Professor Ian Harris
Orthopaedic Surgery, UNSW Sydney; Honorary Professor, School Public Health, the University of Sydney, Australia
Ian Harris is Professor of Orthopaedic Surgery at UNSW Sydney and Honorary Professor at the School Public Health at the University of Sydney. His research is focussed on the effectiveness of surgery. He is also raises awareness of over-treatment, over diagnosis and the dangers of medicalisation and our over-reliance on modern medicine. He has published 400 papers, has grant funding totalling over AU$50M and has published two books critical of modern medicine: Surgery, the Ultimate Placebo (2016) and Hippocrasy: How Doctors Are Betraying Their Oath (with Rachelle Buchbinder, 2021).
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The Effectiveness of Surgery for Chronic Musculoskeletal Pain
A large proportion of the surgical procedures performed worldwide are for chronic musculoskeletal pain. This study aims to quantify the experimental evidence for such surgery. We identified the most common surgical procedures for musculoskeletal pain and searched the literature for all randomised controlled trials published on these procedures. We determined the proportion of all RCTs for each procedure that compared the procedure to not performing the procedure. From that proportion, we determined the proportion that were supportive of surgery, defined as having a statistically significant and clinically important benefit.
6734 RCTs were retrieved on 15 procedures, of which 64 (less than 1%) compared performing the procedure to not performing the procedure (i.e. tested effectiveness). Of those 64 trials, 9 (14%) showed a statistically significant and clinically important benefit to surgery. Of the 12 RCTs that used patient blinding, none showed the procedure to be effective.
There is a lack of experimental evidence testing the effectiveness of many common surgical procedures, and the experimental evidence that exists shows that many common procedures are not more effective than not performing the procedure.
6734 RCTs were retrieved on 15 procedures, of which 64 (less than 1%) compared performing the procedure to not performing the procedure (i.e. tested effectiveness). Of those 64 trials, 9 (14%) showed a statistically significant and clinically important benefit to surgery. Of the 12 RCTs that used patient blinding, none showed the procedure to be effective.
There is a lack of experimental evidence testing the effectiveness of many common surgical procedures, and the experimental evidence that exists shows that many common procedures are not more effective than not performing the procedure.
Effectiveness of Lumbar Spine Fusion
Lumbar spine fusion is a common procedure associated with a high cost burden and risk of serious complications. We aimed to summarise systematic reviews on the effectiveness of lumbar spine fusion for most diagnoses. We found no high-quality systematic reviews and the risk of bias of the randomised controlled trials in the reviews was generally high. The available evidence does not support a benefit from spine fusion compared to non-operative alternatives for back pain associated with degeneration. The available evidence does not support a clinical benefit from spine fusion compared to non-operative treatment or stabilisation without fusion for thoracolumbar burst fractures. Benefits of spine fusion compared to non-operative treatment for isthmic spondylolisthesis are unclear (one trial at high risk of bias). Surgical intervention for metastatic carcinoma of the spine associated with spinal cord compromise improves mobility and neurological outcome (based on a single trial). Better evidence is required to determine more accurately the effectiveness of spine fusion surgery for all indications. Patients contemplating spinal fusion should be fully informed about the evidence base for their particular problem, including the relative potential benefits and harms of fusion compared with non-operative treatments.
A Meta-Epidemiological Study on the Reported Treatment Effect of Pregabalin in Neuropathic Pain Trials Over Time
Introduction
Pregabalin is a drug used to treat neuropathic pain, and its use has increased substantially since 2007. Early trials found a strong treatment effect on pain for post-herpetic neuralgia and diabetic neuropathy. However more recent studies have failed to replicate these results.
Aims
This meta-epidemiological study aimed to assess change in the reported effectiveness of pregabalin in neuropathic pain trials over time, and if a change is present, determine any associated factors.
Methods
We performed electronic searches for published trials in Medline, Embase and Cochrane Central Register of Controlled Trials databases; and unpublished trials on ClinicalTrials.gov, the EU Clinical Trials Register, and the Australia New Zealand Clinical Trials Registry with no restrictions. included randomized, placebo-controlled trials of pregabalin for treatment of neuropathic pain in adults. Two authors independently extracted study data: sample size and mean baseline, end-point and change in pain scores with measures of variance, trial end year, publication year, clinical indication, funding source, country of study, treatment duration, treatment dose, mean age and percentage male. We defined treatment effect as the mean difference in pain scores between pregabalin and placebo groups at trial end-point and assessed for change over time using a random-effects meta-regression, adjusted for sample size, indication, treatment duration (weeks) and treatment dose.
Results
We included 38 randomized published trials (9038 participants) and found that between 2003 and 2020, the reported treatment effect of pregabalin decreased by 0.4 points (95% CI: 0.3 to 0.6; p<0.001) on an 11-point pain scale per 5-year interval, from 1.3 points (95% CI: 1.0 to 1.5) in trials conducted in 2001–2005, to 0.3 (95% CI: -0.1 to 0.7) in trials conducted in 2016–2020. The reported treatment effect was lower than the minimal clinically important difference (MCID) of 1.7 points across all time periods, doses and most indications and was not found to be associated with study characteristics.
Conclusions
The reported treatment effect or analgesic efficacy of pregabalin from clinical trials has
diminished over time. Clinical recommendations may need to be re-evaluated to account for recent evidence and to consider whether pregabalin therapy is indicated.
Pregabalin is a drug used to treat neuropathic pain, and its use has increased substantially since 2007. Early trials found a strong treatment effect on pain for post-herpetic neuralgia and diabetic neuropathy. However more recent studies have failed to replicate these results.
Aims
This meta-epidemiological study aimed to assess change in the reported effectiveness of pregabalin in neuropathic pain trials over time, and if a change is present, determine any associated factors.
Methods
We performed electronic searches for published trials in Medline, Embase and Cochrane Central Register of Controlled Trials databases; and unpublished trials on ClinicalTrials.gov, the EU Clinical Trials Register, and the Australia New Zealand Clinical Trials Registry with no restrictions. included randomized, placebo-controlled trials of pregabalin for treatment of neuropathic pain in adults. Two authors independently extracted study data: sample size and mean baseline, end-point and change in pain scores with measures of variance, trial end year, publication year, clinical indication, funding source, country of study, treatment duration, treatment dose, mean age and percentage male. We defined treatment effect as the mean difference in pain scores between pregabalin and placebo groups at trial end-point and assessed for change over time using a random-effects meta-regression, adjusted for sample size, indication, treatment duration (weeks) and treatment dose.
Results
We included 38 randomized published trials (9038 participants) and found that between 2003 and 2020, the reported treatment effect of pregabalin decreased by 0.4 points (95% CI: 0.3 to 0.6; p<0.001) on an 11-point pain scale per 5-year interval, from 1.3 points (95% CI: 1.0 to 1.5) in trials conducted in 2001–2005, to 0.3 (95% CI: -0.1 to 0.7) in trials conducted in 2016–2020. The reported treatment effect was lower than the minimal clinically important difference (MCID) of 1.7 points across all time periods, doses and most indications and was not found to be associated with study characteristics.
Conclusions
The reported treatment effect or analgesic efficacy of pregabalin from clinical trials has
diminished over time. Clinical recommendations may need to be re-evaluated to account for recent evidence and to consider whether pregabalin therapy is indicated.