MD, PhD, FMedSci, FSB, FRCP, FRCPEd

bias

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While my last post was about the risk following some naturopaths’ advice, this one is about the effectiveness of naturopathic treatments. This is a complex subject, not least because naturopaths use a wide range of therapies (as the name implies, they pride themselves of employing all therapeutic means supplied by nature). Some of these interventions are clearly supported by good evidence; for instance, nobody would doubt the effectiveness of a healthy diet or the benefits of regular exercise. But what about all the other treatments naturopaths use? The best approach to find an answer might be to assess not each single therapy but to evaluate the entire package of the naturopathic approach, and not a single study but all such trials.

This is precisely what US researchers have recently done. The purpose of this interesting, new systematic review was to compile and consolidate research that has investigated the whole practice of naturopathic medicine as it is practiced in community settings in order to better assess the quantity and quality of the research, and clinical effect, if any.

In order to get included into the review, studies had to report results from multi-modal treatment delivered by North American naturopathic doctors. The effect size for each study was calculated; no meta-analysis was undertaken.

Fifteen studies met the authors’ inclusion criteria. They covered a wide range of chronic diseases. Most studies had low to medium risks of bias including acknowledged limitations of pragmatic trials. Effect sizes for the primary medical outcomes varied and were statistically significant in 10 out of 13 studies. A quality of life metric was included in all of the RCTs with medium effect size and statistical significance in some subscales.

The authors concluded that previous reports about the lack of evidence or benefit of naturopathic medicine (NM) are inaccurate; a small but compelling body of research exists. Further investigation is warranted into the effectiveness of whole practice NM across a range of health conditions.

This sounds like good news for naturopathy! However, there are several important caveats:

  • the authors seem to have only looked at US studies (naturopathy is a European tradition!),
  • the searches were done three years ago, and more recent data were thus omitted,
  • the authors included all sorts of investigations, even uncontrolled studies; only 6 were RCTs,
  • rigorous trials were very scarce; and for each condition, they were even more so,
  • the authors mention the PRISMA guidelines for systematic reviews implying that they followed them but, in fact, they did not.

My biggest concern, however, is something else. It relates to the interventions tested in these studies. The authors claim that their results table provides full details on this issue but this is unfortunately not true. All we have by way of an explanation is the authors’ remark that the interventions tested in the studies of their review included diet counseling and nutritional recommendations, specific home exercises and physical activity recommendations, deep breathing techniques or other stress reduction strategies, dietary supplements including vitamins, hydrotherapy, soft-tissue manual techniques, electrical muscle stimulation, and botanical medicines.

Survey data from two US states tell us that the most commonly prescribed naturopathic therapeutics are botanical medicines (51% of visits in Connecticut, 43% in Washington), vitamins (41% and 43%), minerals (35% and 39%), homeopathy (29% and 19%) and allergy treatments (11% and 13%). They also inform us that the mean length of a consultation with an US naturopath is about 40 minutes.

I think, this puts things into perspective. If I advise a patient with diabetes or hypertension or coronary heat disease to follow an appropriate diet, exercise and to adhere to some stress reduction program, if in addition I show empathy and compassion during a 40 minute consultation and make sure that my advise is taken seriously and subsequently adhered to, the outcome is likely to be positive. Naturopaths may elect to call this package of intervention ‘naturopathy’, however, I would call it good conventional medicine.

The problem, I think is clear: good therapeutic advice is effective but it is not naturopathy, and it cannot be used to justify the use of doubtful interventions like homeopathy or all sorts of dodgy supplements. Testing whole treatment packages of this nature can therefore lead to highly misleading results, particularly if the researchers draw unwarranted conclusions about specific schools of health care.

When I come across a study with the aim to “examine the effectiveness of acupuncture to relieve symptoms commonly observed in patients in a hospice program” my hopes are high. When I then see that its authors are from the ‘New England School of Acupuncture’, the ‘All Care Hospice and the ‘Tufts University School of Medicine, Boston, my hopes for a good piece of science are even higher. So, let’s see what this new paper has to offer.

A total of 26 patients participated in this acupuncture ‘trial’, receiving a course of weekly treatments that ranged from 1 to 14 weeks. The average number of treatments was five. The Edmonton Symptom Assessment Scale (ESAS) was used to assess the severity of pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and dyspnoea. A two-tailed, paired t test was applied to the data to compare symptom scores pre- versus post-acupuncture treatment. Patients enrolled in All Care Hospice’s home care program were given the option to receive acupuncture to supplement usual care offered by the hospice team. Treatment was provided by licensed acupuncturists in the patient’s place of residence.

The results indicated that 7 out of 9 symptoms were significantly improved with acupuncture, the exceptions being drowsiness and appetite. Although the ESAS scale demonstrated a reduction in symptom severity post-treatment for both drowsiness and appetite, this reduction was not found to be significant.

At tis stage, I have lost most of my hopes for good science. This is not a ‘trial’ but a glorified case-series. There is no way that the stated aim can be pursued with this type of methodology. There is no reason whatsoever to assume that the observed outcome can be attributed to acupuncture; the additional attention given to these patients is but one of several factors that are quite sufficient to explain their symptomatic improvements.

This is yet another disappointment then from the plethora of ‘research’ into alternative medicine that, on closer inspection, turns out to be little more than thinly disguised promotion of quackery. These days, I can bear such disappointments quite well – after all, I had many years to get used to them. What I find more difficult to endure is the anger that overcomes me when I read the authors’ conclusion: Acupuncture was found to be effective for the reduction and relief of symptoms that commonly affect patient QOL. Acupuncture effectively reduced symptoms of pain, tiredness, nausea, depression, anxiety, and shortness of breath, and enhanced feelings of well-being. More research is required to assess the long-term benefits and symptom reduction of acupuncture in a palliative care setting.

This is not disappointing; in my view, this is scientific misconduct by

  • the authors,
  • the institutions employing the authors,
  • the ethics committee that has passed the ‘research’,
  • the sponsors of the ‘research’,
  • the peer-reviewers of the paper,
  • the journal and its editors responsible for publishing this paper.

The fact that this sort of thing happens virtually every day in the realm of alternative medicine does not render this case less scandalous, it merely makes it more upsetting.

This article is hilarious, I think. It was written by Heike Bishop, a homeopath who works in Australia. Here she tries to advise colleagues how best to defend homeopathy and how to deal effectively with the increasingly outspoken criticism of homeopathy. Below is the decisive passage from her article; I have not changed or omitted a word, not even her grammatical or other mistakes [only the numbers in brackets were inserted by me; they refer to my comments added below]:

Getting up in the morning and hearing that all the television and radio station report that it is dangerous for people to see their homoeopath, is utterly heart breaking. Even more so because I grew up in East Germany where the government suppressed free speech and anything that was off the beaten path [1]. So what can we do in times like these?

First of all, watch out for Government inquiries. History has shown that they are usually not favourable towards homoeopathy [2] unless you live in Switzerland [3]. It is vitally important in times like these to put differences aside amongst our professional peers. Every association should be mobilised to take an active and ONGOING role to educate and advertise the benefits of homoeopathy [4]. If things have gone too far already, talk about freedom of choice [5]. Write articles and join blogs talking about what you can do specifically for certain conditions [6].  Encourage your patients to tell their success stories in blogs and other social media forums [7]. It is in most cases utterly useless to engage in any conversation [8] online with trolls [9].

Try to develop a calloused skin when it comes to criticism. Your patients don’t want to hear how difficult it is to be a homeopath [10], they want you to be in control and to be reassured that their treatment continues [11]. When someone asks you to comment on an attack on homoeopathy, put your best smile on and state how threatened the pharmaceutical industry must be to resort to such tactics [12].

Staphysagria is indeed a good remedy. Hahnemann also knew its benefits and even alternated it with Arsenicum the day his first wife died and he got a letter that the hospital built in his name allowed patients to choose their treatment between allopathy and homoeopathy [13]. That was the only time he took two remedies on the same day! [14]

Find out what you can about your country’s own internet trolls [15]. However, don’t underestimate their effectiveness in swaying popular opinion [16]. There is no denying that their methods are very effective [17]. It doesn’t matter how ludicrous their comments are, don’t go into direct explanation [18]. Learn from the enemy [19] and repeat a positive message over and over again so it can’t be contorted [20].

Our colleges should support post-graduate studies featuring marketing and media courses [21]. I once met a Homoeopath from the UK and she pointed out that part of the training in the UK is for students to hold homoeopathic first aid courses to promote homoeopathy [22]. Everyone is different – some of us are happy to stand in front of an audience others choose the pen as their sword [23]. The main thing is to do something to save the image of our healing art [24].

  1. Is she implying that facing criticism of homeopathy is akin to living in a totalitarian state? Or that criticism is a violation of free speech?
  2. I wonder why this is so – nothing to do with the evidence, I presume?
  3. Does she refer to the famous ‘Swiss Government report’ which was not by the Swiss Government at all?
  4. ‘Advertise and educate’ seems to be homeopathic speak for ‘MISLEAD’
  5. Good idea! Freedom of choice is a perfect argument (in this case, my choice would be to have a bottle of champagne at around 6 pm every day – on the NHS, of course).
  6. Certain conditions??? And I thought homeopaths do not treat conditions, only whole people.
  7. And forbid them to disclose stories where things did not work out quite so well?
  8. Very wise! Conversations are fraught with the danger of being found wrong.
  9. Critics are not critics but ‘trolls’ – makes sense.
  10. I would have thought that practising as a homeopath is not difficult at all – in most countries, they don’t even check whether you can spell the name correctly.
  11. Is it not rather the homeopath who wants the treatment to continue – after all, it is her livelihood?
  12. Ah yes, BIG PHARMA, the last resort of any quack!
  13. Did she not just praise patient choice as an important virtue?
  14. Hahnemann was famously cantankerous and argumentative all his life; does that mean that his remedies did not work?
  15. Homeopaths might need that for your ad hominem attacks.
  16. Never underestimate the power of truth!!!
  17. This might show that it is you and not the ‘trolls’ who are ludicrous.
  18. Particularly as there are no direct explanations for homeopathy.
  19. First the critics were ‘trolls’, now they have been upgraded to ‘enemy’! Is it really a war?
  20. You need to repeat it at least regularly so that eventually you believe it yourself.
  21. Are marketing and media a substitute for evidence?
  22. Really, first aid? Do homeopaths know what this is? Obviously not!
  23. But real clinicians, homeopaths call them allopaths, are quite happy simply with effective treatments that help patients to improve.
  24. And I thought the main thing was to treat patients with the most effective therapies available.

ENOUGH JOKING AND SARCASM!

There is, of course, a very serious message in all of this: when under pressure, homeopaths seem to think of all sorts of things in their (and homeopathy’s) defense – some more rational than others – but the ideas that criticism might be a good way to generate progress, and that a factual debate about the known facts might improve healthcare, do not seem to be amongst them.

The last time I had contact with Dr Fisher was when he fired me from the editorial board of his journal ‘Homeopathy’. He did that by sending me the following letter:

Dear Professor Ernst,

This is to inform you that you have been removed from the Editorial Board of Homeopathy.  The reason for this is the statement you published on your blog on Holocaust Memorial Day 2013 in which you smeared homeopathy and other forms of complementary medicine with a ‘guilt by association’ argument, associating them with the Nazis.

I should declare a personal interest….[Fisher goes on to tell a story which is personal and which I therefore omit]…  I mention this only because it highlights the absurdity of guilt by association arguments.

Sincerely

Peter Fisher Editor-in-Chief, Homeopathy

I did not expect to have any more dealings with him after this rather unpleasant encounter. But, as it turns out, I recently did have a further encounter.

When the BMJ invited me to write a debate article about the question whether homeopathy should continue to be available on the NHS, I accepted (with some reservations, I hasten to add). At the time, I did not know who would do the ‘other side’ of this debate. It turned out to be Peter Fisher, and our two articles have just been published.

As one would expect from a good journal, the articles were both peer reviewed. One of the peer-reviewers of my piece was most scathing of it essentially claiming that it was entirely worthless. Feeling that this was a bit harsh and very impolite, I was keen to see who this reviewer had been; it was none other than Andrew Vickers. This is remarkable because Vickers had not only published several homeopathic papers with Fisher, but also had been in the employment of the ‘Royal London Homeopathic Hospital’ under Fisher. To the best of my knowledge, his conflicts of interested had not been disclosed. I did point that out to the BMJ, but they seemed to think nothing of it.

Anyway, I was pleased to eventually (the whole procedure took many months) see the articles published, but at the same time somewhat irritated by Fisher’s piece. It contained plenty of misleading information that the peer-reviewers obviously had failed to correct. Here is a small sample from Fishers piece:

… recent overviews have had more favourable conclusions, including a health technology assessment commissioned by the Swiss federal government that concluded that homeopathy is “probably” effective for upper respiratory tract infections and allergies.

Readers interested in the clinical evidence can access the CORE-HOM database of clinical research in homeopathy free of charge (www.carstens-stiftung.de/core-hom). It includes 1117 clinical trials of homeopathy, of which about 300 are randomised controlled trials.

In the podcast that accompanies the articles Fisher insists that, on this database, there are well over 300 RCT, and I had to admit that this was new to me. Keen to learn more, I registered with the database and had a look. What I found startled me. True, the database does claim that almost 500 RCTs are available, but just a very superficial scrutiny of these studies reveals that

  • some are not truly randomised,
  • some are not even clinical trials,
  • the list includes dual publications, re-analyses of already published studies as well as aborted trials,
  • many have never been peer-reviewed,
  • many are not double-blind,
  • many are not placebo controlled,
  • the majority are of poor methodological quality.

As to the other thing mentioned in the above excerpt from Fisher’s article, the famous ‘health technology assessment commissioned by the Swiss federal government’, I can refer my readers to a blog post by J W Nienhuys which probably says it all, if not, there is plenty more criticism of this report available on the Internet.

My conclusion from all this?

THE QUEEN’S HOMEOPATH USES ARGUMENTS THAT SEEM JUST AS BOGUS AS HOMEOPATHY ITSELF.

One could define alternative medicine by the fact that it is used almost exclusively for conditions for which conventional medicine does not have an effective and reasonably safe cure. Once such a treatment has been found, few patients would look for an alternative.

Alzheimer’s disease (AD) is certainly one such condition. Despite intensive research, we are still far from being able to cure it. It is thus not really surprising that AD patients and their carers are bombarded with the promotion of all sorts of alternative treatments. They must feel bewildered by the choice and all too often they fall victim to irresponsible quacks.

Acupuncture is certainly an alternative therapy that is frequently claimed to help AD patients. One of the first websites that I came across, for instance, stated boldly: acupuncture improves memory and prevents degradation of brain tissue.

But is there good evidence to support such claims? To answer this question, we need a systematic review of the trial data. Fortunately, such a paper has just been published.

The objective of this review was to assess the effectiveness and safety of acupuncture for treating AD. Eight electronic databases were searched from their inception to June 2014. Randomized clinical trials (RCTs) with AD treated by acupuncture or by acupuncture combined with drugs were included. Two authors extracted data independently.

Ten RCTs with a total of 585 participants were included in a meta-analysis. The combined results of 6 trials showed that acupuncture was better than drugs at improving scores on the Mini Mental State Examination (MMSE) scale. Evidence from the pooled results of 3 trials showed that acupuncture plus donepezil was more effective than donepezil alone at improving the MMSE scale score. Only 2 trials reported the incidence of adverse reactions related to acupuncture. Seven patients had adverse reactions related to acupuncture during or after treatment; the reactions were described as tolerable and not severe.

The Chinese authors of this review concluded that acupuncture may be more effective than drugs and may enhance the effect of drugs for treating AD in terms of improving cognitive function. Acupuncture may also be more effective than drugs at improving AD patients’ ability to carry out their daily lives. Moreover, acupuncture is safe for treating people with AD.

Anyone reading this and having a friend or family member who is affected by AD will think that acupuncture is the solution and warmly recommend trying this highly promising option. I would, however, caution to remain realistic. Like so very many systematic reviews of acupuncture or other forms of TCM that are currently flooding the medical literature, this assessment of the evidence has to be taken with more than just a pinch of salt:

  • As far as I can see, there is no biological plausibility or mechanism for the assumption that acupuncture can do anything for AD patients.
  • The abstract fails to mention that the trials were of poor methodological quality and that such studies tend to generate false-positive findings.
  • The trials had small sample sizes.
  • They were mostly not blinded.
  • They were mostly conducted in China, and we know that almost 100% of all acupuncture studies from that country draw positive conclusions.
  • Only two trials reported about adverse effects which is, in my view, a sign of violation of research ethics.

As I already mentioned, we are currently being flooded with such dangerously misleading reviews of Chinese primary studies which are of such dubious quality that one could do probably nothing better than to ignore them completely.

Isn’t that a bit harsh? Perhaps, but I am seriously worried that such papers cause real harm:

  • They might motivate some to try acupuncture and give up conventional treatments which can be helpful symptomatically.
  • They might prompt some families to spend sizable amounts of money for no real benefit.
  • They might initiate further research into this area, thus drawing money away from research into much more promising avenues.

IT IS HIGH TIME THAT RESEARCHERS START THINKING CRITICALLY, PEER-REVIEWERS DO THEIR JOB PROPERLY, AND JOURNAL EDITORS STOP PUBLISHING SUCH MISLEADING ARTICLES.

You may feel that homeopaths are bizarre, irrational, perhaps even stupid – but you cannot deny their tenacity. Since 200 years, they are trying to convince us that their treatments are effective beyond placebo. And they seem to get more and more bold with their claims: while they used to suggest that homeopathy was effective for trivial conditions like a common cold, they now have their eyes on much more ambitious things. Two recent studies, for instance, claim that homeopathic remedies can help cancer patients.

The aim of the first study was to evaluate whether homeopathy influenced global health status and subjective wellbeing when used as an adjunct to conventional cancer therapy.

In this pragmatic randomized controlled trial, 410 patients, who were treated by standard anti-neoplastic therapy, were randomized to receive or not receive classical homeopathic adjunctive therapy in addition to standard therapy. The main outcome measures were global health status and subjective wellbeing as assessed by the patients. At each of three visits (one baseline, two follow-up visits), patients filled in two questionnaires for quantification of these endpoints.

The results show that 373 patients yielded at least one of three measurements. The improvement of global health status between visits 1 and 3 was significantly stronger in the homeopathy group by 7.7 (95% CI 2.3-13.0, p=0.005) when compared with the control group. A significant group difference was also observed with respect to subjective wellbeing by 14.7 (95% CI 8.5-21.0, p<0.001) in favor of the homeopathic as compared with the control group. Control patients showed a significant improvement only in subjective wellbeing between their first and third visits.

Our homeopaths concluded that the results suggest that the global health status and subjective wellbeing of cancer patients improve significantly when adjunct classical homeopathic treatment is administered in addition to conventional therapy.

The second study is a little more modest; it had the aim to explore the benefits of a three-month course of individualised homeopathy (IH) for survivors of cancer.

Fifteen survivors of any type of cancer were recruited by a walk-in cancer support centre. Conventional treatment had to have taken place within the last three years. Patients scored their total, physical and emotional wellbeing using the Functional Assessment of Chronic Illness Therapy for Cancer (FACIT-G) before and after receiving four IH sessions.

The results showed that 11 women had statistically positive results for emotional, physical and total wellbeing based on FACIT-G scores.

And the conclusion: Findings support previous research, suggesting CAM or individualised homeopathy could be beneficial for survivors of cancer.

As I said: one has to admire their tenacity, perhaps also their chutzpa – but not their understanding of science or their intelligence. If they were able to think critically, they could only arrive at one conclusion: STUDY DESIGNS THAT ARE WIDE OPEN TO BIAS ARE LIKELY TO DELIVER BIASED RESULTS.

The second study is a mere observation without a control group. The reported outcomes could be due to placebo, expectation, extra attention or social desirability. We obviously need an RCT! But the first study was an RCT!!! Its results are therefore more convincing, aren’t they?

No, not at all. I can repeat my sentence from above: The reported outcomes could be due to placebo, expectation, extra attention or social desirability. And if you don’t believe it, please read what I have posted about the infamous ‘A+B versus B’ trial design (here and here and here and here and here for instance).

My point is that such a study, while looking rigorous to the naïve reader (after all, it’s an RCT!!!), is just as inconclusive when it comes to establishing cause and effect as a simple case series which (almost) everyone knows by now to be utterly useless for that purpose. The fact that the A+B versus B design is nevertheless being used over and over again in alternative medicine for drawing causal conclusions amounts to deceit – and deceit is unethical, as we all know.

My overall conclusion about all this:

QUACKS LOVE THIS STUDY DESIGN BECAUSE IT NEVER FAILS TO PRODUCE FALSE POSITIVE RESULTS.

On 26/5/2015, I received the email reproduced below. I thought it was interesting, looked up its author (“Shawn is a philosopher and writer educated at York University in Toronto, and the author of two books. He’s also worked with Aboriginal youth in the Northwest Territories of Canada”) and decided to respond by writing a blog-post rather than by answering Alli directly.

Hello Dr. Ernst, this is Shawn Alli from Canada, a blogger and philosopher. I recently finished a critical article on James Randi’s legacy. It gets into everything from ideological science, manipulation, ESP, faith healing, acupuncture and homeopathy.

Let me know what you think about it:

http://www.shawnalli.com/james-randi-disingenuous-legacy.html

It’s quite long so save it for a rainy day.

So far, the reply from skeptical organizations range from: “I couldn’t read further than the first few paragraphs because I disagree with the claims…” to one word replies: “Petty.”

It’s always nice to know how open-minded skeptical organizations are.

Hopefully you can add a bit more.

Sincerely,

Shawn

Yes, indeed, I can but try to add a bit more!

However, Alli’s actual article is far too long to analyse it here in full. I therefore selected just the bit that I feel most competent commenting on and which is closest to my heart. Below, I re-produce this section of Alli’s article in full. I add my comments at the end (in bold) by inserting numbered responses which refer to the numbers (in round brackets [the square ones refer to Alli’s references]) inserted throughout Alli’s text. Here we go:

Homeopathy & Acupuncture:

A significant part of Randi’s legacy is his war against homeopathy. This is where Randi shines even above mainstream scientists such as Dawkins or Tyson.

Most of his talks ridicule homeopathy as nonsense that doesn’t deserve the distinction of being called a treatment. This is due to the fact that the current scientific method is unable to account for the results of homeopathy (1). In reality, the current scientific method can’t account for the placebo effect as well (2).

But then again, that presents an internal problem as well. The homeopathic community is divided by those who believe it’s a placebo effect and those that believe it’s more than that, advocating the theory of water memory, which mainstream scientists ridicule and vilify (3).

I don’t know what camp is correct (4), but I do know that the homeopathic community shouldn’t follow the lead of mainstream scientists and downplay the placebo effect as, it’s just a placebo (5).

Remember, the placebo effect is downplayed because the current scientific method is unable to account for the phenomenon (3, 5). It’s a wondrous and real effect, regardless of the ridicule and vilification (6) that’s attached to it.

While homeopathy isn’t suitable as a treatment for severe or acute medical conditions, it’s an acceptable treatment for minor, moderate or chronic ones (7). Personally, I’ve never tried homeopathic treatments. But I would never tell individuals not to consider it. To each their own, as long as it’s within universal ethics (8).

A homeopathic community in Greece attempts to conduct an experiment demonstrating a biological effect using homeopathic medicine and win Randi’s million dollar challenge. George Vithoulkas and his team spend years creating the protocol of the study, only to be told by Randi to redo it from scratch. [29] (9) I recommend readers take a look at:

The facts about an ingenious homeopathic experiment that was not completed due to the “tricks” of Mr. James Randi.

Randi’s war against homeopathy is an ideological one (10). He’ll never change his mind despite positive results in and out of the lab (11). This is the epitome of dogmatic ideological thinking (12).

The same is true for acupuncture (13). In his NECSS 2012 talk Randi says:

Harvard Medical School is now offering an advanced course for physicians in acupuncture, which has been tested endlessly for centuries and it does not work in any way. And believe me, I know what I’m talking about. [30]

Acupuncture is somewhat of a grey area for mainstream scientists and the current scientific method. One ideological theory states that acupuncture operates on principles of non-physical energy in the human body and relieving pressure on specific meridians. The current scientific method is unable to account for non-physical human energy and meridians.

A mainstream scientific theory of acupuncture is one of neurophysiology, whereby acupuncture works by affecting the release of neurotransmitters. I don’t know which theory is correct; but I do know that those who do try acupuncture usually feel better (14).

In regards to the peer-reviewed literature, I believe (15) that there’s a publication bias against acupuncture being seen as a viable treatment for minor, moderate or chronic conditions. A few peer-reviewed articles support the use of acupuncture for various conditions:

Eight sessions of weekly group acupuncture compared with group oral care education provide significantly better relief of symptoms in patients suffering from chronic radiation-induced xerostomia. [31]

It is concluded that this study showed highly positive effects on pain and function through the collaborative treatment of acupuncture and motion style in aLBP [acute lower back pain] patients. [32]

Given the limited efficacy of antidepressant treatment…the present study provides evidence in supporting the viewpoint that acupuncture is an effective and safe alternative treatment for depressive disorders, and could be considered an alternative option especially for patients with MDD [major depressive disorder] and PSD [post-stroke depression], although evidence for its effects in augmenting antidepressant agents remains controversial. [33]

In conclusion: We find that acupuncture significantly relieves hot flashes and sleep disturbances in women treated for breast cancer. The effect was seen in the therapy period and at least 12 weeks after acupuncture treatment ceased. The effect was not correlated with increased levels of plasma estradiol. The current study showed no side effects of acupuncture. These results indicate that acupuncture can be used as an effective treatment of menopausal discomfort. [34]

In conclusion, the present study demonstrates, in rats, that EA [electroacupuncture] significantly attenuates bone cancer induced hyperalgesia, which, at least in part, is mediated by EA suppression of IL-1…expression. [35]

In animal model of focal cerebral ischemia, BBA [Baihui (GV20)-based Scalp acupuncture] could improve IV [infarct volume] and NFS [neurological function score]. Although some factors such as study quality and possible publication bias may undermine the validity of positive findings, BBA may have potential neuroprotective role in experimental stroke. [36]

In conclusion, this randomized sham-controlled study suggests that electroacupuncture at acupoints including Zusanli, Sanyinjiao, Hegu, and Zhigou is more effective than no acupuncture and sham acupuncture in stimulating early return of bowel function and reducing postoperative analgesic requirements after laparoscopic colorectal surgery. Electroacupuncture is also more effective than no acupuncture in reducing the duration of hospital stay. [37]

In conclusion, we found acupuncture to be superior to both no acupuncture control and sham acupuncture for the treatment of chronic pain…Our results from individual patient data meta-analyses of nearly 18000 randomized patients in high-quality RCTs [randomized controlled trials] provide the most robust evidence to date that acupuncture is a reasonable referral option for patients with chronic pain. [38]

While Randi and many other mainstream scientists will argue (16) that the above claims are the result of ideological science and cherry picking, in reality, they’re the result of good science going up against dogmatic (17) and profit-driven (17) ideological (17) science.

Yes, the alternative medicine industry is now a billion dollar industry. But the global pharmaceutical medical industry is worth hundreds of trillions of dollars. And without its patients (who need to be in a constant state of ill health), it can’t survive (18).

Individuals who have minor, moderate, or chronic medical conditions don’t want to be part of the hostile debate between alternative medicine vs. pharmaceutical medical science (19). They just want to get better and move on with their life. The constant war that mainstream scientists wage against alternative medicine is only hurting the people they’re supposed to be helping (20).

Yes, the ideologies (21) are incompatible. Yes, there are no accepted scientific theories for such treatments. Yes, it defies what mainstream scientists currently “know” about the human body (22).

It would be impressive if a peace treaty can exist between both sides, where both don’t agree, but respect each other enough to put aside their pride and help patients to regain their health (23).

END OF ALLI’S TEXT

And here are my numbered comments:

(1) This is not how I understand Randi’s position. Randi makes a powerful point about the fact that the assumptions of homeopathy are not plausible, which is entirely correct – so much so that even some leading homeopaths admit that this is true.

(2) This is definitely not correct; the placebo effect has been studied in much detail, and we can certainly ‘account’ for it.

(3) In my 40 years of researching homeopathy and talking to homeopaths, I have not met any homeopaths who “believe it’s a placebo effect”.

(4) There is no ‘placebo camp’ amongst homeopaths; so this is not a basis for an argument; it’s a fallacy.

(5) They very definitely are mainstream scientists, like F Benedetti, who research the placebo effect and they certainly do not ‘downplay’ it. (What many people fail to understand is that, in placebo-controlled trials, one aims at controlling the placebo effect; to a research-naïve person, this may indeed LOOK LIKE downplaying it. But this impression is wrong and reflects merely a lack of understanding.)

(6) No serious scientist attaches ‘ridicule and vilification’ to it.

(7) Who says so? I know only homeopaths who hold this opinion; and it is not evidence-based.

(8) Ethics demand that patients require the best available treatment; homeopathy does not fall into this category.

(9) At one stage (more than 10 years ago), I was involved in the design of this test. My recollection of it is not in line with the report that is linked here.

(10) So far, we have seen no evidence for this statement.

(11) Which ones? No examples are provided.

(12) Yet another statement without evidence – potentially libellous.

(13) Conclusion before any evidence; sign for a closed mind?

(14) This outcome could be entirely unrelated to acupuncture, as anyone who has a minimum of health care knowledge should know.

(15) We are not concerned with beliefs, we concerned with facts here, aren’t we ?

(16) But did they argue this? Where is the evidence to support this statement?

(17) Non-evidence-based accusations.

(18) Classic fallacy.

(19) The debate is not between alt med and ‘pharmaceutical science’, it is between those who insist on treatments which demonstrably generate more good than harm, and those who want alt med regardless of any such considerations.

(20) Warning consumers of treatments which fail to fulfil the above criterion is, in my view, an ethical duty which can save much money and many lives.

(21) Yes, alt med is clearly ideology-driven; by contrast conventional medicine is not (if it were, Alli would have explained what ideology it is precisely). Conventional medicine changes all the time, sometimes even faster than we can cope with, and is mainly orientated on evidence which is not an ideology. Alt med hardly changes or progresses at all; for the most part, its ideology is that of a cult celebrating anti-science and obsolete traditions.

(22) Overt contradiction to what Alli just stated about acupuncture.

(23) To me, this seems rather nonsensical and a hindrance to progress.

In summary, I feel that Alli argues his corner very poorly. He makes statements without supporting evidence, issues lots of opinion without providing the facts (occasionally even hiding them), falls victim of logical fallacies, and demonstrates an embarrassing lack of knowledge and common sense. Most crucially, the text seems bar of any critical analysis; to me, it seems like a bonanza of unreason.

To save Alli the embarrassment of arguing that I am biased or don’t know what I am talking about, I’d like to declare the following: I am not paid by ‘Big Pharma’ or anyone else, I am not aware of having any other conflicts of interest, I have probably published more research on alt med (some of it with positive conclusions !!!) than anyone else on the planet, my research was funded mostly by organisations/donors who were in favour of alt med, and I have no reason whatsoever to defend Randi (I only met him personally once). My main motivation for responding to Alli’s invitation to comment on his bizarre article is that I have fun exposing ‘alt med nonsense’ and believe it is a task worth doing.

A recent comment to a post of mine (by a well-known and experienced German alt med researcher) made the following bold statement aimed directly at me and at my apparent lack of understanding research methodology:

C´mon , as researcher you should know the difference between efficacy and effectiveness. This is pharmacological basic knowledge. Specific (efficacy) + nonspecific effects = effectiveness. And, in fact, everything can be effective – because of non-specific or placebo-like effects. That does not mean that efficacy is existent.

The point he wanted to make is that outcome studies – studies without a control group where the researcher simply observe the outcome of a particular treatment in a ‘real life’ situation – suffice to demonstrate the effectiveness of therapeutic interventions. This belief is very wide-spread in alternative medicine and tends to mislead all concerned. It is therefore worth re-visiting this issue here in an attempt to create some clarity.

When a patient’s condition improves after receiving a therapy, it is very tempting to feel that this improvement reflects the effectiveness of the intervention (as the researcher mentioned above obviously does). Tempting but wrong: there are many other factors involved as well, for instance:

  • the placebo effect (mainly based on conditioning and expectation),
  • the therapeutic relationship with the clinician (empathy, compassion etc.),
  • the regression towards the mean (outliers tend to return to the mean value),
  • the natural history of the patient’s condition (most conditions get better even without treatment),
  • social desirability (patients tend to say they are better to please their friendly clinician),
  • concomitant treatments (patients often use treatments other than the prescribed one without telling their clinician).

So, how does this fit into the statement above ‘Specific (efficacy) + nonspecific effects = effectiveness’? Even if this formula were correct, it would not mean that outcome studies of the nature described demonstrate the effectiveness of a therapy. It all depends, of course, on what we call ‘non-specific’ effects. We all agree that placebo-effects belong to this category. Probably, most experts also would include the therapeutic relationship and the regression towards the mean under this umbrella. But the last three points from my list are clearly not non-specific effects of the therapy; they are therapy-independent determinants of the clinical outcome.

The most important factor here is usually the natural history of the disease. Some people find it hard to imagine what this term actually means. Here is a little joke which, I hope, will make its meaning clear and memorable.

CONVERATION BETWEEN TWO HOSPITAL DOCTORS:

Doc A: The patient from room 12 is much better today.

Doc B: Yes, we stared his treatment just in time; a day later and he would have been cured without it!

I am sure that most of my readers now understand (and never forget) that clinical improvement cannot be equated with the effectiveness of the treatment administered (they might thus be immune to the misleading messages they are constantly exposed to). Yet, I am not at all sure that all ‘alternativists’ have got it.

Homeopathy has many critics who claim that there is no good evidence for this type of therapy. Homeopaths invariably find this most unfair and point to a plethora of studies that show an effect. They are, of course, correct! There are plenty of trials that suggest that homeopathic remedies do work. The question, however, is HOW RELIABLE ARE THESE STUDIES?

Here is a brand new one which might stand for dozens of others.

In this study, homeopaths treated 50 multimorbid patients with homeopathic remedies identifies by a method called ‘polarity analysis’ (PA) and prospectively followed them over one year (PA enables homeopaths to calculate a relative healing probability, based on Boenninghausen’s grading of polar symptoms).

The 43 patients (86%) who completed the observation period experienced an average improvement of 91% in their initial symptoms. Six patients dropped out, and one did not achieve an improvement of 80%, and was therefore also counted as a treatment failure. The cost of homeopathic treatment was 41% of projected equivalent conventional treatment.

Good news then for enthusiasts of homeopathy? 91% improvement!

Yet, I am afraid that critics might not be bowled over. They might smell a whiff of selection bias, lament the lack of a control group or regret the absence of objective outcome measures. But I was prepared to go as far as stating that such results might be quite interesting… until I read the authors’ conclusions that is:

Polarity Analysis is an effective method for treating multimorbidity. The multitude of symptoms does not prevent the method from achieving good results. Homeopathy may be capable of taking over a considerable proportion of the treatment of multimorbid patients, at lower costs than conventional medicine.

Virtually nothing in these conclusions is based on the data provided. They are pure extrapolation and wild assumptions. Two questions seem to emerge from this:

  1. How on earth can we take this and so many other articles on homeopathy seriously?
  2. When does this sort of article cross the line between wishful thinking and scientific misconduct?

Few subjects lead to such heated debate as the risk of stroke after chiropractic manipulations (if you think this is an exaggeration, look at the comment sections of previous posts on this subject). Almost invariably, one comes to the conclusion that more evidence would be helpful for arriving at firmer conclusions. Before this background, this new publication by researchers (mostly chiropractors) from the US ‘Dartmouth Institute for Health Policy & Clinical Practice’ is noteworthy.

The purpose of this study was to quantify the risk of stroke after chiropractic spinal manipulation, as compared to evaluation by a primary care physician, for Medicare beneficiaries aged 66 to 99 years with neck pain.

The researchers conducted a retrospective cohort analysis of a 100% sample of annualized Medicare claims data on 1 157 475 beneficiaries aged 66 to 99 years with an office visit to either a chiropractor or to a primary care physician for neck pain. They compared hazard of vertebrobasilar stroke and any stroke at 7 and 30 days after office visit using a Cox proportional hazards model. We used direct adjusted survival curves to estimate cumulative probability of stroke up to 30 days for the 2 cohorts.

The findings indicate that the proportion of subjects with a stroke of any type in the chiropractic cohort was 1.2 per 1000 at 7 days and 5.1 per 1000 at 30 days. In the primary care cohort, the proportion of subjects with a stroke of any type was 1.4 per 1000 at 7 days and 2.8 per 1000 at 30 days. In the chiropractic cohort, the adjusted risk of stroke was significantly lower at 7 days as compared to the primary care cohort (hazard ratio, 0.39; 95% confidence interval, 0.33-0.45), but at 30 days, a slight elevation in risk was observed for the chiropractic cohort (hazard ratio, 1.10; 95% confidence interval, 1.01-1.19).

The authors conclude that, among Medicare B beneficiaries aged 66 to 99 years with neck pain, incidence of vertebrobasilar stroke was extremely low. Small differences in risk between patients who saw a chiropractor and those who saw a primary care physician are probably not clinically significant.

I do, of course, applaud any new evidence on this rather ‘hot’ topic – but is it just me, or are the above conclusions a bit odd? Five strokes per 1000 patients is definitely not “extremely low” in my book; and furthermore I do wonder whether all experts would agree that a doubling of risk at 30 days in the chiropractic cohort is “probably not clinically significant” – particularly, if we consider that chiropractic spinal manipulation has so very little proven benefit.

My message to (chiropractic) researchers is simple: PLEASE REMEMBER THAT SCIENCE IS NOT A TOOL FOR CONFIRMING BUT FOR TESTING HYPOTHESES.

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