A comprehensive review of clinical trials suggests that the widely prescribed opioid analgesic, tramadol, offers limited relief for chronic pain and may double the risk of serious adverse events. The findings challenge the common perception of tramadol as a safer alternative to other opioids, urging a reconsideration of its use.
Key Takeaways
- Tramadol showed a statistically significant reduction in chronic pain, but the effect size fell below the predefined threshold for clinical meaningfulness.
- The drug was associated with a higher risk of serious adverse events, including cardiac issues and neoplasms.
- Most included trials had a high risk of bias, potentially overstating benefits and understating harms.
- Researchers recommend minimizing the use of tramadol and exploring safer alternatives for chronic pain management.
Questionable Efficacy for Chronic Pain
A meta-analysis and trial sequential analysis of 19 clinical trials involving over 6,500 participants found that tramadol improved chronic pain scores on the numerical rating scale (NRS) by an average of 0.93 points. However, this effect was below the minimal important difference of 1.0 point, suggesting the pain reduction may not be clinically significant for patients.
Increased Risk of Serious Adverse Events
The review also indicated that tramadol doubled the risk of serious adverse events compared to placebo. These events were primarily driven by a higher proportion of cardiac events, such as chest pain and congestive heart failure, and neoplasms. While a link to cancer was noted, the researchers cautioned that the short follow-up periods in most trials made a causal relationship questionable.
Non-serious side effects like nausea, dizziness, constipation, and somnolence were also more common in patients taking tramadol.
Concerns Over Bias and Perception
Researchers highlighted that most of the included trials had a high risk of bias. This limitation increases the likelihood that the study’s findings may overestimate tramadol’s benefits and underestimate its harms. Despite being classified as a Schedule IV controlled substance, indicating a lower risk of abuse than some other opioids, the study suggests this perception may not be fully supported by evidence.
Recommendations for Minimizing Use
Given the limited clinical benefit and increased risk of harm, the study authors recommend minimizing the use of tramadol for chronic pain. They advocate for prioritizing safer alternatives and suggest that further high-quality trials are needed to clarify tramadol’s risk-benefit profile. Experts also suggest that tramadol should be prescribed with clear functional goals, for limited durations, and with close monitoring for side effects, as part of a broader pain management plan.
Sources
- Risks of Tramadol Likely Outweigh Benefit for Chronic Pain, MedPage Today.
- Commonly used opioid tramadol not that effective for easing chronic pain, new study finds, CNN.
- Study Highlights Safety Concerns With Tramadol, Calls for Careful Prescribing, Pharmacy Times.
- Is Tramadol Safe? New Research Challenges Its Opioid Reputation, New Atlas.
- Tramadol found to offer limited relief for chronic pain while raising risk of serious side effects, News-Medical.