Monthly Archives: November 2014
Guest post by Jan Oude-Aost
ADHD is a common disorder among children. There are evidence based pharmacological treatments, the best known being methylphenidate (MPH). MPH has kind of a bad reputation, but is effective and reasonably safe. The market is also full of alternative treatments, pharmacological and others, some of them under investigation, some unproven and many disproven. So I was not surprised to find a study about Ginkgo biloba as a treatment for ADHD. I was surprised, however, to find this study in the German Journal of Child and Adolescent Psychiatry and Psychotherapy, officially published by the “German Society of Child and Adolescent Psychiatry and Psychotherapy“ (Deutsche Gesellschaft für Kinder- und Jugendpsychiatrie und Psychotherapie). The journal’s guidelines state that studies should provide new scientific results.
The study is called “Ginkgo biloba Extract EGb 761® in Children with ADHD“. EGb 761® is the key ingredient in “Tebonin®“, a herbal drug made by “Dr. Wilma Schwabe GmbH“. The abstract states:
“One possible treatment, at least for cognitive problems, might be the administration of Ginkgo biloba, though evidence is rare.This study tests the clinical efficacy of a Ginkgo biloba special extract (EGb 761®) (…) in children with ADHD (…).“
“Eine erfolgversprechende, bislang kaum untersuchte Möglichkeit zur Behandlung kognitiver Aspekte ist die Gabe von Ginkgo biloba. Ziel der vorliegenden Studie war die Prüfung klinischer Wirksamkeit (…) von Ginkgo biloba-Extrakt Egb 761® bei Kindern mit ADHS.“ (Taken from the English and German abstracts.)
The study sample (20!) was recruited among children who “did not tolerate or were unwilling“ to take MPH. The unwilling part struck me as problematic. There is likely a strong selection bias towards parents who are unwilling to give their children MPH. I guess it is not the children who are unwilling to take MPH, but the parents who are unwilling to administer it. At least some of these parents might be biased against MPH and might already favor CAMmodalities.
The authors state three main problems with “herbal therapy“ that require more empirical evidence: First of all the question of adverse reactions, which they claim occur in about 1% of cases with “some CAMs“ (mind you, not “herbal therapy“). Secondly, the question of drug interactions and thirdly, the lack of information physicians have about the CAMs their patients use.
A large part of the study is based on results of an EEG-protocol, which I choose to ignore, because the clinical results are too weak to give the EEG findings any clinical relevance.
Before looking at the study itself, let’s look at what is known about Ginkgo biloba as a drug. Ginkgo is best known for its use in patients with dementia, cognitive impairment und tinnitus. A Cochrane review from 2009 concluded:
“There is no convincing evidence that Ginkgo biloba is efficacious for dementia and cognitive impairment“ .
The authors of the current Study cite Sarris et al. (2011), a systematic review of complementary treatment of ADHD. Sarris et al. mention Salehi et al. (2010) who tested Ginkgo against MPH. MPH turned out to be much more effective than Ginkgo, but Sarris et al. argue that the duration of treatment (6 weeks) might have been too short to see the full effects of Ginkgo.
Given the above information it is unclear why Ginkgo is judged a “possible“ treatment, properly translated from German even “promising”, and why the authors state that Ginkgo has been “barely studied“.
In an unblinded, uncontrolled study with a sample likely to be biased toward the tested intervention, anything other than a positive result would be odd. In the treatment of autism there are several examples of implausible treatments that worked as long as parents knew that their children were getting the treatment, but didn’t after proper blinding (e.g. secretin).
This study’s aim was to test clinical efficacy, but the conclusion begins with how well tolerated Ginkgo was. The efficacy is mentioned subsequently: “Following administration, interrelated improvements on behavioral ratings of ADHD symptoms (…) were detected (…).“ But the way they where “detected“ is interesting. The authors used an established questionnaire (FBB-HKS) to let parents rate their children. Only the parents. The children and their teachers where not given the FBB-HKS-questionnaires, inspite of this being standard clinical practice (and inspite of giving children questionnaires to determine changes in quality of life, which were not found).
None of the three problems that the authors describe as important (adverse reactions, drug interactions, lack of information) can be answered by this study. I am no expert in statistics but it seems unlikely to me to meaningfully determine adverse effects in just 20 patients especially when adverse effects occur at a rate of 1%. The authors claim they found an incidence rate of 0,004% in “700 observation days“. Well, if they say so.
The authors conclude:
“Taken together, the current study provides some preliminary evidence that Ginkgo biloba Egb 761® seems to be well tolerated in the short term and may be a clinically useful treatment for children with ADHD. Double-blind randomized trials are required to clarify the value of the presented data.“
Given the available information mentioned earlier, one could have started with that conclusion and conducted a double blind RCT in the first place!
The trends of this preliminary open study may suggest that Ginkgo biloba Egb 761® might be considered as a complementary or alternative medicine for treating children with ADHD.“
So, why do I care? If preliminary evidence “may suggest“ that something “might be considered“ as a treatment? Because I think that this study does not answer any important questions or give us any new or useful knowledge. Following the journal’s guidelines, it should therefore not have been published. I also think it is an example of bad science. Bad not just because of the lack of critical thinking. It also adds to the misinformation about possible ADHD treatments spreading through the internet. The study was published in September. In November I found a website citing the study and calling it “clinical proof“ when it is not. But child psychiatrists will have to explain that to many parents, instead of talking about their children’s health.
I somehow got the impression that this study was more about marketing than about science. I wonder if Schwabe will help finance the necessary double-blind randomized trial… See more at: http://summaries.cochrane.org/CD003120/DEMENTIA_there-is-no-convincing-evidence-that-ginkgo-biloba-is-efficacious-for-dementia-and-cognitive-impairment#sthash.oqKFrSCC.dpuf
A German homeopathic journal, Zeitschrift Homoeopathie, has just published the following interesting article entitled HOMEOPATHIC DOCTORS HELP IN LIBERIA. It provides details about the international team of homeopaths that travelled to Liberia to cure Ebola. Here I take the liberty of translating it from German into English. As most of it is fairly self-explanatory, I abstain from any comments of my own – however, I am sure that my readers will want to add their views.
In mid-October, an international team of 4 doctors travelled to the West African country for three weeks. The mission in a hospital in Ganta, a town with about 40 000 inhabitants on the border to Guinea, ended as planned on 7 November. The exercise was organised by the World Association of Homeopathic Doctors, the Liga Medicorum Homoeopathica Internationalis (LMHI), with support of by the German Central Association of Homeopathic Doctors. The aim was to support the local doctors in the care of the population and, if possible, also to help in the fight against the Ebola epidemic. The costs for the three weeks’ stay were financed mostly through donations from homeopathic doctors.
“We know that we were invited mainly as well-trained doctors to Liberia, and that or experience in homeopathy was asked for only as a secondary issue”, stresses Cornelia Bajic, first chairperson of the DZVhA (German Central Association of Homeopathic Doctors). The doctors from India, USA, Switzerland and Germany were able to employ their expertise in several wards of the hospital, to help patients, and to support their Liberian colleagues. It was planned to use and document the homeopathic treatment of Ebola-patients as an adjunct to the WHO prescribed standard treatment. “Our experience from the treatment of other epidemics in the history of medicine allows the conclusion that a homeopathic treatment might significantly reduce the mortality of Ebola patients”, judges Bajic. The successful use of homeopathic remedies has been documented for example in Cholera, Diphtheria or Yellow Fever.
In Ganta, the doctors of the LMHI team treated patients with “at times most serious diseases, particularly inflammatory conditions, children with Typhus, meningitis, pneumonias, and unclear fevers – each time only under the supervision of the local doctor in charge”, reports Dr Ortrud Lindemann, who also worked obstetrically in Ganta. The medical specialist reports after her return: “When we had been 10 days in the hospital, the successes had become known, and the patients stood in queues to get treated by us.” The homeopathic doctors received thanks from the Ganta hospital for their work, it was said that it had been helpful for the patients and a blessing for the employees of the hospital.
POLITICAL CONSIDERATIONS MORE IMPORTANT THAN MEDICAL TREATMENT?
This first LMHI team of doctors was forbidden to care for patients from the “Ebola Treatment Unit”. The decision was based on an order of the WHO. A team of Cuban doctors was also waiting in vain for being allowed to work. “We are dealing here with a dangerous epidemic and a large number of seriously ill patients. And despite a striking lack of doctors in West Africa political considerations are more important than the treatment of these patients”, criticises the DZVhA chairperson Bajic. Now a second team is to travel to Ganta to support the local doctors.
Acupuncture seems to be as popular as never before – many conventional pain clinics now employ acupuncturists, for instance. It is probably true to say that acupuncture is one of the best-known types of all alternative therapies. Yet, experts are still divided in their views about this treatment – some proclaim that acupuncture is the best thing since sliced bread, while others insist that it is no more than a theatrical placebo. Consumers, I imagine, are often left helpless in the middle of these debates. Here are 7 important bits of factual information that might help you make up your mind, in case you are tempted to try acupuncture.
- Acupuncture is ancient; some enthusiast thus claim that it has ‘stood the test of time’, i. e. that its long history proves its efficacy and safety beyond reasonable doubt and certainly more conclusively than any scientific test. Whenever you hear such arguments, remind yourself that the ‘argumentum ad traditionem’ is nothing but a classic fallacy. A long history of usage proves very little – think of how long blood letting was used, even though it killed millions.
- We often think of acupuncture as being one single treatment, but there are many different forms of this therapy. According to believers in acupuncture, acupuncture points can be stimulated not just by inserting needles (the most common way) but also with heat, electrical currents, ultrasound, pressure, etc. Then there is body acupuncture, ear acupuncture and even tongue acupuncture. Finally, some clinicians employ the traditional Chinese approach based on the assumption that two life forces are out of balance and need to be re-balanced, while so-called ‘Western’ acupuncturists adhere to the concepts of conventional medicine and claim that acupuncture works via scientifically explainable mechanisms that are unrelated to ancient Chinese philosophies.
- Traditional Chinese acupuncturists have not normally studied medicine and base their practice on the Taoist philosophy of the balance between yin and yang which has no basis in science. This explains why acupuncture is seen by traditional acupuncturists as a ‘cure all’ . In contrast, medical acupuncturists tend to cite neurophysiological explanations as to how acupuncture might work. However, it is important to note that, even though they may appear plausible, these explanations are currently just theories and constitute no proof for the validity of acupuncture as a medical intervention.
- The therapeutic claims made for acupuncture are legion. According to the traditional view, acupuncture is useful for virtually every condition affecting mankind; according to the more modern view, it is effective for a relatively small range of conditions only. On closer examination, the vast majority of these claims can be disclosed to be based on either no or very flimsy evidence. Once we examine the data from reliable clinical trials (today several thousand studies of acupuncture are available – see below), we realise that acupuncture is associated with a powerful placebo effect, and that it works better than a placebo only for very few (some say for no) conditions.
- The interpretation of the trial evidence is far from straight forward: most of the clinical trials of acupuncture originate from China, and several investigations have shown that very close to 100% of them are positive. This means that the results of these studies have to be taken with more than a small pinch of salt. In order to control for patient-expectations, clinical trials can be done with sham needles which do not penetrate the skin but collapse like miniature stage-daggers. This method does, however, not control for acupuncturists’ expectations; blinding of the therapists is difficult and therefore truly double (patient and therapist)-blind trials of acupuncture do hardly exist. This means that even the most rigorous studies of acupuncture are usually burdened with residual bias.
- Few acupuncturists warn their patients of possible adverse effects; this may be because the side-effects of acupuncture (they occur in about 10% of all patients) are mostly mild. However, it is important to know that very serious complications of acupuncture are on record as well: acupuncture needles can injure vital organs like the lungs or the heart, and they can introduce infections into the body, e. g. hepatitis. About 100 fatalities after acupuncture have been reported in the medical literature – a figure which, due to lack of a monitoring system, may disclose just the tip of an iceberg.
- Given that, for the vast majority of conditions, there is no good evidence that acupuncture works beyond a placebo response, and that acupuncture is associated with finite risks, it seems to follow that, in most situations, the risk/benefit balance for acupuncture fails to be convincingly positive.
The volume of medical research, as listed on Medline, is huge and increases steadily each year. This phenomenon can easily be observed with simple Medline searches. If we use search terms related to conventional medicine, we find near linear increases in the number of articles (here I do not make a distinction between types of articles) published in each area over time, invariably with a peak in 2013, the last year for which Medline listing is currently complete. Three examples will suffice:
PHARMACOTHERAPY 117 414 articles in 2013
PHARMACOLOGY 210 228 articles in 2013
ADVERSE EFFECTS 86 067 articles in 2013
Some of the above subjects are obviously heavily industry-dependent and thus perhaps not typical of the volume of research in health care generally. Let’s therefore look up three fields where there is no such powerful industry to support research:
PSYCHOTHERAPY 7 208 articles in 2013
PHYSIOTHERAPY 7 713 articles in 2013
SURGERY 154 417 articles in 2013
Now, if we conduct similar searches for topics related to alternative medicine, the picture changes in at least three remarkable ways: 1) there is no linear increase of the volume per year; instead the curves look flat and shapeless (the only exception is ‘herbal medicine’ where the increase even looks exponential). 2) The absolute volume does not necessarily peak in 2013 (exceptions are ‘acupuncture’ and ‘herbal medicine’). 3) The number of articles in the year with the most articles (as listed below) is small or even tiny:
ACUPUNCTURE 1 491 articles in 2013
CHIROPRACTIC 283 articles in 2011
HERBAL MEDICINE 2 503 articles in 2013
HOMEOPATHY 233 articles in 2005
NATUROPATHY 69 articles in 2010
You may think: so what? But I find these figures intriguing. They demonstrate that the research output in alternative medicine is minimal compared to that in conventional medicine. Moreover, they imply that this output is not only not increasing steadily, as it is in conventional medicine, but in the case of chiropractic, homeopathy and naturopathy, it has recently been decreasing.
To put this into context, we need to know that:
- there is a plethora of journals dedicated to alternative medicine which are keen to publish all sorts of articles,
- the peer-review process of most of these journals seems farcically poor,
- as a result, the quality of the research into alternative medicine is often dismal, as regularly disclosed on this blog,
- enthusiasts of alternative medicine often see rigorous research into their subject as a dangerous threat: it might disprove their prior beliefs.
In their defence, proponents of alternative medicine would probably claim that the low volume of research is due to a severe and unfair lack of funding. However, I fail to see how this can be the sole or even the main explanation: areas of conventional medicine that do not have industry support seem to manage a much higher output than alternative medicine (and I should stress that I have chosen 5 sections within alternative medicine that are associated with the highest number of articles per year). Research in these areas is usually sponsored by charitable and government sources, and it needs to be stressed that these are open to any researcher who submits good science.
What follows, I think, is simple: in general, alternative medicine advocates have little interest in research and even less expertise to conduct it.
One thing that has often irritated me – alright, I admit it: sometimes it even infuriated me – is the pseudoscientific language of authors writing about alternative medicine. Reading publications in this area often seems to me like being in the middle of a game of ‘bullshit bingo’ (I am afraid that some of the commentators on this blog have importantly contributed to this phenomenon). In an article of 2004, I once discussed this issue in some detail and concluded that “… pseudo-scientific language … can be seen as an attempt to present nonsense as science…this misleads patients and can thus endanger their health…” For this paper, I had focussed on examples from the ‘bioresonance’- literature – more by coincidence than by design, I should add. I could have selected any other alternative treatment or diagnostic method; the use of pseudoscientific language is truly endemic in alternative medicine.
To give you a little flavour, here is the section of my 2004 paper where I used 5 quotes from recent articles on bioresonance and added a brief comment after each of them.
Quote No. 1
‘The biophysical control processes are superordinate to the biochemical processes. In the same way as the atomic processes result in chemical compounds the ultrafine biocommunication results in the biochemical processes. Control signals have an electromagnetic quality. Disturbing signals or ‘disturbing energies’ also have an electromagnetic quality. This is the reason why they can, for example, be conducted through cables and transformed into therapy signals by means of sophisticated electronic devices. The purpose is to clear the pathological part of the signals.’
Here the author uses highly technical language which, at first, sounds very complicated and scientific. However, after a second read, one is bound to discover that the words hide more than they reveal. In particular, the scientific tone distracts from the lack of logic in the argument. The basic message, once the pseudoscientific veneer is stripped away, seems to be the following. Living systems display electromagnetic phenomena. The electromagnetic energies that they rely upon can make us ill. The energies can also be transferred into an electronic instrument where they can be changed so that they don’t cause any more harm.
Quote No. 2
‘A very important advantage of the BICOM device as compared to the original form of the MORA-therapy in paediatry is the possibility to reduce the oscillation, a fact which meets much better the reaction pattern of the child and gives better results’ .
This paragraph essentially states that the BICOM instrument can change (the frequency or amplitude of) some sort of (electromagnetic) wave. We are told that, for children, this is preferable because of the way children tend to react. This would then be more effective.
Quote No. 3
‘The question how causative the Bioresonanz-Therapy can be must be answered in a differentiated way. The BR is in the first place effective on the informative level, which means on the ultrafine biokybernetical regulation level of the organism. This also includes the time factor and with that the functional aspect, and thus it influences the material-biochemical area of the body. The BRT is in comparison to other therapy procedures very high on the scale of causativeness, but it still remains in the physical level, and does not reach into the spiritual area. The freeing of the patient from his diseases can self evidently also lead to a change and improvement of conduct and attitudes and to a general wellbeing of the patient’ .
This amazing statement is again not easy to understand. If my reading is correct, the author essentially wants to tell us that BR interferes with the flow of information within organisms. The process is time-dependent and therefore affects function, physical and biochemical properties. Compared to other treatments, BR is more causative without affecting our spiritual sphere. As BR cures a disease, it can also change behaviour, attitudes and wellbeing.
Quote No. 4
‘MORA therapy is an auto-iso-therapy using the patient’s own vibrations in a wide range of the electromagnetic spectrum. Strictly speaking, we have hyperwaves in a six-dimensional cosmos with two hidden parameters (as predicted by Albert Einstein and others). Besides the physical plane there are six other planes of existence and the MORA therapy works in the biological plane, a region called the M-field, according to Sheldrake and Burkhard Heim’ .
Here we seem to be told that the MORA therapy is a selftreatment using the body’s own resources, namely a broad range of electromagnetic waves. These waves are hyperwaves in 6 dimensions and their existence has already been predicted by Einstein. Six (or 7?) planes of existence seem to have been discovered and the MORA therapy is operative in one of them.
Quote No. 5
‘The author presents an overall medical conception of the world between mass maximum and masslessness and completes it with the pair of concepts of subjectivity/objectivity. Three test procedures of the bioelectronic function diagnostics are presented and incorporated in addition to other procedures in this conception of the world. Therefore, in the sense of a holistic medicine, there is a useful indication for every medical procedure, because there are different objectives associated with each procedure. A one-sided assessment of the procedures does not do justice to the human being as a whole’ .
This author introduces a new concept of the world between maxima and minima of mass or objectivity. He has developed 3 tests of BR diagnosis that fit into the new concept. Therefore, holistically speaking, any therapy is good for something because each may have a different aim. One-sided assessments of such holistic treatments are too narrow bearing in mind the complexity of a human being.
The danger of pseudoscientific language in health care is obvious: it misleads patients, consumers, journalists, politicians, and everyone else (perhaps even some of the original authors?) into believing that nonsense is credible; to express it more bluntly: it is a method of cheating the unsuspecting public. Yes, the way I see it, it is a form of health fraud. Thus it leads to wrong therapeutic decisions and endangers public health.
I could easily get quite cross with the many authors who publish such drivel. But let’s not allow them to spoil our day; let’s take a different approach: let’s try to have some fun.
I herewith invite my readers to post quotes in the comments section of the most extraordinary excesses of pseudoscientific language that they have come across. If the result is sufficiently original, I might try to design a new BULLSHIT BINGO with it.
While the previous post was about seeing a traditional herbalist (who prescribe their own herbal mixtures, tailor-made for each individual patient), this post provides essential information for those consumers who are tempted to take a commercially available herbal remedy available in pharmacies, health food shops, over the Internet etc. These remedies are usually bought by consumers and then be self-administered, or (less frequently) they might be prescribed/recommended/sold by a clinician such as a doctor, naturopath, chiropractor etc. Typically, they contain just one (or relatively few) herbal extracts and are used under similar assumptions as conventional medicines: one (hopefully well-tested) remedy is employed for treating a defined condition, diagnosed according to validated and generally accepted criteria (for instance, St John’s Wort for depression or Devil’s claw for back pain). This approach is sometimes referred to as ‘rational phytotherapy’ – it is certainly more rational than the traditional herbalism referred to in my previous post. The manufacture, promotion and sale of commercial herbal remedies (in many countries marketed as ‘dietary supplements’) has grown into a multi-billion dollar industry.
Here are a few essentials you ought to know before you decide to take such an herbal remedy:
- Many people claim that herbal medicine is effective because many of our modern drugs are based on plants. The latter part of this claim is true, of course, but this does not necessarily mean that herbal remedies are effective. The drugs derived from plants contain one single, well-defined, extensively researched molecule (by definition, this makes them conventional drugs and not herbal remedies), while herbal remedies are based on entire (parts of) plants; thus they contain many pharmacologically active molecules. This often means that it is difficult or impossible to tell what dose of which ingredient is being administered and what pharmacological actions can be expected.
- Even though national regulations differ greatly, herbal remedies generally do not have to be supported by evidence for efficacy in order to be legally available. This means that a given remedy might or might not have been tested in clinical trials to determine whether it works for the condition advertised. In fact, only very few (less than 30, I estimate) herbal remedies are supported by sound evidence for efficacy; thousands do not meet this criterion.
- The extremely wide-spread notion that herbal remedies are by definition natural and therefore safe is nothing but a promotional myth. Plants contain many chemicals which can have pharmacological activity. This means they might be therapeutic, but it also means that they might be toxic (traditionally the most powerful poisons originated from the plant kingdom). If anyone uses the ‘natural = safe fallacy’ remind him/her of hemlock, poison ivy etc.
- In addition to potential toxicity of an herbal ingredient, there are other important safety issues to be considered. Most importantly, herbal remedies can interact with prescribed medicines. For instance, St John’s Wort (one of the best-studied herbal remedies in this respect) powerfully interacts with about 50% of all prescription drugs – in fact, it lowers their level in the blood which means that a patient on anti-coagulants would lose her anti-coagulant protection and might suffer from a (potentially fatal) blood clot.
- In many countries, including the US, the regulation of herbal remedies is so lax, that there is no guarantee that an herbal remedy which is being legally sold is safe. The regulators are only allowed to intervene once there are reports of adverse effects. This means that the burden of proof of safety is effectively reversed which obviously exposes consumers to incalculable risks.
- The quality of the herbal product is equally poorly regulated in most countries. A plethora of investigations in the US, for instance, has shown that the dose of the herbal ingredient printed on the label of a commercial product can range virtually from 0 – 100%. Similarly there is little safe-guard that the ingredients listed on the label correspond to the ones in the preparation. This means that it is worth purchasing not just well-researched herbal remedies but also those marketed by high quality manufacturers via respectable outlets.
- Any regulation of herbal remedies, even the European one that is often praised as protecting consumers adequately, is null and void once consumers go on the Internet and purchase their herbal remedies from one of the many dubious sources found there in truly alarming profusion. Bogus claims, inferior quality and even outright dangerous products abound, and it is often impossible to tell the acceptable from the fraudulent product.
Here I am not writing about herbal medicine in general – parts of which are supported by some encouraging evidence (I will therefore post more than one ‘seven things to remember…’ article on this subject) – here I am writing about the risks and benefits of consulting a traditional herbal practitioner. Herbalists come in numerous guises depending what tradition they belong to: Chinese herbalist, traditional European herbalist, Ayurvedic practitioner, Kampo practitioner etc. If you consult such a therapist, you should be aware of the following issues.
- Worldwide, the treatment by traditional herbal practitioners is by far the most common form of herbal medicine; it is more common than to use specific, well-tested herbs to treat specific conventionally diagnosed conditions (an approach that might best be called ‘rational phytotherapy’).
- Herbalists often use their very own diagnostic methods (think, for instance, of ‘tongue and pulse diagnoses’ used by Chinese herbalists) and reject (or are untrained to use) conventional diagnostic methods. The traditional diagnostic techniques of herbalists have either not been validated at all or they have been tested and found to be not valid.
- Herbalists usually do not recognise conventional disease categories. Instead they arrive at a diagnosis according to their specific philosophy which has no grounding in reality (for instance, energy imbalance in traditional Chinese herbalism).
- Herbalists individualise their treatments, meaning that 10 patients suffering from depression, for instance, might receive 10 different, tailor-made prescriptions according to their individual characteristics (and none of the 10 patients might receive St John’s Wort, the only herbal remedy that actually is proven to work for depression).
- Typically, such prescriptions contain not one herbal ingredient, but are mixtures of many – up to 10 or 20 – herbs or herbal extracts.
- Even though the efficacy of the individualised herbal approach can, of course, be tested in rigorous trials, and even though about a dozen such studies are available today, there is currently no good evidence to show that it is effective.
- The risk of harm through these individualised herbal mixtures can be considerable: the more ingredients, the higher the likelihood that one of them has toxic effects or that one interacts with a prescription medicine. Essentially, this means that there is no good evidence that individualised herbal treatments as used by so many herbal practitioners across the globe generates more good than harm.
Reiki is a form of energy healing that evidently has been getting so popular that, according to the ‘Shropshire Star’, even stressed hedgehogs are now being treated with this therapy. In case you argue that this publication is not cutting edge when it comes to reporting of scientific advances, you may have a point. So, let us see what evidence we find on this amazing intervention.
A recent systematic review of the therapeutic effects of Reiki concludes that the serious methodological and reporting limitations of limited existing Reiki studies preclude a definitive conclusion on its effectiveness. High-quality randomized controlled trials are needed to address the effectiveness of Reiki over placebo. Considering that this article was published in the JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE, this is a fairly damming verdict. The notion that Reiki is but a theatrical placebo recently received more support from a new clinical trial.
This pilot study examined the effects of Reiki therapy and companionship on improvements in quality of life, mood, and symptom distress during chemotherapy. Thirty-six breast cancer patients received usual care, Reiki, or a companion during chemotherapy. Data were collected from patients while they were receiving usual care. Subsequently, patients were randomized to either receive Reiki or a companion during chemotherapy. Questionnaires assessing quality of life, mood, symptom distress, and Reiki acceptability were completed at baseline and chemotherapy sessions 1, 2, and 4. Reiki was rated relaxing and caused no side effects. Both Reiki and companion groups reported improvements in quality of life and mood that were greater than those seen in the usual care group.
The authors of this study conclude that interventions during chemotherapy, such as Reiki or companionship, are feasible, acceptable, and may reduce side effects.
This is an odd conclusion, if there ever was one. Clearly the ‘companionship’ group was included to see whether Reiki has effects beyond simply providing sympathetic attention. The results show that this is not the case. It follows, I think, that Reiki is a placebo; its perceived relaxing effects are the result of non-specific phenomena which have nothing to do with Reiki per se. The fact that the authors fail to spell this out more clearly makes me wonder whether they are researchers or promoters of Reiki.
Some people will feel that it does not matter how Reiki works, the main thing is that it does work. I beg to differ!
If its effects are due to nothing else than attention and companionship, we do not need ‘trained’ Reiki masters to do the treatment; anyone who has time, compassion and sympathy can do it. More importantly, if Reiki is a placebo, we should not mislead people that some super-natural energy is at work. This only promotes irrationality – and, as Voltaire once said: those who make you believe in absurdities can make you commit atrocities.
A special issue of Medical Care has just been published; it was sponsored by the Veterans Health Administration’s Office of Patient Centered Care and Cultural Transformation. A press release made the following statement about it:
Complementary and alternative medicine therapies are increasingly available, used, and appreciated by military patients, according to Drs Taylor and Elwy. They cite statistics showing that CAM programs are now offered at nearly 90 percent of VA medical facilities. Use CAM modalities by veterans and active military personnel is as at least as high as in the general population.
If you smell a bit of the old ad populum fallacy here, you may be right. But let’s look at the actual contents of the special issue. The most interesting article is about a study testing acupuncture for posttraumatic stress disorder (PTSD).
Fifty-five service members meeting research diagnostic criteria for PTSD were randomized to usual PTSD care (UPC) plus eight 60-minute sessions of acupuncture conducted twice weekly or to UPC alone. Outcomes were assessed at baseline and 4, 8, and 12 weeks postrandomization. The primary study outcomes were difference in PTSD symptom improvement on the PTSD Checklist (PCL) and the Clinician-administered PTSD Scale (CAPS) from baseline to 12-week follow-up between the two treatment groups. Secondary outcomes were depression, pain severity, and mental and physical health functioning. Mixed model regression and t test analyses were applied to the data.
The results show that the mean improvement in PTSD severity was significantly greater among those receiving acupuncture than in those receiving UPC. Acupuncture was also associated with significantly greater improvements in depression, pain, and physical and mental health functioning. Pre-post effect-sizes for these outcomes were large and robust.
The authors conclude from these data that acupuncture was effective for reducing PTSD symptoms. Limitations included small sample size and inability to parse specific treatment mechanisms. Larger multisite trials with longer follow-up, comparisons to standard PTSD treatments, and assessments of treatment acceptability are needed. Acupuncture is a novel therapeutic option that may help to improve population reach of PTSD treatment.
What shall we make of this?
I know I must sound like a broken record to some, but I have strong reservations that the interpretation provided here is correct. One does not even need to be a ‘devil’s advocate’ to point out that the observed outcomes may have nothing at all to do with acupuncture per se. A much more rational interpretation of the findings would be that the 8 times 60 minutes of TLC and attention have positive effects on the subjective symptoms of soldiers suffering from PTSD. No needles required for this to happen; and no mystical chi, meridians, life forces etc.
It would, of course, have been quite easy to design the study such that the extra attention is controlled for. But the investigators evidently did not want to do that. They seemed to have the desire to conduct a study where the outcome was clear even before the first patient had been recruited. That some if not most experts would call this poor science or even unethical may not have been their primary concern.
The question I ask myself is, why did the authors of this study fail to express the painfully obvious fact that the results are most likely unrelated to acupuncture? Is it because, in military circles, Occam’s razor is not on the curriculum? Is it because critical thinking has gone out of fashion ( – no, it is not even critical thinking to point out something that is more than obvious)? Is it then because, in the present climate, it is ‘politically’ correct to introduce a bit of ‘holistic touchy feely’ stuff into military medicine?
I would love to hear what my readers think.
Some of the recent comments on this blog have been rather emotional, a few even irrational, and several were, I am afraid, outright insulting (I usually omit to post the worst excesses). Moreover, I could not avoid the impression that some commentators have little understanding of what the aim of this blog really is. I tried to point this out in the very first paragraph of my very first post:
Why another blog offering critical analyses of the weird and wonderful stuff that is going on in the world of alternative medicine? The answer is simple: compared to the plethora of uncritical misinformation on this topic, the few blogs that do try to convey more reflected, sceptical views are much needed; and the more we have of them, the better.
My foremost aim with his blog is to inform consumers through critical analysis and, in this way, I hope to prevent harm from patients in the realm of alternative medicine. What follows, are a few simple yet important points about this blog which I try to spell out here as clearly as I can:
- I am not normally commenting on issues related to conventional medicine – not because I feel there is nothing to criticise in mainstream medicine, but because my expertise has long been in alternative medicine. So commentators might as well forget about arguments like “more people die because of drugs than alternative treatments”; they are firstly fallacious and secondly not relevant to this blog.
- I have researched alternative medicine for many years (~ 40 clinical studies, > 300 systematic reviews etc.) and my readers can be confident that I know what I am talking about. Thus comments like ‘he does not know anything about the subject’ are usually not well placed and just show the ignorance of those who post them.
- I am not in the pocket of anyone. I do not receive payments for doing this blog, nor did I, as an academic, receive any financial or other inducements for researching alternative medicine (on the contrary, I have often been given to understand that my life could be made much easier, if I adopted a more promotional stance towards my alternative medicine). I also do not belong to any organisation that is financed by BIG PHARMA or similar power houses. So my critics might as well abandon their conspiracy theories and focus on a more promising avenue of criticism.
- My allegiance is not with any interest group in (or outside) the field of alternative medicine. For instance, I do not see it as my job to help chiropractors, homeopaths etc. getting their act together. My task here is to point out the deficits in chiropractic (or any other area of alternative medicine) so that consumers are better protected. (I should think, however, that this also creates pressure on professions to become more evidence-based – but I see this as a mere welcome side-effect.)
- If some commentators seem to find my arguments alarmist or see it as venomous scare-mongering, I suggest they re-examine their own position and learn to think a little more (self-) critically. I furthermore suggest that, instead of claiming such nonsense, they point out where they think I have gone wrong and provide evidence for their views.
- Some people seem convinced that I have an axe to grind, that I have been personally injured by some alternative practitioner, or had some other unpleasant or traumatic experience. To those who think so, I have to say very clearly that none of this has ever happened. I recommend they inform themselves of the nature of critical analysis and its benefits.
- This is a blog, not a scientific journal. I try to reach as many lay people as I can and therefore I tend to use simple language and sometimes aim to be entertaining. Those who feel that this renders my blog more journalistic than scientific are probably correct. If they want science, I recommend they look for my scientific articles in the medical literature; I can assure them that they will find plenty.
- I very much invite an open and out-spoken debate. But ad hominem attacks are usually highly counterproductive – they only demonstrate that the author has no rational arguments left, or had none in the first place. Authors of insults also risks being banned from this blog.
- Finally, I fear that some readers of my blog might sometimes get confused in the arguments and counter-arguments, and end up uncertain which side is right and which is wrong. To those who have this problem, I recommend a simple method for deciding where the truth is usually more likely to be found: ask yourself who might be merely defending his/her self-interest and who might be free of such conflicts of interest and thus more objective. For example, in my endless disputes with chiropractors, one could well ask: do the chiropractors have an interest in defending their livelihood, and what interest do I have in questioning whether chiropractors do generate more good than harm?