No abstract

Enhancing quality of life (QoL) is an important objective of disease-modifying therapies in multiple sclerosis (MS). Strategies to substantiate the effect on QoL and depression have been suggested, including injection devices and nursing support. This study assesses QoL and depression in MS patients treated with interferon beta-1b (IFNB-1b) and evaluates the impact of different elements of a patient support programme and of coping strategies on QoL and depression. A prospective, observational, 2-year cohort study was conducted. MS patients were eligible if they had previously switched to IFNB-1b. Data were collected every 6 months. For the measurement of QoL the Functional Assessment of MS (FAMS) was used. Depression symptoms were assessed using the Center for Epidemiologic Studies Depression Scale (CES-D); coping strategies were assessed using the 66-item version of Ways of Coping Questionnaire. A total of 1,077 patients were recruited into the study. Seven hundred (65 %) patients completed the study. Within the subgroup completing questionnaires on QoL (N = 472) and depression (N = 363), QoL increased (110.4 vs. 115.8, p < 0.001), and the proportion of depressed patients decreased from 53.7 to 43.3 % (p < 0.001). Modelling QoL and depressions, the use of the autoinjector Betaject(®) over time showed a positive association with QoL (p = 0.049). The support from a nurse was positively associated with lower depressive symptoms (p = 0.039). The coping strategies 'planful problem-solving' and 'positive reappraisal' were associated with higher QoL and lower depressive symptoms. Patients on IFNB-1b treatment who were included in the patient support programme and completed the study showed an improvement in QoL. Moreover, compared to baseline the proportion of depressive patients decreased. Coping strategies as well as supportive elements such as autoinjectors and nurses had a significant impact on QoL and depression. However, the study had the general limitations of a non-controlled design.

A double-blind study was carried out in 30 female patients with generalized anxiety disorders associated with depressive symptoms to compare the effectiveness and tolerability of etizolam and alprazolam. Patients were allocated at random to receive one or other drug at a dosage of 0.5 mg twice daily for 5 weeks. Assessments were made on entry and after 3 and 5 weeks of treatment using the Hamilton rating scales for anxiety and for depression. The results showed that both drugs had marked anxiolytic and antidepressive activity, there being significant reductions after treatment in mean total rating scores compared to baseline. Although there was no statistically significant difference between the two drugs, there was a trend for etizolam to be more effective in relieving anxiety somatization symptoms. Apart from moderate daytime drowsiness in a few patients, both drugs were considered to be extremely well tolerated.

A double-blind, placebo-controlled study was carried out in 36 patients diagnosed as suffering from Generalized Anxiety Disorder with associated depressive symptoms to assess the efficacy and tolerability of two unitary doses of etizolam. After a 1-week wash-out period on placebo, patients were assigned at random to receive 1 tablet twice daily of either 0.50 mg or 0.25 mg etizolam or placebo for 5 weeks. Assessments were made at entry, on Day 21 and Day 35 of the patients' condition and symptoms using a battery of four psychometric tests (the Hamilton rating scales for anxiety and for depression, the Covi scale for anxiety and the Raskin scale for depression). Ten patients were withdrawn before the end of the study, 8 because of inadequate response (4 on placebo, 3 on 0.25 mg etizolam and 1 on 0.50 mg etizolam) in spite of dosage increase to 1 tablet 3-times daily, and 2 because of side-effects (both on 0.50 mg etizolam). Analysis of the results from the remaining 26 patients showed that, at the 0.50 mg dosage level, etizolam produced significant improvement in anxiety and depressive symptoms, particularly somatic manifestations, and was significantly more effective than placebo or the 0.25 dosage regimen. Etizolam was generally well tolerated and the few side-effects reported, mainly daytime drowsiness, were of mild to moderate severity.

A total of 45 patients with generalized anxiety disorder were treated twice daily for 2 weeks, on a double-blind basis, with 0.5 mg etizolam, 0.5 mg alprazolam or 3 mg bromazepam, and symptoms were assessed using Hamilton's rating scale for anxiety and Hamilton's rating scale for depression. Patients then received the same drug for a further 2 weeks, the drugs being given three times daily if a poor response was observed during the first 2 weeks. All drugs displayed equivalent anxiolytic activity after 2 weeks, but etizolam displayed a progressive increase in anxiolytic activity over 4 weeks of treatment. Etizolam also possessed a more marked antidepressant effect than did alprazolam or bromazepam. There were no differences in the tolerability of the three drugs.