Editorial Views  |   September 2016
Duloxetine for Subacute Pain Management after Total Knee Arthroplasty: Should We Write It Off or Reevaluate?
Author Notes
  • From the Department of Physical Medicine and Rehabilitation, Walter Reed National Military Medicine Center, Bethesda, Maryland (M.B.J.); Uniformed Services University of the Health Sciences, Bethesda, Maryland (M.B.J., S.P.C.); and Departments of Anesthesiology and Critical Care Medicine and Physical Medicine and Rehabilitation, Johns Hopkins School of Medicine, Baltimore, Maryland (S.P.C.).
  • Corresponding article on page 561.
    Corresponding article on page 561.×
  • This editorial discusses an off-label use of a U.S. Food and Drug Administration–approved medication.
    This editorial discusses an off-label use of a U.S. Food and Drug Administration–approved medication.×
  • Accepted for publication May 23, 2016.
    Accepted for publication May 23, 2016.×
  • Address correspondence to Dr. Cohen: scohen40@jhmi.edu
Article Information
Editorial Views / Pain Medicine / Pharmacology
Editorial Views   |   September 2016
Duloxetine for Subacute Pain Management after Total Knee Arthroplasty: Should We Write It Off or Reevaluate?
Anesthesiology 9 2016, Vol.125, 454-456. doi:10.1097/ALN.0000000000001229
Anesthesiology 9 2016, Vol.125, 454-456. doi:10.1097/ALN.0000000000001229
ALL actions have predictable and unpredictable consequences. As a result of the confluence of the rapidly escalating costs of conducting randomized controlled trials and the decline in federal research funding, industry has munificently stepped in to fill the gap. But whereas this has led to some major breakthroughs in pain medicine, it comes at a price. Industry-sponsored studies are 3.6 to 4 times more likely to yield positive results than non–industry-sponsored studies, which is a figure that is even further skewed by publication bias.1  In contrast to large pragmatic and comparative-effectiveness studies that seek to measure benefit in real-life circumstances, the objectives of efficacy studies are intricately tied to those of the stakeholders (i.e., companies) that sponsor them and generally focus on teasing out small effect sizes in an ideal patient population (i.e., those with short duration of pain, moderate disease burden, not taking opioids, no coexisting psychosocial issues, etc.) that rarely reflects those encountered in clinical practice. Yet, even under these idyllic circumstances, the difference separating the treatment from placebo group is usually very small, averaging around 10 to 20% in studies evaluating duloxetine for knee osteoarthritis.2,3  Whereas a two-point or 30% diminution in pain has been shown to constitute a clinically meaningful reduction on an individual basis, these same Initiative on Methods, Measurement and Pain Assessment in Clinical Trials guidelines note that smaller differences between groups can be considered clinically relevant in clinical trials.4  Therefore, a non–industry-sponsored, blinded study that seeks to determine efficacy in a real-world population is greatly needed, and the authors should be applauded for undertaking this endeavor.
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