What pragmatic opioid trials can teach us about childbirth and breastfeeding

35273588 - theory and practice

Aaron Carroll had a fabulous piece in yesterday’s New York Times entitled What if a Study Showed Opioids Weren’t Usually Needed?

Participants were randomly assigned to one of two arms. Both involved stepwise progression from less to more potent medications. One arm involved opioid medications (a progression from hydrocodone/acetaminophen to sustained release morphine to fentanyl patches, for example) and the other involved non-opioid medications (a progression from ibuprofen to nortriptyline to tramadol, for example).

The medications were adjusted based on patient preferences and responses. Providers could switch patients to different drugs at the same level; change the dose or frequency of doses; add other drugs to manage side effects; and move patients up or down levels of intensity. They were also allowed to use any nonpharmacological pain therapies they liked.

The results were unexpected:

It doesn’t matter what works better in theory; it only matters what works better in practice.

The study followed 240 patients for 12 months. Pain-related function, or how much pain affected their activity, was no different between the two groups. Pain intensity was actually better in the non-opioid group, and adverse symptoms were lower in that group as well.

How can that be? We know that opioids are “stronger” than non-opioids in theory; shouldn’t they perform better is practice?

Not necessarily because there is a difference between explanatory trials and pragmatic trials.

…[M]ost studies, even the gold standard of randomized controlled trials, focus squarely on causality. They are set up to see if a treatment will work in optimal conditions, what scientists call efficacy. They’re “explanatory.”

Efficacy is important. But what we also need are studies that test if a treatment will work in the real world — if they have effectiveness.

These … are called pragmatic trials …

It’s the difference between theory and practice. In theory opioids provide superior pain relief; in practice other medications can actually be more effective and have the additional, major benefit of avoiding opioid addiction.

This does NOT mean that the explanatory studies that showed opioids aren’t stronger than non-opioids were wrong. In the perfect conditions of the explanatory studies, opioids are more effective. But in real world conditions, they have no additional benefit and dramatically increased harms.

The take away message is this: it doesn’t matter what works better in theory; it only matters what works better in practice.

What does this have to do with childbirth and breastfeeding? Quite a lot as it turns out.

There are many explanatory studies of childbirth that claim to show that unmedicated vaginal birth is superior to C-sections. Natural childbirth advocates, midwives in particular, have seized upon these studies to rationalize their preference for unmedicated vaginal birth as an ideal toward which providers and hospitals should aim. The Royal College of Midwives in the UK used such studies to justify their “Campaign for Normal Birth.” The RCM predicted that their campaign would reduce intervention rates, save lives and save money.

That’s not what has happened. Indeed, the results have been disastrous. Maternal and infant health has not improved; preventable infant and maternal deaths have climbed; maternity liability payments have exploded.

Why? Partly this reflects the fact that many of the explanatory studies don’t correct for confounding variables so their results don’t show what their authors claimed. But mostly it reflects the fact that although unmedicated vaginal birth — like opioids — may be better in theory; it’s NOT better in practice.

Similarly, there are quite a few explanatory studies of breastfeeding that claim to show that breastfeeding is superior to formula. Lactation professionals have seized on these studies to rationalize their preference for breastfeeding over formula feeding. The Baby Friendly Hospital Initiative (BFHI) is a campaign to promote breastfeeding. Lactation professionals predicted it would increase breastfeeding rates, save lives and save healthcare dollars.

That’s not what happened. While the BFHI has increased initial breastfeeding rates, the fall off after leaving the hospital is quite dramatic. With the exception of extremely premature infants, it hasn’t been shown to save ANY lives in industrialized countries and certainly hasn’t saved any healthcare dollars on term infants. In fact, literally tens of thousands of babies are readmitted to the hospital each year because of breastfeeding problems (primarily insufficient breastmilk) at a cost of hundreds of millions of dollars

Why? Partly this reflects the fact that many of the explanatory studies of breastfeeding don’t correct for confounding variables. But mostly it reflects the fact that while breastfeeding — like opioids — may be better in theory; it’s not better in practice. Indeed, for some babies exclusive breastfeeding leads to serious health problems, permanent brain injuries and even death.

Where do we go from here?

No doubt drug companies will try to discredit the results of pragmatic trials of opioids and continue to bombard doctors with explanatory trials that show that opioids are stronger. Hopefully, doctors will no longer be swayed by the explanatory trials alone and will demand data demonstrating how opioids perform against non-opioids in the real world.

Similarly, midwives and other natural childbirth advocates completely dismiss the fact that campaigns for normal birth have utterly failed to produce the predicted results. They haven’t met a midwifery scandal resulting in preventable infant and maternal deaths that they don’t lie about, deny, hide and ignore. They comfort themselves and each other with “research” by which they mean explanatory trials. The only question remaining for the rest of us is how many more babies and mothers have to be harmed and die before obstetricians, government officials and public health authorities insist that midwives prove their claims are true in practice, not just in theory.

Lactation professionals behave in exactly the same fashion as midwives and opioid manufacturers. They dismiss the fact that the BFHI and other efforts to promote breastfeeding have utterly failed to produce the predicted results. When confronted with data that the benefits of breastfeeding in industrialized countries are trivial, that no term babies lives have been saved and no healthcare dollars have been saved, they wave explanatory studies that demonstrate the theoretical benefits of breastfeeding. The only question remaining for the rest of us is how many more babies and mothers have to be harmed or even die before pediatricians, obstetricians, government officials and public health authorities insist that lactation professionals prove their claims are true in practice, not just in theory.

As Carroll notes:

Randomized controlled trials are great for certain things. They absolutely have their place in determining efficacy and causality. But sometimes pragmatic trials are better. If we want to see improvements in care in the real world, not just the lab, we may need to push for more of them.

That applies to opioids and it applies equally to efforts to promote unmedicated vaginal birth and breastfeeding.

  • Gatita

    I’m surprised tramadol was put into the non-opioid group. Not only is it an opiod, junkies have figured out how to take it so they get high from it.

  • This is OT, but I had to share the rabies coloring book my vet’s office offered. There were no pictures of animals writhing in agony, but a great many terrible rhymes such as “But a single bite is all it takes/To someone’s pet infected make.” I had to laugh. https://uploads.disquscdn.com/images/b282674143d0b6de7be4dce4506ba79016ccc3a926a07e3fb7c999c3e35582d6.jpg

    • Russell Jones

      That’s epic! Here’s hoping we don’t see a Montezuma’s Revenge coloring book in medical office waiting rooms any time soon.

    • Amazed

      That’s great!

      Another OT: I was recently at the archaelogical museum here and I was reminded of an old stone inscription, about 1200 years old. It reads: Khan Malamir is ruler by God. His old Cavhan (the second man in power) Isbul made an aqueduct and gave it to the ruler.

      JFYI: stone inscriptions were made to celebrate great war campaigns, peace treaties, and other important events. This aqueduct in the capital was so important that it merited an inscription of its own. An aqueduct ending in a fountain. The greatest gift of all for the citizens of the capital. Clear water and pipes leading the dirty water away. And hey, epidemics suddenly turned out not to be so contagious after all!

      I repeat: 1200 years. Quite a lot of time, as far as wisdom is concerned. 1200 years ago people knew what a great gift clear water was. Now, we want to put it as less important than breastfeeding while drinking this same unclean water? WTF?

  • The Bofa on the Sofa

    Explanatory trials show that, if all else is equal, X is better than Y (or not).

    The problem is, all else is never equal.

  • RudyTooty

    Great post.

    I feel like I should repeat my story – I post here occasionally – to attest that people can rescue themselves from the WOO.

    I started out as – well, a doula … way back when – then was an apprenticeship to become a CPM. I was enrolled in a MEAC-accredited midwifery program. I slowly extracted myself from that world, became a nurse, started working in clinics and hospitals and am now a nurse-midwife.

    I used to believe all the hype! I believed all the nonsense about natural birth being better, being “empowering”, being healthier…. but luckily, I’ve been blessed with the ability to think for myself – and many times I’ve worked with women in labor with an epidural (that they requested upon admission to the hospital in early labor) and they progressed nicely, maybe took a nap, and pushed without a terrible amount of exertion.

    I was indoctrinated into the idea that epidurals were BAD – and that natural birth was inherently GOOD – but witnessing these smooth and relatively easy labors and births made me question why I would ever suggest that a woman had to give birth in any certain way. Epidural births can be quite lovely! (That is positively sacrilegious to say in certain midwifery circles)

    Now there are no universal truths – bodies and physiology are complicated – so there is no guarantee – sometimes labors with an epidural are still hard, sometimes natural labors are smooth and manageable – there is always variation.

    But after my experiences with women in labor – in homes, in birth centers, in small and large hospitals – I do not ascribe to any one superior ‘method’ of birth. I prefer methods that prioritize safety, a method that the laboring woman does not feel coerced or shamed into, and a method that preserves the health and well-being of mom and baby.