Overview
- The pooled analysis covered 19 randomized trials with 6,506 adults across neuropathic pain, osteoarthritis, chronic low back pain and fibromyalgia, with treatment durations of 2–16 weeks and follow-up of 3–15 weeks.
- Tramadol reduced pain by only a small amount that fell below commonly accepted thresholds for clinical significance.
- Serious adverse events were about twice as likely with tramadol versus placebo, driven largely by more cardiac problems such as chest pain, coronary artery disease and congestive heart failure.
- Non-serious side effects including nausea, dizziness, constipation and sleepiness were more common, and a cancer signal was noted but described as questionable due to short follow-up.
- Authors rated benefit certainty as low and serious-harm certainty as moderate, and the Royal College of GPs advised limiting or stopping tramadol for chronic pain and avoiding new starts, citing the need for safer alternatives and longer-term studies.