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C Barbui

Publications and source records attributed to C Barbui.

36 records · Page 2Linked to original sources
PubMed2001

Amitriptyline v. the rest: still the leading antidepressant after 40 years of randomised controlled trials.

BACKGROUND: Tricyclic antidepressants have similar efficacy and slightly lower tolerability than selective serotonin reuptake inhibitors (SSRIs). However, there are no systematic reviews assessing amitriptyline, the reference tricyclic drug, v. other tricyclics and SSRIs directly. AIMS: To review the tolerability and efficacy of amitriptyline in the management of depression. METHOD: A systematic review of randomised controlled trials (RCTs) comparing amitriptyline with other tricyclics/heterocyclics or with an SSRI. RESULTS: We reviewed 186 RCTs. The overall estimate of the efficacy of amitriptyline revealed a standardised mean difference of 0.147 (95% CI 0.05-0.243), significantly favouring amitriptyline. The overall OR for dropping out was 0.99 (95% CI 0.91-1.08) and that for side-effects was 0.62 (95% CI 0.54-0.70), favouring the control drugs. With drop-outs included as treatment failures, the estimate of the effectiveness of amitriptyline v. tricyclics/heterocyclics and SSRIs showed a 2.5% difference in the proportion of responders in favour of amitriptyline (number needed to treat 40, CI 21-694; OR 1.12 (95% CI 1.01-1.24)). CONCLUSIONS: Amitriptyline is less well tolerated than tricyclics/heterocyclics and SSRIs, but slightly more patients treated on it recover than on alternative antidepressants.

Amitriptyline↗
PubMed2001

Direct costs of schizophrenia in Italian community psychiatric services.

OBJECTIVE: To estimate resource utilisation and direct costs of treatment for patients with schizophrenia in Italian Community Mental Health Centers (CMHCs). DESIGN: Multicentre, retrospective observational study. CMHCs recruited all patients who attended a follow-up consultation during the period September to December 1998. At enrollment, psychiatrists completed a questionnaire on consumption of resources in the 2 months before recruitment. SETTING: 14 CMHCs. PERSPECTIVE: Italian National Health Service (INHS). PATIENTS: 702 patients with a diagnosis of schizophrenia or other psychotic disorders, defined according to the Diagnostic and Statistical Manual of Mental Disorders-fourth edition. These patients had been followed by the CMHCs for at least 2 years and attended a follow-up consultation either during the period September to December 1998 or on randomly selected days during this period. Patients were classified into seven groups according to their diagnosis. RESULTS: The mean direct cost of patients with schizophrenia in the 2-month observation period was 2,234,475 Italian lire [L] (1154.01 Euro; EUR); direct costs ranged from L.1,545,818 to L.2,775,658 (EUR798.35 to EUR1433.51) by prognostic group. There was wide variability for prognostic groups in the impact of most cost components on total cost. Admissions accounted for between 11.4 and 56.3% of the total cost, daycare centre days for between 11.3 and 35.5%, home visits for 7.8 to 16.4%, and day-hospital days for 5.4 to 32.8%. Antipsychotics and anxiolytics were the most prescribed drugs and also the most costly. CONCLUSION: Despite the limitations of the study related to the short period considered, we believe this study offers some interesting information on the burden of schizophrenia, a disease for which its cost has received limited attention so far in Italy.

Adult↗
PubMed2000

Selective serotonin reuptake inhibitors versus tricyclic and heterocyclic antidepressants: comparison of drug adherence.

BACKGROUND: Selective serotonin reuptake inhibitors are thought to have better discontinuation rates (i.e. less people dropping out) than tricyclic and heterocyclic antidepressant drugs. It is important to quantify the drop-out rates of different antidepressant drugs in order to have a better understanding of the relative tolerability of these drugs. OBJECTIVES: To assess the comparative tolerability of selective serotonin reuptake inhibitors and tricyclic/heterocyclic antidepressant drugs. SEARCH STRATEGY: We searched the Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Registers (1997 to 1999), MEDLINE (1966 to 1999), EMBASE (1974 to 1999) We also searched specialist journals, the reference lists of relevant papers and previous systematic reviews, conference abstracts and government documents. Representatives of the pharmaceutical industry were contacted. SELECTION CRITERIA: Parallel group randomised controlled trials comparing selective serotonin reuptake inhibitors with tricyclic or heterocyclic antidepressants in people with depression. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and a third reviewer checked any cases of disagreement. MAIN RESULTS: We included 136 trials. The selective serotonin reuptake inhibitors showed less participants dropping out compared to the tricyclic/heterocyclic group (odds ratio 1.21, 95% confidence interval 1.12 to 1.30). A statistically significant difference was found in total drop-outs between the selective serotonin reuptake inhibitors and the old tricyclics as well as the newer tricyclics. When the selective serotonin reuptake inhibitors were compared to the heterocyclic antidepressants, there was a non significant difference favouring the selective serotonin reuptake inhibitors. The poor tolerability profile of the old tricyclics was explained by differences in drop-outs for side-effects, but not for inefficacy. REVIEWER'S CONCLUSIONS: Whilst selective serotonin reuptake inhibitors do appear to show an advantage over tricyclic drugs in terms of total drop-outs, this advantage is relatively modest. This has implications for pharmaco-economic models, some of which may have overestimated the difference of drop-out rates between selective serotonin reuptake inhibitors and tricyclic antdepressants. These results are based on short-term randomised controlled trials, and may not generalise into clinical practice.

Antidepressive Agents↗
PubMed2000

Does placebo help establish equivalence in trials of new antidepressants?

Clinical trials of new antidepressants usually compare a new drug to a reference antidepressant and to a placebo. The placebo is intended to validate the trial in the case of a no-difference outcome, i.e., it helps in assessing equivalence. The aim of the present paper is to test whether placebo has indeed helped establish equivalence of effect in comparative trials of new antidepressants. We carried out an example of sample size determination first in a trial to show a difference between the new and control drug, and second in a trial to assess equivalence between two competing drugs. Finally, we retrospectively calculated the maximum difference accepted as equivalence of effect in published trials of new antidepressants. Assuming a response rate to antidepressants of 70%, 294 subjects for each treatment group are needed to show a 10% difference between two antidepressant drugs and more than 1,300 to assess equivalence at a 5% level of delta, the maximum difference acceptable as equivalence of effect. The level of delta in published trials of new antidepressants ranges between 12 and 43%, suggesting they cannot claim to demonstrate equivalence of effect. Therefore, the presence of a placebo arm for comparison didn't help establish whether both drugs really worked the same way. Comparative trials of new antidepressants should adopt a two-arm design, a suitable number of patients and a high standard in the experimental design in order to minimise possible control-event rate variation.

Antidepressive Agents↗
PubMed2000

Italy's mad law.

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Commitment of Persons with Psychiatric Disorders↗
PubMed1999

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.

Journal Article↗
PubMed1999

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.

Antidepressive Agents↗
PubMed1999

Clinical trials of new antipsychotics: a critical appraisal.

In recent years the efficacy of new antipsychotics has been investigated through a number of randomized controlled trials. This paper considers some methodological flaws that affect these studies and proposes possible solutions. The final goal is the implementation of a new generation of trials with the aim of demonstrating superiority of effect of the new antipsychotic over the reference one.

Antipsychotic Agents↗
PubMed1999

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.

Activities of Daily Living↗
PubMed1998

Antidepressant agents: from tricyclics to serotonin uptake inhibitors.

BACKGROUND: The number of antidepressant drugs available in the market has grown rapidly in the last few years. The present paper underlines some of the pre-clinical and clinical problems that call close attention from the regulatory authorities when approving new drugs. METHODS: We present here a review of the literature. RESULTS: A wide heterogeneity in the action of the various antidepressants precludes any single theory about the pathogenesis and therapy of depression. Antidepressant activity, in fact, may be achieved by acting on a number of different monoaminergic mechanisms. The variety in the neurochemical effects of antidepressants is not reflected in clinical trials, which tend to stereotypy. In many cases clinical trials aim at demonstrating equivalence rather than differences in efficacy. Regulatory authorities should, therefore, pay attention in accepting the equivalence of effects of a new drug in relation to a reference one: most clinical trials of new antidepressant drugs do not have the power to detect clinically relevant differences. CONCLUSIONS: Unconventional new pre-clinical tests are needed to generate antidepressants with a different mechanism of action. Clinical studies are needed to promote objective comparative evaluation of the cost, benefits and toxic effects of new antidepressants.

Antidepressive Agents↗
PubMed1998

A cross-sectional audit of benzodiazepine use among general practice patients.

In order to assess how many general practice patients take benzodiazepines for long periods, a cross-sectional audit of clinical practice was conducted. During a 3-day census period, 26 general practitioners in the area of Bergamo, Italy, entered into the study every patient who was taking benzodiazepines. The prevalence of use of this class of drugs was 14.0% (CI 12.5-15.7), while the prevalence of daily use for 12 months or more was 4.7% (CI 3.8-5.8). Finally, the prevalence of very long-term use of benzodiazepines, i.e. those taking these drugs for more than 10 years, was 0.65% (CI 0.34-1.14). Compared to non-long-term users, long-term users were older (OR 2.38, CI 1.39-4.08) and had a lower level of education (OR 2.40, CI 1.04-5.54). In addition, insomnia was associated with long-term use of this class of drugs (OR 1.82, CI 1.02-3.24). These findings provide evidence that the long-term use of benzodiazepines is an important issue in everyday general practice and that this calls for precise management tactics.

Adolescent↗
PubMed1998

Olanzapine on trial.

Explore the source record for details and available documents.

Antipsychotic Agents↗
PubMed1997

Poverty and mental illness.

OBJECTIVE: To assess the relationship between poverty and mental illness in order to stimulate debate on future international cooperation programs in mental health. METHOD: Epidemiological data in the international literature addressing the issue of material poverty as a risk factor for the development of mental illness and as a prognostic factor for the outcome of mental illness were reviewed. RESULTS: The international literature reviewed supports the notion that material poverty is a risk factor for a negative outcome among mentally ill people. In addition, preliminary epidemiological data suggest that service-related variables may be determinants of outcome of mental illnesses. In our view, cooperation with developing countries is a great opportunity to evaluate mental health services in a natural setting. CONCLUSIONS: A new generation of programs for international cooperation in mental health is needed, in which knowledge and technology transfer is based on a service-research attitude. Attention should be focused on variables related to the poverty of services that might be linked to the course and outcome of mental illnesses.

Cross-Cultural Comparison↗
PubMed1993

Colchicine allows prolonged survival of highly reactive renal allograft in the rat.

Colchicine, with its immunosuppressive properties, has been used with beneficial effects in autoimmune diseases. Whether colchicine, by virtue of the above properties, could attenuate the process of kidney allograft rejection in the rat is investigated in this report. Untreated Lewis rats (N = 6) given an incompatible kidney allograft from Brown-Norway rats rejected the graft within 12 days. Colchicine at a daily ip dose of 40 (N = 6) or 10 (N = 4) micrograms/kg promoted long-term survival (> 170 days) of major histocompatibility complex-incompatible kidney grafts. Animals (N = 4) given 4 micrograms of colchicine per kilogram had a graft failure within 10 days. Experiments have also been performed to evaluate the effect of colchicine withdrawal at different time intervals from transplantation on subsequent allograft survival. Colchicine (40 micrograms/kg per day ip) was given for 12, 6, or 1 mo or for 15 days to an additional four groups of six animals each without any other immunosuppressants. The withdrawal of colchicine did confer long-term inhibition of the immune system in animals treated for at least 1 mo, as documented by a graft survival of more than 80 days. By contrast, those animals who discontinued colchicine after only 15 days of treatment had graft rejection within the next 8 days. Mixed lymphocyte culture experiments showed a significant (P < 0.01) reduction of the proliferation of peripheral blood lymphocytes taken from all groups of animals 30 days after colchicine withdrawal when challenged with Brown-Norway lymphocytes.(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗
PubMedDate not supplied

[The use of psychotropic drugs in an Italian psychiatric hospital: a two-year-long follow-up study].

OBJECTIVE: Following the introduction of guidelines of rational drug use, the pharmacoepidemiology of psychotropic drugs was investigated in a sample of long-stay patients living in a Italian psychiatric hospital. DESIGN: A prospective, longitudinal two-year follow-up study was carried out. Information about sociodemographic and clinical characteristics of the inpatient population, and about medications prescribed, was collected at baseline and after one and two years of follow-up. SETTING: Three wards of the psychiatric hospital of Milan. MAIN OUTCOME MEASURES: Number of patients taking psychotropic drugs, number of patients taking more than one neuroleptic or benzodiazepine, mean neuroleptic dose, psychopathological status according to the Brief Psychiatric Rating Scale (BPRS). RESULTS: 70 patients were recruited and followed for two years. At follow-up a reduction in the number of patients taking neuroleptic drugs was recorded, together with a 50% decrease in the number of patients taking more than one neuroleptic. A reduction in the use of depot formulations was in addition shown. Patients taking benzodiazepines decreased of 50%. According to the BPRS, no psychopatological changes were observed during the study. CONCLUSIONS: These data suggest that education in psychopharmacology may guide towards a more rational use of drugs; longitudinal clinical audits should be implemented to monitor everyday practice.

Adult↗
PubMedDate not supplied

Studies of privileged sites and organ transplantation.

Extensive research has been carried out in the last years to try to prevent graft rejection by minimizing the side effects related to the use of immunosuppressants. Ideally, one would hope to achieve a state of donor-specific unresponsiveness in order to promote a condition of true tolerance without the need of immunosuppressants. Recent evidence has been provided that this is a pursuing goal, at least in experimental animals, and even in humans increasing data are available that tolerance is achieved in some patients years after transplantation. The interest in donor-specific transplant tolerance has been renewed by the recent observations that in the rat the thymus is an immunologically privileged site into which isolated pancreatic islets can be engrafted and survive indefinitely. Moreover, intrathymic injection induced donor-specific unresponsiveness, which allowed survival of a second donor-strain islet cell allograft transplanted into an extrathymic site. Findings on cellular allograft have been extended to vascularized organ allografts. Recent experiments documented that in the rat intrathymic injection of donor cells allows subsequent renal graft to survive indefinitely. Unresponsiveness to rat kidney graft is donor but not tissue specific and evidence is presented here that the thymus has a central role in such a phenomenon. Hopefully, these studies will open new perspectives in transplantation promoting indefinite graft survival without the complications of long-term immunosuppressants.

Animals↗