MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

medical ethics

‘Alternative truth’ is a term that I used first in 2013 . Since then I had to employ it with increasing frequency. Disturbingly, since then similar terms, such as ‘alternative facts’, ‘alternative science’ etc., have become ‘en vogue’. In an NEJM-editorial on the subject, Alta Caro from the University of Wisconsin Law School, Madison, US recently concluded: Reasonable people may disagree about how to interpret data, but they do not ignore scientific method by giving credence to flawed, fraudulent, or misrepresented studies … Whether in the debates regarding climate change, evolutionary theory, or human reproduction, alternative facts are just fiction, and alternative science is just bad policy.

I am tempted to add AND ALTERNATIVE TRUTHS ARE JUST LIES!!!

On this blog, we are confronted with so many lies that it would be only normal, if we gradually got used to them.

  • I think we must resist this temptation.
  • I think we should expose those who tell untruths again and again.
  • I think it is our moral and ethical duty.
  • I think the truth is far too precious to allow it to be eroded by anyone.

Because I feel strongly about this issue, I would like to use this post to give two of my former colleagues the opportunity to correct the untruths they have published about me and my actions.

The 1st is Prof Harald Walach;

as I pointed out in a previous post, he stated the following untruth (his remarks were in German, and this is my translation):

“My friend and colleague George Lewith from Southampton gave a keynote lecture on his review of chiropractic interventions for infant colic. This was prompted by the claim, made by Singh and Ernst a few years ago, that chiropractic was dangerous, that no data existed showing its effectiveness, and that it had dangerous side-effects, particularly for children. The chiropractors had sued the science journalist Singh for libel and won the case. George Lewith had provided the expert report for the court and has now extended his analysis on children.

To put it briefly: the intervention is even very effective; the effect-size is about one standard deviation. The children cry less long and more rarely. And the search of the literature for dangerous side-effects resulted in no – literally: not one – case of side-effects, not to mention dangerous ones. The fuzz had started back then because an unqualified person had walked over the back of a thin woman and had thus broken her neck. The press had subsequently hyped the whole thing to a “deadly side-effect of a chiropractic intervention”. 

The 2nd is Dr Peter Fisher;

as I pointed out in another post, he too published an untruth about me:

In this article which he published as Dr. Peter Fisher, Homeopath to Her Majesty, the Queen, he wrote: “There is a serious threat to the future of the Royal London Homoeopathic Hospital (RLHH), and we need your help…Lurking behind all this is an orchestrated campaign, including the ’13 doctors letter’, the front page lead in The Times of 23 May 2006, Ernst’s leak of the Smallwood report (also front page lead in The Times, August 2005), and the deeply flawed, but much publicised Lancet meta-analysis of Shang et al…”

And why bring this up again?

For the reasons mentioned above.

And for giving Walach and Fisher the opportunity to correct their errors. If they don’t, their untruths will be henceforth called lies.

This post is based on an article by Ken Harvey, Associate Professor, School of Public Health and Preventive Medicine, Monash University, Australia. I took the liberty of slightly modifying his text for the purpose of this blog. The article informs us about the regulation of nonsense which, as I have often argued, is likely to result in nonsense.

Australia’s drugs regulator seems to be endorsing unfounded claims about homeopathy and traditional Chinese medicine as part of its review of how complementary medicines are regulated. In the latest proposed changes, the Therapeutic Goods Administration (TGA) is looking at what suppliers can claim their products do, known as “permitted indications”. An example of a “low level” permitted indication might be “may relieve the pain of mild osteoarthritis”.

If approved, suppliers will be able to use the permitted indication to market their products. The resulting problem is obvious.  For instance, despite the TGA’s Complaints Resolution Panel upholding complaints of a lack of evidence that magnesium and homeopathy “relieve muscle cramps (and restless legs)”, this permitted indication is on its draft list. Other examples of dodgy claims include “supports transport of oxygen in the body”, “regulates healthy male testosterone levels”. The list contains around 140 traditional Chinese medicine indications, such as “Harmonise middle burner (Spleen and Stomach)”, “Unblock/open/relax meridians”, “Balance Yin and Yang”. None of them have any basis in fact or science. There are also around 900 additional indications for unspecified “traditions”.

Traditional medicines are not necessarily safe, as emerging data highlights how common adverse reactions and drug interactions really are. For example, Hyland’s homeopathic baby teething products were recalled by the US Food and Drug Administration and then the TGA because they contained high levels of belladonna alkaloids which caused adverse events in hundreds of babies. In China, out of the 1.33 million case reports of adverse drug event reports received by the National Adverse Drug Reaction Monitoring Center in 2014, traditional Chinese medicine represented around 17.3% (equivalent to around 230,000 cases).

Listed medicines are supposed to contain pre-approved, relatively low-risk ingredients. They should be produced with good manufacturing practice and only make “low-level” health claims for which evidence is held. However, the TGA does not check these requirements before the product is marketed. To safeguard shoppers, consumer representatives, suggested the proposed list of permitted indications should be short and only contain wordings such as, “may assist” or “may help”. For consumers to make an informed purchase, claims based on “traditional use” should always have a disclaimer along the lines of what the US Federal Trade Commission uses for homeopathic products. For example, “This product’s traditional claims are based on alternative health practices that are not accepted by most modern medical experts. There is no good scientific evidence that this product works”.

MY CONCLUSION

As I see it, the problem is that the evidence for many of the claims which are about to be allowed is either absent, seriously flawed or negative. Yet, the purpose of any regulation of this kind must be to protect consumers from purchasing ineffective and sometimes dangerous products. Regulators are keen to balance this aim against another aim: helping an industry to thrive. It is never easy to get such a balance right. But to allow nonsense, pseudoscience and overt falsehoods to creep in, must surely be wrong, unethical and illegal.

 

In my previous post, I reported that the NHS has included homeopathy and herbal medicine on the list of medications that might no longer get reimbursed. The news was reported by most newspapers in the UK. All of the papers correctly quote NHS England giving their reasons for black-listing homeopathy and herbal remedies. Some papers also quote critics of homeopathy providing short ‘sound bites’ and opinions. None of the articles bother to explain in any detail why homeopathy is so ridiculously implausible or how strong the evidence against it has become. In this post, I intend to analyse some of this press coverage by copying those excerpts from the newspaper articles which I find odd or misleading and by adding short comments by myself.

THE DAILY MAIL claimed that homeopathic remedies are treatments using heavily diluted forms of plants, herbs and minerals. This is factually incorrect; think of remedies like X-ray! The Mail also quoted Don Redding, director of policy at National Voices, stating: ‘Whilst some treatments are available to purchase over the counter, that does not mean that everyone can afford them. There will be distinct categories of people who rely on NHS funding for prescriptions of remedies that are otherwise available over the counter. Stopping such prescriptions would break with the principle of an NHS “free at the point of use” and would create a system where access to treatments is based on a person’s ability to pay.’  This argument might apply to medicines that are proven to work; it does, however, not apply to homeopathy.

THE INDEPENDENT cited Professor Helen Stokes-Lampard, chair of the Royal College of GPs, who said: “If patients are in a position that they can afford to buy over the counter medicines and products, then we would encourage them to do so rather than request a prescription – but imposing blanket policies on GPs, that don’t take into account demographic differences across the country, or that don’t allow for flexibility for a patient’s individual circumstances, risks alienating the most vulnerable in society.” Again, this argument might apply to medicines that are proven to work; it does, however, not apply to homeopathy.

THE DAILY TELEGRAPH also reported the quote from Don Redding, Director of Policy at National Voices which I cited above.

THE DAILY MIRROR quoted The Royal Pharmaceutical Society claiming that such a move raised “serious concerns” for poorer Brits. RPS England Board Chair Sandra Gidley said: “A blanket ban on prescribing of items available to buy will not improve individual quality of life or health outcomes in England. “Those on low incomes will be disproportionately affected.” THE MIRROR also reported what had to say and added that the NHS constitution states that: “Access to NHS services is based on clinical need, not an individual’s ability to pay; NHS services are free of charge, except in limited circumstances sanctioned by parliament.”

THE NEWS & STAR repeated the above quote from The Royal Pharmaceutical Society.

THE GUERNSEY PRESS repeated what RPS England board chair Sandra Gidley said: “We would encourage people with minor health problems to self-care with the support of a pharmacist and to buy medicines where appropriate and affordable to the individual. However, expecting everyone to pay for medicines for common conditions will further increase health inequalities and worsen the health of patients who cannot afford them. A blanket ban on prescribing of items available to buy will not improve individual quality of life or health outcomes in England. Those on low incomes will be disproportionately affected. They should not be denied treatment because of an inability to pay.”

THE TIMES also quoted the RPS and Don Redding misleadingly (see above and below) and concluded their article by citing Cristal Summer, chief executive of the British Homeopathic Association saying: Patients will be prescribed more expensive conventional drugs in place of homeopathy, which defeats the object of the exercise. The NHS also claims it wants to reduce the amount of prescription drugs patients take, then stops offering complementary therapies which can help achieve this. This clearly ignores the fact that ‘the object of the exercise’ for any health service must be to provide effective treatments and avoid placebo therapies like homeopathy. 

THE SUN quoted The Royal Pharmaceutical Society saying such a move raised “serious concerns” for poorer Brits. But it said banning NHS-funded homeopathy was long overdue. THE SUN continued by citing John O’Connell, Chief Executive of the TaxPayers’ Alliance: “The NHS are absolutely right to look at removing homeopathy from their approved prescription list and it’s astonishing that it hasn’t happened sooner.”

METRO pointed out that actress Gwyneth Paltrow, ex-Beatle Paul McCartney and world record sprinter Usain Bolt are all known to swear by homeopathic remedies.

Generally speaking, the newspaper coverage was not bad, in my view. The exception evidently is THE TIMES (see above). Several other articles also have a slight whiff of false balance, introducing seemingly rational counter-arguments where none exist. Even though the headlines invariably focus on homeopathy, some of the quotes used by the papers are clearly about other medicines black-listed. This seems particularly obvious with the quotes by the RPS. Many readers might thus be misled into thinking that there is opposition by reputable organisations to the ban on homeopathy. None of the articles that I read quoted a homeopath at the end saying something like  WE KNOW OF MANY PATIENTS WHOSE LIVES WERE SAVED BY HOMEOPATHY. JUST BECAUSE WE DON’T UNDERSTAND HOW IT WORKS DOES NOT MEAN IT DOES NOT WORK. A BAN WOULD PUT PUBLIC HEALTH AT RISK.

Only a few years ago, this type of conclusion to an article on homeopathy would have been inevitable! Could it be that UK journalists (with the exception of those at THE TIMES?) are slowly learning?

 

NHS England have published a list of medicines that they propose to stop funding. Items were considered for inclusion if they were:

  • Items of low clinical effectiveness, where there is a lack of robust evidence of clinical effectiveness or there are significant safety concerns;
  • Items which are clinically effective but where more cost-effective products are available, including products that have been subject to excessive price inflation; or
  • Items which are clinically effective but, due to the nature of the product, are deemed a low priority for NHS funding.

The list includes both herbal and homeopathic remedies!!!

The document states that the annual Spend on homeopathy amounts to £92,412. It refers to the report by the House of Commons Science and Technology Committee which found that the use of homeopathy was not evidence based and any benefits to patients was down to placebo effect. The group agreed with the findings of the committee for the lack of evidence and considered homeopathy suitable for inclusion in the proposed list.  They advise CCGs that prescribers in primary care should not initiate homeopathic items for any new patient. They also advise CCGs to support prescribers in deprescribing homeopathic items in all patients and, where appropriate, ensure the availability of relevant services to facilitate this change.

A comment published by PULSETODAY stated: NHS England is planning to stop the prescribing of homeopathy as part of new guidance for CCGs on medicines that can be considered to be of low priority for funding. Homeopathy is a new item on the list of possible low-value medicines that GPs will be banned from prescribing. Originally NHS England said that it would review just 10 items, but it has added eight new treatments, including homeopathy and herbal treatments… The original consultation document failed to include homeopathy in its treatments that should be banned. However, following a consultation, a paper presented at today’s NHS England board meeting said: ‘NHS England’s view is that, at best, homeopathy is a placebo and a misuse of scarce NHS funds which could better be devoted to treatments that work. ‘Data on the residual use and cost of homeopathy on the NHS are hard to come by. A recent Freedom of Information request by a third party suggested that at least £578,000 has been spent on prescribed homeopathy over the past five years, with the total cost being higher than that when the cost of consultations was factored in.’ Talking at the NHS England Board meeting today NHS England medical director Sir Bruce Keogh said: ’I think this (homeopathy) has been an issue which has concerned scientific professionals for a long period of time. We can no longer shy away from addressing this particular issue. If we want our NHS to be evidence based and outcomes focused, then we must expect to have difficult conversations over difficult issues.’

This almost sounds as though Sir Bruce has been following the discussions on this blog. I have felt for a long time that the reimbursement of homeopathy by the NHS made a mockery of evidence-based medicine. It is time to end the mockery and use the money for something useful!

But before we start celebrating a victory of rationality, we should consider what happens next. There will be a consultation, and I would not be surprised to hear that the author of multiple ‘spider memos’ is already at it again. So, maybe we should hold our breath and wait.

This new RCT by researchers from the National Institute of Complementary Medicine in Sydney, Australia was aimed at ‘examining the effect of changing treatment timing and the use of manual, electro acupuncture on the symptoms of primary dysmenorrhea’. It had four arms:

  1. low frequency manual acupuncture (LF-MA),
  2. high frequency manual acupuncture (HF-MA),
  3. low frequency electro acupuncture (LF-EA)
  4. and high frequency electro acupuncture (HF-EA).

A total of 74 women were given 12 treatments over three menstrual cycles, either once per week (LF groups) or three times in the week prior to menses (HF groups). All groups received a treatment in the first 48 hours of menses. The primary outcome was the reduction in peak menstrual pain at 12 months from trial entry.

During the treatment period and 9 month follow-up all groups showed statistically significant reductions in peak and average menstrual pain compared to baseline. However, there were no differences between groups. Health related quality of life increased significantly in 6 domains in groups having high frequency of treatment compared to two domains in low frequency groups. Manual acupuncture groups required less analgesic medication than electro-acupuncture groups. HF-MA was most effective in reducing secondary menstrual symptoms compared to both–EA groups.

The authors concluded that acupuncture treatment reduced menstrual pain intensity and duration after three months of treatment and this was sustained for up to one year after trial entry. The effect of changing mode of stimulation or frequency of treatment on menstrual pain was not significant. This may be due to a lack of power. The role of acupuncture stimulation on menstrual pain needs to be investigated in appropriately powered randomised controlled trials.

If I were not used to reading rubbish research of alternative medicine in general and acupuncture in particular, this RCT would amaze me – not so much because of its design, execution, or write-up, but primarily because of its conclusion (why, oh why, I ask myself, did PLOS ONE publish this paper?). They are, I think, utterly barmy.

Let me explain:

  • acupuncture treatment reduced menstrual pain intensity” – oh no, it didn’t; at least this is not what the study proves; the fact that pain was perceived as less could be due to a host of factors, for instance regression towards the mean, or social desirability; as there was no proper control group, nobody can tell;
  • the lack of difference between treatments “may be due to a lack of power”. Yes, but more likely it is due to the fact that all versions of a placebo therapy generate similar outcomes.
  • acupuncture stimulation on menstrual pain needs to be investigated in appropriately powered randomised controlled trials”. Why? Because the authors have a quasi-religious belief in acupuncture? And if they have, why did they not design their study ‘appropriately’?

The best conclusion I can suggest for this daft trial is this: IN THIS STUDY, THE PRIMARY ENDPOINT SHOWED NO DIFFERENCE BETWEEN THE 4 TREATMENT GROUPS. THE RESULTS ARE THEREFORE FULLY COMPATIBLE WITH THE NOTION THAT ACUPUNCTURE IS A PLACEBO THERAPY.

Something along these lines would, in my view, have been honest and scientific. Sadly, in acupuncture research, we very rarely get such honest science and the ‘National Institute of Complementary Medicine in Sydney, Australia’ has no track record of being the laudable exception to this rule.

The Daily Star reported that 9 children have died in Tripura Para of Sitakunda during the last week. At least 46 other children in the remote hilly area are suffering from the same unidentified disease which has not yet been identified. The children aged between one and 12 suffer from fever and other symptoms include body rash, breathing problems, vomiting and blood in stool.

None of the fatalities was taken to a hospital, and two of them were treated homeopathically. The three-year-old Rupali had fever and a rash all over her body for three days. “We took her to a man who practices homeopathy. He lives some two kilometres away. He had given Rupali some medicines”, said her uncle. Asked why they did not take the child to a hospital, Pradip said the next health complex was 15 kilometres away from their home. Besides, they did not have money to buy medicines which would have been prescribed by doctors.

Shimal Tripura was also among the children who died. His father Biman Tripura said the two-year-old boy had been suffering from fever for six days. Shimal was also taken to a local man who practices homeopathy.

“The disease could not be identified immediately,” said a spokesperson. Asked whether the disease could be transmitted by mosquitoes, he said, “It does not seem so. If it was, then why only children were being affected?” A medical team from the Institute of Epidemiology, Disease Control and Research in Dhaka was dispatched for Sitakunda, he said, adding that the local primary school was shut down to prevent the spread of the disease.

I have often pointed out that homeopathy can be deadly – not usually via its remedies (highly diluted homeopathic have no effects whatsoever) but via homeopaths who do not know what they are doing. It seems that here we have yet further tragic cases to confirm this point. Nine children were reported to have died. Two of them received homeopathic remedies and 7 seemed to have had no treatment at all. This looks like a very sad statistic indicating that homeopathy is as bad as no treatment at all.

To a significant extend, this blog has always exposed untruths in the realm of alternative medicine – not just one or two, but hundreds. Obviously, some of them are more clear-cut than others. If, for instance, someone claims that acupuncture has been proven to be effective for a given condition, this many seem like a lie or untruth to you, like a misinterpretation of the evidence to someone else, or like the truth to a third person.

But there are some statements which are demonstrably false. These are often the most irritating lies, frequently forwarded by people who should know better and who nevertheless insist on not being truthful. Below I have listed a few, randomly-chosen examples upon which I have previously commented. For clarity, I have copied the quotes in question, linked them to my original posts, named the authors in brackets, and added a brief comment by myself in bold print.

I was at Exeter when Ernst took over what was already a successful Chair in CAM. (anonymous reviewer of my book at Amazon)

Anyone can check this fairly easily, for instance, in my memoir ‘A SCIENTIST IN WONDERLAND’, there was no pre-existing chair at Exeter.

Ernst’s leak of the Smallwood report (also front page lead in The Times, August 2005), (Dr Peter Fisher, homeopath of the Queen)

This was painfully investigated during a 13 (!) months inquiry which found that I did not leak this report. Again you find the full details in my memoir.

…homeopathic care is recommended for people who have been exposed (or think they have been exposed) to toxic substances… (Dana Ullman US homeopath)

As far as this statement implies that homeopathy is effective for treating intoxications, this is not only a lie but a very dangerous nonsense.

Homeopathy has a long history of being used successfully in veterinary practice for both domestic and farm animals. (UK Faculty of Homeopathy)

If this is to suggest that homeopathy is of proven effectiveness in treating diseases of animals, this is a lie.

Homeoprophylaxis, the homeopathic vaccine alternative, prevents disease through nosodes. (Lisa is the mastermind behind All Natural Ideas)

Homeoprophylaxis has never been proven to prevent any disease; this lie could kill millions.

There are essentially two categories of critics. The first category consists of individuals who are totally ignorant of homeopathy and just repeating propaganda they’ve been exposed to. The second category is people who know that homeopathy works, but have a vested financial interest in destroying it. (Alan Schmukler, US homeopathy)

This lie is quite funny in its transparent defamation of the truth, I think.

Homeopathy works like a vaccine. (Dr Batra, Indian homeopath)

Homeopathy does not even remotely work like a vaccine; in fact, it works like a placebo, if at all.

…UK invests 0% of its research budget on CAM… (Dr Michael Dixon, GP and advisor to Prince Charles)

There has always been a sizable budget for CAM-research in the UK.

Even cancer viruses have, on record, been put into vaccinations. There is no actual vaccine for cancer. The only reason to put cancer viruses in the mix is to create more cases of cancer. In this day and age, one of the most dangerous things you can do for your health is to get vaccinated… (US homeopath)

In this short quote, there are more lies than I care to comment on. The paranoia of the anti-vaccination brigade is astounding and endangers many lives.

A lie is a statement used intentionally for the purpose of deception. In alternative medicine, we encounter so many lies that one would need to continually publish volume after volume to expose just the most harmful untruths. The danger of these lies is that some people might believe them. This could seriously harm their health. Another danger is that we might get used to them, trivialise them, or – like Trump and co – start thinking of them as ‘alternative facts’.

I will continue to do my best to prevent any of this from happening.

 

Isn’t it wonderful when your long-held views are confirmed by someone with influence?

This, of course, is a rhetorical question – I can tell you: it is wonderful!

Matthew Stanbrook, MD PhD recently published an editorial in CMAJ which I find delightful; let me present you a few quotes from it:

The multibillion-dollar market for “natural” health products has flourished under lax government regulations. These regulations have enabled manufacturers to exploit the public’s difficulty in distinguishing nonprescription drugs, with scientifically proven therapeutic benefits, from herbal or homeopathic preparations and supplements that often make similar health claims with little or no evidence and are frequently grounded in unscientific belief systems about health and disease…

In pharmacies, supermarkets and convenience stores, natural health products are displayed side by side with nonprescription drugs. Both tout their approval by Health Canada as an implicit endorsement of efficacy and safety on package labels that make similar health claims. However, although nonprescription drugs and their therapeutic claims require scientific evidence that is carefully scrutinized by Health Canada, natural health products have a separate regulatory system that typically imposes such minimal requirements that it is effectively a rubber stamp. Unlike nonprescription drugs, if a problem arises with a natural health product, Health Canada has little or no authority to compel any changes to its manufacture, labelling or sale.

…Risk is often difficult to perceive accurately without direct evidence. For example, under the proposed framework, Health Canada would continue to classify most homeopathic preparations as low-risk products and, thus, exempt from scientific review. Recently, a homeopathic product sold in the United States that claimed to relieve teething pain in infants and supposedly contained a very dilute extract from the belladonna plant was associated with several deaths of infants who manifested classic signs of anticholinergic poisoning…

…If consumers are unable to separate products with no scientific proof behind them from products supported by evidence, then we need to separate them in stores. Natural health products should be pulled from the shelves where they are mixed with nonprescription drug products and confined to their own separate section, away from any signage implying a therapeutic use.

The double standard perpetuated by both regulators and retailers that enables the deception of unsuspecting Canadians must end. Alternative medicines with claims based on alternative facts do not deserve an alternative, easy regulatory road to market — at the very least, they need to be moved to an alternative shelf.

END OF QUOTES

This, of course, is Canada. But elsewhere progress is also being made.The Australian reported about plans in Australia whereby pharmacies would be banned from selling useless and possibly dangerous homoeopathic remedies. The Australian last year ­revealed a review of pharmacy regulation, headed by Stephen King from the Productivity ­Commission, identified a potential conflict of interest in pharmacists selling vitamins, for example, that may not have a significant ­evidence base, alongside more stringently regulated and government-subsidised medicines. In its interim report, the review panel was “concerned that the sale of complementary medicines alongside other medicines may mislead consumers”. It therefore concludes that “complementary medicines should be held in a separate area within community pharmacies, where customers can easily access a pharmacist for appropriate advice.”

“To avoid potential harm, or the confusion between the efficacies of different types of medicines, pharmacists need to be easily ­accessible to give needed advice when consumers choose a complementary or pharmacy-only medicine,” the review panel said. It was scathing of homo­eopathy and the perception of legitimacy given to those so-called remedies sold in pharmacies. “The only defence put to the panel regarding homoeopathy was that it was harmless and able to be used as a placebo in certain circumstances,” the review panel noted. “The panel does not believe that this argument is sufficient to justify the continued sale of these products in pharmacies …”

AUSTRALIAN JOURNAL OF PHARMACY (AJP) noted that the interim report of the Review of Pharmacy Remuneration and Regulation states that “there are unacceptable risks where community pharmacies are allowed to sell homeopathic products”.

In 2015 Pharmaceutical Society of Australia (PSA) said it did not support the sale of homeopathy in pharmacy. “Our position is that pharmacists must use their professional judgement to prevent the supply of products with evidence of no effect,” PSA president Joe Demarte said at the time. Ian Carr, of Saxby’s Pharmacy in Taree, NSW, and Friends of Science in Medicine member, told the AJP that “in terms of homeopathic products being recommended not to be sold by PBS-approved pharmacies, I one hundred per cent heartily agree with that finding. “I love saying that I believe homeopathy works. But it has never been shown to work better than placebo. There are many things that will work as well as placebo, but it’s not ethical to be selling them as a cure or treatment for something. I would have a bit more time for it if there was a plausible theory behind it, but its basis is entirely implausible – it pushes all the buttons for being a pseudoscience, so I agree it has no place in Australian pharmacy. However, I am at a bit of a loss to understand why they haven’t carried some of that logic over into the comments on complementary medicines generally.”

Mr Carr also told the AJP that “If one conceives of complementary medicines as being vitamins and minerals, that’s one thing. But the marketing of those items has become so diffuse and so wide that on most of these CM shelves we have traditional medicines, we’ve got herbal medicines, we’ve got items that are basically just marketing formulas for certain conditions. The evidence behind most of these things is very very slim, and we still have the possibility of health fraudsters just marching in and taking advantage of the lack of regulation in the industry.”

So, Canada and Australia are making progress in protecting consumers from bogus healthcare products and from pharmacists selling them.

Hurray!!!

When, I ask myself, are the UK, the US and other countries following suit?

 

This recently published report provides updated clinical practice guidelines from the Society for Integrative Oncology on the use of integrative therapies for specific clinical indications during and after breast cancer treatment, including anxiety/stress, depression/mood disorders, fatigue, quality of life/physical functioning, chemotherapy-induced nausea and vomiting, lymphedema, chemotherapy-induced peripheral neuropathy, pain, and sleep disturbance.

The practice guidelines are based on a systematic literature review from 1990 through 2015. The recommendations are as follows:

  • Music therapy, meditation, stress management, and yoga are recommended for anxiety/stress reduction.
  • Meditation, relaxation, yoga, massage, and music therapy are recommended for depression/mood disorders.
  • Meditation and yoga are recommended to improve quality of life.
  • Acupressure and acupuncture are recommended for reducing chemotherapy-induced nausea and vomiting.
  • Acetyl-L-carnitine is not recommended to prevent chemotherapy-induced peripheral neuropathy due to a possibility of harm.
  • No strong evidence supports the use of ingested dietary supplements to manage breast cancer treatment-related side effects.

The authors conclude that there is a growing body of evidence supporting the use of integrative therapies, especially mind-body therapies, as effective supportive care strategies during breast cancer treatment. Many integrative practices, however, remain understudied, with insufficient evidence to be definitively recommended or avoided.

I have to admit that I am puzzled by this paper.

The first obvious point to make is that these treatments are not ‘integrative therapies’; they are alternative or complementary and I fail to see what is integrative about them.

The second point is that the positive recommendations are based on often poor-quality studies which did not control for placebo effects.

The third point is that the negative recommendations are woefully incomplete. There are many more alternative therapies for which there is no strong evidence.

The forth point is the conclusion implying that treatment supported by insufficient evidence should be avoided. I would not claim that any of the mentioned treatments is backed by SUFFICIENT evidence. Therefore, we should avoid them all, one might argue.

But these concerns are perhaps relatively trivial or far-fetched. More important is the fact that a very similar article been published in 2014. Here is the abstract:

Background

The majority of breast cancer patients use complementary and/or integrative therapies during and beyond cancer treatment to manage symptoms, prevent toxicities, and improve quality of life. Practice guidelines are needed to inform clinicians and patients about safe and effective therapies.

Methods

Following the Institute of Medicine’s guideline development process, a systematic review identified randomized controlled trials testing the use of integrative therapies for supportive care in patients receiving breast cancer treatment. Trials were included if the majority of participants had breast cancer and/or breast cancer patient results were reported separately, and outcomes were clinically relevant. Recommendations were organized by outcome and graded based upon a modified version of the US Preventive Services Task Force grading system.

Results

The search (January 1, 1990–December 31, 2013) identified 4900 articles, of which 203 were eligible for analysis. Meditation, yoga, and relaxation with imagery are recommended for routine use for common conditions, including anxiety and mood disorders (Grade A). Stress management, yoga, massage, music therapy, energy conservation, and meditation are recommended for stress reduction, anxiety, depression, fatigue, and quality of life (Grade B). Many interventions (n = 32) had weaker evidence of benefit (Grade C). Some interventions (n = 7) were deemed unlikely to provide any benefit (Grade D). Notably, only one intervention, acetyl-l-carnitine for the prevention of taxane-induced neuropathy, was identified as likely harmful (Grade H) as it was found to increase neuropathy. The majority of intervention/modality combinations (n = 138) did not have sufficient evidence to form specific recommendations (Grade I).

Conclusions

Specific integrative therapies can be recommended as evidence-based supportive care options during breast cancer treatment. Most integrative therapies require further investigation via well-designed controlled trials with meaningful outcomes.

I have harshly criticised this review on this blog in 2016. For instance, I voiced concern about the authors declaration of conflicts of interest and stated:

 

I know none of the authors (Heather Greenlee, Lynda G. Balneaves, Linda E. Carlson, Misha Cohen, Gary Deng, Dawn Hershman, Matthew Mumber, Jane Perlmutter, Dugald Seely, Ananda Sen, Suzanna M. Zick, Debu Tripathy) of the document personally. They made the following collective statement about their conflicts of interest: “There are no financial conflicts of interest to disclose. We note that some authors have conducted/authored some of the studies included in the review.” I am a little puzzled to hear that they have no financial conflicts of interest (do not most of them earn their living by practising integrative medicine? Yes they do! The article informs us that: “A multidisciplinary panel of experts in oncology and integrative medicine was assembled to prepare these clinical practice guidelines. Panel members have expertise in medical oncology, radiation oncology, nursing, psychology, naturopathic medicine, traditional Chinese medicine, acupuncture, epidemiology, biostatistics, and patient advocacy.”). I also suspect they have other, potentially much stronger conflicts of interest. They belong to a group of people who seem to religiously believe in the largely nonsensical concept of integrative medicine

The just-published update has a different statement about conflicts of interest:

DISCLOSURES: Linda E. Carlson reports book royalties from New Harbinger and the American Psychological Association. Misha R. Cohen reports royalties from Health Concerns Inc., outside the submitted work. Matthew Mumber owns stock in I Thrive. All remaining authors report no conflicts of interest.

Is this much better than the previous statement? Was the previous statement therefore false?

I wonder.

What do you think?

Systematic reviews are aimed at summarising and critically evaluating the evidence on a specific research question. They are the highest level of evidence and are more reliable than anything else we have. Therefore, they represent a most useful tool for both clinicians and researchers.

But there are, of course, exceptions. Take, for instance, this recent systematic review by researchers from the

  • Texas Chiropractic College, Pasadena, the Palmer Center for Chiropractic Research, Palmer College of Chiropractic, Davenport,
  • Department of Planning, Policy and Design, University of California, Irvine,
  • VA Puget Sound Health Care System, Tacoma,
  • New York Chiropractic College, Seneca Falls,
  • Logan University College of Chiropractic, Chesterfield,
  • University of Western States, Portland.

Its purpose was to evaluate the effectiveness of conservative non-drug, non-surgical interventions, either alone or in combination, for conditions of the shoulder. The review was conducted from March 2016 to November 2016 in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), and was registered with PROSPERO. Eligibility criteria included randomized controlled trials (RCTs), systematic reviews, or meta-analyses studying adult patients with a shoulder diagnosis. Interventions qualified if they did not involve prescription medication or surgical procedures, although these could be used in the comparison group or groups. At least 2 independent reviewers assessed the quality of each study using the Scottish Intercollegiate Guidelines Network checklists. Shoulder conditions addressed were

  • shoulder impingement syndrome (SIS),
  • rotator cuff-associated disorders (RCs),
  • adhesive capsulitis (AC),
  • nonspecific shoulder pain.

Twenty-five systematic reviews and 44 RCTs met inclusion criteria. Low- to moderate-quality evidence supported the use of manual therapies for all 4 shoulder conditions. Exercise, particularly combined with physical therapy protocols, was beneficial for SIS and AC. For SIS, moderate evidence supported several passive modalities. For RC, physical therapy protocols were found beneficial but not superior to surgery in the long term. Moderate evidence supported extracorporeal shockwave therapy for calcific tendinitis RC. Low-level laser was the only modality for which there was moderate evidence supporting its use for all 4 conditions.

The authors concluded that the findings of this literature review may help inform practitioners who use conservative methods (eg, doctors of chiropractic, physical therapists, and other manual therapists) regarding the levels of evidence for modalities used for common shoulder conditions.

This review has so many defects that it would be boring to list them here.

The PRISMA guidelines  – I happen to be a co-author – state, for instance, that the abstract (the above text is from the abstract) should provide a structured summary including, as applicable: background; objectives; data sources; study eligibility criteria, participants, and interventions; study appraisal and synthesis methods; results; limitations; conclusions and implications of key findings; systematic review registration number. It is obvious that the review authors have omitted several of these items.

And that is just the abstract!  There is much, much more to criticise in this paper.

The most striking deficit, in my view, is the useless conclusion: the one from the abstract (the part of the paper that will be read most widely) could have been written before the review had even been started. It is therefore not based on the data presented. Crucially it does not match the stated aim of this review (“to evaluate the effectiveness of conservative…interventions”).

But why? Why did the authors bother to follow PRISMA? Why did they formulate this bizarre conclusion in their abstract? Why did they do a review in the first place?

I fear, the answers might be embarrassingly simple:

  • They only pretended to follow PRISMA guidelines because that gives their review a veneer of respectability.
  • They formulated the conclusions because otherwise they would have needed to state that the evidence for manual therapy is less than convincing.
  • They conducted the review to promote chiropractic, and when the data were not as they had hoped for, they just back-paddled in an attempt to hide the truth as much as possible.

If this were an isolated case, I would not have bothered to mention it. But sadly, in the realm of chiropractic (and alternative medicine in general) we currently witness a plethora of rubbish reviews (published by rubbish journals). To the naïve observer, they might look rigorous and therefore they will be taken seriously. The end-effect of this pollution of the literature with rubbish is that we get a false-positive impression about the validity of the treatments in question. Consequently, we will see a host of wrong decisions on all levels of healthcare.

The big question is: HOW DO WE PROTECT OURSELVES FROM THIS DANGEROUS TREND?

I only see one solution: completely disregard certain journals that have been identified to regularly publish nonsense. Sadly, the wider medical community is far from having arrived at this point. As far as I can see, the problem has not even been identified yet as a serious issue that needs addressing. For the foreseeable future, we will probably have to live with this type of pollution of our medical literature.

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