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

acupuncture

1 2 3 18

Radiation-induced xerostomia (RIX) is a common, often debilitating, adverse effect of radiation therapy among patients with head and neck cancer. Quality of life can be severely affected, and current treatments have limited benefit. Acupuncture is often recommended, but does it work? This study was aimed at finding out whether acupuncture can prevent RIX in patients with head and neck cancer undergoing radiation therapy.

The 2-center, phase 3, randomized clinical trial compared a standard care control (SCC) with true acupuncture (TA) and sham acupuncture (SA) among patients with oropharyngeal or nasopharyngeal carcinoma who were undergoing radiation therapy in comprehensive cancer centres in the United States and China. Patients were enrolled between December 16, 2011, and July 7, 2015. Final follow-up was August 15, 2016. Analyses were conducted February 1 through 28, 2019. Either TA or SA using a validated acupuncture placebo device were performed 3 times per week during a 6- to 7-week course of radiation therapy. The primary end point was RIX, as determined by the Xerostomia Questionnaire in which a higher score indicates worse RIX, for combined institutions 1 year after radiation therapy ended. Secondary outcomes included incidence of clinically significant xerostomia (score >30), salivary flow, quality of life, salivary constituents, and role of baseline expectancy related to acupuncture on outcomes.

Of 399 patients randomized, 339 were included in the final analysis, including 112 patients in the TA group, 115 patients in the SA group, and 112 patients in the SCC group. For the primary aim, the adjusted least square mean (SD) xerostomia score in the TA group (26.6 [17.7]) was significantly lower than in the SCC group (34.8 [18.7]) (P = .001; effect size = -0.44) and marginally lower but not statistically significant different from the SA group (31.3 [18.6]) (P = .06; effect size = -0.26). Incidence of clinically significant xerostomia 1 year after radiation therapy ended followed a similar pattern, with 38 patients in the TA group (34.6%), 54 patients in the SA group (47.8%), and 60 patients in the SCC group (55.1%) experiencing clinically significant xerostomia (P = .009). Post hoc comparisons revealed a significant difference between the TA and SCC groups at both institutions, but TA was significantly different from SA only at Fudan University Cancer Center, Shanghai, China (estimated difference [SE]: TA vs SCC, -9.9 [2.5]; P < .001; SA vs SCC, -1.7 [2.5]; P = .50; TA vs SA, -8.2 [2.5]; P = .001), and SA was significantly different from SCC only at the University of Texas MD Anderson Cancer Center, Houston, Texas (estimated difference [SE]: TA vs SCC, -8.1 [3.4]; P = .016; SA vs SCC, -10.5 [3.3]; P = .002; TA vs SA, 2.4 [3.2]; P = .45).

The authors concluded that this randomized clinical trial found that TA resulted in significantly fewer and less severe RIX symptoms 1 year after treatment vs SCC. However, further studies are needed to confirm clinical relevance and generalizability of this finding and to evaluate inconsistencies in response to sham acupuncture between patients in the United States and China.

In essence this two-centre study shows that:

  • real acupuncture is better than usual care, but the effect size is small and of doubtful clinical relevance;
  • real acupuncture is not significantly better than sham acupuncture;
  • the findings differ remarkably between the US and the Chinese centre.

I find the last point the most interesting one. We know from previous research that acupuncture studies from China are notoriously unreliable; they never report a negative result and there is evidence that data fabrication is rife in China. The new findings seems to throw more light on this notion. In the US centre, real and sham acupuncture generated practically identical results. By contrast, in the Chinese centre, real acupuncture generated significantly better results than sham. The authors offer several hypotheses to explain this remarkable phenomenon. Yet, in my view, the most likely one is that Chinese researchers are determined to show that acupuncture is effective. Thus all sorts of unconscious or even conscious biases might get introduced into such studies.

In essence, trial therefore confirms that acupuncture is little more than a theatrical placebo, particularly if we consider the US data which, in my opinion, are more trustworthy.

Lorenzo Cohen, Professor of Palliative, Rehabilitation, and Integrative Medicine and director of the Integrative Medicine Program as well as senior author of the paper unsurprisingly disagrees. He was quoted saying: “The evidence is to a point where patients should incorporate acupuncture alongside radiation treatment as a way to prevent the severity of dry mouth symptoms. I think with this study we can add acupuncture to the list for the prevention and treatment of xerostomia, and the guidelines for the use of acupuncture in the oncology setting should be revised to include this important chronic condition.”

Who do you think is closer to the truth?

On 6 November the Guardian published an article in which acupuncture and its risks were briefly mentioned. It prompted a complaint by the British Acupuncture Council which, I think, is sufficiently interesting to merit a discussion. The British Acupuncture Council (BAcC) has a membership of around 3,000 professionally qualified acupuncturists. It is the UK’s largest professional/ self-regulatory body for the practice of traditional acupuncture. Here is their complaint in full:

Re: Guardian article ‘Doctors call for tighter regulation of traditional Chinese medicine’, published 6 November 2019. We wish to respond to the article referenced above, specifically with regards to the two sentences relating to the safety of acupuncture. We request you correct the misleading comments made in the article and publish this letter online.

1. ‘And acupuncture, they will say, “is not necessarily harmless.”’

Yes, of course it may not be harmless: it involves piercing the skin with a sharp object. Hence the need for proper training of acupuncturists, together with evidenced guidelines, a robust code of safe practice and regulatory teeth. These components are all in place for members of the British Acupuncture Council (BAcC). Acupuncture has not been taken into state control in the UK precisely because it has been found to be so safe; instead, the BAcC is entrusted with self-regulation and is an accredited member of the Professional Standards Authority. Statements about the safety of acupuncture commonly conclude: ‘Acupuncture seems, in skilled hands, one of the safer forms of medical intervention’ (White 2001).

2. ‘…A review in 2017 found many injuries, infections and adverse reactions.’
That first part of your acupuncture safety comment was a direct quote from the FEAM/EASAC statement, which was the focus of the article, but it then departs from the script to manufacture the colourful soundbite above. You refer to the same acupuncture safety overview paper (Chan et al 2017) that FEAM/EASAC drew on, but then substantially misrepresent its content and messages. It is neither a quote from the FEAM/EASAC statement, nor from the overview paper. In fact, the latter sums up the findings of the 17 included reviews thus:  ‘However, all the reviews have suggested that adverse events are rare and often minor.’ Your statement about many injuries, infections and adverse reactions gives a very different message to the paper’s authors.
The Guardian article appears to have been written with little understanding of the science involved in investigating medical adverse events. In particular, it is impossible to establish the significance of the numbers of adverse events reported without knowing how many treatments they came from. Chan et al (2017) noted that incidence rates could not be calculated ‘because many adverse events came from case reports and many of the reviews did not include full details about the number of participants in their included studies’. The 17 reviews between them covered literature from 1950 to 2014 and countries across the globe, so potentially millions and millions of treatments. No wonder they turned up plenty of incidents!
One of the ‘gold standard’ acupuncture safety reviews (Xu et al 2013), which was included in Chan’s overview, provides the following information on this issue:

‘Incidence rates for major AEs [adverse events] of acupuncture are best estimated from large prospective surveys of practitioners. Four recent surveys of acupuncture safety among regulated, qualified practitioners, two conducted in Germany (Melchart 2004; Witt 2009), and two in the United Kingdom (MacPherson 2001; White 2001), confirm that serious adverse events after acupuncture are uncommon. Indeed, of these surveys, covering more than 3 million acupuncture treatments all together, there were no deaths or permanent disabilities, and all those with AEs fully recovered (Witt 2011). Thus, it can be concluded that acupuncture has a very low rate of AEs, when conducted among licensed, qualified practitioners in the West.’

The overview authors also raised this concern: ‘A major limitation of the presented information was that no causality could be determined’. In other words there is often no evidence to link acupuncture to the reported event: it is implicated just because it was around at the time. Adverse events only become adverse reactions (your words) if there is a substantiated link.
Your article (and indeed the FEAM/EASAC statement) completely omits perhaps the most important consideration: how does acupuncture compare to other available treatment options? It is most often used by people for chronic pain. The evidence base for this is good (Vickers 2018) and supports acupuncture’s effectiveness compared to conventional treatments (Trinh 2019). The potential harms of opioids and non-steroidal anti-inflammatory drugs are well known and acupuncture is associated with fewer adverse events than medications in controlled trials across a wide range of conditions (Cao 2018; Xu 2018; Lu 2016).  It was estimated that one in 1,200 people taking NSAIDS for at least two months will die of gastrointestinal complications (Tramer 2000). Six percent of hospitalisations in developed countries are due to adverse drug reactions (Angamo 2016).

On safety grounds there is no comparison: no serious adverse events were reported in a survey covering 34,407 acupuncture treatments given by BAcC members (Macpherson 2001). Of the mild transient reactions reported, the most frequent were ‘feeling relaxed’, and ‘feeling energised’. This is not to downplay the potential harms, for they can be serious, but as with any medical intervention there should be a proper assessment of how likely this is, which the Guardian article signally failed to do.
Yours sincerely

Mark Bovey Research Manager British Acupuncture Council

___________________________________________________________________________

I had no involvement in the Guardian article; I nevertheless feel that several things need to be pointed out about this bizarre complaint:

  1. The quote attributed to White A is, in fact, by White, Hayhoe, Hart and Ernst (yes, petty point), and our investigation showed (not petty point) that there were 43 significant minor adverse events reported, a rate of 14 per 10,000, of which 13 (30%) interfered with daily activities. One patient suffered a seizure (probably reflex anoxic) during acupuncture, but no adverse event was classified as serious. Avoidable events included forgotten patients, needles left in patients, cellulitis and moxa burns. This, I think, entirely justifies the words -is not necessarily harmless – published by the Guardian.
  2. The complaint states that there is often no evidence to link acupuncture to the reported event: it is implicated just because it was around at the time. Adverse events only become adverse reactions (your words) if there is a substantiated link. What this seems to imply is this: the BAcC claim that causality of adverse effects remains speculative, while having failed to establish a surveillance system that could establish their causality more firmly. Perhaps the BAcC should file a complaint about themselves?
  3. The BAcC claim that the author of the Guardian article lacks understanding of the science of adverse effect reporting. However, I get the impression that the lack of understanding is embarrassingly evident on the side of the BAcC.
  4. The BAcC then highlight the most important consideration: how does acupuncture compare to other available treatment options? This is more than a little odd. Firstly, such comparisons hardly were the aim of the Guardian article. Secondly, such comparisons only make sense with options that have a comparable risk/benefit profile. As the benefits of acupuncture for most conditions are still debatable, and since its risks are finite, its risk/benefit balance might not be clearly positive. Therefore, such comparisons are of doubtful value and could easily turn out to generate unfavourable evidence against acupuncture.
  5. Comparisons to opioids or NSAIDS are evidently nonsensical for the reason just mentioned.
  6. The Guardian article’s comments on acupuncture risks were of a general nature and were unelated to any specific issues about BAcC members. There are many non-medically trained acupuncturists – both in the UK and abroad – who might represent a substantially higher risk. Therefore the Guardian should not be criticised but praised for publishing words of caution.

The BAcC state that this is not to downplay the potential harms, yet I fear that this is precisely what they are trying to do. Until there is a post-marketing surveillance system, it would be honest and ethical to admit that the risks of acupuncture are essentially not known.

In my view, the complaint has no reasonable basis, tells us more about the BAcC than the Guardian, and should not be acted upon by the Guardian.

 

The medical literature is currently swamped with reviews of acupuncture (and other forms of TCM) trials originating from China. Here is the latest example (but, trust me, there are hundreds more of the same ilk).

The aim of this review was to evaluate the effectiveness of scalp, tongue, and Jin’s 3-needle acupuncture for the improvement of post-apoplectic aphasia. PubMed, Cochrane, Embase databases were searched using index words to identify qualifying randomized controlled trials (RCTs). Meta-analyses of odds ratios (OR) or standardized mean differences (SMD) were performed to evaluate the outcomes between investigational (scalp / tongue / Jin’s 3-needle acupuncture) and control (traditional acupuncture; TA and/or rehabilitation training; RT) groups.

Thirty-two RCTs (1310 participants in investigational group and 1270 in control group) were included. Compared to TA, (OR 3.05 [95% CI: 1.77, 5.28]; p<0.00001), tongue acupuncture (OR 3.49 [1.99, 6.11]; p<0.00001), and Jin’s 3-needle therapy (OR 2.47 [1.10, 5.53]; p = 0.03) had significantly better total effective rate. Compared to RT, scalp acupuncture (OR 4.24 [95% CI: 1.68, 10.74]; p = 0.002) and scalp acupuncture with tongue acupuncture (OR 7.36 [3.33, 16.23]; p<0.00001) had significantly better total effective rate. In comparison with TA/RT, scalp acupuncture, tongue acupuncture, scalp acupuncture with tongue acupuncture, and Jin’s three-needling significantly improved ABC, oral expression, comprehension, writing and reading scores.

The authors concluded that compared to traditional acupuncture and/or rehabilitation training, scalp acupuncture, tongue acupuncture, and Jin’ 3-needle acupuncture can better improve post-apoplectic aphasia as depicted by the total effective rate, the ABC score, and comprehension, oral expression, repetition, denomination, reading and writing scores. However, quality of the included studies was inadequate and therefore further high-quality studies with lager samples and longer follow-up times and with patient outcomes are necessary to verify the results presented herein. In future studies, researchers should also explore the efficacy and differences between scalp acupuncture, tongue acupuncture and Jin’s 3-needling in the treatment of post-apoplectic aphasia.

I’ll be frank: I find it hard to believe that sticking needles in a patient’s tongue restores her ability to speak. What is more, I do not believe a word of this review and its conclusion. And now I better explain why.

  • All the primary studies originate from China, and we have often discussed how untrustworthy such studies are.
  • All the primary studies were published in Chinese and cannot therefore be checked by most readers of the review.
  • The review authors fail to provide the detail about a formal assessment of the rigour of the included studies; they merely state that their methodological quality was low.
  • Only 6 of the 32 studies can be retrieved at all via the links provided in the articles.
  • As far as I can find out, some studies do not even exist at all.
  • Many of the studies compare acupuncture to unproven therapies such as bloodletting.
  • Many do not control for placebo effects.
  • Not one of the 32 studies reports findings that are remotely convincing.

I conclude that such reviews are little more than pseudo-scientific propaganda. They seem aim at promoting acupuncture in the West and thus serve the interest of the People’s Republic of China. They pollute our medical literature and undermine the trust in science.

I seriously ask myself, are the editors and reviewers all fast asleep?

The journal ‘BMC Complement Altern Med‘  has, in its 18 years of existence, published almost 4 000 Medline-listed papers. They currently charge £1690 for handling one paper. This would amount to about £6.5 million! But BMC are not alone; as I have pointed out repeatedly, EBCAM is arguably even worse.

And this is, in my view, the real scandal. We are being led up the garden path by people who make a very tidy profit doing so. BMC (and EBCAM) must put an end to this nonsense. Alternatively, PubMed should de-list these publications.

This has been going on for far too long; urgent action is required!

 

The field of so-called alternative medicine (SCAM) has long been actively supported by many celebrities. In 2006, we tried to  study the phenomenon systematically. Here is our abstract:

OBJECTIVE:

To collect contemporary accounts of celebrity use of complementary and alternative medicine (CAM), to aid clinicians in determining which CAM treatments patients are likely to use.

DESIGN:

Articles published during 2005 and 2006 reporting celebrity use of CAM.

RESULTS:

38 celebrities were found to use a wide range of CAM interventions. Homeopathy, acupuncture and Ayurveda were the most popular modalities.

CONCLUSIONS:

There may be many reasons why consumers use CAM, and wanting to imitate their idols is one of them.

Since then, several celebs have sensed that SCAM offers an opportunity to make money, lots of money. Gwyneth Paltrow and others are earning millions by selling SCAM products to the gullible public. Now it seem that even those areas of SCAM are being targeted by celebs where the sale of SCAM products is not the main focus. This article explains:

Cameron Diaz is taking her passion for fashion health to new heights with her latest investment. The health advocate and Hollywood actress is the latest investor in Arizona-based acupuncture company Modern Acupuncture. Modern Acupuncture has been around for over three years and according to its CEO, Matt Hale, the group aims to provide affordable acupuncture across the United States.

Modern Acupuncture has 60 locations and hopes to double that in the upcoming year, and with an A-lister on the board, they seem to be on the right path…

The star’s investment in the alternative medicine space comes in partnership with Seth Rodsky and his firm Strand Equity, who clearly know what they’re doing. It’s the same firm that brought 50 Cent into Vitamin Water before most of us knew what Vitamin Water was. They also introduced Madonna into Vita Coco Coconut Water back in 2010. Now, Seth stated his team “reached out to Modern Acupuncture in late 2018 after identifying acupuncture as a healthcare and wellness service which we thought to be a large white space.” Bringing Cameron into the mix of investors marks an exciting time for Stand Equity, Cameron and Modern Acupuncture. The CEO explained that Cameron’s addition “amplifies it to an entire different ecosystem.”

MODERN ACUPUNCTURE advertise their services by pointing out that:

• The Mayo Clinic has adopted the practice of acupuncture nationwide.

John Hopkin’s also uses acupuncture for pain and supports many other conditions treated around the world.

• Acupuncture helps reduce use of pain killers in U.S. Army patients. Two-thirds of military hospitals and other treatment centers offer acupuncture.

Cleveland Clinic outlines new government advisory recommended non-addictive options before opioids.  Acupuncture was recommended as a first-line treatment in lower back pain by the American College of Physicians.

• A recent article in the Washington Post highlights Medicare now researching acupuncture for back pain.

• Acupuncture is used in hospitals around the world Acupuncture in hospitals.

___________________________________________________________

I find this most lamentable. It shows two things quite clearly. Firstly, the public is an easy victim of fallacious reasoning; the fact that an reputable institution offers acupuncture (or anything else) is no proof of its efficacy, it merely is an example for the sly use of the ‘appeal to authority’. Secondly, the harm caused by established institutions adopting dubious treatments is not confined to those institutions; its effects are being felt nationally and even internationally. This, I think, should make these institutions think twice before they continue with their short-sighted adoption of SCAM.

Traditional Chinese Medicine (TCM) is a term created by Mao lumping together various modalities in an attempt to pretend that healthcare in the People’s Republic of China (PRC) was being provided despite the most severe shortages of conventional doctors, drugs and facilities. Since then, TCM seems to have conquered the West, and, in the PRC, the supply of conventional medicine has hugely increased. Today therefore, TCM and conventional medicine peacefully co-exist side by side in the PRC on an equal footing.

At least this is what we are being told – but is it true?

I have visited the PRC twice. The first time, in 1980, I was the doctor of a university football team playing several games in the PRC, including one against their national team. The second time, in 1991, I co-chaired a scientific meeting in Shanghai. On both occasions, I was invited to visit TCM facilities and discuss with colleagues issues related to TCM in the PRC. All the official discussions were monitored by official ‘minders’, and therefore fee speech and an uninhibited exchange of ideas are not truly how I would describe them. Yet, on both visits, there were occasions when the ‘minders’ were absent and a more liberal discussion could ensue. Whenever this was the case, I did not at all get the impression that TCM and conventional medicine were peacefully co-existing. The impression that I did get was that their co-existence resembled more a ‘shot-gun marriage’.

During my time running the SCAM research unit at Exeter, I had the opportunity to welcome several visiting researchers from the PRC. This experience seemed to confirm my impression that TCM in the PRC was less than free. As an example, I might cite one acupuncture project I was once working on with a scientist from the PRC. When it was nearing its conclusion and I mentioned that we should now think about writing it up to publish the findings, my Chinese colleague said that being a co-author was unfortunately not an option. Knowing how important publications in Western journals are for researchers from the PRC, I was most surprised by this revelation. The reason, it turned out, was that our findings failed to be favourable for TCM. My friend explained that such a paper would not advance but hinder an academic career, once back in the PRC.

Suspecting that the notion of a peaceful co-existence of TCM and conventional medicine in the PRC was far from true, I have always been puzzled how the myth could survive for so many years. Now, finally, it seems to crumble. This is from a recent journalistic article entitled ‘Chinese Activists Protest the Use of Traditional Treatments – They Want Medical Science’ which states that thousands of science activists in the PRC protest that the state neglects its duty to treat its citizens with evidence-based medicine (here is the scientific article this is based on):

Over a number of years, Chinese researcher Qiaoyan Zhu, who has been affiliated with the University of Copenhagen’s Department of Communication, has collected data on the many thousand science activists in China through observations in Internet forums, on social media and during physical meetings. She has also interviewed hundreds of activists. Together with Professor Maja Horst, who has specialized in research communication, she has analyzed the many data on the activists and their protests in an article that has just been published in the journal Public Understanding of Science:

“The activists are better educated and wealthier than the average Chinese population, and a large majority of them keep up-to-date with scientific developments. The protests do not reflect a broad popular movement, but the activists make an impact with their communication at several different levels,” Maja Horst explained and added: “Many of them are protesting individually by writing directly to family, friends and colleagues who have been treated with – and in some cases taken ill from – Traditional Chinese Medicine. Some have also hung posters in hospitals and other official institutions to draw attention to the dangers of traditional treatments. But most of the activism takes place online, on social media and blogs.

Activists operating in a regime like the Chinese are obviously not given the same leeway as activists in an open democratic society — there are limits to what the authorities are willing to accept in the public sphere in particular. However, there is still ample opportunity to organize and plan actions online.

“In addition to smaller groups and individual activists that have profiles on social media, larger online groups are also being formed, in some cases gaining a high degree of visibility. The card game with 52 criticisms about Traditional Chinese Medicine that a group of activists produced in 37,000 copies and distributed to family, friends and local poker clubs is a good example. Poker is a highly popular pastime in rural China so the critical deck of cards is a creative way of reaching a large audience,” Maja Horst said.

Maja Horst and Qiaoyan Zhu have also found examples of more direct action methods, where local activist groups contact school authorities to complain that traditional Chinese medicine is part of the syllabus in schools. Or that activists help patients refuse treatment if they are offered treatment with Traditional Chinese Medicine.

________________________________________________________________

I am relieved to see that, even in a system like the PRC, sound science and compelling evidence cannot be suppressed forever. It has taken a mighty long time, and the process may only be in its infancy. But there is hope – perhaps even hope that the TCM enthusiasts outside the PRC might realise that much of what came out of China has led them up the garden path!?

 

Acupuncture is often recommended for relieving symptoms of fibromyalgia syndrome (FMS). The aim of this systematic review was to ascertain whether verum acupuncture is more effective than sham acupuncture in FMS.

Ten RCTs with a total of 690 participants were eligible, and 8 RCTs were eventually included in the meta-analysis. Its results showed a sizable effect of verum acupuncture compared with sham acupuncture on pain relief, improving sleep quality and reforming general status. Its effect on fatigue was insignificant. When compared with a combination of simulation and improper location of needling, the effect of verum acupuncture for pain relief was the most obvious.

The authors concluded that verum acupuncture is more effective than sham acupuncture for pain relief, improving sleep quality, and reforming general status in FMS posttreatment. However, evidence that it reduces fatigue was not found.

I have a much more plausible conclusion for these findings: in (de-randomised) trials comparing real and sham acupuncture, patients are regularly de-blinded and therapists are invariably not blind. The resulting bias and not the alleged effectiveness of acupuncture explains the outcome.

And why do I think that this conclusion is much more plausible?

Firstly, because of Occam’s Razor.

Secondly, because this is roughly what my own systematic review of the subject found (The notion that acupuncture is an effective symptomatic treatment for fibromyaligia is not supported by the results from rigorous clinical trials. On the basis of this evidence, acupuncture cannot be recommended for fibromyalgia). This view is also shared by other critical reviews of the evidence (Current literature does not support the routine use of acupuncture for improving pain or quality of life in FM). Perhaps more crucially, the current Cochrane review seems to concur: There is low to moderate-level evidence that compared with no treatment and standard therapy, acupuncture improves pain and stiffness in people with fibromyalgia. There is moderate-level evidence that the effect of acupuncture does not differ from sham acupuncture in reducing pain or fatigue, or improving sleep or global well-being. EA is probably better than MA for pain and stiffness reduction and improvement of global well-being, sleep and fatigue. The effect lasts up to one month, but is not maintained at six months follow-up. MA probably does not improve pain or physical functioning. Acupuncture appears safe. People with fibromyalgia may consider using EA alone or with exercise and medication. The small sample size, scarcity of studies for each comparison, lack of an ideal sham acupuncture weaken the level of evidence and its clinical implications. Larger studies are warranted.

I have met many acupuncturists who think that homeopathy is bunk. Similarly, I have met many homeopaths who are convinced that acupuncture is a placebo therapy. And, I have met some (not many) practitioners of so-called alternative medicine (SCAM) who think so highly of both SCAMs that they combine the two into one handy treatment: HOMEOPUNCTURE.

I had almost forgotten (or is supressed the correct verb?) but, to be entirely truthful, a long time ago (in the mid 1970s), I even experimented with this odd therapy myself. When I worked as a junior doctor in a homeopathic hospital, several of my collegues practised homeopuncture and taught me how to do it. Essentially, you inject homeopathic remedies into acupuncture points. My colleagues told me that this approach is more powerful than each method alone. I tried it several times but remained unconvinced.

Recently, a German Heilpraktiker (Andreas Maier), reminded me of all this. Here is what he states on his website about homeopuncture:

In traditional Chinese medicine, acupuncture in addition to the herb medicine as well as certain movement therapies (eg. B. Gong Qi) constituting an important element in the treatment of diseases.

By stimulating energy points with the help of fine needles will then attempts to harmonize the flow of vital energy. a disruption of vital energy because (also called Qi), is considered in Chinese medicine as a cause of any disease.

Only when the energy flows freely through all the tissues and organs of the body, the organism can develop normally and is healthy. A similar approach is also the Homeopathy, which originated at the other end of the world, namely in Germany.

Samuel Hahnemann (1755 – 1843), the discoverer of this method of healing, also saw a failure of the life force as a pathogenic factor.

By smallest stimuli the homeopath tries to eliminate these disease-causing disorder and bring about healing. Unlike in the acupuncture reduced drug doses to be used strictly in accordance with the  principle of similarity  are selected.

Mid-19th century was the German physician Dr. August consecration firmly (1840- 1896) that disease with painful spots may accompany the body.

These pain points are often far from the actual disease process. The phenomenon was known to the Chinese for thousands of years in Europe, however, no one had yet busy. Dr. Weihe, himself a keen homeopath, was in the treatment of his patients finally see that by the suitably chosen homeopathic healed not only the disease, but also disappeared the painfulness of the points.

It was surprising that certain homeopathic remedies appear to be well-defined points had a direct bearing on the body.

A few years later, the Chinese medicine and acupuncture also reached the European continent, they took Weihe discoveries closer look. A comparison of the so-called consecration points with acupuncture points showed significant matches.

The more than 300 known Weihe points are also used therapeutically since both diagnosis. Because they can provide information on the pathological processes in the body and on the displayed homeopathic. thus the Homöopunktur brings together the findings from Chinese medicine and homeopathy. The treatment can be done differently.

On the one hand the consecration points can be traditionally stimulated with fine needles, concomitant administration of homeopathic medicine. With the help of injection preparations, means may also be injected directly to the point.

________________________________________________________________

(sorry about my friend’s poor English; I hope you could make sense of it)

I don’t think I need to tell you what the evidence tells us about homeopuncture. Yes, you guessed it: nothing! But the idea of combining SCAMs is fascinating nevertheless. So, let me suggest a few further SCAM combinations that might be attractive:

  • acupuncture + massage (sorry, that already exists under the name of shiatsu)
  • colonic irrigation + coffea (that to is already taken by the Gerson guys)
  • art therapy + homeopathy (too late: this one too already exists; painting homeopathy on the body surface)
  • detox + meditation (no, the health retreat/wellness entrepreneurs might get upset)

I am clearly not very successful at finding viable SCAM combinations. Let’s look for something innovative, something that nobody has yet thought of. How about:

  • homeo-laugh (homeopathy followed by an explanation what homeopathy is resulting in laughter; not sure that this would sell all that well)
  • kinesiology colour taping (instead of using random colours for kinesiology tape, this approach uses the wisdom of coulourtherapists to match the patient’s individual colour requirements; this means the therapists needs dual qualifications and can thus charge double – I think that might be attractive!)
  • autologous slapping therapy (this combination of slapping and autologous blood therapy (ABT) means the therapist has to hit so hard that the patient develops sizable haematomas which are the ABT part of the intervention; perhaps a bit risky, as some patients might call the police)
  • effective reverse energy transfer counselling, ERETC (the patients is counselled that his money can, with the help of the therapist, be converted into pure healing energy; to make it work, the patient needs to transfer it to the account of the therapist – the more the better)

I think I like ERECT best; in fact, I will start work on it straight away. It still needs to be perfected, but once it’s up and running, it will be just great and, as the name already makes clear, effective – not for the patient, but for the therapist!

Controlled clinical trials are methods for testing whether a treatment works better than whatever the control group is treated with (placebo, a standard therapy, or nothing at all). In order to minimise bias, they ought to be randomised. This means that the allocation of patients to the experimental and the control group must not be by choice but by chance. In the simplest case, a coin might be thrown – heads would signal one, tails the other group.

In so-called alternative medicine (SCAM) where preferences and expectations tend to be powerful, randomisation is particularly important. Without randomisation, the preference of patients for one or the other group would have considerable influence on the result. An ineffective therapy might thus appear to be effective in a biased study. The randomised clinical trial (RCT) is therefore seen as a ‘gold standard’ test of effectiveness, and most researchers of SCAM have realised that they ought to produce such evidence, if they want to be taken seriously.

But, knowingly or not, they often fool the system. There are many ways to conduct RCTs that are only seemingly rigorous but, in fact, are mere tricks to make an ineffective SCAM look effective. On this blog, I have often mentioned the A+B versus B study design which can achieve exactly that. Today, I want to discuss another way in which SCAM researchers can fool us (and even themselves) with seemingly rigorous studies: the de-randomised clinical trial (dRCT).

The trick is to use random allocation to the two study groups as described above; this means the researcher can proudly and honestly present his study as an RCT with all the kudos these three letters seem to afford. And subsequent to this randomisation process, the SCAM researcher simply de-randomises the two groups.

To understand how this is done, we need first to be clear about the purpose of randomisation. If done well, it generates two groups of patients that are similar in all factors that might impact on the results of the study. Perhaps the most obvious factor is disease severity; one could easily use other methods to make sure that both groups of an RCT are equally severely ill. But there are many other factors which we cannot always quantify or even know about. By using randomisation, we make sure that there is an similar distribution of ALL of them in the two study groups, even those factors we are not even aware of.

De-randomisation is thus a process whereby the two previously similar groups are made to differ in terms of any factor that impacts on the results of the trial. In SCAM, this is often surprisingly simple.

Let’s use a concrete example. For our study of spiritual healing, the 5 healers had opted during the planning period of the study to treat both the experimental group and the control group. In the experimental group, they wanted to use their full healing power, while in the control group they would not employ it (switch it off, so to speak). It was clear to me that this was likely to lead to de-randomisation: the healers would have (inadvertently or deliberately) behaved differently towards the two groups of patients. Before and during the therapy, they would have raised the expectation of the verum group (via verbal and non-verbal communication), while sending out the opposite signals to the control group. Thus the two previously equal groups would have become unequal in terms of their expectation. And who can deny that expectation is a major determinant of the outcome? Or who can deny that experienced clinicians can manipulate their patients’ expectation?

For our healing study, we therefore chose a different design and did all we could to keep the two groups comparable. Its findings thus turned out to show that healing is not more effective than placebo (It was concluded that a specific effect of face-to-face or distant healing on chronic pain could not be demonstrated over eight treatment sessions in these patients.). Had we not taken these precautions, I am sure the results would have been very different.

In RCTs of some SCAMs, this de-randomisation is difficult to avoid. Think of acupuncture, for instance. Even when using sham needles that do not penetrate the skin, the therapist is aware of the group allocation. Hoping to prove that his beloved acupuncture can be proven to work, acupuncturists will almost automatically de-randomise their patients before and during the therapy in the way described above. This is, I think, the main reason why some of the acupuncture RCTs using non-penetrating sham devices or similar sham-acupuncture methods suggest that acupuncture is more than a placebo therapy. Similar arguments also apply to many other SCAMs, including for instance chiropractic.

There are several ways of minimising this de-randomisation phenomenon. But the only sure way to avoid this de-randomisation is to blind not just the patient but also the therapists (and to check whether both remained blind throughout the study). And that is often not possible or exceedingly difficult in trials of SCAM. Therefore, I suggest we should always keep de-randomisation in mind. Whenever we are confronted with an RCT that suggest a result that is less than plausible, de-randomisation might be a possible explanation.

 

On this blog, we have often noted that (almost) all TCM trials from China report positive results. Essentially, this means we might as well discard them, because we simply cannot trust their findings. While being asked to comment on a related issue, it occurred to me that this might be not so much different with Korean acupuncture studies. So, I tried to test the hypothesis by running a quick Medline search for Korean acupuncture RCTs. What I found surprised me and eventually turned into a reminder of the importance of critical thinking.

Even though I found pleanty of articles on acupuncture coming out of Korea, my search generated merely 3 RCTs. Here are their conclusions:

RCT No1

The results of this study show that moxibustion (3 sessions/week for 4 weeks) might lower blood pressure in patients with prehypertension or stage I hypertension and treatment frequency might affect effectiveness of moxibustion in BP regulation. Further randomized controlled trials with a large sample size on prehypertension and hypertension should be conducted.

RCT No2

The results of this study show that acupuncture might lower blood pressure in prehypertension and stage I hypertension, and further RCT need 97 participants in each group. The effect of acupuncture on prehypertension and mild hypertension should be confirmed in larger studies.

RCT No3

Bee venom acupuncture combined with physiotherapy remains clinically effective 1 year after treatment and may help improve long-term quality of life in patients with AC of the shoulder.

So yes, according to this mini-analysis, 100% of the acupuncture RCTs from Korea are positive. But the sample size is tiny and I many not have located all RCTs with my ‘rough and ready’ search.

But what are all the other Korean acupuncture articles about?

Many are protocols for RCTs which is puzzling because some of them are now so old that the RCT itself should long have emerged. Could it be that some Korean researchers publish protocols without ever publishing the trial? If so, why? But most are systematic reviews of RCTs of acupuncture. There must be about one order of magnitude more systematic reviews than RCTs!

Why so many?

Perhaps I can contribute to the answer of this question; perhaps I am even guilty of the bonanza.

In the period between 2008 and 2010, I had several Korean co-workers on my team at Exeter, and we regularly conducted systematic reviews of acupuncture for various indications. In fact, the first 6 systematic reviews include my name. This research seems to have created a trend with Korean acupuncture researchers, because ever since they seem unable to stop themselves publishing such articles.

So far so good, a plethora of systematic reviews is not necessarily a bad thing. But looking at the conclusions of these systematic reviews, I seem to notice a worrying trend: while our reviews from the 2008-2010 period arrived at adequately cautious conclusions, the new reviews are distinctly more positive in their conclusions and uncritical in their tone.

Let me explain this by citing the conclusions of the very first (includes me as senior author) and the very last review (does not include me) currently listed in Medline:

1st review

penetrating or non-penetrating sham-controlled RCTs failed to show specific effects of acupuncture for pain control in patients with rheumatoid arthritis. More rigorous research seems to be warranted.

Last review

Electroacupuncture was an effective treatment for MCI [mild cognitive impairment] patients by improving cognitive function. However, the included studies presented a low methodological quality and no adverse effects were reported. Thus, further comprehensive studies with a design in depth are needed to derive significant results.

Now, you might claim that the evidence for acupuncture has overall become more positive over time, and that this phenomenon is the cause for the observed shift. Yet, I don’t see that at all. I very much fear that there is something else going on, something that could be called the suspension of critical thinking.

Whenever I have asked a Chinese researcher why they only publish positive conclusions, the answer was that, in China, it would be most impolite to publish anything that contradicts the views of the researchers’ peers. Therefore, no Chinese researcher would dream of doing it, and consequently, critical thinking is dangerously thin on the ground.

I think that a similar phenomenon might be at the heart of what I observe in the Korean acupuncture literature: while I always tried to make sure that the conclusions were adequately based on the data, the systematic reviews were ok. When my influence disappeared and the reviews were done exclusively by Korean researchers, the pressure of pleasing the Korean peers (and funders) became dominant. I suggest that this is why conclusions now tend to first state that the evidence is positive and subsequently (almost as an after-thought) add that the primary trials were flimsy. The results of this phenomenon could be serious:

  • progress is being stifled,
  • the public is being misled,
  • funds are being wasted,
  • the reputation of science is being tarnished.

Of course, the only right way to express this situation goes something like this:

BECAUSE THE QUALITY OF THE PRIMARY TRIALS IS INADEQUATE, THE EFFECTIVENESS OF ACUPUNCTURE REMAINS UNPROVEN.

 

 

In a paper discussed in a previous blog, Ioannidis et al published a comprehensive database of a large number of scientists across science. They used Scopus data to compile a database of the 100,000 most-cited authors across all scientific fields based on their ranking of a composite indicator that considers six citation metrics (total citations; Hirsch h-index; coauthorship-adjusted Schreiber hm-index; number of citations to papers as single author; number of citations to papers as single or first author; and number of citations to papers as single, first, or last author). The authors also added this caution:

Citation analyses for individuals are used for various single-person or comparative assessments in the complex reward and incentive system of science. Misuse of citation metrics in hiring, promotion or tenure decision, or other situations involving rewards (e.g., funding or awards) takes many forms, including but not limited to the use of metrics that are not very informative for scientists and their work (e.g., journal impact factors); focus on single citation metrics (e.g., h-index); and use of calculations that are not standardized, use different frames, and do not account for field. The availability of the data sets that we provide should help mitigate many of these problems. The database can also be used to perform evaluations of groups of individuals, e.g., at the level of scientific fields, institutions, countries, or memberships in diversely defined groups that may be of interest to users.

It seems thus obvious and relevant to employ the new metrics for defining the most ‘influential’ (most frequently cited) researchers in so-called alternative medicine (SCAM). Doing this creates not one but two non-overlapping tables (because ‘complementary&alternative medicine’ is listed both as a primary and a secondary field (not sure about the difference)). Below, I have copied a small part of these tables; the first three columns are self-explanatory; the 4th relates to the number of published articles, the 4th to the year of the author’s first publication, the 5th to the last, the 6th column is the rank amongst 100 000 scientists of all fields who have published more than a couple of papers.

TABLE 1

Ernst, E. University of Exeter gbr 2253 1975 2018 104
Davidson, Jonathan R. T. Duke University usa 426 1972 2017 1394
Kaptchuk, Ted J. Harvard University usa 245 1993 2018 6545
Eisenberg, David M. Harvard University usa 127 1991 2018 8641
Lundeberg, Thomas 340 1983 2016 17199
Linde, Klaus Technische Universitat Munchen deu 276 1993 2018 19488
Schwartz, Gary E. University of Arizona usa 264 1967 2018 21893
Eloff, J.N. University of Pretoria zaf 204 1997 2018 23830
Birch, Stephen McMaster University can 244 1985 2018 31925
Wilson, Kenneth H. Duke University usa 76 1976 2017 40760
Kemper, Kathi J. Ohio State University usa 181 1988 2017 45193
Oken, Barry S. Oregon Health and Science University usa 121 1974 2018 51325
Pittler, M.H. 155 1997 2016 53183
Postuma, Ronald B. McGill University can 159 1998 2018 61018
Patwardhan, Bhushan University of Pune ind 144 1989 2018 64465
Krucoff, Mitchell W. Duke University usa 261 1986 2016 66028
Chiesa, Alberto 87 1973 2017 82390
Baliga, Manjeshwar Shrinath 142 2002 2018 83030
Mischoulon, David Harvard University usa 194 1992 2018 91705
Büssing, Arndt University of Witten/Herdecke deu 207 1980 2018 95907
Langevin, Helene M. Harvard University usa 67 1999 2018 98290
Creath, Katherine 84 1984 2017 99709
Kuete, Victor University of Dschang cmr 239 2005 2018 128347

TABLE 2

White, Adrian University of Plymouth gbr 294 1990 2016 16714
Astin, John A. California Pacific Medical Center usa 50 1994 2014 21379
Kelly, Gregory S. 37 1985 2011 31037
Walach, Harald University of Medical Sciences Poznan pol 246 1996 2018 31716
Berman, Brian M. University of Maryland School of Medicine usa 211 1986 2018 34022
Lewith, George University of Southampton gbr 380 1980 2018 34830
Kidd, Parris M. University of California at Berkeley usa 38 1976 2011 36571
Jonas, Wayne B. 187 1992 2018 42445
MacPherson, Hugh University of York gbr 143 1996 2018 49923
Bell, Iris R. University of Arizona usa 142 1984 2015 51016
Patrick, Lyn 21 1999 2018 57086
Ritenbaugh, Cheryl University of Arizona usa 172 1981 2018 63248
Boon, Heather University of Toronto can 188 1988 2017 69066
Aickin, Mikel University of Arizona usa 149 1996 2014 72040
Lee, Myeong Soo 430 1996 2018 72358
Lao, Lixing University of Hong Kong hkg 247 1990 2018 74896
Witt, Claudia M. Charite – Universitatsmedizin Berlin deu 238 2001 2018 78849
Sherman, Karen J. 136 1984 2017 82542
Verhoef, Marja J. University of Calgary can 190 1989 2016 84314
Smith, Caroline A. University of Western Sydney aus 135 1979 2018 94130
Miller, Alan L. 30 1980 2016 94421
Paterson, Charlotte University of Bristol gbr 71 1995 2017 95130
Milgrom, Lionel R. London Metropolitan University gbr 107 1979 2017 112943
Adams, Jon University of Technology NSW aus 294 1999 2018 128486
Litscher, Gerhard Medical University of Graz aut 245 1986 2018 133122
Chen, Calvin Yu-Chian China Medical University Taichung chn 130 2007 2016 164522

No other researchers are listed in the ‘Complementary&Alternative Medicine’ categories and made it into the list of the 100 000 most-cited scientists.

To make this easier to read, I have ordered all SCAM researchers according to their rank in one single list and, where known to me, added the respective focus in SCAM research (ma = most areas of SCAM):

  1. ERNST EDZARD (ma)
  2. DONALDSON JONATHAN
  3. KAPTCHUK TED (acupuncture)
  4. EISENBERG DAVID (TCM)
  5. WHITE ADRIAN (acupuncture)
  6. LUNDEBERG THOMAS (acupuncture)
  7. LINDE KLAUS (homeopathy)
  8. ASTIN JOHN (mind/body)
  9. SCHWARTZ GARRY (healing)
  10. ELOFF JN
  11. KELLY GREGORY
  12. WALLACH HARALD (homeopathy)
  13. BIRCH STEVEN (acupuncture)
  14. BERMAN BRIAN (acupuncture)
  15. LEWITH GEORGE (acupuncture)
  16. KIDD PARRIS
  17. WILSON KENNETH
  18. JONAS WAYNE (homeopathy)
  19. KEMPER KATHIE (ma)
  20. MACPHERSON HUGH (acupuncture)
  21. BELL IRIS (homeopathy)
  22. OKEN BARRY (dietary supplements)
  23. PITTLER MAX (ma)
  24. PATRICK LYN
  25. RITENBAUGH CHERYL (ma)
  26. POSTUMA RONALD
  27. PATWARDHAN BHUSHAN
  28. KRUCOFF MICHELL
  29. BOON HEATHER
  30. AICKIN MIKEL (ma)
  31. LEE MYEONG SOO (TCM)
  32. LAO LIXING (acupuncture)
  33. WITT CLAUDIA (ma)
  34. CHIESA ALBERTO
  35. SHERMAN KAREN (acupuncture)
  36. BALIGA MANJESHWAR
  37. VERHOEF MARIA (ma)
  38. MISCHOULON DAVID
  39. SMITH CAROLINE (acupuncture)
  40. MILLER ALAN
  41. PATERSON CHARLOTTE (ma)
  42. BUESSING ARNDT (anthroposophical medicine)
  43. LANGEVIN HELENE (ma)
  44. CREATH KATHERINE
  45. MILGROM LIONEL (homeopathy)
  46. KUETE VICTOR
  47. ADAMS JON (ma)
  48. LITSCHER GERHARD
  49. CHEN CALVIN

The list is interesting in several regards. Principally, it offers individual SCAM researchers for the first time the opportunity to check their international standing relative to their colleagues. But, as the original analysis in Ioannidis’s paper contains much more data than depicted above, there is much further information to be gleaned from it.

For instance, I looked at the rate of self-citation (not least because I have sometimes been accused of overdoing this myself). It turns out that, with 7%, I am relative modest and well below average in that regard. Most of my colleagues are well above that figure. Researchers who have exceptionally high self-citation rates include Buessing (30%), Kuete (43%), Adams (36%), Litscher (45%), and Chen (53%).

The list also opens the possibility to see which countries dominate SCAM research. The dominance of the US seems fairly obvious and would have been expected due to the size of this country and the funds the US put into SCAM research. Considering the lack of funds in the UK, my country ranks surprisingly high, I find. No other country is well-represented in this list. In particular Germany does not appear often (even if we would classify Wallach as German); considering the large amounts of money Germany has invested in SCAM research, this is remarkable and perhaps even a bit shameful, in my view.

Looking at the areas of research, acupuncture and homeopathy seem to stand out. Remarkably, many of the major SCAMs are not or not well represented at all. This is in particular true for herbal medicine, chiropractic and osteopathy.

The list also confirms my former team as the leaders in SCAM research. (Yes, I know: in the country of the blind, the one-eyed man is king.) Pittler, White and Lee were, of course, all former co-workers of mine.

Perhaps the most intriguing finding, I think, relates to the many SCAM researchers who did not make it into the list. Here are a few notable absentees:

  1. Behnke J – GERMANY (homeopathy)
  2. Bensoussan A – AUSTRALIA (acupuncture)
  3. Brinkhaus B – GERMANY  (acupuncture)
  4. Bronfort G  – US  (chiropractic)
  5. Chopra D – US (mind/body)
  6. Cummings M – UK (acupuncture)
  7. Dixon M – UK (ma)
  8. Dobos G – GERMANY (ma)
  9. Fisher P – UK (homeopathy)
  10. Fonnebo V – NORWAY (ma)
  11. Frass M – AUSTRIA (homeopathy)
  12. Goertz C – US (chiropractic)
  13. Hawk C -US (chiropractic)
  14. Horneber M – GERMANY (ma)
  15. Jacobs J – US (homeopathy)
  16. Jobst K – UK (homeopathy)
  17. Kraft K – GERMANY (naturopathy)
  18. Lawrence D – US (chiropractic)
  19. Long CR – US (chiropractic)
  20. Meeker WC – US (chiropractic)
  21. Mathie R – UK (homeopathy)
  22. Melchart – GERMANY (ma)
  23. Michalsen A – GERMANY (ma)
  24. Mills S – UK (herbal medicine)
  25. Peters D – UK (ma)
  26. Reilly D -US (homeopathy)
  27. Reily D – UK (homeopathy)
  28. Robinson N – UK (ma)
  29. Streitberger K – GERMANY (acupuncture)
  30. Tuchin PJ – US (chiropractic)
  31. Uehleke – GERMANY (naturopathy)
  32. Ullman D – US (homeopathy)
  33.  Weil A – US (ma)

I leave it to you to interpret this list and invite you to add more SCAM researchers to it.

 

(thanks to Paul Posadski for helping with the tables)

1 2 3 18
Recent Comments

Note that comments can be edited for up to five minutes after they are first submitted but you must tick the box: “Save my name, email, and website in this browser for the next time I comment.”

The most recent comments from all posts can be seen here.

Archives
Categories