bias
Guest post by Ken McLeod
Believe it or not, there are practitioners of a health system with little or no evidence of efficacy and safety who are registered with the Australian Health Practitioner Registration Agency. That is, so-called Traditional Chinese Medicine, whose practitioners are registered alongside evidence-based practitioners such as doctors, nurses, pharmacists, and dentists.
Governments who framed the relevant legislation evidently hoped that registration would enable the public to have confidence that they would be treated with evidence-based medicine. Such confidence is misplaced, as has been shown in The Skeptic and elsewhere many times.
Here’s another example of the failure of the health practitioner registration system.
Jamie Lloyd Allan is registered with AHPRA with the Chinese Medical Registration Number CMR0002096457, with no endorsements. He practices at his clinic in eastern Sydney. He advertises at his website meridianremedies.com.au.
And some of his claims are deeply worrying. Allan claims that he uses “Chinese Herbal medicine & Acupuncture in conjunction with testing and removal of accumulated toxins and heavy metals, developing comprehensive individualised herbal antimicrobial and detoxification protocols.”
He claims that “toxins and heavy metals … enter our bodies, disrupt normal healthy cell behaviour, impair our immune system, often contribute and sometimes cause many different types of illnesses and health conditions.”
His claims are designed to generate unfounded worries in people, offering a smorgasbord of claims how he can help people learn [the words and spelling are his]:
• how mercury from common amalgam fillings can be passed from mother to child to grandchild and why preconception detoxification is important;
• how to assess a dentist to know your [sic] getting the best and safest care during amalgam removal;
• about mercury/autism connection, heavy metal accumulation and neurological diseases such as Alzheimer’s, Parkinson’s and Dementia;
• more about mercury, aluminium, cadmium and lead toxicity;
• how heavy metal accumulation acts as an antenna for electromagnetic radiation from devices such as wifi, cell phone, cordless phones, thus focusing the frequencies on the areas where the metals are stored, causing changes in the proteins and even DNA;
• the science behind electromagnetic radiation and how it affects human cells;
• Glyphosate toxicity, and how many of us have it and how it affects our health, and lots more.
Allan goes into the alleged toxicity of mercury amalgam fillings further at his blog. I should not have to say it, but his claims are baseless and have been debunked many times. The US Food and Drug Administration has said that existing evidence shows that dental amalgam is not harmful to the general population (tinyurl.com/589mbrr6). And as Scientific American said “Mercury and Autism: Enough Already! The science shows that they have nothing to do with each other and never have.” (tinyurl.com/mwwdxxak)
Allan also writes extensively on “EMF Sensitivity Wi-Fi and Cell Phone radiation – Heavy Metals and EMF Sensitivity and Autism” – he claims “Autism rates double every 5 years and the only thing that parallels that in our environment is the increase of man made Electro magnetic Radiation and fields largely in the high frequencies from cell phone Wi-Fi, smart meters and other Electro magnetic devices.’ This is unconscionable; scaring potential clients with this, while conveniently forgetting that correlation does not mean causation.
Allan also offers the following techniques as a “Detox for autism”:
• Sauna or heat therapy (far infrared is best) Cold shower straight after to close pores and wash of toxins
• Clay plasters, Clay on scars, then shower
• Ionic Foot Cleanses, Detox baths, Takara foot Pads, or raw white potato strapped on soles of feet
• Fibre + Enemas or colonics, slippery elm, keep bowls [sic] moving
• Liver gall bladder flush with lemon oil
• Exercise, dry skin brush
• Chi Machine for lymph drainage and movement to parasympathetic dominance
• Olive or other healthy oils for swish and spit
• Genetic, vitamin, mineral testing to guide your diet and supplements
• Western and Chinese Herbs to detox bowls [sic], liver, kidney, lymph
• Homeopathic drops & plenty of water orally
• Laser Energetic detox
• Ozonized bath, Epson salt bath
• Enema for detox reactions in kids
• Stronger detox agents DMPS, DMSA, EDTA can be used in case of high-level toxicity. For children, the use of the above mention techniques over DMPS, DMSA and EDTA is preferred first.
“Raw white potato strapped on soles of feet”!! Come on! This is lunacy. And enemas for children? And what qualifications does Allan hold to diagnose and administer these dangerous pharmaceuticals?
Luckily, Allan offers the perfect scanner to diagnose what’s wrong with you, the Oligoscan.
As described, “This a [sic] spectrographic-based test. Every element on the periodic table has its own unique absorption spectra, meaning that different elements absorb certain wavelengths of light, and reflect others. The spectra of lead will be different from that of mercury, or calcium, or any other element. The Oligoscan shines a laser on different points on the hand, and based off of [sic] which wavelengths of light are absorbed or reflected back, the levels of different metals and minerals in the cells of your hand can be determined. This is similar to how astronomers can analyze the wavelengths of light emitted by distant stars to determine their chemical make-up.
“The Oligoscan has the advantage of testing the levels of metals that are actually in your cells, not what you are able to excrete. It tests the heavy metal load of the tissues. This is important because heavy metals have a affinity [sic] for tissues and are often store [sic] there and not in the blood. It can also measure aluminium, which most other tests will miss. Oligoscan results tend to correlate with other accurate tests.”
A search of the TGA’s register of therapeutic goods did not find the Oligoscan listed.
Clearly, Allan is engaged in a process of scaring potential clients with misinformation, then offering diagnostic and treatment processes that are deceptive, ineffective and dangerous, and not listed with the TGA; for all of which he is not qualified.
COMPLAINT PROCESS
A complaint was sent to the NSW Health Care Complaints Commission describing the above issues. (In NSW and Queensland, complaints concerning health care practitioners, registered and unregistered, are lodged with the relevant State authorities, the HCCC and OHO respectively.) We added that “This should not be treated as merely a case of misleading advertising; Allan is clearly endangering the public, so I recommend a thorough audit of his practice, and when my allegations are found to be proven, suitable disciplinary action taken and entered on the AHPRA register.”
The HCCC responded saying “Following consultation with the Chinese Medicine Council of New South Wales, it was decided to refer this matter to the Australian Health Practitioner
Regulation Agency (AHPRA) as AHPRA is the designated agency to manage concerns about advertising. We did not identify any other issues that would require further action by the Commission.” (We approached the Chinese Medicine Council of NSW – their response is quoted in the sidebar.)
The HCCC continued: “The Commission obtained a written response from Mr Allan. In his response to the Commission, Mr Allan stated that he had no record of providing any care and treatment to you.
“Mr Allan acknowledged that his website may have created a misunderstanding about what actual treatments are offered at his clinic, and what was on his website for educational purposes only.
“Mr Allan noted that he has never owned an Oligoscan or used it at his clinic, he has therefore removed that information from his website.
“Mr Allan confirmed that he does not offer the techniques under the heading ‘detox for autism’ at his clinic, the information was for educational purposes only, and he has now removed this information from his website.
“Further, Mr Allan has confirmed that he has removed the information on his website about Glyphosate Toxicity, Toxicity of Mercury Amalgam fillings, Nutrition for Autism, and all avenues of receiving mercury toxicity.
“Mr Allan also stated that he has since edited the information on EMF Sensitivity Wi-Fi and Cell Phone radiation – Heavy Metals and EMF Sensitivity Autism, as well as editing the information contained on the home and about pages of his website.
“Mr Allan stated that he has left the resources section with all the raw studies, and some information contained in other sections, as he feels that they are of use for anybody wanting to learn more about this specialised area.”
So, in spite of the detailed evidence and a call for a thorough audit of his practice, this was treated as merely a case of misleading advertising. This is standard operating procedure; the regulatory authorities cannot get over the divide between advertising and clinical practice. This has been shown in the hundreds of complaints sent to regulators; misleading advertising of dangerous practices and misinformation is simply treated as an advertising issue. The regulators cannot accept that if a practitioner advertises a therapy then they are more than likely using those therapies and, when those therapies have been found to be ineffective, they are engaging in practice in their clinics that deserves more than the dismissive response we received.
The public deserve much better than that.
Note: All of the quotes above were from Allan’s website until he removed them. The relevant pages have, nonetheless, can be accessed via the WayBack Machine, and can be supplied if required.
The Chinese Medicine Council’s position
The Chinese Medical Council were referred to the issues in the main article and were asked the following questions:
• Is the advice and those therapies [offered by Allan] of any concern to the Council?
• Should the complaint to the NSW Health Care Complaints Commission have led to an audit of his practice and when the allegations are proven, should there have been disciplinary action?
A spokesperson for the Chinese Medicine Council of NSW replied: “The Chinese Medicine Council of NSW (the Council) works in collaboration with the NSW Health Care Complaints Commission (HCCC) to receive and manage complaints about registered practitioners in
NSW. Our paramount legal obligation is to protect the public. We deal with practitioners whose conduct, performance or health may represent a risk to the public or is not in the public interest.
“We do this by assessing complaints, promoting compliance with professional standards and delivering programs to ensure practitioners provide safe care to the public and their patients. We do not have the legal power to discipline a NSW practitioner or to deregister them.
“By law, the Council cannot provide information about an individual practitioner. Only information that is publicly available can be disclosed, such as information recorded on the national register of practitioners which is maintained by the Australian Health Practitioner Regulation Agency (AHPRA), or publication of the outcomes of NCAT [New South Wales Civil and Administrative Tribunal] proceedings.
“Changes to a registered health practitioner’s registration status, such as the imposition of conditions or suspension, are published on the AHPRA online public register.
“The Council will not be making any further public comments at this time.
So, the Chinese Medicine Council have taken no action to protect the public and made no real comment. At least they have promised “Only information that is publicly available can be disclosed”, a statement of breathless inanity.
*‘first published in the Australian Skeptic magazine of June 2022.
I only now learned of the death of one of the most bizarre proponents that the cult of homeopathy has ever produced in its 200-year history. From his official obituary, one would not suspect much weirdness:
John R. Benneth passed away Nov. 9, 2021 in Chico, Calif., after a long battle with Parkinson’s disease.
John shepherded the Pixieland Theatre in Lincoln City for many years, writing, directing, and acting in plays that kept audiences coming back. He appeared often on stage in Portland and became a familiar face in local and national commercials. In the mid-1980s he was the host, writer, and creative force behind The Portland Underground, a weekly, live, late-night local access show. He gave many local actors a chance to stretch their improv talents on that and his earlier show, Mysterious Planet. His was the voice of both Portland Talk Radio’s controversial Jack Hammer, and Kandu the Mystic. He later performed regularly as Mark Twain in Virginia City, Nev., and on cruises on Lake Tahoe. John started working as a private investigator in Portland in 1978, and in 1982, he founded the National Missing Children’s Locate Center, helping parents to find their children across the U.S. He later became internationally known for his research into and advocacy for Homeopathic Medicine and was invited to present a treatise on the subject at London’s Oxford University in 2010.
John was a member of both Hawthorne and Washington Masonic lodges and the Scottish Rite of Portland.
He was preceded in death by his parents, John and Bettiana Benneth; and by his wife, Catherine Benneth. He is survived by his brother, David; and his four sons, Horatio, Merlin, Cyrano and Evan.
The ‘Bolen report’ offers a little more, albeit weirdly unreliable information:
John Benneth, PG Hom.- London (Hons) is the renowned discoverer of the link between Homeopathy and Conventional Ionic Chemistry.
The first to accept a notorious challenge to Homeopathy, he forced the James Randi Educational Foundation (JREF), in 1999, to back down from a spurious offer to award $1,000,000 for a test identifying homeopathic solutes from their liquid aqueous vehicles.
In 2010, by invitation of Nobel laureate physicist Brian Josephson at Cambridge’s Cavendish Laboratory, he presented the Supramolecular Chemistry of the Homeopathic Remedy revealing structural changes and the physics of hydrolysis and molecular self assembling chain reactions.
He is the author of Ebola Prophylaxis and Cure detailing the use of FDA approved homeopathic pharmaceuticals in the treatment of hemorrhagic fevers, presented in advance of the reported successful use of homeopathic remedies to cure Ebola.
He is a proponent for the use of homeopathic pharmaceuticals to cure sepsis and other dire conditions for conventional use in hospital emergency and intensive care, and the Ionic Vaccine for the safe and effective non-molecular prevention of epidemic diseases.
To estimate the true extent of Benneth’s eccentricity, we need to read some of the posts by John himself johnbenneth.wordpress.com. Alternatively, we might access some of his appearances on youtube, quackometer, or even just a post I published several years ago.
I am sad that John is gone. I always thought he was mad like a hatter, but he had me in stitches whenever our paths crossed.
An epidemiological study from the US just published in the BMJ concluded that “the mortality gap in Republican voting counties compared with Democratic voting counties has grown over time, especially for white populations, and that gap began to widen after 2008.”
In a BMJ editorial, Steven Woolf comments on the study and provides further evidence on how politics influence health in the US. Here are his concluding two paragraphs:
Political influence on US mortality rates became overt during the covid-19 pandemic, when public health policies, controlled by states, were heavily influenced by party affiliation. Republican politicians, often seeking to appeal to President Trump and his supporters, challenged scientific evidence and opposed enforcement of vaccinations and safety measures such as masking. A macabre natural experiment occurred in 2021, a year marked by the convergence of vaccine availability and contagious variants that threatened unvaccinated populations: states led by governors who promoted vaccination and mandated pandemic control measures experienced much lower death rates than the “control” group, consisting of conservative states with lax policies and large unvaccinated populations. This behavior could explain why US mortality rates associated with covid-19 were so catastrophic, vastly exceeding losses in other high income countries.
Observers of health trends in the US should keep their eye on state governments, where tectonic shifts in policy are occurring. While gridlock in Washington, DC incapacitates the federal government, Republican leaders in dozens of state capitols are passing laws to undermine health and safety regulations, ban abortion, limit LGBT+ rights, and implement more conservative policies on voting, school curriculums, and climate policy. To understand the implications for population health, researchers must break with custom; although scientific literature has traditionally avoided discussing politics, the growing influence of partisan affiliation on policies affecting health makes this covariate an increasingly important subject of study.
_____________________
What has this to do with so-called alternative medicine (SCAM)?
Not a lot.
Except, of course, that Trump has been quite sympathetic to both quackery and quacks (see, for instance, here and here). Moreover, the embarrassing Dr. Oz, America’s charlatan-in-chief, is now a Republican candidate for the US senate. And the creation of the NHI office for alternative medicine, currently called NCCIH, was the idea of the Republican senator, Tom Harkin.
I think we get the drift: on the US political level, SCAM seems to be a right-wing thing.
Am I claiming that SCAM is the cause of the higher mortality in Republican counties?
No.
Do I feel that both are related to irresponsible attitudes towards healthcare issues?
Yes.
Nausea and vomiting are common symptoms of patients with advanced cancer. While there is some evidence for acupuncture point stimulation in the treatment of these symptoms for patients having anticancer treatment, there is little for when they are not related to such treatment.
This study aimed to determine whether acupressure at the pericardium 6 sites can help treat nausea and vomiting suffered by palliative care patients with advanced cancer. The researchers conducted a double-blind randomized controlled trial-active versus placebo acupressure wristbands. In-patients with advanced cancer in two specialist palliative care units who fitted either or both of the following criteria were approached: nausea that was at least of moderate severity; vomiting daily on average for the prior 3 days.
A total of 57 patients were randomized to have either active or placebo acupressure wristbands. There was no difference in any of the outcome measures between the two groups:
- change from the baseline number of vomits;
- Visual Analogue Scale for ‘did acupressure wristbands help you to feel better?’;
- the total number of doses of antiemetic medication;
- the need for escalation of antiemetics.
The authors concluded that, in contrast to a previously published feasibility study, active acupressure wristbands were no better than placebo for specialist palliative care in patients with advanced cancer and nausea and vomiting.
When the research into acupuncture for nausea and vomiting began some 20 years ago, the evidence turned out to be encouraging. Later, as the studies became more and more rigorous, many trials failed to confirm the initial findings. Today, the totality of the evidence is far less convincing than it seemed years ago.
This is a phenomenon that can be observed not just in acupuncture research but in many types of treatment:
- Initially, over-enthusiastic researchers become victims of their own optimism.
- These investigators are less into testing hypotheses than into confirming their own wishful thinking.
- Thus, several positive trials emerge.
- These, however, turn out to be methodologically flawed.
- Eventually, the subject might be picked up by real scientists who truly test hypotheses.
- More and more negative studies thus emerge.
- Depending on how many flawed studies were initially published and how critical the authors of systematic reviews are, it can take years until the totality of the evidence depicts the true picture which discloses the initial findings as false-positive.
The message is, I think, clear: poor quality studies have the potential to mislead us for many years. Eventually, however, the self-cleansing ability of science should generate the truth about the value of any treatment. In other words:
poor-quality science is not just useless, it causes long-term harm
and
critical thinking prevents harm
As promised, I would like to correct the errors in my previous assessment of this paper. To remind everyone:
This systematic review evaluated individualized homeopathy as a treatment for children with attention deficit and hyperactivity disorder (ADHD) when compared to placebo or usual care alone.
Thirty-seven online sources were searched up to March 2021. Studies investigating the effects of individualized homeopathy against any control in ADHD were eligible. Data were extracted to a predefined excel sheet independently by two reviewers.
Six studies were analyzed:
- 5 were RCTs
- 2 were controlled against standard treatments;
- 4 were placebo-controlled and double-blinded.
The meta-analysis revealed a significant effect size across studies of Hedges’ g = 0.542 (95% CI 0.311-0.772; z = 4,61; p < 0.001) against any control and of g = 0.605 (95% CI 0.05-1.16; z = 2.16, p = 0.03) against placebo. The effect estimations are based on studies with an average sample size of 52 participants.
The authors concluded that individualized homeopathy showed a clinically relevant and statistically robust effect in the treatment of ADHD.
_______________________________
Now that I was able to access the full papers, I would like to offer a thorough analysis.
To get included in the review, primary studies had to be:
- Published after 1980,
- Investigating an individualized homeopathic intervention in childhood ADHD,
- Comparing the intervention to a control condition (placebo, standard care or treatment as usual, both of which are referred to as “active control”) in a randomized or non-randomized parallel-group study
design with one or more arms.
Six studies were included:
- Fibert, P., Peasgood, T. & Relton, C. Rethinking ADHD intervention trials: feasibility testing of two treatments and a methodology. Eur. J. Pediatr. 178, 983–993 (2019). – DOI
- Fibert, P., Relton, C., Heirs, M. & Bowden, D. A comparative consecutive case series of 20 children with a diagnosis of ADHD receiving homeopathic treatment, compared with 10 children receiving usual care. Homeopathy 105, 194–201 (2016). – DOI
- Jacobs, J., Williams, A. L., Girard, C., Njike, V. Y. & Katz, D. Homeopathy for attention-deficit/hyperactivity disorder: a pilot randomized-controlled trial. J. Altern. Complement. Med. 11, 799–806 (2005). – DOI
- Jones, M. The efficacy of homoeopathic simillimum in the treatment of attention-deficit/hyperactivity disorder (AD/HD) in schoolgoing children aged 6-11 years. https://openscholar.dut.ac.za/bitstream/10321/534/1/Jones_2009.pdf (2009).
- Frei, H. et al. Homeopathic treatment of children with attention deficit hyperactivity disorder: a randomised, double blind, placebo controlled crossover trial. Eur. J. Pediatr. 164, 758–767 (2005). – DOI
- Oberai, P. et al. Homoeopathic management of attention deficit hyperactivity disorder: a randomised placebo-controlled pilot trial. Indian J. Res. Homoeopathy 7, 158–167 (2013).
Exclusion criteria were:
- Homeopathic intervention not individualized,
- Serious methodological flaws, such as incidental unblinding, failure to report important data, or insufficient data for meta-analysis.
One study was excluded:
- Lamont, J. Homoeopathic treatment of attention deficit hyperactivity disorder. Br. Homeopathic J. 86, 196–200 (1997). – DOI
I will first make several points about Walach’s systematic review itself and then have a look at the primary studies that it included. Finally, I will try to draw some conclusions.
The review authors state in their introduction that “beneficial effects of this intervention [homeopathy] have been shown for various kinds of medical conditions, including child diarrhea, supportive care in cancer, fibromyalgia, or ADHD.” In other words, already in the introduction, they disclose their strong pro-homeopathy bias; it would, of course, not be difficult to find investigations that contradict their optimism.
Despite the stated inclusion/exclusion criteria, the authors did include the Frei-study that did not follow a parallel-group design (see also below).
The authors included two active-controlled studies both of which did not report the type of treatment received by the control group. In other words, these trials failed to report important data which was a stated exclusion criterium (see below).
In their discussion section, the authors state that “all included studies employed individualized homeopathy and were of comparable, solid quality, hence a lack of methodological rigor is unlikely the reason for the difference between homeopathy and controls…” This, I think, is grossly misleading; even according to the authors’ own assessments, one study was deemed to have a high risk of bias and in two studies the risk of bias was “unclear”.
The overall positive effect of homeopathy demonstrated by the review was determined almost exclusively by the study of Oberai et al (p-value = 0.000). In fact, the studies by Jones and by Jacobs were negative, and the one by Frei was borderline positive with a p-value of 0.46. The authors address this crucial issue repeatedly and claim that excluding Oberai et al would still generate an overall positive meta-analytic result. Yet, they do not mention that the overall result would no longer be clinically relevant.
Looking at the included primary studies, I should make the following points:
- The two Filbert studies, as mentioned, failed to report important data and should, according to the stated exclusion criteria, not have been included.
- The study by Jacobs was a pilot study and generated negative findings.
- The study by Jones is a non-peer-reviewed thesis. In my view, it should never have been included.
- The study by Frei was a cross-over trial. According to the exclusion/inclusion criteria of the authors, it should not have been included.
- The study by Oberai et al is the trial that has by far the largest effect size and thus is the driver of the overall result of the review. It is therefore important to have a closer look at it.
Here is the abstract:
Objective: To evaluate the usefulness of individualised homoeopathic medicines in treatment of Attention Deficit Hyperactivity Disorder (ADHD).
Design: Randomised placebo-controlled single-blind pilot trial.
Setting: Central Research Institute (Homoeopathy), Kottayam, Kerala, India from June 2009 to November 2011.
Participants: Children aged 6-15 years meeting the Diagnostic Statistical Manual of mental disorders (DSM-IV) criteria for ADHD.
Interventions: A total of 61 patients (Homoeopathy = 30, placebo = 31) were randomised to receive either individualised homoeopathic medicine in fifty millesimal (LM) potency or placebo for a period of one year.
Outcome measures: Conner’s Parent Rating Scale-Revised: Short (CPRS-R (S)), Clinical Global Impression-Severity Scale (CGI-SS), Clinical Global Impression- Improvement Scale (CGI-IS) and Academic performance.
Results: A total of 54 patients (homoeopathy = 27, placebo = 27) were analysed under modified intention to treat (ITT). All patients in homoeopathy group showed better outcome in baseline adjusted General Linear Model (GLM) repeated measures ANCOVA for oppositional, cognition problems, hyperactivity and ADHD Index (domains of CPRS-R (S)) and CGI-IS at T3, T6, T9 and T12 (P = 0.0001). The mean baseline-adjusted treatment difference between groups at month 12 from baseline for all individual outcome measures favoured homoeopathy group; Oppositional (−16.4, 95% CI – 20.5 to − 12.2, P = 0.0001), Cognition problems (−15.5, 95% CI − 19.2 to − 11.8, P = 0.0001), Hyperactivity (−20.6, 95% CI − 25.6 to − 15.4, P = 0.0001), ADHD I (−15.6, 95% CI − 19.5 to − 11.6, P = 0.0001), Academic performance 14.4%, 95% CI 8.3 to 20.5, P = 0.0001), CGISS (−1.6, 95% CI − 1.9 to − 1.2, P = 0.0001), CGIIS (−1.6, 95% CI − 2.3 to -0.9, P = 0.0001).
Conclusion: This pilot study provides evidence to support the therapeutic effects of individualised homoeopathic medicines in ADHD children. However, the results need to be validated in multi-center randomised double-blind placebo-controlled clinical trial.
Here are a few points of concern related to the Oberai et al:
- The trial was a mere pilot study.
- Despite the fact that it is now 9 years old, the authors never published a definitive trial.
- The study was published in an obscure journal that is not Medline-listed.
- The study is very poorly reported.
- It is unclear how the diagnosis of ADHD for including the patients was verified.
- The control patients were treated for one year with a placebo and no other therapies. In my view, this is not ethical.
- The method of randomization is unclear.
- The authors state that acute symptoms were treated throughout the study period with homeopathy, even in the control group. This seems odd and defies the principle of a placebo-controlled trial.
- The authors state that only the patients were blind, not the investigators. This opens the door wide for all sorts of biases. It is, for example, likely that it also de-blinded the patients (the verum could be adjusted and changed, while the placebo remained constant).
All in all, this paper is of poor quality, Its findings are far from trustworthy and were not meant to be definitive. According to the following exclusion criteria, it should have been excluded:
- It had several serious methodological flaws.
- It did not blind the investigators.
- It is likely that patients were de-blinded.
- It failed to report important data.
So, why did Walach and his co-authors include it?
Could it be because, without the Oberai-study, the overall findings of the review would at best have turned out to be borderline significant and not clinically relevant?
This systematic review evaluated individualized homeopathy as a treatment for children with attention deficit and hyperactivity disorder (ADHD) when compared to placebo or usual care alone.
Thirty-seven online sources were searched up to March 2021. Studies investigating the effects of individualized homeopathy against any control in ADHD were eligible. Data were extracted to a predefined excel sheet independently by two reviewers.
Six studies were analyzed:
- 5 were RCTs
- 2 were controlled against standard treatments;
- 4 were placebo-controlled and double-blinded.
The meta-analysis revealed a significant effect size across studies of Hedges’ g = 0.542 (95% CI 0.311-0.772; z = 4,61; p < 0.001) against any control and of g = 0.605 (95% CI 0.05-1.16; z = 2.16, p = 0.03) against placebo. The effect estimations are based on studies with an average sample size of 52 participants.
The authors concluded that individualized homeopathy showed a clinically relevant and statistically robust effect in the treatment of ADHD.
This is a counter-intuitive result (to put it mildly), and it is, therefore, wise to have a look at the 6 included studies:
1.Frei, H. et al. Homeopathic treatment of children with attention deficit hyperactivity disorder: a randomised, double blind, placebo controlled crossover trial. Eur. J. Pediatr. 164, 758–767 (2005).
This was a trial with just 62 patients who had previously responded to homeopathy. The study was conducted by known proponents of homeopathy and had a highly unusual design. The results suggested that homeopathy was better than placebo.
2. Oberai, P. et al. Homoeopathic management of attention deficit hyperactivity disorder: a randomised placebo-controlled pilot trial. Indian J. Res. Homoeopathy 7, 158–167 (2013).
This one was published in an obscure journal that I could not access.
3. Jacobs, J., Williams, A. L., Girard, C., Njike, V. Y. & Katz, D. Homeopathy for attention-deficit/hyperactivity disorder: a pilot randomized-controlled trial. J. Altern. Complement. Med. 11, 799–806 (2005)
This study showed that there were no statistically significant differences between homeopathic remedy and placebo groups on the primary or secondary outcome variables.
4. Jones, M. The efficacy of homoeopathic simillimum in the treatment of attention-deficit/hyperactivity disorder (AD/HD) in schoolgoing children aged 6-11 years (2009).
This was a small unpublished (and not peer-reviewed) thesis. Its results showed no statistically significant effect of treatment.
5. Lamont, J. Homoeopathic treatment of attention deficit hyperactivity disorder. Br. Homeopathic J. 86, 196–200 (1997)
This was a small (n=46) trial with an unusual design. Its results suggested that homeopathy was better than placebo.
6. von Ammon, K. et al. Homeopathic RCT embedded in a long-term observational study of children with ADHD—a successful model of whole systems CAM research. Eur. J. Integr. Med. 1, 27 (2008).
Even though the journal is Medline-listed, I was unable to find this paper. I did, however, find a paper by the same authors with the same title. It turned out to be a duplication of the paper by Frei et al listed above.
_________________________
All in all, this brief analysis of the available abstracts (most full papers are behind paywalls) leaves many questions as to the trustworthiness of this systematic review unanswered. The fact that H. Walach (and other apologists of homeopathy) is its senior author does not inspire me with overwhelming confidence. In any case, I very much doubt that the authors’ conclusion is correct. I therefore would encourage someone with access to all full papers to initiate a more thorough analysis; the abstracts obviously leave many questions unanswered. For instance, it would be crucial to know how many of the trials followed an A+B versus B design (I suspect most studies did, and this would completely invalidate the review’s conclusion). I am more than happy to co-operate with such an evaluation.
Today, a 3-day conference is starting on ‘INTEGRATIVE MEDICINE’ (IM) in London. Dr. Michael Dixon, claims that it is going to be the biggest such conference ever and said that it ‘will make history’. Dixon is an advisor to Prince Charles, chair of the College of Medicine and Integrated Health (CoMIH, of which Charles is a patron), and joint-chair of the congress. The other co-chair is Elizabeth Thompson. Both have been the subject of several previous posts on this blog.
Dixon advertised the conference by commenting: “I am seeing amongst by younger colleagues, the newly trained GPs, that they have a new attitude towards healthcare. They are not interested in whether something is viewed as conventional, complementary, functional or lifestyle, they are just looking at what works for their patients. Through this conference, we aim to capture that sense of hope, open-mindedness, and patient-centred care”. I believe that this ‘history-making’ event is a good occasion to yet again review the concept of IM.
The term IM sounds appealing, yet it is also confusing and misleading. The confusion starts with the fact that our American friends call it integrative medicine, while we in the UK normally call it integrated medicine, and it ends with different people understanding different things by IM. In conventional healthcare, for instance, people use the term to mean the integration of social and medical care. In the bizarre world of alternative medicine, IM is currently used to signify the parallel use of alternative and conventional therapies on an equal footing.
Today, there are many different definitions of the latter version of IM. Prince Charles, one of the world’s most ardent supporter of IM, used to simply call it ‘the best of both worlds’. A recent, more detailed definition is a ‘healing-oriented medicine that takes account of the whole person, including all aspects of lifestyle. It emphasizes the therapeutic relationship between practitioner and patient, is informed by evidence, and makes use of all appropriate therapies’. This seems to imply that conventional medicine is not healing-orientated, does not account for the whole person, excludes aspects of lifestyle, neglects the therapeutic relationship, is not informed by evidence, and does not employ all appropriate therapies. This, I would argue is a bonanza of strawman fallacies, i.e. the misrepresentation of an opponent’s qualities with a view of defeating him more easily and making one’s own position look superior. Perhaps this is unsurprising – after all, Dixon has been once named ‘a pyromaniac in a field of (integrative) strawmen’.
Perhaps definitions are too theoretical and it is more productive to look at what IM stands for in real life. If you surf the Internet, you can find thousands of clinics that carry the name IM. It will take you just minutes to discover that there is not a single alternative therapy, however ridiculous, that they don’t offer. What is more, there is evidence to show that doctors who are into IM are also often against public health measures such as vaccinations.
The UK ‘Integrated Medicine Alliance’, a grouping within the CoMIH, offers information sheets on all of the following treatments: Acupuncture, Alexander Technique, Aromatherapy, Herbal Medicine, Homeopathy, Hypnotherapy, Massage, ,Naturopathy, Reflexology, Reiki, Tai Chi, Yoga Therapy. The one on homeopathy, for example, tells us that “homeopathy … can be used for almost any condition either alone or in a complementary manner.” Compare this to what the NHS says about it: “homeopathic remedies perform no better than placebos (dummy treatments)”.
This evidently grates with the politically correct definition above: IM is not well-informed about the evidence, and it does use inappropriate treatments. In fact, it is little more than a clumsy attempt to smuggle unproven and disproven alternative therapies into the mainstream of healthcare. It does render medicine not better but will inevitably make it worse, and this is surely not in the best interest of vulnerable patients who, I would argue, have a right to be treated with the most effective therapies currently available.
The conference can perhaps be characterized best by having a look at its sponsors. ‘Gold sponsor’ is WELEDA, and amongst the many further funders of the meeting are several other manufacturers of mistletoe medications for cancer. I just hope that the speakers at this meeting – Dixon has managed to persuade several reputable UK contributors – do not feel too embarrassed when they pass their exhibitions.
Guest post by Derk P. Kooi
Political lobbying is not only restricted to major companies, even quackery lobbies extensively in Dutch politics as well as at a European and global level. The EUROpean Complementary and Alternative Medicine Stakeholder Group (EUROCAM) has been active in Europe for some time. EUROCAM recently attracted attention with a statement on antibiotic resistance during the European Antibiotics Awareness Day.[1] EUROCAM claims that Complementary and Alternative Medicine (CAM) could enhance the immune system and could therefore contribute to the fight against antibiotic resistance. An early study conducted by the anthroposophist Erik Baars was referenced, inter alia. However, this medical claim turns out to be pure nonsense.
EUROCAM regularly publishes so-called ‘position papers’ on the contribution CAM could provide to the European health care system. EUROCAM is currently cautious with its medical claims, and rightly so, as it has seriously overstepped the mark in the past. For example, claims about the efficacy of CAM for infections referred to research by Erik Baars, doctor, anthroposophical healthcare lector at the University of Applied Sciences Leiden and researcher at the Louis Bolk Institute. Baars is an associate of the society due to his misleading statements in his publications on the usefulness of CAM, more specifically of the anthroposophical variant.
Where does this fairly unknown club actually come from, what does it do and how seriously should we take it? Well, EUROCAM is an umbrella organisation for various alternative therapists and their patients. We are talking about Ayurveda, homeopathy, osteopathy, anthroposophy, herbal medicine, traditional (Chinese) medicine, Reiki and acupuncture. The Dutch Registry of Complementary Care Professionals (RBCZ) is also affiliated with EUROCAM. Classical homeopath Annemieke Boelsma is the contact person of the RBCZ at EUROCAM.
It is unclear precisely when EUROCAM was created, the LinkedIn page says 2009. The figurehead of the club is “secretary general” Ton Nicolaï. This homeopathic doctor is also well known to Vereniging tegen de Kwakzalverij, (www.kwakzalverij.nl) the Dutch Society against Quackery. The treasurer of EUROCAM is business administrator Wim Menkveld. Menkveld is on the Advisory Board of the Hortus Botanicus of Leiden. He is also active on the board of the European Patients’ Federation of Homeopathy. EUROCAM thus seems to have originated mainly from Dutch homeopathic circles.
Furthermore, TV producer Miranda Eilert-Ruchtie from Hilversum sits on the EUROCAM board. According to the EUROCAM website, she acts as their “operations manager” and communications advisor. The German Heilprakterin Sonja Maric, an anthropologist and “specialist in Tibetan medicine”, also acts as a communications consultant.
The European Transparency Register shows that in 2020 the total budget of the organisation was 40,498 euros; no more recent data is available. In the year 2018, 5,000 euros were reserved as an honorarium for Mr Nicolaï, for the 0.5 FTE that he works for the organisation. Miranda Eilert-Ruchtie works a number of hours a week for EUROCAM, as a freelancer. Sonja Maric does this on a voluntary basis.
EUROCAM is a member of the European Public Health Alliance (EPHA), the European Union Health Policy Platform. The World Health Organisation (WHO) recognises the organisation as a non-state actor, which means that both the EU and the WHO consider EUROCAM to be a serious legal entity. In the past, EUROCAM has intervened in public EU consultations in the fields of aging, pharmaceutical strategy, cancer, and digital data and services.
EUROCAM provides the secretariat of the MEP Interest Group on Integrative Medicine and Health, a group of five European parliamentarians who have set themselves the goal of promoting integrative medicine at the European level. Co-chairs are Finish Sirpa Pietikäinen, a European parliamentarian for the Christian Democrats, and French Michèle Rivasi, a European parliamentarian for the Greens. The other members are Luxembourg’s Tilly Metz, the Italian Eleonara Evi, and the Danish Margrete Auken. It is noteworthy that they are European parliamentarians for the Greens. They are all members of the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI). Eleonara Evi was part of the illustrious Five Star Movement until 2020, known for its anti-vaccination stance. The Member of European Parliament (MEP) Interest Group organises annual events with speakers who are the same people who perform at EUROCAM symposia. These include the aforementioned anthroposophist Erik Baars. Baars worked closely with EUROCAM boss Ton Nicolaï in a European research project on CAM alternatives to antibiotics. More about his bad science later.
The texts EUROCAM produces nowadays (on its website) are carefully written, and the medical claims are carefully formulated. The texts are larded with synonyms for “possible”, known in linguistics as hedging. For example “Several CAM methods have shown high potential to reduce cancer pain”.[2] Generic health claims are also often used to suggest medical benefits, for example in the context of COVID-19, ‘In building and maintaining resistance to infectious illness, CAM modalities as a part of Integrative Medicine & Health can play an important role because they mobilise and stimulate people’s self-regulating capacity, thus increasing their resilience, their immune system.’.[3]
Furthermore, claims are put in the mouths of others, which can be read, for example, in quoting patient expectations: ‘While improving quality of life is the major rationale for CAM use, there is a definite undercurrent of expectation, particularly among the younger patients, that some therapies might have an anticancer effect (prolongation of remission periods) and slow/stagnate tumour growth (prolongation of survival periods), boost the immune system, making it easier to overcome the disease.’.[4]
The educated reader will immediately see through these strategies, but the question is whether the lobbied politicians targeted by EUROCAM understand these subtleties. EUROCAM has not always been so cautious, by the way. In an undated (presumably 2013) interview with the Dutch Association for Classical Homeopathy, “secretary general” Ton Nicolaï made a number of remarkable statements. For example, he claimed at the time that research shows “that for a number of herbal medicines there is a reasonable amount of evidence that scientifically confirms their effectiveness in respiratory infection treatments”. [5] Nicolaï bases his assertion on recent research by Erik Baars conducted as part of a European research programme that aimed to find CAM alternatives to antibiotics.
The report of this project, which ended in 2018, can be found on the EUROCAM website.[6] The authors of this report are, not surprisingly, Erik Baars and Ton Nicolaï. The report contains practically no hard science. Sub-studies focus on, for example, the frequency of antibiotic prescribing among alternative-working GPs and on the best practice of CAM believers. A so-called systematic review of systematic reviews offers good starting points to evaluate Mr Nicolaï’s claim: ‘A systematic review of systematic reviews demonstrates that there are specific, evidence-supported, promising CAM treatments for acute, uncomplicated RTIs [uncomplicated respiratory tract infections, ed.] and that they are safe.’
Here, a medical claim is made, which is weakened by the use of the hedge term “promising”. The conclusion can be summarised with “There would be ‘promising’ CAM treatments for respiratory infections, and they would be safe”. However, surprisingly, the project report does not refer to this “systematic review of systematic reviews”, nor to any of the other concrete results of the project!
Due to the lack of references, we cannot but conclude that the claim is based on a 2019 article by Erik Baars. One of the co-authors is Ton Nicolaï.[7] The article was published in the journal Evidence Based Complementary and Alternative Medicine (EBCAM), which has a shady reputation. Even one of the founders of EBCAM states that the peer-review system is a farce, and therefore the majority of the articles published in it are useless nonsense.[8] In this article, besides a large amount of vagueness about the “worldview differences” between CAM and medicine, systematic reviews are discussed about the effectiveness and safety of CAM treatments. From this systematic review of systematic reviews, it is concluded that there are promising CAM treatments for respiratory, urinary tract and skin infections and that there is even evidence that some CAM treatments are effective for respiratory infections, but what is this based on?
The reviews that were looked at were split into Cochrane and non-Cochrane reviews. Among the Cochrane reviews, there is one that would demonstrate the efficacy of CAM. It is a review on the use of immunostimulants for the prevention of respiratory tract infections in children.[9] Of the 35 studies that were analysed, six involve small molecules, such as isoprinosine, levamisole and pidotimod. In other words, regular medicine, if it turns out to work, but describing it as being experimental would be more appropriate. Baars’ article states that the review also contains herbal medicine. This is somewhat exaggerated: only one of the 35 studies deals with herbs. Of the remaining 28 studies, 25 cover bacterial extracts and three thymus extracts. Again: Baars does not make clear what this has to do with the CAM that EUROCAM represents.
In summary, EUROCAM is a small European lobbying organisation with perhaps some influence at both European and WHO level. One keeps coming across the same names. The organisation is currently using woolly, disguising language to mask medical claims and to fend off criticism. In the past, this was different when EUROCAM, by means of Ton Nicolaï among others, made very reprehensible statements about the role of CAM in (respiratory tract) infections. For the time being, this little club does not seem to pose much of a threat, but European politicians should, of course, ignore this hobby club.
References
1. ‘Improving patient resilience to reduce the need to rely on anti-infection treatment: the role of Integrative Medicine’. EUROCAM. https://cam-europe.eu/statement-on-amr-2021/ (visited on 28 December 2021) 2. EUROCAM. https://cam-europe.eu/contribution-of-cam-for-a-better-health/cam-in-the-context-of-cancer/ (visited on 3 October 2021) 3. EUROCAM. https://cam-europe.eu/contribution-of-cam-for-a-better-health/cam-in-the-context-of-cancer/ (visited on 3 October 2021) 4. EUROCAM. https://cam-europe.eu/contribution-of-cam-for-a-better-health/cam-in-the-context-of-cancer/ (visited on 3 October 2021)
5. Miranda Ruchtie. In gesprek met Ton Nicolaï, CAM integreren in de Europese gezondheidszorg. [In discussion with Ton Nicolaï, integrating CAM into the European health care system]. Nederlandse Vereniging van Klassiek Homeopaten. [Dutch Association of Classical Homeopaths] https://www.nvkh.nl/nieuwsbrieven-nvkh/interview-met-ton-nicolai (visited on 3 October 2021)
6. Erik Baars, et al. Reducing the need for antibiotics, the contribution of Complementary and Alternative Medicine. EUROCAM, 2018. https://cam-europe.eu/wp-content/uploads/2019/01/CAM-AMR-EUROCAM-Post-Conference-Paper-2018.pdf (visited on 3 October 2021)
7. Erik W. Baars et al. The Contribution of Complementary and Alternative Medicine to Reduce Antibiotic Use: A Narrative Review of Health Concepts, Prevention, and Treatment Strategies. Evid. Based Complement. Alternat. Med., 2019:5365608. DOI: 10.1155/2019/5365608
8. Edzard Ernst. “EBCAM: an alt med journal that puzzles me a great deal”, URL: http://edzardernst.com/2016/05/ebcam-an-alt-med-journal-that-puzzles-me-a-great-deal/ (visited on 8 January 2022)
9. B. E. Del-Rio-Navarro, F. J. Espinosa-Rosales, V. Flenady, and J. J. Sienra-Monge, “Cochrane Review: Immunostimulants for preventing respiratory tract infection in children,” Evidence-Based Child Health: A Cochrane Review Journal, 2012, 7 (2), 629–717.
Many systematic reviews have summarized the evidence on spinal manipulative therapy (SMT) for low back pain (LBP) in adults. Much less is known about the older population regarding the effects of SMT. This paper assessed the effects of SMT on pain and function in older adults with chronic LBP in an individual participant data (IPD) meta-analysis.
Electronic databases were searched from 2000 until June 2020; reference lists of eligible trials and related reviews were also searched. Randomized controlled trials (RCTs) were considered if they examined the effects of SMT in adults with chronic LBP compared to interventions recommended in international LBP guidelines. The authors of trials eligible for the IPD meta-analysis were contacted and invited to share data. Two review authors conducted a risk of bias assessment. Primary results were examined in a one-stage mixed model, and a two-stage analysis was conducted in order to confirm the findings. The main outcomes and measures were pain and functional status examined at 4, 13, 26, and 52 weeks.
A total of 10 studies were retrieved, including 786 individuals; 261 were between 65 and 91 years of age. There was moderate-quality evidence that SMT results in similar outcomes at 4 weeks (pain: mean difference [MD] – 2.56, 95% confidence interval [CI] – 5.78 to 0.66; functional status: standardized mean difference [SMD] – 0.18, 95% CI – 0.41 to 0.05). Second-stage and sensitivity analysis confirmed these findings.
The authors concluded that SMT provides similar outcomes to recommended interventions for pain and functional status in the older adult with chronic LBP. SMT should be considered a treatment for this patient population.
This is a fine analysis. Unfortunately, its results are less than fine. Its results confirm what I have been saying ad nauseam: we do not currently have a truly effective therapy for back pain, and most options are as good or as bad as the rest. This is most frustrating for everyone concerned, but it is certainly no reason to promote SMT as usually done by chiropractors or osteopaths.
The only logical solution, in my view, is to use those options that:
- are associated with the least risks,
- are the least expensive,
- are widely available.
However you twist and turn the existing evidence, the application of these criteria does not come up with chiropractic or osteopathy as an optimal solution. The best treatment is therapeutic exercise initially taught by a physiotherapist and subsequently performed as a long-term self-treatment by the patient at home.
Two million people in UK are estimated to be currently suffering from long COVID, says the Office for National Statistics. Fatigue continues to be the most common symptom – experienced by 55% of those with self-reported long COVID – followed by 32% with shortness of breath, 23% with a cough, and 23% with muscle ache. The problem is only going to increase in the near future. Thus, many people are frantically looking for an effective therapy. Practitioners of so-called alternative medicine (SCAM) are no exception.
This study aimed to evaluate the potential for inhalation of essential oils to improve energy levels among otherwise healthy female survivors of acute COVID-19 who experience a lack of energy more than five months after recovery.
This was a randomized double-blind, placebo-controlled trial to evaluate the potential for inhalation of Longevity™, a proprietary essential oil blend manufactured by Young Living Essential Oils (Lehi, Utah, USA), on energy levels among female survivors of COVID-19 who continue to experience fatigue more than 5 months recovery from the acute infection. Forty women were randomized to two groups: intervention and placebo. The placebo product contained an inert, odorless fractionated coconut oil. Both groups inhaled the assigned product twice daily for fourteen consecutive days. Fatigue scores were measured using the Multidimensional Fatigue Symptom Inventory (MFSI). Secondary outcomes included scores on each of the MFSI’s ten subscales.
Individuals who inhaled the essential oil blend for 2 weeks had significantly lower fatigue scores after controlling for baseline scores, employment status, BMI, olfactory function, and time since diagnosis, with a large effect size (F (1,39) = 6.15, p = .020, partial eta squared = 0.198). Subscale analysis identified subscales of vigor, as well as global, behavioral, general, and mental fatigue as benefiting from the intervention. This study provides evidence that a proprietary aromatherapy blend can significantly improve energy levels among women who are experiencing fatigue after recovering from COVID-19.
The authors concluded that the use of aromatherapy with Longevity™ essential oil blend to boost energy levels in women who have recovered from COVID-19 provides a novel, non-invasive approach to improving quality of life in this population. This intervention is particularly beneficial for global and mental fatigue, as well as vigor. Other subdomains may experience improvements to energy levels with a smaller effect size; future studies should be conducted to explore this potential.
This trial was funded by Young Living Essential Oils. Perhaps, this explains why there is no mention of the elephant in the room: the trial was not blind! Participants in the verum group knew that they received aromatherapy. Likewise, participants in the placebo group knew that they received the placebo.
Could this fact have influenced the outcome? Certainly!
Could the trial have been designed better? Certainly!
All the investigators needed to do is to use a nice-smelling oil that, according to aromatherapists, does not boost energy, as the placebo.
As it stands, we have no idea whether the authors’ assumption that the verum oil caused the effect is true.
Pity!
Or maybe not?
Perhaps Young Living Essential Oils, the sponsor of the study and producer of the oil never wanted to know the truth. Maybe they are happy to abuse science as a marketing tool?
