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

gullible consumer

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Muscular dystrophies are a rare, severe, and genetically inherited disorders characterized by progressive loss of muscle fibers, leading to muscle weakness. The current treatment includes the use of steroids to slow muscle deterioration by dampening the inflammatory response. Chinese herbal medicine (CHM) has been offered as adjunctive therapy in Taiwan’s medical healthcare plan, making it possible to track CHM usage in patients with muscular dystrophies. This investigation explored the long-term effects of CHM use on the overall mortality of patients with muscular dystrophies.

A total of 581 patients with muscular dystrophies were identified from the database of Registry for Catastrophic Illness Patients in Taiwan. Among them, 80 and 201 patients were CHM users and non-CHM users, respectively. Compared to non-CHM users, there were more female patients, more comorbidities, including chronic pulmonary disease and peptic ulcer disease in the CHM user group. After adjusting for age, sex, use of CHM, and comorbidities, patients with prednisolone usage exhibited a lower risk of overall mortality than those who did not use prednisolone. CHM users showed a lower risk of overall mortality after adjusting for age, sex, prednisolone use, and comorbidities. The cumulative incidence of the overall survival was significantly higher in CHM users. One main CHM cluster was commonly used to treat patients with muscular dystrophies; it included Yin-Qiao-San, Ban-Xia-Bai-Zhu-Tian-Ma-Tang, Zhi-Ke (Citrus aurantium L.), Yu-Xing-Cao (Houttuynia cordata Thunb.), Che-Qian-Zi (Plantago asiatica L.), and Da-Huang (Rheum palmatum L.).

The authors concluded that the data suggest that adjunctive therapy with CHM may help to reduce the overall mortality among patients with muscular dystrophies. The identification of the CHM cluster allows us to narrow down the key active compounds and may enable future therapeutic developments and clinical trial designs to improve overall survival in these patients.

I disagree!

What the authors have shown is a CORRELATION, and from that, they draw conclusions implying CAUSATION. This is such a fundamental error that one has to wonder why a respected journal let it go past.

A likely causative explanation of the findings is that the CHM group of patients differed in respect to features that the statistical evaluations could not control for. Statisticians can never control for factors that have not been measured and are thus unknown. A possibility in the present case is that these patients had adopted a different lifestyle together with employing CHM which, in turn, resulted in a longer survival.

As discussed regularly on this blog, there is plenty of evidence to show that many chiropractors, homeopaths, and naturopaths discourage their patients from getting vaccinated. Now, a further investigation from the US seems to confirm these findings.

This analysis aims to evaluate differences between categories of so-called alternative medicine (SCAM) regarding vaccination behavior among US adults.

The data from the 2017 National Health Interview Survey (NHIS; n = 26,742; response rate 80.7%) was used for this purpose. Prevalences of flu vaccination, consultations with SCAM practitioners in the past 12 months, and their potential interactions were examined.

A total of 42.7% of participants had received the flu vaccination in the past 12 months, 32.4% had seen one or more SCAM practitioners. Users of any type of SCAM were as likely as non-users to have received a flu vaccination (44.8% users versus 41.7% non-users; p = 0,862; adjusted odds ratio [AOR] = 1.01, 95% confidence interval [CI] = 0.95-1.07).

Regarding specific SCAMs, individuals consulting with

  • naturopaths (p < 0.001; AOR = 0.67, 95 %CI = 0.54-0.82),
  • homeopaths (p < 0.001; AOR = 0.55; 95 %CI = 0.44-0.69),
  • chiropractors (p = 0.016; AOR = 0.9, 95 %CI = 0.83-0.98)

were less likely, while other SCAM approaches showed no significant association with flu vaccination behavior. Independent predictors for a flu shot were prior diabetes, cancer, current asthma, kidney disease, overweight and current pregnancy. As well, higher educational level, age, ethnicity, health insurance coverage, and having seen a general physician or medical specialist in the past 12 months were also associated with a higher vaccination rate.

The authors concluded that SCAM users were equally likely to receive an influenza vaccination compared with non-users. Different complementary therapies showed varied associations with vaccination behavior. Further analyses may be needed to distinguish influencing factors among patients’ vaccination behavior.

This investigation confirms the prevalent anti-vax stance within chiropractic, homeopathy, and naturopathy. The effect is strongest by far with homeopaths. Nothing new! We knew this for a very long time. The question is WHAT ARE WE DOING ABOUT IT? Or more specifically, are the professional organizations of these SCAM professions finally going to take any actions against even the most rabid anti-vaxxers in their midst?

And the answer?

You guessed it: NO!

And the irony of all this must not get lost here: chiropractors, homeopaths, naturopaths, and their respective organizations all pride themselves regularly that they attribute particular importance to disease prevention.

Guest post by Emeritus Professor Alastair MacLennan AO, MB ChB, MD, FRCOG, FRANZCOG

The sale and promotion of a therapeutic drug in most countries require rigorous assessment and licencing by that country’s therapeutic regulatory body. However, a new surgical technique can escape such checks and overview unless the technique is subject to local medical ethics review in the context of a research trial. New medical devices in Australia such as carbon dioxide or Er-YAG lasers can be listed on its therapeutic register without critical review of their efficacy and safety. Thermal injury to the postmenopausal vaginal wall in the hope of rejuvenating it has become a lucrative fad for some surgeons outside formal well-conducted clinical trials.

There are many published studies of this technique but the large majority are small, uncontrolled and observational. The few randomised controlled trials using sham controls show a placebo effect and debatable clinical efficacy with limited follow-up of adverse effects. A review of these therapies in July 2020 published by The National Institute for Health and Care Excellence summarised apparent claims for some efficacy in terms of vaginal dryness, dyspareunia, sexual function, and incontinence but noted confounding in the study’s designs such as concurrent breast cancer treatments, local oestrogen therapy and lubricants (!). Most studies had very limited follow up for adverse events but elsewhere the literature has reported burns, infection, increased dyspareunia and scarring. There is no physiological mechanism by which burning atrophic vaginal epithelium will magically rejuvenate it.

A recent well-conducted randomised sham-controlled trial with a 12-month follow-up of Fractional Carbon Dioxide Laser for the treatment of vaginal symptoms associated with menopause has been published in JAMA by Li et al has shown no efficacy for this treatment(2).

At 12 months, there was no difference in overall symptom severity based on a 0-100 scale (zero equals no symptoms), with a reduction in symptom severity of 17.2 in the treatment group compared with 26.6 in the sham group.

The treatment had no impact on quality of life. “Sexual activity rates and quality of sex were not significantly different between the groups at baseline or 12 months”. The study compared 46 paired vaginal wall biopsies, taken at baseline and six months into treatment, and no significant histological improvement with laser was evident.

“The annual cost of laser treatment to the individual for management of vaginal menopausal symptoms was reported to be AUD$2,733, and because there is no demonstrable difference versus sham treatment, it cannot be considered to be cost-effective.”

Although one could still call for more quality sham-controlled randomised trials in different circumstances there is no justification for touting this therapy commercially. Complications following this therapy outside of ethical trials could become the next medico-legal mine-field.

Vaginal atrophy in the years after menopause is almost universal and is primarily due to oestrogen deficiency. The efficient solution is local vaginal oestrogen or systemic hormone replacement therapy. However, the misreporting of the Women’s Health Initiative and Million Women’s Study has created exaggerated fear of oestrogen therapies and thus a market for alternative and often unproven therapies (3). The way forward is education and tailoring of hormonal therapies to minimise risk and maximise efficacy and quality of life and not to resort to quackery.

References

1. https://www.nice.org.uk/guidance/ipg697/documents/overview

2. Li FG, Maheux-Lacroix S, Deans R et al. Effect of Fractional Carbon Dioxide Laser vs Sham Treatment on Symptom Severity in Women With Postmenopausal Vaginal Symptoms A Randomized Clinical Trial. JAMA. 2021;326:1381-1389.

3. MacLennan AH. Evidence-based review of therapies at the menopause. Int J Evid Based Healthc 2009; 7: 112-123.

Recently, I wrote about the court case of a French naturopath. Last week, the judge has issued his verdict. Miguel Barthéléry was sentenced to a two-year suspended prison term and to a fine of 5 000 Euros. Two cancer patients had died following his treatments and recommendations. Barthéléry was also found guilty of impersonating a doctor and illegally practising medicine. In addition, he was also banned for life from practising as a healthcare professional.

The Paris criminal court found that Miguel Barthéléry had deliberately created confusion about his qualifications by presenting himself as a doctor on the internet and in text messages to the two victims. The defendant had claimed to have a doctorate and a post-doctorate from the United States. The judgment “has the consequence of dissuading all those who engage in the same abuses, they are now warned that we can not do anything with the health of people,” said the judge.

The case had begun in February 2019 with the complaint of the companion of a man who had died two months earlier of testicular cancer. Diagnosed in 2016, the patient had not consulted a doctor but had preferred to follow a “health plan” drawn up by the naturopath. It was based on fasting and cures, raw food, and essential oils. Later, the family of a Belgian physiotherapist, who died of uterine cancer at the age of 39, joined the legal case. However, according to Code Source, the Parisien podcast, the case is more extensive, with seven further suspicious deaths of Barthéléry’s patients.

Barthéléry’s lawyer said that the decision “raises questions more generally about the appreciation that we now have of alternative therapeutic practices, which now seem, although not prohibited by law, to be subject to condemnation by the courts.”

 

One argument that we hear regularly in the comment sections of this blog and elsewhere goes something like this:

“Why worry about a bit of so-called alternative medicine (SCAM like homeopathy or chiropractic, or Reiki, or Bach flower remedies, or detox, etc.)? Why should it bother us? Why not let everyone use what they want? Why not be a bit more tolerant?”

Tolerance is defined as sympathy or indulgence for beliefs or practices differing from or conflicting with one’s own. It is, of course, a quality that normally should be welcomed, taught, and celebrated. So, why not be more tolerant with enthusiasts of pseudoscientific SCAM?

In my view, there are several reasons.

  1. Ineffective therapies harm patients. The public tends to believe that SCAM is inherently safe. This is, of course, not true – think of chiropractic, for instance. But some treatments seem entirely harmless. Homeopathy might be a good example; its remedies contain nothing and therefore homeopathy can do no harm. Sadly, this is not true either. If a patient uses homeopathy to treat a serious condition, she is likely to harm herself by not treating that condition effectively. In extreme cases, this course of action can be fatal.
  2. Ineffective therapies are a waste of resources. It seems obvious that the money spent on something that does not work is money wasted. This is true whether we buy a car that is beyond repair or a SCAM that does not work beyond placebo.
  3. Pseudoscience makes a mockery of evidence-based medicine. If we are tolerant towards useless SCAM and accept that some people make money on, and mislead the public about SCAM, we basically send out a message that evidence is of secondary importance. This would weaken the trust in evidence-based medicine which, in turn, is bound to render healthcare less effective and stand in the way of progress.
  4. Pseudoscience undermines rationality and one form of irrationality begets another. Perhaps the biggest danger of tolerating promoters of quackery is that this undermines rational thinking far beyond the realm of healthcare. “Those who can make you believe absurdities can make you commit atrocities,” wrote Voltaire. I fear that he might have been correct.

In my view, tolerance about pseudoscientific, implausible, ineffective, or harmful SCAMs is misplaced. On the contrary, I feel that it is our duty to limit the harm they do to the public, patients, and progress by exposing them for what they are.

The ‘International Chiropractors Association’ (ICA) has just issued a statement entitled “International Chiropractors Association Affirms Policy on Health Freedom“. On the background of the fact that US President Biden, issued a series of Executive Orders related to mandating federal employees and federal contractors to receive the COVID-19 vaccine, the ICA try to explain their position regarding vaccinations. Here are a few passages from this statement:

…In a world of public health that promotes evidence-based decision making, we see the importance of natural immunity being ignored and replaced with a totalitarian approach of compulsory vaccination.  At a time when the Surgeon General says misinformation has become an urgent threat to public health, misinformation is now being used in an attempt to discredit the chiropractic profession, the International Chiropractors Association, and all chiropractic patients who desire to focus on improving health naturally. After enduring 18 months of shutdowns, lockdowns, flattening the curve, masking, limitations of speech on social media; and a cancel culture environment that threatens the basic freedoms our country was founded upon in 1776, ICA will not compromise on the importance of protecting health freedom…

The ICA Policy on Immunization and Vaccination has remained unchanged for almost 50 years and clearly states:

“The International Chiropractors Association recognizes that the use of vaccines is not without risk and questions the wisdom of mass vaccination programs.  Chiropractic principles favor the enhancement of natural immunity over artificial immunization.

The ICA supports each individual’s right to select his or her own health care and to be made aware of the possible adverse effects of vaccines upon a human body.  In accordance with such principles and based upon the individual’s right to freedom of choice, the ICA is opposed to compulsory programs which infringe upon such rights.

The International Chiropractors Association is supportive of a conscience clause or waiver in compulsory vaccination laws, providing an elective course of action for all regarding immunization, thereby allowing patients freedom of choice in matters affecting their bodies and health.”

The International Chiropractors Association maintains that all healthcare interventions, including the chiropractic adjustment, are associated with some level of risk and that every individual is entitled to be informed of those risks, no matter how insignificant. All individuals must retain the freedom to accept or reject any healthcare product, procedure, or medication including vaccinations.  The International Chiropractors Association therefore strongly opposes the use of medical mandates that violate personal sovereignty, violate the principles of informed consent, and constrain the rights of patients to make their own health care choices…

The ICA encourages the recognition that natural efforts to enhance the innate immune system ability to adapt to novel viruses are grounded in science and rejects the notion that the patients’ freedom to rely on naturally acquired immunity is not based upon unscientific beliefs.

The ICA rejects the premise that the chiropractic profession’s long history of promoting health freedom and supporting conscientious exemptions is based upon unscientific or non-mainstream beliefs…

I find this statement clear as mud and have the following questions:

  • Do the ICA recommend vaccinations?
  • In particular, do they encourage their members to get vaccinated with the COVID-19 vaccines?
  • Do they advise to recommend COVID-19 vaccinations to their patients?
  • Or do they think that natural immunity is preferable and advise their members and patients accordingly?
  • Do they believe that spinal manipulation enhances natural immunity?
  • Do they think that spinal manipulations are an effective alternative to COVID-19 vaccinations?
  • Do they believe that scientific evidence trumps dogma or vice versa?
  • Which of the two should, according to their conviction, must influence the decision-making processes in healthcare?
  • If the ICA object to misinformation about COVID, why do they not stop their members from promoting it?
  • What makes them think that information about the possible adverse effects of vaccines upon a human body is unavailable?
  • If the ICA recognizes the risks of spinal manipulation, why do they not inform the public about them regularly and objectively?
  • If the ICA knows about the importance of informed consent, why do not all of their members adhere to it?
  • And finally, why do the ICA insist on the term ‘international’ in the name of their organization, if they purely deal with the US situation?

I do not expect the ICA to give me the answers to these questions. But perhaps their Wiki page goes some way towards answering some of them: “… The ICA supports the efforts of the National Vaccine Information Center (NVIC).[13] The NVIC is known for promoting false and misleading information about vaccines, in particular the discredited claim that vaccines cause autism.

The ICA’s annual conferences have featured anti-vaccination propaganda. In 2018 Guest Speaker Beau Pierce (Pierce co-produced a series entitled Vaccines Revealed) hosted a session entitled Vaccines Revealed.,[14] and Jeff Hays, known for producing the anti-Vaccine propaganda Vaccines Revealed, was invited to host a session the 2017 ICA Council on Chiropractic Pediatrics Annual Conference. In 2016 the widely discredited anti-vaccination propaganda film VAXXED was shown at a conference sponsored by the ICA’s Council on Chiropractic Pediatrics …”

SAY NO MORE!

Germany seems to have a significant problem with anti-vaxxers. Today, only 68% of the population has had a COVID vaccination. In the UK and France, these figures are 72% and 75% respectively.

How come?

This study investigated the willingness to vaccinate of parents of minors and people without children who are minors. The investigation was based on a random sample of Germans (telephone survey, n = 2,014, collected between 12 November and 10 December 2020). The evaluation is primarily based on the sub-sample of people with minors in the household (n = 461).

Parents of minors consistently show a lower willingness to be vaccinated with a COVID-19 vaccine than respondents without minors (54.1% vs 71.1%). Fathers show a stronger willingness to be vaccinated than mothers. Furthermore, men are more willing to get their own child vaccinated with a COVID-19 vaccine than are women.

The authors concluded that among parents and especially mothers, a considerable misrepresentation of vaccination risks and frequent beliefs in vaccination conspiracy theories can be observed. Clear and easily understandable information on the effects and side effects of vaccination with a COVID-19 vaccine by relevant institutions and physicians is recommended.

And what has this to do with so-called alternative medicine (SCAM) and homeopathy?

In the results section of the paper, the authors report interesting  additional findings (my translation):

In the total sample, a significantly higher willingness to vaccinate is associated with the rejection of “alternative healing methods”. There is also a significant correlation between the attitude towards homeopathy and one’s own willingness to vaccinate: if homeopathy is supported, the willingness to vaccinate is lower. This correlation between the attitude towards homeopathy and willingness to vaccinate is also evident in the sub-sample of parents. Among parents, it is again women who significantly more often have a positive attitude towards homeopathy than men, who more often do not think anything of it.

The authors also report that the parents were asked: “If a vaccine against the coronavirus is approved in Germany, would you get vaccinated?” CERTAINLY NOT was the answer of:

  • 41% of homeopathy fans
  • 10% of people who thought nothing at all about homeopathy
  • 15% of participants who were not fully convinced by homeopathy

Yes, Germany seems to have a problem with the anti-vaccination brigade but it seems that at the heart of it is a problem with a homeopathy cult.

 

Practitioners of so-called alternative medicine (SCAM) regularly claim with great pride that they treat the ROOT CAUSES of disease. The claim has at least 4 effects:

  1. It distracts from the true causes of disease which are often multifactorial.
  2. It attracts customers to SCAM.
  3. It implies that conventional medicine is at best symptomatic and thus far inferior to SCAM.
  4. It encourages the patients of SCAM practitioners to turn their backs on mainstream healthcare.

The notion that SCAM practitioners treat the root causes is based on the practitioners’ understanding of etiology:

  • If a traditional acupuncturist, for instance, becomes convinced that all disease is the expression of an imbalance of life-forces, and that needling acupuncture points will re-balance these forces thus restoring health, he must automatically assume that he is treating the root causes of any condition.
  • If a chiropractor believes that all diseases are due to ‘subluxations’ of the spine, it must seem logical to him that spinal ‘adjustment’ is synonymous with treating the root cause of whatever complaint his patient is suffering from.
  • If a Bowen therapist is convinced that “the Bowen Technique aims to balance the whole person, not just the symptoms“, he is bound to be equally sure that the root cause of “practically any problem can potentially be addressed” by this intervention.
  • If a homeopath is convinced that all illness stems from a weakness of the ‘vital force’ and that only homeopathic remedies can revitalize it, they are likely to believe that their remedies tackle the root cause of all diseases.
  • Etc., etc.

So, are SCAM practitioners correct when they claim to treat the root causes of disease?

When a root cause has been eliminated, the disease has been eliminated by its root. Treating a root cause, therefore, means that the disease is permanently cured. The above question can therefore be re-phrased as follows:

Is there any SCAM that cures any disease permanently?

I think the answer is NO. (At least, I know none. I would, however, be most grateful if someone could name one together with the evidence)

Even demonstrably effective forms of SCAM are effective only in terms of alleviating the symptoms. The one with the best evidence is probably St John’s wort. It works fine for mild to moderate depression. Yet, it does not cure depression: if we discontinue the treatment, the depression is likely to return.

And what about conventional medicine? Does it offer any permanent cures?

I have been searching and have to admit that I cannot find many either. Here is my list so far of diseases that are potentially curable (meaning they are unlikely to come back once the treatment has stopped and excluding disease prevention) with conventional medicine – and again, I would be really grateful if readers could add to my preliminary list:

  • Acute emergencies, like anaphylaxis, cardiac arrest, etc.
  • Bacterial infections (well most of them)
  • Cancer (some), like Hodgkin lymphoma
  • Malnutrition like beriberi of iron-deficiency anemia
  • Phobias (some)
  • Fungal infections (some)
  • Poisonings (some)
  • Many surgical indications such as appendicitis, gall stones, carpal tunnel syndrome, etc.

Not a long list, I admit (but better than nothing!) – so, please help me to prolong it by adding diseases that I did not mention.

THANKS

 

Kratom (Mitragyna speciosa, Korth.) is an evergreen tree that is indigenous to Southeast Asia. It is increasingly being used as a recreational drug, to help with opium withdrawal, and as a so-called alternative medicine (SCAM) for pain, erectile dysfunction, as a mood stabilizer, and for boosting energy or concentration.  When ingested, Kratom leaves produce stimulant and opioid-like effects (see also my previous post).

Kratom contains 7‑hydroxymitragynine, which is active on opioid receptors. The use of kratom carries significant risks, e.g. because there is no standardized form of administration as well as the possibility of direct damage to health and of addiction.

There are only very few clinical trials of Kratom. One small placebo-controlled study concluded that the short-term administration of the herb led to a substantial and statistically significant increase in pain tolerance. And a recent review stated that Kratom may have drug interactions as both a cytochrome P-450 system substrate and inhibitor. Kratom does not appear in normal drug screens and, especially when ingested with other substances of abuse, may not be recognized as an agent of harm. There are numerous cases of death in kratom users, but many involved polypharmaceutical ingestions. There are assessments where people have been unable to stop using kratom therapy and withdrawal signs/symptoms occurred in patients or their newborn babies after kratom cessation. Both banning and failure to ban kratom places people at risk; a middle-ground alternative, placing it behind the pharmacy counter, might be useful.

In Thailand, Kratom had been outlawed since 1943 but now it has become (semi-)legal. Earlier this year, the Thai government removed the herb from the list of Category V narcotics. Following this move, some 12,000 inmates who had been convicted when Kratom was still an illegal drug received amnesty. However, Kratom producers, traders, and even researchers will still require licenses to handle the plant. Similarly, patients looking for kratom-based supplements will need a valid prescription from licensed medical practitioners. Thai law still prohibits bulk possession of Kratom. Users are encouraged to handle only minimum amounts of the herb to avoid getting prosecuted for illegal possession.

In 2018, the US Food and Drug Administration stated that Kratom possesses the properties of an opioid, thus escalating the government’s effort to slow usage of this alternative pain reliever. The FDA also wrote that the number of deaths associated with Kratom use has increased to a total of 44, up from a total of 36 since the FDA’s November 2017 report. In the majority of deaths that the FDA attributes to Kratom, subjects ingested multiple substances with known risks, including alcohol.

In most European countries, Kratom continues to be a controlled drug. In the UK the sale, import, and export of Kratom are prohibited. Yet, judging from a quick look, it does not seem to be all that difficult to obtain Kratom via the Internet.

The global market for dietary supplements has grown continuously during the past years. In 2019, it amounted to around US$ 353 billion. The pandemic led to a further significant boost in sales. Evidently, many consumers listened to the sly promotion by the supplement industry. Thus they began to be convinced that supplements might stimulate their immune system and thus protect them against COVID-19 infections.

During the pre-pandemic years, the US sales figures had typically increased by about 5% year on year. In 2020, the increase amounted to a staggering 44 % (US$435 million) during the six weeks preceding April 5th, 2020 relative to the same period in 2019. The demand for multivitamins in the US reached a peak in March 2020 when sales figures had risen by 51.2 %. Total sales of vitamins and other supplements amounted to almost 120 million units for that period alone. In the UK, vitamin sales increased by 63 % and, in France, sales grew by around 40–60 % in March 2020 compared to the same period of the previous year.

Vis a vis such impressive sales figures, one should ask whether dietary supplements really do produce the benefit that consumers hope for. More precisely, is there any sound evidence that these supplements protect us from getting infected by COVID-19? In an attempt to answer this question, I conducted several Medline searches. Here are the conclusions of the relevant clinical trials and systematic reviews that I thus found:

Confused?

Me too!

Does the evidence justify the boom in sales of dietary supplements?

More specifically, is there good evidence that the products the US supplement industry is selling protect us against COVID-19 infections?

No, I don’t think so.

So, what precisely is behind the recent sales boom?

It surely is the claim that supplements protect us from Covid-19 which is being promoted in many different ways by the industry. In other words, we are being taken for a (very expensive) ride.

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