SynthesisMedicine2016
Placebo-Controlled Trials in Surgery: A Systematic Review and Meta-Analysis.
Synthesis in Medicine, 2016. 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.
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.
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.
Who cites it
20 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Use of Placebo and Nonoperative Control Groups in Surgical Trials: A Systematic Review and Meta-analysis.JAMA network open · 2022Pooled it
- The intrinsic plasticity of medial vestibular nucleus neurons during vestibular compensation-a systematic review and meta-analysis.Systematic reviews · 2020Pooled it
- Reporting of key methodological issues in placebo-controlled trials of surgery needs improvement: a systematic review.Journal of clinical epidemiology · 2020Pooled it
- Pain and quality of life after endodontic surgery with or without advanced platelet-rich fibrin membrane application: a randomized clinical trial.Clinical oral investigations · 2020Trial
- Neural and molecular changes during a mind-body reconceptualization, meditation, and open label placebo healing intervention.Communications biology · 2025Observational
- Review
- Placebo Effect in the Treatment of Patellar Tendinopathy and Its Influencing Factors: Systematic Review With Meta-analysis and Meta Regression of Randomized Controlled Trials.Orthopaedic journal of sports medicine · 2024Review
- Adapting to Evolving Technologies and Treatment Guidelines in a Procedural Trial: A Qualitative Review of the CREST-2 Experience.Neurology · 2023Review
- Intra-operative applications of augmented reality in glioma surgery: a systematic review.Frontiers in surgery · 2023Review
- Article
- Article
- Is There a Surgeons' Effect on Patients' Physical Health, Beyond the Intervention, That Requires Further Investigation? A Systematic Review.Therapeutics and clinical risk management · 2022Review
- Ethics of Early Clinical Trials of Bio-Artificial Organs.Transplant international : official journal of the European Society for Organ Transplantation · 2022Article
- Systematic reviews in surgery-recommendations from the Study Center of the German Society of Surgery.Langenbeck's archives of surgery · 2021Review
- Placebo comparator group selection and use in surgical trials: the ASPIRE project including expert workshop.Health technology assessment (Winchester, England) · 2021Article
- The effect of animated consent material on participants' willingness to enrol in a placebo-controlled surgical trial: a protocol for a randomised feasibility study.Pilot and feasibility studies · 2021Article
- What is an invasive procedure? A definition to inform study design, evidence synthesis and research tracking.BMJ open · 2019Article
- Evidence-Based Evaluation of the Ethics of Sham Surgery for Parkinson's Disease.Journal of Parkinson's disease · 2019Article
- Optimal literature search for systematic reviews in surgery.Langenbeck's archives of surgery · 2018Review
- Journal impact factor and methodological quality of surgical randomized controlled trials: an empirical study.Langenbeck's archives of surgery · 2017Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This systematic review was performed to investigate the ethical justification, methodological quality, validity and safety of placebo controls in randomized placebo-controlled surgical trials.Central, MEDLINE, and EMBASE were systematically searched to identify randomized controlled trials comparing a surgical procedure to a placebo. "Surgical procedure" was defined as a medical procedure involving an incision with instruments. Placebo was defined as a blinded sham operation involving no change to the structural anatomy and without an expectable physiological response in the target body compartment.Ten randomized placebo-controlled controlled surgical trials were included, all of them published in high-ranking medical journals (mean impact factor: 20.1). Eight of 10 failed to show statistical superiority of the experimental intervention. Serious adverse events did not differ between the groups (rate ratio [RR] 1.38, 95% confidence interval [CI]: 0.92-2.06, P = 0.46). None of the trials had a high risk of bias in any domain. The ethical justification for the use of a placebo control remained unclear in 2 trials.Placebo-controlled surgical trials are feasible and provide high-quality data on efficacy of surgical treatments. The surgical placebo entails a considerable risk for study participants. Consequently, a placebo should be used only if justified by the clinical question and by methodological necessity. Based on the current evidence, a pragmatic proposal for the use of placebo controls in future randomized controlled surgical trials is made.
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What OpenQuestion holds
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.