empirical treatment

Medical Hypotheses and Proposed Clinical Research

This page summarizes our salient medical hypotheses and tentative clinical research agenda. First read our About page for better context and for some definitions. Then read the present page in the order it is presented.

Our proposed trials build on one another, working towards our ultimate goal of empirically treating multiple chronic diseases with a robust multi-interventional natural medicine protocol. Although we will publish many hypotheses and narrative reviews – either through our article series or through peer-reviewed journals – this page only mentions those which are both directly related to our proposed clinical research and which we will be putting through peer-review.

As we progress through an estimated 5 year preliminary task of completing our article series, we will have ample opportunity to dialogue with you, the reader, to help us define, adjust, (scrap?), and elaborate upon our hypotheses and research goals. And of course, there is always the possibility that “the eyes are bigger than the stomach”, as the proverb goes. But with the support of our community, we expect to be able to overcome any logistical challenges. This is a long-term vision, and we hope you will help us patiently work it out.

Elicitation of Jarisch-Herxheimer Reactions in Chronic Lyme Disease Patients Using “Rife” Machines

Royal Raymond Rife was a notable physician of the early 1900’s who invented an electromagnetic device that was intended to treat cancer and infectious diseases. Since the 1980’s, individuals with suspected chronic Lyme disease (CLD) started inventing and applying electromagnetic devices with the intention of treating their own infections. Though these modern devices are highly diverse and bear no technical similarity to the device of Dr. Rife, they are all popularly referred to as “Rife machines”. Anecdotally, some individuals who considered themselves to have CLD have improved or completely recovered with the use of such machines. And as with many other anti-infective treatments used by CLD patients, there are many anecdotal reports of Jarisch-Herxheimer reactions (JHR) from the use of Rife machines, popularly referred to as “herx reactions”. Some of these reactions have been so severe that they could theoretically be life-threatening. JHR’s are periods of exacerbation of symptoms believed to be due to a transient spike in biotoxins released by dying pathogenic organisms and an increase in inflammatory cytokines. Such reactions were first noted in the treatment of syphilis. Like Borrelia burgdorferi – the causative agent of Lyme disease – syphilis is also a spirochete (a spiral or corkscrew-shaped organism). One of the most common methods of using electromagnetism with the intention to treat CLD has been to use any of a number of Rife machines capable of exposing the body to a relatively strong 432Hz electromagnetic field for a duration that usually ranges from seconds to minutes. There is microscopic-videographic evidence that electromagnetic frequencies ranging from 0 to 3,000 hertz are capable of inhibiting live microorganisms, including 432Hz inhibiting the movement of spirochete organisms cultured from the oral cavity.

Strangely, the JHR itself has literally never been studied in a controlled setting. We propose enrolling 50 patients diagnosed with CLD and 50 healthy controls in this trial. Within each group, patients will be randomized to receive a short exposure to a 432Hz electromagnetic field, or a sham treatment. Subjective reports of the incidence and severity of JHRs will be collected. Patients will be invited for multiple treatments in order to safely ramp up the time of exposure to the active treatment, so as to not cause JHRs of excessive severity. This will also give more opportunity for subjects to observe JHRs with greater accuracy.

We hypothesize the following:

  1. The CLD subgroup receiving active treatment will report significantly greater incidence and severity of JHRs than the healthy control subgroup receiving active treatment.
  2. Within both the CLD and healthy groups respectively, active treatment will elicit significantly greater incidence and severity of JHRs than sham treatments, with this effect being more pronounced within the CLD group.
  3. Active groups will correctly guess the group they are in significantly more than controls, with this effect being more pronounced within the CLD group.

If our hypothesis is correct, all of the following might be gleaned from this study:

  1. The JHR is a real phenomenon that should not be brushed off as psychosomaticism among CLD patients.
  2. Both CLD patients and healthy controls may have an active Borrelia infection which makes them susceptible to JHRs.
  3. The CLD group’s greater susceptibility to JHRs as compared to healthy controls may be explained by a greater severity of infection.
  4. Electromagnetic sensitivity is a real phenomenon and should not be brushed off as psychosomaticism.
  5. Underlying infection may predispose individuals to EMF sensitivity.
  6. Low-frequency electromagnetic exposure could potentially offer a novel means of both diagnosing (through series) and treating CLD, and should be further investigated. The same might be true of other infections.

Long-term trials of antibiotics in the treatment of CLD are in our opinion naive. Effective clinicians are employing antibiotics in combination, rotation, and pulsation. Existing trials completely ignore these complexities. And aside, these trials are designed to test efficacy of a treatment, and are not suitable for testing accuracy of a diagnosis. If we wish to indicate the presence of infection, we suggest that researchers have been looking at the wrong time frame. We hypothesize that more reliable differences between patient groups would be found if we looked at the immediate-term effects of anti-infectives, rather than the long-term. Our proposed trial will be a first in this regard.

A Review of Electrically Isolated Silver (a.k.a. Colloidal Silver)

Electrically Isolated Silver Tyndall Effect

Strong Tyndall effect indicates the presence of large silver-containing colloids.

Electrically isolated silver (EIS) is an anti-infective which is at present grossly misunderstood, with there being a nearly complete vacuum of accurate peer-reviewed information on the subject. Since EIS will be a component of multiple of our planned clinical trials, there is a need to first publish a review of the subject.

The term EIS was coined by Jason Eaton (silvermedicine.org) and Stephen Quinto (Natural Immunogenics). EIS is defined as any silver-containing material that meets the following criteria:

  1. It is an aqueous solution and/or suspension whose only theoretical ingredients are silver, hydrogen, and/or oxygen. Although in practice there will be trace amounts of contamination such as carbon and nitrogen.
  2. All the silver is in stable solution and/or suspension owing to electrical properties. In the case of silver ions (Ag+), the electrical property is ionic repulsion. In the case of silver-containing colloids, the property is an electrostatic repulsion called zeta potential.

By far the most common species of EIS sold on the market is a solution/suspension of silver made by a process of low-voltage direct current (LVDC) electrolysis. Two silver electrodes are submerged in distilled water, and a voltage is applied between them. Silver ions then migrate from the anode into solution. Some silver ends up forming either silver oxide (Ag2O) or silver hydroxide (AgOH). These silver compounds then agglomerate into particles, which are stable colloids with a negative zeta potential. These particles may vary in diameters ranging from less than 1nm to more than 100nm, depending on the physical parameters of the electrolysis process. The total concentration of silver typically ranges from 3ppm to 26ppm. Typically, somewhere from 80% to 95% of the silver is in the form of ions, and the remaining 5% to 20% is in colloidal suspension. Since this material is by far the most prevalent species of EIS, whenever no speciation of EIS is overtly stated, the term EIS by default refers to this species, produced by LVDC electrolysis. Although it is this form of EIS which is most commonly denoted by the popular term “colloidal silver” (CS), the term is somewhat of a misnomer, or at least misleading. Hence, we endorse the term EIS.

Any material that meets the definition of EIS, and further meets the criteria that more than 50% of the mass of silver is present in the form of stable colloids may be defined as “colloidal silver”. So by these definitions, all colloidal silver is EIS, but not all EIS is colloidal silver. Aside from EIS, the other major classes of silver-containing aqueous medicinals are silver compounds and silver proteins. Silver proteins generally contain large particles of silver bonded to proteins such as gelatin or casein. The proteins keep the silver in suspension, else it would precipitate.

Not strictly a safety concern, argyria is a cosmetic condition where human skin may take on a gray or blue tint owing to the bioaccumulation of silver through various routes of administration. Peer-reviewed literature expresses a rather unfair and inaccurate phobia of silver owing to a perceived potential to cause argyria. The fact of the matter is that most such published papers have serious errors. They tend to lump all classes of silver medicinals into one and treat them equivalently. They also make inadequate distinction regarding route of administration, absolute dosage, concentration, or frequency. And they make no mention at all of predisposing nutritional factors or preventative steps that can be taken. Also there is no mention of the fact that some cases of argyria have even been reversed. While improper use of silver can and does cause argyria – and undoubtedly misinformation on the internet has contributed to such cases – there does in fact appear to be a set of proper parameters that can reduce the chance of developing argyria to almost literally zero. And the most important parameter among these is to use only EIS and no other species of silver medicinal. To the best of our knowledge, there are exactly zero published cases of argyria being caused by EIS. The one or possibly two cases that we are aware of have not been published, and have obvious caveats where the argyria could have been avoided. Furthermore, the available evidence suggests that EIS is 100% eliminated from the body, being mostly recovered in the urine.

Regarding safety, EIS is virtually nontoxic. In fact, even therapeutic levels of silver may fall within the EPA’s allowable limit for drinking water. Most silver compounds are also safe, but some may be caustic if not diluted properly. Even people who exhibit argyria from ingesting silver compounds fail to have any obvious health consequences. Silver proteins however are of significant safety concern. They have been reported to cause sharp drops in blood counts and can also be contaminated with bacterial pyrogens.

Numerous in vitro and animal studies demonstrate the extraordinary broad-spectrum antibacterial, antifungal, antiprotozoal, and antiviral properties of EIS. And thousands of anecdotes from patients and physicians suggest a remarkable efficacy. Yet strangely, not even a single controlled trial has ever been conducted with EIS in the treatment of any internal infection. It is because EIS has been irrationally relegated to this undeserved limbo that we find it necessary to publish a review, before subsequently testing EIS in multiple clinical trials.

There is also evidence that EIS may have anticancer properties. It also appears to be an extremely effective burn treatment.

Hypothesis – Ubiquitous Multiple Chronic Infections Require Empiric Therapy

In our article series, we will identify five classes of environmental causes of chronic disease. We consider chronic infectious disease to be one of these five. As our article series progresses through our review of all the major chronic diseases we face today, we will find that virtually without exception, every one of them has been linked to multiple chronic infectious diseases. In our opinion, the sheer number of possible infections and the infeasibility of cost-effective testing make precise diagnosis a lost cause. Hence we argue that what we need is to develop more robust methods of empirical treatment.

One of the many facets of this hypothesis that we will review is that low levels of 25-hydroxy vitamin D may not solely be a sign of vitamin D deficiency, but can also be a sign of vitamin D dysregulation. Low levels of 25-hydroxy vitamin D may actually be accompanied by high levels of the active metabolite 1,25-dihydroxy vitamin D. A high ratio of the latter to the former indicates vitamin D dysregulation. Furthermore, the cause of such vitamin D dysregulation may actually be the presence of chronic infection.

Empirical Treatment of Chronic Infection with Electrically Isolated Silver

To test the aforementioned hypothesis of ubiquitous chronic infection, we will randomize 100 individuals of various health statuses to receive either electrically isolated silver (EIS) or a placebo for 6 months. Within the last year, patients should not have taken vitamin D supplements, should not have been on a sugar-avoidance or Candida diet, and should not have intentionally treated themselves for suspected infection using any over-the-counter materials such as essential oils, or coconut oil. Patients should have never ingested any silver-containing supplement. Patients will be advised to ramp-up the dose of EIS (or placebo) as to allow control over the severity of potential JHRs, with a target dose of 8 fl. oz. of 10ppm EIS, once a day on empty stomach. Outcomes measured will be vitamin D ratio, total levels of different antibodies, CBC, metabolic panel, inflammatory markers, subjective measures of Jarisch-Herxheimer reactions (JHRs), subjective measures of overall health, and self-imposed dosing schedule. We hypothesize the following will occur in the EIS group, relative to the placebo group:

  1. Vitamin D ratio will significantly decrease.
  2. One or more types of antibodies and inflammatory markers will significantly decrease.
  3. Significantly greater incidence and severity of JHRs will be reported
  4. Subjects will self-impose a significantly slower ramp-up of dosage.
  5. Significantly greater improvements in overall health will be reported.
  6. A significantly greater percentage of patients will accurately guess which group they are in (i.e. unblinding).
  7. Slowness of ramp-up, severity of JHRs, improvement in health, and unblinding will be associated with improved inflammatory markers.

Furthermore, we hypothesize that in the EIS group the following will occur:

  1. CBC and metabolic panels will indicate a lack of toxicity.
  2. Incidence and severity of JHRs will trend towards zero by the end of the trial period.

Given that the only known appreciable effects of EIS that could explain such results are its anti-infective properties, these hypothetical results would indicate that people of various health statuses are exhibiting active chronic infectious disease, and that EIS is an effective anti-infective. Antibodies, inflammatory markers, and vitamin D ratio may be markers of overall chronic infectious burden. Slower self-imposed ramp-up schedules would indicate an intentional effort to limit the severity of JHRs, and hence indicate the presence of infection. Gradual resolution of susceptibility to JHRs would suggest a reduction in infectious burden, and refute a hypothesis of intrinsic side effects due to EIS. Furthermore, EIS may be a suitable material for the empirical treatment of chronic infectious disease.

Empirical Treatment of Chronic Infection with Herbal Polypharmacy

In our article series, we will put forth the hypothesis that simultaneously dosing thousands of phytochemicals in relatively minute amounts may have advantages compared to the generally practiced (and polar opposite) approach of dosing single chemicals in relatively large doses. We propose developing an herbal formula that contains extracts of 100 different herbs (most likely as essential oils). These herbs will be selected based on their anti-infective, anticancer, antitoxicant, antibiofilm, and antilithic properties. This novel approach is an extreme case example of herbal polypharmacy (HPP). We hypothesize that this HPP may provide all of the following benefits:

  1. Efficacy in the treatment of both cancer and infection. We will review evidence that suggests that the complementary activity of myriad phytochemicals may be enough to amount to clinical efficacy, despite their relatively minute amounts.
  2. Reduction of potential for drug-resistance in both cancer and infection, owing to the difficulty of evading the effects of thousands of chemicals simultaneously.
  3. Reduction or elimination of toxicity through emphasizing herbs with a history of dietary use or established low toxicity, through emphasizing the inclusion of herbs with antitoxicant properties, and through phenomena we term diversification of toxicity, and beneficial countervailing.
  4. Potentiation of other anti-infectives and chemotherapies.
  5. Enhanced elimination of heavy metals.
  6. Adequate reproducibility of results despite batch-to-batch variations, owing to a robustness of the treatment.

We propose a trial that will test some (but not all) of these hypothesized benefits. We propose enrolling 100 individuals of various health statuses who will be randomized to receive either the herbal polypharmacy (HPP) or a placebo for 6 months. Within the last year, patients should not have taken vitamin D supplements, should not have been on a sugar-avoidance or Candida diet, and should not have intentionally treated themselves for suspected infection using any over-the-counter materials such as essential oils, coconut oil, or silver-containing supplements. Patients will be advised to ramp-up the dose of HPP (or placebo) as to allow control over the severity of potential JHRs. The target dose will be determined by preliminary animal experiments. Outcomes measured will be vitamin D ratio, total levels of different antibodies, CBC, metabolic panel, inflammatory markers, urinary metals, subjective measures of Jarisch-Herxheimer reactions (JHRs), subjective measures of overall health, and self-imposed dosing schedule. We hypothesize the following will occur in the HPP group, relative to the placebo group:

  1. Vitamin D ratio will significantly decrease.
  2. One or more types of antibodies and inflammatory markers will significantly decrease.
  3. Significantly greater incidence and severity of JHRs will be reported
  4. Subjects will self-impose a significantly slower ramp-up of dosage.
  5. Significantly greater improvements in overall health will be reported.
  6. Significantly greater masses of heavy metals will be excreted through urine.
  7. A significantly greater percentage of patients will accurately guess which group they are in.
  8. Slowness of ramp-up, severity of JHRs, improvement in health, and unblinding will be associated with improved inflammatory markers.

Furthermore, we hypothesize that in the HPP group the following will occur:

  1. CBC and metabolic panels will indicate a lack of toxicity.
  2. Incidence and severity of JHRs will trend towards zero by the end of the trial period.

If our hypothesis is correct, then these results would mirror those of the previous trial of electrically isolated silver (EIS). Although the possible mechanisms of action of herbs are many compared to EIS, these hypothetical results would still further suggest that people of various health statuses may be exhibiting active chronic infectious disease, and that HPP is an effective anti-infective approach. Antibodies, inflammatory markers, and vitamin D ratio may be markers of overall chronic infectious burden. Slower self-imposed ramp-up schedules would indicate an intentional effort to limit the severity of JHRs, and hence indicate the presence of infection. Gradual resolution of susceptibility to JHRs would suggest a reduction in infectious burden, and refute a hypothesis of intrinsic side effects due to HPP. Furthermore, HPP may be a suitable material for the empirical treatment of chronic infectious disease. HPP would also appear to assist in the elimination of heavy metals.

Multi-Interventional Treatments for Infectious Diseases

We propose testing multi-interventional treatments in a number of diagnosed chronic infectious diseases. Where possible, we will consider treating infectious diseases that are considered preventable by vaccinations, such as HPV. The treatments would at minimum include electrically isolated silver (EIS), herbal polypharmacy (HPP), and liposomal vitamin C. Other anti-infective therapies might also be incorporated. Ideally, this combination would be tested against standard treatments. Outcome measures will vary according to the disease.

We may also consider investigating the use of EIS and liposomal vitamin C in sepsis.

An Environmental Hypothesis of Chronic Disease – The Case for Robust Multi-Interventional Empirical Treatment Using Natural Medicines

Upon completing our online article series, we will have seen a clear pattern emerge about the environmental etiologies of chronic disease. In short, many of the chronic diseases we face today are not truly distinct diseases, but are really different flavors of one overarching environmental complex disease. Once this is understood, we argue multi-interventional empirical treatment using natural medicines is an effective approach to treating chronic disease. We will collate our research into a single peer-reviewed hypothesis in which we will espouse all of the following:

  1. The incidences of chronic diseases we see today have grown at rates that cannot be primarily explained by increased diagnosis, longer lifespan, randomness, or genetic inheritance.
  2. The likelihood of one disease being environmental further cannot typically be viewed in strict isolation from other diseases, but must be viewed in a Bayesian framework. Other diseases being primarily environmental may increase the likelihood of a disease in question being environmental.
  3. The field of epigenetics has shown environmental factors have the ability to alter the expression of the human genome to extents previously not thought possible.
  4. Heritability studies may assume disease is caused by genes or environment, but not the interaction between the two. This is a poor assumption.
  5. The set of known environmental etiologies must always be taken as a lower bound on the complete set of environmental etiologies. There will always exist factors we have yet to identify.
  6. There are five major classes of environmental etiologies that have been thoroughly documented in peer-reviewed literature. These are poor diet and nutritional deficiency, stress and lifestyle, toxicants, food allergies and intolerances, and chronic infection.
  7. Virtually every major chronic disease that we face today is associated with multiple members of each and every one of these five classes of environmental etiologies. This phenomenon can be termed environmental etiological complexity.
  8. Individual environmental causes (such as a particular toxicant, particular dietary habit, particular infection etc.) are frequently linked to many chronic diseases, and not just one. This phenomenon can be called environmental etiological overlap.
  9. Each of these five classes of environmental etiologies are not distinct but are rather interdependent. There are many known pathways by which members within a given class of environmental etiologies can cause or exacerbate members of a different class. For example, chronic infection could lead to food allergies, which in turn could lead to malabsorption and nutritional deficiency, which could in turn weaken immunity and worsen infection, which in turn makes someone severely stressed, etc. This phenomenon can be termed environmental etiological entanglement.
  10. Individual natural medicines that target environmental etiologies have frequently shown clinical benefit in many chronic diseases, and not just one. Many have also been associated with reductions in all-cause mortality. Hence we can say an individual natural medicine may exhibit therapeutic versatility, and a set of diseases exhibit therapeutic overlap.
  11. Clinical trials that have treated chronic disease by targeting multiple environmental etiologies and/or by using multiple versatile natural medicines simultaneously have produced impressive results. Furthermore, numerous physicians are already successfully treating chronic diseases using similar models of decision-making, albeit calling them by various names.
  12. Because of all the aforementioned points, and because of a lack of convincing competing hypotheses, the primary causes of chronic disease today must be environmental.
  13. It thus follows that individual environmental etiologies must be evaluated conditioned on the fact that we know the set of true etiologies must primarily belong to the set of environmental etiologies. Hence, we must tend towards giving environmental associations with chronic disease extra probabilistic weight.
  14. The environmental causes of chronic disease are evolving rapidly. We must face the possibility that the present paradigm of evidence-based medicine that aims to make decisions by emphasizing a high level of evidence for each and every isolated treatment and etiology may not be able to keep pace with the evolution of chronic disease. Furthermore, testing isolated interventions may be unable to adequately account for the aforementioned issues of complexity and entanglement. Interventions tested individually may appear ineffective, and yet be effective when tested in combination. Hence, other more adaptive paradigms of research and treatment decision-making should be investigated in order keep pace with disease.
  15. It must be remembered that in evidence-based medicine, predominantly using therapies with “strong” evidence is only a heuristic, and it is not truly possible to prove what constitutes an optimal treatment decision in any given instance.
  16. An optimal treatment decision must balance overage and underage costs. Owing to the inherently toxic nature of many drugs, as well as the highly biased and questionable nature of industry-generated science, the overage costs of using FDA-approved drugs are often very high. However, the overage costs of using many relatively nontoxic natural medicines that have varying levels of evidence are often very low.
  17. The efficacy of a multi-interventional treatment must be viewed in the proper probabilistic light. For example, if 10 simultaneous interventions (for which we assume independence and no overage costs) each have only a 10% probability of benefit in a given disease (NNT= (1/0.1)=10), then the probability of at least one intervention benefiting is 65% (1-(0.910)=0.65). Thus the overall treatment has a Number-Needed-To-Treat (NNT) of 1.5. Natural medicines lend themselves to such a scenario owing to low overage costs and therapeutic versatility. This line of thinking is further merited by the complementary (and at times synergistic) action of many natural medicines, which we will review.
  18. Except in situations where immediate stabilization is needed, it is sensible to always address upstream environmental etiologies prior to embarking on indefinite drug therapies that have narrow downstream biological targets and give no chance of cure.
  19. Because of all of the aforementioned points, a viable decision-making heuristic is to employ a method of empirical treatment that is so robust that it simultaneously or sequentially targets all (or many) possible environmental etiologies (regardless of whether or not they have been or can be diagnosed within a given individual), and that simultaneously incorporates many nontoxic natural medicines that exhibit therapeutic versatility. If such an approach is well-formulated, probabalistically, it can virtually guarantee clinical benefit in the vast majority of chronic diseases. We term this paradigm of treatment decision-making as Robust Empirical Treatment (RET).

What we are proposing is not a one-size-fits-all approach. It is a one-wardrobe-fits-all approach.

The Earth Med Protocol – A Robust Multi-Interventional Natural Medicine Protocol in the Empirical Treatment of Multiple Chronic Diseases

We will test the aforementioned hypothesis through the following trials. Based on the research we will review in our article series, we will formulate a robust, nontoxic, multi-interventional natural medicine protocol that is aimed at optimizing the empirical treatment of chronic disease. Tentative interventions may include the following:

  1. Dietary changes such as eliminating refined sugar and processed foods, adding select therapeutic foods such as coconut oil (an antifungal) and flax seed meal (a source of parent essential fatty acids), drinking magnetically-treated filtered water, alcohol discontinuation, and using table salt that has a balance of sodium and potassium.
  2. Food allergy elimination guided by both subjective sense and IgG antibody testing.
  3. Exercise.
  4. Sun bathing.
  5. Meditation practices.
  6. A liposomal formula including vitamins (A, B-complex, C, D, full spectrum E, full spectrum K), phytochemicals (green tea extract, curcumin, resveratrol, astaxanthin, ecklonia cava extract), and endogenous chemicals (glutathione, alpha-lipoic acid, acetyl-L-carnitine, CoQ10).
  7. A complete mineral supplement which includes generally neglected healthful minerals (such as silica, lithium, boron, molybdenum, rubidium, iodine, indium, vanadium, chromium, etc.), and which diversifies the forms of minerals by chelating a portion of each to the amino acid glycine.
  8. An amino acid and MSM supplement, formulated in ratios shown to cause the amino acids to almost entirely follow the anabolic pathway.
  9. Herbal polypharmacy, as previously discussed.
  10. Electrically isolated silver, as previously discussed.
  11. A novel individualized do-it-yourself probiotic fermented drink.
  12. Oral hygiene modifications, including a calcium toothpaste and a sodium chlorite mouthwash.
  13. Energy oriented therapies such as sleeping above a negative pole magnetic pad, sleeping on a grounded bed sheet, sleeping underneath an EMF-shielding bed sheet, remediating blue-light exposure in the home, and otherwise altering exposure to man-made EMFs.
  14. If necessary, relocating away from a moldy environment.
  15. Discontinuation of prescription drugs, as becomes relevant.

As needed, other individualized therapies may also be used. More comments about the formulation of all of the aforementioned supplements can be read on our About page. Owing to the complexity of this protocol, each patient will be required to enroll a patient advocate to help patients understand and comply with the protocol. Online forums will be established to enable group dialogue between trial participants as well as investigators. Control groups will receive their respective standard treatments. Where unavoidable, the test protocol may include standard drugs and other treatments as adjuncts, with a view to tapering drugs if health improves sufficiently. Most trial durations are tentatively 1 year. We will consider testing this protocol (or modifications thereof) in all of the following chronic diseases, disorders, and scenarios:

Type 2 diabetes and diabetic neuropathy, fibromyalgia, rheumatoid arthritis, osteoporosis, COPD, chronic fatigue syndrome, hypertension, heart disease, Alzheimer’s disease, Parkinson’s disease, Crohn’s disease, kidney disease, multiple sclerosis, obesity, schizophrenia, autism, chronic Lyme disease, congestive heart failure, multiple cancers, mold illness.

We may also consider tailoring multi-interventional treatments for the following diseases and scenarios:

Stroke recovery, chronic spinal cord injury, vaccine-injury recovery, antidepressant discontinuation, and opiod discontinuation.

Primary outcomes will be specific to each disease, but there will also be a standardized set of secondary outcomes such as vitamin D ratio, total levels of different antibodies, CBC, metabolic panel, inflammatory markers, subjective measures of Jarisch-Herxheimer reactions (JHRs), subjective measures of overall health, self-imposed dosing schedule, infectious morbidity, infectious mortality, all-cause mortality, and hospitalization.

We hypothesize that benefit will be evident from the treatment in most or all trials. Furthermore, we hypothesize that instances of dramatic reversal or complete remission will be documented in several trials. If our hypothesized results prove correct, this set of clinical trials may collectively demonstrate the validity of a decision-making paradigm that offers a more adaptive complement to that of evidence-based medicine.

We may also at some point consider doing a large prospective long-term study of our protocol that looks at all-cause mortality as the primary outcome. We hypothesize a large reduction would be evident.

 

Shifting to a lighter note, we have a couple trials planned related to beauty:

The Effect of Amino Acids and MSM on Hair Loss and Hair and Skin Quality

Human hair is composed virtually of 100% amino acids by mass. Trials have shown that cysteine, MSM, and gelatin all improve the quality and/or quantity of hair. However, no one has ever tested complete amino acid supplementation in combination with MSM. The amino acid cysteine comprises only approximately 15% of the mass of hair. What would happen if the other 85% of the mass of hair was represented in an amino acid supplement, along with MSM? Similarly, individual amino acids have shown cosmetic benefit for skin. What effect would complete amino acid and MSM supplementation have on the appearance of skin? We have preliminary evidence that the effect of such a supplement is pronounced in both skin and hair.

We propose conducting a controlled trial in men with hair loss. One group will receive the amino acid and MSM supplement, and the other will not. Both groups will receive standardized hair cuts at the start and end of the trial. They will also have photographs of both hair and skin taken in a controlled environment at the start and end of the trial. Scalp hair density, individual hair density, eyelash length, and hair shine will all be measured before and after. Blinded assessors will be asked to rate the overall beauty of the photographed hair and skin, as well as hair samples, for before and after. Trial duration is tentatively four months. We hypothesize the treatment group will show significant benefits in all measured outcomes, and that the blinded assessors will nearly 100% identify the “after” photographs and hair samples as being more attractive. Both groups will undergo CBC and metabolic panels. We hypothesize a lack of toxicity from the treatment.

Treatment of Hair Loss with Amino Acids, MSM, Dermarolling, and Minoxidil

While amino acids, MSM, dermarolling, and minoxidil have all shown potential benefit in the treatment of male pattern baldness, the combination of these treatments has never been tested. We have preliminary evidence that not only does this combination treatment have the potential to completely remit male pattern baldness and improve the quality of individual hairs, but the results also appear to be permanent, even after discontinuing minoxidil. Research suggests that gains due to minoxidil usually completely regress by two years after discontinuation. We propose an uncontrolled trial where before and after photographs will be taken. We hypothesize that the treatment will yield complete and obvious remission of hair loss that is sustained two years after discontinuing both minoxidil and dermarolling, while continuing amino acids.

This concludes our tentative research agenda.

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