title: Paroxetine: new indication. In generalised anxiety: uncertain efficacy.
abstract: (1) Generalised anxiety is defined as overwhelming anxiety lasting at least 6 months. (2) Psychological treatment should be tried first. When the patient fails to cope the first-line drug is a benzodiazepine such as diazepam, prescribed for a short period. (3) In France, generalised anxiety has now been added to the licensed indications of paroxetine, a "selective" serotonin reuptake inhibitor antidepressant. Two placebo-controlled trials lasting 8 weeks showed a moderate improvement on the Hamilton anxiety score. Another trial showed no significant difference between the paroxetine and placebo groups. The clinical relevance of this improvement is unclear, however, and the trials suffered from methodological biases. Paroxetine has not been reliably compared with benzodiazepines, psychotherapy or buspirone in patients with generalised anxiety. (4) One trial showed 11% relapse in the paroxetine group and 40% in the placebo group during the 6 months following paroxetine withdrawal, among patients who had initially responded; once again, however, methodological flaws undermine these data. (5) The adverse effect profile of paroxetine in generalised anxiety is similar to its profile in other patients: in particular potentially serious drug interactions and withdrawal symptoms when treatment is stopped abruptly. (6) In practice, the standard drug therapy for generalised anxiety is a benzodiazepine such as diazepam. Paroxetine, whose clinical efficacy remains to be established in this setting, offers no tangible therapeutic advance.
mesh_terms: D001007:Anxiety / Q000188:drug therapy*; D002986:Clinical Trials as Topic; D017277:Drug Approval; D005602:France; D006801:Humans; D017374:Paroxetine / Q000009:adverse effects / Q000627:therapeutic use*; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D017374:Paroxetine; D017367:Selective Serotonin Reuptake Inhibitors