of bone mineral density was observed at this time (p < 0.01). After 6 months, serum osteocalcin levels were significantly increased in the treated group (p < 0.01 vs. basal and controls). The other biochemical parameters did not show any significant variations. After 12 months, all the biochemical parameters evaluated, with the exception of serum alkaline phosphatase, were significantly different in comparison with the control group (p < 0.01). Osteocalcin levels also increased in comparison with the basal value (p < 0.01). Adverse effects were mild. However, seven patients stopped the treatment before the 6th month because of gastrointestinal complaints.(ABSTRACT TRUNCATED AT 250 WORDS)

Endocrinology: Observations on the use of purified follicle-stimulating hormone in the treatment of luteal phase defects

We treated 18 infertile patients affected by histologically confirmed luteal phase deficiency with 75 IU of purified follicle-stimulating hormone (FSH) daily during the first 5 days of the cycle. Patients who were not pregnant after the first cycle of treatment underwent a second cycle. In the second cycle the daily doses of purified FSH were doubled if luteal phase deficiency had persisted during the first cycle. During the two cycles before treatment and during treatment, patients underwent an endometrial biopsy 1-3 days before the expected onset of menses. An assessment of progesterone serum concentrations was also performed on days 8, 6 and 4 before the expected onset of menses. Treatment was administered in a total of 33 cycles resulting in 30 ovulatory cycles. Six pregnancies were achieved. Among non-conception ovulatory cycles, 13 presented delayed endometrial dating and 11 normal endometrium. The mean +/- SD of the sum of the three progesterone determinations was 14.7 +/- 1.4 ng/ml in pretreatment cycles, 14.6 +/- 1.6 ng/ml in cycles with normalization of endometrial dating, 14.8 +/- 1.7 ng/ml in cycles with persistence of luteal phase deficiency and 30.4 +/- 3.0 ng/ml in conception cycles (P < 0.05 versus other groups). We conclude that purified FSH, if effective in the treatment of luteal phase deficiency, does not act through an increase in progesterone concentrations.