Use of placebo controls in the evaluation of surgery: systematic review
One article on PainSci cites Wartolowska 2014: Knee Replacement Surgery Doubts
PainSci commentary on Wartolowska 2014: ?This page is one of thousands in the PainScience.com bibliography. It is not a general article: it is focused on a single scientific paper, and it may provide only just enough context for the summary to make sense. Links to other papers and more general information are provided wherever possible.
In 53 placebo-controlled trials of surgeries, a shame produced results just as good as the surgery in 27 (51%). “Placebo controlled trial is a powerful, feasible way of showing the efficacy of surgical procedures.” More properly controlled studies of surgery are badly needed.
~ Paul Ingraham
original abstract †Abstracts here may not perfectly match originals, for a variety of technical and practical reasons. Some abstacts are truncated for my purposes here, if they are particularly long-winded and unhelpful. I occasionally add clarifying notes. And I make some minor corrections.
OBJECTIVE: To investigate whether placebo controls should be used in the evaluation of surgical interventions.
DESIGN: Systematic review.
DATA SOURCES: We searched Medline, Embase, and the Cochrane Controlled Trials Register from their inception to November 2013.
STUDY SELECTION: Randomised clinical trials comparing any surgical intervention with placebo. Surgery was defined as any procedure that both changes the anatomy and requires a skin incision or use of endoscopic techniques.
DATA EXTRACTION: Three reviewers (KW, BJFD, IR) independently identified the relevant trials and extracted data on study details, outcomes, and harms from included studies.
RESULTS: In 39 out of 53 (74%) trials there was improvement in the placebo arm and in 27 (51%) trials the effect of placebo did not differ from that of surgery. In 26 (49%) trials, surgery was superior to placebo but the magnitude of the effect of the surgical intervention over that of the placebo was generally small. Serious adverse events were reported in the placebo arm in 18 trials (34%) and in the surgical arm in 22 trials (41.5%); in four trials authors did not specify in which arm the events occurred. However, in many studies adverse events were unrelated to the intervention or associated with the severity of the condition. The existing placebo controlled trials investigated only less invasive procedures that did not involve laparotomy, thoracotomy, craniotomy, or extensive tissue dissection.
CONCLUSIONS: Placebo controlled trial is a powerful, feasible way of showing the efficacy of surgical procedures. The risks of adverse effects associated with the placebo are small. In half of the studies, the results provide evidence against continued use of the investigated surgical procedures. Without well designed placebo controlled trials of surgery, ineffective treatment may continue unchallenged.
- “Sham Surgery in Orthopedics: A Systematic Review of the Literature,” Louw et al, Pain Med, 2016.
- “To what extent are surgery and invasive procedures effective beyond a placebo response? A systematic review with meta-analysis of randomised, sham controlled trials,” Jonas et al, BMJ Open, 2015.
- Surgery: The ultimate placebo (book), by Ian Harris (book review).
This page is part of the PainScience BIBLIOGRAPHY, which contains plain language summaries of thousands of scientific papers & others sources. It’s like a highly specialized blog. A few highlights:
- Inciting events associated with lumbar disc herniation. Suri 2010 Spine J.
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- Characteristics of patients with low back and leg pain seeking treatment in primary care: baseline results from the ATLAS cohort study. Konstantinou 2015 BMC Musculoskelet Disord.
- Effectiveness and cost-effectiveness of universal school-based mindfulness training compared with normal school provision in reducing risk of mental health problems and promoting well-being in adolescence: the MYRIAD cluster randomised controlled trial. Kuyken 2022 Evid Based Ment Health.
- Is there a relationship between throbbing pain and arterial pulsations? Mirza 2012 J Neurosci.