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

bias

Several previous studies have suggested improvements in sperm quality after vitamin supplementation, and several reviews have drawn tentatively positive conclusions:

Most of the primary trials lacked scientific rigour, however. Now a new study has emerged that overcomes many of the flaws of the previous research.

Professor Anne Steiner from the University of North Carolina at Chapel Hill, USA, presented her study yesterday at the 34th Annual Meeting of ESHRE in Barcelona. This clinical trial of 174 couples has found that an antioxidant formulation taken daily by the male partner for a minimum of three months made no difference to sperm concentration, motility or morphology, nor to the rate of DNA fragmentation. The study was performed in eight American fertility centres.

All men in the study had been diagnosed with male factor infertility, reflected in subnormal levels of sperm concentration, motility, or morphology, or higher than normal rates of DNA fragmentation. These parameters were measured at the start of the trial and at three months. In between, the men allocated to the antioxidant intervention were given a daily supplement containing vitamins C, D3 and E, folic acid, zinc, selenium and L-carnitine; the control group received a placebo.

At three months, results showed only a “slight” overall difference in sperm concentration between the two groups, and no significant differences in morphology, motility, or DNA fragmentation measurements. Sub-group analysis (according to different types of sperm abnormality) found no significant differences in sperm concentration (in oligospermic men), motility (in asthenospermic men), and morphology (in teratospermic men).(1) There was also no change seen after three months in men with high rates of DNA fragmentation (28.9% in the antioxidant group and 28.8 in the placebo group).

Natural conception during the initial three month study period did also not differ between the two groups of the entire cohort – a pregnancy rate of 10.5% in the antioxidant group and 9.1% in the placebo. These rates were also comparable at six months (after continued antioxidant or placebo for the male partner and three cycles of clomiphene and intrauterine insemination for the female partner).

The authors concluded that “the results do not support the empiric use of antioxidant therapy for male factor infertility in couples trying to conceive naturally”.

The story about supplements and health claims seems to be strangely repetitive:

  • the claim that supplements help for condition xy is heavily promoted, e. g. via the Internet;
  • a few flimsy trials seem to support the claim;
  • these results are relentlessly hyped;
  • the profit of the manufacturers grows;
  • eventually a rigorous, independently-funded trial emerges with a negative finding;
  • the card house seems to collapse;
  • the manufacturers claim that the trial’s methodology was faulty (e. g. wrong does, wrong mixture of ingredients);
  • thus another profitable card house is built elsewhere.

In the end, the only supplement-related effects are that 1) the consumers produce expensive urine and 2) the manufacturers have plenty of funds to start a new campaign based on yet another bogus heath claim.

One of the aims in running this blog has always been to stimulate critical thinking (not just in my readers but also in myself).

Critical thinking means making decisions and judgements based on (often confusing) evidence. According to the ‘National Council for Excellence in Critical Thinking’ it is the intellectually disciplined process of actively and skilfully conceptualizing, applying, analysing, synthesizing, and/or evaluating information gathered from, or generated by, observation, experience, reflection, reasoning, or communication, as a guide to belief and action.

Carl Sagan explained it best: “It seems to me what is called for is an exquisite balance between two conflicting needs: the most skeptical scrutiny of all hypotheses that are served up to us and at the same time a great openness to new ideas. Obviously those two modes of thought are in some tension. But if you are able to exercise only one of these modes, whichever one it is, you’re in deep trouble. If you are only skeptical, then no new ideas make it through to you. You never learn anything new. You become a crotchety old person convinced that nonsense is ruling the world. (There is, of course, much data to support you.) But every now and then, maybe once in a hundred cases, a new idea turns out to be on the mark, valid and wonderful. If you are too much in the habit of being skeptical about everything, you are going to miss or resent it, and either way you will be standing in the way of understanding and progress. On the other hand, if you are open to the point of gullibility and have not an ounce of skeptical sense in you, then you cannot distinguish the useful as from the worthless ones.”

Critical thinking is not something one is born with; but I strongly believe that most people can be taught this skill. This study suggests that I may be right. The researchers measured the relationship between student’s religion, gender, and propensity for fantasy thinking with the change in belief for paranormal and pseudoscientific subjects following a science and critical thinking course. Student pre-course endorsement of religious, paranormal, and pseudo-scientific beliefs ranged from 21 to 53%, with religion having the highest endorsement rate. Pre-course belief in paranormal and pseudo-scientific subjects was correlated with high scores in some fantasy thinking scales and showed a gender and a religion effect with females having an 11.1% higher belief across all paranormal and pseudo-science subcategories. Students’ religion, and frequency of religious service attendance, was also important with agnostic or atheist students having lower beliefs in paranormal and pseudo-science subjects compared to religious students. Students with either low religious service attendance or very high attendance had lower paranormal and pseudoscientific beliefs.

Following the critical thinking course, overall beliefs in paranormal and pseudo-scientific subcategories lowered 6.8–28.9%, except for superstition, which did not significantly change. Change in belief had both a gender and religion effect with greater reductions among religious students and females.

The link between religion and alternative medicine is relatively well-established. A 2014 study, for instance, showed an association between alternative medicine use and religiosity. The finding that females have an 11.1% higher belief in the paranormal and pseudo-science is new to me, but it would tie in with the well-documented fact that women use alternative medicine more frequently than men.

The most important finding, however, is clearly that critical thinking can be taught.

That must be good news! As discussed previously, critical thinkers experience fewer bad things in life than those of us who do not have acquired that skill. This cannot come as a surprise – being able to tell useful concepts from worthless ones should achieve exactly that.

Is homeopathy effective for specific conditions? The FACULTY OF HOMEOPATHY (FoH, the professional organisation of UK doctor homeopaths) say YES. In support of this bold statement, they cite a total of 35 systematic reviews of homeopathy with a focus on specific clinical areas. “Nine of these 35 reviews presented conclusions that were positive for homeopathy”, they claim. Here they are:

Allergies and upper respiratory tract infections 8,9
Childhood diarrhoea 10
Post-operative ileus 11
Rheumatic diseases 12
Seasonal allergic rhinitis (hay fever) 13–15
Vertigo 16

And here are the references (I took the liberty of adding my comments in blod):

8. Bornhöft G, Wolf U, Ammon K, et al. Effectiveness, safety and cost-effectiveness of homeopathy in general practice – summarized health technology assessment. Forschende Komplementärmedizin, 2006; 13 Suppl 2: 19–29.

This is the infamous ‘Swiss report‘ which, nowadays, only homeopaths take seriously.

9. Bellavite P, Ortolani R, Pontarollo F, et al. Immunology and homeopathy. 4. Clinical studies – Part 1. Evidence-based Complementary and Alternative Medicine: eCAM, 2006; 3: 293–301.

This is not a systematic review as it lacks any critical assessment of the primary data and includes observational studies and even case series.

10. Jacobs J, Jonas WB, Jimenez-Perez M, Crothers D. Homeopathy for childhood diarrhea: combined results and metaanalysis from three randomized, controlled clinical trials. Pediatric Infectious Disease Journal, 2003; 22: 229–234.

This is a meta-analysis by Jennifer Jacobs (who recently featured on this blog) of 3 studies by Jennifer Jacobs; hardly convincing I’d say.

11. Barnes J, Resch K-L, Ernst E. Homeopathy for postoperative ileus? A meta-analysis. Journal of Clinical Gastroenterology, 1997; 25: 628–633.

This is my own paper! It concluded that “several caveats preclude a definitive judgment.”

12. Jonas WB, Linde K, Ramirez G. Homeopathy and rheumatic disease. Rheumatic Disease Clinics of North America, 2000; 26: 117–123.

This is not a systematic review; here is the (unabridged) abstract:

Despite a growing interest in uncovering the basic mechanisms of arthritis, medical treatment remains symptomatic. Current medical treatments do not consistently halt the long-term progression of these diseases, and surgery may still be needed to restore mechanical function in large joints. Patients with rheumatic syndromes often seek alternative therapies, with homeopathy being one of the most frequent. Homeopathy is one of the most frequently used complementary therapies worldwide.

Proper systematic reviews fail to show that homeopathy is an effective treatment for rheumatic conditions (see for instance here and here).

13. Wiesenauer M, Lüdtke R. A meta-analysis of the homeopathic treatment of pollinosis with Galphimia glauca. Forschende Komplementärmedizin und Klassische Naturheilkunde, 1996; 3: 230–236.

This is a meta-analysis by Wiesenauer of trials conducted by Wiesenauer.

My own, more recent analysis of these data arrived at a considerably less favourable conclusion: “… three of the four currently available placebo-controlled RCTs of homeopathic Galphimia glauca (GG) suggest this therapy is an effective symptomatic treatment for hay fever. There are, however, important caveats. Most essentially, independent replication would be required before GG can be considered for the routine treatment of hay fever. (Focus on Alternative and Complementary Therapies September 2011 16(3))

14. Taylor MA, Reilly D, Llewellyn-Jones RH, et al. Randomised controlled trials of homoeopathy versus placebo in perennial allergic rhinitis with overview of four trial series. British Medical Journal, 2000; 321: 471–476.

This is a meta-analysis by David Reilly of 4 RCTs which were all conducted by David Reilly. This attracted heavy criticism; see here and here, for instance.

15. Bellavite P, Ortolani R, Pontarollo F, et al. Immunology and homeopathy. 4. Clinical studies – Part 2. Evidence-based Complementary and Alternative Medicine: eCAM, 2006; 3: 397–409.

This is not a systematic review as it lacks any critical assessment of the primary data and includes observational studies and even case series.

16. Schneider B, Klein P, Weiser M. Treatment of vertigo with a homeopathic complex remedy compared with usual treatments: a meta-analysis of clinical trials. Arzneimittelforschung, 2005; 55: 23–29.

This is a meta-analysis of 2 (!) RCTs and 2 observational studies of ‘Vertigoheel’, a preparation which is not a homeopathic but a homotoxicologic remedy (it does not follow the ‘like cures like’ assumption of homeopathy) . Moreover, this product contains pharmacologically active substances (and nobody doubts that active substances can have effects).

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So, positive evidence from 9 systematic reviews in 6 specific clinical areas?

I let you answer this question.

Grace Dasilva-Hill has just published an article entitled “Autism/ADHD and Vaccines – are we walking a tightrope whilst blindfolded?“. Who is Grace Dasilva-Hill, you will ask.

She is a professional registered homeopath, based in Charing – East Kent, UK. She has been in practice since 1997. During this time she has developed a busy practice, alongside teaching, running students’ clinics and tutorials. She was a team member of the Ghana Homeopathy Project soon after it started, and later became their treasurer as well. Grace has published in the Journal Homeopathy in Practice, and HPathy. She also is an ‘Energy EFT Master Practitioner Trainer’ and a ‘qualified CEASE therapist’.

And what is the Ghana Homeopathy Project ? It is an organization whose goal is the establishment of homeopathy as a recognised part of the health care system in Africa and Ghana in particular. Their objective is the relief and prevention of disease. They support the development of homeopathic education and wish to make homeopathy available to deprived communities as a valid and affordable form of treatment.

The lengthy article by Grace Dasilva-Hill re-hashes all the bogus arguments about immunisation that you could ever wish for. I will show you only what she calls her ‘conclusions’:

START OF QUOTE

…at the present time we have only just scratched the surface of the issue of autism and ADHD; my aim in this article is to challenge the reader to pause, reflect and ask: do vaccines do more good than harm, or it is actually the other way round? Just who is considered to be responsible for my health and that of my family – my doctor, my country’s government or myself? Do we need to stand up as a profession, and be more pro-active?

The big question seems to be, are we not only failing our patients but also the greater good of the world’s populations, unless we question and do not just ‘accept’ what science and medicine tells us, especially as ‘vested interests’ seem to have such a strong influence on what we are told?
The health journalist Phillip Day has done just that in his book ‘Health Wars’ – he argues how the multinationals have a vested interest in keeping all of us ill, for this is the only way that they can continue making money. His propositions are supported by Goldman Sacks Bank which recently stated that they would not invest in the alternative health industry because it tends to cure people, so there is little profit to be made from it.

I invite you to become an advocate for those who are unable or who are too young to ask questions, or to stand up for themselves, or whose parents don’t have the knowledge or tenacity to challenge.
Children and young adults suffering with autism, ADHD, ASD, deserve our loyalty, support and action.

In the UK, we recently shared the anguish and pain felt by baby Alfie Evans’ parents and family. It is impossible for anyone who is caring to witness such horror, and not to ask any questions. Hopefully we will learn much from this very sad event. There are questions not only about causative factors (ie. the role that vaccinations may have played), but also the issue of parental rights versus the State’s perceived protectionist rights.

What has been happening in the field of healthcare is fast becoming unsustainable. On the other hand Homeopathy has so much to offer, being a sustainable form of medicine not influenced by market forces.

One could argue that one of the reasons why the denialists want to see the demise of homeopathy and other natural modalities, is that more and more people are choosing these modes of healthcare in place of conventional medicine which is reductionist in approach and only has drugs to offer.

I find myself wondering whether there is a need for something radically different to happen. As a profession, do we need to do something collectively? Do we need to stand up more, do we need to speak up more? How do we go about doing this? I know that I am asking more questions than providing answers, and this is because at the moment I don’t have the answers either. But I have a deep and sincere desire to do my best to make a difference that will be both worthwhile and sustainable.
I would like to believe that others in our community would like to do the same for the bigger benefit of sustainable and effective healthcare for all.

Footnote: I have just carried out an impromptu, unrepresentative survey of homeopathic colleagues on a homeopathic professional group. I asked them if they knew of any health care professionals (doctors, nurses, midwives) who did not vaccinate their children. Most of those who replied, surprisingly said that they do know of at least one doctor, or nurse or midwife who did not vaccinate their children, and they added that these professionals keep this quiet. I certainly know of two medical doctors who do not vaccinate their children, and again they do not talk about it. It was shared with me in confidence.

END OF QUOTE

Of course, these words are not really ‘conclusions’, they are just a continuation of a barmy rant.

And yes, such articles exist in abundance. Many homeopaths are active campaigners against vaccination.

The Society of Homeopaths (SoH), the professional UK organisation for lay homeopaths, has recently stated that it is unethical for a homeopath to advise a patient against the use of conventional vaccines…  This could not be clearer! Yet, I suspect that the homeopaths put out such statements mainly to cover their backs and subsequently they do what they feel like – and they rarely feel like supporting vaccinations.

They obviously try to give the impression that lay homeopaths are not antivaxers. I fear, however, this impression is wrong: as we have discussed repeatedly on this blog, many homeopaths do advise their patients against immunisation. And many claim that homeopathic immunisations are an effective alternative. It takes not long to find even VIP-members of the SoH putting parents off from immunising their kids. And thanks to the Ghana Homeopathy and several similar projects, this is happening not just in the UK but also in Africa and elsewhere.

Is that not irresponsible?

In my view, it is!

Is that not illegal?

Apparently not, because such homeopaths usually add a clever disclaimer; Grace Dasilva-Hill for instance states that  Any information obtained here is not to be construed as medical OR legal advice. The decision to vaccinate and how you implement that decision is yours and yours alone. 

The HRI is an innovative international charity created to address the need for high quality scientific research in homeopathy… HRI is dedicated to promoting cutting research in homeopathy, using the most rigorous methods available, and communicating the results of such work beyond the usual academic circles… HRI aims to bring academically reliable information to a wide international audience, in an easy to understand form. This audience includes the general public, scientists, healthcare providers, healthcare policy makers, government and the media.

This sounds absolutely brilliant!

I should be a member of the HRI!

For years, I have pursued similar aims!

Hold on, perhaps not?

This article makes me wonder:

START OF QUOTE

… By the end of 2014, 189 randomised controlled trials of homeopathy on 100 different medical conditions had been published in peer-reviewed journals. Of these, 104 papers were placebo-controlled and were eligible for detailed review:
41% were positive (43 trials) – finding that homeopathy was effective
5% were negative (5 trials) – finding that homeopathy was ineffective
54% were inconclusive (56 trials)

How does this compare with evidence for conventional medicine?

An analysis of 1016 systematic reviews of RCTs of conventional medicine had strikingly similar findings2:
44% were positive – the treatments were likely to be beneficial
7% were negative – the treatments were likely to be harmful
49% were inconclusive – the evidence did not support either benefit or harm.

END OF QUOTE

The implication here is that the evidence base for homeopathy is strikingly similar to that of real medicine.

Nice try! But sadly it has nothing to do with ‘reliable information’!!!

In fact, it is grossly (and I suspect deliberately) misleading.

Regular readers of this blog will have spotted the reason, because we discussed (part of) it before. Let me remind you:

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A clinical trial is a research tool for testing hypotheses; strictly speaking, it tests the ‘null-hypothesis’: “the experimental treatment generates the same outcomes as the treatment of the control group”. If the trial shows no difference between the outcomes of the two groups, the null-hypothesis is confirmed. In this case, we commonly speak of a negative result. If the experimental treatment was better than the control treatment, the null-hypothesis is rejected, and we commonly speak of a positive result. In other words, clinical trials can only generate positive or negative results, because the null-hypothesis must either be confirmed or rejected – there are no grey tones between the black of a negative and the white of a positive study.

For enthusiasts of alternative medicine, this can create a dilemma, particularly if there are lots of published studies with negative results. In this case, the totality of the available trial evidence is negative which means the treatment in question cannot be characterised as effective. It goes without saying that such an overall conclusion rubs the proponents of that therapy the wrong way. Consequently, they might look for ways to avoid this scenario.

One fairly obvious way of achieving this aim is to simply re-categorise the results. What, if we invented a new category? What, if we called some of the negative studies by a different name? What about INCONCLUSIVE?

That would be brilliant, wouldn’t it. We might end up with a simple statistic where the majority of the evidence is, after all, positive. And this, of course, would give the impression that the ineffective treatment in question is effective!

How exactly do we do this? We continue to call positive studies POSITIVE; we then call studies where the experimental treatment generated worst results than the control treatment (usually a placebo) NEGATIVE; and finally we call those studies where the experimental treatment created outcomes which were not different from placebo INCONCLUSIVE.

In the realm of alternative medicine, this ‘non-conclusive result’ method has recently become incredibly popular . Take homeopathy, for instance. The Faculty of Homeopathy proudly claim the following about clinical trials of homeopathy: Up to the end of 2011, there have been 164 peer-reviewed papers reporting randomised controlled trials (RCTs) in homeopathy. This represents research in 89 different medical conditions. Of those 164 RCT papers, 71 (43%) were positive, 9 (6%) negative and 80 (49%) non-conclusive.

This misleading nonsense was, of course, warmly received by homeopaths. The British Homeopathic Association, like many other organisations and individuals with an axe to grind lapped up the message and promptly repeated it: The body of evidence that exists shows that much more investigation is required – 43% of all the randomised controlled trials carried out have been positive, 6% negative and 49% inconclusive.

Let’s be clear what has happened here: the true percentage figures seem to show that 43% of studies (mostly of poor quality) suggest a positive result for homeopathy, while 57% of them (on average the ones of better quality) were negative. In other words, the majority of this evidence is negative. If we conducted a proper systematic review of this body of evidence, we would, of course, have to account for the quality of each study, and in this case we would have to conclude that homeopathy is not supported by sound evidence of effectiveness.

The little trick of applying the ‘INCONCLUSIVE’ method has thus turned this overall result upside down: black has become white! No wonder that it is so popular with proponents of all sorts of bogus treatments.

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But one trick is not enough for the HRI! For thoroughly misinforming the public they have a second one up their sleeve.

And that is ‘comparing apples with pears’  – RCTs with systematic reviews, in their case.

In contrast to RCTs, systematic reviews can be (and often are) INCONCLUSIVE. As they evaluate the totality of all RCTs on a given subject, it is possible that some RCTs are positive, while others are negative. When, for example, the number of high-quality, positive studies included in a systematic review is similar to the number of high-quality, negative trials, the overall result of that review would be INCONCLUSIVE. And this is one of the reasons why the findings of systematic reviews cannot be compared in this way to those of RCTs.

I suspect that the people at the HRI know all this. They are not daft! In fact, they are quite clever. But unfortunately, they seem to employ their cleverness not for informing but for misleading their ‘wide international audience’.

Personally, I find our good friend Dana Ullman truly priceless. There are several reasons for that; one is that he is often so exemplarily wrong that it helps me to explain fundamental things more clearly. With a bit of luck, this might enable me to better inform people who might be thinking a bit like Dana. In this sense, our good friend Dana has significant educational value.

Recently, he made this comment:

According to present and former editors of THE LANCET and the NEW ENGLAND JOURNAL OF MEDICINE, “evidence based medicine” can no longer be trusted. There is obviously no irony in Ernst and his ilk “banking” on “evidence” that has no firm footing except their personal belief systems: https://medium.com/@drjasonfung/the-corruption-of-evidence-based-medicine-killing-for-profit-41f2812b8704

Ernst is a fundamentalist whose God is reductionistic science, a 20th century model that has little real meaning today…but this won’t stop the new attacks on me personally…

END OF COMMENT

Where to begin?

Let’s start with some definitions.

  • Evidence is the body of facts that leads to a given conclusion. Because the outcomes of treatments such as homeopathy depend on a multitude of factors, the evidence for or against their effectiveness is best based not on experience but on clinical trials and systematic reviews of clinical trials (this is copied from my book).
  • EBM is the integration of best research evidence with clinical expertise and patient values. It thus rests on three pillars: external evidence, ideally from systematic reviews, the clinician’s experience, and the patient’s preferences (and this is from another book).

Few people would argue that EBM, as it is applied currently, is without fault. Certainly I would not suggest that; I even used to give lectures about the limitations of EBM, and many experts (who are much wiser than I) have written about the many problems with EBM. It is important to note that such criticism demonstrates the strength of modern medicine and not its weakness, as Dana seems to think: it is a sign of a healthy debate aimed at generating progress. And it is noteworthy that internal criticism of this nature is largely absent in alternative medicine.

The criticism of EBM is often focussed on the unreliability of the what I called above the ‘best research evidence’. Let me therefore repeat what I wrote about it on this blog in 2012:

… The multifactorial nature of any clinical response requires controlling for all the factors that might determine the outcome other than the treatment per se. Ideally, we would need to create a situation or an experiment where two groups of patients are exposed to the full range of factors, and the only difference is that one group does receive the treatment, while the other one does not. And this is precisely the model of a controlled clinical trial.

Such studies are designed to minimise all possible sources of bias and confounding. By definition, they have a control group which means that we can, at the end of the treatment period, compare the effects of the treatment in question with those of another intervention, a placebo or no treatment at all.

Many different variations of the controlled trial exist so that the exact design can be adapted to the requirements of the particular treatment and the specific research question at hand. The over-riding principle is, however, always the same: we want to make sure that we can reliably determine whether or not the treatment was the cause of the clinical outcome.

Causality is the key in all of this; and here lies the crucial difference between clinical experience and scientific evidence. What clinician witness in their routine practice can have a myriad of causes; what scientists observe in a well-designed efficacy trial is, in all likelihood, caused by the treatment. The latter is evidence, while the former is not.

Don’t get me wrong; clinical trials are not perfect. They can have many flaws and have rightly been criticised for a myriad of inherent limitations. But it is important to realise that, despite all their short-comings, they are far superior than any other method for determining the efficacy of medical interventions.

There are lots of reasons why a trial can generate an incorrect, i.e. a false positive or a false negative result. We therefore should avoid relying on the findings of a single study. Independent replications are usually required before we can be reasonably sure.

Unfortunately, the findings of these replications do not always confirm the results of the previous study. Whenever we are faced with conflicting results, it is tempting to cherry-pick those studies which seem to confirm our prior belief – tempting but very wrong. In order to arrive at the most reliable conclusion about the efficacy of any treatment, we need to consider the totality of the reliable evidence. This goal is best achieved by conducting a systematic review.

In a systematic review, we assess the quality and quantity of the available evidence, try to synthesise the findings and arrive at an overall verdict about the efficacy of the treatment in question. Technically speaking, this process minimises selection and random biases. Systematic reviews and meta-analyses [these are systematic reviews that pool the data of individual studies] therefore constitute, according to a consensus of most experts, the best available evidence for or against the efficacy of any treatment.

END OF QUOTE

Other criticism is aimed at the way EBM is currently used (and abused). This criticism is often justified and necessary, and it is again the expression of our efforts to generate progress. EBM is practised by humans; and humans are far from perfect. They can be corrupt, misguided, dishonest, sloppy, negligent, stupid, etc., etc. Sadly, that means that the practice of EBM can have all of these qualities as well. All we can do is to keep on criticising malpractice, educate people, and hope that this might prevent the worst abuses in future.

Dana and many of his fellow SCAMers have a different strategy; they claim that EBM “can no longer be trusted” (interestingly they never tell us what system might be better; eminence-based medicine? experience-based medicine? random-based medicine? Dana-based medicine?).

The claim that EBM can no longer be trusted is clearly not true, counter-productive and unethical; and I suspect they know it.

Why then do they make it?

Because they feel that it entitles them to argue that homeopathy (or any other form of SCAM) cannot be held to EBM-standards. If EBM is unreliable, surely, nobody can ask the ‘Danas of this world’ to provide anything like sound data!!! And that, of course, would be just dandy for business, wouldn’t it?

So, let’s not be deterred  or misled by these deliberately destructive people. Their motives are transparent and their arguments are nonsensical. EBM is not flawless, but with our continued efforts it will improve. Or, to repeat something that I have said many times before: EBM is the worst form of healthcare, except for all other known options.

“This utter hokum is symptomatic of the crass stupidity of the vacuous classes before the lumpen mob rebelled and chopped off their useless heads. Where, oh where, is our mob?”

No, I am not calling for a British re-run of the French revolution. This is a comment that made me chuckle. I found it under an article in the SUNDAY TIMES. As it is about acupuncture, I thought I mention it here and show you a few experts:

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… Prince Harry and Meghan Markle had regular appointments with an acupuncturist in the lead-up to their wedding. They were treated by Ross Barr, acupuncturist to the stars, who has been described as “divertingly handsome” by many of his enthusiastic fans and whose treatments have been lauded as “better than Botox”. Beauty experts say his appointments “go faster than Glastonbury tickets”.

Barr, whose treatments deal with anything from infertility to hair loss and relationship problems, is understood to have been regularly treating the couple since Meghan moved to London last year. The treatments are said to have been so successful that Barr and his wife, the actress Eva Birthistle, were invited to the wedding alongside celebrities including Oprah Winfrey, who had acupuncture live on her television show…

Harry, 33, has spoken of his struggles with anxiety and depression after the death of his mother, Diana, Princess of Wales in 1997. In an interview with The Sunday Times in 2016 he also admitted “my body . . . has basically been ruined over the last 10 years of army service”. His father, the Prince of Wales, is renowned for championing alternative and complementary therapies such as homeopathy and acupuncture…

It is thought Harry was keen to try acupuncture as part of a recent health drive to prepare for his wedding. He is reported to have reduced his alcohol consumption and is now regularly seen exercising at the exclusive KX gym in Chelsea, west London. Meghan, 36, is likely to be a fan of Barr’s “anti-wrinkle acupressure facial”, which aims to smooth fine lines and may have contributed to the American former actress’s radiant complexion on her wedding day…

Both Kensington Palace and Barr declined to comment yesterday.

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Well, let me offer a few comments then:

  1. The article is recklessly promotional and, in my view, very poor journalism.
  2. It does not even include the usual attempt at ‘balance’ where an expert warns at the end of the article that acupuncture is unscientific rubbish.
  3. There is no good evidence that acupuncture works for any of the conditions mentioned in the article.
  4. Critical thinking, journalistic ethics, or objective analysis do not seem to be the forte of the author of this regrettable drivel.

Yes, I know … this is not very important. It is merely a little innocent story about some VIPs for gullible consumers.

Innocent?

Perhaps!

But misleading the public about healthcare can also be seen as short-sighted, counter-productive, unethical, and stupid.

My previous post praised the validity and trustworthiness of Cochrane reviews. This post continues in the same line.

Like osteoarthritis, acute stroke has been a condition for which acupuncture-fans prided themselves of being able to produce fairly good evidence. A Cochrane review of 2005, however, was inconclusive and concluded that the number of patients is too small to be certain whether acupuncture is effective for treatment of acute ischaemic or haemorrhagic stroke. Larger, methodologically-sound trials are required.

So, 13 years later, we do have more evidence, and it would be interesting to know what the best evidence tells us today. This new review will tell us because it is the update of the previous Cochrane Review originally published in 2005.

The authors sought randomized clinical trials (RCTs) of acupuncture started within 30 days from stroke onset compared with placebo or sham acupuncture or open control (no placebo) in people with acute ischemic or haemorrhagic stroke, or both. Needling into the skin was required for acupuncture. Comparisons were made versus (1) all controls (open control or sham acupuncture), and (2) sham acupuncture controls.

Two review authors applied the inclusion criteria, assessed trial quality and risk of bias, and extracted data independently. They contacted study authors to ask for missing data and assessed the quality of the evidence by using the GRADE approach. The primary outcome was defined as death or dependency at the end of follow-up.

In total, 33 RCTs with 3946 participants were included. Twenty new trials with 2780 participants had been completed since the previous review. Outcome data were available for up to 22 trials (2865 participants) that compared acupuncture with any control (open control or sham acupuncture) but for only six trials (668 participants) that compared acupuncture with sham acupuncture control. The authors downgraded the evidence to low or very low quality because of risk of bias in included studies, inconsistency in the acupuncture intervention and outcome measures, and imprecision in effect estimates.

When compared with any control (11 trials with 1582 participants), findings of lower odds of death or dependency at the end of follow-up and over the long term (≥ three months) in the acupuncture group were uncertain (odds ratio [OR] 0.61, 95% confidence interval [CI] 0.46 to 0.79; very low-quality evidence; and OR 0.67, 95% CI 0.53 to 0.85; eight trials with 1436 participants; very low-quality evidence, respectively) and were not confirmed by trials comparing acupuncture with sham acupuncture (OR 0.71, 95% CI 0.43 to 1.18; low-quality evidence; and OR 0.67, 95% CI 0.40 to 1.12; low-quality evidence, respectively).In trials comparing acupuncture with any control, findings that acupuncture was associated with increases in the global neurological deficit score and in the motor function score were uncertain (standardized mean difference [SMD] 0.84, 95% CI 0.36 to 1.32; 12 trials with 1086 participants; very low-quality evidence; and SMD 1.08, 95% CI 0.45 to 1.71; 11 trials with 895 participants; very low-quality evidence).

These findings were not confirmed in trials comparing acupuncture with sham acupuncture (SMD 0.01, 95% CI -0.55 to 0.57; low-quality evidence; and SMD 0.10, 95% CI -0.38 to 0.17; low-quality evidence, respectively).Trials comparing acupuncture with any control reported little or no difference in death or institutional care at the end of follow-up (OR 0.78, 95% CI 0.54 to 1.12; five trials with 1120 participants; low-quality evidence), death within the first two weeks (OR 0.91, 95% CI 0.33 to 2.55; 18 trials with 1612 participants; low-quality evidence), or death at the end of follow-up (OR 1.08, 95% CI 0.74 to 1.58; 22 trials with 2865 participants; low-quality evidence).

The incidence of adverse events (eg, pain, dizziness, fainting) in the acupuncture arms of open and sham control trials was 6.2% (64/1037 participants), and 1.4% of these (14/1037 participants) discontinued acupuncture. When acupuncture was compared with sham acupuncture, findings for adverse events were uncertain (OR 0.58, 95% CI 0.29 to 1.16; five trials with 576 participants; low-quality evidence).

The authors concluded that this updated review indicates that apparently improved outcomes with acupuncture in acute stroke are confounded by the risk of bias related to use of open controls. Adverse events related to acupuncture were reported to be minor and usually did not result in stopping treatment. Future studies are needed to confirm or refute any effects of acupuncture in acute stroke. Trials should clearly report the method of randomization, concealment of allocation, and whether blinding of participants, personnel, and outcome assessors was achieved, while paying close attention to the effects of acupuncture on long-term functional outcomes.

These cautious conclusions might be explained by the fact that Chinese researchers are reluctant to state anything overtly negative about any TCM therapy. Recently, one expert who spoke out was even imprisoned for criticising a TCM product! But in truth, this review really shows that acupuncture has no convincing effect in acute stroke.

And for me, this conclusion is fascinating. I have been involved in acupuncture/stroke research since the early 1990s.

Our RCT produced a resounding negative result concluding that acupuncture is not superior to sham treatment for recovery in activities of daily living and health-related quality of life after stroke, although there may be a limited effect on leg function in more severely affected patients.

Our 1996 systematic review concluded that the evidence that acupuncture is a useful adjunct for stroke rehabilitation is encouraging but not compelling.

By 2001, more data had become available but the conclusion became even less encouraging: there is no compelling evidence to show that acupuncture is effective in stroke rehabilitation.

Finally, by 2010, there were 10 RCT and we were able to do a meta-analysis of the data. We concluded that our meta-analyses of data from rigorous randomized sham-controlled trials did not show a positive effect of acupuncture as a treatment for functional recovery after stroke.

Yes, my reviews were on slightly different research questions. Yet, they do reveal how a critical assessment of the slowly emerging evidence had to arrive at more and more negative conclusions about the role of acupuncture in the management of stroke patients. For a long time, this message was in stark contrast to what acupuncture-fans were claiming. I wonder whether they will now finally change their mind.

I have said it often, and I say it again: I do like well-conducted systematic reviews; and Cochrane reviews are usually the best, i. e. most transparent, most thorough and least biased. Thus, I was pleased to see a new Cochrane review of acupuncture aimed at assessing the benefits and harms of acupuncture in patients with hip OA.

The authors included randomized controlled trials (RCTs) that compared acupuncture with sham acupuncture, another active treatment, or no specific treatment; and RCTs that evaluated acupuncture as an addition to another treatment. Major outcomes were pain and function at the short term (i.e. < 3 months after randomization) and adverse events.

Six RCTs with 413 participants were included. Four RCTs included only people with OA of the hip, and two included a mix of people with OA of the hip and knee. All RCTs included primarily older participants, with a mean age range from 61 to 67 years, and a mean duration of hip OA pain from two to eight years. Approximately two-thirds of participants were women. Two RCTs compared acupuncture versus sham acupuncture; the other four RCTs were not blinded. All results were evaluated at short-term (i.e. four to nine weeks after randomization).In the two RCTs that compared acupuncture to sham acupuncture, the sham acupuncture control interventions were judged believable, but each sham acupuncture intervention was also judged to have a risk of weak acupuncture-specific effects, due to placement of non-penetrating needles at the correct acupuncture points in one RCT, and the use of penetrating needles not inserted at the correct points in the other RCT. For these two sham-controlled RCTs, the risk of bias was low for all outcomes.

The combined analysis of two sham-controlled RCTs gave moderate quality evidence of little or no effect in reduction in pain for acupuncture relative to sham acupuncture. Due to the small sample sizes in the studies, the confidence interval includes both the possibility of moderate benefit and the possibility of no effect of acupuncture (120 participants; Standardized Mean Difference (SMD) -0.13, (95% Confidence Interval (CI) -0.49 to 0.22); 2.1 points greater improvement with acupuncture compared to sham acupuncture on 100 point scale (i.e., absolute percent change -2.1% (95% CI -7.9% to 3.6%)); relative percent change -4.1% (95% CI -15.6% to 7.0%)). Estimates of effect were similar for function (120 participants; SMD -0.15, (95% CI -0.51 to 0.21)). No pooled estimate, representative of the two sham-controlled RCTs, could be calculated or reported for the quality of life outcome.

The four other RCTs were unblinded comparative effectiveness RCTs, which compared (additional) acupuncture to four different active control treatments. There was low quality evidence that addition of acupuncture to the routine primary care that RCT participants were receiving from their physicians was associated with statistically significant and clinically relevant benefits, compared to the routine primary physician care alone, in pain (1 RCT; 137 participants; mean percent difference -22.9% (95% CI -29.2% to -16.6%); relative percent difference -46.5% (95% CI -59.3% to -33.7%)) and function (mean percent difference -19.0% (95% CI -24.41 to -13.59); relative percent difference -38.6% (95% CI -49.6% to -27.6%)). There was no statistically significant difference for mental quality of life and acupuncture showed a small, significant benefit for physical quality of life.

The effects of acupuncture compared with either advice plus exercise or NSAIDs are uncertain. The authors are also uncertain whether acupuncture plus patient education improves pain, function, and quality of life, when compared to patient education alone.

In general, the overall quality of the evidence for the four comparative effectiveness RCTs was low to very low, mainly due to the potential for biased reporting of patient-assessed outcomes due to lack of blinding and sparse data.

Information on safety was reported in 4 RCTs. Two RCTs reported minor side effects of acupuncture, which were primarily minor bruising, bleeding, or pain at needle insertion sites.

The authors concluded that acupuncture probably has little or no effect in reducing pain or improving function relative to sham acupuncture in people with hip osteoarthritis. Due to the small sample size in the studies, the confidence intervals include both the possibility of moderate benefits and the possibility of no effect of acupuncture. One unblinded trial found that acupuncture as an addition to routine primary physician care was associated with benefits on pain and function. However, these reported benefits are likely due at least partially to RCT participants’ greater expectations of benefit from acupuncture. Possible side effects associated with acupuncture treatment were minor.

This is an excellent review of data that (because of contradictions, methodological limitations, heterogeneity etc.) are not easy to evaluate fairly. The review shows that previous verdicts about acupuncture for osteoarthritis might have been too optimistic. Acupuncture has no or only very small specific therapeutic effects. As we have much better therapeutic options for this condition, it means that acupuncture can no longer be recommended as an effective therapy.

That surely must be big news in the little world of acupuncture!

I have been personally involved in several similar reviews:

In 1997, I concluded that the most rigorous studies suggest that acupuncture is not superior to sham-needling in reducing pain of osteoarthritis: both alleviate symptoms to roughly the same degree.

In 2006, the balance of evidence seemed to have shifted and more positive data had emerged; consequently our review concluded that sham-controlled RCTs suggest specific effects of acupuncture for pain control in patients with peripheral joint OA. Considering its favourable safety profile acupuncture seems an option worthy of consideration particularly for knee OA. Further studies are required particularly for manual or electro-acupuncture in hip OA.

Now, it seems that my initial conclusion of 1996 was more realistic. To me this is a fascinating highlight on the fact that in EBM, we change our minds based on the current best evidence. By contrast, in alternative medicine, as we have often lamented on this blog, minds do not easily change and all too often dogma seems to reign.

The new Cochrane review is important in several ways. Firstly, it affirms an appropriately high standard for such reviews. Secondly, it originates from a research team that has, in the past, been outspokenly pro-acupuncture; it is therefore unlikely that the largely negative findings were due to an anti-acupuncture bias. Thirdly – and most importantly – osteoarthritis has been THE condition for which even critical reviewers had to admit that there was at least some good, positive evidence.

It seems therefore, that yet again a beautiful theory has been slain by an ugly fact.

Remember when an international delegation of homeopaths travelled to Liberia to cure Ebola?

Virologists and other experts thought at the time that this was pure madness. But, from the perspective of dedicated homeopaths who have gone through ‘proper’ homeopathic ‘education’ and have the misfortune to believe all the nonsense they have been told, this is not madness. In fact, the early boom of homeopathy, about 200 years ago, was based not least on the seemingly resounding success homeopaths had during various epidemics.

I fully understand that homeopath adore this type of evidence – it is good for their ego! And therefore, they tend to dwell on it and re-hash it time and again. The most recent evidence for this is a brand-new article entitled ‘Homeopathic Prevention and Management of Epidemic Diseases’. It is such a beauty that I present you the original abstract without change:

START OF QUOTE

___________________________________________________________________________

Homeopathy has been used to treat epidemic diseases since the time of Hahnemann, who used Belladonna to treat scarlet fever. Since then, several approaches using homeopathy for epidemic diseases have been proposed, including individualization, combination remedies, genus epidemicus, and isopathy.

METHODS:

The homeopathic research literature was searched to find examples of each of these approaches and to evaluate which were effective.

RESULTS:

There is good experimental evidence for each of these approaches. While individualization is the gold standard, it is impractical to use on a widespread basis. Combination remedies can be effective but must be based on the symptoms of a given epidemic in a specific location. Treatment with genus epidemicus can also be successful if based on data from many practitioners. Finally, isopathy shows promise and might be more readily accepted by mainstream medicine due to its similarity to vaccination.

CONCLUSION:

Several different homeopathic methods can be used to treat epidemic diseases. The challenge for the future is to refine these approaches and to build on the knowledge base with additional rigorous trials. If and when conventional medicine runs out of options for treating epidemic diseases, homeopathy could be seen as an attractive alternative, but only if there is viable experimental evidence of its success.

END OF QUOTE

____________________________________________________________________________________

I don’t need to stress, I think, that such articles are highly irresponsible and frightfully dangerous: if anyone ever took the message that homeopathy has the answer to epidemic seriously, millions might die.

The reasons why epidemiological evidence of this nature is wrong has been discussed before on this blog; I therefore only need to repeat them:

In the typical epidemiological case/control study, one large group of patients [A] is retrospectively compared to another group [B]. In our case, group A has been treated homeopathically, while group B received the treatments available at the time. It is true that several of such reports seemed to suggest that homeopathy works. But this does by no means prove anything; the result might have been due to a range of circumstances, for instance:

  • group A might have been less ill than group B,
  • group A might have been richer and therefore better nourished,
  • group A might have benefitted from better hygiene in the homeopathic hospital,
  • group A might have received better care, e. g. hydration,
  • group B might have received treatments that made the situation not better but worse.

Because these are RETROSPECTIVE studies, there is no way to account for these and many other factors that might have influenced the outcome. This means that epidemiological studies of this nature can generate interesting results which, in turn, need testing in properly controlled studies where these confounding factors are adequately controlled for. Without such tests, they are next to worthless for recommendations regarding clinical practice.

In essence, this means that epidemiological evidence of this type can be valuable for generating hypotheses which, in turn, need testing in rigorous clinical trials. Without these tests, the evidence can be dangerously misleading.

But, of course, Jennifer Jacobs, the author of the new article, knows all this – after all, she has been employed for many years by the Department of Epidemiology, School of Public Health and Community Medicine, University of Washington, Seattle, Washington, United States!

In this case, why does she re-hash the old myth of homeopathy being the answer to epidemics?

I do not know the answer to this question, but I do know that she is a convinced homeopath with plenty of papers on the subject.

And what sort of journal would publish such dangerous, deeply unethical rubbish?

It is a journal we have discussed several before; its called HOMEOPATHY.

This journal is, I think, remarkable: not even homeopaths would deny that homeopathy is a most controversial subject. One would therefore expect that the editorial board of the leading journal of homeopathy (Impact Factor = 1.16) has a few members who are critical of homeopathy and its assumptions. Yet, I fail to spot a single such person of the board of HOMEOPATHY. Please have a look yourself and tell me, if you can identify such an individual:

Editor

Peter Fisher
FRCP, FFHom, London, UK

Senior Deputy Editor

Robert T. Mathie
BSc (Hons), PhD, London, UK

Deputy Editors

Leoni Bonamin
Paulista University, São Paulo, Brazil

Menachem Oberbaum
Shaare Zedek Medical Center, Jerusalem, Israel

Ethics Adviser

Kate Chatfield
University of Central Lancashire, Preston, UK

Editorial Advisory Board

Cees Baas
Centre for Integrative Psychiatry, Groningen, The Netherlands

Stephan Baumgartner
University of Witten-Herdecke, Germany

Iris R. Bell
University of Arizona, USA

Jayesh Bellare
Indian Institute of Technology, Mumbai, India

Philippe Belon
Centre de Recherche et de Documentation Thérapeutique, France

Brian Berman
University of Maryland, School of Medicine, USA

Martien Brands
Centre for Integrative Care, Amsterdam, The Netherlands

Michael Carlston
University of California, Santa Rosa, USA

Kusum S. Chand
Pushpanjali Crosslay Hospital, Ghaziabad, India

Martin Chaplin
London South Bank University, UK

Flávio Dantas
University of Uberlândia, Brazil

Peter Darby
Faculty of Homeopathy, UK

Jonathan Davidson
Duke University, USA

Jean-Louis Demangeat
Haguenau Hospital, France

Christian Endler
Interuniversity College Graz/Castle of Seggau, Austria

Madeleine Ennis
Queen’s University Belfast, UK

Edoardo Felisi
Milan, Italy

Peter Gregory
Veterinary Dean, Faculty of Homeopathy, UK

German Guajardo-Bernal
University of Baja California, Mexico

Carla Holandino Quaresma
Universidade Federal do Rio de Janeiro, Brazil

Jennifer Jacobs
University of Washington, USA

Wayne Jonas
Samueli Institute, Alexandria, USA

Lee Kayne
Faculty of Homeopathy, UK

Steven Kayne
Glasgow Homoeopathic Hospital, UK

David Lilley
Pretoria, South Africa

Klaus Linde
Technical University, Munich, Germany

Russell Malcolm
Faculty of Homeopathy, UK

Raj K. Manchanda
Central Council for Research in Homoeopathy, New Delhi, India

David Peters
University of Westminster, London, UK

Bernard Poitevin
Association Française pour la Recherche en Homéopathie, France

David Reilly
Glasgow Homoeopathic Hospital, UK

David Riley
Integrative Medicine Institute, Portland, USA

ALB Rutten
Breda, The Netherlands

Jürgen Schulte
University of Technology, Sydney, Australia

Trevor Thompson
University of Bristol, UK

André Thurneysen
Centre de médecines intégrées, Switzerland

Alexander Tournier
Homeopathy Research Institute, UK

Francis Treuherz
London, UK

Robbert van Haselen
International Institute for Integrated Medicine, Kingston, UK

Michel Van Wassenhoven
Unio Homeopathica Belgica, Belgium

Harald Walach
University of Witten-Herdecke, Germany

Fred Wiegant
University of Utrecht, The Netherlands

___________________________________________________________________________

I rest my case.

 

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