MD, PhD, FMedSci, FSB, FRCP, FRCPEd

evidence

The WDDTY is not my favourite journal – far from it. The reason for my dislike is simple: far too many of its articles are utterly misleading and a danger to public health. Take this recent one entitled ‘Paleo-type diet reversing Crohn’s and ulcerative colitis’, for instance:

START OF QUOTE
Crohn’s disease and ulcerative colitis are being reversed solely by diet—essentially a Paleo diet. The non-drug approach has been successful in 80 per cent of children who’ve been put on the special diet.

The diet—called the specific carbohydrate diet (SCD)—has been pioneered by Dr David Suskind, a gastroenterologist at Seattle Children’s Hospital. The diet excludes grains, dairy, processed foods and sugars, other than honey, and promotes natural, nutrient-rich foods, including vegetables, fruits, meats and nuts.

Children are going into complete remission after just 12 weeks on the diet, a new study has discovered. Ten children with inflammatory bowel disease (IBD)—an umbrella term for Crohn’s and ulcerative colitis—were put on the diet, and eight were completely symptom-free by the end of the study. Suskind started exploring a dietary approach to IBD because he became convinced that the standard medical treatment of steroids or other medication was inadequate. “For decades, medicine has said diet doesn’t matter, that it doesn’t impact disease. Now we know that diet does have an impact, a strong impact. It works, and now there’s evidence,” he said.

END OF QUOTE

“For decades, medicine has said diet doesn’t matter, that it doesn’t impact disease”.

Really?

In this case, I must have studied an entirely different subject all these years ago at university – I had been told it was medicine but perhaps…???…!!!

It took me some time to find the original paper – they cited a wrong reference (2017 instead of 2016). But eventually I located it. Here is its abstract:

GOAL:

To determine the effect of the specific carbohydrate diet (SCD) on active inflammatory bowel disease (IBD).

BACKGROUND:

IBD is a chronic idiopathic inflammatory intestinal disorder associated with fecal dysbiosis. Diet is a potential therapeutic option for IBD based on the hypothesis that changing the fecal dysbiosis could decrease intestinal inflammation.

STUDY:

Pediatric patients with mild to moderate IBD defined by pediatric Crohn’s disease activity index (PCDAI 10-45) or pediatric ulcerative colitis activity index (PUCAI 10-65) were enrolled into a prospective study of the SCD. Patients started SCD with follow-up evaluations at 2, 4, 8, and 12 weeks. PCDAI/PUCAI, laboratory studies were assessed.

RESULTS:

Twelve patients, ages 10 to 17 years, were enrolled. Mean PCDAI decreased from 28.1±8.8 to 4.6±10.3 at 12 weeks. Mean PUCAI decreased from 28.3±23.1 to 6.7±11.6 at 12 weeks. Dietary therapy was ineffective for 2 patients while 2 individuals were unable to maintain the diet. Mean C-reactive protein decreased from 24.1±22.3 to 7.1±0.4 mg/L at 12 weeks in Seattle Cohort (nL<8.0 mg/L) and decreased from 20.7±10.9 to 4.8±4.5 mg/L at 12 weeks in Atlanta Cohort (nL<4.9 mg/L). Stool microbiome analysis showed a distinctive dysbiosis for each individual in most prediet microbiomes with significant changes in microbial composition after dietary change.

CONCLUSIONS:

SCD therapy in IBD is associated with clinical and laboratory improvements as well as concomitant changes in the fecal microbiome. Further prospective studies are required to fully assess the safety and efficacy of dietary therapy in patients with IBD.

What does this mean?

The WDDTY report bears very little resemblance to the journal article (let alone with the title of their article or any other published research by David Suskind).

How come?

I cannot be sure, but I would not be surprised to hear that the latter was ‘egged up’ to make the former appear more interesting.

If that is so, WDDTY are (once again) guilty of misleading the public to the point of endangering lives of vulnerable patients.

SHAME ON EVERY OUTLET THAT SELLS WDDTY, I’d say.

The ACUPUNCTURE NOW FOUNDATION (ANF) has featured on this blog before. Today I want to re-introduce them because I just came across one of their articles which I found remarkable. In it, they define what many of us have often wondered about: the most important myth about acupuncture.

Is it acupuncture’s current popularity, its long history, its mode of action, its efficacy, its safety?

No, here is the answer directly from the ANF:

The most important myth that needs to be put to rest is the idea promoted by a small group of vocal critics that acupuncture is nothing more than a placebo. Many cite the fact that studies showing acupuncture to be highly effective were of low quality and that several higher quality studies show that, while acupuncture was clinically effective, it usually does not outperform “sham” acupuncture. But those studies are dominated by the first quality issue cited above; studies with higher methodological rigor where the “real” acupuncture was so poorly done as to not be a legitimate comparison. Yet despite the tendency toward poor quality acupuncture in studies with higher methodological standards, a benchmark study was done that showed “real” acupuncture clearly outperforming “sham” acupuncture in four different chronic pain conditions.3 When you add this study together with the fact veterinary acupuncture is used successfully in many different animals, the idea of acupuncture only being placebo must now be considered finally disproven. This is further supported by studies which show that the underlying physiological pathways activated by acupuncture sometimes overlap, but can be clearly differentiated from, those activated by placebo responses.

Disappointed?

Yes, I was too.

The myth, according to the ANF, essentially is that sceptics do not understand the scientific evidence. And these blinkered sceptics even go as far as ignoring the findings from what the ANF consider to be a ‘benchmark study’! Ghosh, that’s nasty of them!!!

But, no – the benchmark study (actually, it was not a ‘study’ but a meta-analysis of studies) has been discussed fully on this blog (and in many other places too). Here is what I wrote in 2012 when it was first published:

An international team of acupuncture trialists published a meta-analysed of individual patient data to determine the analgesic effect of acupuncture compared to sham or non-acupuncture control for the following 4 chronic pain conditions: back and neck pain, osteoarthritis, headache, and shoulder pain. Data from 29 RCTs, with an impressive total of 17 922 patients, were included.

The results of this new evaluation suggest that acupuncture is superior to both sham and no-acupuncture controls for each of these conditions. Patients receiving acupuncture had less pain, with scores that were 0.23 (95% CI, 0.13-0.33), 0.16 (95% CI, 0.07-0.25), and 0.15 (95% CI, 0.07-0.24) SDs lower than those of sham controls for back and neck pain, osteoarthritis, and chronic headache, respectively; the effect sizes in comparison to no-acupuncture controls were 0.55 (95% CI, 0.51-0.58), 0.57 (95% CI, 0.50-0.64), and 0.42 (95% CI, 0.37-0.46) SDs.

Based on these findings, the authors reached the conclusion that “acupuncture is effective for the treatment of chronic pain and is therefore a reasonable referral option. Significant differences between true and sham acupuncture indicate that acupuncture is more than a placebo. However, these differences are relatively modest, suggesting that factors in addition to the specific effects of needling are important contributors to the therapeutic effects of acupuncture”.

… even the enthusiastic authors of this article admit that, when compared to sham, the effect size of real acupuncture is too small to be clinically relevant. Therefore one might argue that this meta-analysis confirms what critics have suggested all along: acupuncture is not a useful treatment for clinical routine.

Unsurprisingly, the authors of the meta-analysis do their very best to play down this aspect. They reason that, for clinical routine, the comparison between acupuncture and non-acupuncture controls is more relevant than the one between acupuncture and sham. But this comparison, of course, includes placebo- and other non-specific effects masquerading as effects of acupuncture – and with this little trick (which, by the way is very popular in alternative medicine), we can, of course, show that even sugar pills are effective.

I do not doubt that context effects are important in patient care; yet I do doubt that we need a placebo treatment for generating such benefit in our patients. If we administer treatments which are effective beyond placebo with kindness, time, compassion and empathy, our patients will benefit from both specific and non-specific effects. In other words, purely generating non-specific effects with acupuncture is far from optimal and certainly not in the interest of our patients. In my view, it cannot be regarded as not good medicine, and the authors’ conclusion referring to a “reasonable referral option” is more than a little surprising in my view.

Acupuncture-fans might argue that, at the very minimum, the new meta-analysis does demonstrate acupuncture to be statistically significantly better than a placebo. Yet I am not convinced that this notion holds water: the small residual effect-size in the comparison of acupuncture with sham might not be the result of a specific effect of acupuncture; it could be (and most likely is) due to residual bias in the analysed studies.

The meta-analysis is strongly driven by the large German trials which, for good reasons, were heavily and frequently criticised when first published. One of the most important potential drawbacks was that many participating patients were almost certainly de-blinded through the significant media coverage of the study while it was being conducted. Moreover, in none of these trials was the therapist blinded (the often-voiced notion that therapist-blinding is impossible is demonstrably false). Thus it is likely that patient-unblinding and the absence of therapist-blinding importantly influenced the clinical outcome of these trials thus generating false positive findings. As the German studies constitute by far the largest volume of patients in the meta-analysis, any of their flaws would strongly impact on the overall result of the meta-analysis.

So, has this new meta-analysis finally solved the decades-old question about the effectiveness of acupuncture? It might not have solved it, but we have certainly moved closer to a solution, particularly if we employ our faculties of critical thinking. In my view, this meta-analysis is the most compelling evidence yet to demonstrate the ineffectiveness of acupuncture for chronic pain.

END OF QUOTE

The ANF-text then goes from bad to worse. First they cite the evidence from veterinary acupuncture as further proof of the efficacy of their therapy. Well, the only systematic review in this are is, I think, by my team; and it concluded that 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.

Lastly, the ANF mentions acupuncture’s mode of action which they seem to understand clearly and fully. Congratulations ANF! In this case, you are much better than the many experts in basic science or neurology who almost unanimously view these ‘explanations’ of how acupuncture might work as highly adventurous hypotheses or speculations.

So, what IS the most important myth about acupuncture? I am not sure and – unlike the ANF – I do not feel that I can speak for the rest of the world, but one of the biggest myths FOR ME is how acupuncture fans constantly manage to mislead the public.

The fact that much of chiropractic might be bogus has frequently been discussed on this blog. A recent press-release provided me with more evidence for this notion. It proudly announced a new book entitled “Beyond the Back: The Chiropractic Alternative For Conditions Beyond Back Pain”

The text claimed that shortly after the launch, the book hit #1 on the Amazon.com best seller list out of all Chiropractor books and also reached #1 for the category of Holistic Medicine.

When I checked (22/12/2016), I was not able to confirm this statement: #47 in Kindle Store > Kindle eBooks > Medical eBooks > Alternative & Holistic > Holistic Medicine, #58 in Books > Medical Books > Allied Health Professions > Chiropractic. But let’s not be petty; let’s rather see what the book has to offer.

‘Beyond the Back’ focuses on how Chiropractic care can do so much more than just alleviate back pain, the press-release says. From avoiding knee surgery to resolving athletic injuries, chiropractic care allegedly is a 100% natural health solution for a wide variety of conditions… In fact, in some cases, chiropractors can help their patients get off medications entirely and even avoid surgery, the press-release continues.

In the book itself, the authors claim that chiropractic is effective for a multitude of conditions, including asthma and colic (in fact, the authors try to give the impression that chiropractic is a veritable panacea), and that there is sound evidence for all these indications from hundreds, if not thousands of studies. The authors make it very clear – even on the book cover – that chiropractic is not an adjunct to conventional healthcare but an alternative to it; an idea, of course, that goes back to the founding fathers of chiropractic. As if this were not enough, the book also promotes diagnostic techniques such as applied kinesiology.

Some commentators on this blog have argued that the chiropractic profession is in the midst of giving up much of the nonsense upon it was originally based and to which it has clung on for more than hundred years. This book, written by 9 US authors of the new generation of chiropractors, seems to demonstrate the opposite.

On Amazon, the book currently has one single customer review: Value information and an easy read! I am a strong believer of chiropractic and this makes it easy for me to share this info with my friends ! 

This comment is apt because it makes clear that chiropractic is a belief system. We must not expect rational thoughts or facts from what, in effect, is a religion for many. I can understand this in a way: belief can be a cosy shelter from the truth; it does not require much thinking; it hardly needs any learning, no changing of minds, etc. However, belief can never be a basis for good healthcare. In my view, ‘Beyond The Back’ provides a perfect example of that.

This meta-analysis was performed “to ascertain the effectiveness of oral aloe vera consumption on the reduction of fasting blood glucose (FBG) and hemoglobin A1c (HbA1c).”

PubMed, CINAHL, Natural Medicines Comprehensive Database, and Natural Standard databases were searched. The searches were limited to clinical trials or observational studies conducted in humans and published in English. Studies of aloe vera’s effect on FBG, HbA1c, homeostasis model assessment-estimated insulin resistance (HOMA-IR), fasting serum insulin, fructosamine, and oral glucose tolerance test (OGTT) in prediabetic and diabetic populations were examined.

Nine studies were included in the FBG parameter (n = 283); 5 of these studies included HbA1c data (n = 89). Aloe vera decreased FBG by 46.6 mg/dL (p < 0.0001) and HbA1c by 1.05% (p = 0.004). Significant reductions of both endpoints were maintained in all subgroup analyses. Additionally, the data suggested that patients with an FBG ≥200 mg/dL may see a greater benefit. A mean FBG reduction of 109.9 mg/dL was observed in this population (p ≤ 0.0001). There was evidence of publication bias with FBG but not with HbA1c.

The authors concluded that the results of this meta-analysis support the use of oral aloe vera for significantly reducing both FBG (46.6 mg/dL) and HbA1c (1.05%) in prediabetic and diabetic patients. However, given the current overall quality and relative scarcity of data, further clinical studies that are more robust and better controlled are warranted to confirm and further explore these findings.

Oh no, the results do not support the use of aloe vera at all!!

Why?

Because this ‘meta-analysis’ is of unacceptably poor quality. Here are just some of the flaws that render it totally useless, particularly for issuing advice such as above:

  • The authors included uncontrolled observational studies which make no attempt to control for non-specific effects.
  • In several studies, the use of concomitant anti-diabetic medications was allowed; therefore it is not possible to establish cause and effect by aloe vera.
  • The search strategy was woefully inadequate; for instance non-English publications were not considered.
  • There was no assessment of the scientific rigor of the included studies; this totally invalidates the reliably of the conclusions.
  • The included studies used preparations of widely different aloe vera preparations, and there is no way of knowing the does of the active ingredients.

Diabetes is a serious condition that affects millions worldwide. If some of these patients are sufficiently gullible to follow the conclusions of this paper, they might be dead within a matter of days. This makes this article one of the most dangerous papers that I have seen in the ‘peer-reviewed’ literature of alternative medicine.

Who publishes such utter and irresponsible rubbish?

You may well ask.

The journal has been discussed on this blog  before for the junk that regularly appears in its pages, and so has its editor in chief. The authors (and the reviewers) are not known to me, but one thing is for sure: they don’t know the first thing about conducting a decent systematic review/meta-analysis.

Yes, to a large extend, quacks make a living by advertising lies. A paper just published confirms our worst fears.

This survey was aimed at identifying the frequency and qualitative characteristics of marketing claims made by Canadian chiropractors, naturopaths, homeopaths and acupuncturists relating to the diagnosis and treatment of allergy and asthma.

A total of 392 chiropractic, naturopathic, homeopathic and acupuncture clinic websites were located in 10 of the largest metropolitan areas in Canada. The main outcome measures were: mention of allergy, sensitivity or asthma, claim of ability to diagnose allergy, sensitivity or asthma, claim of ability to treat allergy, sensitivity or asthma, and claim of allergy, sensitivity or asthma treatment efficacy. Tests and treatments promoted were noted as qualitative examples.

The results show that naturopath clinic websites had the highest rates of advertising at least one of diagnosis, treatment or efficacy for allergy or sensitivity (85%) and asthma (64%), followed by acupuncturists (68% and 53%, respectively), homeopaths (60% and 54%) and chiropractors (33% and 38%). Search results from Vancouver were most likely to advertise at least one of diagnosis, treatment or efficacy for allergy or sensitivity (72.5%) and asthma (62.5%), and results from London, Ontario were least likely (50% and 40%, respectively). Of the interventions advertised, few are scientifically supported; the majority lack evidence of efficacy, and some are potentially harmful.

[Legend to figure above: Percentage of alternative medicine clinic websites advertising at least one of diagnosis, treatment or efficacy for allergy/sensitivity or asthma. Presenting the data in this way demonstrates that the Canadian naturopath, homeopath and acupuncturist websites studied have >50% rates of making at least one health-related claim for both allergy/sensitivity and asthma.]

The authors concluded that the majority of alternative healthcare clinics studied advertised interventions for allergy and asthma. Many offerings are unproven. A policy response may be warranted in order to safeguard the public interest.

In the discussion section, the authors state: “These claims raise ethical issues, because evidence in support of many of the tests and treatments identified on the websites studied is lacking. For example, food-specific IgG testing was commonly advertised, despite the fact that the Canadian Society of Allergy and Clinical Immunology has recommended not to use this test due to the absence of a body of research supporting it. Live blood analysis, vega/electrodiagnostic testing, intravenous vitamin C, probiotics, homeopathic allergy remedies and several other tests and treatments offered all lack substantial scientific evidence of efficacy. Some of the proposed treatments are so absurd that they lack even the most basic scientific plausibility, such as ionic foot bath detoxification…

Perhaps most concerning is the fact that several proposed treatments for allergy, sensitivity or asthma are potentially harmful. These include intravenous hydrogen peroxide, spinal manipulation and possibly others. Furthermore, a negative effect of the use of invalid and inaccurate allergy testing is the likelihood that such testing will lead to alterations and exclusions in diets, which can subsequently result in malnutrition and other physiological problems…”

This survey originates from Canada, and one might argue that elsewhere the situation is not quite as bad. However, I would doubt it; on the contrary, I would not be surprised to learn that, in some other countries, it is even worse.

Several national regulators have, at long last, become aware of the dangers of advertising of outright quackery. Consequently, some measures are now beginning to be taken against it. I would nevertheless argue that these actions are far too slow and by no means sufficiently effective.

We easily forget that asthma, for instance, is a potentially life-threatening disease. Advertising of bogus claims is therefore  much more than a forgivable exaggeration aimed at maximising the income of alternative practitioners – it is a serious threat to public health.

We must insist that regulators protect us from such quackery and prevent the serious harm it can do.

Alternative medicine suffers from what might be called ‘survey overload’: there are far too much such investigations and most of them are of deplorably poor quality producing nothing of value except some promotion for alternative medicine. Yet, every now and then, one finds a paper that is worth reading, and I am happy to say that this survey (even though it has several methodological shortcomings) belongs in this category.

This cross-sectional assessment of the views of general practitioners towards chiropractors and osteopaths was funded by the Department of Chiropractic at Macquarie University. It was designed as a quantitative descriptive study using an anonymous online survey that included closed and open-ended questions with opportunities provided for free text. The target population was Australian general practitioners. Inclusion criteria included current medical registration, membership of the Royal Australian College of General Practitioners and currently practicing as a general practitioner in Australia. The data being reported here were collected between May and December, 2014.

There were 630 respondents to the online survey during this period representing a response rate of 2.6 %. Results were not uniform for the two professions. More general practitioners believed chiropractic education was not evidence-based compared to osteopathic education (70 % and 50 % respectively), while the scope of practice was viewed as similar for both professions. A majority of general practitioners had never referred a patient to either profession (chiropractic: 60 %; osteopathy: 66 %) and indicated that they would not want to co-manage patients with either profession. Approximately two-thirds of general practitioners were not interested in learning more about their education (chiropractors: 68 %; osteopaths: 63 %).

The authors concluded that this study provides an indication of the current views of Australian general practitioners towards chiropractors and osteopaths. The findings suggest that attitudes may have become less favourable with a growing intolerance towards both professions. If confirmed, this has the potential to impact health service provision. The results from this cross-sectional study suggest that obtaining representative general practitioner views using online surveys is difficult and another approach is needed to supplement or replace the current recruitment strategy.

The authors do not speculate on the reasons why the attitudes of general practitioners towards chiropractic and osteopathy might have become more critical. Therefore I decided to offer a few possibilities here. The more negative views could be due to:

  • better education of general practitioners,
  • tightening of healthcare budgets,
  • recent ‘bad press’ and loss of reputation (for instance, the BCA’s libel action against Simon Singh),
  • the work of sceptics in informing the public about the numerous bogus claims made by osteopaths and chiropractors,
  • the plethora of overtly bogus claims which nevertheless continue to be made by these practitioners on a daily basis,
  • a more general realisation that these therapies can cause very serious harm,
  • a mixture of the above factors.

Whatever the reasons are, the finding that there now seems to be a growing scepticism (in Australia, but hopefully elsewhere as well) about the value of chiropractic and osteopathy is something that cheers me up no end.

Yes, this post might come as a surprise to some.

And no, I am not changing sides in the debate in the debate about homeopathy.

But I have long felt that, when sceptics criticise homeopathy, they often wrong-foot themselves by using arguments which are not entirely correct.

Here I want to list seven of them (more details can be found here):

Homeopathy is one single, well-defined entity

During the last 200 years, many different variations of Hahnemann’s classical homeopathy have emerged, for instance clinical homeopathy, complex homeopathy and isopathy. Strictly speaking, they should be differentiated, and it is not correct to generalise across all of them.

In the 200-years’ history of homeopathy, homeopaths have done no good at all

Hahnemann and his followers can be credited with considerable achievements. Foremost, they realised that, 200 years ago, most of the conventional treatments in common use were not just useless but often outright dangerous. Their criticism of ‘heroic medicine’ helped to initiate crucial reforms and to improve health care for the benefit of millions.

No theories to explain how homeopathy might work have ever been put forward

There are several theories which might go some way in explaining how homeopathy works. But all of them are currently just theories, and none provides a full explanation as to the mechanism of action of highly diluted remedies. Yet, to claim that homeopathy is totally implausible might be a counter-productive exaggeration.

There is nothing in it

Many sceptics claim that homeopathic remedies are devoid of active ingredients. Yet, not all homeopathic remedies are highly diluted; some can contain pharmacologically active compounds for affecting human health. These preparations cannot therefore be classified as implausible.

There is no credible evidence at all that might support homeopathy

Several well-conducted clinical studies of homeopathy with positive results have been published. It is therefore not true to claim that there is no good trial evidence at all to support homeopathy. The much better point sceptics should make is that the totality of the reliable evidence fails to show that highly dilute homeopathic remedies are more effective than placebos.

Homeopaths aim at deceiving their patients because they have nothing to offer to them

It would be wrong to claim that all homeopaths aim at deceiving their patients, and it would be misleading to say that homeopaths have nothing to offer to their patients. Many patients of homeopaths primarily treasure the long, compassionate consultations that homeopaths have with their patients and see the homeopathic remedy as secondary. Seen from this perspective, homeopaths do offer something that many patients value highly.

Patients who use homeopathy must be stupid

It would be arrogant, insulting and counter-productive to claim that everyone who uses homeopathy is stupid. Patients consult homeopaths mostly because they have needs which are not met by conventional medicine but which they feel taken care of by homeopathy. Seen from this perspective, the current popularity of homeopathy in some countries is a poignant criticism of conventional medicine. To dismiss it a stupidity means missing a chance to learn an important lesson and to improve mainstream health care.

I know, my stance here can easily get misunderstood (see for instance some of the comments here). But please don’t get me wrong, I am not saying that homeopathy is a useful therapy, nor am I suggesting that we should not criticise it or stop public funding for it. All that I am trying to convey here is this: when we criticise homeopathy, we ought to make sure our arguments are factually correct – if not, we only give ammunition to our opponents.

In a nutshell: I don’t wish to undermine our arguments, but want them to be more effective.

 

 

The Scotsman reported that David Tredinnick, the somewhat feeble-minded Tory MP for Bosworth, has been at it again. Apparently he said that many of his constituents are only alive today because they have been treated with alternative medicine.

Tredennick recently urged ministers to spend more NHS money on alternative therapies such as homeopathy and acupuncture to treat patients. It seems to me that, for him and other quackery promoters, evidence and science are issues beyond comprehension. Mr Tredinnick also disclosed the fact that he received acupuncture at a Chinese medical clinic just before the Commons debate on cancer strategy – a regular treatment he credits with keeping him healthy.

Tredennick told his fellow MPs: “I was talking there to practitioners about what they are able to do for cancer patients, and there is actually a very long list of types of cancer that can be treated using traditional Chinese herbal medicine.“ One, cervical cancer, two, non-Hodkins lymphoma, three, HIV, four, colon cancer, five… six, breast cancer, seven, prostate cancer. And so the list goes on. “I have in my constituency several constituents who I believe are alive today because they have used Chinese medicine.“ And the reason for that is what it does is it strengthens your system, and it strengthens the immune system, and it is very effective after cancer treatment. It deals with particular symptoms.”

This is by no means the first outburst of quackery-promotion by the Right Honourable Gentleman. I have a whole selection of quotes from him which I sometimes use for amusing my audience during public lectures. Because amusing he is; Tredennick seems to be utterly devoid of rational thought when it comes to the subject of alternative medicine, and often his statements make for comedy gold. This time, however, he might be sailing closer to the wind than he perhaps realizes: Under English law, it is an offence to claim that any treatment can cure cancer, I believe.

We all had to learn to laugh about unethical and dangerous nonsense the ‘Tredennicks of this world’ regularly claim about alternative medicine. Laughing is the only solution for coping with such idiocy, I am afrid. If we don’t laugh, we have to consider taking it seriously – and this is a truly frightening prospect, particularly considering that this guy actually sits in parliament and has the power to influence our lives.

Meniscus-injuries are common and there is no consensus as to how best treat them. Physiotherapists tend to advocate exercise, while surgeons tend to advise surgery.

Of course, exercise is not a typical alternative therapy but, as many alternative practitioners might disagree with this statement because they regularly recommend it to their patients, it makes sense to cover it on this blog. So, is exercise better than surgery for meniscus-problems?

The aim of this recent Norwegian study aimed to shed some light on this question. Specifically wanted to determine whether  exercise therapy is superior to arthroscopic partial meniscectomy for knee function in  patients with degenerative meniscal tears.

A total of 140 adults with degenerative medial meniscal tear verified by magnetic resonance imaging were randomised to either receiving 12 week supervised exercise therapy alone, or arthroscopic partial meniscectomy alone. Intention to treat analysis of between group difference in change in knee injury and osteoarthritis outcome score (KOOS4), defined a priori as the mean score for four of five KOOS subscale scores (pain, other symptoms, function in sport and recreation, and knee related quality of life) from baseline to two-year follow-up and change in thigh muscle strength from baseline to three months.

The results showed no clinically relevant difference between the two groups in change in KOOS4 at two years (0.9 points, 95% confidence interval −4.3 to 6.1; P=0.72). At three months, muscle strength had improved in the exercise group (P≤0.004). No serious adverse events occurred in either group during the two-year follow-up. 19% of the participants allocated to exercise therapy crossed over to surgery during the two-year follow-up, with no additional benefit.

The authors concluded that the observed difference in treatment effect was minute after two years of follow-up, and the trial’s inferential uncertainty was sufficiently small to exclude clinically relevant differences. Exercise therapy showed positive effects over surgery in improving thigh muscle strength, at least in the short-term. Our results should encourage clinicians and middle-aged patients with degenerative meniscal tear and no definitive radiographic evidence of osteoarthritis to consider supervised exercise therapy as a treatment option.

As I stated above, I mention this trial because exercise might be considered by some as an alternative therapy. The main reason for including it is, however, that it is in many ways an exemplary good study from which researchers in alternative medicine could learn.

Like so many alternative therapies, exercise is a treatment for which placebo-controlled studies are difficult, if not impossible. But that does not mean that rigorous tests of its value are impossible. The present study shows the way how it can be done.

Meaningful clinical research is no rocket science; it merely needs well-trained scientists who are willing to test the (rather than promote) their hypotheses. Sadly such individuals are as rare as gold dust in the realm of alternative medicine.

You probably remember: the US Federal Trade Commission’s (FTC) has issued a statement announcing that unsupported claims for homeopathic remedies will be no longer allowed. Specifically, they said that, in future, homeopathic remedies have to be held to the same standard as other medicinal products. In other words, American companies must now have reliable scientific evidence for health-related claims that their products can treat specific conditions and illnesses.

Now the AMERICAN INSTITUTE OF HOMEOPATHY (AIH) has published a rebuttal. It is hilarious and embarrassing in equal measure. Here it is in full (I have only omitted their references – they can be seen in the linked original –  and added footnotes in bold square brackets with my very short comments):

START OF QUOTE

November 30, 2016

The American Institute of Homeopathy applauds the Federal Trade Commission’s (FTC) goal of protecting the American public from false advertising claims, but in a recent circumstance we believe the FTC has overstepped its jurisdictional bounds and promulgated false information in what appears to be a bid to restrict health care choices [1] available to the American public.

In Response to the recent Enforcement Policy Statement1 and a Consumer Information Blog,2 both issued by the FTC on November 15, 2016, the American Institute of Homeopathy registers our strong concern regarding the content of the following inaccurate statements:

  1. “Homeopathy… is based on the view that disease symptoms can be treated by minute doses of substances that produce similar symptoms…”

Homeopathy is not based on a “view” or an opinion. It is based on reliable, reproducible, clinically acquired, empiric evidence [2] gathered through two centuries of corroborated data, assisted by thousands of practitioners worldwide [3], demonstrating the actions of different medicinal substances in living systems, aka: the science of homeopathy. In fact, the homeopathic scientific community were pioneers of the modern scientific method including the widespread adoption of blinded and placebo controlled studies in 1885 [4], decades before conventional medicine.3

Homeopathy is not based on a theory or on conjecture, but on principles that have been confirmed by long-studied clinical data, meticulously gathered and analyzed over many years [5].

  1. “Many homeopathic products are diluted to such an extent that they no longer contain detectable levels of the initial substance.”

While the dilution and succussion process of formulating homeopathic medicines does reduce the concentration (and the toxicity) of the original substances, detectable amounts of these materials remain quantifiable in the form of nanoparticles [6] dispersed throughout.4 Multiple independent laboratories, worldwide have confirmed that these nanoparticles persist,5 and that they are biologically active.6 Many other homeopathic products (particularly those sold OTC and described as “low potency”) have dilute amounts of the original substance [7] that remain chemically detectable by straightforward titration.

  1. “…homeopathic product claims are not based on modern scientific methods…”

This statement is false and misleading. The active ingredients within most OTC homeopathic products have hundreds or thousands of case reports from physicians who have used these medicines [8]. These reports of direct clinical experiences establish a collective, real-world dataset that demonstrates which conditions have been observed to respond to treatment. Such historical data is similar to the types of information used to demonstrate effectiveness for many conventional OTC medicines on the market today [9].

The Homeopathic Pharmacopeia Convention of the United States (HPCUS) maintains a formulary describing the appropriate manufacturing standards for homeopathic medicines [10]. Every homeopathic manufacturer member of the American Association of Homeopathic Pharmacists in good ethical standing complies with both manufacturing and labeling standards set by the HPCUS. Consumers should be cautious when using any products that are not distinguished by conformance with “HPUS” on the label.

  1. “…the case for efficacy is based solely on traditional homeopathic theories…”

This statement is false. Neither homeopathy nor homeopathic efficacy is based on any theories. Efficacy for various homeopathic medicines has been established by scientifically reproducible clinical empiric research evidence [11] and cured patient cases followed over many years [12]. Homeopathy is an evidence-based medical subspecialty rooted in patient care.

  1. “…there are no valid studies using current scientific methods showing the product’s efficacy.”

While this statement may have limited accuracy with respect to some OTC products, it is false and misleading with respect to most homeopathic medicines listed in the Homeopathic Pharmacopeia of the United States. Hundreds of state-of-the-art double-blinded, randomized, placebo-controlled studies, many in peer-reviewed journals, demonstrate the superior efficacy of homeopathic medicines in a wide range of conditions, including asthma,7 depression and anxiety,8 chronic illness,9 allergic rhinitis,10 hypertension,11 headaches/migraines,12 sepsis,13 mild traumatic brain injury,14 otitis media,15 cancer,16 and many other conditions [13]. The American Institute of Homeopathy maintains and continually updates an extensive database, available free to the public, with over 6,000 research articles [14].17

Multiple meta-analyses published in peer reviewed medical journals that conclude that homeopathic medicine effects are superior to placebo [15] and that additional study of this therapeutic system is warranted.18,19,20,21,22,23  To that end, we encourage the National Institutes of Health to reverse their current position of blocking funding for homeopathic trials.24

  1. “…marketing claims that such homeopathic products have a therapeutic effect lack a reasonable basis and are likely misleading…”

The conclusion of whether a product has a “reasonable basis” is entirely irrelevant if that product has demonstrable clinical effectiveness. The important question, when it comes to homeopathy, is whether it is effective in clinical settings, not whether it has a “reasonable basis” for how it works. The mechanism by which homeopathy works differs from conventional medicines [16], but this fact does not make these products “misleading”.

Several recent class-action lawsuits brought against homeopathic manufacturers confirm that marketing practices were neither deceptive nor misleading [17].25

The FTC’s inability to formulate a reasonable basis for why homeopathic medicines work should not enter into any governmental enforcement policy statement. The FTC is not a medical organization, lacks expertise in interpreting scientific research [18], and is not qualified to make any comment on the validity of any field of medicine. To be less misleading, the FTC should exclude opinions from its policy statements.

  1. “Homeopathy: Not backed by modern science”

Homeopathy, as a system of medicine, does not fall under the purview of the FTC. Therefore, the FTC has been reckless in expressing an opinion of this magnitude. In this situation, the FTC’s comments can only be construed as being prejudicially biased and intentionally discriminatory against homeopathy. Such statements cause unwarranted harm to public trust and damage to a respected traditional system of medicine in the United States [19].

The American Institute of Homeopathy strongly objects to the FTC’s characterization of the entire field of homeopathic medicine as being without scientific evidence of efficacy. These comments are unqualified and wholly lacking in merit. The release of this Enforcement Policy Statement serves only to align the FTC with several recently released scientifically fraudulent [20] reports by a variety of pseudoscientists [21] and lowers the credibility of this valued consumer protection agency.

This type of misinformation should be embarrassing to a government organization striving to be nonpartisan and objective. The FTC owes an apology to the American Institute of Homeopathy as well as the many consumer groups that look toward this agency for fair and accurate information.

END OF QUOTE

My comments:

1 In healthcare, choice must be restricted to treatments which demonstrably generate more good than harm.

2 The AIH seems to be unaware of the difference between the nature of evidence, anecdote and experience.

3 Fallacy – appeal to popularity.

4 The first randomized, placebo-controlled study of homeopathy was, in fact, published in 1835 – its results were negative.

5 Fallacy – appeal to tradition.

6 The nano-particle explanation of homeopathy is but a theory (at best).

7 Fallacy – appeal to tradition.

8 Fallacy – appeal to authority.

9 Really? Which ones? Examples would help, but I doubt they exist.

10 The proper manufacturing of nonsense must still result in nonsense.

11 See footnote number 2

12 Fallacy – appeal to tradition.

13 For all of these conditions, the totality of the reliable evidence fails to demonstrate efficacy.

14 In this context, only clinical trials are relevant, and their number is nowhere near 6,000.

15 Most of the independent systematic reviews fail to be positive.

16 The mechanism is well-known and is called ‘placebo-effect’.

17 Many class actions also went against the manufacturers of homeopathic preparations.

18 I assume they ‘bought in’ the necessary expertise.

19 Surely, the damage is only to the cash-flow of firms selling bogus products.

20 Really? Name the report you libel here or be quiet!

21 Name the individuals you attack in this way or be quiet!

I must say, I had fun reading this. In fact, I cannot remember having seen a document by an organisation of healthcare professionals which was so embarrassingly nonsensical that it becomes comedy gold. If one of my PhD students, for instance, had submitted such drivel, I would have had no choice but to fail him or her.

Having said that, I need to stress to the AIH:

FULL MARKS FOR AMUSEMENT!!!

 

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