MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

medical ethics

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I was reliably informed that the ‘Australian Acupuncture and Chinese Medicine Association’ (AACMA) are currently – that is AFTER having retracted the falsehoods they previously issued about me – distributing a document which contains the following passage:

It is noted that Mr Ernst derives income from editing a journal called Focus on Alternative and Complementary Medicine which is published by the British Pharmaceutical Society and listed in pharamcologyjournals.com. Ernst has not declared his own pecuniary conflicts of interest and links with the pharmaceutical industry. I note that the FSM webpage declares that:

‘None of the members of the executive has any vested interests in pharmaceutical companies such that our views or opinions might be influenced’.

This statement is disingenuous and deceptive if instead you base your critique on the blog of a person with such pharmaceutical interests without declaring it.

This is a repetition of the lies which the AACMA have already retracted (see comments section of my previous post on this matter). In my view, this is highly dishonest and actionable. For this reason, I today sent them this ‘open letter’ which I also publish here:

Dear Madam/Sir,

As explained more fully in this blog-post, you have recently accused me of undeclared links to and payments from the pharmaceutical industry. This is a serious, potentially liable allegation.

My objections were followed by your retraction of these allegations (see the comments section of my above-mentioned blog-post). However, your retraction displays an embarrassing level of ignorance and contains several grave errors (see the comments section of my above-mentioned blog-post). Crucially, it implies that I formally had an undeclared conflict of interest. This is untrue. More importantly, you currently distribute a document that continues to allege that I currently have ‘pharmaceutical interests’. This too is untrue.

I urge you to either produce the evidence for your allegations, or fully retract them. This strategy would not merely be the only decent and professional way of dealing with the problem, it also might prevent damage to your reputation, and  avoid libel action against you.

Sincerely

Edzard Ernst

Cranio-sacral therapy is firstly implausible, and secondly it lacks evidence of effectiveness (see for instance here, here, here and here). Yet, some researchers are nevertheless not deterred to test it in clinical trials. While this fact alone might be seen as embarrassing, the study below is a particular and personal embarrassment to me, in fact, I am shocked by it and write these lines with considerable regret.

Why? Bear with me, I will explain later.

The purpose of this trial was to evaluate the effectiveness of osteopathic manipulative treatment and osteopathy in the cranial field in temporomandibular disorders. Forty female subjects with temporomandibular disorders lasting at least three months were included. At enrollment, subjects were randomly assigned into two groups: (1) osteopathic manipulative treatment group (n=20) and (2) osteopathy in the cranial field [craniosacral therapy for you and me] group (n=20). Examinations were performed at baseline (E0) and at the end of the last treatment (E1), and consisted of subjective pain intensity with the Visual Analog Scale, Helkimo Index and SF-36 Health Survey. Subjects had five treatments, once a week. 36 subjects completed the study.

Patients in both groups showed significant reduction in Visual Analog Scale score (osteopathic manipulative treatment group: p = 0.001; osteopathy in the cranial field group: p< 0.001), Helkimo Index (osteopathic manipulative treatment group: p = 0.02; osteopathy in the cranial field group: p = 0.003) and a significant improvement in the SF-36 Health Survey – subscale “Bodily Pain” (osteopathic manipulative treatment group: p = 0.04; osteopathy in the cranial field group: p = 0.007) after five treatments (E1). All subjects (n = 36) also showed significant improvements in the above named parameters after five treatments (E1): Visual Analog Scale score (p< 0.001), Helkimo Index (p< 0.001), SF-36 Health Survey – subscale “Bodily Pain” (p = 0.001). The differences between the two groups were not statistically significant for any of the three endpoints.

The authors concluded that both therapeutic modalities had similar clinical results. The findings of this pilot trial support the use of osteopathic manipulative treatment and osteopathy in the cranial field as an effective treatment modality in patients with temporomandibular disorders. The positive results in both treatment groups should encourage further research on osteopathic manipulative treatment and osteopathy in the cranial field and support the importance of an interdisciplinary collaboration in patients with temporomandibular disorders. Implications for rehabilitation Temporomandibular disorders are the second most prevalent musculoskeletal condition with a negative impact on physical and psychological factors. There are a variety of options to treat temporomandibular disorders. This pilot study demonstrates the reduction of pain, the improvement of temporomandibular joint dysfunction and the positive impact on quality of life after osteopathic manipulative treatment and osteopathy in the cranial field. Our findings support the use of osteopathic manipulative treatment and osteopathy in the cranial field and should encourage further research on osteopathic manipulative treatment and osteopathy in the cranial field in patients with temporomandibular disorders. Rehabilitation experts should consider osteopathic manipulative treatment and osteopathy in the cranial field as a beneficial treatment option for temporomandibular disorders.

This study has so many flaws that I don’t know where to begin. Here are some of the more obvious ones:

  • There is, as already mentioned, no rationale for this study. I can see no reason why craniosacral therapy should work for the condition. Without such a rationale, the study should never even have been conceived.
  • Technically,  this RCTs an equivalence study comparing one therapy against another. As such it needs to be much larger to generate a meaningful result and it also would require a different statistical approach.
  • The authors mislabelled their trial a ‘pilot study’. However, a pilot study “is a preliminary small-scale study that researchers conduct in order to help them decide how best to conduct a large-scale research project. Using a pilot study, a researcher can identify or refine a research question, figure out what methods are best for pursuing it, and estimate how much time and resources will be necessary to complete the larger version, among other things.” It is not normally a study suited for evaluating the effectiveness of a therapy.
  • Any trial that compares one therapy of unknown effectiveness to another of unknown effectiveness is a complete and utter nonsense. Equivalent studies can only ever make sense, if one of the two treatments is of proven effectiveness – think of it as a mathematical equation: one equation with two unknowns is unsolvable.
  • Controlled studies such as RCTs are for comparing the outcomes of two or more groups, and only between-group differences are meaningful results of such trials.
  • The ‘positive results’ which the authors mention in their conclusions are meaningless because they are based on such within-group changes and nobody can know what caused them: the natural history of the condition, regression towards the mean, placebo-effects, or other non-specific effects – take your pick.
  • The conclusions are a bonanza of nonsensical platitudes and misleading claims which do not follow from the data.

As regular readers of this blog will doubtlessly have noticed, I have seen plenty of similarly flawed pseudo-research before – so, why does this paper upset me so much? The reason is personal, I am afraid: even though I do not know any of the authors in person, I know their institution more than well. The study comes from the Department of Physical Medicine and Rehabilitation, Medical University of Vienna, Austria. I was head of this department before I left in 1993 to take up the Exeter post. And I had hoped that, even after 25 years, a bit of the spirit, attitude, knowhow, critical thinking and scientific rigor – all of which I tried so hard to implant in my Viennese department at the time – would have survived.

Perhaps I was wrong.

Difficulties breastfeeding?

Some say that Chinese herbal medicine offers a solution.

This Chinese multi-centre RCT included 588 mothers considering breastfeeding. The intervention group received the Chinese herbal mixture Zengru Gao, while the control group received no therapy. The primary outcomes were the percentages of fully and partially breastfeeding mothers, and a secondary outcome was baby’s daily formula intake.

At day 3 and 7 after delivery, significant differences were found in favour of Zengru Gao group on the percentage of full/ partial breastfeeding. At day 7, the percentage of full/ partial breastfeeding of the active group increased to 71.48%/20.70% versus 58.67%/30.26% in the control group, the differences remained significant. No statistically significant differences were detected on primary measures at day. While intake of formula differed between groups at day 1 and 3, this difference did not achieve statistical significance, but this difference was apparent by day 7.

The authors concluded that the Chinese Herbal medicine Zengru Gao enhanced breastfeeding success during one week postpartum. The approach is acceptable to participants and merits further evaluation.

To the naïve observer, this study might look rigorous, but it is a seriously flawed RCT. Here are just some of its most obvious limitations:

  • All we get in the methods section is this explanation: Participants were randomly allocated to the blank control group or the intervention group: Zengru Gao, orally, 30 g a time and 3 times a day. This seems to indicate that the control group got no treatment at all which means there was no blinding nor placebo control. The authors even comment on this point in the discussion section of their paper stating that because we included new mothers who received no treatment as a control group, we were able to prove that the improvement in breastfeeding was not due to the placebo effect. However, this is a totally nonsensical argument.
  • The experimental treatment is not reproducible. The authors state: Zengru Gao, a Chinese herbal formula, which is composed of 8 herbs: Semen Vaccariae, Medulla Tetrapanacis, Radix Rehmanniae Praeparata, Radix Angelicae Sinensis, Radix Paeoniae Alba,Rhizoma Chuanxiong, Herba Leonuri, Radix Trichosanthis. This is not enough information to replicate the study outside China where the mixture is not commercially available.
  • The primary outcome was the percentage of fully, and partially breastfeeding mothers. Breastfeeding was defined as mother’s milk given by direct breast feeding. Full breastfeeding meant that no other types of milk or solids were given. Partially breastfeeding meant that sustained latch with deep rhythmic sucking through the length of the feed, with some pause, on either/ or both breasts. We are not being told how the endpoint was quantified. Presumably women kept diaries. We cannot guess how accurate this process was.
  • As far as I can see, there was no correction for multiple testing for statistical significance. This means that some or all of the significant results might be false-positive.
  • There is insufficient data to show that the herbal mixture is safe for the mothers and the babies. At the very minimum, the researchers should have measured essential safety parameters. This omission is a gross violation of research ethics.
  • Towards the end of the paper, we find the following statement: The authors would like to thank the Research and Development Department of Zhangzhou Pien Tze Huang Pharmaceutical co., Ltd. … The authors declare that they have no competing interests. And the 1st and 3rd authors are “affiliated with” Guangzhou Hipower Pharmaceutical Technology Co., Ltd, Guangzhou, China, i. e. work for the manufacturer of the mixture. This does clearly not make any sense whatsoever.

I have seen too many flawed studies of alternative medicine to be shocked or even surprised by this level of incompetence and nonsense. Yet, I still find it lamentable. But, in my view, the worst is that supposedly peer-reviewed journals such as ‘BMC Complement Altern Med’ publish such overt rubbish.

It would be easy to shrug one’s shoulder and bin the paper. But the effect of such fatally flawed research is too serious for that. In our recent book MORE HARM THAN GOOD? THE MORAL MAZE OF COMPLEMENTARY AND ALTERNATIVE MEDICINE, we discuss that such flawed science amounts to a violation of medical ethics:  CAM journals allocate peer review tasks to a narrow range of CAM enthusiasts who often have been chosen by the authors of the article in question. The raison d’être of CAM journals and CAM researchers is inextricably tied to a belief in CAM, resulting in a self-referential situation which is permissive to the acceptance of weak or flawed reports of clinical effectiveness… Defective research—whether at the design, execution, analysis, or reporting stage—corrupts the repository of reliable medical knowledge. Ultimately, this leads to suboptimal and erroneous treatment decisions…

The Royal London Homeopathic Hospital, recently re-named as the Royal London Hospital for Integrated Medicine (RLHIM), has been one of the most influential homeopathic hospitals in the world. It was founded in 1849 by Dr Frederick Foster Hervey Quin. In 1895, a new and larger hospital was opened on its present site in Great Ormond Street. Many famous homeopaths have worked there, including Robert Ellis Dudgeon, John Henry Clarke, James Compton Burnett, Edward Bach, Charles E Wheeler, James Kenyon, Margaret Tyler, Douglas Borland, Sir John Weir, Donald Foubister, Margery Blackie and Ralph Twentyman. In 1920, the hospital received Royal Patronage from the Duke of York, later King George VI, who also became its president in 1924, and in 1936, the Hospital was honoured by the Patronage of His Majesty the King gaining its ‘Royal’ prefix in 1947. Today, Queen Elizabeth II is the Hospital’s Patron.

On 18 June 1972, 16 of the hospital’s doctors and colleagues on board were killed in a plane crash. During the following years, several reductions in size and income took place. From 2002 to 2005, the hospital underwent a £20m redevelopment and, in 2010, its name was changed to Royal London Hospital for Integrated Medicine.

The hospital just published a new brochure for patients. It contains interesting information and therefore, I will quote directly from this document.

START OF QUOTES

The Royal London Hospital for Integrated Medicine (RLHIM) is part of University College London Hospitals NHS Foundation Trust and accepts all NHS referrals. GP referrals are by letter or via Choose and Book. Patients can also be referred by their NHS hospital consultant.

NHS Choices provides information and an opportunity to provide feedback about our service at www.nhs.uk
….

The General Medicine Service is led by three consultant physicians. The team also includes other doctors and nurses, a dietitian, a physiotherapist, an occupational therapist and a psychotherapist. The service sees patients with chronic and complex conditions. The team is trained in many areas of complementary medicine. These are used alongside orthodox treatment, allowing them to offer a fully integrated General Medicine service. The General Medicine Service offers a full range of diagnostic tests as well as a variety of treatments and advice on orthodox treatment.

From 3rd April 2018, The Royal London Hospital for Integrated Medicine (RLHIM) will no longer be providing NHS-funded homeopathic remedies for any patients as part of their routine care. This is in line with the funding policy of Camden Clinical Commissioning Groups, the local NHS body that plans and pays for healthcare services in this area.

Should you choose you will be able to purchase these medicines from the RLHIM pharmacy, while other homeopathic pharmacies may also be able to supply the medicines. You can speak to your clinician or the RLHIM pharmacy at your next visit about this…

Conditions commonly seen include:

  • Recurrent infections, such as colds, sore throats, cystitis, thrush, chest infections and bacterial infections
  • Some persistent symptoms where tests have not revealed a serious underlying disorder
  • Asthma or chronic obstructive pulmonary disease (COPD)
  • Digestive disorders, for example acid reflux, Irritable Bowel Syndrome and inflammatory bowel disease
  • Endocrine (glandular) disorders such as under-active thyroid
  • Type II diabetes
  • Some types of heart disease, high blood pressure and palpitations (requiring no orthodox treatment)
  • Chronic headache such as migraine or tension-type headache
  • Side effects of prescribed medications

END OF QUOTES

Clearly, the big news here is that the RLHIM has been forced to stop providing NHS-funded homeopathics. This could be indicative of what might soon happen throughout NHS England.

But there are other items that I find remarkable: “The General Medicine Service offers a full range of diagnostic tests as well as a variety of treatments and advice on orthodox treatment.” Call me a nit-picker, but this is not INTEGRATED! Integrated medicine means employing both alternative as well as conventional therapies in parallel. The best of BOTH worlds and all that…

In the same vein is the statement that they treat “some types of heart disease, high blood pressure and palpitations (requiring no orthodox treatment)” I am sorry, but this again is not INTEGRATED MEDICINE! I ask myself, is it ethical to mislead patients, colleagues, NHS officials and everyone else pretending to deliver ‘integrated medicine’, while in fact all they seem to offer is ‘alternative medicine’?

The RLHIM has recently dropped the term HOMEOPATHY from its name. Soon it might have to also abandon the term INTEGRATED, because it does not seem to be able to provide a safe level of conventional medicine.

How shall we then call it?

Suggestions please!

Doctor Jonas is an important figure head of US ‘Integrative Medicine’. As we discussed in a recent post, he pointed out that many US hospital doctors fail to answer the following questions relating to their chronically ill patients:

  1. “What matters most for this patient?
  2. What is the person’s lifestyle like – their nutrition, movement and sleep?
  3. How does that patient manage their stress?
  4. Does that patient have a good support system at home?
  5. What supplements does that patient take? Has your patient seen any CAM practitioners to cope with their condition?
  6. Why do they want to get well?”

In my previous post, I tried to explain that this is embarrassing – embarrassing for doctor Jonas, I meant.

But Jonas also claims that most US hospital doctors he addressed during his lecture tour, were unable to answer these questions. And that might be embarrassing not for Jonas, but for those physicians. Let’s consider this possibility for a moment.

The way I see it, the doctors in question might not have answered to Jonas for the following reasons:

  • They felt that the questions were simply too daft to bother.
  • They were too polite to tell Jonas what they think of him.
  • They were truly unable to answer the questions.

Here I want to briefly deal with the last category.

I do not doubt for a minute that this category of physician exists. They have little interest in what matters to their patients, don’t ask the right questions, have no time and even less empathy and compassion. Yet nobody can deny that medical school teaches all of these qualities, skills and attitudes. And there is no doubt that good doctors practice them; it is not a choice but an ethical and moral imperative.

So, what went wrong with these doctors?

Probably lots, and I cannot begin to tell you what exactly. However, I can easily tell you that those doctors are not practicing good medicine. Similarly, I can tell you what these doctors ought to do: re-train and be reminded of what medical school has once taught them.

And what about those physicians who advocate ‘integrated medicine’ reminding everyone of the core values of healthcare?

Aren’t they fabulous?

No, they aren’t!

Why?

Because they too have evidently forgotten what they should have learnt at medical school. If not, they would not be able to pretend that ‘integrative medicine’ has a monopoly on core values of all healthcare. Their messages are akin to a new ‘school’ of ship-building insisting that it is beneficial to build ships that do not leak.

What I am trying to say in my clumsy way is this:

DOCTORS WHO PRACTICE BAD MEDICINE SHOULD RE-TRAIN – TOGETHER WITH THOSE PHYSICIANS WHO ADVOCATE ‘INTEGRATIVE MEDICINE‘, BECAUSE THEY BOTH HAVE FORGOTTEN WHAT THEY LEARNT AT MEDICAL SCHOOL.

The Australian Acupuncture and Chinese Medicine Association Ltd (AACMA) is the “peak professional body of qualified acupuncture and Chinese herbal medicine practitioners in Australia. AACMA has represented the profession since 1973 and values high standards in ethical and professional practice.”

High standards in ethical and professional practice?

Really?

Somehow, I doubt it!

Why?

Because they recently wrote to ‘Friends of Science in Medicine‘ categorically stating that I have “undeclared links to the pharmaceutical industry”.

To set the record straight (yet again), I here provide a complete list of all my links to the pharmaceutical industry, plus all my sponsorships and inducements from BIG PHARMA and elsewhere :

END OF LIST

As erring is human but lying is unethical, I herewith want to give the The Australian Acupuncture and Chinese Medicine Association an opportunity to withdraw their statement and post an apology. To make sure they know about this invitation, I have sent them this blog via an email. Failing an apology I might take appropriate action and I will certainly declare the association to be neither professional nor ethical.

I am waiting – shall we say until one week from today?

Yesterday, I received a ‘LETTER FROM DR JONAS’ (the capital lettering was his) – actually, it was an email, and not a very personal one at that. Therefore I feel it might be permissible to share some of it here (you do remember Jonas, don’t you? I did mention him in a recent post: “Considering the prominence and experience of Wayne Jonas, the 1st author of this paper, such obvious transgression is more than a little disappointing – I would argue that is amounts to overt scientific misconduct.”)

Here we go:

As part of my book tour, I spent last month visiting hospitals and medical schools, talking to the doctors, nurses and students. I tell them to think of a chronically ill patient, and I ask:

“What matters most for this patient? What is the person’s lifestyle like – their nutrition, movement and sleep? How does that patient manage their stress? Does that patient have a good support system at home? What supplements does that patient take? Has your patient seen any CAM practitioners to cope with their condition? Why do they want to get well?”

Most can’t answer these questions. Providers may know the diagnosis and treatments a patient gets, but few know their primary determinants of health. They know ‘what’s the matter’, but not ‘what matters.’ …

END OF QUOTE

Let’s have a closer look at those items of which Jonas thinks they matter:

  1. What is the person’s lifestyle like – their nutrition, movement and sleep? Depending on the condition of the patient, these issues might indeed matter. And if they do, any good doctor will consider them. There is nothing new about this; it is stuff I learnt in medical school all those years ago.
  2. How does that patient manage their stress? The question supposes that all patients suffer from stress. I know it is fashionable to ‘have stress’, but not every patient suffers from it. If the patient does suffer, it goes without saying that a good doctor would consider it.
  3. Does that patient have a good support system at home? Elementary, my dear Watson! If a doctor does not know about this, (s)he has slept through medical school (where did you go to medical school Wayne, and what did you do during these 6 years?).
  4. What supplements does that patient take? That’s a good one. I suppose Jonas would ask it to see what further nonsense he might recommend. Most rational doctors would ask this question to see what (s)he must advise the patient to discontinue.
  5. Has your patient seen any CAM practitioners to cope with their condition? As above.
  6. Why do they want to get well? Most patients would assume we are pulling their leg, if we really asked this. Instead of a response, they might return a question: Why do you ask, do you think being ill is fun?

So, doctor Jonas’ questions might do well during lectures to a self-selected audience, but in reality they turn out to be a mixture of embarrassing re-discoveries from conventional medicine, platitudes and outright nonsense. “My goal is for integrative healthcare to become the standard of care…” says Jonas towards the end of his ‘LETTER’. I suppose, this explains it!

Thus Jonas’ ‘LETTER’ turns out to be yet another indication to suggest that the reality of ‘integrative medicine’ consists of little more than re-discoveries from conventional medicine, platitudes and outright nonsense.

This is a question most clinicians must have asked themselves. The interest of patients in this area is enormous, and many do seek advice from their doctor, nurse, pharmacist, midwife etc. In a typical scenario, a patient might plug up her courage (yes, for many it does take courage) and ask:

What about therapy xy for my condition? My friend suffers from the same problem, and she says the treatment works very well.

The way I see it, there are essentially 4 options for formulating a reply:

1.       Uncompromisingly negative

2.       Evidence-based

3.       Open-minded

4.       Uncritically promotional

Let me explain and address these 4 options in turn.

1.       Uncompromisingly negative

I know that it can be tempting to be wholly dismissive and simply state that all alternative medicine is rubbish; if it were any good, it would have been adopted by conventional medicine. Therefore, alternative medicine is never an alternative; it is by definition implausible, ineffective and often dangerous.

Even if all of this were true, the uncompromisingly negative approach is not helpful, in my experience. Patients need and deserve some empathy and understanding of their position. If we brusque them, they feel insulted and go elsewhere. Not only would we then lose a patient, but we would run a high risk of exposing her to a practitioner who promotes quackery. The disservice seems obvious.

2.       Evidence-based

Clinicians might consider their patient’s question and reply to it by explaining what the current best available evidence tells us about the therapy in question. This can be done with empathy and compassion. For instance (if that is true), the clinician can explain that the treatment in question lacks a scientific basis, that it has nevertheless been tested in clinical trials which sadly do not show that it works. Crucially, the clinician should subsequently explain what effective treatments do exist and discuss a viable treatment plan with the patient.

The problem with this approach is that many, if not most conventional clinicians are fairly clueless about the evidence as it relates to the plethora of alternative therapies. Therefore, an honest discussion around the current best evidence is often difficult or impossible.

3.       Open-minded

This is the approach many clinicians today use as a default position. They basically tell their patient that there is not a lot of evidence for the treatment in question. However, it seems harmless, and therefore – if the patient is really keen on going down this route – why not? This type of response is, I fear, given regardless of the therapy in question and it largely ignores the evidence – some alternative treatments do work, some don’t, some are fairly safe, some aren’t.

Condoning alternative medicine in this way gives the impression of being ‘open-minded’ and ‘patient-centred’. It has the considerable advantage that it does not require any hard work, such as informing oneself about the current best evidence. It’s disadvantage is that it neither correct nor ethical.

4.       Uncritically promotional

Many clinicians go even one decisive step further. Under the banner of ‘integrative medicine’, they openly recommend using ‘the best of both worlds’ as being ‘holistic’, ’empathetic’, ‘patient-centred’, etc. By this, they usually mean employing as many unproven or disproven treatments as alternative medicine has to offer.

This approach gives the impression of being ‘modern’ and in tune with the wishes of patients. Its disadvantages are, however, obvious. Introducing bogus treatments into clinical routine can only render it less effective, more expensive, and less safe. Integrative medicine is therefore not in the best interest of patients and arguably unethical.

Conclusion

So, how should we advise patients on alternative medicine? I know what I would say and probably most of my readers can guess. But I do not want to prejudge the issue; I prefer to hear your views, please.

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?

 

Some of you will remember the saga of the British Chiropractic Association suing my friend and co-author Simon Singh (eventually losing the case, lots of money and all respect). One of the ‘hot potatoes’ in this case was the question whether chiropractic is effective for infant colic. This question is settled, I thought: IT HAS NOT BEEN SHOWN TO WORK BETTER THAN A PLACEBO.

Yet manipulators have not forgotten the defeat and are still plotting, it seems, to overturn it. Hence a new systematic review assessed the effect of manual therapy interventions for healthy but unsettled, distressed and excessively crying infants.

The authors reviewed published peer-reviewed primary research articles in the last 26 years from nine databases (Medline Ovid, Embase, Web of Science, Physiotherapy Evidence Database, Osteopathic Medicine Digital Repository , Cochrane (all databases), Index of Chiropractic Literature, Open Access Theses and Dissertations and Cumulative Index to Nursing and Allied Health Literature). The inclusion criteria were: manual therapy (by regulated or registered professionals) of unsettled, distressed and excessively crying infants who were otherwise healthy and treated in a primary care setting. Outcomes of interest were: crying, feeding, sleep, parent-child relations, parent experience/satisfaction and parent-reported global change. The authors included the following types of peer-reviewed studies in our search: RCTs, prospective cohort studies, observational studies, case–control studies, case series, questionnaire surveys and qualitative studies.

Nineteen studies were selected for full review: seven randomised controlled trials, seven case series, three cohort studies, one service evaluation study and one qualitative study. Only 5 studies were rated as high quality: four RCTs (low risk of bias) and a qualitative study.

The authors found moderate strength evidence for the effectiveness of manual therapy on: reduction in crying time (favourable: -1.27 hours per day (95% CI -2.19 to -0.36)), sleep (inconclusive), parent-child relations (inconclusive) and global improvement (no effect).

Reduction in crying: RCTs mean difference.

The risk of reported adverse events was low (only 8 studies mentioned adverse effects at all, meaning that the rest were in breach of research and publication ethics): seven non-serious events per 1000 infants exposed to manual therapy (n=1308) and 110 per 1000 in those not exposed.

The authors concluded that some small benefits were found, but whether these are meaningful to parents remains unclear as does the mechanisms of action. Manual therapy appears relatively safe.

For several reasons, I find this review, although technically sound, quite odd.

Why review uncontrolled data when RCTs are available?

How can a qualitative study be rated as high quality for assessing the effectiveness of a therapy?

How can the authors categorically conclude that there were benefits when there were only 4 RCTs of high quality?

Why do they not explain the implications of none of the RCTs being placebo-controlled?

How can anyone pool the results of all types of manual therapies which, as most of us know, are highly diverse?

How can the authors conclude about the safety of manual therapies when most trials failed to report on this issue?

Why do they not point out that this is unethical?

My greatest general concern about this review is the overt lack of critical input. A systematic review is not a means of promoting an intervention but of critically assessing its value. This void of critical thinking is palpable throughout the paper. In the discussion section, for instance, the authors state that “previous systematic reviews from 2012 and 2014 concluded there was favourable but inconclusive and weak evidence for manual therapy for infantile colic. They mention two reviews to back up this claim. They conveniently forget my own review of 2009 (the first on this subject). Why? Perhaps because it did not fit their preconceived ideas? Here is my abstract:

Some chiropractors claim that spinal manipulation is an effective treatment for infant colic. This systematic review was aimed at evaluating the evidence for this claim. Four databases were searched and three randomised clinical trials met all the inclusion criteria. The totality of this evidence fails to demonstrate the effectiveness of this treatment. It is concluded that the above claim is not based on convincing data from rigorous clinical trials.

Towards the end of their paper, the authors state that “this was a comprehensive and rigorously conducted review…” I beg to differ; it turned out to be uncritical and biased, in my view. And at the very end of the article, we learn a possible reason for this phenomenon: “CM had financial support from the National Council for Osteopathic Research from crowd-funded donations.”

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