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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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Metadata
- 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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