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

politics

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These days, I am often not sure what puzzles me more, Boris Johnson or homeopathy. Come to think of it, our PM seems, in fact, to have a lot in common with homeopathy/homeopaths. With my tongue lodged firmly in my cheek, I can see some communalities:

  • They are both popular in the UK but have their origins elsewhere.
  • They were both laughed at by people who are serious.
  • They have both been around for far too long.
  • They both are useless.
  • They both have plenty of charisma.
  • They both, however, have little more than that.
  • They have a long history of misleading the public.
  • They have both been taken to court.
  • They both failed to accept the judgement when it went against them.
  • They are both particularly successful with the female section of the population.
  • They both thrive on personal attacks.
  • They both make far-reaching claims which turn out to be false.
  • They both claim to want only the best for the public.
  • They both consider themselves as progressive.
  • In truth, however, they are both deeply regressive.
  • They both do not to think that ethics are all that important.
  • They both irritate people who are rational thinkers.
  • They both negate the evidence and act in overt contradiction to the evidence.
  • They both tend to think that popularity is a measure of efficacy.
  • They both managed to mislead even the Queen.
  • Nevertheless, they both enjoy royal support (at least for the time being).
  • They both seem to think that the laws (of the land/of nature) do not apply to them.
  • They are both only bearable when highly diluted.
  • They are both a complete waste of money.
  • They are both dangerous when the public follow their advice.

Have I forgotten anything?

Do tell me, please.

On this blog, we have often noted that (almost) all TCM trials from China report positive results. Essentially, this means we might as well discard them, because we simply cannot trust their findings. While being asked to comment on a related issue, it occurred to me that this might be not so much different with Korean acupuncture studies. So, I tried to test the hypothesis by running a quick Medline search for Korean acupuncture RCTs. What I found surprised me and eventually turned into a reminder of the importance of critical thinking.

Even though I found pleanty of articles on acupuncture coming out of Korea, my search generated merely 3 RCTs. Here are their conclusions:

RCT No1

The results of this study show that moxibustion (3 sessions/week for 4 weeks) might lower blood pressure in patients with prehypertension or stage I hypertension and treatment frequency might affect effectiveness of moxibustion in BP regulation. Further randomized controlled trials with a large sample size on prehypertension and hypertension should be conducted.

RCT No2

The results of this study show that acupuncture might lower blood pressure in prehypertension and stage I hypertension, and further RCT need 97 participants in each group. The effect of acupuncture on prehypertension and mild hypertension should be confirmed in larger studies.

RCT No3

Bee venom acupuncture combined with physiotherapy remains clinically effective 1 year after treatment and may help improve long-term quality of life in patients with AC of the shoulder.

So yes, according to this mini-analysis, 100% of the acupuncture RCTs from Korea are positive. But the sample size is tiny and I many not have located all RCTs with my ‘rough and ready’ search.

But what are all the other Korean acupuncture articles about?

Many are protocols for RCTs which is puzzling because some of them are now so old that the RCT itself should long have emerged. Could it be that some Korean researchers publish protocols without ever publishing the trial? If so, why? But most are systematic reviews of RCTs of acupuncture. There must be about one order of magnitude more systematic reviews than RCTs!

Why so many?

Perhaps I can contribute to the answer of this question; perhaps I am even guilty of the bonanza.

In the period between 2008 and 2010, I had several Korean co-workers on my team at Exeter, and we regularly conducted systematic reviews of acupuncture for various indications. In fact, the first 6 systematic reviews include my name. This research seems to have created a trend with Korean acupuncture researchers, because ever since they seem unable to stop themselves publishing such articles.

So far so good, a plethora of systematic reviews is not necessarily a bad thing. But looking at the conclusions of these systematic reviews, I seem to notice a worrying trend: while our reviews from the 2008-2010 period arrived at adequately cautious conclusions, the new reviews are distinctly more positive in their conclusions and uncritical in their tone.

Let me explain this by citing the conclusions of the very first (includes me as senior author) and the very last review (does not include me) currently listed in Medline:

1st review

penetrating or non-penetrating sham-controlled RCTs failed to show specific effects of acupuncture for pain control in patients with rheumatoid arthritis. More rigorous research seems to be warranted.

Last review

Electroacupuncture was an effective treatment for MCI [mild cognitive impairment] patients by improving cognitive function. However, the included studies presented a low methodological quality and no adverse effects were reported. Thus, further comprehensive studies with a design in depth are needed to derive significant results.

Now, you might claim that the evidence for acupuncture has overall become more positive over time, and that this phenomenon is the cause for the observed shift. Yet, I don’t see that at all. I very much fear that there is something else going on, something that could be called the suspension of critical thinking.

Whenever I have asked a Chinese researcher why they only publish positive conclusions, the answer was that, in China, it would be most impolite to publish anything that contradicts the views of the researchers’ peers. Therefore, no Chinese researcher would dream of doing it, and consequently, critical thinking is dangerously thin on the ground.

I think that a similar phenomenon might be at the heart of what I observe in the Korean acupuncture literature: while I always tried to make sure that the conclusions were adequately based on the data, the systematic reviews were ok. When my influence disappeared and the reviews were done exclusively by Korean researchers, the pressure of pleasing the Korean peers (and funders) became dominant. I suggest that this is why conclusions now tend to first state that the evidence is positive and subsequently (almost as an after-thought) add that the primary trials were flimsy. The results of this phenomenon could be serious:

  • progress is being stifled,
  • the public is being misled,
  • funds are being wasted,
  • the reputation of science is being tarnished.

Of course, the only right way to express this situation goes something like this:

BECAUSE THE QUALITY OF THE PRIMARY TRIALS IS INADEQUATE, THE EFFECTIVENESS OF ACUPUNCTURE REMAINS UNPROVEN.

 

 

Apparently, Hahnemann gave a lecture on the subject of veterinary homeopathy in the mid-1810s. Ever since, homeopathy has been used for treating animals. Von Boennighausen was one of the first influential proponents of veterinary homeopathy. However, veterinary medical schools tended to reject homoeopathy, and the number of veterinary homeopaths remained small. In the 1920ies, veterinary homoeopathy was revived in Germany. Members of the “Studiengemeinschaft für tierärztliche Homöopathie” (Study Group for Veterinary Homoeopathy) which was founded in 1936 started to investigate this approach systematically.

Today, veterinary homeopathy is still popular in some countries. Prince Charles has become a prominent advocate who claims to treat his own life stock with homeopathy. In many countries, veterinary homeopaths have their own professional organisations. Elsewhere, however, veterinarians are banned from practicing homeopathy. In the UK, only veterinarians are allowed to use homeopathy on animals (but anyone regardless of background can use it on human patients) and there is a British Academy of Veterinary Homeopathy. In the US, homeopathic vets are organised in the Academy of Veterinary Homeopathy.

If this sounds promising, we should not forget that, as discussed so often on this blog, homeopathy lacks plausibility the evidence for veterinary homeopathy fails to be positive (see for instance here). But, hold on, there is a new study, perhaps it will change everything?

This ‘study‘ was aimed at providing an initial insight into the existing prerequisites on dairy farms for the use of homeopathy (i.e. the consideration of homeopathic principles) and on homeopathic treatment procedures (including anamnesis, clinical examination, diagnosis, selection of a remedy, follow-up checks, and documentation) on 64 dairy farms in France, Germany and Spain.

The use of homeopathy was assessed via a standardised questionnaire during face-to-face interviews. The results revealed that homeopathic treatment procedures were applied very heterogeneously and differed considerably between farms and countries. Farmers also use human products without veterinary prescription as well as other prohibited substances.

The authors of this ‘study’ concluded that the subjective treatment approach using the farmers’ own criteria, together with their neglecting to check the outcome of the treatment and the lack of appropriate documentation is presumed to substantially reduce the potential for a successful recovery of the animals from diseases. There is, thus, a need to verify the effectiveness of homeopathic treatments in farm practices based on a lege artis treatment procedure and homeopathic principles which can be achieved by the regular monitoring of treatment outcomes and the prevailing rate of the disease at herd level. Furthermore, there is a potential risk to food safety due to the use of non-veterinary drugs without veterinary prescription and the use of other prohibited substances.

So did this ‘study’ change the evidence on veterinary homeopathy?

Sadly not!

This ‘study’ is hardly worth the paper it is printed on.

Who conceives such nonsense?

And who finances such an investigation?

The answer to the latter question is one of the few provided by the authors: This project has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under Grant Agreement No 311824 (IMPRO).

Time for a constructive suggestion! Could the European Union’s Seventh Framework Programme with their next research project in veterinary homeopathy please evaluate the question why farmers in the EU are allowed to use disproven therapies on defenceless animals?

In 2016, members of the World Federation of Chiropractic Disability and Rehabilitation Committee conducted an international, cross-sectional survey of all 193 United Nation member countries and seven dependencies to describe the global chiropractic workforce in terms of:
  • the availability (numbers and where they are practising),
  • quality (education and licensing),
  • accessibility (entry and reimbursement),
  • acceptability (scope of practice and legal rights).

An electronic survey was issued to contact persons of constituent member associations of the World Federation of Chiropractic (WFC). In addition, data were collected from government websites, personal communication and internet searches. Data were analysed using descriptive statistics.

Information was available from 90 countries in which at least one chiropractor was present. The total number of chiropractors worldwide was 103,469. The number of chiropractors per country ranged from 1 to 77,000. Chiropractic education was offered in 48 institutions in 19 countries. Direct access to chiropractic services was available in 81 (90%) countries, and services were partially or fully covered by government and/or private health schemes in 46 (51.1%) countries. The practice of chiropractic was legally recognized in 68 (75.6%) of the 90 countries. It was explicitly illegal in 12 (13.3%) countries. The scope of chiropractic practice was governed by legislation or regulation in 26 (28.9%) countries and the professional title protected by legislation in 39 (43.3%). In 43 (47.8%) countries, chiropractors were permitted to own, operate, or prescribe x-rays, in 22 (24.4%) countries they were lawfully permitted to prescribe advanced imaging (MRI or CT), and in 34 (38.8%) countries owning, operating or prescribing diagnostic ultrasound was permitted. Full or limited rights to the prescription of pharmaceutical medication were permitted in 9 (10%) countries, and authorization of sick leave was permitted in 20 (22.2%) countries. The care of children was subject to specific regulations and/or statutory restrictions in 57 (63.3%) countries.

The authors concluded as follows: We have provided information about the global chiropractic workforce. The profession is represented in 90 countries, but the distribution of chiropractors and chiropractic educational institutions, and governing legislations and regulations largely favour high-income countries. There is a large under-representation in low- and middle-income countries in terms of provision of services, education and legislative and regulatory frameworks, and the available data from these countries are limited.

The countries where chiropractic is explicitly illegal are the following:

  • Egypt
  • Argentina
  • Columbia
  • Austria,
  • Estonia,
  • Greece,
  • Hungary,
  • Lebanon,
  • Republic of Korea,
  • Taiwan,
  • Turkey.
  • Ukraine.

Forty-two countries (61.8%) have regulations and/or rules under the legislation to provide for registration or licensure of chiropractors. Chiropractors may be available in 90 countries, but 50% percent of these have 10 or fewer chiropractors. Importantly, the care of children is under regulation or restrictions in most countries.

In comparison to similar professions such as physiotherapy, the chiropractic total workforce is small (worldwide 103,469). The World Confederation of Physical Therapy reports an estimated number of 450,000 physical therapists worldwide with the number of physio therapists per capita per 100,000 ranging from 0.19 in Malawi to 282 in Finland.
This survey holds plenty of interesting information. Here is what I found most remarkable:
  • The World Federation of Chiropractic takes 3 years to publish data which, by then, are of course out-dated.
  • In most countries, the chiropractic care for children is restricted.
  • In many countries chiropractic is illegal.
  • In many countries, there are only very few or no chiropractors at all.
  • There are about 4 times more physiotherapists than chiropractors.
  • In 9 countries, chiropractors have the right to prescribe medicines.

Much of the data revealed in this survey suggests to me that the world can do without chiropractors.

An article in the Sydney Morning Herald might be interesting to some readers. It informs us that, after more than 25 years of running, the University of Technology Sydney (UTS) intends to stop offering its degree in Traditional Chinese Medicine (TCM). A review of the Chinese Medicine Department found it should be wound up at the end of 2021 because

  • it was no longer financially viable,
  • did not produce enough research,
  • and did not fit with the “strategic direction” of the science faculty.

The UTS’s Chinese medicine clinic, which offers acupuncture and herbal treatments, would also close. Students who don’t finish by the end of 2021 will either move to another health course, or transfer to another university (Chinese medicine is also offered by the University of Western Sydney, RMIT in Melbourne, and several private colleges).

TCM “is a historical tradition that pre-dated the scientific era,” said the president of Friends of Science, Associate Professor Ken Harvey. “There’s nothing wrong with looking at that using modern scientific techniques. The problem is people don’t, they tend to teach it like it’s an established fact. If I was a scientifically-orientated vice chancellor I would worry about having a course in my university that didn’t have much of a research profile in traditional Chinese medicine.”

But a spokesman for the University of Technology Sydney said the debate over the scientific validity of Chinese medicine had nothing to do with the decision, and was “in no way a reflection of an institutional bias against complementary health care”. Personally, I find this statement surprising. Should the scientific validity of a subject not be a prime concern of any university?

In this context, may I suggest that the UTS might also have a critical look at their ‘AUSTRALIAN RESEARCH CENTRE IN COMPLEMENTARY AND INTEGRATIVE MEDICINE‘. They call themselves ‘the first centre worldwide dedicated to public health and health services research on complementary and integrative medicine’. Judging from the centre director’s publications, this means publishing one useless survey after another.

The NHS England has stopped paying for homeopathy in 2017. France has just announced to do likewise. What about Germany, the homeland of homeopathy?  

In Germany there are about 150,000 doctors, and around 7,000 specialize in homeopathy. Multiple surveys confirm that Germans do like their SCAMs, particularly homeopathy. Two examples:

  • A 2016 cross-sectional analysis conducted among all patients being referred to the Department of Internal and Integrative Medicine at Essen, Germany, over a 3-year period showed that 35% of the 2,045 respondents reported having used homeopathy for their primary medical complaint.  359 (50.2%) patients reported benefits and 15 (2.1%) reported harm.
  • More recently, a questionnaire survey concerning current and lifetime use of SCAM was distributed to German adults with autism spectrum disorder (ASD). The results suggested that 45% of the respondents were currently using or had used at least one SCAM modality in their life. Homeopathy and acupuncture were most frequently used SCAMs, followed by mind-body interventions.

But since a few years, the German opposition to homeopathy has become much more active. In particular the INH, the GWUP, and the Muensteraner Kreis have been instrumental in informing the public about the uselessness and dangers of homeopathy. The press has now taken up this message and, as this article explains, now the debate about homeopathy has finally reached the political level.

The head of the main doctors’ association and the SPD’s health specialist have called for an end to refunds for homeopathy treatments in Germany. The head of the National Association of Statutory Health Insurance Physicians (KBV), which represents 150,000 doctors and psychotherapists in Germany, recently urged health insurance companies to stop funding homeopathic services. “There is insufficient scientific evidence for the efficacy of homeopathic procedures,” Andreas Gassen told the Rheinische Post. “If people want homeopathic remedies, they should have them — but not at the expense of the community.

Gassen’s comments follow those of the Social Democrat (SPD) health issues specialist and lawmaker Karl Lauterbach who has pressed for a law banning refunds for homeopathy. “We have to talk about it in GroKo,” Lauterbach said earlier this month, suggesting a discussion in the government grand coalition. He said the benefits paid for by insurers should be medically and economically sensible. He has the support of the Federal Joint Committee which decides on what is covered by payments from the statutory health funds.

So, what is going to happen?

As I have written previously, one can only be sure of this:

  • The German homeopathy lobby will not easily give up; after all, they have half a billion Euros per year to lose.
  • They will not argue on the basis of science or evidence, because they know that neither are in their favour.
  • They will fight dirty and try to defame everyone who stands in their way.
  • They will use their political influence and their considerable financial power.

AND YET THEY WILL LOSE!

Not because we are so well organised or have great resources – in fact, as far as I can see, we have none – but because, in medicine, the evidence is invincible and will eventually prevail. Progress might be delayed, but it cannot be halted by those who cling to an obsolete dogma.

 

 

In Switzerland, so-called alternative medicine (SCAM) is officially recognised within the healthcare system and mainly practised in conjunction with conventional medicine. So far no research has been published into the attitude towards, training in and offer of SCAM among paediatricians in Switzerland. This survey addresses this gap by investigating these topics with an online survey of paediatricians in Switzerland.

It employed a 19-item, self-reporting questionnaire among all ordinary and junior members of the Swiss Society of Paediatrics (SSP). A comparison of the study sample with the population of all paediatricians registered with the Swiss Medical Association (FMH) allowed an assessment of the survey’s representativeness. The data analysis was performed on the overall group level as well as for predefined subgroups (e.g. sex, age, language, workplace and professional experience).

A total of 1890 paediatricians were approached and 640, from all parts of Switzerland, responded to the survey (response rate 34%). Two thirds of respondents were female, were aged between 35 and 55 years, trained as paediatric generalist and worked in a practice. Apart from young paediatricians in training, the study sample was representative of all Swiss paediatricians.

According to the authors’ statistics, the results suggest that

  • 23% had attended training in SCAM, most frequently in phytotherapy, homeopathy, acupuncture/traditional Chinese medicine (TCM) and anthroposophic medicine
  • 8% had a federal certificate in one or more SCAM methods.
  • 44% did not routinely ask their patients about their use of SCAM.
  • 84% did not offer SCAM.
  • 65% were interested in SCAM courses and training.
  • 16% provided SCAM services to their patients.
  • 97% were asked by patients/parents about SCAM therapies.
  • More than half of the responding paediatricians use SCAM for themselves or their families.
  • 42% were willing to contribute to paediatric SCAM research.

The authors concluded that in a representative sample of paediatricians in Switzerland, the overall attitude towards SCAM was positive, emphasised by great interest in SCAM training, willingness to contribute to SCAM research and, in particular, by the high rate of paediatricians using SCAM for themselves and their families. However, given the strong demand for SCAM for children, the rate of paediatricians offering SCAM is rather low, despite the official recognition of SCAM in Switzerland. Among the various reasons for this, insufficient knowledge and institutional barriers deserve special attention. The paediatricians’ great interest in SCAM training and support for SCAM research offer key elements for the future development of complementary and integrative medicine for children in Switzerland.

SCAM suffers from acute survey mania. I am anxiously waiting for a survey of SCAM use in left-handed, diabetic policemen in retirement from Devon. But every other variation of the theme has been exploited. And why not? It provides the authors with a most welcome addition to their publication list. And, of course, it lends itself very nicely to SCAM-promotion. Sadly, there is not much else that such surveys offer.

Except perhaps for an opportunity to do an alternative evaluation of their results. Here is an assessment the devil’s advocate in me proposes. Based on the reasonable assumption that those 34% of paediatricians who responded did so because they had an interest in SCAM, and the 64% who did not reply couldn’t care less, it is tempting to do an analysis of the entire population of Swiss paediatricians. Here are my findings:

  • Hardly anyone had attended training in SCAM.
  • Hardly anyone had a federal certificate in one or more SCAM methods.
  • Very few did not routinely ask their patients about their use of SCAM.
  • Hardly anyone offered SCAM.
  • Very few were interested in SCAM courses and training.
  • Hardly anyone provided SCAM services to their patients.
  • Quite a few were asked by patients/parents about SCAM therapies.
  • Very few paediatricians use SCAM for themselves or their families.
  • Few were willing to contribute to paediatric SCAM research.

These results might be closer to the truth but they have one very important drawback: they do not lend themselves to drawing the SCAM-promotional conclusions formulated by the authors.

Oh Yes, reality can be a painful thing!

A few days ago, I reported that the German homeopathy manufacturer Hevert has taken legal action against German critics of homeopathy. This caused a storm of protests on twitter, in the press and even on TV. Hevert has remained silent in all this, but now a spokesperson and part owner of the firm, Mr Mathias Hevert, has given an interview to ‘Pharma Relations’ in an attempt to explain and justify Hevert’s position.

The interview does not tell us much, except for one particular passage:

Frau Grams hat sich meines Wissens nach gar nicht konkret auf die Produkte der Firma Hevert bezogen. Warum fühlten Sie sich dennoch aufgerufen, sozusagen stellvertretend für die Branche juristische Schritte einzuleiten?

Da homöopathische Arzneimittel neben pflanzlichen und schulmedizinischen Präparaten einen wichtigen Teil des breiten Hevert-Sortiments darstellen, fühlen wir uns bereits seit der Firmengründung 1956 eng mit der durch Pastor Emanuel Felke begründeten Komplexmittel-Homöopathie verbunden. Seit Monaten beobachten wir, wie die Homöopathie von Meinungsbildnern in den Sozialen Medien, der Presse und dem Fernsehen undifferenziert und ohne wissenschaftliche Grundlage denunziert wird. In Großbritannien wurden bereits einflussreiche Lobbygruppen aktiv, um die Homöopathie als Ganzes und ohne differenzierte Betrachtung der Datenlage zu verunglimpfen. Mit ihren Bemühungen schafften sie es sogar, die Politik zu gesetzlichen Einschränkungen des Feldes zu drängen. Um ähnliches in Deutschland – dem Mutterland der Homöopathie – zu verhindern, geht Hevert entschlossen gegen ungerechtfertigte und nicht fundierte Diskreditierungen der Homöopathie durch Lobbygruppen und andere Meinungsbildner vor.

Here is my translation of the bit that concerns me:

Q: Frau Grams has, as far as I know, not even concretely referred to the products of Hevert. Why do you still feel compelled to start legal procedures, so to speak for the sector?

A: … We observe since months how homeopathy is being denounced in an undifferentiated manner and without a scientific basis by opinion leaders in social media, the press, an on TV. In England, influential lobby groups have been active to denigrate homeopathy as a whole and without differentiated consideration of the data. Through their efforts, they have even managed to force politicians to implement legal restrictions in this area…

_________________________________________________________

I must admit, I find this response quite extraordinary!

I am not aware of anyone or any group in England denigrating homeopathy without differentiated consideration of the data. All we did was to point out what the best available evidence tells us, exercise our critical thinking abilities, and report facts. And I do strongly object anyone claiming otherwise. In fact, I ask myself whether the above remarks by a representative of a manufacturer of homeopathics are not libellous and thus actionable.

What do you think?

PS

But perhaps I have misunderstood something; in this case, could Mr Hevert please name the UK critics he had in mind when he made these comments?

I have reported about the French activities against homeopathy before (see here and here). Yesterday, this article brought considerable more clarity into the situation. Here is my (not entirely literal) translation and below the French original:

Unsurprisingly, the French health regulator (HAS) has voted on Wednesday with a very large majority (only one vote against) for the discontinuation of the reimbursement of homeopathic products. This decision, which is not denied by the health ministry, will be officially announced this Friday morning by the president of the authority, Prof Dominique Le Guludec, during a press conference. Then it will be up to the health minister, Agnès Buzyn, to decide or not on the discontinuation of reimbursement.

I will follow the advice of the health authority‘ the health minister declared only recently. This advice is the direct consequence of a first meeting of the commission which took place in Mid May and gave an opinion that already went into that direction. The laboratories concerned had the right to be heard and to present their view. Obviously this was not convincing.

______________________________________________________________

Sans surprise, la Commission de la transparence de la Haute autorité de santé a voté ce mercredi à la très grande majorité (une seule voix contre) le déremboursement des produits homéopathiques. Cette décision, que ne dément pas le ministère de la Santé, sera annoncée officiellement vendredi matin par la présidente de la Haute Autorité de santé, la professeur Dominique Le Guludec, au cours d’une conférence de presse. A charge ensuite à la ministre de la Santé, Agnès Buzyn, de décider ou non ce déremboursement.

«Je me tiendrai à l’avis de la Haute Autorité de santé», a encore récemment déclarée la ministre. Cet avis est la conséquence directe d’une première réunion, qui s’est tenue à la mi mai, de la dite Commission, qui avait alors rendu un avis transitoire, allant clairement dans ce sens. Comme le stipule le processus, les laboratoires concernées avaient le droit d’être entendus et de se défendre. Manifestement, ces derniers n’ont pas convaincus.

‘Acute-on-chronic liver failure’ (ACLF) is an acute deterioration of liver function in patients with pre-existing liver disease. It is usually associated with a precipitating event and results in the failure of one or more organs and high short term mortality.

An international team of researchers published a analysis examining data regarding drugs producing ACLF. They evaluated clinical features, laboratory characteristics, outcome, and predictors of mortality in patients with drug-induced ACLF. They identified drugs as precipitants of ACLF among prospective cohort of patients with ACLF from the Asian Pacific Association of Study of Liver (APASL) ACLF Research Consortium (AARC) database. Drugs were considered precipitants after exclusion of known causes together with a temporal association between exposure and decompensation. Outcome was defined as death from decompensation.

Of the 3,132 patients with ACLF, drugs were implicated as a cause in 10.5% of all cases and other non-drug causes in 89.5%. Within the first group, so-called alternative medications (SCAMs) were the commonest cause (71.7%), followed by combination anti-tuberculosis therapy drugs (27.3%). Alcoholic liver disease (28.6%), cryptogenic liver disease (25.5%), and non-alcoholic steatohepatitis (NASH) (16.7%) were common causes of underlying liver diseases. Patients with drug-induced ACLF had jaundice (100%), ascites (88%), encephalopathy (46.5%), high Model for End-Stage Liver Disease (MELD) (30.2), and Child-Turcotte-Pugh score (12.1). The overall 90-day mortality was higher in drug-induced (46.5%) than in non-drug-induced ACLF (38.8%).

The authors concluded that drugs are important identifiable causes of ACLF in Asia-Pacific countries, predominantly from complementary and alternative medications, followed by anti-tuberculosis drugs. Encephalopathy, bilirubin, blood urea, lactate, and international normalized ratio (INR) predict mortality in drug-induced ACLF.

The fact that some SCAMs can damage the liver has long been known. Here, for example, is 2003 our review of herbal medicine and liver problems:

Systematic literature searches were performed on Medline, Embase, The Cochrane Library, Amed and Ciscom. To identify additional data, searches were conducted by hand in relevant medical journals and in our own files. The screening and selection of articles and the extraction of data were performed independently by the two authors. There were no restrictions regarding the language of publication. In order to be included articles were required to report data on hepatotoxic events associated with the therapeutic use of herbal medicinal products.

Single medicinal herbs and combination preparations are associated with hepatotoxic events. Clinically, the spectrum ranges from transient elevations of liver enzyme levels to fulminant liver failure and death. In most instances hepatotoxic herbal constituents are believed to be the cause, while others may be due to herb-drug interactions, contamination and/or adulteration.

A number of herbal medicinal products are associated with serious hepatotoxic events. Incidence figures are largely unknown, and in most cases a causal attribution is not established. The challenge for the future is to systematically research this area, educate all parties involved, and minimize patient risk.

Despite these warnings, progress is almost non-existent. If anything the problem seems to increase in proportion with the rise in the use of SCAM. Hence, one cannot but agree with the conclusion of a more recent overview: The actual incidence and prevalence of herb-induced liver injury in developing nations remain largely unknown due to both poor pharmacovigilance programs and non-application of emerging technologies. Improving education and public awareness of the potential risks of herbals and herbal products is desirable to ensure that suspected adverse effects are formally reported. There is need for stricter regulations and pre-clinical studies necessary for efficacy and safety.

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