title: Efficacy and safety of hydroxyzine in the treatment of generalized anxiety disorder: a 3-month double-blind study.
abstract: BACKGROUND
  The prevalence of generalized anxiety disorder (GAD) represents an important public health issue. Hydroxyzine, an antagonist of histamine receptors, showed both efficacy and safety in previous short-term double-blind studies over placebo in this pathology. The aim of the current study was to confirm those positive results over a 3-month period in adult outpatients.
  
  
  METHODS
  This multicenter, parallel (hydroxyzine [50 mg/day]; bromazepam [6 mg/day]), randomized, double-blind, placebo-controlled trial included 2 weeks of single-blind run-in placebo, 12 weeks of double-blind randomized treatment, and 4 weeks of single-blind run-out placebo. Three hundred thirty-four of 369 selected outpatients with a diagnosis of GAD according to DSM-IV criteria and a Hamilton Rating Scale for Anxiety (HAM-A) total score >/= 20 were randomized before entering the double-blind period. The primary outcome criterion was the change in the HAM-A score from baseline to 12 weeks of double-blind treatment with hydroxyzine compared with placebo.
  
  
  RESULTS
  In the intent-to-treat analysis, the mean +/- SD change in HAM-A scores from baseline to endpoint was -12.16 +/- 7.74 for hydroxyzine and -9.64 +/- 7.74 for placebo (p =.019). Results at endpoint for percentage of responders (p =.003) and remission rates (p =.028), Clinical Global Impressions-Severity scale score (p =.001), maintenance of efficacy (p =.022), and Hospital Anxiety and Depression scale score on day 84 (p =.008) also confirmed the efficacy of hydroxyzine over placebo. The study showed no statistically significant difference between hydroxyzine and bromazepam. Except for drowsiness, which was more frequent with bromazepam, safety results were comparable in the 3 groups.
  
  
  CONCLUSIONS
  Hydroxyzine showed both efficacy and safety in the treatment of GAD and appears to be an effective alternative treatment to benzodiazepine prescription.
authors.affiliation: Hôpital Gabriel Montpied, Clermont-Ferrand, France.
authors.forename: Pierre-Michel
authors.initials: PM
authors.lastname: Llorca
authors.forename: Christian
authors.initials: C
authors.lastname: Spadone
authors.forename: Olivier
authors.initials: O
authors.lastname: Sol
authors.forename: Anne
authors.initials: A
authors.lastname: Danniau
authors.forename: Thierry
authors.initials: T
authors.lastname: Bougerol
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Corruble
authors.forename: Michel
authors.initials: M
authors.lastname: Faruch
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Macher
authors.forename: Eric
authors.initials: E
authors.lastname: Sermet
authors.forename: Dominique
authors.initials: D
authors.lastname: Servant
mesh_terms: D000328:Adult; D000553:Ambulatory Care; D014151:Anti-Anxiety Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001008:Anxiety Disorders / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D005194:Family Practice; D005260:Female; D005500:Follow-Up Studies; D005602:France; D006634:Histamine H1 Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D006919:Hydroxyzine / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010348:Patient Care Team; D010555:Personality Inventory; D011569:Psychiatric Status Rating Scales; D016896:Treatment Outcome
chemical_list: D014151:Anti-Anxiety Agents; D006634:Histamine H1 Antagonists; D006919:Hydroxyzine