scientific misconduct
On the website of the Bristol University Hospital, it was just revealed that UK homeopathy seems to have suffered another blow:
“Homeopathic medicine has been available in Bristol since 1852, when Dr Black first started dispensing from premises in the Triangle. During the next 69 years the service developed and expanded culminating in the commissioning in 1921 of a new hospital in the grounds of Cotham House. The Bristol Homeopathic Hospital continued to provide a full range of services until 1986 when the in-patient facilities were transferred to the Bristol Eye Hospital, where they continue to be provided, and outpatient services were moved to the ground floor of the Cotham Hill site. In 1994, following the sale of the main building to the University by the Bristol and District Health Authority, a new purpose built Department was provided in the Annexe buildings of the main building, adjoining the original Cotham House. The NHS Homeopathic Service is now being delivered on behalf of University Hospital Bristol by the Portland Centre for Integrative Medicine (PCIM), a Community Interest Company.”
The Portland Centre for Integrative Medicine has joined Litfield House offering medical homeopathy with Dr Elizabeth Thompson. And this is how the new service is described [I have added references in the following unabridged quote in bold which refer to my comments below]:
Medical Homeopathy is a holistic [1] approach delivered by registered health care professionals that uses a low dose of an activated [2] natural [3] substance [4] to stimulate a self-healing response in the body [5]. At the first appointment the doctor will take time to understand problem symptoms that might be physical, emotional or psychological and then a treatment plan will be discussed between the patient and the doctor [6], with homeopathic medicines chosen for you or your child on an individual basis.
WHAT CONDITIONS ARE SUITABLE FOR MEDICAL HOMEOPATHY?
Homeopathy can be safely [7] used to improve symptoms and well-being across a wide range of long term conditions: from childhood eczema [8] and ADHD [9]; to adults with medically unexplained conditions [10]; inflammatory bowel disease [11], cancer [12] or chronic fatigue syndrome [13]; and other medical conditions, including obesity [14] and depression [15]. Some people use homeopathy to stay well [16] and others use it to help difficult symptoms and/ or the side effects of conventional treatments [17].
This looks like a fairly bland and innocent little advertisement at first glance. If we analyse it closer, however, we find plenty of misleading claims. Here are the ones that caught my eye:
- Homeopaths claim that their approach is holistic and thus aim at differentiating it from conventional health care. This is misleading because ALL good medicine is by definition holistic.
- Nothing is ‘activated’; homeopaths believe that succession releases the ‘vital force’ in a remedy – but this is little more than hocus-pocus from the dark ages of medicine.
- Nothing is natural about endlessly diluting and shaking a medicine, while pretending that this ritual renders it more active and effective. And nothing is natural about remedies such as ‘Berlin Wall’.
- It is misleading to speak about ‘substance’ in relation to homeopathic remedies, because they can be manufactured also from non-material stuff too; examples are remedies such as X-ray, sol [sun light] or lunar [moonlight].
- The claim that homeopathic remedies stimulate the self-healing properties of the body is pure phantasy.
- “The doctor will take time to understand problem symptoms that might be physical, emotional or psychological and then a treatment plan will be discussed between the patient and the doctor” – this also applies to any consultation with any health care practitioner.
- Homeopathy is not as safe as homeopaths try to make us believe; several posts on this blog have dealt with this issue.
- There is no good evidence to support this claim.
- There is no good evidence to support this claim.
- There is no good evidence to support this claim.
- There is no good evidence to support this claim.
- There is no good evidence to support this claim.
- There is no good evidence to support this claim.
- There is no good evidence to support this claim.
- There is no good evidence to support this claim.
- True, some people use anything for anything; but there is no sound evidence to show that homeopathy is an effective prophylactic intervention for any disease.
- Nor is there good evidence that it is effective to “help difficult symptoms and/ or the side effects of conventional treatments”.
So, what we have here is a short paragraph which, on closer inspection, turns out to be full of misleading statements, bogus claims and dangerous lies. Not a good start for a new episode in the life of the now dramatically down-sized homeopathic clinic in Bristol, I’d say. And neither is it a publication of which the Bristol University Hospital can be proud. I suggest they correct it as a matter of urgency; otherwise they risk a barrage of complaints to the appropriate regulators by people who treasure the truth a little more than they seem to do themselves.
Recently an interesting article caught my eye. It was published in the official journal of the ‘Deutscher Zentralverein Homoeopathischer Aerzte’ (the professional body of German doctor homeopath which mostly acts as a lobby group). Unfortunately it is in German – but I will try to take you through what I believe to be the most important issue.
The article seems to have the aim to defame Natalie Grams, the homeopath who had the courage to change her mind about homeopathy and to even write a book about her transformation. This book impressed me so much that I wrote a post about it when it was first published. The book did, however, not impress her ex-colleagues. Consequently the book review by the German lobbyists is full of personal attacks and almost devoid of credible facts.
A central claim of the defamatory piece is that, contrary to what she claims in her book, homeopathy is supported by sound evidence. Here is the crucial quote: Meta-Analysen von Kleijnen (1991), Linde (1997), Cucherat (2000) und Mathie (2014) [liefern] allesamt positive Ergebnisse zur Wirksamkeit der Homöopathie… This translates as follows: meta-analyses of Kleijnen, Linde, Cucherat and Matie all provide positive results regarding the effectiveness of homeopathy. As this is a claim, we hear ad nauseam whenever we discuss the issue with homeopathy (in the UK, most homeopathic bodies and even the Queen’s homeopath, P Fisher, have issued very similar statements), it may be worth addressing it once and for all.
- CUCHERAT
This paper was the result of an EU-funded project in which I was involved as well; I therefore know about it first hand. The meta-analysis itself is quite odd in that it simply averages the p-values of all the included studies and thus provides a new overall p-value across all trials. As far as I know, this is not an accepted meta-analytic method and seems rather a lazy way of doing the job. The man on our EU committee was its senior author, professor Boissel, who did certainly not present it to us as a positive result for homeopathy (even Peter Fisher who also was a panel member should be able to confirm this). What is more, the published conclusions are not nearly as positive as out lobbyists seem to think: ‘There is some evidence that homeopathic treatments are more effective than placebo; however, the strength of this evidence is low because of the low methodological quality of the trials. Studies of high methodological quality were more likely to be negative than the lower quality studies. Further high quality studies are needed to confirm these results.’
- LINDE
The meta-analysis by Linde et al seems to be the flag-ship in the homeopathic fleet. For those who don’t know it, here is its abstract in full:
BACKGROUND: Homeopathy seems scientifically implausible, but has widespread use. We aimed to assess whether the clinical effect reported in randomised controlled trials of homeopathic remedies is equivalent to that reported for placebo.
METHODS: We sought studies from computerised bibliographies and contracts with researchers, institutions, manufacturers, individual collectors, homeopathic conference proceedings, and books. We included all languages. Double-blind and/or randomised placebo-controlled trials of clinical conditions were considered. Our review of 185 trials identified 119 that met the inclusion criteria. 89 had adequate data for meta-analysis, and two sets of trial were used to assess reproducibility. Two reviewers assessed study quality with two scales and extracted data for information on clinical condition, homeopathy type, dilution, “remedy”, population, and outcomes.
FINDINGS: The combined odds ratio for the 89 studies entered into the main meta-analysis was 2.45 (95% CI 2.05, 2.93) in favour of homeopathy. The odds ratio for the 26 good-quality studies was 1.66 (1.33, 2.08), and that corrected for publication bias was 1.78 (1.03, 3.10). Four studies on the effects of a single remedy on seasonal allergies had a pooled odds ratio for ocular symptoms at 4 weeks of 2.03 (1.51, 2.74). Five studies on postoperative ileus had a pooled mean effect-size-difference of -0.22 standard deviations (95% CI -0.36, -0.09) for flatus, and -0.18 SDs (-0.33, -0.03) for stool (both p < 0.05).
INTERPRETATION: The results of our meta-analysis are not compatible with the hypothesis that the clinical effects of homeopathy are completely due to placebo. However, we found insufficient evidence from these studies that homeopathy is clearly efficacious for any single clinical condition. Further research on homeopathy is warranted provided it is rigorous and systematic.
Again, the conclusions are not nearly as strongly in favour of homeopaths as the German lobby group assumes. Moreover, this paper has been extensively criticised for a wide range of reasons which I shall not have to repeat here. However, one point is often over-looked: this is not an assessment of RCTs, it is an analysis of studies which were double-blind and/or randomised and placebo-controlled. This means that it includes trials that were not randomised and studies that were not double-blind.
But this is just by the way. What seems much more important is the fact that, in response to the plethora of criticism to their article, the same authors published a re-analysis of exactly the same data-set two years later. Having considered the caveats and limitations more carefully, they now concluded that ‘in the study set investigated, there was clear evidence that studies with better methodological quality tended to yield less positive results.’
It is most intriguing to see how homeopaths cite their ‘flagship’ on virtually every possible occasion, while forgetting that a quasi correction has been published which puts the prior conclusions in a very different light !
- KLEIJNEN
The much-cited article by Kleijnen is now far too old to be truly relevant. It includes not even half of the trials available today. But, for what it’s worth, here are Kleijnen’s conclusions: At the moment the evidence of clinical trials is positive but not sufficient to draw definitive conclusions because most trials are of low methodological quality and because of the unknown role of publication bias. This indicates that there is a legitimate case for further evaluation of homoeopathy, but only by means of well performed trials.
If the homeopathy lobby today proclaims that this paper constitutes proof of efficacy, they are in my view deliberately misleading the public.
- MATHIE
The Mathie meta-analysis has been extensively discussed on this blog (see here and here). It is not an overall meta-analysis but merely evaluates the subset of those trials that employed individualised homeopathy. Crucially, it omits the two most rigorous studies which happen to be negative. Its conclusions are as follows: ‘Medicines prescribed in individualised homeopathy may have small, specific treatment effects. Findings are consistent with sub-group data available in a previous ‘global’ systematic review. The low or unclear overall quality of the evidence prompts caution in interpreting the findings. New high-quality RCT research is necessary to enable more decisive interpretation.’
Again, I would suggest that anyone who interprets this as stating that this provides ‘positive results regarding the effectiveness of homeopathy’ is not telling the truth.
MY CONCLUSIONS FROM ALL THIS:
- Some systematic reviews and meta-analyses do indeed suggest that the trial data are positive. However, they all caution that such a result might be false-positive.
- None of these papers provide anything near a proof for the effectiveness of homeopathy.
- Homeopathy has not been shown to be more than a placebo therapy.
- To issue statements to the contrary is dishonest.
If you start reading the literature on chiropractic, you are bound to have surprises. The paucity of rigorous and meaningful research is one of them. I am constantly on the look-out for such papers but am regularly frustrated. Over the years, I got the impression that chiropractors tend to view research as an exercise in promotion – that is promotion of their very own trade.
Take this article, for instance. It seems to be a systematic review of chiropractic for breastfeeding. This is an interesting indication; remember: in 1998, Simon Singh wrote in the Guardian this comment “The British Chiropractic Association claims that their members can help treat children with colic, sleeping and feeding problems, frequent ear infections, asthma and prolonged crying, even though there is not a jot of evidence. This organisation is the respectable face of the chiropractic profession and yet it happily promotes bogus treatments.” As a consequence, he got sued for libel; he won, of course, but ever since, chiropractors across the world are trying to pretend that there is some evidence for their treatments after all.
The authors of the new review searched Pubmed [1966-2013], Manual, Alternative and Natural Therapy Index System (MANTIS) [1964-2013] and Index to Chiropractic Literature [1984-2013] for the relevant literature. The search terms utilized “breastfeeding”, “breast feeding”, “breastfeeding difficulties”, “breastfeeding difficulty”, “TMJ dysfunction”, “temporomandibular joint”, “birth trauma” and “infants”, in the appropriate Boolean combinations. They also examined non-peer-reviewed articles as revealed by Index to Chiropractic Literature and conducted a secondary analysis of references. Inclusion criteria for their review included all papers on breastfeeding difficulties regardless of peer-review. Articles were excluded if they were not written in the English language.
The following articles met the inclusion criteria: 8 case reports, 2 case series, 3 cohort studies and 6 manuscripts (5 case reports and a case series) that involved breastfeeding difficulties as a secondary complaint. The findings revealed a “theoretical and clinical framework based on the detection of spinal and extraspinal subluxations involving the cervico-cranio-mandibular complex and assessment of the infant while breastfeeding.”
Based on these results, the authors concluded that chiropractors care of infants with breastfeeding difficulties by addressing spinal and extraspinal subluxations involving the cervico-cranio-mandibular complex.
Have I promised too much?
I had thought that chiropractors had abandoned the subluxation nonsense! Not really, it seems.
I had thought that systematic reviews are about evidence of therapeutic effectiveness! Not in the weird world of chiropractic.
I would have thought that we all knew that ‘chiropractors care of infants with breastfeeding difficulties’ and do not need a review to confirm it! Yes, but what is good for business deserves another meaningless paper.
I would have thought that the conclusions of scientific articles need to be appropriate and based on the data provided! It seems that, in the realm of chiropractic, these rules do not apply.
An appropriate conclusion should have stated something like THERE IS NO GOOD EVIDENCE THAT CHIROPRACTIC CARE AIDS BREASTFEEDING. But that would have been entirely inappropriate from the chiropractic point of view because it is not a conclusion that promotes the sort of quackery most chiropractors rely upon for a living. And the concern over income is surely more important than telling the truth!
On this blog, we have repeatedly discussed the risks of acupuncture. Contrary to what we often hear, there clearly is potential for harm. Acupuncture is, of course most popular in China where it has been used for thousands of years. Therefore the Chinese literature, which is not easy to access for non-Chinese speakers and therefore often disregarded by Western researchers, might hold treasures of valuable information on the subject. It follows that a thorough review of this information might be helpful. A recent paper by Chinese scientists has tackled this issue.
The objective of this review was to determine the frequency and severity of adverse complications and events in acupuncture treatment reported from 1980 to 2013 in China. All first-hand case reports of acupuncture-related complications and adverse events that could be identified in the scientific literature were reviewed and classified according to the type of complication and adverse event, circumstance of the event, and long-term patient outcome. The selected case reports were published between 1980 and 2013 in 3 databases. Relevant papers were collected and analyzed by 2 reviewers.
Over the 33 years, 182 incidents were identified in 133 relevant papers. Internal organ, tissue, or nerve injury is the main complications of acupuncture especially for pneumothorax and central nervous system injury. Adverse effects also included syncope, infections, hemorrhage, allergy, burn, aphonia, hysteria, cough, thirst, fever, somnolence, and broken needles.
The authors of this review concluded that qualifying training of acupuncturists should be systemized and the clinical acupuncture operations should be standardized in order to effectively prevent the occurrence of acupuncture accidents, enhance the influence of acupuncture, and further popularize acupuncture to the rest of the world.
This is a bizarrely disappointing article followed by a most strange conclusion. The authors totally fail to discuss the most important issue and they arrive at conclusions which, I think, make little sense.
The issue to discuss here is, of course, under-reporting. We know that under-reporting in the Western literature is already huge. For every complication reported there could easily be 10 or even 100 that go unreported. There is no monitoring system for adverse effects, and acupuncturists have no incentive to publish their mistakes. Accurate and realistic prevalence data are therefore anybody’s guess.
In China, under-reporting is likely to be one or two orders of magnitude bigger. I say this because close to zero % of all Chinese papers on acupuncture report negative findings. For China, TCM is a huge export business, and the interest in reporting adverse effects is close to zero.
Seen from this perspective, it seems at first glance laudable that the Chinese authors dared to address this thorny issue. In the text of the article, they even mention that the included complications resulted in a total of 25 fatalities! This seems courageous. But one only needs to read the full article to get a strong suspicion that the authors are either in denial about the real figures, or their paper is a deliberate attempt to ‘white-wash’ acupuncture from its potential to do harm.
In 2010, we published a very similar review of the Chinese literature (unsurprisingly, it was not cited by the authors of the new paper). At the time, we found almost 500 published cases of serious adverse events and stated that we suspect that underreporting of such events in the Chinese-language literature is much higher than in the English-language literature.
The truth is that nobody knows how frequent adverse events of acupuncture truly are in China – or most other countries, for that matter. I believe that, before we “further popularize acupuncture to the rest of the world”, it would be ethical and necessary to 1) state this fact openly and 2) do something about it.
Medical ethics comprise a set of rules and principles which are essential for all aspects of medicine, including of course research. The main issues are:
- Respect for autonomy – patients must have the right to refuse or choose their treatments.
- Beneficence – researchers and clinicians must act in the best interest of the patient.
- Non-maleficence – the expected benefits of interventions must outweigh their risks.
- Justice – the distribution of health resources must be fair.
- Respect for persons – patients must be treated with dignity.
- Truthfulness and honesty – informed consent is an essential element in research and clinical practice.
While all of this has long been fairly standard in conventional health care, it is often neglected in alternative medicine. It is therefore timely to ask, how much of research in the realm of alternative medicine abides by the rules of medical ethics?
After more than two decades of involvement in this sector, I have serious and growing concerns. The subject is, of course complex, but the way I see it, in alternative medicine there are two main areas where medical ethics are violated with some regularity.
- Nonsensical research projects
- Lack of informed consent
NONSENSICAL RESEARCH PROJECTS
At best, nonsensical research is a waste of precious resources, at worst it violates the beneficence principle. In alternative medicine, nonsensical research seems to happen ad nauseam. Regular readers of this blog will have seen plenty of examples of such abuse – for instance, if researchers conduct a clinical trial of chiropractic spinal manipulation for improving the singing voices of choir singers, or homeopaths test whether their remedies enhance female fertility. Often, nonsensical research happens when naïve enthusiasts decide to dabble a bit in science in order to promote their trade – but without realising that research would require a minimum of education.
But there are other occasions when it seems that the investigators know only too well what they are doing. Take for instance the plethora of ‘pragmatic’ trials which are currently so much ‘en vogue’ in alternative medicine. They can be designed in such a way that their results must produce what the researchers intended to show; the ‘A+B versus B’ study design is a prominent and obvious example of this type of abuse which I have repeatedly written about on this blog.
I use the term ‘abuse’ intentionally, because that is precisely what it is, in my view. Nonsensical research abuses the willingness of patients to participate by misleading them that it is a worthwhile sacrifice. In reality it is an unethical attempt to generate findings that can mislead us all. Moreover, it gives science a bad name and can lead to patients’ unwillingness to take part in research that does need doing. The damage done by nonsensical research projects is therefore immeasurable.
INFORMED CONSENT
Informed consent is essential in research for protecting the interests of the volunteering patients. When a clinical trial is first conceived, the researchers need to work out all the details, write a protocol and submit it to their ethics committee. Their submission has to give evidence that all the participating patients have given informed consent in writing before they are enrolled into the study. That means, they have to be told the essential details about what might happen to them during the trial.
In a placebo-controlled trial of homeopathy, for instance, they might be told that they will receive either a homeopathic remedy or a placebo during the study period. They might also be informed that there is some encouraging evidence that the former works, and that the trial is designed to define to what extend this is so. Generating this knowledge, they might further be told, will help future patients and will be an important contribution to improving health care. Based on such phraseology, the ethics committee is likely to allow the study to go ahead, and patients are likely to agree to take part.
But, of course, this information is less than truthful. An honest and full information for patients would need to include the following points:
- you will receive either a homeopathic remedy or a placebo,
- the former contains no active molecules and the totality of the most reliable evidence does not show that it works for your condition,
- this means that you will receive either a homeopathic or a conventional placebo,
- neither of these can possibly help your condition,
- the study can therefore not advance our knowledge in any way,
- during the trial your condition will remain untreated which is likely to increase your suffering unnecessarily.
If any research team would truthfully disclose this information, no ethics committee would pass their protocol. If by some weird mistake they did, no patients would volunteer to participate in the study.
I have chosen here the example of homeopathy (because most readers will understand it quite easily), but I could have used almost any other alternative treatment. The issues are identical or very similar: informed consent is usually misinformed consent. If it were fully and truthfully informed, it would neither pass the hurdle of the essential ethics approval nor would it lend itself to recruiting sufficiently large numbers of patients.
CONCLUSION
There are, I think, very serious concerns about the ethical standards in alternative medicine research. I have been banging on about these issues since many years (for instance here and here and here and here). Predictably, this did not find much resonance in the realm of alternative medicine. Regrettably, very few ethicists have so far taken this subject seriously; they seem to feel that these problems are trivial compared to the important issues medical ethics face in conventional health care. I remain unconvinced that this is true and believe it is high time to systematically address the ethics of alternative medicine.
Conventional cough syrups do not have the best of reputations – but the repute of homeopathic cough syrups is certainly not encouraging. So what should one do with such a preparation? Forget about it? No, one conducts a clinical trial, of course! Not just any old trial but one where science, ethics and common sense are absent. Here are the essentials of a truly innovative study that, I think, has all of these remarkable qualities:
The present prospective observational study investigated children affected by wet acute cough caused by non-complicated URTIs, comparing those who received the homeopathic syrup versus those treated with the homeopathic syrup plus antibiotic. The aims were: 1) to assess whether the addition of antibiotics to a symptomatic treatment had a role in reducing the severity and duration of acute cough in a pediatric population, as well as in improving cough resolution; 2) to verify the safety of the two treatments. Eighty-five children were enrolled in an open study: 46 children received homeopathic syrup alone for 10 days and 39 children received homeopathic syrup for 10 days plus oral antibiotic treatment (amoxicillin/clavulanate, clarithromycin, and erythromycin) for 7 days. To assess cough severity we used a subjective verbal category-descriptive (VCD) scale. Cough VCD score was significantly (P < 0.001) reduced in both groups starting from the second day of treatment (−0.52 ± 0.66 in the homeopathic syrup group and −0.56 ± 0.55 in children receiving homeopathic syrup plus oral antibiotic treatment). No significant differences in cough severity or resolution were found between the two groups of children in any of the 28 days of the study. After the first week (day 8) cough was completely resolved in more than one-half of patients in both groups. Two children (4.3 %) reported adverse effects in the group treated with the homeopathic syrup alone, versus 9 children (23.1 %) in the group treated with the homeopathic syrup plus antibiotics (P = 0.020).
Conclusions
Our data confirm that the homeopathic treatment in question has potential benefits for cough in children as well, and highlight the strong safety profile of this treatment. Additional antibiotic prescription was not associated with a greater cough reduction, and presented more adverse events than the homeopathic syrup alone.
Let us be clear about what has happened here. I think, the events can be summarised as follows:
- the researchers come across a homeopathic syrup (anyone who understands respiratory problems and/or therapeutics would be more than a little suspicious of this product, but this team is exceptional),
- they decide to do a trial with it (a decision which would make some ethicists already quite nervous, but the ethics committee is exceptional too),
- the question raises, what should the researchers give to the control group?
- someone has the idea, why not compare our dodgy syrup against something that is equally dodgy, perhaps even a bit unsafe?
- the researchers are impressed and ask: but what precisely could we use?
- let’s take antibiotics; they are often used for acute coughs, but the best evidence fails to show that they are helpful and they have, of course, risks,
- another member of the team adds: let’s use children, they and their mothers are unlikely to understand what we are up to,
- the team is in agreement,
- Boiron, the world’s largest producer of homeopathic products, accepts to finance the study,
- a protocol is written,
- ethics approval is obtained,
- the trial is conducted and even published by a journal with the help of peer-reviewers who are less than critical.
And the results of the trial? Contrary to the authors’ conclusion copied above, they show that two bogus treatments are worse that one.
BOB’S YOUR UNCLE!
EVERYONE SEEMS HAPPY: THE RESEARCHERS CAN ADD AN ARTICLE TO THEIR PUBLICATION LIST, BOIRON HAS MORE ‘EVIDENCE’ IN FAVOUR OF HOMEOPATHY, AND THE ETHICS COMMITTEE SLEEP JUST AS SOUNDLY AS THE PEER-REVIEWERS.
When I come across a study with the aim to “examine the effectiveness of acupuncture to relieve symptoms commonly observed in patients in a hospice program” my hopes are high. When I then see that its authors are from the ‘New England School of Acupuncture’, the ‘All Care Hospice and the ‘Tufts University School of Medicine, Boston, my hopes for a good piece of science are even higher. So, let’s see what this new paper has to offer.
A total of 26 patients participated in this acupuncture ‘trial’, receiving a course of weekly treatments that ranged from 1 to 14 weeks. The average number of treatments was five. The Edmonton Symptom Assessment Scale (ESAS) was used to assess the severity of pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and dyspnoea. A two-tailed, paired t test was applied to the data to compare symptom scores pre- versus post-acupuncture treatment. Patients enrolled in All Care Hospice’s home care program were given the option to receive acupuncture to supplement usual care offered by the hospice team. Treatment was provided by licensed acupuncturists in the patient’s place of residence.
The results indicated that 7 out of 9 symptoms were significantly improved with acupuncture, the exceptions being drowsiness and appetite. Although the ESAS scale demonstrated a reduction in symptom severity post-treatment for both drowsiness and appetite, this reduction was not found to be significant.
At tis stage, I have lost most of my hopes for good science. This is not a ‘trial’ but a glorified case-series. There is no way that the stated aim can be pursued with this type of methodology. There is no reason whatsoever to assume that the observed outcome can be attributed to acupuncture; the additional attention given to these patients is but one of several factors that are quite sufficient to explain their symptomatic improvements.
This is yet another disappointment then from the plethora of ‘research’ into alternative medicine that, on closer inspection, turns out to be little more than thinly disguised promotion of quackery. These days, I can bear such disappointments quite well – after all, I had many years to get used to them. What I find more difficult to endure is the anger that overcomes me when I read the authors’ conclusion: Acupuncture was found to be effective for the reduction and relief of symptoms that commonly affect patient QOL. Acupuncture effectively reduced symptoms of pain, tiredness, nausea, depression, anxiety, and shortness of breath, and enhanced feelings of well-being. More research is required to assess the long-term benefits and symptom reduction of acupuncture in a palliative care setting.
This is not disappointing; in my view, this is scientific misconduct by
- the authors,
- the institutions employing the authors,
- the ethics committee that has passed the ‘research’,
- the sponsors of the ‘research’,
- the peer-reviewers of the paper,
- the journal and its editors responsible for publishing this paper.
The fact that this sort of thing happens virtually every day in the realm of alternative medicine does not render this case less scandalous, it merely makes it more upsetting.
For ‘my’ journal FACT, I review all the new articles that have emerged on the subject of alternative medicine on a monthly basis. Here are a few impressions and concerns that this activity have generated:
- The number of papers on alternative medicine has increased beyond belief: between the year 2000 and 2010, there was a slow, linear increase from 335 to 610 Medline-listed articles; thereafter, the numbers exploded to 1189 (2011), 1674 (2012) and 2236 (2013).
- This fast growing and highly lucrative ‘market’ has been cornered mainly by one journal: ‘EVIDENCE BASED COMPLEMENTARY AND ALTERNATIVE MEDICINE’ (EBCAM), a journal that I mentioned several times before (see here, for instance). In 2010, EBCAM published 76 papers, while these figures increased to 546, 880 and 1327 during the following three years.
- Undeniably, this is big business, as authors have to pay tidy sums each time they get published in EBCAM.
- The peer-review system of EBCAM is farcical: potential authors who send their submissions to EBCAM are invited to suggest their preferred reviewers who subsequently are almost invariably appointed to do the job. It goes without saying that such a system is prone to all sorts of serious failures; in fact, this is not peer-review at all, in my opinion, it is an unethical sham.
- As a result, most (I estimate around 80%) of the articles that currently get published on alternative medicine are useless rubbish. They tend to be either pre-clinical investigations which never get followed up and are thus meaningless, or surveys of no relevance whatsoever, or pilot studies that never are succeeded by more definitive trials, or non-systematic reviews that are wide open to bias and can only mislead the reader.
- Nowadays, very few articles on alternative medicine are good enough to get published in mainstream journals of high standing.
The consequences of these fairly recent developments are serious:
- Conventional scientists and clinicians must get the impression that there is little research activity in alternative medicine (while, in fact, there is lots) and that the little research that does emerge is of poor quality.
- Consequently alternative medicine will be deemed by those who are not directly involved in it as trivial, and the alternative medicine journals will be ignored or even become their laughing stock.
- At the same time, the field of alternative medicine and its proponents (the only ones who might actually be reading the plethora of rubbish published in alternative medicine journals) will get more and more convinced that their field is supported by an ever- abundance of peer-reviewed, robust science.
- Gradually, they will become less and less aware of the standards and requirements that need to be met for evidence to be called reliable (provided they ever had such knowledge in the first place).
- They might thus get increasingly frustrated by the lack of acceptance of their ‘advances’ by proper scientists – an attitude which, from their perspective, must seem unfair, biased and hostile.
- In the end, conventional and alternative medicine, rather than learning from each other, will move further and further apart.
- Substantial amounts of money will continue to be wasted for research into alternative medicine that, whenever assessed critically, turns out to be too poor to advance healthcare in any meaningful way.
- The ones who medicine should be all about, namely the patients who need our help and rely on the progress of research, are not well served by these developments.
In essence this suggests, I think, that alternative medicine is ill-advised and short-sighted to settle for standards that are so clearly below those generally deemed acceptable in medicine. Similarly, conventional medicine does a serious disfavour to progress and to us all, if it ignores or tolerates this process.
I am not at all sure how to reverse this trend. In the long-term, it would require a change of attitude that obviously is far from easy to bring about. In the short-term, it might help, I think, to de-list journals from Medline that are in such obvious conflict with publication ethics.
NATURAL NEWS announced the death of Nicholas Gonzalez with the following words:
It is with great sadness that we report the death of health freedom advocate and individualized nutrition specialist Dr. Nick Gonzalez, who on the eve of July 21 died from an alleged heart attack. Dr. Gonzalez’ contributions to anticancer nutrition protocols and an array of other nutritional therapies have been invaluable, and we would like to honor this pioneering natural healer by recognizing his benevolent legacy…
In contrast to the conventional cancer treatment model, Dr. Gonzalez’s approach was always about helping individuals heal through individualized care. Along with fellow colleague Dr. Linda Isaacs, Dr. Gonzalez helped build a repository of dietary protocols to help patients overcome their specific conditions through advanced nutritional therapies. His methodology centered around detoxification, supplementation with healing foods and nutrients, and specialized enzyme therapy…
Dr. Gonzalez was always a strong adherent to sound science, and he was never in it for the money. His humble, cogent approach to helping people heal naturally without drugs or surgery is a legacy worth remembering and passing on, and we’re thankful to have gotten to know this honorable man during his time on this earth…
This sounds as though Gonzalez was some kind of medical genius and scientific pioneer. Most cancer experts would disagree very sharply with this. Here is what Louise Lubetkin wrote on this blog about him, and I very much encourage you to read her whole post.
Those who recognize and appreciate a fine example of pseudoscientific baloney when they see one know that there is no richer seam, no more inexhaustible source, than the bustling, huckster-infested street carnival that is alternative medicine. There one can find intellectual swindlers in abundance, all offering outrageously implausible claims with the utmost earnestness and sincerity. But the supreme prize, the Fabergé egg found buried among the bric-a-brac, surely belongs to that most convincing of illusionists, the physician reborn as an ardent advocate of alternative medicine…
So what are we to make of Gonzalez? Is he a cynical fraud or does he genuinely believe that coffee enemas, skin brushing and massive doses of supplements are capable of holding back the tsunami of cancer?
At the end of the day it hardly matters: either way, he’s a dangerous man.
Personally, I believe much more in the text of Louise Lubetkin. How about you?
The press officers of journals like to send out press-releases of articles which are deemed to be particularly good and important. Sadly, it is not often that articles on alternative medicine fulfil these criteria. I was therefore excited to receive this press-release which seemed encouraging, to say the least:
Medical evidence supports the potential for acupuncture to be significantly more effective in the treatment of dermatologic conditions such as dermatitis, pruritus, and urticaria than alternative treatment options, “placebo acupuncture,” or no treatment, according to a review of the medical literature published in The Journal of Alternative and Complementary Medicine, a peer-reviewed publication from Mary Ann Liebert, Inc., publishers…
The abstract was equally promising:
Objectives: Acupuncture is a form of Traditional Chinese Medicine that has been used to treat a broad range of medical conditions, including dermatologic disorders. This systematic review aims to synthesize the evidence on the use of acupuncture as a primary treatment modality for dermatologic conditions.
Methods: A systematic search of MEDLINE, EMBASE, and the Cochrane Central Register was performed. Studies were limited to clinical trials, controlled studies, case reports, comparative studies, and systematic reviews published in the English language. Studies involving moxibustion, electroacupuncture, or blood-letting were excluded.
Results: Twenty-four studies met inclusion criteria. Among these, 16 were randomized controlled trials, 6 were prospective observational studies, and 2 were case reports. Acupuncture was used to treat atopic dermatitis, urticaria, pruritus, acne, chloasma, neurodermatitis, dermatitis herpetiformis, hyperhidrosis, human papillomavirus wart, breast inflammation, and facial elasticity. In 17 of 24 studies, acupuncture showed statistically significant improvements in outcome measurements compared with placebo acupuncture, alternative treatment options, and no intervention.
Conclusions: Acupuncture improves outcome measures in the treatment of dermatitis, chloasma, pruritus, urticaria, hyperhidrosis, and facial elasticity. Future studies should ideally be double-blinded and standardize the control intervention.
One has to read the actual full text article to understand that the evidence presented here is dodgy to the extreme. In fact, one has to go into the tedious details of the methods section to find the reasons why: All searches were limited to clinical trials, controlled studies, case reports, comparative studies, and systematic reviews published in the English language.
There are many more weaknesses of this review, but the inclusion of uncontrolled studies and even anecdotes is, in my view, a virtual death sentence to its credibility. It means that no general conclusions about the effectiveness of acupuncture, such as the authors have decided to make, are possible.
Such overt exaggerations are sadly no rarities in the realm of alternative medicine. I think, this begs a number of serious questions:
- Does this cross the line between flawed research and scientific misconduct?
- Why did the reviewers not pick up these flaws?
- Why did the editor pass this article for publication?
- How can the publisher tolerate such dubious behaviour?
- Should this journal (which I have commented on before here and which is one with the highest impact factor of all the alt med journals) be de-listed from Medline?
I don’t think that we will get answers from the people responsible for this disgrace, but I would like to learn my readers’ opinions.
