From evidence based medicine to safe plausible medicine.

I just want to say it… evidence based medicine has had a good run, but it’s declining in what it has to offer in its current form. We need to move to another model, and it’s called safe plausible medicine.

Among the reasons for the decline of usefulness of evidence based medicine are-

1.Expense. The so called “gold standard” randomised controlled trial (RCT) is incredibly expensive to do properly

2. Strident eligibility restrictions in the modern RCT exclude most “normal” people in favour of those with virtually no other conditions, confounding health factors or medications. That’s not many people. At the end of the trial, you get something like.. this treatment had a 30% better outcome than alternatives. When you look at the study, it hardly applies to any of your usual patients. The findings apply to the lucky 3% of people who are just a little unwell, and isn’t relevant to those with comorbidity. Furthermore the conclusions are possibly invalid regarding your patients, and worse still, could be harmful given that the proposed treatment hasn’t been tested on patients like them. A stark example is those on multiple medications. Good luck with interactions between your test medication and drugs A B C and L, when your trials are done on people who are medication free, or nearly so.

3. Studies are corrupted by all sorts of financial imperatives and biases. Some are obvious, but some are very subtle. Ben Goldacre has documented many of these.

4. What we call evidence has various “levels” and sometimes they are proving the obvious. For example.. why are we still doing studies to show that exercise improves condition X? I’ve rarely seen a condition that doesn’t respond favourably to exercise. But how much exercise, or what type? Who cares. Let’s just be more active. Some low intensity, some high, whatever. Mix it up. That’ll help

5. Results often don’t get converted into policy or taken up by our culture. We are busy longing for and indulging in “more important things” that light up our addictive centers in our brain, but probably don’t benefit us much. My screen addiction is an example. I know bright light at night is bad. But I love reading and writing using technology. It’s nearly midnight as I write this, and I’m dog tired. Knowledge from the studies on sleep deprivation isn’t helping me avoid all the diseases I know result from it.

I could go on, but rather than be so negative, I have a solution. It’s called “safe plausible medicine” and I believe it has a great advantage over much of what we call “evidence based”

Safe plausible medicine goes like this.

If it’s something that is very unlikely to cause harm, and has some pretty plausible explanation for why it might be good, let’s do it. Who cares if it isn’t based on rock solid studies?

The problem is there are lots of people who care enough to block this idea.. the people who are afraid of being blamed if something goes wrong. Their fear based (flawed) logic goes like this..

”Evidence based interventions are safe” therefore “interventions with poor evidence base are unsafe and we shouldn’t recommend them”. 

This is patently untrue, but I hear it daily in my interactions with health professionals, and it reflects poor training in critical thinking.

Let’s break it down.

Statement A. Evidence based interventions are safe. This is often true. There are many good trials out there that verify favourable risk/benefit ratios of medications or treatments but there are many exceptions too. Let’s ignore the exceptions and assume that statement A is true. But to then say statement B is true because of statement A reminds me of basic logic exam questions.. A is true, B is false and B does not flow from A.

There are many treatments that have been administered for decades, sometimes centuries, but have not been properly studied. Are they unsafe? No. They are just untested. Some may seem pretty shonky. Colonic irrigation was such a treatment back in the 1980s when I was a younger doctor. Faecal transplant was potentially laughable given our scientific knowledge at the time. It’s now working (some) miracles, but has a fair way to go before we can use it safely. I can’t recommend it yet.. too much uncertainty. For me it fails the “am I confident it’s safe for most patients?” test. But it’s certainly plausible now, given our knowledge of the microbiome.

Many traditionally accepted treatments are patently now proven to be unsafe. (Mercury bath anyone?)

What IS safe and plausible is the Mediterranean diet. I don’t really need to reference this.. just google it.

What is also safe and plausible is moderate carbohydrate reduction with a caveat that if you have diabetes you shouldn’t do this without medical supervision. We have zero need for added simple carbohydrates in the diet. It’s not possible to reduce carbohydrates to zero as they exist in many foods. Moderate restriction has been demonstrated to improve health, biomarkers of disease such as inflammation, cardiovascular disease, metabolic dysfunction markers and the microbiome. Plausible mechanisms for these changes abound.

Why do people who recommend low carbohydrate diets get persecuted? Beats me. Probably the whistleblower effect. Good luck Tim Noakes, Gary Fettke, Jennifer Elliott and Caryn Zinn. You are brave. Thankyou for pushing the safe and plausible. Thankyou for trying to help reverse the tide of harm we have caused by promoting (in our ignorance) dietary recommendations which are now demonstrably wrong.

Bring on the safe plausible medical revolution. The evidence is in.. Evidence based medicine is no longer God. It still has something to offer.. big data and complex causal analysis is looking pretty good- just a little expensive, and while there’s some low hanging fruit (no pun intended) to tackle, I can’t afford to wait for the results.

Safe and plausible. Let’s do it. If you aren’t on metabolic medications*, you can safely reduce carbs, fast if you can- even overnight helps.. early tea, late breakfast, walk after a meal, sleep long, exercise regularly, connect with friends, laugh, read, avoid screens, cover up in the intense sun, but make sure you get a healthy amount without burning, eat plenty of vegetables, fibre, nuts, legumes. Eat healthy unprocessed fats, and a little meat if you must, but make sure it’s had a healthy natural life and its natural diet. Minimise processed food, especially bread and other food from engineered grains. Eat food that rots, before it rots, and food that ferments, after it’s fermented. Keep animals and avoid antibiotics and caesarean sections. Reflect, slow down and practice mindfulness. Simple, Safe, Plausible. Oh.. and don’t have too many rules!

*if you have type 2 diabetes or are on medications that alter blood sugar, you can still do dietary change, but make sure your medications get lowered as you reduce the demand for insulin or the drugs that assist it. Your doctor can organise this. See this article too- Carbohydrates for people with diabetes is not cautious

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