MD, PhD, FMedSci, FSB, FRCP, FRCPEd

conflict of interest

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Cranio-sacral therapy has been a subject on this blog before, for instance here, here and here. The authors of this single-blind, randomized trial explain in the introduction of their paper that “cranio-sacral therapy is an alternative and complementary therapy based on the theory that restricted movement at the cranial sutures of the skull negatively affect rhythmic impulses conveyed through the cerebral spinal fluid from the cranium to the sacrum. Restriction within the cranio-sacral system can affect its components: the brain, spinal cord, and protective membranes. The brain is said to produce involuntary, rhythmic movements within the skull. This movement involves dilation and contraction of the ventricles of the brain,  which produce the circulation of the cerebral spinal fluid. The theory states that this fluctuation mechanism causes reciprocal tension within the membranes, transmitting motion to the cranial bones and the sacrum. Cranio-sacral therapy and cranial osteopathic manual therapy originate from the observations made by William G. Sutherland, who said that the bones of the human skeleton have mobility. These techniques are based mainly on the study of anatomic and physiologic mechanisms in the skull and their relation to the body as a whole, which includes a system of diagnostic and therapeutic techniques aimed at treatment and prevention of diseases. These techniques are  based on the so-called primary respiratory movement, which is manifested in the mobility of the cranial bones, sacrum,  dura, central nervous system, and cerebrospinal fluid. The main difference between the two therapies is that cranial osteopathy, in addition to a phase that works in the direction of the lesion (called the functional phase), also uses a phase that worsens the injury, which is called structural phase.”

With this study, the researchers wanted to evaluate the effects of cranio-sacral therapy on disability, pain intensity, quality of life, and mobility in patients with low back pain. Sixty-four patients with chronic non-specific low back pain were assigned to an experimental group receiving 10 sessions of craniosacral therapy, or to the control group receiving 10 sessions of classic massage. Craniosacral therapy took 50 minutes and was conducted as follows: With pelvic diaphragm release, palms are placed in transverse position on the superior aspect of the pubic bone, under  the L5–S1 sacrum, and finger pads are placed on spinal processes.  With respiratory diaphragm release, palms are placed transverse under T12/L1 so that the spine lies along the start of fingers and the border of palm, and the anterior hand is placed on the breastbone. For thoracic inlet release, the thumb and index finger are placed on the opposite sides of the clavicle, with the posterior hand/palm of the hand cupping C7/T1. For the hyoid release, the thumb and index finger are placed on the hyoid, with the index finger on the occiput and the cupping finger pads on the cervical vertebrae. With the sacral technique for stabilizing L5/sacrum, the fingers contact the sulcus and the palm of the hand is in contact with the distal part of the sacral bone. The non-dominant hand of the therapist rested over the pelvis, with one hand on one iliac crest and the elbow/forearm of the other side over the other iliac crest. For CV-4 still point induction, thenar pads are placed under the occipital protuberance, avoiding mastoid sutures.  Classic massage protocol was compounded by the following sequence techniques of soft tissue massage on the  low back: effleurage, petrissage, friction, and kneading. The maneuvers are performed with surface pressure, followed by deep pressure and ending with surface pressure again. The techniques took 30 minutes.

Disability (Roland Morris Disability Questionnaire RMQ, and Oswestry Disability Index) was the primary endpoint. Other outcome measures included the pain intensity (10-point numeric pain rating scale), kinesiophobia (Tampa Scale of Kinesiophobia), isometric endurance of trunk flexor muscles (McQuade test), lumbar mobility in flexion, hemoglobin oxygen saturation, systolic blood pressure, diastolic blood pressure, hemodynamic measures (cardiac index), and biochemical analyses of interstitial fluid. All outcomes were measured at baseline, after treatment, and one-month follow-up.

No statistically significant differences were seen between groups for the main outcome of the study, the RMQ. However, patients receiving craniosacral therapy experienced greater improvement in pain intensity (p ≤ 0.008), hemoglobin oxygen saturation (p ≤ 0.028), and systolic blood pressure (p ≤ 0.029) at immediate- and medium-term and serum potassium (p = 0.023) level and magnesium (p = 0.012) at short-term than those receiving classic massage.

The authors concluded that 10 sessions of cranio-sacral therapy resulted in a statistically greater improvement in pain intensity, hemoglobin oxygen saturation, systolic blood pressure, serum potassium, and magnesium level than did 10 sessions of classic massage in patients with low back pain.

Given the results of this study, the conclusion is surprising. The primary outcome measure failed to show an inter-group difference; in other words, the results of this RCT were essentially negative. To use secondary endpoints – most of which are irrelevant for the study’s aim – in order to draw a positive conclusion seems odd, if not misleading. These positive findings are most likely due to the lack of patient-blinding or to the 200 min longer attention received by the verum patients. They are thus next to meaningless.

In my view, this publication is yet another example of an attempt to turn a negative into a positive result. This phenomenon seems embarrassingly frequent in alternative medicine. It goes without saying that it is not just misleading but also dishonest and unethical.

Dengue is a viral infection spread by mosquitoes; it is common in many parts of the world. The symptoms include fever, headache, muscle/joint pain and a red rash. The infection is usually mild and lasts about a week. In rare cases it can be more serious and even life threatening. There’s no specific treatment – except for homeopathy; at least this is what many homeopaths want us to believe.

And, of course, we don’t want to listen to just any odd homeopath, we want true experts to tell us the truth – for instance, experts like Dr. R.K. Manchanda, Deputy Director(Homoeopathy), Directorate of ISM & Homoeopathy, Govt. of NCT of Delhi and Dr. Surinder Verma, Assistant Director (Homoeopathy), Directorate of ISM & Homoeopathy, Govt. of NCT of Delhi. They authored an article which states the following:

There are about 25 homoeopathic drugs available for the treatment of dengue fever. These are Aconite., Arnica, Arsenic-alb., Arum-tri., Baptisia., Belladonna., Bryonia., Cantharis., China officinalis Colocynthis., Eupatorium perfoliatum., Ferrum metallicum., Gelsemium., Hamamelis., Ipecac., Lachesis, Merc-sol, Nux vomica., Podophyllum., Rhus toxicodendron., Rhus-venenata., Sanicula., Secale cornutum and Sul-acidum. These drugs had been successfully used by various homeopaths across the globe for its treatment and management. In 1996 during the epidemic of dengue in Delhi Eupatorium perfoliatum was found most effective.

Sadly, the article does not provide any evidence. A quick Medline search located one (!) single trial on the subject. Here is the abstract:

A double-blind, placebo-controlled randomized trial of a homeopathic combination medication for dengue fever was carried out in municipal health clinics in Honduras. Sixty patients who met the case definition of dengue (fever plus two ancillary symptoms) were randomized to receive the homeopathic medication or placebo for 1 week, along with standard conventional analgesic treatment for dengue. The results showed no difference in outcomes between the two groups, including the number of days of fever and pain as well as analgesic use and complication rates. Only three subjects had laboratory confirmed dengue. An interesting sinusoidal curve in reported pain scores was seen in the verum group that might suggest a homeopathic aggravation or a proving. The small sample size makes conclusions difficult, but the results of this study do not suggest that this combination homeopathic remedy is effective for the symptoms that are characteristic of dengue fever.

This is a 2007 study by a well-known US homeopath. Its results fail to confirm that homeopathy is effective for Dengue. So, surely the homeopathic community has since stopped claiming that homeopathy is an option for this infection!

No, you guessed correctly, they continue claiming that homeopathy works for Dengue. Currently, there are about half a million websites doing exactly that. An example is this article published YESTERDAY (!):

Alopathy is no more the only solution for Dengue these days. Especially in a place like Bengaluru where doctors and medicines are both expensive, residents have now turned to a cheaper and an effective alternative-Homeopathy to combat Dengue.People have been milling Homeopathy clinics and hospitals for an antidote. Dr Sudhir Babu of Javaji Advanced Homeopathy said, “People ask for some cure to keep the disease at bay. We do in fact have medicines to help build immunity against the ailment.”The dosage is for four or five days and is taken daily. Homeopathy has now become a trusted alternative in the field of medicine, especially because of its easy acceptibility among children and adults. According to a survey by IMRB, 100% people know about this form of medicine and 92% perceive it as a reputed form of treatment. The medicines that are administered depending on the symmptoms of Dengue Fever are Aconitum Napellus, Arsenicum Album, Belladonna, Bryonia Alba, Cantharis, Cinchona Officinalis, Eupatorium Perfoliatum, Gelsemium, Ipecacuanha, Nux Vomica, Rhus Toxicodendron and Rhus Venenata.

What I found particularly impressive here is the way popularity has been used to replace evidence. This, I think, begs several questions:

  • How long will homeopaths continue treating self-limiting conditions to claim success based no nothing but their natural history?
  • How long will they continue to lie to the public?
  • How long will they refuse to learn from the evidence?
  • How long will they ignore even the most fundamental rules of medical ethics?
  • How long will we let them get away with all this?

A new Cochrane review evaluated the effectiveness and safety of Chinese herbal medicines (CHM) in the treatment of menopausal symptoms. Its authors conducted a thorough search for randomised controlled trials (RCTs) comparing the effectiveness of CHM with placebo, hormone therapy (HT), pharmaceutical drugs, acupuncture, or another CHM formula in women suffering from menopausal symptoms.

Two review authors independently assessed 864 studies for eligibility. Data extractions were performed by them with disagreements resolved through group discussion and clarification of data or direct contact with the study authors. Data analyses were performed in accordance with Cochrane Collaboration guidelines.

In total, 22 RCTs (2902 women) could be included. When CHM was compared with placebo (8 RCTs), there was little or no evidence of a difference between the groups for the following outcomes: hot flushes per day (MD 0.00, 95% CI -0.88 to 0.89; 2 trials, 199 women; moderate quality evidence); hot flushes per day assessed by an overall hot flush score in which a difference of one point equates to one mild hot flush per day (MD -0.81 points, 95% CI -2.08 to 0.45; 3 RCTs, 263 women; low quality evidence); and overall vasomotor symptoms per month measured by the Menopause-Specific Quality of Life questionnaire (MENQOL, scale 0 to 6) (MD -0.42 points; 95% CI -1.52 to 0.68; 3 RCTs, 256 women; low quality evidence). In addition, results from individual studies suggested there was no evidence of a difference between the groups for daily hot flushes assessed by severity (MD -0.70 points, 95% CI -1.00, -0.40; 1 RCT, 108 women; moderate quality evidence); or overall monthly hot flushes scores (MD -2.80 points, 95% CI -8.93 to 3.33; 1 RCT, 84 women; very low quality evidence); or overall daily night sweats scores (MD 0.07 points, 95% CI -0.19 to 0.33, 1 RCT, 64 women; low quality evidence); or overall monthly night sweats scores (MD 1.30 points, 95% CI -1.76 to 4.36, 1 RCT, 84 women; very low quality evidence). However, one study reported that overall monthly vasomotor symptom scores were lower in the CHM group (MD -4.79 points, 95% CI -5.52 to -4.06; 1 RCT, 69 women; low quality evidence).

When CHM was compared with HT (10 RCTs), only two RCTs reported monthly vasomotor symptoms using MENQOL. It was uncertain whether CHM reduces vasomotor symptoms (MD 0.47 points, 95% CI -0.50 to 1.44; 2 RCTs, 127 women; very low quality evidence).

Adverse effects were not fully reported in the included studies. Adverse events reported by women taking CHM included mild diarrhoea, breast tenderness, gastric discomfort and an unpleasant taste. Effects were inconclusive because of imprecise estimates of effects: CHM versus placebo (RR 1.51; 95% CI 0.69 to 3.33; 7 trials, 705 women; I² = 40%); CHM versus HT (RR 0.96; 95% CI 0.66 to 1.39; 2 RCTs, 864 women; I² = 0%); and CHM versus specific conventional medications (such as Fluoxetine and Estazolam) (RR 0.20; 95% CI 0.03 to 1.17; 2 RCTs, 139 women; I² = 61%).

The authors concluded: We found insufficient evidence that Chinese herbal medicines were any more or less effective than placebo or HT for the relief of vasomotor symptoms. Effects on safety were inconclusive. The quality of the evidence ranged from very low to moderate; there is a need for well-designed randomised controlled studies.

This review seems well done and reports clear findings. The fact that there was insufficient evidence for CHM is probably no surprise to most readers of this blog. However, I would like to draw your attention to a finding that could easily be missed: most of the primary studies failed to mention adverse effects; to be perfectly clear: they did not state “there were no adverse effects”, but they simply did not mention the subject of adverse effects at all.

In my view, this is a breach of research ethics. I have been banging on about this phenomenon for some time now, because I think it is important. Many if not most clinical trials in this area neglect reporting adverse effects. This means that we get an entirely misleading impression about the safety of the treatments in question. Reviewers of such studies are bound to conclude that they seem to be safe, while, in fact, researchers have only been withholding crucial information from us.

The solution to this fast-growing problem would be simple: trialists must be forced to fully report adverse effects. This is less complicated that it might seem: journal editors must insist that all authors fully report adverse effects of alternative treatments. Even if there were none at all – a very unlikely proposition if you think about it – they must disclose this fact.

“THERE IS A SUCKER BORN EVERY MINUTE” – this quote is commonly attributed to P.T.Barnum. If he really coined the sentence, he certainly did not think of the little cups sucking in the skin of patients undergoing cupping therapy. Yet, the recent media coverage of cupping made me think of this quote. The suckers here are not the therapeutic devices employed for cupping but the athletes, the journalists and the general public.

In my experience, athletes are often very worried about their body. This is perhaps understandable but, at the same time, it makes them the ideal victims of all types of charlatans. I am therefore not really surprised to see that some Olympic athletes fell for cupping. They want to use every means allowed by the doping rules to enhance their performance. Cupping therapists claim all sorts of strange and unwarranted things, and some athletes seem to be gullible enough to believe them. Belief can perhaps not move mountains, but it might give you the edge in an Olympic competition.

The ‘beauty’ of cupping when applied to an athlete’s body is that its traces are so publicly visible. During Olympic games, this means that the entire world knows within hours about the cupping-habit of an athlete. What could be more exciting for journalists than these odd cupping marks decorating the muscular bodies of some Olympic athletes? If they are not worth a good story, what is?

There is hardly a newspaper on the planet that did not jump on this band-waggon full of snake oil – there is a sucker born every minute! Nothing wrong with reporting what is happening at the Olympic games, of course. But what has sometimes been reported in the press about cupping beggars belief. Rarely have I read so much nonsense about an alternative therapy in such a short time.

Do you need an example? The DAILY MAIL is as good – or rather bad? – as most; this is what the DM published yesterday on the subject: Chinese media have been cheering cupping’s appearance at the Olympics as proof of the value of traditional culture, with both the official Xinhua news agency and Communist Party mouthpiece People’s Daily touting the soft-power benefits. “Chinese traditions and products proliferate Olympic village”, read one headline on the People’s Daily website. Ding Hui, manager of the Lily Spring Health & Spa in Beijing, said she has seen a 30 percent jump in clients asking for cupping treatment since the Olympics started. “Even though Chinese people have known about it for a long time, they see a great athlete does it and see it really works,” Ding said. “For athletes, they build up harmful lactic acid in the body and cupping can help relieve it.”

You might think that, when reporting about a weird therapy, journalists have little options but to interview weird ‘experts’ relating cupping to even weirder ‘energies’, ‘life forces’, ‘meridians’, yin and yang, TCM, etc. But you would be wrong. They do of course have other options; they would only have needed to log on Medline to find hundreds of references related to the subject. If they had done that, they would even have found an abstract of mine that might have answered many of their question and would have clarified many of the questions about the scientific evidence for or against cupping. Here it is:

The objective of this study was to assess the evidence for or against the effectiveness of cupping as a treatment option for pain. Fourteen databases were searched. Randomized clinical trials (RCTs) testing cupping in patients with pain of any origin were considered. Trials using cupping with or without drawing blood were included, while trials comparing cupping with other treatments of unproven efficacy were excluded. Trials with cupping as concomitant treatment together with other treatments of unproven efficacy were excluded. Trials were also excluded if pain was not a central symptom of the condition. The selection of studies, data extraction and validation were performed independently by three reviewers. Seven RCTs met all the inclusion criteria. Two RCTs suggested significant pain reduction for cupping in low back pain compared with usual care (P < .01) and analgesia (P < .001). Another two RCTs also showed positive effects of cupping in cancer pain (P < .05) and trigeminal neuralgia (P < .01) compared with anticancer drugs and analgesics, respectively. Two RCTs reported favorable effects of cupping on pain in brachialgia compared with usual care (P = .03) or heat pad (P < .001). The other RCT failed to show superior effects of cupping on pain in herpes zoster compared with anti-viral medication (P = .065). Currently there are few RCTs testing the effectiveness of cupping in the management of pain. Most of the existing trials are of poor quality. Therefore, more rigorous studies are required before the effectiveness of cupping for the treatment of pain can be determined.

With just one further click on their keyboard, they would have been able to read the full text of my article which cautioned in no uncertain terms: The number of trials and the total sample size are too small to distinguish between any nonspecific or specific effects, which preclude any firm conclusions. Moreover, the methodological quality was often poor.

Sadly, few journalists seemed to have bothered to do this tiny bit of research. Why? Surely, journalists are trained to investigate their subject before putting pen to paper! Yes, most of them are, but a headline like THE EVIDENCE FOR CUPPING IS FLIMSY does not sell newspapers. The public wants something much more interesting – there is a sucker born every minute!

And what should be wrong with that? People deserve a bit of an entertaining story about their Olympic idols! Perhaps, but there is a downside, of course. The media-hype of the last week will create a demand. The general public will now want the very therapy that helped athletes win gold medals (never mind that it didn’t). Thanks to the media, cupping is now destined to become the alternative therapy of the future.

And what is wrong with that? Quite a lot, I think!

For one, quacks will jump on this fast-moving band-waggon filled with snake oil and try to divert as much cash as they can from their victims’ into their own bank accounts. Perhaps that would not be the worst effect. The worst would be, if some people believe what some quacks will undoubtedly tell them, that cupping is effective (“they see a great athlete does it and see it really works”) for all sorts of conditions, including serious diseases (“Cupping has also been used by some as an alternative treatment for cancer.”) – THERE IS A SUCKER BORN EVERY MINUTE (and some might even die sucking)!

When a leading paper like the FRANKFURTER ALLGEMEINE ZEITUNG (FAZ) publishes in its science pages (!!!) a long article on homeopathy, this is bound to raise some eyebrows, particularly when the article in question was written by the chair of the German Association of Homeopaths (Deutscher Zentralverein homöopathischer Ärzte) and turns out to be a completely one-sided and misleading white-wash of homeopathy. The article (entitled DIE ZEIT DES GEGENEINANDERS IST VORBEI which roughly translates into THE DAYS OF FIGHTING ARE OVER)  is in German, of course, so I will translate the conclusions for you here:

The critics [of homeopathy] … view the current insights of conventional pharmacology as some type of dogma. For them it is unthinkable that a high potency can cause a self-regulatory and thus healing effect on a sick person. Homeopathic doctors are in their eyes “liars”. Based on this single argument, the critics affirm further that therefore no positive studies can exist which prove the efficacy of homeopathy beyond placebo. After all, high potencies “contain nothing”. The big success of homeopathy is a sore point for them, because efficacious high potencies contradict their seemingly rational-materialistic world view. Research into homeopathy should be stopped, the critics say. This tune is played unisono today by critics who formerly claimed that homeopaths block the research into their therapy. The fact is: homeopathic doctors are today in favour of research, even with their own funds, whenever possible. Critics meanwhile demand a ban.

In the final analysis, homeopathic doctors do not want a fight but a co-operation of the methods. Homeopathy creates new therapeutic options for the management of acute to serious chronic diseases. In this, homeopathy is self-evidently not a panacea: the physician decides with every patient individually, whether homeopathy is to be employed as an alternative, as an adjunct, or not at all. Conventional diagnostic techniques are always part of the therapy.

END OF QUOTE

[For those readers who read German, here is the German original:

Die Kritiker … betrachten die heutigen Erkenntnisse der konventionellen Pharmakologie als eine Art Dogma. Für sie ist es undenkbar, dass eine Hochpotenz einen selbstregulativen und damit heilenden Effekt bei einem kranken Menschen auslösen kann. Homöopathische Ärzte sind in ihren Augen “Lügner”. Von diesem einen Argument ausgehend, wird dann weiter behauptet, dass es deshalb gar keine positiven Studien geben könne, die eine Wirksamkeit der Homöopathie über einen Placebo-Effekt hinaus belegen. Schließlich sei in Hochpotenzen “nichts drin”. Der große Erfolg der Homöopathie ist ihnen ein Dorn im Auge, weil wirksame Hochpotenzen ihrem vermeintlich rational-materialistischen Weltbild widersprechen. Die Erforschung der Homöopathie solle gestoppt werden, heißt es. Unisono wird diese Melodie von Kritikern heute gespielt, von ebenjenen Kritikern, die früher behaupteten, die homöopathischen Ärzte sperrten sich gegen die Erforschung ihrer Heilmethode. Fakt ist: Heute setzen sich homöopathische Ärzte für die Forschung ein, auch mit eigenen Mitteln, soweit es ihnen möglich ist. Kritiker fordern mittlerweile das Verbot.

Letztlich geht es homöopathischen Ärzten allerdings nicht um ein Gegeneinander, sondern um ein Miteinander der Methoden. Durch die Homöopathie entstehen neue Therapieoptionen bei der Behandlung von akuten bis hin zu schweren chronischen Erkrankungen. Dabei ist die ärztliche Homöopathie selbstverständlich kein Allheilmittel: Bei jedem erkrankten Patienten entscheidet der Arzt individuell, ob er die Homöopathie alternativ oder ergänzend zur konventionellen Medizin einsetzt – oder eben gar nicht. Die konventionelle Diagnostik ist stets Teil der Behandlung.]

While translating this short text, I had to smile; here are some of the reasons why:

  • ‘conventional pharmacology’ is a funny term; do homeopaths think that there also is an unconventional pharmacology?
  • ‘dogma’… who is dogmatic, conventional medicine which changes almost every month, or homeopathy which has remained essentially unchanged since 200 years?
  • ‘liars’ – yes, that’s a correct term for people who use untruths for promoting their business!
  • ‘Based on this single argument’… oh, I know quite a few more!
  • ‘doctors are today in favour of research’ – I have recently blogged about the research activity of homeopaths.
  • ‘co-operation of the methods’ – I have also blogged repeatedly about the dangerous nonsense of ‘integrative medicine’ and called it ‘one of the most colossal deceptions of healthcare today’. Hahnemann would have ex-communicated the author for this suggestion, he called homeopaths who combined the two methods ‘traitors’!!!
  • ‘new therapeutic options’… neither new nor therapeutic, I would counter; to be accepted as ‘therapeutic’, one would need a solid proof of efficacy.
  • ’employed as an alternative’ – would this be ethical?
  • ‘Conventional diagnostic techniques are always part of the therapy’… really? I was taught that diagnosis and treatment are two separate things.

There were many comments  by readers of the FAZ. Their vast majority expressed bewilderment at the idea that the chair of the German Association of Homeopaths has been given such a platform to dangerously mislead the public. I have to say that I fully agree with this view: the promotion of bogus treatments can only be a disservice to public health.

This is a post that I wanted to write for a while (I had done something similar on acupuncture moths ago); but I had to wait, and wait, and wait…until finally there were the awaited 100 Medline listed articles on homeopathy with a publication date of 2016. It took until the beginning of August to reach the 100 mark. To put this into perspective with other areas of alternative medicine, let me give you the figures for 3 other therapies:

  • there are currently  1 413 articles from 2016 on herbal medicine;
  • 875 on acupuncture;
  • and 256 on chiropractic.

And to give you a flavour of the research activity in some areas of conventional medicine:

  • there are currently almost 100 000 articles from 2016 on surgery;
  • 1 410 on statins;
  • and 33 033 on psychotherapy.

This suggests quite strongly, I think, that the research activity in homeopathy is relatively low (to put it mildly).

So, what do the first 100 Medline articles on homeopathy cover? Here are some of the findings of my mini-survey:

  • there were 4 RCTs;
  • 3 systematic reviews;
  • 8 papers on observational-type data (case series, observational studies etc.);
  • 9 animal studies;
  • 14 other pre-clinical or basic research studies;
  • 1 pilot study;
  • 14 investigations of the quality of homeopathic preparations;
  • 15 surveys;
  • 2 investigations into the adverse effects of homeopathic treatments;
  • 49 other papers (e. g. comments, opinion pieces, letters, perspective articles, editorials).

I should mention that, because I assessed 100 papers, the above numbers can be read both as absolute as well as percentage figures.

How should we interpret my findings?

As with my previous evaluation, I must caution not to draw generalizable conclusions from them. What follows should therefore be taken with a pinch of salt (or two):

  1. The research activity into homeopathy is currently very subdued.
  2. Arguably the main research question of efficacy does not seem to concern researchers of homeopathy all that much.
  3. There is an almost irritating abundance of papers that are data-free and thrive on opinion (my category of ‘other papers’).
  4. Given all this, I find it hard to imagine that this area of investigation is going to generate much relevant new knowledge or clinical progress.

Guest post by Frank Van der Kooy

Something happened in 2008. Something, or a number of things, triggered an exponential rise in the number of rhinos being killed in South Africa. Poaching numbers remained quite low and was stable for a decade with only 13 being killed in 2007. But then suddenly it jumped to 83 in 2008 and it reached a total of 1 175 in 2015. To explain this will be difficult and it will be due to a number of factors or events coinciding in 2008. One possible contributing factor, which I will discuss here, is the growing acceptance of TCM in western countries! For example: Phynova recently advertised a new product as being the first traditional Chinese medicine (TCM) being registered in the UK. By directing customers to a separate site for more information regarding their product they ‘accidently’ linked to a site which ‘advertised’ rhino horn (this link has since been removed). Another example is a University in Australia who published a thesis in 2008, in which they described the current use of Rhino horn as a highly effective medicine, just like you would describe any other real medicine. Surely this will have an impact!

But first a bit of background, so please bear with me. There are two ‘opposing’ aspects regarding TCM that most members of the public do not seem to understand well. Not their fault, because the TCM lobby groups are spending a huge amount of effort to keep the lines between these two aspects as blurred as possible. The first aspect is the underlying pseudoscientific TCM principles; the yin and yang and the vitalistic “energy” flow through “meridians” and much more. Science has relegated this to the pseudosciences, just like bloodletting, which was seen as a cure-all hundreds of years ago. Unfortunately, the pseudoscientific TCM principles are still with us and based on these principles almost every single TCM modality works! From acupuncture to herbs to animal matter (including rhino horn) – everything is efficacious, safe and cost effective. Evidence for this is that close to a 100% of clinical trials done on TCM in China give positive results. Strange isn’t it! People in China should thus no die of any disease – they have ‘effective’ medicine for everything! This is the world of TCM in a nutshell.

The second aspect of TCM is the application of the modern scientific method to test which of the thousands of TCM modalities are really active, which ones are useless and which ones are dangerous. Decades of investigation have come up empty-handed with one or two exceptions. One notable exception is Artemisia annua which contain a single compound that is highly effective for the treatment of malaria, and once identified and intensely studied, it was taken up into conventional medicine – not the herb, but the compound. If you investigate all the plants in the world you are bound to find some compounds that can be used as medicine – it has nothing to do with TCM principles and it can most definitely not be used as evidence that the TCM principles are correct or that it based on science.

These two aspects are therefore quite different.

In the TCM world just about everything works, but it is not backed up by science. It is huge market ($170 billion) and it creates employment for many – something that make politicians smile. In the modern scientific world, almost nothing in TCM works, but it is based on science. It is however not profitable at all – you have to investigate thousands of plants in order to find one useful compound.

Many TCM practitioners and researchers are avidly trying to combine the positives of these two worlds. They focus mainly on the money and employment aspect of the TCM world and try and combine this with the modern scientific approach. They tend to focus on the one example where modern science discovered a useful compound (artemisinin) in the medicinal plant Artemisia annua, which was also coincidently used as an herb in TCM – as evidence that TCM works! Here are some examples:

“To stigmatise all traditional medicine would be unfair. After all, a Chinese medicine practitioner last year won a Nobel prize.” No, a Chinese scientist using the modern scientific method identified artemisinin after testing hundreds or even thousands of different plants.

This year, Chinese medicine practitioners will be registered in Australia. ….. Chinese herbal medicine is administered routinely in hospitals for many chronic diseases. …… This has led to recognising herbs such as Artemisia as a proven anti-malarial ……” No, the compound artemisinin is a proven anti-malarial!

There has been enormous progress in the last 20 years or so. I am sure you are familiar with the use of one of the Chinese herbs in managing resistant malaria.” No, very little progress and no, the compound artemisinin!

So this is a game that is being played with the simple intention to blur the lines between these two aspects regarding TCM – but the real reason might simply be “A new research-led Chinese medicine clinic in Sydney, better patient outcomes and the potential for Australia to tap into the $170 billion global traditional Chinese medicine market”

Prof Alan Bensoussan the director of the National Institute of Complementary Medicine (NICM) and registered in Australia as a TCM and acupuncture practitioner is a champion in blurring this line. Alan has been instrumental in lobbying the Australian regulatory agency that a long tradition of use is all you need to be able to register new products. He was also influential in establishing the Chinese medicine practitioner registry in Australia, in 2012, and thereby legitimising TCM in Australia. He has been actively chipping away at the resistance that the Australian public have against these pseudoscientific healthcare systems such as TCM – one can argue that he has done so quite successfully because they are expanding their operations into the Westmead precinct of Sydney with a new TCM clinic/hospital.

Enough background; so what does all of this have to do with Rhino horn? (and for that matter other endangered species). We have to remember that in the TCM world just about everything works and that includes rhino horn! Searching Western Sydney University’s theses portal for Xijiao (Chinese for Rhino horn) I found a thesis published in 2008 from the NICM and co-supervised by Alan; “Development of an evidence-based Chinese herbal medicine for the management of vascular dementia”

On page 45-46: “Recently, with fast developing science and technologies being applied in the pharmaceutical manufacturing area, more and more herbs or herbal mixtures have been extracted or made into medicinal injections. These have not only largely facilitated improved application to patients, but also increased the therapeutic effectiveness and accordingly reduced the therapeutic courses …… lists the most common Chinese herbal medicine injections used for the treatment of VaD. “

“Xing Nao Jing Injection (for clearing heat toxin and opening brain, removing phlegm) contains ….. Rhinoceros unicornis (Xijiao), …… Moschus berezovskii (Shexiang), …..”

“…. Xing Nao Jing injection has been widely applied in China for stroke and vascular dementia. …. After 1-month treatment intervention, they found the scores in the treatment group increased remarkably, as compared with the control group …… “

They list two endangered species; the Rhino and the Chinese forest musk deer (Moschus berezovskii). But what is truly worrying is that they don’t even mention the endangered status or at least recommend that the non-endangered substitutes, which do exist in the TCM world, should be used instead – or maybe use fingernails as a substitute? It is not discussed at all. Clearly they are stating that using these endangered animals are way more effective than western medicine (the control group) for the treatment of vascular dementia! This is deplorable to say the least. Statements like this fuels the decimation of this species. But this shows that they truly believe and support the underlying pseudoscientific principles of TCM – they have to, their ability to tap into the TCM market depends on it!

As a scientist you are entitled to discuss historic healthcare treatments such as bloodletting. But make sure to also state that this practice has been shown to be ineffective, and quite dangerous, and that modern science has since come up with many other effective treatments. If it is stated that bloodletting is currently being used and it is effective – then you will simply be promoting bloodletting! The same goes for Rhino horn and this is exactly what they have done here. But then again they live in a world where all TCM modalities are active!

How to solve this problem of growing acceptance of TCM in western countries? A simple step could be that people like Alan publicly denounce the underlying pseudoscientific TCM principles and make the ‘difficult’ switch to real science! Admittedly, he will have to part with lots of money from the CM industry and his Chinese partners, and maybe not built his new TCM hospital! But for some reason I strongly doubt that this will happen. The NICM have successfully applied a very thin, but beautiful, veneer of political correctness and modernity over the surface of complementary medicine. Anyone who cares to look underneath this veneer will find a rotten ancient pseudoscientific TCM world – in this case the promotion and the use of endangered animals.

After reading chapter two of this thesis one cannot believe that this is from an Australian University and paid for by the Australian taxpayer! The main question though: Can I directly link this thesis with the increase in rhino poaching? This will be very difficult if not impossible to do. But that is not the problem. Promoting the pseudoscientific principles of TCM in Australia expands the export market for TCM, and hence will lead to an increased need for raw materials, including the banned Rhino horn. That Rhino horn has been a banned substance since the 1980’s clearly does not seem to have any impact looking at the poaching statistics. In an unrelated paper published in 2010 the ingredients in the Xingnaojing injection is listed as “…. consisting of Chinese herbs such as Moschus, Borneol, Radix Curcumae, Fructus Gardeniae, ….” No full list is given in the paper – dare I say because it contains Rhino horn as well? The drug Ice is also banned, but if you are going to promote it at a ‘trusted’ university, then you shouldn’t be surprised that Ice production increases and more of it flows into Australia – even if it is illegal. The same goes for Rhino horn!

On this blog, I have discussed the lamentable quality of TCM products before (e. g. here, here and here). In a nutshell, far too high percentages of them are contaminated with toxic substances or adulterated with prescription drugs. It is no question: these deficits put many consumers at risk. Equally, there is no question that the problem has been known for decades.

For the Chinese exporters, such issues are a great embarrassment, not least because TCM-products are amongst the most profitable of all the Chinese exports. In the past, Chinese officials have tried to ignore or suppress the subject as much as possible. I presume they fear that their profits might be endangered by being open about the dubious quality of their TCM-exports.

Recently, however, I came across a website where unusually frank and honest statements of Chinese officials appeared about TCM-products. Here is the quote:

China is to unroll the fourth national survey of traditional Chinese medicine (TCM) resources to ensure a better development of the industry, said a senior health official…

With the public need for TCM therapies growing, the number of medicine resources has decreased and people have turned to the cultivated ones. However, due to a lack of standards, the cultivated TCM resources are sometimes less effective or even unsafe for human use, said Wang Guoqiang, director of the State Administration of TCM, at a TCM seminar held in Kunming, Yunnan Province in southwest China.

There is a pressing need to protect TCM resources, Wang said. “I’ve heard people saying that medicine quality will spell doom for the TCM industry, which I must admit, is no exaggeration,” he said.

The survey has been piloted in 922 counties in 31 provinces in China since 2011. According to its official website, it will draw a clear picture of the variety, distribution, storage and growth trends of TCM resources, including herbs, animals, minerals and synthetic materials.

TCM includes a range of traditional medical practices originating in China. It includes such treatments as herbal medicine, acupuncture, massage (tuina), exercise (qigong) and dietary therapy.

Although well accepted in the mainstream of medical care throughout East Asia, TCM is considered an alternative medical system in much of the western world and has been a source of controversy. A milestone in the recognition of TCM came when Chinese pharmaceutical chemist Tu Youyou won a Nobel Prize in 2015 for her discovery of Artemisinin, a medicinal herb, to help treat malaria.

END OF QUOTE

Surely, these are remarkable, perhaps even unprecedented statements by Chinese officials:

…cultivated TCM resources are sometimes less effective or even unsafe for human use…

…medicine quality will spell doom for the TCM industry…

Let’s hope that, after such words, there will be appropriate actions… finally.

Informed consent is a basic ethical principle and a precondition for any medical or surgical procedure (e. g. a therapeutic intervention or a diagnostic test). Essentially, there are 4 facets of informed consent:

  1. the patient must have decision-making capacity,
  2. the patient’s decision must be free from coercion or manipulation,
  3. all relevant information must be disclosed to the patient,
  4. the patient must not merely be told but must understand what he/she has been told.

It seems to me that points 1, 2 and 4 are more or less the same in alternative as in conventional medicine. Point 3, however, has fundamentally different implications in the two types of healthcare.

What is meant by ‘all relevant information’? There seems to be general agreement that this should include the following elements:

  1. the indication,
  2. the nature of the procedure,
  3. its potential benefits,
  4. its risks,
  5. other options for the proposed procedure, including the option of doing nothing at all.

If we carefully consider these 5 elements of ‘all relevant information’, we soon realise why there might be profound differences between alternative and conventional medicine. These differences relate not so much to the nature of the procedures but to the competence of the clinicians.

At medical school, doctors-to-be learn the necessary facts that should enable them to adequately deal with the 5 elements listed above. (This does not necessarily mean that, in conventional medical or surgical practice, informed consent is always optimal. But there is little doubt that, in theory, it could be optimal.)

By contrast, alternative practitioners have not normally been to medical school and will have gone through an entirely different type of training. Therefore, the question arises whether – even in theory – they are able to transmit to their patients all essential information as outlined above.

Let’s try to address this question by looking at concrete cases: a patient with frequent headaches consults an alternative practitioner for help. For the sake of argument, the practitioner could be:

  • a chiropractor,
  • an acupuncturist,
  • a homeopath,
  • a naturopath,
  • a traditional herbalist.

Are these alternative practitioners able to convey all the relevant information to their patient before starting their respective treatments?

THE CHIROPRACTOR

  1. Can he provide full information on the indication? In all likelihood he would treat the headache as though it was caused by a spinal subluxation. If our patient were suffering from a brain tumour, for instance, this might dangerously delay the diagnosis.
  2. Can he explain the nature of the procedure? Yes.
  3. Can he explain its potential benefits? He is likely to have a too optimistic view on this.
  4. Can he explain its risks? Many chiropractors deny any risk of spinal manipulation.
  5. Can he provide details about the other options for the proposed procedure, including the option of doing nothing at all? Probably yes for cervicogenic headache. No for most other differential diagnoses.

THE TRADITIONAL ACUPUNCTURIST

  1. Can he provide full information on the indication? The patient might be treated for an assumed ‘energy blockage’; other diagnoses might not be given adequate consideration.
  2. Can he explain the nature of the procedure? Yes.
  3. Can he explain its potential benefits? He is likely to have a too optimistic view on this.
  4. Can he explain its risks? Perhaps.
  5. Can he provide details about the other options for the proposed procedure, including the option of doing nothing at all? No

THE CLASSICAL HOMEOPATH

  1. Can he provide full information on the indication? No, for a classical homeopath, the totality of the symptoms is the only valid diagnosis.
  2. Can he explain the nature of the procedure? Yes.
  3. Can he explain its potential benefits? Doubtful.
  4. Can he explain its risks? Doubtful.
  5. Can he provide details about the other options for the proposed procedure, including the option of doing nothing at all? No.

THE NATUROPATH

  1. Can he provide full information on the indication? Doubtful.
  2. Can he explain the nature of the procedure? Yes.
  3. Can he explain its potential benefits? He is likely to have a too optimistic view on this.
  4. Can he explain its risks? Doubtful.
  5. Can he provide details about the other options for the proposed procedure, including the option of doing nothing at all? No.

THE TRADITIONAL HERBALIST

  1. Can he provide full information on the indication? No.
  2. Can he explain the nature of the procedure? Yes.
  3. Can he explain its potential benefits? He is likely to have a too optimistic view on this.
  4. Can he explain its risks? He is likely to have a too optimistic view on this.
  5. Can he provide details about the other options for the proposed procedure, including the option of doing nothing at all? No.

The answers provided above are based on my experience of more than 20 years with alternative practitioners; I am aware of the degree of simplification required to give short, succinct replies. The answers are, of course, assumptions as well as generalisations. There may well be individual practitioners who would do better (or worse) than the fictitious average I had in mind when answering the questions. Moreover, one would expect important national differences.

If my experience-based assumptions are not totally incorrect, their implications could be most significant. In essence they suggest that, in alternative medicine, fully informed consent can rarely, if ever, be provided. In turn, this means that the current practice of alternative medicine cannot be in line with the most fundamental requirements of medical ethics.

There is very little research on any of these  issues, and thus hardly any reliable evidence. Therefore, this post is simply meant as a deliberately provocative essay to stimulate debate – debate which, in my view, is urgently required.

 

Medical ethics are central to any type of healthcare – and this includes, of course, alternative medicine. The American Medical Association (AMA) have just published their newly revised code of ethics, AMA Principles of Medical Ethics.

It has long been my impression that, in alternative medicine, ethics receive no or far too little attention. Some alternative practitioners thrive to be able to call themselves ‘physicians’. Therefore, it seems interesting to ask whether they would also be able to comply with the ethical duties of a physician as outlined by the AMA.

The following 9 points are taken without change from the new AMA code; in brackets I have put my own, very brief comments pertaining to alternative practitioners. There is much more to be said about each of these points, of course, and I encourage my readers to do so in the comments section.

  1. A physician shall be dedicated to providing competent medical care, with compassion and respect for human dignity and rights. [Most alternative practitioners use unproven treatments; I doubt whether this can be called ‘competent medical care’.]
  2. A physician shall uphold the standards of professionalism, be honest in all professional interactions, and strive to report physicians deficient in character or competence, or engaging in fraud or deception, to appropriate entities. [Treating patients with unproven therapies in the absence of fully informed consent is arguably unprofessional, dishonest and deceptive. Crucially, alternative practitioners never object to even the worst excesses of quackery that occur in their realm.]
  3. A physician shall respect the law and also recognize a responsibility to seek changes in those requirements which are contrary to the best interests of the patient. [Treatment with unproven therapies can hardly be in the best interest of the patient.]
  4. A physician shall respect the rights of patients, colleagues, and other health professionals, and shall safeguard patient confidences and privacy within the constraints of the law. [The right of patients includes full informed consent which is, according to my impression, rare in alternative medicine.]
  5. A physician shall continue to study, apply, and advance scientific knowledge, maintain a commitment to medical education, make relevant information available to patients, colleagues, and the public, obtain consultation, and use the talents of other health professionals when indicated. [Alternative medicine is frequently out of line with or even opposed to medical knowledge.]
  6. A physician shall, in the provision of appropriate patient care, except in emergencies, be free to choose whom to serve, with whom to associate, and the environment in which to provide medical care.
  7. A physician shall recognize a responsibility to participate in activities contributing to the improvement of the community and the betterment of public health. [Some activities of some alternative practitioners are directly opposed to public health, for instance when they advise against immunising children.]
  8. A physician shall, while caring for a patient, regard responsibility to the patient as paramount. [Arguably this is not possible when using unproven therapies.]
  9. A physician shall support access to medical care for all people. [Some alternative practitioners advise their patients against accessing conventional healthcare.]

As I stated above, medical ethics are neglected in alternative medicine. The 9 points of the AMA together with my comments go some way towards explaining why this is so. If ethical principles were applied to alternative medicine, much of it would have to stop instantly.

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