Before any medical product or procedure is adopted, it must undergo clinical trials to evaluate its effectiveness. In a randomized clinical trial, subjects are assigned to two or more groups with some receiving the treatment and others receiving none, or a placebo. By comparing outcomes between the two groups, we should be able to see just how useful a treatment is. The subjects (and in the gold standard, the double-blind trial, the scientists as well) are not told which group they’ve been assigned to, theoretically ensuring that there is no bias in reporting about outcomes.
Unfortunately, not all randomized control trials are conducted under ideal circumstances – there can be ethical misconduct (such as financial pressures) as well as design flaws. If the pool of test subjects is too small or heterogeneous, for example, we might not get statistically significant data.
There’s also the issue of reproducibility – a trial may show positive results but those results can never be replicated. Inadequate trials can be enough to get the ball rolling on a treatment or, in some cases, off-label usage of an FDA-approved treatment can be suggested by a small study and be taken up by the medical community despite inadequate evidence. That’s why we (should) continue to conduct trials on treatments even after they’re in use.
In a recent analysis of 3,000 articles from the world’s leading medical journals, a team of researchers has found nearly 400 instances in which a treatment turned out to be of little or no use and in need of a reversal. A medical reversal occurs when a superior clinical trial contradicts current clinical practices.
Researchers from Oregon Health & Science University, the University of Maryland School of Medicine, and the University of Chicago published the results of their study in the most recent issue of the open-access journal eLife. (You can find the complete article here.)
In order to get this number, the team analyzed randomized clinical trials published over the last 15 years in three of the world’s leading medical journals: the Journal of the American Medical Association, the Lancet, and the New England Journal of Medicine.
Identifying low-value medical practices (those that either don’t work or have a cheaper and equally effective alternative) is key to reducing the cost of health care and assuring public trust in medicine. The researchers hope that their work will help eliminate the use of these practices.
So what doesn’t work?
The list represents practices from all disciplines of medical care, but reversals were most common in procedures related to cardiovascular disease (accounting for 20% of the 400 ineffective measures) followed by public health/preventive medicine and critical care.
Regarding the type of intervention, medications were the most likely to have the effectiveness called into question by later studies (in 33% of the 3000 articles), followed by a procedure (20% of articles), vitamin/supplement (13%), devices (9%), and system intervention (8%).
A summary of selected reversals found in the course of their research indicates that the following were found to be ineffective or no better than cheaper alternatives:
- The use of sertraline and mirtazapine in those with Alzheimer’s disease
- The use of compression stockings to reduce the risk of deep vein thrombosis after stroke
- Mammographic screening every 1–2 years for women ages 40–49
- Wearable technology for long-term weight loss
- Vitamin A supplementation among neonates at birth
- The use of Zopiclone, a non-benzodiazepine sleeping pill, for insomnia
- Automated chest compression devices for resuscitation (compared to manual)
- Pulmonary Artery Catheterization after congestive heart failure
- External hip protectors to prevent hip fractures
- Epidural glucocorticoid injections for lumbar stenosis
You can learn more about the details here.
The researchers also mentioned that these practices add to a previous report in 2013 that listed 146 medical reversals published during the years 2001–2010.
If you’re wondering about the cost, it’s enormous. Prior studies have shown that among Medicare recipients alone a large number are receiving treatments which were later deemed ineffective. In a 2014 study of 26 low-value services provided to older adults through Medicare, the estimated spending was between $1.9 and $8.5 billion in 2008-2009 alone, with 25% of recipients receiving treatments later found to be ineffective or economically inefficient.
The medical reversals were not confined to doctors’ offices, but also included “behavioral practices (e.g., cognitive behavioral therapy or mindfulness interventions), complementary or non-traditional practices (e.g., acupuncture), dietary supplements (e.g. omega-3 fatty acids or vitamin A supplementation), community practices (e.g., programs to prevent teenage pregnancy or self-poisoning), or wearable technology.”
There is a tremendous amount of research that shows up in journals and is implemented based on flawed studies, studies that are too small to be meaningful, and studies whose funding comes from the company selling or licensing the product or procedure. The researchers point out that their study highlights “the importance of independent, governmental and non-conflicted funding of clinical research.”
The majority of reversal studies we found were funded by such sources (63.9%), with a minority funded solely by the industry (9.1%). Conversely, industry-funded research represented between 35–49% of trials registered on ClinicalTrials.gov during years 2006 through 2014.
So what should we be doing differently?
For starters, we should continue to perform randomized clinical trials on both novel and established practices in order to gauge their long-term effectiveness and reproducibility. Next, we should be wary of rushing treatment into practice without good data. Once a treatment becomes widespread, it’s difficult to get people – physicians included – to abandon it.
By aiming to test novel treatments before they are widespread, we can reduce the number of reversals in practice and prevent harm to patients and to the reputation of the medical field.
Nevertheless, the goal, say the researchers, is the de-adoption of low-value medical practices, not only for the sake of patient well-being but for massive cost savings in medical care.