Study: Reducing Opioid Use for Chronic Pain With a Group-Based Intervention. A Randomized Clinical Trial
Ok, so here we go again. Another study, making headlines, where the researchers are making claims that their own study does NOT support. The study’s authors are misrepresenting their results, presumably to get published, to increase their profile, to get a promotion, or whatever. I have no idea why.
And no idea why no one is calling them out!
So let’s take a look.
First, the media headlines:
“New intervention program can help reduce opioid use for chronic pain” [1]
New treatment can help people stop taking opioid painkillers for chronic pain [2]
New treatment can help people stop taking opioid painkillers for chronic pain [3]
Clinical trial: New treatment helps patients end addictive opioid use in chronic pain [4]
New treatment helps people stop addictive opioid painkillers used for chronic pain [5]
I heard the same study described on the JAMA podcast, and they reported the study as “Group-Based Intervention for Reducing Opioid Use for Chronic Pain”. They said that this randomised clinical trial showed that their intervention significantly reduced patient reported use of opioids but had no effect on perceived pain interference with daily activities.
I’ve read this study. The conclusions they are reporting are a huge stretch of the truth at best, and outright deception or fraud at worst.
Here’s a link to the study. I have no doubt that none of these journalists bothered to read it.
https://jamanetwork.com/journals/jama/article-abstract/2805141
There were 608 patients with chronic non-cancer pain. Participants were randomized into two groups, one to receive usual care and the other received “3-day–long group sessions that emphasized skill-based learning and education, supplemented by 1-on-1 support delivered by a nurse and lay person for 12 months.”
The study was trying to find out if this intensive education and support program helped people stop using opioids for chronic pain, as opposed to usual care.
There were two primary outcomes: a Patient-Reported Outcomes Measurement Information System Pain Interference Short Form 8a (PROMIS-PI-SF-8a) (pain) score and the proportion of patients who managed to stop taking opioids at 12 months.
All the articles call the program a resounding success, and all quote the lead researcher Harbinder Kaur Sandhu, Professor of Health Psychology at the University of Warwick, who said:
“The findings from the trial are extremely promising. Many people who have been taking prescription painkillers over a long period time suffer with harmful side effects but can feel reluctant to come off them because they think it could make their pain worse, or they do not know how to approach this with their clinician.
Our trial has found a treatment that could help people to come off opioids, in a way that is safe, supportive and gradual. It’s a supported decision between the patient and the clinician, and not forced tapering. The program helps people to learn alternative ways to manage their pain and help overcome challenges of withdrawal and has the potential to give people an overall better quality of life.”
That sounds great. It’s a pity that none of it is true.
The truth is less than one in five people ceased their opioids. It was around one in seven. The vast majority did NOT cease their long-term opioid therapy, presumably because their pain DID increase when trying to taper, but you’ll find no trace of that fact in the media reporting, or the reporting from the study authors themselves.
Instead, they are stating that people can come off their opioids with no increase of pain.
Worse again, another medical site is reporting this article to say that this new program can help people overcome OPIOID ADDICTION!
Ahhh, that old chestnut. Conflating long term opioid therapy (LTOT) for severe, chronic pain with opioid use disorder (OUD). And using the word ‘addiction’ to describe pain patients who are taking their medications as prescribed, with no adverse events.
Headlne: “Promising clinical trial shows one in five patients successfully overcome opioid addiction” [6]
This is a blatant misrepresentation of the study, these are not people with OUD, they are chronic pain patients taking their opioid pain medications as prescribed. Taking opioids daily does NOT equal addiction. But at least this story is closer to reporting the outcomes truthfully.
Also, to this article’s credit, they pointed out some limitations of the study. Being that all of these people were volunteers who wanted to come off their opioids. The results could be very different if people were forced to come of their opioids. Also, its self-reported, no blood or urine results were used to confirm that people were actually no longer taking opioids. And, very importantly, not all participants adhered to the program. In fact, only 47% adhered to the program. Lastly, the trial results may not reflect typical patients on long term opioid therapy, as 33% of the trial participants were on low-dosage opioids. The results would very likely be different for the majority of patients using moderate or high dose opioids.
Doesn’t sound so successful now, does it?
But still. Why let the facts stop them putting out their pre-determined narrative in their presser.
The facts are there were 608 participants in the study, only 440 people completed the study.
65 out of 225 people in the intervention group ceased opioids at 12 months. That’s 29%.
And 15 out of the 208 in the ‘usual care’ group ceased their opioids. That’s 7%
All up, out of both groups, 80 people ceased their opioids. There were 433 people who finished the trial. So that’s 20% of those who completed the trial.
But there were 608 participants originally. It’s pretty safe to assume that those who did not complete the study did not want to taper their opioids and are still on long term opioid therapy.
In that case, it would be 80 out of 608 people who ceased their opioids. That would be 13%
13% of people were able to cease opioids.
87% either didn’t complete the study or chose to continue their opioid therapy.
That’s the true result of this study.
Yet the lead author is crowing about their great new program that allows people to cease opioids with no increase in pain. It’s a lie. It’s a deception. And its deceptive by design.
And 8% experienced severe adverse events. That’s a very high number of serious adverse events. But you won’t find anything about adverse events in the headlines or resulting media stories. You have to dig into the study to find those.
The truth is when most people are tapered off opioids, the most common outcome is their pain increases. Their disability increases. Their quality-of-life decreases. They experience adverse events, which are sometimes serious. We know this. Many studies have shown this, but they aren’t often reported in the media. THIS study supports the fact that, for most people, pain increases when opioids are tapered, but the authors, with very careful wording and selective reporting of their own results, are stating the opposite in their press releases. Misrepresenting their own data, because ‘opioids are safe and effective long term’ is NOT the message that they want to send.
These researchers are quietly ignoring the 87% of people who chose to stay on long term opioid therapy to manage their pain. And crowing about the minority who were able to taper off their opioids.
A more honest headline would be “Education and one-on-one support helps almost 1 in 7 chronic pain patients taper off opioids”. But that doesn’t sound very impressive. Even people with terrible math can figure out that the vast majority chose not to taper, chose to continue taking their opioid pain-relieving medications.
Again, the goal was to show that people can taper off opioids and not experience increased pain. This study did NOT show that, it showed the reverse. How inconvenient. But why let a little thing like evidence get in the way of a good headline?
My personal headline would be “87% of people on long term opioid therapy are unable to taper off opioids without suffering increased pain”.
We don’t get these headlines because the researchers misrepresented their results and put out press releases that cherry-pick their own data. The journalists don’t read the original study, they just print what the press release says. Quicker that way. Takes less work.
The grain of truth in the study conclusions and the headlines, is that out of the 13% of people who were able to cease their opioids, there was no difference in pain levels between the intervention group and the usual care groups. Those are the people who had no increase in pain. Not the 87% who did experience increased pain and who chose not to continue with the taper.
The study authors are reporting that opioids can be tapered, with no increase in pain. And that opioids are not effective for chronic pain. All of this is a lie. A very harmful, potentially dangerous lie.
It’s so deceptive that I would call it fraudulent. It is absolutely a misrepresentation of the data. Are there no ethical boards, or oversights to prevent this kind of fraud?
The co-lead researcher is directly quoted as saying that people can stop opioids without increasing their pain. Even though he knows that his own study does not support this.
Here’s what the all news reports say, including his quote:
Professor Sam Eldabe, clinical trial co-lead and consultant in pain medicine at The James Cook University Hospital, said: “Despite appreciating the social impact of the drugs, most patients utterly dread a worsening of their pain should they attempt to reduce their opioids.
“Our study shows clearly that opioids can be gradually reduced and stopped within no actual worsening of the pain…”
This study shows no such thing. The study shows the exact reverse of his statement.
He also goes on to draw the conclusion that pain medications do not work for chronic pain. The rest of his quote states :
“This confirms our suspicions that opioids have very little long-term impact on persistent pain.”
Again, not true. He’s just giving the sound grab that he wants journalists to write. This is what he wants reported, not the study outcomes.
He clearly has an anti-opioid agenda and cares nothing about patient care, patient needs and patient preferences. He cares only about tapering people off their opioid pain-relieving medications, even when those people are better off staying on long term opioid therapy. Increased pain and disability are very serious adverse events that no one would choose or should have to suffer for the sake of an ideology.
As for adverse events, 8% of the intervention group and 5% of the usual care group experienced serious adverse events, including gastrointestinal, increased disability, and one person attempted suicide.
It doesn’t get more ‘adverse’ than a suicide attempt. Clearly this person became so distressed by their taper that they tried to take their life.
There is NOTHING in any of the news articles about adverse events, most certainly not the suicide attempt. Even one person attempting suicide is a disastrous outcome.
Suicide is a well-known risk of tapering people off opioids, especially if done involuntarily. We know from multiple, recent, large-scale studies that tapering people off their long-term opioid therapy vastly increases the risk of suicide and death. You would think that the authors would want to warn about this potential. Ensure that any doctor initiating a taper knows to be expect worsening of pain, worsening of mental health and increasing distress over the course of the taper. These are all the most common outcomes of an opioid taper, as shown in many other studies, and they are demonstrated here in this study, if you actually read the data.
But the authors do not report any of it, and actually state the opposite in all their conclusions and media statements.
Lies, damned lies and statistics. How easy the numbers are to manipulate. Especially when your audience is keen to be deceived.
The truth is that only 13% of people tapered off their opioids. And 8% experienced serious adverse events. People in this study were only 5% more likely to successfully taper off opioids than they were to experience a serious adverse event, according to this study.
There’s a headline for you.
These researchers have skilfully glossed over all the negative outcomes and cherry-picked their own study and crafted a press release to make the data show what they wanted it to show. NOT what it actually showed.
These authors have no integrity, professional or personal. But the real danger is that their lack of honesty gives doctors a false sense of security that tapering is safe, and that pain will not increase. Now when patients tell their doctors that their pain is increasing, most likely doctors won’t listen. Because the ‘evidence’ says that people can taper without increased pain. And they will not listen when their patients tell them there are suffering, that their pain is becoming intolerable, and they may not notice when patients are driven to thoughts of suicide. This unethical reporting, and single-minded demonising of long-term opioid therapy is NOT based on science, and it will cause patient harms, and patient deaths.
Once again, deceptive reporting in chronic pain research. Shockingly common.
Most people read the title of a study, maybe the abstract, and definitely the conclusion. This is their ‘conclusions” section.
“Conclusions and Relevance: In people with chronic pain due to non-malignant causes, compared with usual care, a group-based educational intervention that included group and individual support and skill-based learning significantly reduced patient-reported use of opioids, but had no effect on perceived pain interference with daily life activities.”
Bullshit.
My conclusion?
In people with chronic pain due to non-malignant causes, compared with usual care, in BOTH groups, most participants were NOT able to cease their long-term opioid therapy with only 13% achieving opioid cessation. Patients experienced increased pain and increased disability and 8% experienced serious adverse events, and 3% required hospital treatment. One person attempted suicide and all clinicians need to be aware of this rare but very serious adverse outcome.
There. Fixed it for you.
References:
1] https://www.news-medical.net/news/20230523/New-intervention-program-can-help-reduce-opioid-use-for-chronic-pain.aspx
2] https://www.newschainonline.com/news/new-treatment-can-help-people-stop-taking-opioid-painkillers-for-chronic-pain-338594
3] https://www.independent.co.uk/news/health/data-nhs-people-university-of-warwick-england-b2344257.html
4] https://medicalxpress.com/news/2023-05-clinical-trial-treatment-patients-addictive.html
6] https://www.mdlinx.com/article/promising-clinical-trial-shows-one-in-five-patients-successfully-overcome-opioid-addiction/1asa0yjxjhsXj9vgXw8boq
Your article reveals the fraud and misdirection behind so many “studies’ by anti-opioid zealots who set out to “demonstrate” findings that in reality are unsupported by science.
I invite you to joint a US National network of knowledgeable healthcare writers, patients, caregivers, and lawyers working to force the repudiation and withdrawal of opioid prescription guidelines of the CDC, Veterans Administration and DEA. Likewise, I offer the following recent paper on KevinMD that reinforces many of your observations:
https://www.kevinmd.com/2023/05/how-misused-terminology-and-biased-studies-may-be-misguiding-our-understanding-of-opioid-addiction-and-mortality.html
I can be contacted at lawhern@hotmail.com
Thank you, Richard. I started writing and researching because I coudn’t understand how ‘the science’ disagreed so completely with what I experience and witness in real list. And now I see this is standard operating procedure in science, its all about the money, the career progression and people living in severe pain? they don’t give a toss!
I recently read your article and listened to your podcast on KevinMD. I’ve followed your work for a long time and thank you for all that you do to correct the travesty that is pain management. I have joined your mailing list as well. I am located in Australia, where there is no one (except us) advocating for people living with severe, daily pain who require LTOT. The chronic pain NFPs believe the opioid crisis lie, and while they say they are against forced tapers, they do believe that opioids should always be tapered. Another completely contradictory position! Anyway, I will be in touch, thankyou for your email. And we here at PPA will keep working 🙂
Im disgusted but not the least bit surprised. This is the status quo for the media driven, pain management research community.
As an Ehlers-Danlos Syndrome patient with multiple joint issues to include CRPS, at severe pain levels for almost 20 years, I would argu the pain most of us live in is every bit as severe as “cancer related pain”. To be clear, cancer patients (to include adults and children) are also being denied ethical pain control. That being said, its doubtful anyone at severe levels of pain (LTOT at moderate to high doses) volunteered for such a study. This means that its likely that very few, if any, of the 433 who stayed, were no where close to representative of the 50,000 Americans who are in constant, severe pain, requiring LTHDOT.
Ive had very knowledgable PMSs and some who should find another profession (not just a different specialty). They are all guilty of “reading the summary” sometimes. There is so much information being thrown at them. Its dangerous that studies like this one rely on the emotional and physical draining of our doctors to “get one past” them.
I absolutely feel apps like Twitter which envelop the art of “headlining”, play a major roll in the gaslighting of our community. From the nieve reader to doctors, the American public in general has learned to let someone else be responsible for reading the small print. They have learned to have immediate, highly emotional reactions to 64 character posts. This is no longer limited to social media apps though. It’s become a way of life.
Doctors (both GPs and PMSs) have stopped telling patients how to properly take even low-dose opioids. They are no longer told “The medication isn’t effective if taken only when the pain is so severe, you can’t stand it.” Instead, the doctors are EXPECTED to tell patients not to take the medication at regular intervals. This goes back to the new first line of opioid therapy: Every patient is a potential addict. Treat accordingly. Again, short, to the point, no need to read the fine print any longer.
As advocates for our own medical care, as responsible citizens, and as knowledgable doctors working to ethically treat patients, we HAVE to go back to reading the fine print. Thats where the gravy is. Most studies I’ve read, no matter of what the authors want to convey, typically contain the actual results. They are boring to read. They can take a lot of time. But, its clear our lives depend on it. We can no longer take for granted that the media is telling any kind of real truth other than what they want us to know. We can no longer trust statistics or studies our doctors tell us. We have to be vigilant in making sure we know the truth, even if we think we hear it from people we normally trust.
Vicki, I totally agree. There is no empathy, no compassion for people who live with severe, daily pain. I always say there ARE worse things than living with constant, severe pain…but not many.
You also raise a very important point that I didn’t even realise from reading most of the media coverage – these people volunteered! So around 13% were able to taper, and these were people who wanted to taper. Such an incredibly LOW success rate, in this volunteer population. What would the result be if the participants were NOT willing to taper? 1%? The deception is unbelievable.