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 ====== Marshall Protocol ====== ====== Marshall Protocol ======
 +
 +<relatedarticles> [[home:starting:usingforum:home_help_using_forums:a_a_href|5 key elements of MP]] </article>
  
 This document is a one-article summary of key issues related to the Marshall Protocol, especially those relevant to physicians.  Many of the topics covered here are reviewed in greater depth throughout the Knowledge Base.  This document is a one-article summary of key issues related to the Marshall Protocol, especially those relevant to physicians.  Many of the topics covered here are reviewed in greater depth throughout the Knowledge Base. 
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 We strongly urge physicians and patients to take advantage of the following websites: We strongly urge physicians and patients to take advantage of the following websites:
-  * **AutoimmunityResearch.org** – Visit [[http://AutoimmunityResearch.org|AutoimmunityResearch.org]] for Foundation information and links to patient stories.+  * **AutoimmunityResearch.org** – Visit [[https://AutoimmunityResearch.org|AutoimmunityResearch.org]] for Foundation information and links to patient stories.
   * **MPKB.org** – The Marshall Protocol Knowledge Base contains links to peer-reviewed research from the Foundation as well as articles about hundreds of topics written for a variety of audiences.   * **MPKB.org** – The Marshall Protocol Knowledge Base contains links to peer-reviewed research from the Foundation as well as articles about hundreds of topics written for a variety of audiences.
   * **MarshallProtocol.com** – The [[https://MarshallProtocol.com|MarshallProtocol.com]] site helps patients and physicians better understand and engage with details about the application of the Marshall Protocol. It contains science-related discussions and patient reports of response to the protocol. The site has [[home:starting:usingforum:registering|open registration]] for physicians, patients, and those considering the protocol.    * **MarshallProtocol.com** – The [[https://MarshallProtocol.com|MarshallProtocol.com]] site helps patients and physicians better understand and engage with details about the application of the Marshall Protocol. It contains science-related discussions and patient reports of response to the protocol. The site has [[home:starting:usingforum:registering|open registration]] for physicians, patients, and those considering the protocol. 
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 Other patient groups: Other patient groups:
   * **[[home:special:pregnancy|pregnant/lactating women]]** – Both olmesartan and minocycline, the two mainstay medications of the MP, are contraindicated during pregnancy and while breastfeeding. Women of childbearing age on the MP should take adequate contraceptive precautions.   * **[[home:special:pregnancy|pregnant/lactating women]]** – Both olmesartan and minocycline, the two mainstay medications of the MP, are contraindicated during pregnancy and while breastfeeding. Women of childbearing age on the MP should take adequate contraceptive precautions.
-  * **[[home:special:children|children]]** – Children with certain diseases and conditions have been treated with the MP. There are more than a dozen in the study cohort who are doing well. The FDA [[http://www.prnewswire.com/news-releases/fda-approves-benicarr-for-the-treatment-of-high-blood-pressure-in-children-and-adolescents-aged-6-16-84104997.html|recently approved]] the use of olmesartan for hypertensive children ages 6-16.+  * **[[home:special:children|children]]** – Children with certain diseases and conditions have been treated with the MP. There are more than a dozen in the study cohort who are doing well. The FDA [[https://www.prnewswire.com/news-releases/fda-approves-benicarr-for-the-treatment-of-high-blood-pressure-in-children-and-adolescents-aged-6-16-84104997.html|recently approved]] the use of olmesartan for hypertensive children ages 6-16.
  
 Before commencing therapy, physicians and patients should familiarize themselves with the [[home:starting:prempchecklist|pre-MP checklist]], which reviews the medications, eye protection, and possible lifestyle modifications necessary for treatment success and safety. Before commencing therapy, physicians and patients should familiarize themselves with the [[home:starting:prempchecklist|pre-MP checklist]], which reviews the medications, eye protection, and possible lifestyle modifications necessary for treatment success and safety.
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 Patients on the MP often benefit from wearing [[home:lifestyle:light:noirs|glasses that block a broader spectrum of light]] and in many cases must cover their skin when in the sun. Further guidelines are available at the Knowledge Base articles on [[home:lifestyle:light:eye_protection|Eye protection]] and [[home:lifestyle:light:skin_protection|Skin protection]]. Patients on the MP often benefit from wearing [[home:lifestyle:light:noirs|glasses that block a broader spectrum of light]] and in many cases must cover their skin when in the sun. Further guidelines are available at the Knowledge Base articles on [[home:lifestyle:light:eye_protection|Eye protection]] and [[home:lifestyle:light:skin_protection|Skin protection]].
  
-[{{ :home:figure2.gif?450|**Example of immunopathology** – Patients on the MP, such as this 50-year-old male with ankylosing spondylitis, tend to experience temporary increase in markers of inflammation.((Proal AD, Albert PJ, Blaney GP, Lindseth IA, Benediktsson C, Marshall TG. 2011.  //Cell Mol Immunol//. [[http://www.ncbi.nlm.nih.gov/pubmed?term=21278764|Immunostimulation in the era of the metagenome]].))}}]+[{{ :home:figure2.gif?450|**Example of immunopathology** – Patients on the MP, such as this 50-year-old male with ankylosing spondylitis, tend to experience temporary increase in markers of inflammation.((Proal AD, Albert PJ, Blaney GP, Lindseth IA, Benediktsson C, Marshall TG. 2011.  //Cell Mol Immunol//. [[https://www.ncbi.nlm.nih.gov/pubmed?term=21278764|Immunostimulation in the era of the metagenome]].))}}]
  
  
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 If these markers indicate dysfunction sustained for more than several months, we advising using [[home:mp:managing_immunopathology|one or more methods]] to lower immunopathology levels. If these markers indicate dysfunction sustained for more than several months, we advising using [[home:mp:managing_immunopathology|one or more methods]] to lower immunopathology levels.
  
 +**//See also//** [[home:diseases:kidney_disease|Kidney information]]
  
  
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 There are two main vitamin D metabolites: There are two main vitamin D metabolites:
-  * **1,25-dihydroxyvitamin D (1,25-D)** – The presence of high levels of this active vitamin D hormone in patients suggests an ongoing chronic inflammatory disease process.(({{pubmed>long:19758177}})) However, the absence of elevated levels does not mean a patient cannot benefit from treatment particularly since non-MP therapies such as TNF-alpha blockers and other unknown drugs and interventions can alter 1,25-D levels. Whenever possible, use the lab Quest Diagnostics. Quest has recently ceased to routinely freeze the 1,25-D samples, as we find necessary. However, the 1,25-D sample will not be frozen unless the patient specifically asks. +  * **1,25-dihydroxyvitamin D (1,25-D)** – The presence of high levels of this active vitamin D hormone in patients suggests an ongoing chronic inflammatory disease process.(({{pmid>long:19758177}})) However, the absence of elevated levels does not mean a patient cannot benefit from treatment particularly since non-MP therapies such as TNF-alpha blockers and other unknown drugs and interventions can alter 1,25-D levels. Whenever possible, use the lab Quest Diagnostics. Quest has recently ceased to routinely freeze the 1,25-D samples, as we find necessary. However, the 1,25-D sample will not be frozen unless the patient specifically asks. 
-  * **25-hydroxyvitamin D (25-D)** – Unlike 1,25-D, serum samples of 25-D need not be frozen. 25-D is a secosteroid with possible immunosuppressive effects.(({{pubmed>long:17557889}})) Thus, patients on the MP restrict consumption of vitamin D in order to reduce their 25-D at or below 12 ng/ml. Levels of 25-D should be tested every 6-12 months. //Be aware that as 25-D levels fall, immunopathology may increase, sometimes dramatically.//+  * **25-hydroxyvitamin D (25-D)** – Unlike 1,25-D, serum samples of 25-D need not be frozen. 25-D is a secosteroid with possible immunosuppressive effects.(({{pmid>long:17557889}})) Thus, patients on the MP restrict consumption of vitamin D in order to reduce their 25-D at or below 12 ng/ml. Levels of 25-D should be tested every 6-12 months. //Be aware that as 25-D levels fall, immunopathology may increase, sometimes dramatically.//
  
 If the vitamin D metabolite tests do not indicate Th1 inflammation but clinical observation suggests otherwise, a short course of the MP (1 to 2 months) should be used as a therapeutic probe. A longer time period may be needed if 25-D levels remain high, as a therapeutic probe is often not effective unless 25-D levels fall below 25 ng/ml. If the vitamin D metabolite tests do not indicate Th1 inflammation but clinical observation suggests otherwise, a short course of the MP (1 to 2 months) should be used as a therapeutic probe. A longer time period may be needed if 25-D levels remain high, as a therapeutic probe is often not effective unless 25-D levels fall below 25 ng/ml.
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 A decline in systolic pressure greater than 15mm Hg of mercury cannot solely be due to olmesartan’s hypotensive action. Instead, the drop is also likely due to the disease processes itself. A decline in systolic pressure greater than 15mm Hg of mercury cannot solely be due to olmesartan’s hypotensive action. Instead, the drop is also likely due to the disease processes itself.
  
-For example, the widespread destruction of bacteria and human cells infected by bacteria can lower blood pressure. Although this isn’t true of all bacterial forms, when some forms of bacteria are destroyed, they release endotoxins,(({{pubmed>long:7619330}})) the bioavailability of which can lead to a steep decline in blood pressure.(({{pubmed>long:8479465}}))+For example, the widespread destruction of bacteria and human cells infected by bacteria can lower blood pressure. Although this isn’t true of all bacterial forms, when some forms of bacteria are destroyed, they release endotoxins,(({{pmid>long:7619330}})) the bioavailability of which can lead to a steep decline in blood pressure.(({{pmid>long:8479465}}))
  
 If a patient suffers low blood pressure before the MP, low blood pressure will return as a symptom of immunopathology while on the MP. In most cases, we find as bacterial die-off subsides, blood pressure levels begin to return to a normal range even as patients continue to take the same dose of olmesartan. If a patient suffers low blood pressure before the MP, low blood pressure will return as a symptom of immunopathology while on the MP. In most cases, we find as bacterial die-off subsides, blood pressure levels begin to return to a normal range even as patients continue to take the same dose of olmesartan.
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 For the purposes of the MP, olmesartan has two primary actions: it reduces inflammation by blocking the Nuclear Factor-kappaB cytokine pathway and it is an agonist of the Vitamin D Receptor (VDR). As a VDR agonist, olmesartan activates the innate immune response. Research supports the safety of the doses used by MP patients. Olmesartan has minimal interactions with other drugs and is one of the safest drugs on the market. For the purposes of the MP, olmesartan has two primary actions: it reduces inflammation by blocking the Nuclear Factor-kappaB cytokine pathway and it is an agonist of the Vitamin D Receptor (VDR). As a VDR agonist, olmesartan activates the innate immune response. Research supports the safety of the doses used by MP patients. Olmesartan has minimal interactions with other drugs and is one of the safest drugs on the market.
  
-The half-life of olmesartan is reported to be 13 hours. This would imply that the drug would remain active during that period of time, however, we have found that in sick patients, olmesartan is most effective when administered every 4-6 hours, with a maximum of every 8 hours. This may be due to the fact that some intracellular infections (notably //Shigella//), upregulate activity of the caspases, which are proteases that cleave the VDR.(({{pubmed>long:17696608}})) When the VDR is broken apart by the caspases, it is highly likely that any ligands bound to it (such as olmesartan) would stay bound to the fragments of the protein. Therefore, a VDR agonist would be effective over shorter periods of time in patients with infected cells.+The half-life of olmesartan is reported to be 13 hours. This would imply that the drug would remain active during that period of time, however, we have found that in sick patients, olmesartan is most effective when administered every 4-6 hours, with a maximum of every 8 hours. This may be due to the fact that some intracellular infections (notably //Shigella//), upregulate activity of the caspases, which are proteases that cleave the VDR.(({{pmid>long:17696608}})) When the VDR is broken apart by the caspases, it is highly likely that any ligands bound to it (such as olmesartan) would stay bound to the fragments of the protein. Therefore, a VDR agonist would be effective over shorter periods of time in patients with infected cells.
  
-The [[http://www.fda.gov/|U.S. Food and Drug Administration]] has set no safe limit for olmesartan medoxomil (Benicar), as no dose-related adverse events have been identified to this point. FDA post-marketing-experience has shown that Olmesartan has one of the safest profiles of any drug on the market. Note that this does not apply to the combination drugs, such as Benicar HCT, which contains a [[home:othertreatments:diuretics|thiazide]] and //is// harmful, and should //never// be used with an MP dosing schedule.+The [[https://www.fda.gov/|U.S. Food and Drug Administration]] has set no safe limit for olmesartan medoxomil (Benicar), as no dose-related adverse events have been identified to this point. FDA post-marketing-experience has shown that Olmesartan has one of the safest profiles of any drug on the market. Note that this does not apply to the combination drugs, such as Benicar HCT, which contains a [[home:othertreatments:diuretics|thiazide]] and //is// harmful, and should //never// be used with an MP dosing schedule.
  
 The [[https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021286s025lbl.pdf|label for olmesartan medoxomil]] states that the drug is well-tolerated. Adverse events were similar to those experienced by the placebo group. Adverse events were generally “mild, transient and not related to dose.” The frequency of adverse events also had no relationship to the dose of olmesartan. The [[https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021286s025lbl.pdf|label for olmesartan medoxomil]] states that the drug is well-tolerated. Adverse events were similar to those experienced by the placebo group. Adverse events were generally “mild, transient and not related to dose.” The frequency of adverse events also had no relationship to the dose of olmesartan.
  
-A 2001 study published in the //Journal of of Pharmacology// found olmesartan to be safe and well tolerated at dosages of up to 160 mg/day.(({{pubmed>long:11361048}}))+A 2001 study published in the //Journal of of Pharmacology// found olmesartan to be safe and well tolerated at dosages of up to 160 mg/day.(({{pmid>long:11361048}}))
  
-In placebo-controlled trials, the only side effect that occurred in more than 1 percent of olmesartan-treated patients vs. placebo-treated patients was dizziness (3 percent vs. 1 percent).(({{pubmed>long:15291377}}))+In placebo-controlled trials, the only side effect that occurred in more than 1 percent of olmesartan-treated patients vs. placebo-treated patients was dizziness (3 percent vs. 1 percent).(({{pmid>long:15291377}}))
  
 The relevant Knowledge Base article reviews the [[home:protocol:olmesartan:safety|safety profile of olmesartan/Benicar]] in greater detail. The relevant Knowledge Base article reviews the [[home:protocol:olmesartan:safety|safety profile of olmesartan/Benicar]] in greater detail.
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   - **For patients taking corticosteroids, begin olmesartan** – Corticosteroids are contraindicated for MP patients. Before weaning them, patients should first begin olmesartan (see below), which can greatly relieve withdrawal symptoms and help ensure weaning success. It is recommended that olmesartan be started a week or two before beginning to wean. See the [[home:othertreatments:corticosteroids:weaningoffsteroids|weaning guidelines]] for detailed instructions.   - **For patients taking corticosteroids, begin olmesartan** – Corticosteroids are contraindicated for MP patients. Before weaning them, patients should first begin olmesartan (see below), which can greatly relieve withdrawal symptoms and help ensure weaning success. It is recommended that olmesartan be started a week or two before beginning to wean. See the [[home:othertreatments:corticosteroids:weaningoffsteroids|weaning guidelines]] for detailed instructions.
   - **Withdraw or begin to wean contraindicated therapies**   - **Withdraw or begin to wean contraindicated therapies**
-  - **Avoid EMF** [[http://www.newsweek.com/cell-phone-italy-cancer-mobile-phone-brain-tumor-587704|Mobile phone brain tumor]]  **[[https://mpkb.org/home/lifestyle#avoid_where_possible_immune_suppression|avoid  immune suppression]]** +  - **Avoid EMF** [[https://www.newsweek.com/cell-phone-italy-cancer-mobile-phone-brain-tumor-587704|Mobile phone brain tumor]]  **[[https://mpkb.org/home/lifestyle#avoid_where_possible_immune_suppression|avoid  immune suppression]]** 
   - **If necessary, avoid light** – If necessary to avoid the symptoms of photosensitivity, patients should avoid outdoor light and bright indoor lights by staying indoors as much as possible, using heavy curtains or window shades, and covering up well whenever venturing outside during daylight hours. Patients may also need to protect their eyes from both outdoor and indoor light.   - **If necessary, avoid light** – If necessary to avoid the symptoms of photosensitivity, patients should avoid outdoor light and bright indoor lights by staying indoors as much as possible, using heavy curtains or window shades, and covering up well whenever venturing outside during daylight hours. Patients may also need to protect their eyes from both outdoor and indoor light.
   - **Begin olmesartan** – Commence therapy by prescribing 40mg pure olmesartan medoxomil every six hours (e.g.: 6am, noon, 6pm, midnight) to interrupt the inflammatory cycle and reduce the severity of potential immunopathology. Our observations suggest that olmesartan medoxomil is the only angiotensin receptor blocker (ARB) that activates the patient’s innate immune system. "No substitutions" should be written on the prescription. Avoid any combination formulation such as Benicar hydrochlorothiazide (Benicar HCT). Because patients often begin to feel worse when decreasing light and/or vitamin D, olmesartan should be prescribed concurrently with the previous steps, so that it can palliate any resulting immunopathology while the 25-D levels are decreasing.  Patients should keep several weeks’ supply of olmesartan in reserve to use in case it is needed to treat intolerable immunopathology.   - **Begin olmesartan** – Commence therapy by prescribing 40mg pure olmesartan medoxomil every six hours (e.g.: 6am, noon, 6pm, midnight) to interrupt the inflammatory cycle and reduce the severity of potential immunopathology. Our observations suggest that olmesartan medoxomil is the only angiotensin receptor blocker (ARB) that activates the patient’s innate immune system. "No substitutions" should be written on the prescription. Avoid any combination formulation such as Benicar hydrochlorothiazide (Benicar HCT). Because patients often begin to feel worse when decreasing light and/or vitamin D, olmesartan should be prescribed concurrently with the previous steps, so that it can palliate any resulting immunopathology while the 25-D levels are decreasing.  Patients should keep several weeks’ supply of olmesartan in reserve to use in case it is needed to treat intolerable immunopathology.
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 All Other Th1 disease success 59.8%  All Other Th1 disease success 59.8% 
 +<nodisp>
 ===== Notes and comments ===== ===== Notes and comments =====
  
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   - CureMyTh1.org references removed during transition to closing that site. --- //Joyful 01.04.2014//   - CureMyTh1.org references removed during transition to closing that site. --- //Joyful 01.04.2014//
  
-New Danish study on Zith: http://www.nlm.nih.gov/medlineplus/news/fullstory_136424.html +New Danish study on Zith: https://www.nlm.nih.gov/medlineplus/news/fullstory_136424.html 
-===== References =====+===== References =====</nodisp> 
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