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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.

METHOD

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.

CONCLUSION

Hydroxyzine showed both efficacy and safety in the treatment of GAD and appears to be an effective alternative treatment to benzodiazepine prescription.

Links

  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    Hôpital Gabriel Montpied, Clermont-Ferrand, France.

    , , , , , , , ,

    Source

    The Journal of clinical psychiatry 63:11 2002 Nov pg 1020-7

    MeSH

    Adult
    Ambulatory Care
    Anti-Anxiety Agents
    Anxiety Disorders
    Double-Blind Method
    Family Practice
    Female
    Follow-Up Studies
    France
    Histamine H1 Antagonists
    Humans
    Hydroxyzine
    Male
    Middle Aged
    Patient Care Team
    Personality Inventory
    Psychiatric Status Rating Scales
    Treatment Outcome

    Pub Type(s)

    Clinical Trial
    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    12444816

    Citation

    Llorca, Pierre-Michel, et al. "Efficacy and Safety of Hydroxyzine in the Treatment of Generalized Anxiety Disorder: a 3-month Double-blind Study." The Journal of Clinical Psychiatry, vol. 63, no. 11, 2002, pp. 1020-7.
    Llorca PM, Spadone C, Sol O, et al. Efficacy and safety of hydroxyzine in the treatment of generalized anxiety disorder: a 3-month double-blind study. J Clin Psychiatry. 2002;63(11):1020-7.
    Llorca, P. M., Spadone, C., Sol, O., Danniau, A., Bougerol, T., Corruble, E., ... Servant, D. (2002). Efficacy and safety of hydroxyzine in the treatment of generalized anxiety disorder: a 3-month double-blind study. The Journal of Clinical Psychiatry, 63(11), pp. 1020-7.
    Llorca PM, et al. Efficacy and Safety of Hydroxyzine in the Treatment of Generalized Anxiety Disorder: a 3-month Double-blind Study. J Clin Psychiatry. 2002;63(11):1020-7. PubMed PMID: 12444816.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Efficacy and safety of hydroxyzine in the treatment of generalized anxiety disorder: a 3-month double-blind study. AU - Llorca,Pierre-Michel, AU - Spadone,Christian, AU - Sol,Olivier, AU - Danniau,Anne, AU - Bougerol,Thierry, AU - Corruble,Emmanuelle, AU - Faruch,Michel, AU - Macher,Jean-Paul, AU - Sermet,Eric, AU - Servant,Dominique, PY - 2002/11/26/pubmed PY - 2002/12/27/medline PY - 2002/11/26/entrez SP - 1020 EP - 7 JF - The Journal of clinical psychiatry JO - J Clin Psychiatry VL - 63 IS - 11 N2 - 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. METHOD: 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. CONCLUSION: Hydroxyzine showed both efficacy and safety in the treatment of GAD and appears to be an effective alternative treatment to benzodiazepine prescription. SN - 0160-6689 UR - https://www.unboundmedicine.com/medline/citation/12444816/Efficacy_and_safety_of_hydroxyzine_in_the_treatment_of_generalized_anxiety_disorder:_a_3_month_double_blind_study_ L2 - http://www.psychiatrist.com/jcp/article/pages/2002/v63n11/v63n1112.aspx DB - PRIME DP - Unbound Medicine ER -