Placebo-Controlled Trials in Surgery: A Systematic Review and Meta-Analysis.

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, P = 0.46). 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.

journal_name

Medicine (Baltimore)

journal_title

Medicine

authors

Probst P,Grummich K,Harnoss JC,Hüttner FJ,Jensen K,Braun S,Kieser M,Ulrich A,Büchler MW,Diener MK

doi

10.1097/MD.0000000000003516

subject

Has Abstract

pub_date

2016-04-01 00:00:00

pages

e3516

issue

17

eissn

0025-7974

issn

1536-5964

pii

00005792-201604260-00048

journal_volume

95

pub_type

杂志文章,meta分析,评审

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