PAIN
Volume 151, Issue 3 , Pages 592-597 , December 2010

Numbers-needed-to-treat analyses – Do timing, dropouts, and outcome matter? Pooled analysis of two randomized, placebo-controlled chronic low back pain trials

  • R. Andrew Moore

      Affiliations

    • Pain Research and Nuffield Department of Anaesthetics, University of Oxford, Oxford, UK
    • Corresponding Author InformationCorresponding author. Address: Pain Research and Nuffield Department of Anaesthetics, University of Oxford, John Radcliffe Hospital, Level 6 West Wing, Oxford, OX3 9DU, UK. Tel.: +44 1865 231512; fax: +44 1865 234539.
  • ,
  • Steven S. Smugar

      Affiliations

    • Merck Research Laboratories, Rahway, NJ, USA
  • ,
  • Hongwei Wang

      Affiliations

    • Merck Research Laboratories, Rahway, NJ, USA
  • ,
  • Paul M. Peloso

      Affiliations

    • Merck Research Laboratories, Rahway, NJ, USA
  • ,
  • Arnold Gammaitoni

      Affiliations

    • Merck Research Laboratories, Rahway, NJ, USA

Received 29 October 2009 ,Revised 14 June 2010 ,Accepted 14 July 2010.

References 

  1. Akobeng AK. Communicating the benefits and harms of treatments. Arch Dis Child. 2008;93:710–713
  2. Anderson JJ, Baron G, van der HD, Felson DT, Dougados M. Ankylosing spondylitis assessment group preliminary definition of short-term improvement in ankylosing spondylitis. Arthritis Rheum. 2001;44:1876–1886
  3. Austin PC, Mamdani MM, Juurlink DN, Hux JE. Testing multiple statistical hypotheses resulted in spurious associations: a study of astrological signs and health. J Clin Epidemiol. 2006;59:964–969
  4. Bingham CO, Smugar SS, Wang H, Tershakovec AM. Early response to COX-2 inhibitors as a predictor of overall response in osteoarthritis: pooled results from two identical trials comparing etoricoxib, celecoxib and placebo. Rheumatology. 2009;48:1122–1127
  5. Birbara CA, Puopolo AD, Munoz DR, Sheldon EA, Mangione A, Bohidar NR, et al. Treatment of chronic low back pain with etoricoxib, a new cyclo-oxygenase-2 selective inhibitor: improvement in pain and disability – a randomized, placebo-controlled, 3-month trial. J Pain. 2003;4:307–315
  6. Citrome L. Compelling or irrelevant? Using number needed to treat can help decide. Acta Psychiatr Scand. 2008;117:412–419
  7. Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, et al. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008;9:105–121
  8. Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727–735
  9. Furst DE. Are there differences among nonsteroidal antiinflammatory drugs? Comparing acetylated salicylates, nonacetylated salicylates, and nonacetylated nonsteroidal antiinflammatory drugs. Arthritis Rheum. 1994;37:1–9
  10. Grotle M, Brox JI, Vollestad NK. Concurrent comparison of responsiveness in pain and functional status measurements used for patients with low back pain. Spine. 2004;29:E492–E501
  11. Grotle M, Brox JI, Vollestad NK. Functional status and disability questionnaires: what do they assess? A systematic review of back-specific outcome questionnaires. Spine. 2005;30:130–140
  12. Hoffman DL, Sadosky A, Dukes EM, Alvir J. How do changes in pain severity levels correspond to changes in health status and function in patients with painful diabetic peripheral neuropathy?. Pain. 2010;149:194–201
  13. Huskisson EC, Woolf DL, Balme HW, Scott J, Franklin S. Four new anti-inflammatory drugs: responses and variations. Brit Med J. 1976;1:1048–1049
  14. Ioannidis JP. Why most published research findings are false. PLoS Med. 2005;2:e124
  15. Kopec JA, Richardson CG, Llewellyn-Thomas H, Klinkhoff A, Carswell A, Chalmers A. Probabilistic threshold technique showed that patients’ preferences for specific trade-offs between pain relief and each side effect of treatment in osteoarthritis varied. J Clin Epidemiol. 2007;60:929–938
  16. Laupacis A, Sackett DL, Roberts RS. An assessment of clinically useful measures of the consequences of treatment. New Engl J Med. 1988;318:1728–1733
  17. Leucht S, Engel RR, Bauml J, Davis JM. Is the superior efficacy of new generation antipsychotics an artifact of LOCF?. Schizophr Bull. 2007;33:183–191
  18. Liu-Seifert H, Zhang S, D’Souza D, Skljarevski V. A closer look at the baseline-observation-carried-forward (BOCF). Patient Prefer Adhere. 2010;4:11–16
  19. Machado LA, Kamper SJ, Herbert RD, Maher CG, McAuley JH. Analgesic effects of treatments for non-specific low back pain: a meta-analysis of placebo-controlled randomized trials. Rheumatology. 2009;48:520–527
  20. McQuay HJ, Moore RA. Using numerical results from systematic reviews in clinical practice. Ann Int Med. 1997;126:712–720
  21. Moore RA, Derry S, McQuay HJ. Fraud or flawed: adverse impact of fabricated or poor quality research. Anaesthesia. 2010;65:327–330
  22. Moore RA, Eccleston C, Derry C, Wiffen P, Bell RF, Straube S, McQuay HJ, and for the ACTINPAIN writing group of the IASP Special Interest Group (SIG) on Systematic Reviews in Pain Relief and the Cochrane Pain, Palliative and Supportive Care Systematic Review Group editors. “Evidence” in chronic pain – establishing best practice in the reporting of systematic reviews. Pain 2010;150:386-389.
  23. Moore RA, Gavaghan D, Tramèr MR, Collins SL, McQuay HJ. Size is everything – large amounts of information are needed to overcome random effects in estimating direction and magnitude of treatment effects. Pain. 1998;78:209–216
  24. Moore RA, Moore OA, Derry S, Peloso PM, Gammaitoni AR, Wang H. Responder analysis for pain relief and numbers needed to treat in a meta-analysis of etoricoxib osteoarthritis trials: bridging a gap between clinical trials and clinical practice. Ann Rheum Dis. 2010;69:374–379
  25. Moore RA, Straube S, Derry S, McQuay HJ. Chronic low back pain analgesic studies – a methodological minefield. Pain. 2010;149:431–434
  26. Moore RA, Straube S, Paine J, Phillips CJ, Derry S, McQuay HJ. Fibromyalgia: moderate and substantial pain intensity reduction predicts improvement in other outcomes and substantial quality of life gain. Pain. 2010;149:360–364
  27. O’Brien EM, Staud RM, Hassinger AD, McCulloch RC, Craggs JG, Atchison JW, et al. Patient-centered perspective on treatment outcomes in chronic pain. Pain Med. 2010;11:6–15
  28. Ostelo RW, Deyo RA, Stratford P, Waddell G, Croft P, Von Korff M, et al. Interpreting change scores for pain and functional status in low back pain: towards international consensus regarding minimal important change. Spine. 2008;33:90–94
  29. Pallay RM, Seger W, Adler JL, Ettlinger RE, Quaidoo EA, Lipetz R, et al. Etoricoxib reduced pain and disability and improved quality of life in patients with chronic low back pain: a 3 month, randomized, controlled trial. Scand J Rheumatol. 2004;33:257–266
  30. Pham T, van der HD, Altman RD, Anderson JJ, Bellamy N, Hochberg M, et al. OMERACT-OARSI initiative: Osteoarthritis Research Society International set of responder criteria for osteoarthritis clinical trials revisited. Osteoarthr Cartilage. 2004;12:389–399
  31. Preston SJ, Arnold MH, Beller EM, Brooks PM, Buchanan WW. Variability in response to nonsteroidal anti-inflammatory analgesics: evidence from controlled clinical therapeutic trial of flurbiprofen in rheumatoid arthritis. Br J Clin Pharmacol. 1988;26:759–764
  32. Simon LS, Evans C, Katz N, Bombardier C, West C, Robbins J, et al. Preliminary development of a responder index for chronic low back pain. J Rheumatol. 2007;34:1386–1391
  33. Tramer MR, Walder B. Number needed to treat (or harm). World J Surg. 2005;29:576–581
  34. Wen L, Badgett R, Cornell J. Number needed to treat: a descriptor for weighing therapeutic options. Am J Health Syst Pharm. 2005;62:2031–2036

PII: S0304-3959(10)00426-4

doi: 10.1016/j.pain.2010.07.013

PAIN
Volume 151, Issue 3 , Pages 592-597 , December 2010