Efficacy and tolerability of a spray formulation containing Visnadine in women self-reporting sexual symptoms: a randomized double-blind placebo-controlled pilot study.

PURPOSE: The aim of this pilot, double-blind, randomized, placebo-controlled study, was to evaluate both the efficacy and the tolerability of a formulation for vulvar application containing Visnadine, a natural extractive substance with vasoactive properties, (ReFeel® spray, IDI Integratori Dietetici Italiani S.r.l., Italy) in women self-reporting sexual symptoms. METHODS: Sixty women (age range 18-60 years) volunteered to test the product against placebo (PL): Two puffs in the vulvar area, 10 min before sexual stimulation, for 30 days and for a minimum of six times. The main outcome measure was the improvement of the Female Sexual Function Index (FSFI) score (cut-off ≤ 26.55 for female sexual dysfunction [FSD]). Secondary outcomes were sexual satisfaction and tolerability with the product. RESULTS: PL group (n = 28) and Visnadine group (n = 30) were comparable for age, sexual function and rate of FSD at baseline (T0). After 1 month (T1), women in Visnadine group scored from 25.0 ± 3.8 to 27.9 ± 2.4 (p < 0.001), whereas no changes were evident in PL group (from 25.4 ± 5.0 to 25.6 ± 4.7). Statistically significant differences at T1 were reported in women with a positive (p < 0.001) or a negative FSD diagnosis (p < 0.01) using active treatment. Women with FSD reported significantly more improvement in satisfaction with their sexual function when treated with Visnadine spray compared to PL (p < 0.001), as well as more excitation (p < 0.001), pleasure (p < 0.001) and less time to reach orgasm (p < 0.003). No significant side effects were evident in both groups. CONCLUSIONS: On demand, 1-month use of Visnadine spray displayed positive effects on sexual function in women with and without FSD and it was well tolerated. Topical Visnadine may not only be part of multimodal strategies to manage clinically relevant sexual symptoms but also simply to help women to enhance their subjective impaired perception of sexual response.

Endometrial morphology and ultrasound vascular findings. A randomized trial after intramuscular and vaginal progesterone supplementation in IVF.

Luteal-phase supplementation has proved necessary in Gn-RH analog and human gonadotropin-stimulated cycles. We studied the effects of vaginally and intramuscularly delivered progesterone on the endometrium. Thirty patients enrolled in an IVF program without embryo transfer due to absence of fertilization were included in the study. Patients were randomly allocated to two treatment groups. Group A (n = 15) was administered 200 mg progesterone b.i.d. by the vaginal route (Esolut, Angelini) starting on the day of oocyte pick up and group B (n = 15) was given 100 mg intramuscular progesterone once daily (Prontogest, Amsa). Six days after HCG administration, biopsies were obtained for endometrial histological maturation and estrogen (ER) and progesterone (PR) receptor analyses. In addition, ultrasound measurements of endometrial thickness were made and uterine and myometrial artery flow was determined. Serum concentrations of estriol and progesterone were measured on the day of HCG, at oocyte pick up and at endometrial biopsy. The two treatment groups were similar in terms of follicular phase parameters during superovulation with Gn-RH analog and gonadotropin. Histologic, receptor and ultrasonographic analyses showed no significant differences between the two treatment groups. Our results indicate that both intramuscular and vaginal progesterone are equally effective on the endometrium.

The influence of age and sex on nutritional parameters in subjects aged 60 years and over.

The nutritional assessment of the elderly shows several interpretative difficulties due to the lack of standard parameters. Moreover chronic age-related diseases can interfere with the physiological nutritional status. Anthropometric (triceps skinfold, arm muscle area, total body muscle mass, fat mass and Body Mass Index (BMI)), biochemical (serum prealbumin, transferrin, ceruloplasmin, total protein and albumin) and immunological (serum lymphocytes) parameters were measured in 583 out-patients aged 60 years or over selected on the basis of clinical and biochemical criteria and with BMI /= 75) for each sex. The F-test analysis for all anthropometric parameters except BMI showed significant differences with respect to age (P < 0.05) and sex (P < 0.05). Among biochemical parameters, prealbumin showed a significant difference for age (P < 0.05) and sex (P < 0.05) (males, 30.3 +/- 8.2; females, 29.1 +/- 7.5) while ceruloplasmin showed a significant difference for sex only (P < 0.05) (males, 40.9 +/- 9.3; females, 43.8 +/- 8.2). When the biochemical mean values obtained in this study were compared with those utilized in the daily routine of the hospital central laboratory, ceruloplasmin and prealbumin resulted in significantly higher (P < 0.05) while total protein and albumin were significantly lower values (P < 0.05).

Role of triiodothyronine in down-regulation and recovery of lymphocyte beta-adrenoceptors in thyroidectomized patients.

Thyroid function modulates beta-adrenergic sensitivity through the regulation of beta-adrenoceptor density. In particular, thyroidectomy decreases and thyroid hormone injections increase beta-adrenoceptor density on human lymphocytes. In the present paper the relationship between receptor modifications and thyroid hormone levels has been studied in human lymphocytes from patients after thyroidectomy. The patterns of early changes as well as recovery trends have been investigated. Results show a statistically significant fall in receptor density, parallelled by a decrease in T3 levels, 1-3 days after thyroidectomy. Recovery of receptor density is observed 5-8 days after surgical intervention and is accompanied by increased T3 levels. There is a positive correlation between receptor density and T3 levels. On the contrary, no statistically significant correlation was observed for receptor density and T4 levels. The time course of disappearance and recovery of receptor density and that of T3 levels have also been analyzed with the aid of a mathematical model fitting experimental data. On this basis, the hypothesis that both down-regulation and subsequent recovery of beta-adrenoceptor density are driven by the fall and rise of T3 is suggested. Data are also discussed in relation to experimental results we have obtained in animal studies.

Recovery of age-related decline of thymic endocrine activity and PHA response by lysin-arginine combination.

The frequent association of malnutrition, infectious diseases and aging has stressed the role played by some nutrients on the immune efficiency and by nutrient supplementation on the age-dependent immunological decline. In the present paper there are reported evidences that oral administration of two amino acids--lysine and arginine--recovers, in old Balb/c mice, the mitogen responsiveness, the expression of T-cell markers and the production of thymic serum factor (thymuline). The effect of the amino acids or of their combination, as present in a commercially available form (Neoiodarsolo), seems to consist mainly of the reactivation of the endocrine activity of the thymus. Similar reactivation is achieved also in old humans. These data suggest that the age-dependent decline of thymic hormonal activity is not an intrinsic and irreversible event and that some nutritional intervention, such as amino acid treatment, likely through the stimulation of neuroendocrine network, may reactivate the endogenous production of thymic hormones.