J Rheum Dis.  2012 Feb;19(1):25-29. 10.4078/jrd.2012.19.1.25.

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

Affiliations
  • 1Department of Internal Medicine, Eulji University College of Medicine, Seoul, Korea. rheumatism@eulji.ac.kr

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 > or =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.

Keyword

Osteoarthritis; NSAID; Tramadol

MeSH Terms

Aged
Anti-Inflammatory Agents, Non-Steroidal
Constipation
Heartburn
Humans
Knee
Osteoarthritis
Osteoarthritis, Knee
Outcome Assessment (Health Care)
Tablets
Tramadol
Anti-Inflammatory Agents, Non-Steroidal
Tablets
Tramadol

Figure

  • Figure 1 Change of mean VAS (A) and Likert scale (B) between NSAID and Tramadol/Acetaminophen.

  • Figure 2 Distribution of overall adverse events.


Reference

1. Kelley WN. Textbook of rheumatology. 1997. 5th ed. Philadelphia: W.B. Saunders;1547–1548.
2. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update. Arthritis Rheum. 2000. 43:1905–1915.
3. Raffa RB. Pharmacology of oral combination analgesics: rational therapy for pain. J Clin Pharm Ther. 2001. 26:257–264.
4. Raffa RB, Friderichs E, Reimann W, Shank RP, Codd EE, Vaught JL, et al. Complementary and synergistic antinociceptive interaction between the enantiomers of tramadol. J Pharmacol Exp Ther. 1993. 267:331–340.
5. Mullican WS, Lacy JR;. TRAMAP-ANAG-006 Study Group. Tramadol/acetaminophen combination tablets and codeine/acetaminophen combination capsules for the management of chronic pain: a comparative trial. Clin Ther. 2001. 23:1429–1445.
6. Vane J, Botting R. Inflammation and the mechanism of action of anti-inflammatory drugs. FASEB J. 1987. 1:89–96.
7. Roth SH. Efficacy and safety of tramadol HCl in breakthrough musculoskeletal pain attributed to osteoarthritis. J Rheumatol. 1998. 25:1358–1363.
8. Griffin MR, Piper JM, Daugherty JR, Snowden M, Ray WA. Nonsteroidal anti-inflammatory drug use and increased risk for peptic ulcer disease in elderly persons. Ann Intern Med. 1991. 114:257–263.
9. Fayers P. Approaches to sample size estimation in the design of clinical trials--a review. By A. Donner, Statistics in Medicine, 3, 199-214 (1984). Stat Med. 1993. 12:1643.
10. Smith AB, Ravikumar TS, Kamin M, Jordan D, Xiang J, Rosenthal N;. CAPSS-115 Study Group. Combination tramadol plus acetaminophen for postsurgical pain. Am J Surg. 2004. 187:521–527.
11. Buckwalter JA, Mankin HJ, Grodzinsky AJ. Articular cartilage and osteoarthritis. Instr Course Lect. 2005. 54:465–480.
12. Lawrence RC, Helmick CG, Arnett FC, Deyo RA, Felson DT, Giannini EH, et al. Estimates of the prevalence of arthritis and selected musculoskeletal disorders in the United States. Arthritis Rheum. 1998. 41:778–799.
13. Singh G. Treatment options for osteoarthritis. Surg Technol Int. 2003. 11:287–292.
14. McKellar G, Madhok R, Singh G. The problem with NSAIDs: what data to believe? Curr Pain Headache Rep. 2007. 11:423–427.
15. McGettigan P, Henry D. Cardiovascular risk and inhibition of cyclooxygenase: a systematic review of the observational studies of selective and nonselective inhibitors of cyclooxygenase 2. JAMA. 2006. 296:1633–1644.
16. Gislason GH, Jacobsen S, Rasmussen JN, Rasmussen S, Buch P, Friberg J, et al. Risk of death or reinfarction associated with the use of selective cyclooxygenase-2 inhibitors and nonselective nonsteroidal antiinflammatory drugs after acute myocardial infarction. Circulation. 2006. 113:2906–2913.
17. Aisen PS, Schafer K, Grundman M, Thomas R, Thal LJ. NSAIDs and hypertension. Arch Intern Med. 2003. 163:1115.
18. Bennett RM, Kamin M, Karim R, Rosenthal N. Tramadol and acetaminophen combination tablets in the treatment of fibromyalgia pain: a double-blind, randomized, placebo-controlled study. Am J Med. 2003. 114:537–545.
19. Peloso PM, Fortin L, Beaulieu A, Kamin M, Rosenthal N;. Protocol TRP-CAN-1 Study Group. Analgesic efficacy and safety of tramadol/acetaminophen combination tablets (Ultracet) in treatment of chronic low back pain: a multicenter, outpatient, randomized, double blind, placebo controlled trial. J Rheumatol. 2004. 31:2454–2463.
20. Wang G, Zhang H, He F, Fang X. Effect of the CYP2D6*10 C188T polymorphism on postoperative tramadol analgesia in a Chinese population. Eur J Clin Pharmacol. 2006. 62:927–931.
21. Muth-Selbach US, Tegeder I, Brune K, Geisslinger G. Acetaminophen inhibits spinal prostaglandin E2 release after peripheral noxious stimulation. Anesthesiology. 1999. 91:231–239.
22. Choi CB, Song JS, Kang YM, Suh CH, Lee J, Choe JY, et al. A 2-week, multicenter, randomized, double-blind, double-dummy, add-on study of the effects of titration on tolerability of tramadol/acetaminophen combination tablet in Korean adults with knee osteoarthritis pain. Clin Ther. 2007. 29:1381–1389.
Full Text Links
  • JRD
Actions
Cited
CITED
export Copy
Close
Share
  • Twitter
  • Facebook
Similar articles
Copyright © 2024 by Korean Association of Medical Journal Editors. All rights reserved.     E-mail: koreamed@kamje.or.kr