Investigators in California are conducting FDA-approved, double-blind, placebo-controlled phase 1 trials of traditional Eastern medicines to determine the safety and efficacy in mild-to-moderate cases of COVID-19.
Investigators in California are conducting FDA-approved, double-blind, placebo-controlled phase 1 trials of traditional Eastern medicines, i.e., Chinese herbs and medicinal mushrooms, to determine the safety and efficacy in mild-to-moderate cases of COVID-19.1
According to Gordon Saxe, MD, PhD, MPH, epidemiologist and executive director of the Krupp Center for Integrative Research at the University of California San Diego, and Andrew Shubov, MD, director of Inpatient Integrative Medicine, Center for East-West Medicine, at the University of California Los Angeles, the mushrooms and Chinese herbs for COVID-19 (MACH-19) treatment trials are currently ongoing at the 2 institutions.
A third MACH-19 study is recruiting patients to evaluate medicinal mushrooms as an adjuvant therapy to the COVID vaccines.
Mushroom and herbal trials
A combination of over-the-counter supplements, turkey tail and agarikon, are being studied in the first trial with the hope that they have immune-modulating properties against the virus. The use of agarikon goes back to ancient Greece to treat pulmonary disorders and more recently is the subject of preclinical studies of the influenza A viruses H1N1 and H5N1, cowpox virus, and herpes viruses, Saxe explained.
The second trial is evaluating a 21-herb combination derived from 4 Chinese formulations developed to treat Covid in Wuhan, China. The hospitalized patients who received this formulation for at least 3 days at the start of the COVID pandemic had a lower mortality risk compared with those not treated with the formulation in a large study.
In addition to safety, investigators hope to see trends in efficacy markers demonstrated by COVID-19 symptom severity and duration and hospitalization and admission to the intensive care unit.
In the third trial, patients receiving their first vaccine dose will also receive on the same day the mushroom mix or placebo for 4 days. The investigators will evaluate if the mushroom combination increases antibody titers, reduces vaccine adverse effects, extends the vaccine’s therapeutic duration, or affects other markers of immune function, according to Saxe.
A fourth trial will compare the mushrooms with placebo as an adjunct to a COVID-19 booster shot. There is a bit of controversy surrounding this trial regarding the development or lack of development of a cytokine storm in patients.
Results from the first two MACH-19 trials are expected at the end of 2021.
1. Slomski A. Trials test mushrooms and herbs as anti–COVID-19 agents. JAMA. Published online November 3, 2021. doi:10.1001/jama.2021.19388