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

critical thinking

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It has been reported that pharmacies in New Zealand continue to ignore a code of ethics that requires them to inform customers, if a product has no evidence of efficacy. The code of ethics states: “Pharmacists must advise patients when scientific support for treatment is lacking.”

Eight Auckland pharmacies were visited to enquire about a homeopathic product for sale. Pharmacy staff were asked what they knew about a homeopathic product on their shelves and if it worked. All failed to share information about the lack of scientific evidence showing the product works. Instead, they claimed that homeopathic solution of arnica sold as a treatment for injuries, bruising and post-surgery trauma “works really, really well”, was “awesome” and could also cure headaches. One salesperson checked with the pharmacist whether the product was suitable for swelling post-surgery and was told it was fine as long as no other medication was being taken at the same time.

There is no credible evidence the highly diluted homeopathic remedies sold by pharmacists work better than a placebo. Homeopathy’s effectiveness has been rejected by many scientists and by large government reviews conducted in the UK, Australia and Europe.

Even if a staff member personally believes a homeopathic product works, guidelines referenced by the code of ethics say this should not sway the information given to the customer: “Patients must be made aware of the likely effectiveness of a given therapy according to recognised peer-reviewed medical publications, in spite of your personal beliefs.”

Shortly after the code was changed in March 2018, Newsroom performed the same secret shopper experiment at four pharmacies and found the new rule was not followed. Eighteen months on, nothing has improved.

The chair of the consumer advocate group the ‘Society for Science Based Healthcare’, Mark Hanna, said there was no excuse for pharmacies to sell this kind of thing without warning. “Pharmacists should know better. Full stop. They should not be misleading their patients, they should not be letting their staff mislead their patients. If they don’t know, that’s incompetence. I would expect to be given reasonable, evidence-based advice, possibly some different options with the reason why I might choose one over the other. I wouldn’t expect to be misled and sold something that wouldn’t work.

Asked why the code was not being followed a spokesperson of the NZ pharmacists said a reminder of the code of ethics had been sent to pharmacies in June. It was recommended all staff be made aware of the code: “We encourage you to share this protocol with your entire team – even though it is a protocol for pharmacists, the reasoning also extends to other staff members in the pharmacy and it is important that all staff ensure that the patient has been provided with sufficient information to make an informed choice.”

By Jove, we have discussed this issue often enough. If you are interested, here are a few of my more recent posts on this subject:

But pharmacists seem utterly reluctant to change – in NZ or elsewhere. Why? Could it have something to do with money?

If doctors violate their code of ethics, they face being reprimanded by their professional body. It is high time that the same happens with pharmacists, I feel.

I almost forgot!

This would have been no good, after all, Charles has for decades been the most influential supporter of so-called alternative medicine (SCAM) in the UK. He is one of SCAM’s greatest proponent.

So, here is my up-dated, extended and illustrated summary of his achievements in this area.

HAPPY BIRTHDAY CHARLES!

Charles went on a journey of ‘spiritual discovery’ into the wilderness of northern Kenya. His guru and guide at the time was Laurens van der Post (later discovered to be a fraud and compulsive fantasist and to have fathered a child with a 14-year old girl entrusted to him during a sea voyage).

Van der Post wanted to awake Charles’ mind and attune it to the vitalistic  ideas of Carl Jung’s ‘collective unconscious’, and it is this belief in vitalism that provides the crucial link to alternative medicine: virtually every form of alternative therapies is based on the assumption that some sort of vital force exists. Charles was so taken by van der Post that he made him the godfather of Prince William. After Post’s death, he established an annual lecture in his honour (the lecture series was discontinued after Van der Post was discovered to be a fraud).

Some time in the 1970s, Charles met Jimmy Saville and befriended him. Apparently, Saville later advised Charles on several occasions in various health-related matters.

Throughout the 1980s, Charles lobbied for the statutory regulation of chiropractors and osteopaths in the UK. In 1993, this finally became reality. These two SCAM professions are to this day the only ones regulated by statute in the UK.

Osteopathy has strong Royal links: Prince Charles is the President of the GOsC; Princess Diana was the President of the GCRO; and Princess Anne is the patron of the British School of Osteopathy (statement dated 2011).

In 1982, Prince Charles was elected as President of the British Medical Association (BMA) and promptly challenged the medical orthodoxy by advocating alternative medicine. In a speech at his inaugural dinner as President, the Prince lectured the medics: ‘Through the centuries healing has been practised by folk healers who are guided by traditional wisdom which sees illness as a disorder of the whole person, involving not only the patient’s body, but his mind, his self-image, his dependence on the physical and social environment, as well as his relation to the cosmos.’ The BMA-officials ordered a full report on alternative medicine which promptly condemned this area as implausible nonsense.

Six years later, a second report, entitled Complementary Medicine – New Approaches to Good Practice, heralded an astonishing about-turn stating that: “the demand for non-conventional therapies had become so pressing that organised medicine in Britain could no longer ignore its contribution”. At the same time, however, the BMA set in motion a further chapter in the history of SCAM by insisting that it was “unacceptable” to allow the unrestricted practice of non-conventional therapies, irrespective of training or experience.

In 1993, Charles founded his lobby group which, after being re-named several times, ended up being called the ‘Foundation for Integrated Health’ (FIH). It was closed down in 2010 amidst allegations of money laundering and fraud. Its chief executive, George Gray, was later convicted and went to jail. The FIH had repeatedly been a little economical with the truth.

In 2000, Charles wrote an open letter to The Times stating that…It makes good sense to evaluate complementary and alternative therapies. For one thing, since an estimated £1.6 billion is spent each year on them, then we want value for our money. The very popularity of the non-conventional approaches suggests that people are either dissatisfied with their orthodox treatment, or they find genuine relief in such therapies. Whatever the case, if they are proved to work, they should be made more widely available on the NHS…But there remains the cry from the medical establishment of “where’s the proof?” — and clinical trials of the calibre that science demands cost money…The truth is that funding in the UK for research into complementary medicine is pitiful…So where can funding come from?…Figures from the department of complementary medicine at the University of Exeter show that less than 8p out of every £100 of NHS funds for medical research was spent on complementary medicine. In 1998-99 the Medical Research Council spent no money on it at all, and in 1999 only 0.05 per cent of the total research budget of UK medical charities went to this area…

In 2001, Charles worked on plans to help build a model hospital of integrated medicine. It was to train doctors to combine conventional medicine and alternative treatments, such as homeopathy, Ayurvedic medicine and acupuncture, and was to have up to 100 beds. The prince’s intervention marked the culmination of years of campaigning by him for the NHS to assign a greater role to alternative medicine. Teresa Hale, founder of the Hale Clinic in London, said: “Twenty-five years ago people said we were quacks. Now several branches, including homeopathy, acupuncture and osteopathy, have gained official recognition.” The proposed hospital, which was due to open in London in 2003/4, was to be overseen by Mosaraf Ali, who runs the Integrated Medical Centre (IMC) in London. But the hospital never materialised.

This might be due to Mosaraf Ali falling in disrepute: Raj Bathija, 69 and from India, went for a massage at the clinic of Dr Mosaraf Ali and his brother Imran in 2005 after suffering from two strokes. However, he claims that shortly after the treatment, his legs became pale and discoloured. Four days afterwards, Mr Bathija was admitted to hospital, where he had to have both legs amputated below the knee due to a shortage of blood. According to Mr Bathija, Dr Ali and his brother were negligent in that they failed to diagnose his condition and neglected to advise him to go to hospital. His daughter Shibani said: “My father was in a wheelchair but was making progress with his walking. He hoped he might become a bit more independent. With the amputations, that’s all gone.” Dr Ali was sued (if anyone knows the outcome of this case, please let me know).

At the age of 53, Mrs Parker Bowles went on a trek to the Himalayas to ‘re-energise’ her spirits and encourage her to give up smoking. She was in a party of 12 accompanied by the Prince of Wales’s favourite health guru, Dr Mosaraf Ali. Mrs Parker Bowles subsequently became a regular visitor to Dr Ali’s London practice where she has been encouraged to take up yoga both to combat her back pain and to help her give up smoking.

In the same year, Charles published an editorial in the BMJ promoting his ideas around integrative medicine. Its title: THE BEST OF BOTH WORLDS.

In 2003, Prince Charles’ FIH launched a five-year plan which outlined how to improve access to alternative therapies.

In 2004, Charles publicly supported the Gerson diet as a treatment for cancer and Prof Baum, an eminent oncologist, was invited to respond in an open letter to the British Medical Journal: …Over the past 20 years I have treated thousands of patients with cancer and lost some dear friends and relatives to this dreaded disease…The power of my authority comes with knowledge built on 40 years of study and 25 years of active involvement in cancer research. Your power and authority rest on an accident of birth. I don’t begrudge you that authority but I do beg you to exercise your power with extreme caution when advising patients with life-threatening diseases to embrace unproven therapies.

In 2005, the ‘Smallwood-Report’ was published; it had been commissioned by Charles and paid for by Dame Shirley Porter to inform health ministers. It stated that up to 480 million pounds could be saved, if one in 10 family doctors offered homeopathy as an “alternative” to standard drugs for asthma. Savings of up to 3.5 billion pounds could be achieved by offering spinal manipulation rather than drugs to people with back pain. Because I had commented on this report, Prince Charles’ first private secretary asked my vice chancellor to investigate my alleged indiscretion; even though I was found to be not guilty of any wrong-doing, all local support at Exeter stopped which eventually led to my early retirement. ITV later used this incident in a film entitled THE MEDDLING PRINCE, I later published a full account of this sad story in my memoir.

In a 2006 speechPrince Charles told the World Health Organisation in Geneva that alternative medicine should have a more prominent place in health care and urged every country to come up with a plan to integrate conventional and alternative medicine into the mainstream. But British science struck back. Anticipating Prince Charles’s sermon in Geneva, 13 of Britain’s most eminent physicians and scientists wrote an “Open Letter” which expressed concern over “ways in which unproven or disproved treatments are being encouraged for general use in Britain’s National Health Service.” The signatories argued that “it would be highly irresponsible to embrace any medicine as though it were a matter of principle.”

In 2008, The Times published my letter asking the FIH to withdraw two guides promoting alternative medicine, stating: “the majority of alternative therapies appear to be clinically ineffective, and many are downright dangerous.” A speaker for the FIH countered the criticism by stating: “We entirely reject the accusation that our online publication Complementary Healthcare: A Guide contains any misleading or inaccurate claims about the benefits of complementary therapies. On the contrary, it treats people as adults and takes a responsible approach by encouraging people to look at reliable sources of information… so that they can make informed decisions. The foundation does not promote complementary therapies.”

In 2009, the Prince held talks with the health Secretary to persuade him to introduce safeguards amid a crackdown by the EU that could prevent anyone who is not a registered health practitioner from selling remedies. This, it seems, was yet another example of Charles’ disregard of his constitutional role.

In the same year, Charles urged the government to protect alternative medicine because “we fear that we will see a black market in herbal products”, as Dr Michael Dixon (LVO,2015; OBE 2001), then medical director of Charles’ FIH, put it.

In 2009, the health secretary wrote to the prince suggesting a meeting on the possibility of a study on integrating complementary and conventional healthcare approaches in England. The prince had written to Burnham’s predecessor, Alan Johnson, to demand greater access to complementary therapies in the NHS alongside conventional medicine. The prince told him that “despite waves of invective over the years from parts of the medical and scientific establishment” he continued to lobby “because I cannot bear people suffering unnecessarily when a complementary approach could make a real difference”. He opposed “large and threatened cuts” in the funding of homeopathic hospitals and their possible closure. He complained that referrals to the Royal London homeopathic hospital were increasing “until what seems to amount to a recent ‘anti-homeopathic campaign’”. He warned against cuts despite “the fact that these homeopathic hospitals deal with many patients with real health problems who otherwise would require treatment elsewhere, often at greater expense”.

In 2009, it was announced that the ‘College of Integrated Medicine’ (the name was only later changed to ‘College of Medicine’, see below) was to have a second base in India. An Indian spokesman commented: “The second campus of the Royal College will be in Bangalore. We have already proposed the setting up of an All India Institute of Integrated Medicine to the Union health ministry. At a meeting in London last week with Prince Charles, we finalized the project which will kick off in July 2010”.

In 2010, Charles publicly stated that he was proud to be perceived as ‘an enemy of the enlightenment’.

In 2010, ‘Republic’ filed an official complaint about FIH alleging that its trustees allowed the foundation’s staff to pursue a public “vendetta” against a prominent critic of the prince’s support for complementary medicines. It also suggested that the imminent closure of Ernst’s department may be partly down to the charity’s official complaint about him after he publicly attacked its draft guide to complementary medicines as “outrageous and deeply flawed”.

In 2010, former fellows of Charles’ disgraced FIH launched a new organisation, The College of Medicine’ supporting the use of integrated treatments in the NHS. One director of the college is Michael Dixon, a GP in Cullompton, formerly medical director of the Foundation for Integrated Health. My own analysis of the activities of the new college leaves little doubt that it is promoting quackery.

In 2010, Charles published his book HARMONY which is full of praise for even the most absurd forms of alternative therapies and even bogus diagnostic tests used by alternative practitioners.

In 2011, after the launch of Charles’ range of herbal tinctures, I had the audacity to publicly criticise Charles for selling the Duchy Herbals detox tincture which I named ‘Dodgy Originals Detox Tincture’.

In 2011, Charles forged a link between ‘The College of Medicine’ and an Indian holistic health centre (see also above). The collaboration was reported to include clinical training to European and Western doctors in ayurveda and homoeopathy and traditional forms of medicine to integrate them in their practice. The foundation stone for the extended campus of the Royal College known as the International Institution for Holistic and Integrated Medicine was laid by Dr Michael Dixon in collaboration with the Royal College of Medicine.

In 2012, Charles was nominated for ‘THE GOLDEN DUCK AWARD’ for his achievements in promoting quackery. However, Andrew Wakefield beat him to it; Charles certainly was a deserving runner-up.

In 2013, Charles called for society to embrace a broader and more complex concept of health. In his article he described a vision of health that includes the physical and social environment, education, agriculture and architecture.

In 2013, Charles’ Highgrove enterprise offered ‘baby-hampers’ for sale at £195 a piece and made a range of medicinal claims for the products it contained. As these claims were not supported by evidence, there is no way to classify them other than quackery.

By 2013, the ‘Association of Osteomyologists’ were seeking to become regulated by statute, with the help of Prince Charles as their patron. The chairman and founder of this organisation was knighted for services to alternative medicine.  Osteomyologists encourage the use of techniques including cranio-sacral therapy and claim that “we all know that Colleges, Institutions, and Medical Practitioners, are brain washed from the very outset into believing that their discipline is the only way to go.”

In November 2013, Charles invited alternative medicine proponents from across the world, including Dean Ornish, Michael Dixon, chair of College of Medicine, UK and Issac Mathai of Soukya Foundation, Bangalore, to India for a ‘brain storm’ and a subsequent conference on alternative medicine. The prince wanted the experts to collaborate and explore the possibilities of integrating different systems of medicines and to better the healthcare delivery globally, one of the organisers said.

In June 2014, BBC NEWS published the following text about a BBC4 broadcast entitled ‘THE ROYAL ACTIVIST’ aired on the same day: Prince Charles has been a well-known supporter of complementary medicine. According to a… former Labour cabinet minister, Peter Hain, it was a topic they shared an interest in. He had been constantly frustrated at his inability to persuade any health ministers anywhere that that was a good idea, and so he, as he once described it to me, found me unique from this point of view, in being somebody that actually agreed with him on this, and might want to deliver it. Mr Hain added: “When I was Secretary of State for Northern Ireland in 2005-7, he was delighted when I told him that since I was running the place I could more or less do what I wanted to do.*** I was able to introduce a trial for complementary medicine on the NHS, and it had spectacularly good results, that people’s well-being and health was vastly improved. And when he learnt about this he was really enthusiastic and tried to persuade the Welsh government to do the same thing and the government in Whitehall to do the same thing for England, but not successfully,” added Mr Hain. On this blog, I have pointed out that the research in question was fatally flawed and that Charles, once again, overstepped the boundaries of his constitutional role.

In 2015, two books were published which are relevant in this context. My memoir A SCIENTIST IN WONDERLAND recounts most of my dealings with Charles and his sycophants, including how an intervention from his first private secretary eventually led to the closure of my department. The book by Catherine Meyer CHARLES, THE HEART OF A KING is far less critical about our heir to the throne; it nevertheless severely criticises his stance on alternative medicine.

In October 2015, the Guardian obtained the infamous “black spider memos” which revealed that Charles had repeatedly lobbied politicians in favour of alternative medicine (see also above).

In 2016, speaking at a global leaders summit on antimicrobial resistance, Prince Charles warned that Britain faced a “potentially disastrous scenario” because of the “overuse and abuse” of antibiotics. The Prince explained that he had switched to organic farming on his estates because of the growing threat from antibiotic resistance and now treats his cattle with homeopathic remedies rather than conventional medication. “As some of you may be aware, this issue has been a long-standing and acute concern to me,” he told delegates from 20 countries “I have enormous sympathy for those engaged in the vital task of ensuring that, as the world population continues to increase unsustainably and travel becomes easier, antibiotics retain their availability to overcome disease… It must be incredibly frustrating to witness the fact that antibiotics have too often simply acted as a substitute for basic hygiene, or as it would seem, a way of placating a patient who has a viral infection or who actually needs little more than patience to allow a minor bacterial infection to resolve itself.”

In 2017, the ‘College of Medicine’ mentioned above was discretely re-named ‘College of Medicine and Integrated Health’

In the same year, Charles declared that he will open a centre for alternative medicine in the recently purchased Dumfries House in Scotland. Currently, the College of Medicine and Integrated Health is offering two-day Foundation Courses at this iconic location. Gabriel Chiu, a US celebrity cosmetic and reconstructive surgeon, and his wife Christine, joined the Prince of Wales as he opened the integrated health and wellbeing centre on the Dumfries House Estate in East Ayrshire in 2019. As he unveiled a plaque at the event, Prince Charles said: “I’m so glad that all of you have been able to get here today, particularly because I could not be more proud to see the opening of this new integrated health centre at Dumfries House. It’s something I’ve been wanting to do for the last 35 years. I’m also so proud of all the team at Dumfries House who built it, an all in-house team.

“To reach this point where we can now offer a range of social prescribing opportunities is enormously encouraging and I hope it will be able to make some difference to a lot of the health issues that exist in this area.”

Also in 2017, ‘Country News’ published an article about our heir to the throne stating that Prince of Wales has revealed he uses homeopathic treatments for animals on his organic farm at Highgrove to help reduce reliance on antibiotics, the article stated. He said his methods of farming tried wherever possible to ‘‘go with the grain of nature’’ to avoid dependency on antibiotics, pesticides and other forms of chemical intervention.

In 2018, The Prince of Wales accompanied the Prime Minister of India, Narendra Modi, to the Science Museum in London, and praised Asian medicine practices. The heir to the throne and the Indian Prime Minister then jointly unveiled a plaque for the UK’s first centre of excellence for Indian traditional medicine.

In the same year, it was revealed that UK farmers are being taught how to treat their livestock with homeopathy “by kind permission of His Royal Highness, The Prince Of Wales”

In 2019, the Faculty of Homeopathy announced that His Royal Highness The Prince of Wales had accepted to become Patron of the Faculty of Homeopathy. Dr Gary Smyth, President of the Faculty of Homeopathy comments, “As the Faculty celebrates its 175th anniversary this year, it is an enormous honour for us to receive the Patronage of His Royal Highness The Prince of Wales and I am delighted to announce this news today.” Charles’ move amazed observers who saw it as a deliberate protest against the discontinuation of reimbursement of homeopathy by the NHS.

In 2019, Prince Charles said that yoga had “proven beneficial effects on both body and mind,” and has “tremendous social benefits” that help build “discipline, self-reliance and self-care.”

___________________________________________________________________

So again, Happy Birthday Your Royal Highness – and please don’t forget: it’s not too late to start doing good in the realm of healthcare by supporting good science, critical thinking and evidence-based medicine.

Sincerely yours

Edzard Ernst

“Maybe it is as simple as: I enjoyed that treatment, it was worth the amount I spent on it and I feel better.”

This argument between the fans and the critics of so-called alternative medicine (SCAM) might be the key to understanding the two opposing positions. It applies across the board to all the SCAMs that lack solid evidence (which, of course, is most).

  1. The sceptic asks for evidence of effectiveness and finds none that is convincing. He concludes that the SCAM is not evidence-based.
  2. The SCAM enthusiast cannot argue with the evident lack of evidence, but says (as Angela did in a recent comment): “Maybe it is as simple as: I enjoyed that treatment, it was worth the amount I spent on it and I feel better.”

Both positions may well be correct. And both are held with total conviction. Thus, many consumers who are not deeply into SCAM are confused or even bewildered.

So, how can we make sense of this situation?

Let me start with the argument of the SCAM enthusiast. She is, of course, right to sate that she enjoyed reflexology, or aromatherapy, or crystal therapy. She might also enjoy having her hair done, or soaking in a bath, or drinking a glass of champagne. There is nothing wrong with that, and we should all be happy for her.

Enjoying something is often good for you – often but not always. Enjoying a fag isn’t. Enjoying a bottle of whiskey per evening isn’t. Enjoying a drive at neck-breaking speed on a public motorway isn’t. Enjoying sending out hate-mail isn’t. But innocent treats like a foot massage by an aromatherapist probably is!

But none of these things can be considered to be a THERAPY. Feeling better is not necessarily a therapeutic aim.

So, the situation might not be so confusing after all: enjoyments are enjoyments. They are usually fine, and they are often very personal. Some people enjoy being massaged, others don’t. But enjoyments are not therapies. This means that all would be fine, if we stopped calling aromatherapy, reflexology, crystal therapy THERAPIES, and if we stopped calling aromatherapists, etc. THERAPISTS.

Therapies are medical interventions, and as such they need evidence to back them up, evidence that they do something positive to our health. Therapists are healthcare professionals who make therapeutic claims that need evidence to back them up. If that is missing, sceptics are entirely correct to criticise them. In fact, they fulfil a public service when criticising bogus therapies or claims.

So, the confusion mentioned above mainly arises from mislabelling enjoyments as therapies. Lets call aromatherapists, etc. by different names, and the confusion disappears. Let’s stop aromatherapists, etc. making therapeutic claims, and there is no more reason for sceptics to criticise.

The U.S. Food and Drug Administration (FDA) issued another warning about homeopathy. Here are some of the most relevant excerpts:

… Homeopathic products … are marketed without FDA review and may not meet modern standards for safety, effectiveness, quality and labeling. FDA uses a risk-based approach to monitor these products and to evaluate reports of adverse effects.

… Homeopathic drug products are made from a wide range of substances, including ingredients derived from plants, healthy or diseased animal or human sources, minerals and chemicals, including known poisons. These products have the potential to cause significant and even permanent harm if they are poorly manufactured, since that could lead to contaminated products or products that have potentially toxic ingredients at higher levels than are labeled and/or safe, or if they are marketed as substitute treatments for serious or life-threatening diseases and conditions, or to vulnerable populations. In addition, some products may be labeled as homeopathic that do not conform to traditional homeopathic principles.

As the homeopathy industry continues to grow at a rapid pace, we want to clarify for both consumers and industry how we assess the potential safety risks of these products. That’s why in 2017, the FDA issued a draft guidance discussing our, risk-based enforcement approach to drug products labeled as homeopathic. Today, we are taking two new steps toward clarifying this approach.

First, we have revised the 2017 draft guidanceExternal Link Disclaimer to provide further information around our approach and are asking for public input on the revised draft. The draft guidance details a risk-based enforcement policy prioritizing certain categories of homeopathic products that could pose a higher risk to public health, including products with particular ingredients and routes of administration, products for vulnerable populations, and products with significant quality issues. We encourage the public to review this revised draft guidance and comment before it is finalized. We will consider feedback gathered through this new public comment period, the more than 4,500 comments interested stakeholders submitted on the original 2017 draft guidance, and information gleaned from a 2015 public hearing on the current use of homeopathic drug products. When finalized, this guidance will help provide transparency regarding the categories of homeopathic drug products that we intend to prioritize under our risk-based enforcement approach.

Second, the agency is withdrawingExternal Link Disclaimer the Compliance Policy Guide (CPG) 400.400, entitled “Conditions Under Which Homeopathic Drugs May be Marketed.” Risk is an important driver of the FDA’s regulatory and enforcement actions for all drug products, including homeopathic drug products. Since the issuance of CPG 400.400 in 1988, the FDA has encountered multiple situations in which homeopathic drug products posed a significant risk to patients, even though the products, as labeled, appeared to meet the conditions described in CPG 400.400. However, CPG 400.400 is inconsistent with our risk-based approach to regulatory and enforcement action generally and therefore does not reflect our current thinking. Therefore, it is appropriate to withdraw CPG 400.400 at this time.

… the FDA has issued warning letters to companies who produce homeopathic drug products for significant violations of current good manufacturing practice (CGMP) regulations and various other violations. So far in 2019, we’ve issued more than 10 warning letters to companies for violations concerning homeopathic products. Recently, we issued warning letters to Kadesh Inc., U.S. Continental Marketing, Inc., Fill It Pack It Inc. and Bershtel Enterprises LLC dba WePackItAll, which had jointly manufactured and packaged eye drops produced in non-sterile conditions which could result in serious eye infections. These warning letters should alert all companies that homeopathic drug products must be manufactured and labeled in accordance with the requirements of the Federal Food, Drug, and Cosmetic Act and agency regulations…

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If you ask me, ‘homeopathic drug products’ is a misleading name. A drug is defined as a medicine or other substance which has a physiological effect when ingested or otherwise introduced into the body. But highly diluted homeopathics do not contain a substance that has physiological effects.

They should be called

  • homeopathics,
  • homeopathic pseudo-drugs,
  • homeopathic placebos,
  • or fake drugs.

And their labels should make it clear that:

  • these products contain no active ingredients,
  • and have not been shown to work beyond placebo.

That would be the type of honest and transparent information which consumers deserve and have a right to.

 

 

This came a few days ago, completely out of the blue. To be honest, I did not even know what the BOOK AUTHORITY is. So, I looked them up; this is what they say about themselves:

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Only the very best books are featured on BookAuthority. To keep our site objective and unbiased, ratings are calculated purely based on data. We do not accept requests to feature a book, nor are we doing business with publishers or authors.

BookAuthority serves millions of book recommendations every month, was ranked #1 on ProductHunt, and has been featured on CNN, Forbes and Inc.
If you are a blogger, feel free to check out our tools for bloggers.

It does not happen often but, today, I am speechless.

I have recently gone to the trouble of evaluating 150 different modalities from the realm of so-called alternative medicine (SCAM) in a book. This is what it tells you about Reiki:

Reiki is a form of paranormal or energy healing popularised by Japanese Mikao Usui (1865-1926). Rei means universal spirit (sometimes thought of as a supreme being) and ki is the assumed universal life energy.

    1. Reiki is based on the assumptions of Traditional Chinese Medicine and the existence of ‘chi’, the life-force that determines our health.
    2. Reiki practitioners believe that, with their hands-on healing method, they can transfer ‘healing energy’ to a patient which, in turn, stimulates the self-healing properties of the body. They assume that the therapeutic effects of this technique are obtained from a ‘universal life energy’ that provides strength, harmony, and balance to the body and mind.
    3. There is no scientific basis for such notions, and reiki is therefore not plausible.
    4. Reiki is used for a number of conditions, including the relief of stress, tension and pain.
    5. There have been several clinical trials testing the effectiveness of reiki. Unfortunately, their methodological quality is usually poor.
    6. A systematic review summarising this evidence concluded that the evidence is insufficient to suggest that reiki is an effective treatment for any condition. Therefore, the value of reiki remains unproven.[1] And a Cochrane review found that there is insufficient evidence to say whether or not Reiki is useful for people over 16 years of age with anxiety or depression or both.[2]
    7. Reiki appears to be generally safe, and serious adverse effects have not been reported. Some practitioners advise caution about using reiki in people with psychiatric illnesses because of the risk of bringing out underlying psychopathology.

PLAUSIBILITY

Negative

EFFICACY

Negative

SAFETY

Positive

COST

Positive

RISK/BENEFIT BALANCE

Negative

[1] https://www.ncbi.nlm.nih.gov/pubmed/?term=lee+pittler+ernst%2C+reikiv

[2] https://www.ncbi.nlm.nih.gov/pubmed/25835541

So, Reiki is both implausible and unproven. Now a new, large trial has emerged that might change this verdict. The main purpose of this study (published in JCAM) was to measure the effect of a single session of Reiki on physical and psychological health in a large nonclinical sample.

The study design was a single arm effectiveness trial with measures at pre-and postintervention. The study took place at private Reiki practices across the United States. Reiki practitioners were recruited from an online mailing list to participate in the study with their Reiki clients. A total of 99 Reiki practitioners met the inclusion criteria and participated in the study. Reiki practitioners were instructed to give a flyer to each of their Reiki clients that contained information about the study and invited the client to complete a survey before and after their Reiki session.

Trained and certified Reiki Masters conducted the Reiki sessions in person, with each session lasting between 45 and 90 min. The 20-item Positive and Negative Affect Schedule was used to assess affect, and brief, single-item self-report measures were used to assess a wide range of physical and psychological variables immediately before (pre) and after (post) the Reiki session.

A total of N = 1411 Reiki sessions were conducted and included in the analysis. Statistically significant improvements were observed for all outcome measures, including positive affect, negative affect, pain, drowsiness, tiredness, nausea, appetite, shortness of breath, anxiety, depression, and overall well-being (all p-values <0.001).

The authors concluded that the results from this large-scale multisite effectiveness trial suggest that a single session of Reiki improves multiple variables related to physical and psychological health.

Really?

This ‘large scale’ effectiveness trial’ could make you laugh and cry at the same time.

  • Laugh, because it is almost comically daft.
  • Cry, because the conclusion is bound to mislead a lot of gullible people.

Without a control group, the study cannot even attempt to determine anything like the effectiveness of Reiki. What the results truly show is that consumers who consult (and pay) a Reiki master expect to have a positive effect. The expectation translates into a sizable placebo response. The investigators seem to be clueless scientists, or they wilfully mislead the public (the senior author is from the ‘The Center for Reiki Research‘ which, according to its mission statement, is dedicated to gaining acceptance for the practice of Reiki by the medical community).

The only conclusion that can honestly be drawn from the data is that consumers who pay for a serivce often like this service (otherwise they would not use it!). It’s a bit like the thing with the hamburger joint that I often cite: if you ask people eating in a McDonalds whether they enjoy hamburgers, most will answer in the affirmative.

But there might be a valuable lesson in this paper after all: never trust the JACM further than you can throw it.

The medical literature is currently swamped with reviews of acupuncture (and other forms of TCM) trials originating from China. Here is the latest example (but, trust me, there are hundreds more of the same ilk).

The aim of this review was to evaluate the effectiveness of scalp, tongue, and Jin’s 3-needle acupuncture for the improvement of post-apoplectic aphasia. PubMed, Cochrane, Embase databases were searched using index words to identify qualifying randomized controlled trials (RCTs). Meta-analyses of odds ratios (OR) or standardized mean differences (SMD) were performed to evaluate the outcomes between investigational (scalp / tongue / Jin’s 3-needle acupuncture) and control (traditional acupuncture; TA and/or rehabilitation training; RT) groups.

Thirty-two RCTs (1310 participants in investigational group and 1270 in control group) were included. Compared to TA, (OR 3.05 [95% CI: 1.77, 5.28]; p<0.00001), tongue acupuncture (OR 3.49 [1.99, 6.11]; p<0.00001), and Jin’s 3-needle therapy (OR 2.47 [1.10, 5.53]; p = 0.03) had significantly better total effective rate. Compared to RT, scalp acupuncture (OR 4.24 [95% CI: 1.68, 10.74]; p = 0.002) and scalp acupuncture with tongue acupuncture (OR 7.36 [3.33, 16.23]; p<0.00001) had significantly better total effective rate. In comparison with TA/RT, scalp acupuncture, tongue acupuncture, scalp acupuncture with tongue acupuncture, and Jin’s three-needling significantly improved ABC, oral expression, comprehension, writing and reading scores.

The authors concluded that compared to traditional acupuncture and/or rehabilitation training, scalp acupuncture, tongue acupuncture, and Jin’ 3-needle acupuncture can better improve post-apoplectic aphasia as depicted by the total effective rate, the ABC score, and comprehension, oral expression, repetition, denomination, reading and writing scores. However, quality of the included studies was inadequate and therefore further high-quality studies with lager samples and longer follow-up times and with patient outcomes are necessary to verify the results presented herein. In future studies, researchers should also explore the efficacy and differences between scalp acupuncture, tongue acupuncture and Jin’s 3-needling in the treatment of post-apoplectic aphasia.

I’ll be frank: I find it hard to believe that sticking needles in a patient’s tongue restores her ability to speak. What is more, I do not believe a word of this review and its conclusion. And now I better explain why.

  • All the primary studies originate from China, and we have often discussed how untrustworthy such studies are.
  • All the primary studies were published in Chinese and cannot therefore be checked by most readers of the review.
  • The review authors fail to provide the detail about a formal assessment of the rigour of the included studies; they merely state that their methodological quality was low.
  • Only 6 of the 32 studies can be retrieved at all via the links provided in the articles.
  • As far as I can find out, some studies do not even exist at all.
  • Many of the studies compare acupuncture to unproven therapies such as bloodletting.
  • Many do not control for placebo effects.
  • Not one of the 32 studies reports findings that are remotely convincing.

I conclude that such reviews are little more than pseudo-scientific propaganda. They seem aim at promoting acupuncture in the West and thus serve the interest of the People’s Republic of China. They pollute our medical literature and undermine the trust in science.

I seriously ask myself, are the editors and reviewers all fast asleep?

The journal ‘BMC Complement Altern Med‘  has, in its 18 years of existence, published almost 4 000 Medline-listed papers. They currently charge £1690 for handling one paper. This would amount to about £6.5 million! But BMC are not alone; as I have pointed out repeatedly, EBCAM is arguably even worse.

And this is, in my view, the real scandal. We are being led up the garden path by people who make a very tidy profit doing so. BMC (and EBCAM) must put an end to this nonsense. Alternatively, PubMed should de-list these publications.

This has been going on for far too long; urgent action is required!

 

The aim of this update of a Cochrane review was to assess the effectiveness and safety of homeopathic treatment for irritable bowel syndrome (IBS). Hold on, the bit about safety is odd here and does not bode well: one cannot possibly assess the safety of an intervention on the basis of just a few trials.

Randomised controlled trials (RCTs), cohort and case-control studies that compared homeopathic treatment with placebo, other control treatments, or usual care, in adults with IBS were considered for inclusion. Two authors independently assessed the risk of bias and extracted data. The primary outcome was global improvement in IBS as measured by an IBS symptom severity score. Secondary outcomes included quality of life, abdominal pain, stool frequency, stool consistency, and adverse events. The overall certainty of the evidence supporting the primary and secondary outcomes was assessed using the GRADE criteria. The Cochrane risk of bias tool was used to assess risk of bias.

Four RCTs (307 participants) were included. Two studies compared clinical homeopathy (homeopathic remedy, asafoetida or asafoetida plus nux vomica) to placebo for IBS with constipation (IBS-C). One study compared individualised homeopathic treatment (consultation plus remedy) to usual care for the treatment of IBS in female patients. One study was a three armed RCT comparing individualised homeopathic treatment to supportive listening or usual care.

The risk of bias in three studies (the two studies assessing clinical homeopathy and the study comparing individualised homeopathic treatment to usual care) was unclear on most criteria and high for selective reporting in one of the clinical homeopathy studies. The three armed study comparing individualised homeopathic treatment to usual care and supportive listening was at low risk of bias in four of the domains and high risk of bias in two (performance bias and detection bias).

A meta-analysis of the studies assessing clinical homeopathy, (171 participants with IBS-C) was conducted. At short-term follow-up of two weeks, global improvement in symptoms was experienced by 73% (46/63) of asafoetida participants compared to 45% (30/66) of placebo participants (RR 1.61, 95% CI 1.18 to 2.18; 2 studies, very low certainty evidence).

In the other clinical homeopathy study at two weeks, 68% (13/19) of those in the asafoetida plus nux vomica arm and 52% (12/23) of those in the placebo arm experienced a global improvement in symptoms (RR 1.31, 95% CI 0.80 to 2.15; very low certainty evidence).

In the study comparing individualised homeopathic treatment to usual care (N = 20), the mean global improvement score (feeling unwell) at 12 weeks was 1.44 + 4.55 (n = 9) in the individualised homeopathic treatment arm compared to 1.41 + 1.97 (n=11) in the usual care arm (MD 0.03; 95% CI -3.16 to 3.22; very low certainty evidence).In the study comparing individualised homeopathic treatment to usual care, the mean IBS symptom severity score at 6 months was 210.44 + 112.4 (n = 16) in the individualised homeopathic treatment arm compared to 237.3 + 110.22 (n = 60) in the usual care arm (MD -26.86, 95% CI -88.59 to 34.87; low certainty evidence).

The mean quality of life score (EQ-5D) at 6 months in homeopathy participants was 69.07 (SD 17.35) compared to 63.41 (SD 23.31) in usual care participants (MD 5.66, 95% CI -4.69 to 16.01; low certainty evidence). In the study comparing individualised homeopathic treatment to supportive listening, the mean IBS symptom severity score at 6 months was 210.44 + 112.4 (n = 16) in the individualised homeopathic treatment arm compared to 262 + 120.72 (n = 18) in the supportive listening arm (MD -51.56, 95% CI -129.94 to 26.82; very low certainty evidence). The mean quality of life score at 6 months in homeopathy participants was 69.07 (SD 17.35) compared to 63.09 (SD 24.38) in supportive listening participants (MD 5.98, 95% CI -8.13 to 20.09; very low certainty evidence). None of the included studies reported on abdominal pain, stool frequency, stool consistency, or adverse events.

The authors concluded that the results for the outcomes assessed in this review are uncertain. Thus no firm conclusions regarding the effectiveness and safety of homeopathy for the treatment of IBS can be drawn. Further high quality, adequately powered RCTs are required to assess the efficacy and safety of clinical and individualised homeopathy for IBS compared to placebo or usual care.

[The previous version of this review was published in 2013 and concluded: A pooled analysis of two small studies suggests a possible benefit for clinical homeopathy, using the remedy asafoetida, over placebo for people with constipation-predominant IBS. These results should be interpreted with caution due to the low quality of reporting in these trials, high or unknown risk of bias, short-term follow-up, and sparse data. One small study found no statistically difference between individualised homeopathy and usual care (defined as high doses of dicyclomine hydrochloride, faecal bulking agents and diet sheets advising a high fibre diet). No conclusions can be drawn from this study due to the low number of participants and the high risk of bias in this trial. In addition, it is likely that usual care has changed since this trial was conducted. Further high quality, adequately powered RCTs are required to assess the efficacy and safety of clinical and individualised homeopathy compared to placebo or usual care.]

This is a thorough review that is technically well-done (no wonder, as it had to comply with Cochrane standards!). However, as with some other Cochrane reviews of homeopathy, acupuncture and other SCAMs, one might object to the phraseology used in the conclusions (the part that most people would focus on). Don’t get me wrong, the conclusions are technically correct; however, they are not as clear as they should be and hide the essence of the evidence, in my view.

Systematic reviews have one main purpose: they need to inform the reader whether there is or is not good evidence that the treatment in question works for the condition in question. This question is not well addressed by stating THE RESULTS ARE UNCERTAIN. The truth is that a firm conclusion can very well be drawn: THERE IS NO GOOD EVIDENCE THAT ANY FORM OF HOMEOPATHY IS EFFECTIVE FOR IBS!

Surely that’s correct and firm enough!!!

Why do the authors not dare to put this clearly?

Probably because some of them are well-known, long-term proponents of homeopathy.

Why does the Cochrane Collaboration allow them to get away with their petty attempt of obfuscation?

Search me!

 

This systematic review was aimed at investigating the current evidence to determine whether there is an association between chiropractic use and opioid receipt.

Controlled studies, cohort studies, and case-control studies including adults with noncancer pain were eligible for inclusion. Studies reporting opioid receipt for both subjects who used chiropractic care and nonusers were included. Data extraction and risk of bias assessment were completed independently by pairs of reviewers. Meta-analysis was performed and presented as an odds ratio with 95% confidence interval.

In all, 874 articles were identified. After detailed selection, 26 articles were reviewed in full, and 6 met the inclusion criteria. Five studies focused on back pain and one on neck pain. The prevalence of chiropractic care among patients with spinal pain varied between 11.3% and 51.3%. The proportion of patients receiving an opioid prescription was lower for chiropractic users (range = 12.3-57.6%) than nonusers (range = 31.2-65.9%). In a random-effects analysis, chiropractic users had a 64% lower odds of receiving an opioid prescription than nonusers (odds ratio = 0.36, 95% confidence interval = 0.30-0.43, P < 0.001, I2 = 92.8%).

The authors concluded that this review demonstrated an inverse association between chiropractic use and opioid receipt among patients with spinal pain. Further research is warranted to assess this association and the implications it may have for case management strategies to decrease opioid use.

These results are in line with a previous study showing that among New Hampshire adults with office visits for noncancer low-back pain, the likelihood of filling a prescription for an opioid analgesic was significantly lower for recipients of services delivered by doctors of chiropractic compared with nonrecipients. The underlying cause of this correlation remains unknown, indicating the need for further investigation.

The question is: what do such findings tell us?

I have no doubt that chiropractors will claim that using their services will reduce the opioid problem. But this is, of course, wishful thinking. The thing that will reduce it is not more chiro use but quite simply less opioid use!

The important thing to remember here is CORRELATION IS NOT CAUSATION!

People who drive a VW car are less likely to buy a Mercedes.

People who have ordered fish in a restaurant are unlikely to also order a steak.

People who use physiotherapy for back pain will probably use less opioids than those who don’t consult physios.

People who treat their back pain with massage therapy are less likely to also use opioids.

Etc.

Etc.

This is all very obvious, self-evident and perhaps even boring.

The most interesting finding here is in my view the fact that 31.2-65.9% of patients using chiropractic for their neck/back pain also took opioids. This seems to confirm what we often have discussed before:

CHIROPRACTIC TREATMENT IS NOT NEARLY AS EFFECTIVE AS CHIROS WANT US TO BELIEVE.

 

Hirudotherapy, also known as leech therapy, has been used to treat a wide range of disorders for thousands of years. It is also mentioned as a minimal invasive technique called Jalaukavacharana in the Sushruta Samhita, an ancient Sanskrit text of Ayurvedic medicine.

But a long history is a fallacious argument (appeal to tradition) when used to imply efficacy. So, does this treatment work?

A review located a total of 834 articles were found of which 89.8% were original articles. USA was the leading country with 280 publications, followed by UK, Germany and France (128, 101 and 41 items, respectively). The most productive countries regarding hirudotherapy were the UK (1.93), Slovenia (1.44), and Israel (1.32). The peak publication year for hirudotherapy literature was 2011 with 41 papers.

What does that tell us about the efficacy of leech therapy?

Nothing!

The authors of another review concluded that reached the following conclusion: ” Given the low number of reported adverse events, leech therapy may be a useful approach in treating this condition. Further high-quality RCTs are required for the conclusive judgment of its effectiveness and safety.”

Sounds good?

Not really!

The few clinical trials that were reviewed are mostly by one research group – and yes, you guessed it: it was also this group who published the review.

And anyway: why do they conclude that there is a low number of adverse events? Firstly, there is no reporting system for such events; so, a low number is next to meaningless. Secondly, there are several reports of adverse events. Here are three recent cases:

1st case report

A 59-year-old woman was admitted to the emergency department with complaints of redness and swelling in both eyes and face. She had a long history of headache, therefore applied leech treatment occasionally. Swelling began on the face after the treatment of leech therapy. Vital signs were as follows; fever: 36.5°C, BP: 126/81 mmHg, heart rate: 84/min and sO2: 98%; respiratory rate: 12/min. In physical examination, GCS was 15, conscious, oriented cooperative. There was no lymphadenopathy in the palpation of the head and neck examination. Oropharynx was in natural appearance and no uvula edema. Facial palpation revealed redness, pain and heat rise. Other systemic findings were normal. Laboratory tests showed leukocytes: 11,000/mm3 (4,000-10,000/mm3), haemoglobin: 12.8 g/dL (12,00-14,00 g/dL) platelet: 271,000 (100,000-400,000/mm3) CRP: 3.45 mg/L (0-0.5mg/L). Other parameters were within normal limits. Computed tomography (CT) showed bilateral periorbital, frontal subcutaneous soft tissue oedema and lymphatic dilatations. She was hospitalized with the diagnosis of orbital cellulite due to leech therapy.

2nd case report

Anorectal sepsis usually presents with anal abscesses, which may evolve to become anorectal fistulas. Most of these cases are either of cryptoglandular origin, or they develop secondary to inflammatory bowel diseases. A 32-year-old male patient applied to our Proctology Unit with severe anal pain and swelling. Three days before admission, leeches were applied to the hemorrhoidal swellings in a medical center. The abscess was drained with appropriate unroofing and search for any compartments. The patient recovered rapidly. The abscess culture and microscopy revealed mix flora with predominant Escherichia coli. After 6 months, he has been symptom-free with perfect healing of the surgical site. We need to check up on possible handicaps in our modern patient care policies that divert people to such methods. Nevertheless, such alternative methods should be regarded as nonscientific and out of context unless their efficacy and safety are documented.

3rd case report

Pseudolymphoma, also known as Jessner’s lymphocytic infiltration, is a benign but usually chronic, T-cell infiltrating disease with erythematous papules and plaques usually seen on the skin of the face, neck, and back. The use of leech therapy also known as hirudotherapy has increased in recent years. Here, we report a 52-year-old male patient who had undergone hirudotherapy in his neck and developed infiltrating plaques after four months. A skin biopsy confirmed the diagnosis of Jessner’s lymphocytic infiltration. In parallel with the increasing use of hirudotherapy in recent years, the side-effect reports will likely to increase. Indications and contraindications of hirudotherapy, which is being used officially in hospitals, should be taken into consideration.

So, what do we make of this evidence?

I don’t know about you, but I am not likely to try or recommend leech therapy in a hurry.

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