Study finds widely prescribed opioid shows minimal pain relief and increased heart risk
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A widely prescribed opioid pain reliever showed limited effectiveness and an 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 the treatment of chronic pain, the study authors noted.
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“Oftentimes, we can use tramadol to avoid more addictive drugs like other opioids, although in reality, tramadol is a synthetic opioid. It’s much milder,” Dr. Marc Siegel, News senior medical analyst, told 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 studies compared tramadol with a placebo treatment.
The level of pain relief associated with tramadol fell below the threshold normally considered clinically important. (iStock)
Overall, tramadol produced a small decrease in pain, but the amount of relief was less than what is typically considered clinically significant, the authors reported.
“It’s notable how minimal the pain reduction was and how clearly the study highlighted the elevated risk of serious adverse events, even during trials of relatively short duration,” Dr. Alopi M. Patel, an analgesic physician at the Icahn School of Medicine at Mt. Sinai in New York City, told News Digital. (Patel was not involved in the study.)
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Participants who received tramadol experienced an increased risk of adverse events, both serious and non-serious, compared to those who received a placebo.
Serious adverse events mainly included cardiovascular events, such as chest pain, coronary artery disease, and congestive heart failure. The authors concluded that tramadol probably increases the risk of heart-related problems.
Serious adverse events were primarily due to 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 probably outweigh the benefits. The findings call into question the use of tramadol for chronic pain conditions, they said.
Limitations of the study
Most of the trials included in the analysis were short, with treatment periods ranging from two to 16 weeks and follow-up periods ranging from three to 15 weeks.
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This limited the ability to evaluate long-term outcomes, the researchers acknowledged.
The authors reported that many results were at high risk of bias, which may have exaggerated the apparent benefits and understated the reported harms.
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The trials included several different types of chronic pain, but the data were not detailed enough to draw conclusions about any specific condition. This makes it “more difficult to generalize the findings to specific patient populations,” Patel noted.
Most trials were of short duration and compared tramadol only with a placebo, which limited conclusions about long-term effects and comparisons with other treatments. (iStock)
Although the study has value, Siegel said, “seeing a slight increase in rates of cancer or heart disease among those taking the drug is completely misleading, because it is not controlled for other factors and there is no evidence or hint of causality.”
“You would first have to look at the underlying characteristics of the group that took the drugs.”
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The doctor also noted that the study “does not compare [tramadol] with full opioids like Percocet.
Experts emphasize that patients should not stop taking tramadol abruptly, as doing so can lead to withdrawal symptoms. Those who wish to change their medication should consult a doctor.
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“I recommend that doctors and patients engage in transparent, shared decision-making that considers the modest benefits of tramadol along with its risks,” Patel advised.
News Digital contacted several manufacturers of tramadol for comment.
Khloe Quill is a lifestyle production assistant at News Digital. She and the lifestyle team cover a range of topics including food and drink, travel and health.