Journal List > J Rheum Dis > v.19(1) > 1063985

Kim, Ryou, and Hur: Comparison of Effectiveness and Safety of Tramadol/Acetaminophen and Non-steroidal Anti-inflammatory Drugs (NSAIDs) for Treatment of Knee Osteoarthritis in Elderly Patients

Abstract

Objective

To compare the analgesic effectiveness and safety of tramadol 37.5 mg/acetaminophen 325 mg combination tablets (tramadol/acetaminophen) with non-steroidal anti-inflammatory drugs (NSAIDs) for the treatment of osteoarthrits in elderly patients.

Methods

This randomized controlled study enrolled 48 patients with chronic knee osteoarthritis where the diagnostic period was over 3 months. Patients with at least moderate pain [visual analog scale (VAS) with scores ≥40/100 mm] after the washout period were randomized to tramadol/acetaminophen or NSAID. All patients received tramadol/acetaminophen 1 tablet TID or NSAID (naproxen 500 mg) BID. The primary outcome measures were the final pain VAS scores. Secondary measures included pain relief (5 point Likert scale), adverse events, and overall medication assessments.

Results

In total, 43 intent-to-treat (ITT) patients received tramadol/acetaminophen (n=21) or NSAID (n=22). Mean baseline pain VAS scores showed no difference between two groups. ITT analysis showed significantly better mean final VAS scores (38.45 vs 31.24, p=0.004) and mean final pain relief scores (2.18 vs 2.95; p=0.007) for tramadol/acetaminophen rather than for NSAID. The most common treatment related adverse events with tramadol/acetaminophen were nausea/vomiting (47.6%) and constipation (33.3%). Epigastric soreness and heartburn was more frequent in NSAID treatment.

Conclusion

Tramadol/acetaminophen combination showed better effectiveness in pain reduction compared with NSAIDs when used for the treatment of osteoarthritis in elderly patients.

Figures and Tables

Figure 1
Change of mean VAS (A) and Likert scale (B) between NSAID and Tramadol/Acetaminophen.
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Figure 2
Distribution of overall adverse events.
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Table 1
Demographic and baseline characteristics
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*Chi-square test.

Table 2
Kellgren-Lawrence grade at baseline
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Table 3
Baseline and final mean VAS and Likert scale
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Table 4
Overall evaluation of adverse events
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