To what extent are surgery and invasive procedures effective beyond a placebo response? A systematic review with meta-analysis of randomised, sham controlled trials
Open accessAbstract
Objectives: To assess the quantity and quality of randomised, sham-controlled studies of surgery and invasive procedures and estimate the treatment-specific and non-specific effects of those procedures. Design: Systematic review and meta-analysis. Data sources: We searched PubMed, EMBASE, CINAHL, CENTRAL (Cochrane Library), PILOTS, PsycInfo, DoD Biomedical Research, clinicaltrials.gov, NLM catalog and NIH Grantee Publications Database from their inception through January 2015. Study selection: We included randomised controlled trials of surgery and invasive procedures that penetrated the skin or an orifice and had a parallel sham procedure for comparison. Data extraction and analysis: Three authors independently extracted data and assessed risk of bias. Studies reporting continuous outcomes were pooled and the standardised mean difference (SMD) with 95% CIs was calculated using a random effects model for difference between true and sham groups. Results: 55 studies (3574 patients) were identified meeting inclusion criteria; 39 provided sufficient data for inclusion in the main analysis (2902 patients). The overall SMD of the continuous primary outcome between treatment/sham-control groups was 0.34 (95% CI 0.20 to 0.49; p<0.00001; I 2 =67%). The SMD for surgery versus sham surgery was non-significant for pain-related conditions (n=15, SMD=0.13, p=0.08), marginally significant for studies on weight loss (n=10, SMD=0.52, p=0.05) and significant for gastroesophageal reflux disorder (GERD) studies (n=5, SMD=0.65, p<0.001) and for other conditions (n=8, SMD=0.44, p=0.004). Mean improvement in sham groups relative to active treatment was larger in pain-related conditions (78%) and obesity (71%) than in GERD (57%) and other conditions (57%), and was smaller in classical-surgery trials (21%) than in endoscopic trials (73%) and those using percutaneous procedures (64%). Conclusions: The non-specific effects of surgery and other invasive procedures are generally large. Particularly in the field of pain-related conditions, more evidence from randomised placebo-controlled trials is needed to avoid continuation of ineffective treatments.
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It seems clearly adaptive for expectations to modulate sensory perception to some extent.
“It seems clearly adaptive for expectations to modulate sensory perception to some extent13,14.”
From Boundary effects of expectation in human pain perception (2019) · cites this paper as [13]
The Introduction (page not available) identifies patient expectations as a possible contributor to placebo responses, and the Results report improvement in pain outcomes in sham groups. The paper does not establish that expectations modulate sensory perception specifically, or address whether such modulation is adaptive. (LLM, conf=0.76)
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A Conversation with … Ted J. Kaptchuk, Expert in Placebo Effects
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Therapeutic benefits of placebo surgery and challenges in neuromodulation research
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Why are assumptions passed off as established knowledge?
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Maximizing placebo response in neurological clinical practice
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A new role for spinal manual therapy and for chiropractic? Part II: strengths and opportunities
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Bias in neuromodulation studies on chronic pain
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Not the Last Word: Safety Alert: One in 200 Knee Replacement Patients Die Within 90 Days of Surgery
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Open-label placebos reduce weight in obesity: a randomized controlled trial
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Placebo nonresponders: An experimental investigation on their unreliability over time
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- Authors
- Jonas, W. B., Crawford, C., Colloca, L., Kaptchuk, T. J., Moseley, B., Miller, F. G., Kriston, L., Linde, K., & Meissner, K.
- Affiliations
- Samueli Institute (US)
- University of Maryland, Baltimore (US)
- Beth Israel Deaconess Medical Center (US)
- Houston Methodist (US)
- National Institutes of Health (US)
- University Medical Center Hamburg-Eppendorf (DE)
- Technical University of Munich (DE)
- Institut für Medizinische Psychologie (DE)
- Corresponding author
- Jonas, Wayne B
- ORCID
- Venue
- BMJ Open
- Publisher
- BMJ
- Published
- 2015-12
- Volume
- 5
- Issue
- 12
- Pages
- e009655
- ISSN
- 2044-6055 (ISSN-L)
- PMC
- PMC4679929
- OpenAlex
- W2265877516
- Cited by
- 183
- References
- 107
- Citations by year
- 2026: 11 · 2025: 19 · 2024: 14 · 2023: 19 · 2022: 28 · 2021: 14 · 2020: 18 · 2019: 13 · 2018: 26 · 2017: 16 · 2016: 4
- FWCI
- 1.51
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by-nc
- Locations
- BMJ Open (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Digital Access to Scholarship at Harvard (DASH) (Harvard University) (submittedVersion, cc-by)
- Open access LMU (Ludwid Maxmilian's Universitat Munchen) (submittedVersion)
- mediaTUM – the media and publications repository of the Technical University Munich (Technical University Munich) (submittedVersion)
- Funders
- Samueli Institute
- Medical Research and Materiel Command (W81XWH-08-1-0615)
- Topics
- Life Sciences › Neuroscience › Cognitive Neuroscience › Pain Management and Placebo Effect
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Social Sciences › Psychology › Clinical Psychology › Psychotherapy Techniques and Applications
- Keywords
- surgery, invasive procedures, sham surgery, placebo response, non-specific effects, endoscopy, percutaneous intervention, obesity, weight loss, gastroesophageal reflux disease, treatment effectiveness, risk of bias, endoscopic surgery
- MeSH terms
- Gastroesophageal Reflux, Humans, Placebo Effect, Randomized Controlled Trials as Topic, Chronic Pain
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