Effects of a phyto complex on well-being of climacteric women.

AIM: The aim of this study was to assess the effects of a phyto complex on menopausal symptoms. MATERIAL AND METHODS: A total of 151 women aged 42-67 years were enrolled. They were in spontaneous or surgical menopause by at least 12 months, reporting symptoms referable to the climacteric syndrome. Two validated and standardized tests were given to the whole sample at the entrance of the study (T0) and after 6 months of treatment (T6): the Greene Climacteric Scale (GCS) and the Beck Depression Inventory (BDI). Interim evaluations were carried out at 1-3 months (T1 and T3) on five symptoms selected from the GCS. The phyto complex was given to each enrolled woman, from the T0 to T6 time-points, for a total of 180 days. RESULTS: At the T0 time-point, the average scores were: GCS, 28.98 (standard deviation [SD] ± 10.71); BDI, 14.48 (SD ± 6.5). At the T1 time-point, five parameters of the GCS were assessed with a reduction of 36.25% in symptoms (5.69, SD ± 3.53). At the T6 time-point the assessment was completed: average GCS results were 11.54 (SD ± 8.01) with a 60.17% improvement; and average BDI results were 6.11 (SD ± 4.6) with a 58.91% improvement in the depressive symptoms. CONCLUSIONS: The phyto complex under consideration is an effective tool to counter, in a quick and long-lasting manner, the most common and nagging symptoms of the climacteric syndrome, such as hot flushes, insomnia and depression.

Breast safety and efficacy of genistein aglycone for postmenopausal bone loss: a follow-up study.

CONTEXT: Genistein aglycone improves bone metabolism in women. However, questions about the long-term safety of genistein on breast as well as its continued efficacy still remain. OBJECTIVE: We assessed the continued safety profile of genistein aglycone on breast and endometrium and its effects on bone after 3 yr of therapy. DESIGN: The parent study was a randomized, double-blind, placebo-controlled trial involving 389 osteopenic, postmenopausal women for 24-months. Subsequently, a subcohort (138 patients) continued therapy for an additional year. PATIENTS AND INTERVENTIONS: Participants received 54 mg of genistein aglycone daily (n = 71) or placebo (n = 67). Both treatment arms received calcium and vitamin D(3) in therapeutic doses. MAIN OUTCOMES: Mammographic density was assessed at baseline, 24 and 36 months by visual classification scale and digitized quantification. BRCA1 and BRCA2, sister chromatid exchange, and endometrial thickness were also evaluated. Lumbar spine and femoral neck bone mineral density were also assessed. Secondary outcomes were biochemical levels of bone markers. RESULTS: After 36 months, genistein did not significantly change mammographic breast density or endometrial thickness, BRCA1 and BRCA2 expression was preserved, whereas sister chromatid exchange was reduced compared with placebo. Bone mineral density increases were greater with genistein for both femoral neck and lumbar spine compared to placebo. Genistein also significantly reduced pyridinoline, as well as serum carboxy-terminal cross-linking telopeptide and soluble receptor activator of NF-kappaB ligand while increasing bone-specific alkaline phosphatase, IGF-I, and osteoprotegerin levels. There were no differences in discomfort or adverse events between groups. CONCLUSIONS: After 3 yr of treatment, genistein exhibited a promising safety profile with positive effects on bone formation in a cohort of osteopenic, postmenopausal women.

[Penetrating abdominal trauma: 20 years experience in a Western European Trauma Center]. / Traumi penetranti dell'addome. Esperienza di 20 anni in Trauma Center dell'Europa Occidentale.

BACKGROUND: The incidence of penetrating abdominal trauma in Western Europe is low. While non-operative management of blunt trauma has become the gold standard, the management of penetrating trauma is still controversial. Nonoperative management (NOM) and laparoscopy are currently used in selected patients, reducing the rate of unnecessary laparotomy. METHODS: We retrospectively reviewed a 20-years period from the Trauma Registry of our Trauma Center. 6523 patients were admitted for thoraco-abdominal trauma (5861 blunt vs 662 penetrating). We sorted the 114 patients with penetrating abdominal trauma in 2 groups for period (1989-2000 vs 2001-08, before and after the establishment of dedicated trauma unit) analyzing their demographics, clinical, therapeutic characteristics and the outcome in comparison. RESULTS: In the latest period a significant increase in the incidence of penetrating trauma has been observed (doubled from 4.17/year up to 8.53/year, accounting now for 13.95% of all trauma laparotomies vs 7.8% in the past decade). A reduction of GSW (30% vs 12.5%, p = ns) occurred while no differences have been recorded in sex, age, prognostic parameters at arrival such as mean GCS (11.8 vs 13.2), ISS (22 vs 18), pH, BE and blood transfusion (6.4 vs 4.3 U) requirement. Interestingly a markedly significant change has been observed in the demographics of the victims (67.2% were of extra-EU origin vs 8% in the previous decade, p < 0.01). Recently the use of NOM spread widely in selected stable patients (21.9%). The failure rate of NOM was 14.3%. The percentage of unnecessary laparotomies decreased from 36% to 21.1% (p = ns). The introduction of laparoscopy was helpful in achieving a reliable, less invasive exploration, allowing detection of the peritoneal penetration and complete visceral exploration. Two GSW (4%) vs 3 (5.8%) cases of the latest years required Damage Control Surgery. A recent significant reduction in mortality and morbidity rate has been recorded (respectively 3.85% vs 18%, p < 0.05; 20% vs 39%, p = ns). CONCLUSION: The recent immigration phenomenon and social changes contributed towards a significant rise in the incidence of penetrating trauma in Italy in the last decade associated to changes in the mechanism of injury. The increased use of NOM and laparoscopy contributed in decreasing the incidence of unnecessary laparotomies as well as overall morbidity and mortality.

Effects of the phytoestrogen genistein on some predictors of cardiovascular risk in osteopenic, postmenopausal women: a two-year randomized, double-blind, placebo-controlled study.

CONTEXT: Genistein, a soy isoflavone, has received wide attention over the last few years because of its potential preventive role for cardiovascular disease. OBJECTIVE: Our objective was to assess the effects of genistein administration (54 mg/d) on some predictors of cardiovascular risk in osteopenic, postmenopausal women. DESIGN AND SETTING: We conducted a randomized, double-blind, placebo-controlled trial at three Italian university medical centers. INTERVENTION: After a 4-wk stabilization on a standard isocaloric, fat-reduced diet, participants were randomly assigned to receive genistein (n = 198) or placebo (n = 191) daily for 24 months. Both intervention and placebo contained calcium and vitamin D(3). OUTCOME MEASURES: Blood lipid profiles, fasting glucose and insulin, homeostasis model assessment for insulin resistance, fibrinogen, soluble intercellular adhesion molecule-1, soluble vascular cellular adhesion molecule-1, F2-isoprostanes, and osteoprotegerin at baseline and after 12 and 24 months of treatment were measured. RESULTS: Compared with placebo, genistein significantly reduced fasting glucose and insulin as well as homeostasis model assessment for insulin resistance after both 12 and 24 months of treatment. By contrast, genistein administration did not affect blood lipid levels although fibrinogen, F2-isoprostanes, soluble intercellular adhesion molecule-1, and soluble vascular cellular adhesion molecule-1 decreased significantly compared with placebo after 24 months. Serum osteoprotegerin was higher in the genistein group compared with placebo. At 24 months, the genistein group showed no change in endometrial thickness compared with placebo. Most treatment-related adverse events were moderate and composed of gastrointestinal side effects [genistein, n = 37 (19%); placebo, n = 15 (8%)]. CONCLUSIONS: These results suggest that 54 mg genistein plus calcium, vitamin D(3), and a healthy diet was associated with favorable effects on both glycemic control and some cardiovascular risk markers in a cohort of osteopenic, postmenopausal women.

Effects of the phytoestrogen genistein on hot flushes, endometrium, and vaginal epithelium in postmenopausal women: a 1-year randomized, double-blind, placebo-controlled study.

OBJECTIVE: To evaluate in a 12-month, prospective, randomized, double-blind, placebo-controlled study whether pure administration of the phytoestrogen genistein (54 mg/d) might reduce the number and severity of hot flushes in postmenopausal women with no adverse effect on the endometrium. DESIGN: A total of 389 participants met the main study criteria and were randomly assigned to receive the phytoestrogen genistein (n=198) or placebo (n=191). About 40% of participants in both groups did not suffer from hot flushes, and the evaluation was performed in a subgroup of 247 participants (genistein, n=125; placebo, n=122). Reductions from baseline in the frequency and severity of hot flushes were the principal criteria of efficacy. Endometrial thickness was evaluated by ultrasonography. The maturation value was also used to determine hormonal action on the vaginal cells. RESULTS: There were no significant differences in age, time since menopause, body mass index, and vasomotor symptoms between groups at baseline (4.4 +/- 0.33 hot flushes per day in the genistein group and 4.2 +/- 0.35 hot flushes per day in the control group). The effect was already evident in the first month and reached its peak after 12 months of genistein therapy (-56.4% reduction in the mean number of hot flushes). Furthermore, there was a significant difference between the two groups at each evaluation time (1, 3, 6, and 12 months). No significant difference was found in mean endometrial thickness and maturation value score between the two groups, either at baseline or after 12 months. CONCLUSIONS: The phytoestrogen genistein has been shown to be effective on vasomotor symptoms without an adverse effect on endometrium.

The first Italian trauma registry of national relevance: methodology and initial results.

OBJECTIVE: To describe and discuss the ongoing endeavor to establish a multiregional trauma registry in Italy. DESIGN: Prospective observational analysis by description and cohort comparison. SETTING: Three Italian hospitals, referral centers for severely traumatized patients. PATIENTS: trauma victims admitted between 1 July 2004 and 28 February 2005 with an Injury Severity Score >15 or requiring early admission to intensive care. INTERVENTIONS: None. MEASURES: Compilation rates for some 'sentry' variables. Total number of patients and Injury Severity Score. Ten widely used descriptive variables (type of trauma, mechanism of injury, age, gender, Injury Severity Score, Revised Trauma Score, Prognostic Severity Index, 'call-to-hospital' and 'admission-to-ward' intervals, and outcome at 30 days) measured in the subgroup with Injury Severity Score>15, in general and by hospital. RESULTS: A trauma registry has been established that fit the present organization of trauma care in Italy. It seems to compare well with the references available in the literature. Five hundred and forty-nine patients have been enrolled so far. The compilation rate has been well above 70% for all variables in all hospitals, except pre-hospital times in two hospitals. A substantial homogeneity exists among the hospitals in the general characteristics of the patients with Injury Severity Score>15. CONCLUSIONS: The project has achieved its goals so far. The previous estimates on the number of cases (about 300/year/hospital) are confirmed and major shortcomings in methodology seem unlikely. Therefore, positive future developments are possible: usage for quality improvement and research, linkage to other European registries and participation of other hospitals.

Effects of the phytoestrogen genistein on cardiovascular risk factors in postmenopausal women.

OBJECTIVE: The phytoestrogen genistein has been shown to be the most efficacious in clinical and experimental studies. We studied whether genistein treatment affects some cardiovascular risk markers in postmenopausal women. DESIGN: Sixty healthy postmenopausal women, who were 52 to 60 years of age, were enrolled in a 6-month double-blind, placebo-controlled, randomized study. After a 4-week stabilization on a standard fat-reduced diet, participants were randomly assigned to receive either genistein (n = 30; 54 mg/d) or placebo (n = 30). At baseline and after a 6-month treatment, we measured fasting glucose, insulin, insulin resistance (HOMA-IR), osteoprotegerin (OPG), fibrinogen, and sex hormone-binding globulin (SHBG). RESULTS: By comparison with placebo, genistein treatment decreased significantly fasting glucose (genistein = -8.7 +/- 2.3%; placebo = 3.2 +/- 2.3%; P < 0.001), fasting insulin (genistein = -12 +/- 3.33%; placebo = 36 +/- 3.29%; P < 0.001), and HOMA-IR (genistein = -14 +/- 5.8%; placebo = 42 +/- 0.6%; P < 0.001). After genistein-treatment, fibrinogen decreased (genistein = 3.18 +/- 0.12 g/L; placebo = 3.83 +/- 0.04 g/L; P < 0.001) with respect to placebo. In the genistein group, serum OPG was lower (-2 +/- 0.3%) than in placebo (9 +/- 1.5%; P < 0.001), and serum SHBG was higher (63 +/- 3.8 nmol/L) compared with placebo (53 +/- 2.9 nmol/L; P < 0.05). CONCLUSION: Our study suggests that genistein may have a favorable effect on some cardiovascular markers.

[A multidisciplinary organizational Emergency Department model for trauma patients in hypovolemic shock]. / Traumatizzati in shock ipovolemico: un modello organizzativo per l'assistenza multidisciplinare nel Dipartimento di Emergenza.

UNLABELLED: Hypovolemic shock in trauma patients causes high mortality because of exanguination, secondary brain damage, multiple organ disfunction. Good organization and operative protocols are vital to patients in need of a prompt and multidisciplinary treatment. PATIENTS AND METHODS: We collected data about resuscitative and diagnostic process, severity scores and outcome of all trauma patients in hypovolemic shock admitted to the Ospedale Maggiore in Bologna (Italy) after the organization of an Internal Trauma System. RESULTS: We obtained a reduction of both diagnostic and therapeutic times and mortality during the last 14 years. CONCLUSIONS: A valid internal organization can improve mortality of trauma patients without expenditure of extra resources.

Prognosis and treatment of pancreaticoduodenal traumatic injuries: which factors are predictors of outcome?

BACKGROUND/PURPOSE: Abdominal trauma rarely causes injuries involving the duodenum and pancreas. Associated injuries occur in 46% of all pancreatic injuries. The morbidity and mortality of pancreaticoduodenal injuries remain high. METHODS: The present study is a retrospective review of our experience from 1989 to 2008 in the surgical treatment of traumatic pancreaticoduodenal injuries. Mortality, morbidity, prognostic factors, and the value of surgical techniques were analyzed. RESULTS: In our level I Trauma Center, between 1989 and 2008, 55 patients had a pancreaticoduodenal injury. In 68.5% of cases pancreatic injuries were found, 20.4% had duodenal injury, and 11.1% suffered combined pancreaticoduodenal injuries; 85.3% of the patients had blunt abdominal trauma, while 14.9% had penetrating injuries. We treated 78.1% of the patients with external drainage and/or simple suture; distal pancreatectomy was performed in 9% of cases and duodenal resection with anastomosis (3.7%) and diversion procedures (3.7%) were performed in an equal number of patients. Age, American Association for the Surgery of Trauma (AAST) grade, organ involved, hemodynamic status, intraoperative cardiac arrest, and operative time remained strongly predictive of mortality on multivariate analysis. The AAST grade represented, on multivariate analysis, the only independent prognostic factor predictive of overall morbidity. In the past decade we have used feeding jejunostomy more frequently, with a reduction of mortality and operating time, due also to a better approach from a dedicated trauma team. CONCLUSIONS: Optimal management and better outcome of pancreaticoduodenal injuries seem to be associated with shorter operative time, and with simple and fast damage control surgery (DCS), in contrast to definitive surgical procedures.

Effects of the phytoestrogen genistein on hot flushes, endometrium, and vaginal epithelium in postmenopausal women: a 2-year randomized, double-blind, placebo-controlled study.

OBJECTIVE: To evaluate in a 24-month, prospective, randomized, double-blind, placebo-controlled study whether pure administration of the phytoestrogen genistein (54 mg/d) might reduce the number and severity of hot flushes in postmenopausal women, with no adverse effect on the endometrium and vagina. METHODS: A total of 389 participants met the parent study criteria and were randomly assigned to receive the phytoestrogen genistein (n = 198) or placebo (n = 191). About 40% of participants in both groups did not experience hot flushes, and the evaluation was performed in a subgroup of 236 participants (genistein, n = 119; placebo, n = 117). Reductions from the baseline in the frequency and severity of hot flushes were the principal criteria of efficacy. Endometrial thickness was evaluated by ultrasonography. The maturation value was also used to determine hormonal action on the vaginal cells. RESULTS: There were no significant differences in vasomotor symptoms between groups at the baseline (4.4 +/- 0.33 hot flushes per day in the genistein group and 4.2 +/- 0.35 hot flushes per day in the control group). After 12 months of genistein therapy, there was a significant reduction (-56.4%) in the mean number of hot flushes, with a significant difference compared with the control group. After 24 months, there was no further decrease in the number of hot flushes in both groups. No significant difference was found in mean endometrial thickness and the maturation value score between the two groups, either at the baseline or after 24 months. CONCLUSIONS: The phytoestrogen genistein has been shown to be effective on vasomotor symptoms without an adverse effect on the endometrium and vagina, but after the first year, there was no further improvement in the decrease in hot flushes.

OPG and sRANKL serum concentrations in osteopenic, postmenopausal women after 2-year genistein administration.

INTRODUCTION: RANKL and its decoy receptor osteoprotegerin (OPG) constitute a complex physiological mediator system involved in the regulation of bone resorption and may be responsible for the homeostatic mechanism of normal bone remodeling. Genistein, an isoflavone representing 1-5% of total phytoestrogen content in soybean products, may positively regulate cellular bone metabolism, but its mechanism of action on bone is not yet fully understood. MATERIALS AND METHODS: We studied the serum levels of both soluble RANKL (sRANKL) and OPG and the sRANKL/OPG ratio in 389 postmenopausal women (age, 49-67 yr) with a femoral neck BMD <0.795 g/cm(2) and no significant comorbid conditions after 24-mo therapy with genistein, (n = 198; 54 mg/d) or placebo (n = 191). Both intervention and placebo contained calcium and vitamin D(3). All patients received dietary instruction in an isocaloric fat-reduced diet. RESULTS: In comparison with placebo, sRANKL level was lower (p < 0.001 versus placebo) and OPG higher in genistein recipients (p < 0.001 versus placebo) at 1 and 2 yr, respectively. Moreover, at the end of 24 mo, genistein produced a significant reduction in the sRANKL/OPG ratio compared with placebo (genistein = -0.021, 95% CI, -0.020 to -0.022; placebo = +0.004, 95% CI, 0.003-0.005; difference = -0.020, 95% CI, -0.015 to -0.025, p < 0.001). CONCLUSIONS: Our findings suggest that genistein plus calcium and vitamin D(3) as part of a healthy diet is able to positively modulate bone turnover in a cohort of osteopenic, postmenopausal women and improve sRANKL-OPG balance after 24 mo of treatment.

Are pre-hospital time and emergency department disposition time useful process indicators for trauma care in Italy?

BACKGROUND: It is recommended that process indicators (PI) for trauma-care be validated in the setting where they are applied for quality assurance (QA) and quality improvement (QI). In a pilot attempt at trauma QA and QI, we evaluated pre-hospital time (PT) and emergency department disposition time (EDt) as possible PIs in three Italian trauma-referral hospitals. METHODS: We used registry data on all the 753 major (ISS>15) trauma cases admitted to the participating hospitals between the 1 July 2004 and the 31 June 2005. The distribution of PT and EDt in the hospitals was investigated together with the performances of the hospitals. The performances were evaluated in terms of patient outcome with multivariate regression models. Outcome measures were trauma death, Euroqol 5-D (EQ5D), and Glasgow Outcome Score (GOS). The possible PIs were then evaluated as independent predictors of outcome. RESULTS: In the hospital with the best outcome-measures (Hospital A) PT and EDt were also the shortest. The differences in PT and EDt were significant (p<0.05) versus Hospital B and Hospital C, respectively. However, at the patient level, longer PT and EDt were not independently associated with bad outcome. Neither a threshold could be found that indicated higher risks of bad outcome. EDt>120 min was paradoxically associated with lower mortality. CONCLUSION: Although PT and EDt were significantly shorter in the hospital with best outcome performances, we could not confirm at the patient level their expected independent association with outcome. More evidence is needed before these indicators can be validated as standard tools for system analysis in our setting.

The effect of the phytoestrogen genistein and hormone replacement therapy on homocysteine and C-reactive protein level in postmenopausal women.

BACKGROUND: The aim of the study was to evaluate the effect, in postmenopausal women, of the phytoestrogen genistein and hormone replacement therapy (HRT) on circulating two independent factors of cardiovascular risk: homocysteine and C-reactive protein (CRP). METHODS: Ninety healthy postmenopausal women, from 50 to 60 years of age, were randomly assigned to receive genistein (n = 30; 54 mg/die) or continuous combined estrogen/progestin therapy (17-beta-estradiol 1 mg plus norethisterone acetate 0.5 mg) or placebo. Plasma homocysteine and serum CRP were measured at baseline and after 6 months of treatment. RESULTS: In the genistein group, plasma homocysteine and serum CRP showed no statistically significant difference from baseline (homocysteine: 11.36 +/- 0.39 micromol/l; CRP: 1.73 +/- 0.31 mg/l) to 6 months treatment (homocysteine: 10.72 +/- 0.46 micromol/l; CRP: 2.13 +/- 0.45 mg/l), without any significant difference versus the placebo group (homocysteine: 11.25 +/- 0.43 micromol/l; CRP: 1.74 +/- 0.22 mg/l). In the HRT group there was a slight, but not significant reduction, of plasma homocysteine mean value from baseline (11.21 +/- 0.44 micromol/l) to 6 months treatment (10.45 +/- 0.38 micromol/l); whereas CRP mean value at the end of treatment (3.30 +/- 0.55 mg/l) was significantly higher from baseline (1.61 +/- 0.25 mg/l) (P < 0.01). However, after 6 months, no significant difference existed with the other two groups. CONCLUSIONS: The phytoestrogen genistein, after 6 months treatment, does not modify the independent cardiovascular risk linked to circulating homocysteine or CRP level. Our experience confirms critical increase of CRP serum level after HRT treatment, but not plasma homocysteine significant variation.