Protocol for Long Haul COVID-19

In June 2021, Front Line COVID-19 Critical Care Alliance (FLCCC Alliance) released a protocol for Long Haul COVID-19 Syndrome (LHCS). FLCCC Alliance, led by Dr. Paul Marik, is the same group of researchers that developed the MATH+ protocol for COVID-19 patients.

The group’s I-RECOVER Management Protocol addresses the many, often debilitating symptoms experienced after infection, including fatigue, headaches, sleep difficulties, smell disorder, decreased appetite, painful joints, dyspnea, chest pain, and cognitive dysfunction. The symptoms are similar to chronic inflammatory response syndrome (CIRS)/myalgic encephalomyelitis/chronic fatigue; but those with LHCS tend to recover on their own, “albeit slowly.” Marik reports, “…many consider post-COVID-19 to be a variant of the mast cell activation syndrome.”

LHCS can affect people who received a COVID-19 injection (“likely due to monocyte activation by the spike protein from the vaccine”) as well those who were infected with the actual virus. Younger people and those who had mild-to-moderate infections appear to be more affected by LHCS than older people or those with co-morbidities. FLCCC Alliance says, “It is likely that delayed treatment (with ivermectin) in the early symptomatic phase will result in a high viral load, which increases the risk and severity of LHCS.”

No government health agency has provided guidance on LHCS treatment. I-RECOVER protocol was developed in collaboration with expert clinicians, including Dr. Mobeen Syed, Dr. Ram Yogendra, Dr. Bruce Patterson, and Dr. Tina Peers. Because no clinical treatment trials for LHCS have been conducted, the group says, “these recommendations are based on the pathophysiologic mechanisms of COVID-19 and post-viral illnesses along with our collective experience observing profound and sustained clinical responses achieved with the treatment approaches below.”

Ivermectin is the first treatment given to LHCS patients. This inexpensive drug binds to the spike protein, disrupting its ability to attach to ACE-2 receptors. It also has multiple anti-inflammatory and anti-viral effects, as described in a June 2021 review article by Asiya Kamber Zaidi and Puya Dehgani-Mobaraki. Patients with cognitive symptoms are given fluvoxamine. Those with shortness of breath or low oxygen levels need to be assessed for secondary organizing pneumonia.

In addition to a course of ivermectin, patients are also given macrophage/monocyte repolarization therapy consisting of vitamin C, omega-3 fatty acids, atorvastatin, melatonin, and vitamin D3. If all symptoms do not resolve after two-to-four weeks of ivermectin treatment, the protocol recommends treatment with prednisone. If symptoms are still present after ivermectin and prednisone, patients are treated for suspected mast cell activation. The exact protocol with dosages is given at the flccc.net website.

The research group states that this protocol is a work in progress: “As with all FLCCC protocols, we must emphasize that multiple aspects of the protocol may change as scientific data and clinical experience in this condition evolve, thus it is important to check back frequently or join the FLCCC Alliance to receive notification of any protocol changes.”

Zaidi AK, Dehgani-Mobaraki P. The mechanisms of action of Ivermectin against SARS-CoV-2: An evidence-based clinical review article. J Antibiot (Tokyo). June 15, 2021: 1–13.

Nagalase, GcMAF, and Cancer

High serum levels of nagalase (alpha-N-acetylgalactosaminidase) indicate an immune system deficiency and are associated with the presence of cancer, viral infections, and other conditions, including autism. Nagalase, an enzyme, inhibits the production of Gc protein-derived macrophage activating factor (GcMAF); the Gc protein is also known as vitamin D3-binding protein DBP. By inhibiting GcMAF production and the activation of macrophages, nagalase cripples the immune system’s ability to detect and destroy unhealthy cells. Nagalase is secreted by cancer cells and is found in the envelope protein that surrounds some types of viruses.

Reducing nagalase levels has produced clinical improvement in patients with diverse cancers, including prostate, breast, pancreas, liver, lung, colon, stomach, kidney, and ovarian cancers as well as mesothelioma, melanoma, fibrosarcoma, glioblastoma, neuroblastoma, and various leukemias. In a 2020 article, Daniel F. Royal, DO, reports, “Nagalase activity is directly proportional to viable tumor burden.” He uses salicinium, a nagalase inhibitor, intravenously and in oral form (Orasal) to lower nagalase levels. Royal’s case report of a patient with lymphoma appears in this issue of Townsend Letter (page?). Townsend Letter has also published several articles on salicinium: “Salicinium: An Excellent Addition to My Armamentarium for Cancer Patients” by Carol M. Brown, DO, PhD (August/September 2016); “Salicinium – Disrupting Anaerobic Glycolosis and Improving GcMAF Immune Response” by Virginia Osborne, ND (August/September 2017); “Salicinium Treats and Prevents Cancer and Viral Infections” by Jeffrey J. King, MS (August/September 2019). All are available online.

Another way to decrease nagalase levels is to increase GcMAF levels via supplementation. In addition to increasing macrophage activity, GcMAF also directly binds to and inhibits human nagalase in vitro, according to Marco Ruggiero, MD, PhD. Purified human GcMAF, along with other GcMAF-boosting nutrients, have been used to treat cancer with some success. Beta-glucans, glutathione, vitamins D2 and D3, nitric oxide, and bovine colostrum help the body produce GcMAF, according to an article by B. George et al. Also, microorganisms in Bravo Probiotic (Les Alpes, Wellington, New Zealand) produce GcMAF from milk and colostrum Gc-globulin during fermentation. Recently, Ruggiero and colleagues developed a supplement, called imuno® (imuno.org) that reportedly has significantly greater activity against nagalase than GcMAF itself. Imuno® consists of low-molecular-weight microbial chondroitin sulfate, ultrapure phosphatidylcholine, and vitamin D3.

George B, et al. The Orthomolecular Components Needed to optimize the in vivo production of GcMAF. Available at academia.edu.

Health Diagnostics and Research Institute. Nagalase in Blood. Available at http://www.hdri-usa.com/tests/nagalase/

Royal DF. A Clinical Study: Modifying Nagalase with Glycome. Proccdings of ACIM Researcher. 2020;2(1).

Ruggiero M. imuno® is over 100 times more effective than pure GcMAF.

Homeopathic Treatment and Non-Small Cell Lung Cancer

A 2020 double-blind, randomized, multicenter Austrian study found that homeopathic treatment improved quality of life and survival in patients diagnosed with late-stage, non-small cell lung cancer (NSCLC). In this three-arm trial, 52 patients received usual care (control group); 51 patients received homeopathic treatment, and 47 patients received placebos that appeared and tasted like homeopathic remedies. The usual-care group acted as the control for the placebo participants who received individual attention from homeopathic physicians.

Homeopathic physicians interviewed each of the treatment and placebo participants and determined an appropriate constitution remedy that primarily addressed mental, emotional, and general symptoms. The constitutional remedies were given in the Q/LM potency (1:50,000) and applied as a liquid. Homeopathics to address adverse symptoms caused by the chemotherapy treatment were prescribed in less diluted potencies (decimal [1:10] or centesimal [1:100]) and delivered as sugar pellets. The doctors faxed their prescriptions for each patient to a pharmacy.

At the pharmacy, patients were randomized into the treatment group or the placebo group. A pharmacist (who did not take part in the randomization) prepared the homeopathic or placebo medications for each patient, packaged them in identical packaging, and mailed them to patients. The investigators, doctors, patients, and the statistician who received the raw data were blinded to treatment allocation until study completion and the data analyses were completed.

Patients in the treatment and placebo arms completed four questionnaires upon entering the study: EORTC QLQ-C30 (measures quality of life), the RAND short-form health survey (SF-36), the Subjective Well-Being Questionnaire, and one that assessed the patient’s attitude toward homeopathy and complementary/alternative medicine. Patients completed the same questionnaires after nine weeks when they were assessed by a homeopathic physician, and again at the 18-week assessment. During these appointments, the homeopaths “evaluated whether to continue with the same remedies or change them, based on patient reporting and routine cancer assessment.” Each patient was followed for 24 months or until death.

Data from the nine-week questionnaires showed a significant reduction in all symptom scales except pain, diarrhea, and financial difficulties scores in the homeopathy group compared to the placebo group—“by both univariate analysis of the individual symptom scales and by multivariate analysis of all symptoms scales.” All symptom were significantly lower in the homeopathy group after 18 weeks. Also, the homeopathy group showed progressive improvement between visit 1 and visit 2 and, then, between visit 2 and visit 3—improvement that did not occur in the placebo group.

The homeopathy group also had a longer mean survival time than both the placebo group and the control: “Estimate survival time (hazard ratio for mean was 477 (95% CI: 410-545) days in homeopathy group, 352 (95% CI: 278-427) days in placebo group and 274 (95% CI: 215-333) days in control group.” Moreover, more homeopathic patients were alive after 24 months than placebo or control patients: “Survival rate in the homeopathy group was 45.1% [23 of 51], in the placebo group was 23.4% [11 of 47], and in the control group was 13.5% [7 of 52].” The difference in survival rate between the placebo and control groups was not statistically significant (p=.154).

During the study’s five-year recruitment period, conventional treatment for late-stage NSCLC did not include immune-oncologic therapy The authors say, “Today, immune-oncologic and chemotherapy are established as first-line therapy. Therefore, further studies with immune-oncologic therapy are necessary to investigate the effect of homeopathic therapy with modern forms of therapy.” This well-designed study indicates that adding homeopathic care can improve quality of life and survival in cancer patients. Homeopathy has the advantages of not interacting with other treatments and of being low cost.

Frass M, et al. Homeopathic Treatment as an Add-On Therapy May Improve Quality of Life and Prolong Survival in Patients with Non-Small Cell Lung Cancer: A Prospective, Randomized, Placebo-Controlled, Double-blind, Three-Arm, Multicenter Study. The Oncologist. 2020;25:e1930-e1955.

Group Drumming for Mental Health

“One of the community music interventions growing in popularity for mental health is group drumming, perhaps due to the inclusiveness of drumming circles, lack of fine motor skill requirements and strong steadying rhythms,” write Daisy Fancourt and colleagues. Their 2016 study indicates that engaging in group drumming improves mental wellbeing and decreases depression and anxiety. Surprisingly, it also reduces the inflammatory immune response.

This UK study compared people who attended at least eight of 10 weekly sessions of group drumming (n=30) to a group that regularly attended other non-musical social activities each week (n=15). All participants were receiving mental health services. Over the 10 weeks, a professional drummer, experienced in leading community music activities, taught participants the basics of playing djembe drums as they sat in a circle. The 90-minute drumming sessions consisted of ‘call-and-response’ exercises, during which participants copied the leader to learn increasingly complex rhythmic patterns. They were also given times to improvise on their own “creating musical accompaniment to different scenarios such as the sound of water.” The drumming leader had no knowledge about the participants’ backgrounds or psychological profiles.

Participants in the drumming and control groups completed self-administered questionnaires that measured demographics, anxiety and depression, well-being, stress, and social function at baseline, weeks 6 and 10, and three months after the drumming sessions ended. In addition, drummers had cortisol and cytokine levels assessed with saliva testing.

By week 10, the drumming group showed a significant average decrease of 20% in anxiety and a 38% decrease in depression while the control group’s average had no significant change. Social resilience in the drumming group also improved 23%. Wellbeing scores improved in the drumming group (not statistically significant) and remained unchanged in the control. Perceived stress did not change in either group. At the three-month follow-up, the drummers retained much of their improvement.

The saliva tests showed a significant increase in the anti-inflammatory cytokine IL4 while most other measures remained unchanged: “At baseline, a comparison of levels of TNFα and IL4 was elevated towards TNFα (a pro-inflammatory response); however, over the intervention period, there was a shift towards IL4 (an anti-inflammatory response) which reached significance by week 6….” In comparing the psychological and biological measures, the authors found increases in IL4 associated with decreases in anxiety (p=.044) and declines in IL17 correlated to improved social resilience (p=.080).

The authors say, “It would be instructive to focus in future work on specific subgroups, such as those with major depressive disorder or generalized anxiety disorder, to assess where drumming interventions have the greatest therapeutic potential.” Given that many people with cancer and other serious illnesses also experience anxiety and depression, I wonder if group drumming might be helpful for them also.

Fancourt D, et al. Effects of Group Drumming Interventions on Anxiety, Depression, Social Resilience and Inflammatory Immune Response among Mental Health Service Users. PLOS One. March 14, 2016.