MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

TCM

1 2 3 7

Alternative practitioners practise highly diverse therapies. They seem to have nothing in common – except perhaps that ALL of them are allegedly stimulating our self-healing powers (and except that most proponents are latently or openly against vaccinations). And it is through these self-healing powers that the treatments in question cure anything and become a true panacea. When questioned what these incredible powers really are, most practitioners would (somewhat vaguely) name the immune system as the responsible mechanism. With this post, I intend to provide a short summary of the evidence on this issue:

Acupuncture: no good evidence to show stimulation of self-healing powers.

Aromatherapy: no good evidence to show stimulation of self-healing powers.

Bioresonance: no good evidence to show stimulation of self-healing powers.

Chiropractic: no good evidence to show stimulation of self-healing powers.

Detox: no good evidence to show stimulation of self-healing powers.

Energy healing: no good evidence to show stimulation of self-healing powers.

Feldenkrais: no good evidence to show stimulation of self-healing powers.

Gua sha: no good evidence to show stimulation of self-healing powers.

Herbal medicine: no good evidence to show stimulation of self-healing powers.

Homeopathy: no good evidence to show stimulation of self-healing powers.

Macrobiotics: no good evidence to show stimulation of self-healing powers.

Naturopathy: no good evidence to show stimulation of self-healing powers.

Osteopathy: no good evidence to show stimulation of self-healing powers.

Power bands: no good evidence to show stimulation of self-healing powers.

Reiki: no good evidence to show stimulation of self-healing powers.

Reflexology: no good evidence to show stimulation of self-healing powers.

Shiatsu: no good evidence to show stimulation of self-healing powers.

Tai chi: no good evidence to show stimulation of self-healing powers.

TCM: no good evidence to show stimulation of self-healing powers.

Vibrational therapy: no good evidence to show stimulation of self-healing powers.


Vaccinations: very good evidence to show stimulation of self-healing powers.


THE END

My previous post praised the validity and trustworthiness of Cochrane reviews. This post continues in the same line.

Like osteoarthritis, acute stroke has been a condition for which acupuncture-fans prided themselves of being able to produce fairly good evidence. A Cochrane review of 2005, however, was inconclusive and concluded that the number of patients is too small to be certain whether acupuncture is effective for treatment of acute ischaemic or haemorrhagic stroke. Larger, methodologically-sound trials are required.

So, 13 years later, we do have more evidence, and it would be interesting to know what the best evidence tells us today. This new review will tell us because it is the update of the previous Cochrane Review originally published in 2005.

The authors sought randomized clinical trials (RCTs) of acupuncture started within 30 days from stroke onset compared with placebo or sham acupuncture or open control (no placebo) in people with acute ischemic or haemorrhagic stroke, or both. Needling into the skin was required for acupuncture. Comparisons were made versus (1) all controls (open control or sham acupuncture), and (2) sham acupuncture controls.

Two review authors applied the inclusion criteria, assessed trial quality and risk of bias, and extracted data independently. They contacted study authors to ask for missing data and assessed the quality of the evidence by using the GRADE approach. The primary outcome was defined as death or dependency at the end of follow-up.

In total, 33 RCTs with 3946 participants were included. Twenty new trials with 2780 participants had been completed since the previous review. Outcome data were available for up to 22 trials (2865 participants) that compared acupuncture with any control (open control or sham acupuncture) but for only six trials (668 participants) that compared acupuncture with sham acupuncture control. The authors downgraded the evidence to low or very low quality because of risk of bias in included studies, inconsistency in the acupuncture intervention and outcome measures, and imprecision in effect estimates.

When compared with any control (11 trials with 1582 participants), findings of lower odds of death or dependency at the end of follow-up and over the long term (≥ three months) in the acupuncture group were uncertain (odds ratio [OR] 0.61, 95% confidence interval [CI] 0.46 to 0.79; very low-quality evidence; and OR 0.67, 95% CI 0.53 to 0.85; eight trials with 1436 participants; very low-quality evidence, respectively) and were not confirmed by trials comparing acupuncture with sham acupuncture (OR 0.71, 95% CI 0.43 to 1.18; low-quality evidence; and OR 0.67, 95% CI 0.40 to 1.12; low-quality evidence, respectively).In trials comparing acupuncture with any control, findings that acupuncture was associated with increases in the global neurological deficit score and in the motor function score were uncertain (standardized mean difference [SMD] 0.84, 95% CI 0.36 to 1.32; 12 trials with 1086 participants; very low-quality evidence; and SMD 1.08, 95% CI 0.45 to 1.71; 11 trials with 895 participants; very low-quality evidence).

These findings were not confirmed in trials comparing acupuncture with sham acupuncture (SMD 0.01, 95% CI -0.55 to 0.57; low-quality evidence; and SMD 0.10, 95% CI -0.38 to 0.17; low-quality evidence, respectively).Trials comparing acupuncture with any control reported little or no difference in death or institutional care at the end of follow-up (OR 0.78, 95% CI 0.54 to 1.12; five trials with 1120 participants; low-quality evidence), death within the first two weeks (OR 0.91, 95% CI 0.33 to 2.55; 18 trials with 1612 participants; low-quality evidence), or death at the end of follow-up (OR 1.08, 95% CI 0.74 to 1.58; 22 trials with 2865 participants; low-quality evidence).

The incidence of adverse events (eg, pain, dizziness, fainting) in the acupuncture arms of open and sham control trials was 6.2% (64/1037 participants), and 1.4% of these (14/1037 participants) discontinued acupuncture. When acupuncture was compared with sham acupuncture, findings for adverse events were uncertain (OR 0.58, 95% CI 0.29 to 1.16; five trials with 576 participants; low-quality evidence).

The authors concluded that this updated review indicates that apparently improved outcomes with acupuncture in acute stroke are confounded by the risk of bias related to use of open controls. Adverse events related to acupuncture were reported to be minor and usually did not result in stopping treatment. Future studies are needed to confirm or refute any effects of acupuncture in acute stroke. Trials should clearly report the method of randomization, concealment of allocation, and whether blinding of participants, personnel, and outcome assessors was achieved, while paying close attention to the effects of acupuncture on long-term functional outcomes.

These cautious conclusions might be explained by the fact that Chinese researchers are reluctant to state anything overtly negative about any TCM therapy. Recently, one expert who spoke out was even imprisoned for criticising a TCM product! But in truth, this review really shows that acupuncture has no convincing effect in acute stroke.

And for me, this conclusion is fascinating. I have been involved in acupuncture/stroke research since the early 1990s.

Our RCT produced a resounding negative result concluding that acupuncture is not superior to sham treatment for recovery in activities of daily living and health-related quality of life after stroke, although there may be a limited effect on leg function in more severely affected patients.

Our 1996 systematic review concluded that the evidence that acupuncture is a useful adjunct for stroke rehabilitation is encouraging but not compelling.

By 2001, more data had become available but the conclusion became even less encouraging: there is no compelling evidence to show that acupuncture is effective in stroke rehabilitation.

Finally, by 2010, there were 10 RCT and we were able to do a meta-analysis of the data. We concluded that our meta-analyses of data from rigorous randomized sham-controlled trials did not show a positive effect of acupuncture as a treatment for functional recovery after stroke.

Yes, my reviews were on slightly different research questions. Yet, they do reveal how a critical assessment of the slowly emerging evidence had to arrive at more and more negative conclusions about the role of acupuncture in the management of stroke patients. For a long time, this message was in stark contrast to what acupuncture-fans were claiming. I wonder whether they will now finally change their mind.

I have said it often, and I say it again: I do like well-conducted systematic reviews; and Cochrane reviews are usually the best, i. e. most transparent, most thorough and least biased. Thus, I was pleased to see a new Cochrane review of acupuncture aimed at assessing the benefits and harms of acupuncture in patients with hip OA.

The authors included randomized controlled trials (RCTs) that compared acupuncture with sham acupuncture, another active treatment, or no specific treatment; and RCTs that evaluated acupuncture as an addition to another treatment. Major outcomes were pain and function at the short term (i.e. < 3 months after randomization) and adverse events.

Six RCTs with 413 participants were included. Four RCTs included only people with OA of the hip, and two included a mix of people with OA of the hip and knee. All RCTs included primarily older participants, with a mean age range from 61 to 67 years, and a mean duration of hip OA pain from two to eight years. Approximately two-thirds of participants were women. Two RCTs compared acupuncture versus sham acupuncture; the other four RCTs were not blinded. All results were evaluated at short-term (i.e. four to nine weeks after randomization).In the two RCTs that compared acupuncture to sham acupuncture, the sham acupuncture control interventions were judged believable, but each sham acupuncture intervention was also judged to have a risk of weak acupuncture-specific effects, due to placement of non-penetrating needles at the correct acupuncture points in one RCT, and the use of penetrating needles not inserted at the correct points in the other RCT. For these two sham-controlled RCTs, the risk of bias was low for all outcomes.

The combined analysis of two sham-controlled RCTs gave moderate quality evidence of little or no effect in reduction in pain for acupuncture relative to sham acupuncture. Due to the small sample sizes in the studies, the confidence interval includes both the possibility of moderate benefit and the possibility of no effect of acupuncture (120 participants; Standardized Mean Difference (SMD) -0.13, (95% Confidence Interval (CI) -0.49 to 0.22); 2.1 points greater improvement with acupuncture compared to sham acupuncture on 100 point scale (i.e., absolute percent change -2.1% (95% CI -7.9% to 3.6%)); relative percent change -4.1% (95% CI -15.6% to 7.0%)). Estimates of effect were similar for function (120 participants; SMD -0.15, (95% CI -0.51 to 0.21)). No pooled estimate, representative of the two sham-controlled RCTs, could be calculated or reported for the quality of life outcome.

The four other RCTs were unblinded comparative effectiveness RCTs, which compared (additional) acupuncture to four different active control treatments. There was low quality evidence that addition of acupuncture to the routine primary care that RCT participants were receiving from their physicians was associated with statistically significant and clinically relevant benefits, compared to the routine primary physician care alone, in pain (1 RCT; 137 participants; mean percent difference -22.9% (95% CI -29.2% to -16.6%); relative percent difference -46.5% (95% CI -59.3% to -33.7%)) and function (mean percent difference -19.0% (95% CI -24.41 to -13.59); relative percent difference -38.6% (95% CI -49.6% to -27.6%)). There was no statistically significant difference for mental quality of life and acupuncture showed a small, significant benefit for physical quality of life.

The effects of acupuncture compared with either advice plus exercise or NSAIDs are uncertain. The authors are also uncertain whether acupuncture plus patient education improves pain, function, and quality of life, when compared to patient education alone.

In general, the overall quality of the evidence for the four comparative effectiveness RCTs was low to very low, mainly due to the potential for biased reporting of patient-assessed outcomes due to lack of blinding and sparse data.

Information on safety was reported in 4 RCTs. Two RCTs reported minor side effects of acupuncture, which were primarily minor bruising, bleeding, or pain at needle insertion sites.

The authors concluded that acupuncture probably has little or no effect in reducing pain or improving function relative to sham acupuncture in people with hip osteoarthritis. Due to the small sample size in the studies, the confidence intervals include both the possibility of moderate benefits and the possibility of no effect of acupuncture. One unblinded trial found that acupuncture as an addition to routine primary physician care was associated with benefits on pain and function. However, these reported benefits are likely due at least partially to RCT participants’ greater expectations of benefit from acupuncture. Possible side effects associated with acupuncture treatment were minor.

This is an excellent review of data that (because of contradictions, methodological limitations, heterogeneity etc.) are not easy to evaluate fairly. The review shows that previous verdicts about acupuncture for osteoarthritis might have been too optimistic. Acupuncture has no or only very small specific therapeutic effects. As we have much better therapeutic options for this condition, it means that acupuncture can no longer be recommended as an effective therapy.

That surely must be big news in the little world of acupuncture!

I have been personally involved in several similar reviews:

In 1997, I concluded that the most rigorous studies suggest that acupuncture is not superior to sham-needling in reducing pain of osteoarthritis: both alleviate symptoms to roughly the same degree.

In 2006, the balance of evidence seemed to have shifted and more positive data had emerged; consequently our review concluded that sham-controlled RCTs suggest specific effects of acupuncture for pain control in patients with peripheral joint OA. Considering its favourable safety profile acupuncture seems an option worthy of consideration particularly for knee OA. Further studies are required particularly for manual or electro-acupuncture in hip OA.

Now, it seems that my initial conclusion of 1996 was more realistic. To me this is a fascinating highlight on the fact that in EBM, we change our minds based on the current best evidence. By contrast, in alternative medicine, as we have often lamented on this blog, minds do not easily change and all too often dogma seems to reign.

The new Cochrane review is important in several ways. Firstly, it affirms an appropriately high standard for such reviews. Secondly, it originates from a research team that has, in the past, been outspokenly pro-acupuncture; it is therefore unlikely that the largely negative findings were due to an anti-acupuncture bias. Thirdly – and most importantly – osteoarthritis has been THE condition for which even critical reviewers had to admit that there was at least some good, positive evidence.

It seems therefore, that yet again a beautiful theory has been slain by an ugly fact.

On this blog, we have seen more than enough evidence of how some proponents of alternative medicine can react when they feel cornered by critics. They often direct vitriol in their direction. Ad hominem attacks are far from being rarities. A more forceful option is to sue them for libel. In my own case, Prince Charles went one decisive step further and made sure that my entire department was closed down. In China, they have recently and dramatically gone even further.

This article in Nature tells the full story:

A Chinese doctor who was arrested after he criticized a best-selling traditional Chinese remedy has been released, after more than three months in detention. Tan Qindong had been held at the Liangcheng county detention centre since January, when police said a post Tan had made on social media damaged the reputation of the traditional medicine and the company that makes it.

On 17 April, a provincial court found the police evidence for the case insufficient. Tan, a former anaesthesiologist who has founded several biomedical companies, was released on bail on that day. Tan, who lives in Guangzhou in southern China, is now awaiting trial. Lawyers familiar with Chinese criminal law told Nature that police have a year to collect more evidence or the case will be dismissed. They say the trial is unlikely to go ahead…

The episode highlights the sensitivities over traditional Chinese medicines (TCMs) in China. Although most of these therapies have not been tested for efficacy in randomized clinical trials — and serious side effects have been reported in some1TCM has support from the highest levels of government. Criticism of remedies is often blocked on the Internet in China. Some lawyers and physicians worry that Tan’s arrest will make people even more hesitant to criticize traditional therapies…

Tan’s post about a medicine called Hongmao liquor was published on the Chinese social-media app Meipian on 19 December…Three days later, the liquor’s maker, Hongmao Pharmaceuticals in Liangcheng county of Inner Mongolia autonomous region, told local police that Tan had defamed the company. Liangcheng police hired an accountant who estimated that the damage to the company’s reputation was 1.4 million Chinese yuan (US$220,000), according to official state media, the Beijing Youth Daily. In January, Liangcheng police travelled to Guangzhou to arrest Tan and escort him back to Liangcheng, according to a police statement.

Sales of Hongmao liquor reached 1.63 billion yuan in 2016, making it the second best-selling TCM in China that year. It was approved to be sold by licensed TCM shops and physicians in 1992 and approved for sale over the counter in 2003. Hongmao Pharmaceuticals says that the liquor can treat dozens of different disorders, including problems with the spleen, stomach and kidney, as well as backaches…

Hongmao Pharmaceuticals did not respond to Nature’s request for an interview. However, Wang Shengwang, general manager of the production center of Hongmao Liquor, and Han Jun, assistant to the general manager, gave an interview to The Paper on 16 April. The pair said the company did not need not publicize clinical trial data because Hongmao liquor is a “protected TCM composition”. Wang denied allegations in Chinese media that the company pressured the police to pursue Tan or that it dispatched staff to accompany the police…

Xia is worried that the case could further silence public criticism of TCMs, environmental degredation, and other fields where comment from experts is crucial. The Tan arrest “could cause fear among scientists” and dissuade them from posting scientific comments, he says.

END OF QUOTE

On this blog, we have repeatedly discussed concerns over the validity of TCM data/material that comes out of China (see for instance here, here and here). This chilling case, I am afraid, is not prone to increase our confidence.

Prof Ke’s Asante Academy (Ke claims that asante is French and means good health – wrong, of course, but that’s the least of his errors) offers many amazing things, and I do encourage you to have a look at his website. Prof Ke is clearly not plagued by false modesty; he informs us that “I am proud to say that we have gained a reputation as one of the leading Chinese Medicine clinics and teaching institutes in the UK and Europe. One CEO from a leading Acupuncture register commented that we were the best in the country. One doctor gave up his medical job in a European country to come study Chinese medicine at Middlesex University (our partner) – he said simply it was because of Asante. Our patients, from royalty and celebrities to hard working people all over the world, have praised us highly for successfully treating their wide-ranging conditions, including infertility, skin problems, pain and many others. We are also very pleased to have pioneered Acupuncture service in the NHS and for over a decade we have seen tens of thousands of NHS patients in hospitals.”

He provides treatments for any condition you can imagine, courses in various forms of TCM, a range of videos (they are particularly informative), as well as interesting explanations and treatment plans for dozens of conditions. From the latter, I have chosen just two diseases and quote some extracts to give you a vivid impression of the Ke’s genius:

CANCER

There are some ways in which Chinese medicine can help cancer cases where Western medicine cannot. Various herbal prescriptions have been shown to help in bolstering the immune system and some herbs can actually attack the abnormal cells and viruses which are responsible for certain types of cancer.

Chinese Medicine treatment aims first to increase the body’s own defence mechanisms, then to kill the cancer cells. Effective though radiotherapy and chemotherapy may be, they tend to have a drastic effect on the body generally and patients often feel very tired and weak, suffer from stress, anxiety, fear, insomnia and loss of appetite. Chinese Medicine practitioners regard strengthening the patient psychologically and physically to be of primary importance.

Chinese Medicine herbal remedies can help reduce or eliminate the side-effects from radiotherapy or chemotherapy. Astragalus will help raise the blood cell count, the sickness caused by chemotherapy can be relieved with fresh ginger and orange peel, and acupuncture can also help. To attack the cancer itself, depending on type and location, different herbs will be used.

A Chinese Medicine practitiioner will decide whether the illness is the result of qi energy deficiency, blood deficiency or yin or yang deficiencyGinseng,astragalusChinese angelicacooked rehmannia rootwolfberry rootChinese yam and many tonic herbs may be used. But it is vital to remember that no one tonic is good for everybody. All treatments are dependent upon the individual. Some anti-cancer herbs used are very strong and sometimes make people sick, but this is because one poison is being used against another. How they work, and how clinically effective they are, is still being researched. No claims can be made for them based on modern scientific evaluation.

Acupuncture and meditation are also very important parts of the Chinese Medicine traditional approach to the treatment of cancer. These alleviate pain and induce a sense of calmness, instill confidence and build up the spirit of the body, so that patients do not need to take so many painkillers. In China, they have many meditation programmes which are used to treat cancer.

MENINGITIS

Chinese Medicine herbal treatment for meningitis has been very successful in China. In the recent past there were many epidemics, particularly in the north, and the hospitals routinely used Chinese herbs as treatment, with a high degree of success. One famous remedy in Chinese Medicine is called White Tiger Decoction, the main ingredients of which are gypsum and rice. These are simple things but they reduce the high fever and clear the infection from the brain. Modern medicine and Chinese Medicine used together is the most effective treatment.

END OF QUOTES

Ghosh, I am so glad that finally someone explained these things to me, and so logically and simply too. I used to have doubts about the value of TCM for these conditions, but now I am convinced … so much so that I go on Medline to find the scientific work of Prof Ke. But what, what, what? That is not possible; such a famous professor and no publications?

I conclude that my search skills are inadequate and throw myself into studying the plethora of courses Ke offers for the benefit of mankind:

Since 2000, Asanté Academy has officially collaborated with Middlesex University in running and teaching the BSc and MSc in Traditional Chinese Medicine.

  • BSc Degrees in Acupuncture and Traditional Chinese Medicine
  • MSc Degree in Chinese Medicine
  • Professional Practice in Herbal Medicine, Chinese Herbal Medicine and Acupuncture

But perhaps this is a bit too arduous; maybe so-called diploma courses suit me better? Personally, I am tempted by the ‘24-day Certificate Course in TCM Acupuncture‘ – it’s a bargain, just £ 2,880!

PS

Prof Ke, if you read these lines, would you please tell us where and when you got your professorship? Your otherwise ostentatious website seems to fail to disclose this detail.

The plethora of dodgy meta-analyses in alternative medicine has been the subject of a recent post – so this one is a mere update of a regular lament.

This new meta-analysis was to evaluate evidence for the effectiveness of acupuncture in the treatment of lumbar disc herniation (LDH). (Call me pedantic, but I prefer meta-analyses that evaluate the evidence FOR AND AGAINST a therapy.) Electronic databases were searched to identify RCTs of acupuncture for LDH, and 30 RCTs involving 3503 participants were included; 29 were published in Chinese and one in English, and all trialists were Chinese.

The results showed that acupuncture had a higher total effective rate than lumbar traction, ibuprofen, diclofenac sodium and meloxicam. Acupuncture was also superior to lumbar traction and diclofenac sodium in terms of pain measured with visual analogue scales (VAS). The total effective rate in 5 trials was greater for acupuncture than for mannitol plus dexamethasone and mecobalamin, ibuprofen plus fugui gutong capsule, loxoprofen, mannitol plus dexamethasone and huoxue zhitong decoction, respectively. Two trials showed a superior effect of acupuncture in VAS scores compared with ibuprofen or mannitol plus dexamethasone, respectively.

The authors from the College of Traditional Chinese Medicine, Jinan University, Guangzhou, Guangdong, China, concluded that acupuncture showed a more favourable effect in the treatment of LDH than lumbar traction, ibuprofen, diclofenac sodium, meloxicam, mannitol plus dexamethasone and mecobalamin, fugui gutong capsule plus ibuprofen, mannitol plus dexamethasone, loxoprofen and huoxue zhitong decoction. However, further rigorously designed, large-scale RCTs are needed to confirm these findings.

Why do I call this meta-analysis ‘dodgy’? I have several reasons, 10 to be exact:

  1. There is no plausible mechanism by which acupuncture might cure LDH.
  2. The types of acupuncture used in these trials was far from uniform and  included manual acupuncture (MA) in 13 studies, electro-acupuncture (EA) in 10 studies, and warm needle acupuncture (WNA) in 7 studies. Arguably, these are different interventions that cannot be lumped together.
  3. The trials were mostly of very poor quality, as depicted in the table above. For instance, 18 studies failed to mention the methods used for randomisation. I have previously shown that some Chinese studies use the terms ‘randomisation’ and ‘RCT’ even in the absence of a control group.
  4. None of the trials made any attempt to control for placebo effects.
  5. None of the trials were conducted against sham acupuncture.
  6. Only 10 studies 10 trials reported dropouts or withdrawals.
  7. Only two trials reported adverse reactions.
  8. None of these shortcomings were critically discussed in the paper.
  9. Despite their affiliation, the authors state that they have no conflicts of interest.
  10. All trials were conducted in China, and, on this blog, we have discussed repeatedly that acupuncture trials from China never report negative results.

And why do I find the journal ‘dodgy’?

Because any journal that publishes such a paper is likely to be sub-standard. In the case of ‘Acupuncture in Medicine’, the official journal of the British Medical Acupuncture Society, I see such appalling articles published far too frequently to believe that the present paper is just a regrettable, one-off mistake. What makes this issue particularly embarrassing is, of course, the fact that the journal belongs to the BMJ group.

… but we never really thought that science publishing was about anything other than money, did we?

What an odd title, you might think.

Systematic reviews are the most reliable evidence we presently have!

Yes, this is my often-voiced and honestly-held opinion but, like any other type of research, systematic reviews can be badly abused; and when this happens, they can seriously mislead us.

new paper by someone who knows more about these issues than most of us, John Ioannidis from Stanford university, should make us think. It aimed at exploring the growth of published systematic reviews and meta‐analyses and at estimating how often they are redundant, misleading, or serving conflicted interests. Ioannidis demonstrated that publication of systematic reviews and meta‐analyses has increased rapidly. In the period January 1, 1986, to December 4, 2015, PubMed tags 266,782 items as “systematic reviews” and 58,611 as “meta‐analyses.” Annual publications between 1991 and 2014 increased 2,728% for systematic reviews and 2,635% for meta‐analyses versus only 153% for all PubMed‐indexed items. Ioannidis believes that probably more systematic reviews of trials than new randomized trials are published annually. Most topics addressed by meta‐analyses of randomized trials have overlapping, redundant meta‐analyses; same‐topic meta‐analyses may exceed 20 sometimes.

Some fields produce massive numbers of meta‐analyses; for example, 185 meta‐analyses of antidepressants for depression were published between 2007 and 2014. These meta‐analyses are often produced either by industry employees or by authors with industry ties and results are aligned with sponsor interests. China has rapidly become the most prolific producer of English‐language, PubMed‐indexed meta‐analyses. The most massive presence of Chinese meta‐analyses is on genetic associations (63% of global production in 2014), where almost all results are misleading since they combine fragmented information from mostly abandoned era of candidate genes. Furthermore, many contracting companies working on evidence synthesis receive industry contracts to produce meta‐analyses, many of which probably remain unpublished. Many other meta‐analyses have serious flaws. Of the remaining, most have weak or insufficient evidence to inform decision making. Few systematic reviews and meta‐analyses are both non‐misleading and useful.

The author concluded that the production of systematic reviews and meta‐analyses has reached epidemic proportions. Possibly, the large majority of produced systematic reviews and meta‐analyses are unnecessary, misleading, and/or conflicted.

Ioannidis makes the following ‘Policy Points’:

  • Currently, there is massive production of unnecessary, misleading, and conflicted systematic reviews and meta‐analyses. Instead of promoting evidence‐based medicine and health care, these instruments often serve mostly as easily produced publishable units or marketing tools.
  • Suboptimal systematic reviews and meta‐analyses can be harmful given the major prestige and influence these types of studies have acquired.
  • The publication of systematic reviews and meta‐analyses should be realigned to remove biases and vested interests and to integrate them better with the primary production of evidence.

Obviously, Ioannidis did not have alternative medicine in mind when he researched and published this article. But he easily could have! Virtually everything he stated in his paper does apply to it. In some areas of alternative medicine, things are even worse than Ioannidis describes.

Take TCM, for instance. I have previously looked at some of the many systematic reviews of TCM that currently flood Medline, based on Chinese studies. This is what I concluded at the time:

Why does that sort of thing frustrate me so much? Because it is utterly meaningless and potentially harmful:

  • I don’t know what treatments the authors are talking about.
  • Even if I managed to dig deeper, I cannot get the information because practically all the primary studies are published in obscure journals in Chinese language.
  • Even if I  did read Chinese, I do not feel motivated to assess the primary studies because we know they are all of very poor quality – too flimsy to bother.
  • Even if they were formally of good quality, I would have my doubts about their reliability; remember: 100% of these trials report positive findings!
  • Most crucially, I am frustrated because conclusions of this nature are deeply misleading and potentially harmful. They give the impression that there might be ‘something in it’, and that it (whatever ‘it’ might be) could be well worth trying. This may give false hope to patients and can send the rest of us on a wild goose chase.

So, to ease the task of future authors of such papers, I decided give them a text for a proper EVIDENCE-BASED conclusion which they can adapt to fit every review. This will save them time and, more importantly perhaps, it will save everyone who might be tempted to read such futile articles the effort to study them in detail. Here is my suggestion for a conclusion soundly based on the evidence, not matter what TCM subject the review is about:

OUR SYSTEMATIC REVIEW HAS SHOWN THAT THERAPY ‘X’ AS A TREATMENT OF CONDITION ‘Y’ IS CURRENTLY NOT SUPPORTED BY SOUND EVIDENCE.

On another occasion, I stated that I am getting very tired of conclusions stating ‘…XY MAY BE EFFECTIVE/HELPFUL/USEFUL/WORTH A TRY…’ It is obvious that the therapy in question MAY be effective, otherwise one would surely not conduct a systematic review. If a review fails to produce good evidence, it is the authors’ ethical, moral and scientific obligation to state this clearly. If they don’t, they simply misuse science for promotion and mislead the public. Strictly speaking, this amounts to scientific misconduct.

In yet another post on the subject of systematic reviews, I wrote that if you have rubbish trials, you can produce a rubbish review and publish it in a rubbish journal (perhaps I should have added ‘rubbish researchers).

And finally this post about a systematic review of acupuncture: it is almost needless to mention that the findings (presented in a host of hardly understandable tables) suggest that acupuncture is of proven or possible effectiveness/efficacy for a very wide array of conditions. It also goes without saying that there is no critical discussion, for instance, of the fact that most of the included evidence originated from China, and that it has been shown over and over again that Chinese acupuncture research never seems to produce negative results.

The main point surely is that the problem of shoddy systematic reviews applies to a depressingly large degree to all areas of alternative medicine, and this is misleading us all.

So, what can be done about it?

My preferred (but sadly unrealistic) solution would be this:

STOP ENTHUSIASTIC AMATEURS FROM PRETENDING TO BE RESEARCHERS!

Research is not fundamentally different from other professional activities; to do it well, one needs adequate training; and doing it badly can cause untold damage.

I have to admit that I had little hope it would come. But after sending my ‘open letter’ twice to their email address, I have just received this:

Click to enlarge

 

 

As you might remember, the AACMA had accused me of an pecuniary undeclared link with the pharmaceutical industry. Their claim was based on me having been the editor of a journal, FACT, which was co-published by the British Pharmaceutical Society (BPS). When I complained and the AACMA learnt that the journal had been discontinued, they retracted their claim but carried on distributing the allegation that I had formerly had an undeclared conflict of interest. When they finally understood that the BPS was not the pharmaceutical industry (all it takes is a simple Google search), and after me complaining again and again, they sent me the above email.

The full details of this sorry story are here and here.

So, the AACMA have done the right thing?

Yes and no!

The have retracted their repeated lies.

But they have not done this publicly as requested (this is partly the reason for me writing this post to make their retraction public).

More importantly, they have not apologised !!!

Why should they, you might ask.

  1. Because they have (tried to) damage my reputation as an independent scientist.
  2. Because they have not done their research before making and insisting on a far-reaching claim.
  3. Because they have shown themselves too stupid to grasp even the most elementary issues.

By not apologising, they have, I find, shown how unprofessional they really are, and how much they lack simple human decency. On their website, the AACMA state that “since 1973, AACMA has represented the profession and values high standards in ethical and professional practice.” Personally, I think that their standards in ethical and professional practice are appalling.

I was reliably informed that the ‘Australian Acupuncture and Chinese Medicine Association’ (AACMA) are currently – that is AFTER having retracted the falsehoods they previously issued about me – distributing a document which contains the following passage:

It is noted that Mr Ernst derives income from editing a journal called Focus on Alternative and Complementary Medicine which is published by the British Pharmaceutical Society and listed in pharamcologyjournals.com. Ernst has not declared his own pecuniary conflicts of interest and links with the pharmaceutical industry. I note that the FSM webpage declares that:

‘None of the members of the executive has any vested interests in pharmaceutical companies such that our views or opinions might be influenced’.

This statement is disingenuous and deceptive if instead you base your critique on the blog of a person with such pharmaceutical interests without declaring it.

This is a repetition of the lies which the AACMA have already retracted (see comments section of my previous post on this matter). In my view, this is highly dishonest and actionable. For this reason, I today sent them this ‘open letter’ which I also publish here:

Dear Madam/Sir,

As explained more fully in this blog-post, you have recently accused me of undeclared links to and payments from the pharmaceutical industry. This is a serious, potentially liable allegation.

My objections were followed by your retraction of these allegations (see the comments section of my above-mentioned blog-post). However, your retraction displays an embarrassing level of ignorance and contains several grave errors (see the comments section of my above-mentioned blog-post). Crucially, it implies that I formerly had an undeclared conflict of interest. This is untrue. More importantly, you currently distribute a document that continues to allege that I currently have ‘pharmaceutical interests’. This too is untrue.

I urge you to either produce the evidence for your allegations, or to fully and publicly retract them. This strategy would not merely be the only decent and professional way of dealing with the problem, it also might prevent damage to your reputation, and  avoid libel action against you.

Sincerely

Edzard Ernst

Difficulties breastfeeding?

Some say that Chinese herbal medicine offers a solution.

This Chinese multi-centre RCT included 588 mothers considering breastfeeding. The intervention group received the Chinese herbal mixture Zengru Gao, while the control group received no therapy. The primary outcomes were the percentages of fully and partially breastfeeding mothers, and a secondary outcome was baby’s daily formula intake.

At day 3 and 7 after delivery, significant differences were found in favour of Zengru Gao group on the percentage of full/ partial breastfeeding. At day 7, the percentage of full/ partial breastfeeding of the active group increased to 71.48%/20.70% versus 58.67%/30.26% in the control group, the differences remained significant. No statistically significant differences were detected on primary measures at day. While intake of formula differed between groups at day 1 and 3, this difference did not achieve statistical significance, but this difference was apparent by day 7.

The authors concluded that the Chinese Herbal medicine Zengru Gao enhanced breastfeeding success during one week postpartum. The approach is acceptable to participants and merits further evaluation.

To the naïve observer, this study might look rigorous, but it is a seriously flawed RCT. Here are just some of its most obvious limitations:

  • All we get in the methods section is this explanation: Participants were randomly allocated to the blank control group or the intervention group: Zengru Gao, orally, 30 g a time and 3 times a day. This seems to indicate that the control group got no treatment at all which means there was no blinding nor placebo control. The authors even comment on this point in the discussion section of their paper stating that because we included new mothers who received no treatment as a control group, we were able to prove that the improvement in breastfeeding was not due to the placebo effect. However, this is a totally nonsensical argument.
  • The experimental treatment is not reproducible. The authors state: Zengru Gao, a Chinese herbal formula, which is composed of 8 herbs: Semen Vaccariae, Medulla Tetrapanacis, Radix Rehmanniae Praeparata, Radix Angelicae Sinensis, Radix Paeoniae Alba,Rhizoma Chuanxiong, Herba Leonuri, Radix Trichosanthis. This is not enough information to replicate the study outside China where the mixture is not commercially available.
  • The primary outcome was the percentage of fully, and partially breastfeeding mothers. Breastfeeding was defined as mother’s milk given by direct breast feeding. Full breastfeeding meant that no other types of milk or solids were given. Partially breastfeeding meant that sustained latch with deep rhythmic sucking through the length of the feed, with some pause, on either/ or both breasts. We are not being told how the endpoint was quantified. Presumably women kept diaries. We cannot guess how accurate this process was.
  • As far as I can see, there was no correction for multiple testing for statistical significance. This means that some or all of the significant results might be false-positive.
  • There is insufficient data to show that the herbal mixture is safe for the mothers and the babies. At the very minimum, the researchers should have measured essential safety parameters. This omission is a gross violation of research ethics.
  • Towards the end of the paper, we find the following statement: The authors would like to thank the Research and Development Department of Zhangzhou Pien Tze Huang Pharmaceutical co., Ltd. … The authors declare that they have no competing interests. And the 1st and 3rd authors are “affiliated with” Guangzhou Hipower Pharmaceutical Technology Co., Ltd, Guangzhou, China, i. e. work for the manufacturer of the mixture. This does clearly not make any sense whatsoever.

I have seen too many flawed studies of alternative medicine to be shocked or even surprised by this level of incompetence and nonsense. Yet, I still find it lamentable. But, in my view, the worst is that supposedly peer-reviewed journals such as ‘BMC Complement Altern Med’ publish such overt rubbish.

It would be easy to shrug one’s shoulder and bin the paper. But the effect of such fatally flawed research is too serious for that. In our recent book MORE HARM THAN GOOD? THE MORAL MAZE OF COMPLEMENTARY AND ALTERNATIVE MEDICINE, we discuss that such flawed science amounts to a violation of medical ethics:  CAM journals allocate peer review tasks to a narrow range of CAM enthusiasts who often have been chosen by the authors of the article in question. The raison d’être of CAM journals and CAM researchers is inextricably tied to a belief in CAM, resulting in a self-referential situation which is permissive to the acceptance of weak or flawed reports of clinical effectiveness… Defective research—whether at the design, execution, analysis, or reporting stage—corrupts the repository of reliable medical knowledge. Ultimately, this leads to suboptimal and erroneous treatment decisions…

1 2 3 7
Recent Comments

Note that comments can be edited for up to five minutes after they are first submitted.


Click here for a comprehensive list of recent comments.

Categories