conflict of interest
This is a question which I have asked myself more often than I care to remember. The reason is probably that, in alternative medicine, I feel surrounded by so much dodgy research that I simply cannot avoid asking it.
In particular, the co-called ‘pragmatic’ trials which are so much ‘en vogue’ at present are, in my view, a reason for concern. Take a study of cancer patients, for instance, where one group is randomized to get the usual treatments and care, while the experimental group receives the same and several alternative treatments in addition. These treatments are carefully selected to be agreeable and pleasant; each patient can choose the ones he/she likes best, always had wanted to try, or has heard many good things about. The outcome measure of our fictitious study would, of course, be some subjective parameter such as quality of life.
In this set-up, the patients in our experimental group thus have high expectations, are delighted to get something extra, even more happy to get it for free, receive plenty of attention and lots of empathy, care, time, attention etc. By contrast, our poor patients in the control group would be a bit miffed to have drawn the ‘short straw’ and receive none of this.
What result do we expect?
Will the quality of life after all this be equal in both groups?
Will it be better in the miffed controls?
Or will it be higher in those lucky ones who got all this extra pampering?
I don’t think I need to answer these questions; the answers are too obvious and too trivial.
But the real and relevant question is the following, I think: IS SUCH A TRIAL JUST SILLY AND MEANINGLESS OR IS IT UNETHICAL?
I would argue the latter!
Because the results of the study are clearly known before the first patient had even been recruited. This means that the trial was not necessary; the money, time and effort has been wasted. Crucially, patients have been misled into thinking that they give their time, co-operation, patience etc. because there is a question of sufficient importance to be answered.
But, in truth, there is no question at all!
Perhaps you believe that nobody in their right mind would design, fund and conduct such a daft trial. If so, you assumed wrongly. Such studies are currently being published by the dozen. Here is the abstract of the most recent one I could find:
The aim of this study was to evaluate the effectiveness of an additional, individualized, multi-component complementary medicine treatment offered to breast cancer patients at the Merano Hospital (South Tyrol) on health-related quality of life compared to patients receiving usual care only. A randomized pragmatic trial with two parallel arms was performed. Women with confirmed diagnoses of breast cancer were randomized (stratified by usual care treatment) to receive individualized complementary medicine (CM group) or usual care alone (usual care group). Both groups were allowed to use conventional treatment for breast cancer. Primary endpoint was the breast cancer-related quality of life FACT-B score at 6 months. For statistical analysis, we used analysis of covariance (with factors treatment, stratum, and baseline FACT-B score) and imputed missing FACT-B scores at 6 months with regression-based multiple imputation. A total of 275 patients were randomized between April 2011 and March 2012 to the CM group (n = 136, 56.3 ± 10.9 years of age) or the usual care group (n = 139, 56.0 ± 11.0). After 6 months from randomization, adjusted means for health-related quality of life were higher in the CM group (FACT-B score 107.9; 95 % CI 104.1-111.7) compared to the usual care group (102.2; 98.5-105.9) with an adjusted FACT-B score difference between groups of 5.7 (2.6-8.7, p < 0.001). Thus, an additional individualized and complex complementary medicine intervention improved quality of life of breast cancer patients compared to usual care alone. Further studies evaluating specific effects of treatment components should follow to optimize the treatment of breast cancer patients.
The key sentence in this abstract is, of course: complementary medicine intervention improved quality of life of breast cancer patients… It provides the explanation as to why these trials are so popular with alternative medicine researchers: they are not real research but they are quite simply promotion! The next step would be to put a few of those pseudo-scientific trials together and claim that there is solid proof that integrating alternative treatments into conventional health care produces better results. At that stage, few people will bother asking whether this is really due to the treatments in questioning or to the additional attention, pampering etc.
My question is ARE SUCH TRIALS ETHICAL?
I would very much appreciate your opinion.
These days, I spend much of my time in France (my wife is French), and one striking thing about this country is the popularity of homeopathy. For instance, it is hard to find a pharmacy where the pharmacist does not approach you trying to sell you a homeopathic remedy for your health problem. But, of course, this is all far too anecdotal. The question therefore is, are there any reliable data on France’s usage of homeopathy?
The answer is YES: the aim of this new paper was to analyse data on medicines, prescribers and patients for homeopathic prescriptions that are reimbursed by French national health insurance.
The French national health insurance databases were used to analyse prescriptions of reimbursed homeopathic drugs or preparations in the overall French population, during the period July 2011-June 2012.
The results show that a total of 6,705,420 patients received at least one reimbursement for a homeopathic preparation during the 12-month period. This number equates to 10.2% of the French population, with a predominance in females (68%) and a peak frequency observed in children aged 0-4 years (18%). About one third of patients had only one reimbursement, and one half of patients had three or more reimbursements.
The cost of all homeopathic treatments prescribed during the 12-month period was approximately €279 million (based on the retail price). The observed mean reimbursement rate was 34%. This cost corresponded to nearly €98 million for the French national health insurance and amounted to 0.3% of France’s total drug bill. The most commonly prescribed stock was ‘Arnica montana’, followed by ‘Influenzinum’, Ignatia amara’ and ‘Gelsemium sempervirens’.
A total of 120,110 healthcare professionals (HCPs) prescribed at least one homeopathic drug or preparation. They represented 43.5% of the overall population of HCPs, nearly 95% of general practitioners, dermatologists and pediatricians, and 75% of midwives. Homeopathy accounted for 5% of the total number of drug units prescribed by HCPs. Conventional medicines were co-prescribed with 55% of homeopathic prescriptions.
From these data, the authors concluded that many HCPs occasionally prescribe reimbursed homeopathic preparations, representing however a small percentage of reimbursements compared to allopathic medicines. About 10% of the French population, particularly young children and women, received at least one homeopathic preparation during the year. In more than one half of cases, reimbursed homeopathic preparations are prescribed in combination with allopathic medicines.
So, my impression that homeopathy is much more popular in France than elsewhere was not entirely correct. Like in most other countries, it is used by a minority; but this minority is fairly vocal and gets plenty of press coverage. When discussing homeopathy with friends in France, I have regularly discovered that they have very little understanding about what homeopathy is truly about; they seem to favour it because it is heavily advertised as a harmless solution to benign health problems. In no other country have I seen regular TV commercials for homeopathy! The ones who earn by far the most from this is, of course, the pharmacist – in France, homeopathic products can only be found in pharmacies!
Seen from this angle, the French usage of homeopathy is a triumph of profit over reason: the two most popular preparations (Arnica and Influenzinum) are not just not evidence-based (like all other homeopathic remedies), they have been shown in systematic reviews not to work better than placebos.
A recent comment to a post of mine (by a well-known and experienced German alt med researcher) made the following bold statement aimed directly at me and at my apparent lack of understanding research methodology:
C´mon , as researcher you should know the difference between efficacy and effectiveness. This is pharmacological basic knowledge. Specific (efficacy) + nonspecific effects = effectiveness. And, in fact, everything can be effective – because of non-specific or placebo-like effects. That does not mean that efficacy is existent.
The point he wanted to make is that outcome studies – studies without a control group where the researcher simply observe the outcome of a particular treatment in a ‘real life’ situation – suffice to demonstrate the effectiveness of therapeutic interventions. This belief is very wide-spread in alternative medicine and tends to mislead all concerned. It is therefore worth re-visiting this issue here in an attempt to create some clarity.
When a patient’s condition improves after receiving a therapy, it is very tempting to feel that this improvement reflects the effectiveness of the intervention (as the researcher mentioned above obviously does). Tempting but wrong: there are many other factors involved as well, for instance:
- the placebo effect (mainly based on conditioning and expectation),
- the therapeutic relationship with the clinician (empathy, compassion etc.),
- the regression towards the mean (outliers tend to return to the mean value),
- the natural history of the patient’s condition (most conditions get better even without treatment),
- social desirability (patients tend to say they are better to please their friendly clinician),
- concomitant treatments (patients often use treatments other than the prescribed one without telling their clinician).
So, how does this fit into the statement above ‘Specific (efficacy) + nonspecific effects = effectiveness’? Even if this formula were correct, it would not mean that outcome studies of the nature described demonstrate the effectiveness of a therapy. It all depends, of course, on what we call ‘non-specific’ effects. We all agree that placebo-effects belong to this category. Probably, most experts also would include the therapeutic relationship and the regression towards the mean under this umbrella. But the last three points from my list are clearly not non-specific effects of the therapy; they are therapy-independent determinants of the clinical outcome.
The most important factor here is usually the natural history of the disease. Some people find it hard to imagine what this term actually means. Here is a little joke which, I hope, will make its meaning clear and memorable.
CONVERATION BETWEEN TWO HOSPITAL DOCTORS:
Doc A: The patient from room 12 is much better today.
Doc B: Yes, we stared his treatment just in time; a day later and he would have been cured without it!
I am sure that most of my readers now understand (and never forget) that clinical improvement cannot be equated with the effectiveness of the treatment administered (they might thus be immune to the misleading messages they are constantly exposed to). Yet, I am not at all sure that all ‘alternativists’ have got it.
The founder of Johrei Healing (JH), Mokichi Okada, believed that “all human beings have toxins in their physical bodies. Some are inherited, others are acquired by ingesting medicines, food additives, unnatural food, unclean air, most drugs, etc. all of these contain chemicals which cannot be used by the body and are treated as poisons…….. Illness is no more than the body’s way of purifying itself to regain health…… The more we resist illness by taking suppressive medications, the harder and more built up the toxins become…… If we do not allow the toxins to be eliminated from the body, we will suffer more, and have more difficult purification…..on the other hand, if we allow illness to take its course by letting the toxins become naturally eliminated from our bodies, we will be healthier.”
Johrei healers channel light or energy or warmth etc. into the patient’s or recipient’s body in order to stimulate well-being and healing. Sounds wacky? Yes!
Still, at one stage my team conducted research into all sorts of wacky healing practices (detailed reasons and study designs can be found in my recent book ‘A SCIENTIST IN WONDERLAND‘). Despite the wackiness, we even conducted a study of JH. Dr Michael Dixon, who was closely collaborating with us at the time, had persuaded me that it would be reasonable to do such a study. He brought some Japanese JH-gurus to my department to discuss the possibility, and (to my utter amazement) they were happy to pay £ 70 000 into the university’s research accounts for a small pilot study. I made sure that all the necessary ethical safe-guards were in place, and eventually we all agreed to design and conduct a study. Here is the abstract of the paper published once the results were available and written up.
“Johrei is a form of spiritual healing comprising “energy channelling” and light massage given either by a trained healer or, after some basic training, by anyone. This pilot trial aimed to identify any potential benefits of family-based Johrei practice in childhood eczema and for general health and to establish the feasibility of a subsequent randomised controlled trial. Volunteer families of 3-5 individuals, including at least one child with eczema were recruited to an uncontrolled pilot trial lasting 12 months. Parents were trained in Johrei healing and then practised at home with their family. Participants kept diaries and provided questionnaire data at baseline, 3,6 and 12 months. Eczema symptoms were scored at the same intervals. Scepticism about Johrei is presently an obstacle to recruitment and retention of a representative sample in a clinical trial, and to its potential use in general practice. The frequency and quality of practise at home by families may be insufficient to bring about the putative health benefits. Initial improvements in eczema symptoms and diary recorded illness, could not be separated from seasonal factors and other potential confounders. There were no improvements on other outcomes measuring general health and psychological wellbeing of family members.”
Our findings were hugely disappointing for the JH-gurus, of course, but we did insist on our right to publish them. Dr Dixon was not involved in the day to day running of our trial, nor in evaluating its results, nor in writing up the paper. He nevertheless showed a keen interest in the matter, kept in contact with the Japanese sponsors, and arranged regular meetings to discuss our progress. It was at one of those gatherings when he mentioned that he was about to fly to Japan to give a progress report to the JH organisation that had financed the study. My team felt this was odd (not least because, at this point, the study was far from finished) and we were slightly irritated by this interference.
When Dixon had returned from Japan, we asked him how the meeting had been. He said the JH sponsors had received him extremely well and had appreciated his presentation of our preliminary findings. As an ‘aside’, he mentioned something quite extraordinary: he, his wife and his three kids had all flown business class paid for by the sponsors of our trial. This, we all felt, was an overt abuse of potential research funds, unethical and totally out of line with academic behaviour. Recently, I found this fascinating clip on youtube, and I wonder whether it was filmed when Dr Dixon visited Japan on that occasion. One does get the impression that the Johrei organisation is not short of money.
A few months later, I duly reported this story to my dean, Prof Tooke, who was about to get involved with Dr Dixon in connection with a postgraduate course on integrated medicine for our medical school (more about this episode here or in my book). He agreed with me that such a thing was a most regrettable violation of academic and ethical standards. To my great surprise, he then asked me not to tell anybody about it. Today I feel very little loyalty to either of these two people and have therefore decided to publish my account – which, by the way, is fully documented as I have kept all relevant records and a detailed diary (in case anyone should feel like speaking to libel lawyers).
In my last post, I claimed that researchers of alternative medicine tend to be less than rigorous. I did not link this statement to any evidence at all. Perhaps I should have at least provided an example!? As it happens, I just came across a brand new paper which nicely demonstrates what I meant.
According to its authors, this non-interventional study was performed to generate data on safety and treatment effects of a complex homeopathic drug. They treated 1050 outpatients suffering from common cold with a commercially available homeopathic remedy for 8 days. The study was conducted in 64 German outpatient practices of medical doctors trained in CAM. Tolerability, compliance and the treatment effects were assessed by the physicians and by patient diaries. Adverse events were collected and assessed with specific attention to homeopathic aggravation and proving symptoms. Each adverse effect was additionally evaluated by an advisory board of experts.
The physicians detected 60 adverse events from 46 patients (4.4%). Adverse drug reactions occurred in 14 patients (1.3%). Six patients showed proving symptoms (0.57%) and only one homeopathic aggravation (0.1%) appeared. The rate of compliance was 84% for all groups. The global assessment of the treatment effects resulted in the verdict “good” and “very good” in 84.9% of all patients.
The authors concluded that the homeopathic complex drug was shown to be safe and effective for children and adults likewise. Adverse reactions specifically related to homeopathic principles are very rare. All observed events recovered quickly and were of mild to moderate intensity.
So why do I think this is ‘positively barmy’?
The study had no control group. This means that there is no way anyone can attribute the observed ‘treatment effects’ to the homeopathic remedy. There are many other phenomena that may have caused or contributed to it, e. g.:
- a placebo effect
- the natural history of the condition
- regression to the mean
- other treatments which the patients took but did not declare
- the empathic encounter with the physician
- social desirability
To plan a study with the aim as stated above and to draw the conclusion as cited above is naïve and unprofessional (to say the least) on the part of the researchers (I often wonder where, in such cases, the boundary between incompetence and research misconduct might lie). To pass such a paper through the peer review process is negligent on the part of the reviewers. To publish the article is irresponsible on the part of the editor.
In a nut-shell: COLLECTIVELY, THIS IS ‘POSITIVELY BARMY’!!!
On this blog, we have discussed the Alexander Technique before; it is an educational method promoted for all sorts of conditions, including neck pain. The very first website I found when googling it stated the following: “Back and neck pain can be caused by poor posture. Alexander Technique lessons help you to understand how to improve your posture throughout your daily activities. Many people, even those with herniated disc or pinched nerve, experience relief after one lesson, often permanent relief after five or ten lessons.”
Sounds too good to be true? Is there any good evidence?
The aim of this study, a randomized controlled trial with 3 parallel groups, was to test the efficacy of the Alexander Technique, local heat and guided imagery on pain and quality of life in patients with chronic non-specific neck pain. A total of 72 patients (65 females, 40.7±7.9 years) with chronic, non-specific neck pain were recruited. They received 5 sessions of the Alexander Technique, while the control groups were treated with local heat application or guided imagery. All interventions were conducted once a week for 45 minutes each.
The primary outcome measure at week 5 was neck pain intensity quantified on a 100-mm visual analogue scale; secondary outcomes included neck disability, quality of life, satisfaction and safety. The results show no group differences for pain intensity for the Alexander Technique compared to local heat. An exploratory analysis revealed the superiority of the Alexander Technique over guided imagery. Significant group differences in favor of the Alexander Technique were also found for physical quality of life. Adverse events were mild and mainly included slightly increased pain and muscle soreness.
The authors concluded that Alexander Technique was not superior to local heat application in treating chronic non-specific neck pain. It cannot be recommended as routine intervention at this time. Further trials are warranted for conclusive judgment.
I am impressed with these conclusions: this is how results should be interpreted. The primary outcome measure failed to yield a significant effect, and therefore such a negative conclusion is the only one that can be justified. Yet such clear words are an extreme rarity in the realm of alternative medicine. Most researchers in this area would, in my experience, have highlighted the little glimpses of the possibility of a positive effect and concluded that this therapeutic approach may be well worth a try.
In my view, this article is a fine example for demonstrating the difference between true scientists (who aim at testing the effectiveness of interventions) and pseudo-scientists (who aim at promoting their pet therapy). I applaud the authors of this paper!
Many experts have argued that the growing popularity of alternative medicine (AM) mandates their implementation into formal undergraduate medical education. Most medical students seem to feel a need to learn about AM. Yet little is known about the student-specific need for AM education. The objective of this paper was address this issue, specifically the authors wanted to assess the self-reported need for AM education among Australian medical students.
Thirty second-year to final-year medical students participated in semi-structured interviews. A constructivist grounded theory methodological approach was used to generate, construct and analyse the data.
The results show that these medical students generally held favourable attitudes toward AM but had knowledge deficits and did not feel adept at counselling patients about AMs. All students were supportive of integrating AM into education, noting its importance in relation to the doctor-patient encounter, specifically with regard to interactions with medical management. Students recognised the need to be able to effectively communicate about AMs and advise patients regarding safe and effective AM use.
The authors of this survey concluded that Australian medical students expressed interest in, and the need for, AM education in medical education regardless of their opinion of it, and were supportive of evidence-based AMs being part of their armamentarium. However, current levels of AM education in medical schools do not adequately enable this. This level of receptivity suggests the need for AM education with firm recommendations and competencies to assist AM education development required. Identifying this need may help medical educators to respond more effectively.
One might object to such wide-reaching conclusions based on a sample size of just 30. However, there are several similar surveys from other parts of the world which seem to paint a similar picture: most medical students clearly do want to learn about AM. But this issue raises several important questions:
- How can this be squeezed into the already over-full curriculum?
- Should students learn about AM or should they learn how to practice AM?
- Who should teach this subject?
In my view, students should learn the essentials about AM but not how to do this or that therapy. Most deans of medical schools seem to agree with me on that particular point.
The question as to who should teach students about AM is, however, much more contentious. Most conventional medical instructors have no interest in and/or no knowledge of the subject. Consequently, there is a tendency for medical schools to delegate AM by hiring a few alternative practitioners to cover AM. Thus we see homeopaths teaching medical students all (well, almost all) about homeopathy, acupuncturists teaching acupuncture, herbalists teaching herbal medicine etc. To many observers, this might sound right and reasonable – but I beg to differ resolutely.
Most alternative practitioners who I have met (and these were many over the last 20 years) are clearly not capable of teaching their own subject in a way that befits a medical school. They have little or no idea about the nature of scientific evidence and usually lack the slightest hint of critical analysis. Thus a homeopaths might teach homeopathy such that students get the impression that it is well grounded in evidence, for instance. Students who have been taught in this fashion are not likely to advise their future patients responsibly on the subject in question: THE TEACHING OF NONSENSE IS BOUND TO RESULT IN NONSENSICAL PRACTICE!
In my view, AM is an ideal subject to acquaint medical students with the concepts of critical thinking. In this respect, it offers an almost opportunity for medical schools to develop much-needed skills in their students. Sadly, however, this is not what is currently happening. All too often, medical school deans find themselves caught between the devil and the deep blue sea. In the end, they tend to delegate the subject of AM to people who are not competent and should not be let loose on impressionable students.
I fear that progress and care of future patients are bound to suffer.
Distant healing is one of the most bizarre yet popular forms of alternative medicine. Healers claim they can transmit ‘healing energy’ towards patients to enable them to heal themselves. There have been many trials testing the effectiveness of the method, and the general consensus amongst critical thinkers is that all variations of ‘energy healing’ rely entirely on a placebo response. A recent and widely publicised paper seems to challenge this view.
This article has, according to its authors, two aims. Firstly it reviews healing studies that involved biological systems other than ‘whole’ humans (e.g., studies of plants or cell cultures) that were less susceptible to placebo-like effects. Secondly, it presents a systematic review of clinical trials on human patients receiving distant healing.
All the included studies examined the effects upon a biological system of the explicit intention to improve the wellbeing of that target; 49 non-whole human studies and 57 whole human studies were included.
The combined weighted effect size for non-whole human studies yielded a highly significant (r = 0.258) result in favour of distant healing. However, outcomes were heterogeneous and correlated with blind ratings of study quality; 22 studies that met minimum quality thresholds gave a reduced but still significant weighted r of 0.115.
Whole human studies yielded a small but significant effect size of r = .203. Outcomes were again heterogeneous, and correlated with methodological quality ratings; 27 studies that met threshold quality levels gave an r = .224.
From these findings, the authors drew the following conclusions: Results suggest that subjects in the active condition exhibit a significant improvement in wellbeing relative to control subjects under circumstances that do not seem to be susceptible to placebo and expectancy effects. Findings with the whole human database suggests that the effect is not dependent upon the previous inclusion of suspect studies and is robust enough to accommodate some high profile failures to replicate. Both databases show problems with heterogeneity and with study quality and recommendations are made for necessary standards for future replication attempts.
In a press release, the authors warned: the data need to be treated with some caution in view of the poor quality of many studies and the negative publishing bias; however, our results do show a significant effect of healing intention on both human and non-human living systems (where expectation and placebo effects cannot be the cause), indicating that healing intention can be of value.
My thoughts on this article are not very complimentary, I am afraid. The problems are, it seems to me, too numerous to discuss in detail:
- The article is written such that it is exceedingly difficult to make sense of it.
- It was published in a journal which is not exactly known for its cutting edge science; this may seem a petty point but I think it is nevertheless important: if distant healing works, we are confronted with a revolution in the understanding of nature – and surely such a finding should not be buried in a journal that hardly anyone reads.
- The authors seem embarrassingly inexperienced in conducting and publishing systematic reviews.
- There is very little (self-) critical input in the write-up.
- A critical attitude is necessary, as the primary studies tend to be by evangelic believers in and amateur enthusiasts of healing.
- The article has no data table where the reader might learn the details about the primary studies included in the review.
- It also has no table to inform us in sufficient detail about the quality assessment of the included trials.
- It seems to me that some published studies of distant healing are missing.
- The authors ignored all studies that were not published in English.
- The method section lacks detail, and it would therefore be impossible to conduct an independent replication.
- Even if one ignored all the above problems, the effect sizes are small and would not be clinically important.
- The research was sponsored by the ‘Confederation of Healing Organisations’ and some of the comments look as though the sponsor had a strong influence on the phraseology of the article.
Given these reservations, my conclusion from an analysis of the primary studies of distant healing would be dramatically different from the one published by the authors: DESPITE A SIZABLE AMOUNT OF PRIMARY STUDIES ON THE SUBJECT, THE EFFECTIVENESS OF DISTANT HEALING REMAINS UNPROVEN. AS THIS THERAPY IS BAR OF ANY BIOLOGICAL PLAUSIBILITY, FURTHER RESEARCH IN THIS AREA SEEMS NOT WARRANTED.
Twenty years ago, I published a short article in the British Journal of Rheumatology. Its title was ALTERNATIVE MEDICINE, THE BABY AND THE BATH WATER. Reading it again today – especially in the light of the recent debate (with over 700 comments) on acupuncture – indicates to me that very little has since changed in the discussions about alternative medicine (AM). Does that mean we are going around in circles? Here is the (slightly abbreviated) article from 1995 for you to judge for yourself:
“Proponents of alternative medicine (AM) criticize the attempt of conducting RCTs because they view this is in analogy to ‘throwing out the baby with the bath water’. The argument usually goes as follows: the growing popularity of AM shows that individuals like it and, in some way, they benefit through using it. Therefore it is best to let them have it regardless of its objective effectiveness. Attempts to prove or disprove effectiveness may even be counterproductive. Should RCTs prove that a given intervention is not superior to a placebo, one might stop using it. This, in turn, would be to the disadvantage of the patient who, previous to rigorous research, has unquestionably been helped by the very remedy. Similar criticism merely states that AM is ‘so different, so subjective, so sensitive that it cannot be investigated in the same way as mainstream medicine’. Others see reasons to change the scientific (‘reductionist’) research paradigm into a broad ‘philosophical’ approach. Yet others reject the RCTs because they think that ‘this method assumes that every person has the same problems and there are similar causative factors’.
The example of acupuncture as a (popular) treatment for osteoarthritis, demonstrates the validity of such arguments and counter-arguments. A search of the world literature identified only two RCTs on the subject. When acupuncture was tested against no treatment, the experimental group of osteoarthritis sufferers reported a 23% decrease of pain, while the controls suffered a 12% increase. On the basis of this result, it might seem highly unethical to withhold acupuncture from pain-stricken patients—’if a patient feels better for whatever reason and there are no toxic side effects, then the patient should have the right to get help’.
But what about the placebo effect? It is notoriously difficult to find a placebo indistinguishable to acupuncture which would allow patient-blinded studies. Needling non-acupuncture points may be as close as one can get to an acceptable placebo. When patients with osteoarthritis were randomized into receiving either ‘real acupuncture or this type of sham acupuncture both sub-groups showed the same pain relief.
These findings (similar results have been published for other AMs) are compatible only with two explanations. Firstly acupuncture might be a powerful placebo. If this were true, we need to establish how safe acupuncture is (clearly it is not without potential harm); if the risk/benefit ratio is favourable and no specific, effective form of therapy exists one might still consider employing this form as a ‘placebo therapy’ for easing the pain of osteoarthritis sufferers. One would also feel motivated to research this powerful placebo and identify its characteristics or modalities with the aim of using the knowledge thus generated to help future patients.
Secondly, it could be the needling, regardless of acupuncture points and philosophy, that decreases pain. If this were true, we could henceforward use needling for pain relief—no special training in or equipment for acupuncture would be required, and costs would therefore be markedly reduced. In addition, this knowledge would lead us to further our understanding of basic mechanisms of pain reduction which, one day, might evolve into more effective analgesia. In any case the published research data, confusing as they often are, do not call for a change of paradigm; they only require more RCTs to solve the unanswered problems.
Conducting rigorous research is therefore by no means likely to ‘throw out the baby with the bath water’. The concept that such research could harm the patient is wrong and anti-scientific. To follow its implications would mean neglecting the ‘baby in the bath water’ until it suffers serious damage. To conduct proper research means attending the ‘baby’ and making sure that it is safe and well.
In the realm of homeopathy there is no shortage of irresponsible claims. I am therefore used to a lot – but this new proclamation takes the biscuit, particularly as it currently is being disseminated in various forms worldwide. It is so outrageously unethical that I decided to reproduce it here [in a slightly shortened version]:
“Homeopathy has given rise to a new hope to patients suffering from dreaded HIV, tuberculosis and the deadly blood disease Hemophilia. In a pioneering two-year long study, city-based homeopath Dr Rajesh Shah has developed a new medicine for AIDS patients, sourced from human immunodeficiency virus (HIV) itself.
The drug has been tested on humans for safety and efficacy and the results are encouraging, said Dr Shah. Larger studies with and without concomitant conventional ART (Antiretroviral therapy) can throw more light in future on the scope of this new medicine, he said. Dr Shah’s scientific paper for debate has just been published in Indian Journal of Research in Homeopathy…
The drug resulted in improvement of blood count (CD4 cells) of HIV patients, which is a very positive and hopeful sign, he said and expressed the hope that this will encourage an advanced research into the subject. Sourcing of medicines from various virus and bacteria has been a practise in the homeopathy stream long before the prevailing vaccines came into existence, said Dr Shah, who is also organising secretary of Global Homeopathy Foundation (GHF)…
Dr Shah, who has been campaigning for the integration of homeopathy and allopathic treatments, said this combination has proven to be useful for several challenging diseases. He teamed up with noted virologist Dr Abhay Chowdhury and his team at the premier Haffkine Institute and developed a drug sourced from TB germs of MDR-TB patients.”
So, where is the study? It is not on Medline, but I found it on the journal’s website. This is what the abstract tells us:
“Thirty-seven HIV-infected persons were registered for the trial, and ten participants were dropped out from the study, so the effect of HIV nosode 30C and 50C, was concluded on 27 participants under the trial.
Results: Out of 27 participants, 7 (25.93%) showed a sustained reduction in the viral load from 12 to 24 weeks. Similarly 9 participants (33.33%) showed an increase in the CD4+ count by 20% altogether in 12 th and 24 th week. Significant weight gain was observed at week 12 (P = 0.0206). 63% and 55% showed an overall increase in either appetite or weight. The viral load increased from baseline to 24 week through 12 week in which the increase was not statistically significant (P > 0.05). 52% (14 of 27) participants have shown either stability or improvement in CD4% at the end of 24 weeks, of which 37% participants have shown improvement (1.54-48.35%) in CD4+ count and 15% had stable CD4+ percentage count until week 24 week. 16 out of 27 participants had a decrease (1.8-46.43%) in CD8 count. None of the adverse events led to discontinuation of study.
Conclusion: The study results revealed improvement in immunological parameters, treatment satisfaction, reported by an increase in weight, relief in symptoms, and an improvement in health status, which opens up possibilities for future studies.”
In other words, the study had not even a control group. This means that the observed ‘effects’ are most likely just the normal fluctuations one would expect without any clinical significance whatsoever.
The homeopathic Ebola cure was bad enough, I thought, but, considering the global importance of AIDS, the homeopathic HIV treatment is clearly worse.