Placebo-Controlled Trials in Surgery: A Systematic Review and Meta-Analysis.
Medicine (Baltimore)
; 95(17): e3516, 2016 Apr.
Article
in En
| MEDLINE
| ID: mdl-27124060
ABSTRACT
This systematic review was performed to investigate the ethical justification, methodological quality, validity and safety of placebo controls in randomized placebo-controlled surgical trials.Central, MEDLINE, and EMBASE were systematically searched to identify randomized controlled trials comparing a surgical procedure to a placebo. "Surgical procedure" was defined as a medical procedure involving an incision with instruments. Placebo was defined as a blinded sham operation involving no change to the structural anatomy and without an expectable physiological response in the target body compartment.Ten randomized placebo-controlled controlled surgical trials were included, all of them published in high-ranking medical journals (mean impact factor 20.1). Eight of 10 failed to show statistical superiority of the experimental intervention. Serious adverse events did not differ between the groups (rate ratio [RR] 1.38, 95% confidence interval [CI] 0.92-2.06, Pâ=â0.46). None of the trials had a high risk of bias in any domain. The ethical justification for the use of a placebo control remained unclear in 2 trials.Placebo-controlled surgical trials are feasible and provide high-quality data on efficacy of surgical treatments. The surgical placebo entails a considerable risk for study participants. Consequently, a placebo should be used only if justified by the clinical question and by methodological necessity. Based on the current evidence, a pragmatic proposal for the use of placebo controls in future randomized controlled surgical trials is made.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Surgical Procedures, Operative
/
Placebo Effect
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Randomized Controlled Trials as Topic
/
Patient Safety
Type of study:
Clinical_trials
/
Prognostic_studies
/
Systematic_reviews
Aspects:
Ethics
Language:
En
Journal:
Medicine (Baltimore)
Year:
2016
Document type:
Article