November 7, 2016

Researching Functional Medicine Treatments

Several clinical studies underway at Cleveland Clinic


For 25 years, functional medicine has been a medical specialty focused on diet and environmental factors to get to the root cause of disease. In fall 2014, Cleveland Clinic opened the Center for Functional Medicine at its main campus to great demand. This year, staff from the Center for Functional Medicine has embarked on a number of research projects with the goal of gathering more evidence-based data to support the practice of functional medicine on a large scale.


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Patrick Hanaway, MD, is serving as Director of Functional Medicine Research, and he is pleased to announce clinical research studies looking at three chronic dysfunctions that are driven largely by diet and environmental factors – asthma, inflammatory bowel disease (IBD) and diabetes.

Center physicians are teaming up with staff from specialty institutes at Cleveland Clinic to research the efficacy of including the personalized testing and treatment offered by functional medicine practitioners alongside their primary care and specialty colleagues. These Institutional Review Board (IRB)-approved studies will observe patients over a six- to 12-month period, and they are beginning in fall 2016.

Here is a brief description of these patient studies:


Functional medicine is conducting an asthma study with the Asthma Center in Cleveland Clinic’s Respiratory Institute. This randomized control study is looking at adult nonsmokers with moderate to severe asthma whose airflow obstruction is 12 percent below baseline response on the choline challenge test with persistent asthma symptoms despite treatment.

This study will include 60 adult patients, 30 of whom will be receiving standard care for asthma and 30 of whom will receive functional medicine diagnosis and treatment in addition to the standard care for asthma. As is the case with functional medicine, treatment is being tailored to the needs of the patient and may vary from patient to patient. Following the initial medical appointment and treatment plan, patients will have follow-up appointments every couple months to check on their health status and to make treatment changes as needed. Safety assessments are being done to ensure there are no medication interactions or issues. See this webpage for more on this asthma study


Inflammatory Bowel Disease (IBD)

Functional medicine is conducting an IBD study with Cleveland Clinic’s Digestive Disease Institute.

This study is a retrospective chart review looking at the outcomes of approximately 60 functional medicine patients with IBD. Patients are being assessed for treatment in functional medicine with the goal being clinical remission of Crohn’s disease and ulcerative colitis, with a reduction in the medications necessary to achieve and maintain remission. They are targeting a CDAI (Crohn’s disease activity index) score of less than 150.


Functional medicine is conducting a diabetes study with staff from Cleveland Clinic’s Diabetes Center & Endocrinology Institute.

This year-long randomized trial involves 90 adult patients with type 2 diabetes who have been taking insulin daily for one to five years. Half of the study participants are being treated solely by an endocrinologist; the other half are receiving care from a functional medicine physician in addition to traditional treatment from an endocrinologist. The goal of this study is to decrease and/or eliminate the need for insulin therapy while maintaining effective glucose control (HgbA1c < 8).

Studying outcomes

All of these studies are designed to determine if the functional medicine patient outcomes match or improve the outcomes for patients in traditional treatment.


Another broad, long-term research study underway at Cleveland Clinic focuses on the total cost of care for functional medicine services compared with standard treatment approaches. This IRB-approved ‘Total Cost of Care’ Study, will evaluate patient reported outcomes measures (PROMIS) before and after treatment at the Center for Functional Medicine, across a variety of healthcare conditions. These patients will also be compared with matched controls to determine changes in the number of specialty visits and changes in the Total Cost of Care using claims-based insurance data. This will allow the Center for Functional Medicine to measure value; that is, outcomes divided by cost.

Further collaboration

Finally, Center for Functional Medicine leadership is in dialogue with physicians across multiple Cleveland Clinic institutes for additional collaboration on treatment approaches for autoimmune disease, cognitive impairment and prostate cancer.

Functional medicine is currently working with David Levy, MD, from the Glickman Urological & Kidney Institute’s Department of Urology, who recently established a multimodality Prostate Nutrition Clinic that addresses the effect of patient dietary habits on prostate cancer pathology. The clinic, staffed by physicians, nurse practitioners and nutritionists, offers a comprehensive analysis of dietary habits known to be factors in prostate disease as well as an assessment of relevant laboratory data, and is conducting research to identify the specific impact that dietary manipulation and supplements have on prostate cell biology. For details click here.

“It is an exciting time for our functional medicine team as we delve into this research,” says Dr. Hanaway. “It is a great privilege to collaborate with the world class Cleveland Clinic staff. We all look forward to reviewing the results to better understand the ways in which functional medicine can partner with specialty physicians to help patients.”

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