The ACUPUNCTURE NOW FOUNDATION (ANF) have recently published a document that is worth drawing your attention to. But first I should perhaps explain who the ANF are. They state that “The Acupuncture Now Foundation (ANF) was founded in 2014 by a diverse group of people from around the world who were concerned about common misunderstandings regarding acupuncture and wanted to help acupuncture reach its full potential. Our goal is to become recognized as a leader in the collection and dissemination of unbiased and authoritative information about all aspects of the practice of acupuncture.”
This, I have to admit, sounds like music to my ears! So, I studied the document in some detail – and the music quickly turned into musac.
The document which they call a ‘white paper’ promises ‘a review of the research’. Reading even just the very first sentence, my initial enthusiasm turned into bewilderment: “It is now widely accepted across health care disciplines throughout the world that acupuncture can be effective in treating such painful conditions as migraine headaches, and low back, neck and knee pain, as well as a range of painful musculoskeletal conditions.” Any review of research that starts with such a deeply uncritical and overtly promotional statement, must be peculiar (quite apart from the fact that the ANF do not seem to appreciate that back and neck pain are musculoskeletal by nature).
As I read on, my amazement grew into bewilderment. Allow me to present a few further statements from this review (together with a link to the article provided by the ANF in support and a very brief comment by myself) which I found more than a little over-optimistic, far-fetched or plainly wrong:
“Male fertility, especially sperm production and motility, has also been shown to improve with acupuncture. In a recent animal study, electro-acupuncture was found to enhance germ cell proliferation. This action is believed to facilitate the recovery of sperm production (spermatogenesis) and may restore normal semen parameters in subfertile patients.”
The article supplied as evidence for this statement refers to an animal experiment using a model where sperm are exposed to heat. This has almost no bearing on the clinical situation in humans and does not lend itself to any clinical conclusions regarding the treatment of sub-fertile men.
“In a recent meta-analysis, researchers concluded that the efficacy of acupuncture as a stand-alone therapy was comparable to antidepressants in improving clinical response and alleviating symptom severity of major depressive disorder (MDD). Also, acupuncture was superior to antidepressants and waitlist controls in improving both response and symptom severity of post-traumatic stress disorder (PTSD). The incidence of adverse events with acupuncture was significantly lower than antidepressants.”
The review provided as evidence is wide open to bias; it was criticised thus: “the authors’ findings did not reflect the evidence presented and limitations in study numbers, sample sizes and study pooling, particularly in some subgroup analyses, suggested that the conclusions are not reliable”. Moreover, we need to know that by no means all reviews of the subject confirm this positive conclusion, for instance, this, this, or this one; all of the latter reviews are more up-to-date than the one provided by ANF. Crucially, a Cochrane review concluded that “the evidence is inconclusive to allow us to make any recommendations for depression-specific acupuncture”.
“A randomized controlled trial of acupuncture and counseling for patients presenting with depression, after having consulted their general practitioner in primary care, showed that both interventions were associated with significantly reduced depression at three months when compared to usual care alone.”
We have discussed the trial in question on this blog. It follows the infamous ‘A+B versus B’ design which cannot possibly produce a negative result.
Now, please re-read the first paragraph of this post; but be careful not to fall off your chair laughing.
There would be more (much more) to criticise in the ANF report but, I think, these examples are ENOUGH!
Let me finish by quoting from the ANF’s view on the future as cited in their new ‘white paper’: “Looking ahead, it is clear that acupuncture is poised to make significant inroads into conventional medicine. It has the potential to become a part of every hospital’s standard of care and, in fact, this is already starting to take place not only in the U.S., but internationally. The treatment is a cost-effective and safe method of relieving pain in emergency rooms, during in-patient stays and after surgery. It can lessen post-operative nausea, constipation and urinary difficulties, and have a positive impact on conditions like hypertension, anxiety and insomnia…
Driven by popular demand and a growing body of scientific evidence, acupuncture is beginning to be taken seriously by mainstream conventional medicine, which is incorporating it into holistic health programs for the good of patients and the future of health care. In order for this transition to take place most effectively, misunderstandings about acupuncture need to be addressed. We hope this white paper has helped to clarify some of those misunderstandings and encourage anyone with questions to contact the Acupuncture Now Foundation.”
My question is short and simple: IGNORANCE OR FRAUD?
Yes, yes, yes, I know: we have too few women in our ‘ALT MED HALL OF FAME’. This is not because I have anything against them (quite the contrary) but, in alternative medicine research, the boys by far outnumber the girls, I am afraid.
You do remember, of course, you has previously been admitted to this austere club of excellence; only two women so far. Here is the current list of members to remind you:
David Peters (osteopathy, homeopathy, UK)
Nicola Robinson (TCM, UK)
Peter Fisher (homeopathy, UK)
Simon Mills (herbal medicine, UK)
Gustav Dobos (various, Germany)
Claudia Witt (homeopathy, Germany and Switzerland)
George Lewith (acupuncture, UK)
John Licciardone (osteopathy, US)
If you study the list carefully, you will also notice that, until now, I have totally ignored the chiropractic profession. This is a truly embarrassing omission! When it comes to excellence in research, who could possibly bypass our friends, the chiropractors?
Today we are going to correct these mistakes. Specifically, we are going to increase the number of women by 50% (adding one more to the previous two) and, at the same time, admit a deserving chiropractor to the ALT MED HALL OF FAME.
Cheryl Hawk is currently the Executive Director of Northwest Center for Lifestyle and Functional Medicine, University of Western States, Portland, USA. Previously she worked as Director of Clinical Research at the Logan University College of Chiropractic, Chesterfield, USA, and prior to that she was employed at various other institutions. Since many years she has been a shining light of chiropractic research. She is certainly not ‘small fry’ when it comes to the promotion of chiropractic.
Cheryl seems to prefer surveys as a research tool over clinical trials, and it was therefore not always easy to identify those of her 67 Medline-listed articles that reported some kind of evaluation of the value of chiropractic. Here are, as always, the 10 most recent papers where I could extract something like a data-based conclusion (in bold) from the abstract.
Hawk C, Schneider MJ, Vallone S, Hewitt EG.
J Manipulative Physiol Ther. 2016 Mar-Apr;39(3):158-68
All of the seed statements in this best practices document achieved a high level of consensus and thus represent a general framework for what constitutes an evidence-based and reasonable approach to the chiropractic management of infants, children, and adolescents.
Clinical Practice Guideline: Chiropractic Care for Low Back Pain.
Globe G, Farabaugh RJ, Hawk C, Morris CE, Baker G, Whalen WM, Walters S, Kaeser M, Dehen M, Augat T.
J Manipulative Physiol Ther. 2016 Jan;39(1):1-22
The evidence supports that doctors of chiropractic are well suited to diagnose, treat, co-manage, and manage the treatment of patients with low back pain disorders.
Ndetan H, Hawk C, Sekhon VK, Chiusano M.
J Evid Based Complementary Altern Med. 2016 Apr;21(2):138-42.
The odds ratio for perceiving being helped by a chiropractor was 4.36 (95% CI, 1.17-16.31) for respondents aged 65 years or older; 9.5 (95% CI, 7.92-11.40) for respondents reporting head or neck trauma; and 13.78 (95% CI, 5.59-33.99) for those reporting neurological or muscular conditions as the cause of their balance or dizziness.
Schneider MJ, Evans R, Haas M, Leach M, Hawk C, Long C, Cramer GD, Walters O, Vihstadt C, Terhorst L.
Chiropr Man Therap. 2015 May 4;23:16.
American chiropractors appear similar to chiropractors in other countries, and other health professionals regarding their favorable attitudes towards EBP, while expressing barriers related to EBP skills such as research relevance and lack of time. This suggests that the design of future EBP educational interventions should capitalize on the growing body of EBP implementation research developing in other health disciplines. This will likely include broadening the approach beyond a sole focus on EBP education, and taking a multilevel approach that also targets professional, organizational and health policy domains.
Chiropractic identity, role and future: a survey of North American chiropractic students.
Gliedt JA, Hawk C, Anderson M, Ahmad K, Bunn D, Cambron J, Gleberzon B, Hart J, Kizhakkeveettil A, Perle SM, Ramcharan M, Sullivan S, Zhang L.
Chiropr Man Therap. 2015 Feb 2;23(1):4
The chiropractic students in this study showed a preference for participating in mainstream health care, report an exposure to evidence-based practice, and desire to hold to traditional chiropractic theories and practices. The majority of students would like to see an emphasis on correction of vertebral subluxation, while a larger percent found it is important to learn about evidence-based practice. These two key points may seem contradictory, suggesting cognitive dissonance. Or perhaps some students want to hold on to traditional theory (e.g., subluxation-centered practice) while recognizing the need for further research to fully explore these theories. Further research on this topic is needed.
Twist E, Lawrence DJ, Salsbury SA, Hawk C.
Chiropr Man Therap. 2014 Dec 10;22(1):40
These results strongly suggest that chiropractic clinical researchers are not developing ICDs at a readability level congruent with the national average acceptable level. The low number of elements in some of the informed consent documents raises concern that not all research participants were fully informed when given the informed consent, and it may suggest that some documents may not be in compliance with federal requirements. Risk varies among institutions and even within institutions for the same intervention.
Hawk C, Kaeser MA, Beavers DV.
J Chiropr Educ. 2013 Fall;27(2):135-40.
This active learning exercise appeared to be a feasible way to introduce tobacco counseling into the curriculum.
Hawk C, Schneider M, Evans MW Jr, Redwood D.
J Manipulative Physiol Ther. 2012 Sep;35(7):556-67
This living document provides a general framework for an evidence-based approach to chiropractic wellness care.
Ndetan H, Evans MW Jr, Hawk C, Walker C.
J Altern Complement Med. 2012 Apr;18(4):347-53.
C/OM is primarily used for back and neck pain, which is increasing in prevalence in children. Teens are more likely to use it than are younger children.
Dougherty PE, Hawk C, Weiner DK, Gleberzon B, Andrew K, Killinger L.
Chiropr Man Therap. 2012 Feb 21;20(1):3.
Given the utilization of chiropractic services by the older adult, it is imperative that providers be familiar with the evidence for and the prudent use of different management strategies for older adults.
I am pleased to say that Prof Hawk gave me no problems at all; her case is clear: she is a champion of using research as a means for promoting chiropractic, has published many papers in this vein, clearly prefers the journals of chiropractic that nobody other than chiropractors ever access, and has an impeccable track record when it comes to avoiding negative conclusions which could harm chiropractic in any way.
Very well done indeed!
WELCOME, PROF HAWK, TO THE ‘ALT MED HALL OF FAME’.
The queue outside my ‘ALT MED HALL OF FAME’ was getting restless because I did not admit any new members for some time. So, I better get cracking!
You remember, of course, who has been honoured so far; the list of members (main research interest, country) is as follows:
Nicola Robinson (TCM, UK)
Peter Fisher (homeopathy, UK)
Simon Mills (herbal medicine, UK)
Gustav Dobos (various, Germany)
Claudia Witt (homeopathy, Germany and Switzerland)
George Lewith (acupuncture, UK)
John Licciardone (osteopathy, US)
Today, we are going to have a look at Prof David Peters. This is what our friends from the ‘COLLEGE OF MEDICINE’ say about him:
“David Peters MB, ChB, DRCOG, DMSMed MFHom FLCOM trained as a GP, a musculoskeletal physician and also as a homeopathic and osteopathic practitioner. For fifteen years he directed the complementary therapies development programme at Marylebone Health Centre. Professor Peters is one of the founding faculty of the University of Westminster’s School of Life Sciences, where he is Clinical Director. Professor Peters is a member of the Council and former chair of the British Holistic Medical Association and Editor of its Journal of Holistic Healthcare. He has co-authored or edited six books about integrated healthcare. His research interests include the role of non-pharmaceutical treatments in mainstream medicine, wellbeing in long-term conditions and the development of integrated practitioners.”
I did my usual Medline search but found only 16 Medline-listed articles authored by David Peters. This is amazing because he has been involved in UK alt med much longer than I have. Even more amazing is that none of these papers seem to refer to clinical trials. Perhaps he is not convinced of this type of research?
In order to evaluate his output, I took the sentence that came nearest to a conclusion from the most recent 10 articles. Below you find first the titles of each paper (with the link to it), second the list of its authors and third the sentence that formulated a conclusion (in bold).
Cheshire A, Polley M, Peters D, Ridge D.
BMC Complement Altern Med. 2013 Nov 1;13:300. doi: 10.1186/1472-6882-13-300.
The BBPS provided a MSK pain management service that many patients found effective and valuable. Combining self-management with acupuncture was found to be particularly effective, although further consideration is required regarding how best to engage patients in self-management.
Cheshire A, Polley M, Peters D, Ridge D.
BMC Fam Pract. 2011 Jun 13;12:49. doi: 10.1186/1471-2296-12-49.
Provision of acupuncture and osteopathy for MSK pain is achievable in General Practice. A GP surgery can quickly adapt to incorporate complementary therapy provided key principles are followed.
Unwin J, Peters D.
Acupunct Med. 2009 Mar;27(1):21-5. doi: 10.1136/aim.2008.000083.
The Gateway Clinic has become an increasingly popular referral resource. The influences that drive referral to the clinic are multiple and follow “tacit guidelines”. GPs select patients on the basis of their individual clinical experience, informed by positive patient feedback and often only after more conventional medical treatment options have been exhausted.
Lewith GT, Breen A, Filshie J, Fisher P, McIntyre M, Mathie RT, Peters D.
Clin Med (Lond). 2003 May-Jun;3(3):235-40. Review.
This paper describes the current status and evidence base for acupuncture, homeopathy, herbal and manipulative medicine, as well as the regulatory framework within which these therapies are provided. It also explores the present role of the Royal College of Physicians’ Subcommittee on Complementary and Alternative Medicine (CAM) in relation to these developments. A number of CAM professions have encouraged the Royal College of Physicians Subcommittee to act as a reference point for their discussions with the conventional medical profession and the subcomittee believes that they are able to fulfil this function.
Peters D, Pinto GJ, Harris G.
Br Homeopath J. 2000 Jul;89 Suppl 1:S14-9
It is possible to introduce rigour and reflectiveness when providing a homeopathic service in general practice by assessing the needs of patient and practitioners, agreeing intake guidelines, developing referral processes, implementing audit cycles. Clear lines of communication can be established and a patient-centred outcome measure can be introduced into the treatment cycle.
I could not find any further articles that I could classify as providing data; so I stopped well short of the envisaged 10 papers. I have to admit, I was hesitant: does David deserve to be in the ALT MED HALL OF FAME? In the end, I gave him the benefit of the doubt. Why? Mainly because I am impressed with his scope of practice. Here is what he himself wrote about this aspect:
“I use a range of approaches: osteopathy and medical acupuncture, as well as nutrition and mind-body medicine – meditation, relaxation techniques, breath-work, self-hypnosis, biofeedback, and simple yoga-based exercises. Sometimes herbal medicines, complex homeopathy, nutritional supplements, trigger-point or joint injections can be a valuable too. Somatic Experiencing is a gentle form of body-centred psychotherapy for problems that have come on after traumatic incidents. When I want to assess the impact of stress on the body I use a painless approach involving computer-based heart rate variability testing and breath analysis; sometimes salivary cortisol profiling too. Where required I can prescribe conventional medicine and were they are needed I might suggest scans, X-rays or blood tests.”
Peter is perhaps not the most industrious researcher when it comes to publishing papers, but he fulfils the criterion of not ever publishing anything negative that might rock the boat or distract from the true value of alternative medicine.
LONG LIVE THE POSITIVE RESULT!
Seasonal allergic rhinitis (hay fever) is a common condition which can considerably reduce the quality of life of sufferers. Homeopathy is often advocated – but does it work?
A new study was meant to be an “assessment of the clinical effectiveness of homeopathic remedies in the alleviation of hay fever symptoms in a typical clinical setting.”
The investigator performed a ‘clinical observational study’ of eight patients from his private practice using Measure Yourself Medical Outcome Profile (MYMOP) self-evaluation questionnaires at baseline and again after two weeks and 4 weeks of individualized homeopathic treatment which was given as an add-on to conventional treatments.
The average MYMOP scores for the eyes, nose, activity and wellbeing had improved significantly after two and 4 weeks of homeopathic treatment. The overall average MYMOP profile score at baseline was 3.83 (standard deviation, SD, 0.78). After 14 and 28 days of treatment the average score had fallen to 1.14 (SD, 0.36; P<0.001) and 1.06 (SD, 0.25; P<0.001) respectively.
The author concluded as follows: Individualized homeopathic treatment was associated with significant alleviation of hay fever symptoms, enabling the reduction in use of conventional treatment. The results presented in this study can be considered as a step towards a pilot pragmatic study that would use more robust outcome measures and include a larger number of patients prescribed a single or a multiple homeopathic prescription on an individualized basis.
It is hard to name the things that are most offensively wrong here; the choice is too large. Let me just list three points:
- The study design is not matched to the research question.
- The implication that homeopathy had anything to do with the observed outcome is unwarranted.
- The conclusion that the results might lend themselves to develop a pilot study is meaningless.
The question whether homeopathy is an effective therapy for hay fever has been tested before, even in RCTs. It seems therefore mysterious why one needs to revert to tiny observational studies in order to plan a pilot, and even less for an assessment of effectiveness.
There are few conditions which are more time-dependent than hay fever. Any attempt of testing the effectiveness of medical interventions without a control group seems therefore not just questionable but wasteful. Clinical studies absorb resources; even if the author was happy to waste his time, he should not assume that he can freely waste the time, effort and availability of his patients.
Two final points, if I may:
- An observational study of homeopathy for hay-fever without a control group might be utterly useless but it is still an investigation that requires certain things. As far as I can see, this study did not even have ethics approval nor is there a mention of informed consent. Strictly speaking, this makes it an unethical study.
- If we allow research of this nature to take place and be published, we give clinical research a bad name and undermine the confidence of the public in science.
I am puzzled how such a paper could pass peer review and how an Elsevier journal could even consider publishing it.
I am editor in chief of a journal called FACT. It has a large editorial board, and I am always on the look-out for people who might be a good, productive and colourful addition to it. On 3 June, I sent an invitation to Mel Koppelman, who is by now well known to regular readers of this blog. Here is a copy:
can I ask you a question?
would you consider joining the ed-board of FACT [as you mentioned it in one of your comments, I assume you know this journal – but you are wrong in implying that it has anything to do with the pharmaceutical or any other industry]? if you agree, we would expect you to write 2-3 ‘summaries/commentaries’ per year. in return you get a free subscription and, of course, can submit other articles.
no, this is not a joke or a set-up. I like to have the full spectrum of opinion/expertise on my ed-board, and I do think you understand science quite well. our opinions differ but that’s what I think is good for the journal.
think about it – please.
On 6 June, she replied as follows:
Great to hear from you, I hope you enjoyed your weekend.
Thank you very much for the kind offer, it’s something I would consider. I certainly have no problem with, and in fact embrace, people who have different opinions and views from my own, so long as I feel that they have integrity in their approach.
Just a few questions / comments:
1) Regarding FACT’s affiliations, what I said in my comment was that it was a publication of the Royal Pharmaceutical Society. According to Wiley’s website, Focus on Alternative and Complementary Medicine is copyright by Royal Pharmaceutical Society. It’s also listed on the Pharmaceutical Press website.
Are you telling me that’s incorrect? That I’m “wrong” in saying there’s a relationship? I obviously need to understand the nature of the publication whose editorial board I’m considering joining. Very confusing that you as editor say there’s no relationship to the RPS and yet they claim copyright over your publication. Incidentally, is FACT self-sufficient, earning all of its income from subscriptions? Or does any financial support come from the publishers?
2) As enticing as a free subscription to FACT is, I have access to more high quality peer-reviewed reading material than I could enjoy in many lifetimes. Because my skills seem to be in high demand and because I already spend 10-20 hours per week doing unpaid volunteer work, any additional projects that I take on at this time would need to be financially compensated. I understand that this may be a deal-breaker.
3) While I have no issue with you having different views when it comes to medical research, in order to choose to work with your publication, it’s important to me that it’s run by people with a high level of academic integrity and put patient welfare at the forefront of it’s agenda.
In March, you came out in public support of the NICE draft guidelines. You were quoted in the Guardian as saying: “It is good to see that Nice have now caught up with the evidence. Neither spinal manipulation nor acupuncture are supported by good science when it comes to treating low back pain.”
Following this, it was brought to your attention that the recommendations were contrary to best evidence and that the conclusions were unsupportable. While you have the option of following this up to make sure that the record reflects best evidence, you have indicated that you have no interest in evaluating the situation and possibly admitting an error. This behaviour is concerning from the perspective of academic integrity, particularly when it directly leads to increased human suffering (policy in several countries has already been changed based on the draft), and I would be worried that by joining your board I could be associated with such unethical behaviour.
Perhaps if I understood better your position, which seems to be to ignore the situation, not follow up on the concerns raised, and leave your comments uncorrected even though they may be inaccurate and backing guidelines that cause harm to patients, that might allay certain reservations.
Anyways, these are my initial thoughts. I hope you have an opportunity to enjoy the beautiful weather, and I look forward to hearing from you.
At that stage, I began to fear that I had made a mistake. But, giving her the benefit of the doubt, I swallowed my pride and replied as politely as I could to her concerns which, in my view, were odd, to say the least. This is what I wrote on 7 June:
Thank you for your reply to my invitation. Let me address your points in turn:
- I said that FACT has nothing to do with the pharma industry which is true [when you state that “you as editor say there’s no relationship to the RPS” – it suggests to me that you did not read my email properly]. In their own words, the RPS is “the professional membership body for pharmacists and pharmacy in Great Britain and an internationally renowned publisher of medicines information.” [http://www.rpharms.com/home/about-us.asp] They have a similar status as the Royal Colleges. In the 2 decades that I am running the journal, there has been not a single instance of interference of any kind. We use them simply as an excellent publishing house. And yes, FACT is to the best of my knowledge self-sufficient and survives without funds from 3rd parties.
- I am delighted to hear that your skills are in demand.
- I have stated my position regarding the draft NICE guideline ad nauseam: I prefer to wait until I see their next version of the draft before I make further comments on it. In my view, this is both reasonable and honourable. If you disagree, I can do little about it other than expressing my sincere regrets.
I hope these brief clarifications are helpful for you to arrive at a decision.
On 8 June, I received Mel’s reply:
How interesting! Is he trying to ‘keep his enemies closer’ or am I being too skeptical? He has recognised your talents and dedication and intellect so he is not altogether stupid after all! I eagerly await his response to your reply.
Those who have studied with Ernst say that he’s a genuine chap and misunderstood – which I know is almost unimaginable given his behaviour – but we always have to allow for the possibility that we have misjudged people however remote! Also, people can turn – especially when they get older and near retirement. Alternatively he may just fancy you!…
Mel Koppelman Really enjoying hearing y’all’s thoughts on this. I just want to say that If I had thought that the chances of me being able to create positive change by joining FACT were high, I would have tempered the tone of my reply. But the simple fact that EE can’t even be factual or forthright about whose journal it is suggests an irreparable break with reality. And surely there’s an issue (academic? ethical? legal?) with recruiting someone to your board and denying an industry tie when there is one? Not to mention that if the RSP does fund his journal, he’s been lying about his conflicts of interest. Is that someone I want to spend time adding value to that could be spent with family, patients, time in nature or really making positive change by supporting the ANF? I’ll be interested to read his reply if there is one and especially how he responds regarding the relationship between FACT and RSP. Will keep y’all posted.
John McDonald Healthy skepticism! Healthy journal! And it’s 99% fact-free!
I hope that you find these exchanges as amusing as I did – but are they important? Perhaps not exactly, but revealing certainly. They shed some light on the mind-set of acupuncturists and perhaps other alternative practitioners as well. Let me try to explain.
What struck me first was the degree of suspicion, even outright hostility from the acupuncturists. I had made it quite clear that I was asking Mel to join my Editorial-Board because of her views which vastly differ from mine. In science, differences of opinions and backgrounds can be stimulating and often generate progress. That is not something that seems to be wanted by alternative practitioners; they do not seem to tolerate criticism, different perspectives or views. One cannot help asking to what degree this attitude is immature or even dogmatic.
The next thing that baffled me was the speed with which conclusions are jumped upon. Everyone seemed to be instantly convinced that I was via my journal FACT in the pocket of the pharmaceutical industry. Nobody even bothered to look up what the Royal Pharmaceutical Society truly stand for and to verify that they do NOT represent ‘BIG PHARMA’. This blindness to the possibility of being wrong confirms my fear that alternative therapists are guided by strong beliefs which must not be questioned and are hard to influence, even with facts that take less than a minute to research.
And then there are, of course, the personal attacks which came quick, thick and fast. Its authors might think that such attacks get under my skin. If so, they are mistaken: if anything, they amuse me! I have long been of the opinion that they are important victories of reason. When an acupuncturist went as far as diagnosing me as being borderline psychopathic, I almost fell off my chair laughing! To me, this remark (which has emerged several times before) is emblematic, as it suggests several things at once:
- The author is obviously rude
- He/she is incompetent, even stupid
- He/she lacks empathy – after all, one would expect from a healthcare professional to show some understanding, if I were truly ill! And if not, one would expect more respect towards mentally ill patients.
- But, of course, he/she did not mean it like that; he/she merely meant to insult me. And employing mental health issues for this purpose shows a remarkable lack of professionalism, in my view.
Am I making too much of all this? Perhaps – sorry, I am almost done.
But first I need to briefly address Mel’s doubts about my integrity. She can, of course, question what she likes as often as she wants. My point is that repeating nonsensical arguments ad nauseam does not render then sensical.
Finally, there is Mel’s public claim that I have been lying about my conflict of interests. To me, it suggests a degree of desperation, perhaps even fanaticism, that is only surpassed by her inability to apologize after the truth had become undeniable even to her.
I know that there are some people who would have sued for libel.
For that I find all this far too hilarious.
We tend to trust charities; many of us donate to charities; we think highly of the work they do and the advice they issue. And why shouldn’t we? After all, a ‘charity’ is ‘an institution or organization set up to provide help, money, etc, to those in need’. Not a hint at anything remotely sinister here – charities are good!
Except, of course, those that are not so good!
By ‘not so good’ I mean charities that misinform the public to a point where they might even endanger our health, well-being and savings. Yes, I am speaking of those charities that promote unproven or disproven alternative therapies – and unfortunately, there are many of those around today.
Our recent letter in the SUNDAY TIMES, tried to alert the public to this problem and to the fact that the UK regulator seems to be failing to do much about it. A Charity Commission spokesman, in turn, replied that his organisation had received the letter and would respond formally to it:
“The Commission is required to register organisations as charities which are established for exclusively charitable purposes for the public benefit,” he said. “Charitable purposes for the advancement of health include conventional methods as well as complementary, alternative or holistic methods which are concerned with healing mind, body and spirit in the alleviation of symptoms and the cure of illness. Those organisations dealing with complementary and alternative medicines must be able to demonstrate that they are capable of promoting health otherwise they will not be for the public benefit.
“The Commission is the registrar and regulator of charities however it is not the authority in the efficacy of any and every non-traditional medical treatment. These are issues of substantial debate with a variety of opinions. Each case is considered on its merits based on the evidence available. To be charitable there needs to be sufficient evidence of the efficacy of the method to be used. The Commission must further be assured that any potential harm that might be said to arise does not outweigh the benefit identified by the method.
“The Commission expects charities to provide information that is factually accurate with legitimate evidence.”
But is the information provided by all charities factually accurate?
Take, for instance, YES TO LIFE! Have a good look and then decide for yourself.
On their website they state: “We provide support, information and financial assistance to those with cancer seeking to pursue approaches that are currently unavailable on the NHS. We also run a series of educational seminars and workshops which are aimed at the general public who want to know more and practitioners working with people who have cancer.”
The website informs us about many alternative therapies and directly or indirectly promote them for the curative or supportive treatment of cancer. I have chosen 5 of them and copied the respective summaries as published by YES TO LIFE. My main selection criterion was having done some research myself on the modality in question. Here are the 5 cancer treatments which I selected; the text from YES TO LIFE is in bold, and that of my published research is in normal print with a link to the published paper:
Carctol is a relatively inexpensive product, specifically formulated to assist cells with damaged respiration, it is also a powerful antioxidant that targets free radicals, the cause of much cellular damage. It also acts to detoxify the system.
Often given intravenously as part of a programme of Metabolic Therapy, Laetrile is a non-toxic extract of apricot kernels. The claimed mechanism of action that is broken down by enzymes found in cancer cells. Hydrogen cyanide, one of the products of this reaction then has a local toxic effect on the cells.
The claims that laetrile or amygdalin have beneficial effects for cancer patients are not currently supported by sound clinical data. There is a considerable risk of serious adverse effects from cyanide poisoning after laetrile or amygdalin, especially after oral ingestion. The risk-benefit balance of laetrile or amygdalin as a treatment for cancer is therefore unambiguously negative.
Mistletoe therapy was developed as an adjunct to cancer treatment in Switzerland in 1917-20, in the collaboration between Dr I Wegman MD and Dr Rudolf Steiner PhD (1861-1925). Mistletoe extracts are typically administered by subcutaneous injection, often over many years. Mistletoe treatment improves quality of life, supports patients during recommended conventional cancer treatments and some studies show survival benefit. It is safe and has no adverse interactions with conventional cancer treatments.
None of the methodologically stronger trials exhibited efficacy in terms of quality of life, survival or other outcome measures. Rigorous trials of mistletoe extracts fail to demonstrate efficacy of this therapy.
A type of low toxicity chemotherapy derived from a combination of two known cytotoxic drugs that are of little use individually, as the doses required for effective anticancer action are too high to be tolerated. However the combination is effective at far lower doses, with few side effects.
The data from randomised clinical trials suggest Ukrain to have potential as an anticancer drug. However, numerous caveats prevent a positive conclusion, and independent rigorous studies are urgently needed. [To judge the validity of this last treatment, I also recommend reading a previous post of mine.]
Finally, it might be informative to see who the individuals behind YES TO LIFE are. I invite you to have a look at their list of medical advisors which, I think, speaks for itself. It includes, for instance, Dr Michael Dixon of whom we have heard before on this blog, for instance, here, here and here.
Say no more!
This post is dedicated to Mel Koppelman.
Those who followed the recent discussions about acupuncture on this blog will probably know her; she is an acupuncturist who (thinks she) knows a lot about research because she has several higher qualifications (but was unable to show us any research published by herself). Mel seems very quick in lecturing others about research methodology. Yesterday, she posted this comment in relation to my previous post on a study of aromatherapy and reflexology:
Professor Ernst, This post affirms yet again a rather poor understanding of clinical trial methodology. A pragmatic trial such as this one with a wait-list control makes no attempt to look for specific effects. You say “it is quite simply wrong to assume that this outcome is specifically related to the two treatments.” Where have specific effects been tested or assumed in this study? Your statement in no way, shape or form negates the author’s conclusions that “aromatherapy massage and reflexology are simple and effective non-pharmacologic nursing interventions.” Effectiveness is not a measure of specific effects.
I am most grateful for this comment because it highlights an issue that I had wanted to address for some time: The meanings of the two terms ‘efficacy and effectiveness’ and their differences as seen by scientists and by alternative practitioners/researchers.
Let’s start with the definitions.
I often use the excellent book of Alan Earl-Slater entitled THE HANDBOOK OF CLINICAL TRIALS AND OTHER RESEARCH. In it, EFFICACY is defined as ‘the degree to which an intervention does what it is intended to do under ideal conditions. EFFECTIVENESS is the degree to which a treatment works under real life conditions. An EFFECTIVENESS TRIAL is a trial that ‘is said to approximate reality (i. e. clinical practice). It is sometimes called a pragmatic trial’. An EFFICACY TRIAL ‘is a clinical trial that is said to take place under ideal conditions.’
In other words, an efficacy trial investigates the question, ‘can the therapy work?’, and an effectiveness trial asks, ‘does this therapy work?’ In both cases, the question relate to the therapy per se and not to the plethora of phenomena which are not directly related to it. It seems logical that, where possible, the first question would need to be addressed before the second – it does make little sense to test for effectiveness, if efficacy has not been ascertained, and effectiveness without efficacy does not seem to be possible.
In my 2007 book entitled UNDERSTANDING RESEARCH IN COMPLEMENTARY AND ALTERNATIVE MEDICINE (written especially for alternative therapists like Mel), I adopted these definitions and added: “It is conceivable that a given therapy works only under optimal conditions but not in everyday practice. For instance, in clinical practice patients may not comply with a therapy because it causes adverse effects.” I should have added perhaps that adverse effects are by no means the only reason for non-compliance, and that non-compliance is not the only reason why an efficacious treatment might not be effective.
Most scientists would agree with the above definitions. In fact, I am not aware of a debate about them in scientific circles. But they are not something alternative practitioners tend to like. Why? Because, using these strict definitions, many alternative therapies are neither of proven efficacy nor effectiveness.
What can be done about this unfortunate situation?
Simple! Let’s re-formulate the definitions of efficacy and effectiveness!
Efficacy, according to some alternative medicine proponents, refers to the therapeutic effects of the therapy per se, in other words, its specific effects. (That coincides almost with the scientific definition of this term – except, of course, it fails to tell us anything about the boundary conditions [optimal or real-life conditions].)
Effectiveness, according to the advocates of alternative therapies, refers to its specific effects plus its non-specific effects. Some researchers have even introduced the term ‘real-life effectiveness’ for this.
This is why, the authors of the study discussed in my previous post, could conclude that “aromatherapy massage and reflexology are simple… effective… interventions… to help manage pain and fatigue in patients with rheumatoid arthritis.” Based on their data, neither aromatherapy nor reflexology has been shown to be effective. They might appear to be effective because patients expected to get better, or patients in the no-treatment control group felt worse for not getting the extra care. Based on studies of this nature, giving patients £10 or a box of chocolate might also turn out to be “simple… effective… interventions… to help manage pain and fatigue in patients with rheumatoid arthritis.” Based on these definitions of efficacy and effectiveness, there are hardly any limits to bogus claims for any old quackery.
Such obfuscation suits proponents of alternative therapies fine because, using such definitions, virtually every treatment anyone might ever think of can be shown to be effective! Wishful thinking, it seems, can fulfil almost any dream, it can even turn the truth upside down.
Or can anyone name an alternative treatment that cannot even generate a placebo response when administered with empathy, sympathy and care? Compared to doing nothing, virtually every ineffective therapy might generate outcomes that make the treatment look effective. Even the anticipation of an effect alone might do the trick. How often have you had a tooth-ache, went to the dentist, and discovered sitting in the waiting room that the pain had gone? Does that mean that sitting in a waiting room is an effective treatment for dental pain?
In fact, some enthusiasts of alternative medicine could soon begin to argue that, with their new definition of ‘effectiveness’, we no longer need controlled clinical trials at all, if we want to demonstrate how effective alternative therapies truly are. We can just do observational studies without a control group, note that lots of patients get better, and ‘Bob is your uncle’!!! This is much faster, saves money, time and effort, and has the undeniable advantage of never generating a negative result.
To most outsiders, all this might seem a bit like splitting hair. However, I fear that it is far from that. In fact, it turns out to be a fairly fundamental issue in almost any discussion about the value or otherwise of alternative medicine. And, I think, it is also a matter of principle that reaches far beyond alternative medicine: if we allow various interest groups, lobbyists, sects, cults etc. to use their own definitions of fundamentally important terms, any dialogue, understanding or progress becomes almost impossible.
Alternative medicine has no shortage of research that suggests it to be effective. Almost invariably, however, one finds – when looking a bit more carefully at such investigations – that the positive conclusions are not warranted by the data. Here is an excellent, recent example:
This new study, authored by two Turkish nurses, was an RCT where the patients were randomly assigned to either an aromatherapy massage (n = 17), reflexology (n = 17) or the control group (n = 17). Aromatherapy massage was applied to both knees of subjects in group 1 for 30 minutes. Reflexology was administered to both feet of subjects in group 2 for 40 minutes during weekly home visits. The subjects of group 3, the control group, received no intervention.
Fifty-one subjects with rheumatoid arthritis were recruited from a university hospital rheumatology clinic in Turkey between July 2014 and January 2015 for this trial. Data were collected by personal information form, DAS28 index, Visual Analog Scale and Fatigue Severity Scale. Pain and fatigue scores were measured at baseline and within an hour after each intervention for 6 weeks.
Pain and fatigue scores significantly decreased in the aromatherapy massage and reflexology groups compared with the control group (p < .05). The reflexology intervention started to decrease pain and fatigue scores earlier than aromatherapy massage (week 1 vs week 2 for pain, week 1 vs week 4 for fatigue) (p < .05).
The authors concluded that aromatherapy massage and reflexology are simple and effective non-pharmacologic nursing interventions that can be used to help manage pain and fatigue in patients with rheumatoid arthritis.
I am sure that most readers have spotted the snag: the two interventions generated better outcomes than no therapy. It is quite simply wrong to assume that this outcome is specifically related to the two treatments. Both of these treatments are fairly agreeable and generate expectations, involve touch, attention and care. In my view, it is these latter factors which together have caused the better outcomes. And this is, of course, entirely unrelated to any specific effects of the two therapies.
This might well be trivial, but if such sloppy conclusions pollute the literature to the extend that they currently do in the realm of alternative medicine, it becomes important.
Acupuncture, like most other alternative therapies, is particular popular for indications that are
- associated with a high burden of suffering,
- not easily treatable with conventional therapies,
- are frequently resolved without any intervention.
Infertility or subfertility tick most of these boxes. It is therefore not surprising that acupuncturists the world over claim that acupuncture can cure infertility. But is this claim based on evidence or on wishful thinking?
The objective of this new study was to find out. Specifically, the authors wanted to provide preliminary data to explore whether women with subfertility undergoing a course of acupuncture and lifestyle modification compared with an active control of lifestyle modification alone would demonstrate improved reproductive outcomes, improved menstrual cycles, and increased fertility awareness.
In a pragmatic randomised controlled trial, with the A+B versus B design, sub/infertile women were offered an intervention of acupuncture and lifestyle modification or lifestyle modification only. There was a statistically significant increase in fertility awareness in the acupuncture group (86.4%) compared to 40% of the lifestyle only participants. Changes in menstrual regularity were not statistically significant. There was no statistical difference in the pregnancy rate with seven women achieving pregnancy during the course of the study intervention. Those receiving the acupuncture conceived within an average of 5.5 weeks compared to 10.67 weeks for the lifestyle only group.
The authors concluded that the acupuncture protocol tested influenced women who received it compared to women who used lifestyle modification alone: their fertility awareness and wellbeing increased, and those who conceived did so in half the time.
The first sentences of the authors’ discussion are, I think, revealing: The main findings were that this acupuncture intervention, compared to lifestyle only, resulted in significant increases in fertility awareness and quality of life measures in relation to wellbeing; it increased the ability of the recipients to engage in desired activities, such as exercise or rest, and it shortened the time to conception by half. The findings provide preliminary evidence that the acupuncture intervention is acceptable and is not inert and that acupuncture dose may have a significant influence on outcomes.
In my view, the main findings of this study are entirely different. Let me propose alternatives:
- In alternative medicine, if you did a lousy study, you can just call it a ‘pilot study’ and all is forgiven.
- The infamous A+B vs B design continues to be popular for those who cannot bring themselves to publishing negative findings.
- It works perfectly for subjective parameters but less convincingly for objective ones, such as pregnancy rates.
- Doing such research on infertility is good for the cash flow of acupuncturists.
- Making women aware of fertility increases (surprise, surprise!) fertility awareness.
No need to be so cynical!, some will think. After all, the results showed that women receiving the acupuncture conceived within an average of 5.5 weeks compared to 10.67 weeks for the lifestyle only group. True! But there was no statistically significant difference between these two figures. And that means, the difference was a chance finding (which has no place in an abstract) which probably has no relevance whatsoever.
Or perhaps I am wrong?
I am told to always keep an open mind!
So, let’s keep our minds open to some truly alternative explanations. How about this one: regular acupuncture increases the rate of adultery, which, in turn, decreases the time to conception.
Makes sense, doesn’t it? Has anyone a better idea?
The German Association of Homeopaths (Deutscher Zentralverein Homoeopathischer Aerzte) just issued a press-release explaining that they have recently determined that homeopathy works.
Well, aren’t we relieved!
Otherwise, we would have had to assume they are all quacks.
Their statement is based on what they consider a thorough analysis of the published evidence. As the whole document is about 60 pages long, I will not bother you with all the details. Instead, I will focus on what they say about systematic reviews/meta-analyses in the press-release:
Eine Betrachtung der Meta-Analysen zur Homöopathie zeigt überwiegend statistisch signifikante Ergebnisse gegenüber Placebo, die auf eine spezifische Wirksamkeit potenzierter Arzneien hinweisen. Je nach den verwendeten Selektionskriterien werden hierbei unterschiedliche Studien in die Auswertung eingeschlossen. Diese Befunde werden von den Autoren der jeweiligen Meta-Analysen zum Teil stark relativiert. Die angeführten Vorbehalte entsprechen hierbei nicht immer den üblichen wissenschaftlichen Standards.
Let me translate this for you: An assessment of the meta-analyses of homeopathy shows mostly significant results compared to placebo which indicates a specific effectiveness of potentised remedies. Depending on the selection criteria, various studies are included in the evaluation. These results are relativized by the authors of the respective meta-analyses. The listed caveats do not always reflect the usual scientific standards.
You think my English has deteriorated or my brain gone soft? No, it’s their German! It makes almost no sense at all.
Therefore, I am afraid, we need to briefly go into the hefty document after all. Their chapter on meta-analyses concludes as follows: Insgesamt ergibt sich hinsichtlich der bis dato publizierten maßgeblichen Meta-Analysen zur Homöopathie, dass in vier von fünf Fällen tendenziell eine spezifische Wirksamkeit potenzierter Arzneimittel über Placebo hinaus erkennbar ist. That makes (linguistically) a little more sense: Overall, it emerges that the currently published decisive meta-analyses show, in 4 of 5 cases, that a specific effectiveness of potentised remedies is noticeable.
In other words, it is now proven, homeopathic remedies work beyond placebo!!!
But how can this be?
Did the NHMRC not just do a similar analysis concluding that “the evidence from research in humans does not show that homeopathy is effective for treating the range of health conditions considered… homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness. People who are considering whether to use homeopathy should first get advice from a registered health practitioner. Those who use homeopathy should tell their health practitioner and should keep taking any prescribed treatments.
Obviously ‘down under’ they don’t know how to evaluate published data!
Or could it be that the Germans are mistaken? Or are they perhaps joking?
Let’s have a look!
The Germans selected (cherry-picked) 5 meta-analyses which they believed to be ‘decisive’, while the Australian panel of independent experts (funded by government) assessed 57 meta-analyses and systematic reviews (all they found via extensive literature searches).
But the German evaluation was done by homeopaths (and financed by a homeopathic lobby group)! And they understand homeopathy best and would not have a bias or conflict of interest, would they?[FOR A MORE COMPLETE ANALYSIS, SEE HERE (in German)]