The Journal of Allergy and Clinical Immunology
Volume 110, Issue 5 , Page 818, November 2002

Publication bias with cetirizine in atopic dermatitis: Safe but ineffective?

Group Health Cooperative 12400 E. Marginal Way S. Tukwila, WA 98168-2559

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To the Editor: 

In the process of reviewing our formulary treatment options for atopic dermatitis, our reviewers discovered missing data expected from a landmark trial. We hope you will help encourage the publication of these data.

The Early Treatment of the Atopic Child Study Group has completed a large, multicenter, randomized, double-blind, placebocontrolled trial of cetirizine versus placebo in 817 children with atopic dermatitis. The Journal has published 3 articles from this study group: one on adverse effects,1 another on asthma prevention (using data from a 12-month study extension with voluntary enrollment),2 and a third on prevention of acute urticaria. 3 Results on the effect of cetirizine in treating atopic dermatitis have not yet been published. Preliminary findings, reported to have been presented at a conference, found no difference in efficacy between cetirizine and placebo.4 Authors of the first published study stated that the efficacy of cetirizine in the treatment of atopic dermatitis is described in other publications, which is misleading.1

Two systematic reviews have postulated that antihistamines are effective in relieving pruritis of atopic dermatitis only to the extent that they cause sedation. 4, 5 Cetirizine reportedly does not cause somnolence in long-term use.1 Do these findings, together with the absence of published results from the Early Treatment of the Atopic Child Study Group on atopic dermatitis, mean that cetirizine is no more effective than placebo in relieving atopic dermatitis? Will you please encourage study authors to submit the missing study results for publication in the Journal ?

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References 

  1. Simons FER, et al.  Prospective, long-term safety evaluation of the H1-receptor antagonist cetirizine in very young children with atopic dermatitis. ETAC Study Group. Early Treatment of the Atopic Child. J Allergy Clin Immunol. 1999;104(2 Pt 1):433–434
  2. Warner JO, et al.  A double- blind, randomized, placebo- controlled trial of cetirizine in preventing the onset of asthma in children with atopic dermatitis: 18 months' treatment and 18 months' posttreatment follow-up. J Allergy Clin Immunol. 2001;108:929–937
  3. Simons FER, et al.  Prevention of acute urticaria in young children with atopic dermatitis. J Allergy Clin Immunol. 2001;107:703–706
  4. Hoare C, Li Wan Po A, Williams H. Systematic review of treatments of atopic eczema. Health Technol Assess. 2000;4:1–191
  5. Klein PA, Clark RAF, et al.  An evidence-based review of the efficacy of antihistamines in relieving pruritis in atopic dermatitis. Arch Dermatol. 1999;135:1522–1525

PII: S0091-6749(02)70047-X

The Journal of Allergy and Clinical Immunology
Volume 110, Issue 5 , Page 818, November 2002

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