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Clinical Question
Are opioid medications preferable for improving pain-related function in adults with severe chronic back, hip, or knee pain?
Bottom line
Nonopioid medications were at least as effective as opioid medications for improving pain-related function over 12 months in adults with severe chronic back pain or knee or hip osteoarthritis pain. The evidence that opioids are NOT superior to nonopioid medications for both chronic and acute pain continues to mount. The tough job will be getting patients and their clinicians to believe the evidence. 1b
Reference
Study design: Randomized controlled trial (double-blinded)
Funding: Government
Setting: Outpatient (primary care)
Synopsis
For decades both patients and clinicians have believed/assumed that opioids are superior for reducing pain and improving function in patients with severe chronic pain. These investigators identified adults with chronic back pain or hip or knee osteoarthritis pain that rated at least moderately severe on a standard pain rating scale and persisted every day for at least 6 months. Patients with severe depression or posttraumatic stress disorder symptoms were NOT excluded. Study participants (N = 240) randomly received assignment (concealed allocation) to either an opioid or nonopioid pain management group. Patients in the opioid group started taking immediate release (IR) oral opioids with escalation to sustained-released (SA) oral opioids and finally to transdermal fentanyl, if needed. Titration continued to a maximum daily dose of 100 morphine-equivalent milligrams. Patients in the nonopioid medication group started with acetaminophen and nonsteroidal anti-inflammatory drugs, with step-up as needed to adjuvant oral medications (eg, amitriptyline, gabapentin) and topical analgesics (eg, capsaicin, lidocaine), and finally to pregabalin, duloxetine, and/or tramadol, if needed. Medication adherence was monitored by urine drug testing and with regular checking of a state prescription monitoring program. Individuals who assessed outcomes remained masked to treatment group assignment. Follow-up rates ranged from 90% to 98% of patients at 12 months. Mean age was 58.3 years (range = 21 – 80 years) and 13% were women. Using intention-to-treat analyses, there was no significant group difference in pain-related function over 12 months based on standard rating scales. Overall, pain intensity was significantly better in the nonopioid group over 12 months. Drop-outs due to adverse medication-related symptoms were significantly higher in the opioid group than in the nonopioid group (19% vs 8%, respectively). No deaths or diversions were detected in either group. Tramadol was dispensed to 11% of patients in the nonopioid group over the 12 months of follow-up.
Reviewer
David C. Slawson, MD
Professor and Vice Chair of Family Medicine for Education and Scholarship
Atrium Health
Professor of Family Medicine, UNC Chapel Hill
Charlotte, NC
Comments
good poem
1) We are expected to believe that patients with severe back or knee pain were opioid naive when starting the trial. I have no idea where they would have recruited these patients, but it would be rare to find a patient in the US who had not already been on opioids for their pain. Thus, the inception cohort was already selected for failure of opioids.
2) Gabapentin has been shown to be ineffective and possibly harmful in chronic low back pain. Yet somehow it worked here...
3) the difference in pain scores between the two groups was statistically significant, but not clinically significant.
4) and finally - why one or the other? Most patients would prefer to be treated with adjuvant medications AND opioid. There really should have been a third arm.
After 30 yrs as a GP I simply don't believe this I have seen no deaths with older patients taking opiods I have seen deaths with older patients taking nsaids. I do deal with many patients with chronic pain.
This raises many questions. In patients over 65 including hypertensives, diabetics and/or CRF patients, is the risk of opioid addiction greater than the risk of NSAID complications?
What is the addiction potential of gabapentin, pregabalin and tramadol?
No mention of any benefit from various forms of physical therapy, acupuncture or psychotherapy for chronic pain.
Well, I feel like my shackles have finally been removed! Now I have "evidence" to not reach for opioids. Just like my amoxicillin prescribing habits I will now curtain my opioid prescribing habits. I like the list of added meds that were used beyond acetaminophen and NSAIDS since it provides guidance. One weird thing though is given the patient population, wouldn't NSADIS be contraindicated in many? Would have liked info on that point. I have to say though I am a little disappointed by the reviewer's rather flippant editorial comment that, "The tough job will be getting patients and their clinicians to believe the evidence." Come on my dear reviewer, give us (both patients and clinicians) more credit than that. We have been shamelessly brainwashed by the opioid manufacturers for decades. If our medical societies spent us much time educating us about proper pain management as the manufacturers do about how to reach for the opioid prescription pad, we will change our ways!
Tramadol issue
The non opioid arm had tramadol. 10% of patients required it in this study. There are no absolutes in medicine and the inference is that some patients will benefit from opioids. Few patients and at low MEQ.
The recommendations are dangerous to many and will cause harms.
Studies now say that Acetominophen upto 4 G per day is no better than placebo for OA Knee. So.......
Since when is tramadol not an opioid? It was used in the non-opioid arm.
Ignores long term and short term side effects of nsaids
ethics
I would like for the authors to explain how they can honestly say that "non opioids are equal to opioids when the non opioid arm used tramadol, which is an opioid? I find this very misleading and condescending when you also read their comment that the rest of us need to get with the "evidence". What their article proved was that even when you used non opioids to their utmost, some patients still require opioids. So the conclusion is totally contrary to their title. This has impact on the rest of us as govt/cpso officials use misleading articles like this to threaten doctors who prescribe opioids with professional negligence. And this will hurt patients who have severe chronic pain. Also, the authors used tramadol which is not covered by the ontario drug benefit. And most people with chronic pain are on disability or seniors. Another sore point with me, since tramadol would be a better choice for these patients, but it is not available. Why will the govt not pay for it.
I have invented a new five minute test which leads to the appropriate treatment for low back pain which, if severe, is most likely due to a sprain of the ligaments holding the sacroiliac joints. See https://www.youtube.com/watch?v=NXNS6PNKRPo. 50% of those receiving this treatment will end up pain free and 30% with less pain. I have also developed a mannitol containing cream which shuts down the body's main pain receptor, the TRPV1. I use prolotherapy, nerve blocks, perineural injections and nerve hydrodissection and, because of this, I rarely have to use any pain killers. The name of the game is to find out the cause of the pain and to treat it, not to cover it up with medications.
More and more studies come out against the use of opioid in non cancerous chronic pains
The fact that tramadol is an opioid is, obviously, paradoxical. Not sure how eliminating the 11% would affect the ITT analysis.
i am trying hard not to use opioids because i do believe the evidence that shows they are not effective and they are harmful. however i take issue with tramadol being included in the non-opioid arm and also with the fact that the best relief comes from a medication (NSAIDs) that has a high risk profile for many of my patients (essentially all of my older patients who are the ones more likely to suffer from chronic pain)... so i'm stuck with two crappy choices (sure, plus all the adjuncts)
I worked with a doc who prescribes opiates to marginalized populations and does not believe this evidence. I have stated this evidence before. he says the study is flawed. I say you must be careful on how to prescribe your medications.
So sad that so many patients were harmed by Big Pharma's push to maximize their profits , with no concern for the patient's (victim?) well being.
How about the patient who is already on a two or theree non-opioids medication and still have significant pain? What does the evidence say about combining opioids and non-opioids to achieve better pain control?
Excellent