Evidence map›Paper›PMID 12721777›Full record

Trial reportPsychopharmacology2003

Driving ability after acute and sub-chronic administration of levocetirizine and diphenhydramine: a randomized, double-blind, placebo-controlled trial.

Joris C Verster, A Marit de Weert, Saskia I R Bijtjes, Mounir Aarab, Armand W A A van Oosterwijck, Erik J E Eijken, Marinus N Verbaten, Edmund R Volkerts

Abstract readClinical TrialComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Psychopharmacology, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Joris C VersterUtrecht Institute for Pharmaceutical Sciences, Utrecht University, PO Box 80082, 3508 TB Utrecht, The Netherlands. J.C.Verster@pharm.uu.nl
A Marit de Weert
Saskia I R Bijtjes
Mounir Aarab
Armand W A A van Oosterwijck
Erik J E Eijken
Marinus N Verbaten
Edmund R Volkerts

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

rationaleSedation following antihistamine use poses a danger to ambulant patients involved in daily activities such as driving.

objectiveTo investigate effects of levocetirizine (5 mg), diphenhydramine (50 mg), and placebo on driving ability during normal traffic.

methodsForty-eight healthy volunteers participated in a double-blind, placebo-controlled, randomized clinical trial. Treatments were administrated on days 1, 2, 3 and 4, exactly 1.5 h before the start of the standardized driving test (performed on day 1 and day 4). In the standardized driving test, subjects were instructed to drive with a steady lateral position, while maintaining a constant speed (95 km/h). Primary parameter was the standard deviation of lateral position (SDLP; cm). Statistical analyses were performed separately for day 1 and day 4, using analysis of variance and an equivalence test. Equivalence to placebo was evidenced if the 95% confidence interval lay between -2.6 cm and +2.6 cm.

resultsSDLP after levocetirizine was equivalent to placebo on both day 1 (-0.66 cm; +1.12 cm) and day 4 (-0.37 cm; +1.28 cm). In contrast, SDLP after diphenhydramine differed significantly from placebo on both day 1 ( P<0.0001) and day 4 ( P<0.0003). On day 1, the 95% confidence interval of diphenhydramine (+1.85 cm; +3.63 cm) was partially above the upper equivalence limit (+2.6 cm), indicating clinically relevant driving impairment. On day 4, however, the 95% confidence interval of diphenhydramine (+0.74 cm; +2.38 cm) was contained within the acceptance range.

conclusionIn contrast to diphenhydramine, driving performance was not significantly affected while using 5 mg levocetirizine once daily.

Indexed as

Automobile DrivingAdultCetirizineDiphenhydramineDose-Response Relationship, DrugDouble-Blind MethodFemaleHistamine H1 AntagonistsHistamine H1 Antagonists, Non-SedatingHumansMalePiperazinesCetirizineDiphenhydramineHistamine H1 AntagonistsHistamine H1 Antagonists, Non-SedatinglevocetirizinePiperazines

Identifiers

PMID12721777

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.