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

alternative medicine

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By guest blogger Ken Harvey

Loretta Marron was the catalyst. The ‘critical thinking’ bug hit her as a child, reinforced by a BSc in Physics. If something didn’t sound logical, she couldn’t let it go. She had to check. She killed many a party by disputing misinformation – with evidence.

TV advertisements for magnetic underlays got her going, then homeopathic remedies, followed by ‘natural’ cures for cancer. To investigate outlandish claims and submit complaints, she needed to consult with experts. These included Professors John Dwyer (Medicine and Immunology) and Alastair MacLennan (Obstetrics and Gynaecology). They were always willing to help.

They also had concerns about universities teaching pseudoscience, such as ‘subluxation theory’ in chiropractic and ‘meridians’ in Traditional Chinese Medicine.

In late 2011, Professor Dwyer proposed that Loretta join forces with Professors Alastair MacLennan, Marcello Costa (neuroscientist), and Rob Morrison (science communicator) to form a new organisation promoting scientific evidence in health care. Friends of Science in Medicine (FSM) was born. John Dwyer was the inaugural President and Loretta Marron Chief Executive Officer (CEO).

The aim was to emphasise the importance of basing Australian health care on scientifically sound research and established scientific knowledge published in peer-reviewed journals of accepted standing. Valuing scientific rigour is especially important in an age where unsubstantiated health claims are rampant and scientific consensus is ‘imbalanced’ by the views of extremists.

FSM’s focus is helping consumers and health professionals to make more informed choices about medical interventions, medicines, and medical devices. We do this by submitting complaints about unethical practice, analysing policy, making submissions, encouraging regulators to act, and being a credible source of expertise for the media and others. We also encourage tertiary institutions and medicine and health sciences students to critically appraise therapeutic products and services as part of the courses offered.

Currently, FSM has more than 1,200 leading scientists, clinicians, lawyers, and consumer advocates as supporters. We also work closely with organisations such as Australian Skeptics and Choice (Australian Consumers Association).

I took over as President from John Dwyer in 2019. Loretta remains FSM CEO. The founding members continue their involvement as consultants. Ten years on, it’s worth reflecting on what has been achieved and the ongoing challenges.

An appendix lists some of the areas in which FSM has been involved and the outcomes achieved (often with the help of others).

Unethical promotion of therapeutic goods and services remain an ongoing concern. The advertising of therapeutic goods is subject to provisions in the Therapeutic Goods Advertising Code, first promulgated in 1999. Until July 2018, complaints about alleged Code violations were heard by the Therapeutic Goods Advertising Complaints Resolution Panel (CRP), thereafter by the Therapeutic Goods Administration (TGA).

FSM members submitted numerous complaints to the CRP and analysed the outcome. If a complaint was upheld, the CRP could only ‘recommend’ that it be removed. If it was not, the complaint was referred to the TGA for action. We found that certain companies consistently ignored the determinations of the CRP and, when referred to the TGA, took resulting action.

In July 2018, FSM engagement with numerous consultations and reviews eventually resulted in the TGA taking over the advertising complaint system. The TGA was given stronger investigative and compliance powers and a revised, legally enforceable advertising code. However, given the TGA’s previous track record, we continued to submit complaints, including many previously upheld by the CRP, but for which promotion continued.

An analysis of the first 12 months of the new system found that the TGA had classified most complaints as ‘low priority’. These were either ignored or closed by sending the advertiser a ‘Regulatory Obligation letter’ which stated that no further action would be taken. While the letter sometimes worked, often it did not. Stronger compliance powers were rarely used. The new complaint system was also less transparent than the one it replaced. For those low priority complaints with published outcomes, no details of the product, advertiser, or alleged Code violation were published, and no follow-up was recorded. Of 121 higher priority complaints, 79% failed to meet their key performance indicator, time to closure in 60–90 days. These included complaints about dangerous sports supplements and ineffective weight loss and hangover products.

In August 2020, an independent review of the first two years of the TGA’s compliant system was published. The study noted an unexpectedly high volume of complaints since the TGA took over the advertising complaints system, producing a large and growing backlog. A government-appointed consultant (ThinkPlace Pty Ltd) stated that providing more resources would not be in the public interest. Instead, they recommended a more cost-effective and efficient approach: amalgamating all complaints into an information database from which the TGA could consider compliance priorities.

As a result, complaints were closed by sending complainants a letter stating that their complaints will be used for ‘intelligence’ to set priorities. The TGA said risk assessment informed whether a complaint was converted into a case for investigation or stored in their information database to determine future compliance priorities. Therapeutic goods associated with COVID-19 were declared ‘priority 1’, while weight loss, hangover, and four other products groups were said to be ‘priority 2’.

A focus on COVID-19 stimulated the TGA to deal with some of these complaints more effectively. However, apart from token action on individual products, no systemic action was taken on weight loss, hangover products and many other objects of our complaints.

More recently, the TGA’s complaint database for 2018 -2020 has been removed and replaced by a new database containing only a few complaints pre-2021. In addition, the fields of many ‘products’ and ‘responsible person’, are missing. The TGA say that migration of data to the new system is continuing. Meanwhile, complainants now only receive an automated acknowledgment.

Transparency remains a problem as there is no clear indication of how many complaints the TGA receives, what they are about, how many are filed for ‘intelligence’’, how many are actioned, and what outcome eventuates.

Given this lamentable state of affairs, in association with Australian Skeptics, it is proposed to publish reports on all complaints submitted to the TGA in 2022 and their outcomes. Past experience shows that documenting problems, pointing out underlying issues and putting forward solutions can produce progress. But patience and persistence are required.

FSM has grappled with unethical advertising of pseudo-medical interventions. Controls differ for practitioners regulated by the Australian Health Practitioner Regulation Agency (AHPRA) and those regulated by State and Territory Health Complaints Commissioners. The former includes medical practitioners, pharmacists, nurses, chiropractors, osteopaths, and Traditional Chinese Medicine practitioners. The latter includes naturopaths, homeopaths, and practitioners of western herbal medicine.

FSM has held regular meetings with AHPRA senior managers. We have also met several of their national boards and attended stakeholder forums. Chiropractic was an initial focus. Many practitioners advertised that chiropractic care in pregnancy could shorten labour duration and prevent caesarean delivery – despite the absence of evidence. Pregnant women were warned that labour often resulted in the newborn babe’s spinal misalignment, which could lead to numerous problems unless put right by regular chiropractic adjustments. It was also claimed that chiropractic ‘adjustments’ could improve attention deficit hyperactivity disorder, infantile colic, and ear infection.

In 2015, FSM submitted hundreds of complaints to AHPRA, alleging that chiropractic websites were in breach of both s.133 of the Health Practitioner Regulation National Law Act 2009 and the Chiropractic Board of Australia’s Guidelines for advertising regulated health services. These provisions prohibit advertising which is false, misleading, or deceptive, creates an unreasonable expectation of beneficial treatment, or can encourage the indiscriminate or unnecessary use of health services.

Five years have passed since the Chiropractic Board first asked practitioners to ensure that their websites met legal advertising requirements. Over this time, the Board’s sole approach to this problem was educational. Although chiropractors consistently had the highest advertising complaints of all practitioners (38 per 1,000 chiropractors in 2013–14), no penalties nor disciplinary action had been applied for advertising offences.

FSM argued that repeated advertising offences required appropriate penalties. We also pointed out that some practitioners now invited patients to consult them about services they were no longer permitted to advertise. We said that limitations should be placed on chiropractic practice which lacked evidence.

AHPRA responded that, although it could act on misleading advertising, it had no power to restrict the scope of practice of chiropractors (or other registered practitioners). We said that, if lack of good evidence makes it illegal to publicly advertise a treatment, then it should be equally illegal to offer it to patients privately; after all, the real harm is caused by the treatment, not the advertising.

In 2019, following damning publicity and further representations, the Victorian Health Minister eventually instructed Safer Care Victoria (SCV) to undertake an independent review of the practice of chiropractic spinal manipulation on children under 12 years. The result was a recommendation that spinal manipulation should not be provided to children under 12 years of age, for general wellness or for the management of conditions such as hyperactivity disorders, infantile colic, or ear infections.

The Chiropractic Board has also stated that chiropractors are not trained to apply any direct treatment to an unborn child and should not deliver any treatment to the unborn child. Neither should they provide materials, information or advice that is anti-vaccination in nature. After numerous complaints from FSM members, the Chiropractic Board finally referred a prominent anti-vax chiropractor, Simon Floreani, to the Victorian Civil and Administrative Tribunal (VCAT). His registration was suspended for 6 months, and conditions placed on his re-registration.

FSM has not just been concerned about chiropractors. We have complained (with varied success) about medical practitioners promoting stem cell therapy for multiple sclerosis, Traditional Chinese Medical practitioners claiming that acupuncture can treat infertility and dubious laboratory tests used in complementary and alternative medicine.

In conclusion, the peddling of unproven and sometimes dangerous remedies has existed throughout human history.

There will always be companies (and individuals) who put the pursuit of profit before ethical behaviour. There will always be advocates for de-regulation and regulators captured by industry. To protect consumers there must be opposing forces. That is the role that FSM is proud to play, along with colleagues from the sceptical community and consumer movements.

Appendix

FSM activities and outcomes (often in association with others), 2011-2021.

  1. Removal of extravagant claims for acupuncture from the World Health Organization website and instigation of a WHO evidence review.
  2. Involvement in the 2015 Review of the Australian Government Rebate on Private Health Insurance for Natural Therapies. This led to removal of cover for therapies that lacked evidence such as homeopathy, iridology, reflexology and naturopathy (currently being reviewed again to see if additional evidence exits).
  3. Removal of unproven/disproven courses or modules from Australian universities.
  4. Removal of continuing professional development (CPD) points required annually by relevant registered practitioners for a number of AltMed courses.
  5. Following complaints to the TGA, removal of some illegal medicines not on the Australian Register of Therapeutic Goods (ARTG).
  6. De-listing some complementary medicines and medical devices (such as ‘bio-resonance’ machines) lacking evidence.
  7. Getting the TGA to declare two products of self-declared ‘Foods for special medical purposes’ illegal therapeutic goods and have them removed from the market-place.
  8. Publishing academic articles, in peer-reviewed journals, documenting regulatory problems investigated and solutions suggested.
  9. Publishing articles in lay media on current problems including in The Conversation, MJA Insight and Pearls and Irritations (around 200 over the last 5 years).
  10. Responding to consultation requests from the TGA, Medical Boards, National Medicines Policy Review, and others.
  11. Achieving the suspension of anti-vax chiropractor Simon Floreani’s registration.
  12. Stimulating the Chiropractic Board to publish standards on pregnancy and paediatric care.
  13. Responsible for the setting up of AHPRA’s ‘Advertising Compliance’ section, including their pilot auditing system (yet to report).
  14. Responding to requests for information from journalists.
  15. Correction of misinformation from the Victorian government’s ‘Better Health’ Channel.
  16. Providing a complaints avenue for people who want to remain anonymous.

The ‘Control Group Cooperative Ltd‘ is a UK Company (Registration Number: 13477806) is registered at 117 Dartford Road, Dartford, Kent DA1 3EN, UK. On its website, it provides the following statement:

The Vaccine Control Group is a Worldwide independent long-term study that is seeking to provide a baseline of data from unvaccinated individuals for comparative analysis with the vaccinated population, to evaluate the success of the Covid-19 mass vaccination programme and assist future research projects. This study is not, and will never be, associated with any pharmaceutical enterprise as its impartiality is of paramount importance.

The VaxControlGroup is a community cooperative, for the people. All monies raised will be re-invested into the project and its community.

Volunteers for this study are welcome from around the world, providing they have not yet received any of the SARS-CoV-2 vaccinations and are not planning to do so.

So, the Vaccine Control Group (VCC) aims at recruiting people who refuse COVID vaccinations. The VCC issues downloadable and printable COVID-19 Vaccine self exemption forms that you can complete (either online or by hand) supplied by: Professionals for Medical Informed Consent and Non-Discrimination (PROMIC). The form contains the following text:

COVID-19 vaccines, that have been administered to the public under emergency use authorisation, have been
associated with moderate to severe adverse events and deaths in a small proportion of recipients. There are currently insufficient available long-term safety data from Phase 3 trials and post-marketing surveillance to be able to predict which population sub-groups are likely to be most vulnerable to these reactions. However, clinical assessments have identified a range of conditions or medical histories that are associated with increased risk of serious adverse events (see Panel B). Individuals with such medical concerns, along with those who have already had COVID-19 and acquired natural immunity, have justifiable grounds to not consent to COVID-19 vaccination. Such individuals may choose to use alternate approaches to reduce their risk of developing serious COVID-19 disease and associated viral transmission. UK and international law enshrines an individual’s right to refuse any medical treatment or intervention without being subjected to penalty, restriction or limitation of protected rights or freedoms, as this would otherwise constitute coercion.

I do wonder, after reading this, what scientific value this ‘study’ might have (nowhere could I find relevant methodological details about the ‘study’). In search of an answer, I found ‘Doctors & Health Professionals supportive of this project’. The only one supportive of the VCC seems to be Prof Harald Walach who offers his support with these words:

A vaccine control group, especially for Covid-19 vaccines, is extremely useful, even necessary, for the following reasons:

    1. We are dealing with a vaccination technology that has never been used in humans before.
    2. All studies that have planned a control group long term, i.e. longer than only 6 weeks, have meanwhile been compromised, i.e. there are no real control groups around, because those originally allocated to the control group have mostly been vaccinated now. So there are no real control groups available.
    3. Covid-19 vaccinations are one of the biggest experiments on mankind ever conducted – without a control group. Hence those, who are either not willing to be vaccinated or have not yet been vaccinated are our only chance to understand whether the vaccines are safe or whether symptoms reported after vaccination are actually due to the vaccination or are only an incidental occurrence or random fluctuation.

Comparing unvaccinated people and those with a vaccination history regarding Covid-19 vaccines long term is important to determine long-term safety, because in many instances in the past some problems only were seen after quite some time. This can happen, if auto-immune processes are triggered, which often occur only in very few people. Hence, it is also important to have a long-term observation period and a large number of people participating.

Prof. Dr. Dr. phil. Harald Walach

This does not alleviate my doubts about the scientific value at all. Prof Walach, promoter of so-called alternative medicine (SCAM) and pseudoscientist of the year 2012, has in the past drawn our attention to his odd activities around COVID and vaccinations. Here are three recent posts on the subject:

In view of all this, I do wonder what the VCC is truly about.

It couldn’t be a front for issuing dodgy exemption certificates, could it?

Dr. Mehmet Oz is one of the most influential promoters of outright quackery. I once (many years ago) met him at a meeting where we both were lecturing. My impression was that he does not believe a single word he speaks. Oz later became a TV star and had ample occasion to confirm my suspicion.

Oz’s wife, Lisa, is a Reiki master and has spoken widely of her insights into energy and health. Mehmet Oz appeared as a health expert on The Oprah Winfrey Show. In 2009, Winfrey offered to produce a syndicated series. The Dr. Oz Show debuted in September 2009 and became the most successful promotion of charlatanery in the US. During a Senate hearing on consumer protection in 2014, Senator Claire McCaskill stated that “the scientific community is almost monolithic against you” for airing segments on weight loss products that are later cited in advertisements, concluding that Oz plays a role, intentional or not, in perpetuating these scams, and that she is “concerned that you are melding medical advice, news, and entertainment in a way that harms consumers.” This judgement was supported by a 2014 analysis published in the BMJ; here is the abstract:

Objective To determine the quality of health recommendations and claims made on popular medical talk shows.

Design Prospective observational study.

Setting Mainstream television media.

Sources Internationally syndicated medical television talk shows that air daily (The Dr Oz Show and The Doctors).

Interventions Investigators randomly selected 40 episodes of each of The Dr Oz Show and The Doctors from early 2013 and identified and evaluated all recommendations made on each program. A group of experienced evidence reviewers independently searched for, and evaluated as a team, evidence to support 80 randomly selected recommendations from each show.

Main outcomes measures Percentage of recommendations that are supported by evidence as determined by a team of experienced evidence reviewers. Secondary outcomes included topics discussed, the number of recommendations made on the shows, and the types and details of recommendations that were made.

Results We could find at least a case study or better evidence to support 54% (95% confidence interval 47% to 62%) of the 160 recommendations (80 from each show). For recommendations in The Dr Oz Show, evidence supported 46%, contradicted 15%, and was not found for 39%. For recommendations in The Doctors, evidence supported 63%, contradicted 14%, and was not found for 24%. Believable or somewhat believable evidence supported 33% of the recommendations on The Dr Oz Show and 53% on The Doctors. On average, The Dr Oz Show had 12 recommendations per episode and The Doctors 11. The most common recommendation category on The Dr Oz Show was dietary advice (39%) and on The Doctors was to consult a healthcare provider (18%). A specific benefit was described for 43% and 41% of the recommendations made on the shows respectively. The magnitude of benefit was described for 17% of the recommendations on The Dr Oz Show and 11% on The Doctors. Disclosure of potential conflicts of interest accompanied 0.4% of recommendations.

Conclusions Recommendations made on medical talk shows often lack adequate information on specific benefits or the magnitude of the effects of these benefits. Approximately half of the recommendations have either no evidence or are contradicted by the best available evidence. Potential conflicts of interest are rarely addressed. The public should be skeptical about recommendations made on medical talk shows.

During the presidential campaign in 2016, Oz supported Trump and hosted him on his TV show. In 2018, Donald Trump appointed him to the President’s Council on Sports, Fitness, and Nutrition, Oz was criticized as an example of choosing “pundits over experts”. Recently, Oz announced he intends to run for the U.S. Senate as a Republican.

A fellow physician commented that he has the same amount of enthusiasm for Oz’s candidacy as he would with a case of dysentery, the intestinal infection that causes bloody diarrhea. Dr. Daniel Summers, MD, begged Pennsylvania not to elect Oz. “It’s been obvious for years that Oz is more than happy to leverage his reputation as a cardiothoracic surgeon and medical scientist in service to his own celebrity and advancement, and isn’t one to let quaint little things like facts stand in his way,” he wrote. “Stroll down a checkout aisle in your local grocery store, and chances are strong you’ll see his smiling face on the cover of a magazine touting some wildly unhealthy weight-loss claim. He’s been promoting pseudoscience on his show for years, from obesity ‘remedies’ like green coffee and garcinia cambogia to hawking ‘homeopathy starter kits,’ so this is nothing new.” Oz faced criticism for hosting a show in which he debated the utility of “reparative therapy” and “forms of therapy that are designed to turn a gay person straight,” even though they’ve been banned by many states at the urging of the American Psychological Association.

In April 2020, Oz also spurred controversy because he said that children should be sent back into schools despite the fact that the novel coronavirus pandemic had only just begun and there were no vaccines or therapeutics yet available. “I tell you, schools are a very appetizing opportunity,” he said, claiming that resuming classes “may only cost us 2 to 3 percent in terms of total mortality,” according to his “reading” of medical journals. The mistake was so substantial that Oz later provided a kind of half-apology, saying that he “misspoke.”

But what Dr. Summers finds worse is that Oz eagerly pushed treatments like hydroxychloroquine for COVID patients. He even went so far as to push the drug on Fox & Friends. It prompted Dr. Anthony Fauci, a virologist, to explain that the data simply wasn’t clear at the time. “Although there is some suggestion [of effectiveness] with the study that was just mentioned by Dr. Oz . . . I think we’ve got to be careful that we don’t make that majestic leap to assume that this is a knockout drug,” Fauci said at the time. “We still need to do the kinds of studies that definitively prove whether any intervention, not just this one . . . is truly safe and effective.”

“Medical misinformation is literally killing people, and it is unconscionable that anyone who should know better would contribute to it. And Oz most certainly should and does know better,” said Dr. Summers. “It is telling that Oz would see a space for himself in the Republican primary field. The GOP is riddled with prominent figures who undermine the seriousness of the pandemic, refute the importance of getting vaccinated, and denigrate the public health officials tasked with keeping the American people as safe and healthy as possible. Voters for those people are the ones Oz sees himself capable of wooing. That is the base he will need to capture to make his candidacy a success.”

Ovariohysterectomy (OH) is one of the most frequent elective surgical procedures in routine veterinary practice. The aim of this study was to evaluate analgesia with Arnica montana 30cH during the postoperative period after elective OH.

Thirty healthy female dogs, aged 1 to 3 years, weighing 7 to 14 kg, were selected at the Veterinary Hospital in Campo Mourão, Paraná, Brazil. The dogs underwent the surgical procedure with an anaesthetic protocol and analgesia that had the aim of maintaining the patient’s wellbeing. After the procedure, they were randomly divided into three groups of 10. One group received Arnica montana 30cH; another received 5% hydroalcoholic solution; and the third group, 0.9% NaCl saline solution. All animals received four drops of the respective solution sublingually and under blinded conditions, every 10 minutes for 1 hour, after the inhalational anaesthetic had been withdrawn. The Glasgow Composite Measure Pain Scale was used to analyse the effect of therapy. Analysis of variance (ANOVA) followed by the Tukey test was used to evaluate the test data. Statistical differences were deemed significant when p ≤0.05.

The results show that the Arnica montana 30cH group maintained analgesia on average for 17.8 ± 3.6 hours, whilst the hydroalcoholic solution group did so for 5.1 ± 1.2 hours and the saline solution group for 4.1 ± 0.9 hours (p ≤0.05).

The authors concluded that these data demonstrate that Arnica montana 30cH presented a more significant analgesic effect than the control groups, thus indicating its potential for postoperative analgesia in dogs undergoing OH.

I do not have access to the full article (I was fired by the late Peter Fisher from the editorial board of the journal ‘HOMEOPATHY’) which puts me in a somewhat difficult position:

  • not reporting this study could be construed as an anti-homeopathy bias,
  • and reporting it handicaps me as I cannot assess essential details.

So, if anyone has access, please send the full paper to me and I will then study it and revise this post accordingly.

Judging from the abstract, I have to say that the results seem far too good to be true. I doubt that any oral remedy can have the effect that is being described here – let alone one that has been diluted (sorry, potentised) at a rate of 1: 1000000000000000000000000000000000000000000000000000000000000. That fact alone reduces the plausibility of the finding to zero.

At this stage, I do wonder who peer-reviewed the study and ask myself whether the rough data have been checked for reliability.

Yesterday, it was reported that one of Austria’s best-known opponents of vaccination has died as a result of coronavirus infection. He vehemently refused treatment in hospital. Instead, he insisted on treating himself – and tragically, he is not an isolated case.

Miracle Mineral Solution” (MMS) is being promoted as a treatment for all kinds of diseases – including, of course, the coronavirus. But MMS is nothing more than the bleach and disinfectant chlorine dioxide, or CDL for short. It made headlines when Donald Trump suggested it as a remedy against Covid-19. Subsequently, CDL became highly popular amongst the anti-vax brigade.

Johann Biacsics was one of the leading figures of the anti-vaccination scene in Austria. On 11 November, he was seen in a Vienna hospital with an acute corona infection. At this stage, he had already taken chlorine dioxide because of fever complaints. Biacsics was, of course, not vaccinated and refused treatment. He was firmly convinced that he had already overcome the infection thanks to his treatment with chlorine dioxide.

The senior physician at the Vienna hospital saw things differently. His condition was “life-threatening”, she said. But instead of accepting treatment in hospital, Biacsics discharged himself and said he would rather treat himself. Once home, Biacsics put in an IV line with chlorine dioxide and sodium chloride. Two days later he was dead.

Only two weeks before his death, Biacsics had demonstrated in Vienna against the Austrian Corona measures. In a television interview from September, he can be seen in front of the parliament. “There are mainly vaccinated people in the intensive care units. 67 percent of them are vaccinated,” he said on camera at the time. When the reporter corrected him, he only replied that he had “inside information”.

His followers are now suggesting that he was poisoned. And for once they are, of course, correct. He basically poisoned himself with MMS. His family, meanwhile, blames the hospital and claim that he did not die of COVID, nor that Biacsics’ death is the result of treatment with chlorine dioxide.

Biacsics is not the first Austrian Covid patient who has refused treatment or used “alternative remedies”. And he is not the first who has died as a result. Self-treatment is booming among vaccination opponents and Corona deniers. It was even propagated in the Austrian parliament. For weeks, FPÖ leader Herbert Kickl (who also is COVID-positive) and his party colleagues have been promoting the deworming drug ivermectin – despite warnings from doctors, scientists, and the manufacturer.

All too often, the consequences are fatal: In Styria, two patients died from poisoning with ivermectin, in the district of Rohrbach in Upper Austria, a Corona patient left the intensive care unit in critical condition and died. He had also relied on ivermectin and refused other treatments.

 

Psychosocial distress, depression, or anxiety are frequent problems of women after a breast cancer diagnosis and treatment. Many try so-called alternative medicine (SCAM) in an attempt to deal with them. But is this effective?

The purpose of this study was to assess the potential benefit of lavender oil as a perioperative adjunct to improve anxiety, depression, pain, and sleep in women undergoing microvascular breast reconstruction.

This was a prospective, single-blinded, randomized, controlled trial of 49 patients undergoing microvascular breast reconstruction. Patients were randomized to receive lavender oil or a placebo (coconut oil) throughout their period of hospitalization. The effect of lavender oil on perioperative stress, anxiety, depression, sleep, and pain was measured using the hospital anxiety and depression scale, Richards-Campbell Sleep Questionnaire, and the visual analogue scale.

Twenty-seven patients were assigned to the lavender group and 22 patients were assigned to the control group. No significant differences were seen in the perioperative setting between the groups with regard to anxiety (p = 0.82), depression, sleep, or pain scores. No adverse events were noted, and no significant differences in surgery-related complications were observed. When evaluating the entire cohort, postoperative anxiety scores were significantly lower than preoperative scores, while depression scores were significantly higher postoperatively as compared with preoperatively.

The authors concluded that, in the setting of microvascular breast reconstruction, lavender oil and aromatherapy had no significant adverse events or complications; however, there were no measurable advantages pertaining to metrics of depression, anxiety, sleep, or pain as compared with the control group.

One could argue that the sample size of the trial was too low to pick up small differences in the outcome measures. Yet, even then, the findings do not suggest that the treatment did make a large enough difference to justify the effort and expense of the treatment.

One could also argue that – who cares? – if a patient wants aromatherapy (or another SCAM that is harmless), why not? The answer to this is the fact that researchers have the ethical duty to identify the most effective treatment, and clinicians have the ethical duty to employ not just any odd therapy but the one that works demonstrably best. Seen from this perspective, the place of SCAM in cancer care seems far less certain than many enthusiasts try to make us believe.

This review summarized the available evidence on so-called alternative medicine (SCAM) used with radiotherapy. Systematic literature searches identified studies on the use of SCAM during radiotherapy. Inclusion required the following criteria: the study was interventional, SCAM was for human patients with cancer, and SCAM was administered concurrently with radiotherapy. Data points of interest were collected from included studies. A subset was identified as high-quality using the Jadad scale. Fisher’s exact test was used to assess the association between study results, outcome measured, and type of SCAM.

Overall, 163 articles met inclusion. Of these, 68 (41.7%) were considered high-quality trials. Articles published per year increased over time. Frequently identified therapies were biologically based therapies (47.9%), mind-body therapies (23.3%), and alternative medical systems (13.5%). Within the subset of high-quality trials, 60.0% of studies reported a favorable change with SCAM while 40.0% reported no change. No studies reported an unfavorable change. Commonly assessed outcome types were patient-reported (41.1%) and provider-reported (21.5%). The rate of favorable change did not differ based on the type of SCAM or outcome measured.

The authors concluded that concurrent SCAM may reduce radiotherapy-induced toxicities and improve quality of life, suggesting that physicians should discuss SCAM with patients receiving radiotherapy. This review provides a broad overview of investigations on SCAM use during radiotherapy and can inform how radiation oncologists advise their patients about SCAM.

In my recent book, I have reviewed the somewhat broader issue of SCAM for palliative and supportive care. My conclusions are broadly in agreement with the above review:

… some forms of SCAM—by no means all— benefit cancer patients in multiple ways… four important points:
• The volume of the evidence for SCAM in palliative and supportive cancer care is currently by no means large.
• The primary studies are often methodologically weak and their findings are contradictory.
• Several forms of SCAM have the potential to be useful in palliative and supportive cancer care.
• Therefore, generalisations are problematic, and it is wise to go by the current best evidence …

One particular finding of the new review struck me as intriguing: The rate of favorable change did not differ based on the type of SCAM. Combined with the fact that most studies are less than rigorous and fail to control for non-specific effects, this indicates to me that, in cancer palliation (and perhaps in other areas as well), SCAM works mostly via non-specific effects. In other words, patients feel better not because the treatment per se was effective but because they needed the extra care, attention, and empathy.

If this is true, it carries an important reminder for oncology: cancer patients are very vulnerable and need all the empathy and compassion they can get. Seen from this perspective, the popularity of SCAM would be a criticism of conventional medicine for not providing enough of it.

Neck pain affects a vast number of people and leads to reduced quality of life and high costs. Clinically, it is a difficult condition to manage, and the effect sizes of the currently available treatments are moderate at best. Activity and manual therapy are first-line treatment options in several guidelines. But how effective are they really?

This study investigated the combination of home stretching exercises and spinal manipulative therapy in a multicentre randomized controlled clinical trial, carried out in a multidiscipline range of primary care clinics.

The treatment modalities utilized were spinal manipulative therapy combined with home stretching exercises compared to home stretching exercises alone. Both groups received 4 treatments for 2 weeks. The primary outcome was pain, where the subjective pain experience was investigated by assessing pain intensity (NRS – 11) and the quality of pain (McGill Pain Questionnaire). Neck disability and health status were secondary outcomes, measured using the Neck Disability Indexthe EQ-5D, respectively.

One hundred thirty-one adult subjects were randomized to one of the two treatment groups. All subjects had experienced persistent or recurrent neck pain the previous 6 months and were blinded to the other group intervention. The clinicians provided treatment for subjects in both groups and could not be blinded. The researchers collecting data were blinded to treatment allocation, as was the statistician performing data analyses. An intention-to-treat analysis was used.

Sixty-six subjects were randomized to the intervention group, and 65 to the control group. For NRS – 11, a B-coefficient of – 0,01 was seen, indication a 0,01 improvement for the intervention group in relation to the control group at each time point with a p-value of 0,305. There were no statistically significant differences between groups for any of the outcome measures.

Four intense adverse events were reported in the study, three in the intervention group, and one in the control group. More adverse incidents were reported in the intervention group, with a mean pain intensity (NRS-11) of 2,75 compared to 1,22 in the control group. There were no statistically significant differences between the two groups.

The authors concluded that there is no additional treatment effect from adding spinal manipulative therapy to neck stretching exercises over 2 weeks for patients with persistent or recurrent neck pain.

This is a rigorous and well-reported study. It suggests that adjuvant manipulations are not just ineffective for neck pain, but also cause some adverse effects. This seems to confirm many previously discussed investigations concluding that chiropractors do not generate more good than harm for patients suffering from neck pain.

The effectiveness of manipulation versus mobilization for the management of spinal conditions, including cervicogenic headache, is conflicting, and a pragmatic approach comparing manipulation to mobilization has not been examined in a patient population with cervicogenic headache.

This study evaluated the effectiveness of manipulation compared to mobilization applied in a pragmatic fashion for patients with cervicogenic headache.

Forty-five (26 females) patients with cervicogenic headache were randomly assigned to receive either pragmatically selected manipulation or mobilization. Outcomes were measured at baseline, the second visit, discharge, and 1-month follow-up. The endpoints of the study included the Neck Disability Index (NDI), Numeric Pain Rating Scale (NPRS), the Headache Impact Test (HIT-6), the Global Rating of Change (GRC), the Patient Acceptable Symptoms Scale (PASS). The primary outcome measures were the effects of treatment on disability and pain. They were examined with a mixed-model analysis of variance (ANOVA), with treatment group (manipulation versus mobilization) as the between-subjects variable and time (baseline, 48 hours, discharge, and follow-up) as the within-subjects variable.

The interaction for the mixed model ANOVA was not statistically significant for NDI (p = 0.91), NPRS (p = 0.81), or HIT (p = 0.89). There was no significant difference between groups for the GRC or PASS.

The authors concluded that manipulation has similar effects on disability, pain, GRC, and cervical range of motion as mobilization when applied in a pragmatic fashion for patients with cervicogenic headaches.

Essentially, this study is an equivalence trial comparing one treatment to another. As such it would need a much larger sample size than the 45 patients enrolled by the investigators. If, however, we ignored this major flaw and assumed the results are valid, they would be consistent with both manipulation and mobilization being pure placebos.

I can imagine that many chiropractors find this conclusion unacceptable. Therefore, let me offer an alternative: both approaches were equally effective. Therefore, mobilization, which is associated with far fewer risks, is preferable. This means that patients suffering from cervicogenic headache should see an osteopath who is less likely to use manipulation than a chiropractor.

And again, I can imagine that many chiropractors find this conclusion unacceptable.

The complex links between so-called alternative medicine (SCAM) and the pandemic have been a regular subject on this blog. Here is more:

This study investigated if people’s response to the official recommendations during the COVID-19 pandemic is associated with conspiracy beliefs related to COVID-19, a distrust in the sources providing information on COVID-19, and an endorsement of SCAM.

The sample consisted of 1325 Finnish adults who filled out an online survey advertised on Facebook. Structural regression analysis was used to investigate whether:

1) conspiracy beliefs, a distrust in information sources, and endorsement of SCAM predict people’s response to the non-pharmaceutical interventions (NPIs) implemented by the government during the COVID-19 pandemic,

2) conspiracy beliefs, a distrust in information sources, and endorsement of CAM are related to people’s willingness to take a COVID-19 vaccine.

The results indicate that individuals with more conspiracy beliefs and lower trust in information sources were less likely to have a positive response to the NPIs. Individuals with less trust in information sources and more endorsement of SCAM were more unwilling to take a COVID-19 vaccine. Distrust in information sources was the strongest and most consistent predictor in all models. In addition, the analyses revealed that some of the people who respond negatively to the NPIs also have a lower likelihood to take the vaccine. This association was partly related to lower trust in information sources.

The authors concluded that distrusting the establishment to provide accurate information, believing in conspiracy theories, and endorsing treatments and substances that are not part of conventional medicine, are all associated with a more negative response to the official guidelines during COVID-19. How people respond to the guidelines, however, is more strongly and consistently related to the degree of trust they feel in the information sources than to their tendency to hold conspiracy beliefs or endorse CAM. These findings highlight the need for governments and health authorities to create communication strategies that build public trust.

I also believe that these findings highlight the urgent need for improvements in education. In my view, it should start at school and continue into adult life. It should focus on a better understanding of science and – crucially – on the ability to differentiate facts from fiction and conspiracies.

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