Chinese herbal formula used to treat coronavirus patients in China is currently in clinical trials in the United States for possible approval for people with mild to moderate symptoms of viral disease .
Qingfei Paidu, more commonly known as QFPD, is a 21-herb formula whose name literally means “cleansing and detoxifying the lungs.”
The US Food and Drug Administration approved a “double-blind, randomized control” trial of the treatment in June. Such a trial, considered the gold standard for epidemiological studies, is a trial where neither the participant nor the researcher knows whether the patient is receiving an experimental treatment or a placebo.
The two principal investigators of the trial are Dr. Andrew Shubov, an internal medicine specialist at the University of California at Los Angeles, and Dr. Gordon Saxe, a cancer and nutrition specialist, at the San Diego campus of the ‘university.
The trial is currently recruiting volunteers.
In China, the use of QFPD has been recommended in official government guidelines for treating coronavirus since early 2020 and is widely used across the country. It was used in a mobile hospital in Wuhan, the epicenter of the coronavirus outbreak in China last year, and most recently in the Delta variation outbreak in Nanjing in late July.
However, there hasn’t been much discussion of the treatment in American medical circles.
Online platforms like Amazon show increasing public demand for herbal therapeutic products. Searching for keywords like “lung cleanser” or “Chinese herb for COVID” will bring up many products in capsule or tea form. However, a close reading shows that these are mainly dietary supplements or wellness products.
In a rare deviation from usual clinical trials, testing of QFPD in the United States required Drug Enforcement Administration approval because the formula contains herbs that are highly regulated in the United States, such as my huang, or herba ephedrae. Ephedrae comes from a shrub. Among its many applications, the ephedrine derivative is used to prevent arterial hypotension during spinal anesthesia.
In the United States, ephedra supplements were banned from the over-the-counter mass market in the early part of the 21st century due to what were considered serious safety risks.
According to Shubov, who said he was very concerned about misinformation related to COVID-19, it is not clear whether these products are true to the original formula.
“To translate oriental medicine in the West for an American audience, you have to use the same language,” he told the Shanghai Daily in a recent Zoom interview. “The language spoken by the West is made up of double-blind randomized controlled trials rather than anecdotes. These weren’t there when we were exploring what was available early last year, so we’re done. by doing it ourselves. “
He added, “It’s a long and expensive process to do testing in the United States, and Chinese medicine usually doesn’t have the backing of big companies with millions of dollars to spend on it. It’s even more difficult for us since we’re not doing it for commercial purposes. “
Shubov, director of the east-west inpatient medicine consultation service at UCLA, said he and his colleagues – mostly internal and family medicine physicians – often work with Chinese drugs at their facility and are familiar with challenges. They seek to help integrate traditional Chinese medicine into the healthcare system in the United States.
“Chinese medicine has a strong, long and rich history of epidemics, but for various reasons there is not much discussion about Chinese medicine in the Western world,” Shubov said.
“Our intention is to demonstrate the value of Chinese herbal medicine during the coronavirus pandemic and hopefully shed light on a new style of treatment that the Western world was not aware of,” he explained. .
In general, Traditional Chinese Medicine, with a history dating back over 2,000 years, is often viewed as an alternative rather than an integrated treatment for conditions such as chronic pain. When used in the West, a treatment such as acupuncture is much preferred over herbal medicine.
Shanghai Daily searched for US Chinese herbal medicine trials on the cliniclatrials.gov website. Only two for the coronavirus have come forward, with around 10 for other illnesses. Most of the trials focus on medicinal plants that are not classified as drugs but rather as food supplements.
Shubov and his colleagues discovered the QFPD from official Chinese government guidelines, which are available in English online.
The treatment in China is administered in the form of broth. A capsule form was approved for wide use last March by the National Medicines Administration of China. Two other herbal capsules for the treatment of COVID were also approved at the same time.
QFPD integrates four classic prescriptions into a “one-size-fits-all” treatment for patients with mild to moderate symptoms. According to Chinese media, it was administered as a broth during the recent Delta variant outbreak in Nanjing City.
All patients over 18 at the municipal public health center received TCM treatment every day. No deaths occurred.
Various Chinese doctors have published research papers in English since last year. Most are retrospective results that are not considered double-blind randomized controlled trials.
The lack of high-quality clinical trial results may be one of the reasons why many Westerners are still not convinced of the effectiveness of Chinese medicine. Unexpected challenges, such as drug authority approval, are another.
In Shubov’s case, sourcing herbs that met all of the FDA’s requirements took a long time. Research on herbal-herbal and herbal-drug interactions was also needed.
And with all that, turning the original 21-herb broth formula into capsules ended up requiring a large amount of pills – the equivalent of 60 capsules per day. This forced researchers to explore new technologies and extend the admission period.
The team wanted to stay as true to the original formula as possible and only substituted one highly regulated herb. Therefore, the result was called “modified QFPD”.
The phase I trial aims to establish the safety and feasibility of the use of modified QFPD compared to placebo in 66 subjects. A Chinese medicine specialist has been added to the team to monitor any side effects that may occur.
How was the QFPD born?
According to a July 2020 QFPD report on Xinhuanet, traditional medicine practitioners believed that humidity or high humidity in the body is the root cause of many illnesses, including respiratory problems.
They noted that the city of Wuhan was hot and rainy before the outbreak. Coronavirus patients exhibited a layer of mucus on the tongue, a sign of dampness and turbidity in traditional Chinese medicine.
Practitioners have said that the goal of traditional medicine is not to kill the virus but to drive it out by restoring internal balance and strengthening the body’s defenses.
In formulating a treatment, they chose herbs that protect multiple organs and strengthen the body’s immune system.
The report cited anecdotal evidence. He said a patient from Hebei came out of a fever and his white blood cell count returned to normal after taking QFPD once. In Shanxi province, some coronavirus patients have tested negative after being given QFPD for three days.
According to the National Administration of Traditional Chinese Medicine, 1,337 COVID-19 patients were enrolled in China’s QFPD clinical treatment program as of May 20, 2020, and 99% have graduated, Xinhuanet said.