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

evidence

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Someone alerted me to a short article (2008) of mine that I had forgotten about. In it, I mention the 32 Cochrane reviews of acupuncture available at the time and the fact that they showed very little in favour of acupuncture. This made me wonder to what extent the situation might have changed in the last 12 years. So, I made a renewed attempt at evaluating this evidence. The entire exercise comes in three parts:

  1. My original paper from 2008
  2. The current evidence from Cochrane reviews
  3. Comments on the new evidence

PART 1

Acupuncture has a long history of ups and downs. Its latest renaissance started in 1971, when a journalist in President Nixon’s press corps experienced symptomatic relief after being treated for postoperative abdominal distension. He reported this experience in The New York Times, which triggered a flurry of interest and research. In turn, it was discovered that needling might release endorphins in the brain or act via the gate control mechanism. Thus, plausible modes of action seemed to have been found, and the credibility of acupuncture increased significantly. Numerous clinical trials were initiated, and their results often suggested that acupuncture is clinically effective for a surprisingly wide range of conditions. Both a World Health Organization report and a National Institutes of Health consensus conference provided long lists of indications for which acupuncture allegedly was of proven benefit.

Many of the clinical studies, however, lacked scientific rigor. Most experts therefore remained unconvinced about the true value of acupuncture, particularly as a treatment for all ills. Some investigators began to suspect that the results were largely due to patient expectation. Others showed that the Chinese literature, a rich source of acupuncture trials, does not contain a single negative study of acupuncture, thus questioning the reliability of this body of evidence.

A major methodological challenge was the adequate control for placebo effects in clinical trials of acupuncture. Shallow needling or needling at non-acupuncture points had been used extensively for this purpose. Whenever the results of such trials did not show what acupuncture enthusiasts had hoped, they tended to claim that these types of placebos also generated significant therapeutic effects. Therefore, a negative result still would be consistent with acupuncture being effective. The development of non-penetrating needles was aimed at avoiding such problems. These “stage dagger”-like devices are physiologically inert and patients cannot tell them from real acupuncture. Thus, they fulfil the criteria for a reasonably good placebo.

The seemingly difficult question of whether acupuncture works had become complex—what type of acupuncture, for what condition, compared with no treatment, standard therapy, or to placebo, and what type of placebo? Meanwhile, hundreds of controlled clinical trials had become available, and their results were far from uniform. In this situation, systematic reviews might be helpful in establishing the truth, particularly Cochrane reviews, which tend to be more rigorous, transparent, independent, and up-to-date than other reviews. The traditional Chinese concept of acupuncture as a panacea is reflected in the fact that 32 Cochrane reviews are currently (January 2008) available, and a further 35 protocols have been registered. The notion of acupuncture as a “heal all” is not supported by the conclusions of these articles. After discarding reviews that are based on only 3 or fewer primary studies, only 2 evidence-based indications emerge: nausea/vomiting and headache. Even this evidence has to be interpreted with caution; recent trials using the above-mentioned “stage-dagger” devices as placebos suggest that acupuncture has no specific effects in either of these conditions.

Further support for the hypothesis that acupuncture is largely devoid of specific therapeutic effects comes from a series of 8 large randomized controlled trials (RCTs) initiated by German health insurers (Figure). These studies had a similar, 3-parallel-group design: pain patients were randomized to receive either real acupuncture, shallow needling as a placebo control, or no acupuncture. Even though not entirely uniform, the results of these studies tend to demonstrate no or only small differences in terms of analgesic effects between real and placebo acupuncture. Yet, considerable differences were observed between the groups receiving either type of acupuncture and the group that had no acupuncture at all.

The most recent, as-yet-unpublished trial also seems to confirm the “placebo hypothesis.” This National Institutes of Health-sponsored RCT included 640 patients with chronic back pain. They received either individualized acupuncture according to the principles of traditional Chinese medicine, or a standardized form of acupuncture, or sham acupuncture. The results demonstrate that acupuncture added to usual care was superior to usual care alone, individualized acupuncture was not more effective than standardized acupuncture, and neither type of real acupuncture was more effective than sham acupuncture.

Figure

Schematic representation of the recent acupuncture trials all following a similar 3-group design. These 8 randomized controlled trials related to chronic back pain, migraine, tension headache, and knee osteoarthritis (2 trials for each indication). Their total sample size was in excess of 5000. Patients in the “no acupuncture” group received either standard care or were put on a waiting list. Sham acupuncture consisted of shallow needling at non-acupuncture points. Real acupuncture was semi-standardized. The differences between the effects of both types of acupuncture and no acupuncture were highly significant in each study. The differences between sham and real acupuncture were, with the exception of osteoarthritis, not statistically significant.

Enthusiasts employ such findings to argue that, in a pragmatic sense, acupuncture is demonstrably useful: it is clearly better than no acupuncture at all. Even if it were merely a placebo, what really matters is to alleviate pain of suffering patients, never mind the mechanism of action. Others are not so sure and point out that all well-administrated treatments, even those that generate effects beyond placebo, will induce a placebo response. A treatment that generates only non-specific effects (for conditions that are amenable to specific treatments) cannot be categorized as truly effective or useful, they insist.

So, after 3 decades of intensive research, is the end of acupuncture nigh? Given its many supporters, acupuncture is bound to survive the current wave of negative evidence, as it has survived previous threats. What has changed, however, is that, for the first time in its long history, acupuncture has been submitted to rigorous science—and conclusively failed the test.

[references in the original paper]

Part 2 will be posted tomorrow.

“Unless positive evidence emerges, the risk/benefit balance of ozone therapy for any condition fails to be positive.”  This is the conclusion I recently drew after assessing the evidence for or against this therapy. Now a new review has just been published. Does it change my verdict?

This review evaluated the available literature on the application of oxygen-ozone therapy (OOT) in the treatment of knee osteoarthritis (KOA) to understand its therapeutic potential and to compare it with other conservative treatment options.

Eleven studies involving 858 patients met the inclusion criteria. Patients in the control groups received different treatments:

  • placebo in 1 trial;
  • hyaluronic acid in 2 studies;
  • hyaluronic acid and PRP in 1 trial;
  • corticosteroids in 4;
  • hypertonic dextrose, radiofrequency, or celecoxib + glucosamine in the remaining 3 trials.

The quality of these studies was poor; none of the studies included reached “good quality” standard, 2 were ranked as “fair,” and the rest were considered “poor.” No major complications or serious adverse events were reported following intra-articular OOT, which provided encouraging pain relief at short term. On the basis of the available data, no clear indication emerged from the comparison of OOT with other established treatments for KOA.

The authors concluded that the analysis of the available RCTs on OOT for KOA revealed poor methodologic quality, with most studies flawed by relevant bias, thus severely limiting the possibility of drawing conclusions on the efficacy of OOT compared with other treatments. On the basis of the data available, OOT has, however, proven to be a safe approach with encouraging effects in pain control and functional recovery in the short-middle term.

The use of ozone for treatment of KOA is highly controversial. The mechanism of action of ozone therapy for the treatment of KOA is unclear. Some studies have suggested that ozone injections results in pain relief, reduction of oedema, and improved mobility. The above review might be valuable in summarising the evidence, however, I fing its conclusion odd:

  • The authors write that they cannot arrive at a verdict about efficacy because of the poor quality of the primary studies. I think the conclusion is very clear and should have been expressed bluntly. THE AVAILABLE DATA FAIL TO SHOW EFFICACY; THE THERAPY IS THUS UNPROVEN AND SHOULD THEREFORE NOT BE USED. Simple!
  • I also disagree that OOT was proven to be safe. No treatment can be proven to be safe on the basis of just a few studies. This would require a much, much greater sample size.

This leaves us with the following situation:

  1. OOT is not plausible.
  2. OOT is unproven.
  3. The risks of OOT are unknown.

To me this means that we should stop using it (and I don’t need to change my above-quotes verdict).

The Foundation for Integrated Health (FIH) does no longer exist. But it is historically important, in my view. So, I decided to do some research in order to document its perplexing history. In the course of this activity, I found that someone had beaten me to it. This article that does the job very well; I therefore take the liberty of copying it here and adding a few points at the end:

The Foundation for Integrated Health (FIH) was a controversial charity run by Charles, Prince of Wales, founded in 1993. The Foundation promoted complementary and alternative medicine, preferring to use the term “integrated health”, and lobbied for its inclusion in the National Health Service. The charity closed in 2010 after allegations of fraud and money laundering led to the arrest of a former official.

History

Prince Charles established the charity in 1993 to explore “how safe, proven complementary therapies can work in conjunction with mainstream medicine”. [1]

Dr Michael Dixon was appointed the Foundation’s medical director. From 2005 to 2007, FIH received a grant from the Department of Health to help organise the self-regulation of complementary therapies. There had been concern that with a large proportion of the public turning to complementary approaches, there were few safeguards in place to ensure that non-statutorily regulated therapists were safe, trained and would act in an appropriate way. FIH worked to bring together the representative bodies of many complementary professions to talk and agree standards. [2] The result was the formation of the Complementary and Natural Healthcare Council (CNHC) which had hoped to register 10,000 practitioners of complementary medicine by the end of 2009 but which by September 2009 had succeeded in enrolling less than a tenth of that number due to lack of interest on the part of some of their professional associations. The Department of Health is currently continuing to fund the CNHC but future funding will be dependent on substantial progress being made towards the target (which has now been reduced to 2,000). Alternative medicine campaigners argued that the move toward regulation conferred undue respectability on unproven and possibly unsafe complementary & alternative medicine (CAM) approaches.

FIH also worked with medical schools to increase the understanding of complementary approaches amongst new doctors and ran an annual awards ceremony for integrated health schemes both within the medical world and in the community.

The papers of the Foundation for Integrated Health are held at the Wellcome Library, Archives and Manuscripts, and are available for consultation by appointment. Further details about the collection can be found on the Wellcome online catalogue. [3]

Controversy

The Prince of Wales has demonstrated an interest in alternative medicine, the promotion of which has occasionally resulted in controversy. [4] In 2004, the Foundation divided the scientific and medical community over its campaign encouraging general practitioners to offer herbal and other alternative treatments to National Health Service patients, [5] [6] and in May 2006, The Prince made a speech to an audience of health ministers from various countries at the World Health Assembly in Geneva, urging them to develop a plan for integrating conventional and alternative medicine. [7]

In April 2008, The Times published a letter from Professor Edzard Ernst that asked the Prince’s Foundation to recall two guides promoting “alternative medicine”, saying: “the majority of alternative therapies appear to be clinically ineffective, and many are downright dangerous.” A speaker for the foundation 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.” [8] Ernst has recently published a book with science writer Simon Singh condemning alternative medicine called Trick or Treatment: Alternative Medicine on Trial . The book is ironically dedicated to “HRH the Prince of Wales” and the last chapter is very critical of his advocacy of “complementary” and “alternative” treatments. [9]

The Prince’s Duchy Originals have produced a variety of CAM products including a “Detox Tincture” that Ernst has denounced as “financially exploiting the vulnerable” and “outright quackery“. [10] In May 2009, the Advertising Standards Authority criticised an email that Duchy Originals had sent out to advertise its Echina-Relief, Hyperi-Lift and Detox Tinctures products saying it was misleading. [11]

In Ernst’s book More Good Than Harm? The Moral Maze of Complementary and Alternative Medicine he and ethicist Kevin Smith call Charles “foolish and immoral” and “conclude that it is not possible to practice alternative medicine ethically”. Ernst further claims that the private secretary of the Prince contacted the vice chancellor of Exeter University to investigate Ernst’s complaints against the “Smallwood Report” which the Prince had commissioned in 2005. While Ernst was “found not to be guilty of any wrong-doing, all local support at Exeter stopped, which eventually led to my early retirement.” [12]

Between 2005 and 2007 the charity’s annual turnover was about £1.2 million. [13] In 2007 it received significant funding from The Prince’s Charities Foundation, and a £300,000 grant from the Department of Health for the regulation of complementary medicine. [14]

Lobbying allegations

The Prince personally wrote at least seven letters [15] to the Medicines and Healthcare products Regulatory Agency (MHRA) shortly before they relaxed the rules governing labelling of herbal products such as the ones sold by his duchy, a move that has been widely condemned by scientists and medical bodies. [16]

On 31 October 2009 it was reported that Prince Charles had personally lobbied Health Secretary Andy Burnham regarding greater provision of alternative treatments on the NHS. [10]

Charity Commission complaint

In March 2010, the political organisation Republic, which campaigns for an elected head of state, registered a complaint with the Charity Commission for England and Wales over a possible breach of charity regulations, suggesting that the foundation’s staff had pursued a public vendetta against Ernst. [17]

Fraud allegations and closure

In 2010, following accounting irregularities noted by the foundation’s auditor, it was reported that the Metropolitan Police Economic and Specialist Crime Command had begun an inquiry into alleged fraud. [18] Within weeks, two former officials at the Prince’s Foundation were arrested for fraud believed to total £300,000. [1] [19] Four days later, on 30 April 2010, the foundation announced [20] that it would close. The foundation stated that its closure was the result of the fraud allegations. [21]

The charity’s finance director, accountant George Gray, was convicted of theft totalling £253,000 and sentenced to three years in prison. [22] [23]

Rebranding as “The College of Medicine”

Following the disbanding of the Prince’s Foundation, many of the individuals and organisations involved launched a new organisation in late 2010 called The College of Medicine, with which the Prince of Wales was not overtly involved. Several commentators writing in The Guardian and The British Medical Journal, have expressed the opinion that the new organisation is simply a re-branding of the Prince’s Foundation, [22] [24] [25] [26] [27] describing it as “Hamlet without the Prince”. [28]

In support of this connection with Prince Charles, alternative medicine critic and pharmacologist David Colquhoun has argued that the College (originally called “The College of Integrated Health”) is extremely well-funded [29] and seemed from the beginning to be very confident of the Prince’s support; explicitly describing its mission as “to take forward the vision of HRH the Prince of Wales”. [30]

These claims have been contested by the College. [31]

  1. Robert Booth (26 April 2010). “Prince Charles’s aide at homeopathy charity arrested on suspicion of fraud”. London: guardian.co.uk.
  2. ↑ Regulating complementary therapies – Prince’s Foundation for Integrated Health
  3. ↑ “Wellcome Library Western Manuscripts and Archives catalogue”. Archives.wellcomelibrary.org. Retrieved 2015-09-07.
  4. ↑ Barnaby J. Feder, Special To The New York Times (9 January 1985). “More Britons Trying Holistic Medicine — New York Times”. Query.nytimes.com. Retrieved 2008-10-12.
  5. ↑ Carr-Brown, Jonathon (14 August 2005). “Prince Charles’ alternative GP campaign stirs anger”The Times. London. Retrieved 11 March 2009.
  6. ↑ Revill, Jo (2004-06-27). “Now Charles backs coffee cure for cancer”. London: The Observer. Retrieved 2007-06-19.
  7. ↑ Cowell, Alan (2006-05-24). “Lying in wait for Prince Charles”The New York Times. Retrieved 2009-10-15.
  8. ↑ Henderson, Mark (17 April 2008). “Prince of Wales’s guide to alternative medicine ‘inaccurate. London: Times Online. Retrieved 2008-08-30.
  9. ↑ Singh, S. & Ernst, E. (2008). Trick or Treatment: Alternative Medicine on Trial. Corgi.
  10. Tim Walker (31 Oct 2009). “Prince Charles lobbies Andy Burnham on complementary medicine for NHS”. London: Daily Telegraph. Retrieved 2010-04-01.
  11. ↑ “Duchy Originals Pork Pies”The Quackometer Blog. 11 March 2009.
  12. ↑ Ernst, Edzard (2018). “Why Did We Call Prince Charles Foolish and Immoral?”. Skeptical Inquirer. Committee for Skeptical Inquiry. 42 (3): 8–9.
  13. ↑ Charity CommissionThe Prince’s Foundation for Integrated Health, registered charity no. 1026800.
  14. ↑ The Prince’s Foundation for Integrated Health – 2007 accounts (PDF), Charity Commission, retrieved 2010-04-30
  15. ↑ “HRH “meddling in politics. DC’s Improbable Science. March 12, 2007.
  16. ↑ Nigel Hawkes & Mark Henderson (September 1, 2006). “Doctors attack natural remedy claims”The Times. London.
  17. ↑ Booth, Robert (19 March 2010). “Prince Charles health charity accused of vendetta against critic”. London: The Guardian.
  18. ↑ Delgado, Martin; Young, Andrew (4 April 2010). “Police probe into missing £300k at Prince Charles’ charity after bosses fail to file accounts”Daily Mail. London.
  19. ↑ “Prince Charles charity to close amid fraud inquiry”BBC News. 30 April 2010.
  20. ↑ Robert Booth (30 April 2010). “Prince of Wales’s health charity wound up in wake of fraud investigation”The Guardian.
  21. ↑ Laura Donnelly (15 May 2010). “Homeopathy is witchcraft, say doctors”. London: The Telegraph.
  22. Ian Sample (August 2, 2010). “College of Medicine born from ashes of Prince Charles’s holistic health charity”. London: The Guardian.
  23. ↑ Peter Dominiczak (20 August 2010). “Three years jail for accountant at Charles charity who stole £253,000”. Evening Standard. Archived from the original on 30 June 2011. Retrieved 2 February 2011.
  24. ↑ Jane Cassidy (15 June 2011). “Lobby Watch: The College of Medicine”British Medical Journal343: d3712. doi:10.1136/bmj.d3712PMID   21677014.
  25. ↑ David Colquhoun (12 July 2011). “The College of Medicine is Prince’s Foundation reincarnated”British Medical Journal343: d4368. doi:10.1136/bmj.d4368PMID   21750061.
  26. ↑ James May (12 July 2011). “College of Medicine: What is integrative health?”British Medical Journal343: d4372. doi:10.1136/bmj.d4372PMID   21750063.
  27. ↑ Edzard Ernst (12 July 2011). “College of Medicine or College of Quackery?”British Medical Journal343: d4370. doi:10.1136/bmj.d4370PMID   21750062.
  28. ↑ Nigel Hawkes (2010). “Prince’s foundation metamorphoses into new College of Medicine”341. British Medical Journal. p. 6126. doi:10.1136/bmj.c6126.
  29. ↑ David Colquhoun (July 25, 2010). “Buckinghamgate: the new “College of Medicine” arising from the ashes of the Prince’s Foundation for Integrated Health”. DC’s Improbable Science.
  30. ↑ David Colquhoun (29 October 2010). “Don’t be deceived. The new “College of Medicine” is a fraud and delusion”.
  31. ↑ Lewith, G. T.; Catto, G; Dixon, M; Glover, C; Halligan, A; Kennedy, I; Manning, C; Peters, D (12 July 011). College of Medicine replies to its critics”British Medical Journal343: d4364. :10.1136/bmj.d4364.    21750060.

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This article is, as far as I can see, factually correct. I might just add some details:

  • Dixon became medical director of the FIH only a few months before it had to close.
  • The FIH was also involved in Prince Charles’ complaint about me alleging I had breached confidence in relation to the Smallwood report, even though the FHI had officially nothing to do with the report.
  • Mr Smallwood told me that, at that stage, Prince Charles considered the FIH to be ‘a waste of space’.
  • Some time ago, the College of Medicine quietly re-named itself as the ‘College of Medicine and Integrated Health’.
  • Prince Charles recently became the patron of the College of Medicine and Integrated Health.

SIMILE is the newsletter of ‘The Faculty of Homeopathy’ which is the professional organisation of doctor homeopaths in the UK. Readers of this blog might know about SIMILE because I once published a post about it. Two years ago, the late Dr Peter Fisher (then the Queen’s homeopath) used SIMILE to re-publish a serious lie about me:

A prepublication draft [of the Smallwood report] was circulated for comment with prominent warnings that it was confidential and not to be shared more widely (I can personally vouch for this, since I was one of those asked to comment). Regrettably, Prof Ernst did precisely this, leaking it to The Times who used it as the basis of their lead story. The editor of The Lancet, Richard Horton, certainly no friend of homeopathy, promptly denounced Ernst for having “broken every professional code of scientific behaviour”.

Sir Michael Peat, the Prince of Wales’ Principal Private Secretary, wrote to the vice chancellor of Exeter University protesting at the leak, and the university conducted an investigation. Ernst’s position became untenable, funding for his department dried up and he took early retirement. Thirteen years later he remains sore; in his latest book More Harm than Good? he attacks the Prince of Wales as “foolish and immoral”.

At the time, I complained and SIMILE (not Fisher) apologised unreservedly.

The current (May 2020) issue of SIMILE carries the following article. I find it quite humorous and therefore take the liberty of copying it here for you:

Every year in Austria a sceptic group called the Society for the Scientific Investigation of Parasciences (GWUP) announces the winner of the Golden Board in Front of the Head Award for what they deem as “unscientific nonsense”. Their award frequently goes to a representative of Austria’s homeopathy community.

However, it now appears Austrian homeopaths have turned the tables on their antagonists by bestowing the 2019 Award for pseudoscience to the GWUP.

But what seems on the surface to be a light hearted tit-for-tat gesture is in truth an attempt to raise questions about who these sceptic groups represent and their real aims.

The Austrian Society of Medical Homeopathy and the Veterinary Society for Homeopathy justify the award on the grounds that the GWUP is trying to agitate against complementary medicine and homeopathy without disclosing their true motives and donors. They say that under the guise of science and purported “scientific truths” these “all-knowing” activists, many of whom are without any medical qualifications, deliberately misrepresent scientific studies that support the efficacy of homeopathy beyond placebo.

The homeopaths accuse the sceptic group of fanatical and aggressive lobbying and media work to discredit proven methods of complementary medicine, which are successfully used by a large number of people around the world. Their aim, claim the homeopaths, is to position complementary medicine in an “esoteric, frivolous corner, to curtail plurality and freedom of choice in healthcare, and to hinder progress towards inclusive medicine”.

As we can see, SIMILE learnt an important lesson: they now tell lies in a way that does no loner put them in the firing line. Instead they report then as said by someone else:

  • GWUP is trying to agitate against complementary medicine and homeopathy without disclosing their true motives and donors = lie No 1
  • under the guise of science and purported “scientific truths” these “all-knowing” activists, many of whom are without any medical qualifications, deliberately misrepresent scientific studies that support the efficacy of homeopathy beyond placebo = lie No 2
  • fanatical and aggressive lobbying and media work to discredit proven methods of complementary medicine = lie No 3
  • position complementary medicine in an “esoteric, frivolous corner, to curtail plurality and freedom of choice in healthcare, and to hinder progress towards inclusive medicine” = lie No 4

Congratulation guys!

You have managed to find a way which enables you to promote untruth and shelter yourselves from considering criticism. You have, in other words, continued the age-old homeopathic tradition of effectively avoiding critical thinking.

People who use so-called alternative medicines (SCAM) tend to be more vaccine hesitant. One possible conclusion that can be drawn from this is that trusting SCAM results in people becoming more vaccine hesitant. An alternative possibility is that vaccine hesitancy and use of SCAM are both consequences of a distrust in conventional treatments. an International team of researchers conducted analyses designed to disentangle these two possibilities.

They measured vaccine hesitancy and SCAM use in a representative sample of Spanish residents (N = 5200). They also quantified their trust in three CCAM interventions;     

  1. acupuncture,
  2. reiki,
  3. homeopathy                                                                  

and in two conventional medical interventions:

  1. chemotherapy,
  2. antidepressants.

Vaccine hesitancy turned out to be strongly associated with (dis)trust in conventional medicine, and this relationship was particularly strong among SCAM users. In contrast, trust in SCAM was a relatively weak predictor of vaccine hesitancy, and the relationship was equally weak regardless of whether or not participants themselves had a history of using SCAM.

According to the authors of this paper, the implication for practitioners and policy makers is that SCAM is not necessarily a major obstacle to people’s willingness to vaccinate, and that the more proximal obstacle is people’s mistrust of conventional treatments.

This is an interesting study. Yet, it begs a few questions:

  1.  Is it possible to reliably establish trust in SCAM by asking about just 3 specific therapies?
  2. Is it possible to reliably establish trust in conventional medicine by asking about just 2 treatments?
  3. Why those therapies out of hundreds of options?
  4. Could it be that here are national differences (in other countries distrust in conventional medicine is not a strong determinant of SCAM use)?
  5. Is trust in SCAM and distrust in conventional medicine perhaps the common expression of an anti-science attitude or cultist tendencies?

THE HINDU reported on 22 May the following amazing story:

A corporator from Borivali, Riddhi Khursange, has distributed 10,000 bottles of Arsenicum Album 30, the homoeopathy medicine that was recommended by Ministry of AYUSH as a prophylactic for COVID-19. Another corporator from Ghatkopar, Pravin Chheda, has bought 25,000 bottles and has distributed over 7,100 in the past four days…

“The AYUSH Ministry must have based their claims on the benefits of the medication. The municipal corporation has also approved it for distribution,” said Mr. Chheda, who aims to distribute one lakh vials. He said all his family members have taken the three-day dose.

While the recommendation from AYUSH was issued on March 6, the Brihanmumbai Municipal Corporation (BMC) on May 8 issued a circular that 20 lakh people, including those in quarantine centres, will get the medicine.

Some experts, however, do not agree with such random, mass distribution. Also known as Ars Alb, the medication was termed as genus epidemicus (homoeopathy medicine indicated for an epidemic) during the H1N1 outbreak of 2008-2009. “Back then, Ars Alb proved extremely beneficial. But the current claim of AYUSH Ministry has not been backed by the process of genus epidemicus,” said Dr Bahubali Shah, former president of the Maharashtra Council of Homoeopathy.

“Another major problem is this general mass distribution of the medicine without an attempt to collect data on efficacy. There has to be a proper distribution protocol and a protocol for analysis. Right now, corporators, NGOs, the BMC and everyone who can get their hands on the medication are distributing it without any record-keeping,” he said.

Well-known chest physician, Dr. Zarir Udwadia, who is part of the State’s COVID-19 task force, said any alternative treatment still has to undergo a trial. “In my opinion, it should not be added on ad hoc,” said Dr. Udwadia.

The State government has set up a new committee to exclusively look at AYUSH remedies. Dr. T.P. Lahane, who is a part of the committee, said a meeting was planned on Thursday evening to discuss various options.

Meanwhile, a trial on 44 COVID-19 patients in Agra has shown that a homoeopathy medicine called Bryonia Alba was more beneficial than Ars Alb. “We have submitted our findings to Central Council of Homoeopathy and are now enrolling more patients for a bigger trial,” said Dr. Pradeep Gupta, principal of the Naiminath Homeopathy College and Hospital, who is conducting the trial.

He said 22 patients were given a placebo while 22 others were given homoeopathy medicines, Bryonia Alba, Ars Alb and Gelsemium. “19 patients who had fever, cough and weakness, responded to Bryonia within the first three days, two patients who had respiratory distress were first given Ars Alb, which relieved the breathing discomfort, but they had to be put on Bryonia Alba to relieve their fever and cough. Only one patient who came in with drowsiness was first given Gelsemium, but later put on Bryonia Alba for other symptoms,” said Dr. Gupta.

For patients in Agra, Bryonia Alba seems to be the genus epidemicus, he said. Dr. Gupta has now written to the Maharashtra government to conduct a similar trial on patients here.

Are they serious?

To me this sounds as though some amateurs are playing doctor and scientist.

I am sure we will have some homeopathy fans pointing out that India is doing very well in the pandemic and that this must be due to the widespread use of homeopathy. To this I answer that firstly India is sadly no longer doing all that well, and secondly that proof of efficacy requires more than speculation. They will reply that homeopathy has proven itself in many previous epidemics. And I will counter that this is just wishful thinking.

So, will the current pandemic finally provide the proof that homeopathy works?

No!

And the Indian homeopaths seem to be doing their utmost to obscure the picture in their hope that, in the end, they can nevertheless claim victory out of a shameful defeat.

Guest post by: Loretta Marron

In March 1991, the Australian College of Allergy published an article in the Medical Journal of Australia (MJA) about a ‘bioresonance’ device for allergy testing. Titled “VEGA testing in the diagnosis of allergic conditions”, it stated that it was “an unorthodox method of diagnosing allergic and other diseases” with “no established scientific basis” and “no controlled trials to support its usefulness”.

The article raised concerns that this test “may lead to inappropriate treatment and expense to the patient and community”. VEGA is one of nearly 30 ‘energy medicine’ devices, some of which continue to cite Therapeutic Goods Administration (TGA) ‘listing numbers’.

Sometime costing more than $34,000, the sponsors tell practitioners that they can earn up to $150,000 annually with these computerised devices. Referring to ‘bioresonance’ as “the medicine of the future”, they claim that all toxins, viruses and bacteria have unique ‘frequency patterns’, which, when ‘neutralised’ by the device, restore the patient to health. They may also claim that it can cure addictions to alcohol, cocaine, crack, nicotine, heroin, opiates, cannabis, spice, ‘legal highs’ and other medications. Some claim that it can cure cancer, hay fever, allergies, auto-immune diseases, behavioural problems, smoking addiction and that they can kill parasites – the list goes on.

The devices are ‘based’ on acupuncture, homeopathy and ‘quantum physics’. More than 60 reviews in the Cochrane Collaboration (the ‘Gold Standard’ for evidence-based Medicine), have failed to find robust evidence for clinically significant outcomes for acupuncture for any disease or disorders. The National Health & Medical Research Council concluded, “there are no health conditions for which there is reliable evidence that homeopathy is effective” and quantum physics “is not at work”. In February 2020, nearly 30 years after that MJA article, the TGA’s cancellation of two of these devices saw the last of them removed from their register, but not from permissible advertising or practice.

From 2014 to 2018, Friends of Science in Medicine (FSM) had repeatedly written letters and submissions to the TGA asking for these devices to be investigated. Meeting with the national manager in 2016, we were told that these devices could not be cancelled because they were ‘biofeedback’ devices, which had a legitimate place in health care. In 2018, FSM sourced comments from informed experts here and overseas. These disputed the ‘biofeedback’ claim. FSM sent screenshots from more than 200 websites to the TGA advertising complaints. In 2019, after issuing a warning on bioresonance, the TGA closed the complaints and commenced an ‘education campaign’. They also engaged a credible Australian scientific organisation to review the evidence provided by eight ‘sponsors’ of 12 bioresonance’ devices listed in the Australian Register of Therapeutic Goods).

All devices have now been cancelled by their sponsors or by the TGA. The ‘education campaign’ continues. Even though the devices are still widely used, and courses still being run, FSM considers this a modestly satisfactory outcome.

Informed opinions:

Biofeedback:

o Michelle G Aniftos BCN, FCCLP, QEEGD, MEd, MPsych (Clinical), GradCertClinNeurophysiology, Fellow, Biofeedback Certification International Alliance, &

o Dr Tania M. Slawecki, PhD. Energy and the Environment Laboratory (formerly Materials Research Lab), Penn State University, USA (Author of “How to Distinguish Legitimate Biofeedback/Neurofeedback Devices”;

Electronic devices:

o Dr Stephen J Roberts, BSc ARCS DIC PhD. Consultant on electronic devices;

Psychology:

o Emeritus Professor Joseph P Forgas, AM, DPhil, Dsc (Oxford), FASSA, Scientia Professor, Psychology, UNSW &

Alternative medicine:

o Emeritus Professor Edzard Ernst MD, PhD, FMed Sci, FSB, FRCP, FRCP(Edin)

Their comments include the following:

· Ms Aniftos: “Having reviewed the specifications of the BICOM device, I find that its inclusion on the ARTG as a ‘biofeedback device’ is erroneous”;

· Dr Slawecki: “the BICOM device does not fit the criteria of a legitimate biofeedback device”;

· Dr Roberts: “The claims of how the BICOM and CyberScan work are preposterous.”Quantum physics” is not at work”;

· Professor Forgas: “The BICOM is NOT a biofeedback device and should be cancelled”; “The description of this device makes it crystal clear that it cannot possibly have any effective diagnostic or therapeutic function, and certainly has nothing at all to do with biofeedback.

“The claims made for the device amount to the worst kind of psychological manipulation, and their sole purpose is to mislead and exploit vulnerable people for financial gain. As a civilised society, we should not allow this kind of immoral exploitation to continue and the device should be banned forthwith”;

· Professor Ernst: “Bioresonance is not biologically plausible, not of proven effectiveness, potentially harmful and associated with exorbitant costs. I cannot recommend it for anyone or any purpose”.

There are many proponents of so-called alternative medicine (SCAM) who advocate the use of high-dose vitamin D for the prevention or treatment of corona-virus infections. Considering that ethnic minorities are disproportionately affected with Covid-19 further research seems justified, especially as there is clear evidence that vitamin D deficiency is particularly common in these ethnic groups.

However, an international team of experts strongly caution against doses higher than the upper limit (4000 IU/day; 100 µg/day); and certainly of very high doses of vitamin D (in some reports, 10 000 IU/day (250 µg/day) of vitamin D are being promoted) unless under personal medical advice/clinical advice by a qualified health professional. Instead, they advocate the following lifestyle strategies for avoiding vitamin D deficiency and ensuring a healthy, balanced diet.

  1. Supplementation with vitamin D according to Government guidelines (eg, 400 IU/day (10 µg/day) for the UK;7 600 IU/day (15 µg/day) for the USA (800 IU/day (20 µg/day) for >70 years) and Europe. These recommendations were established to ensure that 25OHD concentrations in the majority of the population are above 25 nmol/L (UK) in order to protect musculoskeletal health or above 30 nmol/L (USA) to minimise the risk of vitamin D deficiency (the USA recommendation was also established to optimise musculoskeletal health in the population using a 25OHD concentration of 50 nmol/L). Supplementation with vitamin D is particularly important during times of self-isolation associated with limited sunlight exposure. This is in line with the UK Scientific Advisory Committee on Nutrition (SACN) recommendations for vitamin D, and the US Institute of Medicine (IOM) recommendations for vitamin D, both of which were established under the assumption of minimal exposure to sunlight. Thus, re-emphasis of advice on safe sun exposure (below) and reinforcing government advice on supplements especially when sunlight exposure is low would further boost vitamin D status. The UK SACN, US IOM and EU European Food Safety Agency recommend that vitamin D intake (total from both foods and dietary supplements) should be limited to 4000 IU/day (100 µg/day) for adults, and there is broad international consensus that the general public should avoid higher dose supplements that risk total intake from all sources exceeding this level.
  2. Consumption of a nutritionally balanced diet, for example, according to the UK Eatwell Guide and US Food Pyramid including vitamin D rich foods, that is, oily fish, red meat, egg yolk and fortified foods, such as breakfast cereals in the UK, as well as fortified milk in the USA and Canada.
  3. Safe sunlight exposure to boost vitamin D status. Safe sunlight exposure will enable vitamin D production in skin from March through September in the UK, and at most northern latitudes. Dermal synthesis of vitamin D is most efficient with short, regular (daily) exposures when the sun is at its strongest (in the middle of the day). The efficiency of vitamin D synthesis declines well before the threshold for sunburn is reached but the desirable dose is skin-type dependent and so exposure times required differ for different skin types. For the UK about 10 min of exposure at around lunchtime, in-season appropriate clothing, can meet vitamin D needs for white-skinned people; this increases to about 25 min for those of skin type V (ie, South Asian, brown skin tones). What is key is to try to achieve the sunlight exposure without leaving home (eg, in the garden/balcony); and if that is not possible ensure that social distancing is maintained at all times. Increasing the unprotected skin area (skin not protected by clothing or sunscreen) will increase the vitamin D supply from skin while keeping exposure times short and sub-erythemal. Exposing as much skin as temperature and social comfort allow will maximise vitamin D supply through this route. For those of skin type V and VI (brown or black skin) the exposure requirements in UK sunlight are more challenging to achieve than for white-skinned people and oral vitamin D intake is especially important.
  4. Appropriate diet and lifestyle measures, as emphasised by the WHO at this time, including adequate nutrition to protect the immune system.
  5. Targeted nutritional advice, for example, for UK Military personnel as advised by the Defence Nutrition Advisory Service, with specific reference to COVID-19.
  6. Vitamin D—advice for bone health. The Royal Osteoporosis Society provides specific guidelines on the management of vitamin D deficiency in adults with, or at risk of developing, bone disease.

In conclusion, the experts recommend appropriate RCTs to evaluate the effects of vitamin D supplementation on COVID-19 infections. Until there is more robust scientific evidence for vitamin D,  they strongly caution against the use of high vitamin D supplementation (greater than the upper limit of 4000 IU/day (100 µg/day)). Rather, they strongly endorse avoidance of vitamin D deficiency in the population (as per the six points above) and complete adherence to government’s advice worldwide on the prevention of the spread of COVID-19.

I am sure that this will not stop self-appointed SCAM-experts to continue recommending mega-doses of vitamin D. Therefore it is perhaps worth reminding consumers that an excess of vitamin D will lead to a condition called hypervitaminosis D. It is characterised by the following symptoms:

  • Anorexia
  • Dehydration
  • Fatigue
  • Frequent urination
  • Irritability
  • Tinnitus
  • Dizziness
  • Disorientation
  • Confusion
  • Weight loss
  • Muscle weakness
  • Vomiting
  • Excessive thirst
  • High blood pressure
  • Arrhythmias
  • Passing large amounts of urine

It can lead to serious complication, including permanent kidney damage.

As mentioned before, the US ‘Agency for Healthcare Research and Quality (AHRQ) have published a most comprehensive review update entitled ‘Noninvasive Nonpharmacological Treatment for Chronic Pain‘. It followed the AHRQ Methods Guide for Effectiveness and Comparative Effectiveness. The conditions included were:

  • Chronic low back pain
  • Chronic neck pain
  • Osteoarthritis (knee, hip, hand)
  • Fibromyalgia
  • Chronic tension headache

 

Here are the main findings related to spinal manipulation:

LOW BACK PAIN

  • Spinal manipulation was associated with small improvements compared with sham manipulation, usual care, an attention control, or a placebo intervention in short-term (3 trials) and intermediate-term (3 trials) function (strength of evidence : low). There was no difference between spinal manipulation versus sham manipulation, usual care, an attention control, or a placebo intervention in short-term pain (3 trials), but manipulation was associated with a small improvement compared with controls on intermediate-term pain (3 trials) (SOE: low for short term, moderate for intermediate term).

CHRONIC TENSION HEADACHE

  • Spinal manipulation therapy was associated with small improvements in function and moderate improvements in pain compared with usual care over the short term in one trial (: low). Approximately a quarter of the patients had comorbid migraine.

HARMS

It was noted that many trails failed to report on adverse effects (AEs). Non- serious AEs reported included mild to moderate increase in pain, local discomfort and tiredness (2 RCTs).

___________________

Hardly impressive, is it?

Yet, some chiropractors treating chronic pain claim they practice Evidence-based medicine. This review seems to disclose this claim as bogus. What chiropractors do practice on virtually all patients is spinal manipulation which generates more harm than it produces benefit.

Please note yet again that:

  • many chiro trials fail to mention AEs (thus violating research ethics),
  • clinical trials are always too small to give a reliable impression about safety,
  • no post-marketing surveillance exists in chiropractic,
  • we thus have to rely mostly on case reports and similar articles,
  • and the collective evidence from such reports shows quite clearly that spinal manipulations are not safe,
  • chiropractors tend to deny all of the above,
  • this is because they have a monumental conflict of interest.

Can I invite you to join me in a little thought experiment?

Think of a totally useless therapy. I would suggest homeopathy but there are always some who would disagree with this classification. I need a TOTALLY useless therapy, and one where we ALL can agree on the label.

What about ‘Potentised Toe-Nail Powder’ (PoToNaPo)?

PoToNaPo is made from nail clippings, thoroughly sterilised, ground to a powder, serially diluted and potentised. Does anyone claim this remedy to be effective for any condition?

No?

Splendid!

So, we all agree that PoToNaPo is completely ineffective.

Now imagine some charlatan claiming that PoToNaPo is a highly effective cancer cure. Let’s furthermore imagine that he is very successful with his claim.

(No, this is not far fetched! Think of Laetrile, Essiac, etc.)

Imagine our charlatan makes millions with PoToNaPo.

There would soon be some opposition to his quackery. The FDA would issue a statement that PoToNaPo is unproven. Perhaps the NEJM would publish an editorial saying something similar. Ethicists would frown publicly. And many sceptics would head to the pubs where clever guys would give talks about ‘the scandal of PoToNaPo’.

We all know it would happen, because it has happened with PoToNaPo-like remedies many times before.

______________

Now imagine a different scenario, namely one in which our charlatan does not claim that PoToNaPo is a cancer cure; imagine instead he had claimed that PoToNaPo is a holistic medicine that boosts your well-being via re-balancing your vital energies which, in turn, helps with anxiety which in turn might have positive effects on things like mild chronic pain, depressive mood, tension headache, insomnia, erectile dysfunction and many more symptoms of daily life.

Let’s furthermore imagine that our charlatan is very successful with these claims.

No, this is not far fetched! Think of … well … think of any SCAM really.

Imagine the charlatan makes millions with PoToNaPo.

What would happen?

  • He would be invited to conferences on integrative medicine.
  • Become an honorary member/sponsor of the ‘College of Medicine and Integrated Health’.
  • He would be interviewed on the BBC.
  • The Daily Mail would publish advertorials.
  • HRH would perhaps invite him for tea.
  • Trump might hint that PoToNaPo cures virus infections.
  • Ainsworth might buy his patent.
  • There could even be a gong waiting for him.
  • And yes … some sceptics would mutter a bit, but the public would respond: what’s the harm?

We all know that things of this nature might happen, because they have happened before with PoToNaPo-like remedies.

__________________

So what’s the difference?

In both scenarios, our charlatan has marketed the same bogus remedy, PoToNaPo.

In both scenarios, he has made unsubstantiated, even fraudulent claims.

Why does he get plenty of stick in the 1st and becomes a hero in the 2nd case?

Yes, I know, the difference is the nature of the claims. But the invention, production, marketing and selling of a bogus treatment, the lying, the deceit, the fraud, the exploitation of vulnerable people are all the same.

Why then are we, as a society, so much kinder to the charlatan in the 2nd scenario?

I think we shouldn’t be; it’s not logical or consequent. I feel we should name, shame and punish both types of charlatans. They are both dangerous quacks, and it is our ethical duty to stop them.

END OF THOUGHT EXPERIMENT

 

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