MD, PhD, FMedSci, FSB, FRCP, FRCPEd

conflict of interest

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Osteopathy is a confusing subject about which I have reported regularly on this blog (for instance here and here).

Recently, I came across a good article where someone had assessed 100 websites by UK osteopaths. The findings are impressive:

57% of websites in the survey published the ‘self-healing’ claim

70% publicised the fact they offered cranial therapy;

61% made a claim to treat one or more specific ailments not related to the musculoskeletal system;

48% of practitioners also personally offered another CAM therapy;

71% of all sites surveyed located in a setting where other CAM was immediately available.

In total, 93% of the randomly selected websites checked at least one, often more, of the criteria for pseudoscientific claims. The author concluded that quackery is far from existing only on the fringe of osteopathic practice.

In a previous article, the author had stated that “there’s some (not strong) evidence that manual therapy may have some benefit in the case of lower back pain.” This evidence for the assumption that osteopathy works for back pain seems to rely heavily on one researcher: Licciardone JC. He comes from ‘The Osteopathic Research Center, University of North Texas Health Science Center, Fort Worth‘. which also is the flag-ship of research into osteopathy with plenty of funds and a worldwide reputation.

In 2005, he and his team published a systematic review/meta-analysis of RCTs which concluded that “osteopathic manipulative therapy (OMT) significantly reduces low back pain. The level of pain reduction is greater than expected from placebo effects alone and persists for at least three months. Additional research is warranted to elucidate mechanistically how OMT exerts its effects, to determine if OMT benefits are long lasting, and to assess the cost-effectiveness of OMT as a complementary treatment for low back pain.”

This is the article cited regularly to support the statement that osteopathy is an effective therapy for back pain. As the paper is now over 10 years old, we clearly need a more up-to-date systematic review. Such an assessment of clinical research into osteopathic intervention for chronic non-specific low back pain (CNSLBP) was recently published by an Australian team. A thorough search of the literature in multiple electronic databases was undertaken, and all articles were included that reported clinical trials; had adult participants; tested the effectiveness and/or efficacy of osteopathic manual therapies applied by osteopaths, and had a study condition of CNSLBP. The quality of the trials was assessed using the Cochrane criteria. Initial searches located 809 papers, 772 of which were excluded on the basis of abstract alone. The remaining 37 papers were subjected to a detailed analysis of the full text, which resulted in 35 further articles being excluded. There were thus only two studies assessing the effectiveness of manual therapies applied by osteopaths in adult patients with CNSLBP. The results of one trial suggested that the osteopathic intervention was similar in effect to a sham intervention, and the other implies equivalence of effect between osteopathic intervention, exercise and physiotherapy.

In other words, there seems to be an overt contradiction between the conclusions of Licciardone JC and those of the Australian team. Why? we may well ask. Perhaps the Osteopathic Research Center is not in the best position to be impartial? In order to check them out, I decided to have a closer look at their publications.

This team has published around 80 articles mostly in very low-impact osteopathic journals. They include several RCTs, and I decided to extract the conclusions of the last 10 papers reporting RCTs. Here they are:

RCT No 1 (2016)

Subgrouping according to baseline levels of chronic LBP intensity and back-specific functioning appears to be a simple strategy for identifying sizeable numbers of patients who achieve substantial improvement with OMT and may thereby be less likely to use more costly and invasive interventions.

RCT No 2 (2016)

The OMT regimen was associated with significant and clinically relevant measures for recovery from chronic LBP. A trial of OMT may be useful before progressing to other more costly or invasive interventions in the medical management of patients with chronic LBP.

RCT No 3 (2014)

Overall, 49 (52%) patients in the OMT group attained or maintained a clinical response at week 12 vs. 23 (25%) patients in the sham OMT group (RR, 2.04; 95% CI, 1.36-3.05). The large effect size for short-term efficacy of OMT was driven by stable responders who did not relapse.

RCT No 4 (2014)

These findings suggest that remission of psoas syndrome may be an important and previously unrecognized mechanism explaining clinical improvement in patients with chronic LBP following OMT.

RCT No 5 (2013)

The large effect size for OMT in providing substantial pain reduction in patients with chronic LBP of high severity was associated with clinically important improvement in back-specific functioning. Thus, OMT may be an attractive option in such patients before proceeding to more invasive and costly treatments.

RCT No 6 (2013)

The OMT regimen met or exceeded the Cochrane Back Review Group criterion for a medium effect size in relieving chronic low back pain. It was safe, parsimonious, and well accepted by patients.

RCT No 7 (2012)

This study found associations between IL-1β and IL-6 concentrations and the number of key osteopathic lesions and between IL-6 and LBP severity at baseline. However, only TNF-α concentration changed significantly after 12 weeks in response to OMT. These discordant findings indicate that additional research is needed to elucidate the underlying mechanisms of action of OMT in patients with nonspecific chronic LBP.

RCT No 8 (2010)

Osteopathic manipulative treatment slows or halts the deterioration of back-specific functioning during the third trimester of pregnancy.

RCT No 8 (2004)

The OMT protocol used does not appear to be efficacious in this hospital rehabilitation population.

RCT No 9 (2003)

Osteopathic manipulative treatment and sham manipulation both appear to provide some benefits when used in addition to usual care for the treatment of chronic nonspecific low back pain. It remains unclear whether the benefits of osteopathic manipulative treatment can be attributed to the manipulative techniques themselves or whether they are related to other aspects of osteopathic manipulative treatment, such as range of motion activities or time spent interacting with patients, which may represent placebo effects.

RCT No 10

Sorry, there is no 10th paper reporting an RCT.

Most of the remaining articles listed on Medline are comments and opinion papers. Crucially, it would be erroneous to assume that they conducted a total of 9 RCTs. Several of the above cited articles refer to the same RCT.

However, the most remarkable feature, in my view, is that the conclusions are almost invariably positive. Whenever I find a research team that manages to publish almost nothing but positive findings on one subject which most other experts are sceptical about, my alarm-bells start ringing.

In a previous blog, I have explained this in greater detail. Suffice to say that, according to my theory, the trustworthiness of the ‘Osteopathic Research Center’ is nothing to write home about.

What, I wonder, does that tell us about the reliability of the claim that osteopathy is effective for back pain?

The madness of some homeopaths who claim they can cure cancer has irritated me and others repeatedly, for instance here and here. Many apologists of homeopathy say that responsible homeopaths would never make such a claim. They may be right – but the sad reality is than there are far too many irresponsible homeopaths.

This article by Dr Pankaj Aggarwal, a ‘senior homeopathic physician’, marks in my view a new record in homeopathic ineptitude and irresponsibility. Here is an excerpt (it seems that the actual article has disappeared; luckily I saved it before):

“In homeopathy, non-toxic medicines are used to treat this cancer. There are no side-effects associated with homeo medicines for cervical cancer. If this problem is diagnosed at earlier stages, it becomes easier to treat and takes very less time. In advanced stages, more time is required to improve the situation. It is actually possible to treat cancer with homeopathic medicines. In fact, homeopathy is the only treatment method that can completely cure this disease. There are different approaches to treat this disease in homeopathy. Good homeo practitioners usually use a combination of these approaches while treating a cancer patient.

Treatment Approach 1

The first philosophy to treat cancer is to directly target the cancer tumors. In this way, the practitioner selects the proper medicines that match the symptom picture of tumors. An example of such medicine is Conium Maculatum, which can be used to treat immovable, hard and slowly developing tumors. In this approach, other symptoms of patient are also taken into consideration and are treated. This approach targets tumors and reverses their growth to the point where they no more exist or become harmless.

Treatment Approach 2

The second or indirect approach is to strengthen the cell detoxification process and eliminative channels of patients like liver, lymphatic system, urinary tract and kidneys. From this approach, the homeopathy practitioner uses low potency drainage remedies that detoxify particular substances like heavy metals or target particular body systems. The particular medicines used for this drainage is selected after thorough analysis of the particular cancer case.

Treatment Approach 3

In this approach, a complete interview of the patient’s emotional, physical, and mental symptoms is conducted. After that, best matching remedies are selected to address the complete constitution of the patient. Most of the times these homeopathy medicines will affect and target the cancer tumors directly. This treatment, if done properly, can result in complete removal of cancer tumors, resulting in full recovery.”

END OF QUOTE

The facts about homeopathy are very clear and tell a totally different story:

  • the assumptions that underpin homeopathy are implausible,
  • homeopathic remedies usually are far too dilute to have any effects whatsoever,
  • there is no evidence to support any of the above claims,
  • believing such claims will almost inevitably cause great harm to patients.

What follows is simple: HOMEOPATHS WHO MAKE THERAPEUTIC CLAIMS BEHAVE UNETHICALLY, ARGUABLY EVEN CRIMINALLY

This is the conclusion Britt Hermes draws in her new blog post about US naturopaths claiming to be competent to treat children.

Britt is a most remarkable and courageous woman. She clearly knows what she is talking about: “My experience puts me in a unique position to show what naturopathic training looks like from the inside and why, especially for children, naturopathic care is dangerous. I support this point with a critical review of pediatrics syllabi from Bastyr University (Seattle, WA) and Southwest College of Naturopathic Medicine (Phoenix, AZ) and correspondences with a number of pediatricians in the U.S. and Canada.

At Bastyr, I took pediatrics 1 and 2 (NM 7314 and 7315) and an additional elective course in “advanced pediatrics” (NM 9316) from 2010-2011. I also opted to take the elective pediatrics clinical shift at Bastyr’s outpatient teaching clinic. Only pediatrics 1 and 2 were required for graduation. Each class met for 2 hours per week for 10 weeks, not including the 11th week for a final exam. By taking the advanced course, I received a total of 60 hours, but remember, only 40 hours was required. (In the year after I graduated from Bastyr, the curriculum changed to a systems-based program, which folded pediatric instruction into courses linked by medical theme.)…

Here’s the bottom line: a pediatrician gets a combined 20,000 hours of training in medical school and residency; a licensed naturopath has the option of doing a naturopathic residency for 1,300 hours after having done 30 to 40 hours of lecture hours in paediatrics…”

If you think that is bad… it gets worse:

A serious concern with this course syllabus is the book list. Current and Nelson’s Pediatrics are considered standard texts, but these were not even required to read in order to do well in the course. I didn’t buy either book and didn’t complete any of the assigned readings but passed with flying colors.

It should be appalling for anyone to see Dana Ullman’s Homeopathy for Children and Infants and Dr. Bob Sears’s The Vaccine Book, not once, but twice in the list! All of my syllabi for the Bastyr pediatrics courses include these texts. The syllabus for pediatrics at SCNM does not, but its instructor is a known promoter of vaccine myths

Naturopathic students are essentially trained in alternative vaccines schedules, perhaps leading them not to vaccinate. If this isn’t smoking gun proof that naturopaths are anti-vaccine to the core, then what is?”

Britt’s final conclusion is that “Naturopathic programs do not provide their students with medical training that should instil public confidence. Yet, naturopaths argue that they deserve licensure based on the quality of their training and practice.”

I agree completely with Britt’s view and encourage everyone to read her article in full.

This sad story was reported across the world. It is tragic and, at the same time, it makes me VERY angry. A women lost her life after giving birth due to the incompetence of her midwife. On this website, we learn the following gruesome details:

Many question the culpability of Australian midwife Gaye Demanuele in the wake of the investigations into the death of Caroline Lovell during her home birth in 2012. And while Demanuele played a major role in Lovell’s passing, a closer look may show the real culprit: homeopathy. In January 2012, Demanuele, an outspoken home birth advocate, served as senior midwife in Lovell’s home birth. After giving birth, Lovell experienced severe blood loss and begged to call an ambulance. According to the investigating coroner, Demanuele refused several times, never checking her patient’s blood pressure or effectively monitoring her blood loss. Demanuele instead tried a homeopathic “remedy” to relieve Lovell’s anxiety. Only after Lovell fainted in a pool of her own blood and went into cardiac arrest was she taken to a hospital, where she died 12 hours later…

We know that many midwifes are besotted with alternative medicine. Their love-affair with quackery had to lead to serious harm sooner or later. This story is thus tragic and awful – but it is not surprising.

What makes me angry, is the complete lack of critical comment from homeopaths and their professional organisations. Where are the homeopaths who state clearly and categorically that the use of homeopathic remedies in the situation described above (and indeed in midwifery generally) is not based on sound evidence? In fact, it is criminal charlatanry!

Homeopaths are usually not lost for words.

Where is the homeopathic organisation stating that a bleeding patient does not need homeopathy?

How should we interpret this deafening silence?

Does it mean that those homeopaths who quietly tolerate charlatanry are themselves charlatans?

If so, would this not be 100% of them?

Recently, I came across the ‘Clinical Practice Guidelines on the Use of Integrative Therapies as Supportive Care in Patients Treated for Breast Cancer’ published by the ‘Society for Integrative Oncology (SIO) Guidelines Working Group’. The mission of the SIO is to “advance evidence-based, comprehensive, integrative healthcare to improve the lives of people affected by cancer. The SIO has consistently encouraged rigorous scientific evaluation of both pre-clinical and clinical science, while advocating for the transformation of oncology care to integrate evidence-based complementary approaches. The vision of SIO is to have research inform the true integration of complementary modalities into oncology care, so that evidence-based complementary care is accessible and part of standard cancer care for all patients across the cancer continuum. As an interdisciplinary and inter-professional society, SIO is uniquely poised to lead the “bench to bedside” efforts in integrative cancer care.”

The aim of the ‘Clinical Practice Guidelines’ was to “inform clinicians and patients about the evidence supporting or discouraging the use of specific complementary and integrative therapies for defined outcomes during and beyond breast cancer treatment, including symptom management.”

This sounds like a most laudable aim. Therefore I studied the document carefully and was surprised to read their conclusions: “Specific integrative therapies can be recommended as evidence-based supportive care options during breast cancer treatment.”

How can this be? On this blog, we have repeatedly seen evidence to suggest that integrative medicine is little more than the admission of quackery into evidence-based healthcare. This got me wondering how their conclusion had been reached, and I checked the document even closer.

On the surface, it seemed well-made. A team of researchers first defined the treatments they wanted to look at, then they searched for RCTs, evaluated their quality, extracted their results, combined them into an overall verdict and wrote the whole thing up. In a word, they conducted what seems a proper systematic review.

Based on the findings of their review, they then issued recommendations which I thought were baffling in several respects. Let me just focus on three of the SIO’s recommendations dealing with acupuncture:

  1. “Acupuncture can be considered for treating anxiety concurrent with ongoing fatigue…” [only RCT (1) cited in support]
  2. “Acupuncture can be considered for improving depressive symptoms in women suffering from hot flashes…” [RCTs (1 and 2) cited in support] 
  3. “Acupuncture can be considered for treating anxiety concurrent with ongoing fatigue…” [only RCT (1) cited in support]
One or two studies as a basis for far-reaching guidelines? Yes, that would normally be a concern! But, at closer scrutiny, my worries about these recommendation turn out to be much more serious than this.

The actual RCT (1) cited in support of all three recommendations stated that the authors “randomly assigned 75 patients to usual care and 227 patients to acupuncture plus usual care…” As we have discussed often before on this blog and elsewhere, such a ‘A+B versus B study design’ will never generate a negative result, does not control for placebo-effects and is certainly not a valid test for the effectiveness of the treatment in question. Nevertheless, the authors of this study concluded that: “Acupuncture is an effective intervention for managing the symptom of cancer-related fatigue and improving patients’ quality of life.”

RCT (2) cited in support of recommendation number 2 seems to be a citation error; the study in question is not an acupuncture-trial and does not back the statement in question. I suspect they meant to cite their reference number 87 (instead of 88). This trial is an equivalence study where 50 patients were randomly assigned to receive 12 weeks of acupuncture (n = 25) or venlafaxine (n = 25) treatment for cancer-related hot flushes. Its results indicate that the two treatments generated the similar results. As the two therapies could also have been equally ineffective, it is impossible, in my view, to conclude that acupuncture is effective.

Finally, RCT (1) does in no way support recommendation number two. Yet RCT (1) and RCT (2) were both cited in support of this recommendation.

I have not systematically checked any other claims made in this document, but I get the impression that many other recommendations made here are based on similarly ‘liberal’ interpretations of the evidence. How can the ‘Society for Integrative Oncology’ use such dodgy pseudo-science for formulating potentially far-reaching guidelines?

I know none of the authors (Heather Greenlee, Lynda G. Balneaves, Linda E. Carlson, Misha Cohen, Gary Deng, Dawn Hershman, Matthew Mumber, Jane Perlmutter, Dugald Seely, Ananda Sen, Suzanna M. Zick, Debu Tripathy) of the document personally. They made the following collective statement about their conflicts of interest: “There are no financial conflicts of interest to disclose. We note that some authors have conducted/authored some of the studies included in the review.” I am a little puzzled to hear that they have no financial conflicts of interest (do not most of them earn their living by practising integrative medicine? Yes they do! The article informs us that: “A multidisciplinary panel of experts in oncology and integrative medicine was assembled to prepare these clinical practice guidelines. Panel members have expertise in medical oncology, radiation oncology, nursing, psychology, naturopathic medicine, traditional Chinese medicine, acupuncture, epidemiology, biostatistics, and patient advocacy.”). I also suspect they have other, potentially much stronger conflicts of interest. They belong to a group of people who seem to religiously believe in the largely nonsensical concept of integrative medicine. Integrating unproven treatments into healthcare must affect its quality in much the same way as the integration of cow pie into apple pie would affect the taste of the latter.

After considering all this carefully, I cannot help wondering whether these ‘Clinical Practice Guidelines’ by the ‘Society for Integrative Oncology’ are just full of honest errors or whether they amount to fraud and scientific misconduct.

WHATEVER THE ANSWER, THE GUIDELINES MUST BE RETRACTED, IF THIS SOCIETY WANTS TO AVOID LOSING ALL CREDIBILITY.

I do not seem to agree on much these days with doctor Perter Fisher, the Queen’s homeopath (see for instance here, here and here), but I might share his view on vaccinations. This became clear to me through reading a recent comment made by a homeopath, and not just any old homeopath. The author is Rudi Verspoor, the Dean and Chair Department of Philosophy Hahnemann College for Heilkunst, Ottawa. He was Director of the British Institute of Homeopathy Canada from 1993 to early 2001. Part of his time is spent advising the Canadian government on health-care policy and in working for greater acceptance of and access to homeopathy. I take the liberty to reproducing his comments here:

Dr. Peter Fisher, in an interview published in The American Homeopath 2015 edition (p. 39), made some comments related to vaccination. Dr. Fisher supported the validity of vaccination as a health promoting measure. I disagree, but that is not why I’m writing. Dr. Fisher then claimed that Hahnemann himself supported them.

“Some homeopaths attack vaccination unaware that in the 6th edition of the Organon, Hahnemann has said that vaccination is a wonderful thing and it has saved the lives of children. Do see the footnote under paragraph 46. Hahnemann seems to have considered that the Jennerian method of vaccination – scratching cowpox pus under the skin – was both preventative in epidemics and curative when it was used against similar disease states. Both homeopathy and Jenner’s cowpox vaccine came around in the late 1700s and Hahnemann saw the benefits of cowpox vaccination.

In the present day and age, we have been able to eradicate polio, smallpox, diptheria and even tetanus by judicious use of vaccination. I see cervical cancer being wiped out by the use of the HPV immunization program. We have to wake up to the benefit of vaccination. There can be some adverse effects, no doubt, but vaccination has done a lot of good. Homeopaths would be able to do a lot by staying out of the vaccine controversy.”

Presumably because of the ‘fact’ that the very founder of homeopathy himself supported vaccination comes the advice for homeopaths to stay out of the “vaccine controversy.” I can understand, while not agreeing, with the view that getting involved in this controversy might damage the advance of homeopathy. However, I cannot understand nor agree with the claims made about Hahnemann’s views on vaccination.

In the comments that follow I have taken Dr. Fisher’s wise advice “to stick to core knowledge” using the Organon as “our foundation.” As for the advice that “all homeopaths must study it,” I take this to mean a careful and considered study, as presumably all homeopaths have studied it to some degree. In my defence, I offer 30 years of careful study, the fruits of which are available to anyone who cares to examine them, in various articles for homeopathic journals, in particular detailed articles in Homeopathy-On-Line (www.hpathy.com), and most particularly in a comprehensive analysis of all of Hahnemann’s writings, freely available at www.homeopathiceducation.com.

All this to say that I feel I have met the conditions set down by Dr. Fisher, and offer my considered response to his claims regarding Hahnemann and vaccination based on my detailed assessment of the relevant provisions of the Organon, in particular the footnote to Aphorism 46, which Dr. Fisher specifically references.

These are the claims made by Dr. Fisher in respect of Hahnemann and vaccination. I have simply quoted from the text of the interview and in the order they were made:

  1. “in the 6th edition of the Organon, Hahnemann has said that vaccination is a wonderful thing and it has saved the lives of children.”
  2. “Hahnemann seems to have considered that the Jennerian method of vaccination – scratching cowpox pus under the skin – was both preventative in epidemics and curative when it was used against similar disease states.”
  3. “Hahnemann saw the benefits of cowpox vaccination.”

To start, we need to be clear on the term ‘vaccination’. Historically, it refers to ‘the Jennerian method of vaccination’, the cow pox also being referred to as ‘the vaccine disease’ (OED), and then extended by Pasteur to refer to all subsequent inoculations of disease agents to act as a prevention of that disease when encountered naturally.

Next, to assess the three claims against the footnote to Aphorism 46, to which we are specifically referred, we need the context within which each is situated.

In Aphorism 46, the context for the footnote Dr. Fisher refers us to, Hahnemann gives various examples from nature where a stronger similar disease removes a weaker one. This itself follows from the preceding Aphorisms 43-45, wherein Hahnemann sets out the important principle of the law of similar, that in Nature the stronger similar disease annihilates the weaker similar disease. Hahnemann follows this with examples to be found in Nature herself.

Hahnemann first notes that smallpox disease, his most prominent example, has been found to have lifted and cured numerous maladies with similar symptoms and then gives various examples involving a reported cure by smallpox of a similar existing disease in a person. One of these examples involves the natural smallpox disease lifting the cowpox due to similarity and the greater strength of smallpox.

Hahnemann then goes on to comment on the other side of the equation, namely the impact on the stronger smallpox disease from its encounter with the weaker cowpox disease. Though this is not directly concerning the principle of the law of similars he is illustrating, it is nonetheless a valuable observation: “the ensuing outbreak of smallpox is at least greatly diminished (homoeopathically) and made more benign by the cowpox which has already neared its maturity.”

Thus, while the stronger smallpox disease is not, or course, destroyed, it is “at least greatly diminished and made more benign.” The conclusion is that the weaker similar disease (cowpox) does not act preventatively against the incoming disease, but lessens its impact. We also learn that the weaker disease is removed “at once entirely”, consistent with his principle that the stronger similar disease annihilates the weaker one.

At this point, we get the footnote Dr. Fisher is referring to:

This appears to be the reason for the beneficent, remarkable event that, since the general dispersal of Jenner’s cowpox inoculation, smallpox has never again appeared among us either so epidemically or so virulently as 40-50 years ago when a city seized therewith would lose at least half and often three-quarters of its children by the most wretched plague death.

What I understand Dr. Hahnemann to be noting here tangentially, following from his previously mentioned observation regarding the impact of an existing cowpox disease in a person on contracting smallpox, is a possible reason for the reduced severity of smallpox, since Jenner’s deliberate inoculation of people with cowpox disease (as opposed to the more random act of nature in infecting some people with cowpox, such as milk maids).

END OF QUOTE

Fascinating, isn’t it? The minds of some homeopaths seem to work differently from that of a responsible healthcare professional. I am tempted to say WHO CARES WHAT HAHNEMANN WROTE ABOUT IMMUNISATIONS 200 YEARS AGO? IN VIEW OF THE CURRENT EVIDENCE, ONLY A COMPLETELY DELUDED AND DANGEROUS QUACK CAN ARGUE AGAINST THEIR BENEFITS.

In recent blogs, I have written much about acupuncture and particularly about the unscientific notions of traditional acupuncturists. I was therefore surprised to see that a UK charity is teaming up with traditional acupuncturists in an exercise that looks as though it is designed to mislead the public.

The website of ‘Anxiety UK’ informs us that this charity and the British Acupuncture Council (BAcC) have launched a ‘pilot project’ which will see members of Anxiety UK being able to access traditional acupuncture through this new partnership. Throughout the pilot project, they proudly proclaim, data will be collected to “determine the effectiveness of traditional acupuncture for treating those living with anxiety and anxiety based depression.”

This, they believe, will enable both parties to continue to build a body of evidence to measure the success rate of this type of treatment. Anxiety UK’s Chief Executive Nicky Lidbetter said: “This is an exciting project and will provide us with valuable data and outcomes for those members who take part in the pilot and allow us to assess the benefits of extending the pilot to a regular service for those living with anxiety. “We know anecdotally that many people find complementary therapies used to support conventional care can provide enormous benefit, although it should be remembered they are used in addition to and not instead of seeking medical advice from a doctor or taking prescribed medication. This supports our strategic aim to ensure that we continue to make therapies and services that are of benefit to those with anxiety and anxiety based depression, accessible.”

And what is wrong with that, you might ask.

What is NOT wrong with it, would be my response.

To start with, traditional acupuncture relies of obsolete assumptions like yin and yang, meridians, energy flow, acupuncture points etc. They have one thing in common: they fly in the face of science and evidence. But this might just be a triviality. More important is, I believe, the fact that a pilot project cannot determine the effectiveness of a therapy. Therefore the whole exercise smells very much like a promotional activity for pure quackery.

And what about the hint in the direction of anecdotal evidence in support of the study? Are they not able to do a simple Medline search? Because, if they had done one, they would have found a plethora of articles on the subject. Most of them show that there are plenty of studies but their majority is too flawed to draw firm conclusions.

A review by someone who certainly cannot be accused of being biased against alternative medicine, for instance, informs us that “trials in depression, anxiety disorders and short-term acute anxiety have been conducted but acupuncture interventions employed in trials vary as do the controls against which these are compared. Many trials also suffer from small sample sizes. Consequently, it has not proved possible to accurately assess the effectiveness of acupuncture for these conditions or the relative effectiveness of different treatment regimens. The results of studies showing similar effects of needling at specific and non-specific points have further complicated the interpretation of results. In addition to measuring clinical response, several clinical studies have assessed changes in levels of neurotransmitters and other biological response modifiers in an attempt to elucidate the specific biological actions of acupuncture. The findings offer some preliminary data requiring further investigation.”

Elsewhere, the same author, together with other pro-acupuncture researchers, wrote this: “Positive findings are reported for acupuncture in the treatment of generalised anxiety disorder or anxiety neurosis but there is currently insufficient research evidence for firm conclusions to be drawn. No trials of acupuncture for other anxiety disorders were located. There is some limited evidence in favour of auricular acupuncture in perioperative anxiety. Overall, the promising findings indicate that further research is warranted in the form of well designed, adequately powered studies.”

What does this mean in the context of the charity’s project?

I think, it tells us that acupuncture for anxiety is not exactly the most promising approach to further investigate. Even in the realm of alternative medicine, there are several interventions which are supported by more encouraging evidence. And even if one disagrees with this statement, one cannot possibly disagree with the fact that more flimsy research is not required. If we do need more studies, they must be rigorous and not promotion thinly disguised as science.

I guess the ultimate question here is one of ethics. Do charities not have an ethical and moral duty to spend our donations wisely and productively? When does such ill-conceived pseudo-research cross the line to become offensive or even fraudulent?

As we all know, homeopathy was invented in Germany, and the Germans have always been very fond of it. Perhaps this is the explanation why there has been so little criticism of homeopathy in this country.

But this situation seems to be changing as we speak. Our initiative ‘INFORMATIONS NETZWERK HOMOEOPATHIE’ had an unprecedented response, for instance, in the German press. Even the German ‘Heilpraktiker’ (German alternative practitioner) have deemed it necessary to defend their favourite therapy against our arguments.

On their website they published a press release in response to our activities. Here they recycled an argument which is as old as it is fallacious. Nevertheless, it is surprisingly popular and therefore it is perhaps worth having a closer look at it. The fallacy goes something like this:

  • conventional medicine is also largely unproven;
  • but this does not bother anyone;
  • only if an alternative medicine lacks evidence, the ‘ideologists’ of medicine kick a fuzz;
  • nobody knows, for instance, how analgesics work;
  • another example is Aspirin which was used much before, in the 1970s, scientists found out how it works;
  • the list of such examples could be extended ad lib,
  • so, insisting on sound evidence for homeopathy merely displays the double standards of a few weird ‘ideologists’.

(For those who read German, here is their original text: “Schulmedizinischen Methoden dagegen hat man mangelnde wissenschaftliche Belegbarkeit zum wiederholten Mal nachgesehen… Aber niemand weiß bis heute wie ein Betäubungsmittel wirklich funktioniert… Aspirin wurde über Jahrzehnte angewendet, obwohl erst im Jahr 1970 der Wirkmechanismus vollständig geklärt werden konnte. Die Liste der Beispiele ließe sich noch beliebig fortsetzen.)

Sounds convincing?

Yes, many lay people (such as Heilpraktiker) are convinced by such nonsense.

I did say ‘nonsense’, so I better explain. Perhaps I can make this brief, merely using a few bullet points:

  • true, not everything is proven in medicine, but we are working very hard on it, and we have made huge progress, both in terms of increasing our knowledge and (much more importantly) improving patient care;
  • in homeopathy, we have made no progress whatsoever;
  • critical thinkers kick a fuzz wherever the evidence is flimsy, regardless whether this is in alt med or in real med;
  • we do know how analgesics work (perhaps Heilpraktiker don’t but that’s their problem);
  • true, we did use Aspirin before its mode of action had been discovered (and a Nobel Prize was awarded for it);
  • we would use any therapy without knowing how it works, regardless of its label;
  • all that matters is whether it works;
  • Aspirin was and is used because it works;
  • homeopathy should NOT be used because it does not work.

SIMPLE, REALLY!

The current ‘Acupuncture Awareness Week’ is perhaps a good occasion to look beyond acupuncture for humans. The ‘Chi Institute’ is an organisation that teaches TCM for animals. There you can specialise in all sorts of intriguing things that a critical mind would have never thought about. Take acupuncture for horses, for instance; on their website, the Institute informs us that:

The Equine Acupuncture Program…certifies students in veterinary acupuncture with an emphasis on horses. The program begins with an overview of fundamental aspects of Chinese Medicine, including Ying-Yang and Five Elements theory, which serve as a foundation for case diagnosis and treatment presented later in the class. A variety of acupuncture techniques are taught, including electro-acupuncture and moxibustion, in addition to conventional “dry” needling. Students of the program learn acupuncture points on large animals only, and horses are used for practice in the wet labs.

The program is presented in five sessions (two online and three on-site) over a period of six months. Online sessions are composed of lectures that students can stream at their own convenience. Afternoon wet-labs of on-site sessions give students the opportunity to learn acupuncture points on live animals in small lab groups of five to six students per instructor. A spring class and a fall class are held each year. Equine Acupuncture is offered to licensed veterinarians and veterinary school junior/senior students only.

Major Topics: 

  • Traditional Chinese Veterinary Medicine (TCVM) Principles: Five Elements, Yin-Yang, Eight Principles, Zang-Fu Physiology and Pathology, Meridians and Channels
  • Scientific Basis of Acupuncture
  • 200 Transpositional Equine Acupuncture Points (hands-on, wet-lab demos)
  • 70 Classical Equine Acupuncture Points (hands-on, wet-lab demos)
  • How to needle acupuncture points in horses
  • TCVM Diagnostic Systems, including Tongue and Pulse Diagnosis
  • How to integrate acupuncture into your practice
  • How to use veterinary acupuncture to diagnose and treat:
      1. Musculoskeletal conditions, lameness and neurological disorders
      2. Cardiovascular diseases and respiratory disorders
      3. Gastrointestinal disorders and behavioral problems
      4. Dermatological problems and immune-mediated diseases
      5. Renal & urinary disorders and reproductive disorders
  • Veterinary acupuncture techniques:
      1. Dry needle (conventional needling)
      2. Aqua-acupuncture (point injection)
      3. Electro-acupuncture
      4. Hemo-acupuncture
      5. Moxibustion

But is there not something missing, I asked myself when I read this. What about the evidence? What about the question whether there is any proof that any of this works?
As it happens, some time ago, we looked into this by conducting a systematic review. Here is our abstract ( I should mention that the first author of this paper was a vet who was very fond of acupuncture):

Acupuncture is a popular complementary treatment option in human medicine. Increasingly, owners also seek acupuncture for their animals. The aim of the systematic review reported here was to summarize and assess the clinical evidence for or against the effectiveness of acupuncture in veterinary medicine. Systematic searches were conducted on Medline, Embase, Amed, Cinahl, Japana Centra Revuo Medicina and Chikusan Bunken Kensaku. Hand-searches included conference proceedings, bibliographies, and contact with experts and veterinary acupuncture associations. There were no restrictions regarding the language of publication. All controlled clinical trials testing acupuncture in any condition of domestic animals were included. Studies using laboratory animals were excluded. Titles and abstracts of identified articles were read, and hard copies were obtained. Inclusion and exclusion of studies, data extraction, and validation were performed independently by two reviewers. Methodologic quality was evaluated by means of the Jadad score. Fourteen randomized controlled trials and 17 nonrandomized controlled trials met our criteria and were, therefore, included. The methodologic quality of these trials was variable but, on average, was low. For cutaneous pain and diarrhea, encouraging evidence exists that warrants further investigation in rigorous trials. Single studies reported some positive intergroup differences for spinal cord injury, Cushing’s syndrome, lung function, hepatitis, and rumen acidosis. These trials require independent replication. On the basis of the findings of this systematic review, there is no compelling evidence to recommend or reject acupuncture for any condition in domestic animals. Some encouraging data do exist that warrant further investigation in independent rigorous trials.

What a pity that the pupils of the above course are not being told that THERE IS NO COMPELLING EVIDENCE that any of the tings they are about to learn has any value…but that would be bad for business, wouldn’t it? And we cannot have a bit of evidence jeopardize a nice little earner, can we?

Yes, we discussed this study on a previous blog post. But, as it is ‘ACUPUNCTURE AWARENESS WEEK’ in the UK, and because of another reason (which will become clear in a minute) I decided to revisit the trial.

In case you have forgotten, here is its abstract once again:

Background: Hot flashes (HFs) affect up to 75% of menopausal women and pose a considerable health and financial burden. Evidence of acupuncture efficacy as an HF treatment is conflicting.

Objective: To assess the efficacy of Chinese medicine acupuncture against sham acupuncture for menopausal HFs.

Design: Stratified, blind (participants, outcome assessors, and investigators, but not treating acupuncturists), parallel, randomized, sham-controlled trial with equal allocation. (Australia New Zealand Clinical Trials Registry: ACTRN12611000393954)

Setting: Community in Australia.

Participants: Women older than 40 years in the late menopausal transition or postmenopause with at least 7 moderate HFs daily, meeting criteria for Chinese medicine diagnosis of kidney yin deficiency.

Interventions: 10 treatments over 8 weeks of either standardized Chinese medicine needle acupuncture designed to treat kidney yin deficiency or noninsertive sham acupuncture.

Measurements: The primary outcome was HF score at the end of treatment. Secondary outcomes included quality of life, anxiety, depression, and adverse events. Participants were assessed at 4 weeks, the end of treatment, and then 3 and 6 months after the end of treatment. Intention-to-treat analysis was conducted with linear mixed-effects models.

Results: 327 women were randomly assigned to acupuncture (n = 163) or sham acupuncture (n = 164). At the end of treatment, 16% of participants in the acupuncture group and 13% in the sham group were lost to follow-up. Mean HF scores at the end of treatment were 15.36 in the acupuncture group and 15.04 in the sham group (mean difference, 0.33 [95% CI, −1.87 to 2.52]; P = 0.77). No serious adverse events were reported.

Limitation: Participants were predominantly Caucasian and did not have breast cancer or surgical menopause.

Conclusion: Chinese medicine acupuncture was not superior to noninsertive sham acupuncture for women with moderately severe menopausal HFs.

When I first discussed this trial, I commented that the trial has several strengths: it includes a large sample size and the patients were adequately blinded to eliminate the effects of expectations. It was published in a top journal, and we can therefore assume that it was properly peer-reviewed. Combined with the evidence from our previous systematic review, this indicates that acupuncture has no effect beyond placebo.

The reason for bringing it up again is that a comment about the study has recently appeared, not just any old comment but one from the British Medical Acupuncture Society. It is, in my view, gratifying and interesting. It was published on ‘facebook’ and is therefore in danger of getting forgotten. I hope to preserve it by citing it in full.

Here it is:

A large rigorous trial published in a prestigious general medical journal, and the usual mantra rings out – acupuncture is no better than sham. In this case there was not a fraction of difference from a non-penetrating sham in a two-armed trial with over 300 women. Ok,…so we have known for some time that we really need 400 in each arm to demonstrate the usual difference over sham seen in meta-analysis in pain conditions, but there really was not even a sniff of a difference here. So is that it for acupuncture in hot flushes? Well, we have a 40% symptom reduction in both groups, and a strong conviction from some practitioners that it really seems to work. Is 40% enough for a strong conviction? I have heard some dramatic stories from medical acupuncturist colleagues that really would be hard to dismiss as non-specific effects, and from others I have heard relative ambivalence about the effects in hot flushes.

Personally I always try to consider mechanisms, and I wish researchers in the field would do the same before embarking on their trials. That is not intended as a criticism of this trial, but some consideration of mechanisms might allow us to explain all our data, including the contribution of this trial.

Acupuncture has recognised effects that are local to the needle, in the spinal cord (mainly in the segments stimulated) and in the brain (as well as humoral effects in CSF and blood). The latter are probably the mildest of the three categories, and require the best group of patient responders for them to be observable in clinical practice.

Menopausal hot flushes are explained by the effects of reduced oestrogens on the thermoregulatory centre in the anterior hypothalamus. It is certainly plausible that the neuro-inhibitory effects of endogenous opioids such as beta-endorphin, which we know can be released by acupuncture stimulation in experimental settings, could stablise neurones in the anterior hypothalamus that have become irritable due to a sudden drop in oestrogens.

So are endogenous opioids always released by acupuncture? Well, they and their effects seem to be measurable in experiments that use what I call proper acupuncture. That is, strong stimulation to deep somatic tissue. In the laboratory, and indeed in my clinic, this is only usually achieved in a palatable manner by electroacupuncture to muscle, although repeated manual stimulation every few minutes may have similar effects.

Ee et al used a relatively gentle acupuncture protocol, so they may have only generated measurable effects, based on mechanistic speculation, in the most responsive patients, perhaps less than 10%.

What does all this tell us? Well this trial clearly demonstrates that gentle acupuncture protocols generate effects in women with hot flushes via context rather than penetrating needling. In conditions that rely on central effects, I think we still need to consider stronger stimulation protocols and enriched enrollment in trials, ie preselecting responders before randomisation.

In my original comment I also predicted: “One does not need to be a clairvoyant to predict that acupuncturists will now find what they perceive as a flaw in the new study and claim that its results were false-negative.”

I am so glad Mike Cummings and the BMAS rushed to prove me right.

It’s so nice to know one can rely on someone in these uncertain times!

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