TCM
Imagine an area of therapeutics where 100% of all findings of hypothesis-testing research is positive, i.e. comes to the conclusion that the treatment in question is effective. Theoretically, this could mean that the therapy is a miracle cure which is useful for every single condition in every single setting. But sadly, there are no miracle cures. Therefore something must be badly and worryingly amiss with the research in an area that generates 100% positive results.
Acupuncture is such an area; we and others have shown that Chinese trials of acupuncture hardly ever produce a negative finding. In other words, one does not need to read the paper, one already knows that it is positive – even more extreme: one does not need to conduct the study, one already knows the result before the research has started. But you might not believe my research nor that of others. We might be chauvinist bastards who want to discredit Chinese science. In this case, you might perhaps believe Chinese researchers.
In this systematic review, all randomized controlled trials (RCTs) of acupuncture published in Chinese journals were identified by a team of Chinese scientists. A total of 840 RCTs were found, including 727 RCTs comparing acupuncture with conventional treatment, 51 RCTs with no treatment controls, and 62 RCTs with sham-acupuncture controls. Among theses 840 RCTs, 838 studies (99.8%) reported positive results from primary outcomes and two trials (0.2%) reported negative results. The percentages of RCTs concealment of the information on withdraws or sample size calculations were 43.7%, 5.9%, 4.9%, 9.9%, and 1.7% respectively.
The authors concluded that publication bias might be major issue in RCTs on acupuncture published in Chinese journals reported, which is related to high risk of bias. We suggest that all trials should be prospectively registered in international trial registry in future.
I applaud the authors’ courageous efforts to conduct this analysis, but I do not agree with their conclusion. The question why all Chinese acupuncture trials are positive has puzzled me since many years, and I have quizzed numerous Chinese colleagues why this might be so. The answer I received was uniformly that it would be very offensive for Chinese researchers to conceive a study that does not confirm the views held by their peers. In other words, acupuncture research in China is conducted to confirm the prior assumption that this treatment is effective. It seems obvious that this is an abuse of science which must cause confusion.
Whatever the reasons for the phenomenon, and we can only speculate about them, the fact has been independently confirmed several times and is now quite undeniable: acupuncture trials from China – and these constitute the majority of the evidence-base in this area – cannot be trusted. The only way to adequately deal with this problem that I can think of is to discard them outright.
In China (and increasingly elsewhere too), the gentle, meditative exercise of tai chi is being promoted and used for disease prevention, particularly for the prevention of cardiovascular disease (CVD). But are these exercises effective? We carried out a Cochrane review to find out.
We searched both English language and Asian electronic databases as well as trial registers and reference lists for relevant studies. No language restrictions were applied. We considered randomised clinical trials (RCTs) of tai chi lasting at least three months and involving healthy adults or adults at high risk of CVD. The comparison groups received no or only minimal interventions. Our outcome measures were CVD clinical events and CVD risk factors. We excluded trials involving multifactorial lifestyle interventions or focusing on weight loss. Two reviewers independently selected trials for inclusion, abstracted the data and assessed the risk of bias of each included study.
We identified 13 trials with a total of 1520 participants and three on-going studies. All of them had at least one domain with unclear risk of bias, and some were at high risk of bias. Duration and style of tai chi differed between trials. Seven studies recruited 903 healthy participants, the other studies recruited people with hypertension, elderly people at high risk of falling, and people with ‘liver or kidney yin deficiency syndromes’.
No studies reported on cardiovascular mortality, all-cause mortality or non-fatal events as most studies were short-term. There was also considerable heterogeneity between studies, which meant that it was not possible to combine studies statistically for cardiovascular risk. Nine trials measured systolic blood pressure (SBP), and 6 of them found reductions in SBP. Two trials found no clear evidence of a difference, and one trial found an increase in SBP with tai chi. A similar pattern was seen for diastolic blood pressure (DBP): three trials found a reduction in DBP, while three found no clear evidence of a difference.
Three trials reported lipid levels and two found reductions in total cholesterol, LDL-C and triglycerides, while the third study found no clear evidence of a difference between groups on lipid levels. Quality of life was measured in only one trial: tai chi improved quality of life at three months. None of the included trials reported on adverse events, costs or occurrence of type 2 diabetes.
From these findings, we drew the following conclusions: “There are currently no long-term trials examining tai chi for the primary prevention of CVD. Due to the limited evidence available currently no conclusions can be drawn as to the effectiveness of tai chi on CVD risk factors. There was some suggestion of beneficial effects of tai chi on CVD risk factors but this was not consistent across all studies. There was considerable heterogeneity between the studies included in this review and studies were small and at some risk of bias. Results of the ongoing trials will add to the evidence base but additional longer-term, high-quality trials are needed.”
These findings are somewhat disappointing. Tai chi might convey many health benefits, but whether a reduction of cardiovascular risk is amongst them seems doubtful. Even if a risk reduction were established beyond doubt, one would need to ask whether its effect size is larger than that achievable through regular conventional exercise. In my view, this is unlikely.
A recent meta-analysis evaluated the efficacy of acupuncture for treatment of irritable bowel syndrome (IBS) and arrived at bizarrely positive conclusions.
The authors state that they searched 4 electronic databases for double-blind, placebo-controlled trials investigating the efficacy of acupuncture in the management of IBS. Studies were screened for inclusion based on randomization, controls, and measurable outcomes reported.
Six RCTs were included in the meta-analysis, and 5 articles were of high quality. The pooled relative risk for clinical improvement with acupuncture was 1.75 (95%CI: 1.24-2.46, P = 0.001). Using two different statistical approaches, the authors confirmed the efficacy of acupuncture for treating IBS and concluded that acupuncture exhibits clinically and statistically significant control of IBS symptoms.
As IBS is a common and often difficult to treat condition, this would be great news! But is it true? We do not need to look far to find the embarrassing mistakes and – dare I say it? – lies on which this result was constructed.
The largest RCT included in this meta-analysis was neither placebo-controlled nor double blind; it was a pragmatic trial with the infamous ‘A+B versus B’ design. Here is the key part of its methods section: 116 patients were offered 10 weekly individualised acupuncture sessions plus usual care, 117 patients continued with usual care alone. Intriguingly, this was the ONLY one of the 6 RCTs with a significantly positive result!
The second largest study (as well as all the other trials) showed that acupuncture was no better than sham treatments. Here is the key quote from this trial: there was no statistically significant difference between acupuncture and sham acupuncture.
So, let me re-write the conclusions of this meta-analysis without spin, lies or hype: These results of this meta-analysis seem to indicate that:
- currently there are several RCTs testing whether acupuncture is an effective therapy for IBS,
- all the RCTs that adequately control for placebo-effects show no effectiveness of acupuncture,
- the only RCT that yields a positive result does not make any attempt to control for placebo-effects,
- this suggests that acupuncture is a placebo,
- it also demonstrates how misleading studies with the infamous ‘A+B versus B’ design can be,
- finally, this meta-analysis seems to be a prime example of scientific misconduct with the aim of creating a positive result out of data which are, in fact, negative.
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.
The news that the use of Traditional Chinese Medicine (TCM) positively affects cancer survival might come as a surprise to many readers of this blog; but this is exactly what recent research has suggested. As it was published in one of the leading cancer journals, we should be able to trust the findings – or shouldn’t we?
The authors of this new study used the Taiwan National Health Insurance Research Database to conduct a retrospective population-based cohort study of patients with advanced breast cancer between 2001 and 2010. The patients were separated into TCM users and non-users, and the association between the use of TCM and patient survival was determined.
A total of 729 patients with advanced breast cancer receiving taxanes were included. Their mean age was 52.0 years; 115 patients were TCM users (15.8%) and 614 patients were TCM non-users. The mean follow-up was 2.8 years, with 277 deaths reported to occur during the 10-year period. Multivariate analysis demonstrated that, compared with non-users, the use of TCM was associated with a significantly decreased risk of all-cause mortality (adjusted hazards ratio [HR], 0.55 [95% confidence interval, 0.33-0.90] for TCM use of 30-180 days; adjusted HR, 0.46 [95% confidence interval, 0.27-0.78] for TCM use of > 180 days). Among the frequently used TCMs, those found to be most effective (lowest HRs) in reducing mortality were Bai Hua She She Cao, Ban Zhi Lian, and Huang Qi.
The authors of this paper are initially quite cautious and use adequate terminology when they write that TCM-use was associated with increased survival. But then they seem to get carried away by their enthusiasm and even name the TCM drugs which they thought were most effective in prolonging cancer survival. It is obvious that such causal extrapolations are well out of line with the evidence they produced (oh, how I wished that journal editors would finally wake up to such misleading language!) .
Of course, it is possible that some TCM drugs are effective cancer cures – but the data presented here certainly do NOT demonstrate anything like such an effect. And before such a far-reaching claim is being made, much more and much better research would be necessary.
The thing is, there are many alternative and plausible explanations for the observed phenomenon. For instance, it is conceivable that users and non-users of TCM in this study differed in many ways other than their medication, e.g. severity of cancer, adherence to conventional therapies, life-style, etc. And even if the researchers have used clever statistical methods to control for some of these variables, residual confounding can never be ruled out in such case-control studies.
Correlation is not causation, they say. Neglect of this elementary axiom makes for very poor science – in fact, it produces dangerous pseudoscience which could, like in the present case, lead a cancer patient straight up the garden path towards a premature death.
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…
So?
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?
