MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

Traditional Chinese Medicine (TCM) is popular, not least because it is heavily marketed and thus often perceived as natural and safe. But is this assumption true?

This study analysed  liver tests before and following treatment with herbal Traditional Chinese Medicine (TCM) in order to evaluate the risk of liver injury. Patients with normal values of alanine aminotransferase (ALT) as a diagnostic marker for ruling out pre-existing liver disease were enrolled in a prospective study of a safety program carried out at the First German Hospital of TCM from 1994 to 2015. All patients received herbal products, and their ALT values were reassessed 1-3 d prior to discharge. To evaluate causality for suspected TCM herbs, the Roussel Uclaf Causality Assessment Method (RUCAM) was used.

The report presents data of 21470 patients. ALT ranged from 1 × to < 5 × upper limit normal (ULN) in 844 patients (3.93%) and suggested mild or moderate liver adaptive abnormalities. A total of 26 patients (0.12%) experienced higher ALT values of ≥ 5 × ULN (300.0 ± 172.9 U/L, mean ± SD). Causality for TCM herbs was estimated to be probable in 8/26 patients, possible in 16/26, and excluded in 2/26 cases.

Compared with the large TCM study cohort, patients in the liver injury study cohort were older and contained a higher percentage of women, whereas the duration of the hospital stay was similar in both cohorts. The TCM herbs were rarely applied mostly as mixtures consisting of several herbs adding up to 35 different drugs during the patients’ four-week stay. The daily dosage was 95 ± 30 g and thus slightly higher than in the TCM study cohort. Among the many herbal TCM used by the 26 patients in the liver injury cohort, Bupleuri radix and Scuterllariae radix were the two TCM herbs most frequently implicated in liver injury, with variable RUCAM-based causality gradings. Most of the patients received one to six TCM drugs that were associated with potential liver injury as evidenced from the scientific literature, e.g., one patient (case 8) received six potentially hepatotoxic herbal TCM drugs during their hospital stay.

The authors concluded that in 26 (0.12%) of 21470 patients treated with herbal TCM, liver injury with ALT values of ≥ 5 × ULN was found, which normalized shortly following treatment cessation, also substantiating causality.

In the discussion section of the paper, the authors comment that the use of TCM is widely considered less risky as compared with synthetic drugs, although data on direct comparisons are not available in support of this view. Populations using herbal TCM, drugs, either alone, or combined experience more drug-induced liver injury (DILI) than herb-induced liver injury (HILI), possibly due to a higher use of drugs. Valid data of incidence and prevalence of HILI caused by TCM herbs are lacking, and respective data cannot be derived from the present study.

This study is most valuable, in my view. Its strength is clearly the huge sample size. Top marks for the authors for publishing it!

Having said that, we need to take the incidence figures with a pinch of salt, I think. In reality they could be much higher because:

  • other settings will not be as tightly supervised as the unusual hospital setting;
  • in most other situations the quality of the Chinese herbs might be less controlled;
  • there could be adulteration;
  • there could be contamination.

The ‘elephant in the room’ obviously is the inevitable question about benefit. Like any other treatment, TCM cannot be judged on the basis of its risk but must be evaluated according to its risk/benefit balance. I realise that this was not the subject of the present study, but it is nevertheless crucial: do the benefits of TCM outweigh its risks?

I am not aware that this is the case (but more than willing to consider any sound evidence readers might supply). More importantly, I am not aware of good evidence to show that, for any condition, TCM would be superior in terms of risk/benefit balance than conventional options. This is not a trivial issue: clinicians have the ethical obligation to apply the best (the one with the most positive risk/benefit balance) treatment to their patients.

If I am right, then TCM should not be used in therapeutic routine in or outside hospitals.

If I am right, the ‘First German Hospital of TCM‘ should close asap; it would be violating fundamental ethical principles.

If I am right, the debate about the risks of TCM is almost irrelevant because we simply should not use it.

Or did I misunderstand something here?

What do you think?

 

11 Responses to Liver damage after Chinese herbal treatments – much more than meets the eye

  • I agree that the authors are to be commended for this study. I also agree that incidence of liver damage caused by TCM herbs in the real world could be significantly greater than was found in the carefully controlled setting of this study. Indeed, unsafe preparations were discovered during the implementation of the study.

    Given the absence of convincing evidence of benefit from TCM herbs, and presence of convincing evidence of their potential harm, prudence suggests they should not be used if there are well tested alternatives showing convincing evidence of benefit.

    If not then patients should be informed of the fact that the risk/benefit ratio of TCM is anyone’s guess.

  • JAMA 1906 :

    “WHITHER ARE WE DRIFTING IN THERAPEUTICS

    CLARENCE H. VAUGHT, M.D.

    Vice-President State Association of Railway Surgeons: President Central Kentucky Medical Society.

    RICHMOND, KY.

    I believe that one of the greatest questions of our time is before us and one that we can have more influence in solving than can any other class of men or profession with which I am acquainted.

    “The patent and proprietary medicine conspiracy.” which has reached the climax of human endurance, is being assailed from many quarters, and the rankest of these gigantic frauds are on the run, and I want this society to get on the firing line and, if possible, to assist in their speedy extermination.

    A number of high-class periodicals, the Ladies’ Home Journal, Collier’s Weekly and others, are the means, and Edward Bok, Norman Hapgood, Samuel Hopkins Adams and M. J. Sullivan are the men behind the means. that have caused such an awakening among the profession throughout the country. These men are real pioneers in this noble work. Is it not strange that a great profession like ours, with the massive intellect among our members, has been so stupid to the real situation, so well satisfied, so afraid, perhaps, that some wag might accuse the members of selfish motives that not an effective word has been written or said against this monst” “its”? Suppose we are accused of selfish motives an “very other thing in the calendar. This should not “isconcert us or cause us to swerve so much as a line from out duty to ourselves and to humanity. I believe that every medical association in this country should elect to

    * Read before the Madison County Medical Society.

    honorary membership these men who are doing such conspicuously good work for all the people and our profession as well. Since this great question has been brought to our very door by laymen in a lay press, I thought it might be pertinent to ask, “Whither are we drifting”? Have we, by careful analysis and deduction, made any advancement toward a higher and more perfect therapy, or have we, like so many others, been drifting by the enormity of the advertising matter and the seductive wiles of that ever-present and always agreeable gentleman, the detail man of proprietary medicine, back to the abyss of necromacy, ignorance and superstition? Have we not been cajoled by this means into giving at least our tacit indorsement to most, if not all, the proprietaries and specials that we see, many of which are without merit, others absolutely harmful? No man can foreknow what will be the action of from ten to fifteen medicines together, even could the action of a single one be foretold. Your office and mine are being liberally supplied with samples of these new compounds, almost daily, of every imaginable name, some beautiful, others poetic, but we could never tell from the name what one of these compounds contained. The reason for this, I suppose, is because a name that means nothing can be as easily copyrighted as one that means something. The idea is to protect patent or secret formulas from other vultures, whose prey is human hope and credulity, and the ignorance or carelessness of the profession of which we are or should be representative.

    THE DETAIL MAN.

    The detail man calls on you at your office—doesn’t want to take much of your valuable time, but has something that he knows is of interest to you when you have a moment’s leisure. With visions of the importance of the message and of the fact that a stranger is within, you rush matters, and the doctor, it may be, who has failed in practice or a young one who uses this means’ of saving sufficient money to enable him to begin the practice, shows you what he has to offer (always ethical and meeting every test), gives you enough literature to last you and your family a month, and a liberal supply of samples, and expresses the hope that you will try them.

    THE DESIRED EFFECT.

    Strange as it may seem, at your first opportunity you do try them. The visit had the desired effect. You accept the statement, ethics and all, and some unfortunate, it may be the first patient who comes to vou, is made the victim. It makes little difference for what the patient consults you, as many of the proprietaries are fully recommended, and testimonials from thoughtless physicians are not wanting to show you that you have a specific for any disease that confronts you. The medicine is tried on different patients, some of them have told you perhaps that the medicine at least was palpable, sailing seems easy, a ready-made prescription for all who call, so easy to write, perfectly simple, the other fellow doing the work you should do, while you get the pay.

    Behold your surprise, however, in the course of a short time. You have been called to a home. After your visit has been concluded, you perhaps have suggested the use of some medicine for a poultice, you give explicit directions that the medicine should be applied to a cloth, then to the offending part. At this time some godly grandmother elevates her spectacles and asks, “Doctor, is that medicine, you are going to send, this Philogistine”? It may be some younger and more charming member of the household who thus rudely breaks in on your dreams of what you expected to accomplish with the new remedy for all inflammatory conditions (for each member of the household knows all about it). You are compelled to answer, “Yes, this is the medicine I intended to send you.” Grandma will say to you that “Mrs. Jones used it on her cow’s leg, and Mrs. Smith used it on her husband’s leg—they had some of it left and sent it over—we tried it, but it didn’t do John’s lungs any good.” This is simply an illustration that could be duplicated many times in the course of a year with this and hundreds of other proprietaries.

    You will, no doubt, say that this and that one has done good service for you. Perhaps this is true, but have you at such times taken into account that great law of natural therapeutics, the operation of the vis medicatric natura, the manner and processes of healing which occur independently of our art? It is this law that enables the homeopath to relate his sugar cures and the medical skeptic to smile in his infidelity and that brings you and me out of the many close places into which proprietaries and carelessness have placed us. And thus have we not been duped ourselves in seeking some more potent means to relieve the suffering that we see around us?

    SEEKING REMEDIES.

    Yet we ought not to be criticised for this alone, as it has been truly said, “Man from the earliest antiquity has continually sought for means for the relief of pain.” “The most ancient record of the race introduces the hero of the flood, plunged in a deep and scandalous sleep under the influence of wine which he had prepared. At the siege of Troy the Grecian surgeons were skilled in the art of assuaging pains of injured men by the application of alcohol and carbonic acid to their wounds. Thus the venerable Nestor came to the relief of the wounded Macheon, with a poultice composed of onions, cheese and meal, mixed with the wine of Pramos. “Other agents still more potent were known to the wise men of Egypt, and by them transmitted to their friends in other lands. Some preparation of opium or Indian hemp it may have been with which the beautiful Helen, after the siege was ended, once more in her lawful home, coming out of the ‘sweet smelling lofty room chamber, drove away sad memories from the minds of her husband and his friends by making them drink of wine into which she had cast a drug, chosen from the cunning and excellent stock presented to her by an Egyptian princess. Most potent drug this must have been, for we are told that it delivered men from grief and wrath, and caused oblivion from every ill.” Seeking relief from pain is certainly our province and our duty. We see that this idea has been handed down to us from the earliest antiquity, but whither are we drifting in its pursuit? You will observe from the history of these early times that people then and now in no way connected with the art or the practice of medicine prescribed and found others ever ready to swallow the potion regardless of its contents. There is or must be a charm or witchcraft in the act of prescribing, especially so for the other fellow, for this practice began at an early day and shows a steady growth all down through the ages until now. There is certainly nothing that we can imagine that so delights the laity as to prescribe something for the relief of a condition of which they are profoundly and totally ignorant.

    PRETENDERS. There is no profession which is more frequently used as a cloak by all kinds of mountebanks, charlatans and pretenders than is ours, and these pretenders too often

    prescribe for conditions concerning which they are ignorant. The medical profession is noble and beneficent in, its aims, presenting more opportunities for doing good than perhaps any other, and yet within its ranks practitioners of the black art flourish on the credulity of the people with whom they come in contact. The medical profession offers a fertile field for men of this class. especially in this day of proprietaries and secret formulas, when little or no skill is required in writing or in filling a prescription. USING PROPRIETARIES.

    You might flatter yourself that only the ignorant and unlettered could become the victims of this class of medicine men, but in this you are sadly mistaken, for you will often have your pulse beat faster and your quiet indignation pitched to its highest point by seeing some of your most cultured people falling in line, possibly your best friend or your best patient. Sir Dyce Duckworth, before a scientific body in London, England, recently stated that “the art of medicine is fast declining,” and he links together, inadvertently no doubt, literary culture and scientific habit. The editor of Hospital, in same city, regrets that this should have been done, exclaiming that they are incompatible and adds, “Men of literary culture, but destitute of scientific training, furnish most conspicuous examples of incapability to observe accurately and of inability to reason correctly, which we witness every day in the world around us. They are the patrons of quack medicines and anti-societies; they are apt to dogmatize serenely concerning matters of the very elements of which they are profoundly ignorant.” This well illustrates my oft repeated statement that ours is a profession that none can know anything about save the initiated, and all of them unfortunately do not know. But whither are we drifting? I fear I tell but the truth when I say that, with the great commercial spirit of the day, we are drifting toward proprietaries and quack medicines. Some of us perhaps have anchored. To them I would say, cut loose from your mooring. We are not drifting into this habit altogether by preference or for the interest of our patients, but carelessness and ease, I think, are likewise responsible for part of it. This habit, insidious as it is, I be: lieve our worst enemy. Samuel Hopkins Adams states, in Collier’s Weekly, that “ignorance and credulous hope make the market for proprietary medicines.” I do not mean to imply that all proprietary medicines should be condemned. Many have been found useful, if their preparation requires greater skill or more complicated apparatus than your druggist possesses, and if the formulas are known and approved they should be used when indicated. Imagine yourself prescribing something that you know absolutely nothing about except what the genial detail man has told you. Imagine, again. if you will, that same gentleman telling you the indication for the use of the medicine that your case demands: you accept it and use the medicine suggested to you by this source. In doing so do you not lower professional standard, your own dignity and become the dupe of the manufacturer of the drug and the well-groomed agent who tells you in what class of cases to use it?

    WHAT IS OUR DUTY 7

    The state of North Dakota has a law that prevents the sale of patent medicine (and this includes secret proprietaries), unless the formula is printed on the pack. age; and Kentucky has a bill now pending to make a similar law (presented by Hon. L. F. Johnson of Franklin County). I hope that a similar law will be enacted in all the states. If we were to do our duty, we would need no law to protect us and our patients whose lives are put in our keeping, and we should not under any conditions or circumstances prescribe a medicine that we were not absolutely familiar with. I trust that the members of this society will join with me in resolving to use in the future only those drugs from which we can reasonably expect results, and, if possible, to have all remedies compounded by our own druggists. We should also notify the druggists that we shall accept only pure chemicals, such as those made by reputable firms. It is not our province altogether to find only palatable drugs. Let the homeopath have a monopoly along this line if he will; that which we most desire is results. Occasionally a medicine that is pleasant to the taste can have little or no therapeutic value, except for its mental effect on some of our most unfortunate cases. That we will appeal to the intellect rather than to the superstition, prejudice and ignorance. I see each succeeding day signs of better things and that there is room for improvement no one can doubt. since it is estimated that over $100,000,000 has been expended annually for patent and proprietary nostrums. No wonder is it that legislatures are slow to enact laws to modify the sale of these “patents”; no wonder it is that the manufacturers of these miserable compounds are on the run, because at least $75,000,000 of this money must be profit, and if there is any one thing that will invite a keener interest than another it is the probable loss of money. Then think what so vast a sum as this could and would do in influencing legislation that would be detrimental to this nefarious business. The manufacturers use every device known to the professional pirate and plunderer, such as threatening newspapers with loss of their advertising and appealing to retail druggists to help protect their property rights. These vendors Want and demand our closest secrecy in protecting their rights, as they say. Afraid even to let the uneducated class of their countrymen know what they have been swallowing for all these years and for what they have paid so many honest dollars, notwithstanding the fact that these manufacturers know that the users of their medicines are of all people, most gullible! I have seen it estimated that 75 per cent of all the prescriptions that are written by the medical profession of this country call for proprietaries whose formulas are known and proprietaries whose formulas are secret, about one-half each. Is this not a shame when we know that many of the so-called proprietaries are no better than the rankest of the patents? Let us see to it that we have a druggist prepare our prescriptions who is competent so to do; that we demand of him a square deal and only the purest meditimes that can be had, asking no quarter from any source and showing none, save when compatible with the highest sense of duty to our patients and to our. silves, and lend our assistance in this campaign of “lucation wherever and whenever we can be of service. Thus the people with whom we live and practice our art will have a higher regard for our ability and fidelity.”.

    from: https://books.google.com/books?pg=PA1160&lpg=PA1160&dq=secret+formulas+remedy+skeptic&sig=aZ6EE7yF8sb8IWHODio78oT6mzI&id=0CUzAQAAMAAJ&output=text

  • On the money as usual. Arguments to the contrary will smell of fish.
    Whether with liver damage, permanent scarring or severe neurological-complications from manipulation…perhaps enough honest research on TCM will eventually substantiate the large risks vs. the spurious benefits.
    Zhongguo Gu Shang. 2017 Mar 25;30(3):252-255. doi: 10.3969/j.issn.1003-0034.2017.03.013.
    [Clinical characteristics analysis of lumbar disc herniation with symptoms aggravated/caused by spinal manipulative therapy]. (translated from Chinese).
    Zhao F, Pei JP et al

  • Edzard

    “The authors concluded that in 26 (0.12%) of 21470 patients treated with herbal TCM, liver injury with ALT values of ≥ 5 × ULN was found, which normalized shortly following treatment cessation, also substantiating causality.”

    But you are smarter: as usual assume results: “……we need to take the incidence figures with a pinch of salt, I think. In reality they could be much higher because: the researchers were stupid, did not know the reality and just threw around figures for the benefit of TCM”

    The truth is:

    “Medications are a popular cause of liver damage. While there are close to 1,000 medicines, drugs, and herbs that can injure the liver, ten in particular pose a significant threat. Each year, two thousand people experience liver failure in the United States. Around half of these situations are the direct result of medications.
    https://edrugsearch.com/worst-medications-for-liver/

    With close to a 1000 drugs that can injure the liver, ONLY 1000 die? poor assumption?

    Look at the confusion (or is it hiding facts):

    “Finding even a few cases of serious liver toxicity in clinical trial subjects exposed to a drug can be a reason for discontinuing the trial. Also, cases of serious liver toxicity have prompted FDA to request sponsors to withdraw their approved drugs from the market.
    Senior explains there’s no easy way to identify the people who might be vulnerable. “The drug-disease relationship is not so simple,” he says. “Identifying drugs that may cause liver injury only solves half the problem. The other half: Drugs that appear to be safe in pre-clinical studies still may be harmful to some patients.”
    Meanwhile, we have an aging population that is more dependent on drugs. “The more medications you take, the more likely you are to have trouble,” Senior says.
    A few drugs are toxic to the liver only when used in excess. One example is acetaminophen.
    “Acetaminophen when used as labeled is generally considered to be safe. But overdoses of acetaminophen are the most common cause of drug-related liver injury, whether these occur accidentally or otherwise,” says Mark Avigan, M.D., a medical reviewer at FDA with a background in gastroenterology and hepatology. “With acetaminophen overdoses, some people get a more severe reaction than others.”
    Acetaminophen is an active ingredient in hundreds of OTC and prescription medicines commonly used to treat musculoskeletal pain and fever, allergies, coughing, colds, flu, and even sleeplessness. Overdoses leading to serious liver injury have resulted from consumers inadvertently taking both OTC and prescription drugs containing acetaminophen.
    Inadvertent overdoses with prescription drugs that contain acetaminophen and a narcotic have been responsible for a significant proportion of all the cases of acetaminophen-related liver failure in the United States, some of which have resulted in liver transplant or death.”

    And you are wasting everyone’s time on TCM!!!!!!

  • 1)
    Chinese Medicine (the western societies added “Traditional”) is a reinvented conglomerate and arbitrary mixture of different old regional medical school traditions under Mai Zedong in the 1965ties. Old Chinese Medicine included the believe of magic evil spirits and demons.

    2,)
    All old chinese doctors and their association stopped practising and medical education in the 1920 by their own decision declaring themselves as not effective compared to western medicine. They terminated liquidated and dissoluted the associatiin of Chinese doctors at those times. So there is no permant education in old Chinese medicine for more than 45 years.

    Under Mao Zedung around the 1965ties the term Chinese Medicine was used for the new so called “bare foot doctors” poorly educated community nurses in reality. They were poorly educated in the old Chinese medical practice as well now free of demons and evil spirits but mixed up with Western medical explanations.

    3.)
    There is no intercultural standard to compare in a scientific way the old chinese medical pictures related to the paradigmata of farming and qualities of a landscape with Western medical pictures related to detailed local anatomy physiology and detailed pathology. “Modern” TCM is a wild mixture of both.

    4.)
    The problem of pollution with heavy metal soil particles fungicids herbicids and other not allowed particles from bad harvesting and drying in herbs is known as it is with any other production of medical herbs and foodstuff.

    5.)
    A lot of effort is done in Germay to control every imports of medical herbs according to German pharmaceutical laws and standards. As in any medication adverse drug reactions are known and a liver and kidney screening should follow before and after the use of TCM herbal decocts.

    More information under:

    http://www.tcm-apo.de

    7.)
    To have herbs of highest quality standards in growing harvesting drying and further processing the production of TCM herbs also is done in a govermental insitute of farming and scientifically (laboratory) controlled according to German pharmaceutical laws and standards in Bavaria:

    http://www.lfl.bayern.de/ipz/heilpflanzen/039461/

    That means that the results done in The First German Hospital for TCM in Kötzting in Bavaria are depending on the highest recommended standard in herbal production and pharmaceutical control available. So there is no bias by a use of unchecked unregulated herbs.

    Other reseonable studies in this case related to TCM and Ayurveda Indigenious Medicine if India (not the wellness branch of Ayurveda)! are done by other instituts with university standard e.g.
    http://www.kliniken-essen-mitte.de/tcm

  • Most medicines are toxic by design. Most medicines provide treatments, with no attempt to cure. Singling out a class of medicines, instead of evaluating individual products is irresponsible.

    Most arguments, analysis, and clinical studies comparing conventional medicines to alternative medicines are discussions asking the question:

    Which medicine, conventional or alternative, does not cure better?

    When we endeavor to find cures, many of these discussions become irrelevant, because most cures come from health, not from medicines. When a disease that can only be cured by health is treated with medicines, it is converted to a chronic disease, and considered incurable by many conventional and alternative medical practices.

    • so much BS makes me speechless

    • @Tracy Kolenchuk

      WTF?! This turns lunacy into an art form.

    • You seem to be attempting to get a point across, however what that point is defies my understanding. But perhaps by ‘health’ you mean ‘healthy lifestyle’? Though suggesting that those individuals who do not improve their ‘lifestyle’ (to a healthy one) and are treated with medicine for their condition will see that condition become chronic is simply nonsensical.
      And opting for “Alternatives” i.e. ineffectual medicine, to actually arrive at a “cure” is also nonsensical. Millions of people’s lives are improved and elongated via medicine even though many might be much less plagued if they had an ideal healthy lifestyle (which has never been proven to require “alternative” junk remedies and potions). Additionally are you suggesting no one who has this nebulous ‘health’ (lifestyle) ever gets sick and requires a researched and approved medicine?
      Perhaps you should write in a language you’re fluent in?

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