The efficacy of hydroxyzine and buspirone, controlled by placebo, was investigated in a double-blind, parallel group, multicentre study conducted in France and the UK. A total of 244 patients with generalised anxiety disorder in primary care was allocated randomly to treatments with hydroxyzine (12.5 mg morning and mid-day, 25 mg evening), buspirone (5 mg morning and mid-day, 10 mg evening) or placebo (three capsules/day) for 4 weeks, preceded by a 1-week single-blind placebo run-in and followed by 1-week single-blind placebo administration. Rating scales were applied on days -7,0,7,14, 12,28 and 35. Seventy percent of the patients were female, the average age was 41 +/- 11 years, and the mean Hamilton Anxiety Score at day 0 was 26.5 +/- 4.2. Only 31 of the 244 patients dropped out, but equally in the three groups. Intention-to-treat LOCF analyses on the primary variable showed a significant difference only between hydroxyzine and placebo with respect to improvement on the Hamilton Anxiety Scale (10.75 versus 7.23 points, respectively). Secondary variables such as CGI and self-ratings (HAD scale) showed both hydroxyzine and buspirone to be more efficacious than placebo. Thus, hydroxyzine is a useful treatment for GAD.
A cross-sectional study was conducted on a random sample of 1,200 health care professionals in Marseille, France, in order to assess the prevalences of depression and burnout, and to compare these two entities. Depression was assessed by the Center for Epidemiologic Studies-Depression scale (CES-D), and burnout by the Maslach Burnout Inventory (MBI). Burnout is a syndrome of emotional exhaustion, depersonalization towards patients, and reduced sense of personal accomplishment. Some psychiatrists consider burnout to be a clinical form of depression. The prevalences of depression and burnout were very close: 17.1% and 15.7% among the women, 19.4% and 22% among the men, but 6.5% of the women and 9.4% of the men were both depressive and burned-out. A correlation was found between the CES-D and the subscales Emotional Exhaustion and Depersonalization of the MBI. Multivariate analysis and logistic regression models showed that many demographic and subjective variables influenced depression and burnout in different ways.
SUMMARYA consensus conference on the topic of clinical drug trials in cognitive disorders of the elderly was held in Marseille on January [28][29] 1993. At the end of this conference, several recommendations were made. Drugs used in trials must be chosen according to solid neurobiological evidence. Clinical trials profoundly alter the relations between the doctor, the patient and his family and this aspect must be taken into account. Clinical trials should be designed to obtain meaningful and useful data in the domains of pharmacology and epidemiology. Patient selection criteria must be defined with strict attention to the nosology of syndromes causing cognitive disorders in the elderly. Objective evaluation tests able to detect subtle drug effects must be carefully chosen according to the requirements of each trial. Whenever possible, laboratory tests should be used in addition to clinical data. The ethical implications of clinical trials in demented patients require special adaptation to satisfy legal requirements.KEY woms-Clinical trials, cognitive disorders, neurobiologic basis, pharmacology, ethical considerations.Treatment of cognitive disorders in the elderly is a rapidly expanding domain of neuropsychopharmacology. A few reports dealing with this topic can be found in the international literature (Alperovitch, 1989;Dartigues, 1985;Dehen et al., 1986;Derouesne, 1980;Forette et al., 1991;Orgogozo and Spiegel, 1987;Piette, 1989) and workshops have been convened in an effort to standardize methodology for clinical trials (Bruno et al., 1990;Dordain, 1993;Jarvik et al., 1990;Reisberg et al., 1992;Spriet, 1993; Swash et al., 1991). This report describes the consensus recommendations of a group of French specialists who met in Marseille on January 28 and 29, 1993. To our knowledge, this is the first detailed description of the French approach.
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