ReviewBMC medical research methodology2011
Novel study designs to investigate the placebo response.
Review in BMC medical research methodology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 2 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
25 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- How do they add up? The interaction between the placebo and treatment effect: A systematic review.British journal of clinical pharmacology · 2022Pooled it
- Quantifying the placebo effect in psychological outcomes of exercise training: a meta-analysis of randomized trials.Sports medicine (Auckland, N.Z.) · 2015Pooled it
- Transcranial direct current stimulation to modulate fMRI drug cue reactivity in methamphetamine users: A randomized clinical trial.Human brain mapping · 2022Trial
- Expectancy effects on serotonin and dopamine transporters during SSRI treatment of social anxiety disorder: a randomized clinical trial.Translational psychiatry · 2021Trial
- Randomised clinical trial: gut microbiome biomarkers are associated with clinical response to a low FODMAP diet in children with the irritable bowel syndrome.Alimentary pharmacology & therapeutics · 2015Trial
- Randomised controlled trials may underestimate drug effects: balanced placebo trial design.PloS one · 2014Trial
- Effects of ginger and expectations on symptoms of nausea in a balanced placebo design.PloS one · 2012Trial
- Distinguishing caffeine expectancy from pharmacological effects: a comparative review of experimental designs with future directions.Frontiers in physiology · 2026Review
- Considerations for Issues of Regression to the Mean and Contextual Effects in Clinical Trials for Pain in Rheumatic Diseases.Arthritis care & research · 2026Review
- A novel provocation protocol to identify nocebo effects in clinical practice-a proof-of-concept n-of-1 study.Frontiers in pharmacology · 2026Article
- When does the placebo effect have an impact on network meta-analysis results?BMJ evidence-based medicine · 2024Article
- Vaccine hesitancy prospectively predicts nocebo side-effects following COVID-19 vaccination.Scientific reports · 2022Article
- Editorial: defining a microbial signature to predict non-response to a low FODMAP diet-a step closer or is it? Authors' reply.Alimentary pharmacology & therapeutics · 2021Article
- Advancing the understanding of placebo effects in psychological outcomes of exercise: Lessons learned and future directions.European journal of sport science · 2020Review
- Sympathetic Effect of Auricular Transcutaneous Vagus Nerve Stimulation on Healthy Subjects: A Crossover Controlled Clinical Trial Comparing Vagally Mediated and Active Control Stimulation Using Microneurography.Frontiers in physiology · 2020Article
- Re-evaluation of Significance and the Implications of Placebo Effect in Antidepressant Therapy.Frontiers in psychiatry · 2019Article
- A Literature Review of Methodologies Used in Randomized Clinical Trials of Agitation in Alzheimer's Disease.The journal of prevention of Alzheimer's disease · 2018Review
- Mechanisms of Perceived Treatment Assignment and Subsequent Expectancy Effects in a Double Blind Placebo Controlled RCT of Major Depression.Frontiers in psychiatry · 2018Article
- Placebo and Active Treatment Additivity in Placebo Analgesia: Research to Date and Future Directions.International review of neurobiology · 2018Article
- Mental Training for Better Achievement: Effects of Verbal Suggestions and Evaluation (of Effectiveness) on Cognitive Performance.Frontiers in psychiatry · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundInvestigating the size and mechanisms of the placebo response in clinical trials have relied on experimental procedures that simulate the double-blind randomized placebo-controlled design. However, as the conventional design is thought to elucidate drug rather than placebo actions, different methodological procedures are needed for the placebo response.
methodsWe reviewed the respective literature for trials designs that may be used to elucidate the size of the placebo response and the mechanisms associated with it.
resultsIn general, this can be done by either manipulation the information provided to the subjects, or by manipulation the timing of the drug applied. Two examples of each strategy are discussed: the "balanced placebo design" (BDP) and the "balanced cross-over design" (BCD) and their variants are based on false information, while the "hidden treatment" (HT) and the ""delayed response test" (DRT) are based on manipulating the time of drug action. Since most such approaches include deception or incomplete information of the subjects they are suitable for patient only with authorized deception.
conclusionBoth manipulating the information provided to subjects (BDP, DCD) or manipulating the timing of drug application (HT, DRT) allows overcoming some of the restrictions of conventional drug trials in the assessment of the placebo response, but they are feasible mostly in healthy subjects for ethical reasons.
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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.