PMID- 31349865
OWN - NLM
STAT- MEDLINE
DCOM- 20200205
LR  - 20231013
IS  - 1745-6215 (Electronic)
IS  - 1745-6215 (Linking)
VI  - 20
IP  - 1
DP  - 2019 Jul 26
TI  - Nocebo effects of a simplified package leaflet compared to unstandardised oral 
      information and a standard package leaflet: a pilot randomised controlled trial.
PG  - 458
LID - 10.1186/s13063-019-3565-3 [doi]
LID - 458
AB  - BACKGROUND: The 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. 
      METHODS: We 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. RESULTS: We 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. CONCLUSIONS: This 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 REGISTRATION: ClinicalTrials.gov identifier: 
      NCT03428035. Registered 2 February 2018.
FAU - Prediger, Barbara
AU  - Prediger B
AD  - Institute for Research in Operative Medicine, Witten/Herdecke University, 
      Ostmerheimer Str. 200, 51109, Cologne, Germany.
FAU - Meyer, Esther
AU  - Meyer E
AD  - Institute for Research in Operative Medicine, Witten/Herdecke University, 
      Ostmerheimer Str. 200, 51109, Cologne, Germany.
FAU - Buchter, Roland
AU  - Buchter R
AD  - Institute for Research in Operative Medicine, Witten/Herdecke University, 
      Ostmerheimer Str. 200, 51109, Cologne, Germany.
FAU - Mathes, Tim
AU  - Mathes T
AUID- ORCID: 0000-0002-5304-1717
AD  - Institute for Research in Operative Medicine, Witten/Herdecke University, 
      Ostmerheimer Str. 200, 51109, Cologne, Germany. tim.mathes@uni-wh.de.
LA  - eng
SI  - ClinicalTrials.gov/NCT03428035
GR  - MA 6775/3/Deutsche Forschungsgemeinschaft/
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20190726
PL  - England
TA  - Trials
JT  - Trials
JID - 101263253
SB  - IM
MH  - Adult
MH  - Female
MH  - Germany
MH  - *Health Knowledge, Attitudes, Practice
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - *Nocebo Effect
MH  - Orthopedic Procedures/*adverse effects
MH  - *Pamphlets
MH  - Patient Education as Topic/*methods
MH  - Pilot Projects
MH  - Postoperative Complications/*etiology
MH  - Risk Factors
MH  - Treatment Outcome
MH  - Young Adult
PMC - PMC6660653
OTO - NOTNLM
OT  - Nocebo effect
OT  - Patient information leaflets
OT  - Randomised controlled trial
COIS- The authors declare that they have no financial or scientific competing 
      interests. The funding body has no role in the design of the study or collection, 
      analysis and interpretation of data or in writing the manuscript.
EDAT- 2019/07/28 06:00
MHDA- 2020/02/06 06:00
PMCR- 2019/07/26
CRDT- 2019/07/28 06:00
PHST- 2019/01/31 00:00 [received]
PHST- 2019/07/09 00:00 [accepted]
PHST- 2019/07/28 06:00 [entrez]
PHST- 2019/07/28 06:00 [pubmed]
PHST- 2020/02/06 06:00 [medline]
PHST- 2019/07/26 00:00 [pmc-release]
AID - 10.1186/s13063-019-3565-3 [pii]
AID - 3565 [pii]
AID - 10.1186/s13063-019-3565-3 [doi]
PST - epublish
SO  - Trials. 2019 Jul 26;20(1):458. doi: 10.1186/s13063-019-3565-3.