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Cited by 183Pain Management and Placebo EffectMeta-analysis and systematic reviewsPsychotherapy Techniques and Applications

The DOI matches its Crossref record; 108 of the 108 references it cites were found in a registry or an index.

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 access
Jonas, Wayne B, Crawford, Cindy, Colloca, Luana, Kaptchuk, Ted J, Moseley, Bruce, Miller, Franklin G, Kriston, Levente, Linde, Klaus, Meissner, Karin·2015·BMJ Open
DOI 10.1136/bmjopen-2015-009655PMC PMC4679929
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Abstract

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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Figure 1 Flow chart of included studies. RCT, randomised controlled trial.
Figure 1 Flow chart of included studies. RCT, randomised controlled trial.CC BY-NC · PubMed Central
Figure 2 The specific effect of invasive procedures and surgery.
Figure 2 The specific effect of invasive procedures and surgery.CC BY-NC · PubMed Central
Figure 3 Funnel plot using continuous outcomes (effects of active vs sham treatment) of the 39 studies included in the main meta-analysis.
Figure 3 Funnel plot using continuous outcomes (effects of active vs sham treatment) of the 39 studies included in the main meta-analysis.CC BY-NC · PubMed Central
Figure 4 Relative contribution to improvement in the placebo and active treatment groups.
Figure 4 Relative contribution to improvement in the placebo and active treatment groups.CC BY-NC · PubMed Central

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  1. 10.1037//0033-2909.92.2.490 · DOI
  2. 10.1097/00006324-199805000-00022 · DOI

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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)
DOI
10.1136/bmjopen-2015-009655
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
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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