Future of Functional Medicine Review Clinical Newsletter

Practical Solutions for Practitioners – September 2021

by Dr. Joe Mather and the Ruscio Institute for Functional Medicine Clinical Team

Medically reviewed & fact checked by a
board-certified doctor
Medically reviewed & fact checked by a
board-certified doctor
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Resolution of bloating and constipation through reduction of a Hiatal Hernia

TREATING CLINICIAN: JOE MATHER, MD, MPH&TM

Patient Info:

  • Brian, 32 y/o, Male
  • Previous Dx
    • SIBO (methane dominant)
    • Laryngeal reflux
  • Rx 
    • Omeprazole
  • Chief complaints 
    • Constipation 
    • Acid reflux 
    • Bloating
    • Sinus pressure/congestion, dry skin, feeling cold
    • Tinnitus
    • Acne 
    • Keratosis pilaris

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Visit 1 (Day 1) – History and Exam:

Initial impression:

  • Brian is a 32 y/o father of 2 young children and a pharmacist starting his own health coaching business with constipation, postprandial bloating that appears and drags on for days. He also has acid reflux, cold intolerance, dry skin, and tinnitus.
  • Previous testing:
    • Previous SIBO test – patient reports CH4 was elevated
  • Onset:
    • Multiple long-term antibiotics as a child for cystic acne (bactrim, cleocin, doxy, tetracycline).
    • Poor diet with high sugar/carb intake, always irritable as a kid, low mood, anxious, somewhat depressed. In college – heavy beer drinking, noticed more IBS-D, irritability, still with cystic acne.
    • PCP has told him he has low stomach acid and possibly hiatal hernia
  • Prior Treatments:
    • Helpful:
      • Probiotics 
      • Herbal Antimicrobials (Oregano, Berberine, Allicin, antiparasitics)
      • Anti-histamines (Quercetin, Resveratrol, Claritin, Benadryl)
      • Atrantil 
      • Diflucan – In 2019 treated for 21 days and noticed drastic improvement in symptoms; noticed normal BMs, irritability went away, noticed less swelling in hands
    • Non Responsive:
      • Digestive repair nutrients (glutamine, aloe, etc..)
      • Magnesium
      • Natural laxative
      • Mycotoxin binders (charcoal, Welchol, Cholestyramine, etc..).
      • Candibactin AR/BR
    • Reactive:
      • Prebiotics
  • Notes/DDX:
    • Brian mentions that has noticed acid reflux “more positionally and not necessarily related to food”
  • Supplements:
    • Brian comes in taking Atranril, Oil of Oregano, Pepto Bismol
  • Previous Diets:
    • Helpful:
      • Paleo (most helpful)
      • Fasting or intermittent fasting (most helpful)
    • Reactive:
      • Apples, bananas 
      • Quinoa seems to make reflux worse

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Visit 2 (A Few Days Later) – Testing and Initial Recommendations

Testing:

  • LabCorp Testing:
    • CMP, CBC w diff, 
    • Iron panel, ferritin
    • Vit D, lipids, 
    • TSH, fT4, fT3, TPO
    • ANA
    • Heavy metal panel
  • Rationale
    • Brian had not had comprehensive blood work in some time, and so we opted to order some basics.
    • Important to rule out hypothyroidism given his symptoms. 

Recommendations:

First stop all supplements and omeprazole. Trial the hiatal hernia maneuvers and complete the testing.

Next resume a Paleo Diet, then add triple probiotic therapy. 

  • Diet:
    • Start paleo diet
    • Intermittent fast for 14-18 hours, 1-2 days per week
  • Lifestyle:
    • Meditate or perform breathwork daily
    • Hiatal hernia maneuvers
      • Please try the self adjustment technique shown below three times daily for 1 week to see if your symptoms improve. When the maneuver is successful, patients report feeling that they can take a deeper breath than before, are less bloated and feel lighter. If you feel better doing this then continue the technique at least daily. If you don’t notice any improvement after a week, then stop the maneuver. Let me know the result at your next follow-up appointment.”
      • How to Self Adjust: https://www.youtube.com/watch?v=qofS1iVuwoQ&t=155s
  • GI:
    • Lacto bifido probiotic

    • S. boulardii probiotic

    • Soil-based probiotic

  • Follow up 6-7 weeks
  • Rationale
    • Brian had previously been treated for SIBO and Candida and had persistent symptoms despite treatment. Hiatal hernias can cause chronic bloating and mimic SIBO. A week’s trial of hiatal hernia manipulations is a safe way to determine if this condition is contributing to persistent bloating. The trial was recommended on its own to determine the effect independent of the diet and probiotics.

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Visit 3 – Lab Interpretation and Treatment Evaluation

Subjective Assessment:

  • Improved:
    • Reflux
    • Constipation
    • Bloating
    • Keratosis pilaris 
    • Sinuses
    • Cold intolerance
  • No change:
    • Cold extremities
  • Worse:
    • N/A

Lab interpretation:

  • Blood Test Results
    • ANA neg, B12 851 
    • WBC 3.1, hgb 13.5, hct 38, MCV 89, plt 139
    • CMP wnl, ast 21, alt 22
    • Iron 115, % sat 44
    • Thyroid great: F3 2.8, F4 1.3, TPO 6

Impression:

  • Significant improvement. Reports better bowel movements, fewer overall symptoms. 
  • Hiatal hernia maneuver was very helpful. After feeling initial improvement through using the maneuver on his own he sought out a local chiropractor who continued manipulation. Brain reports that he “very rarely feels bloating now.” Keratosis pilaris is improving. Constipation resolved. Feels that the combination of HH maneuvers have been most helpful.
  • He also feels that both paleo and triple probiotic therapy have had additional benefit.

Recommendations:

Starting

  • GI repair formula

  • Follow up in 2 months

Clinician’s Comments

I wanted to feature this case study to highlight an overlooked cause of bloating. 

I speculate that the vagus nerve can become compressed even in small hiatal hernias leading to poor motility and constipation. I have now seen several cases where chronic constipation has significantly improved following this maneuver. 

I think it is unlikely that Brian will need further antimicrobial treatment and that the combination of a paleo diet, probiotics, and GI repair formula will get Brian healed and symptom free.

Clinical Rule:

Consider a hiatal hernia in patients with a clinical history or who aren’t responding to typical treatment.


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RESEARCH REVIEW

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Diagnosis of Mast Cell Activation Syndrome: A Global "Consensus-2"

PMID – 32324159 

Study Purpose

  • To review various diagnostic criteria for MCAS
  • Mast Cell Activation Disorder is a recently recognized condition, distinct from mastocytosis and characterized the inappropriate activation of mast cells
  • The paper reviews two guidelines for the diagnosis of MCAS, termed “Consensus 1” and “Consensus 2”
  • As MCAS is a fairly common condition in patients with chronic illness, and the majority of these patients are able to have their symptoms reduced significantly, it is important to be able to accurately diagnose this condition. However, as it has only been described and recognized in the past few years, there is some disagreement on the best way to diagnose and characterize this condition. This paper reviews several proposed diagnostic criteria for MCAS. 

Consensus-1:

  • Published in 2011
    • Criticized as being inappropriately narrow and therefore underdiagnosing patients 
    • Diagnosing MCAS by this criteria requires serological proof of abnormal levels of mast cell mediators (elevated levels of tryptase, PGD2, heparin). 
      • Following publication there has been subsequent disagreement whether the “20% + 2” formula for tryptase was a consensus agreement of the authors, and has been criticized as not validated or reproduced in the scientific literature.
      • There is disagreement on the usefulness of tryptase as a marker.
        • “The majority of MCAS patients have a normal tryptase level (at baseline and during symptomatic flares)”
        • Mast cells can produce over 1000 mediators, and mast cell patients can express a large variety of problematic mediators, not just tryptase. 

Consensus-1 Criteria for mast cell activation syndrome (MCAS):

Diagnosis made by demonstrating all three of the above-noted criteria; the diagnosed individual should then be assessed for primary, secondary, or idiopathic MCAS as outlined previously.

  1. Typical clinical signs of severe, recurrent (episodic) systemic MCA are present (often in form of anaphylaxis) (definition of systemic: involving at least 2 organ systems) (symptoms typically associated with local or systemic MCA include urticaria, flushing, pruritus, angioedema, nasal congestion, nasal pruritus, wheezing, throat swelling, hoarseness, headache, hypotensive syncope, tachycardia, abdominal cramping, and diarrhea)
  2. Involvement of MCs is documented by biochemical studies; preferred marker: increase in serum tryptase level from the individual’s baseline to plus 20% + 2 ng/mL; other MC-derived markers of MCA (histamine and histamine metabolites, PGD2 metabolites, and heparin) have also been proposed, but are less specific compared with tryptase
  3. Response of symptoms to therapy with MC-stabilizing agents, drugs directed against MC mediator production, or drugs blocking mediator release or effects of MC-derived mediators

Consensus-2:

  • First published in 2010, adjusted in 2012. Described by its authors as a “consensus” document
    • “However, followers of MCAS literature know there is another sizable world-wide contingent of investigators and practitioners – and patients – who feel there are significant problems with the “consensus” approach and who thus favor the alternative approach advocated by the authors of the 2011 paper”

Consensus-2 Criteria per Original Publication

Diagnosis established upon demonstration of both major criteria or at least one major criterion combined with at least one minor criterion (and in the unstated but inferred absence of any other disease better accounting for the patient’s problems).

Major Criteria:

  1. Multifocal or disseminated dense infiltrates of mast cells in bone marrow biopsies and/or in sections of other extracutaneous organ(s) (e.g., gastrointestinal tract biopsies; CD117-, tryptase- and CD25-stained)
  2. Unique constellation of clinical complaints as a result of a pathologically increased mast cell activity (mast cell mediator release syndrome)
Minor Criteria:

  1. Mast cells in bone marrow or other extracutaneous organ(s) show an abnormal morphology (>25%) in bone marrow smears or in histologies
  2. Mast cells in bone marrow express CD2 and/or CD25
  3. Detection of genetic changes in mast cells from blood, bone marrow or extracutaneous organs for which an impact on the state of activity of affected mast cells in terms of an increased activity has been proved
  4. Evidence of a pathologically increased release of mast cell mediators by determination of the content of

a. Tryptase in serum
b. N-methylhistamine in urine
c. Heparin in plasma
d. Chromogranin A in serum
e. Other mast cell-specific mediators (e.g., leukotrienes, prostaglandin D2)

Author’s Summary:

  • Broadly accepted characteristics defining the mast cell activation syndrome (MCAS) population.
    • An MCAS patient must have signs/symptoms of aberrant MCA in multiple (i.e. at least two) organ systems
    • An MCAS patient must have symptoms consistent with chronic MCA, which is aberrant (i.e. abnormal, whether constitutive/baseline and/or reactive to some identifiable trigger; note most MCAS patients have both constitutive and reactive MCA, even if either form is just to a modest degree at a given point), and, in many patients, accompanied by periodic flares (a.k.a. “spells,” “episodes,” and such) of certain subsets of their symptoms
    • An MCAS patient must (with reasonable confidence) not have some other disease accounting better than MCA for the full range and duration of the observed symptoms/signs

Clinician’s Comments

  • My experience is that mold toxicity is the primary driver of mast cell activation syndrome and a diagnosis of MCAS should prompt a search for mold exposure.
  • I am primarily concerned when MCAS is preventing a patient from eating an appropriate diet or taking the supplements or medications they need to heal. 
    • I ask the question: “Are you having multiple symptoms within 5 minutes of eating, drinking or taking a medicine or supplement? If so, how many times a week?”
  • “In our estimation most drugs tried for MCAS which do not demonstrate clear benefit by 2–4 weeks after having reached a “reasonably potent” dose should be abandoned out of futility.”
    • My observation in patients is that a benefit or lack of response for MCAS supplements or medication is typically apparent within 1 week. Ideal is finding several agents that clearly reduce reactivity. However there are cases where despite there not being any one clear effective agent, once several agents have been added the patient begins to feel better and reactivity declines. Typically I am having patients try one H1 blocker, one H2 blocker and two natural mast cell stabilizers, each added over the course of a week. They are told to stop any agent that makes them worse, but continue any agent even if they are unsure it is helping. They then continue the 4 agents for an additional month looking for reduced reactivity. A successful regimen will reduce the number of times they react to food, drink or supplements in a week.

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Effect of a Single High Dose of Vitamin D3 on Hospital Length of Stay in Patients With Moderate to Severe COVID-19

PMID: 33595634 

Study Purpose

  • To investigate the effect of a single high dose of vitamin D3 on hospital length of stay in patients with COVID-19.

Intervention:

  • Patients were randomly assigned to receive a single oral dose of 200 000 IU of vitamin D3 (n = 120) or placebo (n = 120).

Main Results:

  • Median length of stay was not significantly different between the vitamin D3 (7.0 days) and placebo groups (7.0 days) P = .59;
  • The difference between the vitamin D3 group and the placebo group was not significant for
    • In-hospital mortality (7.6% vs 5.1% P = .43)
    • Admission to the intensive care unit (16.0% vs 21.2%; P = .30)
    • Or need for mechanical ventilation (7.6% vs 14.4%; P = .09). 
  • Mean serum levels of 25-hydroxyvitamin D significantly increased after a single dose of vitamin D3 vs placebo (44.4 ng/mL vs 19.8 ng/mL; difference, 24.1 ng/mL [95% CI, 19.5-28.7]; P < .001).
  • There were no adverse events, but an episode of vomiting was associated with the intervention

Authors Conclusion:

  • Among hospitalized patients with COVID-19, a single high dose of vitamin D3, compared with placebo, did not significantly reduce hospital length of stay. The findings do not support the use of a high dose of vitamin D3 for treatment of moderate to severe COVID-19.

Clinician’s Comments

  • Vitamin D3 is frequently recommended in the treatment of COVID-19 by integrative and functional medicine practitioners on the theory that its immunomodulatory and anti-inflammatory properties would improve outcomes. This study showed no difference in outcomes when given high dose vitamin D3 despite the treatment group being deficient in vitamin D with average serum levels of 21.2.

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Report on Absorption of Magnesium Sulfate (Epsom Salts) Across the Skin

Epsom Salt Baths

Introduction

  • I began experimenting with Epsom Salt Baths following Dr. Ruscio’s podcast with Dr. Greg Nigh, who referenced this study.
    • It is worth noting that this study hasn’t been published in a scientific, peer-reviewed journal, and was found on the commercial site of the Epson-salt-council.
    • A paper has been published that disputes the efficacy of transdermal magnesium calling it “a scientifically not yet proven form of magnesium application.” 

Intervention:

  • Subjects were recruited from the staff of the School of Biosciences, University of Birmingham. In all, 19 subjects (10M, 9F) were recruited for the various aspects of the study. All were in good health, and not on any current medication. No subject smoked more than 5 cigarettes/day or drank more than 2 units of alcohol/day. The ages ranged from 24-64 years. 
  • All volunteers took baths (temperatures 50-55°C) and stayed in the bath for 12 minutes. They added varying amounts of magnesium sulfate (Epsom salts) to the bath before entry and ensured that the salts were completely in solution.

Main Results:

  • Bathing in Epsom salts is a safe and easy way to increase sulfate and magnesium levels in the body.
    • Free inorganic sulfate levels in plasma rose in all subjects after bathing in Epsom salts (mean prebath, 3.28 nmol/mg protein ± 1.40, 2h after 1st bath, mean 5.59 nmol/mg protein ± 3.08). In some individuals, the level post-bath reached > 9 nmol/mg protein. The plasma levels after 7 days showed a mean of 3.57 nmol/mg protein ± 1.70, lower than the peak value, suggesting that sulfate stores in the body were being filled.
    • Magnesium levels in blood are very tightly controlled. Of 19 subjects, all except 3 showed a rise in magnesium concentrations in plasma, though this was small in some cases. The values before the first bath were, mean 104.68 ± 20.76 ppm/ml; after the first bath the mean was 114.08 ± 25.83 ppm/ml. Continuation of bathing for 7 days in all except 2 individuals gave a rise to a mean of 140.98 ± 17.00ppm/ml. Prolonged soaking in Epsom salts therefore increases blood magnesium concentrations.

Clinical Takeaways:

  • In patients who cannot tolerate magnesium, or who I suspect have insufficient sulfur levels an Epsom Salt Bath can be very helpful. 
  • Similar to the Hiatal Hernia technique I ask patients to try this for 7 days, continue if it is helpful, and stop if it is not. 
    • I have seen this most helpful in patients with chronic constipation, pain and fatigue from mold colonization, rheumatic arthritic joint pain, and patients with CH4 SIBO. 
    • Here’s the language I provide to them: 
      • “Some of my patients have improved dramatically with a series of Epsom Salt baths, and I’d like for you to do a trial to see if this is helpful for you or not. This works by improving your magnesium and bioavailable sulfur levels. Please mix 4 cups of Epsom Salts into a hot bath and soak for 20 minutes daily x 1 week. Afterwards you can decrease to twice weekly (or more) as needed. While the majority of even my sensitive and sickest patients are doing extremely well with this treatment, if you have any difficulty, simply reduce the frequency or the amount of Epsom Salt per bath.”

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Blood, Urine, and Sweat (BUS) Study: Monitoring and Elimination of Bioaccumulated Toxic Elements

PMID: 21057782 

Study Purpose

  • There is limited understanding of the toxicokinetics of bioaccumulated toxic elements and their methods of excretion from the human body. This study was designed to assess the concentration of various toxic elements in three body fluids: blood, urine and sweat.

Intervention:

  • This study was designed to assess the concentration of various toxic elements in three body fluids: blood, urine and sweat. Blood, urine, and sweat were collected from 20 individuals (10 healthy participants and 10 participants with various health problems) and analyzed for approximately 120 various compounds, including toxic elements.

Main Results:

  • Many toxic elements appeared to be preferentially excreted through sweat. 
  • Presumably stored in tissues, some toxic elements readily identified in the perspiration of some participants were not found in their serum. Induced sweating appears to be a potential method for elimination of many toxic elements from the human body. 
  • Biomonitoring for toxic elements through blood and/or urine testing may underestimate the total body burden of such toxicants. Sweat analysis should be considered as an additional method for monitoring bioaccumulation of toxic elements in humans.

Interesting Notes:

  • I found it interesting to see how readily lead is excreted in sweat. I have found lead to be removed more slowly than mercury and arsenic using oral programs. This study implies that sauna therapy should be incorporated into metal detox whenever possible.
  • Cadmium and aluminum are also noteworthy toxic metals that are eliminated more efficiently in sweat than urine.

Authors Conclusion:

  • Biomonitoring based exclusively on measurements from blood and/or urine can provide misleading conclusions about the state of toxicant accrual and can underestimate the total body burden of xenobiotics. Furthermore, with the abundance of unsubstantiated information relating to detoxification, evidence from this research demonstrates that there may be a role for induced perspiration as a preventive and therapeutic measure to assist individuals and groups at health risk resulting from exposure to and bioaccumulation of toxic elements. 

Clinical Takeaways:

  • From a therapeutic standpoint, induced sweating may have potential as a clinical intervention for elimination of some toxic elements. However, the concomitant loss of required trace minerals into sweat, which is also evident from the data, serves to remind that sauna users should secure adequate intake of required minerals to compensate for losses and to replete diminished reserves.
  • From a public health perspective, clusters of people, such as firefighters, who by the nature of their occupations are exposed to toxic elements, may be advised to regularly undertake induced sweating. Further research is required, however, to determine whether induced sweating on the day of exposure is beneficial or detrimental because enhanced circulation to the skin associated with sauna may stimulate greater absorption of toxicants on the skin.

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Rapid-Fire Research: Ultra-Concise Summaries of Noteworthy Studies

Dietary Flaxseed as a Strategy for Improving Human Health

PMID – 31130604

  • Flaxseed is a rich source of the omega-3 fatty acid, alpha linolenic acid, the lignan secoisolariciresinol diglucoside and fiber. These compounds provide bioactivity of value to the health of animals and humans through their anti-inflammatory action, anti-oxidative capacity and lipid modulating properties. 
    • “Two recent randomized trials have generated results of great interest for the introduction of flaxseed ito diets for relief from constipation… They found that the flaxseed reduced constipation symptoms, weight, fasting plasma glucose, triglycerides, and LDL and HDL cholesterol levels. In a subsequent trial using the same type of patent population, flaxseed affected all of these parameters once again and, important was superior in its capacity to reduce constipation symptoms to psyllium.”

Prevention of Influenza Episodes With Colostrum Compared With Vaccination in Healthy and High-Risk Cardiovascular Subjects: The Epidemiologic Study in San Valentino

PMID: 17456621

  • The efficacy of a 2-month treatment with oral colostrum in the prevention of flu episodes compared with anti influenza vaccination was evaluated. Groups included healthy subjects without prophylaxis and those receiving both vaccination and colostrum.
    • After 3 months of follow-up, the number of days with flu was 3 times higher in the non-colostrum subjects.
    • The colostrum group had 13 episodes , 14 in the colostrum + vaccination group,
    • 41 in the group without prophylaxis (no vaccination, no colostrum),
    • And 57 in nontreated subjects (vaccine only).
  • Part 2 of the study had a similar protocol with 65 very high-risk cardiovascular subjects, all of whom had prophylaxis. The incidence of complications and hospital admission was higher in the group that received only a vaccination compared with the colostrum groups.

Mixed Mold Mycotoxicosis: Immunological Changes in Humans Following Exposure in Water-damaged Buildings

PMID: 15143854

  • The study described was part of a larger multicenter investigation of patients with multiple health complaints attributable to confirmed exposure to mixed-molds infestation in water-damaged buildings.
  • Abnormally high levels of ANA, ASM, and CNS myelin (immunoglobulins [Ig]G, IgM, IgA) and PNS myelin (IgG, IgM, IgA) were found; odds ratios for each were significant at 95% confidence intervals, showing an increased risk for autoimmunity.
  • The authors conclude that exposure to mixed molds and their associated mycotoxins in water-damaged buildings leads to multiple health problems involving the CNS and the immune system, in addition to pulmonary effects and allergies. Mold exposure also initiates inflammatory processes.

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Practitioner Question

What Is a Root Cause?

I’d like to propose a definition:

A disorder of normal anatomy or physiology which, when treated, results in the diminishment or resolution in clinical symptoms.

A root cause is not abnormalities on lab testing, or a mechanism of disease – unless specifically addressing that issue leads to clinical improvement.


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Practitioner Tip

Set Firm Boundaries

Practicing good functional medicine is an extremely difficult undertaking. Most functional medicine practitioners are called to their profession out of a deep desire to heal the suffering of others and many are strongly empathic, feeling the emotions of their patients. Working with suffering patients can take an emotional toll on healers.

This desire to help often leads dedicated practitioners to give high levels of access to their patients. Many five out their cell phone number or let patients email them directly. In our modern day connected society, many feel the pressure to be available at all times. 

As one excellent and deeply caring physician wrote: This patient is making me question my desire to help the complex chronic patient as I don’t seem able to move the needle with her and she is so distressed that she emails me 3-4 times per week with detailed descriptions of her symptoms.”

Establish firm guidelines at the initial visit for when and how patients can contact you. If you don’t you will get overrun, burnt out and be unable to help anyone.

  • Coach your staff on how to explain your policies to patients. Have your staff explain that your job is to be completely focused on the patient in front of you, and this is impossible if you also have to juggle emails, texts, and phone calls.
  • Set up email autoresponders on clinic email that explains your communication policy.
  • Have patients sign a communication policy prior to working with you to set expectations on how and when they may contact your office.
  • Dedicate a block of time daily or weekly for acute emergency visits.

Discussion

I care about answering your questions and sharing my knowledge with you. Leave a comment or connect with me on social media asking any health question you may have and I just might incorporate it into our next listener questions podcast episode just for you!