MD, PhD, FMedSci, FSB, FRCP, FRCPEd

TCM

1 2 3 5

The ACUPUNCTURE NOW FOUNDATION (ANF) has featured on this blog before. Today I want to re-introduce them because I just came across one of their articles which I found remarkable. In it, they define what many of us have often wondered about: the most important myth about acupuncture.

Is it acupuncture’s current popularity, its long history, its mode of action, its efficacy, its safety?

No, here is the answer directly from the ANF:

The most important myth that needs to be put to rest is the idea promoted by a small group of vocal critics that acupuncture is nothing more than a placebo. Many cite the fact that studies showing acupuncture to be highly effective were of low quality and that several higher quality studies show that, while acupuncture was clinically effective, it usually does not outperform “sham” acupuncture. But those studies are dominated by the first quality issue cited above; studies with higher methodological rigor where the “real” acupuncture was so poorly done as to not be a legitimate comparison. Yet despite the tendency toward poor quality acupuncture in studies with higher methodological standards, a benchmark study was done that showed “real” acupuncture clearly outperforming “sham” acupuncture in four different chronic pain conditions.3 When you add this study together with the fact veterinary acupuncture is used successfully in many different animals, the idea of acupuncture only being placebo must now be considered finally disproven. This is further supported by studies which show that the underlying physiological pathways activated by acupuncture sometimes overlap, but can be clearly differentiated from, those activated by placebo responses.

Disappointed?

Yes, I was too.

The myth, according to the ANF, essentially is that sceptics do not understand the scientific evidence. And these blinkered sceptics even go as far as ignoring the findings from what the ANF consider to be a ‘benchmark study’! Ghosh, that’s nasty of them!!!

But, no – the benchmark study (actually, it was not a ‘study’ but a meta-analysis of studies) has been discussed fully on this blog (and in many other places too). Here is what I wrote in 2012 when it was first published:

An international team of acupuncture trialists published a meta-analysed of individual patient data to determine the analgesic effect of acupuncture compared to sham or non-acupuncture control for the following 4 chronic pain conditions: back and neck pain, osteoarthritis, headache, and shoulder pain. Data from 29 RCTs, with an impressive total of 17 922 patients, were included.

The results of this new evaluation suggest that acupuncture is superior to both sham and no-acupuncture controls for each of these conditions. Patients receiving acupuncture had less pain, with scores that were 0.23 (95% CI, 0.13-0.33), 0.16 (95% CI, 0.07-0.25), and 0.15 (95% CI, 0.07-0.24) SDs lower than those of sham controls for back and neck pain, osteoarthritis, and chronic headache, respectively; the effect sizes in comparison to no-acupuncture controls were 0.55 (95% CI, 0.51-0.58), 0.57 (95% CI, 0.50-0.64), and 0.42 (95% CI, 0.37-0.46) SDs.

Based on these findings, the authors reached the conclusion that “acupuncture is effective for the treatment of chronic pain and is therefore a reasonable referral option. Significant differences between true and sham acupuncture indicate that acupuncture is more than a placebo. However, these differences are relatively modest, suggesting that factors in addition to the specific effects of needling are important contributors to the therapeutic effects of acupuncture”.

… even the enthusiastic authors of this article admit that, when compared to sham, the effect size of real acupuncture is too small to be clinically relevant. Therefore one might argue that this meta-analysis confirms what critics have suggested all along: acupuncture is not a useful treatment for clinical routine.

Unsurprisingly, the authors of the meta-analysis do their very best to play down this aspect. They reason that, for clinical routine, the comparison between acupuncture and non-acupuncture controls is more relevant than the one between acupuncture and sham. But this comparison, of course, includes placebo- and other non-specific effects masquerading as effects of acupuncture – and with this little trick (which, by the way is very popular in alternative medicine), we can, of course, show that even sugar pills are effective.

I do not doubt that context effects are important in patient care; yet I do doubt that we need a placebo treatment for generating such benefit in our patients. If we administer treatments which are effective beyond placebo with kindness, time, compassion and empathy, our patients will benefit from both specific and non-specific effects. In other words, purely generating non-specific effects with acupuncture is far from optimal and certainly not in the interest of our patients. In my view, it cannot be regarded as not good medicine, and the authors’ conclusion referring to a “reasonable referral option” is more than a little surprising in my view.

Acupuncture-fans might argue that, at the very minimum, the new meta-analysis does demonstrate acupuncture to be statistically significantly better than a placebo. Yet I am not convinced that this notion holds water: the small residual effect-size in the comparison of acupuncture with sham might not be the result of a specific effect of acupuncture; it could be (and most likely is) due to residual bias in the analysed studies.

The meta-analysis is strongly driven by the large German trials which, for good reasons, were heavily and frequently criticised when first published. One of the most important potential drawbacks was that many participating patients were almost certainly de-blinded through the significant media coverage of the study while it was being conducted. Moreover, in none of these trials was the therapist blinded (the often-voiced notion that therapist-blinding is impossible is demonstrably false). Thus it is likely that patient-unblinding and the absence of therapist-blinding importantly influenced the clinical outcome of these trials thus generating false positive findings. As the German studies constitute by far the largest volume of patients in the meta-analysis, any of their flaws would strongly impact on the overall result of the meta-analysis.

So, has this new meta-analysis finally solved the decades-old question about the effectiveness of acupuncture? It might not have solved it, but we have certainly moved closer to a solution, particularly if we employ our faculties of critical thinking. In my view, this meta-analysis is the most compelling evidence yet to demonstrate the ineffectiveness of acupuncture for chronic pain.

END OF QUOTE

The ANF-text then goes from bad to worse. First they cite the evidence from veterinary acupuncture as further proof of the efficacy of their therapy. Well, the only systematic review in this are is, I think, by my team; and it concluded that there is no compelling evidence to recommend or reject acupuncture for any condition in domestic animals. Some encouraging data do exist that warrant further investigation in independent rigorous trials.

Lastly, the ANF mentions acupuncture’s mode of action which they seem to understand clearly and fully. Congratulations ANF! In this case, you are much better than the many experts in basic science or neurology who almost unanimously view these ‘explanations’ of how acupuncture might work as highly adventurous hypotheses or speculations.

So, what IS the most important myth about acupuncture? I am not sure and – unlike the ANF – I do not feel that I can speak for the rest of the world, but one of the biggest myths FOR ME is how acupuncture fans constantly manage to mislead the public.

Yes, to a large extend, quacks make a living by advertising lies. A paper just published confirms our worst fears.

This survey was aimed at identifying the frequency and qualitative characteristics of marketing claims made by Canadian chiropractors, naturopaths, homeopaths and acupuncturists relating to the diagnosis and treatment of allergy and asthma.

A total of 392 chiropractic, naturopathic, homeopathic and acupuncture clinic websites were located in 10 of the largest metropolitan areas in Canada. The main outcome measures were: mention of allergy, sensitivity or asthma, claim of ability to diagnose allergy, sensitivity or asthma, claim of ability to treat allergy, sensitivity or asthma, and claim of allergy, sensitivity or asthma treatment efficacy. Tests and treatments promoted were noted as qualitative examples.

The results show that naturopath clinic websites had the highest rates of advertising at least one of diagnosis, treatment or efficacy for allergy or sensitivity (85%) and asthma (64%), followed by acupuncturists (68% and 53%, respectively), homeopaths (60% and 54%) and chiropractors (33% and 38%). Search results from Vancouver were most likely to advertise at least one of diagnosis, treatment or efficacy for allergy or sensitivity (72.5%) and asthma (62.5%), and results from London, Ontario were least likely (50% and 40%, respectively). Of the interventions advertised, few are scientifically supported; the majority lack evidence of efficacy, and some are potentially harmful.

[Legend to figure above: Percentage of alternative medicine clinic websites advertising at least one of diagnosis, treatment or efficacy for allergy/sensitivity or asthma. Presenting the data in this way demonstrates that the Canadian naturopath, homeopath and acupuncturist websites studied have >50% rates of making at least one health-related claim for both allergy/sensitivity and asthma.]

The authors concluded that the majority of alternative healthcare clinics studied advertised interventions for allergy and asthma. Many offerings are unproven. A policy response may be warranted in order to safeguard the public interest.

In the discussion section, the authors state: “These claims raise ethical issues, because evidence in support of many of the tests and treatments identified on the websites studied is lacking. For example, food-specific IgG testing was commonly advertised, despite the fact that the Canadian Society of Allergy and Clinical Immunology has recommended not to use this test due to the absence of a body of research supporting it. Live blood analysis, vega/electrodiagnostic testing, intravenous vitamin C, probiotics, homeopathic allergy remedies and several other tests and treatments offered all lack substantial scientific evidence of efficacy. Some of the proposed treatments are so absurd that they lack even the most basic scientific plausibility, such as ionic foot bath detoxification…

Perhaps most concerning is the fact that several proposed treatments for allergy, sensitivity or asthma are potentially harmful. These include intravenous hydrogen peroxide, spinal manipulation and possibly others. Furthermore, a negative effect of the use of invalid and inaccurate allergy testing is the likelihood that such testing will lead to alterations and exclusions in diets, which can subsequently result in malnutrition and other physiological problems…”

This survey originates from Canada, and one might argue that elsewhere the situation is not quite as bad. However, I would doubt it; on the contrary, I would not be surprised to learn that, in some other countries, it is even worse.

Several national regulators have, at long last, become aware of the dangers of advertising of outright quackery. Consequently, some measures are now beginning to be taken against it. I would nevertheless argue that these actions are far too slow and by no means sufficiently effective.

We easily forget that asthma, for instance, is a potentially life-threatening disease. Advertising of bogus claims is therefore  much more than a forgivable exaggeration aimed at maximising the income of alternative practitioners – it is a serious threat to public health.

We must insist that regulators protect us from such quackery and prevent the serious harm it can do.

The boom of alternative medicine in the US – and consequently in the rest of the developed world – is intimately connected with a NHI centre now called NCCIH (National Center for Complementary and Integrative Health). It was founded in the early 1990s because some politicians were bent on promoting quackery. Initially the institution had modest funding but, after more political interference, it had ample cash to pursue all sorts of activities, including sponsoring research into alternative therapies at US universities. A most interesting video summarising the history of the NCCIH can be seen here.

No other institution in the world had more funds for research into alternative medicine than the NCCIH, and it soon became the envy of alt med researchers globally. I have been invited by the NCCHI on several occasions and invariably was impressed by their apparent affluence. While we Europeans usually had to do our research on a shoe-string, our American colleagues seemed to be ‘rolling in it’.

I was often far less impressed with the research they sponsored. Not only it was invariably eye-wateringly expensive, but also its quality seemed often dismal. Sometimes, I even got the impression that research was used as a means of mainstreaming quackery for the unsuspecting American – and consequently world-wide – public.

An example of this mainstreaming is an article in JAMA published yesterday. Here is a short but telling excerpt:

Researchers led by Richard L. Nahin, PhD, MPH, lead epidemiologist at the NIH’s National Center for Complementary and Integrative Health (NCCIH), examined efficacy and safety evidence in 105 randomized controlled trials (RCTs) conducted between January 1966 and March 2016. The review—geared toward primary care physicians as part of the journal’s Symposium on Pain Medicine—focused on popular complementary approaches to common pain conditions.

Unlike a typical systematic review that assigns quality values to the studies, the investigators conducted a narrative review, in which they simply looked at the number of positive and negative trials. “If there were more positives than negatives then we generally felt the approach had some value,” Nahin explained. “If there were more negatives, we generally felt the approach had less value.” Trials that were conducted outside of the United States were excluded from the review.

Based on a “preponderance” of positive vs negative trials, complementary approaches that may offer pain relief include acupuncture and yoga for back pain; acupuncture and tai chi for osteoarthritis of the knee; massage therapy for neck pain; and relaxation techniques for severe headaches and migraine. Several other techniques had weaker evidence, according to the qualitative assessments, for specific pain conditions (see “Selected Complementary Health Approaches for Pain”). The treatments were generally safe, with no serious adverse events reported.

To me, this looks that NCCIH has now managed to persuade even the editors of JAMA to white-wash their dodgy science. The review referred to here is a paper we discussed some time ago on this blog. I then stated about it the following:

Reading the article carefully, it is impossible not to get troubled. Here are a few points that concern me most:

  • the safety of a therapy cannot be evaluated on the basis of data from RCTs (particularly as it has been shown repeatedly that trials of alternative therapies often fail to report adverse effects); much larger samples are needed for that; any statements about safety in the aims of the paper are therefore misplaced;
  • the authors talk about efficacy but seem to mean effectiveness;
  • the authors only included RCTs from the US which must result in a skewed and incomplete picture;
  • the article is from the National Center for Complementary and Integrative Health which is part of the NIH but which has been criticised repeatedly for being biased in favour of alternative medicine;
  • not all of the authors seem to be NIH staff, and I cannot find a declaration of conflicts of interest;
  • the discussion of the paper totally lacks any critical thinking;
  • there is no assessment of the quality of the trials included in this review.

My last point is by far the most important. A summary of this nature that fails to take into account the numerous limitations of the primary data is, I think, as good as worthless. As I know most of the RCTs included in the analyses, I predict that the overall picture generated by this review would have changed substantially, if the risks of bias in the primary studies had been accounted for.

I find it puzzling that the ‘lead epidemiologist at the NIH’s National Center for Complementary and Integrative Health’ would publish such dubious research. Why does he do it? If you have watched the video mentioned above, you are inclined to think that it might be because of political interference.

However, I suggest another, in a way much more damming reason or contributing factor: the NCCIH has so long indulged in such poor science that even its top people have forgotten what good science looks like. I know this is a bold hypothesis; so, let me try to support it with some data.

Several years ago, my team together with several other researches have looked at the NCCIH-sponsored research systematically according to 4 different subject areas. Here are the conclusions of our articles reporting the findings:

ACUPUNCTURE

Seven RCTs had a low risk of bias. Numerous methodological shortcomings were identified. Many NCCAM-funded RCTs of acupuncture have important limitations. These findings might improve future studies of acupuncture and could be considered in the ongoing debate regarding NCCAM-funding. [Focus on Alternative and Complementary Therapies Volume 17(1) March 2012 15–21]

HERBAL MEDICINE

This independent assessment revealed a plethora of serious concerns related to NCCAM studies of herbal medicine. [Perfusion 2011; 24: 89-102]

ENERGY MEDICINE

In conclusion, the NCCAM-funded RCTs of energy medicine are prime examples of misguided investments into research. In our opinion, NCCAM should not be funding poor-quality studies of implausible practices. The impact of any future studies of energy medicine would be negligible or even detrimental. [Focus on Alternative and Complementary Therapies Volume 16(2) June 2011 106–109 ]

CHIROPRACTIC

In conclusion, our review demonstrates that several RCTs of chiropractic have been funded by the NCCAM. It raises numerous concerns in relation to these studies; in particular, it suggests that many of these studies are seriously flawed. [https://www.ncbi.nlm.nih.gov/pubmed/21207089]

I think I can rest my case and urge you to watch the video mentioned above.

The Scotsman reported that David Tredinnick, the somewhat feeble-minded Tory MP for Bosworth, has been at it again. Apparently he said that many of his constituents are only alive today because they have been treated with alternative medicine.

Tredennick recently urged ministers to spend more NHS money on alternative therapies such as homeopathy and acupuncture to treat patients. It seems to me that, for him and other quackery promoters, evidence and science are issues beyond comprehension. Mr Tredinnick also disclosed the fact that he received acupuncture at a Chinese medical clinic just before the Commons debate on cancer strategy – a regular treatment he credits with keeping him healthy.

Tredennick told his fellow MPs: “I was talking there to practitioners about what they are able to do for cancer patients, and there is actually a very long list of types of cancer that can be treated using traditional Chinese herbal medicine.“ One, cervical cancer, two, non-Hodkins lymphoma, three, HIV, four, colon cancer, five… six, breast cancer, seven, prostate cancer. And so the list goes on. “I have in my constituency several constituents who I believe are alive today because they have used Chinese medicine.“ And the reason for that is what it does is it strengthens your system, and it strengthens the immune system, and it is very effective after cancer treatment. It deals with particular symptoms.”

This is by no means the first outburst of quackery-promotion by the Right Honourable Gentleman. I have a whole selection of quotes from him which I sometimes use for amusing my audience during public lectures. Because amusing he is; Tredennick seems to be utterly devoid of rational thought when it comes to the subject of alternative medicine, and often his statements make for comedy gold. This time, however, he might be sailing closer to the wind than he perhaps realizes: Under English law, it is an offence to claim that any treatment can cure cancer, I believe.

We all had to learn to laugh about unethical and dangerous nonsense the ‘Tredennicks of this world’ regularly claim about alternative medicine. Laughing is the only solution for coping with such idiocy, I am afrid. If we don’t laugh, we have to consider taking it seriously – and this is a truly frightening prospect, particularly considering that this guy actually sits in parliament and has the power to influence our lives.

Not being a native English speaker, I was not entirely sure what precisely slapping means. A dictionary informed me that it stands for “hitting somebody/something with the flat part of your hand”. And ‘slapping therapy’? What on earth is that? It occurred to me that there might be several types of slapping therapy.

HITTING SOMEONE WHO DISAGREES

Yes, it might be therapeutic to do that! Imagine you discuss with someone and realize that you do not have very good arguments to defend an irrational position. Eventually, you are cornered and angry. All you can think of is to slap your opponent.

No, not very constructive, but all too human, I suppose.

This sort of thing has happened to me several times during discussions at conferences: my opponents went so mad that I saw them clinching their fists or raising their hands. Fortunately, I can run quite fast and (so far) always managed to avoid the impending physical violence.

INSULTING SOMEONE WHO DISAGREES

That sort of thing happens regularly. I have written posts about the phenomenon here, here, here and here, for instance. If you read the comments sections of this blog, you regrettably find plenty of examples.

If I am honest, I must admit that, on some occasions, I have in desperation joined into such mud-battles. I am not proud of it but sometimes it just happens. We are all just human, and it certainly feels therapeutic to be rude to someone who is a continuous and deplorable nuisance by hurling insults at opponents.

Having made this confession, I must stress (again) that, on this blog, we ought to avoid this sort of slapping therapy. In the long run, it is unhelpful and only escalates the aggression.

KINKY SLAPPING

When I googled ‘slapping’ I was referred to all sorts of sleazy websites which were essentially displaying maso-sadistic pornography that involved one person slapping another for sexual pleasure. Personally, I do not get a kick out of this type of slapping therapy and find it sad that some people obviously do.

PAIDA

Paida is the form of slapping therapy that recently made headlines and which therefore prompted this post. Paida in Chinese means to slap your body. Sure enough, the TCM people have made it into an alternative treatment which is usually called SLAPPING THERAPY (what will they think of next? you may well ask!). Already the sexual version of slapping therapy was not really funny, but this certainly is where the satire stops!

Hongchi Xiao, a Chinese-born investment banker, popularised this treatment some time ago. It involves slapping the body surface with a view of stimulating the flow of ‘chi’. Slapping therapists – no, they are not called ‘slappers’!!! – believe that this ritual restores health and eliminates toxins. In fact, they claim that the bruises which patients tend to develop after their treatment are the visible signs of toxins coming to the surface.

The treatment is not based on evidence — I know of not even a single clinical trial showing that it works — and it is certainly not agreeable. But at least it’s safe! No, you’d be wrong to think so: if slapping therapy, or any other bizarre and useless intervention is being employed as a replacement for treating a serious condition, it inevitably becomes life-threatening.

Recently, it was reported that a woman from East Sussex died after receiving slapping therapy; other fatalities have been documented previously. The latest victim had been suffering from diabetes and was led to believe that Paida was an effective treatment for her condition. Consequently, she discontinued her medication, a decision which eventually killed her.

Deaths after apparently harmless alternative treatments are being reported with depressing regularity. However, much more often, the resulting harm is not quite so dramatic, simply because the conditions treated are fortunately not life-threatening. In such cases, the ineffectiveness of the treatment does not lead to disaster, but it nevertheless causes unnecessary expense and prolongation of suffering.

We live in a time where we are constantly being told, for instance by ‘experts’ like Prince Charles, that we ought to be respectful towards ancient traditions of healthcare. So, let’s be clear: I am all for respect towards other cultures, but in medicine there should be limits. I do not see any benefit in either respecting or implementing ancient, obsolete notions of life energies, meridians, toxins and other disproven assumptions of alternative practitioners. They originate from a pre-scientific era and have been disproven. They do not belong in modern treatment manuals; at best, they belong in the history books of medicine.

 

 

 

Acupuncture for hot flushes?

What next?

I know, to rational thinkers this sounds bizarre – but, actually, there are quite a few studies on the subject. Enough evidence for me to have published not one but four different systematic reviews on the subject.

The first (2009) concluded that “the evidence is not convincing to suggest acupuncture is an effective treatment of hot flash in patients with breast cancer. Further research is required to investigate whether there are specific effects of acupuncture for treating hot flash in patients with breast cancer.”

The second (also 2009) concluded that “sham-controlled RCTs fail to show specific effects of acupuncture for control of menopausal hot flushes. More rigorous research seems warranted.”

The third (again 2009) concluded that “the evidence is not convincing to suggest acupuncture is an effective treatment for hot flush in patients with prostate cancer. Further research is required to investigate whether acupuncture has hot-flush-specific effects.”

The fourth (2013), a Cochrane review, “found insufficient evidence to determine whether acupuncture is effective for controlling menopausal vasomotor symptoms. When we compared acupuncture with sham acupuncture, there was no evidence of a significant difference in their effect on menopausal vasomotor symptoms. When we compared acupuncture with no treatment there appeared to be a benefit from acupuncture, but acupuncture appeared to be less effective than HT. These findings should be treated with great caution as the evidence was low or very low quality and the studies comparing acupuncture versus no treatment or HT were not controlled with sham acupuncture or placebo HT. Data on adverse effects were lacking.”

And now, there is a new systematic review; its aim was to evaluate the effectiveness of acupuncture for treatment of hot flash in women with breast cancer. The searches identified 12 relevant articles for inclusion. The meta-analysis without any subgroup or moderator failed to show favorable effects of acupuncture on reducing the frequency of hot flashes after intervention (n = 680, SMD = − 0.478, 95 % CI −0.397 to 0.241, P = 0.632) but exhibited marked heterogeneity of the results (Q value = 83.200, P = 0.000, I^2 = 83.17, τ^2 = 0.310). The authors concluded that “the meta-analysis used had contradictory results and yielded no convincing evidence to suggest that acupuncture was an effective treatment of hot flash in patients with breast cancer. Multi-central studies including large sample size are required to investigate the efficiency of acupuncture for treating hot flash in patients with breast cancer.”

What follows from all this?

  • The collective evidence does NOT seem to suggest that acupuncture is a promising treatment for hot flushes of any aetiology.
  • The new paper is unimpressive, in my view. I don’t see the necessity for it, particularly as it fails to include a formal assessment of the methodological quality of the primary studies (contrary to what the authors state in the abstract) and because it merely includes articles published in English (with a therapy like acupuncture, such a strategy seems ridiculous, in my view).
  • I predict that future studies will suggest an effect – as long as they are designed such that they are open to bias.
  • Rigorous trials are likely to show an effect beyond placebo.
  • My own reviews typically state that MORE RESEARCH IS NEEDED. I regret such statements and would today no longer issue them.

Stable angina is a symptom of coronary heart disease which, in turn, is amongst the most frequent causes of death in developed countries. It is an alarm bell to any responsible clinician and requires causal, often life-saving treatments of which we today have several options. The last thing a patient needs in this condition is ACUPUNCTURE, I would say.

Yet acupuncture is precisely the therapy such patients might be tempted to employ.

Why?

Because irresponsible or criminally naïve acupuncturists advertise it!

Take this website, for instance; it informs us that a meta-analysis of eight clinical trials conducted between 2000 and 2014 demonstrates the efficacy of acupuncture for the treatment of stable angina. In all eight clinical trials, patients treated with acupuncture experienced a greater rate of angina relief than those in the control group treated with conventional drug therapies (90.1% vs 75.7%)….

I imagine that this sounds very convincing to patients and I fear that many might opt for acupuncture instead of potentially invasive/unpleasant but life-saving intervention. The original meta-analysis to which the above promotion referred to is equally optimistic. Here is its abstract:

Angina pectoris is a common symptom imperiling patients’ life quality. The aim of this study is to evaluate the efficacy and safety of acupuncture for stable angina pectoris. Clinical randomized-controlled trials (RCTs) comparing the efficacy of acupuncture to conventional drugs in patients with stable angina pectoris were searched using the following database of PubMed, Medline, Wanfang and CNKI. Overall odds ratio (ORs) and weighted mean difference (MD) with their 95% confidence intervals (CI) were calculated by using fixed- or random-effect models depending on the heterogeneity of the included trials. Total 8 RCTs, including 640 angina pectoris cases with 372 patients received acupuncture therapy and 268 patients received conventional drugs, were included. Overall, our result showed that acupuncture significantly increased the clinical curative effects in the relief of angina symptoms (OR=2.89, 95% CI=1.87-4.47, P<0.00001) and improved the electrocardiography (OR=1.83, 95% CI=1.23-2.71, P=0.003), indicating that acupuncture therapy was superior to conventional drugs. Although there was no significant difference in overall effective rate relating reduction of nitroglycerin between two groups (OR=2.13, 95% CI=0.90-5.07, P=0.09), a significant reduction on nitroglycerin consumption in acupuncture group was found (MD=-0.44, 95% CI=-0.64, -0.24, P<0.0001). Furthermore, the time to onset of angina relief was longer for acupuncture therapy than for traditional medicines (MD=2.44, 95% CI=1.64-3.24, P<0.00001, min). No adverse effects associated with acupuncture therapy were found. Acupuncture may be an effective therapy for stable angina pectoris. More clinical trials are needed to systematically assess the role of acupuncture in angina pectoris.

In the discussion section of the full paper, the authors explain that their analysis has several weaknesses:

Several limitations were presented in this meta-analysis. Firstly, conventional drugs in control group were different, this may bring some deviation. Secondly, for outcome of the time to onset of angina relief with acupuncture, only one trial included. Thirdly, the result of some outcomes presented in different expression method such as nitroglycerin consumption. Fourthly, acupuncture combined with traditional medicines or other factors may play a role in angina pectoris.

However, this does not deter them to conclude on a positive note:

In conclusion, we found that acupuncture therapy was superior to the conventional drugs in increasing the clinical curative effects of angina relief, improving the electrocardiography, and reducing the nitroglycerin consumption, indicating that acupuncture therapy may be effective and safe for treating stable angina pectoris. However, further clinical trials are needed to systematically and comprehensively evaluate acupuncture therapy in angina pectoris.

So, why do I find this irresponsibly and dangerously misleading?

Here a just a few reasons why this meta-analysis should not be trusted:

  • There was no systematic attempt to evaluate the methodological rigor of the primary studies; any meta-analysis MUST include such an assessment, or else it is not worth the paper it was printed on.
  • The primary studies all look extremely weak; this means they are likely to be false-positive.
  • They often assessed not acupuncture alone but in combination with other treatments; consequently the findings cannot be attributed to acupuncture.
  • All the primary studies originate from China; we have seen previously (see here and here) that Chinese acupuncture trials deliver nothing but positive results which means that their results cannot be trusted: they are false-positive.

My conclusion: the authors, editors and reviewers responsible for this article should be ashamed; they committed or allowed scientific misconduct, mislead the public and endangered patients’ lives.

I have warned you before to be sceptical about Chinese studies. This is what I posted on this blog more than 2 years ago, for instance:

Imagine an area of therapeutics where 100% of all findings of hypothesis-testing research are positive, i.e. come 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.

END OF QUOTE

Now an even more compelling reason emerged for taking evidence from China with a pinch of salt:

A recent survey of clinical trials in China has revealed fraudulent practice on a massive scale. China’s food and drug regulator carried out a one-year review of clinical trials. They concluded that more than 80 percent of clinical data is “fabricated“. The review evaluated data from 1,622 clinical trial programs of new pharmaceutical drugs awaiting regulator approval for mass production. Officials are now warning that further evidence malpractice could still emerge in the scandal.
According to the report, much of the data gathered in clinical trials are incomplete, failed to meet analysis requirements or were untraceable. Some companies were suspected of deliberately hiding or deleting records of adverse effects, and tampering with data that did not meet expectations.

“Clinical data fabrication was an open secret even before the inspection,” the paper quoted an unnamed hospital chief as saying. Contract research organizations seem have become “accomplices in data fabrication due to cutthroat competition and economic motivation.”

A doctor at a top hospital in the northern city of Xian said the problem doesn’t lie with insufficient regulations governing clinical trials data, but with the failure to implement them. “There are national standards for clinical trials in the development of Western pharmaceuticals,” he said. “Clinical trials must be carried out in three phases, and they must be assessed at the very least for safety,” he said. “But I don’t know what happened here.”

Public safety problems in China aren’t limited to the pharmaceutical industry and the figure of 80 percent is unlikely to surprise many in a country where citizens routinely engage in the bulk-buying of overseas-made goods like infant formula powder. Guangdong-based rights activist Mai Ke said there is an all-pervasive culture of fakery across all products made in the country. “It’s not just the medicines,” Mai said. “In China, everything is fake, and if there’s a profit in pharmaceuticals, then someone’s going to fake them too.” He said the problem also extends to traditional Chinese medicines, which are widely used in conjunction with Western pharmaceuticals across the healthcare system.
“It’s just harder to regulate the fakes with traditional medicines than it is with Western pharmaceuticals, which have strict manufacturing guidelines,” he said.

According to Luo, academic ethics is an underdeveloped field in China, leading to an academic culture that is accepting of manipulation of data. “I don’t think that the 80 percent figure is overstated,” Luo said.

And what should we conclude from all this?

I find it very difficult to reach a verdict that does not sound hopelessly chauvinistic but feel that we have little choice but to distrust the evidence that originates from China. At the very minimum, I think, we must scrutinise it thoroughly; whenever it looks too good to be true, we ought to discard it as unreliable and await independent replications.

A website I recently came across promised to teach me 7 things about acupuncture. This sort of thing is always of interest to me; so I read them with interest and found them so remarkable that I decided to reproduce them here:

1. Addiction recovery

Acupuncture calms and relaxes the mind making it easier for people to overcome addictions to drugs, cigarettes, and alcohol by reducing the anxiety and stress they feel when quitting.

2. Helps the body heal itself

The body contains natural pain relief chemicals, such as endorphins and has an amazing capacity for self-healing. Acupuncture helps stimulate the natural healing mechanisms and causes the body to manufacture pain relieving chemicals.

3. Builds a stronger immune system

The body’s immune system is negatively affected by stress, poor diet, illness and certain medical treatments, but acupuncture targets the underlying imbalances naturally and helps it to regain balance.

4. Eliminate that killer hangover

While it may not have been the best choice to finish off that bottle of wine, acupuncture can help the body detox and flush out the morning side effects.

5. Mood stabilizer

If you find yourself snapping at friends, family, or co-workers for unexplained reasons, acupuncture can get to the root of the problem, find the imbalance and help your body return to a healthier state of mind.

6. Chronic stomach problems

Some people suffer from stomach problems and never find the cause. Acupuncture targets your whole body, including the digestive tract and helps it to work in harmony with the rest of the body’s systems.

7. Coping with death

Grief can have an overwhelming effect on the body and manifest itself physically. Acupuncture helps reduce the anxiety of dealing with loss and help you cope with the stress.

END OF QUOTE

The ‘7 things’ are remarkably mislabelled – they should be called 7 lies! Let me explain:

  1. There are several Cochrane reviews on the subject of acupuncture for various addictions. Here are their conclusions: There is currently no evidence that auricular acupuncture is effective for the treatment of cocaine dependence. The evidence is not of high quality and is inconclusive. Further randomised trials of auricular acupuncture may be justified. There is no clear evidence that acupuncture is effective for smoking cessation.  There is currently no evidence that auricular acupuncture is effective for the treatment of cocaine dependence. The evidence is not of high quality and is inconclusive. Further randomised trials of auricular acupuncture may be justified.
  2. Even if the ‘endorphin story’ is true (in my view, it’s but a theory), there is no good evidence that acupuncture enhances our body’s self-healing mechanisms via endorphins or any other mechanism.
  3. Stronger immune system? My foot! I have no idea where this claim comes from, certainly not from anything resembling good evidence.
  4. Acupuncture for hangover or detox? This is just a stupid joke with no evidential support. I imagine, however, that it is superb marketing.
  5. The same applies to acupuncture to ‘stabilize’ your mood.
  6. Unexplained stomach problems? Go and see a doctor! Here is the conclusion of a Cochrane review related to IBS which is one of the more common unexplained stomach complaint: 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.
  7. I am not aware of any good evidence to show that acupuncture could ease the grieving process; I even doubt that this would be such a good or desirable thing: grieving is a necessary and essential process.

So, what we have here are essentially 7 fat lies. Yes, I know, the literature and the internet are full of them. And I suspect that they are a prominent reason why acupuncture is fairly popular today. Lies are a major marketing tool of acupuncturists – but that does not mean that we should let them get away with them!

Why?

Bogus claims may be good for the cash flow of alternative practitioners, but they are certainly not good for our health and well-being; in fact, they can cost lives!!!

IN THIS SPIRIT, LET ME ADD SEVEN THINGS YOU DO NEED TO KNOW ABOUT ACUPUNCTURE

  1. Traditional acupuncture is based on complete hocus pocus and is therefore implausible.
  2. ‘Western’ acupuncture is based on endorphin and other theories, which are little more than that and at best THEORIES.
  3. Acupuncture is often promoted as a ‘cure all’ which is implausible and not supported by evidence.
  4. Meridians, acupoints chi and all the other things acupuncturists claim to exist are pure fantasy.
  5. For a small list of symptoms, acupuncture is backed up by some evidence, but this is less than convincing and could well turn out to rely on little more than placebo.
  6. The claim of acupuncturists that acupuncture is entirely safe is false.
  7. Acupuncture studies from China cannot be trusted.

In alternative medicine, good evidence is like gold dust and good evidence showing that alternative therapies are efficacious is even rarer. Therefore, I was delighted to come across a brand-new article from an institution that should stand for reliable information: the NIH, no less.

According to its authors, this new article “examines the clinical trial evidence for the efficacy and safety of several specific approaches—acupuncture, manipulation, massage therapy, relaxation techniques including meditation, selected natural product supplements (chondroitin, glucosamine, methylsulfonylmethane, S-adenosylmethionine), tai chi, and yoga—as used to manage chronic pain and related disability associated with back pain, fibromyalgia, osteoarthritis, neck pain, and severe headaches or migraines.”

The results of this huge undertaking are complex, of course, but in a nutshell they are at least partly positive for alternative medicine. Specifically, the authors state that “based on a preponderance of positive trials vs negative trials, current evidence suggests that the following complementary approaches may help some patients manage their painful health conditions: acupuncture and yoga for back pain; acupuncture and tai chi for OA of the knee; massage therapy for neck pain with adequate doses and for short-term benefit; and relaxation techniques for severe headaches and migraine. Weaker evidence suggests that massage therapy, SM, and osteopathic manipulation might also be of some benefit to those with back pain, and relaxation approaches and tai chi might help those with fibromyalgia.”

This is excellent news! Finally, we have data from an authoritative source showing that some alternative treatments can be recommended for common pain conditions.

Hold on, not so fast! Yes, the NIH is a most respectable organisation, but we must not blindly accept anything of importance just because it appears to come form a reputable source. Let’s look a bit closer at the actual evidence provided by the authors of this paper.

Reading the article carefully, it is impossible not to get troubled. Here are a few points that concern me most:

  • the safety of a therapy cannot be evaluated on the basis of data from RCTs (particularly as it has been shown repeatedly that trials of alternative therapies often fail to report adverse effects); much larger samples are needed for that; any statements about safety in the aims of the paper are therefore misplaced;
  • the authors talk about efficacy but seem to mean effectiveness;
  • the authors only included RCTs from the US which must result in a skewed and incomplete picture;
  • the article is from the National Center for Complementary and Integrative Health which is part of the NIH but which has been criticised repeatedly for being biased in favour of alternative medicine;
  • not all of the authors seem to be NIH staff, and I cannot find a declaration of conflicts of interest;
  • the discussion of the paper totally lacks any critical thinking;
  • there is no assessment of the quality of the trials included in this review.

My last point is by far the most important. A summary of this nature that fails to take into account the numerous limitations of the primary data is, I think, as good as worthless. As I know most of the RCTs included in the analyses, I predict that the overall picture generated by this review would have changed substantially, if the risks of bias in the primary studies had been accounted for.

Personally, I find it lamentable that such a potentially worthy exercise ended up employing such lousy methodology. Perhaps even more lamentable is the fact that the NIH (or one of its Centers) can descend that low; to mislead the public in this way borders on scientific misconduct and is, in my view, unethical and unacceptable.

1 2 3 5
Recent Comments

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


Click here for a comprehensive list of recent comments.

Categories