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10.1097/MD.0000000000003516

http://scihub22266oqcxt.onion/10.1097/MD.0000000000003516
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C4998723!4998723!27124060
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suck abstract from ncbi


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pmid27124060      Medicine+(Baltimore) 2016 ; 95 (17): ä
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  • Placebo-Controlled Trials in Surgery: A Systematic Review and Meta-Analysis #MMPMID27124060
  • Probst P; Grummich K; Harnoss JC; Hüttner FJ; Jensen K; Braun S; Kieser M; Ulrich A; Büchler MW; Diener MK
  • Medicine (Baltimore) 2016[Apr]; 95 (17): ä PMID27124060show ga
  • 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.
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