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

commercial interests

An article referring to comments Prof David Colquhoun and I recently made in THE TIMES about acupuncture for children caught my attention. In it, Rebecca Avern, an acupuncturist specialising in paediatrics and heading the clinical programme at the College of Integrated Chinese Medicine, makes a several statements which deserve a comment. Here is her article in full, followed by my short comments.

START OF QUOTE

Just before Christmas an article appeared in the Times with the headline ‘Professors raise alarm over rise of acupuncture for children’. There has been little or nothing in the mainstream press relating to paediatric acupuncture. So, in a sense, and in the spirit of ‘all press is good press’, this felt like progress. The article quoted myself and Julian Scott, and mentioned several childhood conditions for which children seek treatment. It also mentioned some of the reasons that parents choose acupuncture for their children.

However, it included some negative quotes from our old friends Ernst and Colquhoun. The first was Ernst stating that he was ‘not aware of any sound evidence showing that acupuncture is effective for any childhood conditions’. Colquhoun went further to state that there simply is not ‘the slightest bit of evidence to suggest that acupuncture helps anything in children’. Whilst they may not be aware of it, good evidence does exist, albeit for a limited number of conditions. For example, a 2016 meta-analysis and systematic review of the use of acupuncture for post-operative nausea and vomiting (PONV) concluded that children who received acupuncture had a significantly lower risk of PONV than those in the control group or those who received conventional drug therapy.[i]

Ernst went on to mention the hypothetical risk of puncturing a child’s internal organs but he failed to provide evidence of any actual harm. A 2011 systematic review analysing decades of acupuncture in children aged 0 to 17 years prompted investigators to conclude that acupuncture can be characterised as ‘safe’ for children.[ii]

Ernst also mentioned what he perceived is a far greater risk. He expressed concern that children would miss out on ‘effective’ treatment because they are having acupuncture. In my experience running a paediatric acupuncture clinic in Oxford, this is not the case. Children almost invariably come already having received a diagnosis from either their GP or a paediatric specialist. They are seeking treatment, such as in the case of bedwetting or chronic fatigue syndrome, because orthodox medicine is unable to effectively treat or even manage their condition. Alternatively, their condition is being managed by medication which may be causing side effects.

When it comes to their children, even those parents who may have reservations about orthodox medicine, tend to ensure their child has received all the appropriate exploratory tests. I have yet to meet a parent who will not ensure that their child, who has a serious condition, has the necessary medication, which in some cases may save their lives, such as salbutamol (usually marketed as Ventolin) for asthma or an EpiPen for anaphylactic reactions. If a child comes to the clinic where this turns out not to be the case, thankfully all BAcC members have training in a level of conventional medical sciences which enables them to spot ‘red flags’. This means that they will inform the parent that their child needs orthodox treatment either instead of or alongside acupuncture.

The article ended with a final comment from Colquhoun who believes that ‘sticking pins in babies is a rather unpleasant form of health fraud’. It is hard not to take exception to the phrase ‘sticking pins in’, whereas what we actually do is gently and precisely insert fine, sterile acupuncture needles. The needles used to treat babies and children are usually approximately 0.16mm in breadth. The average number of needles used per treatment is between two and six, and the needles are not retained. A ‘treatment’ may include not only needling, but also diet and lifestyle advice, massage, moxa, and parental education. Most babies and children find an acupuncture treatment perfectly acceptable, as the video below illustrates.

The views of Colquhoun and Ernst also beg the question of how acupuncture compares in terms of safety and proven efficacy with orthodox medical treatments given to children. Many medications given to children are so called ‘off-label’ because it is challenging to get ethical approval for randomised controlled trials in children. This means that children are prescribed medicines that are not authorised in terms of age, weight, indications, or routes of administration. A 2015 study noted that prescribers and caregivers ‘must be aware of the risk of potential serious ADRs (adverse drug reactions)’ when prescribing off-label medicines to children.[iii]

There are several reasons for the rise in paediatric acupuncture to which the article referred. Most of the time, children get better when they have acupuncture. Secondly, parents see that the treatment is gentle and well tolerated by their children. Unburdened by chronic illness, a child can enjoy a carefree childhood, and they can regain a sense of themselves as healthy. A weight is lifted off the entire family when a child returns to health. It is my belief that parents, and children, vote with their feet and that, despite people such as Ernst and Colquhoun wishing it were otherwise, more and more children will receive the benefits of acupuncture.

[i] Shin HC et al, The effect of acupuncture on post-operative nausea and vomiting after pediatric tonsillectomy: A meta-analysis and systematic review. Accessed January 2019 from: https://www.ncbi.nlm.nih.gov/pubmed/26864736

[ii] Franklin R, Few Serious Adverse Events in Pediatric Needle Acupuncture. Accessed January 2019from: https://www.medscape.com/viewarticle/753934?src=trendmd_pilot

[iii] Aagaard L (2015) Off-Label and Unlicensed Prescribing of Medicines in Paediatric Populations: Occurrence and Safety Aspects. Basic and Clinical Pharmacology and Toxicology. Accessed January 2019 from: https://onlinelibrary.wiley.com/doi/pdf/10.1111/bcpt.12445

END OF QUOTE

  1. GOOD EVIDENCE: The systematic review cited by Mrs Avern was based mostly on poor-quality trials. It even included cohort studies without a control group. To name it as an example of good evidence, merely discloses an ignorance about what good evidence means.
  2. SAFETY: The article Mrs Avern referred to is a systematic review of reports on adverse events (AEs) of acupuncture in children. A total of 279 AEs were found.  Of these, 25 were serious (12 cases of thumb deformity, 5 infections, and 1 case each of cardiac rupture, pneumothorax, nerve impairment, subarachnoid haemorrhage, intestinal obstruction, haemoptysis, reversible coma, and overnight hospitalization), 1 was moderate (infection), and 253 were mild. The mild AEs included pain, bruising, bleeding, and worsening of symptoms. Considering that there is no reporting system of such AEs, this list of AEs is, I think, concerning and justifies my concerns over the safety of acupuncture in children. The risks are certainly not ‘hypothetical’, as Mrs Avern claimed, and to call it thus seems to be in conflict with the highest standard of professional care (see below). Because the acupuncture community has still not established an effective AE-surveillance system, nobody can tell whether such events are frequent or rare. We all hope they are infrequent, but hope is a poor substitute for evidence.
  3. COMPARISON TO OTHER TREATMENTS: Mrs Avern seems to think that acupuncture has a better risk/benefit profile than conventional medicine. Having failed to show that acupuncture is effective and having demonstrated that it causes severe adverse effects, this assumption seems nothing but wishful thinking on her part.
  4. EXPERIENCE: Mrs Avern finishes her article by telling us that ‘children get better when they have acupuncture’. She seems to be oblivious to the fact that sick children usually get better no matter what. Perhaps the kids she treats would have improved even faster without her needles?

In conclusion, I do not doubt the good intentions of Mrs Avern for one minute; I just wished she were able to develop a minimum of critical thinking capacity. More importantly, I am concerned about the BRITISH ACUPUNCTURE COUNCIL, the organisation that published Mrs Avern’s article. On their website, they state: The British Acupuncture Council is committed to ensuring all patients receive the highest standard of professional care during their acupuncture treatment. Our Code of Professional Conduct governs ethical and professional behaviour, while the Code of Safe Practice sets benchmark standards for best practice in acupuncture. All BAcC members are bound by these codes. Who are they trying to fool?, I ask myself.

On this blog, many of us have been frightfully critical of Dana Ullman; some were even harsh and demeaning. Meanwhile, I have spent some time on-line to study the man more closely. And yes, I have changed my mind (despite all the insults he has hurled at me).

Guys, we (and the US judge who made that nasty comment about Dana) have done him wrong!

So wrong!

For instance, did you know he has written a thesis at UC Berkeley? Here is its summary:

In the Approach of this paper, this writer introduced his own Approach to the world. His subjective goals, needs, attitudes, and beliefs were presented. The subjective attitude was considered the source of his understanding himself and the universe. Then, the goals of this paper, the definitions of terms (beliefs), and the questions to be answered were discussed. To understand as much of oneself and the universe as possible was our goal, need, and scientific endeavor. Within this infinite realm, we specifically sought to understand the learning process and, in particular, to investigate why a person learns some things and not others. To help put our question into a workable framework, we introduced the concepts Approach, Method, and Content as sub-processes of the learning process.           

In our Method we chose the Behavior Psychologist as an example to help understand a person’s use of the Approach, Method, and Content in the learning process and in the way they affect what a person learns and doesn’t learn.

The Approach and Method led us into the Content – the answers to our questions.* Our answers emphasized the subjective nature of all things. We discovered a symbiotic relationship between the three sub-processes. The Approach was recognized as particularly important because it manifested into a question that predisposed limits upon the Method to study it and the Content it could find. From this disposition, we found that a person’s Approach plays a large role in determining what a person learns and doesn’t learn. Finally, we introduced some methods to better understand one’s Approach in order to help a person lead chimself to a deeper awareness of chimself and a greater comprehension of worldly phenomena. In this way, we hope we have helped chim expand the bounds of what che can learn and also helped chim understand why che doesn’t learn.

If I am not mistaken, this piece of research is not just brilliant, it also earned Dana the master’s degree in public health that he likes to mention so often.

Amongst the many informative sources that I found, his own website tells it best, I think. Here is an excerpt:

Dana Ullman, MPH, CCH, (MPH = Masters in Public Health, U.C. Berkeley;  CCH = Certified in Classical Homeopathy) has authored 10 books on homeopathy and is one of America’s leading advocates for homeopathy, and he has authored chapters on homeopathic medicine in three medical textbooks. He has served on advisory boards of alternative medicine institutes at Harvard and Columbia (you can learn more about him at this link; see About Dana Ullman, MPH, CCH).

Dana Ullman, MPH, CCH, provides phone and email consultation OR he can provide a personalized referral to leading homeopaths in North America (and often in many other countries in the world). There is a $45 fee for a 10-minute conversation, and there is a $40 additional fee for each 10 minute. Call or email to make an appointment for this conversation, or if you want, everything can be done online. You will need to provide us with a Visa, MasterCard, American Express, or Discover cards for payment….or payment can be made via PayPal to email@homeopathic.com.  Dana is also able to accept “Wellness Cards” and from “Health Savings Accounts” (credit cards sometimes given to employees for “health services”).

Generally, a homeopath seeks to prescribe a “homeopathic constitutional medicine” that will strengthen a person’s overall level of health.  This consultation delves into a person’s family history, his/her own health history, and the totality of physical and psychological symptoms and characteristics.  In most cases, this first consultation takes one-hour, costing $245.00, though people with a complex health condition may require more time.  Follow-ups are usually 10 minutes to 40 minutes (or $45 to $165), with follow-ups vary depending upon the complexity of a person’s health…and some follow-ups will require more than 40 minutes.

Dana Ullman provides personalized and individualized homeopathic treatment for people with a wide variety of acute and chronic health problems.  He regularly treats infants and children with either physical or psychological challenges, from chronic ear infections to various ADD/ADHD or autistic spectrum problems (Dana’s book on Homeopathic Medicines for Children and Infants was published in 1991).  Dana also treats people with a wide variety of pain syndromes, including people with fibromyalgia and arthritic disorders, shingles or sciatica, and headaches (Dana co-authored a chapter in a leading conventional medical textbook on pain management, called “Weiner’s Pain Management”).  Dana also treats people in various stages of cancer (Dana was the lead author written with three medical doctor a chapter on homeopathy and cancer care in a textbook published by Oxford University Press called “Integrative Oncology”).  Dana provide “adjunctive health care” that is in addition to whatever other health or medical care the person is receiving (many of his patients use an integration of conventional and homeopathic medicines).

Dana Ullman provides homeopathic treatment via phone, Skype, and in our Berkeley office! You will need to phone or email us (email@homeopathic.com) to set-up an appointment. Please clarify if you prefer an in-office or on-telephone or Skype appointment.

Also, if you have questions about homeopathy, specific homeopathic medicines, the care that you have received from a homeopath, how to best learn homeopathy, what homeopathic research exists, or many other subjects in this field, you may benefit from a personal consultation with Dana Ullman, MPH, CCH. Call or email us to set up a phone appointment. An email conversation is also possible, but this tends to require more time than an interactive discussion.

You might frown upon telephone consultations. But stop being so sceptical, Dana is sacrificing his precious time to help as many patients as he can – even those with AIDS, autism or cancer. Does that not deserve some respect?

And look at his many achievements: 10 own books! 3 chapters is medical textbooks! What, you ask which textbooks? Here they are:

  1. Homeopathic Medicine: Principles and Research, in Complementary and Alternative Veterinary Medicine: Principles and Practice, edited by Allen M. Schoen, DVM, and Susan G. Wynn, DVM, PhD, New York: Mosby, 1998.
  2. Homeopathy (co-authored with Michael Loes, MD), in Weiner’s Pain Management: A Practical Guide for Clinicians, edited by M. V. Boswell and B. E. Cole, 7th edition, New York: Taylor and Francis, 2006.
  3. Homeopathy for Primary and Adjunctive Cancer Therapy (co-authored with Menacham Oberbaum, MD, Iris Bell, MD, PhD, and Shepherd Roee Singer, MD), in Integrative Oncology, edited by Andrew Weil, MD and Donald Abrams, MD, published in March, 2009, by Oxford University Press.

Not impressed?

In this case, you suffer from closed-mindedness and denialism.

You might need help!

Phone Dana, he will prescribe a cure (and ameliorate his income).

 

 

[*I have noticed that, in the past, some of my readers seem to have difficulties in detecting satire; for them I should disclose: THIS POST IS PURE SATIRE!]

The General Chiropractic Council (GCC) is the statutory body regulating all chiropractors in the UK. Their foremost aim, they claim, is to ensure the safety of patients undergoing chiropractic treatment. They also allege to be independent and say they want to protect the health and safety of the public by ensuring high standards of practice in the chiropractic profession.

That sounds good and (almost) convincing.

But is the GCC truly fit for purpose?

In a previous post, I found good reason to doubt it.

In a recent article, the GCC claimed that they started thinking about a new five-year strategy and began to shape four key strategic aims. So, let’s have a look. Here is the crucial passage:

 

A clear strategy is vital but, of course, implementation and getting things changed are where the real work lie. With that in mind, we have a specific business plan for 2019 – the first year of the new strategic plan. You can read it here. This means you’ll see some really important changes and benefits including:

  • Promote standards: review and improvements to CPD processes, supporting emerging new degree providers, a campaign to promote the public choosing a registered chiropractor
  • Develop the profession: supporting and enabling work with the professional bodies
  • Investigate and act: a full review of, and changes to, our Fitness to Practice processes to enable a more ‘right touch’ approach within our current legal framework, sharing more learning from the complaints we receive
  • Deliver value: a focus on communication and engagement, further work on our culture, a new website, an upgraded registration database for an improved user experience.

The changes being introduced, backed by the GCC’s Council, will have a positive effect. I know Nick, the new Chief Executive and Registrar and the staff team will make this a success. You as chiropractors also have an important role to play – keep engaging with us and take your own action to develop the profession, share your ideas and views as we transform the organisation, and work with us to ensure we maintain public confidence in the profession of chiropractic.

END OF QUOTE

Am I the only one who finds this more than a little naïve and unprofessional? More importantly, this statement hints at a strategy mainly aimed at promoting chiropractors regardless of whether they are doing more good than harm. This, it seems, is not in line with the GCC’s stated aims.

  • How can they already claim that the changes being introduced will have a positive effect?
  • Where in this strategy is the GCC’s alleged foremost aim, the protection of the public?
  • Where is any attempt to get chiropractic in line with the principles of EBM?
  • Where is an appeal to chiropractors to adopt the standards of medical ethics?
  • Where is an independent and continuous assessment of the effectiveness of chiropractic?
  • Where is a critical evaluation of its safety?
  • Where is an attempt to protect the public from the plethora of bogus claims made by UK chiropractors?

I feel that, given the recent history of UK chiropractic, these (and many other) points should be essential elements in any long-term strategy. I also feel that this new and potentially far-reaching statement provides little hope that the GCC is on the way towards getting fit for purpose.

Mistletoe treatment of cancer patients was the idea of Rudolf Steiner. Mistletoe grows on a host tree like a parasite and eventually might kill it. This seems similar to a cancer killing a patient, and Steiner – influenced by the homeopathic ‘like cures like’ notion – thought that mistletoe should thus be an ideal treatment of all cancers. Despite the naivety of this concept, it somehow did catch on, and mistletoe has now become the number one cancer SCAM in Europe which is spreading fast also to the US and other countries.

But, as we all know, the fact that a therapy lacks plausibility does not necessarily mean that it is clinically useless. To decide, we need clinical trials; and to be sure, we need rigorous reviews of all reliable trials. Two such papers have just been published.

The aim of the systematic review was to give an extensive overview about current state of research concerning mistletoe therapy of oncologic patients regarding survival, quality of life and safety.

The authors extensive literature searches identified 3647 hits and 28 publications with 2639 patients were finally included in this review. Mistletoe was used in bladder cancer, breast cancer, other gynecological cancers (cervical cancer, corpus uteri cancer, and ovarian cancer), colorectal cancer, other gastrointestinal cancer (gastric cancer and pancreatic cancer), glioma, head and neck cancer, lung cancer, melanoma and osteosarcoma. In nearly all studies, mistletoe was added to a conventional therapy. Patient relevant endpoints were overall survival (14 studies, n = 1054), progression- or disease-free survival or tumor response (10 studies, n = 1091). Most studies did not show any effect of mistletoe on survival. Especially high quality studies did not show any benefit.

The authors concluded that, with respect to survival, a thorough review of the literature does not provide any indication to prescribe mistletoe to patients.

The aim of the second systematic review by the same team was to give an extensive overview about the current state of evidence concerning mistletoe therapy of oncologic patients regarding quality of life and side effects of cancer treatments. The same studies were used for this analysis as in the first review. Regarding quality of life, 17 publications reported results. Studies with better methodological quality showed less or no effects on quality of life.

The authors concluded that with respect to quality of life or reduction of treatment-associated side effects, a thorough review of the literature does not provide any indication to prescribe mistletoe to patients with cancer.

In 2003, we published a systematic review of the same subject. Here is its abstract:

Mistletoe extracts are widely used in the treatment of cancer. The results of clinical trials are however highly inconsistent. We therefore conducted a systematic review of all randomised clinical trials of this unconventional therapy. Eight databases were searched to identify all studies that met our inclusion/exclusion criteria. Data were independently validated and extracted by 2 authors and checked by the 3rd according to predefined criteria. Statistical pooling was not possible because of the heterogeneity of the primary studies. Therefore a narrative systematic review was conducted. Ten trials could be included. Most of the studies had considerable weaknesses in terms of study design, reporting or both. Some of the weaker studies implied benefits of mistletoe extracts, particularly in terms of quality of life. 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.

As we see, 16 years and 18 additional trials have changed nothing!

I therefore think that it is time to call it a day. We should stop the funding for further research into this dead-end alley. More importantly, we must stop giving false hope to cancer patients. All that mistletoe therapy truly does is to support a multi-million Euro industry.

Chiropractors believe that their spinal manipulations bring about a reduction in pain perception, and they often call this ‘manipulation-induced hypoalgesia’ (MIH). It is unknown, however, whether MIH following high-velocity low-amplitude spinal manipulative therapy is a specific and clinically relevant treatment effect.

This systematic review was an effort in finding out.

The authors investigated changes in quantitative sensory testing measures following high-velocity low-amplitude spinal manipulative therapy in musculoskeletal pain populations, in randomised controlled trials. Their objectives were to compare changes in quantitative sensory testing outcomes after spinal manipulative therapy vs. sham, control and active interventions, to estimate the magnitude of change over time, and to determine whether changes are systemic or not.

Fifteen studies were included. Thirteen measured pressure pain threshold, and 4 of these were sham-controlled. Change in pressure pain threshold after spinal manipulative therapy compared to sham revealed no significant difference. Pressure pain threshold increased significantly over time after spinal manipulative therapy (0.32 kg/cm2, CI 0.22–0.42), which occurred systemically. There were too few studies comparing to other interventions or for other types of quantitative sensory testing to make robust conclusions about these.

The authors concluded that they found that systemic MIH (for pressure pain threshold) does occur in musculoskeletal pain populations, though there was low quality evidence of no significant difference compared to sham manipulation. Future research should focus on the clinical relevance of MIH, and different types of quantitative sensory tests.

An odd conclusion, if there ever was one!

A more straight forward conclusion might be this:

MIH is yet another myth to add to the long list of bogus claims made by chiropractors.

Oscillococcinum is by now well-known to readers of this blog, I am sure (see for instance here, here and here). It seems an important topic, not least because the infamous duck-placebo is the world’s best-selling homeopathic remedy. Just how popular it is was recently shown in a survey by the formidable ‘Office for Science and Society’ of the McGill University in Canada.

The researchers surveyed the five biggest pharmacy chains in Quebec: Jean-Coutu, Familiprix, Uniprix, Proxim, and Pharmaprix. For each chain, a sample of 30 pharmacies was chosen by a random number generator.

The calls started with the following script: “I would like to know if you carry a certain homeopathic remedy. It’s called Oscillococcinum, it’s a homeopathic remedy against the flu made by Boiron.” If they did not have it, the investigator asked if this was something they normally carried. He spoke to either a floor clerk or a member of the pharmacy staff behind the counter, depending on who knew the answer.

Out of the 150 pharmacies on the island of Montreal that were called for this investigation, 66% of them reported carrying Oscillococcinum (30% did not, while 4% could not be reached, often because the listed pharmacy had closed). Some chains were more likely to sell the product, with Jean-Coutu and Pharmaprix being the most likely (80% of their stores had it) and Proxim being the least likely (50% of their stores carried it).

The McGill researcher stated that the fact that two-thirds of Montreal-based pharmacies will sell us a pseudo-treatment for the flu that targets adults, children and infants alike is hard to square with the Quebec Order of Pharmacists’ mission statement. They describe said mission as “ensuring the protection of the public”, but how is the public protected when pharmacies are selling them placebo pills? The harm is partly financial: 30 doses of these worthless globules retail for CAD 36. It is also in the false sense of security parents will gain and the delay in proper treatment if needed. And, ultimately, it is in the legitimization of a pseudoscience the founding principle of which is that the more you add water to something (like alcohol), the more powerful it becomes.

I can only full-heartedly agree. One might even add a few more things, for instance that there are other dangers as well:

  1. If pharmacists put commercial gain before medical ethics, we might find it hard to trust this profession.
  2. If people take Oscillococcinum and their condition subsequently disappears (because of the self-limiting nature of the disease), they might believe that homeopathy is effective and consequently use it for much more serious conditions – with grave consequences, I hasten to add.
  3. If consumers thus start trusting homeopaths, they might also fall for some of their abominable health advice, e. g. that about not vaccinating their children.
  4. If a sufficiently large percentage of people believe in the magic of shaken water, our rationality will be undermined and we will encounter phenomena like Brexit or fascists as presidents (sorry, I has to get that off my chest).

The objective of this ‘real world’ study was to evaluate the effectiveness of integrative medicine (IM) on patients with coronary artery disease (CAD) and investigate the prognostic factors of CAD in a real-world setting.

A total of 1,087 hospitalized patients with CAD from 4 hospitals in Beijing, China were consecutively selected between August 2011 and February 2012. The patients were assigned to two groups:

  1. Chinese medicine (CM) plus conventional treatment, i.e., IM therapy (IM group). IM therapy meant that the patients accepted the conventional treatment of Western medicine and the treatment of Chinese herbal medicine including herbal-based injection and Chinese patent medicine as well as decoction for at least 7 days in the hospital or 3 months out of the hospital.
  2. Conventional treatment alone (CT group).

The endpoint was a major cardiac event [MCE; including cardiac death, myocardial infarction (MI), and the need for revascularization].

A total of 1,040 patients finished the 2-year follow-up. Of them, 49.4% received IM therapy. During the 2-year follow-up, the total incidence of MCE was 11.3%. Most of the events involved revascularization (9.3%). Cardiac death/MI occurred in 3.0% of cases. For revascularization, logistic stepwise regression analysis revealed that age ⩾ 65 years [odds ratio (OR), 2.224], MI (OR, 2.561), diabetes mellitus (OR, 1.650), multi-vessel lesions (OR, 2.554), baseline high sensitivity C-reactive protein level ⩾ 3 mg/L (OR, 1.678), and moderate or severe anxiety/depression (OR, 1.849) were negative predictors (P<0.05); while anti-platelet agents (OR, 0.422), β-blockers (OR, 0.626), statins (OR, 0.318), and IM therapy (OR, 0.583) were protective predictors (P<0.05). For cardiac death/MI, age ⩾ 65 years (OR, 6.389) and heart failure (OR, 7.969) were negative predictors (P<0.05), while statin use (OR, 0.323) was a protective predictor (P<0.05) and IM therapy showed a beneficial tendency (OR, 0.587), although the difference was not statistically significant (P=0.218).

The authors concluded that in a real-world setting, for patients with CAD, IM therapy was associated with a decreased incidence of revascularization and showed a potential benefit in reducing the incidence of cardiac death or MI.

What the authors call ‘real world setting’ seems to be a synonym of ‘lousy science’, I fear. I am not aware of good evidence to show that herbal injections and concoctions are effective treatments for CAD, and this study can unfortunately not change this. In the methods section of the paper, we read that the treatment decisions were made by the responsible physicians without restriction. That means the two groups were far from comparable. In their discussion section, the authors state; we found that IM therapy was efficacious in clinical practice. I think that this statement is incorrect. All they have shown is that two groups of patients with similar diagnoses can differ in numerous ways, including clinical outcomes.

The lessons here are simple:

  1. In clinical trials, lack of randomisation (the only method to create reliably comparable groups) often leads to false results.
  2. Flawed research is currently being used by many proponents of  SCAM (so-called alternative medicine) to mislead us about the value of SCAM.
  3. The integration of dubious treatments into routine care does not lead to better outcomes.
  4. Integrative medicine, as currently advocated by SCAM-proponents, is a nonsense.

The claim that homeopathy can cure cancer is so absurd that many people seem to think no homeopaths in their right mind would make it. Sadly, this turns out to be not true. A rather dramatic example is this extraordinary book. Here is what the advertisement says:

The global medical fraternity has been exploring various alternative approaches to cancer treatment. However, this exceptional book, “Healing Cancer: A Homoeopathic Approach” by Dr Farokh J Master, does not endorse a focused methodology, but it paves the way to a holistic homoeopath’s approach. For the last 40 years, the author has been utilising this approach which is in line with the Master Hahnemann’s teachings, where he gives importance to constitution, miasms, susceptibility, and most important palliation. It is a complete handbook, a ready reference providing authentic information on every aspect of malignant diseases. It covers the cancer related topics beginning from cancer archetype, clinical information on diagnosis, prevention, conventional treatment, homoeopathic aspects, therapeutics, polycrest remedies, rare remedies, Indian remedies, wisdom from the repertory, naturopathic and dietary suggestions, Iscador therapy, and social aspects of cancer to the latest researches in the field of cancer. Given the efforts put in by the author in writing this vast book, encompassing decades of clinical experience, this is indeed a valuable addition to the homoeopathic literature. In addition to homoeopaths, this book will indeed be useful for medical doctors of other modalities of therapeutics who also wish to explore a holistic approach to cancer patients since this book is the outcome of author’s successful efforts in introducing and integrating homoeopathy to the mainstream cancer treatment.

END OF QUOTE

I do wonder what goes on in the head of a clinician who spent much of his life convincing himself and others that his placebos cure cancer and then takes it upon him to write a book about this encouraging other clinician to follow his dangerous ideas.

Is he vicious?

Is he in it for the money?

Is he stupid?

Is he really convinced?

Whatever the answer, he certainly is dangerous!

For those who do not know already: homeopathy is totally ineffective as a treatment for cancer; to think otherwise can be seriously harmful.

Belgian homeopaths, together with the ‘European Committee for Homeopathy’, have published a statement which I find too remarkable to withhold it from you:

START OF QUOTE

Users of homeopathic medicines can no longer remain silent about the untruths circulating in the media. These lies raise doubts which naïve and gullible people take on board all too easily and then see homeopathy as quackery. None of this is accurate!

Because they fear seeing some of their ‘certainties’ questioned, the SKEPP movement is firing off at anything that current science cannot yet explain with both barrels.

The contents of homeopathic medicines
SKEPP states that a homeopathic medicine is nothing more than a drop of water in a swimming pool and therefore has nothing in it. This is  wrong. Tests performed on a high homeopathic potency (30CH) of Gelsemium sempervirens (Yellow Jasmine, a very common homeopathic medicine) have detected 36 micrograms of a specific substance per gram of solution [1]. Opponents denounce homeopathic medicines as being nothing but water. This is  wrong. This water, the solvent itself, contains a specific signature of the active ingredient. Basic research has demonstrated this [2].

Clinical efficacy.
By asserting at every opportunity that there is no evidence of the clinical effectiveness of homeopathy, opponents sow doubt. Correction:  such proof [3] does exist.  The fact that critics refuse to look at or accept these data speaks volumes about their attitude to science.
What is true, however, is that there is  not enough  scientific evidence of effectiveness. Science demands a lot of such evidence – and rightly so. There would be more if the universities applied the rules correctly!  For example: The Professional Union of Homeopathic Physicians had accepted a double-blind research protocol for fibromyalgia which took account of homeopathy’s individualized approach. This research was to be carried out at the Rheumatology Department of a hospital in Brussels with the agreement of the Rector of the Faculty of Medicine. But the hospital’s ethics committee decided that it would be unethical to test a ‘placebo’ (the homeopathic medicine) versus another placebo! Making an a priori assumption that homeopathic medicine is just a placebo, even before beginning the study, flies in the face of scientific objectivity.

Patients are not stupid!
In the meantime, Pro Homeopathia, the Belgian association of homeopathy patients, is no longer able to contain its members’ exasperation. It has published an article [4]  which denounces in direct terms the accusations of credulity, or even stupidity levelled at patients, in blatant disregard of their therapeutic freedom of choice and their capacity for critical thought.

Dare to ask questions! 
Why all this misinformation in the press? Why do these ‘experts’, whose opinions on homeopathy above all betray their profound misunderstanding of this discipline, flood the media with fake news? What is the hidden agenda behind this campaign of systematic denigration? Homeopathy and many other complementary medicines only want to collaborate, both in medical practice and in scientific research … fair play! It’s called integrative medicine!

References
[1]Nanoparticle Characterization of Traditional Homeopathically-Manufactured Cuprum metallicum and Gelsemium Sempervirens Medicines and Controls. Novembre 2018: https://www.thieme-connect.de/DOI/DOI?10.1055/s-0038-1666864)
[2]Nuclear Magnetic Resonance characterization of traditional homeopathically-manufactured copper (Cuprum metallicum) and a plant (Gelsemium sempervirens) medicines and controls. Août 2017: https://doi.org/10.1016/j.homp.2017.08.001
[3]Model validity and risk of bias in randomized placebo-controlled trials of individualised homeopathic treatment. 2016: http://dx.doi.org/10.1016/j.ctim.2016.01.005 //Clinical verification in homeopathy and allergic conditions. 2012 http://dx.doi.org/10.1016/j.homp.2012.06.002 //Scientific framework of homeopathy 2017. www.lmhi.org/Article/Detail/42)
[4]http://www.homeopathie-unio.be/uploads/files/unprotected/Presse/Attaques%20Hom%C3%A9o-FR2.pdf

END OF QUOTE

For regular readers of this blog, any comment on this little article might well be superfluous. For newcomers, I nevertheless provide a few thoughts. In doing so, I simply follow the three headings used above.

The contents of homeopathic medicines

A homeopathic C30 potency (the one that is used most frequently) is a dilution of 1 part homeopathic stock to 1000000000000000000000000000000000000000000000000000000000000 parts of diluent. This amounts to little more than one molecule of stock per universe. This is an undeniable fact, and the reference provided (incidentally, the link to it is dead) does not change it in any way. The theory of ‘the memory of water’ is an implausible hypothesis that has no basis in reality. It is believed only by homeopaths, and ‘studies’ that seemingly support it are flimsy, false or biased, and usually only get published in journals such as ‘Homeopathy’ (where also the reference provided appeared).

Clinical efficacy

This is a subject that we have already discussed ad nauseam. Highly diluted homeopathic remedies are pure placebos. If someone does not believe this nor all the evidence provided on this blog, they perhaps trust the many independent international bodies that have looked at the totality of the reliable evidence for or against homeopathy. Their verdicts are unanimously negative. (The above-cited decision of the ethics committee is therefore the only one that is ethically possible.)

Patients are not stupid!

That is absolutely correct; patients are certainly not stupid. And their experiences are certainly real. What is often wrong, however, is the interpretation of their experiences. When a patient’s symptoms improve after taking a highly diluted remedy, the perceived improvement is due to a long list of factors that are unrelated to the remedy: placebo, natural history, regression towards the mean, etc.

Patients are not stupid, but the misinformation homeopaths incessantly publish might render them stupid – one more reason why such irresponsible nonsense ought to stop.

 

In 1995, Dabbs and Lauretti reviewed the risks of cervical manipulation and compared them to those of non-steroidal, anti-inflammatory drugs (NSAIDs). They concluded that the best evidence indicates that cervical manipulation for neck pain is much safer than the use of NSAIDs, by as much as a factor of several hundred times. This article must be amongst the most-quoted paper by chiropractors, and its conclusion has become somewhat of a chiropractic mantra which is being repeated ad nauseam. For instance, the American Chiropractic Association states that the risks associated with some of the most common treatments for musculoskeletal pain—over-the-counter or prescription nonsteroidal anti-inflammatory drugs (NSAIDS) and prescription painkillers—are significantly greater than those of chiropractic manipulation.

As far as I can see, no further comparative safety-analyses between cervical manipulation and NSAIDs have become available since this 1995 article. It would therefore be time, I think, to conduct new comparative safety and risk/benefit analyses aimed at updating our knowledge in this important area.

Meanwhile, I will attempt a quick assessment of the much-quoted paper by Dabbs and Lauretti with a view of checking how reliable its conclusions truly are.

The most obvious criticism of this article has already been mentioned: it is now 23 years old, and today we know much more about the risks and benefits of these two therapeutic approaches. This point alone should make responsible healthcare professionals think twice before promoting its conclusions.

Equally important is the fact that we still have no surveillance system to monitor the adverse events of spinal manipulation. Consequently, our data on this issue are woefully incomplete, and we have to rely mostly on case reports. Yet, most adverse events remain unpublished and under-reporting is therefore huge. We have shown that, in our UK survey, it amounted to exactly 100%.

To make matters worse, case reports were excluded from the analysis of Dabbs and Lauretti. In fact, they included only articles providing numerical estimates of risk (even reports that reported no adverse effects at all), the opinion of exerts, and a 1993 statistic from a malpractice insurer. None of these sources would lead to reliable incidence figures; they are thus no adequate basis for a comparative analysis.

In contrast, NSAIDs have long been subject to proper post-marketing surveillance systems generating realistic incidence figures of adverse effects which Dabbs and Lauretti were able to use. It is, however, important to note that the figures they did employ were not from patients using NSAIDs for neck pain. Instead they were from patients using NSAIDs for arthritis. Equally important is the fact that they refer to long-term use of NSAIDs, while cervical manipulation is rarely applied long-term. Therefore, the comparison of risks of these two approaches seems not valid.

Moreover, when comparing the risks between cervical manipulation and NSAIDs, Dabbs and Lauretti seemed to have used incidence per manipulation, while for NSAIDs the incidence figures were bases on events per patient using these drugs (the paper is not well-constructed and does not have a methods section; thus, it is often unclear what exactly the authors did investigate and how). Similarly, it remains unclear whether the NSAID-risk refers only to patients who had used the prescribed dose, or whether over-dosing (a phenomenon that surely is not uncommon with patients suffering from chronic arthritis pain) was included in the incidence figures.

It is worth mentioning that the article by Dabbs and Lauretti refers to neck pain only. Many chiropractors have in the past broadened its conclusions to mean that spinal manipulations or chiropractic care are safer than drugs. This is clearly not permissible without sound data to support such claims. As far as I can see, such data do not exist (if anyone knows of such evidence, I would be most thankful to let me see it).

To obtain a fair picture of the risks in a real life situation, one should perhaps also mention that chiropractors often fail to warn patients of the possibility of adverse effects. With NSAIDs, by contrast, patients have, at the very minimum, the drug information leaflets that do warn them of potential harm in full detail.

Finally, one could argue that the effectiveness and costs of the two therapies need careful consideration. The costs for most NSAIDs per day are certainly much lower than those for repeated sessions of manipulations. As to the effectiveness of the treatments, it is clear that NSAIDs do effectively alleviate pain, while the evidence seems far from being conclusively positive in the case of cervical manipulation.

In conclusion, the much-cited paper by Dabbs and Lauretti is out-dated, poor quality, and heavily biased. It provides no sound basis for an evidence-based judgement on the relative risks of cervical manipulation and NSAIDs. The notion that cervical manipulations are safer than NSAIDs is therefore not based on reliable data. Thus, it is misleading and irresponsible to repeat this claim.

 

Recent Comments

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

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

Categories