Bridging the Gaps: Special Commentary

What can the POINT study tell us? Jane C. Ballantyne

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ncreased prescribing of opioids for chronic pain in many developed countries has led to increases in opioid abuse and related deaths.11 In the United States, which has seen the greatest increase in prescribing, opioid abuse has been termed an “epidemic.”12 The alarm bells have made us begin to question the value of chronic opioid treatment in terms its benefits and its harms and question for which patients the harms outweigh the benefits. Many attempts have been made to dredge the literature in search of evidence to support or refute the benefit of long-term opioid pain therapy, but the answer is always the same; evidence is lacking and more research is needed.1,5 Randomized trials do not help because they are not conducted for long enough, and the individuals entering trials tend to be very different from realworld patients.2 Population studies, and there are many now that have singled out opioid-treated chronic pain, are not reassuring.6,8,14 But, population studies can always be criticized because they are unable to show causation; maybe, the outcomes are bad because of the underlying reasons for pain, and not because of the opioid. The Australian Pain and Opioids IN Treatment (POINT) study takes a novel approach; it aims to prospectively examine the demographic and clinical predictors of chronic opioid benefits and harms in a large cohort of opioidtreated patients (1514) identified through pharmacies, consenting to take part in the study and providing self-reports of outcomes over 2 years.3 This edition of PAIN® includes a report of the baseline characteristics of the POINT study cohort.4 Although not very different from other population studies at baseline, the POINT study at completion will provide unique data on predictive factors because of its prospective design and large cohort. The baseline data published here are valuable in themselves because they add to existing population statistics that help us appreciate what the real-life population being prescribed long-term opioids looks like. A remarkable two-thirds of the cohort is unemployed or in receipt of a government benefit, while almost half of the sample has low income that is equivalent to or below the Australian unemployment or disability benefit level. This finding adds to an already large literature suggesting that opioids may impede, and at the very least do not help improve workplace functionality.9,10,15,17,18 In addition, 80% of the cohort has multiple pain conditions, 50% has significant depression, 50% is treated with antidepressants, 50% has had suicidal ideation, over 50% report a history of childhood abuse or neglect, and over 30% has a lifetime alcohol use disorder. This may define the chronic pain The author declares no conflict of interest. Department of Anesthesiology and Pain Medicine, University of Washington School of Medicine, Seattle, WA, USA E-mail address: [email protected] (J. C. Ballantyne). PAIN 156 (2015) 201–202 © 2015 International Association for the Study of Pain http://dx.doi.org/10.1097/01.j.pain.0000460298.33454.9c

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patient population as much as it defines the opioid-treated population, but nevertheless, suggests that the population treated with long-term opioids is a population at high risk of adverse outcome, including abuse and dependence, overdose, and death. Another finding pinpointing high risk is that two-thirds of the patients are taking benzodiazepines in addition to opioid, which we know is a significant risk factor for apnea and death.7,19 The reason that the findings of this and other studies concerning the effect of opioids on employment are important is simply this: chronic opioid therapy has been promoted on the basis that by improving pain, the therapy will improve function and restore people toward normalcy. But, that does not seem to be what is happening.9 Is it time to reexamine what the goals of chronic opioid therapy should actually be, and can the POINT study help in identifying predictors that lead to realistic achievements for opioids as opposed to the idealistic goals that seem to be eluding us? For example, should we be thinking about when opioids help people cope with bad circumstances (both life and medical), accepting that their role is to provide comfort rather than to achieve the miracle of normal function.16 The question that the POINT study cannot answer is what would the study patients be like if they had never started opioids. There is a hint of comparative effects from another population study of Australian patients with chronic pain that finds opioidtreated patients faring worse than those not receiving opioids in terms of health, distress, and function.13 But again, although efforts are made in this and other such studies to match the comparison groups, only a randomized study can reliably exclude the possibility that the patients who accept and stay on opioids are fundamentally different from those who prefer not taking opioids. Therefore, we cannot look to the POINT study to tell us whether opioid treatment was a good choice in principle for the patients who have ended up on the therapy. What it can do though is help identify which baseline characteristics for patients already treated with opioids predict which good outcomes or bad outcomes, and in so doing, help build a construct that might improve our understanding of which outcomes are desirable for which patients, and possibly our understanding of which patients stray so far from reasonable and matched goals that they should be considered not suitable candidates. If we accept what the baseline data have already revealed, that those in the treated population tend to have difficult lives, then what are we aiming for when we treat them with opioids? Maybe not a return to work, or consequent easing of the economic burden of chronic pain, or maybe not even dramatic pain relief. The POINT study is an excellent opportunity to consider this question.

References [1] Agency for Healthcare Research and Quality. The effectiveness and risks of long-term opioid treatment of chronic pain. U.S. Department of Health and Human Services, 2014; AHRQ Publication No. 14-E005-EF, Rockville, MD.

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[2] Ballantyne JC, Shin NS. Efficacy of opioids for chronic pain: a review of the evidence. Clin J Pain 2008;24:469–78. [3] Campbell G, Mattick R, Bruno R, Larance B, Nielsen S, Cohen M, Lintzeris N, Shand F, Hall WD, Hoban B, Kehler C, Farrell M, Degenhardt L. Cohort protocol paper: the Pain and Opioids In Treatment (POINT) study. BMC Pharmacol Toxicol 2014;15:17. [4] Campbell G, Nielsen S, Bruno R, Lintzeris N, Cohen M, Hall W, Larance B, Mattick RP, Degenhardt L. The Pain and Opioids IN Treatment (POINT) study: characteristics of a cohort using opioids to manage chronic noncancer pain. PAIN 2015;156:231–42. [5] Chou R, Ballantyne JC, Fanciullo GJ, Fine PG, Miaskowski C. Research gaps on use of opioids for chronic noncancer pain: findings from a review of the evidence for an American Pain Society and American Academy of Pain Medicine clinical practice guideline. J Pain 2009;10:147–59. [6] Dillie KS, Fleming MF, Mundt MP, French MT. Quality of life associated with daily opioid therapy in a primary care chronic pain sample. J Am Board Fam Med 2008;21:108–17. [7] Dunn KM, Saunders KW, Rutter CM, Banta-Green CJ, Merrill JO, Sullivan MD, Weisner CM, Silverberg MJ, Campbell CI, Psaty BM, Von Korff M. Opioid prescriptions for chronic pain and overdose: a cohort study. Ann Intern Med 2010;152:85–92. [8] Eriksen J, Sjogren P, Bruera E, Ekholm O, Rasmussen NK. Critical issues on opioids in chronic non-cancer pain: an epidemiological study. PAIN 2006;125:172–9. [9] Franklin GM. Opioids for chronic noncancer pain: a position paper of the American Academy of Neurology. Neurology 2014;83:1277–84. [10] Gross DP, Stephens B, Bhambhani Y, Haykowsky M, Bostick GP, Rashiq S. Opioid prescriptions in canadian workers’ compensation claimants:

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Copyright Ó 2015 by the International Association for the Study of Pain. Unauthorized reproduction of this article is prohibited.

What can the POINT study tell us?

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