Metabolic syndrome and drug discontinuation in schizophrenia: a randomized trial comparing aripiprazole olanzapine and haloperidol.

OBJECTIVE: To determine whether the prescription of aripiprazole, compared with olanzapine and haloperidol, was associated with a lower frequency of metabolic syndrome (MS) and treatment discontinuation at 1 year. METHOD: Patients were randomly assigned to be treated open-label and according to usual clinical practice with either aripiprazole, olanzapine, or haloperidol and followed up for 1 year. RESULTS: Three hundred out-patients with persistent schizophrenia were recruited in 35 mental health services. The intention-to-treat (ITT) analysis found no significant differences in the rate of MS between aripiprazole (37%), olanzapine (47%), and haloperidol (42%). Treatment discontinuation for any cause was higher for aripiprazole (52%) than for olanzapine (33%; OR, 0.41; P = 0.004), or haloperidol (37%; OR, 0.51; P = 0.030). No significant difference was found between olanzapine and haloperidol. Time to discontinuation for any cause was longer for olanzapine than for aripiprazole (HR, 0.55; P < 0.001). No significant differences were found between haloperidol and aripiprazole, or between olanzapine and haloperidol. CONCLUSION: The prescription of aripiprazole did not significantly reduce the rates of MS, but its treatment retention was worse. Aripiprazole cannot be considered the safest and most effective drug for maintenance treatment of schizophrenia in routine care, although it may have a place in antipsychotic therapy.

Lithium use from 2000 to 2010 in Italy: a population-based study.

INTRODUCTION: Lithium is a highly specific and evidence-supported drug for the acute and maintenance treatment of bipolar disorder. METHODS: The purpose of this study was to calculate the prevalence and incidence of lithium use and to investigate the prescribing patterns of other mood-stabilizing agents in lithium users. We analyzed lithium utilization from 2000 to 2010 in a large area in Italy on the basis of dispensing data drawn from the regional administrative database. For each calendar year those who had at least one recorded dispensation of lithium were defined as lithium users. Those who received more than 4 dispensations per year were defined as lithium-treated. RESULTS: Rates of lithium utilization did not change during the observation period, but the amount of drug prescribed increased as a result of longer treatment and higher doses. The prevalence of use showed an initial increase of 8% (2000-2002), followed by a 13% decrease (2002-2006) and a subsequent rise of 11% (2006-2010). The prevalence of treatment grew by 38% during the whole observation period. The proportion of former lithium users who received other drugs or discontinued any treatment increased from 41% in 2002 to 52% in 2006, and then fell to 40% in 2010. CONCLUSION: The initial decline (2002-2006) and the subsequent rise (2006-2010) of lithium use can be explained by a fall and rise of new prescriptions. This finding together with a similar but opposite change in prescriptions of the other mood-stabilizing agents suggests a temporary change in prescribing attitudes which was subsequently reconsidered.

Validation of the Italian version of the Functioning Assessment Short Test (FAST) for bipolar disorder.

Aim. The Functioning Assessment Short Test (FAST) is a useful instrument for the assessment of overall functioning of people with bipolar disorder, showing good psychometric properties. The aim of this study is to validate the Italian version of FAST. Methods. Translation and back-translation of the original FAST Spanish version were performed. Participants with bipolar disorder (n = 132) and healthy controls (n = 132) completed the FAST as a part of an assessment package including the Montgomery-Asberg Depression Rating Scale and the Young Mania Rating Scale. Internal consistency, inter-rater reliability, construct and discriminant validity were assessed. Results. The FAST Italian version showed good internal consistency, inter-rater reliability and discriminant validity. The cut-off discriminating patients from controls was 15, with a sensitivity of 0.79 and a specificity of 0.80. Principal component analysis with oblique rotation showed factor loadings consistent with the a priori structure of the instrument. Conclusions. This study confirmed the psychometric properties of FAST and extended its generalization and validity to the Italian population.

Marital therapy for depression.

BACKGROUND: Marital therapy for depression has the two-fold aim of modifying negative interaction patterns and increasing mutually supportive aspects of couple relationships, thus changing the interpersonal context linked to depression. OBJECTIVES: 1. To conduct a meta-analysis of all intervention studies comparing marital therapy to other psychosocial and pharmacological treatments, or to non-active treatments. 2. To conduct an assessment of the internal validity and external validity. 3. To assess the overall effectiveness of marital therapy as a treatment for depression. 4. To identify mediating variables through which marital therapy is effective in depression treatment. SEARCH STRATEGY: CCDANCTR-Studies was searched on 5-9-2005, Relevant journals and reference lists were checked. SELECTION CRITERIA: Randomised controlled trials examining the effectiveness of marital therapy versus individual psychotherapy, drug therapy or waiting list/no treatment/minimal treatment for depression were included in the review. Quasi-randomised controlled trials were also included. DATA COLLECTION AND ANALYSIS: Data were extracted using a standardised spreadsheet. Where data were not included in published papers, two attempts were made to obtain the data from the authors. Data were synthesised using Review Manager software. Dichotomous data were pooled using the relative risk (RR), and continuous data were pooled using the standardised mean difference (SMD), and 95% confidence intervals (CIs) were calculated. The random effects model was employed for all comparisons. A formal test for heterogeneity, the natural approximate chi-squared test, was also calculated. MAIN RESULTS: Eight studies were included in the review. No significant difference in effect was found between marital therapy and individual psychotherapy, either for the continuous outcome of depressive symptoms, based on six studies: SMD -0.12 (95% CI -0.56 to 0.32), or the dichotomous outcome of proportion of subjects remaining at caseness level, based on three studies: RR 0.84 (95% CI 0.32 to 2.22). In comparison with drug therapy, a lower drop-out rate was found for marital therapy: RR 0.31 (95% CI 0.15 to 0.61), but this result was greatly influenced by a single study. The comparison with no/minimal treatment, showed a large significant effect in favour of marital therapy for depressive symptoms, based on two studies: SMD -1.28 (95% CI -1.85 to -0.72) and a smaller significant effect for persistence of depression, based on one study only. The findings were weakened by methodological problems affecting most studies, such as the small number of cases available for analysis in almost all comparisons, and the significant heterogeneity among studies. AUTHORS' CONCLUSIONS: There is no evidence to suggest that marital therapy is more or less effective than individual psychotherapy or drug therapy in the treatment of depression. Improvement of relations in distressed couples might be expected from marital therapy. Future trials should test whether marital therapy is superior to other interventions for distressed couples with a depressed partner, especially considering the role of potential effect moderators in the improvement of depression.

Health effects of job insecurity among employees in the Swiss general population.

This study looks at the health consequences of the social distress caused by perceived levels of job insecurity. Through interviews with full- and part-time employees drawn from a random sample (N = 2,024) of the Swiss general population, the authors measured prevalence rates of ten self-reported indicators of health and health-related behavior according to three levels of perceived job insecurity (low, middle, high), and estimated odds ratios using logistic regression adjusted for relevant respondent characteristics. The results show that the psychosocial stress induced by job insecurity (fear of unemployment) has a negative effect on these health indicators. Fear of unemployment had a stronger unfavorable effect on health for highly educated employees than for the less educated. The authors make some recommendations for raising awareness about the health effects of job insecurity and taking these effects into account in policies and legislation affecting the labor market and work environment.

Family interventions in schizophrenia and related disorders: a critical review of clinical trials.

OBJECTIVE: To update evidence from studies on family intervention in schizophrenia looking carefully at methodological issues. METHOD: Twenty-five studies were reviewed, using specific outcome criteria, and computing effect sizes whenever possible. RESULTS: Effect on relapse is relatively well assessed, although differences emerged particularly in comparison with poor control treatments and disappeared in recent studies. Findings on patient's symptoms, social functioning or family variables are limited and affected by methodological pitfalls. No difference between intervention models emerged, although behavioural/psycho-educational approaches were better investigated. Patients' inclusion, greater frequency and length of treatment led to better results. The main flaws were: poor control of standard treatment, small sample sizes, failure in evaluating clinical significance in continuous outcome variables. CONCLUSION: It remains unclear whether the effect depends on family treatment or on more intensive care. The failure to relate outcome to family-mediating variables is a challenge to the rationale underlying family interventions.

Host-related and environmental risk factors for cutaneous basal cell carcinoma: evidence from an Italian case-control study.

BACKGROUND: Despite its frequency, there is a paucity of data on risk factors for basal cell carcinoma. OBJECTIVE: We assessed potential risk factors for basal cell carcinoma in a population from southern Europe. METHODS: This multicenter case-control study involved 528 newly diagnosed cases and 512 controls. RESULTS: In the multivariate analysis, red hair, lighter colored eyes, high nevus counts on the upper limbs, and the presence of solar lentigines and actinic keratoses were all associated with basal cell carcinoma. The risk of the tumor increased in subjects who reported burning easily and experiencing sunburn episodes before 15 years of age. An association was documented with indices of recreational sun exposure but no clear evidence of exposure-effect relationship was found. No relation was found with occupational sun exposure. Finally, basal cell carcinoma appeared to be significantly associated with a family history of skin tumors, a personal history of tumors other than those on skin, and radiotherapy. CONCLUSION: Genetic and environmental factors appear to be involved in the onset of basal cell carcinoma.

Misoprostol and congenital anomalies.

Purpose- To evaluate the risk of having a baby with congenital anomalies in mothers who used misoprostol during pregnancy.Methods- Hospital-based case - control study from Hospital Chateaubriand, Fortaleza, Brasil. Cases were 37 babies weighing less than 1500 g with congenital anomalies of various types, and the comparison group included 387 infants also weighing less than 1500 g, and without congenital anomalies.Results- The multivariate odds ratio of having a baby with congenital anomalies was 2.4 (95% confidence interval 1.0 - 6.2) in mothers who reported having used misoprostol compared with those who did not.Conclusions- Misoprostol use during pregnancy might be related to a broad spectrum of congenital anomalies in infants. Copyright (c) 2000 John Wiley & Sons, Ltd.

The Qualyop Project. 1: Monitoring the dismantlement of Italian public psychiatric hospitals. Characteristics of patients scheduled for discharge.

OBJECTIVES: Monitoring and evaluating the Italian psychiatric hospitals closure process, stated by the law to be concluded by 31 December 1996, and then postponed to 31 March 1998, identifying characteristics related to the possibility of discharge in 4493 patients living in twenty-two public psychiatric hospitals. METHOD: Sociodemographic and clinical data, information on impairment and functioning and plans for discharge in the subsequent twelve months of all patients were collected at baseline using a standard questionnaire. RESULTS: Discharge was planned within twelve months for 11% of the patients: 4% to other psychiatric or non-psychiatric institutions and 7% to community settings. Severely disabled patients and patients with some behavioural problems were more frequently scheduled to go to institutional settings. For both types of discharge, an adequate network of social relationships was an important determinant. Patients were more frequently planned for discharge if they resided in hospitals with a higher care providers/patients ratio, and in Emilia Romagna and Rome, than in Lombardy and Liguria. CONCLUSION: Frequency of planned discharge depended partly on the patients' personal characteristics related to independence and functioning, but the effect of these factors on frequency of planned discharge was influenced by characteristics of the hospitals where the patients lived.

Antidepressant drug use in Italy since the introduction of SSRIs: national trends, regional differences and impact on suicide rates.

Little is known about the use of antidepressant drugs in Italy since the introduction of selective serotonin reuptake inhibitors (SSRIs). To fill this gap, we examined antidepressant drug sales data from 1988 to 1996 for the whole country, and for the years 1995 and 1996 on the regional level. National suicide trends from 1988 to 1994 were also examined to assess whether the increasing use of SSRI antidepressants was associated with changes in suicide rates. From 1988 to 1996 an increase of antidepressant sales of 53% was recorded. This increase reflected increasing use of SSRIs, which in 1996 accounted for more than 30% of total antidepressants sold. The analysis of regional differences demonstrated heterogeneity between north, center, and south. In the south prescriptions of antidepressants and use of SSRIs were lower than in the rest of the country. In the 7-year period over which SSRI use increased, male suicide rates increased from 9.8 to 10.2 per 100,000 inhabitants, and female suicide rates declined from 3.9 to 3.2 per 100,000. These data suggest that SSRIs gave a new impetus to antidepressant sales. However, possible public health benefits related to the shift from old to new antidepressants have yet to be demonstrated.

QUALYOP project 2: monitoring the dismantling of Italian psychiatric hospitals. Psychotropic drug use in 1072 inpatients.

OBJECTIVE: This study describes the use of psychotropic drugs in a sample of eight Italian psychiatric hospitals. METHODS: A cross-sectional approach was used to collect information about sociodemographic and clinical characteristics of the inpatient population, and about medications prescribed. Prescribing behaviour in the hospitals was compared using three indicators: the number of patients taking psychotropic drugs, the use of high doses of neuroleptics and the use of multiple neuroleptics. RESULTS: More than a thousand patients were resident in the eight hospitals on the census day, 56% of them males. Half the population had an ICD-X diagnosis of schizophrenia, one third of mental retardation. Sixty-nine percent of the sample was on neuroleptic therapy, nearly 47% on benzodiazepines and 4% on antidepressants. Twenty percent of the sample did not take any psychotropic drug on the census day. After adjustment for sociodemographic and clinical variables, setting-related variables resulted as determinants of psychotropic drug use. CONCLUSIONS: These data call for continuing education in psychopharmacology towards a more rational use of drugs; longitudinal audits of clinical practice should be implemented to guide clinicians toward a more rational use of psychotropic drugs.

Beta-carotene intake and risk of nonfatal acute myocardial infarction in women.

There are indications that beta-carotene, but not pre-formed vitamin A, is protective on the risk of acute myocardial infarction (AMI). The relationship between nonfatal AMI and the intake of beta-carotene and retinol was investigated in a case-control study conducted between 1983 and 1992 in northern Italy on 433 women with nonfatal AMI and 869 controls in hospital for acute, non-cardiovascular, non-neoplastic, non-digestive, non-hormone related conditions. Odds ratios (OR), with their 95% confidence intervals (CI), were computed by unconditional multiple logistic regression analysis, including terms for age, education, body mass index, smoking, alcohol and coffee drinking, menopausal status, hormone replacement therapy and history of diabetes, hypertension and hyperlipidemia. The risk of AMI was inversely related to beta-carotene intake, with an OR of 0.5 (95% CI: 0.3 to 0.8) for the highest quintile of intake compared to the lowest (chi2 trend = 10.53, p < 0.01). Retinol intake was not associated with AMI, with an OR of 0.9 (95% CI: 0.6 to 1.3) for the highest quintile of intake compared to the lowest. Analysis in separate strata of covariates indicated that the inverse association of beta-carotene intake with risk of AMI was appreciably stronger in younger, lean women with no history of diabetes or hypertension, and in current smokers. The results of this study indicate that the risk of nonfatal AMI in women is inversely related to intake of beta-carotene containing foods, but not foods containing retinol.

Body weight and risk of nonfatal acute myocardial infarction among women: a case-control study from northern Italy.

BACKGROUND: The relationship between nonfatal acute myocardial infarction (AMI) and self-reported body weight and body mass index (BMI; Quetelet index, kg/m2) has been investigated. METHODS: A case-control study was conducted between 1983 and 1992 in northern Italy on 432 women with nonfatal AMI and 867 controls in hospital for acute, noncardiovascular, nonneoplastic, nondigestive, non-hormone-related conditions. Odds ratios (OR), with their 95% confidence intervals (CI), were computed by unconditional multiple logistic regression analysis, including terms for age, education, and smoking, plus history of selected diseases. RESULTS: Women with body weight and BMI in the highest quartile had an increased risk of AMI after allowance for age, education, and smoking status (OR 1.5, 95% CI 1.0 to 2.2, and OR 1.7, 95% CI 1.2 to 2.4, respectively). Compared with leaner women, the risk was higher among women with BMI above the median, in association with a history of diabetes (OR 5.2) or hyperlipidemia (OR 6.0). Hypertensive women had similar OR in the two strata of BMI (OR 5.1 and 4.8). The association of BMI with risk of AMI was apparently stronger among women younger than 50 years and among less educated women, but was similar among smokers and never smokers. CONCLUSIONS: The results of this study confirm that AMI among women is related to excess BMI, with a population attributable risk of 17%. The excess risk was substantial among overweight women with history of diabetes or hyperlipidemia, stressing the importance of controlling body weight among these women.

Selected micronutrient intake and thyroid carcinoma risk.

BACKGROUND: Protection from thyroid carcinoma due to certain dietary factors was suggested by several studies, but the findings were relatively inconsistent. The role of micronutrients has not yet been systematically analyzed. To investigate the relationship between micronutrient intake and thyroid carcinoma risk, the authors used data from a case-control study conducted in northern Italy between 1986 and 1992. METHODS: The study included 399 incident, histologically confirmed thyroid carcinoma cases and 617 controls admitted to the hospital for acute, nonneoplastic, nonhormone-related diseases. RESULTS: Retinol intake showed a direct association with thyroid carcinoma risk, with odds ratios (ORs) of 1.39 (95% confidence Interval [CI], 0.9-2.0) in the third quartile of consumption and 1.52 (95% CI, 1.0-2.3) in the highest quartile, whereas beta-carotene had an inverse relationship, with ORs of 0.63 (95% CI, 0.4-0.9) in the third quartile of consumption and 0.58 (95% CI, 0.4-0.9) in the highest quartile compared with the lowest quartile. Some protection was observed for measures of vitamin C intake (with an OR of 0.72) and vitamin E (with an OR of 0.67) for the highest quartile of consumption, although the estimates were not statistically significant, and were reduced after adjustment for beta-carotene intake. No clear pattern in risk appeared for vitamin D, lolate, calcium, thiamin, or riboflavin. The inverse relationship between beta-carotene and thyroid carcinoma was observed in both papillary and follicular carcinomas. CONCLUSIONS: In this study, a significant inverse association between beta-carotene and thyroid carcinoma was observed, and some protection against thyroid carcinoma from vitamins C and E was also suggested.

An assessment, and reproducibility of food frequency data provided by hospital controls.

In order to assess the comparability and reproducibility of information from a questionnaire used in a case-control study on digestive tract cancers conducted in Italy, a total of 400 subjects were randomly selected from a large sample of hospital controls and contacted at home to repeat the interview. Of these, 294 (73%) subjects were re-interviewed. Mean values of intake were computed for the 400 subjects selected, and among the 294 responders for the first and second interview. These values were comparable, most of them being within a 10% range. Spectrum correlation coefficient (rs) values of consumption between the first and second interview were > 0.65 for consumption of pastries, pasta or rice, bread, fish, milk, green vegetables, eggs and apples; between 0.50 and 0.65 for meat, chicken, liver, ham, cold cuts, cheese, fruit, cabbage, carrots, tomatoes, peppers, salad, citrus fruit and melon; and lower than 0.50 for a few infrequently eaten foods. For all foods, the estimated average weekly intake in the second interview increased consistently and substantially with increasing tertile of the first interview. This study shows a satisfactory comparability of dietary information from subjects interviewed at home with that provided during their original interview in the hospital, and a good reproducibility of information collected in the two settings.

Quitting smoking in northern Italy: a cross-sectional analysis of 2621 subjects.

To describe the relationship between sociodemographic factors, life-style habits, selected dietary indicators, smoking-related variables, and quitting smoking we analyzed data derived from the comparison group of a case-control study of colorectal and breast cancers based on a network of teaching and general hospitals in Northern Italy. A total of 2621 subjects (1215 women and 1406 men) who were ever cigarette smokers were included for analysis. Age-adjusted rates of stopping smoking (quit rates) and multivariate odds ratios (OR) of quitting smoking were computed. The overall age-adjusted quit rate was 38.6% for males and 24.9% for females, corresponding to an OR of quitting of 0.6 (95% CI: 0.5-0.7) for females vs males. The quitting rate increased with increasing age. After allowing for age, smoking cessation was more frequently reported by more educated or higher social class individuals. No relationship was present between quitting smoking and alcohol consumption, but quitting smoking was inversely related to coffee consumption. The probability of quitting smoking increased directly with number of cigarettes among males but not among females, who showed a J-shaped pattern. Older, heavy smokers were more likely to give up smoking. A general pattern of increasing rates of quitting smoking with higher consumption of vegetables and fruit, and hence beta-carotene, was present. This study confirms a positive association between quitting smoking and increasing age, higher education, low coffee consumption, heaviness of smoking and high consumption of vegetables and fruit.

Nutrient intake according to education, smoking, and alcohol in Italian women.

The control group of a hospital-based case-control study on breast cancer was used to assess the relationships between education, smoking habits, alcohol consumption, and intake of selected macro- and micronutrients in Italian women. The study subjects were 2,588 women admitted to a network of hospitals in various Italian regions for nonneoplastic, acute diseases unrelated to long-term changes in the diet. Although relatively few differences were observed, less educated subjects consumed more linoleic acid and polyunsaturated fats than did more educated women. Smoking habits were associated with the largest differences in selected antioxidant vitamins. Significant differences were observed for beta-carotene and vitamin C intake, with an 11% higher intake of beta-carotene and a 12% higher intake of vitamin C in ex-smokers than in current smokers. Heavier alcohol drinkers tended to consume more retinol and iron but less beta-carotene than did moderate or nondrinkers. Thus the differences in macro- and micronutrient intake were generally moderate across categories of education, smoking, and alcohol consumption in this data set of Italian women. Nonetheless, they confirm the importance of allowing for these variables in analyzing the relationship between nutritional factors and disease risk.