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Kalea Wattles: I think back to school and my information literacy classes, and reading the journal articles, and then trying to translate that into, what does that mean in the clinic?  

Shilpa Saxena: Yeah, right. So we’re trying to take research and then meld it with what we are working to achieve in the office space, in the exam room with patients. But evidence-based medicine, and I want to kind of rely on some notes just to be sure that I’m holding the origins and honoring them, it relies on three pillars. Number one is individual clinical expertise. I mean, that’s something that we believe in, in functional medicine. Number two, the values and desires of the patient. Now, it’s really interesting, I didn’t think of evidence-based medicine being sensitive to the patient or the experience that I had. And then also, of course, solid, evidence-based, medical, clinical research. So I think one of the fallacies that many of us may have is, is that evidence-based medicine is really just what we get presented by many pharmaceutical companies or what we see in literature, but the origins of it really does try to honor the values and preferences of patients and allows you to bring in your clinical expertise. And that’s what creates true evidence-based medicine, not just the research part.  

Kalea Wattles: Yeah, well, I think you’ve highlighted the fact that maybe many of us don’t have a completely well-rounded version of what evidence-based practice or evidence-based medicine looks like. From your perspective, what are some contemporary ideas about an evidence-based practice that are flawed? 

Shilpa Saxena: Yeah, that’s a great question. So let’s just keep talking about this whole single variable testing, right? So many of us, we’ve talked about how in evidence-based medicine, we believe, like let’s say we’re testing for a blood pressure medication. So we’re only going to take men, and only aged 40 to 65, and they cannot be diabetic, and they cannot be on this medicine. And so we take a patient who’s got multiple aspects to them, multiple variables, and then we filter down to this very homogenous set of study participants. And then we test the medication. And then we extrapolate it back out to the generalized population. And that’s where many of us will start to say, ah, I don’t know how relatable this is, or how suitable this medication is, because it’s not being tested in women, or it’s not being tested in diabetics, per se.   

So I think the number one flaw is to assume that when research says that this medication works in this population, they’re not saying, so, only this population, always for this population, and always for everybody else. Evidence-based medicine says, you must also put this into context with the patient that is sitting in front of you. And so, I think, to a certain extent in training and maybe in popular medical culture, we might be fed this concept that, no, it’s just exactly what the research says is what is the truth. And so that’s why I think we’ve gotten to become a little hesitant about looking at research, because we don’t think it’s all-encompassing, we don’t think it’s applicable. But evidence-based medicine says, this is just one part of the whole equation is looking at the research, because it is the way they’re doing the research to look at the one variable, but they’re not saying, so forget your women, forget your diabetics. They’re saying, use your clinical judgment to decide, how could this be used in a 25 year old, or how would this be used in a female who’s pregnant? It’s really allowing us to use our clinical judgment, which is what we do in functional medicine all the time is we take evidence, and then we have to extrapolate it, or kind of use the principles and figure out, how could this make sense with what we understand with the pathophysiology for this specific patient and their timeline? 

Kalea Wattles: Well, on this topic of data, and particularly, very patient-centered data, you’ve been really involved lately with using practice data analytics to make patient data actually work for practitioners. So talk to us a little bit about how you got interested in data collection and why you got into the work that you’re doing now. 

Shilpa Saxena: So I am so excited to be part of an organization. It’s called Forum Health. It is a nationwide network of integrative and functional medicine providers. And one of our goals is to be able to—as we’ve maybe heard, people sometimes feel like they’re on islands, trying to go through the research, trying to figure out, how do I apply this research? And there’s little mini genius bits of magic happening all around the world when functional medicine providers are applying research and creating great outcomes with their patients. So in this role as chief medical officer, my first goal with our team and our network of providers was to start sharing these clinical pearls. What are you finding works with your gut detoxification program? And how does that relate to what I’m doing here? And what can we learn? Because we’re actually pooling our data, to some extent. It’s not formal data, but it’s anecdotal in our mind. And then what we actually did as an organization was we decided to create a composite gut detoxification program. And then we had over 1,700 people who were placed into this trial.   

Now, let me tell you something, when we started this, we didn’t know that we were going to do a study design. We actually just wanted to compile a program that was the best of what people had been sharing, ideas, and we wanted to make it available to the network. So we did that. And then after we did that, we’re like, wait a second. We should actually just gather data on this. Now, here’s some of the stuff that I’ll be sharing in the presentation at the Annual International Conference that, when you don’t know that you have data that you’re sitting on, you sometimes don’t set your programs up to be able to be easy data collection systems, right?  

So once we realized, oh, we do want to collect data on this program, we started doing it. And we were able to show, because we started ordering labs pre and post and having people follow a more standardized algorithm with opportunities to personalize based on dietary preferences, or allergies, or sensitivities, we started seeing, oh, this is working. And the data is showing a 52% improvement in the MSQ and a 40% reduction in hs-CRP. So what was gorgeous about this whole thing was a group of people came together, decided to share best practices, create a larger N, and then start speaking in the language of evidence, like here’s labs pre, here’s labs post, here’s a symptom scoring questionnaire pre and post. And we’re now speaking some language of evidence-based medicine. And we’re hoping to take that to a higher and higher level as we continue to put out programs that are related to the functional medicine systems biology approach. It’s just been so much fun. And now I’m wondering, why didn’t I do this for 10 years with all the things that I kind of really believe work with my patients? Why didn’t I just set up simple algorithms and collect data? 

Kalea Wattles: It’s fun to hear you talk about research design as gorgeous. That’s maybe a first for this show. And I love that. Knowing your personality, I really, I think that was perfectly fitting. And it’s also fun to hear you talk about this as a network, because we know that functional medicine is this multimodal approach. It rarely involves single treatments in isolation, and that can actually make it difficult to study in that traditional, one-variable way that you described earlier. So how can we use data analytics to help practitioners make sense out of their patient outcomes in a way that can really improve their practice efficiency and efficacy? 

Shilpa Saxena: You’re going to go back to research and scientific process 101. Number one, you have to understand, what is the question that you want to answer, or what are the questions that you want to answer? And I always remind people, you might be answering clinical questions, like, do we need 400 milligrams of magnesium or is 250 milligrams enough? So you first want to understand your questions, and they may be clinical. They could also be operational, like, is two shakes a day too much for compliance? So you would collect compliance data as well—two shakes a day too much for the population that I’m serving or does one shake a day plus two capsules that have a similar kind of set of ingredients or supplements in there going to be better for compliance? And I think, the better compliance is, the better workflows go, the better results go. And that does have a clinical outcome as well. But sometimes you want to ask questions on operational workflow. And then last, you might have financial questions.   

Now, it could be that you are working to try to improve the finances of your practice, or it could be that you are trying to save money for patients, but there may be a financial question that you’re asking. So you have to first, number one, know what questions you want answered, and then you want to reverse engineer back. Well, how will I set up this study design to be able to answer these questions? And how can I allow for a flow chart of options that are still relatively algorithmic or standardized so that I can go back and track where people went in the algorithm, track the data points, and then answer these three questions that I had from the beginning? It’s kind of common sense, but you don’t need an engineering degree, but you need to start thinking a little bit like an engineer, but I think that’s the way we all originally were taught to think. We were really taught to think in structure, and flow, and algorithms. We became very fluid, I think, when we started working with kind of the therapeutic partnership, but we might need to bring in just a bit more of that structured design for this aspect. 

Kalea Wattles: Well, and probably so many of us are sitting on a pool of data and case reports and all of this good information. And we know that data supporting the functional medicine model of care is really important as we all work to build the functional medicine evidence base. So how can practitioners with all of the data they have, even from a micropractice, really help us to push this goal forward of building this functional medicine evidence base? 

Shilpa Saxena: I think that’s wonderful. And during my talk, I’m going to be talking about how The Institute for Functional Medicine has some research standards that you can now start looking to, to be able to either decide, is the research that I’m looking at in compliance with what we’re looking for as a standard in systems biology, evidence-based medicine? Or if I have some data that I want to start evaluating, analyzing, how can I make it conform to some of the ideals and standards that The Institute for Functional Medicine has created? Because this is a big priority for the industry as a whole. And I really respect that IFM is taking a lead on helping all of us start to understand that we are sitting on these gold mines of data.  

So as you have this data, maybe the first thing that I would ask you to consider is, what do I do really well here? Where am I really consistently—and when I say I, I mean us as a team and us with a partner, okay? But as you’re talking to yourself, you’re saying, I. So where do we really succeed? Maybe PCOS is just your thing. You have such a great protocol with PCOS, then you might consider, well, what do I do? You might start scribbling down, this is kind of what I do. And if they say this, I go to this, and you almost are kind of rough drafting an algorithm. And then you can decide, okay, do I want to look at this like a spreadsheet that, okay, I’m going to look at the different tests that I put across the top? And these are the interventions I put on the vertical. And then I start plotting. I just have somebody do regular old data entry. And then you can put that on a little spreadsheet. And then you can start seeing trends just from simple data analytics like that.  

You can absolutely get more fancy, hire people who have trained for years on how to look at these data. But I think it’s really important for us just to know, you’re sitting on gold mines, to start thinking about, where have I been contributing to this field and I don’t even know it? And how can I take this information and start working with others? And it doesn’t take a lot of people. Just working with others to start making some contributions to functional medicine with what I’ve already figured out. I think it’s so possible if we could all just realize that we’ve learned so much and we just don’t even know just the gems that we just need to prove out and show. 

Kalea Wattles: Well, Shilpa, I’ve heard you talk for years about pattern recognition in terms of recognizing kind of the type of patient that comes into your office and what might be going on with them cardiometabolically, but this is so interesting to take it to the next level and say, well, we also see some patterns and some trends in how patients respond to our treatment, which is so cool. 

Shilpa Saxena: Right? There’s a business principle called Pareto’s principle, which says that, Kalea, I know that you’re very much into women’s health and fertility and all this. And I bet you that as you look at how you approach, let’s say an infertility client, you have a certain algorithm that goes on in your mind and you walk people through it. And there’s probably, 20% of what you do likely helps 80% of your infertility clients. And the, that’s the, what I call the magic 20, that you might want to put into your data design. Let’s test out this 20% that I do. It consistently makes the difference. How can I create that algorithm to show that this can help 80% of people? Because that’s statistically significant, if you can show that. 

Kalea Wattles: Well, my wheels are certainly turning, as many others are who are listening. Before we move on from this topic, I have to touch on the access piece, because I think that’s a goal that many of us also hold dear is how do we increase access to functional medicine? How might this type of work help us to do that, help us to increase access to functional medicine for all?  

Shilpa Saxena: Well, that’s one of our big goals at Forum Health is that when we start creating data analytics with Ns that are in the 200s and thousands, now we’re competing, maybe not at the same level as a pharmaceutical, but the statistical significance starts to become much easier when we start having these higher N participant numbers. And what we’re hoping to do is start putting functional medicine on the map. Let’s just put it into the conversation.   

Obviously, The Institute for Functional Medicine at Cleveland Clinic is working to create the same. That is in a hospital-based system, taking insurance is one model of delivery for functional medicine. And then there’s many providers who kind of operate out of a private micropractice model. But the whole goal is the same. How can we take the principles that we’re using, prove them out, and then, now, start getting insurance organizations to validate this? Maybe even employers considering this as a benefit. We even have an insurance company here in Florida that I had been working with that wants to support functional medicine therapies, because they see the value of how it can help their employer groups save tremendous amounts of money in the fields of autoimmunity and diabetes. If you just think of some of the most expensive disease states there are, if we, as a functional medicine community, can put our heads together, start putting data out, and start showing insurance companies and employers, this is actually more cost-effective to the patient, then these patients will hopefully get support, financial insurance support for it and get access this way, because let’s face it, the majority of the US population does rely on insurance to be able to pay for a large chunk of their health care.  

Kalea Wattles: This is actually a great transition to the next question I have for you about how we work with insurance and navigating what’s evidence-based, because what we’re finding is that patients themselves are becoming so savvy. They come into the office. They’ve done their research. They know what they want to talk about. They already have some ideas of things they want to try. How do we navigate that conversation with a patient who might bring in a therapeutic that we might consider to be emerging? There might not be a lot of research behind it. How do we navigate those types of conversations? 

Shilpa Saxena: Carefully. And I think it should be with this understanding that this person really is super invested in getting better, getting healthier, resolving what ails them, and the fact that they entrust that to us is something we must remember. Gather yourself, because this is what this person has done. They’ve gathered themselves and gathered some data to bring to you. Talk about, GOTOIT. They’re starting the GOTOIT for them, right?  

 So when they come to us, and early on in my functional medicine career, this was standard. I didn’t know about fish oil and probiotics. I didn’t know about functional medicine, honestly, in the beginning. So when people were bringing me research, and especially if it was in the language of how I learned pharmaceutical-based healthcare, I was like, oh, this is a proper trial. And this is looking at this dietary supplement or this procedure. So number one, I always like to acknowledge the patient for their effort. And then I always say it’s really important to make sure that we discriminate between saying no and I don’t know. So when someone brings something, I want to make sure that I don’t drop the no hammer just because I don’t know about something. So when I see something, I’d say, let me think about this. Can I evaluate it? Can I research it more? Can I look into the places that I know that might have similar research, and let me put that up against some of the other medications that you’re on? And then we have another meeting, because I don’t feel the need to have to answer that question right then.  

 And I do think most patients appreciate that you’re doing some due diligence when they bring you something that you’re not familiar with. And then afterwards, as I’m going through, okay, so it looks like this, it looks like this. This is the risks. These are the benefits. These are the alternatives. Then I think it goes back to informed decision-making, shared decision-making. We come back to the table and say, this is what I found. And as the risk, benefits, alternatives. This conversation comes up quite often with statins and heart disease, whether it’s primary prevention or secondary prevention. I also see a lot of this with people wanting to be on blood thinners versus natural blood thinning agents versus kind of the prescribed standard of care. And what’s interesting in our own Cardiometabolic Advanced Practice Module, there are things that we’ll say, listen, the data isn’t clear for you to use, for example, nattokinase as a substitute for a pharmaceutical agent that has been shown to help mitigate risk status post a stroke, let’s say.  

 And sometimes we will have to let the patient know the data isn’t clear. Now, it’s still up to the patient to say, I still refuse this medication, this pharmaceutical medication. And that’s where documentation comes in. But many times, I feel like 80% of the time, patients are bringing us things that have good value, relatively low risk, relatively high yield. And so that’s when we have to use that version of evidence-based medicine, which is our clinical expertise, patient’s values and preferences, and whatever research we do have available, because sometimes there isn’t a great, perfect case study on what they have, and we don’t have a definitive answer. And so we use that trio to help guide the patient into what’s best, what they think is best for them. 

Kalea Wattles: I think it’s really important that you highlighted, as functional medicine practitioners, we’re really students for life. There’s always something to research, because functional medicine is always looking ahead to the use of these maybe novel therapeutics, finding new and safe and cost-effective ways that we can help our patients. So from that lens, what has been your experience incorporating innovative tools and techniques into your practice to really stay on that cutting edge?  

Shilpa Saxena: Well, my latest kind of love and passion is really in the world of mental health. Life opens up opportunities, and you never know sometimes that it’s an opportunity. Sometimes you have to look kind of retrospectively, look at me speaking data here. But mental health was already something that was starting to become an interest to me. And then the COVID pandemic took it to another level, because I do feel like this has changed the way humans behave and the way our bodies are behaving. It’s a giant research model of the impact of stress. And I wish it wasn’t there, but we’re able to learn from it.   

So in this scenario, I had an 18-year-old patient come to see me, and they had been to multiple psychiatrists, been on multiple psychiatric medications. And the parents were on suicide watch for this 18 year old for severe depression. And the patient had already been Baker Acted once. And I don’t know if you can even imagine an 18 year old who’s kind of coming from a relatively sheltered life, gets placed in an inpatient facility, Baker Acted with a whole variety of other patients with mental health conditions. What happened was he was released after the requisite amount of time and became worse because of the experience of being in the hospital. So the mother comes to us as functional medicine providers and tells us. Now, in the timeline, there was definitely some strong gut kind of—the assimilation node was lighting up. Something about bananas. There was just something very specific about gut that I needed to address. But in the back of my mind, I’m like, I’m going to work on the gut, but I don’t know if this is going to transform and get this person quickly better. And one of my colleagues was using ketamine. And I remember thinking, that’s nice for you. Ketamine seems pretty hardcore and kind of not my standard of care.  

But then when I met this boy, I was compelled to learn more about ketamine. And so I started looking at the research. And I don’t know if you know, but a single ketamine infusion with assisted psychotherapy can flip somebody out of suicide. And so, this is just the beauty of how you can find research and use innovation and partnership. So we did that with using amino acids to help nourish the brain with neurotransmitters and help the gut barrier integrity, removed his food triggers, and he’s functioning at college now, and away at college. And that’s just the way that you could bring in what you know, be brave enough to bring in what you don’t know and that you might have been afraid of, and use research and evidence-based medicine to help you feel a little bit more confident about taking that step forward into an unknown.  

Kalea Wattles: Well, as I’m listening to you speak, it comes up to me that this concept of evidence-based medicine, evidence-based practice, it’s so interesting, because actually, if we think about it, almost everything we do now with our patients, all of our treatment approaches, were at one point just this new idea that was being evaluated for clinical use. You’ve mentioned that you’re speaking at the Annual International Conference this year, and that’s really the venue for some of these new practices, new approaches to shine. 

Shilpa Saxena: The Annual International Conference is a great place to be for so many reasons. For me, number one, I love community. I just love being around people who are inspiring. And whenever I go to or attend an Annual International Conference, I always find that there’s three kinds of people. There’s the intellectuals, I’ll call it, like the thinkers. And I’m just mesmerized, like, gosh, this person’s so smart. I never thought about that. Like some of the speakers, and forget the speakers, there’s people out in the, just sitting at my table, or chatting up pearls upon pearls of intellectual wisdom. And then the second group I find to be the feelers, the hearts. They’re the ones who are sharing these beautiful stories and just inspiring me into action, right? They’re not being intellectual about it. They’re being all heart-centered about it. And we need that. You just can’t come from a pure intellectual base, in my opinion, in this field. And then the third people are the doers, the people who are getting stuff done. I love being around people who are getting stuff done, because it just inspires me. Like, I can do this. So AIC is where you get around the people who are the thinkers, the feelers, the doers. And sometimes we need an injection of that to remind us of our power. And that’s all in the milieu of all these great ideas being shared.  

So I’m really excited about the new format as well this year, because one of the things that many of us likely suffer from is conference fatigue. Like, oh my gosh, it’s so much information. But here, having these two kind of shortened days, I can imagine myself, this is what I plan to do, is when the conference is over, I’m going to allot two hours, and I’m going to go from the knowing stage to the doing. I’m going to write down, what am I going to do because of this lecture? Not just, that’s nice to know, because knowing is not going to change results for my patients. It’s like, how am I going to put this in action? Okay, when I get back Monday, I’m going to ask Mary about this, this, this. I’m going to find out which company sells… I feel like while it’s rich in your head, put your doing plan in so that you get a result, because as soon as we get our first taste of a result from something we learned, I feel like we’re hooked. Like, okay, gimme some more. It’s like a drug. In a good way. 

Kalea Wattles: Yes. And you mentioned that there’s a really accessible format, and IFM is offering AIC also at a lower price point this year, because these research findings should really be shared with as many clinicians as possible, whether they’re familiar with functional medicine or not. You mentioned you work with a whole network of different types of practitioners. What would you say to some colleagues who might be new to functional medicine and attending AIC for the first time? What can they expect from the experience? 

Shilpa Saxena: To have your world turned upside down, number one, but in a good way, because when it turns upside down, I think you’re going to land in a place that actually feels quite familiar to you intuitively. Many of us, when we go to our first functional medicine conference, there’s information that just blows our mind. But then when you settle into it, you realize, this is what I intuitively thought all the time. I love getting the information to help connect my intuition and my clinical expertise with some solid, evidence-based medicine and research. So I think all it’s going to do, like it does for patients, is continue to connect with intuition, and common sense, and what you kind of see in clinical practice. You just don’t know how to articulate it, but you’re going to see that be expressed with the speakers so that you can put it into action. So don’t be afraid. It’s really just your intuition or your common sense calling out to you. Things that you’ve been hesitating on in clinical practice, you’re going to have the solid foundations to do it because of the material presented at these conferences.  

Kalea Wattles: Fantastic advice. And we know that you’ll be presenting at this year’s conference. You’ve touched on it a little bit. Without giving too much away, are you willing just to give us a little sneak peek, a preview of what you’ll be talking about this year? 

Shilpa Saxena: I don’t want to give too much away, because I do want you to attend. And I really want to tell you that I am at that podium representing the day-to-day clinician. I will have to tell you, sometimes I’m sitting in the audience and I’m looking at the researchers and these amazing scientists. And I’m like, wow, they are so smart. And I’m excited to represent the voice of the day-to-day clinician, brilliant in a whole different way, but needs to be represented up there. So my talk is really going to be quite approachable in terms of what you’re doing day to day, give you a little background on evidence-based medicine, but really get into the nitty gritty about how you can take what you’re doing every single day and start organizing it to create usable data, data that you can use to support your clinical questions, your financial questions, your operational questions. Just start to get more value out of your time and your efforts. So I’m hoping to create structure and a little engineering grid for you so that you can plug and play what you are already doing, not only for yourself, but maybe even contribute to the movement, because I think most of us would not consider ourselves kind of researchers. We’re just like, I’m a clinician. I’m seeing patients. That’s what I do. But you can do both, which I’m excited to be able to introduce to you. 

Kalea Wattles: Well, we’re very much looking forward to this talk. And I think our conversation today really touched on the importance of clinical research, but also how practitioners can both absorb that information but actually participate in building that evidence base, which is so exciting. So I wanted to thank you so much for spending your time with us and giving us all these wonderful research insights. 

Shilpa Saxena: Thank you, Kalea. It’s always a pleasure. You make everything so easy and comfortable. Bye, everybody. See you at AIC. 

Kalea Wattles: IFM’s Annual International Conference is coming up soon. Learn about the latest advancements in functional medicine research and what they mean for your practice. Join us June 4th and 5th for a reimagined online experience. I’ll see you there. Visit aic.ifm.org for more information.  

Show Notes

More information on the Pareto Principle: https://www.investopedia.com/terms/p/paretoprinciple.asp