ArticleJournal of medical ethics2013
The potential benefit of the placebo effect in sham-controlled trials: implications for risk-benefit assessments and informed consent.
Article in Journal of medical ethics, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 31 papers, 4 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.
Objective Randomised Blinded Investigation of Therapeutic Ablation Versus Cardioversion for Persistent Atrial Fibrillation
Objective Randomised Blinded Investigation of Cardioversion Versus Ablation for Persistent Atrial Fibrillation (ORBICA-AF)
Who cites it
31 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Pooled it
- Pooled it
- Placebo effects in trials evaluating 12 selected minimally invasive interventions: a systematic review and meta-analysis.BMJ open · 2015Pooled it
- Reporting of Design Features and Analysis Details in Randomized Clinical Trials of Procedural Treatments for Cancer Pain: An ACTTION Systematic Review.Regional anesthesia and pain medicinePooled it
- One spinal manipulation session reduces local pain sensitivity but does not affect postural stability in individuals with chronic low back pain: a randomised, placebo-controlled trial.Chiropractic & manual therapies · 2024Trial
- Efficacy and safety of skin-adhesive low-level light therapy for overactive bladder: a Phase III study.International urogynecology journal · 2022Trial
- Trial
- The effect of mobilization with movement on pain and function in patients with knee osteoarthritis: a randomized double-blind controlled trial.BMC musculoskeletal disorders · 2019Trial
- Functional Electrical Stimulation and Stroke Rehabilitation Research: The Critical Role of Sham Control Groups.Physiotherapy research international : the journal for researchers and clinicians in physical therapy · 2026Article
- Erectile dysfunction and Peyronie's disease: from biologics to nanomedicine-enabled therapies.Sexual medicine · 2026Review
- Recommended methodologies for clinical investigations of high-risk medical devices-Conclusions from the European Union CORE-MD Project.The Lancet regional health. Europe · 2025Review
- Sham controls in device trials for chronic pain - tricky in practice-a review article.Contemporary clinical trials communications · 2023Review
- Differences between experimental and placebo arms in manual therapy trials: a methodological review.BMC medical research methodology · 2022Review
- Article
- Source localized infraslow neurofeedback training in people with chronic painful knee osteoarthritis: A randomized, double-blind, sham-controlled feasibility clinical trial.Frontiers in neuroscience · 2022Article
- Review
- Measuring individual benefits of psychiatric treatment using longitudinal binary outcomes: Application to antipsychotic benefits in non-cannabis and cannabis users.Journal of biopharmaceutical statistics · 2020Article
- A within-subject comparison of the effect of two putative sham light therapies on mood and fatigue in cancer survivors: Results from a series of N-of-1 trials.Psychiatry research · 2019Article
- Article
- The selection of comparators for randomized controlled trials of health-related behavioral interventions: recommendations of an NIH expert panel.Journal of clinical epidemiology · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
Abstract
There has been considerable debate surrounding the ethics of sham-controlled trials of procedures and interventions. Critics argue that these trials are unethical because participants assigned to the control group have no prospect of benefit from the trial, yet they are exposed to all the risks of the sham intervention. However, the placebo effect associated with sham procedures can often be substantial and has been well documented in the scientific literature. We argue that, in light of the scientific evidence supporting the benefits of sham interventions for pain and Parkinson's disease that stem from the placebo effect, these sham-controlled trials should be considered as offering potential direct benefit to participants. If scientific evidence demonstrates the positive effect of placebo from sham interventions on other conditions, sham-controlled trials of interventions for the treatment of these conditions should be considered to have prospects of benefit as well. This potential benefit should be taken into account by research ethics committees in risk-benefit analyses, and be included in informed consent documents.
Indexed as
Identifiers
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.