Edzard Ernst

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

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.

 

 

It is hard to deny that many practitioners of so-called alternative medicine (SCAM) advise their patients to avoid ‘dangerous chemicals’. By this they usually mean prescription drugs. If you doubt how strong this sentiment often is, you have not followed the recent posts and the comments that regularly followed. Frequently, SCAM practitioners will suggest to their patients to not take this or that drug and predict that patients would then see for themselves how much better they feel (usually, they also administer their SCAM at this point).

Lo and behold, many patients do indeed feel better after discontinuing their ‘chemical’ medicines. Of course, this experience is subsequently interpreted as a proof that the drugs were dangerous: “I told you so, you are much better off not taking synthetic medicines; best to use the natural treatments I am offering.”

But is this always interpretation correct?

I seriously doubt it.

Let’s look at a common scenario: a middle-aged man on several medications for reducing his cardiovascular risk (no, it’s not me). He has been diagnosed to have multiple cardiovascular risk factors. Initially, his GP told him to change his life-style, nutrition and physical activity – to which he was only moderately compliant. Despite the patient feeling perfectly healthy, his blood pressure and lipids remained elevated. His doctor now strongly recommends drug treatment and our chap soon finds himself on statins, beta-blockers plus ACE-inhibitors.

Our previously healthy man has thus been turned into a patient with all sorts of symptoms. His persistent cough prompts his GP to change the ACE-inhibitor to a Ca-channel blocker. Now the patients cough is gone, but he notices ankle oedema and does not feel in top form. His GP said that this is nothing to worry about and asks him to grin and bear it. But the fact is that a previously healthy man has been turned into a patient with reduced quality of life (QoL).

This fact takes our man to a homeopath in the hope to restore his QoL (you see, it certainly isn’t me). The homeopath proceeds as outlined above: he explains that drugs are dangerous chemicals and should therefore best be dropped. The homeopath also prescribes homeopathics and is confident that they will control the blood pressure adequately. Our man complies. After just a few days, he feels miles better, his QoL is back, and even his sex-life improves. The homeopath is triumphant: “I told you so, homeopathy works and those drugs were really nasty stuff.”

When I was a junior doctor working in a homeopathic hospital, my boss explained to me that much of the often considerable success of our treatments was to get rid of most, if not all prescription drugs that our patients were taking (the full story can be found here). At the time, and for many years to come, this made a profound impression on me and my clinical practice. As a scientist, however, I have to critically evaluate this strategy and ask: is it the correct one?

The answer is YES and NO.

YES, many (bad) doctors over-prescribe. And there is not a shadow of a doubt that unnecessary drugs must be scrapped. But what is unnecessary? Is it every drug that makes a patient less well than he was before?

NO, treatments that are needed should not be scrapped, even if this would make the patient feel better. Where possible, they might be altered such that side-effects disappear or become minimal. Patients’ QoL is important, but it is not the only factor of importance. I am sure this must sound ridiculous to lay people who, at this stage of the discussion, would often quote the ethical imperative of FIRST DO NO HARM.

So, let me use an extreme example to explain this a bit better. Imagine a cancer patient on chemo. She is quite ill with it and QoL is a thing of the past. Her homeopath tells her to scrap the chemo and promises she will almost instantly feel fine again. With some side-effect-free homeopathy see will beat the cancer just as well (please, don’t tell me they don’t do that, because they do!). She follows the advice, feels much improved for several months. Alas, her condition then deteriorates, and a year later she is dead.

I know, this is an extreme example; therefore, let’s return to our cardiovascular patient from above. He too followed the advice of his homeopath and is happy like a lark for several years … until, 5 years after discontinuing the ‘nasty chemicals’, he drops dead with a massive myocardial infarction at the age of 62.

I hope I made my message clear: those SCAM providers who advise discontinuing prescribed drugs are often impressively successful in improving QoL and their patients love them for it. But many of these practitioners haven’t got a clue about real medicine, and are merely playing dirty tricks on their patients. The advise to stop a prescribed drug can be a very wise move. But frequently, it improves the quality, while reducing the quantity of life!

The lesson is simple: find a rational doctor who knows the difference between over-prescribing and evidence-based medicine. And make sure you start running when a SCAM provider tries to meddle with necessary prescribed drugs.

Some people seem to think that all so-called alternative medicine (SCAM) is ineffective, harmful or both. And some believe that I am hell-bent to make sure that this message gets out there. I recommend that these guys read my latest book or this 2008 article (sadly now out-dated) and find those (admittedly few) SCAMs that demonstrably generate more good than harm.

The truth, as far as this blog is concerned, is that I am constantly on the lookout to review research that shows or suggests that a therapy is effective or a diagnostic technique is valid (if you see such a paper that is sound and new, please let me know). And yesterday, I have been lucky:

This paper has just been presented at the ESC Congress in Paris.

Its authors are: A Pandey (1), N Huq (1), M Chapman (1), A Fongang (1), P Poirier (2)

(1) Cambridge Cardiac Care Centre – Cambridge – Canada

(2) Université Laval, Faculté de Pharmacie – Laval – Canada

Here is the abstract in full:

Introduction: Regular physical activity may modulate the inflammatory process and be cardio-protective. Yoga is a form of exercise that may have cardiovascular benefits. The effects of yoga on global cardiovascular risk have not been adequately described. The purpose of this study is to determine whether the addition of yoga to a regular exercise regimen reduces global cardiovascular risk.
Methods: Sixty consecutive individuals with essential hypertension were recruited in a lifestyle intervention program. All individuals with known hypertensive end organ damage, known cardiovascular diseases, as well as those taking medications/supplements that affected blood pressure, blood sugar, cholesterol or vascular inflammation were excluded. Participants were randomized to either a yoga group or similar duration stretching control group. Participants, over the 3-month intervention regimen, performed 15 minutes of either yoga or stretching in addition to 30 minutes of aerobic exercises thrice weekly. Blood pressure, cholesterol levels and hs-CRP were measured, and Reynold’s Global Cardiovascular Risk Score was calculated at baseline and at the end of the 3-month intervention program.
Results: At screening, there were no statistically significant differences between the groups in any measured parameters or the 10-year risk of a cardiovascular event as measured by the Reynolds Risk Score. (8.2 vs. 9.0%; yoga vs. control group) After the 3-month intervention period, there was a statistically significantly greater decrease in the Reynold’s Risk Score in the yoga vs. the control group. (7.0 vs. 8.4%, p=0.003, relative reduction 13.2 vs. 6.5%, p<0.0001)
Conclusions: In patients with essential hypertension on no medications and with no known end organ damage, the practice of yoga incorporated into a 3-month exercise intervention program was associated with significant greater improvement in the Reynold’s Risk of a 10-year cardiovascular event, when compared to the control stretching group. If these results are validated in more diverse populations over a longer duration of follow up, yoga may represent an important addition to traditional cardiovascular disease prevention programs.

Yes, this study was small, too small to draw far-reaching conclusions. And no, we don’t know what precisely ‘yoga’ entailed (we need to wait for the full publication to get this information plus all the other details needed to evaluate the study properly). Yet, this is surely promising: yoga has few adverse effects, is liked by many consumers, and could potentially help millions to reduce their cardiovascular risk. What is more, there is at least some encouraging previous evidence.

But what I like most about this abstract is the fact that the authors are sufficiently cautious in their conclusions and even state ‘if these results are validated…’

SCAM-researchers, please take note!

Dr Alice Hodkinson is a GP in Cambridge, England. She says of herself that she is interested in supporting people to make informed choices about their own health, reduce the burden of illness and lighten the load of medication on patients and the country’s National Health Service. She is studying medical ethics and law at King’s College London.

Even though we live in the same town, I don’t know Dr Hodkinson personally and never met her. My only contact with her is the one depicted here: on Twitter I had posted my recent article entitled ‘A new, comprehensive review: HOMEOPATHY = PLACEBO THERAPY‘. This prompted the following exchange:
__________________________________________________________________

Alice @HodkinsonAlice

At the very least homeopathy and placebos don’t cause harm that medicines do.
__________________________________________________________________

Edzard Ernst @EdzardErnst

have you heard of something called ‘risk/benefit balance’?
__________________________________________________________________

Alice @HodkinsonAlice

Which is precisely where homeopathy wins over toxins I prescribe as medication.
__________________________________________________________________

Edzard Ernst @EdzardErnst

oh really? I do worry about the students you teach
__________________________________________________________________

Alice @HodkinsonAlice

I worry about the over-use of toxins that harm. Lots of ppl get much better when meds are stopped. They come back from the dead and live much happier. Lots of evidence for this.
__________________________________________________________________

Edzard Ernst @EdzardErnst

” Lots of ppl get much better when meds are stopped.” surely this is a sign that they never needed them; in other words, it is the mistake of the GP who did the prescription
__________________________________________________________________

Alice @HodkinsonAlice

It’s a sign meds’ aren’t reviewed and they do harm. Water doesn’t harm, unless in excess. Promoting water as a cure might be harmful, yet there are sooooo many conditions where medicine has no answers, and for these, homeopathy comes up trumps.
__________________________________________________________________

Edzard Ernst @EdzardErnst

I am sooooooo pleased you are not my GP!
__________________________________________________________________

Alice @HodkinsonAlice

I’m bored. Go poison yourself on prescribed medication!
__________________________________________________________________
END OF EXCHANGE

I don’t know why this shocks me more than any of the often much more disagreeable disputes I have with other proponents of homeopathy on Twitter or on this blog. Perhaps it is because it occurred with a person who is a doctor like myself, or because it happened with a complete stranger, or because it was with someone who is, for all I know, an entirely reasonable clinician in other medical matters, or because Dr Hodkinson is studying medical ethics? I really don’t know.

Or perhaps nobody have ever told me to poison myself?

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)

I have often felt that practitioners of so-called alternative medicine (SCAM) tend to be foolishly overconfident, often to the point of being dangerous. In a word, they are plagued by hubris.

Here is an example of osteopathic hubris:

The aim of this study was to determine the impact of visceral osteopathy on the incidence of nausea/vomiting, constipation and overall quality of life (QoL) in women operated for breast cancer and undergoing adjuvant chemotherapy in Centre Georges François Leclerc, CGFL.

Ninety-four women operated for a breast cancer stage 1-3, in complete resection and to whom a 3 FEC 100 chemotherapy was prescribed, were randomly allocated to experimental or placebo group. Experimental group underwent a visceral osteopathic technique and placebo group was subjected to a superficial manipulation after each chemotherapy cycle. Rate of grade ≥1 nausea/vomiting or constipation, on the first 3 cycles of FEC 100, were reported. QoL was evaluated using the EORTC QLQ-C30 questionnaire.

Rate of nausea/vomiting episodes of grade ≥1 was high in both experimental and placebo group. Constipation episodes of grade ≥1 were also frequent. No significant differences were found between the two groups concerning the rate of nausea/vomiting (p = 0.569) or constipation (p = 0.204) according to clinician reported side-effects but patient reported impact of constipation and diarrhoea on quality of life was significantly lower in experimental group (p = 0.036 and p = 0.038, respectively).

The authors concluded that osteopathy does not reduce the incidence of nausea/vomiting in women operated for breast cancer and undergoing adjuvant chemotherapy. In contrast, patient reported digestive quality of life was significantly ameliorated by osteopathy.

Visceral osteopathy has been discussed here several times already (for instance here and here). In my new book, I summarise the evidence as follows:

Several studies have assessed the diagnostic reliability of the techniques involved. The totality of this evidence fails to show that they are sufficiently reliable to be of practical use.

Other studies have tested whether the therapeutic techniques used in visceral osteopathy are effective in curing disease or alleviating symptoms. The totality of this evidence fails to show that visceral osteopathy works for any condition.

The treatment itself is probably safe, yet the risks of visceral osteopathy are nevertheless considerable: if a patient suffers from symptoms related to her inner organs, a visceral osteopath is likely to misdiagnose them and subsequently mistreat them. If the symptoms are due to a serious disease, this would amount to medical neglect and could, in extreme cases, cost the patient’s life.

PLAUSIBILITY negative
EFFICACY negative
SAFETY debatable
COST negative
RISK/BENEFIT BALANCE negative

_____________________________________________________________________________

The key message here should be that visceral osteopathy lacks plausibility. So why test its effectiveness for any condition, especially chemo-induced nausea where there is no conceivable mechanism of action and no hint that it might work?

The answer, I am afraid, might be quite simple: osteopathic hubris!

Archives of Psychiatric Nursing disseminates original, peer-reviewed research that is of interest to psychiatric and mental health care nurses. The field is considered in its broadest perspective, including theory, practice and research applications related to all ages, special populations, settings, and interdisciplinary collaborations in both the public and private sectors. Through critical study, expositions, and review of practice, Archives of Psychiatric Nursing is a medium for clinical scholarship to provide theoretical linkages among diverse areas of practice.

If peer-review, critical study and clinical scholarship are not just empty platitudes, what – if anything – should such a journal publish about Bach flower remedies? Perhaps something like this (straight from my new book)?

________________________________________________________________

Bach flower remedies were invented in the 1920s by Dr Edward Bach (1886-1936), a doctor homeopath who had previously worked in the London Homeopathic Hospital. They have since become very popular in Europe and beyond.

  1. Bach flower remedies are clearly inspired by homeopathy; however, they are not the same because they do not follow the ‘like cures like’ principle and are they potentised.
  2. They are manufactured by placing freshly picked specific flowers or parts of plants in water which is subsequently mixed with alcohol, bottled and sold.
  3. Like most homeopathic remedies, they are highly dilute and thus do not contain therapeutic amounts of the plant printed on the bottle.
  4. Bach developed 38 different remedies, each corresponding to an emotional state which he believed to be the cause of all illness:

Agrimony – mental torture behind a cheerful face
Aspen – fear of unknown things
Beech – intolerance
Centaury – the inability to say ‘no’
Cerato – lack of trust in one’s own decisions
Cherry Plum – fear of the mind giving way
Chestnut Bud – failure to learn from mistakes
Chicory – selfish, possessive love
Clematis – dreaming of the future without working in the present
Crab Apple – the cleansing remedy, also for self-hatred
Elm – overwhelmed by responsibility
Gentian – discouragement after a setback
Gorse – hopelessness and despair
Heather – self-centredness and self-concern
Holly – hatred, envy and jealousy
Honeysuckle – living in the past
Hornbeam – procrastination, tiredness at the thought of doing something
Impatiens – impatience
Larch – lack of confidence
Mimulus – fear of known things
Mustard – deep gloom for no reason
Oak – the plodder who keeps going past the point of exhaustion
Olive – exhaustion following mental or physical effort
Pine – guilt
Red Chestnut – over-concern for the welfare of loved ones
Rock Rose – terror and fright
Rock Water – self-denial, rigidity and self-repression
Scleranthus – inability to choose between alternatives
Star of Bethlehem – shock
Sweet Chestnut – extreme mental anguish, when everything has been tried and there is no light left
Vervain – over-enthusiasm
Vine – dominance and inflexibility
Walnut – protection from change and unwanted influences
Water Violet – pride and aloofness
White Chestnut – unwanted thoughts and mental arguments
Wild Oat – uncertainty over one’s direction in life
Wild Rose – drifting, resignation, apathy
Willow – self-pity and resentment
Rescue Remedy, a combination remedy made up of five different remedies, is promoted against anxiety and stress.

 

  1. There are only few clinical trials of Bach flower remedies. Collectively, they fail to show that they are effective beyond placebo. A systematic review of all 7 studies concluded that the most reliable clinical trials do not show any differences between flower remedies and placebos.[1]
  2. Since they do not contain any pharmacologically active molecules (other than alcohol), Bach flower remedies are unlikely to cause adverse effects other than those to the consumer’s wallet.
  3. Considering that Bach flower remedies are not effective, their risk/benefit balance cannot be positive.

 

 

PLAUSIBILITY Negative
EFFICACY Negative
SAFETY Positive
COST Negative
RISK/BENEFIT BALANCE Negative

 

[1] https://www.ncbi.nlm.nih.gov/pubmed/20734279

____________________________________________________________

And what did the journal in fact publish? Here is an excerpt from a truly remarkable article that just appeared in the Archives of Psychiatric Nursing:

… Bach Flowers are liquids that come in 10 and 20 ml “mother” bottles. The liquids are the essence of the substance used in the remedy preserved in a small amount of brandy. As is the case with homeopathic remedies, Bach Flowers are essences or energetic remedies.

Two drops from the mother bottle of the specific Bach Flower remedy are placed in a 1 oz glass dropper bottle that is filled with water. Because the Bach system is an energetic plant remedy system, using more than two drops in a bottle is not harmful but is also unnecessary as it is not more useful. The most important part in the use of the system is picking the correct remedy. There are books and the original Bach website (www.bachcentre.com) that provide Bach’s descriptions of the patterns of behaviors and health patterns associated with each of the remedies. For example, those who feel overwhelmed by their responsibilities can try taking “elm.”

The remedies are also powerful healers in infants and children. Behavior changes can be immediate with the use of the right remedy at the right time. The key is getting to know well the specific patterns of each of the 38 healers. The nurse who is knowledgeable of the 38 healers can then better perceive the patterns reflected in the infant’s behavior and then suggest the remedies that parents might want to read about. For example, walnut is used for those experiencing emotional difficulties related to transition and change. When a new infant is born, other children go through significant change and transition in their view of the world which is their family. Walnut can help all of the children if and when they exhibit signs of distress. Walnut is also helpful when infants are teething. Parents often ask whether a person who is allergic to walnuts would be allergic to the walnut flower essence Bach remedy. “The active ingredient in a flower remedy is an energy from the plant, not a physical substance” (Bach Centre, n.d..). It should not cause allergic reactions and should not interfere with the physical action of other remedies and medicines.

Illness is defined by Bach as it is in many healing traditions as the stagnation of energy flow. The remedies help to move people through emotion; they do not suppress emotions. Bach writes that, “the action of these remedies is to raise our vibrations and open up our channels for the reception of our Spiritual Self, to flood our natures with a particular virtue we need, and wash out from us the fault which is causing harm. They are able like beautiful music…to raise our very natures, and bring us nearer to our Souls…They cure not by attacking disease, but by flooding our bodies with the beautiful vibrations of our Higher Nature, in the presence of which disease melts as snow in the sunshine” (Howard & Ramsell, 1990, p. 62).

The Bach remedies move emotions but they do so very gently. Two drops of any remedy diluted in 1 oz of water can be put in the infant’s mouth or on their skin. One way to get to know the Bach Flower remedy system is to try the Rescue Remedy first, a combination of five of the 38 healers used in cases of stress, anxiety, and trauma. Four drops of Rescue Remedy can be put into any size container of water and then given in sips to help infants experiencing intense stress. For example, I once had to participate in the suturing of the forehead of a two-year-old. He was brought to the clinic by his father, a veteran who had seen combat. The child, who was normally curious and friendly, was wild with fear. He thrashed about with his head throwing blood everywhere. The nurses had a standing order to give Rescue Remedy to any patient and so we got permission from the dad and squirted a dropper of the remedy in his mouth while telling him that the flower remedy would help. It did. The child immediately stopped his thrashing. He did not stop crying or saying “no” as he held onto his father’s hand. But he was whimpering rather than thrashing about as we took care of his wound. The trauma and subsequent memory were abated.

____________________________________________________________________

YES, FOR ONCE, I AM SPEACHLESS.

Is homeopathy an effective treatment for PMS?

No, how could it?

Previous studies have thus had mixed results:

A feasibility study of 2018 showed that, in Germany, the study could not proceed because of legal limitations. In Sweden, recruitment proved extremely difficult. In the Netherlands and Sweden, 60 women were randomized (UC + HT: 28; UC: 32), data of 47/46 women were analyzed (ITT/PP). After 4 months, relative mean change of DRSP scores in the UC + HT group was significantly better than in the UC group (p = 0.03).

A case series with 23 women suggested that homeopathic treatment was well tolerated and seemed to have a positive impact on PMS symptoms. Folliculinum was the most frequent homeopathic medicine prescribed. There appears to be scope for a properly designed, randomized, placebo-controlled trial to investigate the efficacy of individual homeopathic medicines in PMS.

And a pilot study reported that homeopathic treatment was found to be effective in alleviating the symptoms of PMS in comparison to placebo. The use of symptom clusters in this trial may offer a novel approach that will facilitate clinical trials in homeopathy. Further research is in progress.

The authors of this pilot include several prominent homeopath who have honoured their word by publishing their definitive study. This double-blind placebo-controlled RCT tested the efficacy of individually prescribed homeopathic medicines in women with premenstrual syndrome (PMS).

In an outpatient department of a university clinic in Jerusalem, Israel, women with PMS, aged 18 to 50 years, entered a 2-month screening phase with prospective daily recording of premenstrual symptoms by the Menstrual Distress Questionnaire (MDQ). They were included after being diagnosed with PMS. A reproducible treatment protocol was used: women received a homeopathic prescription based on symptom clusters identified in a questionnaire. The symptoms were verified during a complementary, structured, interview. Only women whose symptoms matched the symptom profile of one of 14 pre-selected homeopathic medicines were included. Each participant was administered active medicine or placebo via random allocation. Primary outcome measures were differences in changes in mean daily premenstrual symptom (PM) scores by the MDQ. Analysis was by intention-to-treat.

A total of 105 women were included: 49 were randomized to active medicine and 56 to placebo. Forty-three women in the active medicine group and 53 in the placebo group received the allocated intervention with at least one follow-up measurement and their data were analyzed. Significantly greater improvement of mean PM scores was measured in the active medicine group compared to placebo.

The authors concluded that individually prescribed homeopathic medicines were associated with significantly greater improvement of PM scores in women with PMS, compared to placebo. Replication, with larger sample size and other refinements, is recommended to confirm the efficacy of this treatment in other settings.

Not being able to assess the full paper – remember, I was fired from the journal’s editorial board – I am unable to scrutinise this trial properly. As I suspect that the authors were the victim of some hidden biases, I concur only with the second part of their conclusion: replication is needed before we can accept these findings – but please, make it an INDEPENDENT replication!

Another presentation from the 2nd OFFICIAL SIPS CONFERENCE ON PLACEBO STUDIES caught my eye. As it is not available on-line, I have copied here the unabbreviated abstract:

Open-label placebo vs. conventional and alternative medicine – An online study on expected effectiveness 1. Marcel Wilhelm. Philipps-University Marburg, Marburg, Germany. 2. Winfried Rief. Philipps-University Marburg, Marburg, Germany. 3. Frank Euteneuer. Medical School Berlin, Berlin, Germany.

Background: Treatment expectations are a key mechanism in placebo effects. Optimizing these expectations is a main goal in placebo designs but is often based on deception. To address ethical concerns, open-label placebo treatments seem to be effective without deception, although the role of expectations for their effect is rather unclear. Methods: Participants (N=253) who occasionally suffer from headaches were recruited online and randomized to receive one of three hypothetical descriptions of a doctor-patient-situation in which a certain headache treatment is prescribed: 1) conventional medicine, 2) open-label placebo, 3) alternative medicine (homeopathy). Subsequently, participants rated how strongly they expect that the given treatment can be effective. Results: One-way ANOVA revealed differences in expected effectiveness between groups. The highest expected effectiveness occurred in the conventional medicine group, the lowest in the open-label placebo group as well as in the homeopathy group. Potential moderators are discussed, e.g., socioeconomic variables, health literacy, locus of control. Conclusions: Participants expect lower effectiveness of treatment if they are truthfully informed about the inertness of a prescribed treatment (open-label placebo). While the descriptions were otherwise identical, the homeopathy group also scored lower levels of expectancy compared to conventional medicine. Homeopathy can be interpreted as a placebo prescription with deception as it does not contain pharmacologically active substances. The expected effectiveness in the homeopathy group did not differ from open-label placebo. These results suggest that prescribing a placebo while truthfully informing about placebo effects seems to be as feasible as to prescribe homeopathy regarding the expected effectiveness.

I am not sure what these results indicate. However, the fact that the authors describe homeopathy as a ‘placebo prescription with deception’ is definitely interesting.

I wonder whether homeopaths agree.

A chiro, a arms dealer and a Brexit donor meet in a bar.

The arms dealer: my job is so secret, I cannot tell my neighbour what I do.

The Brexit donor: I have to keep things so close to my chest that not even my wife knows what I am doing.

The chiro: that’s nothing; my work is so secret that not even I know what I am doing.

CHILDISH, I KNOW!

But I am yet again intrigued by a survey aimed at finding out what chiropractors are up to. One might have thought that, after 120 years, they know what they are doing.

This survey described the profiles of chiropractors’ practice and the reasons, nature of the care provided to their patients and extent of interprofessional collaborations in Ontario, Canada. The researchers randomly recruited chiropractors from a list of registered chiropractors (n=3978) in active practice in 2015. Of the 135 randomly selected chiropractors, 120 were eligible, 43 participated and 42 completed the study.

Each chiropractor recorded information for up to 100 consecutive patient encounters, documenting patient health profiles, reasons for encounter, diagnoses and care provided. Descriptive statistics summarised chiropractor, patient and encounter characteristics, with analyses accounting for clustering and design effects. Thus data on 3523 chiropractor-patient encounters became available. More than 65% of participating chiropractors were male, mean age 44 years and had practised on average 15 years. The typical patient was female (59% of encounters), between 45 and 64 years (43%) and retired (21%) or employed in business and administration (13%). Most (39.4%) referrals were from other patients, with 6.8% from physicians. Approximately 68% of patients paid out of pocket or claimed extended health insurance for care. Most common diagnoses were back (49%, 95% CI 44 to 56) and neck (15%, 95% CI 13 to 18) problems, with few encounters related to maintenance/preventive care (0.86%, 95% CI 0.2 to 3.9) and non-musculoskeletal problems (1.3%, 95% CI 0.7 to 2.3). The most common treatments included spinal manipulation (72%), soft tissue therapy (70%) and mobilisation (35%).

The authors concluded that this is the most comprehensive profile to date of chiropractic practice in Canada. People who present to Ontario chiropractors are mostly adults with a musculoskeletal condition. Our results can be used by stakeholders to make informed decisions about workforce development, education and healthcare policy related to chiropractic care.

I am so sorry to have mocked this paper. I shouldn’t have, because it actually does reveal a few interesting snippets:

  1. Only 7% of referrals come from real doctors.
  2. The vast majority of all patients receive spinal manipulations.
  3. About 6% of them are under 14 years of age.
  4. Chiropractors seem to dislike surveys; only 35% of those asked complied.
  5. 23% of all consultations were for general or unspecified problems,
  6. 8% for neurologically related problems,
  7. 5% for non-musculoskeletal problems (eg, digestive, ear, eye, respiratory, skin, urology, circulatory, endocrine and metabolic, psychological).
  8. Chiropractors rarely refer patients to other clinicians; this only happened in less than 3% of encounters.
  9. Apart from manipulation, chiropractors employ all sorts of other dubious therapies (ultrasound 3%, acupuncture 3%, , traction 1%, interferential therapy 3%, soft laser therapy 3%).
  10.  68% of patients pay out of their own pocket…

… NO WONDER, THEY DO NOT SEEM TO BE IN NEED OF ANY TYPE OF TREATMENT: 54% of all patients reported being in “excellent/very good overall health”!

If you want to be able to edit your comment for five minutes after you first submit it, you will need to tick the box: “Save my name, email, and website in this browser for the next time I comment.”

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