Landmark Study with Researcher Dr. Robert Abbott
The autoimmune paleo (or AIP) diet and community support together can benefit patients with Hashimoto’s thyroiditis, according to a landmark study. AIP removes nightshades, eggs, nuts, seeds, ghee, and caffeine, in addition to standard paleo restrictions. The study’s community support (which included online health coaching) contributed to 90-100% adherence to this diet. Interestingly, multiple participants improved symptomatically and/or were able to reduce thyroid medication, while their antibody levels didn’t change. This suggests that caution is warranted when drawing conclusions about one’s health status from thyroid antibody levels. In this podcast, Dr. Robert Abbott—third-time guest on the show and researcher on the study—discusses other health lessons, and insights on beneficial clinical models.
Dr. Michael Ruscio, DC: Hi, everyone. Welcome to Dr. Ruscio Radio. This is Dr. Ruscio. Today, I am here again in a third time appearance with Dr. Robert Abbott. He has published what I found to be a fantastic study using the autoimmune paleo diet in a group of patients with hypothyroidism and with thyroid autoimmunity. And I’m exceedingly excited to have him expand upon the results. So, Rob, thrice times, welcome back.
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Dr. R’s Fast Facts Summary
Diet and Community Intervention
- In a recent study, both diet (AIP) and the aspect of community appeared to contribute to improvements in patients with Hashimoto’s Thyroiditis
- The AutoImmune Paleo diet (AIP) was introduced in addition to health coaching and community support
- AIP diet is more restrictive than the Paleo diet
- Eliminates = eggs, nut/seeds, nightshade vegetables
Study: Efficacy of the Autoimmune Protocol Diet as Part of a Multi-disciplinary, Supported Lifestyle Intervention for Hashimoto’s Thyroiditis.
Dr. Robert Abbott, MD: Man, I don’t know what I did to deserve to get on the show. But yeah, it’s great to be on here and I hope we can really get into the nuance of the study, because in social media and even blog posts, it can be really difficult to get into the deep nuance of the research to really help people. I don’t want you just to accept that we did a study, and if you’re in our echo chamber, to accept it. We need to be positively critical. So this’ll be a great opportunity to get into more of the details of the study.
DrMR: Absolutely. And I do want to also explore some of the ways people are reacting to this study. I could certainly see if people are staunch dietary advocates, there are some points in this study that may not support “we need to go all the way, to the extent of using the autoimmune paleo diet.” I could see someone who’s a very staunch diet advocate, again, could have some issues with that. So I do want to get into some of those particulars.
AIP Diet & Lifestyle Study for Hashimoto’s
But before we get into the nuance, can you start us off with the short high-level summary of the study and its findings?
DrRA: Yeah. So the title of this study is “Efficacy of the Autoimmune Protocol Diet [or Autoimmune Paleo Diet (AIP)] as Part of a Multi-disciplinary, Supported Lifestyle Intervention for Hashimoto’s Thyroiditis.” I want to first point that out, telling people that it’s important in a title to put as much information about what was really studied as possible (not too much). And I want to focus more on what I put in there as multi-disciplinary, supported lifestyle intervention.
This was not just a dietary study. It wasn’t a dietary study. It was a multi-component, multifaceted intervention. And we’ll maybe get into more details of what we did for folks. So I really want to point that out to the folks before we start, because diet is only a single tool. And it’s a powerful tool, but it’s a single tool in the toolkit. There are a lot of other things that we’re doing in functional and bio-individual medicine that are very helpful.
DrMR: Those are great points.
DrRA: So, that’s the title. And we were able to do essentially a single-arm pilot study of 17 women with Hashimoto’s thyroiditis. They were all what I would call middle age—so ages between 20 to 45, with Hashimoto’s thyroiditis—diagnosed by medical records from their current provider and laboratory tests indicating elevated thyroid peroxidase antibodies or antithyroglobulin antibodies. Outside of that, we only really eliminated folks who had chronic organ disease or an active secondary autoimmune condition. So even though it sounds somewhat restrictive, I think we actually kept it as open as possible. And we even tried to get men, although we only had, like, three apply. 500 people applied to this study.
But what folks did is participated in a 10-week lifestyle and dietary intervention, where they joined an online community of supported health coaching. So two health coaches—Angie Alt and Andrea Hirsh—facilitated an online community where the individuals could interact with the health coaches themselves and each other, walking through a phased elimination of the autoimmune protocol. So, essentially starting with whatever diet they were on in the beginning and walking them over weeks through various eliminations.
And for folks that are maybe not totally familiar with AIP or the autoimmune protocol diet, it’s essentially a more restrictive version of an ancestral or paleo diet. It removes things that could be potentially immunogenic to an individual such as eggs or nuts and seeds, certain nightshade vegetables and certain seed and fruit-based spices. So, it’s certainly a restrictive diet. And the design for the program and this study was to make it much more easy for folks to do these dietary eliminations, rather than saying, “Okay, day one, you cannot eat these foods and you can only eat these foods.”
I can count on my hand the number of people I’ve worked with, or seen, who were in a bad enough place or motivated enough to be able to do that even unsupported, let alone supported. We had different phases of elimination, starting with things like grains and alcohol in the beginning. Essentially we tried to remove the things that were most likely to be problematic and least nutrient-dense in the beginning, and in the sixth week, removing things that are very nutrient-dense and least likely to be problematic (like some of the nuts and seeds).
And over those weeks, we worked with folks to help them troubleshoot how to start cooking differently and removing some of these foods as they went along. After the six-week period, they then maintained the full elimination for an additional four weeks. Overall, it was 10 weeks. After the sixth week, they were actually in full AIP. And it was pretty amazing to be able to work with these individuals. Because I actually also did what would be considered traditional or functional medicine care individually with the people alongside the health coaching.
As you can see, just from this little bit (the summary), there was a lot going on in the study. There was interaction in the group, there were visits with me to discuss thyroid labs and some of the other functional medicine tests. There was interaction with the health coaches. And the education was not just dietary in nature, while that was a big piece. There was also guidance on medication, how to incorporate stress management practices, focusing on sleep. There were so many things going on here. And some researchers don’t like doing research like this because they can’t, once it’s over, say, “This was the thing that helped,” or “This was the thing that didn’t help.”
It’s so naturally confounded that some people just don’t want to do this type of research. I see it as amazingly relevant to folks in the real world, because this is how we practice. This is how we make lifestyle changes. It’s not about controlling this variable and this variable, and I’m not going to do this or not do this. So I see it as having a lot of real-world relevance, even if we can’t, from a scientific perspective, say, “Yep, it was just the diet,” or “It was just this.”
DrMR: Agreed, and allow me now to provide some of what I felt to be the more impactful findings from the study. And then, if you want to amend those, comment on those, push back on any of those, please feel free there. There are a couple of things here that I think are important to factor into how we look at this study and the conclusions that we draw.
First of all, it seemed that the group being studied were already somewhat privy to healthy dietary recommendations. I’m assuming a number of these patients were already gluten-free, or had dabbled with a paleo type of diet. They seemed to be not just your general population of people, who had not paid any attention to their diet and were drinking soda and eating a bunch of bread and what have you. So we may have had a pretty good group here at baseline. And then as you said, Rob, they went in this controlled, guided manner onto the autoimmune paleo diet protocol, combined with that very important aspect of community support and coaching.
Thyroid Antibodies: Not the Whole Picture
And what I found to be really insightful and interesting here is that there was a substantial improvement in symptoms as measured by a couple of different methods. But your research-validated questionnaires—what’s known as a short-form 36—essentially measures general well-being. And people were healthier from a symptomatic perspective and some of their inflammatory markers seem to have improved, which was great. So people felt better. Awesome. I would expect that and that’s very encouraging.
What I also found interesting was, there was not an appreciable change in thyroid antibodies. Which tells us, I think, a few important and empowering things. One is, we shouldn’t be obsessively looking at antibody levels, because people can get quite a bit healthier, as this study documents—at least symptomatically they were feeling better—while there was no change in their thyroid antibodies. Now, to the people who naysay and say, “Well, that shows you that diet has no impact on thyroid antibodies,” it could be that this group had already made some of the most major dietary changes and they had less room to improve from a dietary perspective. This also may indicate the power of community, in this case, leading to this symptomatic improvements.
And one of the things I’d like to get your comments on also, Rob, is I know that six patients were able to decrease their thyroid medication dose, even though the antibodies didn’t change. Which I look at as at least loose support for a contention I’ve held for a while now, which is, reduction in thyroid medication after making dietary changes or using interventions such as probiotics—that can heal the gut—is likely more due to increased absorption of the medication, rather than this rapid healing of the thyroid gland and then an ability of the thyroid gland to make more hormone. I think we sometimes attribute symptomatic improvements to the antibodies. But more often, I think what’s happening in the patients in these cases is they’re absorbing the medication better, and it’s more a gut absorption issue than it is an autoimmunity issue, per se.
In closure, it looks like we can see some nice symptomatic improvement from a diet and community-based intervention, that will manifest as people reporting, “I feel healthier, better energy, better subjective well-being, better mental clarity,” what have you, but it wasn’t necessarily tied to thyroid antibodies. So those were some of the things that I thought were the most relevant. But Rob, please, any tweaks or comments that you want to make on that?
DrRA: Yeah. That was really spot on. I think that was a great, honest and clear summary of some of the main results and I agree. So a lot of folks who read the scientific literature are probably pretty familiar with standard statistical analysis, tables, graphs. But oftentimes, what’s left out is a more in-depth analysis, an actual case summary or case reviews of individuals in the studies (one of the things I wanted to do in this study). When I look at some of the studies such as ours that had 17 women, even smaller sample sizes that don’t include these things, I’m like, “Well, you certainly could have.” If you had a hundred people, yeah, I don’t expect you to provide me with in-depth case summaries of a hundred people in a study. But it provides a lot more nuance—especially in a lifestyle intervention like this—that points to individuals and their experience rather than just looking at the statistics as a whole.
And when I reviewed food frequency questionnaires and diet journals, (doing a food frequency questionnaire at the beginning of this study that asked you to recall food over a year) certainly I was not going to use that as a hundred-percent guarantee that this is what you did. But it gave me a ballpark. And I used it qualitatively to try to assess food groups.
When you looked at that and you talked to people—I completely agree—everyone was at least familiar with AIP, had even maybe done it for a day or two. No one had done it for three or four weeks at a time. People were familiar with it and were eating what I would consider an above-average diet. They were eating foods that they were informed about: “Yeah, I should maybe remove this, remove this.” So some of them had already removed gluten or were eating a gluten-free diet, had removed dairy, made some of these first-level dietary changes, but maybe still included something like regular nuts and seeds (some of the foods that would be eliminated on AIP). So we were starting at baseline with folks that were well-informed and had a good expectancy, which I think is not something you should see as a negative behind a dietary intervention. I don’t want people who force people to follow a diet that they don’t believe in. There’s a positive expectancy there. But also, they were just fairly healthy at baseline, in terms of the types of food they were eating.
Now, they did have a pretty big symptomatic burden which we saw decrease, which is pretty wonderful. And I think it’s also important when you tie the baseline findings of their food intake with what the thyroid levels at the beginning of the study were.
Going back to the exclusion and inclusion criteria for this study, I did not want to include only individuals with TPO antibodies, say, above 500. Because I wanted to prevent having a phenomenon known as regression to the mean. So, say you only get folks with antibodies in the thousands. Then you do something for 10 weeks and then you see an average comes down to 750. Well, maybe you’re going to erroneously say that that was your intervention when it was just that you took people with really high antibodies and followed them for a short period of time, and they started to naturally come down.
So I had no idea what the baseline antibody levels for the group were going to be before we started. I only needed to have documentation upon enrollment of elevated antibodies above… I think I was using 34, as my threshold of either TGA or TPO. So after the baseline testing, I think the group average was just above 200. Which, as you’ve been documenting in previous newsletters and talking about‚ I see as a pretty good clinical win. I’m usually trying to get people—if they’re coming to me above 500, 600—below 200, below 500, somewhere in that range, obviously monitoring them clinically.
But I don’t see the same associations with folks—as you’re pointing out—once they get below that level, if we keep decreasing it incrementally, that they’re having radical improvements in their symptoms or other aspects of thyroid function. I’m just not seeing that. It’s just my short-term experience, but I feel like that’s what you’ve been seeing as well.
And to bring an even greater example of that, there was one woman who had previously elevated antibodies, but when she did testing at the beginning, her levels were just inside the normal range. She had, I think, if not the worst, the second worst symptomatic burden based off of one of the questionnaires. So I look at that and say, “Just because you have normal antibodies doesn’t mean you’re going to feel well,” or “If you have really high antibodies, it doesn’t mean you should feel poorly.” There’s potential—depending on the degree of the level—that it could be associated, but it’s not a strong association.
So we have to get out of this paradigm, like you’re saying, when we look at someone’s thyroid antibodies level, seeing that as the direct be-all end-all of what’s happening in terms of an autoimmune process. Even those things are going to potentially lag behind any type of effect that’s happening systemically.
And there are a lot of other things. Like when we recognize what’s really happening in Hashimoto’s thyroiditis: when you look under the microscope (if someone gets an FNA or a biopsy), they see this lymphocytic infiltrate, its cellular infiltrates. It’s oftentimes a TH1-dominant process that’s destroying the thyroid. It’s not the antibodies themselves necessarily leading to thyroid destruction. So we don’t really have a great way to quantify that in terms of a lab test. We only have invasive things like biopsies and doing FNAs to look at things under the microscope.
And there’s even a small subset of people that are antibody-negative, so actually, the only way you diagnose them with Hashimoto’s is through a biopsy, an ultrasound, some other test to actually look at the thyroid tissue, because they don’t have the antibodies in the blood. They would be the people that are missed by screening tests if they’re not truly hypothyroid, by screening tests that even look at antibodies.
So that was a big ramble and I think I didn’t get quite to everything you’d mentioned, but really wanted to point out we have to take a bigger view, especially in this functional medicine space. I believe in testing for antibodies, especially at initial diagnosis, to get someone and say, “We have a definitive autoimmune process. We can potentially support you with different dietary tools than we would if it otherwise wasn’t.” But we can’t get stuck on trying to track them, because I’ve seen too many people have a no-SIBO effect where they suddenly got sicker because they checked their antibodies again and it went up a little bit, even though they were symptomatically feeling better.
DrMR: Yup. Well said.
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Know What Antibody Tests Really Mean
And to piggyback on your last point there, this is one of the areas where I think quite a bit of damage is being done in functional medicine, when patients are getting these multi-tissue and multi-antibody assays and being told, “Well, you have antibodies against this tissue, that tissue, the other tissue.” And while I have not yet had the chance to fact-check the validity behind all these markers—how they’re being measured, what ranges those labs are reporting as normal and abnormal—from the couple that I have checked into, one being thyroid antibodies, you see that the need for alarm is not anywhere near as bad as it is portrayed to be.
So I’m assuming what I’m going to find—and at some point I will report back on this more formally—is that many of these preventative antibody tests, unfortunately, create far more fear and more damage than they do aid. Because it’s built upon this false assumption that there’s this high correlation between antibody levels and either current symptoms or disease activity, or risk of progression to a given disease in the future. Again, using thyroid antibodies as an example, you would think that any positivity in thyroid antibodies puts you at high risk. And in fact, it’s not until you get above 500 with TPO antibodies, and even then, the risk is fairly minimal that you will actually progress to overt hypothyroidism.
And I may be slightly off in my numbers here, but I believe the estimation from the one study that looked at this in a going-forward-in-time, or prospective, fashion found about an 8% to 19% chance that someone with elevated antibodies would actually progress into overt hypothyroidism. The take-home there should be (but unfortunately, oftentimes it is not) is that if you have these antibodies, you have a small chance of becoming hypothyroid in the future, and only if your antibodies are significantly above 500.
Unfortunately, what people are told is, “You have Hashimoto’s,” in a very definitive way. They are made to believe that they’re kind of a ticking time bomb, and that fear is very counterproductive. And there are certainly things that we can do to increase the probability that you won’t have any disease or autoimmunity in the future, and those are some pretty basic interventions—like we discuss ad nauseam on the podcast—regarding lifestyle, sleep, exercise, sun exposure, gut health. Then, some basic nuanced therapies for a given autoimmune condition, like for thyroid as an example, selenium is one potential option. And we can do those things in a somewhat relaxed, preventative fashion, not needing to do these highly meticulous, repeat antibody assays and get really worked up over the levels.
Because again, the probability of progression, even if you’re in the worst-case scenario—again, here my numbers may be a little bit off, but they’re in the ballpark—you have about 8% or 9% to about 19% chance of becoming hypothyroid with your antibodies consistently elevated above 500. And that’s in a group of people who aren’t doing anything.
Now, imagine if you were taking a bunch of steps. So the prognosis is a whole heck of a lot better than people are led to believe. We can still go through these interventions, but we want to do them in a less dogmatic, less fear-based way, because there’s not this high probability that you’re going to be in dire straits, super sick, unhealthy, and diseased. And I think your study really helped to reinforce some of those points.
Again, I returned your long rant with my long rant of my own! But I do appreciate that finding in the study, and I hope it will be taken in an empowering way.
Reception to AIP & Lifestyle Study
How do you feel these results are being received as they’re disseminating out into the Internet?
DrRA: Yeah. Honestly, in the initial publication at the end of April, in some of the social media discussions and things, it’s been 99% really positive. This has been, I think, really well-received. Moreso when people truly understand the process that we had to go through to even do this study. To put this in perspective, I think a lot of folks are familiar with the scientific process and understand there’s a natural progression. You’ve talked a lot about the different levels of evidence, so I won’t waste too much time with that. But at this time, there really had never been an interventional trial of a dietary and lifestyle intervention for Hashimoto’s thyroiditis. So we can’t just jump and say, “Yeah, we need to do a trial of 300 people and it’s going to cost us $1 million.” You can’t just jump to that a mil. You have to go through a progression.
So, starting with a pilot study that was based off of a framework of a similar trial—looking at this dietary approach and the group health coaching with inflammatory bowel disease, published by Dr. Kenneth Jetty in 2017—we had some evidence that, in a different disease state, this could be helpful. So it made sense to do an additional pilot study. And we actually crowdfunded the budget for this study. And I and Adam Sadowski (who participated tremendously) as well as Angie Alt essentially volunteered our entire time for this study for free. The total study budget was basically directed towards a HIPAA-compliant questionnaire tool, as well as the laboratory testing. We ended up raising $12,000 from folks in the community who wanted this research to be done.
Then we did the study essentially over a six-month period, from enrollment and getting people started to publication. The whole thing took less than a year. When I look at that, I’m like, “Man, this is insane how we even pulled this off. We did this.” And tried to remove some of the bias that can come when you’re industry-sponsored or getting money from a pharmaceutical company. So it’s telling me, look, this community is getting engaged. The citizen scientist wants to support research like this. So we were getting a lot of positive feedback from folks recognizing that we were putting ourselves out into the fire. It’s much, much more challenging to actually create and do science than to critique it. And I’m the first one to tell you… I’m very big into critiquing literature and helping people understand and giving them a framework to positively critique literature.
My first reaction once you get published is, “Yeah, I’m published,” but I needed to look at it myself with a positively critical eye. If I was somebody who had no idea how to replace autoimmune diet with some other diet I’d never heard of, how would I look at the paper? And so, I was just really blown away by people with positive support, who recognize the study process.
There was just a handful of people who made the standard critiques of, “Oh, it’s a small study. It wasn’t controlled. It didn’t do this.” We knew all of that before we even started and we didn’t try to make any crazy conclusions to say that everyone with Hashimoto’s thyroid should go on AIP. I didn’t say that, and it’s also how I practice. I’m not recommending that every single person that comes into my clinic with autoimmune thyroid disease follow an autoimmune protocol diet, whether it’s on their own or part of a group setting, because everyone has different circumstances. I’m not a dietary zealot when it comes to AIP. It can be really profound and beneficial. But we have other tools, things like low FODMAP, things like a ketogenic diet, even just a basic paleo diet, depending on where someone’s coming in from. All of these can be very therapeutic in context and should be applied in individual settings.
We’re even starting to get folks who are coming to the clinic now who recognize that we apply the AIP diet in therapeutic context, and sometimes who are even surprised when we’re not initially recommending it. I tell them, “For certain reasons, I don’t think this is the dietary approach that you need to follow.” I want to put that in context for people, to realize that, yeah, while I’m researching this, I want to gain evidence. I’ve seen it anecdotally do so much for so many people. Even after this study, I’m not going to suddenly put every single person I see with autoimmune thyroid disease on AIP.
DrMR: Yeah. Many great points and things I want to follow up on there. I experienced something similar when we collected the data in our office on biofilms. We did that comparative data collection, looking at treating patients with SIBO with antimicrobial therapy plus or minus anti-biofilm agents. And for the first time, we found and documented a significant impact of the anti-biofilm agents. That led a lot of patients to ask, “Well, aren’t we going to use anti-biofilm agents to treat my SIBO?” The challenge there is, just because that intervention may be helpful for some of the more recalcitrant and stubborn cases doesn’t mean we have to use that on everyone.
In my opinion, that is one of the major hallmarks that separates a good clinician from a non-optimal clinician, understanding that we don’t have to always be doing more. And oftentimes, I guess you can say, a good clinician will be able to get you results and make it look easy. Your patients should be saying that to you, if you’re doing things right. Not every patient… Some cases are, of course, harder than others. And some people are harder to make happier than others. But you should have some patients saying, like, “Wow, I’d never thought it could be this easy.” If you’re not hearing that as a clinician, there’s some work to be done, and that’s okay. We’re all constantly evolving as clinicians. But you should be hearing that, because that tells you that you’re using the minimum effective dose or the minimum intervention necessary. That is one thing I think is definitely worth reiteration.
Pilot Studies Are Often “Rough Drafts”
And to the evidence point… when we look at evidence, yes, there is this pinnacle of a meta-analysis of randomized controlled trials. But we have to start with whatever evidence we have. So right now, this is the best study on the autoimmune paleo diet for Hashimoto’s.
Now, could it have been a better study? Yes, but we have to start with the best evidence we have. Now, if there was a randomized placebo-controlled trial in a thousand patients, and you had your study, and you were trying to make a proclamation that was counter to what a better piece of evidence had cited already or had found already, then obviously someone should take issue with that. But if you’re producing the best study done to date, then I don’t understand where people want to criticize the level of evidence, unless they’re ignorant to the body of evidence currently. We want to use the best evidence that we have. And as long as we’re not making any strong conclusions, as you did not, then I don’t really see much to take issue with there.
DrRA: Yeah. Thank you for saying that. One of my friends gave a good analogy or good description: pilot studies are often rough drafts, of being able to figure out, “Did we do this study in the right way? Did we conduct it in the right way? Did we measure the right blood markers…”
DrMR: Going through the rigors of setting up a randomized controlled trial, absolutely.
DrRA: Yes. And especially when I mentioned we crowdfunded money… not that I would want to “waste” anybody’s money, but I would feel really bad if we set this up at the beginning with 100 people, raised all this money in the community and then it was just poorly designed, people dropped out, no one participated, independent even of any of the results. That would just be a poor decision and a lot of research. I don’t want to get too off in the weeds, because I’ll get really riled up, but a lot of biomedical research should never have been done in the first place. A lot of dietary research is just very poorly designed and would never have shown anything that was relevant.
I read some of this stuff and it just boggles my mind how these things can get past IRBs. I understand they’re looking for ethics and steady conduction, but looking at what they’re actually studying, I’m just like, “How in the world did this get passed?” It’s just feeding into this greater system and problems that we see with the medical news. I can just take something, run with it, and completely distort it. Then everyone in the populace gets a conclusion that the study authors didn’t even make, wouldn’t have said, or didn’t say in their study.
So yes, there’s a sequence to these things. And we’re already beginning to plan and structure what the next study looks like.
Weight and Thyroid Hormone Interactions
And even to backtrack, to finish answering that question about what the potential mechanism by which people needed less thyroid medication or saw symptomatic improvement was… while we can’t, as I mentioned earlier, really say anything specific about certain individuals, we can make inferences based off of their dietary questionnaires, based off of certain aspects of the tests.
We did see a statistical and clinically significant decrease in weight. Now, the women in the beginning were either normal weight or overweight. So that means they had a BMI of less than 29. And I did that knowing this program would be successful, and having seen a lot of clinical wins with it. Knowing that people would probably lose weight. And not being their primary provider (as I was working with people virtually as the study physician), I didn’t want to create another variable of having to really monitor thyroid hormone if someone started losing a ton of weight. Because the main parameter by which thyroid medication is dosed, and how it can change from time to time, is someone’s weight.
We did, though, still see a statistical and clinically significant decrease in weight of both the overweight subgroup—which is about half the participants—and the group as a whole. It was around six or seven pounds. Now this is self-reported, but the women didn’t have any reason to be reporting a crazily wrong number. And when I talked with the women individually, there was clearly a clinical effect of weight loss. So for some of the individuals, a degree or most of the reason they needed less medication was related to weight loss.
However, there were a couple interesting cases. One woman maintained the exact same weight, but her TSH dropped such that she needed less medication. And she had testing. In the beginning we performed comprehensive stool analysis and organic acid tests. They were exploratory in nature because they were donated by Genova Diagnostics, but they were used to inform my clinical decision-making on dietary recommendations halfway through the study. But this woman in particular showed evidence of pancreatic insufficiency by a low fecal elastase, and some other markers that pointed to probably some dysbiosis in the gut. I think she also had growth of Blastocystis hominis. So, a lot going on in her gut, some clear malabsorption, pancreatic insufficiency. Her repeat stool study showed some improvement. But I would guess in her case—since her weight was stable and her TSH had this pretty big drop—that it was gut-mediated: she was absorbing the medication more, we decreased some of her inflammatory burden. She was also, I think, working out quite a bit, kind of overexerting herself in Crossfit, and so she laid back on that. I think all of those things helped for her.
There were a couple of other women too, who saw pretty big drops in TSH, who didn’t necessarily need less medication by the study end. They started with the TSH around four and dropped around two. I couldn’t explain that drop alone by weight. They had only lost a few pounds, four or five pounds. Which, when you correlate with dosing, just isn’t enough to see these big changes. They also had some gut symptoms and dysfunction based on the comprehensive stool analysis. So I agree with you completely: there is some form of positive effect that’s happening with the gut, whether it’s modulation of the gut microbiome, improving the barrier. How that’s affecting the immune system, I can’t fully say, but I think absorption, at least in that one woman’s case, was pretty well-documented.
And I’ll give you one last individual case that I found pretty fascinating. I think I mentioned her actually in the other podcast, so maybe this is a repeat, but there was a woman who was taking T3-only medication at the beginning of the study, which I do not recommend. It’s not safe in any way. She had no T4. Her T4 levels were in the toilet. I recommended halfway through the study that she go to her practitioner and get on a combination medication. While I wasn’t going to be able to include her in the group analysis because of the medication change, I followed her. And at the end of the study, we repeated labs and saw her T4 had come up into the low end of the range. I asked her, “So which combination did you start?”
She said, “I didn’t start a combination, I just started taking a little bit less T3.” In her case, there was a little bit of weight loss. There was now slightly less suppression of the thyroid because of taking a little bit less T3. But there was another effect too. Maybe it was the intervention that allowed her thyroid to start making hormone. And that was in as little as 10 weeks. While at the group level we didn’t see changes in thyroid hormones, TSH, T4, T3, we didn’t see those changes in antibodies… if you really look at these individual cases, then you start to see some of these changes in TSH, people that need less medication for various different reasons. And it just becomes very compelling. While you could take that and say, “Oh yeah, AIP did all this,” I don’t take it that way. I take it as, “Wow, we need to do another study with more people, to see if we can tease out some of these effects that are difficult to see when you have a small sample size.”
Is Diet or Community More Beneficial?
DrMR: And that’s one of the other questions I want to ask you. I know this may not be easy to answer, in more of a formal numeric way (but if you can, please). I’m assuming it may be more of an intuitive gauge. Okay, we have this group of people who aren’t on a bad diet to begin with, and we’re going to tweak their diet to make it even better (compared to people for whom we don’t know what their community set up was like prior and how much support they have). But now they’re getting that community support. It begs the question, what was more effective, if we had to assign a higher value to one of these two, the diet or the community effect, in terms of contributing to the improved subjective well-being and overall symptoms that was experienced in this group?
DrRA: Yeah, that’s a million-dollar question. I think when you look at the SF-36, it has multiple subdomains that look at emotional well-being, mental health, vitality, and other physical parameters. We saw dramatic statistical and clinical improvements in all those subdomains, which tells me there’s more than just an emotional/mental improvement in being in a group. Not to say that you can’t physically feel better in being a group. You can. But we saw those improvements that also correlated with some dramatic decreases in symptoms. We didn’t have a control group, as I mentioned. But if you put in an estimated placebo expectancy effect of 20% to 30%, we still saw massive effects beyond that with the symptoms and the quality of life.
From my clinical experience, having worked with Angie Alt—who has been doing this program, “SAD to AIP in Six,” which is that six-week elimination, and then optional four-week maintenance—and working with her clients (and working with clients individually in my practice), there is a clear benefit from people being able to have an accountability community and someone to help them really troubleshoot things. And I saw men and women do really well in that group setting.
I can’t give you this percent quantification, but as I mentioned earlier, all the women who participated were aware of AIP, and many of them mentioned just not being able to do it on their own. By introducing a group, a community aspect, that provided that level of accountability beyond just one person (whether it’s a health coach or a doctor). I think there was a great connection between the women. When I reviewed their food frequency questionnaires at the end of the study—once again, it’s self-report—it was massive adherence, between 90% to 100%. People were following the dietary protocol. I have to give huge credence to the phased elimination, the community structure.
And that’s why I mentioned at the very beginning of this, the title of the study is “Multidisciplinary Supported Lifestyle and Intervention.” This is not just handing people a recipe book or handing them a list of foods. I’m not saying that’s a bad thing, and I’m not discounting people who are able to do that on their own… that’s amazing. But what we really looked at here was a really high-touch intervention with a program that Angie has been curating for five to six years, and really perfecting, then adding in another layer of functional medicine care and oversight from a provider.
A Possible Approach for Complex Conditions
This really is the future. I don’t want to jump ahead too much to a conclusion. But really what I see this study showing is so much validation for the greater functional medicine, bio-individual medicine community. And what this is actually doing for me clinically—more than telling me I should put my Hashimoto’s thyroiditis patients on AIP—is telling me how to approach very complex sick folks. Because these folks had lots of symptoms in the beginning, and it would’ve been really easy (if they walked in your door) as a functional medicine clinician to just start ordering every test under the sun. Start getting into really complicated protocols without really giving due diligence to nutritional approaches and to lifestyle. So this was just a 10-week intervention, less than three months, that was all food-related. And we saw dramatic benefits.
While we did testing in the beginning, the comprehensive stool analysis and the organic acids, we weren’t doing complicated treatment protocols based on that, because we just had diet as an approach. It was more used as just an exploratory analysis.
So, as practitioners, we really should be potentially changing how we’re working with folks that come in with symptoms across multiple domains. I don’t know if the joint pain is related to this, or this, or this. And what this showed me—and it’s played out, because I’ve started to work with a few of the women after the study—is whatever is left after you do a very comprehensive dietary and lifestyle program is what you should focus on. You’ve just trimmed and got rid of a bunch of the mess: “Oh man, your joint pain could have been from chronic Lyme disease and this and that.” You do all this crazy testing. Well, maybe it was just an inflammatory cascade because you’re eating this food and have dysregulation in the gut.
I think there could have been an even greater added benefit more quickly with some of the women, if there was a component of digestive enzyme therapy or probiotic therapy. So we used the means that we had for this study. But this could be clinically game-changing, add so much value, decrease costs, and start to eliminate wasteful care. It’s going to make you as the practitioner (who’s collaborating with nutritionist or health coaches to get folks better) look better too. Because when they come to you after say six, eight, 10 weeks having done something like this, you’re going to know what to dig into and the test to perform. You’re going to know the protocol to pursue because it’s smacking you in the face now, once you’ve gotten rid of everything else.
DrMR: Yeah, great point. And it hearkens back to something we were discussing before we started the recording, which is this unfortunate observation that I think we both see in an unfortunately large aspect of functional medicine. Once you get beyond working with a functional medicine provider and once you’ve done some of the basic interventions—try cutting out gluten, dairy, processed foods, try a multivitamin, vitamin D, a probiotic, maybe some curcumin or fish oil—as a patient, you fall off a pretty sharp cliff. Going from a little bit of stuff to a bunch of stuff applied in a very haphazard shotgun-esque fashion. Observations like this could really be helpful in steering us back and correcting this effect of this big chasm of, “Okay, you don’t respond to the basics, now we’re going to go all the way to the other end of the spectrum and pull out every tool, every nuance, every test and treatment,” that sometimes should only be reserved for select cases, but now everyone’s just going to get inundated with this excessive model.
I share what I think you’re alluding to there, a desire to help people better navigate between the extreme of, “Here’s the basics where we start,” and “Okay, you haven’t responded to the basics,” on the one end. And at the other end, “What do we do for the most chronic cases?” And this semi-linear way of thinking helps people do that in a more effective fashion.
DrRA: Yeah. And I really hope that we’re getting into an age, too, where health coaches are coming out the woodwork. This study is starting to really validate the work of health coaching. Both individuals also had a background in nutritional therapy and being able to apply that in a group setting. Now we also have to moderate that. Does every single person need an individual health coach? No. This was a group intervention. It was a very practical structure that minimized cost and played on the benefit of having folks in a community.
I’m seeing that there’s going to be a lot of value for practitioners like this who are truly integrated. I use this word “integrated” over “integrative” with other providers. I was speaking with Angie regularly, speaking with Andrew regularly. I was with the group, so I had the information I needed when I met with them individually. We discussed what the goals were going to be. They knew how to help people troubleshoot. It wasn’t me working in my silo, the nutritionist working in their silo, we were really integrated. And it’s going to take novel, innovative clinical structures like this to start really helping people.
I’m just so excited to be able to continue working with Angie, and with other health coaches and nutritional therapists. To start really being able to add more value and make my job as a practitioner more fulfilling and easier so that we don’t get stuck. Because I’m not immune, like anyone else, to jumping in and mistakenly making everything more complex than it needs to be. We get folks—I mentioned earlier, coming to the clinic or calling—who I tell, “Now is actually not the right time to do your full consultation. I would recommend going through this program. Let’s see what’s still around and then we can talk.”
Angie and I, and my partner Trisha who I work with, and Ryan Hall, are talking about how to modify and play upon what was studied in this study as a new clinical model to, like I said, keep providing greater value to people. The last thing I want is for everyone to feel like they have to go see the functional medicine provider—who is charging so much money and ordering all these tests—and feel like that’s the only way to get better. There are a lot of ways to get better. This study showed one of them.
We need to come together as a community if we’re going to move this movement forward to start to create value. If I can get from A to Z with this amount of money in this process, while you’re getting from A to Z with that amount of money in your process, we need to look at that and say, “It’s not okay if your process costs $10,000 to get from A to Z and mine costs $2,000.” Even if it took maybe 10 weeks more, or 12 weeks more. I’m speaking in hypotheticals. But these are types of discussions we need to have.
We need to get people to start making innovative decisions. We have a lot of good baseline information on how to help people. There was nothing radical about this intervention in terms of the therapies applied. I’m not studying some novel cytokine pathway or some new nutrient or some fancy supplement. This is using basic principles, but using a clinical structure that’s innovative. And that, I would argue, is the area we need to start spending a lot of time in. Obviously we’re going to keep studying the gut because that’s such a huge domain. But I wish people would spend more time to develop really robust clinical systems, get innovative about how they’re working with people. To use the tools that we already have in a really robust and meaningful way.
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DrMR: And you know something, Rob, I’ll just plant this seed, in case it’s something that you can incorporate into a future study. But I’d be very curious to see if, in a future study, you had one arm that received coaching, plus, let’s say, the autoimmune paleo diet again, and another arm that received coaching and just your basic entry level dietary advice. That way you could control or isolate for the effect of diet, because the coaching and community effect would be consistent amongst both groups. I don’t paint that scenario trying to say one is better than the other, but if we can show an importance of community over diet, then I think that could be compelling to help clinicians make a change that’s sometimes harder (now we have to try to figure out a way of integrating community into our practice, as opposed to just giving people good dietary resources). If we had the evidence showing, “Geez, once you get beyond dietary basics, you’ll get more out of community-based interventions than you will additional dietary interventions,” that could really inform in the way practice is being done. And I think that could be some very compelling and powerful research to have.
DrRA: I totally agree. That would be a wonderful control arm or controlled study for an intervention like this. I would also love to be able to just do paleo with people. What if we just did paleo side by side with AIP? How much is the next level of removal? But somehow try to control for that effect. Because you’re right, it would be really wonderful to be able to have information like that. I’m sure health coaches and allied providers in this realm would love to be able to have evidence to show the true value of their care, beyond just the nuts and bolts of what people are doing.
DrMR: Yeah. That’s well said. Do you have anything that you want to leave people with here, as we transition to a close? Then, please remind people where they can connect with you on the Internet.
DrRA: Yeah, so I just want to reach out, because I’m sure there’s probably somebody listening here who donated money for this study. We had, I think, over 100 people as part of the crowdfunding efforts. So really, thank you to everyone who either donated or supported this study. I can’t say thank you enough and emphasize that we can be a part of positive change. We are not beholden to pharmaceutical industries. We are not beholden to where all the money seems to lie. We can do really rigorous research. And I’m in this recording alongside a great researcher, as well as Angie Alt, Lucy Mailing, who is going to be doing another study pilot, a similar intervention for AIP and eczema and psoriasis. And so these things are going to continue. We’re going to keep doing studies.
We’re going to be forming a research board to be able to help design the next studies and decide what we should look at. But it’s going to come from this community. Even if we can start to get grant funding and funding from larger sources, it’s a grassroots movement. I hope people feel empowered by that. We want to do research that matters, that’s relevant to individuals, that’s actually showing something—whether we have positive and negative findings—that’s meaningful and can be applied in a good context.
And then, I am in Charlottesville, Virginia. I have a fairly new practice called Resilient Roots, functional and evolutionary medicine. I work alongside Ryan Hall, who is a functional nutritionist. We work together to help people with various chronic diseases such as autoimmune disease. We also are focusing on cancer as well as gastrointestinal disorders.
We see folks in person at our office, and I can do full scope in the state of Virginia, but I’m doing telemedicine as well for the broader scope of functional medicine care that people are probably wanting and desiring. You can check out a link to our clinic page, Resilient Roots. If you’re interested in working with us, we’ll be more than happy to start working with folks. The last thing I want is people to feel like they can’t get the support that they need. So we’re trying to help improve this movement to create practitioners that are doing evidence-based care.
DrMR: Awesome. Well, Rob, I love it. I’m really glad that we were able to get you out to my office to shadow. Gosh, that feels like almost a lifetime ago now. But it wasn’t actually that long ago.
DrRA: I know, yeah.
DrMR: And connect, and just watch how much you’ve done in only a handful of years. It’s fantastic stuff. So, really appreciate you and what you’re doing. Keep up the good work.
DrRA: Thank you, really, for helping jumpstart. That was early on in my career, trying to figure out how to get into this space and do meaningful work. And a total random thought, but I’ll leave the folks listening with it. I just turned 29 years old, and I was a fourth-year student when I was able to shadow with you, Michael. And I think there’s a phenomenon in my generation and even younger folks, like, “I need to network with this person, that person, and this person.” And I tell you, don’t worry about networking. Go and do something meaningful with your energy and your time. Follow your passion.
I spent three years in school just in my incubator, learning about stuff. And it wasn’t until a few months just before reaching out to you, that I was really ready to want to learn and grow more, and then doing this type of work. So I tell people, “Put your energy into those things.” I’m not completely bashing networking, but networking alone won’t get you where you want to be. Do meaningful work.
DrMR: Agreed. Yeah, and if you do meaningful work, somehow the network just pops up all around you.
DrRA: Well, you know?
DrMR: My experience. So I think that’s well said. Awesome. Rob, thank you again, my friend. I really appreciate it.
DrRA: Yeah, appreciate it.
What do you think? I would like to hear your thoughts or experience with this.
Dr. Ruscio is your leading functional and integrative doctor specializing in gut related disorders such as SIBO, leaky gut, Celiac, IBS and in thyroid disorders such as hypothyroid and hyperthyroid. For more information on how to become a patient, please contact our office. Serving the San Francisco bay area and distance patients via phone and Skype.