The Pall Protocol for Treating CFS/ME

Dr. Martin Pall’s NO/ONOO– (“No! Oh, no!”) hypothesis is probably the most comprehensive explanation of cellular dysregulation in CFS and other oxidative stress illnesses. His model proposes that the chronic stage of CFS is driven by a vicious cycle of oxidative stress, in which the basic mechanisms that are meant to control pathogens don’t turn off. The result is oxidants run amok, creating havoc in the cell’s energy cycles, and increasing inflammation.

The protocol described here was originally put together by Dr. Pall and by Dr. Grace Ziem. It is based on antioxidant treatments which break the vicious cycle of oxidative stress as well as other agents that act to lower other parts of the cycle, such as lowering inflammatory responses, improving mitochondrial function and lowering excessive NMDA activity. However, taking large quantities of single antioxidants can actually increase oxidative stress. Once antioxidants such as tocopherols (vitamin E), vitamin C, and flavonoids react with free radicals, these antioxidants are themselves converted into free radicals. Other antioxidants are then needed to neutralize those newly formed free radicals. Therefore, a wide variety of antioxidants is optimal.

PLEASE NOTE: Dr. Pall emphasizes that he is a Ph.D., not an M.D., and none of these therapies should be viewed as medical advice.

Below is a list of Dr. Pall’s therapies. More detailed information follows.

  1. Nebulized reduced glutathione
  2. Nebulized inhaled hydroxocobalamin
  3. Mixed natural tocopherols
  4. Buffered C
  5. Magnesium, as malate
  6. Four flavonoids: gingko, cranberry extract, silymarin and bilberry
  7. Selenium, as selenium-grown yeast
  8. CoQ10
  9. Folic acid
  10. Carotenoids including lycopene, lutein and B carotene
  11. Alpha lipoic acid
  12. Zinc (modest dose), manganese (low dose), copper (low dose)
  13. Vitamin B6, as pyridoxal phosphate
  14. Riboflavin 5′-phosphate
  15. Betaine (trimethylglycine)
  16. Acetyl-carnitine
  17. Taurine

Detailed antioxidant protocol:

Vitamin C. Pall suggests doses on the order of 500 to 1000 mg/day, taken several times per day. Vitamin C can act to regenerate tetrahydrobiopterin (BH4) and, therefore, may act to lower nitric oxide synthase (NOS) uncoupling, and high doses of vitamin C can be useful in scavenging peroxynitrite (ONOO–), the most central element in his NO/ONOO– cycle hypothesis.

CoQ10. CoQ10 has been used in a number of diseases to improve mitochondrial function. It scavenges free radicals, protects against loss of mitochondrial respiratory function, increases energy metabolism, and down regulates NMDA activity. Take early in the day.

Magnesium. This mineral lowers NMDA activity, reducing excitotoxicity. Dr. Pall believes that “magnesium is one of the most promising agents for treatment of multisystem diseases, but, like other such agents, it produces modest responses and may best be used in a complex, combination therapy.”

Selenium. Selenium is considered an antioxidant because certain proteins that contain selenium have antioxidant properties. Selenium occurs in glutathione peroxidases, enzymes that eliminate peroxide in cells. Selenium is also essential in making T3, the most active form of thyroid hormone. The best form of selenium is selenomethionine, which is a selenium-grown yeast. (For those who are yeast-sensitive, there are non-yeast forms.)

Carotenoids. These are plant pigments which are quite active in scavenging free radicals. Lycopene is more active than beta-carotene as a peroxynitrite scavenger. Lutein and zeaxanthin, two carotenoids, may also have special roles as antioxidants because of the way they insert into biological membranes.

Flavonoids. Anthocyanidins, which are found in purple plants, lower inflammatory activity, act as potent chain-breaking antioxidants, and regenerate other chain-breaking antioxidants after they have been converted to free radicals. Flavonoids also act as chelators for free iron, protecting cells from oxidative damage. Many flavonoids are soluble in both water and lipids. Flavonoids from green tea, citrus, grape seed extract, gingko, soy, olive, hawthorn, blueberry, and purple rice are effective antioxidants. Silymarin scavenges peroxynitrite, and increases the synthesis of SOD (superoxide dismutase), which makes it especially important. Flavonoids are rapidly absorbed in foods, and are quickly excreted through the kidneys, so they need to be eaten (or taken) throughout the day.

Acetyl-L-carnitine. Carnitine transports fatty acids into mitochondria, and is therefore essential for providing cellular energy. Acetyl-L-carnitine is more effective than L-carnitine because most oral L-carnitine ends up being excreted by the kidneys before it can be transported through the blood-brain barrier. Acetyl-L-carnitine is transported more efficiently. Recently, it has been shown that acetyl-L-carnitine lowers excessive NMDA activity and this may well be more important than the effects on mitochondrial function for lowering the NO/ONOO– cycle.

Reductive Stress Agents. Reductive stress causes oxidative stress. Methyl groups – SAMe, betaine, and carnitine – act as protective agents. Dr. Pall’s preference for a methylated compound is betaine (TMG.) It is cheaper and more stable than SAMe.

Hydroxocobalamin form of B12. B12 is a potent nitric oxide scavenger, but it is difficult to absorb. Oral absorption of B12 is limited by intrinsic factor. [Independent of intrinsic factor, the absorption rate of B12 is less than 1% of the total amount ingested.] Hydroxocobalamin taken as a nasal spray or injection is more effective.

Folate (folic acid). Reduced folate decreases uncoupling of NOS activity. Reduced folate in the form of 5-methyltetrahydrofolate (5-MTHF) is a potent scavenger of peroxynitrite and may well turn out to be among the most useful agents for lowering the NO/ONOO– cycle. Optimal dosage may well vary among different individuals but, in general, it should be taken along with quite a bit of vitamin C (at least 500 mg and preferably perhaps twice this amount). The reaction between peroxynitrite and 5-MTHF is important not only because it can be used to lower peroxynitrite levels. It is also important because in NO/ONOO– diseases, elevated peroxynitrite will act to lower the levels of 5-MTHF, lowering methylation cycle activity, and will also act to lower all reduced folates in the body. In this way, lowered methylation activity may be caused by the NO/ONOO– cycle.

B6, as P5P. B6 minimizes neurotoxicity. The best form is pyridoxine phosphate (P5P).

Riboflavin. Riboflavin is important for the production of reduced glutathione. It is also useful in the treatment of migraine.

Alpha Lipoic Acid (ALA) scavenges free radicals. As an added benefit, it can regenerate other antioxidants by reducing oxidized and free radical forms of glutathione, tocopherols, vitamin C and flavonoids. It can maintain glutathione pools by turning oxidized glutathione into its active form, reduced glutathione. ALA can cross the blood-brain barrier, making it an effective tool for reducing damage due to oxidative stress in the brain.

Zinc, Manganese and Copper. These minerals are components of superoxide dismutases (SOD), the enzymes that convert the oxidant superoxide into hydrogen peroxide and oxygen. Zinc, copper and manganese deficiencies can produce oxidative stress, part of which may be due to the lowered ability to produce SODs. Doses of these metals can be tricky. Excessive levels of copper and manganese can themselves produce oxidative stress. Excessive zinc lowers copper levels. Dr. Pall suggests “modest levels.”

Taurine is an unusual amino acid, because it is an antioxidant as well as a neurotransmitter. Taurine acts to stimulate the synthesis of GABA, and is transported easily across the blood-brain barrier, allowing it to work in the brain. Taurine stimulates several inhibitory receptors, leading to lowered NMDA activity. It also acts to lower intracellular calcium levels, thus lowering NO synthesis.

Long-chain omega-3 fatty acids. Polyunsaturated fatty acids (PUFAs) are more susceptible to lipid peroxidation than are other fatty acids, and consequently they tend to be depleted whenever there is oxidative stress. Fish oil, borage oil and flaxseed oil are sources of long-chain omega-3 fatty acids.

Curcumin, honokiol (from magnolia), cat’s claw, vinpocetine and feverfew all reduce inflammation by lowering NF-kappaB activity, as do a number of conventional pharmaceuticals.

Vitamin E should not be taken as synthetic alpha-tocopherol, which is the most commonly taken form, Pall argues. Rather, it should be taken as relatively high doses of gamma-tocopherol and tocotrienols with modest amounts of natural alpha-tocopherol. These other forms of vitamin E have important functions, such as lowering inflammation, scavenging an important breakdown product of peroxynitrite, lowering excessive NMDA activity and improving mitochondrial function, all important for lowering NO/ONOO– cycle diseases.

Algal supplements. Both chlorella and blue-green algae are rich in antioxidants. Blue-green algae contain phycocyanin, which is a potent free radical scavenger.

FURTHER READING:

Pall, Martin. Explaining “Unexplained Illnesses”: Disease Paradigm for Chronic Fatigue Syndrome, Multiple Chemical Sensitivity, Fibromyalgia, Post-Traumatic Stress Disorder, Gulf War Syndrome and Others. New York: Harrington Park Press, trade division of Haworth Press, Inc. 2007.

This book is technical, but well worth reading. Dr. Pall has made a remarkable contribution to the study of “unexplained illnesses.”

“How Can We Cure NO/ONOO– Cycle Diseases: Approaches to Curing Chronic Fatigue Syndrome/Myalgic Encephalomyelitis, Fibromyalgia, Multiple Chemical Sensitivity, Gulf War Syndrome and Possibly Many Others.” Martin Pall. Townsend Letter. Feb/March 2010.

Excellent paper by Martin Pall on agents that lower parts of the NO/ONOO? cycle. Contains detailed information on protocols and potential therapeutic agents. 

Martin Pall – MEPedia’s comprehensive page on Dr. Pall includes publications, talks, interviews, papers, and more.

Antioxidant Suggestions from Dr. Martin Pall, Ph.D.  Tables of supplements recommended by Dr. Pall, along with mechanisms and comments.


Development and Implementation of an Online Patient Education Program for Children and Adolescents With Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, Their Parents, Siblings, and School Personnel: Protocol for the Prospective BAYNET FOR ME/CFS Study

Abstract:

Background: Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) presents significant challenges for affected children and adolescents, their social environment, and treating physicians, due to its profound impact on quality of life and the lack of causal therapeutic approaches. One crucial aspect of care that has been missing for these patients is comprehensive education for both them and their social circles.

Objective: This study protocol aims to outline the goals, study design, execution, and evaluation of the subproject within the BAYNET FOR ME/CFS project. The focus is on developing online education programs for children and adolescents with ME/CFS, as well as for their parents, siblings, and school staff. These programs are designed to improve independent disease management, increase knowledge, and promote interaction with other affected individuals.

Methods: In phase I, the group-based online education programs were developed by a multidisciplinary team based on the ModuS concept created by the Competence Network for Patient Education (KomPaS). These programs were then piloted and finalized. Phase II involved recruiting participants and implementing the finalized programs. Given the restricted physical and cognitive capacities of the affected individuals, the patient education programs were exclusively designed in a digital format to facilitate participation. In phase III, the programs will be evaluated for acceptance, completeness, and participant satisfaction. The qualitative assessment will focus on individual expectations and benefits derived from the training. Phase IV will further assess the programs in terms of improvements in disease knowledge, health-related quality of life, life satisfaction, and family burden.

Results: The programs were developed, piloted, and finalized during phase I, which ran from December 2022 to May 2023. The pilot phase, from March to May 2023, led to adaptations in the program concept. In total, 8 patients and their parents, 5 siblings, and 59 school staff participated in the piloting. Adjustments were made to the format, content, duration, and schedule to better meet the needs of the affected individuals and their social circles. In phase II, participant recruitment for the patient education program took place from January to July 2023. The study successfully recruited 24 young patients with ME/CFS and their parents, along with 8 siblings and 51 school staff. Two program blocks for patients and parents and 2-3 blocks for siblings and school staff commenced in May 2023 and were completed within the same year. Phase III began after phase II and involves the evaluation of the programs, with the process expected to conclude by the end of 2024. Phase IV, planned for 2025-2026, will involve the rollout of the program to 150 children and their caretakers. This phase will focus on evaluating disease knowledge, health-related quality of life, life satisfaction, and family burden, as well as include longitudinal assessments.

Conclusions: The data aim to support the development of a comprehensive, interprofessional care model for children and adolescents with ME/CFS.

Source: Keicher F, Thomann J, Erlenwein J, Schottdorf M, Reiter NL, Scholz-Schwärzler NP, Vogel B, Warlitz C, Stojanov S, Augustin S, Goldbrunner L, Schanz L, Dodel V, Zipper C, Schiweck N, Jaeschke R, Saramandic M, Wiejaczka K, Eberhartinger M, Dettmer K, Hattesohl DBR, Englbrecht S, Behrends U, Spiegler J. Development and Implementation of an Online Patient Education Program for Children and Adolescents With Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, Their Parents, Siblings, and School Personnel: Protocol for the Prospective BAYNET FOR ME/CFS Study. JMIR Res Protoc. 2024 Nov 21;13:e54679. doi: 10.2196/54679. PMID: 39570662. https://www.researchprotocols.org/2024/1/e54679 (Full text)

Home-based testing protocol to measure physiological responses to everyday activities in ME: a feasibility study

Abstract:

Background and objectives: Individuals with Myalgic Encephalomyelitis (ME) have shown altered physiological responses during maximum cardiopulmonary exercise testing. However, maximal testing is not representative of the everyday activities reported to cause or increase symptoms in ME, and is not accessible for those with severe or very severe illness. The aim of this study was to assess the feasibility and acceptability of a home-based testing protocol to measure physiological responses in ME to everyday activity.

Methods: Researchers attended participants’ homes to collect data and provide equipment for independent testing. Adults with ME who met the International Consensus Criteria wore a portable metabolic assessment system and a physiological stress monitor. Blood pressure, heart rate, oxygen saturation and lactic acid were assessed during a range of everyday positions and activities in their own homes.

Results: Online recruitment yielded 70 volunteers in 24 h. 17 eligible individuals reflecting a range of illness severities were enrolled. All participants found the procedures acceptable with 12 (70%) subjects completing every listed activity. Apparent physiological abnormalities were identified in all participants.

Conclusion: Physiological measurement during everyday activities was feasible for our participants who represented a range of ME severities. Activities must be adapted for different levels of severity to avoid significant symptom exacerbation. Further research is needed to develop home-based assessment protocols to advance the biobehavioral understanding of ME.

Trial registration number: ISRCTN78379409

Source: Nicola Clague-Baker, Sarah Tyson, Karen Leslie, Helen Dawes, Michelle Bull & Natalie Hilliard (2023) Home-based testing protocol to measure physiological responses to everyday activities in ME: a feasibility study, Fatigue: Biomedicine, Health & Behavior, DOI: 10.1080/21641846.2023.2245584 https://www.tandfonline.com/doi/full/10.1080/21641846.2023.2245584 (Full text)

The Facilitation of Clinical and Therapeutic Discoveries in Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome and Related Diseases: A Protocol for the You + ME Registry Research Platform

Abstract:

Background: ME/CFS (Myalgic Encephalomyelitis / Chronic Fatigue Syndrome) is a chronic, complex, heterogeneous disease that affects millions and lacks both diagnostics and treatments. Big data, or the collection of vast quantities of data that can be mined for information, has transformed the understanding of many complex illnesses like cancer and multiple sclerosis, by dissecting heterogeneity, identifying subtypes, and enabling the development of personalized treatments. It is possible that big data can reveal the same for ME/CFS.

Objective: To describe the protocol for the You + ME Registry, present preliminary results related to participant enrollment and satisfaction, and discuss the limitations of the registry as well as next steps.

Methods: Solve M.E. developed and launched the You + ME Registry to collect longitudinal health data from people with ME/CFS, people with Long COVID (LC) and control volunteers using rigorous protocols designed to harmonize with other groups collecting data from similar groups of people.

Results: The Registry now has over 4,200 geographically-diverse participants (3,033 people with ME/CFS, 833 post-COVID, and 473 control volunteers) with an average of 72 new people registered every week. It has qualified as “great” using a Net Promotor Score, indicating registrants are likely to recommend to a friend. Analyses of collected data are currently underway and preliminary findings are expected in the near future.

Conclusions: The Registry is an invaluable resource because it integrates with a symptom tracking app, as well as a biorepository, to provide a robust and rich dataset that is available to qualified researchers. Accordingly, it facilitates collaboration that may ultimately uncover causes and help accelerate the development of therapies.

International registered report: DERR1-10.2196/36798.

Source: Ramiller A, Mudie K, Seibert E, Whittaker S. The Facilitation of Clinical and Therapeutic Discoveries in Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome and Related Diseases: A Protocol for the You + ME Registry Research Platform. JMIR Res Protoc. 2022 Jun 5. doi: 10.2196/36798. Epub ahead of print. PMID: 35816681. https://pubmed.ncbi.nlm.nih.gov/35816681/ https://preprints.jmir.org/preprint/36798/accepted (Full study available as PDF file)

Considerations in establishing a post-mortem brain and tissue bank for the study of myalgic encephalomyelitis/chronic fatigue syndrome: a proposed protocol

Abstract:

BACKGROUND: Our aim, having previously investigated through a qualitative study involving extensive discussions with experts and patients the issues involved in establishing and maintaining a disease specific brain and tissue bank for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), was to develop a protocol for a UK ME/CFS repository of high quality human tissue from well characterised subjects with ME/CFS and controls suitable for a broad range of research applications. This would involve a specific donor program coupled with rapid tissue collection and processing, supplemented by comprehensive prospectively collected clinical, laboratory and self-assessment data from cases and controls.

FINDINGS: We reviewed the operations of existing tissue banks from published literature and from their internal protocols and standard operating procedures (SOPs). On this basis, we developed the protocol presented here, which was designed to meet high technical and ethical standards and legal requirements and was based on recommendations of the MRC UK Brain Banks Network. The facility would be most efficient and cost-effective if incorporated into an existing tissue bank. Tissue collection would be rapid and follow robust protocols to ensure preservation sufficient for a wide range of research uses. A central tissue bank would have resources both for wide-scale donor recruitment and rapid response to donor death for prompt harvesting and processing of tissue.

CONCLUSION: An ME/CFS brain and tissue bank could be established using this protocol. Success would depend on careful consideration of logistic, technical, legal and ethical issues, continuous consultation with patients and the donor population, and a sustainable model of funding ideally involving research councils, health services, and patient charities. This initiative could revolutionise the understanding of this still poorly-understood disease and enhance development of diagnostic biomarkers and treatments.

 

Source: Nacul L, O’Donovan DG, Lacerda EM, Gveric D, Goldring K, Hall A, Bowman E, Pheby D. Considerations in establishing a post-mortem brain and tissue bank for the study of myalgic encephalomyelitis/chronic fatigue syndrome: a proposed protocol. BMC Res Notes. 2014 Jun 18;7:370. doi: 10.1186/1756-0500-7-370. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4076507/ (Full article)

 

Comparing specialist medical care with specialist medical care plus the Lightning Process for chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME): study protocol for a randomised controlled trial (SMILE Trial)

Abstract:

BACKGROUND: Chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME) is a relatively common and potentially serious condition with a limited evidence base for treatment. Specialist treatment for paediatric CFS/ME uses interventions recommended by National Institute for Health and Clinical Excellence (NICE) including cognitive behavioural therapy, graded exercise therapy and activity management. The Lightning Process (LP) is a trademarked intervention derived from osteopathy, life-coaching and neuro-linguistic programming, delivered over three consecutive days as group sessions. Although over 250 children with CFS/ME attend LP courses each year, there are no reported studies on the effectiveness or cost-effectiveness.

METHODS: This pragmatic randomised controlled trial is set within a specialist paediatric CFS/ME service in the south west of England. Children and young people with CFS/ME (n = 80 to 112), aged 12 to 18 years old will be randomised to specialist medical care (SMC) or SMC plus the LP. The primary outcome will be physical function (SF-36 physical function short form) and fatigue (Chalder Fatigue Scale).

DISCUSSION: This study will tell us whether adding the LP to SMC is effective and cost-effective compared to SMC alone. This study will also provide detailed information on the implementation of the LP and SMC.

TRIAL REGISTRATION: Current Controlled Trials ISRCTN81456207 (31 July 2012).

 

Source: Crawley E, Mills N, Hollingworth W, Deans Z, Sterne JA, Donovan JL, Beasant L, Montgomery A. Comparing specialist medical care with specialist medical care plus the Lightning Process for chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME): study protocol for a randomised controlled trial (SMILE Trial). Trials. 2013 Dec 26;14:444. doi: 10.1186/1745-6215-14-444. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3879423/ (Full article)