US FDA And American Health Authorities Start Exploring Mushrooms, Herbs, Traditional Chinese Medicine And Even Thai Herbal Teas To Treat COVID-19
: Despite the US Food and Drug Administration (FDA) approving the MACH-19 trials (the acronym for Mushrooms and Chinese Herbs for COVID-19) after researchers applied for approval in April 2021, the actual implementations of these clinical trials were met with lots of bureaucracy and red tape and the projects only started kicking off at the need of 2021 .
Hence a number of early trials are under way to test medicinal mushrooms, Chinese herbs and even Thailand Medical News' Teas to treat COVID-19 patients with mild to moderate symptoms.
Two trials involving first the use of medicinal mushrooms have started. The first two phase 1 randomized, double-blind, placebo-controlled trials have begun at the University of California Los Angeles and San Diego campuses to treat COVID-19 patients who were quarantining at home with mild to moderate symptoms. A third trial is investigating the use of medicinal mushrooms as an adjuvant to COVID-19 vaccines.
The COVID-19 Herbs
study teams from UCLA have also launched a fourth trial testing the mushrooms against placebo as an adjunct to a COVID booster shot. It looks at the effect in people who have comorbidities that would reduce their vaccine response.
These trials involving the mushrooms were described in an article published in the peer reviewed journal: JAMA. https://jamanetwork.com/journals/jama/fullarticle/2786023
Two identified mushroom varieties that have a rich pharmacological profile are being tested ie the turkey tail (Trametes versicolor) and agarikon (Fomitopsis officinalis).
Both these mushrooms are already available as over-the-counter supplements with many people using these mushrooms as immune boosters or to treat cancer or.
These mushrooms are a separate class from the hallucinogenic or "magic" mushrooms being tested for other uses in medicine.
Principal investigator for the MACH-19 trials, Dr Gordon Saxe, MD, PhD, MPH, told Thailand Medical News
, "These mushrooms are not even as psychoactive as a cup of tea!"
The researchers from UCLA and UCSD plan to recruit 66 people who are quarantined at home with mild to moderate COVID-19 symptoms for each of the MACH-19 treatment trials.
Clinical trial participants will be randomly assigned either to receive the mushroom combination, the Chinese herbs, the TMN Teas or a placebo for 2 weeks.
Dr D. Craig Hopp, PhD, deputy director of the Division of Extramural Research at the National Center for Complementary and Integrative Health (NCCIH), told Thailand Medical News
that he was "mildly concerned" about using mushrooms to treat people with active SARS-CoV-2 infection.
Dr Hopp said, "We know that a cytokine storm poses the greatest risk of COVID mortality, not the virus itself. The danger is that an immune-stimulating agent like mushrooms might supercharge an individual&a
mp;#39;s immune response, leading to a cytokine storm."
Dr Stephen Wilson, PhD, an immunologist who consulted on the trials when he was chief operating officer of the La Jolla Institute for Immunology however says that a cytokine storm is unlikely for these patients because the mushroom components "don't mimic inflammatory cytokines." Dr Wilson is now chief innovations officer at Statera Biopharma, a company exploring various herbs and phytochemicals.
Dr Wilson added, "We think the mushrooms increase the number of immunologic opportunities to better see and respond to a specific threat. In the doses used, the mushrooms perturb the immune system in a good way but fall far short of driving hyper or sustained inflammation.”
Dr Saxe said the FDA process was extensive and rigorous and FDA investigators also asked about potential cytokine storms before approving the trials.
Dr Saxe pointed out cytokine storm is not an issue with a healthy response. It's a response that's not balanced or modulated.
The same issue was brought about when individuals first proposed using the herb Echinacea as a prophylactic or therapeutic to treat COVID-19. Many ignorant doctors said that the herb will aggravate the cytokine storms. However, many studies and clinical trials later, it has now emerged that Echinacea does have the potential to treat COVID-19 with another latest clinical trial whose findings were only published in January this year showing its efficacy. https://www.thailandmedical.news/news/randomized-clinical-trial-studies-show-that-echinacea-is-effective-against-a-variety-of-coronavirus-infections-including-sars-cov-2
Dr Saxe added, "Mushrooms are immunomodulatory. In some ways they very specifically enhance immunity. In other ways they calm down overimmunity."
He noted that they did a sentinel study for the storm potential "and we didn't see any evidence for it."
Dr Saxe also pointed out that one of the mushrooms in the combo they use ie agarikon was used to treat pulmonary infections 2300 years ago.
He said, "Hippocrates, the father of western medicine, used mushrooms. Penicillin comes from fungi. It's not a crazy concept. Most individuals who oppose the use of mushrooms, herbs and phytochemicals in medical treatments are skeptics who are simply ignorant. They are not aware that literally 80 percent of drugs used in modern medicine have their origins from herbs and phytochemicals."
Dr Saxe explained that there are receptors on human cells that bind specific mushroom polysaccharides.
He said, "There's a hand-in-glove fit there and that's one-way mushrooms can modulate immune cell behavior, which could have an effect against SARS-CoV-2.”
Chief of the Division of Infectious Diseases at Brigham and Women's Hospital in Boston, Massachusetts, Dr Daniel Kuritzkes, MD, who was not part of the study said he wasn't surprised the U S FDA approved moving forward with the trials.
Dr Kuritzkes said, "As long as you can demonstrate that there is a rationale for doing the trial and that you have some safety data or a plan to collect safety data, they are fairly liberal about doing early-phase studies. It would be a much different issue, I think, if they were proposing to do a study for actual licensing or approval of a drug.”
He noted however that it has not been identified which key phytochemical component of the mushrooms or herbs is having the effect. It will be a challenge, he said, to know from one batch of the compound to the next that you have the same amount of material and that it's going to have the same potency among lots.
He also warned that another challenge is how the mushrooms and herbs might interact with other therapies.
Dr Kuritzkes gave the example of St. John's Wort, which has been problematic in HIV treatment.
He said, "If someone is on certain HIV medicines and they also are taking St. John's Wort, they basically are causing the liver to eat up the HIV drug and they don't get adequate levels of the drug.”
Dr Kuritzkes acknowledged that though there are many challenges ahead,"this is a great starting point." He too stressed and pointed out that many traditional medicines were discovered from plants.
He added, "The most famous of these is quinine, which came from cinchona bark that was used to treat malaria.Digitalis, often used to treat heart failure, comes from the fox glove plant.”
Dr Kuritzkes said it's important to remember that "individuals shouldn't be seeking experimental therapies in place of proven therapies, they should be thinking of them in addition to proven therapies."
The later clinical trials which will start in late March will involves Traditional Chinese Herbs (TCM) that are also being used in China to treat COVID-19. https://www.thailandmedical.news/news/must-read-china-s-secret-to-controlling-the-covid-19-outbreak-is-traditional-chinese-medicine-concoctions-used-alone-or-in-conjunction-with-antiviral-
It should be noted that Thailand Medical news was the first entity documented online that proposed using traditional herbs to treat COVID-19 since January 2020, a few weeks after the SARS-CoV-2 coronavirus made its debut in Wuhan China. https://www.thailandmedical.news/news/further-research-into-the-phytochemicals-contained-in-licorice-root-might-yield-a-treatment-for-the-new-coronavirus-strain-in-china
Subsequently a lot of charlatans from Germany, India, Taiwan, Malaysia and even the United States and Thailand, tried to follow our lead but they could only come up with inferior products that do not have much efficacy as they do not understand much about herbs, phytochemicals, pharmacological processes and also the pathogenesis of SARS-CoV-2 and its various variants along with the need to keep updated with studies on the changing and emerging data about how the virus affects the various human cellular pathways and even in terms of the just the antiviral aspects, how even the M proteins are constantly evolving in subtle terms.
In late April 2022, Thailand Medical News (TMN) own blend of prophylactic and therapeutic teas will also be tested in the same trials. TMN’s teas have been in use since July 2020 and has underdone numerous reformulations based on emerging data on the SARS-CoV-2 virus and its pathogenesis. More than 1.4 million people worldwide have used the teas so far with reports of success and no side effects. https://www.thailandmedical.news/news/new-therapeutic-teas-
Thailand Medical News
will be covering the results of all these clinical trials as they emerge.
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