Evidence map›Paper›PMID 25636794›Full record

SynthesisBMJ open2015

Placebo effects in trials evaluating 12 selected minimally invasive interventions: a systematic review and meta-analysis.

Robin Holtedahl, Jens Ivar Brox, Ole Tjomsland

Abstract readMeta-AnalysisSystematic Review
In one paragraph

Synthesis in BMJ open, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 3 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

20 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
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  13. Ethics of Early Clinical Trials of Bio-Artificial Organs.Transplant international : official journal of the European Society for Organ Transplantation · 2022
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  18. Article
  19. Miscommunication in Doctor-Patient Communication.Topics in cognitive science · 2018
    Article
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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

3 authors.

Robin HoltedahlFram Rehabilitation Centre, Bærum, Norway.ORCID http://orcid.org/0000-0002-8436-4519
Jens Ivar BroxDepartment of Physical Medicine and Rehabilitation, Oslo University Hospital, Oslo, Norway.
Ole TjomslandSouth-Eastern Norway Regional Health Authority, Hamar, Norway.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo analyse the impact of placebo effects on outcome in trials of selected minimally invasive procedures and to assess reported adverse events in both trial arms.

designA systematic review and meta-analysis. DATA SOURCES AND STUDY SELECTION: We searched MEDLINE and Cochrane library to identify systematic reviews of musculoskeletal, neurological and cardiac conditions published between January 2009 and January 2014 comparing selected minimally invasive with placebo (sham) procedures. We searched MEDLINE for additional randomised controlled trials published between January 2000 and January 2014. DATA SYNTHESIS: Effect sizes (ES) in the active and placebo arms in the trials' primary and pooled secondary end points were calculated. Linear regression was used to analyse the association between end points in the active and sham groups. Reported adverse events in both trial arms were registered.

resultsWe included 21 trials involving 2519 adult participants. For primary end points, there was a large clinical effect (ES≥0.8) after active treatment in 12 trials and after sham procedures in 11 trials. For secondary end points, 7 and 5 trials showed a large clinical effect. Three trials showed a moderate difference in ES between active treatment and sham on primary end points (ES ≥0.5) but no trials reported a large difference. No trials showed large or moderate differences in ES on pooled secondary end points. Regression analysis of end points in active treatment and sham arms estimated an R(2) of 0.78 for primary and 0.84 for secondary end points. Adverse events after sham were in most cases minor and of short duration.

conclusionsThe generally small differences in ES between active treatment and sham suggest that non-specific mechanisms, including placebo, are major predictors of the observed effects. Adverse events related to sham procedures were mainly minor and short-lived. Ethical arguments frequently raised against sham-controlled trials were generally not substantiated.

Indexed as

Minimally Invasive Surgical ProceduresPlacebo EffectCardiac Surgical ProceduresHumansNeurosurgical ProceduresResearch DesignTreatment Outcome

Identifiers

PMID25636794
PMCPMC4316431

What OpenQuestion holds

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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.