Efficacy of genistein aglycone on some cardiovascular risk factors and homocysteine levels: A follow-up study.

BACKGROUND AND AIM: Recent evidence suggests that genistein aglycone may act beneficially on surrogate cardiovascular risk markers in postmenopausal women. We assessed the effects of genistein aglycone on some cardiovascular risk factors and homocysteine levels after 3-years of continued therapy in a cohort of osteopenic, postmenopausal women. METHODS AND RESULTS: The parent study was a randomized, double-blind, placebo-controlled trial involving 389 postmenopausal women with low bone mass for 24 months. Subsequently, a subcohort (138 patients) continued therapy for an additional year. Participants received 54mg of genistein aglycone (n=71) or placebo (n=67), daily. Both arms received calcium and vitamin D(3) in therapeutic doses. Moreover, 4 weeks before randomization procedures and during our follow-up study, all patients received dietary instructions in an isocaloric fat-restricted diet. Blood lipid profiles, fasting glucose and insulin, insulin resistance (HOMA-IR), fibrinogen, osteoprotegerin (OPG) and homocysteine at baseline and after 24 and 36 months of treatment were measured. Compared to placebo, genistein significantly decreased fasting glucose and insulin, HOMA-IR, fibrinogen and homocysteine after 24 and 36 months of treatment. By contrast, isoflavone administration did not affect high-density lipoprotein cholesterol and triglycerides though serum OPG was higher in the genistein recipients. There were no differences in adverse events or discomfort between groups. Results on routine biochemical, liver function, and hematologic testing did not change over time in placebo or genistein group. CONCLUSIONS: After 3-years of treatment, genistein aglycone plus calcium, vitamin D(3) and a healthy diet showed positive effects on some cardiovascular risk factors and homocysteine levels in a cohort of postmenopausal women with low bone mass.

Body composition estimated by bioimpedance analysis in Sicilian climacteric women.

AIM: The aim of this study was to evaluate the effects of menopause transition on body weight, and body composition in a Sicilian climacteric population. METHODS: Two hundred and nine (60 pre- and one 149 postmenopausal) untreated, healthy women were selected. Body composition was estimated by BIA101 of AKERN SRL. Body Mass Index (BMI), waist and hip circumferences were also measured. RESULTS: The mean BMI of the study population was 29.4+/-0.7. There was no significative difference between pre- and postmenopausal subjects regarding BMI (chi-squared=9.25; P=0.16), its class distribution, fat mass (FM), TBW and waist-to-hip ratio (WHR). The FM was significantly more represented in pre- than in postmenopausal women (47.43+/-1.33 vs 45.02+/-0.81 kg) (P<0.01). Linear regression analysis showed a positive correlation between BMI and fat free mass (FM) percentage (chi-squares=0.7045) nevertheless among the subjects aged=or>55 years, in 57% of the normo-weight the body fat (BF) percentage was undesirably high. CONCLUSION: Climacteric changes and aging process are related to changes in body weight and fat distribution; even subjects apparently ''normo-weight'' (BMI below 25) were ''over-fat'', because revealed undesirably high BF%. Further investigation in larger population is needed to define whether BMI or BF% better predicts the risk of obesity-related diseases in climacteric Sicilian women.

Efficacy on menopausal neurovegetative symptoms and some plasma lipids blood levels of an herbal product containing isoflavones and other plant extracts.

OBJECTIVES: To assess the efficacy of a product containing isoflavones and other plant extracts (BIO) on whole menopausal symptomatology and plasma lipids profile. METHODS: Multicentre, randomized, double blind, placebo controlled clinical investigation on 125 menopausal women randomly assigned to two groups treated for 6 months with placebo or one tablet daily of an herbal product containing 72 mg/dose of isoflavones of different plants origin and other plant extracts (BIO). Primary end-point: Kupperman Menopause Index (KI) variations; secondary end-point: activity on plasma lipids profile and clinical global impression (CGI) on efficacy and tolerability by investigators and patients. The usual parametric test (paired Student t test) was performed to evaluate the significance. In case of non-applicability of parametric tests, the non-parametric Mann-Whitney U test was used. The differences where considered significant at p<0.05 level. RESULTS: At the end of treatment in both groups KI showed a significant decrease (p<0.001). However, in the BIO group the KI reduction was significantly higher (p=0.0265) than in the placebo group after 4 and 6 months of treatment. In the BIO treated patients the LDL cholesterol showed a borderline but not significant reduction compared to placebo (p=0.0608) and triglyceride (TG) a significant (p=0.0151) decrease compared to placebo. The investigator's and patient's CGI on BIO group where superior as compared to placebo. Clinical tolerability was good in booth groups. CONCLUSION: On the basis of positive effects on KI and lipids profile as well as of good clinical tolerability, BIO can be considered one of the possible alternative therapy for conventional HRT.

Randomized, double-blind, placebo-controlled study on effects of raloxifene and hormone replacement therapy on plasma no concentrations, endothelin-1 levels, and endothelium-dependent vasodilation in postmenopausal women.

The endothelium is thought to play an important role in the genesis of atherosclerosis, and several lines of evidence suggest that the effect of an intervention on endothelial function might predict its involvement in coronary disease progression and in the rate of cardiovascular events. Estrogen has direct effects on the blood vessel wall, indicating that vascular endothelium may play a key role in the cardiovascular protective effects of hormone replacement therapy (HRT). Raloxifene relaxes coronary arteries in vitro by an estrogen receptor-dependent and NO-dependent mechanism, thus suggesting that this selective estrogen receptor modulator could also have beneficial effects on endothelial function. This study compared the effects of HRT and raloxifene on NO products, endothelin-1 plasma levels, and endothelium-dependent vasodilatation in postmenopausal women. Healthy postmenopausal women (n=90) were enrolled in a double-blind, randomized, placebo-controlled, 6-month trial. Women were randomly assigned to receive continuous HRT (1 mg 17beta-estradiol combined with 0.5 mg norethisterone acetate), raloxifene (60 mg/d), or placebo for 6 months. Flow-mediated endothelium-dependent vasodilation of the brachial artery, plasma NO concentrations, and endothelin levels were measured at baseline and after 6 months of therapy. The mean baseline level of NO breakdown products was 26.5+/-10.7 micromol/L and increased to 36.3+/-11.4 micromol/L after 6 months of treatment with raloxifene. The mean baseline plasma endothelin level was 17.3+/-8.9 pg/mL and decreased to 11.5+/-2.1 pg/mL after 6 months of treatment with the selective estrogen receptor modulator. The mean baseline ratio of NO (breakdown products) to endothelin was also significantly increased at the end of treatment with raloxifene. Postmenopausal women treated with HRT had similar changes in plasma nitrites/nitrates and endothelin levels as well as in the ratio of NO to endothelin. In contrast, these markers of endothelial function did not change in the placebo-treated women. Flow-mediated endothelium-dependent vasodilation of the brachial artery was 8.3+/-2.1% at baseline and increased to 12.3+/-2.1% after 6 months of treatment with raloxifene. HRT also caused a significant and similar increase in flow-mediated endothelium-dependent vasodilation. No change in flow-mediated vasodilation was observed in the participants treated with placebo. We conclude that raloxifene therapy and HRT influence endothelial function and improve flow-mediated endothelium-dependent vasodilation to a comparable extent in healthy postmenopausal women at least after a 6-month treatment period. However, further investigation is warranted to enhance our understanding of the mechanisms of the effect of raloxifene on vascular function and to determine whether its effect on endothelial function may contribute to the reduction in cardiovascular-related morbidity and mortality.

Compliance with hormone replacement therapy in postmenopausal Sicilian women.

OBJECTIVE: To verify the compliance with hormone replacement therapy (HRT) over 2 years in a population of postmenopausal women in East Sicily. STUDY DESIGN: Patients starting hormonal therapy for the first time were enrolled in this study. A telephone survey was then conducted after 3, 6, 12 and 24 months and the reasons for any discontinuation were recorded. RESULTS: Of a total of 138 women who agreed to be enrolled in this prospective longitudinal study 72 were still taking the treatment after 1 year and only 56 at the end of the study, although only three patients reported that they had experienced no benefit. CONCLUSIONS: Type of work, surgical menopause and previous use of oral contraceptives were significantly statistically associated with better HRT compliance. Side effects and fear of breast cancer, which we maintain is exaggerated by the women and their family doctors, were the commonest reasons for early discontinuation of the hormonal treatment.

Sexually and well-being in early menopause. Effect of transdermal estradiol therapy.

BACKGROUND: This study focus on the effect of 6 months transdermal estradiol therapy (TTS) on the sexual behaviour and the quality of life in early menopausal women, complaining of uncomfortable menopausal symptoms. METHODS: Three hundred and sixty-two postmenopausal women, aged 48-56, participated in this study. One hundred and seventy-one of them were given continuous solid matrix patch TTS 50 mg/day for 6 months. Sexual behaviour, menopausal symptoms and well-being were evaluated through a self-rating method. We used a structured questionnaire with three obligatory answers (less/same/more) for each question--sexual life, hot flushes, touchiness, insomnia, blood pressure, work willing, memory loss, well-being--filled in by the women themselves or by the medical equipe after a telephone interview. RESULTS: Seventy five per cent of women aged 51-53 and 84% aged 54-56, who had been treated for 6 months with TTS showed a fall of sexual drive, if compared with, respectively, 62% and 48% of untreated subjects. Relief of hot flushes, touchiness and insomnia occurred in 80% of treated women, with slight differences among the various groups while 61% showed increase of well-being. CONCLUSIONS: The results of our study demonstrate that continuous TTS for 6 months decreased sexual drive in 69% of women, improved menopausal symptoms in 80% women but increased well-being only in 61% of women. These differences suggest that women's well-being does not seem linked only to the relief of menopausal symptoms and the impairment of their sexual life can play a negative role.

A behavioral measure of AIDS information seeking by drug and alcohol inpatients.

A nonreactive, observational research method was used to measure AIDS information-seeking behavior of patients on four drug and alcohol inpatient units at a large public hospital in New York City. Results showed only 23 inquiries from 271 male and female patients over a six-week interval. Possible explanations and implications of these results are discussed.

[Membranous glomerulonephritis and pregnancy]. / Glomerulonefrite membranosa e gravidanza.

The authors report two pregnancies that occurred within a brief period of time in the same woman, who suffered from a histologically diagnosed membranous glomerulonephritis. The good final result is to be related to the active cooperation among obstetrists and nephrologists specialists. Moreover, they point out the full unsuitability of the schemes for the evaluation of the obstetric risk in women with chronic pathologies.

Training resident anesthesiologists in adult challenging intubation comparing Truview EVO2 and Macintosh laryngoscope: a preliminary study.

AIM: Teaching airway management continues to be of high importance to the anesthesiologist, since the care of each individual patient depends on the expertise, training and knowledge of the anesthetist with different airway devices, techniques and algorithms. The aim of our study was to compare intubation performed by resident anesthesiologists in training, under senior supervision, using Truview EVO2 (Group 1) or Macintosh blade (Group 2) in a group of adult patients undergoing elective surgery. METHODS: This was a pilot prospective study. Thirty patients who were scheduled for surgery under general anesthesia were randomized into two groups. In Group 1, intubation was performed by using the Truview EVO2, and in Group 2 intubation was performed by using the Macintosh blade. Mallampati score, thyromental distance and neck mobility were recorded for each patient. The exclusion criteria included a Mallampati score =or<2 and a Patil distance >6 cm. The time of intubation and any occurrence of complications were recorded. RESULTS: Intubation was always successful on the first attempt in Group 1, while it failed for 46.7% of patients in Group 2 (P=0.006). The time of intubation was not different between the two groups. No complications were recorded for Group 1 (Truview), while seven were reported in Group 2 (Macintosh) (P=0.003). CONCLUSIONS: The resident managed to intubate all patients on the first attempt with the Truview, which led to a lower incidence of complications. Despite the exiguity of the population in the study, Truview EVO2 and other videolaryngoscopes can be considered to be useful tools in training resident anesthesiologists in elective intubation.

[Emergency diagnostic imaging in thoracic trauma. A clinical case]. / Diagnosi d'urgenza per immagini nel trauma toracico. Caso clinico.

The authors report a case of thoracic trauma with pulmonary contusion in which chest X-ray was not significant, nevertheless severe clinical state. They underline the importance of CT in the early evaluation of pulmonary lesions and in their development.

Ciaglia percutaneous dilational tracheostomy. Early and late complications and follow-up.

AIM: Evaluation of the safety of percutaneous dilational tracheostomy (PDT) for perioperative, early and late complications. DESIGN: we prospectively collected complications in patients who underwent PDT for mechanical ventilation; patients were interviewed 8 months after discharge, symptomatic cases underwent ENT control. SETTING: 10 bed general ICU in a 650 -bed general hospital treating 450 patients per year. PARTICIPANTS AND INTERVENTION: 181 patients admitted between July 1998 and June 2000 who underwent PDT for mechanical ventilation. Prospe-ctive collection of data on patients and procedures and screening by a phone interview for symptoms possibly related to the tracheostomy. Symptomatic patients were referred to the ENT specialist. RESULTA: We found 17 perioperative minor complications and 10 minor during hospital stay complications. We traced 83 patients, alive 8 months after discharge. Sixty-one patients (73.5%) were symptom free. Four (4.8) complained of minimal dysphonia. Eighteen patients (21.7%) complained of symptoms deserving ENT control. Eleven patients came to the ENT control that was positive in 5 cases. In 2 patients swallowing uncoordination was found, in 1 arytenoid movement uncoordination. In 1 case (1.2%) a 25% tracheal stenosis was found. The stenosis was asymptomatic. One patient (1.2%) had a severe tracheal stenosis and had a Montgomery tracheal stent in place. CONCLUSIONS: In our experience Ciaglia PDT had an overall low rate of complications (21.8%). No patient had severe early complication. We found only 1 (1.2%) severe late complication. In selected patients, Ciaglia PDT with endoscopic control guarantees a high safety standard.

[Propofol-ketamine vs propofol-fentanyl in short gynecologic surgery]. / Propofol-ketamina vs propofol-fentanyl nella piccola chirurgia ginecologica.

The study was performed to investigate efficacy and tolerability of the association propofol-ketamine as alternative to propofol-fentanyl. Forty female, classified ASA I-II, aged 18-50 years and scheduled for short gynecologic procedures under general anesthesia were included in a comparative, randomized, single blind study. Patients were divided in two groups; in group K anesthesia was induced with propofol 1.5 mg/kg and ketamine 1 mg/kg i.v. In group F anesthesia was induced with propofol 2.5 mg/kg and fentanyl 1.5 micrograms/kg. Arterial blood pressure (BP), heart rate (HR), respiratory rate (RR) and arterial O2 saturation (SATO2) were measured. Though preliminary, our data suggest that the association propofol-ketamine reach an adequate level of anesthesia with few and negligible effects on cardiorespiratory system, thus allowing a better operability and safety. The incidence of post operative psychotic disturbances seems to be low and moderate. We can't draw any definitive conclusion, but we think that other studies should be performed to clarify the possible role of ketamine in propofol anesthesia.

[Atropine poisoning. Importance of the clinical diagnosis]. / Intossicazione da atropina. Importanza della diagnosi clinica.

A case of suspected high dose atropine poisoning is described. In a veterinarian good healthy young man the appearance of light coma with psychomotor agitation and the contemporary presence of evident symptoms of muscarinic peripheral block, suggesting an anticholinergic syndrome, an atropine-like intoxication in absence of toxicological analysis. The safely clinical course of the poisoning during observation in intensive care unit permitted the discharge of the patient without sequelae and without treatment with physostigmine as antidote.

[Changes in the cell-mediated immune system in post-traumatic sepsis]. / Alterazioni del sistema immunitario cellulo-mediato nella sepsi post-traumatica.

OBJECTIVE: We studied the alterations of cell-mediated immunity (CMI) in polytrauma patients and its relation with sepsis. DESIGN: a prospective study. SETTING: ICU, Ospedale Maggiore, Bologna (Italy). PATIENTS: We included in the study 42 patients with at least two of following criteria: 1) Trauma Score < or = 12; 2) Abbreviated Injury Score > or = 4; 3) Arterial Pressure on admission < or = 80 mmHg; 4) Injury Severity Score > or = 16. CMI examinations were carried out at three different post-traumatic times (T0-T2). Seventeen patients developed a sepsis within the first eight days from admission. RESULTS: Sepsis caused a temporary impairment in some lymphocyte subsets at T2. The patients who developed sepsis showed a significant subset percentage difference for CD3, CD3 activated (p < 0.05) and for interleukin-2 receptor (IL-2R) (p < 0.01) in comparison with the non septic group. At T2, the seven septic patients who died, showed a marked depression of IL-2 values (0.37 +/- 0.12 UI/ml) in comparison with the values of septic patients who survived (0.66 +/- 0.25 UI/ml; p < 0.01) and with the group of non septic patients (0.83 +/- 0.5 UI/ml; p < 0.001). Septic patients who had a IL-2 value of 0.45 or lower had a mortality of 75%. IL-2 values showed a specificity of 89% and a sensibility of 75% in predicting mortality in septic trauma patients. CONCLUSION: We believe that in polytrauma patients IL-2 values monitoring could be a reliable index of the disfunction of CMI and that IL-2R sieric levels could be a diagnostic marker of impending sepsis.

Cardiovascular effects of raloxifene hydrochloride.

Raloxifene hydrochloride binds to the estrogen receptor and shows tissue-selective effects; thus, it belongs to a class of drugs recently described as selective estrogen receptor modulators (SERMs). Tissue selectivity of raloxifene may be achieved through several mechanisms: the ligand structure, interaction of the ligand with different receptor subtypes in various tissues, and intracellular events after ligand binding. Raloxifene has estrogen-agonist effects on bone and lipids and estrogen antagonist effects on the breast and uterus. In addition to its well established effects on osteoporosis, recent preclinical and clinical findings suggest that raloxifene also possesses beneficial effects on the cardiovascular system. These findings indicated that raloxifene may have cardioprotective properties without an increased risk of cancer or other side effects. Raloxifene has been shown to reduce total and low-density lipoprotein cholesterol concentrations in plasma, an effect similar to that produced by estrogens. Unlike estrogens, however, raloxifene does not increase high-density lipoprotein cholesterol and triglyceride levels in plasma. Endothelium is thought to play an important role in the genesis of atherosclerosis. Several lines of evidence suggest that an intervention with endothelial function might influence the progression of coronary disease and the incidence of cardiovascular events. Raloxifene increases the nitric oxide/endothelin-1 ratio, and improves endothelium-dependent vasomotion in post-menopausal women to the same extent as estrogens. Furthermore, in two randomized trials on post-menopausal women raloxifene reduced homocysteine levels, another independent risk factor for the development of cardiovascular disease. Although estrogens remain the drugs of choice in the hormonal therapy of most postmenopausal women, raloxifene may represent and alternative in women who are at risk of coronary artery disease.