If you would like to read the full article on the
National Institute of Health website, click here:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7498439/

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Below is the pre-print version of the article.

 

TITLE:

Dangers of Scientific Bias against Herbal Drugs for Covid-19

 

AUTHOR:

Dr. Jonathan M. Fields, DAOM
Integrative Medicine US
Coral Springs, FL

KEYWORDS:

herbal drugs, covid-19, sars-cov-2, coronavirus, herbal medicine, integrative medicine, tcm, traditional chinese medicine

 

ABSTRACT:

On May 15, 2020, the Lancet published an article titled, “Use of herbal drugs to treat COVID-19 should be with caution”. While this is true of all drugs, herbal and otherwise; the data is possibly biased and warranting of a scientific response. We believe these types of reports will unfairly and negatively impact the field of integrative medicine as a whole, and need to be addressed with facts and statistics that truly represent the current situation.

 

INTRODUCTION
The author of the Lancet submission [1] took issue with three herbal drugs that were approved in China to include Covid-19 treatment. They have cited lack of evidence and safety concerns, as well as a host of other reasons as to why China should not have moved ahead with approving these herbal drugs for SARS-CoV-2 symptoms. We believe this critique to have been overly harsh, partially inaccurate and some of the data to be taken out of context. The following is a point by point rebuttal and further explanation of the details as to why herbal drugs are safe and effective.

EXISTING PEER REVIEWED STUDIES
The Lancet author claims that there have been no high quality, rigorously peer-reviewed clinical trials of herbal drugs published in internationally recognized journals. However, The International Journal of Biological Sciences published a review as early as March 15, 2015 [2] and they reported that out of 72,528 patients in the study, 85% of them were treated with herbal remedies, including some of the patent herbal drugs in question, in addition to the standard drug therapy.The study also cites the success of herbal remedies and many studies that were published with promising results in regards to the 2002-2003 SARS outbreak, in which the current Covid-19 shares 79.5% of the genome sequence. There have been many other smaller studies published as well.

The author claims these studies are based on anecdotal clinical data. While partially true, this is a large scale study and many ongoing studies are being conducted in Europe and other places. It’s also based on current data for an ongoing epidemic. It’s not realistic to expect that any of these would exist for herbal drugs or conventional drugs at the moment because this is all happening real time. We don’t have the luxury to wait.

Furthermore, the same logic also dictates that no pharmaceutical medications are safe or effective either. There have been no large scale, high quality, peer reviewed randomized clinical trials of western drugs for the treatment of Covid-19.

SAFETY CONCERNS
The author quotes safety concerns about herbal remedies. First, he brings up a study about a weight loss herbal product from the 1990’s that injured a total of about 9 women. [3] They all survived. The clinic had previously been running for over 15 years without incident. This is a prime example of anecdotal clinical data and he does not even mention if any of these herbs are in the current Covid-19 treatments.

He says that further investigation revealed the culprit was, “aristolochic acid, a compound found in many traditional herbs.” This is simply false. There are thousands of traditional herbs, about 200 or so in common use, and only about 5 or 6 known to contain this compound. [4] They are rarely used and some are banned in the United States and Europe. Even when they are prescribed, they are commonly used in micro-doses in combination with other herbs and are processed in ways to mitigate toxicity.

While this is concerning, NSAIDS like Aspirin, Ibuprofen and Tylenol cause over 7,600 deaths per year in the United States alone and internal bleeding in many more cases. [5]

This entire point can be invalidated very quickly with the following questions:
How many people have died on record last year from herbal drugs? Maybe a handful. Do we have proof of even one? They certainly did not list any evidence to suggest so, only a study from nearly 30 years ago with 9 injuries and no deaths.
How many people died last year from prescription opiods, nsaids and medication errors in hospitals in the USA alone? Hundreds of thousands. [5] [6] [7]
How many drugs have been recalled after being thoroughly researched in exactly the type of high quality studies they are requesting, yet went on to kill hundreds of thousands of people before being pulled from the market? Viox, Losartan, Fen-Phen, Baycol, Posicor, Bextra and the list goes on.

So scientifically speaking and based on all the statistics we have, herbal drugs are infinitely more safe than pharmaceuticals will ever be. He advocates for more evidence through controlled clinical trials. We wholeheartedly agree. We’d like to see the same for all medications being used to treat Covid-19 as well. But should we not try anything until they are all proven?

CUSTOMIZED REMEDIES
The author takes issue with herbal remedies being tailored to the individual. However, we clearly know the allopathic, western pharmaceutical, one size fits all model does not always work. People have to switch medications all the time due to allergies, side effects, reactions etc. Sometimes, no matter what they try, the medicine completely fails them. An integrative approach is quickly becoming more common in conventional settings because of its demonstrated scientific success.

HISTORICAL USE
The author argues, “Thousands of years of usage and faith cannot be taken as evidence for efficacy of traditional herbs.” While there is ample reason to be concerned about blind faith in substances, thousands of years of well documented clinical data, tested on billions of people, should not be completely discarded as unscientific. We literally have case studies from thousands of years ago, as well as the last 50 plus years of modern laboratory research.

Furthermore, the European model for standard registration of herbal medicines clearly allows for herbal medicines to be used when demonstrated safe and effective without cumbersome clinical trials. “The Committee on Herbal Medicinal Products (HMPC) issues scientific opinions on herbal substances and preparations, along with information on recommended uses and safe conditions, on behalf of the European Medicines Agency (EMA). Traditional use registration is granted (Article 16a(1) of Directive 2001/83/EC): No clinical tests and trials on safety and efficacy are required as long as sufficient safety data and plausible efficacy are demonstrated Involves assessment of mostly bibliographic safety and efficacy data. Must have been used for at least 30 years, including at least 15 years within the EU. Are intended to be used without the supervision of a medical practitioner and are not administered by injection.” [8]

Lastly, according the WHO global report on traditional and complementary medicine in 2019, the World Health Organization says, “Traditional medicine Traditional medicine has a long history. It is the sum total of the knowledge, skill and practices based on the theories, beliefs and experiences indigenous to different cultures, whether explicable or not, used in the maintenance of health as well as in the prevention, diagnosis, improvement or treatment of physical and mental illness.” [9]

MOLECULAR MECHANISMS & EFFICACY
The author complains about the molecular mechanism being obscure, yet they openly admit that some of these patent herbal drugs have wide spectrum anti-viral and anti-inflammatory effects, and cite the respective studies. [10] [11]
The fact is that almost every single pharmaceutical drug in use today is based on compounds extracted from herbs. Just because we don’t know the exact method of action for each compound of each herb, does not mean that it’s not safe or effective. Quite the opposite is true. We have thousands of years of actual clinical experience, as well as the recent data during this outbreak and the initial SARS outbreak of  2002, that proves it is safe and effective. We don’t know exactly how safe or how effective, but tens of thousands of lives are at stake now on a daily basis. We cannot afford to hold herbal drugs to impossible standards that are even more stringent than pharmaceuticals based on prejudice. We need solutions yesterday and herbal drugs are proven to be much safer than conventional drugs.

The authors states, “Limited experimental cell cultures and animal studies cannot guarantee safety and efficacy.” But the whole world is currently testing pharmaceutical medications and vaccines right now on people without any of these same studies.

An excellent reminder, is the 2015 Chinese Nobel Prize winner, Professor Youyou Tu. She saved millions of lives from drug resistant malaria with an herbal drug based on Traditional Chinese Medicine. (12)  Due to the time crunch, she tested the final model on herself and her team for safety before going into production. Had they waited for lengthy clinical trials, millions would have perished in the meantime, even though they had a perfectly working prototype.

OVER THE COUNTER AVAILABILITY
Finally, the author claims that being available over the counter will delay people from seeking proper medical diagnosis and treatment of the disease and make it harder to trace. Sure, in the same way Tylenol, Sudafed, NyQuil, Ibuprofen and every other over the counter medicine does just that as well. So should we pull them all off the shelves worldwide when 80-90% of the cases are mild and the symptoms are effectively managed by these medicines?

During the early stages of the outbreak in the United States and Europe, citizens were encouraged not to go to the hospital or seek treatment unless they had severe symptoms. They were told to stay home, self-quarantine, and use OTC remedies. Testing was not widely available. That is still the current recommendation, with the only difference being that testing is available and can be used for tracing. In times like these, it’s common sense to stock up on just-in-case remedies and over the counter products. Yet the author seems to only discourage the use of herbal products, and completely disregard the alternatives.

 

CONCLUSION
We believe articles such as this try to exaggerate disproportionately the safety of herbal drugs versus pharmaceuticals. Unfortunately, many readers see these headlines, skim these articles and improperly assume there are major risks and safety issues with herbal remedies. This is clearly not the case and these types of articles may discourage people from seeking safe and effective treatments. We cannot afford to run that risk with Covid-19, especially when the complications from herbal remedies are so low, that they are nearly non-existent. These approved patents should continue to be tested in the field now and should be expanded for trials in other countries as well.

 

REFERENCES:

[1] Yang Y. Use of herbal drugs to treat COVID-19 should be with caution. Lancet 2020; Vol 395, Issue 10238, P:1689-1690.
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31143-0/fulltext

[2] Yang Y, Islam S, Wang J, Li Y, Chen X. Traditional Chinese Medicine in the Treatment of Patients Infected with 2019-New Coronavirus (SARS-CoV-2): A Review and Perspective. Int J Biol Sci. 2020; 16(10): 1708–1717
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7098036/

[3] Vanherweghem JL, Depierreux M, Tielemans C, Abramowicz D, Dratwa M, Jadoul C, et al.
Rapidly progressive interstitial renal fibrosis in young women: association with slimming regimen including Chinese herbs. Lancet. 1993; 341: 387-391
https://pubmed.ncbi.nlm.nih.gov/8094166/

[4] IARC Working Group on the Evaluation of Carcinogenic Risk to Humans. Pharmaceuticals. Lyon (FR): International Agency for Research on Cancer; 2012. (IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, No. 100A.) PLANTS CONTAINING ARISTOLOCHIC ACID. https://www.ncbi.nlm.nih.gov/books/NBK304331/

[5] Tamblyn R, Berkson L, Dauphinee D, Gayton D, Grad R, Huang A, Isaac L, et al. Unnecessary Prescribing of NSAIDs and the Management of NSAID-Related Gastropathy in Medical Practice. Annals of Int Med 1997; Vol 127, Issue 6, P: 429-438
https://www.acpjournals.org/doi/10.7326/0003-4819-127-6-199709150-00003

[6] Panagioti M, Khan K, Keers Richard NR, Abuzour A, Phipps D, Kontopantelis E, et al. Prevalence, severity, and nature of preventable patient harm across medical care settings: systematic review and meta-analysis BMJ 2019; 366: l4185
https://www.bmj.com/content/366/bmj.l4185

[7] NIDA. Overdose Death Rates. National Institute on Drug Abuse website. https://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates March 10, 2020. Accessed May 31, 2020.

[8] European Medicines Agency. (‎2001)‎. Herbal Medicine Products 2001. European  Medicines Agency https://www.ema.europa.eu/en/human-regulatory/herbal-medicinal-products.  [9] World Health Organization. (‎2019)‎. WHO global report on traditional and complementary medicine 2019. World Health Organization. https://apps.who.int/iris/handle/10665/312342.
License: CC BY-NC-SA 3.0 IGO
[10] Ding Y,  Zeng L, Li R, Chen Q, Zhou B, Chen Q, et al. The Chinese prescription lianhuaqingwen capsule exerts anti-influenza activity through the inhibition of viral propagation and impacts immune function. BMC Complement Altern Med. 2017; 17: 130
https://link.springer.com/article/10.1186/s12906-017-1585-7

[11] Runfeng L, Yunlong H, Jicheng H, Weiqi P, Qinhai M, Yongxia S, et al.
Lianhuaqingwen exerts anti-viral and anti-inflammatory activity against novel coronavirus (SARS-CoV-2). Pharmacol Res. 2020; 156: 104761
https://www.sciencedirect.com/science/article/pii/S104366182030743X

[12] Zheng WR, Li EC, Peng S, Wang XS. Tu Youyou winning the Nobel Prize: Ethical research on the value and safety of traditional Chinese medicine. Bioethics. 2020;34(2):166‐171. doi:10.1111/bioe.12456
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7027749/