MD, PhD, FMedSci, FSB, FRCP, FRCPEd

medical ethics

Rigorous research into the effectiveness of a therapy should tell us the truth about the ability of this therapy to treat patients suffering from a given condition — perhaps not one single study, but the totality of the evidence (as evaluated in systematic reviews) should achieve this aim. Yet, in the realm of alternative medicine (and probably not just in this field), such reviews are often highly contradictory.

A concrete example might explain what I mean.

There are numerous systematic reviews assessing the effectiveness of acupuncture for fibromyalgia syndrome (FMS). It is safe to assume that the authors of these reviews have all conducted comprehensive searches of the literature in order to locate all the published studies on this subject. Subsequently, they have evaluated the scientific rigor of these trials and summarised their findings. Finally they have condensed all of this into an article which arrives at a certain conclusion about the value of the therapy in question. Understanding this process (outlined here only very briefly), one would expect that all the numerous reviews draw conclusions which are, if not identical, at least very similar.

However, the disturbing fact is that they are not remotely similar. Here are two which, in fact, are so different that one could assume they have evaluated a set of totally different primary studies (which, of course, they have not).

One recent (2014) review concluded that acupuncture for FMS has a positive effect, and acupuncture combined with western medicine can strengthen the curative effect.

Another recent review concluded that a small analgesic effect of acupuncture was present, which, however, was not clearly distinguishable from bias. Thus, acupuncture cannot be recommended for the management of FMS.

How can this be?

By contrast to most systematic reviews of conventional medicine, systematic reviews of alternative therapies are almost invariably based on a small number of primary studies (in the above case, the total number was only 7 !). The quality of these trials is often low (all reviews therefore end with the somewhat meaningless conclusion that more and better studies are needed).

So, the situation with primary studies of alternative therapies for inclusion into systematic reviews usually is as follows:

  • the number of trials is low
  • the quality of trials is even lower
  • the results are not uniform
  • the majority of the poor quality trials show a positive result (bias tends to generate false positive findings)
  • the few rigorous trials yield a negative result

Unfortunately this means that the authors of systematic reviews summarising such confusing evidence often seem to feel at liberty to project their own pre-conceived ideas into their overall conclusion about the effectiveness of the treatment. Often the researchers are in favour of the therapy in question – in fact, this usually is precisely the attitude that motivated them to conduct a review in the first place. In other words, the frequently murky state of the evidence (as outlined above) can serve as a welcome invitation for personal bias to do its effect in skewing the overall conclusion. The final result is that the readers of such systematic reviews are being misled.

Authors who are biased in favour of the treatment will tend to stress that the majority of the trials are positive. Therefore the overall verdict has to be positive as well, in their view. The fact that most trials are flawed does not usually bother them all that much (I suspect that many fail to comprehend the effects of bias on the study results); they merely add to their conclusions that “more and better trials are needed” and believe that this meek little remark is sufficient evidence for their ability to critically analyse the data.

Authors who are not biased and have the necessary skills for critical assessment, on the other hand, will insist that most trials are flawed and therefore their results must be categorised as unreliable. They will also emphasise the fact that there are a few reliable studies and clearly point out that these are negative. Thus their overall conclusion must be negative as well.

In the end, enthusiasts will conclude that the treatment in question is at least promising, if not recommendable, while real scientists will rightly state that the available data are too flimsy to demonstrate the effectiveness of the therapy; as it is wrong to recommend unproven treatments, they will not recommend the treatment for routine use.

The difference between the two might just seem marginal – but, in fact, it is huge: IT IS THE DIFFERENCE BETWEEN MISLEADING PEOPLE AND GIVING RESPONSIBLE ADVICE; THE DIFFERENCE BETWEEN VIOLATING AND ADHERING TO ETHICAL STANDARDS.

Some people are their worst enemies, and it seems as though chiropractors are no strangers to this strange phenomenon.

On this blog, I frequently criticise chiropractic; my main concerns are that

  1. chiropractors make far too many bogus claims far too often,
  2. there is precious little evidence that their hallmark treatment, spinal manipulation, generates more good than harm.

I repeatedly voice those concerns because I feel strongly that consumers have the right to unbiased information for making evidence-based therapeutic decisions. When I do this, I get invariably attacked by some chiropractors who disagree with me. Frequently, these chiropractors are not interested to discuss the issues I raised with me; instead they insult me in the most primitive way imaginable.

This happens far too often to write about each time, but occasionally things are so extraordinary that I do blog about them. A case in point is the email I recently received out of the blue from “Dr” Brian Moravec, a chiropractor who believes in subluxation and claims that new-born babies should have spinal adjustments. My last post quotes his astonishing views in full; he believes I am a self proclaimed “expert” on alternative medicine, promoting so much misinformation with regard to chiropractic care.  Unfortunately he failed to tell me which of my statements he considers to be misleading and he continued: fortunately you look old.  and soon will be gone. 

Rejoicing at the (hopefully not so) imminent demise of a fellow human being is perhaps not what one might expect from a health care professional. Yet it does fit into the behaviour of chiropractors which tends to turn outright self-destructive when challenged. The comments by chiropractors that followed my post seem to confirm this tendency. They show that the demolition of chiropractic’s reputation by chiropractors is relentless.

One chiropractor claimed Moravec’s opinion could “have been better put”… and “come over as a somewhat personal attack” while quickly changing the subject by starting a discussion on the evidence-base of chiropractic. This ended abruptly in him agreeing with me to disagree. Other chiropractors seemed to concur.

At that stage, one chiropractor noted that Moeavec’s email is doing no favours to the reputation of chiropractic, a ray of light which quickly was instantly overshadowed by a further chiropractor’s comments. This man – or perhaps woman (hiding behind a pseudonym) – is a regular commentator on my blog. He felt that Moravec’s comments were rather polite an opinion which he justified as follows: Dr. Moravec thinks you are old because of your unflattering (IMO) photo. The shiny, bald look adds years to a person’s looks, especially in photos. It is the old glass half-empty or half-full debate. IOW, have you lost hair or have you gained face? The mustache is so fifties, too. The perpetual scowl, however, does suit you rather well. Just sayin’.  

At this point, I cannot help but laugh out loud. Someone asked how I can bear those vicious attacks. The answer is that I merely cringe at the stupidity on display.  Are these guys really so limited as to not realise what they are doing to their own reputation? Do they not notice that this amounts to a relentless and general demolition of chiropractic’s reputation?

All of this would, of course, be rather trivial fun, if it were a single occurrence – but it is most definitely not!

As I already pointed out, such things happen to me all the time. More remarkably, chiropractors have repeatedly tried to get me fired. Much more importantly, chiropractors have behaved in this way when they decided to sue Simon Singh for libel. Each time, they ended up with plenty of egg on their faces.

Isn’t it time that they learn a lesson? Isn’t it time that they learn to consider criticism seriously? Isn’t it time the more rational one amongst them do something about the many cranks in their midst? Isn’t it time they got their act together?

“Dr” Brian Moravec is a chiropractor from the US; he has a website where he describes himself and his skills as follows: I attended Chiropractic College and I am a graduate of Palmer College of Chiropractic in Davenport Iowa. I earned a Bachelor of Science degree as well as my Doctor of Chiropractic degree from Palmer College, which is the first chiropractic college in the world and the origin of our profession. I also attend continuing education seminars designed to keep doctors current with regard to clinical chiropractic, technique and nutrition.

The key to overall health and wellness is to have a healthy nervous system and that is what I do as a chiropractor – I make sure that your spine is functioning at its best so that your nervous system functions at its best. When the nervous system is functioning at 100%, you are a healthier individual that experiences a higher quality of life and health. I know this to be true in myself, my family and my patients.

I go to great lengths to provide my patients with the best chiropractic care I can give. I work with my patients to design a treatment plan that will be effective for their particular condition and specific to their needs. We utilize manual and low force techniques (safe and effective for newborns to seniors), to correct sublaxations in the spine. Chiropractic adjustments remove nerve interference, which allows the body to perform at its best again. I also am available for consultations on nutrition and diet, dietary supplementation and how to minimize the wear and tear on your spine.

[Emphases are mine]

What he does not state is the fact that he also is a nifty e-mail writer!

To my great surprise, I received an e-mail from him which is far too good to be kept for myself. So I decided to share it with my readers; here it is in its full and unabbreviated beauty:

its interesting to see someone with your education, and is a self proclaimed “expert” on alternative medicine, promote so much misinformation with regard to chiropractic care.   fortunately you look old.  and soon will be gone.  I always refer to the few of you anti chiropractic fools left here as “dinosaurs”.   the proof is in the pudding my “friend”.  chiropractic works and will continue to be here for centuries more.   you and others with much much more power than you (the AMA for example) have tried to perpetuate lies and squash chiropractic.  you fail, and they failed, because whatever better serves mankind will stand the test of time.   you’re a dying breed edzard.  thank God.
yours in health,

brian moravec d.c.

I am encouraged to see that he recognises my education but do wonder why his upbringing obviously failed so dismally teach him even a minimum of politeness, tact, or critical thinking. It is disappointing, I think, that he does not even mention what he perceives as my lies about his beloved chiropractic. So sad, I am sure it would have been fun to debate with him.

‘Healing, hype or harm? A critical analysis of complementary or alternative medicine’ is the title of a book that I edited and that was published in 2008. Its publication date coincided with that of ‘Trick or Treatment?’ and therefore the former was almost completely over-shadowed by the latter. Consequently few people know about it. This is a shame, I think, and this post is dedicated to encouraging my readers to have a look at ‘Healing, hype or harm?’

One reviewer commented on Amazon about this book as follows: Vital and informative text that should be read by everyone alongside Ben Goldacre’s ‘Bad Science’ and Singh and Ernt’s ‘Trick or Treatment’. Everyone should be able to made informed choices about the treatments that are peddled to the desperate and gullible. As Tim Minchin famously said ‘What do you call Alternative Medicine that has been proved to work? . . . Medicine!’

This is high praise indeed! But I should not omit the fact that others have commented that they were appalled by our book and found it “disappointing and unsettling”. This does not surprise me in the least; after all, alternative medicine has always been a divisive subject.

The book was written by a total of 17 authors and covers many important aspects of alternative medicine. Some of its most famous contributors are Michael Baum, Gustav Born, David Colquhoun, James Randi and Nick Ross. Some of the most important subjects include:

  • Compassion
  • Quackademia
  • Impartiality
  • Ethics
  • Politics
  • Holism
  • Vitalism
  • Placebo

As already mentioned, our book is already 6 years old; however, this does not mean that it is now out-dated. The subject areas were chosen such that it will be timely for a long time to come. Nor does this book reflect one single point of view; as it was written by over a dozen different experts with vastly different backgrounds, it offers an entire spectrum of views and attitudes. It is, in a word, a book that stimulates critical thinking and thoughtful analysis.

I sincerely think you should have a look at it… and, in case you think I am hoping to maximise my income by telling you all this: all the revenues from this book go to charity.

Many experts have warned us that, when we opt for dietary supplements, we might get more than we bargained for. A recent article reminded us that the increased availability and use of botanical dietary supplements and herbal remedies among consumers has been accompanied by an increased frequency of adulteration of these products with synthetic pharmaceuticals. Unscrupulous producers may add drugs and analogues of various classes, such as phosphodiesterase type 5 (PDE-5) inhibitors, weight loss, hypoglycemic, antihypertensive and anti-inflammatory agents, or anabolic steroids, to develop or intensify biological effects of dietary supplements or herbal remedies. The presence of such adulterated products in the marketplace is a worldwide problem and their consumption poses health risks to consumers.

Other authors recently warned that these products are often ineffective, adulterated, mislabeled, or have unclear dosing recommendations, and consumers have suffered injury and death as a consequence. When Congress passed the Dietary Supplement Health and Education Act, it stripped the Food and Drug Administration of its premarket authority, rendering regulatory controls too weak to adequately protect consumers. State government intervention is thus warranted. This article reviews studies reporting on Americans’ use of dietary supplements marketed for weight loss or muscle building, notes the particular dangers these products pose to the youth, and suggests that states can build on their historical enactment of regulatory controls for products with potential health consequences to protect the public and especially young people from unsafe and mislabeled dietary supplements.

A new study has shown that these problems are not just theoretical but are real and common.

Twenty-four products suspected of containing anabolic steroids and sold in fitness equipment shops in the UK were analyzed for their qualitative and semi-quantitative content using full scan gas chromatography-mass spectrometry (GC-MS), accurate mass liquid chromatography-mass spectrometry (LC-MS), high pressure liquid chromatography with diode array detection (HPLC-DAD), UV-Vis, and nuclear magnetic resonance (NMR) spectroscopy. In addition, X-ray crystallography enabled the identification of one of the compounds, where reference standard was not available.

Of the 24 products tested, 23 contained steroids including known anabolic agents; 16 of these contained steroids that were different to those indicated on the packaging and one product contained no steroid at all. Overall, 13 different steroids were identified; 12 of these are controlled in the UK under the Misuse of Drugs Act 1971. Several of the products contained steroids that may be considered to have considerable pharmacological activity, based on their chemical structures and the amounts present.

The authors concluded that such adulteration could unwittingly expose users to a significant risk to their health, which is of particular concern for naïve users.

The Internet offers thousands of supplements for sale; specifically for bodybuilders there are hundreds of supplements all claiming things that are untrue or untested. The lax regulations that exist in this area seem to be often ignored completely. I think it is important to inform customers that most supplements are a waste of money and some even a waste of health.

If you think that homeopathy is risk-free, you should read what this US homeopath proclaims on his website. I have copied several sections from his lengthy article (everything that is in normal print is his writing; mine is in bold). The author first gives a general introduction into homeopathy and why he believes in it; then he continues:

…Now, on the surface, you might think that since there is some common ground between homeopathy and vaccinations, that homeopathic doctors would be, all-in, when it comes to vaccines. The fact is, most homeopaths today are against vaccinations. The main reason for that is not because of the underlying principle, but because the process have been perverted by eugenics. Today, the real purpose of vaccinations is to cause sterilization and early death. Bill Gates spends billions of dollars on global vaccination, admittedly, to reduce the population. All kinds of heavy metals like aluminum, mercury and other poisons and pathogens are put into vaccinations. People, especially children, are given many more times the amount of vaccinations today than they were decades gone by, when it can be argued, vaccinations were effective and were needed.Even cancer viruses have, on record, been put into vaccinations. There is no actual vaccine for cancer. The only reason to put cancer viruses in the mix is to create more cases of cancer. In this day and age, one of the most dangerous things you can do for your health is to get vaccinated…

With homeopathy, you never have to worry about heavy metals, cancer viruses or other poisons being mixed in with the natural ingredients. Even though some of the underlying foundations of homeopathy and vaccinations are similar, there are a number of differences. With vaccinations, the actual disease that they are allegedly trying to build up immunity to is in the injection. In homeopathy, that is not the case, except in rare exception, and due to the dilution process, there is never any risk. Another difference is that homeopathic remedies are taken orally, rather than injected…

Homeopathic remedies have no side effects. That’s a great thing. On the other hand, every drug comes with lots of side effects. And then, you can get in a vicious cycle where you keep taking (or being prescribed) more and more drugs to deal with more and more side effects. In time, this often leads to emergency “live saving” surgery. When they are successful and the patient doesn’t die on the operating table, everyone praises modern medicine for saving those millions of lives, all the while ignoring that the reason those millions of surgeries were needed in the first place, was due to those allegedly wonderful and so-called scientifically proven drugs. Plus, many times, these surgeries aren’t truly needed. If the patient would simply quit taking the drugs, the body could, often, heal itself from life threatening conditions…

Homeopathy is much more well known in Europe and various other nations than it is known in the United States. There is a huge medical conspiracy against the use of homeopathy and other medical modalities that threaten the financial dominance of the current medical industry. The conspiracy extends world-wide, but it is strongest in the USA…This conspiracy is being perpetrated on a conscious level, for going on 200 years. Then, on the heels of that, there is a massive amount of ignorance from ironically, highly educated people, who have been influenced by the conspirators. (Most of these people you might not be able to classify as conspirators, because they believe what they are saying.) Doctors who have never even tried a homeopathic remedy on themselves, or their patients, often say that there is no evidence that homeopathy works. When you point to the innumerable raving fans of homeopathy around the world, each of whom have testimonies of homeopathic remedies working extremely well, the detractors simply call those, anecdotal evidence, not worthy of consideration. When you point out some of the clinical case histories of undeniable healings that have come to patients of homeopathic doctors, the opponents of homeopathy chalk it all up to the placebo effect. They say they want scientific proof and that none exists, but the truth is, numerous studies have shown very positive results, and have outperformed drugs and/or placebo. There are more than 150 placebo controlled clinical studies, most of which have shown positive results, either compared with a placebo or compared with a conventional drug. Moreover, they did so with zero side effects, (unlike drugs, which often have that little side effect known as, death.) And yet, the detractors always have a Rolodex of never ending excuses, why those studies, “don’t count.” They range from, the studies are too small; they are conducted by people who believe in homeopathy – (I’m serious!); the doctors aren’t well known enough; there must have been some breakdown of the scientific procedure that has yet to come out, etc. These people are unable to deal with the conundrum, that homeopathic remedies become more potent, with dilution, instead of less potent, like you would assume. From there, they assume that it can’t work, and no matter how much healing is done with homeopathic remedies, it’s nothing more than mind of matter, (placebo effect.) …The evidence is overwhelming to anyone with an open mind that homeopathy is for real. Does everyone magically become well? Will you not have to die? You know the answers to that, and nobody is suggesting it.

What is undeniable is that the pharmaceutical industry peddles toxic drugs that do more harm than good, by far. Big pharma corporations get caught faking studies, bribing doctors and all kinds of dirty, illegal activity, for which they are fined billions of dollars. To call them purveyors of science is laughable. There are drugs like Vioxx, that have killed anywhere from tens of thousands to more than a million people (depending on whether you go by Merck and the FDA statistics, or outside investigators), which, shockingly, aren’t even pulled from the market by the government. The company finally quits peddling them once the lawsuits make it unprofitable…

I’ve finally come to the conclusion that these people aren’t interested in finding the truth. They only want to protect their status quo, and well as their paradigms of how the world works. They don’t have room for experiential evidence. When these type of people write research papers smearing homeopathy, they are being intellectually dishonest. They consciously obfuscate facts and mold findings to seem to conform to their beliefs – let the evidence be damned…

These medical mafia type of people, don’t even care about logic. They stopped making sense a long, long time ago. When you are done reading these two articles, if you have a modicum of an open mind, you will at the very least, not be able to deny that there really is a very genuine conspiracy against homeopathy…

Such utter nonsense speaks, I think, for itself. Therefore perhaps just this as my comment. 

I have said and written it often: the homeopathic remedy might be harmless, however, many homeopaths are clearly not.

In a way, I should be thankful to the author of this truly amazing article enforcing my point.

 

As a pharmacy professional, you must:

1. Make patients your first concern
2. Use your professional judgement in the interests of patients and the public
3. Show respect for others
4. Encourage patients and the public to participate in decisions about their care
5. Develop your professional knowledge and competence
6. Be honest and trustworthy
7. Take responsibility for your working practices.

Even though these 7 main principles were laid down by the UK General Pharmaceutical Council, they are pretty much universal and apply to pharmacists the world over.

On this blog, I have repeatedly criticised community pharmacists (here I am only discussing this branch of pharmacists) for selling remedies which are not just of debatable efficacy but which fly in the face of science and have been all but disproven. Recently, I came across this website of a working group of the Austrian Society of Pharmacists. It is in German, so I will translate a few sections for you.

They say that it is their aim to find “explanatory models for the mechanisms of action of homeopathy”. This is a strange aim, in my view, not least because there is no proven efficacy; why then search for a mechanism?

Things go from bad to worse when we consider the ‘Notfallapotheke’, the emergency kit which they recommend to consumers who might find themselves in desperate need for emergency care. It includes the following remedies, doses and indications:

Aconitum C 30 2 x 5 Glob, first remedy in cases of fever
Allium cepa C 12 3 x 5 Glob, hayfever or cold
Anamirta cocculusLM 12 : 2 x 5, travel sickness
Apis mellifica C 200 2 x 5 Glob, insect bites
Arnica C 200 1 x 5 Glob, injuries
Acidum arsenicosum C 12 3 – 5 x 5, food poisoning
Atropa belladonna C 30 2 x 5 Glob, high fever
Cephaelis ipecacuahna C 12 2 x 5 Glob, nausea and vomiting
Coffea arabica C 12 2 x 5 Glob, insomnia and restlessness
Euphrasia officinalis C 12 3 x 5 Glob, eye problems
Ferrum phosphoricum C 12 2 x 5 Glob, nose bleed
Lachesis muta C 30 1 x 5 Glob, infected wounds
Lytta vesicatoria C 200 1 – 2 x 5, burns,
Matricaria chamomilla C 30 1 x 3 Glob, toothache
Mercurius LM 12 2 x 5 Glob ear ache, weakness
Pulsatilla LM 12 2 x 5 Glob, ear ache, indigestion
Solanum dulcamara C12 3 x 5 Glob, cystitis
Strychnos nux vomica LM 12 2 x 5 Glob, hangover
Rhus toxicodendron C 200 2 x 5 Glob, rheumatic pain
Veratrum album C12, 3-5 x 3, watery diarrhoea, nausea, vomiting, circulatory problems, collapse.

I can well imagine that, after reading this, some of my readers are in need of some Veratrum album because of near collapse with laughter (or fury?).

We all know that most pharmacists sell such useless remedies; and we might pity them for such behaviour, as they claim they have no choice. But if pharmacists’ professional organisations put themselves so very clearly behind quackery thereby violating all ethical rules in the book, one is truly speechless.

Do I hear someone mutter “what has Austria to do with us?”?

Not a lot, perhaps – but have a look at the range of similar ‘homeopathic emergency kits’ sold outside Austria. Or be stunned by the plethora of homeopathic pharmacies across the globe here and UK-wide here. Or consider the fact that most non-homeopathic pharmacies in the world sell homeopathic remedies. Or let me remind you that a snapshot investigation into UK pharmacies revealed that 13 out of 20 pharmacisits failed to explain that there’s no clinical evidence that homeopathy works. Or be once again reminded that it is “the ethical role of the pharmacist is to give accurate, impartial information regarding the homeopathic therapy, the current scientific proof on their therapeutic effects, including the placebo effect.”

And what is the current scientific proof?

The most reliable verdict that I am aware of comes from the Australian ‘NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL’ (NHMRC) who have assessed the effectiveness of homeopathy. The evaluation concluded that “the evidence from research in humans does not show that homeopathy is effective for treating the range of health conditions considered.”

I rest my case.

In 2004, I published an article rather boldly entitled ‘Ear candles: a triumph of ignorance over science’. Here is its summary:

Ear candles are hollow tubes coated in wax which are inserted into patients’ ears and then lit at the far end. The procedure is used as a complementary therapy for a wide range of conditions. A critical assessment of the evidence shows that its mode of action is implausible and demonstrably wrong. There are no data to suggest that it is effective for any condition. Furthermore, ear candles have been associated with ear injuries. The inescapable conclusion is that ear candles do more harm than good. Their use should be discouraged.

Sadly, since the publication of this paper, ear candles have not become less but more popular. There are about 3 000 000 websites on the subject; most are trying to sell products and make claims which are almost comically misguided; three examples have to suffice:

I said ALMOST comical because such nonsense has, of course a downside. Not only are consumers separated from their cash for no benefit whatsoever, but they are also exposed to danger; again, three examples from the medical literature might explain:

  • Otolaryngologists from London described a case of ear candling presenting as hearing loss, and they concluded that this useless therapy can actually cause damage to the ears.
  • A 50-year-old woman presented to her GP following an episode of ear candling. After 15 minutes, the person performing the candling burned herself while attempting to remove the candle and spilled candle wax into the patient’s right ear canal. On examination, a piece of candle wax was found in the patient’s ear, and she was referred to the local ear, nose, and throat department. Under general aesthetic, a large mass of solidified yellow candle wax was removed from the deep meatus of the ear. The patient had a small perforation in her right tympanic membrane. Results of a pure tone audiogram showed a mild conductive hearing loss on the right side. At a follow-up appointment 1 month later, the perforation was still there, and the patient’s hearing had not improved.
  • case report of a 4-year-old girl from New Zealand was published. The patient was diagnosed to suffer from otitis media. During the course of the ear examination white deposits were noticed on her eardrum; this was confirmed as being caused by ear candling.

I should stress that we do not know how often such events happen; there is no monitoring system, and one might expect that the vast majority of cases do not get published. Most consumers who experience such problems, I would guess, are far to embarrassed to admit that they have been taken in by this sort of quackery.

It was true 10 yeas ago and it is true today: ear candles are a triumph of ignorance over science. But also they are a victory of gullibility over common sense and the unethical exploitation of naive hope by greedy frauds.

Dodgy science abounds in alternative medicine; this is perhaps particularly true for homeopathy. A brand-new trial seems to confirm this view.

The aim of this study was to test the hypothesis that homeopathy (H) enhances the effects of scaling and root planing (SRP) in patients with chronic periodontitis (CP).

The researchers, dentists from Brazil, randomised 50 patients with CP to one of two treatment groups: SRP (C-G) or SRP + H (H-G). Assessments were made at baseline and after 3 and 12 months of treatment. The local and systemic responses to the treatments were evaluated after one year of follow-up. The results showed that both groups displayed significant improvements, however, the H-G group performed significantly better than C-G group.

The authors concluded that homeopathic medicines, as an adjunctive to SRP, can provide significant local and systemic improvements for CP patients.

Really? I am afraid, I disagree!

Homeopathic medicines might have nothing whatsoever to do with this result. Much more likely is the possibility that the findings are caused by other factors such as:

  • placebo-effects,
  • patients’ expectations,
  • improved compliance with other health-related measures,
  • the researchers’ expectations,
  • the extra attention given to the patients in the H-G group,
  • disappointment of the C-G patients for not receiving the additional care,
  • a mixture of all or some of the above.

I should stress that it would not have been difficult to plan the study in such a way that these factors were eliminated as sources of bias or confounding. But this study was conducted according to the A+B versus B design which we have discussed repeatedly on this blog. In such trials, A is the experimental treatment (homeopathy) and B is the standard care (scaling and root planning). Unless A is an overtly harmful therapy, it is simply not conceivable that A+B does not generate better results than B alone. The simplest way to comprehend this argument is to imagine A and B are two different amounts of money: it is impossible that A+B is not more that B!

It is unclear to me what relevant research question such a study design actually does answer (if anyone knows, please tell me). It seems obvious, however, that it cannot test the hypothesis that homeopathy (H) enhances the effects of scaling and root planing (SRP). This does not necessarily mean that the design is necessarily useless.  But at the very minimum, one would need an adequate research question (one that matches this design) and adequate conclusions based on the findings.

The fact that the conclusions drawn from a dodgy trial are inadequate and misleading could be seen as merely a mild irritation. The facts that, in homeopathy, such poor science and misleading conclusions emerge all too regularly, and that journals continue to publish such rubbish are not just mildly irritating; they are annoying and worrying – annoying because such pseudo-science constitutes an unethical waste of scarce resources; worrying because it almost inevitably leads to wrong decisions in health care.

If you believe herbalists, the Daily Mail or similarly reliable sources, you come to the conclusion that herbal medicines are entirely safe – after all they are natural, and everything that is natural must be safe. However, there is plenty of evidence that these assumptions are not necessarily correct. In fact, herbal medicines can cause harm in diverse ways, e. g. because:

  • one or more ingredients of a plant are toxic,
  • they interact with prescribed drugs,
  • they are contaminated, for instance, with heavy metals,
  • they are adulterated with prescription drugs.

There is no shortage of evidence for any of these 4 scenarios. Here are some very recent and relevant publications:

German authors reviewed recent case reports and case series that provided evidence for herbal hepatotoxicity caused by Chinese herbal mixtures. The implicated remedies were the TCM products Ban Tu Wan, Chai Hu, Du Huo, Huang Qin, Jia Wei Xia Yao San, Jiguja, Kamishoyosan, Long Dan Xie Gan Tang, Lu Cha, Polygonum multiflorum products, Shan Chi, ‘White flood’ containing the herbal TCM Wu Zhu Yu and Qian Ceng Ta, and Xiao Chai Hu Tang. the authors concluded that stringent evaluation of the risk/benefit ratio is essential to protect traditional Chinese medicines users from health hazards including liver injury.

A recent review of Nigerian anti-diabetic herbal remedies suggested hypoglycemic effect of over 100 plants. One-third of them have been studied for their mechanism of action, while isolation of the bioactive constituent(s) has been accomplished for 23 plants. Several plants showed specific organ toxicity, mostly nephrotoxic or hepatotoxic, with direct effects on the levels of some liver function enzymes. Twenty-eight plants have been identified as in vitro modulators of P-glycoprotein and/or one or more of the cytochrome P450 enzymes, while eleven plants altered the levels of phase 2 metabolic enzymes, chiefly glutathione, with the potential to alter the pharmacokinetics of co-administered drugs

US authors published a case of a 44-year-old female who developed subacute liver injury demonstrated on a CT scan and liver biopsy within a month of using black cohosh to resolve her hot flashes. Since the patient was not taking any other drugs, they concluded that the acute liver injury was caused by the use of black cohosh. The authors concluded: we agree with the United States Pharmacopeia recommendations that a cautionary warning about hepatotoxicity should be labeled on the drug package.

Hong Kong toxicologists recently reported five cases of poisoning occurring as a result of inappropriate use of herbs in recipes or general herbal formulae acquired from books. Aconite poisoning due to overdose or inadequate processing accounted for three cases. The other two cases involved the use of herbs containing Strychnos alkaloids and Sophora alkaloids. These cases demonstrated that inappropriate use of Chinese medicine can result in major morbidity, and herbal formulae and recipes containing herbs available in general publications are not always safe.

Finally, Australian emergency doctors just published this case-report: A woman aged 34 years presented to hospital with a history of progressive shortness of breath, palpitations, decreased exercise tolerance and generalised arthralgia over the previous month. A full blood count revealed normochromic normocytic anaemia and a haemoglobin level of 66 g/L. The blood film showed basophilic stippling, prompting measurement of lead levels. Her blood lead level (BLL) was 105 µg/dL. Mercury and arsenic levels were also detected at very low levels. On further questioning, the patient reported that in the past 6 months she had ingested multiple herbal preparations supplied by an overseas Ayurvedic practitioner for enhancement of fertility. She was taking up to 12 different tablets and various pastes and powders daily. Her case was reported to public health authorities and the herbal preparations were sent for analytical testing. Analysis confirmed high levels of lead (4% w/w), mercury (12% w/w), arsenic and chromium. The lead levels were 4000 times the maximum allowable lead level in medications sold or produced in Australia. Following cessation of the herbal preparations, the patient was commenced on oral chelation therapy, iron supplementation and contraception. A 3-week course of oral DMSA (2,3-dimercaptosuccinic acid) was well tolerated; BLL was reduced to 13 µg/dL and haemoglobin increased to 99 g/L. Her symptoms improved over the subsequent 3 months and she remains hopeful about becoming pregnant.

So, how safe are herbal medicines? Unfortunately, the question is unanswerable. Some herbal medicines are quite safe, others are not. But always remember: whenever you administer a treatment you should ask yourself one absolutely crucial question: do the documented benefits outweigh the risks? There are several thousand different herbal medicines, and for less than a dozen of them can the honest answer to this question be YES.

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