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Tramadol/acetaminophen combination as add-on therapy in the treatment of patients with ankylosing spondylitis

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Abstract

This study aimed to determine the safety and efficacy of tramadol 37.5 mg/acetaminophen 325 mg combination tablets (Ultracet®) in patients with ankylosing spondylitis (AS). This was a 12-week, randomized, double-blind, placebo-controlled study. Sixty patients with active AS according to the Modified New York Criteria were enrolled. Active disease was defined by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for more than 3 at randomization. Subjects were randomized equally into two groups: the treatment group received aceclofenac plus Ultracet® one tablet twice a day, and the control group received aceclofenac plus placebo for 12 weeks. The primary endpoint was a difference of Assessment in Ankylosing Spondylitis (ASAS20) response criteria between two groups at week 12. At week 12, ASAS20 was achieved by 53.3 % of the aceclofenac plus Ultracet group and 31 % of the aceclofenac alone group (p = 0.047). For the pain visual analogue scale at week 12, there was a reduction of 45.6 % in aceclofenac plus Ultracet group and 25.7 % in the aceclofenac alone group (p = 0.087). There was no statistically significant difference between two groups in BASDAI, Bath Ankylosing Spondylitis Functional Index, Bath Ankylosing Spondylitis Global Index, Physician Global Assessment, spinal mobility, ESR, hs-CRP, and Ankylosing Spondylitis Quality of Life Questionnaire. A slight increase in total adverse events was noted with dizziness (7.5 vs 1.5 %), vertigo (4.5 vs 1.5 %), and nausea/vomiting (6 vs 0 %) in the Ultracet arm compared to placebo. The tramadol 37.5 mg/acetaminophen 325 mg combination tablet (Ultracet®) might has additional effect to nonsteroidal anti-inflammatory drugs in the treatment of patients with ankylosing spondylitis. It showed marginal benefit in pain and disease activity. However, a slight increase in minor adverse events was noted.

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References

  1. Braun J, Sieper J (2007) Ankylosing spondylitis. Lancet 369:1379–1390

    Article  PubMed  Google Scholar 

  2. Wang CY, Chiang PY, Lee HS, Wei JC (2009) The effectiveness of exercise therapy for ankylosing spondylitis: a review. Int J Rheum Dis 12:207–210

    Article  PubMed  Google Scholar 

  3. Zochling J, van der Heijde D, Dougados M, Braun J (2006) Current evidence for the management of ankylosing spondylitis: a systematic literature review for the ASAS/EULAR management recommendations in ankylosing spondylitis. Ann Rheum Dis 65:423–432

    Article  PubMed  CAS  Google Scholar 

  4. Auleley GR, Dougados M, Baron G (2002) Sample sizes estimated in clinical trials using either a composite index (ASAS response criteria) or single outcome variables in ankylosing spondylitis. Arthritis Rheum 46:1693–1694

    Article  PubMed  Google Scholar 

  5. Koh WH, Pande I, Samuels A, Jones SD, Calin A (1997) Low dose amitriptyline in ankylosing spondylitis: a short term, double blind, placebo controlled study. J Rheumatol 24:2158–2161

    PubMed  CAS  Google Scholar 

  6. Chen J, Liu C (2005) Sulfasalazine for ankylosing spondylitis. Cochrane Database Syst Rev 2:CD004800

    Google Scholar 

  7. Huang F, Gu J, Zhao W, Zhu J, Zhang J, Yu DT (2002) One-year open-label trial of thalidomide in ankylosing spondylitis. Arthritis Rheum 47:249–254

    Article  PubMed  CAS  Google Scholar 

  8. Wei JC, Chan TW, Lin HS, Huang F, Chou CT (2003) Thalidomide for severe refractory ankylosing spondylitis: a 6-month open-label trial. J Rheumatol 30:2627–2631

    PubMed  CAS  Google Scholar 

  9. Brandt J, Haibel H, Cornely D, Golder W, Gonzalez J, Reddig J et al (2000) Successful treatment of active ankylosing spondylitis with the anti-tumor necrosis factor alpha monoclonal antibody infliximab. Arthritis Rheum 43:1346–1352

    Article  PubMed  CAS  Google Scholar 

  10. Haibel H, Rudwaleit M, Brandt HC, Grozdanovic Z, Listing J, Kupper H et al (2006) Adalimumab reduces spinal symptoms in active ankylosing spondylitis: clinical and magnetic resonance imaging results of a fifty-two-week open-label trial. Arthritis Rheum 54:678–681

    Article  PubMed  CAS  Google Scholar 

  11. Emkey R, Rosenthal N, Wu SC, Jordan D, Kamin M (2004) Efficacy and safety of tramadol/acetaminophen tablets (Ultracet) as add-on therapy for osteoarthritis pain in subjects receiving a COX-2 nonsteroidal antiinflammatory drug: a multicenter, randomized, double-blind, placebo-controlled trial. J Rheumatol 31:150–156

    PubMed  CAS  Google Scholar 

  12. Bennett RM, Kamin M, Karim R, Rosenthal N (2003) Tramadol and acetaminophen combination tablets in the treatment of fibromyalgia pain: a double-blind, randomized, placebo-controlled study. Am J Med 114:537–545

    Article  PubMed  CAS  Google Scholar 

  13. Peloso PM, Fortin L, Beaulieu A, Kamin M, Rosenthal N (2004) 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 31:2454–2463

    PubMed  CAS  Google Scholar 

  14. van der Linden S, Valkenburg HA, Cats A (1984) Evaluation of diagnostic criteria for ankylosing spondylitis. A proposal for modification of the New York criteria. Arthritis Rheum 27:361–368

    Article  PubMed  Google Scholar 

  15. Anderson JJ, Baron G, van der Heijde D, Felson DT, Dougados M (2001) Ankylosing spondylitis assessment group preliminary definition of short-term improvement in ankylosing spondylitis. Arthritis Rheum 44:1876–1886

    Article  PubMed  CAS  Google Scholar 

  16. Garrett S, Jenkinson T, Kennedy LG, Whitelock H, Gaisford P, Calin A (1994) A new approach to defining disease status in ankylosing spondylitis: the Bath Ankylosing Spondylitis Disease Activity Index. J Rheumatol 21:2286–2291

    PubMed  CAS  Google Scholar 

  17. Calin A, Garrett S, Whitelock H, Kennedy LG, O'Hea J, Mallorie P et al (1994) A new approach to defining functional ability in ankylosing spondylitis: the development of the Bath Ankylosing Spondylitis Functional Index. J Rheumatol 21:2281–2285

    PubMed  CAS  Google Scholar 

  18. Jenkinson TR, Mallorie PA, Whitelock HC, Kennedy LG, Garrett SL, Calin A (1994) Defining spinal mobility in ankylosing spondylitis (AS). The Bath AS Metrology Index. J Rheumatol 21:1694–1698

    PubMed  CAS  Google Scholar 

  19. Hiller B, Rosenberg M (2003) Ultracet: a new combination analgesic. J Mass Dent Soc 52:38–40

    PubMed  Google Scholar 

  20. Marincsak R, Toth BI, Czifra G, Szabo T, Kovacs L, Biro T (2008) The analgesic drug, tramadol, acts as an agonist of the transient receptor potential vanilloid-1. Anesth Analg 106:1890–1896

    Article  PubMed  CAS  Google Scholar 

  21. Freeman R, Raskin P, Hewitt DJ, Vorsanger GJ, Jordan DM, Xiang J et al (2007) Randomized study of tramadol/acetaminophen versus placebo in painful diabetic peripheral neuropathy. Curr Med Res Opin 23:147–161

    Article  PubMed  CAS  Google Scholar 

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Authors and Affiliations

  1. Division of Allergy, Immunology and Rheumatology, Zuoying Armed Forces General Hospital, Kaohsiung, Taiwan

    Jhi-Kai Chang

  2. Division of Bone Disease, Department of Orthopedic Surgery, Changhua Christian Hospital, Changhua, Taiwan

    Chen-Tung Yu

  3. Department of Statistics and Informatics Science, Providence University, Taichung, Taiwan

    Ming-Yung Lee

  4. Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan

    KJ Yeo & James Cheng-Chung Wei

  5. Division of Allergy, Immunology and Rheumatology, Chung Shan Medical University Hospital, Taichung, Taiwan

    KJ Yeo & James Cheng-Chung Wei

  6. Department of Orthopaedic Surgery, Chang-Shan Medical University Hospital, School of Medicine, Chung Shan Medical University, Taichung, Taiwan

    I-Chang Chang

  7. Department of Neurosurgery, Taichung Veterans General Hospital, Taichung, Taiwan

    Hsi-Kai Tsou

  8. Institute of Medicine, Chung Shan Medical University, Division of Allergy, Immunology and Rheumatology, Chung Shan Medical University, No. 110, Sec. 1, Jianguo N. Rd., South District, Taichung, 40201, Taiwan

    James Cheng-Chung Wei

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  1. Jhi-Kai Chang
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  2. Chen-Tung Yu
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Correspondence to James Cheng-Chung Wei.

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Chang, JK., Yu, CT., Lee, MY. et al. Tramadol/acetaminophen combination as add-on therapy in the treatment of patients with ankylosing spondylitis. Clin Rheumatol 32, 341–347 (2013). https://doi.org/10.1007/s10067-012-2125-y

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  • DOI: https://doi.org/10.1007/s10067-012-2125-y

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