This week is acupuncture awareness week, and I will use this occasion to continue focusing on this therapy. This first time ever event is supported by the British Acupuncture Council who state that it aims to “help better inform people about the ancient practice of traditional acupuncture. With 2.3 million acupuncture treatments carried out each year, acupuncture is one of the most popular complementary therapies practised in the UK today.“
Right, let’s inform people about acupuncture then! Let’s show them that there is often more to acupuncture research than meets the eye.
My team and I have done lots of research into acupuncture and probably published more papers on this than any other subject. We had prominent acupuncturists on board from the UK, Korea, China and Japan, we ran conferences, published books and are proud to have been innovative and productive in our multidisciplinary research. But here I do not intend to dwell on our own achievements, rather I will highlight several important new papers in this area.
Korean authors just published a meta-analysis to assess the effectiveness of acupuncture as therapy for gouty arthritis. Ten RCTs involving 852 gouty arthritis patients were included. Six studies of 512 patients reported a significant decrease in uric acid in the treatment group compared with a control group, while two studies of 120 patients reported no such effect. The remaining four studies of 380 patients reported a significant decrease in pain in the treatment group.
The authors conclude “that acupuncture is efficacious as complementary therapy for gouty arthritis patients”.
We should be delighted with such a positive and neat result! Why then do I hesitate and have doubts?
I believe that this paper reveals several important issues in relation to systematic reviews of Chinese acupuncture trials and studies of other TCM interventions. In fact, this is my main reason for discussing the new meta-analysis here. The following three points are crucial, in my view:
1) All the primary studies were from China, and 8 of the 10 were only available in Chinese.
2) All of them had major methodological flaws.
3) It has been shown repeatedly that all acupuncture-trials from China are positive.
Given this situation, the conclusions of any review for which there are only Chinese acupuncture studies might as well be written before the actual research has started. If the authors are pro-acupuncture, as the ones of the present article clearly are, they will conclude that “acupuncture is efficacious“. If the research team has some critical thinkers on board, the same evidence will lead to an entirely different conclusion, such as “due to the lack of rigorous trials, the evidence is less than compelling.“
Systematic reviews are supposed to be the best type of evidence we currently have; they are supposed to guide therapeutic decisions. I find it unacceptable that one and the same set of data could be systematically analysed to generate such dramatically different outcomes. This is confusing and counter-productive!
So what is there to do? How can we prevent being misled by such articles? I think that medical journals should refuse to publish systematic reviews which so clearly lack sufficient critical input. I also believe that reviewers of predominantly Chinese studies should provide English translations of these texts so that they can be independently assessed by those who are not able to read Chinese – and for the sake of transparency, journal editors should insist on this point.
And what about the value of acupuncture for gouty arthritis? I think I let the readers draw their own conclusion.
Everyone knows, I think, that smoking is bad for our health. Why then do so many of us still smoke? Because smoking is addictive – and addictions are, by definition, far from easy to get rid of. Many smokers try acupuncture, and acupuncturists are making a ‘pretty penny’ on the assumption that their treatment is an effective way to stop the habit. But what does the best evidence tell us?
A new randomized, double-blind, placebo-controlled clinical trial with 125 smokers was conducted to determine whether ear acupuncture with electrical stimulation (auriculotherapy) once a week for 5 consecutive weeks is more effective than sham treatment.
The results showed that there was no difference in the rate of smoking cessation between the two groups. After 6 weeks, the auriculotherapy group achieved a rate of 20.9% abstinence which was not significantly different from the 17.9% in the sham group.
The authors of this study concluded that “the results … do not support the use of auriculotherapy to assist with smoking cessation. It is possible that a longer treatment duration, more frequent sessions, or other modifications of the intervention protocol used in this study may result in a different outcome. However, based on the results of this study, there is no evidence that auriculotherapy is superior to placebo when offered once a week for 5 weeks, as described in previous uncontrolled studies.”
Of course, they are correct to state that, theoretically, a different treatment regimen might have generated different outcomes. But how likely is that in reality?
To answer this question, we might consult the Cochrane review on the subject (which incidentally is close to my heart: I initiated it many years ago and was its senior author until it was plagiarised by my former co-worker and my name was replaced by that of his new boss [never a dull day in alternative medicine research!]).
The latest version of this article concludes that “there is no consistent, bias-free evidence that acupuncture, acupressure, laser therapy or electrostimulation are effective for smoking cessation, but lack of evidence and methodological problems mean that no firm conclusions can be drawn. Further, well designed research into acupuncture, acupressure and laser stimulation is justified since these are popular interventions and safe when correctly applied, though these interventions alone are likely to be less effective than evidence-based interventions”
This is a very, very (yes, I meant very, very) odd conclusion, I think. If I had still been an author of this plagiarised paper, I would have suggested something a little more straightforward: 33 studies of various types of acupuncture for smoking cessation are currently available (if we include the new trial, the number is 34). The totality of this evidence fails to show that acupuncture is effective. Therefore acupuncture should NOT be considered a valid option for this indication.
“They would say that, wouldn’t they?” is the quote attributed to Mandy Rice-Davies giving witness in the Profumo affair. I think, it aptly highlights some of the issues related to conflicts of interest in health care.
These days, when a researcher publishes a paper, he will in all likelihood have to disclose all conflicts of interest he might have. The aim of this exercise is to be as transparent as possible; if someone has received support from a commercial company, for example, this fact does not necessarily follow that his paper is biased, but it is important to lay open the fact so that the readers can make up their own minds.
The questionnaires that authors have to complete prior to publication of their article focus almost exclusively on financial issues. For instance, one has to disclose any sponsorship, fees, travel support or shares that one might own in a company. In conventional medicine, these matters are deemed to be the most important sources for potential conflicts of interest.
In alternative medicine, financial issues are generally thought to be far less critical; it is generally seen as an area where there is so little money that it is hardly worth bothering. Perhaps this is the reason why few journals in this field insist on declarations of conflicts of interests and few authors disclose them.
After having been a full-time researcher of alternative medicine for two decades, I have become convinced that conflicts of interest are at least as prevalent and powerful in this field as in any other area of health care. Sure, there is less money at stake, but this fact is more than compensated by non-financial issues. Quasi-evangelic convictions abound in alternative medicine and it is, I think, obvious that they can amount to significant conflicts of interest.
During their training, alternative practitioners are being taught many things which are unproven, have no basis in fact or are just plainly wrong. Eventually this schooling can create a belief system which often is adhered to regardless of the scientific evidence and which tends to be defended at all cost. As some of my readers are bound to object to this remark, I better cite an example: during their training, students of chiropractic develop a more and more firm stance against immunization which in all likelihood is due to the type of information they receive at the chiropractic college. There is no question in my mind that creeds can represent an even more powerful conflict of interest than financial matters.
Moreover, this belief is indivisibly intertwined with existential issues. In alternative medicine, there may not be huge amounts of money at stake but practitioners’ livelihoods are perceived to be at risk. If an acupuncturist, for instance, argues in favour of his therapy, he also consciously or sub-consciously is trying to protect his income.
Some might say that this not different from conventional medicine, but I disagree: if we take away one specific therapy from a doctor because it turns out to be useless or unsafe, he will be able to use another one; if we take the acupuncture needle away from an acupuncturist, we have deprived him of his livelihood.
This is why conflicts of interest in alternative medicine tend to be very acute, powerful and personal. And this is why enthusiasts of alternative medicine are incapable or unwilling to look upon any type of critical assessment of their area as anything else than an attack on their income, their beliefs, their status, their training or their person. If anyone should doubt it, I recommend studying the comments I received to previous posts of this blog.
When Mandi Rice-Davies gave evidence during the trial of Stephen Ward, the osteopath who had introduced her to influential clients, the prosecuting council noted that Lord Astor denied having had an affair with her. Mrs Rice-Davies allegedly replied “Well, he would say that, wouldn’t he?” (Actually, she did not say these exact words but something rather similar) When I read the comments following my posts on this blog, I am often reminded of this now classical quote.
When chiropractors deny that neck manipulations carry a risk, when herbalists insist that traditional herbalism is based on good evidence, when homeopaths claim that their remedies are more than placebos, I believe we should ask who, in these debates, might have a conflict of interest.
Is there a circumstance of one party in the discussion where personal interests might benefit from the argument? Who is more likely to be objective, the person whose livelihood is endangered or the independent expert who studied the subject in depth but has no axe to grind? If you ask these questions, you might conclude as I frequently do: “they would say that, wouldn’t they?”
In 2010, I have reviewed the deaths which have been reported after chiropractic treatments. My article suggested that 26 fatalities had been published in the medical literature and many more might have remained unpublished. The alleged pathology usually was a vascular accident involving the dissection of a vertebral artery. Whenever I write about the risks of spinal manipulation, chiropractors say that I am irresponsible and alarmist. Yet I believe I am merely doing my duty in alerting health care professionals and the public to the possibility that this intervention is associated with harm and that caution is therefore recommended.
Fortunately, I am not alone, as a new report from China shows.This review summarised published cases of injuries associated with cervical manipulation in China, and to describe the risks and benefits of the therapy.
A total of 156 cases met the inclusion criteria. They included the following problems: syncope = 45 cases , mild spinal cord injury or compression = 34 cases, nerve root injury = 24 cases, ineffective treatment or symptom increased = 11 cases ; cervical spine fracture = 11 cases, dislocation or semiluxation = 6 cases, soft tissue injury = 3 cases, serious accident = 22 cases including paralysis, death and cerebrovascular accident. Manipulation including rotation was involved in 42.00%, 63 cases). 5 patients died.
The authors conclude that “it is imperative for practitioners to complete the patients’ management and assessment before manipulation. That the practitioners conduct a detailed physical examination and make a correct diagnosis would be a pivot method of avoiding accidents. Excluding contraindications and potential risks, standardizing evaluation criteria and practitioners’ qualification, increasing safety awareness and risk assessment and strengthening the monitoring of the accidents could decrease the incidence of accidents” (I do apologize for the authors’ poor English).
It is probable that someone will now calculate that the risk of harm is minute. Chinese traditional healers seem to use spinal manipulation fairly regularly, so the incidence of complications would be one in several millions.
Such calculations are frequently made by chiropractors in an attempt to define the incidence rates of risks associated with chiropractic in the West. They look convincing but, in fact, they are complete nonsense.
The reason is that under-reporting can be huge. Clinical trials of chiropractic often omit any mention of adverse effects (thus violating publication ethics) and, in our case-series, under-reporting was precisely 100% (none of the cases we discovered had been recorded anywhere). This means that these estimates are entirely worthless.
I sincerely hope that the risk turns out to be extremely low – but without a functioning reporting system for such events, we might as well read tea-leaves.
Since weeks I have been searching for new (2013) studies which actually report POSITIVE results. I like good news as much as the next man but, in my line of business, it seems awfully hard to come by. Therefore I am all the more delighted to present these two new articles to my readers.
The first study is a randomized trial with patients suffering from metastatic cancer who received one of three interventions: massage therapy, no-touch intervention or usual care. Primary outcomes were pain, anxiety, and alertness; secondary outcomes were quality of life and sleep. The mean number of massage therapy sessions per patient was 2.8.
The results show significant improvement in the quality of life of the patients who received massage therapy after 1-week follow-up which was not observed in either of the other groups. Unfortunately, the difference was not sustained at 1 month. There were also trends towards improvement in pain and sleep of the patients after massage. No serious adverse events were noted.
The authors conclude that “providing therapeutic massage improves the quality of life at the end of life for patients and may be associated with further beneficial effects, such as improvement in pain and sleep quality. Larger randomized controlled trials are needed to substantiate these findings“.
The second study examined the effectiveness of a back massage for improving sleep quality in 60 postpartum women suffering from poor sleep. They were randomized to either the intervention or the control group. Participants in both groups received the same care except for the back massages. The intervention group received one 20-minutes back massage at the same time each evening for 5 consecutive days by a certified massage therapist. The outcome measure was the Pittsburgh Sleep Quality Index (PSQI). The results showed that the changes in mean PSQI were significantly lower in the intervention group than in controls indicating a positive effect of massage on sleep quality.
The authors’ conclusions were clear: “an intervention involving back massage in the postnatal period significantly improved the quality of sleep.”
Where I was trained (Germany), massage is not deemed to be an alternative but an entirely mainstream treatment. Despite this fact, there is precious little evidence to demonstrate that it is effective. Our own research has found encouraging evidence for a range of conditions, including autism, cancer palliation, constipation, DOMS and back pain. In addition, we have shown that massage is not entirely free of risks but that its potential for harm is very low (some might say that this was never in question but it is good to have a bit more solid evidence).
The new studies are, of course, not without flaws; this can hardly be expected in an area where logistical, financial and methodological problems abound. The fact that there are many different approaches to massage does not make things easier either. The new evidence is nevertheless encouraging and seems to suggest that massage has relaxing effects which are clinically relevant. In my view, massage is a therapy worth considering for more rigorous research.
The UK General Chiropractic Council has commissioned a survey of chiropractic patients’ views of chiropractic. Initially, 600 chiropractors were approached to recruit patients, but only 47 volunteered to participate. Eventually, 70 chiropractors consented and recruited a total of 544 patients who completed the questionnaire in 2012. The final report of this exercise has just become available.
I have to admit, I found it intensely boring. This is mainly because the questions asked avoided contentious issues. One has to dig deep to find nuggets of interest. Here are some of the findings that I thought were perhaps mildly intriguing:
15% of all patients did not receive information about possible adverse effects (AEs) of their treatment.
20% received no explanations why investigations such as X-rays were necessary and what risks they carried.
17% were not told how much their treatment would cost during the initial consultation.
38% were not informed about complaint procedures.
9% were not told about further treatment options for their condition.
18% said they were not referred to another health care professional when the condition failed to improve.
20% noted that the chiropractor did not liaise with the patient’s GP.
I think, one has to take such surveys with more than just a pinch of salt. At best, they give a vague impression of what patients believe. At worst, they are not worth the paper they are printed on.
Perhaps the most remarkable finding from the report is the unwillingness of chiropractors to co-operate with the GCC which, after all, is their regulating body. To recruit only ~10% of all UK chiropractors is more than disappointing. This low response rate will inevitably impact on the validity of the results and the conclusions.
It can be assumed that those practitioners who did volunteer are a self-selected sample and thus not representative of the UK chiropractic profession; they might be especially good, correct or obedient. This, in turn, also applies to the sample of patients recruited for this research. If that is so, the picture that emerged from the survey is likely to be be far too positive.
In any case, with a response rate of only ~10%, any survey is next to useless. I would therefore put it in the category of ‘not worth the paper it is printed on’.
As mentioned several times on this blog, homeopathy lacks a solid evidence base (to put it mildly). There are powerful organisations which attempt to mislead the public about this fact, but most homeopathy-fans know this only too well, in my opinion. Some try to bypass this vexing fact by trying to convince us that homeopathy is value for money, never mind the hard science of experimental proof of its principles or the complexity of the clinical data. They might feel that politicans would take notice, if homeopathy would be appreciated as a cheap form of health care. In this context, it is worth mentioning that researchers from Sheffield have just published a systematic review of economic evaluations of homeopathy
They included 14 published assessments in their review. Eight studies found cost savings associated with the use of homeopathy. Four investigations suggested that improvements in homeopathy patients were at least as good as in control group patients, at comparable costs. Two studies found improvements similar to conventional treatment, but at higher costs. The researchers also noted that studies were highly heterogeneous and had numerous methodological weaknesses.
The authors concluded that “although the identified evidence of the costs and potential benefits of homeopathy seemed promising, studies were highly heterogeneous and had several methodological weaknesses. It is therefore not possible to draw firm conclusions based on existing economic evaluations of homeopathy“.
Thre are, of course, several types of economic evaluations of medical interventions; the most basic of these simply compares the cost of one medication with those of another. In such an analysis, homeopathy would normally win against conventional tratment, as homeopathic remedies are generally inexpensive. If one adds the treatment time into the equation, things become a little more complex; homeopathic consultations tend to be considerably longer that conventional ones, and if the homeopaths’ time is costed at the same rate as the time of conventional doctors, it is uncertain whether homeopathy would still be cheaper.
Much more relevant, in my view, are cost-effective analyses which compare the relative costs and outcomes of two or more treatments. The results of such evaluations are often expressed in terms of a ratio where the denominator is a gain in health from a treatment and the numerator is the cost associated with the health gain. The most common measure used to express this is the QUALY.
Any cost-effective analysis can only produce meaningfully positive results, if the treatment in question supported by sound evidence for effectivenes. A treatment that is not demonstrably effective cannot be cost-effective! And this is where the principal problem with any cost-effectiveness analysis of homeopathy lies. Homeopathic remedies are placebos and thus can be neither effective nor cost-effective. Arguments to the contrary are in my view fallacious.
The authors of the new article say they have identified evidence of the potential benefits of homeopathy. How can this be? They based this conclusion only on the 14 studies included in their review. But this is only about 5% of the total available data. Reliable estimates of effectiveness should be based on the totality of the available evidence and not on a selection thereof.
I therefore think it is wise to focus on the part of the authors’ conclusion that does make sense: ” It is… not possible to draw firm conclusions based on existing economic evaluations of homeopathy“. In plain English: economic evaluations of homeopathy fail to show that it is value for money.
Acupuncture remains a highly controversial treatment: its mechanism of action is less than clear and the clinical results are equally unconvincing. Of course, one ought to differentiate between different conditions; the notion that acupuncture is a panacea is most certainly nonsense.
In many countries, acupuncture is being employed mostly in the management of pain, and it is in this area where the evidence is perhaps most encouraging. Yet, even here the evidence from the most rigorous clinical trials seems to suggest that much, if not all of the effects of acupuncture might be due to placebo.
Moreover, we ought to be careful with generalisations and ask what type of pain? One very specific pain is that caused by aromatase inhibitors (AI), a medication frequently prescribed to women suffering from breast cancer. Around 50 % of these patients complain of AI-associated musculoskeletal symptoms (AIMSS) and 15 % discontinue treatment because of these complaints. So, can acupuncture help these women?
A recent randomised, sham-controlled trial tested whether acupuncture improves AIMSS. Postmenopausal women with early stage breast cancer, experiencing AIMSS were randomized to eight weekly real or sham acupuncture sessions. The investigators evaluated changes in the Health Assessment Questionnaire Disability Index (HAQ-DI) and pain visual analog scale (VAS). Serum estradiol, β-endorphin, and proinflammatory cytokine concentrations were also measured pre and post-intervention. In total, 51 women were enrolled of whom 47 were evaluable (23 randomized to real and 24 to sham acupuncture).
Baseline characteristics turned out to be balanced between groups with the exception of a higher HAQ-DI score in the real acupuncture group. The results failed to show a statistically significant difference in reduction of HAQ-DI or VAS between the two groups. Following eight weekly treatments, a significant reduction of IL-17 was noted in both groups. No significant modulation was seen in estradiol, β-endorphin, or other proinflammatory cytokine concentrations in either group. No difference in AIMSS changes between real and sham acupuncture was seen.
Even though this study was not large, it was rigorously executed and well-reported. As many acupuncturists claim that their treatment alleviates pain and as many women suffering from AM-induced pain experience benefit, acupuncture advocates will nevertheless claim that the findings of this study are wrong, misleading or irrelevant. The often remarkable discrepancy between experience and evidence will again be the subject of intense discussions. How can a tiny trial overturn the experience of so many?
The answer is: VERY EASILY! In fact, the simplest explanation is that both are correct. The trial was well-done and its findings are thus likely to be true. The experience of patients is equally true – yet it relies not on the effects of acupuncture per se, but on the context in which it is given. In simple language, the effects patients experience after acupuncture are due to a placebo-response.
This is the only simple explanation which tallies with both the evidence and the experience. Once we think about it carefully, we realise that acupuncture is highly placebo-genic:
It is exotic.
It is invasive.
It is slightly painful.
It involves time with a therapist.
It involves touch.
If anyone had the task to develop a treatment that maximises placebo-effects, he could not come up with a better intervention!
Ahhh, will acupuncture-fans say, this means that acupuncture is a helpful therapy. I don’t care how it works, as long as it does help. Did we not just cover this issues in some detail? Indeed we did – and I do not feel like re-visiting the three fallacies which underpin this sentence again.
During the last decade, Professor Claudia Witt and co-workers from the Charite in Berlin have published more studies of homeopathy than any other research group. Much of their conclusions are over-optimistic and worringly uncritical, in my view. Their latest article is on homeopathy as a treatment of eczema. As it happens, I have recently published a systematic review of this subject; it concluded that “the evidence from controlled clinical trials… fails to show that homeopathy is an efficacious treatment for eczema“. The question therefore arises whether the latest publication of the Berlin team changes my conclusion in any way.
Their new article describes a prospective multi-centre study which included 135 children with mild to moderate atopic eczema. The parents of the kids enrolled in this trial were able to choose either homeopathic or conventional doctors for their children who treated them as they saw fit. The article gives only scant details about the actual treatments administered. The main outcome of the study was a validated symptom score at 36 months. Further endpoints included quality of life, conventional medicine consumption, safety and disease related costs at six, 12 and 36 months.
The results showed no significant differences between the groups at 36 months. However, the children treated conventionally seemed to improve quicker than those in the homeopathy group. The total costs were about twice higher in the homoeopathic compared to the conventional group. The authors conclude as follows: “Taking patient preferences into account, while being unable to rule out residual confounding, in this long-term observational study, the effects of homoeopathic treatment were not superior to conventional treatment for children with mild to moderate atopic eczema, but involved higher costs“.
At least one previous report of this study has been available for some time and had thus been included in my systematic review. It is therefore unlikely that this new analysis might change my conclusion, particularly as the trial by Witt et al has many flaws. Here are just some of the most obvious ones:
Patients were selected according to parents’ preferences.
This means expectations could have played an important role.
It also means that the groups were not comparable in various, potentially important prognostic variables.
Even though much of the article reads as though the homeopaths exclusively employed homeopathic remedies, the truth is that both groups received similar amounts of conventional care and treatments. In other words, the study followed a ‘A+B versus B’ design (here is the sentence that best gives the game away “At 36 months the frequency of daily basic skin care was… comparable in both groups, as was the number of different medications (including corticosteroids and antihistamines)…”). I have previously stated that this type of study-design can never produce a negative result because A+B is always more than B.
Yet, at first glance, this new study seems to prove my thesis wrong: even though the parents chose their preferred options, and even though all patients were treated conventionally, the addition of homeopathy to conventional care failed to produce a better clinical outcome. On the contrary, the homeopathically treated kids had to wait longer for their symptoms to ease. The only significant difference was that the addition of homeopathy to conventional eczema treatments was much more expensive than conventional therapy alone (this finding is less than remarkable: even the most useless additional intervention costs money).
So, is my theory about ‘A+B versusB’ study-designs wrong? I don’t think so. If B equals zero, one would expect exactly the finding Witt et al produced: A+0=A. In turn, this is not a compliment for the homeopaths of this study: they seem to have been incapable of even generating a placebo-response. And this might indicate that homeopathy was not even usefull as a means to generate a placebo-response. Whatever interpretation one adopts, this study tells us very little of value (as children often grow out of eczema, we cannot even be sure whether the results are not simply a reflection of the natural history of the disease); in my view, it merely demonstrates that weak study designs can only create weak findings which, in this particular case, are next to useless.
The study was sponsored by the Robert Bosch Stiftung, an organisation which claims to be dedicated to excellence in research and which has, in the past, spent millions on researching homeopathy. It seems doubtful that trials of this caliber can live up to any claim of excellence. In any case, the new analysis is certainly no reason to change the conclusion of my systematic review.
To their credit, Witt et al are well aware of the many weaknesses of their study. Perhaps in an attempt to make them appear less glaring, they stress that “the aim of this study was to reflect the real world situation“.Usually I do not accept the argument that pragmatic trials cannot be rigorous – but I think Witt et al do have a point here: the real word tells us that homeopathic remedies are pure placebos!
The most common pronouncement regarding alternative medicine that I have heard over the years from consumers, health care professionals or decision makers with a liking of alternative medicine goes as follows: “I don’t care how it works, as long as it helps.”
At first glance, this argument seems reasonable, logic and correct; it would be foolish, perhaps even unethical, to reject an effective treatment simply because we fail to understand how its effectiveness comes about – this would not be pragmatic and it is not what we do in medicine: aspirin, for instance, was used and helped many patients long before we understood how it worked. However, once we consider the way this notion is regularly used to defend the use of unproven therapies, we see that, in this context, it is fallacious – in fact, if we dissect it carefully, we find that it crams three large fallacies in one tiny sentence.
The first thing we notice is that the argument combines two fundamentally different issues which really should be separate 1) the mechanism of action of a therapy and 2) its clinical effectiveness. The matter gets clearer, if we discuss it not in the abstract, but in relation to a concrete example: BACH FLOWER REMEDIES (BFRs). I could have selected many other alternative therapies but BFRs seem fine, particularly as they have so far received no mention on this blog.
Similar to homeopathic preparations, BFRs are so dilute that they do not contain any active ingredients to speak of (they differ from homeopathic preparations, however, in that they do not follow the ‘like cures like’ principle). Several clinical trials of BFRs have been published; collectively, their results show very clearly that the clinical effects of BFRs do not differ from those of placebo. (This does not stop manufacturers selling and consumers buying them; in fact, BFRs are a thriving business.)
The principles backing up BFRs are scientifically implausible, and even BFR-practitioners would probably admit that they have no scientifically defensible idea how their remedies work. Scientists might add that a mechanism of action of such highly dilute remedies is not just unknown but unknowable; there is no way to explain how they work without re-writing several laws of nature.
The overall situation is thus quite clear: BFRs are not effective and there is no plausible mechanism of action.Yet it is hard to deny that many patients feel better after having consulted a BFR-practitioner (or after self-medicating BFRs), and those satisfied customers often insist: “I don’t care how BFRs work, as long as they help me.”
As previously discussed, symptoms can improve for a range of reasons which are related to any specific therapeutic effect: the natural history of the condition, regression towards the mean, placebo-effects etc. Only rigorously controlled trials can tell us whether the therapy or other factors caused the clinical outcome; our perception alone cannot identify cause and effect.
The fact that thousands of patients swear by BFRs, does therefore not constitute proof for their efficacy. The explanation of the apparently different impressions from experience and the results of clinical trials is therefore simple: the empathetic encounter with a therapist and/or a placebo-effect and/or the natural history of the condition are perceived as helpful, while the BFRs are pure placebos.
Back to the notion “I don’t care how this therapy works, as long as it helps” – it turns out to be based on at least three misunderstandings all tightly woven together.
Firstly, it was not the treatment itself that helped, but something else (see above). To imply that the treatment worked is therefore a fallacy.
Secondly, the reference to an unknown mechanism of action is aimed at misleading the opponent: it distracts from the first fallacy (“the treatment is effective”) by super-imposing a second fallacy (that there might be a mechanism of action). Crucially it attempts to wrong-foot the opponent by implying: “you reject something useful simply because you cannot explain it; this is poor logic and even worse ethics – shame on you!”.
BFR-enthusiasts are bound to see all this quite differently. They will probably claim that a placebo-effect is also a plausible mechanism. “Surely” they might say “this means that BFRs are useful and should be widely employed”.
In proclaiming this, they turn the double-fallacy into a triple fallacy. What they forget is that we do not need a placebo to generate placebo-effects. An effective treatment administered with time, compassion and empathy will, of course, also generate a placebo-effect – what is more, it would generate a specific therapeutic effect on top of it. Thus the BFR are quite useless in comparison. There is rarely a good justification for using placebos in clinical routine.
In conclusion, the often-used and seemingly reasonable sentence “I don’t care how it works, as long as it is helpful turns out to be a package of fallacies when used to support the use of unproven treatments.