I've written about nonsense like this before, yet it still lives to plague us.
The Journal of the American Dental Association, January 4, 2025
Just what we need! Another study to convince the medical world how much better we'll all be with fewer choices for our pain, something I'm sure the millions of you in too much of it to get out of bed will welcome with open arms. (Sarcasm break over.)
How many of these studies must I go through to explain why it was designed to compare the maximum effect of acetaminophen, ibuprofen, or some combination of the two with the minimum effect of a cursed opioid pill?
I guess the answer is At least one more, but not before noting that I debunked a conceptually identical study in 2017. It's based on the same strategy that appears to be anti-opioid by any measure.
The trial
The study aimed to evaluate the effectiveness of opioid versus non-opioid analgesics in managing pain after third molar extraction. It assessed patient comfort and whether comparable pain relief could be achieved without opioids. Before we get into the details, let's call BS. Why?
It would seem that the authors revealed their anti-opioid agenda by using an old and long-debunked statement:
The opioid crisis, with an estimated 81,000 deaths per year, continues to be fueled by unnecessary use of opioids to manage postsurgical pain.
Cecile A. Feldman DMD, et. al., (perhaps with the blessings of Andy Kolodny, who has being saying crap like this forever)
In no universe can anyone credibly claim that the few Vicodin pills prescribed by dentists are fueling the opioid crisis. The authors seem two decades out of date or (intentionally) unaware of illicit fentanyl, the real driver of overdose deaths. Notably, 'fentanyl' is absent from the 10,813-word paper, reinforcing the perception that anti-opioid studies are published without question. Perhaps anything that has an anti-opioid bent can be published.
Let's test this out by creating a new journal!
Back to the trial
A total of 1,815 adults who were undergoing 3rd molar extraction were divided into two groups:
- The opioid group received 5 mg of hydrocodone plus 300 mg of acetaminophen up to 4-6 times per day.
- The non-opioid group received 400 mg ibuprofen with 500 mg acetaminophen up to 4-6 times per day.
- The endpoints were satisfactory pain levels and adverse effects over the postoperative period.
What could possibly be wrong with this protocol?
Plenty. It's all about the dose.
Dosage in the non-opioid group
This is where the paper's title doesn't exactly match the results. The maximum dose of ibuprofen (OTC) is 1,200 mg per day. For prescription ibuprofen, that number is 3,200 mg per day. The participants could receive as much as 2,400 stomach detonating mg per day. This comes out to 12 200 mg tablets, which is double the OTC maximum and damn close to the absolute maximum for the prescription version. Suffice it to say that this is a mongo dose of Advil and it would be amazing if people who took this amount didn't suffer from at least some gastrointestinal side effects.
This group also received as much as 3,000 mg of acetaminophen, which is 1,000 mg less than the 4,000 mg daily amount allowed by the FDA. Most manufacturers now recommend that patients take no more than 3,000 mg because it is a liver toxin and can be dangerous, even deadly for people who are chronic drinkers or those with liver disease.
Dosage in the opioid group
It's quite a different story here. While the non-opioid group received very high daily doses of two drugs the opioid group got 5 mg – the absolute lowest therapeutic dose of Vicodin (hydrocodone), which is, itself, the least potent of commonly used opioid analgesics (1). This doesn't seem fair, does it? Let's take a look at real-world recommended doses of Vicodin doses from various healthcare sources.
- Mayo Clinic: For moderate to severe pain oral dosage form - 10 milligrams
- Drugs.com: One or two 5 mg tablets every four to six hours as needed for pain.
- Medical Professional's Guide: For 5mg/325mg tablets: 1–2 tabs every 4–6 hours as needed; max 8 tabs/day. For 7.5mg/325mg or 10mg/325mg tablets: 1 tab every 4–6 hours as needed; max 6 tabs/day.
- NIH: The usual adult dosage is one or two tablets (5/325) every four to six hours as needed for pain. The total daily dosage should not exceed 8 tablets.
- UCSF: 5-10mg every 4 to 6 hours. Dosing should be titrated to effect
- MD Anderson: 5-10 mg PO (orally) every 6 hours
While I haven't visited every medical site on the planet it should be clear that in most cases 5 mg is the lowest effective, if that, dose of hydrocodone. Note that when 5 mg is mentioned as the recommended dose in every case a dose of 1-2 tablets is also mentioned. Why? Because 5 mg of Vicodin will not be effective for most people in pain.
Bottom line
This is just one more study where the lowest dose of an opioid is compared to the highest doses of Advil and Tylenol. Is this fair? I think not. It should be pointed out that the high-dose Advil and Tylenol regimen was effective in controlling the patient's pain, perhaps even better than the hydrocodone, as the authors claim. But this trial is rigged in its design.
Lost in translation is that 2,400 mg of ibuprofen and 3,000 mg of acetaminophen might work just fine in this study, but how many people can safely take this quantity of either? What about those of us who cannot take ibuprofen at all, let alone such high doses of it? This includes people with ulcers, liver disease, kidney disease, and severe heart disease.
Below the bottom line
I'm getting mighty tired of studies (and people) that speak of ibuprofen as if it were a magical elixir. It's a pretty good pain drug for those who can take it, but perhaps we could relax a bit and freely dispense two 5 mg Vicodin pills rather than one. At this twisted time of opioid prohibition, it's really cool right now to brag about how little Vicodin or Percocet doctors and hospitals can dispense. Perhaps less so for people with severe pain. Then it's not so cool.
NOTE
(1) I’m omitting tramadol from this “list.” You could reasonably argue that it shouldn’t be called an opioid at all. Also, it’s very weak. And codeine, which is technically an opioid, is also weak, rarely used, and has a complicated metabolism, has been omitted as well.
Josh Bloom
Director of Chemical and Pharmaceutical Science
Dr. Josh Bloom, the Director of Chemical and Pharmaceutical Science, comes from the world of drug discovery, where he did research for more than 20 years. He holds a Ph.D. in chemistry.
