2003 issue 3


Volume 19, issue 3


A multicentre double-blind study investigating the anxiolytic efficacy of diazepam, hydroxyzine and tofisopam in patients with generalized anxiety

Małgorzata Rzewuska1
1. Samodzielna Pracownia Farmakoterapii Instytutu Psychiatrii i Neurologii w Warszawie
Farmakoterapia w Psychiatrii i Neurologii, 2003, 3, 53-65


The efficacy of tofisopam and hydroxyzine was investigated in a double-blind, parallel group and compared with diazepam. A total of 84 out patients with generalized anxiety disorder was allocated randomly to treatment with hydroxyzine (75 mg/d), tofisopam (150 mg/d) and diazepam (25 mg/d) for 6 weeks. Rates scales (HAMA, HDRS, CGI) were applied on days 0, 14, 42 and 2 weeks after end of the treatment. 21 (25%) of the 84 patients dropped out, but equally in the three groups.
All drugs reduced the anxiety symptom s (HAMA) in the first two and 6 week of treatment. It wasn’t differences in the efficacy and frequency of adverse event between drugs. The tofisopam may be useful and safer alternative to the benzodiazepines and hydroxyzine.