Many proponents of alternative medicine seem somewhat suspicious of research; they have obviously understood that it might not produce the positive result they had hoped for; after all, good research tests hypotheses and does not necessarily confirm beliefs. At the same time, they are often tempted to conduct research: this is perceived as being good for the image and, provided the findings are positive, also good for business.
Therefore they seem to be tirelessly looking for a study design that cannot ‘fail’, i.e. one that avoids the risk of negative results but looks respectable enough to be accepted by ‘the establishment’. For these enthusiasts, I have good news: here is the study design that cannot fail.
It is perhaps best outlined as a concrete example; for reasons that will become clear very shortly, I have chosen reflexology as a treatment of diabetic neuropathy, but you can, of course, replace both the treatment and the condition as it suits your needs. Here is the outline:
- recruit a group of patients suffering from diabetic neuropathy – say 58, that will do nicely,
- randomly allocate them to two groups,
- the experimental group receives regular treatments by a motivated reflexologist,
- the controls get no such therapy,
- both groups also receive conventional treatments for their neuropathy,
- the follow-up is 6 months,
- the following outcome measures are used: pain reduction, glycemic control, nerve conductivity, and thermal and vibration sensitivities,
- the results show that the reflexology group experience more improvements in all outcome measures than those of control subjects,
- your conclusion: This study exhibited the efficient utility of reflexology therapy integrated with conventional medicines in managing diabetic neuropathy.
This method is fool-proof, trust me, I have seen it often enough being tested, and never has it generated disappointment. It cannot fail because it follows the notorious A+B versus B design (I know, I have mentioned this several times before on this blog, but it is really important, I think): both patient groups receive the essential mainstream treatment, and the experimental group receives a useless but pleasant alternative treatment in addition. The alternative treatment involves touch, time, compassion, empathy, expectations, etc. All of these elements will inevitably have positive effects, and they can even be used to increase the patients’ compliance with the conventional treatments that is being applied in parallel. Thus all outcome measures will be better in the experimental compared to the control group.
The overall effect is pure magic: even an utterly ineffective treatment will appear as being effective – the perfect method for producing false-positive results.
And now we hopefully all understand why this study design is so very popular in alternative medicine. It looks solid – after all, it’s an RCT!!! – and it thus convinces even mildly critical experts of the notion that the useless treatment is something worth while. Consequently the useless treatment will become accepted as ‘evidence-based’, will be used more widely and perhaps even reimbursed from the public purse. Business will be thriving!
And why did I employ reflexology for diabetic neuropathy? Is that example not a far-fetched? Not a bit! I used it because it describes precisely a study that has just been published. Of course, I could also have taken the chiropractic trial from my last post, or dozens of other studies following the A+B versus B design – it is so brilliantly suited for misleading us all.
On this blog, I have often pointed out how dismally poor most of the trials of alternative therapies frequently are, particularly those in the realm of chiropractic. A brand-new study seems to prove my point.
The aim of this trial was to determine whether spinal manipulative therapy (SMT) plus home exercise and advice (HEA) compared with HEA alone reduces leg pain in the short and long term in adults with sub-acute and chronic back-related leg-pain (BRLP).
Patients aged 21 years or older with BRLP for least 4 weeks were randomised to receive 12 weeks of SMT plus HEA or HEA alone. Eleven chiropractors with a minimum of 5 years of practice experience delivered SMT in the SMT plus HEA group. The primary outcome was subjective BRLP at 12 and 52 weeks. Secondary outcomes were self-reported low back pain, disability, global improvement, satisfaction, medication use, and general health status at 12 and 52 weeks.
Of the 192 enrolled patients, 191 (99%) provided follow-up data at 12 weeks and 179 (93%) at 52 weeks. For leg pain, SMT plus HEA had a clinically important advantage over HEA (difference, 10 percentage points [95% CI, 2 to 19]; P = 0.008) at 12 weeks but not at 52 weeks (difference, 7 percentage points [CI, -2 to 15]; P = 0.146). Nearly all secondary outcomes improved more with SMT plus HEA at 12 weeks, but only global improvement, satisfaction, and medication use had sustained improvements at 52 weeks. No serious treatment-related adverse events or deaths occurred.
The authors conclude that, for patients with BRLP, SMT plus HEA was more effective than HEA alone after 12 weeks, but the benefit was sustained only for some secondary outcomes at 52 weeks.
This is yet another pragmatic trial following the notorious and increasingly popular A+B versus B design. As pointed out repeatedly on this blog, this study design can hardly ever generate a negative result (A+B is always more than B, unless A has a negative value [which even placebos don't have]). Thus it is not a true test of the experimental treatment but all an exercise to create a positive finding for a potentially useless treatment. Had the investigators used any mildly pleasant placebo with SMT, the result would have been the same. In this way, they could create results showing that getting a £10 cheque or meeting with pleasant company every other day, together with HEA, is more effective than HEA alone. The conclusion that the SMT, the cheque or the company have specific effects is as implicit in this article as it is potentially wrong.
The authors claim that their study was limited because patient-blinding was not possible. This is not entirely true, I think; it was limited mostly because it failed to point out that the observed outcomes could be and most likely are due to a whole range of factors which are not directly related to SMT and, most crucially, because its write-up, particularly the conclusions, wrongly implied cause and effect between SMT and the outcome. A more accurate conclusion could have been as follows: SMT plus HEA was more effective than HEA alone after 12 weeks, but the benefit was sustained only for some secondary outcomes at 52 weeks. Because the trial design did not control for non-specific effects, the observed outcomes are consistent with SMT being an impressive placebo.
No such critical thought can be found in the article; on the contrary, the authors claim in their discussion section that the current trial adds to the much-needed evidence base about SMT for subacute and chronic BRLP. Such phraseology is designed to mislead decision makers and get SMT accepted as a treatment of conditions for which it is not necessarily useful.
Research where the result is known before the study has even started (studies with a A+B versus B design) is not just useless, it is, in my view, unethical: it fails to answer a real question and is merely a waste of resources as well as an abuse of patients willingness to participate in clinical trials. But the authors of this new trial are in good and numerous company: in the realm of alternative medicine, such pseudo-research is currently being published almost on a daily basis. What is relatively new, however, that even some of the top journals are beginning to fall victim to this incessant stream of nonsense.
Most of the underlying assumptions of alternative medicine (AM) lack plausibility. Whenever this is the case, so the argument put forward by an international team of researchers in a recent paper, there are difficulties involved in obtaining a valid statistical significance in clinical studies.
Using a mostly statistical approach, they argue that, since the prior probability of a research hypothesis is directly related to its scientific plausibility, the commonly used frequentist statistics, which do not account for this probability, are unsuitable for studies exploring matters in various degree disconnected from science. Any statistical significance obtained in this field should be considered with great caution and may be better applied to more plausible hypotheses (like placebo effect) than the specific efficacy of the intervention.
The researchers conclude that, since achieving meaningful statistical significance is an essential step in the validation of medical interventions, AM practices, producing only outcomes inherently resistant to statistical validation, appear not to belong to modern evidence-based medicine.
To emphasize their arguments, the researchers make the following additional points:
- It is often forgotten that frequentist statistics, commonly used in clinical trials, provides only indirect evidence in support of the hypothesis examined.
- The p-value inherently tends to exaggerate the support for the hypothesis tested, especially if the scientific plausibility of the hypothesis is low.
- When the rationale for a clinical intervention is disconnected from the basic principles of science, as in case of complementary alternative medicines, any positive result obtained in clinical studies is more reasonably ascribable to hypotheses (generally to placebo effect) other than the hypothesis on trial, which commonly is the specific efficacy of the intervention.
- Since meaningful statistical significance as a rule is an essential step to validation of a medical intervention, complementary alternative medicine cannot be considered evidence-based.
Further explanations can be found in the discussion of the article where the authors argue that the quality of the hypothesis tested should be consistent with sound logic and science and therefore have a reasonable prior probability of being correct. As a rule of thumb, assuming a “neutral” attitude towards the null hypothesis (odds = 1:1), a p-value of 0.01 or, better, 0.001 should suffice to give a satisfactory posterior probability of 0.035 and 0.005 respectively.
In the area of AM, hypotheses often are entirely inconsistent with logic and frequently fly in the face of science. Four examples can demonstrate this instantly and sufficiently, I think:
- Homeopathic remedies which contain not a single ‘active’ molecule are not likely to generate biological effects.
- Healing ‘energy’ of Reiki masters has no basis in science.
- Meridians of acupuncture are pure imagination.
- Chiropractic subluxation have never been shown to exist.
Positive results from clinical trials of implausible forms of AM are thus either due to chance, bias or must be attributed to more credible causes such as the placebo effect. Since the achievement of meaningful statistical significance is an essential step in the validation of medical interventions, unless some authentic scientific support to AM is provided, one has to conclude that AM cannot be considered as evidence-based.
Such arguments are by no means new; they have been voiced over and over again. Essentially, they amount to the old adage: IF YOU CLAIM THAT YOU HAVE A CAT IN YOUR GARDEN, A SIMPLE PICTURE MAY SUFFICE. IF YOU CLAIM THERE IS A UNICORN IN YOUR GARDEN, YOU NEED SOMETHING MORE CONVINCING. An extraordinary claim requires an extraordinary proof! Put into the context of the current discussion about AM, this means that the usual level of clinical evidence is likely to be very misleading as long as it totally neglects the biological plausibility of the prior hypothesis.
Proponents of AM do not like to hear such arguments. They usually insist on what we might call a ‘level playing field’ and fail to see why their assumptions require not only a higher level of evidence but also a reasonable scientific hypothesis. They forget that the playing field is not even to start with; to understand the situation better, they should read this excellent article. Perhaps its elegant statistical approach will convince them – but I would not hold my breath.
Medical treatments with no direct effect, such as homeopathy, are surprisingly popular. But how does a good reputation of such treatments spread and persist? Researchers from the Centre for the Study of Cultural Evolution in Stockholm believe that they have identified the mechanism.
They argue that most medical treatments result in a range of outcomes: some people improve while others deteriorate. If the people who improve are more inclined to tell others about their experiences than the people who deteriorate, ineffective or even harmful treatments would maintain a good reputation.
They conducted a fascinating study to test the hypothesis that positive outcomes are overrepresented in online medical product reviews, examined if this reputational distortion is large enough to bias people’s decisions, and explored the implications of this bias for the cultural evolution of medical treatments.
The researchers compared outcomes of weight loss treatments and fertility treatments as evidenced in clinical trials to outcomes reported in 1901 reviews on Amazon. Subsequently, in a series of experiments, they evaluated people’s choice of weight loss diet after reading different reviews. Finally, a mathematical model was used to examine if this bias could result in less effective treatments having a better reputation than more effective treatments.
The results of these investigations confirmed the hypothesis that people with better outcomes are more inclined to write reviews. After 6 months on the diet, 93% of online reviewers reported a weight loss of 10 kg or more, while just 27% of clinical trial participants experienced this level of weight change. A similar positive distortion was found in fertility treatment reviews. In a series of experiments, the researchers demonstrated that people are more inclined to begin a diet that was backed by many positive reviews, than a diet with reviews that are representative of the diet’s true effect. A mathematical model of medical cultural evolution suggested that the size of the positive distortion critically depends on the shape of the outcome distribution.
The authors concluded that online reviews overestimate the benefits of medical treatments, probably because people with negative outcomes are less inclined to tell others about their experiences. This bias can enable ineffective medical treatments to maintain a good reputation.
To me, this seems eminently plausible; but there are, of course, other reasons why bogus treatments survive or even thrive – and they may vary in their importance to the overall effect from treatment to treatment. As so often in health care, things are complex and there are multiple factors that contribute to a phenomenon.
Twenty years ago, when I started my Exeter job as a full-time researcher of complementary/alternative medicine (CAM), I defined the aim of my unit as applying science to CAM. At the time, this intention upset quite a few CAM-enthusiasts. One of the most prevalent arguments of CAM-proponents against my plan was that the study of CAM with rigorous science was quite simply an impossibility. They claimed that CAM included mind and body practices, holistic therapies, and other complex interventions which cannot not be put into the ‘straight jacket’ of conventional research, e. g. a controlled clinical trial. I spent the next few years showing that this notion was wrong. Gradually and hesitantly CAM researchers seemed to agree with my view – not all, of course, but first a few and then slowly, often reluctantly the majority of them.
What followed was a period during which several research groups started conducting rigorous tests of the hypotheses underlying CAM. All too often, the results turned out to be disappointing, to say the least: not only did most of the therapies in question fail to show efficacy, they were also by no means free of risks. Worst of all, perhaps, much of CAM was disclosed as being biologically implausible. The realization that rigorous scientific scrutiny often generated findings which were not what proponents had hoped for led to a sharp decline in the willingness of CAM-proponents to conduct rigorous tests of their hypotheses. Consequently, many asked whether science was such a good idea after all.
But that, in turn, created a new problem: once they had (at least nominally) committed themselves to science, how could they turn against it? The answer to this dilemma was easier that anticipated: the solution was to appear dedicated to science but, at the same time, to argue that, because CAM is subtle, holistic, complex etc., a different scientific approach was required. At this stage, I felt we had gone ‘full circle’ and had essentially arrived back where we were 20 years ago – except that CAM-proponents no longer rejected the scientific method outright but merely demanded different tools.
A recent article may serve as an example of this new and revised stance of CAM-proponents on science. Here proponents of alternative medicine argue that a challenge for research methodology in CAM/ICH* is the growing recognition that CAM/IHC practice often involves complex combination of novel interventions that include mind and body practices, holistic therapies, and others. Critics argue that the reductionist placebo controlled randomized control trial (RCT) model that works effectively for determining efficacy for most pharmaceutical or placebo trial RCTs may not be the most appropriate for determining effectiveness in clinical practice for either CAM/IHC or many of the interventions used in primary care, including health promotion practices. Therefore the reductionist methodology inherent in efficacy studies, and in particular in RCTs, may not be appropriate to study the outcomes for much of CAM/IHC, such as Traditional Korean Medicine (TKM) or other complex non-CAM/IHC interventions—especially those addressing comorbidities. In fact it can be argued that reductionist methodology may disrupt the very phenomenon, the whole system, that the research is attempting to capture and evaluate (i.e., the whole system in its naturalistic environment). Key issues that surround selection of the most appropriate methodology to evaluate complex interventions are well described in the Kings Fund report on IHC and also in the UK Medical Research Council (MRC) guidelines for evaluating complex interventions—guidelines which have been largely applied to the complexity of conventional primary care and care for patients with substantial comorbidity. These reports offer several potential solutions to the challenges inherent in studying CAM/IHC. [* IHC = integrated health care]
Let’s be clear and disclose what all of this actually means. The sequence of events, as I see it, can be summarized as follows:
- We are foremost ALTERNATIVE! Our treatments are far too unique to be subjected to reductionist research; we therefore reject science and insist on an ALTERNATIVE.
- We (well, some of us) have reconsidered our opposition and are prepared to test our hypotheses scientifically (NOT LEAST BECAUSE WE NEED THE RECOGNITION THAT THIS MIGHT BRING).
- We are dismayed to see that the results are mostly negative; science, it turns out, works against our interests.
- We need to reconsider our position.
- We find it inconceivable that our treatments do not work; all the negative scientific results must therefore be wrong.
- We always said that our treatments are unique; now we realize that they are far too holistic and complex to be submitted to reductionist scientific methods.
- We still believe in science (or at least want people to believe that we do) – but we need a different type of science.
- We insist that RCTs (and all other scientific methods that fail to demonstrate the value of CAM) are not adequate tools for testing complex interventions such as CAM.
- We have determined that reductionist research methods disturb our subtle treatments.
- We need pragmatic trials and similarly ‘soft’ methods that capture ‘real life’ situations, do justice to CAM and rarely produce a negative result.
What all of this really means is that, whenever the findings of research fail to disappoint CAM-proponents, the results are by definition false-negative. The obvious solution to this problem is to employ different (weaker) research methods, preferably those that cannot possibly generate a negative finding. Or, to put it bluntly: in CAM, science is acceptable only as long as it produces the desired results.
Readers of this blog will know that few alternative treatments are more controversial and less plausible than homeopathy. Therefore they might be interested to read about the latest attempt of homeopathy-enthusiasts to convince the public that, despite all the clinical evidence to the contrary, homeopathy does work.
The new article was published in German by Swiss urologist and is a case-report describing a patient suffering from paralytic ileus. This condition is a typical complication of ileocystoplasty of the bladder, the operation the patient had undergone. The patient had also been suffering from a spinal cord injury which, due to a pre-existing neurogenic bowel dysfunction, increases the risk of paralytic ileus.
The paraplegic patient developed a massive paralytic ileus after ileocystoplasty and surgical revision. Conventional stimulation of bowel function was unsuccessful. But after adjunctive homeopathic treatment normalization of bowel function was achieved.
The authors conclude that adjunctive homeopathic therapy is a promising treatment option in patients with complex bowel dysfunction after abdominal surgery who do not adequately respond to conventional treatment.
YES, you did read correctly: homeopathic therapy is a promising treatment…
In case anyone doubts that this is more than a trifle too optimistic, let me suggest three much more plausible reasons why the patient’s bowel function finally normalised:
- It could have been a spontaneous recovery (in most cases, even severe ones, this is what happens).
- It could have been all the conventional treatments aimed at stimulating bowel function.
- It could have been a mixture of the two.
The article made me curious, and I checked whether the authors had previously published other material on homeopathy. Thus I found two further articles in a very similar vein:
We present the clinical course of a patient with an epididymal abscess caused by multiresistant bacteria. As the patient declined surgical intervention, a conservative approach was induced with intravenous antibiotic treatment. As the clinical findings did not ameliorate, adjunctive homeopathic treatment was used. Under combined treatment, laboratory parameters returned to normal, and the epididymal abscess was rapidly shrinking. After 1 week, merely a subcutaneous liquid structure was detected. Fine-needle aspiration revealed sterile purulent liquid, which was confirmed by microbiological testing when the subcutaneous abscess was drained. Postoperative course was uneventful.
As the risk for recurrent epididymitis is high in persons with spinal cord injury, an organ-preserving approach is justified even in severe cases. Homeopathic treatment was a valuable adjunctive treatment in the above-mentioned case. Therefore, prospective studies are needed to further elucidate the future opportunities and limitations of classical homeopathy in the treatment of urinary tract infections.
Recurrent urinary tract infections (UTI) in patients with spinal cord injury are a frequent clinical problem. Often, preventive measures are not successful. We present the case reports of five patients with recurrent UTI who received additional homeopathic treatment. Of these patients, three remained free of UTI, whereas UTI frequency was reduced in two patients. Our initial experience with homeopathic prevention of UTI is encouraging. For an evidence-based evaluation of this concept, prospective studies are required.
It seems clear that all of the three more plausible explanations for the patients’ recovery listed above also apply to these two cases.
One might not be far off speculating that J Pannek, the first author of all these three articles, is a fan of homeopathy (this suspicion is confirmed by a link between him and the HOMEOPATHY RESEARCH INSTITUE: Prof Jürgen Pannek on the use of homeopathy for prophylaxis of UTI’s in patients with neurogenic bladder dysfunction). If that is so, I wonder why he does not conduct a controlled trial, rather than publishing case-report after case-report of apparently successful homeopathic treatments. Does he perhaps fear that his effects might dissolve into thin air under controlled conditions?
Case-reports of this nature can, of course, be interesting and some might even deserve to be published. But it would be imperative to draw the correct conclusions. Looking at the three articles above, I get the impression that, as time goes by, the conclusions of Prof Pannek et al (no, I know nobody from this group of authors personally) are growing more and more firm on less and less safe ground.
In my view, responsible authors should have concluded much more cautiously and reasonably. In the case of the paralytic ileus, for instance, they should not have gone further than stating something like this: adjunctive homeopathic therapy might turn out to be a promising treatment option for such patients. Despite the implausibility of homeopathy, this case-report might deserve to be followed up with a controlled clinical trial. Without such evidence, firm conclusions are clearly not possible.
Blinding patients in clinical trials is a key methodological procedure for minimizing bias and thus making sure that the results are reliable. In alternative medicine, blinding is not always straight forward, and many studies are therefore not patient-blinded. We all know that this can introduce bias into a trial, but how large is its effect on study outcomes?
This was the research question addressed by a recent systematic review of randomized clinical trials with one sub-study (i.e. experimental vs control) involving blinded patients and another, otherwise identical, sub-study involving non-blinded patients. Within each trial, the researchers compared the difference in effect sizes (i.e. standardized mean differences) between the two sub-studies. A difference <0 indicates that non-blinded patients generated a more optimistic effect estimate. The researchers then pooled the differences with random-effects inverse variance meta-analysis, and explored reasons for heterogeneity.
The main analysis included 12 trials with a total of 3869 patients. Ten of these RCTs were studies of acupuncture. The average difference in effect size for patient-reported outcomes was -0.56 (95% confidence interval -0.71 to -0.41), (I(2 )= 60%, P = 0.004), indicating that non-blinded patients exaggerated the effect size by an average of 0.56 standard deviation, but with considerable variation. Two of the 12 trials also used observer-reported outcomes, showing no indication of exaggerated effects due lack of patient blinding.
There was an even larger effect size difference in the 10 acupuncture trials [-0.63 (-0.77 to -0.49)], than in the two non-acupuncture trials [-0.17 (-0.41 to 0.07)]. Lack of patient blinding was also associated with increased attrition rates and the use of co-interventions: ratio of control group attrition risk 1.79 (1.18 to 2.70), and ratio of control group co-intervention risk 1.55 (0.99 to 2.43).
The authors conclude that this study provides empirical evidence of pronounced bias due to lack of patient blinding in complementary/alternative randomized clinical trials with patient-reported outcomes.
This is a timely, rigorous and important analysis. In alternative medicine, we currently see a proliferation of trials that are not patient-blinded. We always suspected that they are at a high risk of generating false-positive results – now we know that this is, in fact, the case.
What should we do with this insight? In my view, the following steps would be wise:
- Take the findings from the existing trials that are devoid of patient-blinding with more than just a pinch of salt.
- Discourage the funding of future studies that fail to include patient-blinding.
- If patient-blinding is truly and demonstrably impossible – which is not often the case – make sure that the trialists at least include blinding of the assessors of the primary outcome measures.
There must be well over 10 000 clinical trials of acupuncture; Medline lists ~5 000, and many more are hidden in the non-Medline listed literature. That should be good news! Sadly, it isn’t.
It should mean that we now have a pretty good idea for what conditions acupuncture is effective and for which illnesses it does not work. But we don’t! Sceptics say it works for nothing, while acupuncturists claim it is a panacea. The main reason for this continued controversy is that the quality of the vast majority of these 10 000 studies is not just poor, it is lousy.
“Where is the evidence for this outraging statement???” – I hear the acupuncture-enthusiasts shout. Well, how about my own experience as editor-in-chief of FACT? No? Far too anecdotal?
How about looking at Cochrane reviews then; they are considered to be the most independent and reliable evidence in existence? There are many such reviews (most, if not all [co-]authored by acupuncturists) and they all agree that the scientific rigor of the primary studies is fairly awful. Here are the crucial bits of just the last three; feel free to look for more:
Or how about providing an example? Good idea! Here is a new trial which could stand for numerous others:
This study was performed to compare the efficacy of acupuncture versus corticosteroid injection for the treatment of Quervain’s tendosynovitis (no, you do not need to look up what condition this is for understanding this post). Thirty patients were treated in two groups. The acupuncture group received 5 acupuncture sessions of 30 minutes duration. The injection group received one methylprednisolone acetate injection in the first dorsal compartment of the wrist. The degree of disability and pain was evaluated by using the Quick Disabilities of the Arm, Shoulder, and Hand (Q-DASH) scale and the Visual Analogue Scale (VAS) at baseline and at 2 weeks and 6 weeks after the start of treatment. The baseline means of the Q-DASH and the VAS scores were 62.8 and 6.9, respectively. At the last follow-up, the mean Q-DASH scores were 9.8 versus 6.2 in the acupuncture and injection groups, respectively, and the mean VAS scores were 2 versus 1.2. Thus there were short-term improvements of pain and function in both groups.
The authors drew the following conclusions: Although the success rate was somewhat higher with corticosteroid injection, acupuncture can be considered as an alternative option for treatment of De Quervain’s tenosynovitis.
The flaws of this study are exemplary and numerous:
- This should have been a study that compares two treatments – the technical term is ‘equivalence trial – and such studies need to be much larger to produce a meaningful result. Small sample sizes in equivalent trials will always make the two treatments look similarly effective, even if one is a pure placebo.
- There is no gold standard treatment for this condition. This means that a comparative trial makes no sense at all. In such a situation, one ought to conduct a placebo-controlled trial.
- There was no blinding of patients; therefore their expectation might have distorted the results.
- The acupuncture group received more treatments than the injection group; therefore the additional attention might have distorted the findings.
- Even if the results were entirely correct, one cannot conclude from them that acupuncture was effective; the notion that it was similarly ineffective as the injections is just as warranted.
These are just some of the most fatal flaws of this study. The sad thing is that similar criticisms can be made for most of the 10 000 trials of acupuncture. But the point here is not to nit-pick nor to quack-bust. My point is a different and more serious one: fatally flawed research is not just a ‘poor show’, it is unethical because it is a waste of scarce resources and, even more importantly, an abuse of patients for meaningless pseudo-science. All it does is it misleads the public into believing that acupuncture might be good for this or that condition and consequently make wrong therapeutic decisions.
In acupuncture (and indeed in most alternative medicine) research, the problem is so extremely wide-spread that it is high time to do something about it. Journal editors, peer-reviewers, ethics committees, universities, funding agencies and all others concerned with such research have to work together so that such flagrant abuse is stopped once and for all.
When someone has completed a scientific project, it is customary to publish it ['unpublished science is no science', someone once told me many years ago]. To do so, he needs to write it up and submit it to a scientific journal. The editor of this journal will then submit it to a process called ‘peer review’.
What does ‘peer review’ entail? Well, it means that 2-3 experts are asked to critically assess the paper in question, make suggestions as to how it can be improved and submit a recommendation as to whether or not the article deserves to be published.
Peer review has many pitfalls but, so far, nobody has come up with a solution that is convincingly better. Many scientists are under pressure to publish ['publish or perish'], and therefore some people resort to cheating. A most spectacular case of fraudulent peer review has been reported recently in this press release:
London, UK (08 July 2014) – SAGE announces the retraction of 60 articles implicated in a peer review and citation ring at the Journal of Vibration and Control (JVC). The full extent of the peer review ring has been uncovered following a 14 month SAGE-led investigation, and centres on the strongly suspected misconduct of Peter Chen, formerly of National Pingtung University of Education, Taiwan (NPUE) and possibly other authors at this institution.
In 2013 the then Editor-in-Chief of JVC, Professor Ali H. Nayfeh,and SAGE became aware of a potential peer review ring involving assumed and fabricated identities used to manipulate the online submission system SAGE Track powered by ScholarOne Manuscripts™. Immediate action was taken to prevent JVC from being exploited further, and a complex investigation throughout 2013 and 2014 was undertaken with the full cooperation of Professor Nayfeh and subsequently NPUE.
In total 60 articles have been retracted from JVC after evidence led to at least one author or reviewer being implicated in the peer review ring. Now that the investigation is complete, and the authors have been notified of the findings, we are in a position to make this statement.
While investigating the JVC papers submitted and reviewed by Peter Chen, it was discovered that the author had created various aliases on SAGE Track, providing different email addresses to set up more than one account. Consequently, SAGE scrutinised further the co-authors of and reviewers selected for Peter Chen’s papers, these names appeared to form part of a peer review ring. The investigation also revealed that on at least one occasion, the author Peter Chen reviewed his own paper under one of the aliases he had created.
Unbelievable? Perhaps, but sadly it is true; some scientists seem to be criminally ingenious when it comes to getting their dodgy articles into peer-reviewed journals.
And what does this have to do with ALTERNATIVE MEDICINE, you may well ask. The Journal of Vibration and Control is not even medical and certainly would never consider publishing articles on alternative medicine. Such papers go to one of the many [I estimate more that 1000] journals that cover either alternative medicine in general or any of the modalities that fall under this wide umbrella. Most of these journals, of course, pride themselves with being peer-reviewed – and, at least nominally, that is correct.
I have been on the editorial board of most of the more important journals in alternative medicine, and I cannot help thinking that their peer review process is not all that dissimilar from the fraudulent scheme set up by Peter Chen and disclosed above. What happens in alternative medicine is roughly as follows:
- a researcher submits a paper for publication,
- the editor sends it out for peer review,
- the peer reviewers are either those suggested by the original author or members of the editorial board of the journal,
- in either case, the reviewers are more than likely to be uncritical and recommend publication,
- in the end, peer review turns out to be a farcical window dressing exercise with no consequence,
- thus even very poor research and pseudo-research are being published abundantly.
The editorial boards of journals of alternative medicine tend to be devoid of experts who are critical about the subject at hand. If you think that I am exaggerating, have a look at the editorial board members of ‘HOMEOPATHY’ (or any other journal of alternative medicine) and tell me who might qualify as a critic of homeopathy. When the editor, Peter Fisher, recently fired me from his board because he felt I had tarnished the image of homeopathy, this panel lost the only person who understood the subject matter and, at the same time, was critical about it (the fact that the website still lists me as an editorial board member is merely a reflection of how slow things are in the world of homeopathy: Fisher fired me more than a year ago).
The point I am trying to make is simple: peer review is never a perfect method but when it is set up to be deliberately uncritical, it cannot possibly fulfil its function to prevent the publication of dodgy research. In this case, the quality of the science will be inadequate and generate false-positive messages that mislead the public.
Reiki is a Japanese technique which, according to a proponent, … is administered by “laying on hands” and is based on the idea that an unseen “life force energy” flows through us and is what causes us to be alive. If one’s “life force energy” is low, then we are more likely to get sick or feel stress, and if it is high, we are more capable of being happy and healthy…
A treatment feels like a wonderful glowing radiance that flows through and around you. Reiki treats the whole person including body, emotions, mind and spirit creating many beneficial effects that include relaxation and feelings of peace, security and wellbeing. Many have reported miraculous results.
Reiki is a simple, natural and safe method of spiritual healing and self-improvement that everyone can use. It has been effective in helping virtually every known illness and malady and always creates a beneficial effect. It also works in conjunction with all other medical or therapeutic techniques to relieve side effects and promote recovery [my emphasis].
Many websites give much more specific information about the health effects of Reiki:
- Creates deep relaxation and aids the body to release stress and tension,
- It accelerates the body’s self-healing abilities,
- Aids better sleep,
- Reduces blood pressure
- Can help with acute (injuries) and chronic problems (asthma, eczema, headaches, etc.) and aides the breaking of addictions,
- Helps relieve pain,
- Removes energy blockages, adjusts the energy flow of the endocrine system bringing the body into balance and harmony,
- Assists the body in cleaning itself from toxins,
- Reduces some of the side effects of drugs and helps the body to recover from drug therapy after surgery and chemotherapy,
- Supports the immune system,
- Increases vitality and postpones the aging process,
- Raises the vibrational frequency of the body,
- Helps spiritual growth and emotional clearing.
With such remarkable claims being made, I had to look into this extraordinary treatment.
In 2008, I had a co-worker in my team who was (still is, I think) a Reiki healer. He also happened to be a decent scientist, and we thus decided to conduct a systematic review summarising the evidence for the effectiveness of Reiki. We searched the literature using 23 databases from their respective inceptions through to November 2007 (search again 23 January 2008) without language restrictions. Methodological quality was assessed using the Jadad score. The searches identified 205 potentially relevant studies. Nine randomised clinical trials (RCTs) met our inclusion criteria. Two RCTs suggested beneficial effects of Reiki compared with sham control on depression, while one RCT did not report intergroup differences. For pain and anxiety, one RCT showed intergroup differences compared with sham control. For stress and hopelessness, a further RCT reported effects of Reiki and distant Reiki compared with distant sham control. For functional recovery after ischaemic stroke there were no intergroup differences compared with sham. There was also no difference for anxiety between groups of pregnant women undergoing amniocentesis. For diabetic neuropathy there were no effects of reiki on pain. A further RCT failed to show the effects of Reiki for anxiety and depression in women undergoing breast biopsy compared with conventional care.
Overall, the trial data for any one condition were scarce and independent replications were not available for any condition. Most trials suffered from methodological flaws such as small sample size, inadequate study design and poor reporting. We therefore concluded that the evidence is insufficient to suggest that Reiki is an effective treatment for any condition. Therefore the value of Reiki remains unproven.
But this was in 2008! In the meantime, the evidence might have changed. Here are two recent publications which, I think, are worth having a look at:
The first article is a case-report of a nine-year-old female patient with a history of perinatal stroke, seizures, and type-I diabetes was treated for six weeks with Reiki. At the end of this treatment period, there was a decrease in stress in both the child and the mother, as measured by a modified Perceived Stress Scale and a Perceived Stress Scale, respectively. No change was noted in the child’s overall sense of well-being, as measured by a global questionnaire. However, there was a positive change in sleep patterns on 33.3% of the nights as reported on a sleep log kept by the mother. The child and the Reiki Master (a Reiki practitioner who has completed all three levels of Reiki certification training, trains and certifies individuals in the practice of Reiki, and provides Reiki to individuals) experienced warmth and tingling sensations on the same area of the child during the Reiki 7 minutes of each session. There were no reports of seizures during the study period.
The author concluded that Reiki is a useful adjunct for children with increased stress levels and sleep disturbances secondary to their medical condition. Further research is warranted to evaluate the use of Reiki in children, particularly with a large sample size, and to evaluate the long-term use of Reiki and its effects on adequate sleep.
In my view, this article is relevant because it typifies the type of research that is being done in this area and the conclusions that are being drawn from it. It should be clear to anyone who has the slightest ability of critical thinking that a case report of this nature tells us as good as nothing about the effectiveness of a therapy. Considering that Reiki is just about the least plausible intervention anyone can think of, the child’s condition in all likelihood improved not because of the Reiki healing but because of a myriad of unrelated factors; just think of placebo-effects, regression towards the mean, natural history of the condition, concomitant treatments, etc.
The plausibility of energy/biofield/spiritual healing such as Reiki is also the focus of the second remarkable article that was just published. It reports a systematic review of studies designed to examine whether bio-field therapists undergo physiological changes as they enter the healing state (remember: the Reiki healer in the above study experienced ‘warmth and tingling sensations’ during therapies). If reproducible changes could be identified, the authors argue, they might serve as markers to reveal events that correlate with the healing process.
Databases were searched for controlled or non-controlled studies of bio-field therapies in which physiological measurements were made on practitioners in a healing state. Design and reporting criteria, developed in part to reflect the pilot nature of the included studies, were applied using a yes (1.0), partial (0.5), or no (0) scoring system.
Of 67 identified studies, the inclusion criteria were met by 22, 10 of which involved human patients. Overall, the studies were of moderate to poor quality and many omitted information about the training and experience of the healer. The most frequently measured biomarkers were electroencephalography (EEG) and heart rate variability (HRV). EEG changes were inconsistent and not specific to bio-field therapies. HRV results suggest an aroused physiology for Reconnective Healing, Bruyere healing, and Hawaiian healing, but no changes were detected for Reiki or Therapeutic Touch.
The authors of this paper concluded that despite a decades-long research interest in identifying healing-related biomarkers in bio-field healers, little robust evidence of unique physiological changes has emerged to define the healers׳ state.
Now, let me guess why this is so. One does not need to be a rocket scientist to come up with the suggestion that no robust evidence for Reiki and all the other nonsensical forms of healing can be found for one disarmingly simple reason: NO SUCH EFFECTS EXIST.