Monthly Archives: March 2019
‘The Horse‘ is not a publication I often read. But I was alerted to an article in this magazine that fascinated me. Allow me to show you a few short quotes:
In essence, holistic medicine falls under the realm of what we now refer to as, “complementary, alternative, and integrative veterinary medicine,” or CAIVM. The American Veterinary Medical Association (AVMA) describes CAIVM as “a heterogeneous group of preventive, diagnostic, and therapeutic philosophies and practices that are not considered part of conventional (Western) medicine as practiced by most veterinarians.”
… Joyce Harman, DVM, owner of Harmany Equine Ltd., in Flint Hill, Virginia, is one veterinarian committed to the practice of CAIVM. She’s certified in acupuncture and chiropractic and has completed advanced training in veterinary homeopathy, nutrition, and herbal medicine. “If you’re looking for a local practitioner, find one with extensive training in the modality you’re interested in,” she says…
Let’s have a look at the actual evidence for or against these treatments. Here are (again) the most up-to-date systematic reviews for acupuncture, chiropractic and homeopathy in veterinary medicine:
Acupuncture is a popular complementary treatment option in human medicine. Increasingly, owners also seek acupuncture for their animals. The aim of the systematic review reported here was to summarize and assess the clinical evidence for or against the effectiveness of acupuncture in veterinary medicine. Systematic searches were conducted on Medline, Embase, Amed, Cinahl, Japana Centra Revuo Medicina and Chikusan Bunken Kensaku. Hand-searches included conference proceedings, bibliographies, and contact with experts and veterinary acupuncture associations. There were no restrictions regarding the language of publication. All controlled clinical trials testing acupuncture in any condition of domestic animals were included. Studies using laboratory animals were excluded. Titles and abstracts of identified articles were read, and hard copies were obtained. Inclusion and exclusion of studies, data extraction, and validation were performed independently by two reviewers. Methodologic quality was evaluated by means of the Jadad score. Fourteen randomized controlled trials and 17 nonrandomized controlled trials met our criteria and were, therefore, included. The methodologic quality of these trials was variable but, on average, was low. For cutaneous pain and diarrhea, encouraging evidence exists that warrants further investigation in rigorous trials. Single studies reported some positive intergroup differences for spinal cord injury, Cushing’s syndrome, lung function, hepatitis, and rumen acidosis. These trials require independent replication. On the basis of the findings of this systematic review, there is no compelling evidence to recommend or reject acupuncture for any condition in domestic animals. Some encouraging data do exist that warrant further investigation in independent rigorous trials.
There are no studies of chiropractic for animals and hence no systematic review. However, I did publish a blog-post about veterinary chiropractic. It arrived at this conclusion: chiropractors treating animals and those treating humans have one important characteristic in common. THEY HAPPILY PROMOTE BOGUS TREATMENTS.
Meta-analysis of randomised controlled trials (RCTs) of veterinary homeopathy has not previously been undertaken. For all medical conditions and species collectively, we tested the hypothesis that the outcome of homeopathic intervention (treatment and/or prophylaxis, individualised and/or non-individualised) is distinguishable from corresponding intervention using placebos.
All facets of the review, including literature search strategy, study eligibility, data extraction and assessment of risk of bias, were described in an earlier paper. A trial was judged to comprise reliable evidence if its risk of bias was low or was unclear in specific domains of assessment. Effect size was reported as odds ratio (OR). A trial was judged free of vested interest if it was not funded by a homeopathic pharmacy. Meta-analysis was conducted using the random-effects model, with hypothesis-driven sensitivity analysis based on risk of bias.
Nine of 15 trials with extractable data displayed high risk of bias; low or unclear risk of bias was attributed to each of the remaining six trials, only two of which comprised reliable evidence without overt vested interest. For all N = 15 trials, pooled OR = 1.69 [95% confidence interval (CI), 1.12 to 2.56]; P = 0.01. For the N = 2 trials with suitably reliable evidence, pooled OR = 2.62 [95% CI, 1.13 to 6.05]; P = 0.02).
Meta-analysis provides some very limited evidence that clinical intervention in animals using homeopathic medicines is distinguishable from corresponding intervention using placebos. The low number and quality of the trials hinders a more decisive conclusion.
So, what shall we make of ‘holistic horse care’ in view of this evidence?
I think I let you answer this question.
As you can imagine, I get quite a lot of ‘fan-post’. Most of the correspondence amounts to personal attacks and insults which I usually discard. But some of these ‘love-letters’ are so remarkable in one way or another that I answer them. This short email was received on 20/3/19; it belongs to the latter category:
You have been trashing homeopathy ad nauseum for so many years based on your limited understanding of it. You seem to know little more than that the remedies are so extremely dilute as to be impossibly effective in your opinion. Everybody knows this and has to confront their initial disbelief.
Why dont you get some direct understanding of homeopathy by doing a homeopathic proving of an unknown (to you) remedy? Only once was I able to convince a skeptic to take the challenge to do a homeopathic proving. He was amazed at all the new symptoms he experienced after taking the remedy repeatedly over several days.
Please have a similar bravery in your approach to homeopathy instead of basing your thoughts purely on your speculation on the subject, grounded in little understanding and no experience of it.
THIS IS HOW I RESPONDED
Dear Mr …
thank you for this email which I would like to answer as follows.
Your lines give the impression that you might not be familiar with the concept of critical analysis. In fact, you seem to confuse my criticism of homeopathy with ‘trashing it’. I strongly recommend you read up about critical analysis. No doubt you will then realise that it is a necessary and valuable process towards generating progress in healthcare and beyond.
You assume that I have limited understanding of homeopathy. In fact, I grew up with homeopathy, practised homeopathy as a young doctor, researched the subject for more than 25 years and published several books as well as over 100 peer-reviewed scientific papers about it. All of this, I have disclosed publicly, for instance, in my memoir which might interest you.
The challenge you mention has been taken by me and others many times. It cannot convince critical thinkers and, frankly, I am surprised that you found a sceptic who was convinced by what essentially amounts to little more than a party trick. But, as you seem to like challenges, I invite you to consider taking the challenge of the INH which even offers a sizable amount of money, in case you are successful.
Your final claim that my thoughts are based purely on speculation is almost farcically wrong. The truth is that sceptics try their very best to counter-balance the mostly weird speculations of homeopaths with scientific facts. I am sure that, once you have acquired the skills of critical thinking, you will do the same.
Best of luck.
This paper notes that, according to the World Naturopathic Federation (WNF), the naturopathic profession is based on two fundamental philosophies of medicine (vitalism and holism) and seven principles of practice (healing power of nature; treat the whole person; treat the cause; first, do no harm; doctor as teacher; health promotion and disease prevention; and wellness). The philosophy, theory, and principles are translated to clinical practice through a range of therapeutic modalities. The WNF has identified seven core modalities: (1) clinical nutrition and diet modification/counselling; (2) applied nutrition (use of dietary supplements, traditional medicines, and natural health care products); (3) herbal medicine; (4) lifestyle counselling; (5) hydrotherapy; (6) homeopathy, including complex homeopathy; and (7) physical modalities (based on the treatment modalities taught and allowed in each jurisdiction, including yoga, naturopathic manipulation, and muscle release techniques).
The ‘scoping’ review was to summarize the current state of the research evidence for whole-system, multi-modality naturopathic medicine. Studies were included, if they met the following criteria:
- Controlled clinical trials, longitudinal cohort studies, observational trials, or case series involving five or more cases presented in any language
- Human studies
- Multi-modality treatment administered by a naturopath (naturopathic clinician, naturopathic physician) as an intervention
- Non-English language studies in which an English title and abstract provided sufficient information to determine effectiveness
- Case series in which five or more individual cases were pooled and authors provided a summative discussion of the cases in the context of naturopathic medicine
- All human research evaluating the effectiveness of naturopathic medicine, where two or more naturopathic modalities are delivered by naturopathic clinicians, were included in the review.
- Case studies of five or more cases were included.
Thirty-three published studies with a total of 9859 patients met inclusion criteria (11 US; 4 Canadian; 6 German; 7 Indian; 3 Australian; 1 UK; and 1 Japanese) across a range of mainly chronic clinical conditions. A majority of the included studies were observational cohort studies (12 prospective and 8 retrospective), with 11 clinical trials and 2 case series. The studies predominantly showed evidence for the efficacy of naturopathic medicine for the conditions and settings in which they were based. Overall, these studies show naturopathic treatment results in a clinically significant benefit for treatment of hypertension, reduction in metabolic syndrome parameters, and improved cardiac outcomes post-surgery.
The authors concluded that to date, research in whole-system, multi-modality naturopathic medicine shows that it is effective for treating cardiovascular disease, musculoskeletal pain, type 2 diabetes, polycystic ovary syndrome, depression, anxiety, and a range of complex chronic conditions. Overall, these studies show naturopathic treatment results in a clinically significant benefit for treatment of hypertension, reduction in metabolic syndrome parameters, and improved cardiac outcomes post-surgery.
Where to start?
There are many issues here to choose from:
- The definition of naturopathy used in this review may be the one of the WHF, but it has little resemblance to the one used elsewhere. German naturopathic doctors, for instance, would not consider homeopathy to be a naturopathic treatment. They would also not, like the WNF does, subscribe to the long-obsolete humoral theory of disease. The only German professional organisation that is a member of the WNF is thus not one of naturopathic doctors but one of Heilpraktiker (the notorious German lay-practitioner created by the Nazis during the Third Reich).
- A review that includes observational studies and even case series, while drawing far-reaching conclusions on therapeutic effectiveness is, in my view, little more than embarrassing pseudo-science. Such studies are unable to differentiate between specific and non-specific therapeutic effects and therefore can tell us nothing about the effectiveness of a treatment.
- A review on a subject such as naturopathy (an approach which, after all, originated in Europe) that excludes studies not published in English (and without an English abstract providing sufficient information to determine effectiveness) is likely to be incomplete.
- The authors call their review a ‘scoping review’; they nevertheless draw conclusions not about the scope but the effectiveness of naturopathy.
- Many of the studies included in this review do, in fact, not comply with the inclusion criteria set by the review-authors.
- The review does not assess or even comment on the risks of naturopathic treatments.
- Several of the included studies are not investigations of naturopathy but of approaches that squarely fall under the umbrella of integrative or alternative medicine.
- Of the 33 studies included, only 5 were RCTs, and none of these was free of major limitations.
- None of the RCTs have been independently replicated.
- There is a remarkable absence of negative trials suggestion a strong influence of bias.
- The review lacks any trace of critical thinking.
- The authors are affiliated to institutions of naturopathy but declare no conflicts of interest.
- No funding source was named but it seems that it was supported by the WNF; their primary goal is to promote and advance the naturopathic profession.
- The review appeared in the notorious Journal of Complementary and Alternative Medicine.
Prof Dwyer, the founding president of the Australian ‘Friends of Science in Medicine’, said the study damaged Southern Cross University’s reputation. “At the heart of this is the credibility of Southern Cross University,” he said. “There’s been a stand-off between SCU and the rest of the scientific community in Australia for a number of years and there have been challenges to whether they are really upholding the highest standards of evidence-based medicine.” Professor Dwyer also raised questions about the university’s credibility late last year when it accepted a $10 million donation from vitamin company Blackmore’s to establish a National Centre for Naturopathic Medicine.
My conclusion of naturopathy, as defined by the WNF, is that it is an obsolete form of quackery steeped in concepts of vitalism that should be abandoned sooner rather than later. And my conclusion about the new review agrees with Prof Dwyer’s judgement: it is an embarrassment to all concerned.
This ‘nationwide, population-based ‘cohort study’ was meant to investigate the probable effect of TCM to decrease the fracture rate. Its authors identified cases with osteoporosis and selected a comparison group that was frequency-matched according to sex, age (per 5 years), diagnosis year of osteoporosis, and index year. The difference between the two groups in the development of fracture was estimated using the Kaplan-Meier method and the log-rank test.
After inserting age, gender, urbanization level, and comorbidities into the Cox’s proportional hazard model, patients who used TCM had a lower hazard ratio (HR) of fracture compared to the non-TCM user group. The Kaplan-Meier curves showed that osteoporosis patients who used TCM had a lower incidence of fracture events than those who did not. Our study also demonstrated that the longer the TCM use, the lesser the fracture rate.
The authors concluded that their study showed that TCM might have a positive impact on the prevention of osteoporotic fracture.
The authors also mention three weaknesses of their study:
- Firstly, we were unable to include medicines taken at the patient’s own expense. According to the specification of the NHI program, Western medicine for osteoporosis can only be applied after a fracture occurred. It is possible that the patients source such medicines at their own expense when they were diagnosed with osteoporosis before a fracture happens.
- Secondly, some data related to fractures, such as a patient’s exercise, lifestyle, BMI, alcohol, and cigarette use is not available from the NHI program.
- Thirdly, the Kaplan–Meier curve might be influenced by economic levels and patient severity. However, we can conclude that TCM might have a positive impact on the prevention of osteoporotic fracture…
Disregarding these limitations, they nevertheless state that their study not only reveals the preventative value of TCM use for patients with osteoporosis in the clinical setting, but also provides valuable information regarding the most common prescriptions provided to osteoporotic patients.
So, is there a causal link between TCM and osteoporosis?
Yes, it is possible.
But is it proven?
Is it likely?
By far the most plausible explanation of the findings is that the two groups that were compared here were not comparable in many ways that affect the osteoporosis-risk.
Major risk factors of osteoporosis include:
- Inadequate nutritional absorption
- Lack of physical activity or fall risk
- Weight loss
- Cigarette smoking
- Alcohol consumption
- Air pollution
I suggest therefore that this study shows that the two populations differed regarding these risk factors.
I also suggest that researchers of SCAM might benefit from a minimum of critical thinking.
I furthermore suggest that, if SCAM-fans want to test whether causal effects exist, they use controlled clinical trials rather than cohort or case-control studies
Lastly, I suggest that authors, journal editors, reviewers and funders (this study was funded by the ‘Taiwan Ministry of Health and Welfare Clinical Trial Center’) remind themselves that they have a responsibility and thus avoid misleading the public.
An impressive 17% of US chiropractic patients are 17 years of age or younger. This figure increases to 39% among US chiropractors who have specialized in paediatrics. Data for other countries can be assumed to be similar. But is chiropractic effective for children? All previous reviews concluded that there is a paucity of evidence for the effectiveness of manual therapy for conditions within paediatric populations.
This systematic review is an attempt to shed more light on the issue by evaluating the use of manual therapy for clinical conditions in the paediatric population, assessing the methodological quality of the studies found, and synthesizing findings based on health condition.
Of the 3563 articles identified through various literature searches, 165 full articles were screened, and 50 studies (32 RCTs and 18 observational studies) met the inclusion criteria. Only 18 studies were judged to be of high quality. Conditions evaluated were:
- attention deficit hyperactivity disorder (ADHD),
- cerebral palsy,
- cranial asymmetry,
- cuboid syndrome,
- infantile colic,
- low back pain,
- obstructive apnoea,
- otitis media,
- paediatric dysfunctional voiding,
- paediatric nocturnal enuresis,
- postural asymmetry,
- preterm infants,
- pulled elbow,
- suboptimal infant breastfeeding,
- suboptimal infant breastfeeding,
- temporomandibular dysfunction,
- upper cervical dysfunction.
Musculoskeletal conditions, including low back pain and headache, were evaluated in seven studies. Only 20 studies reported adverse events.
The authors concluded that fifty studies investigated the clinical effects of manual therapies for a wide variety of pediatric conditions. Moderate-positive overall assessment was found for 3 conditions: low back pain, pulled elbow, and premature infants. Inconclusive unfavorable outcomes were found for 2 conditions: scoliosis (OMT) and torticollis (MT). All other condition’s overall assessments were either inconclusive favorable or unclear. Adverse events were uncommonly reported. More robust clinical trials in this area of healthcare are needed.
There are many things that I find remarkable about this review:
- The list of indications for which studies have been published confirms the notion that manual therapists – especially chiropractors – regard their approach as a panacea.
- A systematic review evaluating the effectiveness of a therapy that includes observational studies without a control group is, in my view, highly suspect.
- Many of the RCTs included in the review are meaningless; for instance, if a trial compares the effectiveness of two different manual therapies none of which has been shown to work, it cannot generate a meaningful result.
- Again, we find that the majority of trialists fail to report adverse effects. This is unethical to a degree that I lose faith in such studies altogether.
- Only three conditions are, according to the authors, based on evidence. This is hardly enough to sustain an entire speciality of paediatric chiropractors.
Allow me to have a closer look at these three conditions.
- Low back pain: the verdict ‘moderate positive’ is based on two RCTs and two observational studies. The latter are irrelevant for evaluating the effectiveness of a therapy. One of the two RCTs should have been excluded because the age of the patients exceeded the age range named by the authors as an inclusion criterion. This leaves us with one single ‘medium quality’ RCT that included a mere 35 patients. In my view, it would be foolish to base a positive verdict on such evidence.
- Pulled elbow: here the verdict is based on one RCT that compared two different approaches of unknown value. In my view, it would be foolish to base a positive verdict on such evidence.
- Preterm: Here we have 4 RCTs; one was a mere pilot study of craniosacral therapy following the infamous A+B vs B design. The other three RCTs were all from the same Italian research group; their findings have never been independently replicated. In my view, it would be foolish to base a positive verdict on such evidence.
So, what can be concluded from this?
I would say that there is no good evidence for chiropractic, osteopathic or other manual treatments for children suffering from any condition.
And why do the authors of this new review arrive at such dramatically different conclusion? I am not sure. Could it perhaps have something to do with their affiliations?
- Palmer College of Chiropractic,
- Canadian Memorial Chiropractic College,
- Performance Chiropractic.
What do you think?
A new update of the current Cochrane review assessed the benefits and harms of spinal manipulative therapy (SMT) for the treatment of chronic low back pain. The authors included all randomised controlled trials (RCTs) examining the effect of spinal manipulation or mobilisation in adults (≥18 years) with chronic low back pain with or without referred pain. Studies that exclusively examined sciatica were excluded.
The effect of SMT was compared with recommended therapies, non-recommended therapies, sham (placebo) SMT, and SMT as an adjuvant therapy. Main outcomes were pain and back specific functional status, examined as mean differences and standardised mean differences (SMD), respectively. Outcomes were examined at 1, 6, and 12 months.
Forty-seven RCTs including a total of 9211 participants were identified. Most trials compared SMT with recommended therapies. In 16 RCTs, the therapists were chiropractors, in 14 they were physiotherapists, and in 5 they were osteopaths. They used high velocity manipulations in 18 RCTs, low velocity manipulations in 12 studies and a combination of the two in 20 trials.
Moderate quality evidence suggested that SMT has similar effects to other recommended therapies for short term pain relief and a small, clinically better improvement in function. High quality evidence suggested that, compared with non-recommended therapies, SMT results in small, not clinically better effects for short term pain relief and small to moderate clinically better improvement in function.
In general, these results were similar for the intermediate and long term outcomes as were the effects of SMT as an adjuvant therapy.
Low quality evidence suggested that SMT does not result in a statistically better effect than sham SMT at one month. Additionally, very low quality evidence suggested that SMT does not result in a statistically better effect than sham SMT at six and 12 months. Low quality evidence suggested that SMT results in a moderate to strong statistically significant and clinically better effect than sham SMT at one month. Additionally, very low quality evidence suggested that SMT does not result in a statistically significant better effect than sham SMT at six and 12 months.
(Mean difference in reduction of pain at 1, 3, 6, and 12 months (0-100; 0=no pain, 100 maximum pain) for spinal manipulative therapy (SMT) versus recommended therapies in review of the effects of SMT for chronic low back pain. Pooled mean differences calculated by DerSimonian-Laird random effects model.)
About half of the studies examined adverse and serious adverse events, but in most of these it was unclear how and whether these events were registered systematically. Most of the observed adverse events were musculoskeletal related, transient in nature, and of mild to moderate severity. One study with a low risk of selection bias and powered to examine risk (n=183) found no increased risk of an adverse event or duration of the event compared with sham SMT. In one study, the Data Safety Monitoring Board judged one serious adverse event to be possibly related to SMT.
The authors concluded that SMT produces similar effects to recommended therapies for chronic low back pain, whereas SMT seems to be better than non-recommended interventions for improvement in function in the short term. Clinicians should inform their patients of the potential risks of adverse events associated with SMT.
This paper is currently being celebrated (mostly) by chiropractors who think that it vindicates their treatments as being both effective and safe. However, I am not sure that this is entirely true. Here are a few reasons for my scepticism:
- SMT is as good as other recommended treatments for back problems – this may be so but, as no good treatment for back pain has yet been found, this really means is that SMT is as BAD as other recommended therapies.
- If we have a handful of equally good/bad treatments, it stand to reason that we must use other criteria to identify the one that is best suited – criteria like safety and cost. If we do that, it becomes very clear that SMT cannot be named as the treatment of choice.
- Less than half the RCTs reported adverse effects. This means that these studies were violating ethical standards of publication. I do not see how we can trust such deeply flawed trials.
- Any adverse effects of SMT were minor, restricted to the short term and mainly centred on musculoskeletal effects such as soreness and stiffness – this is how some naïve chiro-promoters already comment on the findings of this review. In view of the fact that more than half the studies ‘forgot’ to report adverse events and that two serious adverse events did occur, this is a misleading and potentially dangerous statement and a good example how, in the world of chiropractic, research is often mistaken for marketing.
- Less than half of the studies (45% (n=21/47)) used both an adequate sequence generation and an adequate allocation procedure.
- Only 5 studies (10% (n=5/47)) attempted to blind patients to the assigned intervention by providing a sham treatment, while in one study it was unclear.
- Only about half of the studies (57% (n=27/47)) provided an adequate overview of withdrawals or drop-outs and kept these to a minimum.
- Crucially, this review produced no good evidence to show that SMT has effects beyond placebo. This means the modest effects emerging from some trials can be explained by being due to placebo.
- The lead author of this review (SMR), a chiropractor, does not seem to be free of important conflicts of interest: SMR received personal grants from the European Chiropractors’ Union (ECU), the European Centre for Chiropractic Research Excellence (ECCRE), the Belgian Chiropractic Association (BVC) and the Netherlands Chiropractic Association (NCA) for his position at the Vrije Universiteit Amsterdam. He also received funding for a research project on chiropractic care for the elderly from the European Centre for Chiropractic Research and Excellence (ECCRE).
- The second author (AdeZ) who also is a chiropractor received a grant from the European Chiropractors’ Union (ECU), for an independent study on the effects of SMT.
After carefully considering the new review, my conclusion is the same as stated often before: SMT is not supported by convincing evidence for back (or other) problems and does not qualify as the treatment of choice.
I ought to admit to a conflict of interest regarding today’s post:
I am not a fan of Mr Corbyn!
He fooled us prior to the Referendum claiming he was backing Remain and subsequently campaigned less than half-heartedly for it. Not least thanks to him and his sham of a campaign Leave won the referendum. Subsequently, the UK embarked on a bonanza of self-destruction and a frenzy of xenophobia which changed the UK beyond recognition. Currently, Mr Corbyn is doing the same trick again. He had to concede in the Labour manifesto that his party would eventually support a People’s Vote, and now he bends over backwards to avoid doing anything remotely like it. This strategy, together with his rather non-transparent stance on anti-Semitism does it for me. I could not vote for Corbyn in a million years now.
NOTHING TO DO WITH ALTERNATIVE MEDICINE!, I hear you exclaim.
Yes, you are right – but this has:
Excuse my frankness, but I find this short tweet embarrassingly stupid (regardless of who authored it).
Apart from two spelling mistakes, it contains several fundamental errors and fallacies:
- Corbyn seems to think that, because some people experience improvement after taking a homeopathic remedy, homeopathy is effective. Does he also believe that the crowing of a cock makes the sun rise in the morning? The statement shows a most irritating lack of understanding as to what constitutes medical evidence and what not. That it was made by a politician makes it only worse.
- Corbyn also tells us that homeopathy is an appropriate adjunct to conventional healthcare. His impression is based on the fact that ‘it works for some people’. This assumption reveals a naivety that is deplorable in a politician who evidently thinks himself sufficiently well-informed to tweet about the matter.
- The final straw is Corbyn’s little afterthought: they both come from organic matter. Many conventional medicines come from inorganic matter. And homeopathic remedies? Yes, many also come from inorganic materials.
Yes, I know, you probably think me a bit pedantic here. As I said, I have strong misgivings against Mr Corbyn.
But, even leaving my prejudice aside, I do think that politicians and other people of influence should comment on issues only after they informed themselves about them sufficiently to make good sense. Otherwise they are in danger to merely disclose their ineptitude in the same way as Corbyn did when he wrote the above tweet.
I stared my Exeter post in October 1993. It took the best part of a year to set up a research team, find rooms etc. So, our research began in earnest only mid 1994. From the very outset, it was clear to me that investigating the risks of so-called alternative medicine (SCAM) should be our priority. The reason, I felt, was simple: SCAM was being used a million times every day; therefore it was an ethical imperative to check whether these treatments were as really safe as most people seemed to believe.
In the course of this line of investigation, we did discover many surprises (and lost many friends). One of the very first revelation was that homeopathy might not be harmless. Our initial results on this topic were published in this 1995 article. In view of the still ongoing debate about homeopathy, I’d like to re-publish the short paper here:
Homoeopathic remedies are believed by doctors and patients to be almost totally safe. Is homoeopathic advice safe, for example on the subject of immunization? In order to answer this question, a questionnaire survey was undertaken in 1995 of all 45 homoeopaths listed in the Exeter ‘yellow pages’ business directory. A total of 23 replies (51%) were received, 10 from medically qualified and 13 from non-medically qualified homoeopaths.
The homoeopaths were asked to suggest which conditions they perceived as being most responsive to homoeopathy. The three most frequently cited conditions were allergies (suggested by 10 respondents), gynaecological problems (seven) and bowel problems (five).
They were then asked to estimate the proportion of patients that were referred to them by orthodox doctors and the proportion that they referred to orthodox doctors. The mean estimated percentages were 1 % and 8%, respectively. The 23 respondents estimated that they spent a mean of 73 minutes on the first consultation.
The homoeopaths were asked whether they used or recommended orthodox immunization for children and whether they only used and recommended homoeopathic immunization. Seven of the 10 homoeopaths who were medically qualified recommended orthodox immunization but none of the 13 non-medically qualified homoeopaths did. One non-medically qualified homoeopath only used and recommended homoeopathic immunization.
Homoeopaths have been reported as being against orthodox immunization’ and advocating homoeopathic immunization for which no evidence of effectiveness exists. As yet there has been no attempt in the United Kingdom to monitor homoeopaths’ attitudes in this respect. The above findings imply that there may be a problem. The British homoeopathic doctors’ organization (the Faculty of Homoeopathy) has distanced itself from the polemic of other homoeopaths against orthodox immunization, and editorials in the British Homoeopathic Journal call the abandonment of mass immunization ‘criminally irresponsible’ and ‘most unfortunate, in that it will be seen by most people as irresponsible and poorly based’.’
Homoeopathic remedies may be safe, but do all homoeopaths merit this attribute?
This tiny and seemingly insignificant piece of research triggered debate and research (my group must have published well over 100 papers in the years that followed) that continue to the present day. The debate has spread to many other countries and now involves numerous forms of SCAM other than just homeopathy. It relates to many complex issues such as the competence of SCAM practitioners, their ethical standards, education, regulation, trustworthiness and the risk of neglect.
Looking back, it feels odd that, at least for me, all this started with such a humble investigation almost a quarter of a century ago. Looking towards the future, I predict that we have so far merely seen the tip of the iceberg. The investigation of the risks of SCAM has finally started in earnest and will, I am sure, continue thus leading to a better protection of patients and consumers from charlatans and their bogus claims.
“Most of the supplement market is bogus,” Paul Clayton*, a nutritional scientist, told the Observer. “It’s not a good model when you have businesses selling products they don’t understand and cannot be proven to be effective in clinical trials. It has encouraged the development of a lot of products that have no other value than placebo – not to knock placebo, but I want more than hype and hope.” So, Dr Clayton took a job advising Lyma, a product which is currently being promoted as “the world’s first super supplement” at £199 for a one-month’s supply.
Lyma is a dietary supplement that contains a multitude of ingredients all of which are well known and available in many other supplements costing only a fraction of Lyma. The ingredients include:
- vitamin D3.
Apparently, these ingredients are manufactured in special (and patented) ways to optimise their bioavailabity. According to the website, the ingredients of LYMA have all been clinically trialled with proven efficacy at levels provided within the LYMA supplement… Unless the ingredient has been clinically trialled, and peer reviewed there may be limited (if any) benefit to the body. LYMA’s revolutionary formulation is the most advanced and proven super supplement in the world, bringing together eight outstanding ingredients – seven of which are patented – to support health, wellbeing and beauty. Each ingredient has been selected for its efficacy, purity, quality, bioavailability, stability and ultimately, on the results of clinical studies.
The therapeutic claims made for the product are numerous:
- it will improve your hair, skin and nails (80% improvement in skin smoothness, 30% increase in skin moisture, 17% increase in skin elasticity, 12% reduction in wrinkle depth, 47% increase in hair strength & 35% decrease in hair loss)
- it will support energy levels in both the body and the brain (increase in brain membrane turnover by 26% and increase brain energy by 14%),
- it will improve cognitive function,
- it will enhance endurance (cardiorespiratory endurance increased by 13% compared to a placebo),
- it will improve quality of life,
- it will improve sleep (reducing insomnia by 70%),
- it will improve immunity,
- it will reduce inflammation,
- it will improve your memory,
- it will improve osteoporosis (reduce risk of osteoporosis by 37%).
These claims are backed up by 197 clinical trials, we are being told.
If true, this would be truly sensational – but is it true?
I asked the Lyma firm for the 197 original studies, and they very kindly sent me dozens papers which all referred to the single ingredients listed above. I emailed again and asked whether there are any studies of Lyma with all its ingredients in one supplement. Then I was told that they are ‘looking into a trial on the final Lyma formula‘.
I take this to mean that not a single trial of Lyma has been conducted. In this case, how do we be sure the mixture works? How can we know that the 197 studies have not been cherry-picked? How can we be sure that there are no interactions between the active constituents?
The response from Lyma quoted the above-mentioned Dr Paul Clayton stating this: “In regard to LYMA, clinical trials at this stage are not necessary. The whole point of LYMA is that each ingredient has already been extensively trialled, and validated. They have selected the best of the best ingredients, and amalgamated them; to enable consumers to take them all in a convenient format. You can quite easily go out and purchase all the ingredients separately. They aren’t easy to find, and it would mean swallowing up to 12 tablets and capsules a day; but the choice is always yours.”
It’s kind, to leave the choice to us, rather than forcing us to spend £199 each month on the world’s first super-supplement. Very kind indeed!
Having the choice, I might think again.
I might even assemble the world’s maximally evidence-based, extra super-supplement myself, one that is supported by many more than 197 peer-reviewed papers. To not directly compete with Lyma, I could use entirely different ingredients. Perhaps I should take the following five:
- Vitamin C (it has over 61 000 Medline listed articles to its name),
- Vitanin E (it has over 42 000 Medline listed articles to its name),
- Collagen (it has over 210 000 Medline listed articles to its name),
- Coffee (it has over 14 000 Medline listed articles to its name),
- Aloe vera (it has over 3 000 Medline listed articles to its name).
I could then claim that my extra super-supplement is supported by some 300 000 scientific articles plus 1 000 clinical studies (I am confident I could cherry-pick 1 000 positive trials from the 300 000 papers). Consequently, I would not just charge £199 but £999 for a month’s supply.
But this would be wrong, misleading, even bogus!!!, I hear you object.
On the one hand, I agree.
On the other hand, as Paul Clayton rightly pointed out: Most of the supplement market is bogus.
*If my memory serves me right, I met Paul many years ago when he was a consultant for Boots (if my memory fails me, I might need to order some Lyma).
Osteopathy is a tricky subject:
- Osteopathic manipulations/mobilisations are advocated mainly for spinal complaints.
- Yet many osteopaths use them also for a myriad of non-spinal conditions.
- Osteopathy comprises two entirely different professions; in the US, osteopaths are very similar to medically trained doctors, and many hardly ever employ osteopathic manual techniques; outside the US, osteopaths are alternative practitioners who use mainly osteopathic techniques and believe in the obsolete gospel of their guru Andrew Taylor Still (this post relates to the latter type of osteopathy).
- The question whether osteopathic manual therapies are effective is still open – even for the indication that osteopaths treat most, spinal complaints.
- Like chiropractors, osteopaths now insist that osteopathy is not a treatment but a profession; the transparent reason for this argument is to gain more wriggle-room when faced with negative evidence regarding they hallmark treatment of osteopathic manipulation/mobilisation.
A new paper authored by osteopaths is an attempt to shed more light on the effectiveness of osteopathy. The aim of this systematic review evaluated the impact of osteopathic care for spinal complaints. Only randomized controlled trials conducted in high-income Western countries were considered. Two authors independently screened the titles and abstracts. Primary outcomes included ‘pain’ and ‘functional status’, while secondary outcomes included ‘medication use’ and ‘health status’.
Nineteen studies were included and qualitatively synthesized. Nine studies were from the US, followed by Germany with 7 studies. The majority of studies (n = 13) focused on low back pain.
In general, mixed findings related to the impact of osteopathic care on primary and secondary outcomes were observed. For the primary outcomes, a clear distinction between US and European studies was found, where the latter RCTs reported positive results more frequently. Studies were characterized by substantial methodological differences in sample sizes, number of treatments, control groups, and follow-up.
The authors concluded that “the findings of the current literature review suggested that osteopathic care may improve pain and functional status in patients suffering from spinal complaints. A clear distinction was observed between studies conducted in the US and those in Europe, in favor of the latter. Today, no clear conclusions of the impact of osteopathic care for spinal complaints can be drawn. Further studies with larger study samples also assessing the long-term impact of osteopathic care for spinal complaints are required to further strengthen the body of evidence.”
Some of the most obvious weaknesses of this review include the following:
- In none of the studies employed blinding of patients, care provider or outcome assessor occurred, or it was unclear. Blinding of outcome assessors is easily implemented and should be standard in any RCT.
- In three studies, the study groups differed to some extent at baseline indicating that randomisation was not successful..
- Five studies were derived from the ‘grey literature’ and were therefore not peer-reviewed.
- One study (the UK BEAM trial) employed not just osteopaths but also chiropractors and physiotherapists for administering the spinal manipulations. It is therefore hardly an adequate test of osteopathy.
- The study was funded by an unrestricted grant from the GNRPO, the umbrella organization of the ‘Belgian Professional Associations for Osteopaths’.
Considering this last point, the authors’ honesty in admitting that no clear conclusions of the impact of osteopathic care for spinal complaints can be drawn is remarkable and deserves praise.
Considering that the evidence for osteopathy is even far worse for non-spinal conditions (numerous trials exist for all sorts of other conditions, but they tend to be flimsy and usually lack independent replications), it is fair to conclude that osteopathy is NOT an evidence-based therapy.