It is almost 10 years ago that Prof Kathy Sykes’ BBC series entitled ALTERNATIVE MEDICINE was aired. I had been hired by the BBC as their advisor for the programme and had tried my best to iron out the many mistakes that were about to be broadcast. But the scope for corrections turned out to be narrow and, at one stage, the errors seemed too serious and too far beyond repair to continue with my task. I had thus offered my resignation from this post. Fortunately this move led to some of my concerns being addressed after all, and they convinced me to remain in post.
The first part of the series was on acupuncture, and Kathy presented the opening scene of a young women undergoing open heart surgery with the aid of acupuncture. All the BBC had ever shown me and asked me to advise on was the text – I had never seen the images. Kathy’s text included the statement that the patient was having the surgery “with only needles to control the pain.” I had not objected to this statement in the firm belief that the images of the film would back up this extraordinary claim. As it turned out, it did not; the patient clearly had all sorts of other treatments given through intra-venous lines and, in the film, these were openly in the view of Kathy Sykes.
This overt contradiction annoyed not just me but several other people as well. One of them was Simon Singh who filed an official complaint against the BBC for misleading the public, and eventually won his case.
The notion that acupuncture can serve as an alternative to anaesthesia or other surgical conditions crops up with amazing regularity. It is important not least because is often used as a promotional tool with the implication that, IF ACUPUNCTURE CAN ACHIVE SUCH DRAMATIC EFFECTS, IT MUST BE AN INCREDIBLY USEFUL TREATMENT! It is therefore relevant to ask what the scientific evidence tells us about this issue.
This was the question we wanted to address in a recent publication. Specifically, our aim was to summarise recent systematic reviews of acupuncture for surgical conditions.
Thirteen electronic databases were searched for relevant reviews published since 2000. Data were extracted by two independent reviewers according to predefined criteria. Twelve systematic reviews met our inclusion criteria. They related to the prevention or treatment of post-operative nausea and vomiting as well as to surgical or post-operative pain. The reviews drew conclusions which were far from uniform; specifically for surgical pain the evidence was not convincing. We concluded that “the evidence is insufficient to suggest that acupuncture is an effective intervention in surgical settings.”
So, Kathy Sykes’ comment was misguided in more than just one way: firstly, the scene she described in the film did not support what she was saying; secondly, the scientific evidence fails to support the notion that acupuncture can be used as an alternative to analgesia during surgery.
This story has several positive outcomes all the same. After seeing the BBC programme, Simon Singh contacted me to learn my views on the matter. This prompted me to support his complaint against the BBC and helped him to win this case. Furthermore, it led to a co-operation and friendship which produced our book TRICK OR TREATMENT.
After a traumatic brain injury (TBI) the risk of stroke is significantly increased. Taiwanese researchers conducted a study to find out whether acupuncture can help to protect TBI patients from stroke. They used Taiwan’s National Health Insurance Research Database to conduct a retrospective cohort study of 7409 TBI patients receiving acupuncture treatment and 29,636 propensity-score-matched TBI patients without acupuncture treatment as controls. Both TBI cohorts were followed for up to two years and adjusted for immortal time to measure the incidence and adjusted hazard ratios (HRs) of new-onset stroke.
TBI patients with acupuncture treatment (4.9 per 1000 person-years) had a lower incidence of stroke compared with those without acupuncture treatment (7.5 per 1000 person-years), with a HR of 0.59 (95% CI = 0.50-0.69) after adjustment for sociodemographics, coexisting medical conditions and medications. The association between acupuncture treatment and stroke risk was investigated by sex and age group (20-44, 45-64, and ≥65 years). The probability curve with log-rank test showed that TBI patients receiving acupuncture treatment had a lower probability of stroke than those without acupuncture treatment during the follow-up period (p<0.0001).
The authors conclude that patients with TBI receiving acupuncture treatment show decreased risk of stroke compared with those without acupuncture treatment. However, this study was limited by lack of information regarding lifestyles, biochemical profiles, TBI severity, and acupuncture points used in treatments.
I want to congratulate the authors for adding the last sentence to their conclusions. There is no plausible mechanism that I can think of by which acupuncture might bring about the observed effect. This does not mean that an effect does not exist; it means, however, that it is wise to be cautious and to not jump to conclusions which later need to be revised. The simplest interpretation, by far, of the observed phenomenon is that those patients opting to have acupuncture were, on average, less ill and therefore had a lower risk of stroke.
Having said that, the findings are, I think, intriguing enough to conduct further investigations – provided they are rigorous and eliminate the confounders that prevented this study from arriving at more definitive conclusions.
One of the questions I hear regularly is ‘HOW DO THE EFFECTS OF THIS ALTERNATIVE TREATMENT COMPARE TO THOSE OF CONVENTIONAL OPTIONS’? Take acupuncture in the management of osteoarthritis, for instance. There is some encouraging evidence suggesting it might help. The most recent systematic review that I know of concluded that “acupuncture provided significantly better relief from knee osteoarthritis pain and a larger improvement in function than sham acupuncture, standard care treatment, or waiting for further treatment.” However, in order to estimate its value in practice, we ought to know whether it is as good as or perhaps even better than standard treatments. In other words, what we really want to know is its relative effectiveness.
Data to evaluate the relative effectiveness of acupuncture or other alternative therapies are hard to come by. Ideally, one would require clinical trials which provide direct comparisons between the alternative and the conventional therapy. Sadly, such studies are scarce or even non-existent. Therefore we might have to rely on more indirect evidence. A new paper could be a step in the right direction.
The aim of this systematic review was to critically evaluate existing osteoarthritis (OA) management guidelines to better understand potential issues and barriers.
A systematic review of the literature in MEDLINE published from January 1, 2000 to April 1, 2013 was performed and supplemented by bibliographic reviews, following PRISMA guidelines and a written protocol. Following initial title and abstract screening, two authors independently reviewed full-text articles; a third settled disagreements. Two independent reviewers extracted data into a standardized form. Two authors independently assessed guideline quality; three generated summary recommendations based on the extracted guideline data.
Overall, 16 articles were included in the final review. There was broad agreement on recommendations by the various organizations. For non-pharmacologic modalities, education/self-management, exercise, weight loss if overweight, walking aids as indicated, and thermal modalities were widely recommended. For appropriate patients, joint replacement was recommended; arthroscopy with debridement was not recommended for symptomatic knee OA. Pharmacologic modalities most recommended included acetaminophen/paracetamol for first line treatment and oral or topical NSAIDs for second line therapy. Intra-articular corticosteroids were generally recommended for hip and knee OA. Controversy remains about the use of acupuncture, knee braces, heel wedges, intra-articular hyaluronans, and glucosamine/chondroitin.
I think that this tells us fairly clearly that, compared to other options, acupuncture is not considered to be an overwhelmingly effective treatment for osteoarthritis by those who understand that condition best. Several other therapies seem to be preferable because the evidence is clearer and stronger and their effect sizes is larger. This, I think begs the question whether it is in the best interest of patients or indeed ethical to ignore this knowledge and recommend acupuncture as a treatment of osteoarthritis.
More generally speaking, we should always bear in mind that it is not enough proving a therapy to be effective; we usually also need to consider what else is on offer. And if you think that this is rather complex, you are, of course, correct – but wait until someone mentions issues such as safety and cost of all the relevant therapeutic options.
Advocates of alternative medicine are incredibly fond of supporting their claims with anecdotes, or ‘case-reports’ as they are officially called. There is no question, case-reports can be informative and important, but we need to be aware of their limitations.
A recent case-report from the US might illustrated this nicely. It described a 65-year-old male patient who had had MS for 20 years when he decided to get treated with Chinese scalp acupuncture. The motor area, sensory area, foot motor and sensory area, balance area, hearing and dizziness area, and tremor area were stimulated once a week for 10 weeks, then once a month for 6 further sessions.
After the 16 treatments, the patient showed remarkable improvements. He was able to stand and walk without any problems. The numbness and tingling in his limbs did not bother him anymore. He had more energy and had not experienced incontinence of urine or dizziness after the first treatment. He was able to return to work full time. Now the patient has been in remission for 26 months.
The authors of this case-report conclude that Chinese scalp acupuncture can be a very effective treatment for patients with MS. Chinese scalp acupuncture holds the potential to expand treatment options for MS in both conventional and complementary or integrative therapies. It can not only relieve symptoms, increase the patient’s quality of life, and slow and reverse the progression of physical disability but also reduce the number of relapses and help patients.
There is absolutely nothing wrong with case-reports; on the contrary, they can provide extremely valuable pointers for further research. If they relate to adverse effects, they can give us crucial information about the risks associated with treatments. Nobody would ever argue that case-reports are useless, and that is why most medical journals regularly publish such papers. But they are valuable only, if one is aware of their limitations. Medicine finally started to make swift progress, ~150 years ago, when we gave up attributing undue importance to anecdotes, began to doubt established wisdom and started testing it scientifically.
Conclusions such as the ones drawn above are not just odd, they are misleading to the point of being dangerous. A reasonable conclusion might have been that this case of a MS-patient is interesting and should be followed-up through further observations. If these then seem to confirm the positive outcome, one might consider conducting a clinical trial. If this study proves to yield encouraging findings, one might eventually draw the conclusions which the present authors drew from their single case.
To jump at conclusions in the way the authors did, is neither justified nor responsible. It is unjustified because case-reports never lend themselves to such generalisations. And it is irresponsible because desperate patients, who often fail to understand the limitations of case-reports and tend to believe things that have been published in medical journals, might act on these words. This, in turn, would raise false hopes or might even lead to patients forfeiting those treatments that are evidence-based.
It is high time, I think, that proponents of alternative medicine give up their love-affair with anecdotes and join the rest of the health care professions in the 21st century.
There are numerous types and styles of acupuncture, and the discussion whether one is better than the other has been long, tedious and frustrating. Traditional acupuncturists, for instance, individualise their approach according to their findings of pulse and tongue diagnoses as well as other non-validated diagnostic criteria. Western acupuncturists, by contrast, tend to use formula or standardised treatments according to conventional diagnoses.
This study aimed to compare the effectiveness of standardized and individualized acupuncture treatment in patients with chronic low back pain. A single-center randomized controlled single-blind trial was performed in a general medical practice of a Chinese-born medical doctor trained in both western and Chinese medicine. One hundred and fifty outpatients with chronic low back pain were randomly allocated to two groups who received either standardized acupuncture or individualized acupuncture. 10 to 15 treatments based on individual symptoms were given with two treatments per week.
The main outcome measure was the area under the curve (AUC) summarizing eight weeks of daily rated pain severity measured with a visual analogue scale. No significant differences between groups were observed for the AUC (individualized acupuncture mean: 1768.7; standardized acupuncture 1482.9; group difference, 285.8).
The authors concluded that individualized acupuncture was not superior to standardized acupuncture for patients suffering from chronic pain.
But perhaps it matters whether the acupuncturist is thoroughly trained or has just picked up his/her skills during a weekend course? I am afraid not: this analysis of a total of 4,084 patients with chronic headache, lower back pain or arthritic pain treated by 1,838 acupuncturists suggested otherwise. There were no differences in success for patients treated by physicians passing through shorter (A diploma) or longer (B diploma) training courses in acupuncture.
But these are just one single trial and one post-hoc analysis of another study which, by definition, cannot be fully definitive. Fortunately, we have more evidence based on much larger numbers. This brand-new meta-analysis aimed to evaluate whether there are characteristics of acupuncture or acupuncturists that are associated with better or worse outcomes.
An existing dataset, developed by the Acupuncture Trialists’ Collaboration, included 29 trials of acupuncture for chronic pain with individual data involving 17,922 patients. The available data on characteristics of acupuncture included style of acupuncture, point prescription, location of needles, use of electrical stimulation and moxibustion, number, frequency and duration of sessions, number of needles used and acupuncturist experience. Random-effects meta-regression was used to test the effect of each characteristic on the main effect estimate of pain. Where sufficient patient-level data were available, patient-level analyses were conducted.
When comparing acupuncture to sham controls, there was little evidence that the effects of acupuncture on pain were modified by any of the acupuncture characteristics evaluated, including style of acupuncture, the number or placement of needles, the number, frequency or duration of sessions, patient-practitioner interactions and the experience of the acupuncturist. When comparing acupuncture to non-acupuncture controls, there was little evidence that these characteristics modified the effect of acupuncture, except better pain outcomes were observed when more needles were used and, from patient level analysis involving a sub-set of 5 trials, when a higher number of acupuncture treatment sessions were provided.
The authors of this meta-analysis concluded that there was little evidence that different characteristics of acupuncture or acupuncturists modified the effect of treatment on pain outcomes. Increased number of needles and more sessions appear to be associated with better outcomes when comparing acupuncture to non-acupuncture controls, suggesting that dose is important. Potential confounders include differences in control group and sample size between trials. Trials to evaluate potentially small differences in outcome associated with different acupuncture characteristics are likely to require large sample sizes.
My reading of these collective findings is that it does not matter which type of acupuncture you use nor who uses it; the clinical effects are similar regardless of the most obvious potential determinants. Hardly surprising! In fact, one would expect such results, if one considered that acupuncture is a placebo-treatment.
For those who know about the subject, this is an old hat, of course. But for many readers of this blog, it might be news: ‘Traditional’ Chinese Medicine (TCM) is not nearly as traditional as it pretends to be. In fact, it is an artefact of recent creation. The man who has been saying that for years is Professor Paul Unschuld, one of the leading sinologist worldwide and an expert who has written many books and journal articles on the subject.
During an interview given in 2004, he defined TCM as “an artificial system of health care ideas and practices generated between 1950 and 1973 by committees in the People’s Republic of China, with the aim of restructuring the vast and heterogenous heritage of Chinese traditional medicine in such a way that it fitted the principles–Marxist Maoist type democracy and modern science and technology on which the future of the PRC was to be built…[the Daoist underpinning for TCM] is incorrect for two reasons. First . . . TCM is a product of Communist China. Second, even if we were to apply the term TCM to pre-revolutionary Chinese medicine, the Daoist impact should be considered minimal.”
In a much more recent interview entitled INVENTION FROM THE FAR EAST which he gave to DER SPIEGEL (in German), he explained this in a little more detail (I have tried to translate his words as literally as possible):
What is being offered in our country to patients as TCM is a construct that was created in China on an office desk which has been altered further on its way to the West.
Already at the beginning of the 20th century, reformers and revolutionaries urged that the traditional medicine in China should be abolished and that the western form of medicine should be introduced instead. Traditional thinking was seen as backwards and it was held responsible for the oppressing superiority of the West. The introduction of Western natural sciences, medicine and technology was also thought later, after the foundation of the People’s Republic, to be essential for rendering the country competitive again. Since the traditional Chinese medicine could not be totally abolished then because it offered a living to many citizens, it was reduced to a kernel, which could be brought just about in line with the scientific orientation of the future communist society. In the 1950s and 60s, an especially appointed commission had been working on this task. The filtrate which they created from the original medical tradition was hence forward to be called TCM vis a vis foreigners.
There is little more to add, I think – perhaps just two brief after-thoughts. TCM is a most lucrative export article for China. So don’t expect Chinese officials to rid TCM of the highly marketable ‘TRADITIONAL’ label. And remember: the ‘appeal to tradition’ argument is a fallacy anyway.
What is ear acupressure?
Proponents claim that ear-acupressure is commonly used by Chinese medicine practitioners… It is like acupuncture but does not use needles. Instead, small round pellets are taped to points on one ear. Ear-acupressure is a non-invasive, painless, low cost therapy and no significant side effects have been reported.
Ok, but does it work?
There is a lot of money being made with the claim that ear acupressure (EAP) is effective, especially for smoking cessation; entrepreneurs sell gadgets for applying the pressure on the ear, and practitioners earn their living through telling their patients that this therapy is helpful. There are hundreds of websites with claims like this one: Auricular therapy (Acupressure therapy of the ear region) has been used successfully for Smoking cessation. Auriculotherapy is thought to be 7 times more powerful than other methods used for smoking cessation; a single auriculotherapy treatment has been shown to reduce smoking from 20 or more cigarettes a day down to 3 to 5 a day.
But what does the evidence show?
This new study investigated the efficacy of EAP as a stand-alone intervention for smoking cessation. Adult smokers were randomised to receive EAP specific for smoking cessation (SSEAP) or a non-specific EAP (NSEAP) intervention, EAP at points not typically used for smoking cessation. Participants received 8 weekly treatments and were requested to press the five pellets taped to one ear at least three times per day. Participants were followed up for three months. The primary outcome measures were a 7-day point-prevalence cessation rate confirmed by exhaled carbon monoxide and relief of nicotine withdrawal symptoms (NWS).
Forty-three adult smokers were randomly assigned to SSEAP (n = 20) or NSEAP (n = 23) groups. The dropout rate was high with 19 participants completing the treatments and 12 remaining at followup. One participant from the SSEAP group had confirmed cessation at week 8 and end of followup (5%), but there was no difference between groups for confirmed cessation or NWS. Adverse events were few and minor.
And is there a systematic review of the totality of the evidence?
Sure, the current Cochrane review arrives at the following conclusion: There is no consistent, bias-free evidence that acupuncture, acupressure, laser therapy or electrostimulation are effective for smoking cessation…
Yes, we may well ask! If most TCM practitioners use EAP or acupuncture for smoking cessation telling their customers that it works (and earning good money when doing so), while the evidence fails to show that this is true, what should we say about such behaviour? I don’t know about you, but I find it thoroughly dishonest.
Alternative medicine thrives in the realm of common chronic conditions which conventional medicine cannot cure and which respond well to treatment with placebos. Irritable bowel syndrome (IBS) is such a condition, and IBS-sufferers who are often frustrated with the symptomatic relief conventional medicine has to offer are only too keen to try any therapy that promises help. There is hardly an alternative therapy which does not claim to be the solution to IBS-symptoms: herbal medicine, mind-body interventions, homeopathy (the subject of my next post), acupuncture, even ‘MOXIBUSTION‘.
Moxibustion is a derivative of acupuncture; instead of needles, this method employs heat to stimulate acupuncture points. Proponents believe that the effects of moxibustion are roughly equivalent to those of acupuncture but many acupuncturists feel that they are less powerful. One website explains: Moxibustion is a traditional Chinese medicine technique that involves the burning of mugwort, a small, spongy herb, to facilitate healing. Moxibustion has been used throughout Asia for thousands of years; in fact, the actual Chinese character for acupuncture, translated literally, means “acupuncture-moxibustion.” The purpose of moxibustion, as with most forms of traditional Chinese medicine, is to strengthen the blood, stimulate the flow of qi, and maintain general health.
Many proponents of moxibustion claim that their treatment works for IBS. The evidence is, however, far less clear. Two recent meta-analyses might tell us more.
The first systematic review and meta-analysis was published by Korean researchers and aimed at critically evaluating the current evidence on moxibustion for improving global symptoms of IBS. The authors conducted extensive searches and found a total of 20 RCTs to be included in their analyses. The risk of bias in these studies was generally high. Compared with pharmacological medications, moxibustion significantly alleviated overall IBS symptoms but there was a moderate inconsistency among the 7 RCTs. Moxibustion combined with acupuncture was more effective than pharmacological therapy but a moderate inconsistency among the 4 studies was found. When moxibustion was added to pharmacological medications or herbal medicine, no additive benefit of moxibustion was shown compared with pharmacological medications or herbal medicine alone. One small sham-controlled trial found no difference between moxibustion and sham control in symptom severity. Moxibustion appeared to be associated with few adverse events but the evidence is limited due to poor reporting.
The authors concluded that moxibustion may provide benefit to IBS patients although the risk of bias in the included studies is relatively high. Future studies are necessary to confirm whether this finding is reproducible in carefully-designed and conducted trials and to firmly establish the place of moxibustion in current practice.
The way I see it, these conclusions are far too optimistic. There was only one RCT that controlled for placebo-effects, and the results of that study were negative. Thus I would conclude that some studies report effectiveness of moxibustion for IBS, yet the effects seem not to be caused by the treatment per se but are most likely due to a placebo-effect.
The second systematic review and meta-analysis was published by Chinese researchers and aimed at evaluating the clinical efficacy and safety of moxibustion and acupuncture in treatment of IBS. The authors included randomized and quasi-randomized clinical trials in their analyses and were able to include 11 trials. Their meta analysis suggests that the effectiveness of the combined methods of acupuncture and moxibustion is superior to conventional western medication treatment. The authors concluded that acupuncture-moxibustion for IBS is better than the conventional western medication treatment.
While the first meta-analysis was at least technically sound, the second seems to have too many flaws to mention: the search methodology was flimsy, many available studies were not included, their risk of bias was not assessed critically, the conclusions are based more on wishful thinking than on the available data, etc.
If we consider that moxibustion is a method of stimulating acupoints, we have to assume that it can at best be as effective as acupuncture, quite possibly slightly less. Thus it is relevant to see what the evidence tells us about acupuncture for IBS. The current Cochrane review of acupuncture for IBS shows that sham-controlled RCTs have found no benefits of acupuncture relative to a credible sham acupuncture control for IBS symptom severity or IBS-related quality of life.
I think I rest my case.
This post will probably work best, if you have read the previous one describing how the parallel universe of acupuncture research insists on going in circles in order to avoid admitting that their treatment might not be as effective as they pretend. The way they achieve this is fairly simple: they conduct trials that are designed in such a way that they cannot possibly produce a negative result.
A brand-new investigation which was recently vociferously touted via press releases etc. as a major advance in proving the effectiveness of acupuncture is an excellent case in point. According to its authors, the aim of this study was to evaluate acupuncture versus usual care and counselling versus usual care for patients who continue to experience depression in primary care. This sounds alright, but wait!
755 patients with depression were randomised to one of three arms to 1)acupuncture, 2)counselling, and 3)usual care alone. The primary outcome was the difference in mean Patient Health Questionnaire (PHQ-9) scores at 3 months with secondary analyses over 12 months follow-up. Analysis was by intention-to-treat. PHQ-9 data were available for 614 patients at 3 months and 572 patients at 12 months. Patients attended a mean of 10 sessions for acupuncture and 9 sessions for counselling. Compared to usual care, there was a statistically significant reduction in mean PHQ-9 depression scores at 3 and 12 months for acupuncture and counselling.
From this, the authors conclude that both interventions were associated with significantly reduced depression at 3 months when compared to usual care alone.
Acupuncture for depression? Really? Our own systematic review with co-authors who are the most ardent apologists of acupuncture I have come across showed that the evidence is inconsistent on whether manual acupuncture is superior to sham… Therefore, I thought it might be a good idea to have a closer look at this new study.
One needs to search this article very closely indeed to find out that the authors did not actually evaluate acupuncture versus usual care and counselling versus usual care at all, and that comparisons were not made between acupuncture, counselling, and usual care (hints like the use of the word “alone” are all we get to guess that the authors’ text is outrageously misleading). Not even the methods section informs us what really happened in this trial. You find this hard to believe? Here is the unabbreviated part of the article that describes the interventions applied:
Patients allocated to the acupuncture and counselling groups were offered up to 12 sessions usually on a weekly basis. Participating acupuncturists were registered with the British Acupuncture Council with at least 3 years post-qualification experience. An acupuncture treatment protocol was developed and subsequently refined in consultation with participating acupuncturists. It allowed for customised treatments within a standardised theory-driven framework. Counselling was provided by members of the British Association for Counselling and Psychotherapy who were accredited or were eligible for accreditation having completed 400 supervised hours post-qualification. A manualised protocol, using a humanistic approach, was based on competences independently developed for Skills for Health. Practitioners recorded in logbooks the number and length of sessions, treatment provided, and adverse events. Further details of the two interventions are presented in Tables S2 and S3. Usual care, both NHS and private, was available according to need and monitored for all patients in all three groups for the purposes of comparison.
It is only in the results tables that we can determine what treatments were actually given; and these were:
1) Acupuncture PLUS usual care (i.e. medication)
2) Counselling PLUS usual care
3) Usual care
Its almost a ‘no-brainer’ that, if you compare A+B to B (or in this three-armed study A+B vs C+B vs B), you find that the former is more than the latter – unless A is a negative, of course. As acupuncture has significant placebo-effects, it never can be a negative, and thus this trial is an entirely foregone conclusion. As, in alternative medicine, one seems to need experimental proof even for ‘no-brainers’, we have some time ago demonstrated that this common sense theory is correct by conducting a systematic review of all acupuncture trials with such a design. We concluded that the ‘A + B versus B’ design is prone to false positive results…What makes this whole thing even worse is the fact that I once presented our review in a lecture where the lead author of the new trial was in the audience; so there can be no excuse of not being aware of the ‘no-brainer’.
Some might argue that this is a pragmatic trial, that it would have been unethical to not give anti-depressants to depressed patients and that therefore it was not possible to design this study differently. However, none of these arguments are convincing, if you analyse them closely (I might leave that to the comment section, if there is interest in such aspects). At the very minimum, the authors should have explained in full detail what interventions were given; and that means disclosing these essentials even in the abstract (and press release) – the part of the publication that is most widely read and quoted.
It is arguably unethical to ask patients’ co-operation, use research funds etc. for a study, the results of which were known even before the first patient had been recruited. And it is surely dishonest to hide the true nature of the design so very sneakily in the final report.
In my view, this trial begs at least 5 questions:
1) How on earth did it pass the peer review process of one of the most highly reputed medical journals?
2) How did the protocol get ethics approval?
3) How did it get funding?
4) Does the scientific community really allow itself to be fooled by such pseudo-research?
5) What do I do to not get depressed by studies of acupuncture for depression?
Has it ever occurred to you that much of the discussion about cause and effect in alternative medicine goes in circles without ever making progress? I have come to the conclusion that it does. Here I try to illustrate this point using the example of acupuncture, more precisely the endless discussion about how to best test acupuncture for efficacy. For those readers who like to misunderstand me I should explain that the sceptics’ view is in capital letters.
At the beginning there was the experience. Unaware of anatomy, physiology, pathology etc., people started sticking needles in other people’s skin, some 2000 years ago, and observed that they experienced relief of all sorts of symptoms.When an American journalist reported about this phenomenon in the 1970s, acupuncture became all the rage in the West. Acupuncture-fans then claimed that a 2000-year history is ample proof that acupuncture does work.
BUT ANECDOTES ARE NOTORIOUSLY UNRELIABLE!
Even the most enthusiastic advocates conceded that this is probably true. So they documented detailed case-series of lots of patients, calculated the average difference between the pre- and post-treatment severity of symptoms, submitted it to statistical tests, and published the notion that the effects of acupuncture are not just anecdotal; in fact, they are statistically significant, they said.
BUT THIS EFFECT COULD BE DUE TO THE NATURAL HISTORY OF THE CONDITION!
“True enough”, grumbled the acupuncture-fans and conducted the very first controlled clinical trials. Essentially they treated one group of patients with acupuncture while another group received conventional treatments as usual. When they analysed the results, they found that the acupuncture group had improved significantly more. “Now do you believe us?”, they asked triumphantly, “acupuncture is clearly effective”.
NO! THIS OUTCOME MIGHT BE DUE TO SELECTION BIAS. SUCH A STUDY-DESIGN CANNOT ESTABLISH CAUSE AND EFFECT.
The acupuncturists felt slightly embarrassed because they had not thought of that. They had allocated their patients to the treatment according to patients’ choice. Thus the expectation of the patients (or the clinician) to get relief from acupuncture might have been the reason for the difference in outcome. So they consulted an expert in trial-design and were advised to allocate not by choice but by chance. In other words, they repeated the previous study but randomised patients to the two groups. Amazingly, their RCT still found a significant difference favouring acupuncture over treatment as usual.
BUT THIS DIFFERENCE COULD BE CAUSED BY A PLACEBO-EFFECT!
Now the acupuncturists were in a bit of a pickle; as far as they could see, there was no good placebo for acupuncture! Eventually some methodologist-chap came up with the idea that, in order to mimic a placebo, they could simply stick needles into non-acupuncture points. When the acupuncturists tried that method, they found that there were improvements in both groups but the difference between real acupuncture and placebo was tiny and usually neither statistically significant nor clinically relevant.
NOW DO YOU CONCEDE THAT ACUPUNCTURE IS NOT AN EFFECTIVE TREATMENT?
Absolutely not! The results merely show that needling non-acupuncture points is not an adequate placebo. Obviously this intervention also sends a powerful signal to the brain which clearly makes it an effective intervention. What do you expect when you compare two effective treatments?
IF YOU REALLY THINK SO, YOU NEED TO PROVE IT AND DESIGN A PLACEBO THAT IS INERT.
At that stage, the acupuncturists came up with a placebo-needle that did not actually penetrate the skin; it worked like a mini stage dagger that telescopes into itself while giving the impression that it penetrated the skin just like the real thing. Surely this was an adequate placebo! The acupuncturists repeated their studies but, to their utter dismay, they found again that both groups improved and the difference in outcome between their new placebo and true acupuncture was minimal.
WE TOLD YOU THAT ACUPUNCTURE WAS NOT EFFECTIVE! DO YOU FINALLY AGREE?
Certainly not, they replied. We have thought long and hard about these intriguing findings and believe that they can be explained just like the last set of results: the non-penetrating needles touch the skin; this touch provides a stimulus powerful enough to have an effect on the brain; the non-penetrating placebo-needles are not inert and therefore the results merely depict a comparison of two effective treatments.
YOU MUST BE JOKING! HOW ARE YOU GOING TO PROVE THAT BIZARRE HYPOTHESIS?
We had many discussions and consensus meeting amongst the most brilliant brains in acupuncture about this issue and have arrived at the conclusion that your obsession with placebo, cause and effect etc. is ridiculous and entirely misplaced. In real life, we don’t use placebos. So, let’s instead address the ‘real life’ question: is acupuncture better than usual treatment? We have conducted pragmatic studies where one group of patients gets treatment as usual and the other group receives acupuncture in addition. These studies show that acupuncture is effective. This is all the evidence we need. Why can you not believe us?
NOW WE HAVE ARRIVED EXACTLY AT THE POINT WHERE WE HAVE BEEN A LONG TIME AGO. SUCH A STUDY-DESIGN CANNOT ESTABLISH CAUSE AND EFFECT. YOU OBVIOUSLY CANNOT DEMONSTRATE THAT ACUPUNCTURE CAUSES CLINICAL IMPROVEMENT. THEREFORE YOU OPT TO PRETEND THAT CAUSE AND EFFECT ARE IRRELEVANT. YOU USE SOME IMITATION OF SCIENCE TO ‘PROVE’ THAT YOUR PRECONCEIVED IDEAS ARE CORRECT. YOU DO NOT SEEM TO BE INTERESTED IN THE TRUTH ABOUT ACUPUNCTURE AT ALL.