Encephale
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
[Comparison of 6 different methods for lorazepam withdrawal. A controlled study, hydroxyzine versus placebo].
154 outpatients with generalized anxiety (DSM III-R criteria), followed by general practitioners, gave an informed written consent to participate in this multicenter, randomized, placebo controlled study previously approved by a legal ethic committee (CCPPRB). The patients had to be long term consumers (at least 3 months) of 2 mg daily of lorazepam and were withdrawn using transiently an antihistaminic anxiolytic (hydroxyzine or placebo TAD) according to 6 different procedures defining 6 parallel groups: hydroxyzine 50 mg, abrupt or progressive withdrawal; hydroxyzine 25 mg, abrupt or progressive withdrawal; placebo, abrupt or progressive withdrawal. Following this 4 week-period of withdrawal, the patients were without any treatment for a post-study follow up 2 month-period. Clinical evaluations for anxiety (HARS, Zung), sleep (Spiegel), BZD withdrawal syndrome (Tyrer), adverse reactions and clinical global impression (CGI) were performed at D0, D7, D14, D28, D35 and D88. Investigators opinion and patients attitude towards BZD were collected at D88. ⋯ These results proved a significant improvement of anxiety, a decrease of side effects in both the groups treated with hydroxyzine and a reduction of withdrawal symptomatology in hydroxyzine 50 mg group. When a patient is engaged to be withdrawn from of a lorazepam long term treatment, it can therefore be proposed as a support a transient prescription of hydroxyzine 25 mg TAD to markedly anxious patients and of hydroxyzine 50 mg TAD to patients presenting a withdrawal symptomatology.