MD, PhD, FMedSci, FSB, FRCP, FRCPEd

TCM

Moxibustion is an ancient variation of acupuncture using  moxa made from dried mugwort (Artemisia argyi). It has long played an important role in the traditional heath care systems of China and other Asian countries. More recently, it has become popular also in the West. Practitioners use moxa sticks indirectly to warm acupuncture needles, or burn it close to the patient’s skin. Essentially, moxibustion is a treatment where acupuncture points are stimulated mainly or exclusively by the heat of burning moxa.

Because of moxibustion’s long history of usage and the fact that it is employed in many countries for a very wide range of conditions, some might argue that it has stood the ‘test of time’ and should be considered to be a well-established therapy. More critical thinkers would, however, point out that this is not an argument but a classical fallacy.

My team at Exeter regularly had research fellows from Korea and other Asian countries, and we managed to develop a truly productive cooperation. It enabled us to conduct systematic reviews including the Asian literature – and this is how we got involved in an unusual amount of research into moxibustion which, after all, is a fairly exotic alternative therapy. In 2010, we began a series of systematic reviews of moxibustion.

One of the first such articles included 9 RCTs testing the effectiveness of this treatment for stroke rehabilitation. Three RCTs reported favorable effects of moxibustion plus standard care on motor function versus standard care alone Three randomized clinical trials compared the effects of moxibustion on activities of daily living alone but failed to show favorable effects of moxibustion.

Also in 2010, our systematic review of RCTs of moxibustion as a treatment of ulcerative colitis (UC) concluded that current evidence is insufficient to show that moxibustion is an effective treatment of UC. Most of included trials had high risk of bias. More rigorous studies seem warranted.

Our (2010) systematic review od RCTs of moxibustion as a therapy in cancer care found that the evidence was limited to suggest moxibustion is an effective supportive cancer care in nausea and vomiting. However, all studies had a high risk of bias so effectively there was not enough evidence to draw any conclusion.

Our (2010) systematic review of RCTs of moxibustion for treating hypertension concluded that there was insufficient evidence to suggest that moxibustion is an effective treatment for hypertension.

Our (2010) systematic review of RCTs of moxibustion for constipation concluded as follows: Given that the methodological quality of all RCTs was poor, the results from the present review are insufficient to suggest that moxibustion is an effective treatment for constipation. More rigorous studies are warranted.

Our (2010) systematic review found few RCTs were available that test the effectiveness of moxibustion in the management of pain, and most of the existing trials had a high risk of bias. Therefore, more rigorous studies are required before the effectiveness of moxibustion for the treatment of pain can be determined.

Our (2011) systematic review of 14 RCTs of moxibustion for rheumatic conditions failed to provide conclusive evidence for the effectiveness of moxibustion compared with drug therapy in rheumatic conditions.

The, so far, last article in this series has only just been published. The purpose of this systematic review was to assess the efficacy of moxibustion as a treatment of chemotherapy-induced leukopenia. Twelve databases were searched from their inception through June 2014, without a language restriction. Randomized clinical trials (RCTs) were included, if moxibustion was used as the sole treatment or as a part of a combination therapy with conventional drugs for leukopenia induced by chemotherapy. Cochrane criteria were used to assess the risk of bias.

Six RCTs with a total of 681 patients met our inclusion criteria. All of the included RCTs were associated with a high risk of bias. The trials included patients with various types of cancer receiving ongoing chemotherapy or after chemotherapy. The results of two RCTs suggested the effectiveness of moxibustion combined with chemotherapy vs. chemotherapy alone. In four RCTs, moxibustion was more effective than conventional drug therapy. Six RCTs showed that moxibustion was more effective than various types of control interventions in increasing white blood cell counts.

Our conclusion: there is low level of evidence based on these six trials that demonstrates the superiority of moxibustion over drug therapies in the treatment of chemotherapy-induced leukopenia. However, the number of trials, the total sample size, and the methodological quality are too low to draw firm conclusions. Future RCTs appear to be warranted.

Was all this research for nothing?

I know many people who would think so. However, I disagree. If nothing else, these articles demonstrated several facts quite clearly:

  • There is quite a bit of research even on the most exotic alternative therapy; sometimes one needs to look hard and include languages other than English.
  • Studies from China and other Asian counties very rarely report negative results; this fact casts a dark shadow on the credibility of such data.
  • The poor quality of trials in most areas of alternative medicine is lamentable and must be stimulus for researchers in this field to improve their act.
  • Authors of systematic reviews must resist the temptation to draw positive conclusions based on flawed primary data.
  • Moxibustion is a perfect example for demonstrating that the ‘test of time’ is no substitute for evidence.
  • As for moxibustion, it cannot currently be considered an evidence-based treatment for any condition.

Acupuncture seems to be as popular as never before – many conventional pain clinics now employ acupuncturists, for instance. It is probably true to say that acupuncture is one of the best-known types of all alternative therapies. Yet, experts are still divided in their views about this treatment – some proclaim that acupuncture is the best thing since sliced bread, while others insist that it is no more than a theatrical placebo. Consumers, I imagine, are often left helpless in the middle of these debates. Here are 7 important bits of factual information that might help you make up your mind, in case you are tempted to try acupuncture.

  1. Acupuncture is ancient; some enthusiast thus claim that it has ‘stood the test of time’, i. e. that its long history proves its efficacy and safety beyond reasonable doubt and certainly more conclusively than any scientific test. Whenever you hear such arguments, remind yourself that the ‘argumentum ad traditionem’ is nothing but a classic fallacy. A long history of usage proves very little – think of how long blood letting was used, even though it killed millions.
  2. We often think of acupuncture as being one single treatment, but there are many different forms of this therapy. According to believers in acupuncture, acupuncture points can be stimulated not just by inserting needles (the most common way) but also with heat, electrical currents, ultrasound, pressure, etc. Then there is body acupuncture, ear acupuncture and even tongue acupuncture. Finally, some clinicians employ the traditional Chinese approach based on the assumption that two life forces are out of balance and need to be re-balanced, while so-called ‘Western’ acupuncturists adhere to the concepts of conventional medicine and claim that acupuncture works via scientifically explainable mechanisms that are unrelated to ancient Chinese philosophies.
  3. Traditional Chinese acupuncturists have not normally studied medicine and base their practice on the Taoist philosophy of the balance between yin and yang which has no basis in science. This explains why acupuncture is seen by traditional acupuncturists as a ‘cure all’ . In contrast, medical acupuncturists tend to cite neurophysiological explanations as to how acupuncture might work. However, it is important to note that, even though they may appear plausible, these explanations are currently just theories and constitute no proof for the validity of acupuncture as a medical intervention.
  4. The therapeutic claims made for acupuncture are legion. According to the traditional view, acupuncture is useful for virtually every condition affecting mankind; according to the more modern view, it is effective for a relatively small range of conditions only. On closer examination, the vast majority of these claims can be disclosed to be based on either no or very flimsy evidence. Once we examine the data from reliable clinical trials (today several thousand studies of acupuncture are available – see below), we realise that acupuncture is associated with a powerful placebo effect, and that it works better than a placebo only for very few (some say for no) conditions.
  5. The interpretation of the trial evidence is far from straight forward: most of the clinical trials of acupuncture originate from China, and several investigations have shown that very close to 100% of them are positive. This means that the results of these studies have to be taken with more than a small pinch of salt. In order to control for patient-expectations, clinical trials can be done with sham needles which do not penetrate the skin but collapse like miniature stage-daggers. This method does, however, not control for acupuncturists’ expectations; blinding of the therapists is difficult and therefore truly double (patient and therapist)-blind trials of acupuncture do hardly exist. This means that even the most rigorous studies of acupuncture are usually burdened with residual bias.
  6. Few acupuncturists warn their patients of possible adverse effects; this may be because the side-effects of acupuncture (they occur in about 10% of all patients) are mostly mild. However, it is important to know that very serious complications of acupuncture are on record as well: acupuncture needles can injure vital organs like the lungs or the heart, and they can introduce infections into the body, e. g. hepatitis. About 100 fatalities after acupuncture have been reported in the medical literature – a figure which, due to lack of a monitoring system, may disclose just the tip of an iceberg.
  7. Given that, for the vast majority of conditions, there is no good evidence that acupuncture works beyond a placebo response, and that acupuncture is associated with finite risks, it seems to follow that, in most situations, the risk/benefit balance for acupuncture fails to be convincingly positive.

Here I am not writing about herbal medicine in general – parts of which are supported by some encouraging evidence (I will therefore post more than one ‘seven things to remember…’ article on this subject) – here I am writing about the risks and benefits of consulting a traditional herbal practitioner. Herbalists come in numerous guises depending what tradition they belong to: Chinese herbalist, traditional European herbalist, Ayurvedic practitioner, Kampo practitioner etc. If you consult such a therapist, you should be aware of the following issues.

  1. Worldwide, the treatment by traditional herbal practitioners is by far the most common form of herbal medicine; it is more common than to use specific, well-tested herbs to treat specific conventionally diagnosed conditions (an approach that might best be called ‘rational phytotherapy’).
  2. Herbalists often use their very own diagnostic methods (think, for instance, of ‘tongue and pulse diagnoses’ used by Chinese herbalists) and reject (or are untrained to use) conventional diagnostic methods. The traditional diagnostic techniques of herbalists have either not been validated at all or they have been tested and found to be not valid.
  3. Herbalists usually do not recognise conventional disease categories. Instead they arrive at a diagnosis according to their specific philosophy which has no grounding in reality (for instance, energy imbalance in traditional Chinese herbalism).
  4. Herbalists individualise their treatments, meaning that 10 patients suffering from depression, for instance, might receive 10 different, tailor-made prescriptions according to their individual characteristics (and none of the 10 patients might receive St John’s Wort, the only herbal remedy that actually is proven to work for depression).
  5. Typically, such prescriptions contain not one herbal ingredient, but are mixtures of many – up to 10 or 20 – herbs or herbal extracts.
  6. Even though the efficacy of the individualised herbal approach can, of course, be tested in rigorous trials, and even though about a dozen such studies are available today, there is currently no good evidence to show that it is effective.
  7. The risk of harm through these individualised herbal mixtures can be considerable: the more ingredients, the higher the likelihood that one of them has toxic effects or that one interacts with a prescription medicine. Essentially, this means that there is no good evidence that individualised herbal treatments as used by so many herbal practitioners across the globe generates more good than harm.

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:

All of the studies had a high risk of bias

All included trials had a high risk of bias…

The studies were not judged to be free from bias…

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.

If you are pregnant, a ‘breech presentation’ is not good news. It occurs when the fetus presents ‘bottom-down’ in the uterus. There are three types:

  • Breech with extended legs (frank) – 85% of cases
  • Breech with fully flexed legs (complete)
  • Footling (incomplete) with one or both thighs extended

The significance of breech presentation is its association with higher perinatal mortality and morbidity when compared to cephalic presentations. This is due both to pre-existing congenital malformation, increased incidence of breech in premature deliveries and increased risk of intrapartum trauma or asphyxia. Caesarean section has been adopted as the ‘normal’ mode of delivery for term breech presentations in Europe and the USA, as the consensus is that this reduces the risk of birth-related complications.

But Caesarian section is also not a desirable procedure. Something far less invasive would be much more preferable, of course. This is where the TCM-practitioners come in. They claim they have the solution: moxibustion, i.e. the stimulation of acupuncture points by heat. But does it really work? Can it turn the fetus into the correct position?

This new study aimed to assess the efficacy of moxibustion (heating of the acupuncture needle with an igniting charcoal moxa stick) with acupuncture for version of breech presentations to reduce their rate at 37 weeks of gestation and at delivery. It was a randomized, placebo-controlled, single-blind trial including 328 pregnant women recruited in a university hospital center between 33 4/7 and 35 4/7 weeks of gestation. Moxibustion with acupuncture or inactivated laser (placebo) treatment was applied to point BL 67 for 6 sessions. The principal endpoint was the percentage of fetuses in breech presentation at 37 2/7 weeks of gestation.

The results show that the percentage of fetuses in breech presentation at 37 2/7 weeks of gestation was not significantly different in both groups (72.0 in the moxibustion with acupuncture group compared with 63.4% in the placebo group).

The authors concluded that treatment by moxibustion with acupuncture was not effective in correcting breech presentation in the third trimester of pregnancy.

You might well ask why on earth anyone expected that stimulating an acupuncture point would turn a fetus in the mother’s uterus into the optimal position that carries the least risk during the process of giving birth. This is what proponents of this technique say about this approach:

During a TCM consultation to turn a breech baby the practitioner will take a comprehensive case history, make a diagnosis and apply the appropriate acupuncture treatment.  They will assess if moxibustion might be helpful. Practitioners will then instruct women on how to locate the appropriate acupuncture points and demonstrate how to safely apply moxa at home. The acupuncture point UB 67 is the primary point selected for use because it is the most dynamic point to activate the uterus.  Its forte is in turning malpositioned babies.  It is located on the outer, lower edge of both little toenails. According to TCM theory, moxa has a tonifying and warming effect which promotes movement and activity.  The nature of heat is also rising.  This warming and raising effect is utilised to encourage the baby to become more active and lift its bottom up in order to gain adequate momentum to summersault into the head down position. This technique can also be used to reposition transverse presentation, a situation where the baby’s has its shoulder or back pointing down, or is lying sideways across the abdomen.

Not convinced? I can’t say I blame you!

Clearly, we need to know what the totality of the most reliable evidence shows; and what better than a Cochrane review to inform us about it? Here is what it tells us:

Moxibustion was not found to reduce the number of non-cephalic presentations at birth compared with no treatment (P = 0.45). Moxibustion resulted in decreased use of oxytocin before or during labour for women who had vaginal deliveries compared with no treatment (risk ratio (RR) 0.28, 95% confidence interval (CI) 0.13 to 0.60). Moxibustion was found to result in fewer non-cephalic presentations at birth compared with acupuncture (RR 0.25, 95% CI 0.09 to 0.72). When combined with acupuncture, moxibustion resulted in fewer non-cephalic presentations at birth (RR 0.73, 95% CI 0.57 to 0.94), and fewer births by caesarean section (RR 0.79, 95% CI 0.64 to 0.98) compared with no treatment. When combined with a postural technique, moxibustion was found to result in fewer non-cephalic presentations at birth compared with the postural technique alone (RR 0.26, 95% CI 0.12 to 0.56).

In other words, there is indeed some encouraging albeit not convincing evidence! How can this be? There is no plausible explanation why this treatment should work!

But there is a highly plausible explanation why the results of many of the relevant trials are false-positive thus rendering a meta-analysis false-positive as well. I have repeatedly pointed out on this blog that practically all Chinese TCM-studies report (false) positive results; and many of the studies included in this review were done in China. The Cochrane review provides a strong hint about the lack of rigor in its ‘plain language summary':

The included trials were of moderate methodological quality, sample sizes in some of the studies were small, how the treatment was applied differed and reporting was limited. While the results were combined they should be interpreted with caution due to the differences in the included studies. More evidence is needed concerning the benefits and safety of moxibustion.

So, would I recommend moxibustion for breech conversion? I don’t think so!

Traditional Chinese medicine (TCM) is often promoted as an effective therapy for cancer, and are numerous controlled clinical studies published in Chinese literature, yet no systematic analysis has been done of this body of evidence. This systematic review summarizes the evidence from controlled clinical studies published in Chinese on this subject.

The researchers looked for controlled clinical studies of TCM therapies for all kinds of cancers published in Chinese in four main Chinese electronic databases and found 2964 reports including 2385 randomized clinical trials and 579 non-randomized controlled studies.

The top seven cancer types treated were lung cancer, liver cancer, stomach cancer, breast cancer, esophagus cancer, colorectal cancer and nasopharyngeal cancer. The majority of studies (72%) applied TCM therapy combined with conventional treatments, whilst fewer (28%) applied only TCM therapy in the experimental groups. Herbal medicine was the most frequently tested TCM therapy (2677 studies, 90.32%).

The most frequently reported outcome was clinical symptom improvement (1667 studies, 56.24%) followed by biomarker indices (1270 studies, 42.85%), quality of life (1129 studies, 38.09%), chemo/radiotherapy induced side effects (1094 studies, 36.91%), tumor size (869 studies, 29.32%) and safety (547 studies, 18.45%). Completeness and adequacy of reporting appeared to improve with time.

The authors of this paper drew the following conclusion: data from controlled clinical studies of TCM therapies in cancer treatment is substantial, and different therapies are applied either as monotherapy or in combination with conventional medicine. Reporting of controlled clinical studies should be improved based on the CONSORT and TREND Statements in future. Further studies should address the most frequently used TCM therapy for common cancers and outcome measures should address survival, relapse/metastasis and quality of life.

Almost 3000 controlled clinical trials! This number is likely to impress many people – unless, of course, one knows that the quality of these studies is dismal. Interestingly, no formal assessment of study quality was included in this analysis. But it was mentioned that only 63 of these trials reported patient-blinding, and only 5 were deemed to be “relatively well designed” by the authors of this paper (who, incidentally, are strong proponents of TCM).

What I find the most interesting aspect of this article is the fact that the authors fail to mention how many of the studies reported a positive result – in a way, they don’t need to: there is plenty of evidence to show that virtually all of the Chinese studies of TCM are positive. In my view, this invalidates this body of evidence completely.

Analysis like the present one tend to lead us up the garden path. They suggest that there is a realistic hope for effective new treatments hidden in this difficult to access, large amount of data. This might lead other researchers to try to replicate some of the original studies. I fear that they would be wasting their time. From all I know, they are irreproducible.

Tai Chi has been suggested to have many health benefits. Might it even prolong life? There are many enthusiasts who claim just that, but is there any evidence?

This study is a retrospective cross-sectional investigation to compare the rejuvenating and anti-ageing effects among a Tai Chi group (TCC) and a brisk walking group (BW) and a no exercise habit group (NEH) of volunteers. Thirty-two participants were separated into three groups: the TCC group (practicing TC for more than 1 year), the BW group (practicing BW for more than 1 year), and the NEH group. The CD34+ cell counts in peripheral blood of the participants was determined, and the Kruskal‐Wallis test was used to evaluate and compare the antiaging effects of the three groups. The results show that the participants in the TCC group (N = 10) outperformed the NEH group (N = 12) with respect to the number of CD34+ progenitor cells. No significant difference was found between the TCC group and the BW group. The authors of this study conclude that TCC practice sustained for more than 1 year may be an intervention against aging as effective as BW in terms of its benefits on the improvement of CD34+ number.

I was alerted to this new paper by several rather sensational headlines in the daily press which stated that Tai chi (TC) had anti-aging effects. So I searched for the press release about the article where I found the following quotes:

“It is possible that Tai Chi may prompt vasodilation and increase blood flow,” said Lin. “Considering that BW may require a larger space or more equipment, Tai Chi seems to be an easier and more convenient choice of anti-aging exercise.” “This study provides the first step into providing scientific evidence for the possible health benefits of Tai Chi.” said Dr. Paul R. Sanberg, distinguished professor at the Center of Excellence for Aging and Brain Repair, Morsani College of Medicine, University of South Florida, Tampa, FL. “Further study of how Tai Chi can elicit benefit in different populations and on different parameters of aging are necessary to determine its full impact.”

Personally, I find both the press release and the original conclusions of the authors quite amazing. If anyone wanted to write a textbook on how not to do such things, he/she could use them as excellent examples.

Seen with just a tinge of critical thinking the paper reports a flimsy case-control study comparing three obviously self-selected groups of people who had chosen to follow different exercise regimen for several months. In all likelihood they also differed in terms of life-style, nutrition, sleeping pattern, alcohol intake, smoking habits and a million other things. These rather tiny groups were then compared according to a surrogate measure for ageing and some differences were identified.

BIG DEAL!

To conclude from this, or even to imply, that TC has anti-ageing effects is as far-fetched as claiming the tooth fairy has money problems.

This story could be just funny or trivial or boring – however, I think, it is also a bit worrying. It shows, I fear, how uncritical researchers in conjunction with some naïve press officer are able to induce silly journalists and headline-writers to mislead the public.

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:

  1. currently there are several RCTs testing whether acupuncture is an effective therapy for IBS,
  2. all the RCTs that adequately control for placebo-effects show no effectiveness of acupuncture,
  3. the only RCT that yields a positive result does not make any attempt to control for placebo-effects,
  4. this suggests that acupuncture is a placebo,
  5. it also demonstrates how misleading studies with the infamous ‘A+B versus B’ design can be,
  6. finally, this meta-analysis seems to be a prime example of scientific misconduct with the aim of creating a positive result out of data which are, in fact, negative.
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