Evidence map›Paper›PMID 27872745›Full record

ReviewAnnals of medicine and surgery (2012)2016

Critical review of sham surgery clinical trials: Confounding factors analysis.

Massimo Ciccozzi, Rosa Menga, Giovanna Ricci, Massimiliano Andrea Vitali, Silvia Angeletti, Ascanio Sirignano, Vittoradolfo Tambone

Registry-linked trialOpen access · diamondAbstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Annals of medicine and surgery (2012), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03390049 (Randomized Controlled Trial of Fractional CO2 Laser vs Sham Laser for Women With Provoked Vestibulodynia Who Have Failed Conservative Management), which is not on this map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
1.2field-weighted citation impact, top 22% of its field
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.

NCT03390049 nawithdrawnnot on this mapstarted 2018, after this paper: background citation

Randomized Controlled Trial of Fractional CO2 Laser vs Sham Laser for Women With Provoked Vestibulodynia Who Have Failed Conservative Management

TypeinterventionalSponsorWake Forest University Health SciencesRan2018 to 2019Enrolled0ConditionsVestibulodyniaArmsFractional CO2 Laser Treatment, Sham Laser Treatment
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 28 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Intra-arterial lidocaine administration of lidocaine in middle meningeal artery for short-term treatment of subarachnoid hemorrhage-related headaches.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2025
    Article
  5. Article
  6. Article
  7. Article
  8. Review
  9. Putting placebos to the test.PLoS biology · 2017
    Review
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

7 authors at 2 institutions in 1 country.

Massimo CiccozziDepartment of Infectious, Parasitic, and Immune-Mediated Diseases, Epidemiology Unit, Reference Centre on Phylogeny, Molecular Epidemiology, and Microbial Evolution (FEMEM), National Institute of Health, 00161 Rome, Italy; Unit of Clinical Pathology and Microbiology, University Campus Bio-Medico of Rome, Italy.
Rosa MengaFaculty of Medicine, Campus Bio-Medico University of Rome, Italy.
Giovanna RicciSchool of Law, University of Camerino, 62032 Camerino, Italy.
Massimiliano Andrea VitaliMedical Direction of Campus Bio-Medico Hospital, University Campus Bio-Medico of Rome, Italy.
Silvia AngelettiUnit of Clinical Pathology and Microbiology, University Campus Bio-Medico of Rome, Italy.
Ascanio SirignanoSchool of Medical Sciences and Health Products, University of Camerino, 62032 Camerino, Italy.
Vittoradolfo TamboneInstitute of Philosophy of Scientific and Technological Practice, University Campus Bio-Medico of Rome, Italy.
Università Campus Bio-Medico · ITUniversità di Camerino · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveSham surgery (placebo surgery) is an intervention that omits the step thought to be therapeutically necessary. In surgical clinical trials, sham surgery serves an analogous purpose to placebo drugs, neutralizing biases such as the placebo effect. A critical review was performed to study the statistical relevance of the clinical trials about sham surgery in the light of potential confounding factors. MATERIALS AND

methodsFor the critical review 52 articles were included. The possible confounding factors have been studied using a structured interpretative research form designed by the authors. This form includes the following ten confounding factors: I), lack of homogeneity among inclusion/exclusion criteria. II), false double blind. III), lack of post-surgery double blind. IV), power of the study. V), sample characteristics. VI), lost patients to Follow-up. VII), gender distribution. VIII), age equilibrium. IX), lack of psychological patient evaluation. X), lack of psychiatric patient evaluation. In most of the studies, at least one confounding factor was present.

resultsThe analysis of the confounding factors showed that they could influence the reliability of the surgical placebo effects.

conclusionsThe validity of sham surgery should be reconsidered.

Indexed as

Clinical trial/epidemiologyClinical trials/ethicsMedical ethicsPlacebo effectPublic healthSham surgery

Identifiers

PMID27872745
PMCPMC5109256
OpenAlexW2539867487

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.