Chronic Inflammatory Response Syndrome (CIRS) is a complex, multi-system illness often triggered by exposure to biotoxins in water-damaged buildings. The Shoemaker Protocol, developed by Dr. Ritchie Shoemaker, is a systematic approach to diagnosing and treating CIRS by addressing the underlying physiological abnormalities caused by biotoxin exposure. This article provides a detailed guide to the Shoemaker Protocol, outlining each step and its purpose in restoring health.
Understanding CIRS and the Biotoxin Pathway
The Shoemaker Protocol is built upon an understanding of the Biotoxin Pathway, a complex chain reaction that occurs when genetically susceptible individuals are exposed to biotoxins. This pathway involves the innate immune system and leads to chronic inflammation and various health problems.
The Shoemaker Protocol: A Step-by-Step Guide
The Shoemaker Protocol is a multi-step treatment plan, often visualized as a pyramid, with foundational steps at the base and more advanced treatments at the top. Each level typically needs to be addressed before successfully moving to the next. The protocol consists of three phases and a total of 12 steps, followed by a final retesting phase.
Phase 1: Removal, Binding, and Eradication
1. Removal from Ongoing Exposure
The first and most crucial step is to identify and remove the source of ongoing biotoxin exposure. Potential sources include Lyme disease, Ciguatera, Pfiesteria, and, most commonly, mold. Mold accounts for 80% of biotoxin exposure, and individuals may have multiple exposures.
- Testing: An Environmental Relative Moldiness Index (ERMI) test is recommended to assess mold levels in the environment. A positive ERMI for someone with CIRS is defined as >2 if their Melanocyte-Stimulating Hormone (MSH) is less than 35. If their C4a testing was >20,000 and MSH<35, then a safe ERMI is <-1. After remediation, once the HERTSMI-2 is <11, the building is safe to enter again.
- Remediation: If mold is present, professional remediation or relocation may be necessary. Air sampling for spores is not considered an adequate substitute for ERMI or HERTSMI-2 testing.
2. Treat with Cholestyramine or Other Binder
Biotoxins must be removed from the body, particularly for those with a genetic predisposition to CIRS. Cholestyramine (CSM), a bile acid sequestrant, is the preferred binder.
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- Mechanism: CSM binds negatively charged ionophores, facilitating their excretion in the bile. Biotoxins are ionophores that are difficult to excrete, and CSM aids in their removal.
- Dosage: Start with ½ a packet or ½ a scoop daily mixed with 6-8 ounces or water or juice and build up to four times daily over 1-2 weeks. Take CSM an hour before a meal or an hour after a meal. If you develop constipation, consider soluble fiber, psyllium, magnesium citrate or high dose buffered vitamin C to maintain at least one bowel movement daily. Continue dosing the CMS four times daily for 6 weeks and until the patient passes their VCS testing.
- Alternatives: If CSM is not tolerated, Welchol can be used, although it is only ¼ as effective. Activated charcoal, sterols, and chlorella are less potent binders.
- Considerations:
- "Pure resin" CSM is recommended due to the lack of additives.
- Certain medications, such as thyroid hormones, thiazide diuretics, and coumadin, should be taken 2 hours after CSM dosing.
- Recheck the VCS after one month of CSM treatment and with each additional step in the treatment protocol.
- If re-exposure to mold occurs, repeat the dosing of CSM at four times daily for three days.
- If treatment with CSM fails consider the following: continued exposure, false negative ERMI, wrong diagnosis, non-compliance or untreated MARCoNS.
3. Treat Multiple Antibiotic Resistant Staphylococcus Aureus (MARCoNS)
MARCoNS treatment involves using an antimicrobial biofilm-reducing compounded nasal spray.
- Treatment: Traditionally, this was BEG (0.2% Bactroban, 1% EDTA and 0.5% Gentamycin) sprayed twice in each nostril three time daily for 6 weeks. However, early in 2018 this combination was changed to EDTA 1% with colloidal silver 25ppm in Mucolox 15%. Recent studies have shown this new combination to be effective without the potential ototoxicity of gentamycin. Instructions are the same as with BEG Nasal spray.
- Instructions: After the initially 6 weeks of treatment, discontinue the nasal spray for 5-10 days and reculture for MARCoNS. If negative, then continue with the Biotoxin Pathway treatment. If positive, resume treatment.
- Considerations:
- If the infection is difficult to eradicate, consider re-exposure, continued suppressed MSH, partner with suppressed MSH and MARCoNS, dog exposure, or non-compliance.
- If unable to clear after two to three rounds, the practitioner may either revert to BEG Nasal spray for a round of treatment or perform and extended round of EDTA/Silver nasal for three months, then retest.
- Do not treat nasal fungal infections with azole antifungals.
4. Correct Anti-Gliadin Antibodies
If someone has a positive anti-gliadin antibody, then they need to be 100% gluten free.
- Action: If an individual is found either on lab testing or endoscopic biopsy to have Celiac Disease, then all gluten containing foods must be removed.
- Monitoring: After three months of a no gluten diet, recheck the anti-Gliadin antibodies. If normalized, gluten can be re-introduced as tolerated.
5. Correct Androgens
Ideally, the dysregulated gonadotropins, ACTH, cortisol and testosterone will be corrected as the biotoxin treatment is implemented in a stepwise process. However, this does not always occur.
- Hormone Panel: A full hormone panel should be checked, including free and total testosterone, estradiol, estrone, SHBG, LH, FSH, DHEA, DHEA-S, and pregnenolone.
- Treatment: If DHEA is still low by the time of Step V, a short-term dosing of DHEA for several months can be considered. DHEA has immune regulatory effects and has been used for autoimmune conditions such as Lupus, the John’s Hopkins Lupus Center currently is doing this. If the levels of DHEA-S are low, the dosing regimen is as follows: in men 25-75mg daily, in women 5-25mg daily. This is not supraphysiologic, as is the dosing for treatment of autoimmune diseases.
- Cortisol Dysregulation: Cortisol dysregulation is addressed by the entire treatment protocol and its effects on the hypothalamic-pituitary-adrenal axis.
Phase 2: Addressing Physiological Imbalances
6. Correct ADH/osmolality
Antidiuretic hormone is crucial in regulating the bodies blood concentration of electrolytes, known as osmolality. If at this stage in CIRS treatment, there remains a degree of ADH/Osmolality dysregulation, DDAVP support may temporarily be provided.
- Criteria for DDAVP Use: DDAVP is only used in cases of dysregulation where the ADH is absolutely or relatively low related to the osmolality:
- Osmolality is high > 295
- Osmolality > 292 and ADH < 2 (relatively low ADH)
- Dosage: After repeat labs verify this continued dysregulation and a normal to high normal sodium level, DDAVP 0.2mg orally is begun every other night for 5 doses. After the 5th dose, blood serum is retested for osmolality and electrolyte levels. If these are both within the normal range and symptoms persist, then the DDAVP is advanced to 0.2mg nightly. Repeat testing in another 5 doses. Some patients will need 0.2mg twice daily, these patients must be watched closely for any aberration in their osmolality or electrolytes.
- Monitoring: Correction of ADH/Osm may occur as quickly at 10 days, so be sure to follow the labs on a weekly basis.
7. Correct MMP-9 Levels
Biotoxins can cause cytokines to become elevated resulting in the release of MMP-9 from neutrophils and macrophages.
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- Treatment:
- High-dose omega-3 fatty acids: EPA dosed at 2400mg daily and DHA at 1800mg daily.
- Low amylose/mold diet
- Pioglitazone: If levels remain elevated, a specific PPAR gamma agonist known as pioglitazone may be used. This is a diabetes medication that has been in use for over fifteen years. It is used for 30 days along with a low amylose diet after which time pioglitazone is halted but the diet is continued. Typical dosing is 45mg daily.
- Considerations:
- If a person’s leptin level is <7, or age <18, they shouldn’t take pioglitazone.
- Other Treatments: Other treatments to lower MMP-9 levels include: Astaxanthin 12mg daily, Resolvins (in SPM Active), butyrate (which increases resolvins), resveratrol 200mg twice daily, berberine, astragalus, scutalleria, curcumin, cordyceps, phosphatidyl choline, glutathione, glutamine, progesterone, pycnogynol and camelia sensensis. But these are not part of the official Biotoxin Pathway treatment protocol.
8. Correct VEGF
Steps 7 and 8 are often done together, as both can lower and elevated VEGF.
- Treatment: If still elevated, additional CIRS treatments begin with graded exercise.
9. Correct Complement C3a
This can be elevated if there is the presence of bacterial membranes such as those with acute Borreliosis.
- Treatment: If high, the Borrelia needs to be treated first with antibiotics as per treatment protocol. If the levels remain high, a statin can be used to lower the level.
10. Correct Complement C4a
If levels are greater than 2830 ng/ml
- Treatment: VIP is the current treatment of choice. Note that this lab test needs to be run at National Jewish Hospital in Denver.
11. Correct TGF-B (Transforming Growth Facter Beta)
If elevated (over 2380 pg/mL), the treatment is losartan up to 25 mg bid. A metabolite of losartan called exp3179 lowers TGF beta.
Phase 3: VIP Therapy and Final Evaluation
12. VIP (Vasoactive Intestinal Polypeptide)
If the patient remains symptomatic after following all of the above steps, then the use of VIP is needed.
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- Administration: It is a nasal spray that is dosed at 50 mcg/mL, 1 spray 4 times a day. The first dose should be given in the office.
- Considerations:
- It is critical that there be no continued mold exposure before starting VIP otherwise it will be ineffective. VCS must also be normal and MARCONS must not be present to ensure that VIP will be effective.
- Benefits: According to Dr. Shoemaker’s paper published in 2013, administration of VIP will correct C4a, TGF beta, VEGF, MMP-9, estradiol, testosterone, vitamin D3, and PASP. More importantly, it improves the quality of life.
13. Retesting
The final step involves retesting labs and VCS to assess the effectiveness of the treatment and ensure that the body has been cleared of toxins.
The Importance of Professional Guidance
Due to the complexity of CIRS and the treatments involved, patients should only work with a certified practitioner or a medical doctor trained in the Biotoxin Pathway model-of-treatment. Self-treating can be ineffective and potentially harmful.