Sham Surgery Studies in Orthopaedic Surgery May Just Be a Sham: A Systematic Review of Randomized Placebo-Controlled Trials

Review of Randomized Placebo-Controlled Trials

“…The sham surgeryecontrolled investigation attempts to mitigate the effect of the surgical placebo response and truly identify whether the actual intervention works (i.e., is it the actual specific effect of the arthroscopic meniscectomy that works, or is it just the placebo effect [and contextual effects] of the knee arthroscopy?). We agree with both the letter to the editor by Harris et al 1 and the excellent text Surgery, The Ultimate Placebo by Harris 7 that there are several reasons that an individual in the placebo group may improve after a treatment or surgical procedure that are not a result of the placebo effect: self-limiting natural history of the condition (Voltaire's "amusing the patient while nature cures the disease"), regression to the mean, concomitant treatment(s), and potentially, other unknown reasons. It is perhaps for these reasonsdand not an "actual placebo effect" (which contradicts its definition)dthat patients improve after a sham or placebo operation.…”

“…We read the recent review by Sochacki et al 1 with great interest. The authors' main conclusion is that major orthopaedic trials involving sham surgery have methodologic deficiencies that may invalidate their conclusions.…”

A Mini-Review of Sham Surgery in Orthopedics

“…Most carried fundamental deficiencies, which led to invalid conclusions. Not enough manpower, no genetic susceptibility analysis, no blinding index due to high crossover rates, short term follow-up, exclusion of non-treatment group and per-protocol analysis: those were just some of the downfalls observed [13].…”

Editorial Commentary: Published Sham Trials in Orthopaedic Surgery Are Flawed and Potentially Unethical—A Wolf in Sheep’s Clothing

“…Placebo-controlled randomized controlled trials have received a lot of attention in the current era of value-based healthcare 2 . The efficacy of few surgeries in sports medicine has been investigated utilizing sham surgery as placebo 3 . The potential benefit of this study design is to isolate the effect of surgery from the placebo effect of surgical treatment.…”

“…In the article entitled "Sham Surgery Studies May Just Be a Sham: A Systematic Review of Randomized Placebo-Controlled Trials" Sochacki, Mather, Nwachukwu, Dong, Nho, Cote and Harris report a systematic review that examined seven sham controlled randomized controlled trials in sports medicine 3 .…”