Trial reportThe British journal of dermatology2014
Night-time sedating H1 -antihistamine increases daytime somnolence but not treatment efficacy in chronic spontaneous urticaria: a randomized controlled trial.
Trial report in The British journal of dermatology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 62 citations in OpenAlex.
- Management of chronic urticaria in children: a clinical guideline.Italian journal of pediatrics · 2019Guideline
- H1-antihistamines for chronic spontaneous urticaria.The Cochrane database of systematic reviews · 2014Pooled it
- Sleep Disturbance and Chronic Urticaria: A Narrative Review of Its Relationship, Treatment and Evolving Literature.Health science reports · 2025Article
- Allergic rhinitis and urticaria burden and antihistamine treatment options in Thailand: A modified Delphi study.The journal of allergy and clinical immunology. Global · 2025Article
- Clinical review: The suggested management pathway for urticaria in primary care.Clinical and translational allergy · 2022Review
- Omalizumab as a treatment option for antihistamine-refractory aquagenic urticaria.BMJ case reports · 2022Article
- A Comparative, Three-Arm, Randomized Clinical Trial to Evaluate the Effectiveness and Tolerability of Bilastine vs Fexofenadine vs Levocetirizine at the Standard Dose and Bilastine vs Fexofenadine at Higher Than the Standard Dose (Up-Dosing) vs Levocetirizine and Hydroxyzine (in Combination) in Patients with Chronic Spontaneous Urticaria.Clinical, cosmetic and investigational dermatology · 2022Article
- Practical Management of New-Onset Urticaria and Angioedema Presenting in Primary Care, Urgent Care, and the Emergency Department.The Permanente journal · 2021Review
- Mild cutaneous reactions to drugs.Acta bio-medica : Atenei Parmensis · 2019Review
- Using Patient Profiles To Guide The Choice Of Antihistamines In The Primary Care Setting In Malaysia: Expert Consensus And Recommendations.Therapeutics and clinical risk management · 2019Review
- Urticaria and Angioedema: an Update on Classification and Pathogenesis.Clinical reviews in allergy & immunology · 2018Review
- Effectiveness and safety of antihistamines up to fourfold or higher in treatment of chronic spontaneous urticaria.Clinical and translational allergy · 2017Article
- A 63-year-old man with chronic spontaneous urticaria.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2016Article
- Aquagenic urticaria: diagnostic and management challenges.Journal of asthma and allergy · 2016Review
- Treatment of allergic rhinitis and urticaria: a review of the newest antihistamine drug bilastine.Therapeutics and clinical risk management · 2016Review
- Advances in Understanding and Managing Chronic Urticaria.F1000Research · 2016Review
- Knowledge and Attitude of Medical Resident Doctors Toward Antihistamines.Indian journal of dermatologyArticle
Corrections and comments
- Commented on by
Authors and funding
8 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMany physicians believe that the most effective way to treat chronic urticaria is to take a nonsedating second-generation H1 -antihistamine in the morning and a sedating first-generation H1 -antihistamine, usually hydroxyzine, at night to enhance sleep. But is this belief well founded?
objectivesTo test this belief by comparing the effectiveness and prevalence of unwanted sedative effects when treating patients with chronic spontaneous urticaria (CSU) with levocetirizine 15 mg daily plus hydroxyzine 50 mg at night (levocetirizine plus hydroxyzine) vs. levocetirizine 20 mg daily (levocetirizine monotherapy).
methodsIn this randomized, double-blind, cross-over study, 24 patients with difficult-to-treat CSU took levocetirizine plus hydroxyzine or levocetirizine monotherapy for periods of 5 days each. At the end of each treatment period, assessments were made of quality of life (Chronic Urticaria Quality of Life Questionnaire, CU-Q2 oL), severity of urticaria symptoms (Urticaria Activity Score, UAS), sleep disturbance during the night and daytime somnolence.
resultsBoth treatments significantly decreased UAS, night-time sleep disturbances and CU-Q2 oL scores (P < 0·001) without significant differences between the two. Compared with baseline, daytime somnolence was significantly reduced by levocetirizine monotherapy (P = 0·006) but not by levocetirizine plus hydroxyzine (P = 0·218). Direct comparison of the two treatment modalities in terms of daytime somnolence favoured levocetirizine monotherapy (P = 0·026).
conclusionsThe widespread belief that sleep is aided by the addition of a sedating first-generation H1 -antihistamine, usually hydroxyzine, at night is not supported. These results are in line with the urticaria guidelines, which state that first-line treatment for urticaria should be new-generation, nonsedating H1 -antihistamines only.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.