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H1-Antihistamines for Chronic Spontaneous Urticaria Sharma, M., Bennett, C., Cohen, S,N

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H1-Antihistamines for Chronic Spontaneous Urticaria Sharma, M., Bennett, C., Cohen, S,N H1-antihistamines for chronic spontaneous urticaria Sharma, M., Bennett, C., Cohen, S,N. and Carter, B. Published version deposited in CURVE November 2015 Original citation & hyperlink: Sharma, M., Bennett, C., Cohen, S,N. and Carter, B. (2014) H1-antihistamines for chronic spontaneous urticaria. Cochrane Database of Systematic Reviews, volume 2014 (11): Article number CD006137. http://dx.doi.org/10.1002/14651858.CD006137.pub2 Copyright © and Moral Rights are retained by the author(s) and/ or other copyright owners. A copy can be downloaded for personal non-commercial research or study, without prior permission or charge. This item cannot be reproduced or quoted extensively from without first obtaining permission in writing from the copyright holder(s). The content must not be changed in any way or sold commercially in any format or medium without the formal permission of the copyright holders. CURVE is the Institutional Repository for Coventry University http://curve.coventry.ac.uk/open H1-antihistamines for chronic spontaneous urticaria (Review) Sharma M, Bennett C, Cohen SN, Carter B This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2014, Issue 11 http://www.thecochranelibrary.com H1-antihistamines for chronic spontaneous urticaria (Review) Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. TABLE OF CONTENTS HEADER....................................... 1 ABSTRACT ...................................... 1 PLAINLANGUAGESUMMARY . 3 SUMMARY OF FINDINGS FOR THE MAIN COMPARISON . ..... 4 BACKGROUND .................................... 6 OBJECTIVES ..................................... 7 METHODS ...................................... 7 Figure1. ..................................... 9 RESULTS....................................... 11 Figure2. ..................................... 14 Figure3. ..................................... 15 ADDITIONALSUMMARYOFFINDINGS . 27 DISCUSSION ..................................... 44 AUTHORS’CONCLUSIONS . 46 ACKNOWLEDGEMENTS . 48 REFERENCES ..................................... 48 CHARACTERISTICSOFSTUDIES . 65 DATAANDANALYSES. 224 Analysis 1.1. Comparison 1 Loratadine 10 mg versus placebo, Outcome 1 Proportion of participants with ’good’ or ’excellent’ response whilst taking H1-antihistamines. ................ 229 Analysis 2.1. Comparison 2 Loratadine 10 mg versus cetirizine 10 mg, Outcome 1 Proportion of participants with complete suppression of urticaria whilst taking H1-antihistamines. .................. 230 Analysis 3.1. Comparison 3 Loratadine 10 mg versus desloratadine 5 mg, Outcome 1 Proportion of participants with complete suppression of urticaria whilst taking H1-antihistamines. ............... 231 Analysis 3.2. Comparison 3 Loratadine 10 mg versus desloratadine 5 mg, Outcome 2 Proportion of participants with ’good’ or ’excellent’ response whilst taking H1-antihistamines.................. 232 Analysis 4.1. Comparison 4 Loratadine 10 mg versus mizolastine 10 mg, Outcome 1 Proportion of participants with complete suppression of urticaria whilst taking H1-antihistamines. ............... 233 Analysis 4.2. Comparison 4 Loratadine 10 mg versus mizolastine 10 mg, Outcome 2 Proportion of participants with ’good’ or ’excellent’ response whilst taking H1-antihistamines. ................. 234 Analysis 4.3. Comparison 4 Loratadine 10 mg versus mizolastine 10 mg, Outcome 3 Proportion of participants with at least 50% improvement in QoL whilst taking H1-antihistamines................. 235 Analysis 4.4. Comparison 4 Loratadine 10 mg versus mizolastine 10 mg, Outcome 4 Serious adverse events (i.e. serious enough to require withdrawal of treatment). ......... 236 Analysis 5.1. Comparison 5 Loratadine 10 mg versus emedastine 2 mg, Outcome 1 Proportion of participants with complete suppression of urticaria whilst taking H1-antihistamines. ............... 236 Analysis 5.2. Comparison 5 Loratadine 10 mg versus emedastine 2 mg, Outcome 2 Proportion of participants with good or excellent response whilst taking H1-antihistamines. ............... 237 Analysis 5.3. Comparison 5 Loratadine 10 mg versus emedastine 2 mg, Outcome 3 Serious adverse events (i.e. serious enough to require withdrawal of treatment). ......... 237 Analysis 6.1. Comparison 6 Loratadine 10 mg versus hydroxyzine 25 mg, Outcome 1 Proportion of participants with complete suppression of urticaria whilst taking H1-antihistamines. ............... 238 Analysis 7.1. Comparison 7 Cetirizine 10 to 20 mg versus placebo, Outcome 1 Proportion of participants with complete suppression of urticaria whilst taking H1-antihistamines. .................. 238 Analysis 7.2. Comparison 7 Cetirizine 10 to 20 mg versus placebo, Outcome 2 Serious adverse events (i.e. serious enough to require withdrawal of treatment). 239 Analysis 8.1. Comparison 8 Cetirizine 10 mg versus hydroxyzine 25 mg, Outcome 1 Serious adverse events (i.e. serious enough to require withdrawal of treatment). ......... 240 Analysis 9.1. Comparison 9 Desloratadine 5 to 20 mg versus placebo, Outcome 1 Proportion of participants with complete suppression of urticaria whilst taking H1-antihistamines. .................. 241 H1-antihistamines for chronic spontaneous urticaria (Review) i Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 9.2. Comparison 9 Desloratadine 5 to 20 mg versus placebo, Outcome 2 Serious adverse events (i.e. serious enough to require withdrawal of treatment). ......... 242 Analysis 10.1. Comparison 10 Hydroxyzine 25 mg versus placebo, Outcome 1 Serious adverse events (i.e. serious enough to require withdrawal of treatment to withdrawal). ............. 243 Analysis 11.1. Comparison 11 Levocetirizine 5 to 20 mg versus placebo, Outcome 1 Proportion of participants with complete suppression of urticaria whilst taking H1-antihistamines. ............... 244 Analysis 12.1. Comparison 12 Rupatadine 10 to 20 mg versus placebo, Outcome 1 Proportion of participants with ’good’ or ’excellent’ response whilst taking H1-antihistamines. ................. 245 APPENDICES ..................................... 245 WHAT’SNEW..................................... 250 CONTRIBUTIONSOFAUTHORS . 250 DECLARATIONSOFINTEREST . 251 SOURCESOFSUPPORT . 251 DIFFERENCES BETWEEN PROTOCOL AND REVIEW . .... 251 NOTES........................................ 252 INDEXTERMS .................................... 252 H1-antihistamines for chronic spontaneous urticaria (Review) ii Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. [Intervention Review] H1-antihistamines for chronic spontaneous urticaria Maulina Sharma1, Cathy Bennett2a, Stuart N Cohen3b, Ben Carter4 1Department of Dermatology, Derby Hospitals NHS Foundation Trust, London Road Community Hospital, Derby, UK. 2Centre for Technology Enabled Health Research (CTEHR), Coventry University, Coventry, UK. 3Nottingham University Hospitals NHS Trust, Nottingham, UK. 4Institute of Primary Care & Public Health, Cardiff University School of Medicine, Cardiff, UK aJoint second author. bJoint second author Contact address: Maulina Sharma, Department of Dermatology, Derby Hospitals NHS Foundation Trust, London Road Community Hospital, London Road, Derby, DE1 2QY, UK. [email protected]. Editorial group: Cochrane Skin Group. Publication status and date: Edited (no change to conclusions), published in Issue 7, 2015. Review content assessed as up-to-date: 3 June 2014. Citation: Sharma M, Bennett C, Cohen SN, Carter B. H1-antihistamines for chronic spontaneous urticaria. Cochrane Database of Systematic Reviews 2014, Issue 11. Art. No.: CD006137. DOI: 10.1002/14651858.CD006137.pub2. Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. ABSTRACT Background Chronic spontaneous urticaria (CSU) is characterised by the development of crops of red, itchy, raised weals or hives with no identifiable external cause. Objectives To assess the effects of H1-antihistamines for CSU. Search methods We searched the following databases up to June 2014: Cochrane Skin Group Specialised Register, CENTRAL (2014, Issue 5), MED- LINE (from 1946), EMBASE (from 1974) and PsycINFO (from 1806). We searched five trials registers and checked articles for references to relevant randomised controlled trials. Selection criteria We included randomised controlled trials of H1-antihistamines for CSU. Interventions included single therapy or a combination of H1-antihistamines compared with no treatment (placebo) or another active pharmacological compound at any dose. Data collection and analysis We used standard methodological procedures as expected by The Cochrane Collaboration. Our primary outcome measures were proportion of participants with complete suppression of urticaria: ’good or excellent’ response, 50% or greater improvement in quality of life measures, and adverse events. We present risk ratios (RR) with 95% confidence intervals (CIs). H1-antihistamines for chronic spontaneous urticaria (Review) 1 Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Main results We identified 73 studies (9759 participants); 34 studies provided data for 23 comparisons. The duration of the intervention was up to two weeks (short-term) or longer than two weeks and up to three months (intermediate-term). Cetirizine 10 mg once daily in the short term and in the intermediate term led to complete suppression of urticaria by more participants than was seen with placebo (RR 2.72, 95%
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