Efficacy of a food supplement in patients with hashimoto thyroiditis.

Thyroid inflammation has been commonly seen in recent decades, due to a series of factors and is considered as the most frequent thyroid illness. It is characterized by some distinctive traits, which include morphological and hormonal modifications, often in association with an elevated anti-thyroid autoantibody title. The aim of the therapy is to improve symptoms as fast as possible, treating inflammation and subsequent hypothyroidism, when present. Therefore, we evaluated the efficacy of a Food Supplement (FS) containing enzymes which is commonly used in various inflammatory processes and is able to modulate immune reactions during inflammation in a very rapid and efficacious way. An open, controlled study was then designed and 45 patients with Hashimoto thyroiditis were enrolled and divided into 3 groups (FS alone; thyroid hormones alone; FS plus thyroid hormones). Blood, morphological and subjective parameters were considered. The results obtained indicate that the FS used in our study is efficacious and safe when used alone and/or in combination with thyroid hormones in the treatment of autoimmune thyroiditis, as documented by the improvement of the majority of the parameters considered. The efficacy was considered faster than thyroid hormones alone as far as subjective symptomatology is considered. In conclusion, the use of the food supplement evaluated herein during inflammation may be considered an additional tool in clinicians’ hands, when facing patients with autoimmune thyroiditis, especially in presence of subjective symptomatology, in order to rapidly alleviate it.

The Combined therapy myo-inositol plus D-Chiro-inositol, in a physiological ratio, reduces the cardiovascular risk by improving the lipid profile in PCOS patients.

BACKGROUND: Women with Polycystic Ovarian Syndrome (PCOS) present several factors that increase the cardiovascular risk, such as insulin resistance and dyslipidemia. Myo-inositol and D-chiro-inositol have been shown to improve insulin resistance, hyperandrogenism and to induce ovulation in PCOS women. However, their effects on dyslipidemia are less clear. The aim of the present study was to evaluate whether the combined therapy myo-inositol plus D-chiro-inositol (in a in a physiological ratio of 40:1) improve the metabolic profile, therefore, reducing cardiovascular risk in PCOS patients. PATIENTS AND METHODS: Twenty obese PCOS patients [BMI 33.7 ± 6 kg/m2 (mean ± SD)] were recruited. The lipid profile was assessed by measuring total cholesterol, LDL, HDL and triglycerides before and after 6 months treatment with the combined therapy. Secondary end points included changes in BMI, waist-hip ratio, percentage of body fat, HOMA-IR and blood pressure. RESULTS: The combined therapy myo-inositol and D-chiro-inositol improved LDL levels (3.50 ± 0.8 mmol/L versus, 3 ± 1.2 mmol/L p < 0.05), HDL (1.1 mmol/L ± 0.3 versus 1.6 mmol/L ± 0.4 p < 0.05) and triglycerides (2.3 ± 1.5 mmol/L versus 1.75 ± 1.9 mmol/L p < 0.05). Furthermore, significant improvements in HOMA-IR were also observed. CONCLUSIONS: The combined therapy myo-inositol plus D-chiro-inositol is able to improve the metabolic profile of PCOS women, therefore, reducing the cardiovascular risk.

The combined therapy with myo-inositol and D-chiro-inositol reduces the risk of metabolic disease in PCOS overweight patients compared to myo-inositol supplementation alone.

BACKGROUND: PCOS is the main cause of infertility due to metabolic, hormonal and ovarian dysfunctions. Women affected by PCOS often suffer of insulin resistance and of a compensatory hyperinsulinemia. These conditions put the patients at risk of developing several metabolic disorders. Both myo-inositol (MI) and D-chiro inositol (DCI) glycans administration has been reported to exert beneficial effects at metabolic, hormonal and ovarian level. Beside these common features, MI and DCI are indeed different molecules: they belong to two different signal cascades and regulate different biological processes. AIM: In this study, we aim to verify whether the two molecules have a synergistic action by acting on their specific cellular pathways. The effectiveness in reducing the risk of metabolic syndrome as well as in enhancing the ovarian functions of a combined therapy with MI and DCI was compared to a mono therapy in a randomized controlled trial. METHODS: Fifty overweight women with PCOS were enrolled and divided in two groups to receive MI and DCL (MI+DCI group) or MI alone (MI group) for a period of six months. Baseline measurements were repeated at three months (T1) and at the end of the treatment (T2). RESULTS: At the end of the treatment, both MI and MI+DCI groups showed an improvement of the metabolic parameters and no significant differences were found. As expected, the combined supplementation with MI and DCI resulted to be more effective, compared to the MI group, after three months of treatment. CONCLUSIONS: The combined administration of MI and DCI in physiological plasma ratio (40:1) should be considered as the first line approach in PCOS overweight patients, being able to reduce the metabolic and clinical alteration of PCOS and, therefore, reduce the risk of metabolic syndrome.

Treatment of lean PCOS teenagers: a follow-up comparison between Myo-Inositol and oral contraceptives.

OBJECTIVE: Polycystic ovary syndrome (PCOS) is an endocrinological and metabolic disorder widely diffused and diagnosed in women of reproductive age. The pathology exhibits alteration of the reproductive functions, including conditions as hyperandrogenism, menstrual cycle irregularity, type 2 diabetes. These conditions are visible in the patients through phenotypical manifestations as hirsutism, acne, and obesity. Even if the syndrome is characterized by common features among both adult and adolescent women, the diagnostic criteria are different for the two age categories and to date still controversial. We investigated different treatments in PCOS adolescents with non-severe metabolic conditions, to evaluate which could be the appropriate therapeutical approach for these patients. PATIENTS AND METHODS: We enrolled lean teenagers with PCOS, and we divided the patients in two age ranges: 13-16 years old and 17-19 years old. They were treated for 3 months either with oral contraceptive pills (OCP) drospirenone/ethinylestradiol (group A), myo-Inositol (myo-Ins) (group B), or OCP plus myo-Ins (group C). Data were analyzed with a descriptive statistics summarizing quantitative variables including median, 25th and 75th percentiles. RESULTS: We pointed out that the group of 13-16 years old lean teenagers treated with myo-Ins exhibit a significant decrease of weight and body mass index (BMI), and an effective improvement the metabolic and hormonal parameters achieved with a non-pharmacological treatment. In the older teenagers aged 17-19 years, data highlights that myo-Ins treatment in combination with OCP prevents the increases of weight and BMI, improves the metabolic profile of the patients, and strongly ameliorates the hormonal parameters analyzed. CONCLUSIONS: The results indicate a different scenario in the two age ranges considered and interestingly suggest an important role of myo-Ins in the PCOS context. A therapy based on this natural compound alone or in combination with OCP seems effective to improve both metabolic and hormonal parameters of PCOS adolescents and thus could represent a novel and valid option to consider for the treatment of this syndrome.

Present and future of kidney replacement therapy in Italy: the perspective from Italian Dialysis and Transplantation Registry (IDTR).

Incidence of kidney replacement therapy (KRT) stabilizes or declines both in Europe and in the US; however, it is predictable that global prevalence of KRT will double by 2030. In this paper, we focus on the patterns of incidence, mortality, and prevalence of KRT in Italy, and we compare, when possible, the findings with other countries. The Italian Dialysis and Transplantation Registry (IDTR) currently collects aggregate data from regional registries. In Italy, KRT yearly incidence is around 160 patients per million population (pmp). This incidence showed an increasing trend up until 2011 with an average annual percentage change (AAPC) of 1.8%, after which it stabilized. Older age is an important determinant for KRT incidence, and it is strongly associated with the variability between Italian regions. Incidence is very stable within patients less than 50 years old; however, it greatly differs between regions for patients over 75 years old, ranging from 400 to 900 pmp. Moreover, the incidence for patients over 50 years old declined from 366 pmp in 2011 to 285 in 2017. An age-period-cohort (APC) model showed a very strong cohort effect, which shows the decline in incidence seems mainly due to the better health conditions of people born after 1940. Mortality rate in KRT patients was 109 per 1000 patient-year (py) between 2011 and 2017 with great differences among treatment modalities: 162 per 1000 py in haemodialysis, 117 per 1000 py in peritoneal dialysis, and 16 per 1000 py in kidney transplantation. Premature death is better detected by the standard expected years of life lost (YLL). The distribution of YLL rate per age shows a sharp increase between 40 and 70 years old both in haemodialysis and peritoneal dialysis patients with an AAPC of 5.2% and 4.1% respectively. Transplanted patients experience a very low YLL rate at any age. KRT prevalence was 1118 pmp in 2017 and it should be close to 1175 pmp by 2025 with a projected increase of transplanted patients' prevalence to 500 pmp, and a decrease of dialysis patients from 714 to 680 pmp. The proportion of patients treated with one of the three modalities strictly depends on age, with a sharp increase of haemodialysis after the age of 50. All data suggests the necessity to improve the care of middle and older age patients who experience the higher incidence of disease and mortality.

[Reliability of administrative databases in epidemiological research: the example of end-stage renal disease requiring renal replacement therapy in patients with diabetes]. / Attendibilita' dei database amministrativi nelle indagini epidemiologiche in ambito nefrologico: il caso dell'insufficienza renale che necessita terapia sostitutiva nella popolazione diabetica.

Health and administrative databases are widely used in epidemiology, mostly in studies of chronic diseases, but biases may undermine the external validity of the results. In nephrology, the use of these data sources is in its early days and needs to be validated. The aim of this study was to compare the data on the incidence of ESRD and death in a cohort of patients with type 2 diabetes (DM2) obtained from administrative databases with the results of a traditional, well-performed cohort study. The study was conducted in the Health District of Venice (Italy) on a cohort of 18,416 DM2 patients on hypoglycemic drug therapy enrolled from 1 January 1998 to 31 December 2002 from administrative databases.Comorbid conditions were recorded from hospital discharge records, the database of death certificates was used to identify patients who died within 31 December 2004, and the database of the Dialysis and Transplantation Registry of the Veneto Region served to identify patients who started renal replacement therapy within 31 December 2004. Record linkage was performed using the unique personal identification codes (fiscal number) of Italian citizens. The cumulative incidence of ESRD was estimated using Gray's method for competing risks. The mortality rate was 50.95 per 1000 person-years, the ESRD incidence was 0.68 per 1000 person-years, with a relative risk of 2.62 with respect to all other causes of ESRD. The crude cumulative incidence of death was 22% and that of ESRD 0.33% at the end of follow-up. The results were similar to those obtained in traditional cohort studies. The results of our study prove the external validity of the administrative database approach in epidemiological studies in nephrology.

[The Veneto Region's Registry of Dialysis and Transplantation: 2006-2007 report]. / Registro Veneto di Dialisi e Trapianto - Report 2006-2007.

INCIDENCE: Five hundred and sixty patients began renal replacement therapy in 2006, giving an incidence of 117.51 pmp; in 2007 there were 579 new patients, for an incidence rate of 120.01 pmp. Analysis of the incidence between 1998 and 2007 for both raw and age-standardized data (based on the 2001 census) shows a slow, gradual increase that is statistically significant. Most of the patients were between 55 and 85 years old; the modal class for males was between 65 and 70, and between 75 and 80 for females. The median age of the population beginning replacement therapy is clearly over 65 years old. The year 2000 was particularly significant because the incidence of new patients undergoing renal replacement therapy over the age of 75 definitively exceeded that of the next younger class (65-74 years old), a trend that remained constant until 2007. In 2006 and 2007, males account for 64.4% and 66.4%, respectively, of new patients, a proportion that is constant over the years. The greater incidence of males is also to be found across the other age groups and tends to be even more noticeable in the oldest age class. Incidence by province is highly variable, however, there is a constant trend within provinces during these years, since the incidence in some provinces is lower than the regional average and higher in others. After adjusting for age, there are no significant differences in the incidence between provinces: the age structure of the population accounts for the variability of the incidence of terminal uremia across the Veneto provinces. The conditions most responsible for renal insufficiency requiring replacement therapy are vascular diseases, diabetes and nephropathies of unknown origin. Although diabetic and vascular nephropathies are subject to wide fluctuations, they remain stable over the years, whereas the frequency of nephropathy of unknown origin appears to be on the rise. The first treatment for most of the patients is hemodialysis. In 2006, 436 patients (78%) were given extracorporeal dialysis as first treatment, compared to 122 patients (22%) who were given peritoneal dialysis and 2 (0.35%) who received live-donor kidney transplant. In 2007 the situation was very similar, with 435 patients treated with extracorporeal dialysis, 142 with peritoneal dialysis and 1 by a live-donor transplant. The proportion between patients treated with hemodialysis and peritoneal dialysis was constant from 1998 to 2007. The choice between hemodialysis or peritoneal dialysis as the initial treatment modality depends on many factors, ranging from clinical indications to cultural attitudes at the facility to individual patient preferences. Logistic regression of the factors influencing the choice of dialysis treatment shows that peritoneal dialysis is offered primarily to patients between the ages of 45 and 65 who do not have an underlying systemic or nephropathy of unknown origin and who do not have any comorbidities. This confirms the positive selection made with regard to these patients, widely described in the literature. Initial treatment by transplant is an exceptional event: starting from 2003, it was used in only 1 or 2 patients per year. Seventy-two percent of patients starting replacement therapy present with at least one comorbidity. Thirty-six percent of patients also present with more than one associated disease. The RVDT has been gathering data on the vascular access used for new dialysis patients since 2006. Roughly 43% of patients start treatment with an arteriovenous fistula, 38% with a temporary catheter, less than 1% with a prosthesis, 9% with a tunneled catheter, and 10% with a peritoneal catheter. Logistic regression was used to evaluate what role age, primary nephropathies and comorbidities present at the start of treatment play in determining the choice of a temporary catheter. The logistic model estimates a 29% probability of starting treatment with a temporary access. This probability decreases if the patient suffers from a familiar or hereditary nephropathy but increases if the patient has secondary glomerulonephritis or is affected by a group of various diseases (multiple myeloma or other pathologies) or if the patient suffers at the same time from cardiac insufficiency or an infection. The estimated probability of starting hemodialysis with a mature fistula is 40%, but this figure diminishes significantly in female patients, if the patient has secondary glomerulonephritis, cardiac insufficiency or infections. PREVALENCE: As of December 31, 2006, there were 4,071 patients being treated with extracorporeal or peritoneal dialysis or by kidney transplant, leading to a prevalence of 852.82 patients pmp; as of December 31, 2007, there were 4,200 patients treated, with a corresponding prevalence of 869.14 pmp. The breakdown in prevalence by age group shows that the increase in prevalence is highly significant in the top two age classes, namely, between 65 and 75 years of age and over 75, while remaining negligible in the other classes. Between 1998 and 2007, the prevalence increased by 40% in patients over 75 and increased by 20% in the class of 65-to-75 year olds. The elderly contribute a greater weight in the renal replacement therapy population, reflected in the gradual increase of the median age of the prevalent population from 1998 to 2007. During 2006 and 2007, males made up 63.99% and 64.36% of the patients, respectively. This relative frequency mirrors the findings for incidence and is constant over the years. The distribution of primary diseases is very different in the prevalent population compared to findings in the incident patients. Primary glomerulonephritis, at fourth place among incident patients, is the most frequent disease in the prevalent population (although there is a clearly downward trend over the years). The percentages of diabetes and vascular disease, on the other hand, are lower compared to what is observed in the incident population. The prevalence expressed by treatment modality pmp increased for all three types. In analyzing the annual percentage rise in prevalence, using 1998 as the baseline, the most significant figure regards transplant patients, whose prevalence increased by over 60% between 1998 and 2007. Prevalence of hemodialysis patients rose moderately by only slightly over 10%. Peritoneal dialysis shows a rather linear increase, similar to the transplant trend. Our study used longitudinal regression models to analyze factors predictive of a patient starting and continuing to undergo the same type of treatment over the years. The results show that a patient has a greater probability of being treated with hemodialysis based on several primary nephropathies, when aged > 45, and in the presence of the main comorbidities. The predictive factors for peritoneal dialysis mentioned earlier have a diametrically opposed role. The presence of comorbidities (except high blood pressure), the type of nephropathy, and age > 65 lead to a lower probability of receiving a transplant. We analyzed peritoneal dialysis failures - defined as changing over to extracorporeal dialysis for any reason (clinical, psychological or social) - and the cumulative incidence of failure, taking into account the two competing outcomes of transplant and death. The only variable associated with peritoneal dialysis failure was the presence of infections. Older patients, patients with peripheral vascular disease, and those with neoplasia are less frequently taken off peritoneal dialysis to receive a transplant, an event occurring more frequently, however, in patients with hypertension. Death is dependent on age, on the presence of peripheral vascular disease and is less frequent in hypertensives. As is the case for peritoneal dialysis, the natural history of kidney transplant can have two competing outcomes: return to dialysis and death. The risk factors associated with return to dialysis are the presence of peripheral vascular disease, hypertension and infections; risk factors associated with death include age, the presence of cerebral vascular disease and neoplasia. From 1998 to 2007, the prevalence of hepatitis C virus-antibody-positive patients decreased by almost one third. The number of antigen-positive hepatitis B patients is declining slowly, but the levels remain in any case very low. The association between the two infections is disappearing: already at very low levels in 1998, that figure was halved by 2007. MORTALITY AND SURVIVAL: The mortality of uremic patients on renal replacement therapy was calculated both as a cumulative incidence, expressed as the number of deaths over patients at risk (alive at the beginning of the study year) and as a mortality rate, expressed as the number of deaths per patients/year. The figure was constant over the years, at around 10%. The mortality of males was no different from that of females; this finding differs from what is observed in the general population where male mortality is markedly higher than that of females. The mortality rate is dependent on the age group of the patient at start of treatment and shows an upward trend that is growing exponentially. The mortality rate in hemodialysis patients remained stable at 15% between 2000 and 2007, while the mortality rate in peritoneal dialysis patients gradually decreased down to 13%. The mortality rate for transplant patients was low and constant, at under 2%. The trend for the various causes of death is stable over the years and shows that the main cause of death is cardiac, accounting for between 30% and 35%, while mortality due to vascular, neoplastic, infection or cachexia-related causes are all roughly at the same rate, between 10% and 15%. (ABSTRACT TRUNCATED)

The 40:1 myo-inositol/D-chiro-inositol plasma ratio is able to restore ovulation in PCOS patients: comparison with other ratios.

OBJECTIVE: The aim of this clinical trial was to evaluate the efficacy of seven different ratios between two inositols stereoisomers, myo-inositol (MI) and D-chiro-inositol (DCI), in the therapy of polycystic ovary syndrome (PCOS). PATIENTS AND METHODS: fifty-six PCOS patients (8 for each group) were treated by oral route using the following formulations: DCI alone, and 1:3.5; 2.5:1; 5:1; 20:1; 40:1, 80:1 MI/DCI ratio. They received 2 g of inositols twice a day for 3 months. The primary outcome was ovulation, the secondary outcome included the improvement of FSH, LH, Sex Hormone Binding Globulin (SHBG), 17-beta-Estradiol (E2), free testosterone, basal and postprandial insulin levels, as well as HOMA index, BMI and menses. RESULTS: We found that the 40:1 MI/DCI ratio is the best for PCOS therapy aimed at restoring ovulation and normalizing important parameters in these patients. The other formulations were less effective. In particular, a decreased activity was observed when the 40:1 ratio was modified in favour of DCI. CONCLUSIONS: Our data demonstrated that DCI activity is beneficial mainly at a specific ratio with MI, whereas the increase of DCI causes the loss of the beneficial effects at reproductive level. These results in humans validate a previous preclinical study with different MI/DCI ratios carried out in an experimental model of PCOS mice.

Efficacy of wrists overnight compression (HT 7 point) on insomniacs: possible role of melatonin?

AIM: Insomnia is a major problem which decreases life quality. Many causes are involved with it and anxiety is often associated. The underlying mechanism is not completely understood, even though different factors seem to be associated. Among them melatonin and its circadian rhythm is thought to have an important role. In addition, acupressure and acupuncture are known to ameliorate insomnia and anxiety, when a specific wrist point is stimulated (HT 7 Shenmen). With these bases, the aim of the present study has been to evaluate the efficacy of an acupressure device, ''H7-insomnia control'', positioned on HT 7 points, during the night, in terms of general health and anxiety levels, together with the evaluation of sleep quality and the urinary melatonin metabolite 6-hydroxymelatonin sulphate determination, in a number of insomniacs. METHODS: Forty patients with insomnia were divided into two groups and randomly received either the H7 or placebo treatments, in a double-blind protocol, for 20 nights. Before and after treatments every subject answered a series of questionnaires (General Health Questionnaire 28 items; State-Trait Anxiety Inventory; Pittsburgh Sleep Quality Index) and collected 24 h urines, divided into two samples of 12 h each. Urinary melatonin metabolite was then determined using a RIA method. RESULTS: Data obtained indicate that the device H7-insomnia control is efficacious to ameliorate quality of sleep and reduce anxiety levels in insomniacs, at a higher extent than in the placebo group. In addition, the 24 hours urinary melatonin metabolite rhythm, obtained at the end of treatment, was considered as being normal in a higher percentage of H7-treated patients, with respect to the placebo group. CONCLUSION: It is plausible to hypothesize that the wrist acupressure device might be considered a valid tool, without adverse effects since it does not contain pharmaceutical products, that is able to naturally ameliorate sleep quality in insomniacs, acting through a not jet completely clarified mechanism, that may involve melatonin.

Evaluation of thyroid nodule characteristics in subclinical hypothyroid patients under a myo-inositol plus selenium treatment.

OBJECTIVE: The anticancer effect of myo-inositol (MI) is catching researchers' attention worldwide. Thyroid nodules (TNs) have been detected by ultrasound (US) in up to 76% of the general population and, although most of them are benign, thyroid cancer is the most common malignancy of the endocrine system. PATIENTS AND METHODS: A retrospective, observational study was conducted in 642 patients with suspected hypothyroidism undergoing US. The analysis was addressed exclusively to patients with subclinical hypothyroidism (SCH) or thyroid-stimulating hormone (TSH) levels borderline associated to TNs classified as class I and II; 1 group (control, no. 16) no treatment was prescribed; the other group (treated, no. 18) underwent treatment with 1 tablet containing MI plus selenium (Se) every day, for six months. Clinical data were collected to evaluate the nodular size, number, and elasticity, as well as TSH levels. RESULTS: Final data were analyzed from 34 patients: in 76% of mixed TNs was observed a significant reduction of their size and 56% of them significantly regressed nodule stiffness following oral supplementation with MI plus Se. The mean number of mixed nodules for patient shifted from 1.39 ± 0.16 to 1.05 ± 0.15 (p ≤ 0.05). TSH levels dropped from 4.2 ± 0.21 mIU/L at baseline to 2.1 ± 0.20 mIU/L post-treatment (p < 0.001). In the control group, 38% of TNs reduced their diameter but TSH levels significantly increased up to the threshold after six months (from 3.95 ± 0.18 mIU/L to 4.30 ± 0.22 mIU/L, p ≤ 0.05). CONCLUSIONS: In SCH patients undergoing treatment with MI plus Se, a reduction of the size, number and elasticity score of TNs as well as TSH levels was observed. Further studies are required, either in vitro and in vivo, to investigate the use of MI plus Se for the management of TNs.

A novel treatment for subclinical hyperthyroidism: a pilot study on the beneficial effects of l-carnitine and selenium.

OBJECTIVE: The definition itself of subclinical hyperthyroidism (SHyper) and, therefore, the therapeutic approach to patients with SHyper still remains undefined and controversial. Therefore, the interest of finding a novel and alternative therapy for SHyper has caught the attention. An observational pilot study was performed to assess the effects of l-carnitine and selenium in the management of SHyper symptoms and endocrine profile in patients affected by this disease. PATIENTS AND METHODS: Patients with TSH levels between 0.1-0.4 mIU/L and positive antibodies were recruited in this study. Subjects received orally one tablet containing 500 mg of l-carnitine and 83 mcg of selenium (L-Carn + Se), daily for 1 month. The primary outcome was the improvement of the quality of life (QoL) with the disappearance of main symptoms (subjective symptomatology) associated to SHyper, evaluated through a 9-items short form survey. Secondary outcomes included TSH, fT3, and fT4, TPOAb, TgAb measurement. Primary and secondary outcomes were evaluated at baseline, after the completion of treatment and after a successive month without treatment. RESULTS: After 1-month treatment, the subjective symptomatology significantly dropped from 25.61 ± 1.19 to 12.11 ± 1.15 (p < 0.05). On the other hand, during the following 1-month period without treatment, it increased back to 23.33 ± 1.35 (p < 0.05). Thyroid hormones and auto-antibodies remained in their normal range. CONCLUSIONS: The present pilot study has shown that L-Carn + Se significantly reduced symptoms associated with SHyper, improving QoL of patients, without significant modifications of their endocrine profile. In addition, it is noteworthy that the extension of treatment seems necessary to prevent symptoms reappearance. Prospective randomized controlled trials are needed to address clinicians to define the appropriate treatment-settings for this disorder.

Myo-inositol plus selenium supplementation restores euthyroid state in Hashimoto's patients with subclinical hypothyroidism.

OBJECTIVE: Clinical evidence suggests that oral supplementation with myo-inositol (MI) and selenium (Se) is useful in the treatment of autoimmune thyroiditis. The purpose of this study was to highlight the positive response of Hashimoto's patients with subclinical hypothyroidism (SH) treated with MI and Se (MI-Se) in restoring a normal thyroid function. PATIENTS AND METHODS: A total of 168 patients with Hashimoto's thyroiditis (HT) having Thyroid Stimulating Hormone (TSH) levels between 3 and 6 µIU/ml were randomized into 2 groups: one receiving MI-Se and the other one Se alone. RESULTS: TSH, anti-thyroid peroxidase (TPOAb) and anti-thyroglobulin (TgAb) levels were significantly decreased in patients treated with combined MI-Se after six months of treatment. Also, a significant free serum T4 increase was observed in MI-Se group, along with an amelioration of patients' quality of life. CONCLUSIONS: The administration of MI-Se is significantly effective in decreasing TSH, TPOAb and TgAb levels, as well as in enhancing thyroid hormones and personal wellbeing. Such treatment restored euthyroidism in patients diagnosed with autoimmune thyroiditis.

[Census 2004 of the Italian Renal and Dialysis Units. Veneto, Friuli Venezia Giulia and Trentino Alto Adige]. / Censimento 2004 dei Centri di Nefrologia e Dialisi Italiani. Veneto - Friuli Venezia Giulia - Trentino Alto Adige.

The Italian Society of Nephrology (SIN) promoted a national survey of the Renal and Dialysis Units using an online questionnaire on some aspects of structural, technological and personnel resources, as well as organisation and activity. The major aim of this initiative was to obtain a reference benchmark on a national and regional basis. In this paper the data of the northestern regions of Italy (Veneto, Friuli-Venezia Giulia and Trentino-Alto Adige) are reported and compared with the recently published results of the northwestern regions (Piedmont, Liguria and Valle d'Aosta). From an epidemiologic point of view, the prevalence of dialysis patients was 534 pmp (per million population) in Veneto, 667 pmp in Friuli VG and 545 in Trentino AA, the prevalence of transplanted patients was 265, 294 and 404 pmp, respectively; the incidence of dialysis patients was 137, 182 and 130 pmp; gross mortality was 12.5, 14.3 and 16.5%; the distribution of vascular accesse in prevalently dialysis patients was: arteriovenous fistulas = 84.5, 70.4 and 80.9%, central venous catheters = 10.6, 20.0 and 10.2%, vascular graft = 4.9, 9.6 and 8.8%. Regarding structural resources, the distribution of hospital bed numbers was 38, 42 and 43 pmp; dialysis places were 137, 181 and 172 pmp. Human resources were given by renal physicians = 28.3, 38.2 and 23.6 pmp and renal nurses = 138, 200 and 172 pmp; each renal physician took care of 19, 17 and 23 dialysis patients and each renal nurse cared for 3.9, 3.3 and 3.2 dialysis patients. Activity data showed 1436, 1328 and 974 pmp hospital admissions, kidney biopsies were 106, 114 and 31 pmp. Overall, the Italian Northeast shows a significantly lower prevalence and incidence of end-stage renal disease patients than the Northwest; on the contrary, the incidence of patients with acute renal failure is significantly higher. In the Italian Northeast a significantly lower number of hospital beds devoted to renal patients is observed, while dialysis places are more frequent. In the Northeast fewer renal physicians are present than in the Northwest, whereas renal nurses are equivalent if related to the number of dialysis patients. Activity indexes, intended as amount of hospital admissions and renal biopsies standardised per population, are less significant in the Northeast. The results of the survey in Veneto, Friuli VG and Trentino AA show some discrepancies in the treatment of chronic kidney disease between the three regions and even more among different areas of Italy. Despite similar health care models, a relevant inequality in health care resources is evident.

[Standardization criteria to ensure the uniformity of data collection by the Italian Registry of Dialysis and Transplantation]. / Criteri di uniformità per la raccolta dei dati del Registro Italiano di Dialisi e Trapianto.

The Italian Registry of Dialysis and Transplantation (RIDT) collects data concerning patients in renal replacement therapy (RRT) sent from Regional Registries. Until 2003, the data were sent in summary tables. From 2004, each region has been sending patient data as single non-summarized forms (i.e. one record for each patient). This paper summarizes the collection criteria and the ideal method to codify data ensuring that data sent to the RIDT are consistent. This standardization process is necessary to ensure the statistical analyzability of the data and their comparability with data from other registries. Moreover, the standardization process is the initial step in allowing the RIDT to obtain clinical data to transform the registry from an epidemiological registry to a clinical governance instrument.

Aspirin inhibition of naloxone-induced luteinizing hormone secretion in man.

It is well known that endogenous opioid peptides exert a tonic inhibitory control on GnRH release, leading to the inhibition of LH secretion, whereas eicosanoids, particularly prostaglandin E2(PGE2), stimulate GnRH output. Furthermore, in vitro studies suggest the existence of an interaction between these two regulatory systems in animals. The present work was designed to evaluate the acute effect of the prostaglandin blocker aspirin on plasma LH response to the opiate antagonist naloxone or GnRH in normal volunteers in a placebo-controlled, single-blind study. To exclude a hypothetical action of aspirin directly at the testis level, plasma testosterone concentrations were monitored during basal sampling after acetylsalicylic acid ingestion, whereas the efficacy of the drug as a prostaglandin blocker was tested by the determination of seminal PGE2 levels. Aspirin pretreatment significantly lowered seminal PGE2 levels (from 86 +/- 5 before to 11 +/- 2 micrograms/mL [corrected] after drug administration; P < 0.001) without affecting testosterone concentrations. Moreover, the drug induced a significant reduction of LH response to naloxone, assessed as the mean integrated area under the curve, from 1666.5 +/- 116 to 1197.5 +/- 98 mUI/mL per min (P < 0.05), whereas it did not influence GnRH-induced LH release. We conclude that the effective cycloxygenase blockade inhibits the stimulatory activity of naloxone on LH release, suggesting that the inhibitory tone of opioids on GnRH secretion may be caused by the block of hypothalamic prostaglandin biosynthesis with consequent inhibition of PGE2-induced GnRH secretion.

Rate of reproductive involution following either exposure to short days or daily administration of melatonin is faster in inbred than in random-bred female Syrian hamsters.

The onset of cessation of oestrous cyclicity and associated organ and hormonal changes were compared in random-bred (RB) and inbred (IB) female Syrian hamsters kept either under short days (8 h light:16 h darkness; 8L:16D) or long days (14L:10D) and given daily afternoon injections of 25 micrograms melatonin. In response to short-day treatment, 100% of the IB hamsters exhibited vaginal acyclicity within 35 days; by comparison, none of the RB animals were acyclic at this time. The IB hamsters also exhibited other changes associated with exposure to short days, including increased body weight, enlarged ovaries, regressed uteri, elevated pituitary concentrations of FSH, and depressed pituitary and plasma concentrations of prolactin. At this time, only the pituitary FSH levels were increased in the RB animals kept under the same short-day conditions. In a second experiment, RB and IB female Syrian hamsters were maintained under long days (14L:10D) and the rate of reproductive regression in response to daily afternoon injections of melatonin was compared. After 8 weeks of melatonin injections, 80% of the IB females were anoestrous, while all RB hamsters were still exhibiting 4-day oestrous cycles. Other changes associated with melatonin administration in the IB females included a marked drop in uterine weight and a depression in pituitary and plasma prolactin levels. The RB hamsters, although they were all still cyclic after 8 weeks, had increased body and ovarian weights, increased pituitary concentrations of FSH, and lower pituitary and plasma prolactin levels.(ABSTRACT TRUNCATED AT 250 WORDS)

Endothelin stimulates testosterone secretion by rat Leydig cells.

The present study was designed to evaluate the effects of endothelin (ET) on rat testicular steroidogenesis in vitro and the involvement of prostaglandins (PG) and extracellular calcium in its mechanism of action. To this purpose we examined the effects of ET-1 and ET-3 on basal testosterone secretion, the influence of ET-1 on PGE2 release, the interaction of ET-1 and ET-3 with human chorionic gonadotrophin (hCG) and the interference of indomethacin (an inhibitor of cyclooxygenase) and nifedipine (a calcium-channel blocker) in purified rat Leydig cells. The data indicate that ET-1 and ET-3 stimulate basal and hCG-induced testosterone production although the effects of ET-3 were less marked. In addition, a concomitant release of PGE2 was observed after exposure to ET-1. A synergistic interaction between ET-1 and hCG in stimulating testicular steroidogenesis was revealed. Indomethacin was ineffective in modifying ET-1 evoked testosterone output, while in the presence of nifedipine the stimulatory effect of ET-1 was completely abolished. Since it has been shown by others that ET-1 is produced by rat Sertoli cells and specific binding sites are present in Leydig cells, the results of our study indicate that such a peptide may be regarded as a new paracrine factor able to influence steroidogenesis in Leydig cells. The action of ET-1 requires the activity of voltage-operated Ca2+ channels, while PGE2 activation is not essential for its steroidogenic effect.

Failure to stimulate melatonin synthesis in the rat pineal gland with an adenosine analog.

Recent studies indicate the presence of adenosine binding sites in rat pinealocytes and an effect of their activation on pineal serotonin metabolism. However, controversial data exist, and reports suggest that the role of adenosine in pineal physiology is complex. On this basis, we evaluated the effects of an adenosine analog (N-ethyl-carboxamido-adenosine: NECA) on in vitro and in vivo melatonin production in the rat pineal gland. In the in vitro protocol, pineals were incubated with NECA (0.5 mM, 1 mM, or 2.5 mM) or isoproterenol (ISO: 10(-6)M) for 4 hr. In the in vivo experiments, animals were given NECA (1 mg/kg IP), ISO (0.5 mg/kg IP) or 1 ml saline diluent and sacrificed 2 hr later. The samples were assayed for pineal N-acetyltransferase (NAT) activity and melatonin concentrations. ISO caused the expected marked rise in NAT activity and melatonin levels in both protocols. NECA was ineffective in causing any modification of the parameters measured. We conclude that the adenosine analog NECA may not be involved in the activation of melatonin production. These data contrast with others in which NECA administration resulted in an increase in melatonin levels. The participation, if any, of the purinergic system in the physiology of the pineal gland is still far from being characterized.

Acute amino acids supplementation enhances pituitary responsiveness in athletes.

PURPOSE: The purpose of this study was to determine the effect of a mixture of amino acids on pituitary responsiveness to a stimulation test (GnRH + CRH) in athletes. METHODS: In a double blinded counterbalanced experimental protocol, 10 moderately trained male athletes performed the pituitary stimulation test 60 min after a single oral administration of a placebo (P1-AS) or an amino acid mixture solution (AS) (L-arginine hydrochloride 100 mg x kg(-1) + L-ornithine hydrochloride 80 mg x kg(-1) + L-branched chain amino acids 140 mg x kg(-1): 50% L-leucine, 25% L-isoleucine, 25% L-valine) on two different occasions. Plasma ACTH, LH, FSH, GH, and cortisol were evaluated before (-60, -30, 0 min) and after (+15, +30, +45, +60, +90 min) the stimulation test. RESULTS: The ACTH, LH and FSH response to CRH + GnRH was significantly higher in AS group both as absolute values and area under curve (AUC) values than in P1-AS group. Pre-test and post-test cortisol AUC levels were significantly higher in P1-AS group although a higher percent increase in post-test cortisol was found in AS group. The total GH-AUC was higher in AS group and, as expected, the absolute GH concentrations at different time points were not influenced by CRH + GnRH administration. CONCLUSION: The amino acid mixture used enhanced the ACTH, LH, and FSH response to CRH + GnRH.

[Melatonin/circadian rhythm. Is there a feedback between epiphysis and hypophysis?]. / Melatonina orologio biiologico. Esiste un feedback tra epifisi ed ipofisi?

BACKGROUND: The study evaluates the circadian rhythm of melatonin in relation to sex and age and identified contemporary alterations in the secreton of some hypophyseal hormones, suggesting that melatonin may exert a modulatory action on the latter. METHODS: The melatonin metabolite (6-hydroxymelatonin sulfate) was assayed in urine samples from 48 subjects of both sexes aged between 25 and 60 years old using the RIA method described by Arendt, modified for the ise of iodine markers. A blood sample was taken from the same subjects to assay hypophyseal hormones. RESULTS: Melatonin secretion does not remain constant over 24 hours in young subjects of both sexes, but instead is rhythmic. This rhythmic secretion is lacking in adults, revealing a daytime pineal secreton that is surprisingly higher than in younger persons. A difference in secretion levels was also found between sexes, a higher melatonin peak in females compared to males. Some young female subjects reveal a contemporary hypersecretion of the somatotropic hormone in line with the falling nocturnal peak of melatonin. Subjects with latent hypothyroidism show a diminished melatonin peak compared to that in euthyroid subjects. CONCLUSIONS: Changes in pineal secretion between the second and sixth decade of life are characterised by the loss of rhythmic secretion, linked not only to the loss of the nocturnal peak but an increased daytime secretion compared to younger subjects. The other finding that emerged from this study was the difference in secretion levels between the sexes. Lastly, we affirm that the pineal gland may exert a modulating influence on the hypophysis.