ethics
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.
Therapeutic touch (TT) is a popular ‘energy therapy’ which is based on the use of hand movements and detection of ‘energy field congestion’ to correct alleged imbalances that, in turn, are postulated to stimulate self-healing. The effectiveness of TT during radiotherapy for breast cancer is unknown, and this study was aimed at shedding some light on it.
Women undergoing adjuvant radiation for stage I/II breast cancer post surgery were recruited for this study. TT treatments were administered to patients in the experimental group three times per week following radiation therapy. The control group did not receive any TT. Both groups had conventional care in addition.
The effectiveness of TT was evaluated by documenting the ‘time to develop’ and the ‘worst grade of radiation’ dermatitis. Toxicity was assessed using NCIC CTC V3 dermatitis scale. Cosmetic rating was performed using the EORTC Breast Cosmetic Rating. The quality of life, mood and energy, and fatigue were assessed by EORTC QLQ C30, POMS, and BFI, respectively. The parameters were assessed at baseline, and serially during treatment.
A total of 49 patients entered the study (17 in the TT group and 32 in the control group). Median age in TT arm was 63 years and in control arm was 59 years. TT was considered feasible as all 17 patients screened completed TT treatment. There were no side effects observed with the TT treatments. In the TT group, the worst grade of radiation dermatitis was grade II in nine patients (53%). Median time to develop the worst grade was 22 days. In the control group, the worst grade of radiation dermatitis was grade III in 1 patient. However, the most common toxicity grade was II in 15 patients (47%). Three patients did not develop any dermatitis. Median time to develop the worst grade in the control group was 31 days. There was no difference between cohorts for the overall EORTC cosmetic score and there was no significant difference in before and after study levels in quality of life, mood and fatigue.
Based on these findings, the authors drew the following conclusions: This study is the first evaluation of TT in patients with breast cancer using objective measures. Although TT is feasible for the management of radiation induced dermatitis, we were not able to detect a significant benefit of TT on NCIC toxicity grade or time to develop the worst grade for radiation dermatitis. In addition, TT did not improve quality of life, mood, fatigue and overall cosmetic outcome.
Like all forms of ‘energy healing’, TT lacks any biological plausibility and is not clinically effective. At best, it can generate a placebo-response; but in this particular study it did not even manage that.
Is it not time to stop fooling patients with outright quackery?
Is it not time to stop spending scarce research resources on such nonsense?
Is it not time that editors stop considering such rubbish for publication?
Is it not time to stop allowing TT-proponents to undermine rationality?
Is it not time to make progress and move on?
The question why patients turn to homeopathy – or indeed any other disproven treatment – has puzzled many people. There has been a flurry of research into these issues. Here is the abstract of a paper that I find very remarkable and truly fascinating:
Interviews with 100 homeopathic patients in the San Francisco Bay Area show that for the most part the patients are young, white and well-educated, and have white-collar jobs; most had previously tried mainstream medical care and found it unsatisfactory. Among the reasons for their dissatisfaction were instances of negative side effects from medication, lack of nutritional or preventive medical counseling, and lack of health education. Experiences with conventional physicians were almost evenly divided: nearly half of the subjects reported poor experiences, slightly fewer reported good experiences. Three quarters of the patients suffered from chronic illness and about half considered their progress to be good under homeopathic care. The majority were simultaneously involved in other nontraditional health care activities.
If you read the full article, you will see that the authors make further important points:
- Patients who use alternative treatments are by no means ignorant or unsophisticated.
- Most of these patients use other treatments in parallel – but they seem to attribute any improvements in their condition to homeopathy.
- Dissatisfaction with conventional medicine seems the prime motivation to turn to homeopathy. In particular, patients need more time with their clinician and want to share the responsibility for their own health – and these needs are met by homeopaths better than by conventional doctors.
- Most homeopaths (63%) adhere to Hahnemann’s dictum that homeopathic remedies must never be combined with other treatments. This renders then potentially dangerous in many situations.
At this point you might say BUT WE KNEW ALL THIS BEFORE! True! Why then do I find this paper so remarkable?
It is remarkable mostly because of its publication date: 1978! In fact, it may well be the very first of hundreds of similar surveys that followed in the years since.
The questions I ask myself are these:
- IF WE KNEW ALL THIS SINCE ALMOST 40 YEARS, WHY HAVE WE NOT DONE MORE ABOUT IT?
- WHY ARE WE SO UNSUCCESSFUL IN GETTING THE FACTS THROUGH TO OUR PATIENTS?
- WHY HAVE WE NOT MANAGED TO IMPROVE CONVENTIONAL MEDICINE SUCH THAT PATIENTS STOP CONSULTING QUACKS?
- WHY ARE WE STILL CONDUCTING SURVEY AFTER SURVEY WHEN THE EMBARRASSING FACTS ARE PLAIN TO SEE?
Who – apart from quacks – would not want to get rid of all quackery, once and for all? It would be a huge improvement to medicine, save thousands of lives, and reduce our expenditure for health care considerably.
But how? How can we possibly get rid of something that is as ancient as medicine itself?
Simple!
All we need to do is to employ the existing ethical imperatives. I am thinking in particular about INFORMED CONSENT.
Informed consent is a process for obtaining permission from a patient before treating him/her. It requires the patient’s clear and full understanding of the relevant facts, implications, and consequences of the treatment. It is a ‘condition sine qua non’; no health care professional must commence a treatment without it.
And how would informed consent get rid of all quackery?
This is perhaps best explained by giving an example. Imagine a patient is about to receive a quack treatment – let’s take crystal healing (we could have chosen any other implausible non-evidence based therapy, e. g. homeopathy, chiropractic, Bach Flower Remedies, faith-healing, etc.) – for his/her condition – let’s say diabetes (we could have chosen any other condition, e. g. cancer, asthma, insomnia, etc.). Informed consent would require that, before starting the intervention, the therapist informs the patient about the relevant facts, implications and consequences of having crystal healing for diabetes. This would include the following:
- the therapy is not plausible, it is not in line with the laws of nature as we understand them today,
- there is no evidence that the treatment will cure your condition or ease your symptoms beyond a placebo-effect,
- the treatment may harm you in several ways: 1) it might cause direct harm (unlikely with crystal healing but not with chiropractic, for instance), 2) it will harm your finances because the therapist wants to be paid, 3) most importantly, if you believe that it could help you and therefore forego effective therapy for your diabetes, it could easily kill you within a few days.
It is impossible to dispute that these facts are true and relevant, I think. And if they are relevant, the practitioner must convey them in such a way that they are fully appreciated by the patient. If the patient comprehends the implications fully, he/she is unlikely to agree to the treatment. If most patients refuse to be treated, the market for crystal healing quickly collapses, and crystal healers move into other, more productive jobs. This might even help the general economy!
But quacks are not in the habit of obtaining fully informed consent, I hear you say. I agree, and this is why they must be taught to do so in their quack colleges. If informed consent was taught to all budding quacks, they would soon realise that quackery is not a viable business and go to a proper school where they lean something useful (this too might help the economy). If that happens, the quack colleges would soon run out of money and close.
Meanwhile, one could remind the existing quacks that they break the law, if they neglect informed consent. In the interest of the patient, one could closely monitor the consent giving process, and even think of increasingly heavy finds for those who break the law.
As we see, almost all the means for rendering health care quack-free already exist. All we need to do is implement them. That shouldn’t be difficult, should it?
AND NOW I STOP DAY-DREAMING AND DO SOMETHING USEFUL.
Much has been written on this blog and elsewhere about the risks of spinal manipulation. It relates almost exclusively to the risks of manipulating patients’ necks. There is far less on the safety of thrust joint manipulation (TJM) when applied to the thoracic spine. A new paper focusses on this specific topic.
The purpose of this review was to retrospectively analyse documented case reports in the literature describing patients who had experienced severe adverse events (AE) after receiving TJM to their thoracic spine.
Case reports published in peer reviewed journals were searched in Medline (using Ovid Technologies, Inc.), Science Direct, Web of Science, PEDro (Physiotherapy Evidence Database), Index of Chiropractic literature, AMED (Allied and Alternative Medicine Database), PubMed and the Cumulative Index to Nursing and Allied Health (CINHAL) from January 1950 to February 2015.
Case reports were included if they: (1) were peer-reviewed; (2) were published between 1950 and 2015; (3) provided case reports or case series; and (4) had TJM as an intervention. The authors only looked at serious complications, not at the much more frequent transient AEs after spinal manipulations. Articles were excluded if: (1) the AE occurred without TJM (e.g. spontaneous); (2) the article was a systematic or literature review; or (3) it was written in a language other than English or Spanish. Data extracted from each case report included: gender; age; who performed the TJM and why; presence of contraindications; the number of manipulation interventions performed; initial symptoms experienced after the TJM; as well as type of severe AE that resulted.
Ten cases, reported in 7 articles, were reviewed. Cases involved females (8) more than males (2), with mean age being 43.5 years. The most frequent AE reported was injury (mechanical or vascular) to the spinal cord (7/10); pneumothorax and hematothorax (2/10) and CSF leak secondary to dural sleeve injury (1/10) were also reported.
The authors point out that there were only a small number of case reports published in the literature and there may have been discrepancies between what was reported and what actually occurred, since physicians dealing with the effects of the AE, rather than the clinician performing the TJM, published the cases.
The authors concluded that serious AE do occur in the thoracic spine, most commonly, trauma to the spinal cord, followed by pneumothorax. This suggests that excessive peak forces may have been applied to thoracic spine, and it should serve as a cautionary note for clinicians to decrease these peak forces.
These are odd conclusions, in my view, and I think I ought to add a few points:
- As I stated above, the actual rate of experiencing AEs after having chiropractic spinal manipulations is much larger; it is around 50%.
- Most complications on record occur with chiropractors, while other professions are far less frequently implicated.
- The authors’ statement about ‘excessive peak force’ is purely speculative and is therefore not a legitimate conclusion.
- As the authors mention, it is hardly ever the chiropractor who reports a serious complication when it occurs.
- In fact, there is no functioning reporting scheme where the public might inform themselves about such complications.
- Therefore their true rate is anyone’s guess.
- As there is no good evidence that thoracic spinal manipulations are effective for any condition, the risk/benefit balance for this intervention fails to be positive.
- Many consumers believe that a chiropractor will only manipulate in the region where they feel pain; this is not necessarily true – they will manipulate where they believe to diagnose ‘SUBLUXATIONS’, and that can be anywhere.
- Finally, I would not call a review that excludes all languages other than English and Spanish ‘systematic’.
And my conclusion from all this? THORACIC SPINAL MANIPULATIONS CAN CAUSE CONSIDERABLE HARM AND SHOULD BE AVOIDED.
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.
One of the questions that I hear regularly is: ‘What happened to your research unit at Exeter?’ Therefore it might be a good idea to put the full, shameful story on this blog.
After the complaint by Prince Charles’ secretary to my Vice Chancellor alleging that I had breached confidentiality over the Smallwood report, my University conducted a 13 months investigation into my actions. At the end of it, I was declared innocent as charged (it should have been clear from a 10 minute discussion that I had done nothing wrong: I had not disclosed any information from the report, and even if I had, it would have been a matter of public interest and medical ethics to blow the whistle. However, the Vice Chancellor never once bothered to talk to me.). Subsequently, all support that I had once enjoyed broke down, my staff’s contracts were terminated, and I eventually had to take early retirement (full details of this part of the story can be found in ‘A SCIENTIST IN WONDERLAND’).
A few months later, a new dean was appointed at my medical school. The new man seemed to have a lot more understanding for my situation than his predecessor. Provided that I accept to go into early retirement, he offered to re-employ me for one year (half time) to help him find a successor for my position.
I did accept because, above everything, I wanted to prevent the closure of my unit. We then developed criteria for advertising the post and conducted two rounds of advertisements. Several candidates applied but none them seemed suited in our view. Eventually we did find several experts who were promising; one even came to Exeter from abroad and had detailed talks with the dean and several other people.
However, Exeter was unwilling to equip my potential successor with any funds to speak of. The suggestion was to appoint the new chair with the onus to raise all the necessary funds himself. This is a proposition that no well-qualified academic at the professorial level can possibly find attractive. Consequently, the candidates all declined.
Meanwhile, there had been an initiative by several altruistic UK public figures and friends to raise funds for the new chair and thus save my unit from closure. Sadly, however, these activities did not generate in the necessary cash. When my year of half-time re-employment had expired, I left Exeter and my unit disappeared for good.
To the present day, I am not at all sure what the true intentions of Exeter had been during this final stage.
- Was I offered re-employment simply to keep me sweet?
- Did they fear that I would otherwise sue them or cause a public scandal?
- Did they truly believe they could find a suitable successor?
- If so, why did they not put up the money?
I do not expect to ever find conclusive answers for any of these questions. However, I do know what, in an ideal world, should have become of my unit. If it had been for me to decide, I would have equipped the chair with the necessary core funds and appointed an ethicist with a documented interest in alternative medicine as the new professor. I see two main reasons for this perhaps less than obvious choice:
- In my experience, Exeter would greatly benefit from an ethicist to give them guidance on a range of matters.
- After two decades of being involved in alternative medicine research, I have become convinced that this field foremost needs the input of a critical ethicist.
In case either of these last two statements puzzles you, I recommend you read ‘A SCIENTIST IN WONDERLAND’.
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.
