• M S Cepeda, F Camargo, C Zea, and L Valencia.
• Javeriana University School of Medicine, Department of Anesthesia, Cra 4- 70 -69, Bogota, Colombia. scepeda@javeriana.edu.co
• Cochrane Db Syst Rev. 2006 Jan 1(3):CD005522.

BackgroundTramadol is increasingly used for the treatment of osteoarthritis because, in contrast to nonsteroidal anti-inflammatory drugs (NSAIDs), tramadol does not produce gastrointestinal bleeding or renal problems, and does not affect articular cartilage.ObjectivesWe sought to determine the analgesic effectiveness, the effect on physical function, the duration of benefit and the safety of oral tramadol in people with osteoarthritis.Search StrategyWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and LILACS databases up to August 2005.Selection CriteriaWe included randomized controlled trials (RCTs) that evaluated the effect of tramadol or tramadol plus paracetamol on pain levels and/or physical function in people with osteoarthritis. No language restriction was applied.Data Collection And AnalysisWe analyzed separately placebo-controlled and active-controlled studies. We used fixed-effect models for the meta-analyses as the results across studies were similar.Main ResultsWe included eleven RCTs with a total of 1019 participants who received tramadol or tramadol/paracetamol and 920 participants who received placebo or active-control. The placebo-controlled studies indicated that participants who received tramadol had less pain (-8.5 units on a 0 to 100 scale; 95% confidence interval (CI) -12.0 to -5.0) than patients who received placebo. This represents a 12% relative decrease in pain intensity from baseline. Participants who received tramadol had a 37% increase (95% CI 1.2 to 1.5) in the likelihood of reporting moderate improvement (number needed to treat to benefit = 6; 95% CI 4 to 9). Participants who received tramadol had 2.27 times the risk of developing minor adverse events and 2.6 times the risk of developing major adverse events, compared to participants who received placebo. Of every eight people who receive tramadol or tramadol/paracetamol, one will stop taking the medication because of adverse events, number needed to treat to harm (NNTH)= 8 (95% CI 7 to 12) for major adverse events. No conclusion could be drawn on how tramadol or tramadol/paracetamol compared with available pharmacological treatments because of the limited number of studies that evaluated such therapies.Authors' ConclusionsTramadol or tramadol/paracetamol decreases pain intensity, produces symptom relief and improves function, but these benefits are small. Adverse events, although reversible and not life threatening, often cause participants to stop taking the medication and could limit tramadol or tramadol plus paracetamol usefulness.

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