A Systematic Review of Duloxetine for Osteoarthritic Pain: What is the Number Needed to Treat, Number Needed to Harm, and Likelihood to be Helped or Harmed?

References

• . Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bull World Health Organ. 2003;81(9):646–656
   PubMed Web of Science ®Google Scholar
• . McKenzie S, Torkington A. Osteoarthritis—management options in general practice. Aust Fam Physician. 2010;39(9):622–625
   PubMedGoogle Scholar
• . Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules for Oral Use [package insert]. Revised May 2011. Indianapolis, IN: Eli Lilly and Co; 2011. http://pi.lilly.com/us/cymbalta-pi.pdf. Accessed August 30, 2011
   Google Scholar
• . Chappell AS, Ossanna MJ, Liu–Seifert H,. Duloxetine, a centrally acting analgesic, in the treatment of patients with osteoarthritis knee pain: a 13-week, randomized, placebo-controlled trial. Pain. 2009;146(3):253–260
   PubMed Web of Science ®Google Scholar
• . Chappell AS, Desaiah D, Liu–Seifert H,. A double-blind, randomized, placebo-controlled study of the efficacy and safety of duloxetine for the treatment of chronic pain due to osteoarthritis of the knee. Pain Pract. 2011;11(1):33–41
   PubMed Web of Science ®Google Scholar
• . ClinicalTrials.gov. Duloxetine Versus Placebo for Osteoarthritis Knee Pain. Eli Lilly and Co. Updated July 7, 2009. http://clinicaltrials.gov/ct2/show/NCT00408421. Accessed August 30, 2011
   Google Scholar
• . ClinicalTrials.gov. Duloxetine vs. Placebo in the Treatment of Osteoarthritis Knee Pain. Eli Lilly and Co. Updated August 26, 2009. http://clinicaltrials.gov/ct2/show/NCT00433290. Accessed August 30, 2011
   Google Scholar
• . ClinicalTrials.gov. A Study of Duloxetine in Patients With Osteoarthritis Knee Pain. Eli Lilly and Co. Updated February 11, 2011. http://clinicaltrials.gov/ct2/show/NCT00945945. Accessed August 30, 2011
   Google Scholar
• . ClinicalTrials.gov. A Study Comparing Duloxetine Versus Placebo in Patients Taking a Nonsteroidal Anti-inflammatory Drug (NSAID) for Knee Pain Due to Osteoarthritis. Eli Lilly and Co. Updated April 28, 2011. http://clinicaltrials.gov/ct2/show/NCT01018680. Accessed August 30, 2011
   Google Scholar
• . ClinicalTrials.gov. A Clinical Trial for Pain Related to Knee Osteoarthritis. University of Michigan. http://clinicaltrials.gov/ct2/show/NCT01377038. Accessed August 30, 2011
   Google Scholar
• . Eli Lilly and Company. Clinical Study Summary: Study F1 J-MC-HMEP; Duloxetine 60 to 120 mg versus Placebo in the Treatment of Patients with Osteoarthritis Knee Pain. August 4, 2008. http://www.clinicalstudyresults.org/documents/company-study_4528_0.pdf. Accessed August 30, 2011
   Google Scholar
• . US Food and Drug Administration. Anesthetic Life Support Drugs Advisory Committee Meeting; Cymbalta (Duloxetine)/Eli Lilly and Company. August 19, 2010. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndLifeSupportDrugsAdvisoryCommittee/UCM233737.pdf. Accessed August 30, 2011
   Google Scholar
• . Eli Lilly and Company. Anesthetic Life Support Drugs Advisory Committee Briefing Document; Cymbalta (duloxetine) Chronic Pain. August 19, 2010. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndLifeSupportDrugsAdvisoryCommittee/UCM222702.pdf. Accessed August 30, 2011
   Google Scholar
• . US Food and Drug Administration. Summary Review for Regulatory Action; Cymbalta (Duloxetine HCl) for the management of chronic pain. November 4, 2010. http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022516Orig1s000SumR.pdf. Accessed August 30, 2011
   Google Scholar
• . US Food and Drug Administration. NDA approval: Cymbalta (duloxetine hydrochloride), chronic musculoskeletal pain. November 4, 2010. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022516s000ltr.pdf. Accessed August 30, 2011
   Google Scholar
• . Citrome L. Compelling or irrelevant? Using number needed to treat can help decide. Acta Psychiatr Scand. 2008;117(6):412–419
   PubMed Web of Science ®Google Scholar
• . Citrome L. Quantifying risk: the role of absolute and relative measures in interpreting risk of adverse reactions from product labels of antipsychotic medications. Curr Drug Saf. 2009;4(3):229–237
   PubMedGoogle Scholar
• . Citrome L, Kantrowitz J. Antipsychotics for the treatment of schizophrenia: likelihood to be helped or harmed, understanding proximal and distal benefits and risks. Expert Rev Neurother. 2008;8(7):1079–1091
   PubMedGoogle Scholar
• . Straus SE. Individualizing treatment decisions. The likelihood of being helped or harmed. Eval Health Prof. 2002;25(2):210–224
   PubMed Web of Science ®Google Scholar
• . Kidd BL. Osteoarthritis and joint pain. Pain. 2006;123(1–2):6–9
   PubMed Web of Science ®Google Scholar
• . Mease PJ, Hanna S, Frakes EP, Altman RD. Pain mechanisms in osteoarthritis: understanding the role of central pain and current approaches to its treatment. J Rheumatol. 2011;38(8):1546–1551
   PubMed Web of Science ®Google Scholar
• . Fishbain D. Evidence-based data on pain relief with antidepressants. Ann Med. 2000;32(5):305–316
   PubMed Web of Science ®Google Scholar
• . Wohlreich MM, Sullivan MD, Mallinckrodt CH,. Duloxetine for the treatment of recurrent major depressive disorder in elderly patients: treatment outcomes in patients with comorbid arthritis. Psychosomatics. 2009;50(4):402–412
   PubMed Web of Science ®Google Scholar
• . Osiri M, Suarez–Almazor ME, Wells GA, Robinson V, Tugwell P. Number needed to treat (NNT): implication in rheumatology clinical practice. Ann Rheum Dis. 2003;62(4):316–321
   PubMed Web of Science ®Google Scholar
• . Caldwell JR, Rapoport RJ, Davis JC,. efficacy and safety of a once-daily morphine formulation in chronic, moderate-to-severe osteoarthritis pain: results from a randomized, placebo-controlled, double-blind trial and an open-label extension trial. J Pain Symptom Manage. 2002;23(4):278–291
   PubMed Web of Science ®Google Scholar
• . Kraemer HC, Kupfer DJ. Size of treatment effects and their importance to clinical research and practice. Biol Psychiatry. 2006;59(11): 990–996
   PubMed Web of Science ®Google Scholar
• . Citrome L. Relative vs. absolute measures of benefit and risk: what's the difference? Acta Psychiatr Scand. 2010;121(2):94–102
   PubMed Web of Science ®Google Scholar
• . Richmond J, Hunter D, Irrgang J,; American Academy of Orthopaedic Surgeons. American Academy of Orthopaedic Surgeons clinical practice guideline on the treatment of osteoarthritis (OA) of the knee. J Bone Joint Surg Am. 2010;92(4):990–993
   PubMed Web of Science ®Google Scholar
• . Cochrane Library. http://www2.cochrane.org/reviews/. Accessed August 30, 2011
   Google Scholar
• . Citrome L. Evidence-based medicine: it's not just about the evidence. Int J Clin Pract. 2011;65(6):634–635
   PubMed Web of Science ®Google Scholar
• . Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn't. BMJ. 1996;312 (7023):71–72
   PubMed Web of Science ®Google Scholar