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The powerful opioid analgesic Tramadol is not as effective in relieving chronic pain for which it is widely prescribed, concludes a pooled data analysis of available research conducted by the Rigshospitalet Clinical Interventions Research Center in Copenhagen, Denmark. The results are published in ‘BMJ Evidence Based Medicine’. Also, depending on the job, Tramadol probably increases the risk of serious side effectsincluding heart disease, the findings indicate, leading researchers to conclude that Tramadol’s potential harms likely outweigh its benefits and? its use should be minimized.
It is worth contextualizing that Tramadol is a dual-action opioid widely prescribed for the treatment of acute and chronic pain.moderate to intense. For this reason, it is recommended in several medical guidelines for pain management, the researchers point out. Its use has increased in recent years and it is now one of the most prescribed opioids in the United States.possibly due to its lower perceived risk of side effects and the widespread belief that it is safer and less addictive than other short-acting opioidsthey add.
Although tramadol has been included in previous systematic reviews, none have provided a comprehensive evaluation of the efficacy and safety of tramadol in a variety of chronic pain conditions. In an attempt to fill this knowledge gap, researchers searched research databases randomized clinical trials published until February 2025 comparing tramadol with placebo (dummy treatment) for patients with chronic pain, including cancer pain.

Study points to serious side effects
Nineteen clinical trials with 6,506 participants with chronic pain were eligible for analysis. Five analyzed the impact of tramadol on neuropathic pain; nine focused on osteoarthritis; four in chronic low back pain; and one in fibromyalgia. The average age of trial participants was 58 yearsbut ranged between 47 and 69. The main formulation used was tablets; only one trial included topical cream. Treatment duration ranged from 2 to 16 weeks.while the follow-up duration oscillated between 3 and 15 weeks.
Pooled data analysis of the trial results showed that, Although tramadol relieved pain, the effect was small and below what would be considered clinically effective. Eight of the trials reported on the proportion of serious side effects that occurred after treatment during follow-up periods of between 7 and 16 weeks. Statistical analysis of the results of these trials indicated a doubling of risk of harms associated with tramadol compared to placebodriven mainly by a higher proportion of “cardiac events”such as chest pain, coronary artery disease, and congestive heart failure.
Tramadol use was also associated with an increased risk of some types of canceralthough the follow-up period was short, making this finding “questionable”say the researchers. Pooled data analysis of all trial results indicated that Tramadol treatment was associated with an increased risk of several milder side effectssuch as nausea, dizziness, constipation and drowsiness.

Potential harms may outweigh benefits
The researchers recognize that the results were at high risk of biasbut this increases the probability that findings overestimate the beneficial effects and underestimate the harmful effects of tramadolthey suggest. In this way, they point out: “Approximately 60 million people worldwide experience the addictive effects of opioids. In 2019, drug use was responsible for approximately 600,000 deathsof which almost 80% were associated with opioids and approximately 25% were due to opioid overdoses.”
In USAthe number of opioid-related overdose deaths increased from 49,860 in 2019 to 81,806 in 2022. Given these trends and current findings, the use of tramadol and other opioids should be minimized as much as possible.
Thus, the researchers conclude: “Tramadol may have a slight effect in reducing chronic pain (low certainty of the evidence), although probably increases the risk of serious adverse events (moderate certainty of the evidence) and mild (very low certainty of the evidence). The possible associated damage with the use of tramadol for pain management probably outweigh its limited benefits“.
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