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

TCM

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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!

 

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!?

 

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)

An article in the Sydney Morning Herald might be interesting to some readers. It informs us that, after more than 25 years of running, the University of Technology Sydney (UTS) intends to stop offering its degree in Traditional Chinese Medicine (TCM). A review of the Chinese Medicine Department found it should be wound up at the end of 2021 because

  • it was no longer financially viable,
  • did not produce enough research,
  • and did not fit with the “strategic direction” of the science faculty.

The UTS’s Chinese medicine clinic, which offers acupuncture and herbal treatments, would also close. Students who don’t finish by the end of 2021 will either move to another health course, or transfer to another university (Chinese medicine is also offered by the University of Western Sydney, RMIT in Melbourne, and several private colleges).

TCM “is a historical tradition that pre-dated the scientific era,” said the president of Friends of Science, Associate Professor Ken Harvey. “There’s nothing wrong with looking at that using modern scientific techniques. The problem is people don’t, they tend to teach it like it’s an established fact. If I was a scientifically-orientated vice chancellor I would worry about having a course in my university that didn’t have much of a research profile in traditional Chinese medicine.”

But a spokesman for the University of Technology Sydney said the debate over the scientific validity of Chinese medicine had nothing to do with the decision, and was “in no way a reflection of an institutional bias against complementary health care”. Personally, I find this statement surprising. Should the scientific validity of a subject not be a prime concern of any university?

In this context, may I suggest that the UTS might also have a critical look at their ‘AUSTRALIAN RESEARCH CENTRE IN COMPLEMENTARY AND INTEGRATIVE MEDICINE‘. They call themselves ‘the first centre worldwide dedicated to public health and health services research on complementary and integrative medicine’. Judging from the centre director’s publications, this means publishing one useless survey after another.

Acupuncture is effective in alleviating angina when combined with traditional antianginal treatment, according to a study published today in JAMA Internal Medicine. Researchers conducted a 20-week randomized clinical trial at 5 clinical centres in China. Patients with chronic, stable angina (a serious symptom caused by coronary heart disease) were randomly assigned to 4 groups:

  1. acupuncture on acupoints in the disease-affected meridian,
  2. acupuncture on a non-affected meridian,
  3. sham acupuncture,
  4. waitlist group that did not receive acupuncture.

All participants also received recommended antianginal medications. Acupuncture was given three times each week for 4 weeks. Patients were asked to keep a diary to record angina attacks. 398 patients were included in the intention-to-treat analysis. Greater reductions in angina attacks occurred in those who received acupuncture at acupoints in the disease-affected meridian compared with those in the nonaffected meridian group, the sham acupuncture group and the wait list group.

“Acupuncture was safely administered in patients with mild to moderate angina”, Zhao et al wrote. “Compared with the [control] groups, adjunctive acupuncture showed superior benefits … Acupuncture should be considered as one option for adjunctive treatment in alleviating angina.”

This study is well-written and looks good – almost too good to be true!

Let me explain: during the last 25 years, I must have studied several thousand clinical trials of SCAM, and I think that, in the course of this work, I have developed a fine sense for detecting trials that are odd or suspect. While reading the above RCT, my alarm-bells were ringing loud and clear.

The authors claim they have no conflicts of interest. This may well be true as far as financial conflicts of interest are concerned, but I have long argued that, in SCAM, ideological conflicts are much more powerful than financial ones. If we look at some of the authors’ affiliations, we get a glimpse of this possibility:

  • Acupuncture and Tuina School, Chengdu University o fTraditional Chinese Medicine, Chengdu, Sichuan, China
  • Department of Acupuncture, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China
  • Acupuncture and Tuina School, Hunan University of  Traditional Chinese Medicine, Changsha, Hunan, China
  • Acupuncture and Tuina School, Guiyang University of Traditional Chinese Medicine, Guiyang, Guizhou, China
  • Acupuncture and Tuina School, Shaanxi University of Chinese Medicine, Xianyang, Shaanxi, China
  • Acupuncture and Tuina School, Yunnan Provincial Hospital of Traditional Chinese Medicine, Kunming, Yunnan, China

I have reported repeatedly that several independent analyses have shown that as good as no TCM studies from China ever report negative results. I have also reported that data falsification is said to be rife in China.

I am aware, of course, that these arguments are hardly evidence-based and therefore amount to mere suspicions. So, let me also mention a few factual points about the new trial:

  • The study was concluded 4 years ago; why is it published only now?
  • The primary outcome measure was entirely subjective; an objective endpoint would have been valuable.
  • Patient blinding was not checked but would have been important.
  • The discussion is devoid of any critical input; this is perhaps best seen when looking at the reference list. The authors cite none of the many critical analyses of acupuncture.
  • The authors did actually not use normal acupuncture but electroacupuncture. One would have liked to see a discussion of effects of the electrical current versus those of acupuncture.
  • The therapists were not blinded (when using electroacupuncture, this would have been achievable). Therefore, one explanation for the outcome is lies in the verbal/non-verbal communication between therapists and patients.
  • Acupuncture was used as an add-on therapy, and it is conceivable that patients in the acupuncture group were more motivated to take their prescribed medications.
  • The costs for 12 sessions of acupuncture would have been much higher (in the UK) than those for an additional medication.
  • The practicality of consulting an acupuncturist three times a week need to be addressed.
  • The long-term effects of acupuncture on angina pectoris (which is a long-term condition) are unknown.

Coming back to my initial point about the reliability of the data, I feel that it is important to not translate these findings into clinical routine without independent replications by researchers from outside China who are not promoters of acupuncture. Until such data are available, I believe that acupuncture should NOT be considered as one option for adjunctive treatment in alleviating angina.

Many cancer patients use so-called alternative medicine (SCAM) such as Traditional Chinese Medicine (TCM). On this blog, we have repeatedly discussed whether this does more good than harm. This study sheds new light on the question. Specifically, it aims to explore the benefits of TCM therapy in the long-term survival of patients with hepatocellular carcinoma in China.

In total, 3483 patients with HCC admitted to the Beijing Ditan Hospital of Capital Medical University were enrolled. The researchers used 1:1 frequency matching by sex, age, diagnosis time, Barcelona Clinic Liver Cancer staging, and type of treatments to compare the TCM users (n = 526) and non-TCM users (n = 526). A Cox multivariate regression model was employed to evaluate the effects of TCM therapy on the HR value and Kaplan-Meier survival curve for mortality risk in HCC patients. A log-rank test was performed to analyse the effect of TCM therapy on the survival time of HCC patients.

The Cox multivariate analysis indicated that TCM therapy was an independent protective factor for 5-year survival in patients with HCC. The Kaplan-Meier curve also showed that after PS matching, TCM users had a higher overall survival rate and a higher progression-free survival rate than non-TCM users. TCM users, regardless of the classification of etiology, tumor stage, liver function level, or type of treatment, all benefited significantly from TCM therapy. The most commonly used Chinese patent medications used were Fufang Banmao Capsule, Huaier Granule, and Jinlong Capsule.

The authors concluded that using traditional Chinese medications as adjuvant therapy can probably prolong median survival time and improve the overall survival among patients with HCC. Further scientific studies and clinical trials are needed to examine the efficiency and safety.

I was unable to access the full article and therefore am unable to provide a detailed critique of it. From reading the abstract, I should point out, however, that this was not an RCT. To minimise bias, the researchers used a matching technique to generate two comparable groups. Such methods can be successful in matching for the named parameters, but they cannot match for the plethora of variables that might be relevant but were not measured. Therefore, the survival difference between the two groups might be due not to the therapies they received, but to the fact that the groups were not comparable in terms of factors that impact on survival.

Another important point about this paper is the obvious fact that it originates from China. We know from several independent investigations that such studies almost never report negative findings. We also know that TCM is a hugely important export item for China. Adding two and two together should therefore make us sceptical. I for one take the present findings with more than a pinch of salt.

Kampo, the traditional Japanese herbal medicine, developed out of traditional Chinese herbal medicine after it was introduced into Japan in the 7th century. In the early 20th century, Kampo was further influenced by modern Western medicine and science. The Kampo system is a pragmatic and simplified version of Chinese herbal medicine. Kampo medicines are standardised and not normally individualised as in Chinese herbal medicine. They are based on the symptoms of the patient, interpreted in the tradition of Kampo. Kampo diagnostic criteria consider hypofunction and hyperfunction, heat and cold, superficies and interior, and yin and yang.

Today, Kampō is fully integrated into the Japanese national health care system, and numerous Kampo preparations are registered in Japan and reimbursable from public funds. In Japan, Kampo is thus not a so-called alternative medicine (SCAM), but outside this country it clearly is.

Standardised Kampo formulas contain mixtures of herbal ingredients. They are manufactured under proper quality control. The most commonly used plants include liquorice, ginger and Chinese peony root. Most Japanese doctors routinely prescribe Kampo medicines, and most patients combine Kampo with Western medicine. Since 2002, the teaching of Kampo has been included in Japanese curricula of medical and pharmacy education. The efficacy of Kampo medicines is often less solidly documented than one would hope or expect. There is a remarkable shortage of high-quality clinical trials.

As Kampo medicines contain pharmacologically active ingredients, they can also cause adverse effects and might interact with synthetic drugs. Yet, the risks of Kampo are currently woefully under-investigated. And this is why an analysis of adverse events associated with Kampo formulations that was just published is particularly important.

The researchers obtained reports of adverse events associated with ethical Kampo formulations from the domestic adverse-event data from July 30, 2003, to March 31, 2018. Adverse events were then categorized, and the relationships between categories of adverse events and crude drugs were analysed.

There were 4,232 reported adverse events associated with Kampo. They related to liver injury, 1,193; lung injury, 1,177; pseudoaldosteronism, 889; mesenteric phlebosclerosis, 223; drug eruption, 185; and others, 565. Among events related to both liver injury and lung injury, approximately 70% were suspected to be induced by Kampo formulations containing Scutellariae Radix.

The pseudoaldosteronism-related events, which are induced by Glycyrrhizae Radix, included several events related to muscle injury, heart failure, and arrhythmia. Events related to mesenteric phlebosclerosis, believed to be induced by long-term use of Kampo formulas containing Gardeniae Fructus, increased remarkably during the study period. Among the events related to drug eruption, approximately 35% were suspected to be induced by Kampo formulations containing Ephedrae Herba.

The authors concluded that Kampo medicines may cause various adverse events. The present results provide valuable information regarding adverse events associated with Kampo medicines from the viewpoint of patient safety.

While this paper presents invaluable data, its authors offer little by way of critical discussion. There is hardly any good evidence to show that any of the Kampo formulas are effective. Thus a discussion needs to be had about the question whether they generate more good than harm. The authors are completely silent on this important issue, and I suspect the reason might be that Kampo is a bit of a ‘holy cow’ in Japan that must not be questioned.

The numbers of adverse events are impressively high, but we do not know how they compare to adverse events in other areas of healthcare. For instance, it would be valuable to have comparative data indicating how many adverse events occurred with Kampo compared to synthetic drugs per 1 000 patients using them.

Thus we are left with the conclusion that, once proper post-marketing methods are employed to monitor SCAM, we are likely to realise that adverse events do occur more frequently than SCAM enthusiasts might have predicted. In my view, it is high time that we have effective adverse event monitoring in all areas of SCAM.

Radix Salviae Miltiorrhizae (Danshen) is a herbal remedy that is part of many TCM herbal mixtures. Allegedly, Danshen has been used in clinical practice for over 2000 years.

But is it effective?

The aim of this systematic review was to evaluate the current available evidence of Danshen for the treatment of cancer. English and Chinese electronic databases were searched from PubMed, the Cochrane Library, EMBASE, and the China National Knowledge Infrastructure (CNKI), VIP database, Wanfang database until September 2018. The methodological quality of the included studies was evaluated by using the method of Cochrane system.

Thirteen RCTs with 1045 participants were identified. The studies investigated the lung cancer (n = 5), leukemia (n = 3), liver cancer (n = 3), breast or colon cancer (n = 1), and gastric cancer (n = 1). A total of 83 traditional Chinese medicines were used in all prescriptions and there were three different dosage forms. The meta-analysis suggested that Danshen formulae had a significant effect on RR (response rate) (OR 2.38, 95% CI 1.66-3.42), 1-year survival (OR 1.70 95% CI 1.22-2.36), 3-year survival (OR 2.78, 95% CI 1.62-4.78), and 5-year survival (OR 8.45, 95% CI 2.53-28.27).

The authors concluded that the current research results showed that Danshen formulae combined with chemotherapy for cancer treatment was better than conventional drug treatment plan alone.

I am getting a little tired of discussing systematic reviews of so-called alternative medicine (SCAM) that are little more than promotion, free of good science. But, because such articles do seriously endanger the life of many patients, I do nevertheless succumb occasionally. So here are a few points to explain why the conclusions of the Chinese authors are nonsense:

  • Even though the authors claim the trials included in their review were of high quality, most were, in fact, flimsy.
  • The trials used no less than 83 different herbal mixtures of dubious quality containing Danshen. It is therefore not possible to define which mixture worked and which did not.
  • There is no detailed discussion of the adverse effects and no mention of possible herb-drug interactions.
  • There seemed to be a sizable publication bias hidden in the data.
  • All the eligible studies were conducted in China, and we know that such trials are unreliable to say the least.
  • Only four articles were published in English which means those of us who cannot read Chinese are unable to check the correctness of the data extraction of the review authors.

I know it sounds terribly chauvinistic, but I do truly believe that we should simply ignore Chinese articles, if they have defects that set our alarm bells ringing – if not, we are likely to do a significant disservice to healthcare and progress.

Reiki is a form of energy healing popularised by the Japanese Mikao Usui (1865-1926). ‘Rei’ means universal spirit (sometimes thought of as a supreme being), and ‘ki’ is the assumed universal life energy. Reiki is broadly based on some of the obsolete concepts of Traditional Chinese Medicine. Reiki practitioners believe that they can transfer ‘healing energy’ to a patient which, in turn, stimulates the self-healing properties of the body. They assume that the therapeutic effects of this technique are obtained from a ‘universal life energy’ that provides strength, harmony, and balance to the body and mind.

This study (entitled ‘ The Power of Reiki’) was conducted to pilot testing the feasibility and efficacy of Reiki to provide pain relief among pediatric patients undergoing hematopoietic stem cell transplantation (HSCT). Paediatric patients undergoing HSCT during the inpatient phase in the Stem Cell Transplantation Unit were eligible to participate. Short and medium effects were assessed investigating the increase or decrease of patient’s pain during three specific time periods (“delta”) of the day: morning of the Reiki session versus assessment before Reiki session (within subjects control period), assessment before Reiki session versus assessment after Reiki session (within subjects experimental period) and assessment after Reiki session versus morning the day after Reiki session (within subject follow-up period). The effect of 88 Reiki therapy sessions in nine patients was analysed following a short, medium, and long-term perspective. Repeated-measures analysis of variance revealed a significant difference among the three periods: a decrease of the pain occurred in the experimental period in short and medium term, while in the follow-up period, the pain level remained stable.

The authors concluded that this study demonstrates the feasibility of using Reiki therapy in pediatric cancer patients undergoing HSCT. Furthermore, these findings evidence that trained pediatric oncology nurses can insert Reiki into their clinical practice as a valid instrument for diminishing suffering from cancer in childhood.

This is an unusual conclusion in that it is strictly speaking correct. What is wrong, however, that the abstract reports findings related to the alleged effectiveness of Reiki. A feasibility study is not designed for that purpose. I therefore suggest to ignore all allusions to therapeutic effects.

This, I think, begs the question as to why it is necessary or productive to study Reiki in clinical trials.

  • The treatment is not plausible.
  • There have been many trials already.
  • The ones that are sufficiently rigorous fail to show that it has any effects beyond placebo.
  • The medical literature is already highly polluted with Reiki studies reporting false-positive results.
  • This can only confuse researchers who attempt to conduct reviews on the subject.
  • Reiki studies discredit clinical research.
  • They are a waste of valuable resources.
  • Arguably, they are even unethical.

If you ask me, it is high time to stop researching such implausible nonsense.

 

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