OTC pain meds just as effective as Opioids! Except that’s not true
The oldest trick in the 'non-opioid pain medications are just as effective as opioids' book.
“Study Finds OTC Pain Relievers Outperform Opioids”
Great headline. Heard it before. Shame it’s not true.
So, here’s the study:
Nonopioid vs opioid analgesics after impacted third-molar extractions
They were looking to prove that non-opioid pain medications were at least as effective as opioid pain relievers.
Anyone who has ever experienced severe pain knows this is not true. And that opioids are the only medications that are effective for severe pain. And yet, this study somehow found that non-opioids are JUST AS GOOD as opioids for post-op pain.
Before I even read the study, I had a pretty good idea of how they made the magic happen. I’ve read many studies like this, and they always use this one simple trick…
What’s the trick?
It’s all in the dosing. Make the dose of opioid so low that most people will get no effect. Simple! If the opioid does exactly nothing, then anything its pitted against is going to do better. Even placebo wins in this scenario.
Its not so ethical…but who cares about ethics…opioids are bad, right?
I’m sure these researchers believe the ends justify the means. As so many do.
But they are forgetting the patient harm they are causing. The unnecessary pain. Pain that is safely treated with opioids, but now you’ll risk your kidney or your liver with a super-mega-dose of Nsaids and acetaminophen instead!
And you’ll STILL be in pain.
This study got a lot of media coverage. All of the below media articles sing the praises of non-opioid pain medications and it seems NOT ONE read the study.
New Study Finds OTC Pain Relievers Outperform Opioids
Study Reveals Tylenol and Advil Outperform Opioids for Wisdom Tooth Pain
Over-the-counter meds beat opioids after wisdom tooth removal
I especially love the last one “Ditch the opioids!”.
Creative journalism at its BEST there.
Whatever happened to checking your sources? I know, life is busy. It’s much, much easier to regurgitate the university’s press release. Quicker too.
But trust me, this study is garbage. If you’re having your wisdom teeth removed, or any kind of surgery, you’re going to want the opioids. Or at least the option of opioids. Do NOT ditch the opioids!
But studies like this ensure that dentists won’t prescribe opioids anymore, because they read these headlines. It sounds great! So the dentist offer up simple analgesics for severe, post op pain. Patients suffer horrible post-op pain. Patients complain. And dentists wonder why all their patients are unhappy and gave them bad reviews.
Because you listened to bad science.
You acted on a headline.
YOU DIDN’T READ THE STUDY.
Sigh.
But back to the study. There were almost1800 participants. All had their wisdom teeth removed. Half received a combination of ibuprofen and acetaminophen, and the other half received a combination of acetaminophen and hydrocodone. The tablets looked identical and neither the patients nor the clinicians knew who had received which medication.
Participants taking the non-opioid medications reported less pain during the first two days after surgery, compared to those taking opioids. Apparently, they were more satisfied with their pain management and slept better, compared to those taking opioids, as well.
Sounds like opioids are no better than OTC medications, doesn’t it?
But wait, lets look at the dosing.
Participants were randomized to receive 5 mg of hydrocodone with 300 mg of acetaminophen (opioid) or 400 mg of ibuprofen and 500 mg of acetaminophen (nonopioid). After an initial dose, analgesic was taken every 4 through 6 hours as needed for pain.
The starting dose for an opioid naïve patient of hydrocodone and acetaminophen is 5-7.5mg. That’s what the guidelines say. But most people need 7.5mg (or more) of hydrocodone to get any effect.
Here, in Australia, oxycodone is more commonly used. The lowest dose of oxycodone is 5mg. For dental pain, opioid naïve patients would receive 5-10mg of oxycodone.
That would be the equivalent of 7.5 – 15mg of hydrocodone.
The DOSE of opioid pain medication they gave was simply TOO LOW to have any effect.
Oldest trick in the “opioids are not effective” book.
I have seen this done, over and over. The Krebs study, the OPAL study. I will write those up soon.
Not surprising the ibuprofen/acetaminophen group slept better...they had at least some pain relief. The opioid group had no pain relief, because they prescribed a dose of opioid that was so low that most people would find it ineffective.
Meanwhile they loaded the acetaminophen and ibuprofen group up the gills. More than the maximum daily recommended amount for OTC.
They get away with this because NO ONE READS THE STUDY.
These studies are used as ‘evidence’ that opioids are not necessary to treat severe pain. Which is a blatant lie. This study is fraudulent, as so many opioid studies are.
For the love all that’s good and right in the world, PLEASE READ THE STUDY. Please do NOT change your prescribing practice because of a headline.
Anyhoo.
Let’s look at the doses of ibuprofen and acetaminophen
They were given 400mg of ibuprofen and 500mg of acetaminophen and, after the initial dose, could take it as often as every four hours for pain.
The maximum dose of ibuprofen is 3200 mg/day (on prescription); 1200 mg/day (over-the-counter).
If patients were taking the pain meds as often as allowed, and I bet they were, they would have been taking a tablet of 400mg ibuprofen and 500mg acetaminophen every four hours. That’s a maximum of 6 per 24 hour period. Which equals:
2400mg of ibuprofen and
3000mg of acetaminophen.
That’s DOUBLE the recommended OTC maximum dose for ibuprofen. Anything more than that requires a prescription and only under close medical supervision. Because the side effects of NSAIDs (like ibuprofen) can be very serious, including bleeding ulcers, cardiovascular issues, kidney damage…Good thing these people only took these doses for two days, otherwise there would have been a very high number of adverse events!
The maximum daily dose of acetaminophen was 3000mg, which is under the 4000mg daily dose limit. But many are pushing for the maximum dose of acetaminophen to be lowered to 3000mg, due to the high number of overdoses.
Yes, that’s’ right, overdoses. Fatal and non-fatal acetaminophen overdoses are becoming quite common. Acetaminophen overdose is a common cause of liver injury and transplant in young people in Australia.
However, when paired with the hydrocodone, the opioid, there was only 300mg of acetaminophen. 200mg LESS of acetaminophen per dose than the non-opioid pain medication.
The opioid regimen was way too low to get any benefit from the acetaminophen OR the hydrocodone.
In short, they set up the opioid protocol to FAIL.
I really, really hope these study authors have dental, or any, surgery soon. And they get given ibuprofen and acetaminophen.
I don’t know how these people can sleep at night.
Dentists WILL change their prescribing habits based on these headlines. We’ve seen it before, over and over. They don’t read the study, just the headlines. And patients will SUFFER! And suffer needlessly.
This is very poor practice, I’d go so far as to say negligent. It’s certainly not guidelines-based practice, but that’s what WILL happen.
All because these researchers are building their careers!
How much pain are they comfortable with inflicting on people, so that they can get more money, more grants, more accolades? How much unecessary pain is OK by them?
What is WRONG with these people? Do they just forget what their study is for? What the end result will be? That actual PEOPLE are harmed by their ‘research’?
Ok, that’s enough. I’ll get off my high horse. Don’t want to fall off again.
Looking at the exclusions its clear they are aware that they were giving potentially dangerous doses of ibuprofen:
Patients who self-report the following were excluded: History of gastrointestinal bleeding or peptic ulcer History of kidney disease (excluding kidney stones) History of hepatic disease History of cardiovascular disease (myocardial infarction or stroke with the past 6 mo).
They excluded anyone who would be high risk to take ibuprofen. They didn’t want any bleeding ulcers or heart attacks or kidney failure from their study.
Speaking of which, adverse events…were very similar. But there were MORE adverse events with opioids. All the adverse events noted were very minor, nausea, stomach-ache, stuff like that.
They didn’t even measure addiction and overdose.
That’s because no one overdosed, and no one became addicted to hydrocodone.
NO addiction, NO overdose. Funny that.
The media tells us that opioids are SO dangerous, that overdose and addiction are common AND inevitable. But in these head-to-head studies, they never even measure them. Because overdose and addiction are in fact far too rare to appear in a study this small.
But whatever.
Bottom line? Once again, a fraudulent study dominates the headlines with a study that was designed to prove that opioids are no better than over the counter pain medications.
Once again, the tiniest dose of opioid is pitted against a truckload of non-opioid pain medications. Which, at that dose, will make a dent in your pain, but might also send you into multiorgan failure. Especially if you’re geriatric, or paediatric.
I’d like to see the study done properly, with a proper dose of opioid. Titrated to effect. And THEN ask people which regimen they preferred.
But that isn’t going to happen. Because the point here was to ‘prove’ that opioids are no better than simple, OTC pain medications.
There are many ways to manipulate data to make it say what you want it to say. And may ways to design a study for a specific outcome. Unfortunately, this is rampant in studies on opioids, and studies on chronic pain.
Unfortunately, the science can’t be trusted.
I should mention there were instructions for those who found the pain relief insufficient:
“If pain relief was insufficient, 2 additional doses per 24-period could be taken after consultation with surgeon.”
So, after the first day if the pain was bad, they could take EVEN MORE ibuprofen. That would take them to the maximum prescription dose. And the maximum dose for acetaminophen. I cannot see how this can be considered ‘safe’. Its three times the over the counter maximum daily dose for ibuprofen.
And If that still wasn’t enough:
“If rescue pain relief was required, 5 mg of oxycodone was prescribed with instructions to take rescue medication every 6 hours as needed for pain.”
Ahh, finally. A proper dose of opioid. Thye’ve switched to oxycodone, 5mg. That’s a higher dose of opioid than the study protocol. Still the lowest possible dose, remember in Australia the starting dose for dental pain would be 5-10mg of oxycodone. But at least he rescue dose has a chance of working.
BUT it would not affect the study results, because all the articles only reported on the first two days. It would take at least two days to get to the rescue dose.
Tehstdy actually found that for the first two days, non-opioids were superior to opioids. Then, for then for the 3rd and 4th days, opioids were non-inferior. Interesting difference there.
The study doesn’t tell us how many people needed rescue medication, that is, oxycodone. Effective pain medicine that won’t blow up your kidneys and make your stomach bleed. I think that would be important data, but I can’t find that info.
Also interesting was that the people taking hydrocodone returned 8.5 out of 20 of the provided pills. They were useless, so why keep them?
But again…if ADDICTION is so crazy dangerous and people CANNOT RESIST opioids, and become ‘ACCIDENTAL ADDICTS’ after just one dose of opioid…how come people willingly returned their opioids?
If all that were true, if the myth of the accidental addict were true, there would be NO retuned opioid pills.
The do not mention how many pills the non-opioid group returned. I assume they did not return any; they took them all.
It’s clear the study was rigged; the outcome was planned from the start. The narrative was set and the study was designed to support that narrative.
It was enough to get many journalists to reprint the press release and certainly many dentists will now be tormenting their patients on the basis of those headlines.
People will experience more pain, but they will recover. They have been saved from an almost ZERO risk of addiction, after all.
Great work, guys. Great work. You must be so proud.
Please. Read the study. Not the headline.
And journalists? Read the study. Don’t just reprint the press release. YOu’re promoting lies, and contributing to the real ‘opioid epidemic’…and epidemic of fraud and disinformation.
And patient harm.
I'm so embarrassed that I hadn't spotted the fraud in these studies. What a disgrace.