MD, PhD, FMedSci, FSB, FRCP, FRCPEd

commercial interests

I find it always nice to see that people appreciate my work. Yet sometimes I am a little surprised to realise what some commercially interested firms make of it. Recently I came across a website that proudly used my research for advertising the use of magnetic bracelets against pain. Here is the text in question:

The extra strong magnets make this magnetic bracelet the fastest acting pain reliever. While wearing this magnetic bracelet customers with wrist and hand pain report significant pain relief….

What is a magnetic bracelet and what are the benefits? Magnetic bracelets are a piece of jewelry, worn for the therapeutic benefits of the magnetic field. Magnetic bracelets has been used successfully by many people for pain relief of inflammatory conditions such as arthritis, tendinitis and bursitis.

A randomized, placebo controlled trial with three parallel groups, came to the conclusion : Pain from osteoarthritis of the hip and knee decreases when wearing magnetic bracelets. It is uncertain whether this response is due to specific or non-specific (placebo) effects. Tim Harlow, general practitioner, Colin Greaves, research fellow, Adrian White, senior research fellow, Liz Brown, research assistant, Anna Hart, statistician, Edzard Ernst, professor of complementary medicine.

The entrepreneurs seem to have forgotten a few things which we tried to make clear in our paper:

  • this article was published in the Christmas issue of the BMJ which specialises in publishing unusual and odd findings with a high entertainment value,
  • in our paper, we point out that “the contamination of group B with stronger magnets prevented a more objective estimation of any-placebo effect”,
  • and stressed that “there were problems with the weak magnets”,
  • and that “a per-specification analysis suggested (but could not confirm) a specific effect of magnetic bracelets over and above placebo”.

Most importantly, this was just one trial, and surely one swallow does not make a summer! We should always consider the totality of the reliable evidence. Being conscientious researchers, at the time, we did exactly that and conducted a systematic review. Here is the abstract in its full beauty:

BACKGROUND:

Static magnets are marketed with claims of effectiveness for reducing pain, although evidence of scientific principles or biological mechanisms to support such claims is limited. We performed a systematic review and meta-analysis to assess the clinical evidence from randomized trials of static magnets for treating pain.

METHODS:

Systematic literature searches were conducted from inception to March 2007 for the following data sources: MEDLINE, EMBASE, AMED (Allied and Complementary Medicine Database), CINAHL, Scopus, the Cochrane Library and the UK National Research Register. All randomized clinical trials of static magnets for treating pain from any cause were considered. Trials were included only if they involved a placebo control or a weak magnet as the control, with pain as an outcome measure. The mean change in pain, as measured on a 100-mm visual analogue scale, was defined as the primary outcome and was used to assess the difference between static magnets and placebo.

RESULTS:

Twenty-nine potentially relevant trials were identified. Nine randomized placebo-controlled trials assessing pain with a visual analogue scale were included in the main meta-analysis; analysis of these trials suggested no significant difference in pain reduction (weighted mean difference [on a 100-mm visual analogue scale] 2.1 mm, 95% confidence interval -1.8 to 5.9 mm, p = 0.29). This result was corroborated by sensitivity analyses excluding trials of acute effects and conditions other than musculoskeletal conditions. Analysis of trials that assessed pain with different scales suggested significant heterogeneity among the trials, which means that pooling these data is unreliable.

INTERPRETATION:

The evidence does not support the use of static magnets for pain relief, and therefore magnets cannot be recommended as an effective treatment. For osteoarthritis, the evidence is insufficient to exclude a clinically important benefit, which creates an opportunity for further investigation.

So, would I, on the basis of the current best evidence, recommend magnetic bracelets to people who suffer from pain? No! In my view, only charlatans would do such a thing.

In the early 1920s, a French physician thought he had discovered the virus that caused the Spanish flu. It oscillated under his microscope, and he thus called it oscillococcus. Not only did it cause the flu, in the opinion of his discoverer, but it was also responsible for a whole host of other diseases, including cancer. In fact, the virus does not exist, or at least nobody ever confirmed it existed, but that fact did not stop our good doctor to make a homeopathic remedy from it which he thought would cure all these diseases. His remedy, Oscillococcinum, is made from the liver and heart of a duck because the imaginative inventor believed that the fictitious virus was present in these organs of this animal.

To understand all this fully, one needs to know that the duck organs are so highly diluted that no molecule of the duck is present in the remedy. It is sold in the C200 potency. This means that one part of organ extract is diluted 1: 10 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 (a note to Boiron’s legal team: I had a hell of a time getting all these zeros right; in case, I got it wrong after all, it is an honest error – please do not sue me for it!). The dilution is so extreme that it amounts to a single molecule per a multitude of universes.

Given these facts it seems unlikely that the remedy has any effects on human health which go beyond those of a placebo. Let’s see what the current Cochrane review says about its effectiveness: There is insufficient good evidence to enable robust conclusions to be made about Oscillococcinum(®) in the prevention or treatment of influenza and influenza-like illness. Our findings do not rule out the possibility that Oscillococcinum(®) could have a clinically useful treatment effect but, given the low quality of the eligible studies, the evidence is not compelling. There was no evidence of clinically important harms due to Oscillococcinum(®).

Considering that the first author of this review works for the British Homeopathic Association and the senior author is the homeopath of the Queen, this seems a pretty clear statement, don’t you think?

Regardless of the scientific evidence, Oscillococcinum made of ‘Anas Barbariae Hepatis et Cordis Extractum‘, as it is officially called, became a homeopathic best-seller. In the US alone Boiron, the manufacturer, is said to sell US$ 15 m per year of this product. Not only that, in France, where the remedy is a popular medicine sold in virtually all pharmacies and often recommended as soon as you walk into a pharmacy, it is hard to find anyone who does not swear by the ‘potentized‘ duck or is willing to discuss its merits critically.

The amazing duck, it seems, has turned into a ‘holy cow’.

If we search on ‘Medline’ for ‘complementary alternative medicine’ (CAM), we currently get about 13000 hits. A little graph on the side of the page demonstrates that, during the last 4 years, the number of articles on this subject has grown exponentially.

Surely, this must be very good news: such intense research activity will soon tell us exactly which alternative treatments work for which conditions and which don’t.

I beg to differ. Let me explain why.

The same ‘Medline’ search informs us that the majority of the recent articles were published in an open access journal called ‘Evidence-Based Complementary and Alternative Medicine’ (eCAM). For example, of the 80 most recent articles listed in Medline (on 26/5/2014), 53 came from that journal. The publication frequency of eCAM and its increase in recent years beggars belief: in 2011, they published just over 500 articles which is already a high number, but, in 2012, the figure had risen to >800, and in 2013 it was >1300 (the equivalent 2013 figure for the BMJ/BMJ Open by comparison is 4, and that for another alt med journal, e.g. Forsch Komplement, is 10)

How do they do it? How can eCAM be so dominant in publishing alt med research? The trick seems to be fairly simple.

Let’s assume you are an alt med researcher and you have an article that you would like to see published. Once you submit it to eCAM, your paper is sent to one of the ~150 members of the editorial board. These people are almost all strong proponents of alternative medicine; critics are a true rarity in this group. At this stage, you are able to suggest the peer reviewers for your submission (all who ever accepted this task are listed on the website; they amount to several thousand!), and it seems that, with the vast majority of submissions, the authors’ suggestions are being followed.

It goes without saying that most researchers suggest colleagues for peer reviewing who are not going to reject their work (the motto seems to be “if you pass my paper, I will pass yours). Therefore even faily flimsy bits of research pass this peer review process and get quickly published online in eCAM.

This process explains a lot, I think: 1) the extraordinarily high number of articles published 2) why currently more than 50% of all alt med research originate from eCAM 3) why so much of it is utter rubbish.

Even the mere titles of some of the articles might demonstrate my point. A few examples have to suffice:

  • Color distribution differences in the tongue in sleep disorder
  • Wen-dan decoction improves negative emotions in sleep-deprived rats by regulating orexin-a and leptin expression.
  • Yiqi Huoxue Recipe Improves Heart Function through Inhibiting Apoptosis Related to Endoplasmic Reticulum Stress in Myocardial Infarction Model of Rats.
  • Protective Effects of Bu-Shen-Huo-Xue Formula against 5/6 Nephrectomy-Induced Chronic Renal Failure in Rats
  • Effects and Mechanisms of Complementary and Alternative Medicine during the Reproductive Process
  • Evidence-based medicinal plants for modern chronic diseases
  • Transforming Pain into Beauty: On Art, Healing, and Care for the Spirit

This system of uncritical peer review and fast online publication seems to suit many of the people involved in this process: the journal’s owners are laughing all the way to the bank; there is a publication charge of US$ 2000 per article, and, in 2013, the income of eCAM must therefore have been well over US$2 000 000. The researchers are equally delighted; they get even their flimsiest papers published (remember: ‘publish or perish’!). And the evangelic believers in alternative medicine are pleased because they can now claim that their field is highly research-active and that there is plenty of evidence to support the use of this or that therapy.

But there are others who are not served well by eCAM habit of publishing irrelevant, low quality articles:

  • professionals who would like to advance health care and want to see reliable evidence as to which treatments work and which don’t,
  • the public who, in one way or another, pay for all this and might assume that published research tends to be relevant and reliable,
  • the patients who have given their time to researchers in the hope that their gift will improve health care,
  • ill individuals who hope that alternative treatments might relieve their suffering,
  • politicians who rely on research to be reliable in order to arrive at the right decisions.

Come to think of it, the vast majority of people should be less than enchanted with eCAM and similar journals.

Manufacturers of homeopathic remedies are having a hard time, it seems. The following press release has just reached me, and I thought it might be worth sharing it with my readers:

 

Baden-Baden, Germany, May 23, 2014 – Heel Group today announced the cessation of its business activities in the United States and Canada on August 31, 2014.

 

In the USA and Canada, manufacturers of OTC homeopathic medicinal products have been confronted with accusations through class action lawsuits. Heel Inc., the Heel Group’s U.S.-based subsidiary, was also faced with two such attempts recently. Both cases have been settled without conceding the allegations. The financial burden on Heel Inc., however, was substantial.

In a subsequent risk-benefit analysis of its global activities, the Heel Group decided to focus on strengthening its excellent position in South America, Central Europe and Eastern Europe and to withdraw from business activities in the USA and Canada for the time being.

Heel’s operations in both the USA and Canada will accordingly be discontinued as of August 31, 2014.

In the USA, negotiations with MediNatura Inc., a Delaware Corporation, are close to completion by which the Heel Group will transfer its stock in Heel Inc., to MediNatura by the end of August 2014. The transaction does, however, not include any of Heel’s trusted and leading global brands such as Traumeel, Neurexan, Zeel, Oculoheel, Luffeel, Sinusin, Vinceel, Nectadyn, Adrisin, Gripp-Heel, Viburcol, Vertigoheel, Spascupreel, Engystol, and Lymphomyosot*. Completion of the acquisition is subject to standard closing procedures.

As a trailblazer and leader in the field of scientific research into natural healthcare and a leading manufacturer of homeopathic medicines, the Heel Group will continue to invest in research and development on a global scale, also involving the medical-scientific community in North America.

Ralph Schmidt, CEO of the Heel Group: “As a global player, we are continuously reviewing our portfolio. This means that we are sometimes required to focus on specific regions at the expense of others in order to efficiently carry out our ambitious expansion plans. I would not exclude the possibility of re-entering the markets in the USA and Canada with a new business concept.”

It is somewhat sobering from my point of view to realise that all the science proving that homeopathy had no health effects beyond placebo had little effect on the market for homeopathic remedies. If anything, the sales figures seemed to get better and better as the evidence got more and more negative during the last decades. The ‘globulisation’ of the world seemed imminent due to those homeopathic manufacturers who wanted to become ‘global players’ (is there not a homeopathic remedy against megalomania?). It was only the legal actions that seemed to have an effect. The multiple North American class actions were more effective than the science, it seems.

Is there a lesson here? Perhaps! It could be that scientists working on their own are not always powerful enough to improve health care. Particularly when confronted with an alliance of evangelic belief and commercial interests, scientists, sceptics, journalists, lawyers, politicians and other professions might have to co-operate to bring about meaningful change.

 

The question whether infant colic can be effectively treated with manipulative therapies might seem rather trivial – after all, this is a benign condition which the infant quickly grows out of. However, the issue becomes a little more tricky, if we consider that it was one of the 6 paediatric illnesses which were at the centre of the famous libel case of the BCA against my friend and co-author Simon Singh. At the time, Simon had claimed that there was ‘not a jot of evidence’ for claiming that chiropractic was an effective treatment of infant colic, and my systematic review of the evidence strongly supported his statement. The BCA eventually lost their libel case and with it the reputation of chiropractic. Now a new article on this intriguing topic has become available; do we have to reverse our judgements?

The aim of this new systematic review was to evaluate the efficacy or effectiveness of manipulative therapies for infantile colic. Six RCTs of chiropractic, osteopathy or cranial osteopathy alone or in conjunction with other interventions were included with a total of 325 infants. Of the 6 included studies, 5 were “suggestive of a beneficial effect” and one found no evidence of benefit. Combining all the RCTs suggested that manipulative therapies had a significant effect. The average crying time was reduced by an average of 72 minutes per day. This effect was sustained for studies with a low risk of selection bias and attrition bias. When analysing only those studies with a low risk of performance bias (i.e. parental blinding) the improvement in daily crying hours was no longer statistically significant.

The quality of the studies was variable. There was a generally low risk of selection bias but a high risk of performance bias. Only one of the studies recorded adverse events and none were encountered.

From these data, the authors drew the following conclusion: Parents of infants receiving manipulative therapies reported fewer hours crying per day than parents whose infants did not and this difference was statistically significant. Most studies had a high risk of performance bias due to the fact that the assessors (parents) were not blind to who had received the intervention. When combining only those trials with a low risk of such performance bias the results did not reach statistical significance.

Does that mean that chiropractic does work for infant colic? No, it does not!

The first thing to point out is that the new systematic review included not just RCTs of chiropractic but also osteopathy and cranio-sacral therapy.

The second important issue is that the effects disappear, once performance bias is being accounted for which clearly shows that the result is false positive.

The third relevant fact is that the majority of the RCTs were of poor quality. The methodologically best studies were negative.

And the fourth thing to note is that only one study mentioned adverse effects, which means that the other 5 trials were in breach of one of rather elementary research ethics.

What makes all of this even more fascinating is the fact that the senior author of the new publication, George Lewith, is the very expert who advised the BCA in their libel case against Simon Singh. He seems so fond of his work that he even decided to re-publish it using even more misleading language than before. It is, of course, far from me to suggest that his review was an attempt to white-wash the issue of chiropractic ‘bogus’ claims. However, based on the available evidence, I would have formulated conclusions which are more than just a little different from his; something like this perhaps:

The current best evidence suggests that the small effects that emerge when we pool the data from mostly unreliable studies are due to bias and therefore not real. This systematic review therefore fails to show that manipulative therapies are effective. It furthermore points to a serious breach of research ethics by the majority of researchers in this field.

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.

My comments:

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.

My comments:

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.

My Comments:

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.

IMPLICATION

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.

It has been reported that Belgium has just officially recognised homeopathy. The government had given the green light already in July last year, but the Royal Decree has only now become official. This means that, from now on, Belgian doctors, dentists and midwives can only call themselves homeopaths, if they have attended recognised courses in homeopathy and are officially certified. While much of the new regulation is as yet unclear (at least to me), it seems that, in future, only doctors, dentists and midwives are allowed to practice homeopathy, according to one source.

However, the new law also seems to provide that those clinicians with a Bachelor degree in health care who have already been practicing as homeopaths can continue their activities under a temporary measure.

Moreover, the official recognition as a homeopath does not automatically imply that the services will be refunded from a health insurance.

It is said that, in general, homeopaths are happy with the new regulation; they are delighted to have been up-graded in this way and argue that the changes will result in higher quality standards: “This is a very important step and it can only be to the benefit of the patients’ safety. Patients will know whether or not they are dealing with someone who correctly applies homeopathic medicine”, Leon Schepers of the Unio Homeopathica Belgica was quoted saying.

The delight of homeopaths is in sharp contrast to the dismay of rational thinkers. The NHMRC recently assessed the effectiveness of homeopathy. The evaluation is both comprehensive and independent; it concluded that “the evidence from research in humans does not show that homeopathy is effective for treating the range of health conditions considered.” In other words, homeopathic remedies are implausible, over-priced placebos.

Granting an official status to homeopaths cannot possibly benefit patients. On the contrary, it will only render health care less effective and charlatans more assertive.

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.

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:

  1. currently there are several RCTs testing whether acupuncture is an effective therapy for IBS,
  2. all the RCTs that adequately control for placebo-effects show no effectiveness of acupuncture,
  3. the only RCT that yields a positive result does not make any attempt to control for placebo-effects,
  4. this suggests that acupuncture is a placebo,
  5. it also demonstrates how misleading studies with the infamous ‘A+B versus B’ design can be,
  6. 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?

Recent Comments

Note that comments can be edited for up to five minutes after they are first submitted.


Click here for a comprehensive list of recent comments.

Categories