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

gullible consumer

According to its authors, this study‘s objective was to demonstrate that acupuncture is beneficial for decreasing the risk of ischaemic stroke in patients with rheumatoid arthritis (RA).

The investigation was designed as a propensity score-matched cohort nationwide population-based study. Patients with RA diagnosed between 1 January 1997 and 31 December 2010, through the National Health Insurance Research Database in Taiwan. Patients who were administered acupuncture therapy from the initial date of RA diagnosis to 31 December 2010 were included in the acupuncture cohort. Patients who did not receive acupuncture treatment during the same time interval constituted the no-acupuncture cohort. A Cox regression model was used to adjust for age, sex, comorbidities, and types of drugs used. The researchers compared the subhazard ratios (SHRs) of ischaemic stroke between these two cohorts through competing-risks regression models.

After 1:1 propensity score matching, a total of 23 226 patients with newly diagnosed RA were equally subgrouped into acupuncture cohort or no-acupuncture cohort according to their use of acupuncture. The basic characteristics of these patients were similar. A lower cumulative incidence of ischaemic stroke was found in the acupuncture cohort (log-rank test, p<0.001; immortal time (period from initial diagnosis of RA to index date) 1065 days; mean number of acupuncture visits 9.83. In the end, 341 patients in the acupuncture cohort (5.95 per 1000 person-years) and 605 patients in the no-acupuncture cohort (12.4 per 1000 person-years) experienced ischaemic stroke (adjusted SHR 0.57, 95% CI 0.50 to 0.65). The advantage of lowering ischaemic stroke incidence through acupuncture therapy in RA patients was independent of sex, age, types of drugs used, and comorbidities.

The authors concluded that this study showed the beneficial effect of acupuncture in reducing the incidence of ischaemic stroke in patients with RA.

It seems obvious that the editors of ‘BMJ Open’, the peer reviewers of the study and the authors are unaware of the fact that the objective of such an investigeation is not to to demonstrate that acupuncture is beneficial but to test whether acupuncture is beneficial. Starting a study with the intention to to show that my pet therapy works is akin to saying: “I am intending to mislead you about the value of my intervention”.

One needs therefore not be surprised that the authors of the present study draw very definitive conclusions, such as “acupuncture therapy is beneficial for ischaemic stroke prevention”. But every 1st year medical or science student should know that correlation is not the same as causation. What the study does, in fact, show is an association between acupuncture and stroke. This association might be due to dozens of factors that the ‘propensity score matching’ could not control. To conclude that the results prove a cause effect relationship is naive bordering on scientific misconduct. I find it most disappointing that such a paper can pass all the hurdles to get published in what pretends to be a respectable journal.

Personally, I intend to use this study as a good example for drawing the wrong conclusions on seemingly rigorous research.

 

 

An article entitled “Homeopathy for worm infestations in children’s” caught my eye. Here is the un altered abstract:

Unusual sorts of worms can be there in a child’s stomach and may initiate several health complications such as pain, infection etc. To treat worm infections, one must identify about various categories of worms, and after understanding the kind of infection induced by the worm’s the treatment for the babies or children can planned. There are various Homeopathic medicines available which be used to treat worm infections without any side effects on the health of the children’s. In this paper we have discussed how the worm infection has been treated at our homeopathic research institute.

In the paper itself, the author, Dr. AK Dwivedi (Professor and H.O.D, Department of Physiology and Biochemistry, SKRP Guajarati Medical College, Indore, Madhya Pradesh, India), explains:

Homeopathic do not take care of just the disease, but is prescribed on the base of physical, emotional and genetic condition of a person. Homeopathic medicines act on both the mental and physical levels of individuals. Homeopathy is a natural and mild system of medicines that utilizes minute doses of well-researched remedies to improve the body’s natural curing procedure. Homeopathic medicines originate from substances that come’s from plants, minerals & animals.

The author’s conclusion is equally impressive:

On the basis of our research and after analysing the patients after medication we have found that homeopathy can completely cure the worm infection, If the dosages are properly prescribed and taken on that basis of investigation reports from time to time under guidance of experienced Homeopathic Physician worm infection can be treated with homeopathy effectively.

Yes, this level of incompetence could be quite funny! But sadly, it is also quite concerning. Most worm infestations are easily treated with effective conventional therapies. Untreated, they can have serious consequences. To advocate homeopathy – which is of course ineffective – is irresponsible, unethical and arguably criminal, in my view.

 

There are many variations of acupuncture. Electroacupuncture (EA) and Laseracupuncture (LA) are but two examples both of which are commonly used. However, it remains uncertain whether LA is as effective as EA. This study aimed to compare EA and LA head to head in dysmenorrhea.

A crossover, randomized clinical trial was conducted. EA or LA was applied to selected acupuncture points. Participants were randomized into two sequence treatment groups who received either EA or LA twice per week in luteal phase for 3 months followed by 2-month washout, then shifted to other groups (sequence 1: EA > LA; sequence 2: LA > EA). Outcome measures were heart rate variability (HRV), prostaglandins (PGs), pain, and quality-of-life (QoL) assessment (QoL-SF12). We also compared the effect of EA and LA in low and high LF/HF (low frequency/high frequency) status.

43 participants completed all treatments. Both EA and LA significantly improved HRV activity and were effective in reducing pain (Visual Analog Scale [VAS]; EA: p < 0.001 and LA: p = 0.010) and improving QoL (SF12: EA: p < 0.001, LA, p = 0.017); although without intergroup difference. EA reduced PGs significantly (p < 0.001; δ p = 0.068). In low LF/HF, EA had stronger effects than LA in increasing parasympathetic tone in respect of percentage of successive RR intervals that differ by more than 50 ms (pNN50; p = 0.053) and very low-frequency band (VLF; p = 0.035).

The authors concluded that there is no significant difference between EA and LA in improving autonomic nervous system dysfunction, pain, and QoL in dysmenorrhea. EA is prominent in PGs changing and preserving vagus tone in low LF/HF; yet LA is noninvasive for those who have needle phobia. Whether LA is equivalent with EA and the mechanism warrants further study.

Looking at the affiliations of the authors, one might expect that they should be able to design a meaningful study:

  • 1Division of Hemato-Oncology, Department of Internal Medicine, Branch of Zhong-Zhou, Taipei City Hospital, Taipei, Taiwan.
  • 2Institute of Traditional Medicine, National Yang-Ming Chiao Tung University, Taipei, Taiwan.
  • 3Department of Traditional Medicine, Branch of Yang-Ming, Taipei City Hospital, Taipei, Taiwan.
  • 4Department of Traditional Medicine, Branch of Kunming, Taipei City Hospital, Taipei, Taiwan.
  • 5Department of Gynecology and Obstetrics, Branch of Yang-Ming, Taipei City Hospital, Taipei, Taiwan.

Sadly, this assumption is evidently mistaken.

The trial certainly does not show what they claim and neither had it ever the chance to show anything relevent. A clinical trial is comparable to a mathematical equation. It can be solved, if it has one unkown; it cannot produce a result, if it has two unknowns.

The efficacy of EA and LA for dysmenorrhea are both unknown. A comparative study with two unknowns cannot produce a meaningful result. EA and LA did not both improve autonomic nervous system dysfunction, pain, and QoL in dysmenorrhea but most likely they both had no effect. What caused the improvement was not the treatment per se but the ritual, the placebo effect, the TLC or other non-specific factors. The maginal differences in other parameters are meaningless; they are due to the fact that – as an equivalence trial – the study was woefully underpowered and thus open to coincidental differences.

Clinical trials should be about contributing to our knowledge and not about contributing to confusion.

Here is the abstract of a recent article that I find worrying:

In 2020, severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) challenged the world with a global outbreak that led to millions of deaths worldwide. Coronavirus disease 2019 (COVID-19) is the symptomatic manifestation of this virus, which can range from flu-like symptoms to utter clinical complications and even death. Since there was no clear medicine that could tackle this infection or lower its complications with minimal adverse effects on the patients’ health, the world health organization (WHO) developed awareness programs to lower the infection rate and limit the fast spread of this virus. Although vaccines have been developed as preventative tools, people still prefer going back to traditional herbal medicine, which provides remarkable health benefits that can either prevent the viral infection or limit the progression of severe symptoms through different mechanistic pathways with relatively insignificant side effects. This comprehensive review provides scientific evidence elucidating the effect of 10 different plants against SARS-CoV-2, paving the way for further studies to reconsider plant-based extracts, rich in bioactive compounds, into more advanced clinical assessments in order to identify their impact on patients suffering from COVID-19.

The conclusions of this paper read as follows:

…since these 10 herbs hold distinct bioactive compounds with significant properties in vitro and with remarkable benefits to human health, it is possible to prevent SARS-CoV-2 infection and reduce its symptomatic manifestations by consuming any of these 10 plants according to the recommended dose. The diversity in bioactive molecules between the different plants exerts various effects through different mechanisms at once, which makes it more potent than conventional synthetic drugs. Nonetheless, more studies are needed to highlight the clinical efficacy of these extracts and spot their possible side effects on patients, especially those with comorbidities who take multiple conventional drugs.

I should point out that the authors fail to offer a single reliable trial that would prove or even imply that any of the 10 herbal remedies can effectively treat or prevent COVID infections (to the best of my knowledge, no such studies exist). Laguage like “it is possible to prevent SARS-CoV-2 infection and reduce its symptomatic manifestations” is therefore not just misleading but highly dangerous and deeply unethical. Sadly, such evidence-free claims abound in herbal medicine.

I think the journal editor, the peer-reviewer, the authors and their universities ( University of Tripoli in Lebanon, American University of the Middle East, Egaila in Kuwait, University of Balamand, Kalhat, Tripoli in Lebanon, Lebanese University, Tripoli in Lebanon, Aix-Marseille Université in France) should be ashamed to produce such dangerous rubbish.

Traditional herbal medicine (THM) is frequently used in pediatric populations. This is perticularly true in many low-income countries. Yet THM has been associated with a range of adverse events, including liver toxicity, renal failure, and allergic reactions. Despite these concerns, its impact on multi-organ dysfunction syndrome (MODS) risk has so far not been thoroughly investigated.

This study aimed to investigate the incidence and predictors of MODS in a pediatric intensive care unit (PICU) in Ethiopia, with a focus on the association between THM use and the risk of MODS. It was designed as a single-center prospective cohort study conducted at a PICU in the university of Gondar Comprehensive Specialized hospital, Northwest Ethiopia. The researchers enrolled eligible patients aged one month to 18 years admitted to the PICU during the study period. Data on demographic characteristics, medical history, clinical and laboratory data, and outcome measures using standard case record forms, physical examination, and patient document reviews. The predictors of MODS were assessed using Cox proportional hazards models, with a focus on the association between traditional herbal medicine use and the risk of MODS.

A total of 310 patients were included in the final analysis, with a median age of 48 months and a male-to-female ratio of 1.5:1. The proportion and incidence of MODS were 30.96% (95% CI:25.8, 36.6) and 7.71(95% CI: 6.10, 9.40) per 100-person-day observation respectively. Renal failure (17.74%), neurologic failure (15.16%), and heart failure (14.52%) were the leading organ failures identified. Nearly one-third of patients (32.9%) died in the PICU, of which 59.8% had MODS. The rate of mortality was higher in patients with MODS than in those without. The Cox proportional hazards model identified renal disease (AHR = 6.32 (95%CI: 3.17,12.61)), intake of traditional herbal medication (AHR = 2.45, 95% CI:1.29,4.65), modified Pediatric Index of Mortality 2 (mPIM 2) score (AHR = 1.54 (95% CI: 1.38,1.71), and critical illness diagnoses (AHR = 2.68 (95% CI: 1.77,4.07)) as predictors of MODS.

The authors concluded that the incidence of MODS was high. Renal disease, THM use, mPIM 2 scores, and critical illness diagnoses were independent predictors of MODS. A more than twofold increase in the risk of MODS was seen in patients who used TMH. Healthcare providers should be aware of risks associated with THM, and educate caregivers about the potential harms of these products. Future studies with larger sample sizes and more comprehensive outcome measures are needed.

I do fully agree with the authors about the high usage of herbal and other so-called alternative medicines by children. We have shown that, in the UK the average one-year prevalence rate was 34% and the average lifetime prevalence was 42%. We have furthermore shown that the evidence base for these treatments in children is weak, even more so than for general populations. Finally, we can confirm that adverse effects are far from rare and often serious.

It is therefore high time, I think, that national regulators do more to protect children from SCAM practitioners who are at best uncritical about their treatments and at worse outright dangerous.

Of all the forms of so-called alternative medicine (SCAM), Reiki is amongst the least plausible. It is a form of paranormal or ‘energy healing’ popularised by Japanese Mikao Usui (1865–1926). Reiki is based on the assumptions of Traditional Chinese Medicine and the existence of ‘chi’, the life-force that is assumed to determine our health.

Reiki practitioners believe that, with their hands-on healing method, they can transfer ‘healing energy’ to a patient which, in turn, stimulates the self-healing properties of the body. They assume that the therapeutic effects of this technique are obtained from a ‘universal life energy’ that provides strength, harmony, and balance to the body and mind.

Despite its implausibility, Reiki is used for a very wide range of conditions. Some people are even convinced that it has positive effects on sexuality. But is that really so?

This randomised clinical trial was aimed at finding out. Specifically, its authors wanted to determine the effect of Reiki on sexual function and sexual self-confidence in women with sexual distress*. It was was conducted with women between the ages of 15–49 years who were registered at a family health center in the eastern region of Turkey and had sexual distress.

The sample of the study consisted of 106 women, 53 in the experimental group and 53 in the control group. Women in the experimental group received Reiki once a week for four weeks, while no intervention was applied to those in the control group. Data were collected using the Female Sexual Distress Scale-Revised (FSDS-R), the Arizona Sexual Experiences Scale (ASEX), and the Sexual Self-confidence Scale (SSS).

The levels of sexual distress, sexual function, and sexual self-confidence of women in both groups were similar before the intervention, and the difference between the groups was not statistically significant (p > 0.05). After the Reiki application, the FSDS-R and ASEX mean scores of women in the experimental group significantly decreased, while their SSS mean score significantly increased, and the difference between the groups was statistically significant (p < 0.05).

The authors concluded that Reiki was associated with reduced sexual distress, positive outcomes in sexual functions, and increase sexual self-confidence in women with sexual distress. Healthcare professionals may find Reiki to positively enhance women’s sexuality.

Convinced?

I hope not!

The study has the most obvious of all design flaws: it does not control for a placebo effect, nor the effect of empaty/sympathy received from the therapist, nor the negative impact of learning that you are in the control group and will thus not receive any treatment or attention.

To me, it is obvious that these three factors combined must be able to bring about the observed outcomes. Therefore, I suggest to re-write the conclusions as follows:

The intervention was associated with reduced sexual distress, positive outcomes in sexual functions, and increase sexual self-confidence in women with sexual distress. Considering the biological plausibility of a specific effect of Reiki, the most likely cause for the outcome are non-specific effects of the ritual.

*[Sexual distress refers to persistent, recurrent problems with sexual response, desire, orgasm or pain that distress you or strain your relationship with your partner. Yes, I had to look up the definition of that diagnosis.]

 

Yesterday, someone (hopefully) unknown to me (hiding under the pseudonym ‘Queristfrei’) tweeted this rather bizarre comment [in German, my translation]:

This trivialisation of the unjust GDR state, in which people died for political reasons, shows how “lost” the people are who @amardeo, @Skepges, @EdzardErnst and the @Skepges respect and defend. That’s historical fabrication to the power of ten! #GWUP

Normally, I would have discarded the comment as just one of those many irrelevant idiocies posted by cranks that I am constantly exposed to on social media. However, the mention of the GWUP, the German skeptics organisation, links it to the current woke-motivated destruction of the GWUP and thus gives it special significance.

‘Woke’ and the various related terms are in fashion and polute discussions on far too many subjects. To be blunt, I don’t like ‘woke, WOKE, anti-woke, unwoke, wokerati’, etc. – so much so that, for the purpose of this post, I will invent an umbrella term that captures all of these words: ANTI-UNWOKERATI, AUWEI for short (yes, there might be a German root in this abbreviation. I know it is a silly acronym but, in my mind, the subject deserves nothing serious).

As already mentioned, I am anti-AUWEI which means I am as much anti-woke as anti-antiwoke. Or, to put it differently, I feel that the world would be a better place, if ‘woke’ had never become en vogue. Here I have listed (in no particular order) several reasons why I dislike AUWEI:

  • AUWEI means different things to different people and is thus a fertile basis for misunderstandings.
  • Every Tom, Dick and Harry uses the AUWEI terminology pretending to be an expert without expertise.
  • Much of what is said and written in the name of AUWEI is pure bullshit.
  • AUWEI has become an ideology.
  • Even worse, it is a straight jacket of the mind that makes us pre-judge a subject regardless of the evidence.
  • Worse still, it is abused by all the wrong politicians.
  • AUWEI serves many as a replacement for evidence.
  • Even worse, it often seems to be an alternative to critical thinking.
  • Most AUWEI-obsessed people seem to have lost their humor (or never had any).
  • AUWEI renders complex issues falsely simple.
  • AUWEI inhibits free thought.
  • AUWEI inhibits nuances and puts you in one camp or another – black or white.
  • AUWEI is unnecessarily devisive.
  • AUWEI invites intolerance and unproductive dispute.

Personally, I like to make up my own mind about things; to do this, I want to see the evidence. Once I have understood it, I go where the evidence leads me – not where AUWEI dictates me to go.

There are many AUWEI subjects that do not interest me and perhaps even more that I find outright silly. Personally, I don’t want AUWEI to tell me that I must have an opinion on them or quietly follow that of my AUWEI ‘peers’.

No, really; AUWEI is not for me.

These days – 11 years after the closure of my department at Exeter – it is not often that I co-author a peer-reviewed paper. All the more reason, I think, to celebrate when it does happen:

Our review was aimed at determining the effectiveness of meditation, primarily mindfulness-based interventions (MBIs) and transcendental meditation (TM), for the primary and secondary prevention of CVD.

We searched CENTRAL, MEDLINE, Embase, three other databases, and two trials registers on 14 November 2021, together with reference checking, citation searching, and contact with study authors to identify additional studies. We included randomised controlled trials (RCTs) of 12 weeks or more in adults at high risk of CVD and those with established CVD. We explored four comparisons: MBIs versus active comparators (alternative interventions); MBIs versus non-active comparators (no intervention, wait list, usual care); TM versus active comparators; TM versus non-active comparators. We used standard Cochrane methods. Our primary outcomes were CVD clinical events (e.g. cardiovascular mortality), blood pressure, measures of psychological distress and well-being, and adverse events. Secondary outcomes included other CVD risk factors (e.g. blood lipid levels), quality of life, and coping abilities. We used GRADE to assess the certainty of evidence.

We included 81 RCTs (6971 participants), with most studies at unclear risk of bias. MBIs versus active comparators (29 RCTs, 2883 participants) Systolic (SBP) and diastolic (DBP) blood pressure were reported in six trials (388 participants) where heterogeneity was considerable (SBP: MD -6.08 mmHg, 95% CI -12.79 to 0.63, I2 = 88%; DBP: MD -5.18 mmHg, 95% CI -10.65 to 0.29, I2 = 91%; both outcomes based on low-certainty evidence). There was little or no effect of MBIs on anxiety (SMD -0.06 units, 95% CI -0.25 to 0.13; I2 = 0%; 9 trials, 438 participants; moderate-certainty evidence), or depression (SMD 0.08 units, 95% CI -0.08 to 0.24; I2 = 0%; 11 trials, 595 participants; moderate-certainty evidence). Perceived stress was reduced with MBIs (SMD -0.24 units, 95% CI -0.45 to -0.03; I2 = 0%; P = 0.03; 6 trials, 357 participants; moderate-certainty evidence). There was little to no effect on well-being (SMD -0.18 units, 95% CI -0.67 to 0.32; 1 trial, 63 participants; low-certainty evidence). There was little to no effect on smoking cessation (RR 1.45, 95% CI 0.78 to 2.68; I2 = 79%; 6 trials, 1087 participants; low-certainty evidence). None of the trials reported CVD clinical events or adverse events. MBIs versus non-active comparators (38 RCTs, 2905 participants) Clinical events were reported in one trial (110 participants), providing very low-certainty evidence (RR 0.94, 95% CI 0.37 to 2.42). SBP and DBP were reduced in nine trials (379 participants) but heterogeneity was substantial (SBP: MD -6.62 mmHg, 95% CI -13.15 to -0.1, I2 = 87%; DBP: MD -3.35 mmHg, 95% CI -5.86 to -0.85, I2 = 61%; both outcomes based on low-certainty evidence). There was low-certainty evidence of reductions in anxiety (SMD -0.78 units, 95% CI -1.09 to -0.41; I2 = 61%; 9 trials, 533 participants; low-certainty evidence), depression (SMD -0.66 units, 95% CI -0.91 to -0.41; I2 = 67%; 15 trials, 912 participants; low-certainty evidence) and perceived stress (SMD -0.59 units, 95% CI -0.89 to -0.29; I2 = 70%; 11 trials, 708 participants; low-certainty evidence) but heterogeneity was substantial. Well-being increased (SMD 0.5 units, 95% CI 0.09 to 0.91; I2 = 47%; 2 trials, 198 participants; moderate-certainty evidence). There was little to no effect on smoking cessation (RR 1.36, 95% CI 0.86 to 2.13; I2 = 0%; 2 trials, 453 participants; low-certainty evidence). One small study (18 participants) reported two adverse events in the MBI group, which were not regarded as serious by the study investigators (RR 5.0, 95% CI 0.27 to 91.52; low-certainty evidence). No subgroup effects were seen for SBP, DBP, anxiety, depression, or perceived stress by primary and secondary prevention. TM versus active comparators (8 RCTs, 830 participants) Clinical events were reported in one trial (201 participants) based on low-certainty evidence (RR 0.91, 95% CI 0.56 to 1.49). SBP was reduced (MD -2.33 mmHg, 95% CI -3.99 to -0.68; I2 = 2%; 8 trials, 774 participants; moderate-certainty evidence), with an uncertain effect on DBP (MD -1.15 mmHg, 95% CI -2.85 to 0.55; I2 = 53%; low-certainty evidence). There was little or no effect on anxiety (SMD 0.06 units, 95% CI -0.22 to 0.33; I2 = 0%; 3 trials, 200 participants; low-certainty evidence), depression (SMD -0.12 units, 95% CI -0.31 to 0.07; I2 = 0%; 5 trials, 421 participants; moderate-certainty evidence), or perceived stress (SMD 0.04 units, 95% CI -0.49 to 0.57; I2 = 70%; 3 trials, 194 participants; very low-certainty evidence). None of the trials reported adverse events or smoking rates. No subgroup effects were seen for SBP or DBP by primary and secondary prevention. TM versus non-active comparators (2 RCTs, 186 participants) Two trials (139 participants) reported blood pressure, where reductions were seen in SBP (MD -6.34 mmHg, 95% CI -9.86 to -2.81; I2 = 0%; low-certainty evidence) and DBP (MD -5.13 mmHg, 95% CI -9.07 to -1.19; I2 = 18%; very low-certainty evidence). One trial (112 participants) reported anxiety and depression and found reductions in both (anxiety SMD -0.71 units, 95% CI -1.09 to -0.32; depression SMD -0.48 units, 95% CI -0.86 to -0.11; low-certainty evidence). None of the trials reported CVD clinical events, adverse events, or smoking rates.

We concluded that despite the large number of studies included in the review, heterogeneity was substantial for many of the outcomes, which reduced the certainty of our findings. We attempted to address this by presenting four main comparisons of MBIs or TM versus active or inactive comparators, and by subgroup analyses according to primary or secondary prevention, where there were sufficient studies. The majority of studies were small and there was unclear risk of bias for most domains. Overall, we found very little information on the effects of meditation on CVD clinical endpoints, and limited information on blood pressure and psychological outcomes, for people at risk of or with established CVD. This is a very active area of research as shown by the large number of ongoing studies, with some having been completed at the time of writing this review. The status of all ongoing studies will be formally assessed and incorporated in further updates.

Some people will say that meditation is not a form of so-called alternative medicine (SCAM) but rather an aspect of lifestyle used for relaxation and well-being. As such, it should not be scrutinized like a therapy. This might be partly true, but as soon as proper health claims are made for meditation or similar modalities, they do need to be tested like any other therapy, in my view.

As our review demonstrates, meditation and similar treatments are not nearly as well supported by evidence as their proponents try to make us believe. In other words, the often-voiced claims that such therapies are effective for the primary and secondary prevention of cardiovascular disease are largely unfounded.

Guest post by Ken McLeod

This week a Coroner’s Inquest into the death of Jarrad Antonovich resumes [1] in Byron Bay, New South Wales, Australia. Meanwhile, pending the outcome of Inquests and other investigations, the NSW Health Care Complaints Commission has imposed interim prohibition order on Mr Soulore Solaris, ‘….a Counsellor who facilitates Ayahuasca ceremonies.’

Under section 41AA of the Health Care Complaints Act 1993 (Act), Mr Solaris: “….must not under any circumstances provide, or cause to be provided, any health services, either in paid employment or voluntary, to any member of the public.” [2] This applies until 11 March 2024, when the matter will be reconsidered.

So what is all this about? To go back a while, Mr Antonovich died from a perforated oesophagus after consuming ayahuasca and kambo frog toxin in October 2021, at the age of 46, while attending the ‘Dreaming Arts festival’, a six-day retreat at Arcoora near Kyogle in northern New South Wales. At the festival he had consumed ayahuasca and participated in a “Kambo” ceremony, involving secretions harvested from an Amazonian tree frog.

Ayahuasca is a psychedelic substance made from boiling plants that is used in ritualistic ceremonies in the Amazon basin. [3] Ayahuasca contains chemicals of concern, such as N,N-Dimethyltryptamine (DMT), a highly psychedelic substance and a Schedule I drug under the Convention on Psychotropic Substances. Ayahuasca is illegal in many countries, and it is illegal to sell, import, produce and possess it in Australia. [4]

Kambo is made from secretions harvested from an Amazonian tree frog. Kambo is usually used in a group setting, called a Kambo circle or Kambo ceremony. Wikipedia lists a whole smorgasbord of dangerous consequences, including tachycardia, nausea, vomiting, diarrhea, psychosis, SIADH, kidney damage (including acute renal failure), pancreas damage, liver damage including toxic hepatitis, dermatomyositis, esophageal rupture, seizures, and death. [5]

The Australian Therapeutic Goods Administration has listed it as a schedule 10 poison, in the category for “substances of such danger to health as to warrant prohibition of sale, supply and use”. [6]

Earlier in the Inquest we heard that:

  • – While Jarrad Antonovich‘s condition worsened there was resistance to calling for an ambulance. An ambulance was finally called at 11.30pm and took an hour to arrive because of the remote location.
  • -One ambulance officer reported that a female told them to “move away from Jarrad because it was affecting his aura” and no one told them he had consumed Kambo. [7]
  • -The event organiser Soulore “Lore” Solaris described Jarrad Antonovich’s death as ‘beautiful.’ [8]
  • -Fred Woller, the site manager at Arcoora, was unaware those running the event did not have any medical training. [9]
  • -Soulore “Lore” Solaris said Mr Antonovich ”…. had good support, a couple of kinesiologists with him and they couldn’t find anything wrong,” [10]
  • -Mr Antonovich “was surrounded by people who loved him and an Aboriginal elder called Uncle Andrew who was chanting sacred songs and calling the spirit out of his body” and “the koalas were making a special sound that is known to the elders when the land accepts a spirit”.
  • -“Mr Solaris has stated that he has plans to leave Australia for Brazil to visit his teachers.” [11]

We will keep you informed.

REFERENCES

  • 1 Court Lists http://tinyurl.com/3fzjd6uy
  • 2 Health Care Complaints Commission http://tinyurl.com/yh76rzc6
  • 3 The Guardian http://tinyurl.com/328manjt
  • 4 Wikipedia https://en.wikipedia.org/wiki/Legal_status_of_ayahuasca_by_country
  • 5 Wikipedia https://en.wikipedia.org/wiki/Kambo_(drug)
  • 6 The Guardian http://tinyurl.com/2s398psy
  • 7 The Guardian http://tinyurl.com/328manjt
  • 8 ABC http://tinyurl.com/5n7ejydy
  • 9 The Guardian http://tinyurl.com/59wa3rmn
  • 10 ABC http://tinyurl.com/5n7ejydy
  • 11 Byron Bay Echo http://tinyurl.com/44n78s2w

The French ‘National Assembly’ has yesterday adopted a major law aimed at reinforcing the prevention and combat against sectarian aberrations in France. This marks a significant step forward in strengthening the protection of citizens against abuse and manipulation by charlatans, gurus and other sectarian movements.

This bill, the result of particularly fruitful work and debate in both chambers, reflects the Government’s commitment to meeting the expectations of the victims of these sectarian movements.

Some of the key measures voted through by parliamentarians include:

  • The enshrinement in law of the powers of MIVILUDES (Interministerial Mission of Vigilance and Combat against Sectarian Aberrations);
  • The reinforcement of the penal response with the creation of the offence of placing or maintaining in a state of psychological or physical subjection;
  • The creation of an offence of incitement to abandon or refrain from treatment, or to adopt practices which clearly expose the person concerned to a serious health risk;
  • Support for victims, with the extension of the categories of associations that can bring civil action;
  • Information for the judiciary, with the introduction of an “amicus curiae” role for certain government departments in legal cases relating to cults.

Despite sometimes heated debates, particularly around article 4, fuelled by the opinion of the Conseil d’Etat, the adoption of this law by the National Assembly bears witness to a shared desire to protect the rights and freedoms of individuals while providing better protection for our fellow citizens against sectarian aberrations.

This bill is part of a multi-annual national strategy for 2023-2027 resulting from the conference on sectarian aberrations held in spring 2023. It is a major step towards strengthening the penal arsenal and protecting victims.

_______________

Sabrina Agresti-Roubache, Secretary of State for Citizenship and Urban Affairs, commented:

“Long-awaited by victim support associations, this text aims to strengthen our legal arsenal in the fight against sectarian aberrations. I’m delighted that all the articles have been adopted, particularly Article 4, which creates an offence of incitement to abandon or abstain from treatment. There have been some passionate debates in the Chamber, but I’d like to reiterate the basis of this bill: the State is not fighting against beliefs, opinions or religions, but against all forms of sectarian aberrations, these dangerous behaviors which represent a threat to our social cohesion and put lives at risk.”

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Obviously, we shall have to see how the new law will be applied. But, in any case, it is an important step into the right direction and could put an end to much of so-called alternative medicine that endangers the health of French consumers.

Other nations should consicer following the Franch example.

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