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A widely prescribed opioid painkiller showed limited effectiveness and increased risk of negative effects in a new analysis published in BMJ Evidence-Based Medicine.
The study examined tramadol, a common prescription opioid used to treat chronic pain.
Tramadol has historically been perceived as a safer or less addictive opioid, which has contributed to its widespread use in chronic pain treatment, the study authors noted.
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“Often, we may use tramadol to avoid more addictive drugs like other opioids, though in fact tramadol is a synthetic opioid. It is much milder,” Dr. Marc Siegel, senior medical analyst for Fox News, told Fox News Digital.
In the new analysis, researchers used data from 19 randomized clinical trials involving 6,506 adults with conditions including osteoarthritis, chronic low back pain, neuropathic pain and fibromyalgia. All the studies compared tramadol to a placebo treatment.
The level of pain relief associated with tramadol fell below the threshold typically considered clinically important. (iStock)
Overall, tramadol led to a small decrease in pain, but the amount of relief was less than what is usually considered clinically meaningful, the authors reported.
“It is notable how minimal the pain reduction was and how clearly the study highlighted the elevated risk of serious adverse events, even over relatively short trial durations,” Alopi M. Patel, M.D., pain medicine physician at Icahn School of Medicine at Mt. Sinai in New York City, told Fox News Digital. (Patel was not involved in the study.)
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Participants receiving tramadol experienced a higher risk of adverse events, both serious and non-serious, compared with those receiving a placebo.
Serious adverse events primarily included cardiovascular events, such as chest pain, coronary artery disease and congestive heart failure. The authors concluded that tramadol likely increases the risk of heart-related issues.
Serious adverse events were primarily driven by cardiovascular outcomes, including chest pain, coronary artery disease and congestive heart failure. (iStock)
The authors concluded that the benefits of tramadol for chronic pain are small and that the harms likely outweigh the benefits. The findings call into question the use of tramadol for chronic pain conditions, they stated.
Study limitations
Most of the trials included in the analysis were short, with treatment periods ranging from two to 16 weeks and follow-up periods from three to 15 weeks. This limited the ability to assess long-term outcomes, the researchers acknowledged.
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The authors reported that many outcomes had a high risk of bias, which may have exaggerated the apparent benefits and minimized the reported harms.
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The trials involved several different types of chronic pain, but the data were not detailed enough to draw conclusions for any specific condition. This makes it “harder to generalize the findings to specific patient populations,” noted Patel.
Most included trials were short in duration and compared tramadol only with a placebo, limiting conclusions about long-term effects and comparisons with other treatments. (iStock)
Though the study has value, Siegel said, “looking at slight increased rates of cancer or heart disease among those on the drug is completely misleading, because it is not controlled for other factors and there is no evidence or hint of causation.”
“You would have to first look at underlying characteristics of that group who took the meds.”
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The doctor also pointed out that the study “doesn’t compare [tramadol] with full-on opioids like Percocet.”
Experts emphasize that patients should not stop taking tramadol abruptly, as doing so can lead to withdrawal symptoms. Those looking to change their medication should consult a doctor.
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“I recommend that clinicians and patients engage in transparent, shared decision-making that considers tramadol’s modest benefits alongside its risks,” Patel advised.
Fox News Digital reached out to several manufacturers of tramadol requesting comment.