Evidence map›Paper›PMID 31349865›Full record

Trial reportTrials2019

Nocebo effects of a simplified package leaflet compared to unstandardised oral information and a standard package leaflet: a pilot randomised controlled trial.

Barbara Prediger, Esther Meyer, Roland Büchter, Tim Mathes

Registry-linked trialAbstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03428035 (Neutral Formulated and Designed Package Insert or Only Verbal Information Compared to Package Insert According EU-directive), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 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.

NCT03428035 naunknown statusnot on this map

Neutral Formulated and Designed Package Insert or Only Verbal Information Compared to Package Insert According EU-directive: a Pilot Randomised Controlled Trial to Analyse the Influence on the Nocebo Effect and Non-adherence

TypeinterventionalSponsorUniversity of Witten/HerdeckeRan2018 to 2018Enrolled60ConditionsOrthopedic SurgeryArmsPackage Insert
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
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

4 authors.

Barbara PredigerInstitute for Research in Operative Medicine, Witten/Herdecke University, Ostmerheimer Str. 200, 51109, Cologne, Germany.
Esther MeyerInstitute for Research in Operative Medicine, Witten/Herdecke University, Ostmerheimer Str. 200, 51109, Cologne, Germany.
Roland BüchterInstitute for Research in Operative Medicine, Witten/Herdecke University, Ostmerheimer Str. 200, 51109, Cologne, Germany.
Tim MathesInstitute for Research in Operative Medicine, Witten/Herdecke University, Ostmerheimer Str. 200, 51109, Cologne, Germany. tim.mathes@uni-wh.de.ORCID http://orcid.org/0000-0002-5304-1717

Funding

Deutsche Forschungsgemeinschaft MA 6775/3
6 · The paper itself

Abstract

backgroundThe term "nocebo effect" describes the phenomenon that the mere knowledge and anticipation of possible negative consequences of an intervention can increase the probability of experiencing these consequences. Our objective was to assess whether different information presentations on adverse events (AEs) in package information leaflets (PILs) could influence the nocebo effect.

methodsWe included patients undergoing orthopaedic surgery in this pilot randomised controlled trial (pRCT). Patients were assigned by random, computerised and centralised allocation to one of three groups: Simplified-PIL, No-PIL or Standard-PIL on ibuprofen. The Simplified-PIL was written in plain language, and AEs were reported with a focus on avoiding biased risk perception. Only the outcome assessment was blinded.

resultsWe included 35, 33 and 34 patients in the Simplified-PIL, No-PIL and Standard-PIL groups, respectively. All patients were included in the intention-to-treat analysis. Six patients in the Simplified-PIL, four in the No-PIL and eight in the Standard-PIL group reported an AE. This corresponds to relative risks of 0.80 (95% confidence interval (CI) 0.27-1.90) for the Simplified-PIL and 0.50 (95% CI 0.14-1.46) for the No-PIL compared with the Standard-PIL group. The Simplified-PIL increased knowledge, reduced anxiety and improved adherence, although statistical uncertainty was high for all of these outcomes.

conclusionsThis pRCT provides the first hints on the way information on AEs is reported in PILs can affect the nocebo effect. This pRCT shows that a definitive RCT is feasible. If the results are confirmed in a definitive large RCT, a revision of the current practice for designing PILs should be considered.

trial registrationClinicalTrials.gov identifier: NCT03428035. Registered 2 February 2018.

Indexed as

Health Knowledge, Attitudes, PracticeNocebo EffectPamphletsAdultFemaleGermanyHumansMaleMiddle AgedOrthopedic ProceduresPatient Education as TopicPilot ProjectsPostoperative ComplicationsRisk FactorsTreatment OutcomeYoung AdultNocebo effectPatient information leafletsRandomised controlled trial

Identifiers

PMID31349865
PMCPMC6660653

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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.