Shoemaker Protocol

Part 4: The Shoemaker Protocol

The Shoemaker protocol is a systematic treatment plan consisting of several steps that need to be followed in order. The full protocol consists of 14 steps, however depending on biomarkers and symptoms not all steps may have to be followed. Only the main steps are outlined here.

4.1 Step 1: Removal from Exposure

This is of paramount importance but is often the most difficult step. One must live, work and otherwise reside in and visit buildings with a HERTSMI of < 11 at a minimum. Otherwise you’ll continue to be exposed to inflammation causing biotoxins even if binders are used. If re-exposed to another WDB you may need to re-start the protocol from this step.

4.1.1 What is mould avoidance / extreme mould avoidance?

Some CIRS patients, especially those with low or undetectable levels of MSH and VIP, will react to even tiny amounts of biotoxins in water-damaged buildings. These extreme reactors often resort to camping in dry locations such as deserts in tents or caravans and converted trailers.

The most well-known mould avoider is Erik Johnson, who was the prototype for CFS in Lake Tahoe, Nevada in the mid-1980s. He effectively cured himself of CFS in six months with extreme mould avoidance only, and did not follow the rest of the Shoemaker protocol. For more on Erik’s story and mould avoidance techniques read the book Back from the edge by Lisa Petrison (see resources).

4.2 Step 2: Binding of biotoxins

Once clear of exposure you will need to clear the biotoxins from your body via ingestion of binders.

4.2.1 Cholestyramine – The binder of first choice

Cholestyramine (CSM) is a fifty year old cholesterol lowering medication which has been extensively studied and has an excellent safety profile. This negatively charged binding resin attracts positively charged biotoxins from bile and excretes them in the feces. It is not absorbed systemically. It is available in Australia either as Questran Lite, which contains aspartame or as a pure compounded version. The compounded version may contain stevia and various forms of cellulose, which are harmless excipients in the vast majority of people. See resources for compounding pharmacies. The full dosage is four grams four times per day (QID), thirty minutes before meals/medications or one hour after meals/medications. It is suggested you start with a small dose (1-4 grams) and work your way up to the full dose.

4.2.2 How long do I stay on CSM?

A minimum of one month with the average time being six-twelve months, although some people stay on it for longer. Duration is dependent on the VCS being passed, symptom reduction and absence of exposure to further water-damaged buildings. Some people stay on a lower maintenance dose (4 grams, twice a day) on a continual basis or prophylactically, taking it short term when re-exposed to WDBs (full dose, 3-7 days after exposure).

4.2.3 Are there any side-effects?

The usual side-effects are constipation, gas and reflux. Constipation can usually be ameliorated with magnesium citrate/ vitamin C/ soluble fibre (chia seeds, flax seeds and psyllium). Long term use can deplete fat soluble vitamins (A, E, D, K, Co Q10) so it is suggested to supplement those, away from CSM dosing. It is also advised to increase healthy fats in the diet such as eggs, butter/ghee, coconut oil, avocados and olive oil.

4.2.4 Alternative binders

Activated charcoal, bentonite clay, chlorella, soluble fibre, chitosan, glutathione, vegetable juicing etc. have all been advocated by patients and several doctors but there is no good data on their effectiveness. Shoemaker didn’t find that any of these were of benefit statistically speaking but your results may vary and some may be helpful adjunctive therapies.

At this stage the only recommended alternative is the cholesterol-lowering medication Welchol, although this is not commercially available in Australia.

4.2.5 Intensification (“Herxing”)

CSM and BEG spray can cause intensification reactions commonly but incorrectly referred to as herxing or a herx especially in Lyme patients. This is because as biotoxins enter the bloodstream, instead of cell receptors, they cause a rise in inflammatory cytokines.

Symptoms will generally exacerbate along with worsening of VCS, in columns D and E, and MMP-9 will increase.

Start these interventions from 30 to 10 days before you start CSM. If intensification gets too much either lower the CSM dose or stop and then follow the intervention(s) below for 5-10 days before restarting CSM.

No amylose diet

A no amylose diet enhances the effectiveness of Actos or fish oil by a factor of 500.

Amylose is found in most grains, vegetables grown below the ground (root vegetables) and bananas. Read Dr. Shoemaker’s book Lose the weight you hate for in-depth advice. Similar diets include low carbohydrate, grain free, paleo diets such as the Bulletproof diet, Wahls Diet or Doug Kaufman’s Phase I diet for at least the duration of CSM treatment.

High dose fish oil OR Actos

Slender patients can use high dose fish oils to reduce intensification. This means fish oils where the daily total of EPA is a minimum of 2.4 grams per day and DHA is 1.8 grams for 10 days (CSM started on day 6) although you can stay on fish oils for longer.

Overweight patients with leptin levels above 8 may have more success with Actos (pioglitazone) a medication for diabetics at 45mg for 10 days (CSM started on day 6).

Note: Dr. Gupta hasn’t had good success with preventing intensification with fish oil thus far.

4.3 Step 3: MARCoNS testing and eradication

Multiple Antibiotic Resistant Coagulase Negative Staphylococci (MARCoNS) are bacteria that colonise in the nasopharynx area forming biofilms and creating exotoxins. These form due to low levels of MSH which protects mucus membranes, such as the nose and stomach, from microbes that can themselves lower MSH further. See the Biotoxin pathway diagram to see how hormones and immunity are affected in CIRS.

  • Obtaining tube (two ways)
    1. Order swab kit from Microbiology Dx free of charge. Go to the ‘Order Collection Kits’ page and fill in the details. You’ll need to put Australia onto the ‘City, State, Zip’ field. You will need to include your doctor’s details on the web form. Alternatively you can use an aerobic nasal swab from your doctor and get your doctor to fill out the requisition form.
    2. Order a kit via NutriPATH, who send it on to Microbiology Dx.
  • Performing swab
    • This can be done by a doctor or patient. The swab needs to go through the nose right up to the back of the throat, about 3 inches. Swivel the swab for 3-5 seconds when you reach the throat. It is unpleasant but not painful. See the blog post on Biotoxin Journey for directions.
  • Sending swab to Microbiology Dx
    • When used with the correct swab, the sample is viable for 14-30 days. There are several options for sending it to Microbiology Dx. The cheapest is normal air mail, letter ($2.75). You can also send the swab via Australia Post’s EMS Courier ($57-ish) or via FedEx (if ordering a kit from Microbiology Dx they provide a FedEx bag) costing around $80 AUD.
  • Sending swab to NutriPATH
    • Follow the instructions in the NutriPATH kit.
  • Cost
    • Currently the cost is $85 USD. The results will be emailed to your doctor. NutriPATH is more expensive.
  • Interpretation
    • If the culture reveals coagulase negative staph which are resistant to two or more antibiotics then you are positive for MARCoNS and should be treated with BEG or similar spray. The amount (“large amount” etc.) is not important. If the culture is methicillin resistant you may herx more. Staph coag positive (golden staph), staph coag neg with only one antibiotic resistance, non-staph bacteria, as well as fungus (if requested) are common findings and do not need to be treated generally.
  • Treatment
    • If positive for MARCoNS the usual treatment is 30 days or more of BEG nasal spray. BEG contains EDTA to break down the biofilms and two antibiotics (gentamicin, bactroban). If the MARCoNS is Gentamicin resistant than Rifampicin may be included instead. This combination is known as the BER spray. Intensification can occur and the gentamicin can irritate the nasal passages. If the MARCoNS is resistant to four or more antibiotic classes then EDTA alone in a nasal spray is used as that is all that is generally required to eradicate the organisms.
  • Alternative treatment
    • Neti pot or nasal spray of water with iodine / salt / xylitol (xyclear) / colloidal silver nasal spray may help. According to Greg Muske nebulised PVP-iodine is also very effective. See the More MARCoNS and Even more MARCoNS on the Biotoxin Journey site (free membership required).
  • Follow up testing
    • After one-two months of treatment it is recommended to repeat the MARCoNS test. If still positive, continue treatment with the appropriate spray until a negative culture is obtained.

4.4 Mid-level Steps: Correcting gluten intolerence, hormones and inflammatory factors

If you test positive for gliadin antibodies you should trial a gluten free diet for three months. Gluten intolerance/sensitivity is due to low MSH and not celiac disease in CIRS generally, although celiac still needs to be ruled out. Other steps to balance hormones and reduce inflammatory markers may be required and treated for, please consult with your health care practitioner.

4.5 Final Step: VIP Spray

Vasoactive Intestinal Polypeptide is a neuropeptide hormone that is predominately made in the hypothalamus and  along with MSH is critical in controlling inflammation and the immune system. In a 2013 study, and in clinical practice, Dr. Shoemaker found that VIP:

  • Increased plasma VIP levels
  • Reduced symptoms to the level of healthy controls
  • Reduced inflammatory cytokines (TGF-b1, C4a, MMP-9)
  • Increased VEGF
  • Balanced Treg immunity
  • Increased 25-Vitamin D levels
  • Normalised low testosterone levels in Males
  • Normalised high estradiol (estrogen) levels in Males
  • Increased tolerance to water damaged buildings

However there is a caveat to VIP therapy and that is if you are still being exposed to biotoxins from water damaged buildings or MARCoNS then instead of reducing inflammation VIP can increase it (TGF-b1, C4a). It is therefore imperative then that the following conditions must be met before using VIP spray.

  • You live, work, study in buildings with a HERTSMI-2 score of < 11
  • You pass the VCS test
  • You test negative for MARCoNS
  • You have normal lipase levels

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