Tramadol's Limited Benefits Outweigh Potential Harms in Chronic Pain Management

Strategic Insights -

Researchers at Copenhagen's Rigshospitalet have published a systematic review of 19 clinical trials involving 6,506 participants to assess the benefits and harms of tramadol compared to placebo in adults with chronic pain. The study, published in the BMJ Evidence-Based Medicine journal, concluded that the potential harms associated with tramadol use likely outweigh its limited benefits. The review found evidence of a beneficial effect of tramadol on chronic pain, but the results were at high risk of bias and the overall quality of life and other outcomes were not significantly improved.

Key Takeaways:

  • The study involved 19 randomised placebo-controlled clinical trials enrolling 6,506 participants with chronic pain.
  • The research found that tramadol had a beneficial effect on chronic pain, with a mean difference of -0.93 points on the numerical rating scale (NRS), but this result was at high risk of bias.
  • The review concluded that the potential harms associated with tramadol use likely outweigh its limited benefits.
  • The study authors assessed the risk of bias according to the Cochrane Handbook for Systematic Reviews of Interventions.
  • The included trials were published and unpublished randomised clinical trials comparing tramadol to placebo in adults with any type of chronic pain.
  • The main outcome measures were pain level, adverse events, quality of life, dependence, abuse, and depressive symptoms.

Statistics:

  • 6,506 participants were included in the 19 clinical trials.
  • The mean difference in pain level between tramadol and placebo was -0.93 points on the numerical rating scale (NRS).
  • The Cochrane Handbook for Systematic Reviews of Interventions was used to assess the risk of bias.
  • 97.5% CI -1.26 to -0.60 was the confidence interval for the mean difference in pain level between tramadol and placebo.

Sources:

  • NewsRx. "Study Data from Rigshospitalet Update Understanding of Chronic Pain (Tramadol versus placebo for chronic pain: a systematic review with meta-analysis and trial sequential analysis)". Health & Medicine Week, 2025, p 7841.
  • Johanne Juul Petersen, et al. "Tramadol versus placebo for chronic pain: a systematic review with meta-analysis and trial sequential analysis." BMJ Evidence-Based Medicine, 2025, vol. 2025, article CINR011.