MD, PhD, FMedSci, FSB, FRCP, FRCPEd

evidence

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WHAT IS THE WORST THAT COULD HAPPEN TO HOMEOPATHS?

This might seem like a strange question, but I think it is quite interesting… bear with me.

The worse, you might think, is that the we all agree that highly diluted homeopathic remedies are pure placebos. Apart from the fact that this already is a broad consensus shared by virtually everyone in healthcare (except the homeopaths, of course), I think this is not the worst that could happen to homeopaths. They simply ignore the consensus, continue much as before and carry on earning a living by fooling the public (and often themselves as well).

No, the worse is the opposite of the above. The worse is that we all accept the homeopaths’ view. The worse is to say: Very well, we agree for the moment that your remedies are highly effective. And therefore we need to regulate them just as any other medicine.

In our yesterday’s response to the German homeopaths’ statement affirming the effectiveness of homeopathy, we tried to express exactly that. Here is the passage I am referring to:

Wenn dies für Homöopathen also so eindeutig ist, dann können die zuständigen Institutionen in den Arzneimittel-Gesellschaften (BfArM, AMG) Homöopathika genau so bewerten wie normale Medikamente…  die Politik sollte die Homöopathen bei ihrem eigenen Wort nehmen und sie denselben Prüfverfahren unterwerfen wie alle anderen Behandlungsverfahren auch.

And this is my (somewhat liberal) translation:

If homeopathy’s effectiveness is so crystal clear, the regulators should assess homeopathic remedies just like normal drugs…  politicians and regulators should take homeopaths by their own word and should apply the same standards as for all other medicines.

In the past, homeopaths have always wanted the cake and eat it; they pleaded that their remedies are so special and therefore they need special regulations and extra considerations. Because of these, they were sheltered and escaped any legal or ethical obligations to demonstrate effectiveness. This introduced an unjustified and regressive double standard with was detrimental to good healthcare, medical ethics and scientific progress.

Now that homeopaths (the Germans are merely an example, other countries’ homeopaths are much the same) have agreed on what they think is solid scientific proof, it is right and necessary to remove the special protection which homeopathy used to enjoy. Let’s for the moment accept the homeopaths’ argument (‘homeopathy is effective just like other medicines) and then force them to deliver the proof of their opinion according to the standards all medicines must be judged by!

That would surely be the end of all this nonsense, and homeopaths would find themselves hoisted by their own petard.

 

The German Association of Homeopaths (Deutscher Zentralverein Homoeopathischer Aerzte) just issued a press-release explaining that they have recently determined that homeopathy works.

Well, aren’t we relieved!

Otherwise, we would have had to assume they are all quacks.

Their statement is based on what they consider a thorough analysis of the published evidence. As the whole document is about 60 pages long, I will not bother you with all the details. Instead, I will focus on what they say about systematic reviews/meta-analyses in the press-release:

Eine Betrachtung der Meta-Analysen zur Homöopathie zeigt überwiegend statistisch signifikante Ergebnisse gegenüber Placebo, die auf eine spezifische Wirksamkeit potenzierter Arzneien hinweisen. Je nach den verwendeten Selektionskriterien werden hierbei unterschiedliche Studien in die Auswertung eingeschlossen. Diese Befunde werden von den Autoren der jeweiligen Meta-Analysen zum Teil stark relativiert. Die angeführten Vorbehalte entsprechen hierbei nicht immer den üblichen wissenschaftlichen Standards.

Let me translate this for you: An assessment of the meta-analyses of homeopathy shows mostly significant results compared to placebo which indicates a specific effectiveness of potentised remedies. Depending on the selection criteria, various studies are included in the evaluation. These results are relativized by the authors of the respective meta-analyses. The listed caveats do not always reflect the usual scientific standards.

You think my English has deteriorated or my brain gone soft? No, it’s their German! It makes almost no sense at all.

Therefore, I am afraid, we need to briefly go into the hefty document after all. Their chapter on meta-analyses concludes as follows: Insgesamt ergibt sich hinsichtlich der bis dato publizierten maßgeblichen Meta-Analysen zur Homöopathie, dass in vier von fünf Fällen tendenziell eine spezifische Wirksamkeit potenzierter Arzneimittel über Placebo hinaus erkennbar ist. That makes (linguistically) a little more sense: Overall, it emerges that the currently published decisive meta-analyses show, in 4 of 5 cases, that a specific effectiveness of potentised remedies is noticeable.

In other words, it is now proven, homeopathic remedies work beyond placebo!!!

But how can this be?

Did the NHMRC not just do a similar analysis concluding that “the evidence from research in humans does not show that homeopathy is effective for treating the range of health conditions considered… homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness. People who are considering whether to use homeopathy should first get advice from a registered health practitioner. Those who use homeopathy should tell their health practitioner and should keep taking any prescribed treatments.

Obviously ‘down under’ they don’t know how to evaluate published data!

Or could it be that the Germans are mistaken? Or are they perhaps joking?

Let’s have a look!

The Germans selected (cherry-picked) 5 meta-analyses which they believed to be ‘decisive’, while the Australian panel of independent experts (funded by government) assessed 57 meta-analyses and systematic reviews (all they found via extensive literature searches).

But the German evaluation was done by homeopaths (and financed by a homeopathic lobby group)! And they understand homeopathy best and would not have a bias or conflict of interest, would they?

[FOR A MORE COMPLETE ANALYSIS, SEE HERE (in German)]

“Conflicts of interest should always be disclosed.”

This is what I wrote in the ‘RULES’ of this blog when I first started it almost 4 years ago. Sadly, very few people writing comments observe this rule. Perhaps, I just thought, I did not observe it either? So, here are my conflicts of interest: none.

Not true!!! I hear some people say. But it is!

I have no financial interest in any ‘Big Pharma’ or  ‘TINY CAM’, and I get not a penny for writing this blog.

How do I pay for my living? Mind your own business… well, on second thought, even that must not be a secret: I get a small pension and have some savings.

Still not convinced?

Perhaps it’s time to define what ‘conflicts of interests’ are. According to Wikipedia, they can be defined as  situations in which a person or organization is involved in multiple interests, financial interest, or otherwise, one of which could possibly corrupt the motivation of the individual or organization.

So, not having financial benefits from my current work does not necessarily mean that I have no conflicts of interest. The above definitions vaguely mentions ‘or otherwise’ – and that could be important. What could this mean in the context of this blog?

Well, I might have very strong beliefs, for instance (for instance, very strong beliefs that acupuncture is by definition nonsense [see below]). We all know that strong beliefs can corrupt motivation (and a lot more). And if I ask myself, do you have strong beliefs?, I have to say: Yes, absolutely!

I believe that:

  • good evidence is a prerequisite for progress in healthcare,
  • good evidence must be established by rigorous research,
  • we should not tolerate double standards in healthcare,
  • patients deserve to be treated with the best available treatments,
  • making therapeutic claims that are not supported by sound evidence is wrong.

These strong beliefs might make me biased in the eyes of many who comment on this blog. In Particular, we recently had a bunch of acupuncturists who went on the rampage attacking me personally the best they could. However, a rational analysis of my beliefs can hardly produce evidence for bias against anything other than the promotion of unproven therapies to the unsuspecting public.

The above mentioned acupuncturists seem to think that I have always been against acupuncture for the sake of being against acupuncture. However, this is not true. The proof for this statement is very simple: I have published quite a bit of articles that concluded positively – even (WOULD YOU BELIEVE IT?) about acupuncture for back pain! A prominently published meta-analysis of 2005 (with me as senior author) concluded:  “Acupuncture effectively relieves chronic low back pain.” (This of course was 11 years ago when the evidence was, in fact, positive; today, this seems to have changed – just like the NICE guidelines [probably not a coincidence!])

Conflicts of interest? No, not on my side, I think.

But what about the ‘other side’?

The unruly horde of acupuncturists (no, this is not an ad hominem attack, it’s a fact) who recently made dozens of ad hominem attacks against me, what about them?

  • They earn their money with acupuncture.
  • They have invested in acupuncture training often for long periods of time.
  • They have invested in practice equipment etc.
  • Some of them sell books on acupuncture.
  • Others run courses.
  • And all of them very clearly and demonstrably  have strong beliefs about acupuncture.

I think the latter point constitutes by far the most important conflict of interest in this context.

And this is where the somewhat trivial story has an unexpected twist and gets truly bizarre:

I have just leant that the same group of conflicted acupuncturists are now planning to publicly attack the panel of experts responsible for drafting the NICE guidelines. The reason? They feel that this panel had significant conflicts of interest that led them to come out against acupuncture.

Perhaps I should mention that I was not a member of this group, but I suspect that some of its members might have links to the pharmaceutical industry. It is almost impossible to find top experts in any area of medicine who do not have such links. You either gather experts with potential conflicts of interest, or you get non-experts without them. Would that bias them against acupuncture or any other alternative therapy? I very much doubt it.

What I do not doubt for a minute is that conflicts of interest are of major importance in these discussions. And by that I mean the more than obvious (but nevertheless undeclared) conflicts of interest of the acupuncturists. It seems that those with the strongest conflicts of interest shout the loudest about the non-existent or irrelevant conflict of interest of those who do not happen to share their quasi-religious belief in acupuncture.

Polycystic ovarian syndrome (PCOS) is a common condition characterised by oligo-amenorrhoea, infertility and hirsutism. Conventional treatment of PCOS includes a range of oral pharmacological agents, lifestyle changes and surgical modalities. Some studies have suggested that acupuncture might be helpful but the evidence is often flawed and the results are mixed. What is needed in such a situation is, of course, a systematic review.

The aim of this new Cochrane review was to assess the effectiveness and safety of acupuncture treatment of oligo/anovulatory women with polycystic ovarian syndrome (PCOS). The authors identified relevant studies from databases including the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, EMBASE, PsycINFO, CNKI and trial registries. The data are current to 19 October 2015.

They included randomised controlled trials (RCTs) that studied the efficacy of acupuncture treatment for oligo/anovulatory women with PCOS. We excluded quasi- or pseudo-RCTs. Primary outcomes were live birth and ovulation (primary outcomes), and secondary outcomes were clinical pregnancy, restoration of menstruation, multiple pregnancy, miscarriage and adverse events. We assessed the quality of the evidence using GRADE methods.

Two review authors independently selected the studies, extracted data and assessed risk of bias. They calculated Mantel-Haenszel odds ratios (ORs) and mean difference (MD) and 95% confidence intervals (CIs).

Five RCTs with 413 women were included. They compared true acupuncture versus sham acupuncture (two RCTs), true acupuncture versus relaxation (one RCT), true acupuncture versus clomiphene (one RCT) and electroacupuncture versus physical exercise (one RCT). Four of the studies were at high risk of bias in at least one domain. No study reported live birth rate. Two studies reported clinical pregnancy and found no evidence of a difference between true acupuncture and sham acupuncture (OR 2.72, 95% CI 0.69 to 10.77, two RCTs, 191 women, very low quality evidence). Three studies reported ovulation. One RCT reported number of women who had three ovulations during three months of treatment but not ovulation rate. One RCT found no evidence of a difference in mean ovulation rate between true and sham acupuncture (MD -0.03, 95% CI -0.14 to 0.08, one RCT, 84 women, very low quality evidence). However, one other RCT reported very low quality evidence to suggest that true acupuncture might be associated with higher ovulation frequency than relaxation (MD 0.35, 95% CI 0.14 to 0.56, one RCT, 28 women). Two studies reported menstrual frequency. One RCT reported true acupuncture reduced days between menstruation more than sham acupuncture (MD 220.35, 95% CI 252.85 to 187.85, 146 women). One RCT reported electroacupuncture increased menstrual frequency more than no intervention (0.37, 95% CI 0.21 to 0.53, 31 women). There was no evidence of a difference between the groups in adverse events. Evidence was very low quality with very wide CIs and very low event rates. Overall evidence was low or very low quality. The main limitations were failure to report important clinical outcomes and very serious imprecision.

The authors concluded that, thus far, only a limited number of RCTs have been reported. At present, there is insufficient evidence to support the use of acupuncture for treatment of ovulation disorders in women with PCOS.

This is, in my view, a rigorous assessment of the evidence leading to a clear conclusion. Foremost, I applaud the authors from the Faculty of Science, University of Technology Sydney for using such clear language. Such clarity seems to be getting a rare event in reviews of alternative medicine. To demonstrated this point, here are the most recent 5 systematic reviews which came up on my screen when I searched today Medline for ‘complementary alternative medicine, systematic review’.

The combination of TGP and LEF in treatment of RA presented the characteristics of notably decreasing the levels of laboratory indexes and higher safety in terms of liver function. However, this conclusion should be further investigated based on a larger sample size.

Compared to control groups, both MA and EA were more effective in improving AHI and mean SaO2. In addition, MA could further improve apnea index and hypopnea index compared to control.

CHM as an adjunctive therapy is associated with a decreased risk of in-hospital mortality compared with WT in patients with AKI. Further studies with high quality and large sample size are needed to verify our conclusions.

clinicians may consider Tai Chi as a viable complementary and alternative medicine for chronic pain conditions.

As an important supplementary treatment, TCM may provide benefits in repair of injured spinal cord. With a general consensus that future clinical approaches will be diversified and a combination of multiple strategies, TCM is likely to attract greater attention in SCI treatment.

I think the phenomenon is fairly obvious: authors of such papers are far too often not able or willing to express the bottom line of their work openly. As systematic reviews are supposed to be the ultimate type of evidence, this trend is very worrying, I think. In my view, such conclusions merely display the bias of the authors. If the evidence is not convincingly positive (which it very rarely is), authors have an ethical obligation to clearly say so.

If they don’t do it, journal editors have the duty to correct the error. If neither of these actions happen, funding agencies should make sure that such teams get no further research money until they can demonstrate that they have learnt the lesson.

This may sound a bit drastic but I think such steps would be both necessary and urgent. The problem is now extremely common, and if we do not quickly implement some effective preventative measures, our scientific literature will become contaminated to the point of becoming useless. This surely would be a disaster that affects us all.

There can, of course, be several reasons for the evidence being not positive:

  • there can be a paucity of data
  • the results might be contradictory
  • the trials might be open to bias
  • some of the primary data might look suspicious

In all of these cases, the evidence would be not convincingly positive, and it would be wrong and unhelpful not to be frank about it. Beating about the bush, like so many authors nowadays do, is misleading, unhelpful, unethical and borderline fraudulent. Therefore it constitutes a disservice to everyone concerned.

I am pleased to report that my ‘ALTERNATIVE MEDICINE HALL OF FAME’ is growing steadily. So far, this elite club includes:

Gustav Dobos

Claudia Witt

George Lewith

John Licciardone

Time, I think, to elect another member. I was fascinated to read what the COLLEGE OF MEDICINE (I have published about this organisation before, for instance, here) writes about a former co-worker of mine, Simon Mills (those who have read my memoir will know more about him and about my struggle to disassociate me and my work from him and his activities):

Simon Mills is a member of the College of Medicine Council. He is a Cambridge graduate in medical sciences who has since 1977 been a herbal practitioner and natural therapist in Exeter. In that time he has led the main organizations for herbal medicine in the UK (the British Herbal Medicine Association, the College of Practitioners of Phytotherapy, and National Institute of Medical Herbalists) and served on Government and House of Lords committees. Since 1997 he has been Secretary of ESCOP, the lead herbal scientific network in Europe, that produces defining monographs on herbal medicines for the European Medicines Agency. He has also written award-winning seminal herbal medicine textbooks, notably with Kerry Bone the two editions of Principles and Practice of Phytotherapy and the Essential Book of Herbal Safety. He has long been involved in academic work having co-founded the world’s first University centre for complementary health in Exeter (1987), the first integrated health course at a UK medical school at the Peninsula Medical School in Exeter (2000) and the first masters degree programme in herbal medicine in the USA (2001). He has published in many peer-reviewed scientific journals including full clinical trials with herbal medicines, and has supervised 10 successful doctorate theses. Simon is currently building a new role for healthcare practitioners as ‘health guides. With health workbooks, training programmes, community projects and websites.

It was new to me that he has ‘published in many peer-reviewed scientific journals’, so I did a Medline search and found a total of 14 articles. Most of these were comments, letters etc. I decided to identify the first 10 papers that drew some sort of conclusions about the value of alternative therapies. This is what I found (as usual, I have copied the conclusions in bold):

Short-term study on the effects of rosemary on cognitive function in an elderly population.

Pengelly A, Snow J, Mills SY, Scholey A, Wesnes K, Butler LR.

J Med Food. 2012 Jan;15(1):10-7. doi: 10.1089/jmf.2011.0005. Epub 2011 Aug 30.

The positive effect of the dose nearest normal culinary consumption points to the value of further work on effects of low doses over the longer term.

Continuous PC6 wristband acupressure for relief of nausea and vomiting associated with acute myocardial infarction: a partially randomised, placebo-controlled trial.

Dent HE, Dewhurst NG, Mills SY, Willoughby M.

Complement Ther Med. 2003 Jun;11(2):72-7.

Continuous 24-h PC6 acupressure therapy as an adjunct to standard antiemetic medication for post-MI nausea and vomiting is feasible and is well accepted and tolerated by patients. In view of its benefits, further studies are worthwhile using earlier onset of treatment.

Effect of a proprietary herbal medicine on the relief of chronic arthritic pain: a double-blind study.

Mills SY, Jacoby RK, Chacksfield M, Willoughby M.

Br J Rheumatol. 1996 Sep;35(9):874-8.

It is concluded that Reumalex has a mild analgesic effect in chronic arthritis at a level appropriate to self-medication.

Yes, there were just three such papers; perhaps the College of Medicine’s description is just a trifle misleading? As all of these arrived at positive conclusions, I think Mr Mills nevertheless deserves a place in my ALTERNATIVE MEDICINE’S HALL OF FAME.

Shiatsu is a popular alternative therapy with a remarkable void of research. According to one of the rare reviews on the subject, Shiatsu is a form of Japanese massage, working on the meridian system of the body; the energetic pathways along which the acupuncture points are placed. The theory for shiatsu is based in the system of traditional Chinese medicine, understood in China for over 2000 years. Shiatsu can be valuable for reintegrating the body, mind and spirit, helping with the general energy level of the body as well as specific symptoms… Feelings of deep relaxation, support and increased vitality are common following a shiatsu treatment. The method, strength and frequency of treatment can be varied to suit individual need…

If this seems an optimistic evaluation to you, have a look on the Internet where bogus claims for Shiatsu abound. But such uncritical nonsense is, of course, neither informative nor responsible. In a previous post, I have been a little more critical about the value of Shiatsu and concluded that is an unproven therapy. I reached this conclusion mainly because, for our Oxford Handbook of Complementary Medicine (2008), we systematically researched the evidence and found very little of it. In fact, we concluded that NO CONVINCING DATA AVAILABLE TO SUGGEST THAT SHIATSU IS EFFECTIVE FOR ANY CONDITION.

Since then, a systematic review has been published. The Shiatsu studies found comprised just one single RCT, three controlled non-randomised, one within-subjects study, one observational study and 3 uncontrolled studies investigating mental and physical health issues. The authors, who usually are very much in favour of alternative therapies, concluded that more research is needed, particularly for Shiatsu, where evidence is poor.

This seems to indicate that our verdict of 2008 is still not far off the mark.

And what about the risks?

On this aspect of Shiatsu, it is even harder to find reliable information. One website, for instance, warns that certain individuals should take caution and consult a physician before receiving shiatsu. For example, there’s some concern that shiatsu may have harmful effects in pregnant women, patients who have recently undergone chemotherapy or radiation, and people with such conditions as osteoporosis, heart disease, and blood clotting disorders. Additionally, shiatsu should not be performed directly over bruises, inflamed skin, unhealed wounds, tumors, abdominal hernia, or areas of recent fractures. Shiatsu should also be avoided immediately after surgery, and by people with infectious skin disease, rash, or open wounds.

But what about adverse reactions and complications?

Another website, tells us that, when performed properly, shiatsu is not associated with any significant side effects. Some people may experience mild discomfort, which usually disappears during the course of the treatment session.

So, is Shiatsu without side-effects?

The answer, I am afraid, is NO – but has to dig deep to find even a tentative answer to this question.

A prospective, 6 months cohort, pragmatic study of the effects and experience of shiatsu within three countries (Austria, Spain and the UK) has been published by UK authors in 2009 . Data were collected via postal questionnaires, including on client-perceived negative responses. Shiatsu was delivered by the practitioner in routine practice. 633 clients provided full follow-up data, a response rate of 67%. A prevalence rate of 12-22 per 100 of client-perceived ‘negative responses’ was found across the three countries. Transitional effects accounted for 82% of all the client-described ‘negative’ responses. Nine clients (1.4% of the total), relating to 10 sets of written comments, reported a negative response that was classified as ‘a potentially adverse event or effect’ that might represent a risk to client safety.

In addition there are much more serious complications such as strokes. These might be extreme rarities – but who knows? Nobody! Why? Because, as with most alternative therapies, there is no reporting or monitoring system for such events. Therefore the true prevalence is anyone’s guess.

The bottom line, I am afraid, is all too familiar: There is no good evidence for effectiveness and some evidence of risk – which can only mean one thing: the proven benefits do not outweigh the potential harm.

 

A recent comment to a blog-post about alternative treatments for cancer inspired me to ponder a bit. I think it is noteworthy because it exemplifies so many of the comments I hear in the realm of alternative medicine on an almost daily basis. Here is the comment in question:

“Yes…it appears that the medical establishment have known for years that chemotherapy a lot of the time kills patients faster than if they were untreated…what’s more, it worsens a person’s quality of life in which many die directly of the severe effects on the endocrine, immune system and more…cancers often return in more aggressive forms metastasising with an increased risk of apoptosis. In other words it makes things worse whereas there are many natural remedies which not only do no harm but accumulating evidence points to their capacity to fight cancer…some of it is bullshit whilst some holds some truth!! So turning away from toxic treatments that kill towards natural approaches that are showing more hope with the backing of trials kinda reverses the whole argument of this article.”

The comment first annoyed me a bit, of course, but later it made me think and consider the differences between conspiracy theories, assumptions, opinions, evidence and scientific facts. Let’s tackle each of these in turn.

CONSPIRACY THEORIES

A conspiracy theory is an explanatory or speculative theory suggesting that two or more persons, or an organization, have conspired to cause or cover up, through secret planning and deliberate action, an event or situation typically regarded as illegal or harmful.

Part of the above comment bears some of the hallmarks of a conspiracy theory: “…the medical establishment have known for years that chemotherapy a lot of the time kills patients faster than if they were untreated…” The assumption here is that the conventional healthcare practitioners are evil enough to knowingly do harm to their patients. Such conspiracy theories abound in the realm of alternative medicine; they include the notions that

  • BIG PHARMA is out to kill us all in order to maximize their profits,
  • the ‘establishment’ is suppressing any information about the benefits of alternative treatments,
  • vaccinations are known to be harmful but nevertheless being forced on to our children,
  • drug regulators are in the pocket of the pharmaceutical industry,
  • doctors accept bribes for prescribing dangerous drugs
  • etc. etc.

In a previous blog-post, I have discussed the fact that the current popularity of alternative medicine is at least partly driven by the conviction that there is a sinister plot by ‘the establishment’ that prevents people from benefitting from the wonders of alternative treatments. It is therefore hardly surprising that conspiracy theories like the above are voiced regularly on this blog and elsewhere.

ASSUMPTION

An assumption is something taken for granted or accepted as true without proof.

The above comment continues stating that “…[chemotherapy] makes things worse whereas there are many natural remedies which not only do no harm but accumulating evidence points to their capacity to fight cancer…” There is not proof for these assertions, yet the author takes them for granted. If one were to look for the known facts, one would find the assumptions to be erroneous: chemotherapy has saved countless lives and there simply are no natural remedies that will cure any form of cancer. In the realm of alternative medicine, this seems to worry few, and assumptions of this or similar nature are being made every day. Sadly the plethora of assumptions or bogus claims eventually endanger public health.

OPINION

An opinion is a judgment, viewpoint, or statement about matters commonly considered to be subjective.

The above comment continues with the opinion that “…turning away from toxic treatments that kill towards natural approaches that are showing more hope with the backing of trials kinda reverses the whole argument of this article.” In general, alternative medicine is based on opinions of this sort. On this blog, we have plenty of examples for that in the comments section. This is perhaps understandable; evidence is usually in short supply, and therefore it often is swiftly replaced with often emotionally loaded opinions. It is even fair to say that much of alternative medicine is, in truth, opinion-based healthcare.

EVIDENCE

Evidence is anything presented in support of an assertion. This support may be strong or weak. The strongest type of evidence is that which provides direct proof of the truth of an assertion.

One remarkable feature of the above comment is that it is bar of any evidence. In a previous post, I have tried to explain the nature of evidence regarding the efficacy of medical interventions:

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 (e. g. placebo effects, natural history of the condition, regression towards the mean), 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.

SCIENTIFIC FACTS

Scientific facts are verified by repeatable careful observation or measurement (by experiments or other means).

Some facts related to the subject of alternative medicine have already been mentioned:

  • chemotherapy prolongs survival of many cancer patients;
  • no alternative therapy has achieved anything remotely similar.

The comment above that motivated me to write this somewhat long-winded post is devoid of facts. This is just one more feature that makes it so typical of the comments by proponents of alternative medicine we see with such embarrassing regularity.

My last post was about a researcher who manages to produce nothing but positive findings with the least promising alternative therapy, homeopathy. Some might think that this is an isolated case or an anomaly – but they would be wrong. I have previously published about researchers who have done very similar things with homeopathy or other unlikely therapies. Examples include:

Claudia Witt

George Lewith

John Licciardone

But there are many more, and I will carry on highlighting their remarkable work. For example, the research of a German group headed by Prof Gustav Dobos, one of the most prolific investigator in alternative medicine at present.

For my evaluation, I conducted a Medline search of the last 10 of Dobos’ published articles and excluded those not assessing the effectiveness of alternative therapies such as surveys, comments, etc. Here they are with their respective conclusions and publication dates:

SYSTEMATIC REVIEW COMPARING DIFFERENT YOGA STYLES (2016)

RCTs with different yoga styles do not differ in their odds of reaching positive conclusions. Given that most RCTs were positive, the choice of an individual yoga style can be based on personal preferences and availability.

SYSTEMATIC REVIEW OF YOGA FOR WEIGHT LOSS (2016)

Despite methodological drawbacks, yoga can be preliminarily considered a safe and effective intervention to reduce body mass index in overweight or obese individuals.

REVIEW OF INTEGRATIVE MEDICINE IN GYNAECOLOGICAL ONCOLOGY (2016)

…there is published, positive level I evidence for a number of CAM treatment forms.

SYSTEMATIC REVIEW OF MINDFULNESS FOR PSYCHOSES (2016)

Mindfulness- and acceptance-based interventions can be recommended as an additional treatment for patients with psychosis.

RCT OF CABBAGE LEAF WRAPS FOR OSTEOARTHOSIS (2016)

Cabbage leaf wraps are more effective for knee osteoarthritis than usual care, but not compared with diclofenac gel. Therefore, they might be recommended for patients with osteoarthritis of the knee.

SYSTEMATIC REVIEW OF HERBAL MEDICINES FOR COUGH (2015)

This review found strong evidence for A. paniculata and ivy/primrose/thyme-based preparations and moderate evidence for P. sidoides being significantly superior to placebo in alleviating the frequency and severity of patients’ cough symptoms. Additional research, including other herbal treatments, is needed in this area.

SYSTEMATIC REVIEW OF DIETARY APPROACHES FOR METABOLIC SYNDROME (2016)

Dietary approaches should mainly be tried to reduce macronutrients and enrich functional food components such as vitamins, flavonoids, and unsaturated fatty acids. People with Metabolic Syndrome will benefit most by combining weight loss and anti-inflammatory nutrients.

SYSTEMATIC REVIEW OF MIND BODY MEDICINE FOR CORONARY HEART DISEASE (2015)

In patients with CHD, MBM programs can lessen the occurrence of cardiac events, reduce atherosclerosis, and lower systolic blood pressure, but they do not reduce mortality. They can be used as a complement to conventional rehabilitation programs.

CRANIOSACRAL THERAPY (CST) FOR BACK PAIN (2016)

CST was both specifically effective and safe in reducing neck pain intensity and may improve functional disability and the quality of life up to 3 months after intervention.

REVIEW OF INTEGRATED MEDICINE FOR BREAST CANCER (2015)

Study data have shown that therapy- and disease-related side effects can be reduced using the methods of integrative medicine. Reported benefits include improving patients’ wellbeing and quality of life, reducing stress, and improving patients’ mood, sleeping patterns and capacity to cope with disease.

Amazed?

Dobos seems to be an ‘all-rounder’ whose research tackles a wide range of alternative treatments. That is perhaps unremarkable – but what I do find remarkable is the impression that, whatever he researches, the results turn out to be pretty positive. This might imply one of two things, in my view:

I let my readers chose which possibility they deem to be more likely.

The current issues of ‘homeopathy 4 everyone’ (April 2016) carries several articles on homeoprophylaxis, the use of homeopathic remedies for the prevention of mostly infectious diseases promoted by homeopathy as a safe and effective alternative to immunizations. They are worth reading – but watch your blood pressure! Here I will give you a flavour by citing from one of these articles:

“…As I have been teaching about Homeoprophylaxis (“HP”) throughout the United States and in Europe, some things have become unmistakably clear.  One is the ever increasing desire of people to know that there is a nontoxic alternative when it comes to disease prevention.  Another is a profound misunderstanding or, perhaps better said, a lack of education among many regarding HP…

The effectiveness of HP is being shown fairly consistently to be about 90%1, which is comparable to any vaccine.  With this in mind, too, those who utilize homeoprophylaxis work to help their clients understand fundamentally that disease is generally not to be feared—that disease-causing pathogens are a necessary part of our environment and that the body generally becomes healthier once it has been exposed to a disease and has worked its way through it…

My passion regarding spreading the word and helping people learn about homeoprophylaxis led to my becoming the co-founder/director of the first international conference of its type in the world—Homeoprophylaxis: A Worldwide Choice, which took place in Dallas, Texas, USA in October, 2015.  Isaac Golden was our keynote speaker…

Frequently seen is the protocol Isaac Golden utilizes. This is a once monthly method, where one single remedy/nosode is introduced at potency.  If following, for example, a pediatric regimen that lists several nosodes, it will be the next month that either a larger dose of that same nosode is taken, or the next nosode is introduced.  For pediatric HP, this is cycled through until all nosodes in the protocol are taken, the higher potency being started after the lower potency is completed. A booklet is provided to the clientele to keep track of these…

Ultimately, homeoprophylaxis has been in use since the days of Hahnemann.  What is apparent when one considers the entire picture, noting the meticulous studies that have been and are yet being done as well as the current increasing demand of people worldwide— perhaps especially parents— for a nontoxic alternative for disease prevention, it truly makes sense to be promoting  homeoprophylaxis.  Our children are the most vulnerable in our society and deserve our utmost attention and concern.  Not every practitioner needs to utilize HP.  However, because there are many who do, support of this should be encouraged.  It is an alternative people deserve to know about so that they can make an educated choice, and health for our society, especially our children, can be promoted.”

END OF QUOTE

By now, you are probably wondering who wrote this article. It was Cathy Lemmon, BA, C.HP, D.Psc,  Co-Founder/Director of Homeoprophylaxis: A Worldwide Choice for Disease Prevention, she is also working on future conferences for the promotion of HP. She has studied HP with Isaac Golden of Australia and Ravi Roy and Carola Lage-Roy of Germany. She also has certificates in homeopathic treatment of vaccine injury as well as, through the ARHF in the Netherlands, treatment of epidemics and trauma. She completed studies at the School of Homeopathy and is completing specialized homeopathic studies through Gesundes Bewußtsein in Germany as well as post-graduate work in homeopathy through the College of Practical Homeopathy in London.

With all these ‘qualifications’, she has obviously escaped any education in real science and evidence-based medicine; if not she would know that her views are not just wrong but also dangerous. To Be clear:

  • Homeoprophylaxis is not biologically plausible.
  • There is no evidence that it works.
  • The concept misleads people to think that conventional immunizations are superfluous.
  • This has the potential to kill thousands.

The ‘ALTERNATIVE MEDICINE SOCIETY’ claims to be a ‘a global network of medical practitioners and contributors who scour the best research and findings from around the world to provide the best advice on alternative, holistic, natural and integrative medicines and treatments for free.’

Sounds great!

They even give advice on ‘7 common diseases you can treat through natural medicine.’ This headline fascinated me, and I decided to have a closer look at what is being recommended there. The following is copied from the website which looks to me as though it was written by a naturopath. My comments appear dispersed in the original text and are in bold.

Despite an exponential research advancement in recent years, we’re finding more and more problems with conventional medicine – from reports of fraud, to terrible medicinal side effects, to bacterial tolerance to antibiotics. Thus, it’s no surprise that more and more people are looking towards more natural medicine for disease management. Many people are seeking solutions which are not only inexpensive, but are also less harmful. Did you know that a lot of the medical conditions suffered by patients today can be adequately treated with natural medicine? Here are seven diseases you can treat through natural medicine:

  1. High blood pressure/hypertension

High blood pressure, or hypertension, is a condition most of us are really familiar with. It’s a risk factor, not a ‘disease’. Defined as the elevation of blood pressure in systemic arteries, hypertension left untreated could lead to serious, possibly fatal complications such as strokes and heart attacks. Conventional treatments for hypertension usually include a cocktail of several drugs (no, good conventional doctors start with life-style advice, if that is not successful, one adds a diruretic, and only if that does not work, one adds a further drug) consisting of vasodilators, alpha/beta blockers, and enzyme inhibitors. However, hypertension can be managed, and altogether avoided with the use of natural medicine. Alternative treatments involve lifestyle changes (e.g. intentionally working out, alcohol intake moderation), dietary measures (e.g. lowering salt intake, choosing healthier food options), and natural medicine (e.g. garlic). As pointed out already, this is the conventional approach! Unfortunately, it often does not work because it is either not sufficiently effective or the patient is non-compliant. Altogether alternative treatments play only a very minor (many experts would say no) role in the management of hypertension.

  1. Arthritis

Arthritis literally translated from Greek, means joint (arthro-) inflammation (-itis). There are two main categories of arthritis: inflammatory and degenerative, and they need to be managed differently. This condition is common in old patients, due to prior dietary choices (diet is not important enough to be mentioned on 1st place), and the natural wearing out of joint structures. Doctors typically prescribe anti-inflammatory drugs (e.g. steroids) to reduce irritation, and pain relievers (e.g. analgesics) for managing the pain. On the other hand, natural medicine could do an equally effective job in treating arthritis, through the use of several herbs such as willow, turmeric, ginger, and capsicum. It is not true that these herbs have been shown to be of equal effectiveness. Research has also shown that lifestyle measures such as weight loss (that would be the advice of conventional doctors), and other natural treatments such as acupuncture (not very effective for degenerative arthritis and ineffective for inflammatory arthritis) and physical therapy (that is conventional medicine), also lessen pain and inflammation in patients. Altogether alternative treatments play only a very minor role in the management of arthritis.

  1. Bronchitis

Bronchitis may be defined as the irritation, or swelling of the bronchial tubes connecting our nasal cavity to our lungs commonly cause by infections or certain allergens (that would be asthma, not bronchitis). Patients with bronchitis typically deal with breathing difficulties, coughing spells, nasal congestion, and fever. There are usual prescriptions for bronchitis, but there are also very effective natural medicine available. Natural medicine include garlic, ginger, turmeric, eucalyptus, Echinacea, and honey. None of these have been shown by good evidence to be ‘very effective’! These herbs may be prepared at home as tonics, tea, or taken as is, acting as anti-microbial agents for fighting off the infections. Altogether alternative treatments play only a very minor role in the management of bronchitis.

  1. Boils

Boils are skin infections which occur as pus-filled pimples in various parts of the body. Despite being highly contagious and painful, boils can easily be treated with natural medicine. Some of the herbs proven to be effective in treating boils include Echinacea, turmeric, garlic, and tea tree oil, due to the presence of natural chemicals which have antibiotic capacities. There is no good evidence to support this claim. Repeated exposure to topical application of these natural medicine is guaranteed to cure your boils in no time. Altogether alternative treatments play only a very minor role in the management of boils.

  1. Eczema

Eczema is also a skin condition resulting from allergic reactions which are typically observed as persistent rashes. The rashes are usually incredibly itchy, showing up in the most awkward places such as the inside of the knees and thighs. Thankfully, eczema can be managed by lifestyle measures (such as avoiding certain foods which elicit allergies – these measures would be entirely conventional and require conventional allergy testing to be effective), and natural medicine. These includes herbal components such as sunflower seed oil, coconut oil, evening primrose oil and chamomile. There is no good evidence to show that these therapies are effective. These natural medicine contain different active ingredients which are not only able to moisturize the affected skin, but are also able to reduce inflammation and soothe itchiness. Altogether alternative treatments play only a very minor role in the management of eczema.

  1. Constipation

Constipation is a normal (??? why should it be normal???) medical condition in which patients are unable to empty bowels at ease. It may be caused by a wide variety of reasons such as bowel stricture, hyperparathyroidism, or simply a case of terrible (???) food choices. However, it can very easily be treated with natural medicine. Some common remedies are molasses, sesame seeds, fiber, ginger or mint tea, lemon water, prunes, castor oil (an old-fashioned and largely obsolete conventional treatment) and coffee (for none of the other treatments is there good evidence). The action of these natural medicine involves laxative effects which stimulate contractions along the colon which incidentally moves your bowels along. Conventional doctors would recommend life-style changes and would warn patients NOT to use laxatives long-term. Altogether alternative treatments play only a very minor role in the management of constipation.

  1. Hay Fever

Allergic rhinitis, as hay fever is also known, are allergic reactions to certain particles like dust or pollen which incite coughing sprees, sneezing spells, and congested sinuses. There are very good natural medicine options for treating hay fever, which contain ingredients which act the same way as your conventional anti-histamine drugs. If they act the same way, what would be their advantage? Some of the natural medicine used to treat hay fever include chamomile, ginger, green, and peppermint teas, as well as butterbur, calendula, and grapefruit. Butterbur is the only one in this list that is supported by some evidence. Altogether alternative treatments play only a very minor role in the management of hay fever.

In essence, none of the 7 ‘diseases’ can be treated effectively with any of the alternative treatments recommended here. ‘The best advice on alternative, holistic, natural and integrative medicines and treatments’, it seems to me, is therefore: AVOID CHARLATANS WHO TELL YOU THAT ALTERNATIVE TREATMENTS ARE MORE EFFECTIVE THAN CONVENTIONAL MEDICINE. 

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