The Future of Functional Healthcare & Evidence-Based Care

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Intro:

Welcome to Dr. Ruscio radio providing practical and science-based solutions to feeling your best. To stay up to date on the latest topics as well as all of our prior episodes, please make sure to subscribe in your podcast player. For weekly updates, DrRuscio.com. The following discussion is for educational purposes only and is not intended to diagnose or treat any disease. Please do not apply any of this information without first speaking to your doctor. Now let’s head to the show.

DrMichaelRuscio:

September FFMR Promo

DrMR:

Hi everyone. Today, we’re going to be talking about kind of a potpourri of different topics. First up a systematic review on the low FODMAP diet for IBS. There are some very important lessons in this paper. A case study of what I would call insanely wasteful functional medicine, leading to patient suffering. Thankfully we were able to help this person, but the case just shows so many areas for improvement in the field. Also, we will discuss the significance of using thyroid antibodies to predict who will become – hyperthyroid, there are also some crucially important details here. These three pieces are taken from the Future of Functional Medicine Review. This is our paid access, clinicians’ monthly newsletter. Because I want to make this as easy for people as possible, we are running a promotion for the month of September. So if you are a clinician, anything from a health coach, all the way up through a conventional medical doctor, the case studies and the research studies in that newsletter should help you become a better clinician. To make it easy for you to decide if this is something that could be valuable on your path and for your education, we are running a promotion for the month of September. If you sign up during the month of September, your first month of all access, which includes four years of back issues with case studies and research study reviews, will be $1. If you go to DRRUSCIO.com/review, you can plug in and read the full version of the highpoints that I’ll be going over in the podcast.

DrMR:

Before I go into our first summary, I want to provide a bit of an explanation. With these summaries, my goal is that you will, in three to five minutes, be able to extract all of the value from a research paper, which takes people anywhere from 45 minutes to an hour. Because it’s not just reading it. It’s reading, rereading, making sure you digest the bits and bytes and some of these things, especially in some papers, are not in the plainest language. Unfortunately, academics often try to use the most robust verbiage possible to try to sound more intelligent. I partially understand where that comes from, but it sometimes obfuscates the clinical bottom line – which is basically, how does this change my practice model?

Low FODMAP for IBS

DrMR:

So in the March 2020 Future of Functional Medicine Review newsletter, we highlighted and summarize a study entitled Systematic Review: Quality of Trials on the Symptomatic Affects of the low FODMAP Diet for Irritable Bowel Syndrome. Nine RCTs (randomized controlled trials) were eligible. This included 542 patients. Five of the nine trials reported benefit from low FODMAP. Four of the nine reported no improvement over placebo. There was a high risk of bias identified. I’m not going to go over every bias point here, but I would like to discuss Bias points 1, 3 & 5. The control diets in some cases were high FODMAP. This had the potential to falsely inflate the positive impact of the low FODMAP diet since the control, what it was being compared against, was high FODMAP. So that is an important bias to keep mind. The way that you greet this news has a lot to do with how fanatically (to use a charge term) you are regarding diet. Certainly the low FODMAP diet is something that I advocate for. It does clearly seem to be able to help people. However, you’ve probably also heard that I generally take a kind of soft stance on diet. This is one of the reasons why. We can’t say that the data is perfect. We can’t proclaim it is going to help everyone all the time. So there’s no need to beat patients over the head with this very strict application of the low FODMAP diet. We should also not argue that this is the only, or the best diet for IBS. Although there may be some evidence showing that when patients fail out of other frontline dietary recommendations, this seems to be a diet that’s very helpful. So perhaps it is a better diet for IBS, but there’s no need to be kind of an ardent defender of the low FODMAP diet. It’s an option. There is some evidence, the evidence isn’t perfect. That was bias point #1. Bias point #3 is due to the fact that patients are able to tell what diet they were on. You can visually see a high FODMAP food compared to a lower FODMAP food. Granted you would have to have enough familiarity to know what is high FODMAP and be able to identify that on your plate. But you know, that hinders the blinding to some extent. So that’s something to keep in mind. This may be hard to design out of dietary trials, but it’s just a point to be familiar with. Bias point number #5, the impact of a low FODMAP diet may only have applicability in a narrowed setting, tertiary care. It may lack applicability in primary care. This is also important to keep in mind and definitely something where, especially if you’ve been reading some of my case studies, you see that many of my patients have come in, they’ve done paleo, they’ve done perhaps AIP. They may have already done low FODMAP. If someone has already taken care of general food quality, then that’s when the low FODMAP diet likely has the highest likelihood of gain.

DrMR:

But if you have an IBS patient who is on no dietary plan, something akin to a “healthy version” of the standard American diet. Very few people will say “I’m on the standard American diet”, but they may say, “I eat generally healthy”. And when you look into what they’re eating, they’re having a bagel for breakfast, with an Apple, or what have you. So even though the bagel may be whole grain or organic, it may be causing issues. So we have to be careful with patients who tell you they have a generally healthy diet. They may be coming in on a kind of pseudo standard American diet. So from there, just the removal of processed foods, eating whole fresh foods can do a lot. I think the paleo diet is a good framework to start, not the only place, but the point I’m making is we probably don’t have to jump all the way to a low FODMAP for these people.

DrMR:

It comes back to this algorithmic, or hierarchial thinking that I advocate for. Step one in this sort of pseudo standard American diet case would be a general elimination diet and attention to food quality. So this is important to keep in mind and I think that’s one of the better points made in this paper. This all led the authors to conclude the recommendation of the low FODMAP diet as a first line treatment for patients with IBS is based on randomized interventional trial, characterized by a high risk of bias, primarily due to lack of proper blinding or choice of control group. Also remember, those are sometimes hard to achieve. So we want to be even handed in in these criticisms. Continuing, there are many indications in the published literature to suggest the symptomatic effects of the low FODMAP diet are primarily driven by a placebo response. There is likely a degree of that here. Before you say, Oh my God, clearly patients have a hard time with asparagus and avocado, there’s likely truth to both of the extremes. So what we want to do is just take away a moderate application of a low FODMAP diet. Don’t dole out the recommendation too early when someone hasn’t gone through other more preliminary dietary recommendations. But also don’t be ardent in thinking that someone who hasn’t responded to the frontline dietary therapies must be low FODMAP forever, or if that’s not working, it’s the individual or the patient’s fault. Hopefully that kind of helps. My clinical takeaways here, high level scientific evidence has found the low FODMAP diet benefits IBS patients, but the results also carry a higher risk of bias. To guard against this maintain objectivity when counseling patients on the low FODMAP diet. So that seems pretty reasonable. This is important information to have so that when you potentially are having conversations about the low FODMAP diet, you can speak to it responsibly. We don’t want to be overly dismissive, but we also want to be openminded and know how to use this tool the appropriate way.

Sponsored Resources:

Hi everyone. I want to thank Doctor’s Data who helped to make this podcast possible and who I’m very excited to say has now released a profile called the GI 360 which is finally a validated microbiota mapping measure. If you remember back, I’ve discussed numerous times the only lab that is really validating a mapping of the microbiota to have clinical significance is the GA map out of Norway. Well, turns out that Doctor’s Data is not only using the same methodology but also in collaboration with this group in Norway using their parameters to adjust what we call normal, abnormal or dysbiotic and normal. So great news, we finally have a validated measure. Now this test also offers, in addition to the microbiota dysbiosis index, a PCR assessment for bacteria, virus and pathogens, a comprehensive microscopy for a parasite, a MALDI-TOF bacteria and yeast culture. And as you would imagine, because of the rigorous validation they’ve gone through, they also have approval from the CE, which is equivalent to the European FDA. So great test, please check them out. Doctor’s Data is offering 50% off a practitioner’s first GI 360 test kit. Go to doctorsdata.com/Ruscio to claim your first kit, limit one per provider. The offer ends October 31, 2020.

Move and Expansion of the Clinic

DrMR:

Now moving on to a case study from the April, 2020 Future of Functional Medicine Review entitled “Over testing and over use of [inaudible] protocols in functional medicine”. This is a case study from one of the doctors at the expanded version of my clinic. So the backstory, if I have not made a more formal announcement about this yet in the podcast, the clinic and me personally, we’re both located in Walnut Creek, California up until just recently. We both moved to Austin, Texas. In that process, I finally took the time to on board some doctors who I had a lot of confidence in, and also most importantly, train them in the model that I used in the model that I advocate for so that someone could get the same type of care in working with me with another doctor. As of right now, there is myself and two other doctors. I anticipate we’ll probably bring on additional doctors in the future because, as you can imagine, sadly, there are not a lot of great options in functional medicine. I think there are a lot of good people in the field. I think there’s a major educational problem. So the well intentioned people in the field oftentimes are practicing in a model that subjects people to quite a bit of harm as we will delve into in just a moment. So this case study is not from me, but it illustrates the model that we’re using at Austin Functional Medicine, which is the expansion of my clinic into a multidisciplinary team. So if you are looking to work with a functional medicine provider, we offer telehealth, of course, just like my old clinic did, but now instead of waiting perhaps eight months to be seen, you may be able to get in within two to four weeks. So I would definitely urge you to make that move if you are looking to work with someone in functional medicine. It’s challenging for me to of speak about the clinic in such a self promotional way. However, when I read case studies like this, it allays all those internal discomforts. I never want to come off overly self promotional or self-aggrandizing, however, gosh, let’s look at what happens in some of these case studies of people who are out there in the world seeing kind of run the mill functional medicine person again, who I think is probably well intentioned, but the individuals, clinicians and doctors are being really misled by the educational model.

Foundational Take-Aways from Case Studies

DrMR:

So as we get into this case study, I was trying to think through where does all this come from and what are some of the foundational themes that we should be taking away from these case studies? One theme is that for any clinician to really become a better clinician over time, they should be constantly questioning and challenging their own beliefs. I don’t say this platitudinously. Clinician should be asking questions like: Is a given test actually needed? Not just paying it lip service, but really considering throwing out a test that they’ve been doing perhaps for years. Is this test that everyone else is using actually a helpful test? Just not assuming because it’s popular, it’s correct. Do these dietary changes actually help patients, right? All these things I labor over, every new test, every new dietary change, I’m constantly interrogating those things from every angle to make sure that there is some discernible benefit. Is this new therapy or supplement actually helping? Is it better than the other similar options that I have? And actually at some point concluding that the popular facets of functional medicine and the functional medicine care model are ineffective or wrong. This is how you end up having a better model, not just a shiny, newer model based upon the newest gadget, treatment or tests.

Excess Testing, Excess Expense, No Results

DrMR:

So here is a case study that really encapsulates this. I want to be careful in saying that I’m not trying to knock functional medicine, but it is just crushingly disappointing when we see a case study such as this one. Michael, a 62 year old male with a prior medical history of high cholesterol who was seeking support in optimizing his health, right. He was feeling generally well. And he was trying to optimize. Mainly wanting to mitigate the negative effects of quarterly air travel to Asia. His only major symptoms were trying to improve peeing at night and frequent urination as well as a couple kind of aches and pains occasionally in his low back. No other symptoms, no fatigue, no depression, no insomnia, no gas, bloating, GERD, constipation, diarrhea. Okay. So keep that in mind. This is a generally healthy person who has got a couple of aches and pains, “I pee at night a couple of times and I’d like to not feel like I get so thrown off by making the trek to Asia once a quarter”. The concomitant sleep disruption with the time zone change that follows that. Here is what the other functional medicine provider ordered for testing. A GI MAP ($400), a Genova ION profile ($500), the DUTCH Complete profile ($400), the SpectraCell CardioMetabolic panel ($760), basic blood chemistry ($250). Total for lab testing: $2,300. It gets worse. The patient was diagnosed with stage three adrenal fatigue, told to stop coffee and to consume a morning cocktail of lemon water, and Apple cider vinegar, and placed on a slew of adrenal products, including DHA and pregnanolone for an intensive six month treatment plan.

DrMR:

Keep in mind that all of the labs, all of the adrenal labs were normal. Albeit, low normal, but they were all in the normal range. So this person has now been told they have a “condition” which brings distress and worry. Told to stop coffee, which ostensibly they enjoyed and go on this intense protocol for no reason. No symptoms indicating adrenal fatigue. We have discussed the systematic review published now a couple of years ago, also summarized in the Future of Functional Medicine Newsletter if you want to get the jist, that over 50% of the time fatigue scores did not track with adrenal testing. Meaning it didn’t really seem to be a helpful test. So all that money spent to literally make this person worse. He was additionally recommended to complete a comprehensive herbal anti-microbial protocol with Biocidin, silver and other anti-microbials. This was based upon no significant findings on the GI MAP. Just a little bit of noise in the commensal column. The commensal and dysbiotic organisms, sometimes you’ll see a few things there that I would consider noise and do not certainly require anti-microbials. So this is another example of when lab work is used incorrectly, it actually makes patients worse. It leads to worse results. There’s this canard that circulates in the field, my apologies if I’m being a little bit opinionated here, but that if we’re not assessing, we’re guessing and more testing equals better results. I used to say that more testing does not equal better results. And now I think it’s even fair to go as far as to say more testing may actually equal worse results, as you’re seeing here. Continuing, despite the potentially concerning lipid profile, the patient was instructed to continue following a ketogenic style diet, and no comment was made about his dyslipidemia. There are a few things there to unpack, but some people do seem to not have a favorable shift in their lipid profile when on a ketogenic diet. Moving to a moderate carb diet may really rectify that. Now there are important nuances there. LDL seems to go up as does HDL and insulin and triglycerides and glucose go down. So the kind of net assessment from the cardiovascular lipid profile seems to actually be a favorable shift. But if you look just kind of monochromatically at one marker, you may make a false conclusion there. But one of his primary complaints wasn’t even addressed. No tinkering with the diet to see if some macronutrient shifting may lead to improvements in some of those markers.

DrMR:

So remember $2,300 of lab testing resulting in a bogus diagnosis, fear of coffee and the resultant lifestyle disruption that would come from avoiding coffee. As this person said, also waste a boatload of money on supplements, including antimicrobials, that there was no indication for. By the way, he did not experience any improvement from this. So what a waste. Now at Austin Functional Medicine, one of our clinicians made a few simple recommendations. Modified fasting during air travel, which seemed to help with some of the negative effects from the travel. A fasting mimicking diet upon return. Light exposure, well timed, to offset the time zone shifts. Supplementation with vitamin A, D and K. Some mitochondrial support and an adaptogenic complex as desired in the mornings during travel, plus an Omega three and one probiotic. That was enough to help this patient feel as if they were more impervious to the negative effects of travel, and only required one followup blood panel to keep tabs on a few cardiovascular markers. So thousands of dollars wasted only to render a bogus diagnosis, which did not help the patient, but reduced his quality of life. The testing distracted from simple clinically indicated interventions that could help this patient. This really makes me think we’ve lost our way in functional medicine and that the tests are crippling the clinician’s ability to think. This is one of the premises in the Future of Functional Medicine Review. That more testing does not equal better results probably even equals worse results. So this is a case of a really simple patient presentation that certainly does not require testing. You could make the argument for some abridged testing, but $2,300 just absolutely misses the mark.

TPO and TG as Hypothyroid Predictors

DrMR:

Now this ties into another area where lab testing again, can be helpful, but seems to be really misused. This is not a case study, but it’s from the May, 2020 Future of Functional Medicine Review. The title of this study: Significance of Anti TPO as an Early Predictive Marker in Thyroid Disease. 4,500 subjects were tested multiple times for TSH, free T4, TPO antibodies and TG or thyroglobulin antibodies. Just as a refresher TPO (thyroperoxidase) and TG (thyroglobulin antibodies) can be predictive in determining who becomes hypothyroid. They were followed for two years. The main findings were that TPO was predictive while TG or thyroglobulin is not. Now, if you had been reading our newsletter as a clinician, you’d know this, and you hopefully will have kind of phased out the thyroglobulin or at least looked at that in a much less important fashion than you do TPO. Here are a few of the pesky details that really need to be discussed because while this study did find that TPO predicts those who become hypothyroid, the details here are incredibly important to prevent one from losing their moorings and falling over into kind of absolutist heretical conclusions regarding the meaning of the elevated TPO antibodies. 73% of those with elevated TPO later became hypothyroid. But there is a very important point here that, unless you really read this study, which I did, and unless someone kind of broke out the details for you, you may have missed. I’m going to tie a few things together here. We’ve summarized and discussed in the past in the Future of Functional Medicine Review, another research study, a prospective analysis in Tehran that found that 9 to 19% of those with TPO antibodies actually converted to hypothyroid. Now, this is important because to say that thyroid autoimmunity is the primary cause of hypothyroidism, doesn’t tell you how at risk you actually are. This study in Tehran found 9 to 19%. So I think it’s fairly safe to assume many patients and probably clinicians feel that there is a very high likelihood that if you have TPO positive or if you have Hashimoto’s, you’re almost guaranteed to become hypothyroid.

DrMR:

Well, this is not what the prior study in Tehran found. Now, back to the detail here that we need to break out. If you look at those who became true hypothyroid in this study, it was only 16%. So a moment ago, I mentioned that 73% of those with elevated TPO antibodies later became hypothyroid. They are including subclinical hypothyroid and true hypothyroid underneath that same rubric. When you break it out, when you break out that 73% of that 16% became true hypothyroid, the remaining 83% became subclinical. Subclinical is a vastly different animal. We’ve also discussed this in the newsletter. It doesn’t mean that you disregard that completely, but it’s important understand that most cases of subclinical hypothyroid revert to normality on their own over time. To define subclinical hypothyroid, that is elevated TSH, meaning normal range elevated, not functional medicine range, LabCorp and Quest range, TSH elevated, so above 4.5, usually, with normal T4 or free T4, but there’s a nuance there. For those who don’t have a TSH above 10, no benefit from treatment has been demonstrated unless you’re very young or you’re trying to get pregnant. What this adds in terms of context is subclinical hypothyroid, for the most part, is benign. It’s something that people may flicker in and out of and go back to normal and be absolutely fine. So when you read this study critically, you see that 16% became hypothyroid, which falls dead in the range of the Tehran study of 9 to 19%. So these details matter because we don’t want to scare the bejesus out of people if they have elevated TPO antibodies. Sure. We can use dietary changes. There’s been a couple of studies finding that dietary changes lower TPO antibodies. There have been some supplement trials with selenium, vitamin D magnesium, and CoQ10 all finding the ability to lower thyroid antibodies.

DrMR:

There’s been a few other herbs that have shown the ability to also lower TPO antibodies like black cumin. With some of the newer herb studies, there’s only one of them. So I lean more so toward dietary changes and the vitamin D because there is the most evidence there. But it’s important to keep that in mind, in the context of you have a minimal chance of progression. The average TPO level in this study was 252 of those who were elevated. That partially contradicts my hypothesis of 500 being the adequate cutoff. I don’t know that this study, and we tried to get some more feedback from the authors here and we were unable to, but I don’t know if this study really tried to adjudicate, I don’t feel like they did because everyone’s kind of lumped in, but they didn’t try to discern what level led to a minimum or a moderate risk as other studies have. So in this case, I think that’s still up for debate. Although I’m happy to change my opinion as more data comes in. I feel that the general posit still stands, which is that the minority of people who have Hashimoto’s actually become full blown hypothyroid. We still want to act, it’s still a marker to take legitimate, but it is not a marker to cause someone to have a notable reduction in their quality of life, because you’re trying to drive their antibodies down into the normal range for a multitude of reasons. One, within normal limits may be an unreasonable goal. And two, the risk posed by that may actually be fairly minimal now to further contextualize this. One of the things that I’ve seen in the clinic and we’ve talked ad nauseum about, is how many of the symptoms one feels to be caused by the thyroid may actually be extra intestinal manifestations of things like IBS, SIBO, dysbiosis, and inflammation in the GI tract. There’s a lot of support for that when you look at the prevalence of hypothyroid, which is 0.3% as compared to IBS, which is about 20%. That tells us there’s almost an order of magnitude. There are more cases of IBS, then there is hypothyroid. So it seemed reasonable that before one goes too far down the therapeutic rabbit hole for thyroid, they make sure someone’s gut health is tucked away. And there are also, importantly to kind of stay in accordance with my own philosophy, clinical trials finding that some of these symptoms like fatigue and depression actually improve after these gut intervention. So it’s not just to say that there’s observational data that I can cherry pick. There is actual outcome data that has shown that some of these symptoms that can be attributed to, or falsy attributed to hypothyroid actually improve after gut interventions. Also keep in mind that there are some cases where a thyroid hormone medication is inconsistently absorbed and by improving one’s got health. Mainly this has been looked at in models of H. pylori and/or ulcer. The individual will need a reduction of a thyroid dose and we’ll also oftentimes see an improvement in how they’re feeling. We have published a few case studies on our website that have documented that same thing like “someone lost 15 pounds and cut their levothyroxine dose in half while also seeing improved sleep and reductions of joint pain”.

Sponsored Resources:

Hi everyone. This is Dr. Ruscio. In case you need help, I wanted to quickly make you aware of what resources are available to you. If you go to drruscio.com/Resources, you will see a few links you can click through for more. Firstly, there is the clinic, which I’m immensely proud of. The fact that we deliver, cost-effective, simple, but highly efficacious, functional medicine. There’s also my book, Healthy Gut, Healthy You, which has been proven to allow those who’ve been unable to improve their health, even after seeing numerous doctors, be able to help them finally feel better. There’s also our store where there’s a number of products like our Elemental Heal line, our probiotic line, and other gut supportive and health supportive supplements. We now offer health coaching. So if you’ve read the book or listened to a podcast like this one, or are reading about a product and you need some help with how or when to use, or how to integrate with diet, we now offer health coaching to help you along your way. And then finally, if you are a clinician, there is our clinicians newsletter, the Future of Functional Medicine Review. I’m very proud to say, we’ve now had doctors who’ve read that newsletter, find challenging cases in their practices, apply what we teach in the newsletter and be able to help these patients who were otherwise considered challenging cases. Everything for these resources can be accessed through drruscio.com/Resources. Alrighty, back to the show.

Next Steps

DrMR:

So hopefully this all congeals together to show you the value in this monthly publication, the Future of Functional Medicine Review. I’m very excited about the work that we’re doing with the newsletter. Also that clinicians are applying this and thankfully, as this case study by one of the doctors at the Austin Functional Medicine Clinic substantiates, this is not something that is just unique to me. This is a series of thought processes like an algorithm that I’ve been developing for about 10 years. Almost like a computer program, there are certain inputs and outputs. It’s essentially math. That math can be taught to other people and can be replicated by other people. So if you’re in need of functional medicine care, I hope you will reach out to Austin Functional Medicine. It’s accessible through our homepage on our website, should be easy to find. Also if you’re a clinician, you can sign up for the Future of Functional Medicine Review clinical newsletter. Remember, right now, it only costs $1 to get your first month of all access and you can poke around and see if it’s something that you feel would befit you. I can’t emphasize how important the information is that we’re sharing in the Future of Functional Medicine Review newsletter, and yes, I know I am biased. But this all ties together. This TPO antibody study, the case study with the lab testing, the application of the low FODMAP diet. All these things hinge into this philosophy of being open minded, but critical and looking at the details, but also not making anything more complicated than it has to be. This leads to effective, cost effective and non heretical functional medicine that doesn’t waste people’s money. It doesn’t make them think they have adrenal fatigue. It doesn’t make them give up coffee for six months and take $120 worth of adrenal supplements per month. These things have a massive impact on the quality of care that we will offer people. So I really hope we get as many of you in our audience who are clinicians reading this so that you have exposure to examples of relevant research studies, how to interpret those research studies the right way, and then case studies to kind of culminate that. That thyroid study, if this was interpreted the wrong way, it would have been one more data point that a somewhat heretical thyroid provider could cite not understanding that in the details of the study, if read critically, it actually should kind of dampen how zealous we are with the pursuit of thyroid antibodies.

DrMR:

Again, not to say that we’re going to ignore these. Sometimes when I bring this up to clinicians, they say, well, aren’t they important? I mean, it doesn’t mean we’re going to go from one side of the spectrum to the other. But we do want to have a more reasonable perspective on this. So hopefully this has all been helpful and you will consider signing up for the newsletter. If it’s something that you feel would suit you. I really hope that you do, because again, for a dollar, you can give this a test drive. If you’re in need of responsible, effective cost, effective functional medicine care, I hope you will reach out to the clinic. Otherwise, thanks guys for your attention. Please keep sharing the podcast, we keep growing, which is really encouraging to see, and just appreciate your support. We will talk to you next time.

Outro:

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