MD, PhD, FMedSci, FSB, FRCP, FRCPEd

evidence

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It has been reported that ‘Boots the Chemist’ have filed several legal complaints against The Guardian in relation to articles published by the paper in relation to its April 2016 investigation. The Guardian articles in question alleged that Boots, the UK’s largest pharmacy chain, had placed undue pressure on its pharmacists to perform medicines use reviews so that it could claim the maximum payments possible from the NHS. In other words, The Guardian implied that Boots was trying to get more money from our NHS than might have been due.

Personally, I am always uneasy when I hear that someone takes legal action on such matters. I think that legal complaints of such a nature can turn out to be counter-productive, both in general and in this particular instance.

Why?

There could be several reasons. For instance, such actions might give someone the idea of filing complaints against Boots. I am sure it is not difficult to find reasons for that.

In the realm of alternative medicine, for example, someone might question whether selling homeopathic remedies in Boot’s section ‘pharmacy and health’ is not misleading. These remedies might be seen by a naïve customer as masquerading as medicines. As readers of this blog know all too well, they do not, in fact, contain anything (other than lactose) that has any pharmacological activity. Therefore Boots should best market them in the category of ‘confectionary’.

One might even suspect that Boots are fully aware of all this. After all, a spokesperson for the company stated years ago during a parliamentary inquiry: “I have no evidence to suggest that they [homeopathic remedies sold by Boots] are efficacious …”

And it is also not the first time that Boots have been challenged for selling products they know to be placebos. This is what The Guardian reported in 2008 about the issue: “Ernst accuses the company [Boots] of breaching ethical guidelines drawn up by the Royal Pharmaceutical Society of Great Britain, by failing to tell customers that its homeopathic medicines contain no active ingredients and are ineffective in clinical trials.”

A similar void of evidence also applies to Boot’s wide range of Bach Flower Remedies and aromatherapy oils.

Or am I wrong?

Perhaps Boots want to post links to the evidence in the  comment section below?

I am always keen to learn and only too happy to change my mind in view of new, compelling evidence!

Boots also sell a very wide range of herbal medicines, and here the situation is quite different: herbal medicines actually contain molecules that might have pharmacological effects, i. e. they might heal or might harm you. And many of these products imply indications for which they should be taken. I will pick just one example to explain: HERBAL SLIM AID.

Yes, you are absolutely correct – this product is (according to its name) not for gaining weight, it’s for reducing it. Each coated tablet contains 45 mg of extract (as dry extract) from Bladderwrack thallus (Fucus vesiculosus L.) (5:1) (equivalent to 225 mg of Fucus) Extraction solvent: water, ,30 mg Dandelion Root (Taraxacum officinale Weber ex Wigg), 27 mg of extract (as dry extract) from Boldo leaf (Peumus boldus Molina) (4-6:1) (equivalent to 108-162 mg of Boldo leaf) Extraction solvent: Methanol 70% v/v, 10 mg Butternut Bark (Juglans cinerea L.).

Now, I thought I know quite a bit about herbal slimming aids, after all, we had a research focus on this topic for several years and have published about a dozen papers on the subject. But oddly, I cannot remember that this mixture of herbs has been shown to reduce body weight.

Perhaps Boots want to post evidence for the efficacy and safety of this product as well?

I certainly hope so, and I would instantly withdraw any hint of a suspicion that Boots are selling unproven or disproven medicines.

Where is all this going?

I have to admit that am not entirely sure myself.

I suppose all I wanted to express was that it might be unwise to throw stones when one is sitting in a glass-house – a cliché, I know, but it’s true nevertheless.

 

 

 

CONFLICTS OF INTEREST:

None [except I don’t like those who easily take legal action against others]

Turmeric (Curcuma longa) is a truly fascinating plant with plenty of therapeutic potential. It belongs to the ginger family, Zingiberaceae and is native to southern Asia. Its main active ingredients are curcumin (diferuloylmethane) and the related compounds, demethoxycurcumin and bis-demethoxycurcumin (curcuminoids) which are secondary metabolites. Turmeric  has been used extensively in Ayurvedic medicine and has a variety of pharmacologic properties including antioxidant, analgesic, anti-inflammatory, and antiseptic activities.

In the often weird world of alternative medicine, turmeric is currently being heavily hyped as the new panacea. Take this website, for instance; it promotes turmeric for just about any ailment known to mankind. Here is a short excerpt to give you a flavour (pun intended, turmeric is, of course, a main ingredient in many curries):

It comes at a surprise to a lot of people that herbs can be highly effective, if not more effective, than conventional medications …

To date, turmeric is one of the top researched plants. It was involved in more than 5,600 peer-reviewed and published biomedical studies. In one research project that extended over a five year period, it was found that turmeric could potentially be used in preventive and therapeutic applications. It was also noted that it has 175 beneficial effects for psychological health…

The 14 Medications it Mimics

Or should we say the 14 medications that mimic turmeric, since turmeric has been around much longer than any chemical prescription drug. Here’s a quick look at some of them:

  • Lipitor: This is a cholesterol drug that is used to reduce inflammation and oxidative stress inside of patients suffering from type 2 diabetes. When the curcuminoid component inside of turmeric is properly prepared, it can offer the same effects (according to a study published in 2008).
  • Prozac: This is an antidepressant that has been overused throughout the past decade. In a study published back in 2011, turmeric was shown to offer beneficial effects that helped to reduce depressive behaviors (using animal models).
  • Aspirin: This is a blood thinner and pain relief drug. In a study done in 1986, it was found that turmeric has similar affects, which makes it a candidate for patients that are susceptible to vascular thrombosis and arthritis.
  • Metformin: This is a drug that treats diabetes. It is used to activate AMPK (to increase uptake of glucose) and helps to suppress the liver’s production of glucose. In a study published in 2009, it was found that curcumin was 500 to 100,000 times more effective at activating AMPK ad ACC.
  • Anti-Inflammatory Drugs: This includes medications like ibuprofen, aspirin and dexamethasone, which are designed to reduce inflammation. Again, in 2004, it was proven that curcumin was an effective alternative option to these chemical drugs.
  • Oxaliplatin: This is a chemotherapy drug. A study done in 2007 showed that curcumin is very similar to the drug, acting as an antiproliferative agent in colorectal cell lines.
  • Corticosteroids: This is a steroid medication, which is used to treat inflammatory eye diseases. In 1999, it was found that curcumin was effective at managing this chronic condition. Then in 2008, curcumin was used in an animal model that proved it could also aid in therapy used to protect patients from lung transplantation-associated injuries by “deactivating” inflammatory genes.

Turmeric Fights Drug-Resistant Cancers… it’s been shown that curcumin can battle against cancers that are resistant to chemotherapy and radiation…

END OF QUOTE

As I said, turmeric is fascinating and promising, but such hype is clearly counter-productive and dangerous. As so often, the reality is much more sobering than the fantasy of uncritical quacks. Research is currently very active and has produced a host of interesting findings. Here are the conclusions (+links) of a few, recent reviews:

Overall, there is early evidence that turmeric/curcumin products and supplements, both oral and topical, may provide therapeutic benefits for skin health. However, currently published studies are limited and further studies will be essential to better evaluate efficacy and the mechanisms involved.

This meta-analysis of RCTs suggested a significant effect of curcumin in lowering circulating TNF-α concentration.

While statistical significant differences in outcomes were reported in a majority of studies, the small magnitude of effect and presence of major study limitations hinder application of these results.

Overall, scientific literature shows that curcumin possesses anti-diabetic effects and mitigates diabetes complications.

The highlighted studies in the review provide evidence of the ability of curcumin to reduce the body’s natural response to cutaneous wounds such as inflammation and oxidation. The recent literature on the wound healing properties of curcumin also provides evidence for its ability to enhance granulation tissue formation, collagen deposition, tissue remodeling and wound contraction. It has become evident that optimizing the topical application of curcumin through altering its formulation is essential to ensure the maximum therapeutical effects of curcumin on skin wounds.

What emerges from a critical reading of the evidence is that turmeric has potential in several different areas. Generally speaking, clinical trials are still thin on the ground, not of sufficient rigor and therefore not conclusive. In other words, it is far too early to state or imply that we all should rush to the next health food store and buy the supplements.

On the contrary, at this stage, I would even warn people not to be seduced by the unprofessional hype and wait until we know more – much more. There might be risks associated with ingesting turmeric at high doses over long periods of time. And there are fundamental open questions about oral intake. One recent review cautioned: …its extremely low oral bioavailability hampers its application as therapeutic agent.

WATCH THIS SPACE!

The ACUPUNCTURE NOW FOUNDATION (ANF) have recently published a document that is worth drawing your attention to. But first I should perhaps explain who the ANF are. They state that “The Acupuncture Now Foundation (ANF) was founded in 2014 by a diverse group of people from around the world who were concerned about common misunderstandings regarding acupuncture and wanted to help acupuncture reach its full potential. Our goal is to become recognized as a leader in the collection and dissemination of unbiased and authoritative information about all aspects of the practice of acupuncture.”

This, I have to admit, sounds like music to my ears! So, I studied the document in some detail – and the music quickly turned into musac.

The document which they call a ‘white paper’ promises ‘a review of the research’. Reading even just the very first sentence, my initial enthusiasm turned into bewilderment: “It is now widely accepted across health care disciplines throughout the world that acupuncture can be effective in treating such painful conditions as migraine headaches, and low back, neck and knee pain, as well as a range of painful musculoskeletal conditions.” Any review of research that starts with such a deeply uncritical and overtly promotional statement, must be peculiar (quite apart from the fact that the ANF do not seem to appreciate that back and neck pain are musculoskeletal by nature).

As I read on, my amazement grew into bewilderment. Allow me to present a few further statements from this review (together with a link to the article provided by the ANF in support and a very brief comment by myself) which I found more than a little over-optimistic, far-fetched or plainly wrong:

Male fertility, especially sperm production and motility, has also been shown to improve with acupuncture. In a recent animal study, electro-acupuncture was found to enhance germ cell proliferation. This action is believed to facilitate the recovery of sperm production (spermatogenesis) and may restore normal semen parameters in subfertile patients.

The article supplied as evidence for this statement refers to an animal experiment using a model where sperm are exposed to heat. This has almost no bearing on the clinical situation in humans and does not lend itself to any clinical conclusions regarding the treatment of sub-fertile men.

In a recent meta-analysis, researchers concluded that the efficacy of acupuncture as a stand-alone therapy was comparable to antidepressants in improving clinical response and alleviating symptom severity of major depressive disorder (MDD). Also, acupuncture was superior to antidepressants and waitlist controls in improving both response and symptom severity of post-traumatic stress disorder (PTSD). The incidence of adverse events with acupuncture was significantly lower than antidepressants.

The review provided as evidence is wide open to bias; it was criticised thus: “the authors’ findings did not reflect the evidence presented and limitations in study numbers, sample sizes and study pooling, particularly in some subgroup analyses, suggested that the conclusions are not reliable”. Moreover, we need to know that by no means all reviews of the subject confirm this positive conclusion, for instance, thisthis, or this one; all of the latter reviews are more up-to-date than the one provided by ANF. Crucially, a Cochrane review concluded that “the evidence is inconclusive to allow us to make any recommendations for depression-specific acupuncture”.

“A randomized controlled trial of acupuncture and counseling for patients presenting with depression, after having consulted their general practitioner in primary care, showed that both interventions were associated with significantly reduced depression at three months when compared to usual care alone.”

We have discussed the trial in question on this blog. It follows the infamous ‘A+B versus B’ design which cannot possibly produce a negative result.

Now, please re-read the first paragraph of this post; but be careful not to fall off your chair laughing.

There would be more (much more) to criticise in the ANF report but, I think, these examples are ENOUGH!

Let me finish by quoting from the ANF’s view on the future as cited in their new ‘white paper’: “Looking ahead, it is clear that acupuncture is poised to make significant inroads into conventional medicine. It has the potential to become a part of every hospital’s standard of care and, in fact, this is already starting to take place not only in the U.S., but internationally. The treatment is a cost-effective and safe method of relieving pain in emergency rooms, during in-patient stays and after surgery. It can lessen post-operative nausea, constipation and urinary difficulties, and have a positive impact on conditions like hypertension, anxiety and insomnia…

Driven by popular demand and a growing body of scientific evidence, acupuncture is beginning to be taken seriously by mainstream conventional medicine, which is incorporating it into holistic health programs for the good of patients and the future of health care. In order for this transition to take place most effectively, misunderstandings about acupuncture need to be addressed. We hope this white paper has helped to clarify some of those misunderstandings and encourage anyone with questions to contact the Acupuncture Now Foundation.”

My question is short and simple: IGNORANCE OR FRAUD?

 

The question whether pharmacists should sell unproven alternative medicines will not go away. On this blog, we have discussed it repeatedly, for instance here, here and here. The Australian Journal of Pharmacy’s latest poll shows that readers have their suspicions about the validity of naturopathic medicines, with a whopping 544 voters choosing the option, “No, there’s no evidence they work” at the time of writing.

This constitutes 65% of readers who took part in the poll. A significant minority – 193 readers, with 23% of the vote – said that pharmacies should stock these medicines as they are legitimate products. Five per cent said that while they questioned their efficacy, pharmacy should stock them; and 3% said they were unsure, but the public wanted them.

Taree pharmacist and member of Friends in Science and Medicine Ian Carr, who has spoken to the AJP several times in the last couple of weeks as debate has continued about the subject of naturopathy in pharmacy, said he was surprised and pleased at the strength of the No vote. “I looked at [the poll] on the first day, and there was definitely a majority saying these things have no evidence, but there was still above 30% saying yes, they were legitimate products,” Carr told the AJP. “That’s been dwarfed by a lot of people who’ve looked in, and it’s interesting to have that many people vote. “I’m glad that it seems to be becoming recognised that there’s a need for the evidence base in these things, and the difference between having a naturopathic product or supplement on the shelf, and having somebody there charging for their time, as a naturopath, dispensing advice without knowing the patient’s background and without an intervention by a registered pharmacist.” He encouraged pharmacists concerned about the validity of naturopathy to consider what products and services they offer.

Where naturopaths are used, they should at least be expected to keep a record of products and advice dispensed, he says, similar to protocols around blood pressure and blood glucose monitoring. “If there’s going to be an insistence that naturopaths remain, that’s the way I’d like to see it: that the pharmacy has good records and oversight of what they’re doing. I think, given our connection to the PBS and the fact that we as pharmacists are looking for a more serious role as part of the health care team generally, and having a more active and integrative role, we would be silly to fritter it away on peripheries like naturopathy. I personally see the opportunities in evidence-based medicine and what flows from that, rather than trying to make up dollars. We’re more likely to lose control of pharmacy if we don’t guard it jealousy.”

One of the suppliers of CAM products to pharmacies responded to the article by stating the following:

“The complementary and alternative medicine (CAMs) sector and its role in healthcare management continues to be hotly debated by the media. Rather than dissuade this debate, we actively encourage this discussion, as it shines a light on many issues which need to be addressed. Of priority is the point that not all complementary and alternative medicine products are equal. As in many media articles, an incredibly wide spectrum of products are grouped under the label of ‘CAMs’. Products with specific clinical evidence, high-quality manufacturing processes and transparency on the sourcing of ingredients are not clearly identified from products without these qualities. Consumers and healthcare professionals are unable to distinguish this difference due to a lack of clear labelling. We agree with calls for CAMs products to be more thoroughly assessed, beyond being simply classified as ‘safe’. Healthcare professionals and consumers deserve this information and are indeed asking for it. Consumers are aware of the impact of their choices and that their demand drives industry change. History is littered with recent examples where consumer awareness has changed the marketplace for the better. Consumer-driven change in the CAMs industry IS possible, it just needs to be supported. The Australian CAMs industry needs to increase healthcare professional and consumer education on the importance of evidence-based CAM products; on what ‘evidence-based’ means and what this difference delivers… Healthcare professionals are key to helping their patients understand that not all CAMs or natural medicine products are equal… It takes time to change the way people see CAMs and natural medicines – but it is of inherent value for the consumer. Something, we believe, is integral to the future of the industry.”

The arguments are clearest, if we focus on a specific type of alternative medicine and spell out what precisely we are talking about. The one that comes to mind is, of course, homeopathy. In my view, there is no good reason why pharmacists should sell homeopathic remedies. It is comforting to know that the Chief Scientist of the UK Royal Pharmaceutical Society, Professor Jayne Lawrence, agrees; she stated about a year ago that “the public have a right to expect pharmacists and other health professionals to be open and honest about the effectiveness and limitations of treatments. Surely it is now the time for pharmacists to cast homeopathy from the shelves and focus on scientifically based treatments backed by clear clinical evidence.”

And what has changed since?

Nothing, as far as I can see – but please correct me, if I am wrong.

I think it is important that we remind the community pharmacists everywhere that they have their very own codes of ethics and that they need to adhere to them. If they don’t, they tacitly agree that they are not really healthcare professionals but mere shop-keepers.

We tend to trust charities; many of us donate to charities; we think highly of the work they do and the advice they issue. And why shouldn’t we? After all, a ‘charity’ is ‘an institution or organization set up to provide help, money, etc, to those in need’. Not a hint at anything remotely sinister here – charities are good!

Except, of course, those that are not so good!

By ‘not so good’ I mean charities that misinform the public to a point where they might even endanger our health, well-being and savings. Yes, I am speaking of those charities that promote unproven or disproven alternative therapies – and unfortunately, there are many of those around today.

Our recent letter in the SUNDAY TIMES, tried to alert the public to this problem and to the fact that the UK regulator seems to be failing to do much about it. A Charity Commission spokesman, in turn, replied that his organisation had received the letter and would respond formally to it:

“The Commission is required to register organisations as charities which are established for exclusively charitable purposes for the public benefit,” he said. “Charitable purposes for the advancement of health include conventional methods as well as complementary, alternative or holistic methods which are concerned with healing mind, body and spirit in the alleviation of symptoms and the cure of illness. Those organisations dealing with complementary and alternative medicines must be able to demonstrate that they are capable of promoting health otherwise they will not be for the public benefit.

“The Commission is the registrar and regulator of charities however it is not the authority in the efficacy of any and every non-traditional medical treatment. These are issues of substantial debate with a variety of opinions. Each case is considered on its merits based on the evidence available. To be charitable there needs to be sufficient evidence of the efficacy of the method to be used. The Commission must further be assured that any potential harm that might be said to arise does not outweigh the benefit identified by the method.

“The Commission expects charities to provide information that is factually accurate with legitimate evidence.” 

But is the information provided by all charities factually accurate?

Take, for instance, YES TO LIFE! Have a good look and then decide for yourself.

On their website they state: “We provide support, information and financial assistance to those with cancer seeking to pursue approaches that are currently unavailable on the NHS. We also run a series of educational seminars and workshops which are aimed at the general public who want to know more and practitioners working with people who have cancer.”

The website informs us about many alternative therapies and directly or indirectly promote them for the curative or supportive treatment of cancer. I have chosen 5 of them and copied the respective summaries as published by YES TO LIFE. My main selection criterion was having done some research myself on the modality in question. Here are the 5 cancer treatments which I selected; the text from YES TO LIFE is in bold, and that of my published research is in normal print with a link to the published paper:

CARCTOL

Carctol is a relatively inexpensive product, specifically formulated to assist cells with damaged respiration, it is also a powerful antioxidant that targets free radicals, the cause of much cellular damage. It also acts to detoxify the system.

The claim that Carctol is of any benefit to cancer patients is not supported by scientific evidence.

LAETRILE

Often given intravenously as part of a programme of Metabolic Therapy, Laetrile is a non-toxic extract of apricot kernels. The claimed mechanism of action that is broken down by enzymes found in cancer cells. Hydrogen cyanide, one of the products of this reaction then has a local toxic effect on the cells.

The claims that laetrile or amygdalin have beneficial effects for cancer patients are not currently supported by sound clinical data. There is a considerable risk of serious adverse effects from cyanide poisoning after laetrile or amygdalin, especially after oral ingestion. The risk-benefit balance of laetrile or amygdalin as a treatment for cancer is therefore unambiguously negative.

MISTLETOE

Mistletoe therapy was developed as an adjunct to cancer treatment in Switzerland in 1917-20, in the collaboration between Dr I Wegman MD and Dr Rudolf Steiner PhD (1861-1925). Mistletoe extracts are typically administered by subcutaneous injection, often over many years. Mistletoe treatment improves quality of life, supports patients during recommended conventional cancer treatments and some studies show survival benefit. It is safe and has no adverse interactions with conventional cancer treatments.

None of the methodologically stronger trials exhibited efficacy in terms of quality of life, survival or other outcome measures. Rigorous trials of mistletoe extracts fail to demonstrate efficacy of this therapy.

UKRAIN

A type of low toxicity chemotherapy derived from a combination of two known cytotoxic drugs that are of little use individually, as the doses required for effective anticancer action are too high to be tolerated. However the combination is effective at far lower doses, with few side effects.

The data from randomised clinical trials suggest Ukrain to have potential as an anticancer drug. However, numerous caveats prevent a positive conclusion, and independent rigorous studies are urgently needed. [To judge the validity of this last treatment, I also recommend reading a previous post of mine.]

Finally, it might be informative to see who the individuals behind YES TO LIFE are. I invite you to have a look at their list of medical advisors which, I think, speaks for itself. It includes, for instance, Dr Michael Dixon of whom we have heard before on this blog, for instance, here, here and here.

Say no more!

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.

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