Beyond the Evidence of Evidence-Based Medicine
If you’ve traveled the landscape of modern medicine in search of answers to your chronic health challenges, you’ve likely encountered the profound influence and appeal of Evidence-Based Medicine (EBM). EBM is an approach to medical practice intended to optimize decision-making with evidence gathered from well-designed research. It’s often revered for its rigorous scientific style. And that esteem is understandable, right? We want evidence to support claims, especially when the health of ourselves and our loved ones is at stake. Yet while EBM has guided countless healthcare advancements with its methods, we need to step back and explore the scope of its nuanced application. Does this well-intended compass always point to the most efficacious outcomes for everyone?
Light
Dark
Since health interventions vary widely, from dietary and lifestyle modifications to supplements and prescription medications, it’s important to clarify that EBM is applied primarily to medical interventions and treatments that have undergone stringent testing under a particular gaze. For example, cataract surgeries are performed because evidence demonstrates significant vision recovery in a majority of cases. Similarly, pharmaceuticals are prescribed for certain conditions based on clinical trials indicating improvement in symptoms for a percentage of patients. While I support the application of EBM in appropriate instances, these prescribed interventions represent just a fraction of the steps we can take toward improved health.
I’m also concerned that we’ve gotten confused with the true meaning of the term “Evidence-Based Medicine” and perhaps, hyper-fixated on its promises.
EBM might not mean what you think it does. Or what you want it to.
All too often, I hear people ask whether practices like the removal of gluten for Non-Celiac Gluten Sensitivity (NCGS) or Epsom Salt baths for relaxation are “evidence-based.” There is a growing body of research focused on the clinical impacts of dietary and lifestyle modifications that have potential benefits and minimal risk. But these areas are (unfortunately) not of major interest to testing bodies. This means that some of the best evidence for these everyday adaptations may be personal as opposed to clinical. If you notice something works for you and makes you feel better (something that we refer to as a “positive mediator” in Functional medicine and nutrition), then you need not scour PubMed in search of clinical trials to validate your feelings.
The “evidence” in guideline-driven EBM is like following a precise recipe for baking a cake, where it’s determined that this cake is the best chocolate cake for anyone wanting to serve a chocolate cake for an eight-year-old's birthday party. In the environment that led to the confirmation of this being the “best cake for these circumstances,” the climate is always the same; you have one type of oven, a set of pans of identical material and quality, and every ingredient is measured to the exact gram, from the same source, with no substitutions allowed. This method ensures the cake turns out perfectly every time. But if you’ve ever tried to bake a cake, you’re likely familiar with what happens when you bake in a kitchen at high altitude, with a different oven (particularly one that’s not calibrated) or with slight variations in ingredients. Even the type of flour you use (all-purpose flour, cake flour, bread flour, let alone gluten-free flour…) can yield vastly different results. The strict recipe — while proven in one controlled setting — might not yield the same perfect cake in every kitchen.
The story in health care is also more complex than guideline-driven EBM might suggest, especially for those who live with the nuances of a chronic illness. It stands to reason that guidelines and protocols cannot always promise an ideal outcome because of individual variations. The be-all-end-all interpretation of EBM, now widely relied upon in healthcare settings, tends to overshadow and undermine the value of clinical judgment and patient experiences, leaving care in the hands of that ideal “recipe.”
The Divide Between Evidence and the Individual
It’s important to understand that EBM champions treatments drawn from proposed, approved, and funded clinical studies. The processes behind EBM often involve complex interests that may not always prioritize broad patient concerns. While these mechanisms are designed to uphold scientific rigor, they can also be influenced by the agendas of those holding the purse strings, potentially skewing the direction and outcomes of clinical research.
In addition, EBM protocols are derived from averages and standard deviations. But you are not an average. You live a life full of color and complexity that extends far beyond what can be encapsulated by a statistical average. Your journey through health and illness is marked by a unique set of experiences, relationships, and personal challenges that no clinical study can fully capture. Your struggles, triumphs, and the nuances of your lived experience should not be overlooked when it comes to your healthcare needs.
I believe the long-term care you receive should reflect your individuality, and I trust that you do, too. A linchpin in our current healthcare model, one that EBM often overlooks, is the patient's narrative – their personal evidence.
“Healing begins where the wound was made.”
I’d like to slow down and define some of the terms that I’ve used to describe EBM so that we’re on the same page. But before I do, I want to be clear that EBM's use of guidelines based on averages and standard deviations is more straightforward in acute care – situations where quick, life-saving measures are needed, and there's less time for individual tailoring. As an example, when treating an acute bacterial infection, antibiotics are administered based on a generally effective dose that targets a broad spectrum of potential bacteria, rather than pinpointing the specific bacteria responsible for the infection. This is necessary in critical care situations, even though it may not be precisely tailored to the unique bacterial cause.
Several years ago, I contracted a severe staph infection in my right thumb, which dramatically swelled and sent piercing pain throughout my body, rendering my hand unusable. I found myself in dire need of antibiotics and minor surgery to drain the infected area. At this moment, the specifics of how I contracted the infection — during a stressful time supporting my father post-surgery, juggling responsibilities between Portland (where I live) and San Diego (where my parents live), and managing my role as a single parent — were irrelevant to the treatment. This phase of my life, laden with personal challenges, had zero bearing on the medical intervention required for my thumb. The focus was solely on the immediate treatment, serving as a stark reminder of instances where personal narratives must momentarily take the backseat.
But in chronic care, conditions are often less singular and more multifaceted. They can be influenced by myriad long-term personal factors. These include genetics, environment, lifestyle, personal and psychological impact, and co-existing health conditions, among others. Here, the narrative needs to step forward. And in these cases, treatment protocols derived from averages will likely be less effective because they don’t account for the unique variables in each person’s life and body.
Imagine Sarah, a 42-year old graphic designer living with a chronic autoimmune condition, rheumatoid arthritis (RA). Sarah runs her own small business from home. She’s married with two children, and navigates her busy family life and personal passions for rowing and skiing alongside managing her RA. Her condition, diagnosed in her mid-30s, has been a challenging journey. It’s compounded by the stress of deadlines and the physical demands of parenting. While EBM guidelines suggest a standard medication regimen for RA, Sarah's journey is anything but standard. Despite originally following these guidelines and protocols, Sarah continued to struggle with flares, primarily during times of stress, seasonal changes, and forest fires. These flares weren't adequately addressed by the "average" treatment plan, leaving Sarah disappointed with the limitations of the evidence alone.
It’s also important to note that EBM relies on a variety of study types to develop guidelines. These studies include randomized controlled trials (RCTs), which are considered the gold standard for determining the effectiveness of treatments. Cohort studies and case-control studies, are observational and aim to understand the outcomes and risk factors in larger populations over time. Systematic reviews and meta-analyses synthesize findings from multiple studies to provide an overview of research on a particular topic, with a goal of deriving more generalized conclusions. Each of these study types contributes differently to the body of evidence that shapes clinical guidelines.
And yet Sarah's experience emphasizes the need for a deeper understanding of how treatments developed from EBM protocols might not suit everyone or be enough to offer relief. It invites us to consider what is meant by “protocols derived from averages”.
Randomized Controlled Trials (RCTs): The gold standard in research, these trials randomly assign participants to different groups to compare treatments under controlled conditions, with the goal of determining treatment effectiveness.
Limitations: While they're reliable for establishing cause-and-effect relationships, they can be expensive and time-consuming to conduct. Also, strict eligibility criteria can limit participant diversity, affecting the applicability of the results. In addition to diversity, the population size can vary widely. Large RCTs provide more generalizable data, but small RCTs might not accurately represent the broader population.
Cohort Studies: Observational studies that follow a group of people (a cohort) over time to study outcomes and risks, providing data on long-term effects.
Limitations: These studies typically involve large groups observed over time, but the selection of participants can influence the relevance of findings to different populations. Cohort studies can also be affected by “confounding variables:” unmeasured variables that influence reported outcomes. This makes it difficult to pinpoint the true cause of a study’s results. For example, in a study on the relationship between diet and heart health, factors like exercise habits or genetic predispositions, if not measured and controlled for, could skew the findings.
Case-Control Studies: Retrospective, observational studies comparing people with a particular condition to those without, intended to identify risk factors or outcomes associated with that condition.
Limitations: These are often smaller than cohort studies, which might limit their utility in broader populations. They may also be more prone to bias, particularly recall bias in retrospective studies. Finally, matching controls to cases can be challenging and may not fully account for all variables, as noted with the “confounding variable” problem.
Systematic Reviews: Comprehensive reviews of all relevant studies on a specific topic, seeking to synthesize the findings to provide a clear understanding of what the evidence shows.
Limitations: These reviews inherit the limitations of the individual studies considered, including population size and diversity. That means that the quality of a systematic review is heavily dependent on the quality of the included studies. There’s also a risk of publication bias, where studies with positive findings are more likely to be published and included.
Meta-Analyses: Studies that combine data from multiple studies in a systematic review, using statistical methods to integrate the results and draw more generalized conclusions.
Limitations: Like with systemic reviews, they must also navigate the inherent limitations of the original studies, including the scope of their populations and the diversity within them. Additionally, there is a potential for “apples and oranges” comparisons when combining results from studies that are not sufficiently homogeneous in terms of populations studied, interventions considered, and outcomes measured. They also share the systematic review’s vulnerability to publication bias.
The only variability in Evidence-Based Medicine
EBM treatments are often developed based on the results of clinical studies that involve large groups of people. Researchers look at the outcomes of these studies and calculate an “average” result. For example, if a new medication is tested, they might find that on average it reduces blood pressure by a certain amount. This average is then used to create treatment guidelines and protocols. And yet these averages fail to capture the variability in individual responses to the treatment. Some people might have a much better response, while others might not benefit at all, or could even be harmed.
A “standard deviation” is a statistical measure that speaks to the fluctuations in that response. It tells us how much variation there is from the average (or “mean”) in a set of data. In the context of clinical studies, a “small standard deviation” signifies that the results for most participants were very close to the average result (represented by the blue line on graph below). A “large standard deviation” connotes a wide range of results (represented by the red line). For health treatments, a large standard deviation means that while some people might respond well to a treatment, others might not respond at all, or could even experience adverse effects.
As we explore our cultural obsession with EBM, perhaps an even more concerning limitation is bias in historical studies. The clinical trials that led to many accepted guidelines and protocols used today have predominantly included subjects from specific racial, gender and age profiles – mostly white and male, between ages 18 and 65, and within a certain body composition range. This lack of diversity has big implications outside of the lab and in clinical care. It means the "average" that’s been identified for prescribing your treatment might not represent the response of other racial groups, genders, ages, or body types. That average may not include you. This can lead to misinformed guidelines for those who do not fit the narrow demographic of the research subjects.
Once again, you are not average. In a world that seeks to measure us by averages, we must remember that the beauty of humanity lies in our boundless individuality.
“To know how much there is to know is the beginning of learning to live.”
These systemic oversights, entrenched within research and healthcare systems, are now becoming recognized in the scientific community. Research has begun to unveil how different racial groups can have varied responses to treatments due to genetic, environmental, and socioeconomic factors. Similarly, there's a growing understanding that women and men (**) may exhibit different symptoms and responses to the same condition due to biological (including hormonal) and sociocultural aspects that influence treatment responses, access, and health behaviors. This alone necessitates different approaches to care when we recognize the individual. In addition, body size, age, and genomic influences can affect everything from drug tolerance and metabolism to disease risk factors, making a one-size-fits-all approach to treatment ineffective at best and harmful at worst.
In both acute and chronic care, nuances in patient treatment are crucial. Acute care is, admittedly, out of my scope of practice. But individualized chronic care is very much in my scope, and of utmost importance to anyone suffering from a long-term condition. We must recognize that chronic care requires something very different from the predominantly evidence-based acute care model. And yet, acute care practices and methodologies are frequently applied to manage chronic conditions, a mismatch that can lead to less-than-optimal outcomes. You’ve likely experienced this or watched someone else navigate this misalignment.
The care of your more sustained struggles and pain points requires a personalized approach that takes into account your history, narrative and personal evidence. Recognizing this helps us to understand the individual factors and lived experiences that affect our health outcomes, and not dismiss them as unrelated.
Personal Evidence: The Other Side of the Coin
In my years of clinical practice, I’ve seen and heard countless patient stories that highlight the need to look beyond statistical studies. What I’ve deemed personal evidence can be equally valuable to evidence derived from clinical trials. As I mentioned above, what may be statistically significant in a study can be personally insignificant (or even inappropriate) for you. For instance, while a certain medication may be recognized for enhancing cognitive function, its effectiveness can be nullified if it doesn’t feel good when you take it, it interferes with other elements of your life or healing plan, or if the stress from its cost or required frequency outweighs its potential benefits.
Let's consider Alex, a college student diagnosed with ADHD. Alex started taking Adderall after it was recommended by a healthcare professional, hoping it would help manage symptoms and improve focus during her studies. The use of Adderall, a combination of amphetamine and dextroamphetamine, is an EBM approach common for treating Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy. Its efficacy in improving attention and reducing impulsivity and hyperactivity in ADHD patients is well-documented through numerous clinical trials. Good, right? Well, not so fast…
Initially, Alex noticed a significant improvement in concentration and academic performance. But over time, she began experiencing side effects. Increased anxiety, sleep disturbances, a significant loss of appetite, and body image concerns began to overshadow the benefits. These changes eventually impacted her participation in college sports, which was of particular concern given her swimming scholarship’s requirements for academic and physical excellence. As these side effects began to affect her daily life, Alex was forced to question and reconsider her treatment plan. This is when she came to me. And this is where Functional Nutrition takes center stage, honoring your singular journey and the biological responses that are uniquely yours. We push aside the preoccupation with protocol in favor of the personal.
Alex's daily habits, such as late nights, missed meals, and consuming sugary cereals for midnight snacks, were not conducive to her focus and attention. She had long struggled with bloating and asthma, and her frequent swimming exposed her to high chlorine levels, necessitating a balance to unlock her body’s potential for resilience and focus. By addressing these aspects in a targeted and sustainable manner, suited to her dorm lifestyle and notable anxiety, we explored root causes, identified substantial triggers, and initiated gradual changes. This led to durable habits, significant health improvements, and a heightened self-awareness, all essential for maintaining her academic and athletic commitments while also setting her up for future success in navigating life’s challenges.
Alex’s story underscores the need for individualized monitoring and adjustment of treatment, highlighting the limitations of a one-size-fits-all approach suggested by EBM guidelines.
When you step into my world, the conversation shifts from what generally works to what will work for you.
Let’s look at the intricacies of managing another autoimmune condition like Hashimoto's thyroiditis. EBM might point to a generalized medication plan that works for the majority. More holistic approaches may even anchor on a specific diet and the inclusion of key supplements. Yet, when you step into my world, the conversation shifts from what generally works to what will work for you.
Your history, your response to stress, your genetic makeup, and your relationship with food, your body, and the implementation of lifestyle changes – these are the threads I’d explore to tailor a plan that respects your individuality. They anchor on you vs. the disease state alone.
In addition, EBM, with its roots in objective data, might inadvertently view you from a detached lens. But health outcomes, as you may know, are not solely a physical experience. They’re entangled with our emotions, our stories, our relationships, and our environment. Narrative Medicine provides an overlay, asking us to listen – to really listen – to these stories. It requires us to sit down, slow down, and welcome the context in which our health issues exist. In doing so, we often uncover insights that no algorithm could have predicted. I love this interplay between the two practices (Functional Nutrition and Narrative Medicine) precisely because they highlight parts of your health journey that have been overlooked in the desperate and seemingly never-ending quest for the “fix” or the “cure.”
Dr. Lissa Rankin speaks to the distinction between “curing” and “healing” beautifully: “While I also believe you can cure yourself, one gigantic lesson I learned in the past few years is that healing is not the same as curing. You can cure without healing, and you can heal without curing. In medical school and residency, most of our training focused on curing. Very little attention was focused on healing. You might heal a fracture or heal a gaping surgical wound. But healing a person? Nah. Woo woo, hocus pocus horsesh*t…. healing and curing are inherently different. Curing means ‘eliminating all evidence of disease,’ while healing means ‘becoming whole.’"
In the paradigm of EBM, the guidelines are focused on an attempt to “cure.” The role of healing is beyond its scope, intent, or area of interest. Healing potential is not being measured in those studies. The ideal is to bridge the chasm between population data and personal experience. And only you can build that bridge. Only you can recognize that while clinical trials offer a rough map, they cannot show you the terrain of your life, your next steps, or your journey forward. The journey forward is more poetic. It’s human – sometimes graceful, sometimes clumsy. It’s a dance of adapting guidelines and proclamations to the rhythm of your personal narrative, and the evidence that begs your attention.
I asked a client and colleague, J., to write into this dance. Here is what she shared:
The dance...the ebb and flow, of what feels good and what doesn't and discovering the journey of well-being that is best for me…
When I was 8 years old and diagnosed with Alopecia Areata, I was told there was nothing that could be done. Even at 8 years old, I didn't believe that. I always believed that I would find the answers for what I needed, what my body needed, to be well. It truly has been a journey, one that has been eye opening, with many frustrations, at times, yet a journey that has brought much joy as well, learning to nourish my body, mind and spirit. The drugs that I was prescribed as a young person never worked and into adulthood, I kept seeking. I finally found a path that brought me back to basics: good nutrition (and figuring out what this was/is for MY body), being in nature, physical activity, sleep, nourishing relationships and honoring and trusting my body.
If J. had relied on EBM alone for addressing her Alopecia diagnosis, she would not have found this more comprehensive way of supporting herself. EBM led her to a dead-end.
To effectively address chronic health challenges, we must adopt a more holistic perspective that goes beyond the confines of a narrowly “evidence-based” viewpoint. This broader outlook is essential for several reasons, including:
Time Constraints: Adhering strictly to evidence-based research and clinical methodologies can often be time-consuming, resulting in delays in implementing simple and relevant lifestyle interventions and solutions for those in urgent need of relief.
Cost Considerations: Extensive clinical trials, research endeavors and testing can incur significant expenses, potentially limiting access to healthcare options that are not affordable and accessible to marginalized communities.
Potential for Bias: The reliance on technologies and evidence-based approaches may be subject to bias, affecting the objectivity of research findings and readings, overlooking the unique nuances, needs, and experiences of diverse populations.
Conflicts of Interest: Industry funding and commercial interests can influence the outcomes of clinical studies and treatment recommendations.
Lack of Diversity: Clinical trials may not always include diverse populations, limiting the generalizability of findings.
Resistance to Change: Healthcare systems can be resistant to adopting new evidence-informed findings, slowing the integration of innovative solutions.
From Evidence to Empathy
I recently read an insightful opinion piece by Drs. Steven Phillips and Michelle A. Williams, which cast a critical eye on the limitations of EBM, particularly in managing emerging health issues like Long Covid. It's a condition that has puzzled the medical community since the onset of the pandemic. And while time, effort, and money have been put into the exploration of the syndrome, their research draws parallels to known post-infectious syndromes, such as myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). These similarities suggest that Long Covid may be more familiar than we think, warranting a reevaluation of rigid EBM guidelines in treatment.
Phillips and Williams advocate for adaptable, correlation-driven approaches that consider previously-documented health challenges with similar profiles, allowing for an expanded repertoire of care strategies that don’t have to wait for long-term, conclusive evidence. This purview underscores the idea that our health conditions are not just clinical diagnoses that exist in a vacuum. Instead, they are deeply intertwined with our personal stories and life experiences, historically, clinically and personally.
In Functional Nutrition, our allegiance is not to a single study or statistic, but to the holistic view of your health and to helping you find that commitment within yourself. I think of it as being evidence informed vs. evidence enslaved, a phrase once shared by a dear colleague and friend. And as we navigate the complex waters of chronic health conditions, we draw from the well of personal evidence. The result? A healthcare journey that is not just about managing symptoms, but about managing life with all its intricacies and unexpected turns. This is how we transform evidence into empathetic action, ensuring that you feel seen, heard, and supported.
Is EBM too Narrow for Your Needs?
Envision the old parable of the three blind men and the elephant. Each man touches a distinct part of the elephant and determines it’s something entirely different based on their limited lens. One blind man feels the elephant's leg and declares it's a tree, another feels the tail and says it's a rope, while a third touches the trunk and believes it's a snake. This story serves as a great metaphor for the “true, but partial” nature of EBM. EBM, like the men’s understanding of the elephant, provides us with truths based on specific, controlled, conditions. It offers only a piece of a larger puzzle.
While EBM has undeniably advanced healthcare and deserves our respect, its narrow focus cannot encompass the vast spectrum of individual needs, experiences, or viable interventions. This is where you come in. By broadening your perspective and understanding the true meaning of the type of “evidence” gathered from EBM, you become a more active participant in your own healthcare journey. You empower yourself beyond the confines of conventional evidence and all its circumscribed parameters and potentially empty promises. You embrace the totality of your experiences, your symptoms, and your intimate stories and personal evidence.
When you recognize the actual constraints of the scientific “rigor” promised by EBM, you open the door to a broader, more inclusive understanding of your health. You then welcome a spectrum of evidence, from the empirical to the personal. Only then can you blend the precision of EBM with the subjective truths of your own experience, crafting a healthcare journey that is uniquely yours and leads to the healing you crave. This approach promotes a care model that truly caters to you, the person; not just you, the patient. It starts with acknowledging that your health narrative is as critical as any other evidence that places you somewhere on a standard deviation of statistical averages. Honoring this duality guides treatments that are truly (and finally) tailored to you.
(**) Note: In this discussion, the terms "women" and "men" are used to reflect the traditional binary categories often employed in medical research. It's important to recognize that gender is a spectrum, and these binary terms do not encompass the wide diversity of gender identities. I also want to acknowledge and respect the health experiences of non-binary, transgender, intersex, and gender-diverse individuals, even though such specific data might be less frequently addressed in historical research and clinical findings.
“You haven’t seen a tree until you’ve seen its shadow from the sky.”
Narrative Medicine Invitation:
Write about what’s in the shadow of your care.
Note: There is no “right” or “wrong” here. No “good” or “bad”. Set a timer for just 5 minutes, see what comes to mind, and write freely. I invite you to write as an act of release, not to be or become a writer.
Share your insights and reflections in the comments below or feel free to send them to me at scribe@andreanakayama.com.
References:
Citrome, L. (2011). Evidence-based medicine: It’s not just about the evidence. International Journal of Clinical Practice, 65(6), 634–635. https://doi.org/10.1111/j.1742-1241.2011.02669.x
Dieu, D., & Khoa, N. Q. (2023). Evidence-based medicine: Challenges and consensus for Clinicians & Epidemiologists. Asploro Journal of Biomedical and Clinical Case Reports, 6(1), 30–33. https://doi.org/10.36502/2023/asjbccr.6286
The limitations of evidence-based medicine: Applying population-based recommendations to individual patients. (2011). AMA Journal of Ethics, 13(1), 26–30. https://doi.org/10.1001/virtualmentor.2011.13.1.jdsc1-1101
Mitchelmore, B. R., & Banh, H. L. (2016). Incorporating clinical expertise and the clinical presentation in evidence-based medicine. Journal of Pharmaceutical Care & Health Systems, 1(3). https://doi.org/10.4172/2376-0419.1000e112
Prasad, V. (2023, April 2). Evidence based medicine: Misunderstood and in decline. Evidence based medicine: misunderstood and in decline. https://www.sensible-med.com/p/evidence-based-medicine-misunderstood
Ratnani, I., Fatima, S., Abid, M. M., Surani, Z., & Surani, S. (2023, February 21). Evidence-based medicine: History, review, Criticisms, and Pitfalls. Cureus. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10035760/
Steven Phillips, M. A. W. (2023, September 13). Long Covid is a new name for an old syndrome. STAT. https://www.statnews.com/2023/09/14/long-covid-me-cfs-myalgic-encephalomyelitis-chronic-fatigue/
