Generic selectors
Exact matches only
Search in title
Search in content
Search in posts
Search in pages
Filter by Categories
15th National Conference of the IAOMFP, Chennai, 2006
Abstract
Abstracts from current literature
Acne in India: Guidelines for management - IAA Consensus Document
Addendum
Announcement
Art & Psychiatry
Article
Articles
Association Activities
Association Notes
Award Article
Book Review
Brief Report
Case Analysis
Case Letter
Case Letters
Case Notes
Case Report
Case Reports
Clinical and Laboratory Investigations
Clinical Article
Clinical Studies
Clinical Study
Commentary
Conference Oration
Conference Summary
Continuing Medical Education
Correspondence
Corrigendum
Cosmetic Dermatology
Cosmetology
Current Best Evidence
Current View
Derma Quest
Dermato Surgery
Dermatopathology
Dermatosurgery Specials
Dispensing Pearl
Do you know?
Drug Dialogues
e-IJDVL
Editor Speaks
Editorial
Editorial Remarks
Editorial Report
Editorial Report - 2007
Editorial report for 2004-2005
Errata
Erratum
Focus
Fourth All India Conference Programme
From Our Book Shelf
From the Desk of Chief Editor
General
Get Set for Net
Get set for the net
Guest Article
Guest Editorial
History
How I Manage?
IADVL Announcement
IADVL Announcements
IJDVL Awards
IJDVL AWARDS 2015
IJDVL Awards 2018
IJDVL Awards 2019
IJDVL Awards 2020
IJDVL International Awards 2018
Images in Clinical Practice
In Memorium
Inaugural Address
Index
Knowledge From World Contemporaries
Leprosy Section
Letter in Response to Previous Publication
Letter to Editor
Letter to the Editor
Letter to the Editor - Case Letter
Letter to the Editor - Letter in Response to Published Article
LETTER TO THE EDITOR - LETTERS IN RESPONSE TO PUBLISHED ARTICLES
Letter to the Editor - Observation Letter
Letter to the Editor - Study Letter
Letter to the Editor - Therapy Letter
Letter to the Editor: Articles in Response to Previously Published Articles
Letters to the Editor
Letters to the Editor - Letter in Response to Previously Published Articles
Letters to the Editor: Case Letters
Letters to the Editor: Letters in Response to Previously Published Articles
Medicolegal Window
Messages
Miscellaneous Letter
Musings
Net Case
Net case report
Net Image
Net Letter
Net Quiz
Net Study
New Preparations
News
News & Views
Obervation Letter
Obituary
Observation Letter
Observation Letters
Oration
Original Article
ORIGINAL CONTRIBUTION
Original Contributions
Pattern of Skin Diseases
Pearls
Pediatric Dermatology
Pediatric Rounds
Perspective
Presedential Address
Presidential Address
Presidents Remarks
Quiz
Recommendations
Regret
Report
Report of chief editor
Report of Hon : Treasurer IADVL
Report of Hon. General Secretary IADVL
Research Methdology
Research Methodology
Resident page
Resident's Page
Resident’s Page
Residents' Corner
Residents' Corner
Residents' Page
Retraction
Review
Review Article
Review Articles
Revision Corner
Self Assessment Programme
SEMINAR
Seminar: Chronic Arsenicosis in India
Seminar: HIV Infection
Short Communication
Short Communications
Short Report
Special Article
Specialty Interface
Studies
Study Letter
Supplement-Photoprotection
Supplement-Psoriasis
Symposium - Contact Dermatitis
Symposium - Lasers
Symposium - Pediatric Dermatoses
Symposium - Psoriasis
Symposium - Vesicobullous Disorders
SYMPOSIUM - VITILIGO
Symposium Aesthetic Surgery
Symposium Dermatopathology
Symposium-Hair Disorders
Symposium-Nails Part I
Symposium-Nails-Part II
Tables
Technology
Therapeutic Guidelines
Therapeutic Guidelines - IADVL
Therapeutics
Therapy
Therapy Letter
View Point
Viewpoint
What’s new in Dermatology
View/Download PDF
Letter to the Editor: Articles in Response to Previously Published Articles
2018:84:1;59-60
doi: 10.4103/ijdvl.IJDVL_860_17
PMID: 29271368

Letter in response to “Effectiveness and safety of levocetirizine 10 mg versus a combination of levocetirizine 5 mg and montelukast 10 mg in chronic urticaria resistant to levocetirizine 5 mg: A double-blind, randomized, controlled trial” by Sarkar et al.

Nadine Marrouche1 , Hywel C Williams2
1 Department of Dermatology, Norfolk and Norwich University Hospital NHS Foundation Trust, Norwich, UK
2 Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK

Correspondence Address:
Nadine Marrouche
Norfolk and Norwich University Hospital NHS Foundation Trust, Norwich, NR47UY
UK
How to cite this article:
Marrouche N, Williams HC. Letter in response to “Effectiveness and safety of levocetirizine 10 mg versus a combination of levocetirizine 5 mg and montelukast 10 mg in chronic urticaria resistant to levocetirizine 5 mg: A double-blind, randomized, controlled trial” by Sarkar et al.. Indian J Dermatol Venereol Leprol 2018;84:59-60
Copyright: (C)2018 Indian Journal of Dermatology, Venereology, and Leprology

Sir,

Current international guidelines on managing chronic urticaria are based on evidence from published literature where available. However, there is a scarcity of clinical trials even among well-established therapeutic options. We thank the authors for addressing an important evidence gap by conducting a randomized controlled trial to test the comparability of a standard dose of levocetirizine 5 mg plus montelukast 10 mg and doubling the dose of levocetirizine to 10 mg. We wish to share a number of observations that would benefit from some clarification from the authors.

Although the study was relatively well reported in terms of CONSORT (CONsolidated Standards of Reporting Trials),[1] we thought blinding was not sufficiently described. The authors report in the methods section that “one treatment group was given tablet levocetitizine 10 mg.” Do they mean a single levocetirizine 10 mg tablet or two 5 mg tablets? Then they describe the other group as having “a combination of tablet levocetirizine 5 mg plus montelukast 10 mg.” Does this mean a levocetirizine 5 mg tablet plus another tablet of montelukast 10 mg or was it a preparation that combined the two? This ambiguity leaves the reader in some doubt whether any actual blinding could have occurred. If one pack contained two tablets and the other contained one tablet, then it would have been easy to feel through the sealed opaque envelope.

We also have some concerns regarding potential selective reporting of outcomes. We note that the authors registered the trial retrospectively as recruitment commenced in March 2014 whereas the trial was registered on 26th November 2014. Trial registration should occur before any patients are recruited.[2] Moreover, although the authors report on most of the outcomes as per the registered protocol, we wonder why planned cost outcomes have not been reported in the study results.

We also wish to ask the authors about their choice of Urticaria Total Severity Score as one of the primary outcome measures. We agree the Total Severity Score includes more parameters of disease severity than the Urticaria Activity Score, but we are not aware that Total Severity Score has been validated (construct or criterion) or tested for repeatability or sensitivity to change to render it suitable as an assessment tool for chronic urticaria.

Finally, we would like to highlight an important issue in the study design. We note the study aims to demonstrate that the efficacy of levocetirizine 5 mg combined with montelukast 10 mg is “comparable” to levocetirizine 10 mg in the treatment of chronic urticaria, implying an equivalence or noninferiority trial design. However, the sample size calculation was powered to detect a two-point difference in the Total Severity Score between the two study groups, which implies a superiority rather than equivalence study design. In addition, the authors have focused on reporting and emphasizing inappropriate within-group rather than between-groups differences that address the study question. Equivalence cannot be inferred simply by the absence of a significant difference between treatments in a superiority trial design.[3]

Despite the above concerns, we recognize the importance and clinical relevance of the study objective and acknowledge the authors' efforts at comprehensively reporting the methodology and findings of the trial.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

References
1.
Williams HC. Cars, CONSORT 2010, and clinical practice. Trials 2010;11:33.
[Google Scholar]
2.
Nankervis H, Baibergenova A, Williams HC, Thomas KS. Prospective registration and outcome-reporting bias in randomized controlled trials of eczema treatments: A systematic review. J Invest Dermatol 2012;132:2727-34.
[Google Scholar]
3.
Williams HC, Seed P. Inadequate size of 'negative' clinical trials in dermatology. Br J Dermatol 1993;128:317-26.
[Google Scholar]

Fulltext Views
256

PDF downloads
234
Show Sections