Curious Case Of LHQW: Behind The TCM Central To China’s COVID Zero Policies
Mandatory Distribution In Shanghai
Executive Summary
The role of a traditional Chinese medicine provided to the general public in China to fend off COVID-19 is controversial given limited evidence and even misleading, some say.
When Shanghai residents entered their initial two-week lockdown and received care packages from the government on an early April day, they were surprised to find that apart from cabbage, eggs, dry noodles and some meat were packages of a traditional Chinese medicine (TCM), Lianhua Qingwen (LHQW) capsules made by Shijiazhuang Yiling Pharmaceutical Co., Ltd.
One Shanghai resident showed her package in a twitter post and another said his household of three had received a total four packs of the capsules. The residents of some districts in China’s biggest city received two packages per person. If everyone is assumed to have had a minimum of one pack, that would amount to 25 million packs, each containing 24 capsules - amounting to 600 million capsules distributed in Shanghai alone.
Given that as many as 35 cities in China are under different degrees of restrictions, including Suzhou, Shenzhen, Lanfang, Tianjin and Jilin, the total use of Lianhua Qingwen could easily surpass billions of capsules over March and April.
One resident in Langfang, a commuter city of 5.5 million located midway between Beijing and Tianjin, said that local residents also got TCM capsules distributed by the government. Langfang has been under strict lockdown since late March, when the resident said neighborhoods were sealed off to outsiders and the government has distributed more than 10 packs of the TCM.
These sheer volumes have propped up Yiling's shares and the Shanghai-listed company saw its stock soar from CNY20.30 ($3.17) on 4 January to CNY42.01 on 11 April, a 110% jump.
LHQW first gained attention after Chinese regulators approved it as part of a three-TCM regimen for COVID-19 in April 2020, when no antivirals had been approved - the specific indication was to relieve fever, cough and muscle pains in mild cases.
Soon, other countries in Southeast Asia followed including Thailand, Singapore and Laos, but the approvals were for complementary use, not a sole treatment. In Singapore for instance, the approval was as a Chinese proprietary medicine to relieve cold symptoms, not as a drug specifically for COVID-19.
Controversies
LHQW - which includes multiple ingredients - is described on the external packaging as providing relief for influenza symptoms, shivering, fever, running nose, cough, headache, muscular pains, dry and sore throat and tongue discoloration. In the early days of the pandemic in China, it along with other TCM cold remedy formulas were used by the government to treat people with light symptoms inside specially built central quarantine facilities, the so-called Fangcang Hospitals.
But entering 2022, the ubiquitous distribution and promotion of LHQW by the Chinese government to people in lockdown areas means it could be seen as the main weapon in the fight to eliminate the virus in China’s "dynamic COVID Zero" policy.
The free distribution of the capsules has also sparked debate over the use of the preparation amid the recent surge in cases across China. To fight the worst outbreak since the pandemic epicenter in Wuhan, China's National Medical Products Administration has also recently approved Pfizer Inc.'s Paxlovid (nirmatrelvir and ritonavir) for patients with mild symptoms at risk of developing severe disease. (Also see "TCMs Not Paxlovid Gain Traction As Beijing On High Alert" - Scrip, 8 Apr, 2022.)
One high-profile internet influencer in China, Wang Sicong, the son of China's richest billionaire, the CEO of Wanda Group, openly criticized in a Weibo post the distribution of LHQW and the linking of the TCM with prevention of the viral infection. Wang's account has since been banned from further posting.
Preventative Care Too?
Despite China's Paxlovid approval, the use of LHQW remains central to the government’s arsenal to fight rising infections in multiple cities.
Backed by the strong state support, TCM use is somehow associated with cultural pride and confidence in this area is one of the “Four Confidence” touted by Chinese president Xi Jinping. Physicians in China routinely prescribe various TCMs along with western or conventional drugs, a practice called Chinese-Western integrated treatment.
As China becomes more assertive in its interactions with the outside world and the central government promotes its "Dual Circulation" economic policy to prioritize domestic consumption over the international market, TCM has also gained more attention.
In the early days of the COVID-19 outbreak, when patients with mild symptoms at Fangcang hospitals were treated with TCM formulas, some patients complained about it and posted photos of themselves disposing of the products on social media platforms. (Also see "Spring Shopping: Ping An Bets On Shionogi, TCMs In Coronavirus Aftermath" - Scrip, 1 Apr, 2020.)
Now, the widespread public distribution in huge cities has stirred further debate, including use of LHQW in children. Western antivirals such as Paxlovid are still being clinically evaluated in children and teenagers aged six to 17.
On the prevention side in China, only vaccines are used but the country has still yet to approve the use of more effective mRNA vaccines, despite the recent outbreaks.
As such, the promotion of TCMs has promoted a backlash among Chinese netizens. In a blog post, one questioned the practice - “with LHQW in the left hand and Banlangen (another Chinese herbal medicine for cold remedy) in the right, who needs mRNA vaccines?" they asked.
WHO’s Positions
The debate is particularly controversial amid the World Health Organization’s recently released paper on the use of TCMs for COVID-19, which was based on a three-day discussion held virtually from 28 February to 2 March by an expert group tasked to go through studies presented to them by Chinese researchers.
The group was chaired by Zhang Qi, head of the Traditional, Complimentary and Integrated Health Unit at WHO, and co-chaired by Harry Fong of the University of Illinois Department of Pharmacy and Elaine Elisabetsky, professor of Health Basic Sciences at Federal University of Grande do Sol in Brazil.
The paper, published by the organization on 31 March, has been cited by the Shanghai government to confirm the use of TCMs against COVID-19 - but upon closer examination it raised many questions on efficacy, adverse effects, potential liver function damage and the design of the total 12 studies presented to the group.
During the first day of discussion, one fundamental topic was TCM selection for the studies. While clinically, the selection of a drug for testing should be based on efficacy, safety and quality, “it’s unclear what criteria were used in the Chinese studies as these TCM formulas can be made of numerous plant species and a diversity of chemical ingredients,” the report noted.
LHQW claims to contain 13 medicinal herbs including Banlangen, which is already controversial. In 2003 during the SARS outbreak, Banlangen was hailed as a treatment and sought after by many Chinese.
On TCMs' antiviral potential, the WHO noted there had been only one study showing this, with no detailed data disclosed. Study sizes were also questioned over their sufficiency to establish safety, especially in pregnant women and children. The responses was that one study not included in the 12 submitted looked at use in 202 children in six provinces in China.
However, the WHO guidelines on medicinal products state that these TCMs contain contraindications and should not be used in pregnant women and children without prior data. Furthermore, a study pointed to “reported problems in liver function in some 20% patients,” showing that “COVID-19 is not only a disease of the lungs but may have impact on liver function too.”
During the final day of discussion, the WHO group “while recognizing the studies suggested benefits of TCM, called for further investigation into these products in other publications,” especially international publications. “It was felt that greater collaboration and multicenter research could lead to better evidence in future,” noted the 17-page report.
Overseas Studies
Although Yiling said it is conducting clinical studies to evaluate LHQW outside China, there have been no data released.
Informa Pharma Intelligence’s Trialtrove and Citeline show there are 14 studies underway with the product, most in China and for avian flu and respiratory syncytial virus and three open studies on asymptomatic patients with coronavirus.
Only one study registered as NCT 04431013 is described as a randomized Phase III study to enrol 300 patients to evaluate the TCM as an adjuvant treatment for COVID-19 patients with mild symptoms, to be conducted in Singapore. This was due to be initiated in July 2020 but has been withdrawn, due to an inability "to find suitable site Principle Investigator.”
While Singapore is among several nations to authorize the use of TCMs, the island state’s Health Ministry on 17 November issued a health alert on its website, calling attention to misleading information. “We strongly advise members of the public not to fall prey to unsubstantiated claims or spread unfounded rumors that herbal products can be used to prevent or treat COVID-19," it noted.