conflict of interest
Today, there are several dozens of journals publishing articles on alternative medicine. ‘The Journal of Alternative and Complementary Medicine’ is one of the best known, and it has one of the highest impact factors of them all. The current issue holds a few ‘gems’ which might be worthy of a comment or two. Here I have selected three articles reporting clinical studies, and I reproduce their abstracts (almost) in full (in italics) and add my comments (for clarity in bold). All the articles are available electronically, and I have provided the links for those who want to investigate beyond the abstracts.
STUDY No 1
The first ‘pilot study‘ was aimed to demonstrate the potential of auricular acupuncture (AAT) for insomnia in maintenance haemodialysis (MHD) patients and to prepare for a future randomized controlled trial.
Eligible patients were enrolled into this descriptive pilot study and received AAT designed to manage insomnia for 4 weeks. Questionnaires that used the Pittsburgh sleep quality index (PSQI) were completed at baseline, after a 4-week intervention, and 1 month after completion of treatment. Sleep quality and other clinical characteristics, including sleeping pills taken, were statistically compared between different time points.
A total of 22 patients were selected as eligible participants and completed the treatment and questionnaires. The mean global PSQI score was significantly decreased after AAT intervention (p<0.05). Participants reported improved sleep quality (p<0.01), shorter sleep latency (p<0.05), less sleep disturbance (p<0.01), and less daytime dysfunction (p=0.01). They also exhibited less dependency on sleep medications, indicated by the reduction in weekly estazolam consumption from 6.98±4.44 pills to 4.23±2.66 pills (p<0.01). However, these improvements were not preserved 1 month after treatment.
Conclusions: In this single-center pilot study, complementary AAT for MHD patients with severe insomnia was feasible and well tolerated and showed encouraging results for sleep quality.
In alternative medicine research, it has become far too common (almost generally accepted) to call a flimsy trial a ‘pilot study’. The authors give their game away by stating that, by conducting this trial, they want to ‘demonstrate the potential of AAT’. This is not a legitimate aim of research; science is for TESTING hypotheses, not for PROVING them!
The results of this trial show that patients experienced improvements after receiving AAT which, however, did not last. As there was no placebo control group, the most likely explanation for these outcomes would be that AAT generated a short-lasting placebo effect.
A sample size of 22 is, of course, far to small to allow any conclusions about the safety of the intervention. Despite these obvious facts, the authors seem convinced that AAT is both safe and effective.
STUDY No 2
The aim of the second study was to compare the therapeutic effect of Yamamoto new scalp acupuncture (YNSA), a recently developed microcupuncture system, with traditional acupuncture (TCA) for the prophylaxis and treatment of migraine headache.
In a randomized clinical trial, 80 patients with migraine headache were assigned to receive YNSA or TCA. A pain visual analogue scale (VAS) and migraine therapy assessment questionnaire (MTAQ) were completed before treatment, after 6 and 18 sections of treatment, and 1 month after completion of therapy.
All the recruited patients completed the study. Baseline characteristics were similar between the two groups. Frequency and severity of migraine attacks, nausea, the need for rescue treatment, and work absence rate decreased similarly in both groups. Recovery from headache and ability to continue daily activities 2 hours after medical treatment showed similar improvement in both groups (p>0.05).
Conclusions: Classic acupuncture and YNSA are similarly effective in the prophylaxis and treatment of migraine headache and may be considered as alternatives to pharmacotherapy.
This is what is technically called an ‘equivalence trial’, i.e. a study that compares an experimental treatment (YNSA) to one that is (assumed to be) effective. To demonstrate equivalence, such trials need to have large sample sizes, and this study is woefully underpowered. As it stands, the results show nothing meaningful at all; if anything, they suggest that both interventions were similarly useless.
STUDY No 3
The third study determined whether injection with hypertonic dextrose and morrhuate sodium (prolotherapy) using a pragmatic, clinically determined injection schedule for knee osteoarthritis (KOA) results in improved knee pain, function, and stiffness compared to baseline status.
The participants were 38 adults who had at least 3 months of symptomatic KOA and who were in the control groups of a prior prolotherapy randomized controlled trial (RCT) (Prior-Control), were ineligible for the RCT (Prior-Ineligible), or were eligible but declined the RCT (Prior-Declined).
The injection sessions at occurred at 1, 5, and 9 weeks with as-needed treatment at weeks 13 and 17. Extra-articular injections of 15% dextrose and 5% morrhuate sodium were done at peri-articular tendon and ligament insertions. A single intra-articular injection of 6 mL 25% dextrose was performed through an inferomedial approach.
The primary outcome measure was the validated Western Ontario McMaster University Osteoarthritis Index (WOMAC). The secondary outcome measure was the Knee Pain Scale and postprocedure opioid medication use and participant satisfaction.
The Prior-Declined group reported the most severe baseline WOMAC score (p=0.02). Compared to baseline status, participants in the Prior-Control group reported a score change of 12.4±3.5 points (19.5%, p=0.002). Prior-Decline and Prior-Ineligible groups improved by 19.4±7.0 (42.9%, p=0.05) and 17.8±3.9 (28.4%, p=0.008) points, respectively; 55.6% of Prior-Control, 75% of Prior-Decline, and 50% of Prior-Ineligible participants reported score improvement in excess of the 12-point minimal clinical important difference on the WOMAC measure. Postprocedure opioid medication resulted in rapid diminution of prolotherapy injection pain. Satisfaction was high and there were no adverse events.
Conclusions: Prolotherapy using dextrose and morrhuate sodium injections for participants with mild-to-severe KOA resulted in safe, significant, sustained improvement of WOMAC-based knee pain, function, and stiffness scores compared to baseline status.
This study had nothing that one might call a proper control group: all the three groups mentioned were treated with the experimental treatment. No attempt was made to control for even the most obvious biases: the observed effects could have been due to placebo or any other non-specific effects. The authors conclusions imply a causal relationship between the treatment and the outcome which is wrong. The notion that the experimental treatment is ‘safe’ is based on just 38 patients and therefore not reasonable.
All of this might seem rather trivial, and my comments could be viewed as a deliberate and vicious attempt to discredit one of the most respected journals of alternative medicine. Yet, considering that articles of this nature are more the rule than the exception in alternative medicine, I do think that this flagrant lack of scientific rigour is a relevant issue and has important implications.
As long as research in this area continues to be deeply flawed, as long as reviewers turn a blind eye to (or are not smart enough to detect) even the most obvious mistakes, as long as journal editors accept any rubbish in order to fill their pages, there is a great danger that we are being continuously being mislead about the supposed therapeutic value of alternative therapies.
Many who read this blog will, of course, have the capacity to think critically and might therefore not fall into the trap of accepting the conclusions of fatally flawed research. But many other people, including politicians, journalists and consumers, might not have the necessary appraisal skills and will thus not be able to tell that such studies can serve only one purpose: to popularise bogus treatments and thereby render health care less effective and more dangerous. Enthusiasts of alternative medicine are usually fully convinced that such studies amount to evidence and ram this pseudo-information down the throat of health care decision makers – the effects of such lobbying on public health can be disastrous.
And there is another downside to the publication of such dismal drivel: assuming (as I do) that not all of alternative medicine is completely useless, such embarrassingly poor research will inevitably have detrimental effects on the discipline of alternative medicine. After being exposed to a seemingly endless stream of pseudo-research, critics will eventually give up taking any of it seriously and might claim that none of it is worth the bother. In other words, those who conduct, accept or publish such nonsensical papers are not only endangering medical progress in general, they are also harming the very cause they try so desperately hard to advance.
An article in the ‘Huffpost Healthy Living’ recently discussed “the top three things that surprise people about acupuncture”. On closer inspection, they turn out to be the top three untruths about acupuncture. Here is (in italics and slightly abbreviated) what the article said.
Acupuncture is not just for pain
…It’s true that acupuncture can work wonders on pain conditions…However, acupuncture can alleviate a wide variety of ailments that have nothing to do with physical pain. Whether you have digestive issues, gynecological conditions, emotional concerns such as anxiety and depression, asthma, seasonal allergies, you name it, acupuncture can help address your symptoms.
Acupuncturists go to school for a long time
People tend to be unaware of the extent to which acupuncturists train to become licensed in their profession. Many assume becoming an acupuncturist is similar to becoming a massage therapist or Reiki practitioner or yoga instructor… At minimum, a licensed acupuncturist in the United States has been to three years of graduate school. Four years is more common. They hold master’s degrees. Some acupuncturists with doctorates have studied at the graduate level for five-plus years. Upon graduating from an accredited school, all acupuncturists must pass multiple board exams to become licensed in their state. In addition to the academic and state requirements for practicing acupuncture, many acupuncturists seek hands-on training and mentorship in the form of apprenticeships and continuing education seminars.
Acupuncture is relaxing
Acupuncture needles are surprisingly thin. They do not bear any resemblance to needles that are used for injections or to draw blood… In most cases, the insertion of acupuncture needles does not hurt…Once the needles are in, they start working their magic, which is where the relaxation part comes in. Acupuncture helps shift your body out of sympathetic mode (fight or flight) and into parasympathetic mode (rest and digest). It mellows out the nervous system, decreases muscular tension, and helps quiet internal chatter…
AND NOW THE FACTS:
1) There is not a single condition for which the evidence is truly compelling demonstrating that acupuncture is more than a placebo. Certainly there is no good evidence that acupuncture works for digestive issues, gynecological conditions, emotional concerns such as anxiety and depression, asthma or seasonal allergies.
2) In most countries, anyone can call themselves an acupuncturist, regardless of background or training.
3) The relaxing element of an acupuncture session is foremost the fact that patients lie down and have to keep still for 20 minutes or so. The insertion of needles does cause mild pain in many patients, and the claim about parasympathetic mode is mostly phantasy.
I despair about the nonsense that is published about alternative medicine on a daily basis – not because I have an axe to grind, but because it misleads patients into making wrong therapeutic decisions.
It is not often that we see an article of the great George Vithoulkas, the ‘über-guru‘ of homeopathy, in a medical journal. In fact, this paper, which he co-authored with several colleagues, seems to be a rare exception: in his entire career, he seems to have published just 15 Medline- listed articles most of which are letters to the editor.
According to Wikipedia, Vithoulkas has been described as “the maestro of classical homeopathy” by Robin Shohet; Lyle Morgan says he is “widely considered to be the greatest living homeopathic theorist”; and Scott Shannon calls him a “contemporary master of homeopathy.” Paul Ekins credited Vithoulkas with the revival of the credibility of homeopathy.
In his brand new paper, Vithoulkas provides evidence for the notion that homeopathy can treat infertility. More specifically, the authors present 5 cases of female infertility treated successfully with the use of homeopathic remedies.
Yes, really! The American Medical College of Homeopathy informs us that homeopathy has an absolute solution that can augment your probability of conception. Homeopathic treatment of Infertility addresses both physical and emotional imbalances in a person. Homeopathy plays a role in treating Infertility by strengthening the reproductive organs in both men and women, by regulating hormonal balance, menstruation and ovulation in women, by escalating blood flow into the pelvic region, by mounting the thickness of the uterine lining and preventing the uterus from contracting hence abating chances of a miscarriage, and by increasing quality and quantity of sperm count in men. It can also be advantageous in reducing anxiety so that the embryo implantation can take place in a favourable environment. Homoeopathy is a system of medicine directed at assisting the body’s own healing process.
Imagine: the 5 women in Vithoulkas ‘study’ wanted to have children; they consulted homeopaths because they did not get pregnant in a timely fashion. The homeopaths prescribed individualised homeopathy and treated them for prolonged periods of time. Eventually, BINGO!, all of the 5 women got pregnant.
What a hoot!
It beggars belief that this result is being credited to the administration of homeopathic remedies. Do the authors not know that, in many cases, it can take many months until a pregnancy occurs? Do they not think that the many women they treated unsuccessfully for the same problem should raise some doubts about homeopathy? Do they really believe that their remedies had any causal relationship to the 5 pregnancies?
Vithoulkas was a recipient of the Right Livelihood Award in 1996. I hope they did not give it to him in recognition of his scientific achievements!
Guest Post by Jan Willem Nienhuys
The so-called Swiss government report of 2011 on homeopathy was actually an expanded translation of a 2006 book, which in itself was an expanded version of a document submitted to a Swiss committee (PEK) in charge of evaluation of alternative medicine. It has been severely criticised. A summary of criticisms with links can be found on the RationalWiki item to which we may add the Zeno’s Blog. I present here the results of my scrutiny of chapter 10 (1), although I base my report on the original German edition.
This chapter by itself shows a familiar result: the better the investigation, the less evidence in favor of homeopathy it shows. It shows also how homeopaths systematically distort unfavorable results by mispresenting them. Chapter 10 deals with clinical investigations of homeopathy. The authors restrict their attention to an odd assortment of diseases such as acute rhinitis, allergic rhinitis, allergic asthma, sinusitis, adenoid vegetations, pharyngitis, tonsillitis, influenza-like infection and otitis media, together denoted as ‘upper respiratory tract infections/allergic reactions’ or URTI/A for short.
The number of papers reviewed is very small. The authors looked at much more than randomized clinical trials. Apparently their search did not extend further than 2003, but then they might have found over 150 papers, of which about one third double blind randomized trials that compared how well highly diluted homeopathy and placebo cured one of the indicated diseases. They managed to miss 25 papers mentioned in earlier meta-analyses and about four papers that are summarized in Pubmed.
Among the papers they missed is an extremely strong support for the claim ‘homeopathy works for URTI/A’. For example Riverón-Garrote et al. (2) did a placebo controlled double blind randomized clinical trial of homeopathy (apparently individualised) for asthma. Of about 33 verum patients 32 improved, whereas of about 30 placebo patients only 4 improved. The so-called p-value for such a result is less than 10–11. One wonders why this result wasn’t published in Science or Nature, but only in an obscure Spanish language homeopathic journal. Maybe the paper was excluded because it didn’t state that it was about allergic asthma, but note that in about three quarters of all asthma some kind of allergy is implicated.
Of course this pales in comparison to the paper by Friese and Zabalotnyi (3). Again a double blind randomised clinical trial with 72 sinusitis sufferers for both verum and placebo. But here 71 out of 72 verum patients were free of complaints after three weeks, or at least improved, whereas this was the case for only 8 of the placebo patients. Fisher’s Exact Test gives p = 2.47 times 10-29 (one tailed). A remarkable result, because it is well known that over 80% of sinusitis cases cures spontaneously within two weeks. Maybe placebos are dangerous in the hands of homeopaths. Again one wonders why Friese and Zabalotnyi didn’t share the Nobel prize in, say, 2008, and why it is necessary at all to meticulously analyse papers in which homeopathy shows a marginal advantage.
Instead, Maxion-Bergemann et al. include in their survey a paper by Bahemann (4). We quote the summary of the paper from the internet: ‘In homeopathic practice, Kalium bromatum is known as a remedy in the case of paranoid delusions, e. g. if someone suffers from the delusion of being the object of divine revenge, of being damned, or of being pursued. It is also a very important remedy in the case of nocturnal fears in children as well as in the case of convulsions, when they are hereditary, when they occur in childbed, or during teething. The following case demonstrates the successful treatment of a severe mononucleosis after studying the Materia medica.’ Mononucleosis isn’t even mentioned in the list given that specifies URTI/A. Maybe it was included because one of the symptoms of mononucleosis is a sore throat. Apparently the mononucleosis patient was given Kalium Bromatum (Maxion-Bergemann et al. state that it is Kalium Chromatum 200C, presumably Chromatum and Bromatum don’t differ too much to bother) because of something remarkable the patient said during the anamnesis. The reason for giving Kalium bromatum 200C in cases of paranoia might be that an overdose of bromide can induce psychoses. The homeopathic Materia Medica contains quite a few ‘symptoms’ from accidental poisonings reported in old medical literature; potassium bromide was liberally used in the nineteenth century for the calming of seizure and nervous disorders, according to Wikipedia.
More impressive in the list of 13 RCTs of Maxion-Bergemann are two of the largest ‘homeopathic’ trials known, namely of the remedy Oscillococcinum. These trials cannot be taken seriously. The first one, by Ferley et al. (5), has one glaring fault. They started with 478 ‘influenza’-patients (237 verum), tried to make 149 family physicians note down when the patients recovered, and then elected to restrict their attention to the 63 patients (39 verum) that recovered within 48 hours and therefore probably didn’t have flu at all. Coincidentally this was the only possibility out of 14 that gave a ‘significant’ result: correctly computed, p is just below 0.05. (Ferley et al. based their computation on 462 patients with 228 verum and applied a chi-squared test without continuity correction). It is hardly credible that they set this 48-hour criterion in advance, because even if the remedy worked, the risk of having too few subjects to get a significant result would have been considerable. But if one picks out one result among many possibilities, one should correct for multiple outcome. So the Ferley et al. investigation is at most an exploratory result in need of independent confirmation.
This ‘confirmation’ was undertaken soon afterwards, namely in the beginning of 1991, but the results were only published in 1998 and cannot be found on Pubmed (6). In this paper the definitions are somewhat different, but Papp et al. report that of 334 patients (167 verum) a total of 57 (32 verum) were cured in 48 hours. Now 25 versus 32 is not remarkable at all. One doesn’t need any elaborate computation for this. Calculation gives p=0.4. So one might think that the Ferley hypothesis was soundly refuted. But Papp et al. used something they call ‘the Krauth test’, probably some kind of automated post hoc fishing trip to select the best criteria to distinguish the placebo and verum groups. They claim that this ‘test’ gives p=0.0028. They specifically refer to ‘the null hypothesis (the number of patients free of symptoms after 48 hours is equal in both treatment groups)’, so their computation is wrong. The most remarkable thing about Papp et al. is that nobody seems to have to have noticed the large discrepancy between what the numbers say and the claim of the paper.
Another paper with ‘positive’ results is the 1994 study of Reilly et al. (7), number 28 in Maxion-Bergemann et al. The group of Reilly investigated allergic diseases treated by what they called homeopathy. The typical Reilly experiment consists of administering a highly diluted causative agent such as pollen or house dust mite or cat hairs or bird feathers to persons suffering from pollen allergy (seasonal rhinitis) or allergic asthma. However for true homeopathy one uses a substance that has been the subject of a so-called proving, and the remedy is chosen of the totality of all patient ‘symptoms’ – including things like sleeping position and fear of thunderstorms – sufficiently matches the symptoms of the proving. Let me call Reilly’s method ultra-isopathy. Reilly was already discussing this study on a symposium in 1990, but that paper is not clear. It is about 28 asthma patients, and only 24 were analysed. This small number in itself is already reason enough not to consider it. The main analysis was by comparing a subjective measure of wellbeing, the Visual Analog Scale (VAS). Here we find a significant difference (p=0.003) in favor of ultra-isopathy. However, in the small print we see that change in the very important FEV1-value (Forced Expiratory Volume in 1 second) was non-significant (p=0.08) but this refers only to the 18 patients that took such a test before and after the experiment.
Reilly attracted more attention with his first experiment in this vein (8). He started out with 79 patients in both the verum and the placebo group. The treatment was ultradiluted grass pollen for hay fever. The analysis was only about 56 verum and 52 placebo (in a diagram 53 placebo are shown). Such a large dropout (32%) is not good. On basis of the VAS-scores Reilly found p=0.02. VAS is only an ordinal scale and it is not at all clear that one person’s 60 mm means the same as another person’s 60 mm, and also not that two patients with respectively 40 mm and 80 mm together can be considered as equivalent to two other patients with 60 mm each. If we distinguish only better / equal / worse, then the numbers for the verum group were 34 / 9 / 13 and for the placebo group 27 / 5 / 21. One can analyse this in various ways: as a 3 by 2 contingency table (p=0.15), or as a 2 by 2 table, namely by joining the middle group either to the right (p=0.10) or to the left (p=0.34). In this manner the difference is less impressive.
Maxion-Bergemann et al. collected 29 articles. I take the liberty of removing from these everything that is not a double blind RCT that compares how well highly diluted homeopathy and placebo cures an URTI/A disease. We also remove all research with 50 or less patients. The more or less openly fraudulent or at least grossly mistaken Oscillococcinum trials I also leave out. In order of appearance we have then Wiesenauer 1985 (9)  Reilly 1986 (8)  Wiesenauer 1989 (10)  De Lange-de Klerk 1994 (11)  Aabel 2000 (12)  Jacobs 2001 (13)  Friese 2001 (14)  Lewith 2002 (15)  White 2003 (16)  The square brackets refer to the numbering in Maxion-Bergemann et al. A short review of these nine articles follows.
Wiesenauer 1985: one standard remedy for hayfever. Randomised 213 patients, analysed only 164. “no statistical significance was achieved” says the abstract on Pubmed. Reilly 1986: this we have discussed already. Ultra-isopathy for hayfever. Randomised 158 patients, analysed 108. Statistically significant, but barely so. Wiesenauer 1989: four groups, each with their own standard remedy or placebo for sinusitis, 152 patients. “There was no remarkable difference in the therapeutic success among the investigated homeopathic drug combinations nor between the active drugs and placebo”, according to the abstract in Pubmed De Lange-de Klerk 1994: this research was reported more extensively in the lead author’s dissertation (17). Individualised homeopathy for recurrent URTI in children. 175 children were randomised and 170 analysed after following them for a year. 128 different remedies/potencies were prescribed and all together 1042 different prescriptions were handed out. The result was a non-significant difference between homeopathy and placebo. One striking aspect of this investigation is that only after all computations were done, it was revealed which of the two groups was the placebo group and which the verum group. So the author or her thesis advisors deliberately made it impossible to fall for the temptation to start a fishing expedition in the data after the code was completely broken. See also Pubmed. Aabel 2000: ultra-isopathy for birch pollen allergy. Strictly speaking this investigation shouldn’t be in this short list because it was partly prophylactic. From Pubmed: “Surprisingly, the verum treated patients fared worse than the placebo group”. No measure of statistical significance is mentioned. Remarkably this article is preceded by a similar article (18) that Maxion-Bergemann et al. apparently weren’t able to locate. Jacobs 2001: 75 children with otitis media were treated with individualised homeopathy or placebo. Pubmed: “differences were not statistically significant”. It seems that Jacobs has indulged in a fishing trip because she mentions a “significant decrease in symptoms at 24 and 64 h after treatment in favor of homeopathy”. But that is wrong. Significance only can have a meaning if it refers to a single outcome that was planned before any patients were seen. Just picking out two results out of many and stating they are ‘significant’ betrays a fundamental ignorance of research methodology. Friese 2001: this article is also published elsewhere (19), at least the numbers are exactly the same according to Pubmed. 97 children randomized for either individual homeopathic treatment or placebo treatment of adenoid vegetations, 82 analysed. Apparently these 82 comprised 41 placebo and 41 verum, and of these 12 and 9 respectively required an operation in the end. This allegedly corresponds to p=0.64, “These results show no statistical significance.” Incidentally, this is the same Friese as reference 3. Lewith 2002: again ultra-isopathy, now for asthma, 242 patients randomised, 202 completed all clinical assessments. The full article can be accessed via Pubmed and elsewhere. The main conclusion is “Homoeopathic immunotherapy is not effective in the treatment of patients with asthma.” The authors notice that the averages in both groups behave somewhat erratic, and they have no explanation for this. White 2003: individualised homeopathy compared to placebo for 96 children with asthma, who are followed for 12 months. The conclusion is that there is no evidence that this kind of homeopathy is better than placebo. In other words, out of nine investigations only one (Reilly 1986) obtains a barely significant result.
But the interpretation of Maxion-Bergemann et al. is totally different: “If only the placebo-controlled, randomized trials with the highest EBM evidence are considered, 12 of 16 trials show a positive result for the homeopathically treated group (significantly positive 8/16 and trend 4/16).” Even in the more restricted subset of nine discussed above they are overly optimistic. They mark Wiesenauer (1985), De Lange-de Klerk (1994), Jacobs (2001) as showing a ‘trend for homeopathy’ and Lewith (2002) is even marked ‘significant’. The meticulous and high quality research of De Lange (1993, 1994) is judged ‘trend for homeopathy’.
In case of De Lange it seems clear where this judgement comes from. De Lange had several outcomes (number of sick periods, total duration of sick periods, sum of all dayscores etc., and all these showed roughly the same small non-significant difference in favor of homeopathy. This is not really strange, because these outcomes all measure about the same phenomenon. It is not remarkable that there is a small difference between the averages of the two groups that can only be noticed if the children are followed for a full year. There is not even the beginning of a reason that this has anything to do with the treatment. For example the homeopathy group had ‘significantly’ less pets at home. This might serve as an explanation why they as a group were slightly less sick. One might also speculate that this was retroactively caused by the homeopathic treatment. This is not really more improbable than highly diluted stuff (more than 95% D6 and higher) having an effect.
By convention ‘statistically significant’ is the lower limit where weak conclusions such as ‘worth investigating further’ can be justified, and we repeat: only if it refers to a single outcome measure or endpoint chosen before any data collection has started. De Lange chose recurrent URTI because homeopathy was reputed to be most effective for this type of complaints, especially after investigations such as those of Reilly (1986). If following 170 children for a full year cannot show a clear advantage, then that is simply a negative result. In the case of Lewith the ‘significant for homeopathy’ is probably based on partial results such as that in week 3 ‘homeopathy’ fared better in the asthma VAS. One can just as well point to week 16 where the FEV1 of the placebo group seems much better than in the homeopathy group.
Maxion-Bergemann et al. seem to have been singularly inept in collecting papers on homeopathic trials, and for no apparent reason they decided to look also at a large number of case reports and investigations without control group or blinding, even after investigators as early as 1991 have remarked that henceforth only well designed large double blind RCTs were worth considering. If we restrict our attention to the properly blinded controlled investigations, we see the same thing as in other meta-analyses of homeopathy: there is lots of rubbish in favor of homeopathy, but the good trials say plainly and clearly: homeopathy is ineffective, precisely what can be predicted from the fact that there is nothing in it.
Homeopaths nowadays have a lot to say about RCTs and how they prove homeopathy. RCTs are subtle and complicated scientific tools. It is somewhat strange to see how homeopaths resolutely ignore two centuries of basic science but then argue their cause on the basis of complicated statistics.
Homeopathy is an assortment of wildly different practices and theories. We have seen ultra-isopathy, individualised homeopathy and the practice of giving one standardised remedy for one diagnosis without asking too many personal details from the patient. These standard remedies are often branded mixtures of highly diluted ‘classical’ homeopathy, quite contrary to the opinions of homeopathy’s inventor Hahnemann. There are many more variants of homeopathy and the homeopaths themselves cannot agree which are the correct ones.
Moreover, if a treatment or trial doesn’t work out, then a number of additional hypotheses about homeopathy can be invoked, which is what Maxion-Bergemann et al. do. Homeopathic remedies supposedly are counteracted by lots of regular medications and even by strong tasting or smelling food, such as coffee, parsley, garlic and peppermint. Hahnemann even disapproved of reading in bed and long afternoon naps and prolonged suckling of infants (Organon, section 260). Poor performance of homeopathy can be blamed on something called ‘initial aggravation’ or else on lack of experience of the poorly performing homeopath.
But that these factors are relevant at all is unknown, just like there is no proof at all for the similia principle, nor for the hundred thousands or even millions of ‘symptoms’ associated with highly diluted materials in the homeopathic Materia Medica. If homeopaths really want scientists to share homeopathic beliefs, they should not think up lame excuses for ‘failed’ tests, but for starters they might try to present proofs for all or at least some of their ‘symptoms’. They don’t try very hard and in so far it has been tried, it also has failed (20).
I would like to thank Willem Betz for helpful remarks.
I am a retired mathematician with no other interest than a desire to promote science.
1. Stefanie Maxion-Bergemann, Gudrun Bornhöft, Denise Bloch, Christina Vogt-Frank, Marco Righetti, André Thurneysen. (2011) Clinical Studies on the Effectiveness of Homeopathy for URTI/A (Upper Respiratory Tract Infections and Allergic Reactions) in: Homeopathy in Healthcare – Effectiveness, Appropriateness, Safety, Costs. G. Bornhöft and P.F. Mattheiesen (eds.), Berlin etc., Springer 2011, p. 18-157.
2. Riverón-Garrote, M., Fernandez-Argüelles, R.; Morán-Rodríquez, F.; Campistrou-Labaut, J.L. (1998) Ensayo clínico controlado aleatorízado del tratamiento homeopático del asma bronquial, Boletín Mexicano de Homepatía 1998; 31(2):54-61.
3. Friese, K.-H., Zabalotnyi, D.I. (2007) Homöopathie bei akuter Rhinosinusitis, Eine doppelblinde, placebokontrollierte Studie belegt die Wirksamkeit und Verträglichkeit eines homöopathischen Kombinationsarzneimittels, HNO 55(4):271-277.
4. Bahemann A. (2002) Kalium bromatum bei infektiöser Mononukleose. Zeitschrift für Klassische Homöopathie 46:232–233.
5. Ferley J.P., Zmirou D., D’Adhemar D., Balducci F. (1989). A controlled evaluation of a homoeopathic preparation in the treatment of influenza like syndromes. British Journal of Clinical Pharmacology 27:329-335.
6. Papp R., Schuback G., Beck E., Burkard G., Bengel J., Lehrl S., Belon P. (1998). Oscillococcinum in patients with influenza-like syndromes: a placebo-controlled double-blind evaluation. British Homeopathic Journal 87:69-76.
7. Reilly, D.T., Taylor, M.A., Beattie, N.G.M., Campbell, J.H., McSharry C., Aitchison T.C., Carter R., Stevenson R. (1994) Is evidence for homoeopathy reproducible?, Lancet 1994 344:1601-1606.
8. Reilly, D.T., Taylor, M.A., McSharry, C., Aitchison, T. (1986) Is Homoeopathy a Placebo Response?, Controlled Trial of Homoeopathic Potency – With Pollen in Hayfever as Model, Lancet II.2:881-886.
9. Wiesenauer, M., Gaus, W. (1985) Double-blind Trial Comparing the Effectiveness of Galphimia Potentisation D6 (Homoeopathic Preparation), Galphimia Dilution 10-6 and Placebo on Pollinosis, Arzneimittelforschung 35(11):1745-1747.
10. Wiesenauer M, Gaus W, Bohnacker U, Häussler S (1989) Wirksamkeitsprüfung von homöopathischen Kombinationspräparaten bei Sinusitis: Ergebnisse einer randomisierten Doppelblindstudie unter Praxisbedingungen. Arzneimittelforschung 39:620-625.
11. de Lange-de Klerk E.S.M., Blommers J., Kuik D.J., Bezemer P.D., Feenstra L. (1994). Effects of homoeopathic medicines on daily burden of symptoms in children with recurrent upper respiratory tract infections. BMJ 309:1329-1332.
12. Aabel, S. (2000) No beneficial effect of isopathic prophylactic treatment for birch pollen allergy during a low-pollen season, A double-blind, placebo-controlled clinical trial of homeopathic Betula 30c. British Homeopathic Journal 89(4):169-173.
13. Jacobs, J., Springer, D.A., Crothers, D. (2001) Homeopathic treatment of acute otitis media in children, A preliminary randomized placebo-controlled trial. The Pediatric Infectious Disease Journal 20(2):177-183.
14. Friese K.H., Feuchter U., Lüdtke R., Moeller H. (2001) Results of a randomised prospective double-blind trial on the homeopathic treatment of adenoid vegetations. European Journal of General Practice 7:48-54.
15. Lewith, G.T., Watkins, A.D.; Hyland, M.E.; Shaw, S.; Broomfield, J.A.; Dolan, G.; Holgate, S.T. (2002) Use of ultramolecular potencies of allergen to treat asthmatic people allergic to house dust mite: double blind randomised controlled clinical trial, BMJ 324:520-523.
16. White, A., Slade, P.; Hunt, C.; Hart, A.; Ernst, E. (2003) Individualised homeopathy as an adjunct in the treatment of childhood asthma, A randomised placebo controlled trial. Thorax 58(4):317-321
17. Lange-de Klerk, E.S.M. de, Effects of homoeopathic medicines on children with recurrent upper respiratory tract infections. Vrije Universiteit Amsterdam, 1993 (Dissertation).
18. Aabel, S., Laerum, E.; Dölvik, S.; Djupesland, P. (2000) Is homeopathic ‘immunotherapy’ effective?, A double-blind, placebo-controlled trial with the isopathic remedy Betula 30c for patients with birch pollen allergy. British Homeopathic Journal 89(4):161-168.
19. Friese K.-H., Feuchter U., Möller H. (1997). Die homöopathische Behandling von adenoiden Vegetationen. HNO; 45:618–624.
20. Brien S., Lewith G., Bryant, T. (2003) Ultramolecular homeopathy has no observable clinical effects. A randomized, double-blind, placebo-controlled proving trial of Belladonna 30C.
A recent meta-analysis evaluated the efficacy of acupuncture for treatment of irritable bowel syndrome (IBS) and arrived at bizarrely positive conclusions.
The authors state that they searched 4 electronic databases for double-blind, placebo-controlled trials investigating the efficacy of acupuncture in the management of IBS. Studies were screened for inclusion based on randomization, controls, and measurable outcomes reported.
Six RCTs were included in the meta-analysis, and 5 articles were of high quality. The pooled relative risk for clinical improvement with acupuncture was 1.75 (95%CI: 1.24-2.46, P = 0.001). Using two different statistical approaches, the authors confirmed the efficacy of acupuncture for treating IBS and concluded that acupuncture exhibits clinically and statistically significant control of IBS symptoms.
As IBS is a common and often difficult to treat condition, this would be great news! But is it true? We do not need to look far to find the embarrassing mistakes and – dare I say it? – lies on which this result was constructed.
The largest RCT included in this meta-analysis was neither placebo-controlled nor double blind; it was a pragmatic trial with the infamous ‘A+B versus B’ design. Here is the key part of its methods section: 116 patients were offered 10 weekly individualised acupuncture sessions plus usual care, 117 patients continued with usual care alone. Intriguingly, this was the ONLY one of the 6 RCTs with a significantly positive result!
The second largest study (as well as all the other trials) showed that acupuncture was no better than sham treatments. Here is the key quote from this trial: there was no statistically significant difference between acupuncture and sham acupuncture.
So, let me re-write the conclusions of this meta-analysis without spin, lies or hype: These results of this meta-analysis seem to indicate that:
- currently there are several RCTs testing whether acupuncture is an effective therapy for IBS,
- all the RCTs that adequately control for placebo-effects show no effectiveness of acupuncture,
- the only RCT that yields a positive result does not make any attempt to control for placebo-effects,
- this suggests that acupuncture is a placebo,
- it also demonstrates how misleading studies with the infamous ‘A+B versus B’ design can be,
- finally, this meta-analysis seems to be a prime example of scientific misconduct with the aim of creating a positive result out of data which are, in fact, negative.
Recently, I have been invited by the final year pharmacy students of the ‘SWISS FEDERAL INSTITUTE OF TECHNOLOGY ZURICH‘ to discuss alternative medicine with them. The aspect I was keen to debate was the issue of retail-pharmacists selling medicines which are unproven or even disproven. Using the example of homeopathic remedies, I asked them how many might, when working as retail-pharmacists, sell such products. About half of them admitted that they would do this. In real life, this figure is probably closer to 100%, and this discrepancy may well be a reflection of the idealism of the students, still largely untouched by the realities of retail-pharmacy.
In our discussions, we also explored the reasons why retail-pharmacists might offer unproven or disproven medicines like homeopathic remedies to their customers. The ethical codes of pharmacists across the world quite clearly prohibit this – but, during the discussions, we all realised that the moral high ground is not easily defended against the necessity of making a living. So, what are the possible motivations for pharmacists to sell bogus medicines?
One reason would be that they are convinced of their efficacy. Whenever I talk to pharmacists, I do not get the impression that many of them believe in homeopathy. During their training, they are taught the facts about homeopathy which clearly do not support the notion of efficacy. If some pharmacists nevertheless were convinced of the efficacy of homeopathy, they would obviously not be well informed and thus find themselves in conflict with their duty to practice according to the current best evidence. On reflection therefore, strong positive belief can probably be discarded as a prominent reason for pharmacists selling bogus medicines like homeopathic remedies.
Another common argument is the notion that, because patients want such products, pharmacists must offer them. When considering it, the tension between the ethical duties as a health care professional and the commercial pressures of a shop-keeper becomes painfully obvious. For a shop-keeper, it may be perfectly fine to offer all products which might customers want. For a heath care professional, however, this is not necessarily true. The ethical codes of pharmacists make it perfectly clear that the sale of unproven or disproven medicines is not ethical. Therefore, this often cited notion may well be what pharmacists feel, but it does not seem to be a valid excuse for selling bogus medicines.
A variation of this theme is the argument that, if patients were unable to buy homeopathic remedies for self-limiting conditions which do not really require treatment at all, they would only obtain more harmful drugs. The notion here is that it might be better to sell harmless homeopathic placebos in order to avoid the side-effects of real but non-indicated medicines. In my view, this argument does not hold water: if no (drug) treatment is indicated, professionals have a duty to explain this to their patients. In this sector of health care, a smaller evil cannot easily be justified by avoiding a bigger one; on the contrary, we should always thrive for the optimal course of action, and if this means reassurance that no medical treatment is needed, so be it.
An all too obvious reason for selling bogus medicines is the undeniable fact that pharmacists earn money by doing so. There clearly is a conflict of interest here, whether pharmacists want to admit it or not – and mostly they fail to do so or play down this motivation in their decision to sell bogus medicines.
Often I hear from pharmacists working in large chain pharmacies like Boots that they have no influence whatsoever over the range of products on sale. This perception mat well be true. But equally true is the fact that no health care professional can be forced to do things which violate their code of ethics. If Boots insists on selling bogus medicines, it is up to individual pharmacists and their professional organisations to change this situation by protesting against such unethical malpractice. In my view, the argument is therefore not convincing and certainly does not provide an excuse in the long-term.
While discussing with the Swiss pharmacy students, I was made aware of yet another reason for selling bogus medicines in pharmacies. Some pharmacists might feel that stocking such products provides an opportunity for talking to patients and informing them about the evidence related to the remedy they were about to buy. This might dissuade them from purchasing it and could persuade them to get something that is effective instead. In this case, the pharmacist would merely offer the bogus medicine in order to advise customers against employing it. This strategy might well be an ethical way out of the dilemma; however, I doubt that this strategy is common practice with many pharmacists today.
With all this, we should keep in mind that there are many shades of grey between the black and white of the two extreme attitudes towards bogus medicines. There is clearly a difference whether pharmacists actively encourage their customers to buy bogus treatments (in the way it often happens in France, for instance), or whether they merely stock such products and, where possible, offer responsible, evidence-based advise to people who are tempted to buy them.
At the end of the lively but fruitful discussion with the Swiss students I felt optimistic: perhaps the days when pharmacists were the snake-oil salesmen of the modern era are counted?
There is much debate about the usefulness of chiropractic. Specifically, many people doubt that their chiropractic spinal manipulations generate more good than harm, particularly for conditions which are not related to the spine. But do chiropractors treat such conditions frequently and, if yes, what techniques do they employ?
This investigation was aimed at describing the clinical practices of chiropractors in Victoria, Australia. It was a cross-sectional survey of 180 chiropractors in active clinical practice in Victoria who had been randomly selected from the list of 1298 chiropractors registered on Chiropractors Registration Board of Victoria. Twenty-four chiropractors were ineligible, 72 agreed to participate, and 52 completed the study.
Each participating chiropractor documented encounters with up to 100 consecutive patients. For each chiropractor-patient encounter, information collected included patient health profile, patient reasons for encounter, problems and diagnoses, and chiropractic care.
Data were collected on 4464 chiropractor-patient encounters between 11 December 2010 and 28 September 2012. In most (71%) cases, patients were aged 25-64 years; 1% of encounters were with infants. Musculoskeletal reasons for the consultation were described by patients at a rate of 60 per 100 encounters, while maintenance and wellness or check-up reasons were described at a rate of 39 per 100 encounters. Back problems were managed at a rate of 62 per 100 encounters.
The most frequent care provided by the chiropractors was spinal manipulative therapy and massage. The table shows the precise conditions treated
|Problem group||No. (%) of recorded diagnoses* (n = 5985)||Rate per 100 encounters (n = 4417)||95% CI||ICC|
|Back problem||2757 (46.07%)||62.42||(55.24–70.53)||0.312|
|Neck problem||683 (11.41%)||15.46||(11.23–21.30)||0.233|
|Muscle problem||434 (7.25%)||9.83||(6.64–14.55)||0.207|
|Health maintenance or preventive care||254 (4.24%)||5.75||(3.24–10.22)||0.251|
|Back syndrome with radiating pain||215 (3.59%)||4.87||(2.91–8.14)||0.165|
|Musculoskeletal symptom or complaint, or other||219 (3.66%)||4.96||(2.39–10.28)||0.350|
|Sprain or strain of joint||167 (2.79%)||3.78||(2.30–6.22)||0.115|
|Shoulder problem||87 (1.45%)||1.97||(1.37–2.83)||0.022|
|Nerve-related problem||62 (1.04%)||1.40||(0.72–2.75)||0.072|
|General symptom or complaint, other||51 (0.85%)||1.15||(0.22–6.06)||0.407|
|Bursitis, tendinitis or synovitis||47 (0.79%)||1.06||(0.71–1.60)||0.011|
|Kyphosis and scoliosis||47 (0.79%)||1.06||(0.65–1.75)||0.023|
|Foot or toe symptom or complaint||48 (0.80%)||1.09||(0.41–2.87)||0.123|
|Ankle problem||46 (0.77%)||1.04||(0.40–2.69)||0.112|
|Osteoarthrosis, other (not spine)||39 (0.65%)||0.88||(0.51–1.53)||0.023|
|Hip symptom or complaint||35 (0.58%)||0.79||(0.53–1.19)||0.006|
|Leg or thigh symptom or complaint||35 (0.58%)||0.79||(0.49–1.28)||0.012|
|Musculoskeletal injury||33 (0.55%)||0.75||(0.45–1.24)||0.013|
These findings are impressive in that they suggest that most Australian chiropractors treat non-spinal conditions for which there is no evidence that the most frequently used interventions are effective. The treatments employed are depicted in this graph:
Distribution of techniques and care provided by chiropractors, with 95% CI
[Activator = hand-held spring-loaded device that delivers an impulse to the spine. Drop piece = chiropractic treatment table with a segmented drop system which quickly lowers the section of the patient’s body corresponding with the spinal region being treated. Blocks = wedge-shaped blocks placed under the pelvis.
Chiro system = chiropractic system of care, eg, Applied Kinesiology, Sacro-Occipital Technique, Neuroemotional Technique. Flexion distraction = chiropractic treatment table that flexes in the middle to provide traction and mobilisation to the lumbar spine.]
There is no good evidence I know of demonstrating these techniques to be effective for the majority of the conditions listed in the above table.
A similar bone of contention is the frequent use of ‘maintenance’ and ‘wellness’ care. The authors of the article comment: The common use of maintenance and wellness-related terms reflects current debate in the chiropractic profession. “Chiropractic wellness care” is considered by an indeterminate proportion of the profession as an integral part of chiropractic practice, with the belief that regular chiropractic care may have value in maintaining and promoting health, as well as preventing disease. The definition of wellness chiropractic care is controversial, with some chiropractors promoting only spine care as a form of wellness, and others promoting evidence-based health promotion, eg, smoking cessation and weight reduction, alongside spine care. A 2011 consensus process in the chiropractic profession in the United States emphasised that wellness practice must include health promotion and education, and active strategies to foster positive changes in health behaviours. My own systematic review of regular chiropractic care, however, shows that the claimed effects are totally unproven.
One does not need to be overly critical to conclude from all this that the chiropractors surveyed in this investigation earn their daily bread mostly by being economical with the truth regarding the lack of evidence for their actions.
As promised in the last post, I will try to briefly address the issues which make me uncomfortable about the quotes by Anthony Campbell. Readers will recall that Campbell, an ex-director of what was arguably the most influential homeopathic hospital in the world and a long-time editor of the journal HOMEOPATHY, freely admitted that homeopathy was unproven and its effects were most likely not due to any specific properties of the homeopathic remedies [which are, in fact, pure placebos] but largely rely on non-specific effects.
I agree with much that Campbell wrote but I disagree with one particular implication of his conclusions: “Homeopathy has not been proved to work but neither has it been conclusively disproven….” and “…it is impossible to say categorically that all the remedies are without objective effect…”
This is an argument, we hear from proponents of alternative medicine with unfailing regularity: “MY TREATMENT MAY NOT BE SUPPORTED BY GOOD SCIENCE [BECAUSE GOOD SCIENCE IS EXPENSIVE, AND WE CANNOT AFFORD IT] BUT IT HAS NOT BEEN DISPROVEN EITHER – AND, AS LONG AS IT IS NOT DISPROVEN, NOBODY SHOULD STOP US USING IT”
Campbell does not explicitly draw this latter conclusion but he certainly implies it. In his book, he explains that, even though homeopathic remedies probably are placebos, homeopathy does a lot of good through the placebo effect and through its spiritual aspects. And that is, in his view, sufficient reason to employ it for healing the sick. The very last sentence of his book reads: “Love it or loathe it, homeopathy is here to stay”
So the implication is there: alternative therapies can be as bizarre, nonsensical, implausible, unscientific or idiotic as they like, if we scientists cannot disprove them, they must be legitimate for general use. But there are, of course, two obvious errors in this line of reasoning:
- Why on earth should scientists waste their time and resources on testing notions which are clearly bonkers? It is hard to imagine research that is less fruitful than such an endeavour.
- Disproving homeopathy [or similarly ridiculous treatments] is a near impossibility. Proving a negative is rarely feasible in science.
In the best interest of patients, responsible health care has to follow an entirely different logic: we must consider any treatment to be unproven, while it is not supported with reasonably sound evidence for effectiveness; and in clinical routine, we employ mostly such treatments which are backed by sound evidence, and we avoid those that are unproven. In other words, whether homeopathy or any other medicine is unproven or disproven is of little practical consequence: we try not to use either category.
While I applaud Campbell’s candid judgement regarding the lack of effectiveness of homeopathic remedies, I feel the need to finish his conclusion for him giving it a dramatically different meaning: Homeopathy has not been proved to work but neither has it been conclusively disproven; this means that, until new evidence unambiguously demonstrates otherwise, we should classify homeopathy as ineffective – and this, of course, applies not just to homeopathy but to ALL unproven interventions.
These days, there is so much hype about alternative cancer treatments that it is hard to find a cancer patient who is not tempted to try this or that alternative medicine. Often it is employed without the knowledge of the oncology team, solely on the advice of non-medically qualified practitioners (NMPs). But is that wise? The aim of this survey was to find out.
Members of several German NMP-associations were invited to complete an online questionnaire. The questionnaire explored areas such as the diagnosis and treatment, goals for using complementary/alternative medicine (CAM), communication with the oncologist, and sources of information.
Of a total of 1,500 members of the NMP associations, 299 took part in this survey. The results show that the treatments employed by NMPs were heterogeneous. Homeopathy was used by 45% of the NMPs, and 10% believed it to be a treatment directly against cancer. Herbal therapy, vitamins, orthomolecular medicine, ordinal therapy, mistletoe preparations, acupuncture, and cancer diets were used by more than 10% of the NMPs. None of the treatments were discussed with the respective physician on a regular basis.
The authors concluded from these findings that many therapies provided by NMPs are biologically based and therefore may interfere with conventional cancer therapy. Thus, patients are at risk of interactions, especially as most NMPs do not adjust their therapies to those of the oncologist. Moreover, risks may arise from these CAM methods as NMPs partly believe them to be useful anticancer treatments. This may lead to the delay or even omission of effective therapies.
Anyone faced with a diagnosis of CANCER is understandably keen to leave no stone unturned to bring about a cure of the disease. Many patients thus go on to the Internet and look what alternative options are on offer. There they find virtually millions of sites advertising thousands of bogus cancer ‘cures’. Others consult their alternative practitioners and seek help. This new survey shows yet again that the advice they receive is dangerous. In fact, it might well be even more dangerous than the results imply: the response rate of the survey was dismal, and I fear that the less responsible NMPs tended not to reply.
None of the treatments listed above can cure cancer. For instance, homeopathy, the most popular alternative cancer treatment in Germany, will have no effect whatsoever on the natural history of the disease. To claim otherwise is criminally irresponsible.
But far too many patients are unaware of the evidence and of the dangers of being misled by bogus claims. What we need, I think, is a major campaign to get the word out. It would be a campaign that saves lives!
Informed consent is generally considered to be an essential precondition for any health care practice. It requires the clinician giving the patient full information about the condition and the possible treatments. Amongst other things, the following information may be needed:
- the nature and prognosis of the condition,
- the evidence regarding the efficacy and risks of the proposed treatment,
- the evidence regarding alternative options.
Depending on the precise circumstances of the clinical situation, patient’s consent can be given either in writing or orally. Not obtaining any form of informed consent is a violation of the most fundamental ethics of health care.
In alternative medicine, informed consent seems often to be woefully neglected. This may have more than one reason:
- practitioners have frequently no adequate training in medical ethics,
- there is no adequate regulation and control of alternative practitioners,
- practitioners have conflicts of interest and might view informed consent as commercially counter-productive
In order to render this discussion less theoretical, I will outline several scenarios from the realm of chiropractic. Specifically, I will discuss the virtual case of an asthma patient consulting a chiropractor for alleviation of his symptoms. I should stress that I have chosen chiropractic merely as an example – the issues outlines below apply to chiropractic as much as they apply to most other forms of alternative medicine.
Our patient has experienced breathing problems and has heard that chiropractors are able to help this kind of condition. He consults a ‘straight’ chiropractor who adheres to Palmer’s gospel of ‘subluxation’. She explains to the patient that chiropractors use a holistic approach. By adjusting subluxations in the spine, she is confident to stimulate healing which will naturally ease the patient’s breathing problems. No conventional diagnosis is discussed, nor is there any mention of the prognosis, likelihood of benefit, risks of treatment and alternative therapeutic options.
Our patient consults a chiropractor who does not fully believe in the ‘subluxation’ theory of chiropractic. She conducts a thorough examination of our patient’s spine and diagnoses several spinal segments that are blocked. She tells our patient that he might be suffering from asthma and that spinal manipulation might remove the blockages and thus increase the mobility of the spine which, in turn, would alleviate his breathing problems. She does not mention risks of the proposed interventions nor other therapeutic options.
Our patient visits a chiropractor who considers herself a back pain specialist. She takes a medical history and conducts a physical examination. Subsequently she informs the patient that her breathing problems could be due to asthma and that she is neither qualified nor equipped to ascertain this diagnosis. She tells out patient that chiropractic is not an effective treatment for asthma but that his GP would be able to firstly make a proper diagnosis and secondly prescribe the optimal treatment for her condition. She writes a short note summarizing her thoughts and hands it to our patient to give it to his GP.
One could think of many more scenarios but the three above seem to cover a realistic spectrum of what a patient might encounter in real life. It seems clear, that the chiropractor in scenario 1 and 2 failed dismally regarding informed consent. In other words, only scenario 3 describes a behaviour that is ethically acceptable.
But how likely is scenario 3? I fear that it is an extremely rare turn of events. Even if well-versed in both medical ethics and scientific evidence, a chiropractor might think twice about providing all the information required for informed consent – because, as scenario 3 demonstrates, full informed consent in chiropractic essentially discourages a patient from agreeing to be treated. In other words, chiropractors have a powerful conflict of interest which prevents them to adhere to the rules of informed consent.
AND, AS POINTED OUT ALREADY, THAT DOES NOT JUST APPLY TO CHIROPRACTIC, IT APPLIES TO MOST OF ALTERNATIVE MEDICINE! IT SEEMS TO FOLLOW, I FEAR, THAT MUCH OF ALTERNATIVE MEDICINE IS UNETHICAL.