A recent comment to a post of mine (by a well-known and experienced German alt med researcher) made the following bold statement aimed directly at me and at my apparent lack of understanding research methodology:
C´mon , as researcher you should know the difference between efficacy and effectiveness. This is pharmacological basic knowledge. Specific (efficacy) + nonspecific effects = effectiveness. And, in fact, everything can be effective – because of non-specific or placebo-like effects. That does not mean that efficacy is existent.
The point he wanted to make is that outcome studies – studies without a control group where the researcher simply observe the outcome of a particular treatment in a ‘real life’ situation – suffice to demonstrate the effectiveness of therapeutic interventions. This belief is very wide-spread in alternative medicine and tends to mislead all concerned. It is therefore worth re-visiting this issue here in an attempt to create some clarity.
When a patient’s condition improves after receiving a therapy, it is very tempting to feel that this improvement reflects the effectiveness of the intervention (as the researcher mentioned above obviously does). Tempting but wrong: there are many other factors involved as well, for instance:
- the placebo effect (mainly based on conditioning and expectation),
- the therapeutic relationship with the clinician (empathy, compassion etc.),
- the regression towards the mean (outliers tend to return to the mean value),
- the natural history of the patient’s condition (most conditions get better even without treatment),
- social desirability (patients tend to say they are better to please their friendly clinician),
- concomitant treatments (patients often use treatments other than the prescribed one without telling their clinician).
So, how does this fit into the statement above ‘Specific (efficacy) + nonspecific effects = effectiveness’? Even if this formula were correct, it would not mean that outcome studies of the nature described demonstrate the effectiveness of a therapy. It all depends, of course, on what we call ‘non-specific’ effects. We all agree that placebo-effects belong to this category. Probably, most experts also would include the therapeutic relationship and the regression towards the mean under this umbrella. But the last three points from my list are clearly not non-specific effects of the therapy; they are therapy-independent determinants of the clinical outcome.
The most important factor here is usually the natural history of the disease. Some people find it hard to imagine what this term actually means. Here is a little joke which, I hope, will make its meaning clear and memorable.
CONVERATION BETWEEN TWO HOSPITAL DOCTORS:
Doc A: The patient from room 12 is much better today.
Doc B: Yes, we stared his treatment just in time; a day later and he would have been cured without it!
I am sure that most of my readers now understand (and never forget) that clinical improvement cannot be equated with the effectiveness of the treatment administered (they might thus be immune to the misleading messages they are constantly exposed to). Yet, I am not at all sure that all ‘alternativists’ have got it.
Twenty years ago, I published a short article in the British Journal of Rheumatology. Its title was ALTERNATIVE MEDICINE, THE BABY AND THE BATH WATER. Reading it again today – especially in the light of the recent debate (with over 700 comments) on acupuncture – indicates to me that very little has since changed in the discussions about alternative medicine (AM). Does that mean we are going around in circles? Here is the (slightly abbreviated) article from 1995 for you to judge for yourself:
“Proponents of alternative medicine (AM) criticize the attempt of conducting RCTs because they view this is in analogy to ‘throwing out the baby with the bath water’. The argument usually goes as follows: the growing popularity of AM shows that individuals like it and, in some way, they benefit through using it. Therefore it is best to let them have it regardless of its objective effectiveness. Attempts to prove or disprove effectiveness may even be counterproductive. Should RCTs prove that a given intervention is not superior to a placebo, one might stop using it. This, in turn, would be to the disadvantage of the patient who, previous to rigorous research, has unquestionably been helped by the very remedy. Similar criticism merely states that AM is ‘so different, so subjective, so sensitive that it cannot be investigated in the same way as mainstream medicine’. Others see reasons to change the scientific (‘reductionist’) research paradigm into a broad ‘philosophical’ approach. Yet others reject the RCTs because they think that ‘this method assumes that every person has the same problems and there are similar causative factors’.
The example of acupuncture as a (popular) treatment for osteoarthritis, demonstrates the validity of such arguments and counter-arguments. A search of the world literature identified only two RCTs on the subject. When acupuncture was tested against no treatment, the experimental group of osteoarthritis sufferers reported a 23% decrease of pain, while the controls suffered a 12% increase. On the basis of this result, it might seem highly unethical to withhold acupuncture from pain-stricken patients—’if a patient feels better for whatever reason and there are no toxic side effects, then the patient should have the right to get help’.
But what about the placebo effect? It is notoriously difficult to find a placebo indistinguishable to acupuncture which would allow patient-blinded studies. Needling non-acupuncture points may be as close as one can get to an acceptable placebo. When patients with osteoarthritis were randomized into receiving either ‘real acupuncture or this type of sham acupuncture both sub-groups showed the same pain relief.
These findings (similar results have been published for other AMs) are compatible only with two explanations. Firstly acupuncture might be a powerful placebo. If this were true, we need to establish how safe acupuncture is (clearly it is not without potential harm); if the risk/benefit ratio is favourable and no specific, effective form of therapy exists one might still consider employing this form as a ‘placebo therapy’ for easing the pain of osteoarthritis sufferers. One would also feel motivated to research this powerful placebo and identify its characteristics or modalities with the aim of using the knowledge thus generated to help future patients.
Secondly, it could be the needling, regardless of acupuncture points and philosophy, that decreases pain. If this were true, we could henceforward use needling for pain relief—no special training in or equipment for acupuncture would be required, and costs would therefore be markedly reduced. In addition, this knowledge would lead us to further our understanding of basic mechanisms of pain reduction which, one day, might evolve into more effective analgesia. In any case the published research data, confusing as they often are, do not call for a change of paradigm; they only require more RCTs to solve the unanswered problems.
Conducting rigorous research is therefore by no means likely to ‘throw out the baby with the bath water’. The concept that such research could harm the patient is wrong and anti-scientific. To follow its implications would mean neglecting the ‘baby in the bath water’ until it suffers serious damage. To conduct proper research means attending the ‘baby’ and making sure that it is safe and well.
The Paleo diet is based on the evolutionary discordance hypothesis, according to which departures from the nutrition and activity patterns of our hunter-gatherer ancestors have contributed greatly and in specifically definable ways to the endemic chronic diseases of modern civilization. The assumption is that during the Paleolithic era — a period lasting around 2.5 million years that ended about 10,000 years ago with the advent of agriculture and domestication of animals — humans evolved nutritional needs specific to the foods available at that time, and that the nutritional needs of modern humans remain best adapted to the diet of their Paleolithic ancestors. Today’s humans are said to be not well adapted to eating foods such as grain, legumes, and dairy, and in particular the high-calorie processed foods. Proponents claim that modern humans’ inability to properly metabolize these comparatively new types of food has led to modern-day problems such as obesity, heart disease, and diabetes. They furthermore claim that followers of the Paleolithic diet may enjoy a longer, healthier, more active life.
The Paleo Diet is alleged to work by two fundamental principles:
- Put the optimal nutrition into your body.
- Reduce or eliminate toxins and “interference”.
And what are the results, as claimed by those who promote (and profit from) the Paleo diet? The alleged benefits include:
- Leaner, Stronger Muscles
- Increased Energy
- Significantly More Stamina
- Clearer, Smoother Skin
- Weight Loss Results
- Better Performance and Recovery
- Stronger Immune System
- Enhanced Libido
- Greater Mental Clarity
- No More Hunger/Cravings
- Thicker, Fuller Hair
- Clear Eyes
Critics of the Paleo diet point towards abundant evidence that paleolithic humans did, in fact, eat grains and legumes. They also stress that humans are much more nutritionally flexible than previously thought, that the hypothesis that Paleolithic humans were genetically adapted to specific local diets is unproven, that the Paleolithic period was extremely long and saw a variety of forms of human settlement and subsistence in a wide variety of changing nutritional landscapes, and that currently very little is known for certain about what Paleolithic humans ate.
So, the theories behind the Paleo diet are flimsy and naïve; the most crucial question, however, is does it work?
Overall there is little solid evidence; unsurprisingly, some studies have shown that cardiovascular risk factors can be positively influenced, for instance, in patients with diabetes. But the more specific claims, like the ones above, are not supported by good clinical evidence.
It seems that, yet again, less than responsible entrepreneurs have jumped on a popular band-wagon to exploit the often hopelessly gullible public.
According to Bloomberg Markets, A Nelson & Co Ltd. manufactures and markets natural healthcare products. The company offers arnica creams that provide natural first aid for bruises; plant and flower based remedies that help in managing the emotional demands of everyday life; and over-the-counter homeopathic medicines for everyday ailments, such as relief from travel sickness and relief for the symptoms of hay fever. It also provides hemorrhoid relief creams and soothing hygienic wipes; anti-blemish range products for various skin types and age groups; multi-purpose cream that helps to soothe and restore skin; iron supplements; teething granules that provide relief from the symptoms and discomfort of teething; a range of creams, ointments, and sprays for a range of common skin conditions/complaints; and a range of commonly used herbal remedies. The company offers products for ailments, including aches and pains, mild anxiety, babies and children, colds and minor infections, digestion, emotional health, energy, everyday stresses, first aid, getting older, pets, quit smoking, skin, sleep, travel, and women’s health. It also operates a clinic; and a pharmacy that offers homeopathy and complementary healthcare products. The company offers its products through its pharmacy in the United Kingdom; and distributors in Europe, Latin America, and internationally. It also serves customers online. The company was formerly known as Armbrecht, Nelson & Co. The company was founded in 1860 and is based in London, United Kingdom with subsidiary offices in Boston, Massachusetts; and Hamburg, Germany. A Nelson & Co Ltd. operates as a subsidiary of Nelson and Russell Holdings Ltd.
In the journal ‘Chemist and Druggist’ we find an article informing us that, in 1930, Nelsons Homeopathic Pharmacy was approached by Dr Edward Bach who wanted help making and selling his products. He had created 38 flower remedies to rebalance emotions and later created an emergency remedy, a combination of five flower remedies that became Rescue. The relationship between Nelsons and the Dr Edward Bach Centre, based at Dr Bach’s former home at Mount Vernon in Oxfordshire, continues to this day and both the Bach Original Flower Remedies and Rescue are key ranges for Nelsons.
Nelson’s homeopathic pharmacy has a proud history:
Ernst Louis Armbrecht, a German pharmacist and disciple of Samuel Hahnemann, came to London and founded Nelsonsin 1860. Since then, Nelsons has been supplying homeopathic medicines. “Our wish today” they state “is the same as 152 years ago: to make homeopathy accessible and to provide the highest standards of medicine and advice.”
The highest standards of medicine and advice? It seems that the Advertising Standards Authority (ASA) disagrees. A recent ASA Adjudication on A Nelson & Co Ltd deals with an advertisement by Nelsons for ‘Bach Rescue Night’ which stated “I CAN’T SWITCH OFF…The RESCUE NIGHT range helps your mind switch off, so you can enjoy a natural night’s sleep”
A freelance health writer had challenged whether the claims “I can’t switch off … Rescue Night range helps your mind switch off, so you can enjoy a natural night’s sleep” was an authorised health claim in the EU Register of Nutrition and Health Claims for Foods (the EU Register).
The ASA noted that, according to EC Regulation 1924/2006 on Nutrition and Health Claims made on Foods (the Regulation), which was reflected in the CAP Code, only health claims which appeared on the list of authorised health claims (the Register) could be made in ads promoting foods, including food supplements. Health claims were defined as those that stated, suggested or implied that a relationship existed between a food category, a food or one of its constituents and health.
The ASA furthermore stated: We acknowledged Rescue Remedy’s assertion that their ad had not made specific claims to aid sleep or that it improved sleep. However, we considered that the use of visuals such as a crescent moon and stars on a dark background, that the letter ‘O’ in the word “OFF” resembled a simple on/ off light switch image, the text “… you can enjoy a natural night’s sleep” and the name of the product “Rescue Night” was likely to give the impression to consumers that it was a product that would aid sleep or that it would help consumers fall asleep easily. We understood that ‘unwanted thoughts’ was one reason why consumers might find it difficult to get to sleep and, again, considered this added to the impression that the product would contribute positively to sleep. We therefore considered that the ad made a health claim related to sleep involving a food item.
We understood that some Bach Flower Remedies contained levels of alcohol which would preclude them from bearing health claims altogether, however, we noted that Bach Rescue Night was alcohol free. We acknowledged Rescue Remedy’s points regarding EFSA and ‘on hold’ claims for botanicals. We understood that ‘on hold’ claims for such botanicals could be used in marketing, provided such use had the same meaning as the proposed claim and they were used in compliance with applicable existing national provisions (in this case the CAP Code). However, Rescue Remedy did not provide evidence that relevant proposed claims for white chestnut, or any of the other product ingredients were ‘on hold’. Nevertheless, we understood that there were no ‘on hold’ claims entered onto the Register for white chestnut or the other product ingredients. Furthermore, ‘on hold’ claims should also be supported with adequate substantiation which we did not receive.
Because the ad made health claims relating to Bach Rescue Night as a sleep aid and we had not seen evidence that relevant claims for the botanical ingredients contained in the product were ‘on hold’, we concluded that the ad breached the Code.
The ad breached CAP Code (Edition 12) rules 15.1, 15.1.1 and 15.7 (Food, food supplements and associated health or nutritional claims).
The ASA ruled that the ad must not appear again in its current form. We told A Nelson & Co Ltd t/a rescueremedy.co.uk not to make health claims for botanical ingredients if they did not comply with the requirements of the Regulation.
I am afraid that such a ruling will have very little effect on the sale of Bach Flower Remedies. In case you have any doubt, I should mention that these inventions of Dr Bach are not supported by good evidence. Here is the abstract of my systematic review on the subject:
Bach flower remedies continue to be popular and its proponents make a range of medicinal claims for them. The aim of this systematic review was to critically evaluate the evidence for these claims. Five electronic databases were searched without restrictions on time or language. All randomised clinical trials of flower remedies were included. Seven such studies were located. All but one were placebo-controlled. All placebo-controlled trials failed to demonstrate efficacy. It is concluded that the most reliable clinical trials do not show any differences between flower remedies and placebos.
Bach Flower Remedies have no effect whatsoever!
Come to think of it, this is not entirely true: they obviously keep the ASA busy, they exploit the gullible public, and they are clearly good for the cash flow at Nelson’s.
Henry Louis Mencken (1880-1956) was an outspoken American journalist, essayist and literary critic famous for his vitriolic attacks on what he considered to be the hypocrisy of much of American life. In 1924, he published an essay on chiropractic which, I think, is still poignant today. I take the liberty of reproducing here in a slightly abbreviated form.
This preposterous quackery [chiropractic] flourishes lushly in the back reaches of the Republic, and begins to conquer the less civilized folk of the big cities. As the old-time family doctor dies out in the country towns, with no competent successor willing to take over his dismal business, he is followed by some hearty blacksmith or ice-wagon driver, turned into a chiropractor in six months, often by correspondence… [Chiropractic] pathology is grounded upon the doctrine that all human ills are caused by pressure of misplaced vertebrae upon the nerves which come out of the spinal cord — in other words, that every disease is the result of a pinch. This, plainly enough, is buncombe. The chiropractic therapeutics rest upon the doctrine that the way to get rid of such pinches is to climb upon a table and submit to a heroic pummeling by a retired piano-mover. This, obviously, is buncombe doubly damned.
…Any lout with strong hands and arms is perfectly equipped to become a chiropractor. No education beyond the elements is necessary. The takings are often high, and so the profession has attracted thousands of recruits — retired baseball players, work-weary plumbers, truck-drivers, longshoremen, bogus dentists, dubious preachers, cashiered school superintendents. Now and then a quack of some other school — say homeopathy — plunges into it. Hundreds of promising students come from the intellectual ranks of hospital orderlies.
…[The chiropractor’s] trade is mainly with ambulant patients; they must come to his studio for treatment. Most of them have lingering diseases; they tour all the neighborhood doctors before they reach him. His treatment, being nonsensical, is in accord with the divine plan. It is seldom, perhaps, that he actually kills a patient, but at all events he keeps any a worthy soul from getting well.
…But chiropractic, of course, is not perfect. It has superb potentialities, but only too often they are not converted into concrete cadavers. The hygienists rescue many of its foreordained customers, and, turning them over to agents of the Medical Trust, maintained at the public expense, get them cured. Moreover, chiropractic itself is not certainly fatal: even an Iowan with diabetes may survive its embraces. Yet worse, I have a suspicion that it sometimes actually cures. For all I know (or any orthodox pathologist seems to know) it may be true that certain malaises are caused by the pressure of vagrant vertebra upon the spinal nerves. And it may be true that a hearty ex-boilermaker, by a vigorous yanking and kneading, may be able to relieve that pressure. What is needed is a scientific inquiry into the matter, under rigid test conditions, by a committee of men learned in the architecture and plumbing of the body, and of a high and incorruptible sagacity. Let a thousand patients be selected, let a gang of selected chiropractors examine their backbones and determine what is the matter with them, and then let these diagnoses be checked up by the exact methods of scientific medicine. Then let the same chiropractors essay to cure the patients whose maladies have been determined. My guess is that the chiropractors’ errors in diagnosis will run to at least 95% and that their failures in treatment will push 99%. But I am willing to be convinced.
Where is there is such a committee to be found? I undertake to nominate it at ten minutes’ notice. The land swarms with men competent in anatomy and pathology, and yet not engaged as doctors. There are thousands of hospitals, with endless clinical material. I offer to supply the committee with cigars and music during the test. I offer, further, to supply both the committee and the chiropractors with sound wet goods. I offer, finally, to give a bawdy banquet to the whole Medical Trust at the conclusion of the proceedings.
I imagine that most chiropractors would find this comment rather disturbing. However, I do like it for several reasons:
- it is refreshingly politically incorrect; today journalists seem to be obsessed with the notion of ‘balance’ thus often creating the impression that there are two valid sides to an issue where, in fact, there is only one;
- it gets right at the heart of several problems which have plagued chiropractic from its beginning;
- it even suggests a way to establishing the truth about the value of chiropractic which could easily been followed some 90 years ago;
- finally it predicts a result of such a test – and I would not be surprised, if it turned out to be not far from the truth.
Please let me know what you think, regardless of whether you are a chiropractor or not.
Few alternative remedies are more popular than colloidal silver, i.e. tiny particles of silver suspended in a liquid, and few represent more irresponsible quackery. It is widely promoted as a veritable panacea. Take this website (one of thousands), for instance; it advertises colloidal silver in the most glowing terms:
Here are some of the diseases against which Colloidal Silver has been used successfully Acne, Allergies, Appendicitis, Arthritis, Blood parasites, Bubonic plague, Burns (colloidal silver is one of the few treatments that can keep severe burn patients alive), Cancer, Cholera, Conjunctivitis, Diabetes, Gonorrhoea, Hay Fever, Herpes, Leprosy, Leukaemia, Malaria, Meningitis, Parasitic Infections both viral and fungal, Pneumonia, Rheumatism, Ringworm, Scarlet Fever, Septic conditions of eyes, ears, mouth, throat, Shingles, Skin Cancer, Syphilis, all viruses, warts and stomach ulcer.In addition it also has veterinary uses, such as for canine Parvo virus. You’ll also find Colloidal Silver very handy in the garden since it can be used against bacterial, fungal / viral attacks on plants.It would also appear highly unlikely that any germ warfare agents could survive an encounter with CS, as viruses such as E Bola and Hanta are in the end merely viruses and bacteria.Colloidal Silver is non-toxic, making it safe for both children, adults and pets. Colloidal Silver is in fact a pre 1938 healing modality, making it exempt from FDA jurisdiction.
So why haven’t you heard of it? It’s suspected that the user friendly economics of Colloidal Silver may have something to do with its low profile in the media. Colloidal Silver shines a spotlight on the over expensive and deadly nature of the pharmaceutical industry, who are larger than the Pentagon economically.
That’s right, plenty of bogus claims (it goes without saying that there is no good evidence to support any of them) and, for good measure, some conspiracy theory as well – the perfect mix for making a fast buck!
But sometimes things do not work out as planned. The following text was recently published on the website of Essex County Council:
A man claiming to sell a cure for cancer has been fined £750 following an investigation by Essex Trading Standards. Steven Cook, 54, of East Road, West Mersea, was charged with an offence under the Cancer Act after suggesting Colloidal Silver was a treatment for cancer.
Mr Cook pleaded guilty at Colchester Magistrates’ Court on Friday 12 September. Magistrates imposed a fine of £750 and ordered him to pay £1,500 costs. Cllr Roger Hirst, Essex County Council’s cabinet member for Trading Standards, said: “Trading Standards’ advice to people who are considering whether to take any substance not prescribed for a medical purpose, either preventative or as a treatment, is to consult their doctor first.
“I hope the public feel safer knowing that Essex Trading Standards will take action where traders are trying to sell products which are neither medically proven nor safe.”
Mr Cook runs a website, www.colloidalsilveruk.com, selling various products containing silver. One of the products on sale was “Ultimate Colloidal Silver”, a liquid containing silver that Mr Cook made in his own home. Trading Standards said the website implied that the product can cure cancer – and this is an offence under the Cancer Act. Mr Cook has now updated the website and removed any claims that colloidal silver can cure some cancers.
So, there is some hope! Occasionally, fraudsters are being found out and punished. But the bad news, of course, is that this sort of thing occurs far too rarely and when it does happen, the punishment is far too lenient. Consequently, the public’s protection from fraudsters exploiting the most vulnerable patients is woefully insufficient.
A recent article from THE CHIROPRACTIC REPORT entitled ‘Media Criticism – Whether and How to Respond’ has caught my attention. It provides detailed and, in my view, quite remarkable advice to chiropractors as to how they should react to criticism. Here is an excerpt:
…the easiest media comment to challenge is one that makes an absolute claim – for example Salzberg’s claim that the practice of chiropractic is “highly dubious.” It also means that an effective response should usually not be absolute – claiming for example that chiropractic care can cure, or a specific chiropractic treatment is proven effective for, a specific condition.
Let’s explore this with an example. In 2008 a British journalist, Simon Singh, while promoting a new book he had co-authored that was heavily critical of chiropractic and complementary and alternative medicine in general, wrote an article in the Guardian newspaper in which he claimed that “there is not a jot of evidence” that chiropractic treatment can help children with “colic, sleeping and feeding problems . . . and prolonged crying.” In other words, a black and white claim.
There was and is evidence. Singh was wrong. How might you respond to this? Here are your options for reply, from the outspoken to the restrained:
a. Chiropractic is proven effective for the cure of infantile colic.
b. Spinal manipulation is proven effective for the cure of infantile colic
c. Manual treatments are proven effective for the cure of infantile colic
d. Chiropractic/spinal manipulation/ manual therapies may be effective in reducing the symptoms of infantile colic.
e. Where spinal joint dysfunction/subluxation is found, chiropractic/spinal manipulation/manual therapies may be effective in reducing abnormal and incessant crying in infants medically diagnosed as having infantile colic
f. Chiropractic care has a central focus of assessing and correcting spinal joint dysfunction/subluxation and its biomechanical and physiological effects, and where these are addressed many symptoms may be reduced including those associated with infantile colic.
The first three options are as black and white as Singh’s statement, and are not supported by the evidence. Some studies say yes, some no. All the other options, which have appropriate qualifiers and shades of gray, are supported by sound evidence.
Much of that evidence is referred to and referenced in the March 2010 issue of this Report, available online at www.chiropracticreport.com/pastissues. To answer Singh effectively one only has to produce some of the good quality research and question how he can be credible when he says “there is not a jot of evidence”.
With respect to evidence, in this context that means evidence published in peer-reviewed scientific journals. You may decide to comment on one or more anecdotal case reports from your practice to give your response greater human interest, but this will mean nothing unless supported by higher levels of published evidence.
Am I the only one to find this remarkable?
Am I wrong in interpreting this as detailed instructions to mislead the public?
Are these instructions not merely advice to defend chiropractic commercial interests at the expense of public health?
How can this be ethical?
Reiki healers believe they are able to channel ‘healing energy’ into patients’ body and thus enable them to get healthy. If Reiki were not such a popular treatment, one could brush such claims aside and think “let the lunatic fringe believe what they want”. But as Reiki so effectively undermines consumers’ sense of reality and rationality, I feel a responsibility to inform the public what Reiki truly amounts to.
This pilot study compared the effects of Reiki therapy with those of companionship on improvements in quality of life, mood, and symptom distress in cancer patients receiving chemotherapy. Thirty-six breast cancer patients received one of three treatments:
- usual care,
- Reiki + usual care,
- companionship + usual care.
First, data were collected from patients receiving usual care. Second, patients were randomized to either receive Reiki or a companionship during chemotherapy.
Questionnaires assessing quality of life, mood, symptom distress, and Reiki acceptability were completed at baseline and chemotherapy sessions 1, 2, and 4.
The results show that Reiki was rated relaxing with no side effects. Reiki and companionship groups both reported improvements in quality of life and mood that were greater than those seen in the usual care group.
The authors concluded that interventions during chemotherapy, such as Reiki or companionship, are feasible, acceptable, and may reduce side effects.
Yet another example of utterly bizarre conclusions from a fairly straight forward study and quite clear results. What they really demonstrate is the fact that Reiki is nothing more than a placebo; its perceived benefit relies entirely on non-specific effects. This view is also supported by our systematic review (its 1st author is a Reiki healer!): the evidence is insufficient to suggest that reiki is an effective treatment for any condition. Therefore the value of reiki remains unproven.
In other words, we do not need a trained Reiki master, nor the illusion of some mysterious ‘healing energy’. Simple companionship without woo or make-believe has exactly the same effect without undermining rationality. Or, to put it much more bluntly: REIKI IS NONSENSE ON STILTS.
Poor sleep quality during pregnancy is a frequent problem. Drug treatment can be problematic due to possible adverse effects for mother and embryo/foetus. Many pregnant women prefer natural treatments and assume that ‘natural’ equals harmless.
In the present study, the sedative effects of Bryophyllum pinnatum were investigated. This remedy is a phytotherapeutic medication predominantly used in anthroposophic medicine. In previous clinical studies on its tocolytic effect, B. pinnatum showed a promising risk/benefit ratio for mother and child. A recent analysis of the prescribing pattern for B. pinnatum in a network of anthroposophic physicians revealed sleep disorders as one of the most frequent diagnosis.
In this prospective, multi-centre, observational study, pregnant women suffering from sleep problems were treated with B. pinnatum (350mg tablets, 50% leaf press juice, Weleda AG, Arlesheim, dosage at physician’s consideration). Sleep quality, daily sleepiness and fatigue were assessed with the aid of standardised questionnaires, at the beginning of the treatment and after 2 weeks. Possible adverse effects perceived by the patients during the treatment were recorded.
The results show that the number of wake-ups, as well as the subjective quality of sleep was significantly improved at the end of the treatment with B. pinnatum. The Epworth Sleeping Scale decreased, indicating a reduction in tiredness during the day. There was, however, no evidence for a prolongation of the sleep duration, reduction in the time to fall asleep, as well as change in the Fatigue Severity Scale after B. pinnatum. No serious adverse drug reactions were detected.
From these data, the authors concluded that B. pinnatum is a suitable treatment of sleep problems in pregnancy. The data of this study encourage further clinical investigations on the use of B. pinnatum in sleep disorders.
Clinical trials of anthroposophic remedies, i.e. remedies which are based on the school of medicine founded by Rudolf Steiner, are very rare. Therefore this trial could be important.
B. pinnatum is a plant used in traditional Tai medicine against hypertension, and to some extend this makes sense: it contains cardiac glycosides which might help lowering elevated blood pressure. The reason for its use as a hypnotic, however, is not clear.
So, is B pinnatum really a ‘suitable treatment of sleep problems in pregnancy’? I doubt it for the following reasons:
- the effects documented in this study are far from convincing,
- we would need much more solid data to issue such a general recommendation,
- cardiac glycosides can cause very serious adverse effects,
- the sample size of the study is at least one dimension too small for assuming that it is safe,
- we know nothing about its potential to cause harm to the foetus.
Personally, I find it irresponsible to draw conclusions such as the ones above on the basis of data which are flimsy to the extreme. I ask myself, to what extend wishful thinking might be a regrettable characteristic for the entire field of anthroposophic medicine.
How often have we heard it on this blog and elsewhere?
- chiropractic is progressing,
- chiropractors are no longer adhering to their obsolete concepts and bizarre beliefs,
- chiropractic is fast becoming evidence-based,
- subluxation is a thing of the past.
American chiropractors wanted to find out to what extent these assumptions are true and collected data from chiropractic students enrolled in colleges throughout North America. The stated purpose of their study is to investigate North American chiropractic students’ opinions concerning professional identity, role and future.
A 23-item cross-sectional electronic questionnaire was developed. A total of 7,455 chiropractic students from 12 North American English-speaking chiropractic colleges were invited to complete the survey. Survey items encompassed demographics, evidence-based practice, chiropractic identity and setting, and scope of practice. Data were collected and descriptive statistical analyses were performed.
A total of 1,243 questionnaires were electronically submitted. This means the response rate was 16.7%. Most respondents agreed (34.8%) or strongly agreed (52.2%) that it is important for chiropractors to be educated in evidence-based practice. A majority agreed (35.6%) or strongly agreed (25.8%) the emphasis of chiropractic intervention is to eliminate vertebral subluxations/vertebral subluxation complexes. A large number of respondents (55.2%) were not in favor of expanding the scope of the chiropractic profession to include prescribing medications with appropriate advanced training. Most respondents estimated that chiropractors should be considered mainstream health care practitioners (69.1%). About half of all respondents (46.8%) felt that chiropractic research should focus on the physiological mechanisms of chiropractic adjustments.
The authors of this paper concluded that the chiropractic students in this study showed a preference for participating in mainstream health care, report an exposure to evidence-based practice, and desire to hold to traditional chiropractic theories and practices. The majority of students would like to see an emphasis on correction of vertebral subluxation, while a larger percent found it is important to learn about evidence-based practice. These two key points may seem contradictory, suggesting cognitive dissonance. Or perhaps some students want to hold on to traditional theory (e.g., subluxation-centered practice) while recognizing the need for further research to fully explore these theories. Further research on this topic is needed.
What should we make of these findings? The answer clearly must be NOT A LOT.
- the response rate was dismal,
- the questionnaire was not validated
- there seems to be little critical evaluation or discussion of the findings.
If anything, these findings seem to suggest that chiropractors want to join evidence based medicine, but on their own terms and without giving up their bogus beliefs, concept and practices. They seem to want the cake and eat it, in other words. The almost inevitable result of such a development would be that real medicine becomes diluted with quackery.