conflict of interest
Irritable bowel syndrome (IBS) is common and often difficult to treat – unless, of course, you consult a homeopath. Here is just one of virtually thousands of quotes from homeopaths available on the Internet: Homeopathic medicine can reduce Irritable Bowel Syndrome (IBS) symptoms by lowering food sensitivities and allergies. Homeopathy treats the patient as a whole and does not simply focus on the disease. Careful attention is given to the minute details about the presenting complaints, including the severity of diarrhea, constipation, pain, cramps, mucus in the stools, nausea, heartburn, emotional triggers and conventional laboratory findings. In addition, the patient’s eating habits, food preferences, thermal attributes and sleep patterns are noted. The patient’s family history and diseases, along with the patient’s emotions are discussed. Then the homeopathic practitioner will select the remedy that most closely matches the symptoms.
Such optimism might be refreshing, but is there any reason for it? Is homeopathy really an effective treatment for IBS? To answer this question, we now have a brand-new Cochrane review. The aim of this review was to assess the effectiveness and safety of homeopathic treatment for treating irritable bowel syndrome (IBS). (This type of statement always makes me a little suspicious; how on earth can anyone truly assess the safety of a treatment by looking at a few studies? This is NOT how one evaluates safety!) The authors conducted extensive literature searches to identify all RCTs, cohort and case-control studies that compared homeopathic treatment with placebo, other control treatments, or usual care in adults with IBS. The primary outcome was global improvement in IBS.
Three RCTs with a total of 213 participants were included. No cohort or case-control studies were identified. Two studies compared homeopathic remedies to placebos for constipation-predominant IBS. One study compared individualised homeopathic treatment to usual care defined as high doses of dicyclomine hydrochloride, faecal bulking agents and a high fibre diet. Due to the low quality of reporting, the risk of bias in all three studies was unclear on most criteria and high for some criteria.
A meta-analysis of two studies with a total of 129 participants with constipation-predominant IBS found a statistically significant difference in global improvement between the homeopathic ‘asafoetida’ and placebo at a short-term follow-up of two weeks. Seventy-three per cent of patients in the homeopathy group improved compared to 45% of placebo patients. There was no statistically significant difference in global improvement between the homeopathic asafoetida plus nux vomica compared to placebo. Sixty-eight per cent of patients in the homeopathy group improved compared to 52% of placebo patients.
The overall quality of the evidence was very low. There was no statistically significant difference between individualised homeopathic treatment and usual care for the outcome “feeling unwell”. None of the studies reported on adverse events (which, by the way, should be seen as a breech in research ethics on the part of the authors of the three primary studies).
The authors concluded that a pooled analysis of two small studies suggests a possible benefit for clinical homeopathy, using the remedy asafoetida, over placebo for people with constipation-predominant IBS. These results should be interpreted with caution due to the low quality of reporting in these trials, high or unknown risk of bias, short-term follow-up, and sparse data. One small study found no statistically difference between individualised homeopathy and usual care (defined as high doses of dicyclomine hydrochloride, faecal bulking agents and diet sheets advising a high fibre diet). No conclusions can be drawn from this study due to the low number of participants and the high risk of bias in this trial. In addition, it is likely that usual care has changed since this trial was conducted. Further high quality, adequately powered RCTs are required to assess the efficacy and safety of clinical and individualised homeopathy compared to placebo or usual care.
THIS REVIEW REQUIRES A FEW FURTHER COMMENTS, I THINK
Asafoetida, the remedy used in two of the studies, is a plant native to Pakistan, Iran and Afghanistan. It is used in Ayurvedic herbal medicine to treat colic, intestinal parasites and irritable bowel syndrome. In the ‘homeopathic’ trials, asafoetida was used in relatively low dilutions, one that still contains molecules. It is therefore debatable whether this was really homeopathy or whether it is more akin to herbal medicine – it was certainly not homeopathy with its typical ultra-high dilutions.
Regardless of this detail, the Cochrane review does hardly provide sound evidence for homeopathy’s efficacy. On the contrary, my reading of its findings is that the ‘possible benefit’ is NOT real but a false positive result caused by the serious limitations of the original studies. The authors stress that the apparently positive result ‘should be interpreted with caution’; that is certainly correct.
So, if you are a proponent of homeopathy, as the authors of the review seem to be, you will claim that homeopathy offers ‘possible benefits’ for IBS-sufferers. But if you are not convinced of the merits of homeopathy, you might suggest that the evidence is insufficient to recommend homeopathy. I imagine that IBS-sufferers might get as frustrated with such confusion as most scientists will be. Yet there is hope; the answer could be imminent: apparently, a new trial is to report its results within this year.
IS THIS NEW TRIAL GOING TO CONTRIBUTE MEANINGFULLY TO OUR KNOWLEDGE?
It is a three-armed study (same 1st author as in the Cochrane review) which, according to its authors, seeks to explore the effectiveness of individualised homeopathic treatment plus usual care compared to both an attention control plus usual care and usual care alone, for patients with IBS. (Why “explore” and not “determine”, I ask myself.) Patients are randomly selected to be offered, 5 sessions of homeopathic treatment plus usual care, 5 sessions of supportive listening plus usual care or usual care alone. (“To be offered” looks odd to me; does that mean patients are not blinded to the interventions? Yes, indeed it does.) The primary clinical outcome is the IBS Symptom Severity at 26 weeks. Analysis will be by intention to treat and will compare homeopathic treatment with usual care at 26 weeks as the primary analysis, and homeopathic treatment with supportive listening as an additional analysis.
Hold on…the primary analysis “will compare homeopathic treatment with usual care“. Are they pulling my leg? They just told me that patients will be “offered, 5 sessions of homeopathic treatment plus usual care… or usual care alone“.
Oh, I see! We are again dealing with an A+B versus B design, on top of it without patient- or therapist-blinding. This type of analysis cannot ever produce a negative result, even if the experimental treatment is a pure placebo: placebo + usual care is always more than usual care alone. IBS-patients will certainly experience benefit from having the homeopaths’ time, empathy and compassion – never mind the remedies they get from them. And for the secondary analyses, things do not seem to be much more rigorous either.
Do we really need more trials of this nature? The Cochrane review shows that we currently have three studies which are too flimsy to be interpretable. What difference will a further flimsy trial make in this situation? When will we stop wasting time and money on such useless ‘research’? All it can possibly achieve is that apologists of homeopathy will misinterpret the results and suggest that they demonstrate efficacy.
Obviously, I have not seen the data (they have not yet been published) but I think I can nevertheless predict the conclusions of the primary analysis of this trial; they will read something like this: HOMEOPATHY PROVED TO BE SIGNIFICANTLY MORE EFFECTIVE THAN USUAL CARE. I have asked the question before and I do it again: when does this sort of ‘research’ cross the line into the realm of scientific misconduct?
If we ask how effective spinal manipulation is as a treatment of back pain, we get all sorts of answers. Therapists who earn their money with it – mostly chiropractors, osteopaths and physiotherapists – are obviously convinced that it is effective. But if we consult more objective sources, the picture changes dramatically. The current Cochrane review, for instance, arrives at this conclusion: SMT is no more effective in participants with acute low-back pain than inert interventions, sham SMT, or when added to another intervention. SMT also appears to be no better than other recommended therapies.
Such reviews tend to pool all studies together regardless of the nature of the practitioner. But perhaps one type of clinician is better than the next? Certainly many chiropractors are on record claiming that they are the best at spinal manipulations. Yet it is conceivable that physiotherapists who do manipulations without being guided by the myth of ‘adjusting subluxations’ have an advantage over chiropractors. Three very recent systematic reviews might go some way to answer these questions.
The purpose of the first systematic review was to examine the effectiveness of spinal manipulations performed by physiotherapists for the treatment of patients with low back pain. The authors found 6 RCTs that met their inclusion criteria. The most commonly used outcomes were pain rating scales and disability indexes. Notable results included varying degrees of effect sizes favouring spinal manipulations and minimal adverse events resulting from this intervention. Additionally, the manipulation group in one study reported significantly less medication use, health care utilization, and lost work time. The authors concluded that there is evidence to support the use of spinal manipulation by physical therapists in clinical practice. Physical therapy spinal manipulation appears to be a safe intervention that improves clinical outcomes for patients with low back pain.
The second systematic Review was of osteopathic intervention for chronic, non-specific low back pain (CNSLBP). Only two trials met the authors’ inclusion criteria. They had a lack of methodological and clinical homogeneity, precluding a meta-analysis. The trials used different comparators with regards to the primary outcomes, the number of treatments, the duration of treatment and the duration of follow-up. The authors drew the following conclusions: There are only two studies assessing the effect of the manual therapy intervention applied by osteopathic clinicians in adults with CNSLBP. One trial concluded that the osteopathic intervention was similar in effect to a sham intervention, and the other suggests similarity of effect between osteopathic intervention, exercise and physiotherapy. Further clinical trials into this subject are required that have consistent and rigorous methods. These trials need to include an appropriate control and utilise an intervention that reflects actual practice.
The third systematic review sought to determine the benefits of chiropractic treatment and care for back pain on well-being, and aimed to explore to what extent chiropractic treatment and care improve quality of life. The authors identified 6 studies (4 RCTs and two observational studies) of varying quality. There was a high degree of inconsistency and lack of standardisation in measurement instruments and outcome measures. Three studies reported reduced use of other/extra treatments as a positive outcome; two studies reported a positive effect of chiropractic intervention on pain, and two studies reported a positive effect on disability. The authors concluded that it is difficult to defend any conclusion about the impact of chiropractic intervention on the quality of life, lifestyle, health and economic impact on chiropractic patients presenting with back pain.
Yes, yes, yes, I know: the three reviews are not exactly comparable; so we cannot draw firm conclusions from comparing them. Five points seem to emerge nevertheless:
- The evidence for spinal manipulation as a treatment for back pain is generally not brilliant, regardless of the type of therapist.
- There seem to be considerable differences according to the nature of the therapist.
- Physiotherapists seem to have relatively sound evidence to justify their manipulations.
- Chiropractors and osteopaths are not backed by evidence which is as reliable as they so often try to make us believe.
- Considering that the vast majority of serious complications after spinal manipulation has occurred with chiropractors, it would seem that chiropractors are the profession with the worst track record regarding manipulation for back pain.
Some sceptics are convinced that, in alternative medicine, there is no evidence. This assumption is wrong, I am afraid, and statements of this nature can actually play into the hands of apologists of bogus treatments: they can then easily demonstrate the sceptics to be mistaken or “biased”, as they would probably say. The truth is that there is plenty of evidence – and lots of it is positive, at least at first glance.
Alternative medicine researchers have been very industrious during the last two decades to build up a sizable body of ‘evidence’. Consequently, one often finds data even for the most bizarre and implausible treatments. Take, for instance, the claim that homeopathy is an effective treatment for cancer. Those who promote this assumption have no difficulties in locating some weird in-vitro study that seems to support their opinion. When sceptics subsequently counter that in-vitro experiments tell us nothing about the clinical situation, apologists quickly unearth what they consider to be sound clinical evidence.
An example is this prospective observational 2011 study of cancer patients from two differently treated cohorts: one cohort with patients under complementary homeopathic treatment (HG; n = 259), and one cohort with conventionally treated cancer patients (CG; n = 380). Its main outcome measures were the change of quality life after 3 months, after one year and impairment by fatigue, anxiety or depression. The results of this study show significant improvements in most of these endpoints, and the authors concluded that we observed an improvement of quality of life as well as a tendency of fatigue symptoms to decrease in cancer patients under complementary homeopathic treatment.
Another, in some ways even better example is this 2005 observational study of 6544 consecutive patients from the Bristol Homeopathic Hospital. Every patient attending the hospital outpatient unit for a follow-up appointment was included, commencing with their first follow-up attendance. Of these patients 70.7% (n = 4627) reported positive health changes, with 50.7% (n = 3318) recording their improvement as better or much better. The authors concluded that homeopathic intervention offered positive health changes to a substantial proportion of a large cohort of patients with a wide range of chronic diseases.
The principle that is being followed here is simple:
- believers in a bogus therapy conduct a clinical trial which is designed to generate an apparently positive finding;
- the fact that the study cannot tell us anything about cause and effect is cleverly hidden or belittled;
- they publish their findings in one of the many journals that specialise in this sort of nonsense;
- they make sure that advocates across the world learn about their results;
- the community of apologists of this treatment picks up the information without the slightest critical analysis;
- the researchers conduct more and more of such pseudo-research;
- nobody attempts to do some real science: the believers do not truly want to falsify their hypotheses, and the real scientists find it unreasonable to conduct research on utterly implausible interventions;
- thus the body of false or misleading ‘evidence’ grows and grows;
- proponents start publishing systematic reviews and meta-analyses of their studies which are devoid of critical input;
- too few critics point out that these reviews are fatally flawed – ‘rubbish in, rubbish out’!
- eventually politicians, journalists, health care professionals and other people who did not necessarily start out as believers in the bogus therapy are convinced that the body of evidence is impressive and justifies implementation;
- important health care decisions are thus based on data which are false and misleading.
So, what can be done to prevent that such pseudo-evidence is mistaken as solid proof which might eventually mislead many into believing that bogus treatments are based on reasonably sound data? I think the following measures would be helpful:
- authors should abstain from publishing over-enthusiastic conclusions which can all too easily be misinterpreted (given that the authors are believers in the therapy, this is not a realistic option);
- editors might consider rejecting studies which contribute next to nothing to our current knowledge (given that these studies are usually published in journals that are in the business of promoting alternative medicine at any cost, this option is also not realistic);
- if researchers report highly preliminary findings, there should be an obligation to do further studies in order to confirm or refute the initial results (not realistic either, I am afraid);
- in case this does not happen, editors should consider retracting the paper reporting unconfirmed preliminary findings (utterly unrealistic).
What then can REALISTICALLY be done? I wish I knew the answer! All I can think of is that sceptics should educate the rest of the population to think and analyse such ‘evidence’ critically…but how realistic is that?
According to its authors, this RCT was aimed at investigating the 1) specific effect of individualized homeopathic Q-potencies compared to placebo and 2) the effect of an extensive homeopathic case taking (case history I) compared to a shorter, rather conventional one (case history II) in the treatment of acute major depression. In particular the second research question is intriguing, I think – so let’s have a closer look at this trial.
The study was designed as a randomized, partially double-blind, placebo-controlled, four-armed, 2×2 factorial trial with a 6-week study duration. A total of 44 patients were randomized (2∶1∶2∶1 randomization: 16 homeopathic Q-potencies/case history I, 7 placebo/case history I, 14 homeopathic Q-potencies/case history II, 7 placebo/case history II). Because of recruitment problems, the study was terminated prior to full recruitment, and was thus underpowered for the pre-planned confirmatory hypothesis testing. Exploratory data analyses showed heterogeneous and inconclusive results with large variance. The mean difference for the Hamilton-D after 6 weeks was 2.0 (95%CI -1.2;5.2) for Q-potencies vs. placebo, and -3.1 (-5.9;-0.2) for case history I vs. case history II. Overall, no consistent or clinically relevant results between homeopathic Q-potencies versus placebo and homeopathic versus conventional case taking were observed. The frequency of adverse events was comparable for all groups.
The conclusions were remarkable: although our results are inconclusive, given that recruitment into this trial was very difficult and we had to terminate early, we cannot recommend undertaking a further trial addressing this question in a similar setting.
Alright, the authors encountered problems in recruiting enough patients and they therefore decided to stop the trial early. This sort of thing happens. Most researchers would then not publish any data at all. This team, however, did publish a report, and the decision to do so might be perfectly fine: other investigators might learn from the problems which led to early termination of the study.
But why do they conclude that the results were INCONCLUSIVE? I think the results were not inconclusive but non-existent; these were no results to report other than those related to the recruitment problems. And even if one insists on presenting outcome data as an exploratory analysis, one cannot honestly say they were INCONCLUSIVE, all one might state in this case is that the results failed to show an effect of the remedy or the consultation. This is far less favourable for homeopathy than stating the results were INCONCLUSIVE.
And why on earth do the authors conclude “we cannot recommend undertaking a further trial addressing this question in a similar setting”? This does not make the slightest sense to me. If the trialists encountered recruitment problems, others might find ways of overcoming them. The research question asking whether the effects of an extensive homeopathic case taking differ from those of a shorter conventional one seems important. If answered accurately, it could disentangle much of the confusion that surrounds clinical trials of homeopathy.
I have repeatedly commented on the odd conclusions drawn by proponents of alternative medicine on the basis of data that did not quite fulfil their expectations, and I often ask myself at what point this ‘prettification’ of the results via false positive conclusions crosses the line to scientific misconduct. My theory is that these conclusions appear odd to those capable of critical analysis because the authors bend over backwards in order to conclude more positively than the data would seem to permit. If we see it this way, such conclusions might even prove useful as a fairly sensitive ‘bullshit-detector’.
A most excellent comment by Donald Marcus on what many now call ‘quackademia‘ (the disgraceful practice of teaching quackery (alternology) such as homoeopathy, acupuncture or chiropractic at universities as if they were legitimate medical professions) has recently been published in the BMJ.
Please allow me to quote extensively from it:
A detailed review of curriculums created by 15 institutions that received educational grants from the National Center for Complementary and Alternative Medicine (NCCAM) showed that they failed to conform to the principles of evidence based medicine. In brief, they cited many poor quality clinical trials that supported the efficacy of alternative therapies and omitted negative clinical trials; they had not been updated for 6-7 years; and they omitted reports of serious adverse events associated with CAM therapies, especially with chiropractic manipulation and with non-vitamin, non-mineral dietary supplements such as herbal remedies. Representation of the curriculums as “evidence based” was inaccurate and unjustified. Similar defects were present in the curriculums of other integrative medicine programs that did not receive educational grants….
A re-examination of the integrative medicine curriculums reviewed previously showed that they were essentially unchanged since their creation in 2002-03…Why do academic centers that are committed to evidence based medicine and to comparative effectiveness analysis of treatments endorse CAM? One factor may be a concern about jeopardizing income from grants from NCCAM, from CAM clinical practice, and from private foundations that donate large amounts of money to integrative medicine centers. Additional factors may be concern about antagonizing faculty colleagues who advocate and practice CAM, and inadequate oversight of curriculums.
By contrast to the inattention of US academics and professional societies to CAM education, biomedical scientists in Great Britain and Australia have taken action. At the beginning of 2007, 16 British universities offered 45 bachelor of science degrees in alternative practices. As the result of a campaign to expose the lack of evidence supporting those practices, most courses in alternative therapies offered by public universities in Britain have been discontinued. Scientists, physicians, and consumer advocates in Australia have formed an organization, Friends of Science in Medicine, to counter the growth of pseudoscience in medicine.
The CAM curriculums violate every tenet of evidence based medicine, and they are a disservice to learners and to the public. It could be argued that, in the name of academic freedom, faculty who believe in the benefits of CAM have a right to present their views. However, as educators and role models they should adhere to the principles of medical professionalism, including “a duty to uphold scientific standards.” Faculty at health profession schools should urge administrators to appoint independent committees to review integrative medicine curriculums, and to consider whether provision of CAM clinical services is consistent with a commitment to scholarship and to evidence based healthcare.
One of the first who openly opposed science degrees without science was David Colquhoun; in an influential article published in Nature, he wrote:
The least that one can expect of a bachelor of science (BSc) honours degree is that the subject of the degree is science. Yet in December 2006 the UK Universities and Colleges Admissions Service advertised 61 courses for complementary medicine, of which 45 are BSc honours degrees. Most complementary and alternative medicine (CAM) is not science because the vast majority of it is not based on empirical evidence. Homeopathy, for example, has barely changed since the beginning of the nineteenth century. It is much more like religion than science. Worse still, many of the doctrines of CAM, and quite a lot of its practitioners, are openly anti-science.
More recently, Louise Lubetkin wrote in her post ‘Quackademia‘ that alternative medicine and mainstream medicine are absolutely not equivalent, nor are they by any means interchangeable, and to speak about them the way one might when debating whether to take the bus or the subway to work – both will get you there reliably – constitutes an assault on truth.
I think ‘quackademia’ is most definitely an assault on truth – and I certainly know what I am talking about. When, in 1993, I was appointed as Professor of Complementary Medicine at Exeter, I became the director of a pre-existing team of apologists teaching a BSc-course in alternative medicine to evangelic believers. I was horrified and had to use skill, diplomacy and even money to divorce myself from this unit, an experience which I will not forget in a hurry. In fact, I am currently writing it up for a book I hope to publish soon which covers not only this story but many similarly bizarre encounters I had while researching alternative medicine during the last two decades.
According to a recent comment by Dr Larry Dossey, sceptics are afflicted by “randomania,” “statisticalitis,” “coincidentitis,” or “ODD” (Obsessive Debunking Disorder). I thought his opinion was hilariously funny; it shows that this prominent apologist of alternative medicine who claims that he is deeply rooted in the scientific world has, in fact, understood next to nothing about the scientific method. Like all quacks who have run out of rational arguments, he resorts to primitive ad hominem attacks in order to defend his bizarre notions. It also suggests that he could do with a little scepticism himself, perhaps.
In case anyone wonders how the long-obsolete notions of vitalism, which Dossey promotes, not just survive but are becoming again wide-spread, they only need to look into the best-selling books of Dossey and other vitalists. And it is not just lay people, the target audience of such books, who are taken by such nonsense. Health care professionals are by no means immune to these remnants from the prescientific era.
A recent survey is a good case in point. It was aimed at exploring US student pharmacists’ attitudes toward complementary and alternative medicine (CAM) and examine factors shaping students’ attitudes. In total, 887 student pharmacists in 10 U.S. colleges/schools of pharmacy took part. Student pharmacists’ attitudes regarding CAM were quantified using the attitudes toward CAM scale (15 items), attitudes toward specific CAM therapies (13 items), influence of factors (e.g., coursework, personal experience) on attitudes (18 items), and demographic characteristics (15 items).
The results show a mean (±SD) score on the attitudes toward CAM scale of 52.57 ± 7.65 (of a possible 75; higher score indicated more favorable attitudes). There were strong indications that students agreed with the concepts of vitalism. When asked about specific CAMs, many students revealed positive views even on the least plausible and least evidence-based modalities like homeopathy or Reiki.
Unsurprisingly, students agreed that a patient’s health beliefs should be integrated in the patient care process and that knowledge about CAM would be required in future pharmacy practice. Scores on the attitudes toward CAM scale varied by gender, race/ethnicity, type of institution, previous CAM coursework, and previous CAM use. Personal experience, pharmacy education, and family background were important factors shaping students’ attitudes.
The authors concluded: Student pharmacists hold generally favorable views of CAM, and both personal and educational factors shape their views. These results provide insight into factors shaping future pharmacists’ perceptions of CAM. Additional research is needed to examine how attitudes influence future pharmacists’ confidence and willingness to talk to patients about CAM.
I find the overwhelmingly positive views of pharmacists on even over quackery quite troubling. One of the few critical pharmacists shares my worries and commented that this survey on CAM attitudes paints a concerning portrait of American pharmacy students. However, limitations in the survey process may have created biases that could have exaggerated the overall perspective presented. More concerning than the results themselves are the researchers’ interpretation of this data: Critical and negative perspectives on CAM seem to be viewed as problematic, rather than positive examples of good critical thinking.
One lesson from surveys like these is they illustrate the educational goals of CAM proponents. Just like “integrative” medicine that is making its ways into academic hospital settings, CAM education on campus is another tactic that is being used by proponents to shape health professional attitudes and perspectives early in their careers. The objective is obvious: normalize pseudoscience with students, and watch it become embedded into pharmacy practice.
Is this going to change? Unless there is a deliberate and explicit attempt to call out and push back against the degradation of academic and scientific standards created by existing forms of CAM education and “integrative medicine” programs, we should expect to see a growing normalizing of pseudoscience in health professions like pharmacy.
I have criticised pharmacists’ attitude and behaviour towards alternative medicine more often than I care to remember. I even contributed an entire series of articles (around 10; I forgot the precise number) to THE PHARMACEUTICAL JOURNAL in an attempt to stimulate their abilities to think critically about alternative medicine. Pharmacists could certainly do with a high dose of “randomania,” “statisticalitis,” “coincidentitis,” or “ODD” (Obsessive Debunking Disorder). In particular, pharmacists who sell bogus remedies, i.e. virtually all retail pharmacists, need to remember that
- they are breaking their own ethical code
- they are putting profit before responsible health care
- by selling bogus products, they give credibility to quackery
- they are risking their reputation as professionals who provide evidence-based advice to the public
- they might seriously endanger the health of many of their customers
In discussions about these issues, pharmacists usually defend themselves and argue that
- those working in retail chains cannot do anything about this situation; head office decides what is sold on their premises and what not
- many medicinal products we sell are as bogus as the alternative medicines in question
- other health care professions are also not perfect, blameless or free of fault and error
- many pharmacists, particularly those not working in retail, are aware of this lamentable situation but cannot do anything about it
- retail pharmacists are both shopkeepers and health care professionals and are trying their very best to cope with this difficult dual role
- we usually appreciate your work and critical comments but, in this case, you are talking nonsense
I do not agree with any of these arguments. Of course, each single individual pharmacist is fairly powerless when it comes to changing the system (but nobody forces anyone to work in a chain that breaks the ethical code of their profession). Yet pharmacists have their professional organisations, and it is up to each individual pharmacist to exert influence, if necessary pressure, via their professional bodies and representatives, such that eventually the system changes. In all this distasteful mess, only one thing seems certain: without a groundswell of opinion from pharmacists, nothing will happen simply because too many pharmacists are doing very nicely with fooling their customers into buying expensive rubbish.
And when eventually something does happen, it will almost certainly be a slow and long process until quackery has been fully expelled from retail pharmacies. My big concern is not so much the slowness of the process but the fact that, currently, I see virtually no groundswell of opinion that might produce anything. For the foreseeable future pharmacists seem to have decided to be content with a role as shopkeepers who do not sufficiently care about healthcare-ethics to change the status quo.
A recent article by a South African homeopath promoted the concept of homeopaths taking over the role of primary care practitioners. His argument essentially was that, in South Africa, homeopaths are well trained and thus adequately equipped to do this job responsibly. Responsibly, really? You find that hard to believe? Here are the essentials of his arguments including all his references in full. I think they are worth reading.
Currently, the Durban University of Technology (DUT) and the University of Johannesburg (UJ) offer degree’s in homoeopathy. This involves a 5-year full-time theoretical and practical training course, followed by a Master’s level research project. After fulfilment of these criteria, a Master’s Degree in Technology (Homoeopathy) is awarded. The course comprises of a strong core of medical subjects, such as the basic sciences of Anatomy, Physiology, Medical Microbiology, Biochemistry and Epidemiology, and the clinical sciences of Pathology and Diagnostics. This is complemented with subjects in Classical, Clinical and Modern Homoeopathy and Homoeopharmaceutics4,5…
By law, any person practicing homoeopathy in South Africa must be registered with the Allied Health Professions Council of South Africa (AHPCSA). This is essential, as the Council ensures both medical and homoeopathic competency of practitioners, and that the activities of registered practitioners are closely monitored by the Professional Board. The purpose of the AHPCSA is to ensure that only those with legitimate qualifications of a high enough standard are registered and allowed to practice in South Africa, thus protecting the public against any fraudulent behaviour and illegal practitioners. Therefore, in order to ensure effective homoeopathic treatment, it is essential that any person wishing to prescribe homoeopathic medicine or practice homoeopathy in South Africa must be registered as a Homoeopathic Practitioner with the Allied Health Professions Council of South Africa. This includes conventional Medical Practitioners (dual registration is allowed for Medical Practitioners with both the Health Professions Council and AHPCSA)6, as homoeopathy requires several years of training in order to apply effectively in clinical practice…
Registration with the Council affords medico-legal rights similar to those of a medical professional, where treatment is limited to the scope of homoeopathic practice. Thus a homoeopath is firstly a trained diagnostician, and with successful registration with the Council, obtains the title Doctor. A homoeopath is trained and legally obliged to conduct a full medical history, a comprehensive clinical examination, and request further medical investigations, such as blood tests and X-rays, in order to fully assess patients. This is coupled with the ability to consult with specialist pathologists and other medical specialists when necessary, and refer a patient to the appropriate practitioner if the condition falls outside the scope of homoeopathic practice. A homoeopath may also legally issue a certificate of dispensation (‘Doctor’s note’) with appropriate evidence and within reason, and is deemed responsible for the diagnosis and treatment of patients under their care6. A homoeopath is not trained or licensed in any form of surgery, specialist diagnostics (e.g. colonoscopy or angiograms), cannot prescribe prescription medication and is not lawfully allowed to conduct intra-venous treatment of any kind. However, a registered homoeopath is licensed to use intra-muscular homoeopathic injectables in the treatment of various local or systemic complaints when necessary.
Conventional (allopathic) medicine generally targets specific biochemical processes with mostly chemically synthesised medication, in an attempt to suppress a symptom. However, in doing so, this usually negatively affects other biochemical reactions which results in an imbalance within the system. Homoeopathy, by contrast, seeks to re-establish a balance within the natural functioning of the body, restore proper function and results in the reduction or cessation of symptoms. Homoeopathy therefore enables the body to self-regulate and self-heal, a process known as homeostasis that is intrinsic to every living organism.
Conventional medical treatment is by no means risk free. Iatrogenic (medically induced) deaths in the United States are estimated at 786 000 per year, deaths which are considered avoidable by medical doctors7,8. These figures put annual iatrogenic death in the American medical system above that of cardiovascular disease and cancer as the leading cause of death in that country9, a fact that is not widely reported! South African figures are not easily available, but it is likely that we have similar rates. Although conventional medications have a vital role, are sometimes necessary and can of-course be life-saving, all too often too many patients are put on chronic medication when there are numerous effective, natural, safe and scientifically substantiated options available….
According to the World Health Organisation (WHO), homeopathy is the second largest system of medicine in the world, and world-wide use continues to grow in developed and developing nations10. Homoeopathy is widely considered to be safe and effective, with both clinical and laboratory research providing evidence for the efficacy of homoeopathy11. As the range of potential conditions that homoeopathy can treat is almost limitless, and that treatment is not associated with adverse reactions, homoeopathy should be considered a first-line therapy for all ages. As homoeopaths in South Africa are considered primary health care practitioners, if a conventional approach is deemed necessary, and further diagnostics are required, your practitioner will not hesitate to refer you to the appropriate health care practitioner. Homeopathy is also used alongside conventional medicine and any other form of therapy, and should be seen as ‘complementary’ medicine and not ‘alternative’ medicine.
Homoeopathy is an approach that is widely considered to be safe, and when utilised correctly, can be effective for a wide range of conditions. As a primary health care practitioner, a homoeopath is able to handle all aspects of general practice and family health care, including diagnostics, case management and referral to other practitioners or medical specialists. A registered homoeopath is legally responsible to ensure the adequate treatment of their patients, and is accountable for all clinical decisions and advice. A registered homoeopath understands the role of conventional medicine, and will refer to the appropriate specialist in cases that fall outside the legal scope of practice.
1. http://homeopathyresource.wordpress.com/what-is-homeopathy (accessed 31 March 2010)
2. Bloch R, Lewis B. Homoeopathy for the home. Cape Town, South Africa: Struik Publishers: 2003
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I found this article extremely revealing and scary. It gives us an important glimpse into the way some or perhaps even most homeopaths think. They clearly believe that:
1) Their training is sufficient for them to become competent primary care professionals, i.e. clinicians who are the first port of call for sick people to be diagnosed and treated effectively.
2) Homeopathy is scientifically proven to be efficacious for an ‘almost limitless’ range of conditions. Interestingly, not a single reference is provided to support this claim. Nevertheless, homeopath believe it, and that seems to be enough.
3) Homeopaths seem convinced that they perfectly understand real medicine; yet all they really do is to denounce it as one of the biggest killer of mankind.
4) The fact that homeopaths cannot prescribe real medicine is not seen as a hindrance to their role as primary care practitioner; if anything, homeopaths consider this to be an advantage.
5) Homeopaths view registration with some sort of governing body as the ultimate legitimation of their trade. Once such regulatory measures are in place, the need to support any of their claims with evidence is nil and void.
This article did remind me of the wry statement that ‘HOMEOPATHY IS TO MEDICINE WHAT THE CARPET INDUSTRY IS TO AVIATION’. Homeopaths truly live on a different planet, a planet where belief is everything and responsibility is an alien concept. I certainly hope that they will not take over planet earth in a hurry. If I imagine a world where homeopaths dominate primary care in the way it is suggested in this article, I start having nightmares. It seems to me that people who harbour ideas of this type are not just deluded to the point of madness but they are a danger to public health.
This post will probably work best, if you have read the previous one describing how the parallel universe of acupuncture research insists on going in circles in order to avoid admitting that their treatment might not be as effective as they pretend. The way they achieve this is fairly simple: they conduct trials that are designed in such a way that they cannot possibly produce a negative result.
A brand-new investigation which was recently vociferously touted via press releases etc. as a major advance in proving the effectiveness of acupuncture is an excellent case in point. According to its authors, the aim of this study was to evaluate acupuncture versus usual care and counselling versus usual care for patients who continue to experience depression in primary care. This sounds alright, but wait!
755 patients with depression were randomised to one of three arms to 1)acupuncture, 2)counselling, and 3)usual care alone. The primary outcome was the difference in mean Patient Health Questionnaire (PHQ-9) scores at 3 months with secondary analyses over 12 months follow-up. Analysis was by intention-to-treat. PHQ-9 data were available for 614 patients at 3 months and 572 patients at 12 months. Patients attended a mean of 10 sessions for acupuncture and 9 sessions for counselling. Compared to usual care, there was a statistically significant reduction in mean PHQ-9 depression scores at 3 and 12 months for acupuncture and counselling.
From this, the authors conclude that both interventions were associated with significantly reduced depression at 3 months when compared to usual care alone.
Acupuncture for depression? Really? Our own systematic review with co-authors who are the most ardent apologists of acupuncture I have come across showed that the evidence is inconsistent on whether manual acupuncture is superior to sham… Therefore, I thought it might be a good idea to have a closer look at this new study.
One needs to search this article very closely indeed to find out that the authors did not actually evaluate acupuncture versus usual care and counselling versus usual care at all, and that comparisons were not made between acupuncture, counselling, and usual care (hints like the use of the word “alone” are all we get to guess that the authors’ text is outrageously misleading). Not even the methods section informs us what really happened in this trial. You find this hard to believe? Here is the unabbreviated part of the article that describes the interventions applied:
Patients allocated to the acupuncture and counselling groups were offered up to 12 sessions usually on a weekly basis. Participating acupuncturists were registered with the British Acupuncture Council with at least 3 years post-qualification experience. An acupuncture treatment protocol was developed and subsequently refined in consultation with participating acupuncturists. It allowed for customised treatments within a standardised theory-driven framework. Counselling was provided by members of the British Association for Counselling and Psychotherapy who were accredited or were eligible for accreditation having completed 400 supervised hours post-qualification. A manualised protocol, using a humanistic approach, was based on competences independently developed for Skills for Health. Practitioners recorded in logbooks the number and length of sessions, treatment provided, and adverse events. Further details of the two interventions are presented in Tables S2 and S3. Usual care, both NHS and private, was available according to need and monitored for all patients in all three groups for the purposes of comparison.
It is only in the results tables that we can determine what treatments were actually given; and these were:
1) Acupuncture PLUS usual care (i.e. medication)
2) Counselling PLUS usual care
3) Usual care
Its almost a ‘no-brainer’ that, if you compare A+B to B (or in this three-armed study A+B vs C+B vs B), you find that the former is more than the latter – unless A is a negative, of course. As acupuncture has significant placebo-effects, it never can be a negative, and thus this trial is an entirely foregone conclusion. As, in alternative medicine, one seems to need experimental proof even for ‘no-brainers’, we have some time ago demonstrated that this common sense theory is correct by conducting a systematic review of all acupuncture trials with such a design. We concluded that the ‘A + B versus B’ design is prone to false positive results…What makes this whole thing even worse is the fact that I once presented our review in a lecture where the lead author of the new trial was in the audience; so there can be no excuse of not being aware of the ‘no-brainer’.
Some might argue that this is a pragmatic trial, that it would have been unethical to not give anti-depressants to depressed patients and that therefore it was not possible to design this study differently. However, none of these arguments are convincing, if you analyse them closely (I might leave that to the comment section, if there is interest in such aspects). At the very minimum, the authors should have explained in full detail what interventions were given; and that means disclosing these essentials even in the abstract (and press release) – the part of the publication that is most widely read and quoted.
It is arguably unethical to ask patients’ co-operation, use research funds etc. for a study, the results of which were known even before the first patient had been recruited. And it is surely dishonest to hide the true nature of the design so very sneakily in the final report.
In my view, this trial begs at least 5 questions:
1) How on earth did it pass the peer review process of one of the most highly reputed medical journals?
2) How did the protocol get ethics approval?
3) How did it get funding?
4) Does the scientific community really allow itself to be fooled by such pseudo-research?
5) What do I do to not get depressed by studies of acupuncture for depression?
Has it ever occurred to you that much of the discussion about cause and effect in alternative medicine goes in circles without ever making progress? I have come to the conclusion that it does. Here I try to illustrate this point using the example of acupuncture, more precisely the endless discussion about how to best test acupuncture for efficacy. For those readers who like to misunderstand me I should explain that the sceptics’ view is in capital letters.
At the beginning there was the experience. Unaware of anatomy, physiology, pathology etc., people started sticking needles in other people’s skin, some 2000 years ago, and observed that they experienced relief of all sorts of symptoms.When an American journalist reported about this phenomenon in the 1970s, acupuncture became all the rage in the West. Acupuncture-fans then claimed that a 2000-year history is ample proof that acupuncture does work.
BUT ANECDOTES ARE NOTORIOUSLY UNRELIABLE!
Even the most enthusiastic advocates conceded that this is probably true. So they documented detailed case-series of lots of patients, calculated the average difference between the pre- and post-treatment severity of symptoms, submitted it to statistical tests, and published the notion that the effects of acupuncture are not just anecdotal; in fact, they are statistically significant, they said.
BUT THIS EFFECT COULD BE DUE TO THE NATURAL HISTORY OF THE CONDITION!
“True enough”, grumbled the acupuncture-fans and conducted the very first controlled clinical trials. Essentially they treated one group of patients with acupuncture while another group received conventional treatments as usual. When they analysed the results, they found that the acupuncture group had improved significantly more. “Now do you believe us?”, they asked triumphantly, “acupuncture is clearly effective”.
NO! THIS OUTCOME MIGHT BE DUE TO SELECTION BIAS. SUCH A STUDY-DESIGN CANNOT ESTABLISH CAUSE AND EFFECT.
The acupuncturists felt slightly embarrassed because they had not thought of that. They had allocated their patients to the treatment according to patients’ choice. Thus the expectation of the patients (or the clinician) to get relief from acupuncture might have been the reason for the difference in outcome. So they consulted an expert in trial-design and were advised to allocate not by choice but by chance. In other words, they repeated the previous study but randomised patients to the two groups. Amazingly, their RCT still found a significant difference favouring acupuncture over treatment as usual.
BUT THIS DIFFERENCE COULD BE CAUSED BY A PLACEBO-EFFECT!
Now the acupuncturists were in a bit of a pickle; as far as they could see, there was no good placebo for acupuncture! Eventually some methodologist-chap came up with the idea that, in order to mimic a placebo, they could simply stick needles into non-acupuncture points. When the acupuncturists tried that method, they found that there were improvements in both groups but the difference between real acupuncture and placebo was tiny and usually neither statistically significant nor clinically relevant.
NOW DO YOU CONCEDE THAT ACUPUNCTURE IS NOT AN EFFECTIVE TREATMENT?
Absolutely not! The results merely show that needling non-acupuncture points is not an adequate placebo. Obviously this intervention also sends a powerful signal to the brain which clearly makes it an effective intervention. What do you expect when you compare two effective treatments?
IF YOU REALLY THINK SO, YOU NEED TO PROVE IT AND DESIGN A PLACEBO THAT IS INERT.
At that stage, the acupuncturists came up with a placebo-needle that did not actually penetrate the skin; it worked like a mini stage dagger that telescopes into itself while giving the impression that it penetrated the skin just like the real thing. Surely this was an adequate placebo! The acupuncturists repeated their studies but, to their utter dismay, they found again that both groups improved and the difference in outcome between their new placebo and true acupuncture was minimal.
WE TOLD YOU THAT ACUPUNCTURE WAS NOT EFFECTIVE! DO YOU FINALLY AGREE?
Certainly not, they replied. We have thought long and hard about these intriguing findings and believe that they can be explained just like the last set of results: the non-penetrating needles touch the skin; this touch provides a stimulus powerful enough to have an effect on the brain; the non-penetrating placebo-needles are not inert and therefore the results merely depict a comparison of two effective treatments.
YOU MUST BE JOKING! HOW ARE YOU GOING TO PROVE THAT BIZARRE HYPOTHESIS?
We had many discussions and consensus meeting amongst the most brilliant brains in acupuncture about this issue and have arrived at the conclusion that your obsession with placebo, cause and effect etc. is ridiculous and entirely misplaced. In real life, we don’t use placebos. So, let’s instead address the ‘real life’ question: is acupuncture better than usual treatment? We have conducted pragmatic studies where one group of patients gets treatment as usual and the other group receives acupuncture in addition. These studies show that acupuncture is effective. This is all the evidence we need. Why can you not believe us?
NOW WE HAVE ARRIVED EXACTLY AT THE POINT WHERE WE HAVE BEEN A LONG TIME AGO. SUCH A STUDY-DESIGN CANNOT ESTABLISH CAUSE AND EFFECT. YOU OBVIOUSLY CANNOT DEMONSTRATE THAT ACUPUNCTURE CAUSES CLINICAL IMPROVEMENT. THEREFORE YOU OPT TO PRETEND THAT CAUSE AND EFFECT ARE IRRELEVANT. YOU USE SOME IMITATION OF SCIENCE TO ‘PROVE’ THAT YOUR PRECONCEIVED IDEAS ARE CORRECT. YOU DO NOT SEEM TO BE INTERESTED IN THE TRUTH ABOUT ACUPUNCTURE AT ALL.
Nobody really likes criticism, I suppose. Yet everyone with a functional brain agrees that criticism is a precondition to making progress. So most of us do listen to it, introspect and try to learn a lesson.
Not so in alternative medicine! The last post by Preston Long was a summary of constructive criticism of his own profession; it brought that message home to me much clearer than previous discussions on this blog (probably because it did not directly concern me) and, after some reflection, I realised that apologists of alternative medicine have developed five distinct strategies to avoid progress that otherwise might develop from criticism (alright, these strategies do exist in other fields too, but I think that many of the comments on this blog demonstrate that they are particularly evident in alternative medicine).
We could also call this method ‘The Prince of Wales Technique of Avoiding Progress’ because HRH is famous for making statements ‘ex cathedra’ without ever defending them or facing his critics or allowing others to directly challenge him. When he advocated the Gerson diet for cancer, for instance, Prof Baum challenged him in an open letter asking him to use his influence more wisely. Like with all other criticism directed to him, he decided to ignore it. This strategy is a safe bet for stalling progress and it has the added advantage that it does not require anything other than ignorance.
As it requires some basic understanding of the issues at hand, this method is a little more demanding. You need to look closely at the criticism and subsequently shoot holes in it. If you cannot find any, invent some. For instance, you might state that your critic misquoted the evidence. Very few people will bother to read up the original data, and you are likely to get away even with fairly obvious lies. To beef your response up a bit, pretend that there is plenty of good evidence demonstrating exactly the opposite of what your critic has said. If asked to provide actual references or sources for your claims, don’t listen. An extreme example of the bluff-method is to sue your critic for libel – but be careful, this can backfire in a major way!
A very popular method is to claim that the critic is not actually competent to criticise. The discussion of Long’s post demonstrated that technique in a classic fashion. His detractors argued that he was a failed chiropractor who had an axe to grind and thus had no right to criticise chiropractic (“Preston H Long you are a disgrace to the chiropractic profession…take off your chiropractic hat, you dont deserve to wear it. YOU sir are a shame and a folly!!”). Of course, you need to be a bit simple in order to agree with this type of logic, but lots of people seem to be just that!
Even more popular is the blame-game. It involves arguing that, ok not all is rosy on your side of the fence, but the other side is so, so much worse. Before they dare to challenge you, they should look at their own mess; and while it is not sorted, they must simply shut up. For instance, if the criticism is that chiropractors have put hundreds of their patients into wheelchairs with their neck-manipulations, you must point out that doctors with their nasty drugs are much, much worse (“Long discounts the multitudes that chiropractic has… saved from dangerous drugs and surgery. As far as risks of injury from seeing a chiropractor vs. medicine, all one needs to do is compare malpractice insurance rates to see that insurance carriers rate medicine as an exponentially more dangerous undertaking”). Few people will realise that this is a fallacy and that the risks of any therapy must be seen in relation to its potential benefits.
When criticised, you are understandably annoyed; most people will therefore forgive you calling your critic names which are not normally used in polite circles (“who is this idiot, who wouldnt know the first thing about chiropractic”). Ad hominem attacks are the last resort of apologists of alternative medicine which emerges with depressing regularity when they have run out of rational arguments; they are signs of victories of reason over unreason. In the case of those chiropractors who were unable to stomach Long’s critique, the insults were coming thick and fast. The reason for only very few being visible is quite simple: I often delete the worst excesses of such primitive reactions.