A Comparison between Enriched and Nonenriched Enrollment Randomized Withdrawal Trials of Opioids for Chronic Noncancer Pain

Furlan, Andrea D.; Chaparro, Luis Enrique; Irvin, Emma; Mailis, Angela

doi:10.1155/2011/465281

Cited by 107 publications

(94 citation statements)

References 70 publications

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“…e6 In addition, the AAN, in its Choosing Wisely campaign, recommends not using opioids or butalbital for treatment of migraine, except as a last resort. 13 Furlan et al, 14 in a recent review of RCT of opioids for CNCP, concluded that the overall effectiveness of opioids for pain was modest, and that the effect on function was small. Most of the RCT were shorter than 4 weeks, and none was longer than a few months.…”

Section: Evidence For Efficacy and Effectivenessmentioning

confidence: 99%

Opioids for chronic noncancer pain

2014

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The Patient Safety Subcommittee requested a review of the science and policy issues regarding the rapidly emerging public health epidemic of prescription opioid-related morbidity and mortality in the United States. Over 100,000 persons have died, directly or indirectly, from prescribed opioids in the United States since policies changed in the late 1990s. In the highest-risk group (age 35-54 years), these deaths have exceeded mortality from both firearms and motor vehicle accidents. Whereas there is evidence for significant short-term pain relief, there is no substantial evidence for maintenance of pain relief or improved function over long periods of time without incurring serious risk of overdose, dependence, or addiction. The objectives of the article are to review the following: (1) the key initiating causes of the epidemic; (2) the evidence for safety and effectiveness of opioids for chronic pain; (3) federal and state policy responses; and (4) recommendations for neurologists in practice to increase use of best practices/universal precautions most likely to improve effective and safe use of opioids and to reduce the likelihood of severe adverse and overdose events.

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Section: Evidence For Efficacy and Effectivenessmentioning

confidence: 99%

Opioids for chronic noncancer pain

2014

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“…Interestingly, the little endogenous critical literature on enriched enrollment takes issue not with its limited external validity, but with the claims to improved internal validity. Several authors have noted that the use of a run-in phase prior to randomization, which familiarizes all participants with a drug's effects, presents a risk for unblinding (Leber and Davis, 1998;Staud and Price, 2008a, b;Furlan et al, 2011;Hall and Kaptchuk, 2013). In addition, a recent meta-analysis comparing enriched with non-enriched trials for opioids in chronic non-cancer pain found that contrary to its rationale, EERW studies did not appear to produce stronger measures of efficacy, but tended to underestimate adverse events, which, as we will explore below, has a particular salience for studies of chronic pain treatments (Furlan et al, 2011;Quessy, 2011).…”

Section: "Unsettling Circularity"mentioning

confidence: 99%

“Unsettling circularity”: Clinical trial enrichment and the evidentiary politics of chronic pain

Campbell

King

2017

BioSocieties

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The US Food and Drug Administration's approval of the controversial analgesic Zohydro has drawn attention to its endorsement of so-called 'enrichment strategies' for streamlining clinical trials. Among these is 'enriched enrollment randomized withdrawal' (EERW), a design intended to improve measures of drug efficacy by screening out patients who are non-responsive or suffer adverse effects. EERW has been promoted as a response to the problem of high trial failure rates for drugs that were previously thought to be effective for pain management. This article uses EERW as a window into the evidentiary politics of pain medicine in the twenty-first century, against the backdrop of concerns about prescription opioid abuse. We demonstrate that the reframing of negative trials as 'failed' trials poses a challenge to the evidence hierarchy of evidence-based medicine, and identify several rhetorical strategies used by proponents to normalize EERW by placing it in continuity with routine clinical trial practice and the promise of personalized medicine. Finally, we illustrate how EERW, in the current regulatory context, fails to contribute to the individualization of diagnosis or therapy, and reinforces the perceived gulf between trials for regulatory approval and clinical practice.

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“…1 Opioids have shown only small to moderate benefits in relieving nociceptive and neuropathic pain and improving function. 9 For neuropathic pain, they are considered second-line to alternative therapies, including antidepressants and anticonvulsants, in available guidelines. 10 Opioids are not indicated for migraine or tension headaches or for patients with irritable bowel syndrome.…”

Section: Is For Indicationmentioning

confidence: 99%