Monthly Archives: May 2014
Manufacturers of homeopathic remedies are having a hard time, it seems. The following press release has just reached me, and I thought it might be worth sharing it with my readers:
Baden-Baden, Germany, May 23, 2014 – Heel Group today announced the cessation of its business activities in the United States and Canada on August 31, 2014.
In the USA and Canada, manufacturers of OTC homeopathic medicinal products have been confronted with accusations through class action lawsuits. Heel Inc., the Heel Group’s U.S.-based subsidiary, was also faced with two such attempts recently. Both cases have been settled without conceding the allegations. The financial burden on Heel Inc., however, was substantial.
In a subsequent risk-benefit analysis of its global activities, the Heel Group decided to focus on strengthening its excellent position in South America, Central Europe and Eastern Europe and to withdraw from business activities in the USA and Canada for the time being.
Heel’s operations in both the USA and Canada will accordingly be discontinued as of August 31, 2014.
In the USA, negotiations with MediNatura Inc., a Delaware Corporation, are close to completion by which the Heel Group will transfer its stock in Heel Inc., to MediNatura by the end of August 2014. The transaction does, however, not include any of Heel’s trusted and leading global brands such as Traumeel, Neurexan, Zeel, Oculoheel, Luffeel, Sinusin, Vinceel, Nectadyn, Adrisin, Gripp-Heel, Viburcol, Vertigoheel, Spascupreel, Engystol, and Lymphomyosot*. Completion of the acquisition is subject to standard closing procedures.
As a trailblazer and leader in the field of scientific research into natural healthcare and a leading manufacturer of homeopathic medicines, the Heel Group will continue to invest in research and development on a global scale, also involving the medical-scientific community in North America.
Ralph Schmidt, CEO of the Heel Group: “As a global player, we are continuously reviewing our portfolio. This means that we are sometimes required to focus on specific regions at the expense of others in order to efficiently carry out our ambitious expansion plans. I would not exclude the possibility of re-entering the markets in the USA and Canada with a new business concept.”
It is somewhat sobering from my point of view to realise that all the science proving that homeopathy had no health effects beyond placebo had little effect on the market for homeopathic remedies. If anything, the sales figures seemed to get better and better as the evidence got more and more negative during the last decades. The ‘globulisation’ of the world seemed imminent due to those homeopathic manufacturers who wanted to become ‘global players’ (is there not a homeopathic remedy against megalomania?). It was only the legal actions that seemed to have an effect. The multiple North American class actions were more effective than the science, it seems.
Is there a lesson here? Perhaps! It could be that scientists working on their own are not always powerful enough to improve health care. Particularly when confronted with an alliance of evangelic belief and commercial interests, scientists, sceptics, journalists, lawyers, politicians and other professions might have to co-operate to bring about meaningful change.
Auricular acupuncture (AA), according to the ‘COLLEGE OF AURICULAR ACUPUNCTURE’, has its origins in Modern Europe. In 1957 Dr. Paul Nogier, a neurologist from Lyons in France, observed a locum doctor treating sciatica by cauterizing an area of the ear. This prompted extensive research culminating in the development of the somatopic correspondence of specific parts of the body to the ear based upon the concept of an inverted foetus. Dr. Nogier believed that pain and other symptoms in the body could be alleviated by needling, massaging or electronically stimulating the corresponding region of the ear. Auricular Acupuncture is a specialized complementary therapy where acupuncture points on the outer ear are treated, using either needles or acupunctoscopes (electrical location and stimulation machines) to help relieve many chronic complaints. There are over 200 acupuncture points on the ear, each point named after an area of our anatomy. The outer ear acts like a switchboard to the brain. Each acupuncture point being treated, triggers electrical impulses from the ear via the brain, to the specific part of the body being treated.
Sounds odd? Well, that’s because it is odd!
But just because something is odd does not mean it is ineffective – so, what does the reliable evidence tell us? Here are some conclusions from systematic reviews:
The evidence that auricular acupuncture reduces postoperative pain is promising but not compelling.
The evidence for the effectiveness of AA for the symptomatic treatment of insomnia is limited.
The benefit of ear-acupressure for symptomatic relief of allergic rhinitis is unknown…
All of these analyses point out that the quality of the studies is usually very poor, and stress that more and better research is required. It is therefore interesting to note that a new study has just been published. Perhaps it could settle the question about the effectiveness of AA?
The aim of this study was 1) to evaluate whether auricular acupuncture effective for reducing health care provider stress and anxiety and 2) to determine, if auricular acupuncture impacts provider capacity for developing caring relationships with patients. Pre-intervention and post-intervention surveys were evaluated to see, if auricular acupuncture was associated with changes in State-Trait Anxiety Inventory (STAI), Professional Quality of Life, and Caring Ability Inventory scores. The results indicate that, compared with baseline, participants had a significant reduction in state anxiety (STAI), trait anxiety (STAI), burnout, and secondary traumatic stress scores (Professional Quality of Life). Significant increases were noted in courage and patience, two dimensions of the Caring Ability Inventory.
From these findings, the authors conclude that auricular acupuncture is an effective intervention for the relief of stress/anxiety in providers and supports heightened capacity for caring.
Sounds odd again? Yes, because it is odd!
I would argue that a study of any controversial therapy that has already been tested repeatedly in poor quality trials must have sufficient scientific rigor to advance the field of inquiry. If it does not fulfil this criterion, it is quite simply not ethical. The new study does not even have a control group; we can therefore not begin to tell whether the observed outcomes were due to non-specific effects, the natural history of the condition or regression towards the mean (to mention but a few of the possible sources of bias). To conclude that AA is ‘an effective intervention’ is therefore utterly barmy.
All of this could be entirely trivial and inconsequential. I am afraid, however, that it is not. Alternative medicine is littered with such unethically flawed research conducted by naïve and clueless pseudo-scientists who arrive at outrageous conclusions. This relentless flow of false-positive findings misleads consumers, health care professionals, decision makers and everyone else to draw the wrong conclusions about bogus therapies. And, in the end, this sort of thing even does a grave disfavour to any branch of alternative medicine that might have some degree of respectability.
IT IS HIGH TIME THAT THIS NONSENSE STOPS! IT BORDERS ON SCIENTIFIC MISCONDUCT.
One alternative therapy that I have so far neglected on this blog is the Alexander Technique (AT). Actually, it was not really meant to become an alternative therapy when it was first discovered.
F.M. Alexander (1869-1955), an Australian actor, often experienced chronic laryngitis while performing. As his doctors could not help him, he developed a solution on his own. He found that excess muscular tension in his neck and body were causing his problems, and began to experiment on new ways to speak and move with greater ease. His health improved to such an extent that he decided to teach others what he had learned. Over a career span of more than fifty years, he refined his methods. After teaching for over 35 years, he began to train teachers of the ‘Alexander Technique’.
As used in alternative medicine, AT is an educational method aimed at increased sensory awareness and kinesthetic control to modify postural and movement patterns which might be associated with musculoskeletal problems. Proponents claim AT works for a range of conditions, including:
It has been suggested that AT is effective for chronic low back pain; however, so far only one recent study has determined its effects on chronic non-specific neck pain.
In this randomized controlled trial, patients were randomly allocated to either 5 weekly sessions of AT, heat pack application (HEAT) or guided imagery (GI). The primary outcome measure was the neck pain intensity on a 100-mm visual analogue scale at week 5. Secondary outcomes included neck disability, quality of life, satisfaction and adverse effects. Analyses of covariance were applied on an intention-to-treat population testing ordered hypotheses AT vs. HEAT and AT vs. GI.
A total of 72 patients were included, and 52 of them received all 5 interventions. No significant group difference was found for neck pain intensity when AT was compared to HEAT. However, an exploratory analysis revealed superiority of AT over GI. Significant group differences were also found for physical quality of life in favor of AT vs. HEAT or GI. Adverse events mainly related to slightly increased pain and muscle soreness. AT patients reported increased body awareness and control over the body, relaxing or stimulating effects and mood changes after the sessions.
The authors conclude that 5 sessions of AT were no better than a heat pack application for relieving chronic non-specific neck pain. Therefore it cannot be recommended as routine intervention at this time. Since exploratory analysis revealed some improvements of AT further trials are warranted for conclusive judgment.
One of the most irritating things with alternative medicine research, in my view, is the phenomenon that researchers tend to be quasi-religious advocates of the treatment they investigate. This seems to compel them all too often to extrapolate beyond reason and to drawing conclusions which are way too optimistic, frequently to an extend that borders on scientific misconduct. It is therefore a real pleasure to find an article that does not fall into this trap. I commend the authors for reporting this RCT and for their wisdom of being adequately cautious when formulating their conclusions.
I only wished it would happen more often!
Boiron is the world’s biggest producer of homeopathic remedies. It also is a firm that is relatively active in research into homeopathy. Here is one of their investigations which I find most remarkable.
This study was designed to describe the sociodemographic and clinical characteristics of patients recommended allopathic and/or homeopathic medicines for influenza-like illness (ILI) or ear nose and throat ENT disorders by pharmacists in France and to investigate the effectiveness of these treatments.
The introduction of the article includes interesting information; it informs us that, although homeopathy is more popular in Europe than in the Unites States, sales of homeopathic medicines in the United States grew by more than 1,000% in the late 1970s and early 1980s and continue to grow. In parallel, the number of physicians specializing in homeopathy doubled between 1980 and 1982. In 2003, sales of homeopathic medicines in the United States were estimated to be between $300 and $450 million, with an average growth rate of approximately 8% per year. Homeopathic drugs are among the top 10 nonprescription products sold in the category of analgesics to treat coughs, colds, and flu. The sale of homeopathic medicines in the United States is controlled by the Food, Drug, and Cosmetic Act and regulations issued by the U.S Food and Drug Administration (FDA). Homeopathic medicines in the United States are subject to well-controlled regulatory processes that closely resemble those used for allopathic medicines. FDA regulations for the sale of homeopathic medicines in the United States state that they can only be sold without prescription if they are for self-limiting conditions such as the common cold…
Am I mistaken, or does that paragraph read a bit like a text written by the marketing team of Boiron wanting to establish their products in the US?
Anyway, the methodology and results of the study are described in the abstract as follows:
A prospective, observational, multicenter study was carried out in randomly selected pharmacies across the 8 IDREM medical regions of France. Pharmacies that agreed to participate recruited male or female patients who responded to the following inclusion criteria: age ≥ 12 years presenting with the first symptoms of an ILI or ENT disorder that were present for less than 36 hours prior to the pharmacy visit. All medicines recorded in the study were recommended by the pharmacists. The following data were recorded at inclusion and after 3 days of treatment: the intensity of 13 symptoms, global symptom score, and disease impact on daily activities and sleep. Two groups of patients were compared: those recommended allopathic medicine only (AT group) and those recommended homeopathic medicine with or without allopathic medicine (HAT group). The number and severity of symptoms, change in global symptom score, and disease impact on daily activities and sleep were compared in the 2 treatment groups after 3 days of treatment. Independent predictors of recommendations for homeopathic medicine were identified by multi- factorial logistic regression analysis.
A total of 242 pharmacies out of 4,809 (5.0%) contacted agreed to participate in the study, and 133 (2.8%) included at least 1 patient; 573 patients were analyzed (mean age: 42.5 ± 16.2 years; 61.9% female). Of these, 428 received allopathic medicines only (74.7%; AT group), and 145 (25.3%) received homeopathic medicines (HAT group) alone (9/145, 1.6%) or associated with allopathy (136/145, 23.7%). At inclusion, HAT patients were significantly younger (39.6 ± 14.8 vs. 43.4 ± 16.1 years; P less than 0.05), had a higher mean number of symptoms (5.2 ± 2.5 vs. 4.4 ± 2.5; P less than 0.01), and more severe symptoms (mean global symptom score: 24.3 ± 5.5 vs. 22.3 ± 5.8; P = 0.0019) than AT patients. After 3 days, the improvement in symptoms and disease impact on daily activities and sleep was comparable in both groups of patients.
From these findings, the authors draw the following conclusions: Patients recommended homeopathic medicine by pharmacists were younger and had more severe symptoms than those recommended allopathic medicine. After 3 days of treatment, clinical improvement was comparable in both treatment groups. Pharmacists have an important role to play in the effective management of ILI and ENT disorders.
And, to make perfectly clear what all this is about, the first sentence of the ‘discussion’ puts it to the point by stating that homeopathic medicine, with or without allopathic medicine, appears to be effective at alleviating the symptoms of ILI or ENT disorders.
Oh really?
As I have heard it said that Boiron seems to have the nasty habit of threatening their critics with legal action, I ought to be quite cautious in my assessment of this ‘masterpiece of promotion’. Yet a few comments must surely be permitted.
‘To describe the sociodemographic and clinical characteristics of patients recommended allopathic and/or homeopathic medicines’ is not what I personally find an interesting subject of research, nor is it anything that will affect health care meaningfully, I think. Yet ‘to investigate the effectiveness of these treatments’ is certainly interesting and important. I will therefore focus on this second aim of the study.
Hold on, was this really a ‘study’? On closer inspection, it seemed much more like a survey. People who felt that they were suffering from ILI and ENT disorders and thus went to a pharmacy to buy something for their problem were offered either homeopathic or conventional medicines. Those who accepted either of the recommendations were asked to fill out some self-assessment forms and received a phone call three days later to check their symptoms. 94% of all patients in the homeopathy group took homeopathic medicine in combination with ‘allopathic’ medicine (it is interesting, perhaps even telling, that this term used by the authors was invented by Hahnemann as an insult to conventional medicine!). There was no examination by a doctor to verify what condition the survey-participants were truly suffering from, and there was no verification that the information provided during the follow-up telephone call was in any way real. The most frequently recommended homeopathic medicine was Anas barbariae 200C (Oscillococcinum) which is Boiron’s famous homeopathically diluted (about one molecule per universe, I guess) duck-liver heavily promoted in France against colds and similar conditions.
As it turns out, those survey-participants who accepted the homeopathic recommendation were significantly younger than those who accepted the recommendation for a conventional treatment (many surveys confirm that younger people are more prone to trying alternative medicine than older ones). It stands to reason, that the younger (and therefore fitter) patients were in better general health and therefore might recover quicker than the older ones. But, in fact, they did not!
Could this be due to the homeopathic remedies actually delaying recovery? Of course not! Who would be silly enough to claim that homeopathy could have this (or any other) effect? According to the authors, it is due to the fact that this group ‘had more severe symptoms than those recommended allopathic medicine’. But, as I said, we have to take their word for it; there is no independent verification of this. It would, of course, be quite ridiculous to postulate that those survey-participants accepting homeopathy were also a little more introspective or concerned about their own health (perhaps even more gullible) and thus claimed more severe symptoms!
And what about the authors’ conclusion that clinical improvement was comparable in both treatment groups? Well, this is more than a little problematic, in my view: first, we have no independent verification of the ‘improvement’ in either group. Second, we don’t know that the conventional treatments actually worked, and it could well be that both approaches were similarly ineffective, and that the observed outcomes are merely a reflection of the natural history of the condition. And third, one might expect the homeopathic (younger) group to do not similarly well but slightly better, simply because the natural history of the illness would tend to be more benign in younger people.
Before I finish,I should make a brief comment about the authors’ courageous statement that homeopathic medicine, with or without allopathic medicine, appears to be effective at alleviating the symptoms of ILI or ENT disorders. I think, for the reasons I already provided, this is extremely doubtful. In my view, more critical scientists would have phrased the conclusions differently:
THIS SURVEY SHOWS THAT EVALUATING THE EFFECTIVENESS OF MEDICAL INTERVENTIONS REQUIRES A MORE RIGOROUS METHODOLOGY THAN THAT OF A SURVEY.
But perhaps this would be asking a little too much of the authors; after all, at the end of the article, we find this telling footnote: Laboratoires Boiron provided financial support for the study. Cognet-Dementhon, Thevenard, Duru, and Allaert received consulting fees from Laboratoires Boiron for this study. Danno and Bordet are employees of Laboratoires Boiron.
Yoga, it is often claimed, might be a unique method for disease prevention. One website, for instance, states that numerous studies show how yoga can help prevent these diseases: Heart disease, Alzheimer’s, Osteoporosis and Type II Diabetes.
Cardiovascular diseases (CVD) are responsible for more deaths than any other disease category. Preventing CVD is therefore of prime importance. But are the claims made for yoga really true? What does the reliable evidence tell us?
The aim of our systematic review was to determine the effects of yoga on the primary prevention of CVD. Extensive literature searches were performed to identify all RCTs lasting at least three months, involving healthy adults or people at high risk of CVD. Trials examined any type of yoga and the comparison groups received no intervention or minimal interventions. Outcomes of interest were clinical CVD events and major CVD risk factors. Trials that involved multifactorial lifestyle interventions or weight loss programmes were excluded.
We identified 11 RCTs with a total of just 800 participants. Style and duration of yoga differed between trials. About half of all the trial participants were at high risk of CVD. Most of the studies were at risk of performance bias, with inadequate details reported in many of them to judge the risk of selection bias. None of the studies reported cardiovascular mortality, all-cause mortality or non-fatal events, and most studies were small and short-term.
Yoga was found to produce an average reduction in diastolic blood pressure of 2.90 mmHg. The effect that was small but stable on sensitivity analysis. Triglycerides (-0.27 mmol/l) and high-density lipoprotein (HDL) cholesterol (0.08 mmol/l) were also positively affected. However, these findings were based on small, short-term studies at unclear or high risk of bias. There was no clear evidence of an effect on low-density lipoprotein (LDL) cholesterol. Adverse events, occurrence of type 2 diabetes and costs were not reported in any of the included studies. Quality of life was measured in three trials but the results were inconclusive.
Our conclusion: The limited evidence comes from small, short-term, low-quality studies. There is some evidence that yoga has favourable effects on diastolic blood pressure, HDL cholesterol and triglycerides, and uncertain effects on LDL cholesterol. These results should be considered as exploratory and interpreted with caution.
This systematic review thus offers both good and bad news. The good news is that yoga seems to hold some promise in the prevention of CVD. The bad news, however, is diverse:
- We cannot be sure what type of yoga is best; yoga can entail anything from regular exercise, to breathing techniques, to a complete and comprehensive change of life style.
- The effect sizes are far from remarkable.
- The quality of the research tends to be poor.
- Once again, we have to note that, by not reporting on adverse effects, alt med researchers are violating fundamental research ethics.
Many systematic reviews conclude by stating that more and better research is required – in the case of yoga, this platitude might actually be true.
The question whether infant colic can be effectively treated with manipulative therapies might seem rather trivial – after all, this is a benign condition which the infant quickly grows out of. However, the issue becomes a little more tricky, if we consider that it was one of the 6 paediatric illnesses which were at the centre of the famous libel case of the BCA against my friend and co-author Simon Singh. At the time, Simon had claimed that there was ‘not a jot of evidence’ for claiming that chiropractic was an effective treatment of infant colic, and my systematic review of the evidence strongly supported his statement. The BCA eventually lost their libel case and with it the reputation of chiropractic. Now a new article on this intriguing topic has become available; do we have to reverse our judgements?
The aim of this new systematic review was to evaluate the efficacy or effectiveness of manipulative therapies for infantile colic. Six RCTs of chiropractic, osteopathy or cranial osteopathy alone or in conjunction with other interventions were included with a total of 325 infants. Of the 6 included studies, 5 were “suggestive of a beneficial effect” and one found no evidence of benefit. Combining all the RCTs suggested that manipulative therapies had a significant effect. The average crying time was reduced by an average of 72 minutes per day. This effect was sustained for studies with a low risk of selection bias and attrition bias. When analysing only those studies with a low risk of performance bias (i.e. parental blinding) the improvement in daily crying hours was no longer statistically significant.
The quality of the studies was variable. There was a generally low risk of selection bias but a high risk of performance bias. Only one of the studies recorded adverse events and none were encountered.
From these data, the authors drew the following conclusion: Parents of infants receiving manipulative therapies reported fewer hours crying per day than parents whose infants did not and this difference was statistically significant. Most studies had a high risk of performance bias due to the fact that the assessors (parents) were not blind to who had received the intervention. When combining only those trials with a low risk of such performance bias the results did not reach statistical significance.
Does that mean that chiropractic does work for infant colic? No, it does not!
The first thing to point out is that the new systematic review included not just RCTs of chiropractic but also osteopathy and cranio-sacral therapy.
The second important issue is that the effects disappear, once performance bias is being accounted for which clearly shows that the result is false positive.
The third relevant fact is that the majority of the RCTs were of poor quality. The methodologically best studies were negative.
And the fourth thing to note is that only one study mentioned adverse effects, which means that the other 5 trials were in breach of one of rather elementary research ethics.
What makes all of this even more fascinating is the fact that the senior author of the new publication, George Lewith, is the very expert who advised the BCA in their libel case against Simon Singh. He seems so fond of his work that he even decided to re-publish it using even more misleading language than before. It is, of course, far from me to suggest that his review was an attempt to white-wash the issue of chiropractic ‘bogus’ claims. However, based on the available evidence, I would have formulated conclusions which are more than just a little different from his; something like this perhaps:
The current best evidence suggests that the small effects that emerge when we pool the data from mostly unreliable studies are due to bias and therefore not real. This systematic review therefore fails to show that manipulative therapies are effective. It furthermore points to a serious breach of research ethics by the majority of researchers in this field.
A new book is currently being promoted. It specifically targets cancer patients and misleads them into thinking that alternative therapies offer hope for this vulnerable group of patients. Here is what the press release says:
Endeavoring to provide the 1.2 million Americans diagnosed with cancer annually with alternative treatments co-authors Johanna C. Schipper and Frank J. Vanderlugt announce the launch of “The Natural Cancer Handbook”. The useful book explores how more than fifty alternative treatments work, their price, and where they can be obtained…. Contributing to the war on cancer with a bevy of scientific and anecdotal evidence to support the effectiveness of the treatments the handbook is a respite from the mixed messages patients often endure.
With more than fifty of the most effective alternative cancer treatments listed The Natural Cancer Handbook is the work of two years of research. Used successfully over the last century, the remedies found in the handbook are significantly cheaper than standard cancer treatments and in most cases can be used alongside them.
…The handbook discusses the successful alternative treatments Budwig Diet, Beta 1, 3D Glucan, and the readily available green food supplements such as barley grass, chlorella and spirulina. The Natural Cancer Handbook also explores the benefits of Melatonin, Noni, Resveratrol and the Canadian Resonant Light and the Hulda Clark generators.
…Vanderlugt is a Chartered Accountant with a Bachelor of Science in Biology and Schipper has researched cancer extensively and has five years training in medicine.
Let’s just take the first treatment mentioned above; this is what a reliable source like CANCER RESEARCH UK have to say about it:
The Budwig diet was developed by a German biochemist called Johanna Budwig in the 1950s. It involves eating flaxseed mixed with cottage cheese or milk. Flax is a plant grown in many parts of the world. Pressing its seeds produces linseed oil to use in cooking or as a food supplement. The seeds contain high levels of fibre and many vitamins and minerals. You grind the flaxseed, usually in a coffee grinder. As well as flaxseed and cottage cheese, the Budwig diet is rich in fruit, vegetables and fibre. You also have to avoid sugar, meat, and fats such as butter, margarine and salad oil.
There is no reliable scientific evidence to show that the Budwig diet (or any highly specific diet) helps people with cancer. It is important to make sure that you have a well balanced diet when you are ill, especially if you are undernourished. We know from research that a healthy, well balanced diet can reduce the risk of cancer. You can find information about diet, healthy eating and cancer on our News and Resources website.
This is a polite way of telling us that diets such as this one is not balanced and not what cancer patients need; in fact, such diets are not just ineffective, they can be dangerous to cancer patients.
Texts like the Natural Cancer Handbook tend to make me quite angry. I find it deeply immoral to mislead cancer patients in this way, simply to make a profit. The truth could not be simpler: There is and never will be such a thing as an alternative cancer ‘cure’.
The concept assumes that there exists an effective cure which is being suppressed only because it originates from alternative medicine circles. But this assumption is idiotic. As soon as a treatment shows promise, it will be picked up by the scientific and oncologic communities and researched until its therapeutic value is known. At the end of this process, we might have a new option to treat cancer effectively. Many examples exist where a new drug was developed from a plant; taxol is but one of many examples.
Those who deny these simple facts in order to make a fast buck from the desperation of some of the most vulnerable patients are, in my view, charlatans of the worst kind.
Imagine an area of therapeutics where 100% of all findings of hypothesis-testing research is positive, i.e. comes to the conclusion that the treatment in question is effective. Theoretically, this could mean that the therapy is a miracle cure which is useful for every single condition in every single setting. But sadly, there are no miracle cures. Therefore something must be badly and worryingly amiss with the research in an area that generates 100% positive results.
Acupuncture is such an area; we and others have shown that Chinese trials of acupuncture hardly ever produce a negative finding. In other words, one does not need to read the paper, one already knows that it is positive – even more extreme: one does not need to conduct the study, one already knows the result before the research has started. But you might not believe my research nor that of others. We might be chauvinist bastards who want to discredit Chinese science. In this case, you might perhaps believe Chinese researchers.
In this systematic review, all randomized controlled trials (RCTs) of acupuncture published in Chinese journals were identified by a team of Chinese scientists. A total of 840 RCTs were found, including 727 RCTs comparing acupuncture with conventional treatment, 51 RCTs with no treatment controls, and 62 RCTs with sham-acupuncture controls. Among theses 840 RCTs, 838 studies (99.8%) reported positive results from primary outcomes and two trials (0.2%) reported negative results. The percentages of RCTs concealment of the information on withdraws or sample size calculations were 43.7%, 5.9%, 4.9%, 9.9%, and 1.7% respectively.
The authors concluded that publication bias might be major issue in RCTs on acupuncture published in Chinese journals reported, which is related to high risk of bias. We suggest that all trials should be prospectively registered in international trial registry in future.
I applaud the authors’ courageous efforts to conduct this analysis, but I do not agree with their conclusion. The question why all Chinese acupuncture trials are positive has puzzled me since many years, and I have quizzed numerous Chinese colleagues why this might be so. The answer I received was uniformly that it would be very offensive for Chinese researchers to conceive a study that does not confirm the views held by their peers. In other words, acupuncture research in China is conducted to confirm the prior assumption that this treatment is effective. It seems obvious that this is an abuse of science which must cause confusion.
Whatever the reasons for the phenomenon, and we can only speculate about them, the fact has been independently confirmed several times and is now quite undeniable: acupuncture trials from China – and these constitute the majority of the evidence-base in this area – cannot be trusted. The only way to adequately deal with this problem that I can think of is to discard them outright.
The fact that practitioners of alternative medicine frequently advise their patients against immunising their children has been documented repeatedly. In particular, doctors of anthroposophy, chiropractors and homeopaths are implicated in thus endangering public health. Less is known about naturopaths attitude in this respect. Now new data have emerged which confirm some of our worst fears.
This survey aimed at assessing the attitudes, education, and sources of knowledge surrounding childhood vaccinations of 560 students at National College of Natural Medicine in Portland, US. Students were asked about demographics, sources of information about childhood vaccines, differences between mainstream and CAM education on childhood vaccines, alternative vaccine schedules, adverse effects, perceived efficacy, and credibility of information sources.
A total of 109 students provided responses (19.4% response rate). All students surveyed learned about vaccinations in multiple courses and through independent study. The information sources employed had varying levels of credibility. Only 26% of the responding students planned on regularly prescribing or recommending vaccinations for their patients; 82% supported the general concept of vaccinations for prevention of infectious diseases.
The vast majority (96%) of those who might recommend vaccinations reported that they would only recommend a schedule that differed from the standard CDC-ACIP schedule.
Many respondents were concerned about vaccines being given too early (73%), too many vaccines administered simultaneously (70%), too many vaccines overall (59%), and about preservatives and adjuvants in vaccines (72%). About 40% believed that a healthy diet and lifestyle was more important for prevention of infectious diseases than vaccines. 90% admitted that they were more critical of vaccines than mainstream pediatricians, medical doctors, and medical students.
These results speak for themselves and leave me (almost) speechless. The response rate was truly dismal, and it is fair to assume that the non-responding students held even more offensive views on vaccination than their responding colleagues. The findings seem to indicate that naturopaths are systematically trained to become anti-vaxers who believe that their naturopathic treatments offer better protection than vaccines. They are thus depriving many of their patients of arguably the most successful means of disease prevention that exists today. To put it bluntly: naturopaths seem to be brain-washed into becoming a danger to public health.
Today, there are several dozens of journals publishing articles on alternative medicine. ‘The Journal of Alternative and Complementary Medicine’ is one of the best known, and it has one of the highest impact factors of them all. The current issue holds a few ‘gems’ which might be worthy of a comment or two. Here I have selected three articles reporting clinical studies, and I reproduce their abstracts (almost) in full (in italics) and add my comments (for clarity in bold). All the articles are available electronically, and I have provided the links for those who want to investigate beyond the abstracts.
STUDY No 1
The first ‘pilot study‘ was aimed to demonstrate the potential of auricular acupuncture (AAT) for insomnia in maintenance haemodialysis (MHD) patients and to prepare for a future randomized controlled trial.
Eligible patients were enrolled into this descriptive pilot study and received AAT designed to manage insomnia for 4 weeks. Questionnaires that used the Pittsburgh sleep quality index (PSQI) were completed at baseline, after a 4-week intervention, and 1 month after completion of treatment. Sleep quality and other clinical characteristics, including sleeping pills taken, were statistically compared between different time points.
A total of 22 patients were selected as eligible participants and completed the treatment and questionnaires. The mean global PSQI score was significantly decreased after AAT intervention (p<0.05). Participants reported improved sleep quality (p<0.01), shorter sleep latency (p<0.05), less sleep disturbance (p<0.01), and less daytime dysfunction (p=0.01). They also exhibited less dependency on sleep medications, indicated by the reduction in weekly estazolam consumption from 6.98±4.44 pills to 4.23±2.66 pills (p<0.01). However, these improvements were not preserved 1 month after treatment.
Conclusions: In this single-center pilot study, complementary AAT for MHD patients with severe insomnia was feasible and well tolerated and showed encouraging results for sleep quality.
My comments:
In alternative medicine research, it has become far too common (almost generally accepted) to call a flimsy trial a ‘pilot study’. The authors give their game away by stating that, by conducting this trial, they want to ‘demonstrate the potential of AAT’. This is not a legitimate aim of research; science is for TESTING hypotheses, not for PROVING them!
The results of this trial show that patients experienced improvements after receiving AAT which, however, did not last. As there was no placebo control group, the most likely explanation for these outcomes would be that AAT generated a short-lasting placebo effect.
A sample size of 22 is, of course, far to small to allow any conclusions about the safety of the intervention. Despite these obvious facts, the authors seem convinced that AAT is both safe and effective.
STUDY No 2
The aim of the second study was to compare the therapeutic effect of Yamamoto new scalp acupuncture (YNSA), a recently developed microcupuncture system, with traditional acupuncture (TCA) for the prophylaxis and treatment of migraine headache.
In a randomized clinical trial, 80 patients with migraine headache were assigned to receive YNSA or TCA. A pain visual analogue scale (VAS) and migraine therapy assessment questionnaire (MTAQ) were completed before treatment, after 6 and 18 sections of treatment, and 1 month after completion of therapy.
All the recruited patients completed the study. Baseline characteristics were similar between the two groups. Frequency and severity of migraine attacks, nausea, the need for rescue treatment, and work absence rate decreased similarly in both groups. Recovery from headache and ability to continue daily activities 2 hours after medical treatment showed similar improvement in both groups (p>0.05).
Conclusions: Classic acupuncture and YNSA are similarly effective in the prophylaxis and treatment of migraine headache and may be considered as alternatives to pharmacotherapy.
My comments:
This is what is technically called an ‘equivalence trial’, i.e. a study that compares an experimental treatment (YNSA) to one that is (assumed to be) effective. To demonstrate equivalence, such trials need to have large sample sizes, and this study is woefully underpowered. As it stands, the results show nothing meaningful at all; if anything, they suggest that both interventions were similarly useless.
STUDY No 3
The third study determined whether injection with hypertonic dextrose and morrhuate sodium (prolotherapy) using a pragmatic, clinically determined injection schedule for knee osteoarthritis (KOA) results in improved knee pain, function, and stiffness compared to baseline status.
The participants were 38 adults who had at least 3 months of symptomatic KOA and who were in the control groups of a prior prolotherapy randomized controlled trial (RCT) (Prior-Control), were ineligible for the RCT (Prior-Ineligible), or were eligible but declined the RCT (Prior-Declined).
The injection sessions at occurred at 1, 5, and 9 weeks with as-needed treatment at weeks 13 and 17. Extra-articular injections of 15% dextrose and 5% morrhuate sodium were done at peri-articular tendon and ligament insertions. A single intra-articular injection of 6 mL 25% dextrose was performed through an inferomedial approach.
The primary outcome measure was the validated Western Ontario McMaster University Osteoarthritis Index (WOMAC). The secondary outcome measure was the Knee Pain Scale and postprocedure opioid medication use and participant satisfaction.
The Prior-Declined group reported the most severe baseline WOMAC score (p=0.02). Compared to baseline status, participants in the Prior-Control group reported a score change of 12.4±3.5 points (19.5%, p=0.002). Prior-Decline and Prior-Ineligible groups improved by 19.4±7.0 (42.9%, p=0.05) and 17.8±3.9 (28.4%, p=0.008) points, respectively; 55.6% of Prior-Control, 75% of Prior-Decline, and 50% of Prior-Ineligible participants reported score improvement in excess of the 12-point minimal clinical important difference on the WOMAC measure. Postprocedure opioid medication resulted in rapid diminution of prolotherapy injection pain. Satisfaction was high and there were no adverse events.
Conclusions: Prolotherapy using dextrose and morrhuate sodium injections for participants with mild-to-severe KOA resulted in safe, significant, sustained improvement of WOMAC-based knee pain, function, and stiffness scores compared to baseline status.
My Comments:
This study had nothing that one might call a proper control group: all the three groups mentioned were treated with the experimental treatment. No attempt was made to control for even the most obvious biases: the observed effects could have been due to placebo or any other non-specific effects. The authors conclusions imply a causal relationship between the treatment and the outcome which is wrong. The notion that the experimental treatment is ‘safe’ is based on just 38 patients and therefore not reasonable.
IMPLICATION
All of this might seem rather trivial, and my comments could be viewed as a deliberate and vicious attempt to discredit one of the most respected journals of alternative medicine. Yet, considering that articles of this nature are more the rule than the exception in alternative medicine, I do think that this flagrant lack of scientific rigour is a relevant issue and has important implications.
As long as research in this area continues to be deeply flawed, as long as reviewers turn a blind eye to (or are not smart enough to detect) even the most obvious mistakes, as long as journal editors accept any rubbish in order to fill their pages, there is a great danger that we are being continuously being mislead about the supposed therapeutic value of alternative therapies.
Many who read this blog will, of course, have the capacity to think critically and might therefore not fall into the trap of accepting the conclusions of fatally flawed research. But many other people, including politicians, journalists and consumers, might not have the necessary appraisal skills and will thus not be able to tell that such studies can serve only one purpose: to popularise bogus treatments and thereby render health care less effective and more dangerous. Enthusiasts of alternative medicine are usually fully convinced that such studies amount to evidence and ram this pseudo-information down the throat of health care decision makers – the effects of such lobbying on public health can be disastrous.
And there is another downside to the publication of such dismal drivel: assuming (as I do) that not all of alternative medicine is completely useless, such embarrassingly poor research will inevitably have detrimental effects on the discipline of alternative medicine. After being exposed to a seemingly endless stream of pseudo-research, critics will eventually give up taking any of it seriously and might claim that none of it is worth the bother. In other words, those who conduct, accept or publish such nonsensical papers are not only endangering medical progress in general, they are also harming the very cause they try so desperately hard to advance.
