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), lithium, or St. John's Wort. If concomitant treatment of ULTRAM ER with a drug affecting the serotonergic neurotransmitter system is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases (see
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People in the studies took about 200 mg of tramadol per day or a placebo (fake tablets or powder) or an NSAID or a different pain reliever. People took the drugs for up to one week to three months.
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Serotonergic Drugs: There have been postmarketing reports of serotonin syndrome with use of tramadol and SSRIs/SNRIs or MAOIs and ?2-adrenergic blockers. Caution is advised when ULTRAM ER is coadministered with other drugs that may affect the serotonergic neurotransmitter systems, such as SSRIs, MAOIs, triptans, linezolid (an antibiotic which is a reversible non-selective
- 69 out of 100 people may improve when taking tramadol
Tramadol 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.
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.
Triptans: Based on the mechanism of action of tramadol and the potential for serotonin syndrome, caution is advised when ULTRAM ER is coadministered with a triptan. If concomitant treatment of ULTRAM ER with a triptan is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases (see
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with ULTRAM ER resulted in a 50-60% increase in tramadol exposure and a 50-60% decrease in M1 exposure (see
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It is not known whether tramadol causes more side effects than other drugs for osteoarthritis.
This is a Cochrane review abstract and plain language summary, prepared and maintained by The Cochrane Collaboration, currently published in The Cochrane Database of Systematic Reviews 2008 Issue 3, Copyright ?© 2008 The Cochrane Collaboration. Published by John Wiley and Sons, Ltd.. The full text of the review is available in
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ULTRAM ER was administered to a total of 3108 patients during studies conducted in the U.S. These included four double-blind studies in patients with
There is gold level evidence that to treat osteoarthritis, tramadol taken for up to three months may decrease pain, may improve stiffness and function and overall-well being. Tramadol may cause side effects such as nausea, vomiting, dizziness, constipation, tiredness, and headache.
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- function may improve by 0.32 more points on a scale of 0 to10 with tramadol
). The clinical consequences of these findings are unknown.
It is not known whether tramadol improves symptoms of osteoarthritis more than other drugs. It is also not known whether tramadol still works well after long use. This is because the follow -up of the studies was short.
We 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.
We included eleven RCTs with a total of 1019 participants who received tramadol or tramadol/paracetamol and 920 participants who received placebo or active-control.
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