What Constitutes Functional Medicine Research?
Functional medicine combines current science, evidence, and clinical reasoning to create a whole system approach to health. Practitioners focus on the interconnectedness of body systems, address root causes, and create a personalized approach to patient care. There is significant published evidence for individual elements frequently deployed in the model, such as evaluative methods and treatments. Functional medicine research specifically refers to efforts that investigate the complete functional medicine care model and its outcomes.
IFM's Role in Research
IFM encourages, promotes, and provides strategic and technical guidance for research on the functional medicine care model with an overall goal of demonstrating safety, effectiveness, and value-based care. In so doing, IFM helps to expand the functional medicine evidence base and drive change within the healthcare system. A well-developed functional medicine evidence base supports the confidence and competence of practitioners and the viability of functional medicine to ultimately advance the highest expression of individual health.
Functional Medicine Research
These select studies represent health outcomes from the functional medicine care model, cost of care findings, and research methodology.
An Evaluation of Functional and Conventional Medicine in Chronic Illness
This study measured cross-system outcomes in patients who received care to address antecedents, triggers, and mediators of chronic illness. This is the first publication to compare the functional medicine care model to traditional care in a scientifically robust observational study.
Functional Medicine vs. Conventional Care for Inflammatory Arthritis
Researchers examined the differences in pain and global health outcomes between the two care models. The functional medicine group received standard care plus a personalized lifestyle intervention to address antecedents, triggers, and mediators of dysfunction.
Cost and Outcomes in Shared Functional Medicine Appointments
Researchers compared cost and global health outcomes in patients who participated in shared or individual functional medicine appointments. Treatment included personalized nutrition and lifestyle changes to address systemic antecedents, triggers, and mediators of dysfunction.
A Community-Based Nutrition and Lifestyle Intervention
This study demonstrates a systems approach and intervenes upon antecedents, triggers, and mediators of poor health in a resource-deprived population. The intervention, delivered in a community-based shared medical appointment model, featured modifiable lifestyle factors with a focus on therapeutic partnerships.
Functional Nutrition Exam Informs Personalized Wellness Interventions
Consistent with functional medicine's systems approach, this article highlighted many associations that connect body systems. These associations may assist practitioners in performing a clinical assessment that recognizes patterns of dysfunction and help clinicians create more personalized diagnostic approaches.
A Multi-System Approach to Cognitive Decline
This is the first clinical trial to show improvement in cognitive function based on a multi-system lifestyle intervention in a population with existing cognitive impairment or dementia. The effectiveness of the intervention builds on existing evidence that an insufficiency of certain diet and lifestyle factors may be mediators of cognitive decline.
Functional Medicine in the Veterans Administration
The practitioners in this pilot program treated chronic illnesses associated with military occupational exposures. These exposures may be antecedents, triggers, or mediators of dysfunction. The program leveraged personalized lifestyle changes, therapeutic partnerships, and mental and emotional factors to improve global health in veterans.
Functional Medicine Health Coaching and Patient-Reported Outcomes
This randomized controlled trial examined the impact of functional medicine health coaching on multi-system outcomes. Functional medicine–trained coaches guided study participants through an elimination diet to address potential triggers and mediators of dysfunction.
Functional Medicine and Biological Age
This case series examined the impact of modifiable lifestyle factors and targeted nutrition therapy on biological age. The participants' improvements highlight the potential for nutrition, sleep, exercise, and stress management to address mediators of dysfunction, even in adults without overt disease.
PROMIS: An Ideal Tool for Functional Medicine Research
The Patient-Reported Outcomes Measurement Information System (PROMIS) is a set of validated research tools. PROMIS structures patient-reported outcomes from multiple body systems into standardized, comparable data for both clinicians and researchers.
Functional Medicine Research Component Checklists
These checklists identify the components of studies that evaluate the functional medicine clinical approach and its health outcomes.
Checklist #1: Identifying Existing Functional Medicine Research
These criteria identify studies that include components of the model but may have been conducted independently of an intent to evaluate functional medicine care.
Essential
All must be present
- Reflects a systems approach to health by observing or intervening upon imbalances across body systems that contribute to disturbances in function and/or disease.
- Observes or intervenes upon antecedents, triggers, and mediators of disturbances in function and/or disease.
Recommended
- Features modifiable lifestyle factors as an intervention and/or exposure.
- Offers personalization via adaptive design, subgroup analyses, or other strategies.
Optional
- Acknowledges the importance of the therapeutic partnership.
- Identifies/addresses mental, emotional, and spiritual factors that influence health.
Checklist #2: Designing New Functional Medicine Research
These criteria inform studies specifically designed to evaluate functional medicine care.
Essential
All must be present
- Reflects a systems approach to health by observing or intervening upon imbalances across body systems that contribute to disturbances in function and/or disease.
- Observes or intervenes upon antecedents, triggers, and mediators of disturbances in function and/or disease.
- Features modifiable lifestyle factors as an intervention and/or exposure.
- Offers personalization via adaptive design, subgroup analyses, or other strategies.
Recommended
- Acknowledges the importance of the therapeutic partnership.
- Identifies/addresses mental, emotional, and spiritual factors that influence health.
- Raw data available via public repositories.
More about the functional medicine research checklists
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Each criterion has been designated “essential”, “recommended”, or “optional” to reflect relative importance and feasibility. There are contextual factors for the checklists that differ between experimental studies (i.e., characteristics of the nature of the intervention) versus observational studies (i.e., characteristics of measuring exposures, outcomes, and subgroups), although these criteria are applicable to both categories of research design.
- A systems approach is a foundational characteristic of functional medicine practice and research. This approach examines function and dysfunction across the core systems in human physiology. Study methods, interventions, and observed outcomes will illustrate that a single dysfunction may be associated with multiple conditions or how a single condition may be associated with multiple dysfunctions.
Essential in functional medicine research. - Antecedents, triggers and mediators (ATMs) identify latent, activating, and perpetuating factors that contribute to (are “root causes” of) dysfunction, disease course, and prognosis. ATMs in the study sample should inform study recruitment, stratification, subgroup analyses, observed outcomes, or interventions. If necessary, ATMs may be inferred in studies that observe or intervene with modifiable lifestyle factors if these studies demonstrate improvement in the given dysfunction or condition. This would suggest that the study participants may have had inadequate engagement in one or more of these lifestyle factors at baseline.
Essential in functional medicine research. - Modifiable lifestyle factors are included in numerous disease guidelines as a recognition of their importance in medicine. Modifiable lifestyle factors include nutrition, movement, sleep, stress, and relationships.
Essential in new functional medicine research designs.
Recommended in identifying existing functional medicine research. - Personalized care is a hallmark of functional medicine. Adaptive study designs with flexible protocol rules, subgroup analyses, or other strategies that allow researchers or clinicians to infer how care might be personalized will satisfy this criterion.
Essential in new functional medicine research designs.
Recommended in identifying existing functional medicine research. - Functional medicine emphasizes the therapeutic partnership. Studies will consider the patient perspective or provide an opportunity for patients to participate in their care. If not actively described in the study design, authors may comment on the impact of the therapeutic partnership in the study discussion or conclusions.
Recommended in new functional medicine research designs.
Optional in identifying existing functional medicine research. - Mental, emotional, and spiritual factors are critical components that impact health and well-being. As a best practice, studies will take into account patients’ thoughts, beliefs, or how they ascribe meaning to their lives. An approach may involve incorporating or observing what matters to patients as part of the study design.
Recommended in new functional medicine research designs.
Optional in identifying existing functional medicine research. - As a step toward demonstrating integrity, fostering transparency, and improving trustworthiness of scientific publications worldwide,1 it is recommended that authors make their raw data available via public repositories. These practices also promote replication of results by other groups. When data are not shared, transparent communication of restrictions on data availability are encouraged.
Recommended in new functional medicine research designs.
- A systems approach is a foundational characteristic of functional medicine practice and research. This approach examines function and dysfunction across the core systems in human physiology. Study methods, interventions, and observed outcomes will illustrate that a single dysfunction may be associated with multiple conditions or how a single condition may be associated with multiple dysfunctions.
REFERENCES
- Van Noorden R. Medicine is plagued by untrustworthy clinical trials. How many studies are faked or flawed? Nature. 2023;619(7970):454-458. doi:10.1038/d41586-023-02299-w