BMJ Evid Based Med

Tramadol associated with minimal relief, higher adverse events in chronic pain

October 10, 2025

Study details: This systematic review and meta-analysis evaluated tramadol vs. placebo in 6,506 adults with chronic pain across 19 randomized trials. Researchers used Trial Sequential Analysis and GRADE methodology to assess tramadol’s efficacy and safety. Outcomes included pain scores, adverse events, quality of life, dependence, and depressive symptoms.

Results: Tramadol reduced pain by a mean of 0.93 points on the numerical rating scale (97.5% confidence interval [CI], -1.26 to -0.60; p<0.0001), but this didn’t meet the minimal clinically important difference of 1.0 point (low certainty). Serious adverse events were significantly more frequent with tramadol (odds ratio [OR], 2.13; 97.5% CI, 1.29-3.51; p=0.001; moderate certainty), including cardiac events and neoplasms. Common non-serious side effects included nausea (number needed to harm [NNH], 7), dizziness (NNH, 8), constipation (NNH, 9), and somnolence (NNH, 13), all with very low certainty of evidence.

Clinical impact: Tramadol’s modest analgesic effect and elevated risk profile suggest limited value in chronic pain management. Clinicians should carefully weigh its risks before prescribing.

Source:

Barakji JA, et al. (2025, October 7). BMJ Evid Based Med. Tramadol versus placebo for chronic pain: a systematic review with meta-analysis and trial sequential analysis. https://pubmed.ncbi.nlm.nih.gov/41057269/