Opioids are no more effective than nonopioid drugs in treating moderate to severe chronic back pain or hip or knee osteoarthritis pain, according to findings published online today in JAMA.
Current guidelines discourage opioid prescribing for chronic pain because of the high incidence of opioid-associated deaths, and meta-analyses have shown there is little short-term benefit for opioids over other analgesics in chronic back pain and for arthritis pain. However, there are limited randomized trial data on the long-term value of these drugs for the treatment of chronic musculoskeletal pain vs nonopioids.
Therefore, Erin E. Krebs, MD, MPH, a general internist at the Center for Chronic Disease Outcomes Research in the Veterans Affairs Health Care System, Minneapolis, Minnesota, and coworkers recruited patients from Veterans Affairs primary care clinics who had moderate to severe chronic back pain or hip or knee osteoarthritis pain despite taking analgesics. Of 240 patients enrolled in the Strategies for Prescribing Analgesics Comparative Effectiveness trial, 156 patients (65%) had chronic back pain and 84 patients (35%) had hip or knee osteoarthritis pain. They were evaluated from June 2013 through December 2015, with follow-up by December 2016.
The authors note that medication was delivered using a treat-to-target strategy that involved a pharmacist, who reviewed individual patient treatment goals and past medication history. All patients received drugs in 3 steps.
For the opioid group, step 1 was immediate-release morphine, hydrocodone/acetaminophen, or immediate-release oxycodone. Step 2 was sustained-action morphine or sustained-action oxycodone, and step 3 was transdermal fentanyl.
For the nonopioid group, step 1 was acetaminophen or a nonsteroidal anti-inflammatory drug, step 2 included adjuvant oral medications (such as nortriptyline, amitriptyline, or gabapentin) and topical analgesics (such as capsaicin or lidocaine), and step 3 drugs included pregabalin, duloxetine, and tramadol.
Patients returned for follow-up monthly until the drug regimen was stabilized, and then returned every 1 to 3 months. The investigators were blinded to whether patients were in the opioid or nonopioid group when assessing outcomes.
The opioid and nonopioid groups did not significantly differ in pain-related function during the 12 months (overall P = .58) as assessed with the 7-item Brief Pain Inventory (BPI) interference scale, which was the primary outcome. The mean BPI score was 3.4 (standard deviation [SD], 2.5) in the opioid group vs 3.3 in the nonopioid group (SD, 2.6).
Pain intensity, as assessed with the 4-item BPI severity scale, was significantly better in the nonopioid group (overall P = .03). At 12 months, mean BPI severity was 4.0 in the opioid group (SD, 2.0) vs 3.5 in the nonopioid group (SD, 1.9).
Among the participants taking opioids, 69 patients (59.0%) experienced a functional response, defined as a 30% or greater improvement in BPI interference. Among the participants taking nonopioids, 71 patients (60.7%) improved in functional response (P = .79).
For the pain intensity response (≥30% improvement in BPI severity) 48 patients (41.0%) improved in the opioid group vs 63 patients (53.9%) in the nonopioid group (P = .05).
In addition, secondary outcomes did not differ significantly between the groups, except for anxiety, which was better among opioid users, “consistent with the role of the endogenous opioid system in stress and emotional suffering,” the researchers write. Patients taking opioids had significantly more medication-related symptoms than those in the nonopioid group (P = .03).
Differences depending on site of pain were not significant between the two treatment groups.
“Among patients with chronic back pain or hip or knee osteoarthritis pain, treatment with opioids compared with nonopioid medications did not result in significantly better pain-related function over 12 months…. Overall, opioids did not demonstrate any advantage over nonopioid medications that could potentially outweigh their greater risk of harms,” the investigators conclude.
The researchers note several limitations of the study, including the inability to mask the interventions to the patients because of the complexity of the protocols, reporting bias that might reflect effects of opioids, and extension of findings to non-Veterans Affairs patients.
The researchers have disclosed no relevant financial relationships.
JAMA. 2018;319:872-882. Abstract
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