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Concerns about lack of clinical evidence

“There are no well-controlled studies to support the use of the Marshall Protocol for a given indication.” This statement is accurate. In 2012, patients and physicians who chose to use and administer the MP did so based on the following evidence:
- a 2011 case series of MP patients appearing in the (Nature Publishing Group) journal Clinical & molecular immunology
- a 2008 retrospective survey of 100 MP patients with autoimmuneA condition or disease thought to arise from an overactive immune response of the body against substances and tissues normally present in the body diagnoses
- anecdotal physician and patient reports on MarshallProtocol.com, MEMBERS PROGRESS. Medical personnel need to log in to view those forums. (there are also about 20 patient interviews on the site Bacteriality.com)
- evidence that an immunostimulatory approach may be useful in chronic inflammatory diseases including, for example, reports of infection in these conditions
- evidence of OlmesartanMedication taken regularly by patients on the Marshall Protocol for its ability to activate the Vitamin D Receptor. Also known by the trade name Benicar. having beneficial effects on Cardiovascular function and kidney disease

For some physicians, the above evidence is not sufficiently compelling to warrant automatically starting a patient on the MP without further consideration. Here are some other factors which may play a role in the clinical judgment:

alternative hypotheses and evidence of research ¹⁾, ²⁾, ³⁾, ⁴⁾
evidence for the efficacy of MP versus other available treatment in 2013 data on patient response, see section below
patients' expressed preferences and values⁵⁾
additional benefits of Olmesartan other researched benefits
orphan drug status – Autoimmunity Research Foundation has won orphan drug status from the FDA for several medications and indications, and is committed to working further with the agency to get the MP approved for a broader range of indications.

Finally, a physician may want to try their patient on a therapeutic probeA brief trial of the Marshall Protocol to see if it will generate an immunopathological response. The "gold standard" for testing whether a patient is a good candidate for the MP.. While the randomized controlled trial or RCT is widely praised for its validity in identifying the efficacy of a therapy, according to a well-regarded evidence-based medicine textbook produced by JAMA, “clinicians cannot always rely on the results of randomized controlled trials…. In such cases, clinicians can conduct RCTs in individual patients (n-of-1 RCTs).” According to the 2009 edition, in an N-of-1 RCT the patient begins treatment and the subsequent clinical course determines whether treatment is continued.

Recorded results assessed 2013

DJ posted :- During the summer of 2013 I looked at 2,000 records of people using the Marshall Protocol.

Resulting in significant information pertaining to 864 patients who maintained the Marshall Protocol over a sufficient number of years and continued to report to the study site.

I tried my best to be unbiased as I was expecting to see about a 20% improvement in health of members, or in other words a 20-25% success rate.

I was intending to compare this to the 10% success rate I found done on the use of prednisone to treat Sarcoidosis. That double blind report shows that 10% treated with prednisone achieve remission. (BTW remission in Sarcoidosis as far as I can find out is measured rather subjectively)

(This) is what I found:

Sarcoidosis: 236 members; 179 success; 25 no success; 32 unsure

Chronic Fatigue Syndrome: 183 members; 110 success; 30 no success; 43 unsure

Lyme Disease: 169 members; 113 success; 23 no success; 33 unsure

Rheumatoid arthritis: 39 members; 27 success; 5 no success; 7 unsure

Fibromyalgia: 53 members; 34 success; 6 no success; 13 unsure

Other Th1 diseasesThe chronic inflammatory diseases caused by bacterial pathogens.: 184 members; 110 success; 30 no success 44 unsure

TOTALS: 864 members;573 report success; 119 report no success; and for 172 results are not clear.

SUCCESS RATES: Over all success rate 66.32% Over all unsuccessful 13.77% Over all unsure 19.91%

Sarcoidosis success 75.8%

Chronic Fatigue Syndrome success 60.1%

Lyme disease success 66.9%

Rheumatoid arthritis success 69.2%

Fibromyalgia success 64.2%

Concerns about olmesartan (Benicar)

Patients on the Marshall Protocol (MP) take olmesartan (Benicar)–a drug whose actions are fully known–every four to six hours. A substantial body of research supports the use of olmesartan as a part of a curative therapy for chronic disease.

“Higher than typical doses of olmesartan are unsafe.” Ample research supports the fact that olmesartan is one of the safest and has the most gentle side effects profiles of almost any drug on the market. Read more →
“Off-label use of medications is unsafe.” The United States FDA has issued clear Policy Guidance on off-label prescriptions, clearly stating that it is up to the physician's individual judgment to decide whether an off-label drug should be used. Read more →
“Using a hypotensive for patients with low blood pressure is unsafe.” Olmesartan is a weak hypotensive, reducing diastolic pressure by no more than 12 mm Hg in the dosages suggested by the Marshall Protocol guidelines. The NIH has created no medical standards that define low blood pressure, or a range in which low blood pressure is considered dangerous. Symptoms which appear to be caused by hypotension–dizziness, fatigue, lightheadedness– have been shown to resolve as the inflammationThe complex biological response of vascular tissues to harmful stimuli such as pathogens or damaged cells. It is a protective attempt by the organism to remove the injurious stimuli as well as initiate the healing process for the tissue. resolves, no matter the number of the blood pressure, and appear to be a result of the disease process. Read more →

Concerns about light avoidance

“Marshall Protocol patients are forced to wear special NoIR sunglassesSpecial sunglasses worn by Marshall Protocol patients to block light.–even when they do not need to.” –
Only those MP patients who become photosensitiveAbnormal sensitivity to sunlight and bright lights. Also referred to as "sun flare" or "light flare." should wear sunglasses. Those who aren't photosensitive (after seeing how the treatment affects them) will not need sunglasses. Read more →
“Latitude studies show that disease is reduced by light exposure.” –
Recent studies have compared rates of certain major cancers–most notably breast, colorectal and prostate cancer–to rates of sunlight exposure. This group of research has the liability of being wildly inconsistent. The choice to publish research on a specific latitude gradient may be a better proxy for a researcher's bias. Read more →

Concerns about antibiotics

-Antibiotics are no longer an integral part of the Protocol. They have been and may still be used to modulate symptoms, but seem to be responsible for delaying recovery in some patients, by suppressing immune response.
“Long-term antibiotic therapy is dangerous and will lead to development of antibiotic-resistant bacteria.”
In the the 40 years since the release of minocycline, the primary MP antibiotic, no significant species have been shown to be resistant to it. Minocycline is also one of the few antibiotics that remains active against the bacterial species Methicillin-resistant Staphylococcus aureus (MRSA), despite the fact that it has been prescribed for decades.

Concerns about vitamin D

Patients on the MP abstain from consumption of vitamin D. Although the secosteroid may currently enjoy a positive reputation in the media, molecular research shows that taking vitamin D exacerbates inflammatory disease.

“Avoiding consumption of vitamin D leads to rickets.” – The majority of cases of rickets occurs among children in developing countries who suffer from severe malnutrition. The disease is cited as a primary reason for consuming vitamin D regularly, even though research has demonstrated that rickets is not caused by vitamin D deficiency, but by hypophosphatemia. Read on →
“Avoiding consumption of vitamin D leads to depression or seasonal affective disorder.” – Light exposure does nothing to resolve an underlying disease state and can actually delay progress for MP patients. MP patients who have completed the treatment have been able to attest to the fact that sunshine is not necessary for good health or happiness. Read on →
“Avoiding consumption of vitamin D leads to cancer.” – A variety of studies has suggested that vitamin D protects against cancer. This seemingly intuitive proposition is supported by neither epidemiological nor molecular evidence. In fact, the very opposite has been demonstrated. Read on →
“Avoiding consumption of vitamin D leads to osteoporosis.” – While it is conventional wisdom that vitamin D supplementation reverses osteopenia and osteoporosis, a growing body of evidence, both molecular and epidemiological, shows this is not the case. Instead, current research has demonstrated that osteoporosis and osteopenia are often the direct result of infection with the Th1 pathogensThe community of bacterial pathogens which cause chronic inflammatory disease - one which almost certainly includes multiple species and bacterial forms., a metagenomic microbiotaThe community of bacterial pathogens including those in an intracellular and biofilm state which cause chronic disease., which produce inflammatory cytokines and inactivate the Vitamin D ReceptorA nuclear receptor located throughout the body that plays a key role in the innate immune response.. Read on →

Research with long-term followup

Thumbs Down on Calcium and Vitamin D to Prevent Hip Fracture

Supplementation and Fracture Incidence in Community-Dwelling Older Adults: A Systematic Review and Meta-analysis.

Evaluation of the Effect of Radiofrequency Radiation Emitted From Wi-Fi Router and Mobile Phone Simulator on the Antibacterial Susceptibility of Pathogenic Bacteria Listeria monocytogenes and Escherichia coli.
Altogether, the findings of this study showed that exposure to Wi-Fi and RF simulator radiation can significantly alter the inhibition zone diameters and growth rate for L monocytogenes and E coli. These findings may have implications for the management of serious infectious diseases. ⁶⁾

Previous studies have shown that exposure of microorganisms to RF-EMFs can be associated with a wide spectrum of changes ranged from the modified bacterial growth to the alterations of the pattern of antibiotic resistance.

Our laboratory at the nonionizing department of the Ionizing and Non-ionizing Radiation Protection Research Center has performed experiments on the health effects of exposure to animal models and humans to different sources of electromagnetic fields such as cellular phones, mobile base stations, mobile phone jammers, laptop computers, radars, dentistry cavitrons, magnetic resonance imaging, and Helmholtz coils.

resources for physicians, research

Section to print off - Independent research into Olmesartan with PMIDs for doctor.

¹⁾

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²⁾

Marshall TG, Lee RE, Marshall FE. Common angiotensin receptor blockers may directly modulate the immune system via VDR, PPAR and CCR2b. Theor Biol Med Model. 2006 Jan 10;3:1. doi: 10.1186/1742-4682-3-1.
[PMID: 16403216] [PMCID: 1360063] [DOI: 10.1186/1742-4682-3-1]

³⁾

Proal AD, Albert PJ, Marshall TG. The human microbiome and autoimmunity. Curr Opin Rheumatol. 2013 Mar;25(2):234-40. doi: 10.1097/BOR.0b013e32835cedbf.
[PMID: 23370376] [DOI: 10.1097/BOR.0b013e32835cedbf]

⁴⁾

Marshall TG. Vitamin D discovery outpaces FDA decision making. Bioessays. 2008 Feb;30(2):173-82. doi: 10.1002/bies.20708.
[PMID: 18200565] [DOI: 10.1002/bies.20708]

⁵⁾

Murad MH, Montori VM, Guyatt GH. Incorporating patient preferences in evidence-based medicine. JAMA. 2008 Dec 3;300(21):2483; author reply 2483-4. doi: 10.1001/jama.2008.730.
[PMID: 19050187] [DOI: 10.1001/jama.2008.730]

⁶⁾

Taheri M, Mortazavi SMJ, Moradi M, Mansouri S, Hatam GR, Nouri F. Evaluation of the Effect of Radiofrequency Radiation Emitted From Wi-Fi Router and Mobile Phone Simulator on the Antibacterial Susceptibility of Pathogenic Bacteria Listeria monocytogenes and Escherichia coli. Dose Response. 2017 Jan 23;15(1):1559325816688527. doi: 10.1177/1559325816688527. eCollection 2017 Jan-Mar.
[PMID: 28203122] [PMCID: 5298474] [DOI: 10.1177/1559325816688527]

Table of Contents

Physicians' concerns about the Marshall Protocol