Sham surgical procedures for pain intervention result in significant improvements in pain: Systematic review and meta-analysis

Alice P. Gu, Chris N. Gu, Ahmed T. Ahmed, Mohammad H Murad, Zhen Wang, David F Kallmes, Waleed Brinjikji

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Objective: To perform a systematic review and meta-analysis to study the magnitude of the placebo effect associated with sham surgery procedures. Study Design and Setting: We conducted a systematic search for randomized controlled clinical trials comparing any type of surgery to a corresponding sham placebo group and compared improvements in the sham treatment arms in subjective, objective, categorical, and continuous outcomes, as well as complication rates and mortality. Effect sizes were reported as standardized mean differences (SMDs). This is a systematic review and meta-analysis. Results: The overall effect size for pain improvement after sham surgery was SMD = 0.22 (95% confidence interval [CI] = 0.08-0.35) with improvement most marked at 1 month (SMD = 0.34, 95% CI = 0.26-0.43). There was a higher rate of improvement in subjective outcomes compared to objective outcomes for both dichotomized (number of patients with improvement) (42.8% compared to 27.1%) and continuous outcomes (SMD = 0.12, 95% CI = -0.05, 0.30 vs. SMD = -0.01, 95% CI = -0.05, 0.03). There were no deaths in the sham treatment arms and major complications were very rare (0.2%, 95% CI = 0.0-0.6%). Conclusion: Sham surgery is associated with a large improvement in pain and other subjective patient-reported outcomes but with relatively small effect on objective outcomes. Sham surgeries are overwhelmingly safe. The magnitude of this effect should be used when planning future sham-controlled surgery trials.

Original languageEnglish (US)
JournalJournal of Clinical Epidemiology
DOIs
StateAccepted/In press - 2017

Fingerprint

Meta-Analysis
Pain
Confidence Intervals
Placebos
Placebo Effect
Randomized Controlled Trials
Mortality

Keywords

  • Meta-analysis
  • Pain
  • Placebo
  • Placebo effect
  • Randomized
  • Sham
  • Sham effect
  • Sham surgical
  • Surgery
  • Systematic review

ASJC Scopus subject areas

  • Epidemiology

Cite this

@article{94588e57157a4cd4a5b69fa3f95e530b,
title = "Sham surgical procedures for pain intervention result in significant improvements in pain: Systematic review and meta-analysis",
abstract = "Objective: To perform a systematic review and meta-analysis to study the magnitude of the placebo effect associated with sham surgery procedures. Study Design and Setting: We conducted a systematic search for randomized controlled clinical trials comparing any type of surgery to a corresponding sham placebo group and compared improvements in the sham treatment arms in subjective, objective, categorical, and continuous outcomes, as well as complication rates and mortality. Effect sizes were reported as standardized mean differences (SMDs). This is a systematic review and meta-analysis. Results: The overall effect size for pain improvement after sham surgery was SMD = 0.22 (95{\%} confidence interval [CI] = 0.08-0.35) with improvement most marked at 1 month (SMD = 0.34, 95{\%} CI = 0.26-0.43). There was a higher rate of improvement in subjective outcomes compared to objective outcomes for both dichotomized (number of patients with improvement) (42.8{\%} compared to 27.1{\%}) and continuous outcomes (SMD = 0.12, 95{\%} CI = -0.05, 0.30 vs. SMD = -0.01, 95{\%} CI = -0.05, 0.03). There were no deaths in the sham treatment arms and major complications were very rare (0.2{\%}, 95{\%} CI = 0.0-0.6{\%}). Conclusion: Sham surgery is associated with a large improvement in pain and other subjective patient-reported outcomes but with relatively small effect on objective outcomes. Sham surgeries are overwhelmingly safe. The magnitude of this effect should be used when planning future sham-controlled surgery trials.",
keywords = "Meta-analysis, Pain, Placebo, Placebo effect, Randomized, Sham, Sham effect, Sham surgical, Surgery, Systematic review",
author = "Gu, {Alice P.} and Gu, {Chris N.} and Ahmed, {Ahmed T.} and Murad, {Mohammad H} and Zhen Wang and Kallmes, {David F} and Waleed Brinjikji",
year = "2017",
doi = "10.1016/j.jclinepi.2016.12.010",
language = "English (US)",
journal = "Journal of Clinical Epidemiology",
issn = "0895-4356",
publisher = "Elsevier USA",

}

TY - JOUR

T1 - Sham surgical procedures for pain intervention result in significant improvements in pain

T2 - Systematic review and meta-analysis

AU - Gu, Alice P.

AU - Gu, Chris N.

AU - Ahmed, Ahmed T.

AU - Murad, Mohammad H

AU - Wang, Zhen

AU - Kallmes, David F

AU - Brinjikji, Waleed

PY - 2017

Y1 - 2017

N2 - Objective: To perform a systematic review and meta-analysis to study the magnitude of the placebo effect associated with sham surgery procedures. Study Design and Setting: We conducted a systematic search for randomized controlled clinical trials comparing any type of surgery to a corresponding sham placebo group and compared improvements in the sham treatment arms in subjective, objective, categorical, and continuous outcomes, as well as complication rates and mortality. Effect sizes were reported as standardized mean differences (SMDs). This is a systematic review and meta-analysis. Results: The overall effect size for pain improvement after sham surgery was SMD = 0.22 (95% confidence interval [CI] = 0.08-0.35) with improvement most marked at 1 month (SMD = 0.34, 95% CI = 0.26-0.43). There was a higher rate of improvement in subjective outcomes compared to objective outcomes for both dichotomized (number of patients with improvement) (42.8% compared to 27.1%) and continuous outcomes (SMD = 0.12, 95% CI = -0.05, 0.30 vs. SMD = -0.01, 95% CI = -0.05, 0.03). There were no deaths in the sham treatment arms and major complications were very rare (0.2%, 95% CI = 0.0-0.6%). Conclusion: Sham surgery is associated with a large improvement in pain and other subjective patient-reported outcomes but with relatively small effect on objective outcomes. Sham surgeries are overwhelmingly safe. The magnitude of this effect should be used when planning future sham-controlled surgery trials.

AB - Objective: To perform a systematic review and meta-analysis to study the magnitude of the placebo effect associated with sham surgery procedures. Study Design and Setting: We conducted a systematic search for randomized controlled clinical trials comparing any type of surgery to a corresponding sham placebo group and compared improvements in the sham treatment arms in subjective, objective, categorical, and continuous outcomes, as well as complication rates and mortality. Effect sizes were reported as standardized mean differences (SMDs). This is a systematic review and meta-analysis. Results: The overall effect size for pain improvement after sham surgery was SMD = 0.22 (95% confidence interval [CI] = 0.08-0.35) with improvement most marked at 1 month (SMD = 0.34, 95% CI = 0.26-0.43). There was a higher rate of improvement in subjective outcomes compared to objective outcomes for both dichotomized (number of patients with improvement) (42.8% compared to 27.1%) and continuous outcomes (SMD = 0.12, 95% CI = -0.05, 0.30 vs. SMD = -0.01, 95% CI = -0.05, 0.03). There were no deaths in the sham treatment arms and major complications were very rare (0.2%, 95% CI = 0.0-0.6%). Conclusion: Sham surgery is associated with a large improvement in pain and other subjective patient-reported outcomes but with relatively small effect on objective outcomes. Sham surgeries are overwhelmingly safe. The magnitude of this effect should be used when planning future sham-controlled surgery trials.

KW - Meta-analysis

KW - Pain

KW - Placebo

KW - Placebo effect

KW - Randomized

KW - Sham

KW - Sham effect

KW - Sham surgical

KW - Surgery

KW - Systematic review

UR - http://www.scopus.com/inward/record.url?scp=85011273288&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85011273288&partnerID=8YFLogxK

U2 - 10.1016/j.jclinepi.2016.12.010

DO - 10.1016/j.jclinepi.2016.12.010

M3 - Article

C2 - 28063914

AN - SCOPUS:85011273288

JO - Journal of Clinical Epidemiology

JF - Journal of Clinical Epidemiology

SN - 0895-4356

ER -