Long-term acetyl-L-carnitine treatment in Alzheimer's disease.

In a double-blind, placebo-controlled, parallel-group, randomized clinical trial, we studied the efficacy of long-term (1-year) oral treatment with acetyl-L-carnitine in 130 patients with a clinical diagnosis of Alzheimer's disease. We employed 14 outcome measures to assess functional and cognitive impairment. After 1 year, both the treated and placebo groups worsened, but the treated group showed a slower rate of deterioration in 13 of the 14 outcome measures, reaching statistical significance for the Blessed Dementia Scale, logical intelligence, ideomotor and buccofacial apraxia, and selective attention. Adjusting for initial scores with analysis of covariance, the treated group showed better scores on all outcome measures, reaching statistical significance for the Blessed Dementia Scale, logical intelligence, verbal critical abilities, long-term verbal memory, and selective attention. The analysis for patients with good treatment compliance showed a greater drug benefit than for the overall sample. Reported adverse events were relatively mild, and there was no significant difference between the treated and placebo groups either in incidence or severity.

Direct and indirect costs of schizophrenia in community psychiatric services in Italy. The GISIES study. Interdisciplinary Study Group on the Economic Impact of Schizophrenia.

BACKGROUND: The present work is a cost-of-illness (COI) study that aims at assessing total direct and indirect costs of schizophrenic patients in community psychiatric services in Italy and identifying the variables that influence costs. METHODS: A retrospective prevalence-based multi-centre COI study, was designed. Ten community mental health centres (CMHC) were involved and 100 patients were recruited. Data on patients' costs were gathered through specifically designed instruments. RESULTS: More than half total direct costs were attributed to CMHC interventions. The yearly average costs of schizophrenia per patient amounted to nearly ITL 50 million: 30% for direct costs and 70% for indirect costs. CONCLUSION: CMHCs tend to manage long-term ill patients by adopting a strong community-based system of care. Schizophrenia is correlated to loss of working days and lack of well-being. From the results of this study, it might be argued that the de-institutionalisation programme has produced 'spillovers' in terms of families' greater involvement in patients management.

Mortality of demented patients in a geriatric institution.

A group of 237 elderly patients with dementia of Alzheimer type (DAT) or multi-infarct dementia (MID) was randomly selected in a large geriatric institution in Milan. Mean age of the sample was 78.9 years, 160 (67.5%) were DAT patients and 77 (32.5%) were MID patients. Half of the sample had low levels of autonomy and after 4 years 183 (77.2%) patients were dead. Predictors of mortality, according to a univariate analysis, were age, level of autonomy and type of diagnosis (DAT vs. MID). Mortality rate after 4 years was significantly higher (p less than 0.001) in DAT (86.9%) than in MID (57.1%) patients.

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.

The provision of psychiatric care in southern Italy. Results from the 'Psychiatry in Southern Italy's Services' (De PISIS) survey.

OBJECTIVE: To describe structural features, attenders' characteristics and intervention habits in a large sample of Community Mental Health Departments (CMHDs) in Southern Italy. DESIGN AND SETTING: 1) Survey of resources and organization features of collaborating CMHDs; 2) Unreplicated registration of all attenders and of therapeutic interventions during an index week. RESULTS: A self-selected sample of 47 CMHDs in Southern Italy recruited 3845 patients during the last week of October 1992. Participating CMHDs were serving a socially deprived and severely ill population: 45.8% of attenders had 8 years or less of formal education; only 18.9% were employed, 30.9% of diagnoses were of the schizophrenia spectrum group and 23% of the affective disorders group. Sixty-eight per cent of patients were being treated with psychotropic drugs, while only 19% received rehabilitative interventions. The activity of CMHDs were oriented more towards the control of active symptomatology than towards rehabilitation. A significantly higher proportion of patients receiving a schizophrenia-spectrum disorder diagnosis were found in contact during the index week with those CMHDs providing both residential and semiresidential (day-hospital, community center) facilities.

[An epidemiological study in basic medicine on the health status of the "very old"]. / Studio epidemiologico nella medicina di base sullo stato di salute dei "grandi anziani".

A research protocol on the health and social situation of a sample of "very old" people seen in a setting of general practice. Besides its objective of defining the spectrum of problems presented by this group of patients, the investigation aims at evaluating the impact of an intervention which should include all the members of the care team (doctors, nurses, social and health assistants), to allow due attention also to the problems of relatives and of those who assure home assistance to the elderly.

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.

An example of a clinical trial in patients with Alzheimer's disease: some methodological issues.

UNLABELLED: In ten Italian centers--hospitals and geriatric institutions--130 outpatients and inpatients with a diagnosis of Alzheimer's disease were recruited for a randomized, double blind, placebo controlled clinical trial with 1-acetylcarnitine. In planning the trial, we had to deal with some important and largely open issues. DIAGNOSIS: we decided not to use neuropsychological tests (NPT) in the diagnostic process, both for the unknown risk of false positive and false negative rate and to improve the feasibility of the trial. FOLLOW-UP: it must be representative of the disease and consequently we chose to follow the patients for one year (assessment at baseline, 3rd, 6th and 12th month) in spite of a possible high rate of drop-outs. ASSESSMENT: to assess the patients' outcome we used NPT and behavioural scales. However, the validity, reliability and feasibility of these instruments are rarely discussed and their usefulness as indicators of the relevant aspects of the disease needs a careful evaluation. STATISTICAL ANALYSIS: in this type of trial there is both a high risk of alpha-error, in view of the high number of NPT and behavioural scales used to assess the drug efficacy, and a high risk of beta-error connected with the usually small sample size. Thus, the role of small trials in defining the risk/benefit ratio of a treatment needs to be discussed.

Drug use by the elderly in Italy.

OBJECTIVES: To evaluate drug consumption in the elderly aged 75 years or more living at home. DESIGN: Cross-sectional study. SETTING: Old-old (i.e., > or = 75 y) people living in central Turin, a city in northern Italy. PARTICIPANTS: Thirty-four general practitioners (GPs), with 50 or more old-old people in their patient list, randomly chosen among the GPs working in the Unità Socio-Sanitaria Locale I (Local Health Unit I) of Turin; 261 old-old people (135 men and 126 women) randomly selected from the practice records. METHODS: Data were collected by the GP through a structured questionnaire during an office visit and by a social worker in a home interview within 14 days of the GP visit. GPs were asked to record every diagnosis and drug currently taken by the patient; social workers were trained in the administration of a structured questionnaire exploring sociodemographic variables, drug use (following the medication inventory strategy), disability, cognitive functions, and depressive symptoms. RESULTS: Nearly all subjects (95% of the women and 91% of the men) were taking at least 1 drug. The overall number of drugs recorded was 917 (47.1% for men and 52.9% for women), of which 172 (18.8%) were not reported by the GP but were recorded during the social worker's visit. The mean number of drugs was 3.2 for men and 3.8 for women, with a statistically significant difference (p = 0.02), while the mean number of diagnoses was 2.3 and 2.6, respectively. The study of correlates of drug consumption showed a strong association with number of diagnoses at univariate analysis (p < 0.0001, with a linear correlation coefficient of 0.64). No multivariate model showed a clear superiority over the simple one containing only the number of diagnoses in predicting the total number of drugs taken. Cardiovascular, nervous system, and alimentary tract drugs were the most frequently used. A total of 107 subjects (41%) were taking at least 1 unreported drug. CONCLUSIONS: Our study shows high drug consumption among old-old people, with nearly 20% of drugs taken not reported by the GP. These results emphasize the need for an essential therapeutic approach in old-old people, prescribing only drugs of scientifically proven efficacy. Furthermore, the GP must make more effort when collecting a drug history from old-old patients.

[The elderly and drugs: the possible role of a home visit in improving a "difficult relationship". I. The results of an epidemiological study of drug prescription and use by the elderly conducted in the area of local health unit No. 1-23 in Turin]. / Anziani e farmaci: possibile ruolo di una visita a domicilio nel miglioramento di una "relazione difficile". Parte I: risultati di uno studio epidemiologico sulla prescrizione e l'uso dei farmaci nell'anziano condotto nel territorio dell'U.S.L. 1-23 de Torino.

A random sample of 46 general practitioners of the Unità Sanitaria Locale in Torino recruited 802 elderly outpatients and collected information about complaints and current drug treatment. Within a week each patient received a home interview and details were collected on drug compliance and use of drugs other than those reported by the GP. On average, each patient was taking 3.6 drugs of which 2.9 were correctly reported by the GP and 0.7 were un reported. Among the most prescribed therapeutic groups there were drugs with a narrow therapeutic index (cardiovascular drugs, diuretics, psychotropic agents) and substances whose efficacy has never been fully documented ("cerebroactive/vasoactive"). Age and number of compliants were positively and significantly correlated with number of prescribed drugs. The most common reason for non-compliance was fear of side-effects.