OPEN ACCESS PEER-REVIEWED
RESEARCH ARTICLE
Study Design and Quality of Reporting of Randomized Controlled Trials of Chronic Idiopathic or Autoimmune Urticaria: Review
Abstract
Background
The recommended first-line therapy of chronic urticaria is second-generation antihistamines, but the modalities of treatment remains unclear. Numerous recommendations with heterogeneous conclusions have been published. We wondered whether such heterogeneous conclusions were linked to the quality of published studies and their reporting.
Objective
To review the study design and quality of reporting of randomized control trials investigating pharmacological treatment of autoimmune or idiopathic chronic urticaria.
Methodology/Principal Findings
MEDLINE and EMBASE were searched for pharmacological randomized controlled trials involving patients with chronic autoimmune or idiopathic urticaria, with the main outcome being treatment efficacy. Data were collected on general characteristics of the studies, internal validity, studied treatments, design of the trial, outcome measures and “spin” strategy in interpreting results. Spin was defined as use of specific reporting strategies to highlight that the experimental treatment is beneficial, despite statistically nonsignificant results. We evaluated 52 articles that met our criteria. Patients were reported as blinded in 42 articles (81%) and the outcome assessor was blinded in 37 (71%). A placebo was the only comparator in 13 (25%) studies. The study duration was <8 10="" 12="" 15="" 31.="" 33="" 37="" 39="" 4="" a="" after="" and="" articles="" assessor="" because="" blinding="" centralized.="" clear="" computed="" described="" different="" discontinuation="" double-dummy="" effects="" follow-up="" for="" had="" identical="" in="" major="" no="" nonsignificant="" not="" of="" or="" outcome.="" outcome="" p="" primary="" randomization="" recognizable="" score="" scores="" secondary="" specified="" spin="" strategy="" studies="" the="" they="" total="" treatment="" used.="" used="" was="" weeks="" were="" with="">
Conclusion
For establishing guidelines in treatment of chronic urticaria, studies should focus on choosing clinically relevant and reproducible primary outcomes, long-term follow-up, limited use of placebo and avoiding spin strategies.
Citation: Le Fourn E, Giraudeau B, Chosidow O, Doutre M-S, Lorette G (2013) Study Design and Quality of Reporting of Randomized Controlled Trials of Chronic Idiopathic or Autoimmune Urticaria: Review. PLoS ONE 8(8): e70717. doi:10.1371/journal.pone.0070717
Editor: H. Peter Soyer, The University of Queensland, Australia
Received: November 30, 2012; Accepted: June 26, 2013; Published: August 5, 2013
Copyright: © 2013 Le Fourn et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Funding: This study was supported by a grant from Association Recommandations en Dermatologie, France. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Competing interests: The authors have declared that no competing interests exist.
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