commercial interests
It has been reported that a man has been charged after the death of a woman attending a slapping therapy workshop run by Hongchi Xiao. Danielle Carr-Gomm died aged 71 at Cleeve House in Seend, Wiltshire, on 20 October 2016. Hongchi Xiao (60), an alternative healer who advocates a technique known as “slapping therapy”, living in Cloudbreak in California, has now been charged with manslaughter by gross negligence, after being extradited back to the UK.
Xiao promotes paida lajin therapy, also called slapping therapy, in which patients are slapped or slap themselves repeatedly, ostensibly to release toxins from the body. Patients often end up with bruises or bleeding. The technique has its roots in Chinese medicine, but critics say it has no scientific basis. Xiao, who is originally from China and runs the California-based Pailala Institute, has led paida lajin workshops around the world.
Carr-Gomm’s son Matthew said after his mother’s death that she had sought “alternative methods of treating and dealing with her diabetes” because she struggled to inject insulin due to a fear of needles. “I know she was desperate to try and cure herself of this disease,” he said. “She always maintained a healthy lifestyle and was adamant that nothing would stop her from living a full life.”
A warrant for Mr Xiao’s arrest was originally issued in October 2019. He has now been arrested after returning to the United Kingdom from Australia on an extradition warrant and was taken to Gablecross custody in Swindon where he was charged with manslaughter by gross negligence. Police said Xiao, 60, is due to appear in court in Salisbury, southwest England, on Friday.
The Pailala Institute claims to be a non-profit organization incorporated in California. It is managed by a team of non-paying volunteers to promote and support the self-healing practice of Paida Lajin, led by Mr. HongChi Xiao. Their mission is to “transform our world into a healthier place, by enabling every one of us to awaken our self-healing power, we were born with, to heal ourselves, reducing medical cost and its related potential side effects.”
The institute also claims that “based on Traditional Chinese Medicine, the practice of PaidaLajin helps you to relieve from chronic pain, hypertension or diabetes, without equipment or medication. It can quickly improve your circulation and let your body heal itself. PaidaLajin has facilitated the healing of over 210 different illnesses worldwide. Join millions of practitioners in China, Taiwan, Hong Kong, Bulgaria, Germany, Indonesia, India, South Africa, Australia, etc. Just Google and following their witnesses.”
It goes almost without saying that the evidence for slapping therapy’s effectiveness is non-existent.
Several newspapers have reported that, in the Paris region and in the Alpes-Maritimes, France, some 175 police officers were mobilized yesterday to arrest of Gregorian Bivolaru, 71, the Romanian guru and founder of the Movement for Spiritual Integration Towards the Absolute (Misa), which became the ‘Atman Yoga Federation’ when it expanded outside Romania.
Bivolaru had already been convicted in Romania of rape of a minor and is wanted by Interpol for trafficking women. He has also been the subject of a judicial investigation in France since July 2023 for “human trafficking, “organized gang confinement”, “rape” and “organized gang abuse”. He presents himself as the “spiritual leader” of the Atman yoga federation, which has branches in some 30 countries. Under the guise of teaching tantric yoga, this sect conditions its female followers to accept sexual relations eliminating any notion of consent. The victims were encouraged to accept sexual relations with the group’s leader and to engage in pornographic practices for a fee in France and abroad.
Twenty-six women were released during the police operation. Gregorian Bivolaru was arrested in a house in Ivry-sur-Seine where he used to receive his followers for tantric yoga “sexual initiations”. A dozen women were also held for days in the Paris region, to be handed over to the guru.
Gregorian Bivolaru’s career began in 1990 in Romania, where he first founded Misa. Accused of human trafficking and tax evasion in his home country, he moved to Sweden, where he was granted political asylum in 2005, along with a new identity. A conspiracy theorist, he has always maintained that the proceedings against him were political and that the Romanian legal system was against him.
In 2016, Gregorian Bivolaru was sentenced to six years’ imprisonment in Romania for raping a minor and extradited from France. He remained in custody for just one year. New charges were brought against him in Finland after six women, members of the Atman yoga federation, filed a complaint for “human trafficking”. This led Helsinki to issue an international wanted notice by Interpol, in 2017.
Subsequently, the sect continued to exist, still under the control of Gregorian Bivolaru, based in the Paris region. Former followers claimed that the man financed his activities by forcing his victims to submit to various forms of prostitution in strip clubs and massage parlors, or by forcing them to take part in pornographic films in Romania, Hungary and the Czech Republic.
_____________________
The International Federation of Yoga and Meditation, ATMAN, claims on its website that it is a non-profit organisation and the majority of its members are committed to a non-profit and charitable orientation. ATMAN is providing a basis for communication and cooperation between various traditional yoga schools and genuine spiritual paths worldwide, promoting true spiritual values for the benefit of mankind.
________________________
A website for Tara Yoga states that Gregorian Bivolaru, nicknamed ‘Grieg’, “is the author of the yoga course taught in Tara and our sister schools in the ATMAN Federation. Having dedicated his entire life towards helping people awaken to that which is divine, Grieg is recognised by many as having a high level of enlightenment and spiritual power, and as belonging to the highest category of spiritual guides, bodhaka.”
_______________________
Tara is one of the ten Maha Vidyas or goddesses of the Tantric pantheon. She is the embodiment of knowledge, grace and compassion. Tara is the guiding star of all spiritual seekers, helping aspirants at any moment as they navigate ‘samsara’, the ocean of illusion, on the path to self-knowledge.
According to chiropractic belief, vertebral subluxation (VS) is a clinical entity defined as a misalignment of the spine affecting biomechanical and neurological function. The identification and correction of VS is the primary focus of the chiropractic profession. The purpose of this study was to estimate VS prevalence using a sample of individuals presenting for chiropractic care and explore the preventative public health implications of VS through the promotion of overall health and function.
A brief review of the literature was conducted to support an operational definition for VS that incorporated neurologic and kinesiologic exam components. A retrospective, quantitative analysis of a multi-clinic dataset was then performed using this operational definition.
The operational definition used in this study included:
- (1) inflammation of the C2 (second cervical vertebra) DRG,
- (2) leg length inequality,
- (3) tautness of the erector spinae muscles,
- (4) upper extremity muscle weakness,
- (5) Fakuda Step test,
- radiographic analysis based on the (6) frontal atlas cranium line and (7) horizontal atlas cranium line.
Descriptive statistics on patient demographic data included age, gender, and past health history characteristics. In addition to calculating estimates of the overall prevalence of VS, age- and gender-stratified estimates in the different clinics were calculated to allow for potential variations.
A total of 1,851 patient records from seven chiropractic clinics in four states were obtained. The mean age of patients was 43.48 (SD = 16.8, range = 18-91 years). There were more females (n = 927, 64.6%) than males who presented for chiropractic care. Patients reported various reasons for seeking chiropractic care, including, spinal or extremity pain, numbness, or tingling; headaches; ear, nose, and throat-related issues; or visceral issues. Mental health concerns, neurocognitive issues, and concerns about general health were also noted as reasons for care. The overall prevalence of VS was 78.55% (95% CI = 76.68-80.42). Female and male prevalence of VS was 77.17% and 80.15%, respectively; notably, all per-clinic, age, or gender-stratified prevalences were ≥50%.
The authors concluded that the results of this study suggest a high rate of prevalence of VS in a sample of individuals who sought chiropractic care. Concerns about general health and wellness were represented in the sample and suggest chiropractic may serve a primary prevention function in the absence of disease or injury. Further investigation into the epidemiology of VS and its role in health promotion and prevention is recommended.
This is one of the most hilarious pieces of ‘research’ that I have recently encountered. The strategy is siarmingly simple:
- invent a ficticious pathology (VS) that will earn you plently of money;
- develop criteria that allow you to diagnose this pathology in the maximum amount of consumers;
- show gullible consumers that they are afflicted by this pathology;
- use scare mongering tactics to convince consumers that the pathology needs treating;
- offer a treatment that, after a series of expensive sessions, will address the pathology;
- cash in regularly while this goes on;
- when the consumer has paid enough, declare that your fabulous treatment has done the trick and the consumer is again healthy.
The strategy is well known amongst practitioners of so-called alternative medicine (SCAM), e.g.:
- Traditional acupuncturists diagnose a ficticious imbalance of yin and yang only to normalise it with numerous acupuncture sessions.
- Naturopaths diagnose ficticious intoxications and treat it with various detox measures.
- Iridologists diagnose ficticious abnormalities of the iris that allegedly indicate organ disstress and treat it with whatever SCAM they can offer.
As they say:
No disease can be more surely, effectively, and profitably treated than a condition that the unsuspecting customer did not have in the first place!
PS
Sadly, such behavior exists in convertional medicine occasionally too, but SCAM relies almost entirely on it.
I was alerted to this message on ‘reddit’:
I went in to a chiropractor for a sports injury which was completely unrelated to my neck (wrist). While I was there, the chiropractor insisted on also doing a neck adjustment. To make a very long story short, this adjustment caused a vertebral artery dissection. The injury has left me with lifelong symptoms that I won’t get into here.>Because of tort reform law in Texas, and the $250k cap, I had a very difficult time finding any attorney to represent me even though there’s a mountain of evidence in my favor. My time to file a lawsuit has almost run out (statute of limitations).
Out of principle I want to hold this person accountable. How would I go about at least filing my lawsuit so that I get in within the statute of limitations which is very quickly approaching?
My thought is if I do sue this person within the two year timeframe then I can either self represent, have the option of withdrawing my case, or maybe in the meantime find an attorney to represent me for if/when we go to trial.
Any other advice or things that I should be considering? What would you do?
Thank you
____________________
If anyone can help this person, please do so. I have acted as an expert witness in several such cases and would be happy to do so also in this instance.
Chiropractors will, of course, say that this message is not a proper case report and cannot therefore count as evidence against the safety of chiropractic. I agree that it does not in itself amount to compelling evidence. But I would like to remind the chiros that it is up to them to establish a proper surveillance system for such tragic events which seem to occur far more often than they want us to believe (as discussed ad nauseam on this blog).
I was alerted to a new book entitled “Handbook of Space Pharmaceuticals“. It contains a chapter on “Homeopathy as a Therapeutic Option in Space” (yes, I am not kidding!). Here is its abstract (the numbers were inserted by me and refer to the short comments below):
Homeopathy is one of the largest used unorthodox medicinal systems having a wide number of principles and logic to treat and cure various diseases [1]. Many successful concepts like severe dilution to high agitation have been applied in the homeopathic system [2]. Though many concepts like different treatment for same diseases and many more are contradictory to the allopathic system [3], homeopathy has proved its worth in decreasing drug-related side effects in many arenas [4]. Various treatments and researches are carried out on various diseases; mostly homeopathic treatment is used in joint diseases, respiratory diseases, cancer, and gastrointestinal tract diseases [5]. In this chapter, readers will have a brief idea about many meta-analysis results of most common respiratory diseases, i.e., asthma, incurable hypertension condition, rheumatoid arthritis, and diarrhea and a megareview of all the diseases to see their unwanted effects, uses of drugs, concepts, and issues related to homeopathy [6]. Various limitations of homeopathic treatments are also highlighted which can give a clear idea about the future scope of research [7]. Overall, it can be concluded that placebo and homeopathic treatments give almost the same effect [8], but the less severe side effects of homeopathic drugs in comparison to all other treatment groups catch great attention [9].
Apart from the very poor English of the text and the fact that it has as good as nothing to do with the subject of ‘Homeopathy as a Therapeutic Option in Space’, I have the following brief comments:
- I did not know that homeopathy has ‘a wide number of logic’ and had alwas assumed that there is only one logic.
- Successful concepts? Really?
- So, homeopaths believe that the ‘allopathic system’ treats the same diseases uniformly? In this case, they should perhaps read up what conventional medicine really does.
- I am not aware of good evidence showing that homeopathy reduces drug related adverse effects.
- No, homeopathy is used for all symptoms – Hahnemann did not believe in treating disease entities – and mostly for those that are self-limiting.
- I love the term ‘incurable hypertension condition’; can somebody please explain what it is?
- The main limitation is that homeopathy is nonsense and, as such, does not really require further research.
- Not ‘almost’ but ‘exactly’! But thanks for pointing it out.
- Wishful thinking and not true. Firstly, the author forgot about ‘homeopathic aggravations’ in which homeopaths so strongly believe. Secondly, I know of many non-homeopathic treatments that are free of adverse effects when done properly.
Altogether, I am as disappointed by this article as you must be: we were probably all hoping to hear about the discovery showing that homeopathy works splendidly in space – not least because we have known for a while that homeopaths seem to be from a different planet.
Congratulations to Joseph Prahlow, MD, who is the winner of the Excellence in Homeopathy Award! Here are the conclusions of his winning essay. Special thanks to Hermeet Singh and Boiron for their prize donation.
Despite the many obstacles and challenges which face homeopathy in the 21st century, the homeopathic community should be emboldened and encouraged by the fact that there are also many opportunities for the advancement of homeopathy as an alternative choice in health care.
Proclaim the Truth: Homeopathy Actually Works
Notwithstanding the challenges involved (especially for a student) in arriving at the correct simillimum for a case, let alone the appropriate follow-up and case management, the truth of the matter is that homeopathy does, in fact, work! Those of us who have been the beneficiaries of homeopathic care, or who have seen the benefits in others, know with no doubt whatsoever that homeopathy represents a truly amazing form of alternative medicine that is able to successfully treat patients having a wide range of health concerns, including some very ill individuals. And it’s not just based on “experience” or “perception,” although such evidence should not be discounted. Numerous studies show the effectiveness of homeopathy.6-9 The fact that homeopathy actually works represents one of the biggest and most important opportunities for homeopathy. The corresponding challenge relates to “getting the word out” into the general community as well as the medical community. Instead of homeopathy being the “last resort,” it should increasingly become the “first choice” amongst patients. Only by “spreading the word” of its success can this become a reality.
What intrigued me here was the evidence that an award-winning homeopath believes might justify the claim that
“Numerous studies show the effectiveness of homeopathy”
6. Mathie RT, Lloyd SM, Legg LA, et al. Randomised placebo-controlled trials of individualized homeopathic treatment: systematic review and meta-analysis. Syst Rev. 2014 Dec 6;3:142. doi: 10.1186/2046-4053-3-142.
As we have discussed previously that meta-analysis is phoney and created a false-positive result by omitting at least two negative studies.
7. Taylor JA, Jacobs J. Homeopathic ear drops as an adjunct in reducing antibiotic usage in children with otitis media. Glob Pediatr Health 2014 Nov 21;1:2333794X14559395. doi: 10.1177/2333794X14559395.
This study had the notorious A+B versus B design and thus was unable to test for specific effects of homeopathy. Moreover, the lead author, Dr Jennifer Jacobs, was a paid consultant to Standard Homeopathic Company.
8. Sorrentino L, Piraneo S, Riggio E, et al. Is there a role for homeopathy in breast cancer surgery? A first randomized clinical trial on treatment with Arnica montana to reduce post-operative seroma and bleeding in patients undergoing total mastectomy. J Intercult Ethnopharmacol 2017 Jan 3;6(1):1-8. doi: 10.5455/jice.20161229055245.
This study showed no significant result in the intention to treat analysis. The positive conclusion seems to be based on data dredging only.
9. Frass M, Lechleitner P, Grundling C, et al. Homeopathic treatment as an add-on therapy may improve quality of life and prolong survival in patients with non-small cell lung cancer: a randomized, placebo-controlled, double-blind, three-arm, multic0-e1955enter study. Oncologist 2020 Dec 25(12):e1930-e1955. doi: 10.1002/onco.13548.
This study is since months under investigation for fraud. The reasons for this have been discussed previously.
Perhaps the award winning author should chance the crucial sentence into something like:
Numerous studies have shown how homeopaths try to mislead the public?
In any case, please do not let this stop you from reading the full paper by the award-winning author. I promise you that it will create much hilarity.
What does homeopathy offer our modern ailing world?
NOTHING!
The concept that the outcomes of spinal manipulation therapy (SMT) – the hallmark intervention of chiropractors which they use on practically every patient – are optimized when the treatment is aimed at a clinically relevant joint is commonly assumed and central to teaching and clinical use of chiropractic. But is the assumption true?
This systematic review investigated whether clinical effects are superior when this is the case compared to SMT applied elsewhere. Eligible study designs were randomized controlled trials that investigated the effect of SMT applied to candidate versus non-candidate sites for spinal pain.
The authors obtained studies from four different databases. Risk of bias was assessed using an adjusted Cochrane risk of bias tool, adding four items for study quality. Between-group differences were extracted for any reported outcome or, when not reported, calculated from the within-group changes. Outcomes were compared for SMT applied at a ‘relevant’ site to SMT applied elsewhere. The authors prioritized methodologically robust studies when interpreting results.
Ten studies were included. They reported 33 between-group differences; five compared treatments within the same spinal region and five at different spinal regions.
None of the nine studies with low or moderate risk of bias reported statistically significant between-group differences for any outcome. The tenth study reported a small effect on pain (1.2/10, 95%CI – 1.9 to – 0.5) but had a high risk of bias. None of the nine articles of low or moderate risk of bias and acceptable quality reported that “clinically-relevant” SMT has a superior outcome on any outcome compared to “not clinically-relevant” SMT. This finding contrasts with ideas held in educational programs and clinical practice that emphasize the importance of joint-specific application of SMT.
The authors concluded that the current evidence does not support that SMT applied at a supposedly “clinically relevant” candidate site is superior to SMT applied at a supposedly “not clinically relevant” site for individuals with spinal pain.
I came across this study when I searched for the published work of Prof Stephen Perle, a chiropractor and professor at the School of Chiropractic, College of Health Sciences, University of Bridgeport, US, who recently started trolling me on this blog. Against my expectation, I find his study interesting and worthwhile.
His data quite clearly show that the effects of SMT are non-specific and mainly due to a placebo response. That in itself is not hugely remarkable and has been suspected to some time, e.g.:
- Chiropractic manipulation for migraine is a placebo therapy
- Chiropractic treatments are placebos
- Chiropractic spinal manipulation = placebo!
- Manual therapy (mainly chiropractic and osteopathy) does not have clinically relevant effects on back pain compared with sham treatment
- Manual therapies for back pain: not better than a placebo
- Is spinal manipulation a placebo therapy?
What is remarkable, however, is the fact that Perle and his co-authors offer all sorts of other explanation for their findings without even seriously considering what is stareing in their faces:
SPINAL MANIPULATIONS ARE PLACEBOS
CHIROPRACTIC IS A PLACEBO THERAPY
This might be almost acceptable, if chiropractic would not also be burdened with significant risks (as we have discussed ad nauseam on this blog) – another fact of which chiros like Perle are in denial.
What does all that mean for patients?
The practical implication is fairly straight forward: the risk/benefit balance of chiropractic is negative. And this surely means the only responsible advice to patients is this:
NEVER CONSULT A CHIRO!
On the occasion of a talk that I recently gave in Italy, I was interviewed by VANITY FAIR ITALY. I gave it in English and it was published in Italian. As I don’t expect many readers to be fluent in Italian and since it was a good interview, in my view, I thought I give you here the English original:
1.How can we exactly define «alternative medicine»?
There is much confusion and a plethora of definitions, none of which is fully satisfactory. In fact, the term “alternative medicine” itself is nonsensical: if a therapy works, it belongs to evidence-based medicine; and if it doesn’t work, it cannot possibly be an alternative. I therefore have long been calling it “so-called alternative medicine” (SCAM). The definition I use for SCAM with lay audiences is simple: SCAM is an umbrella term for a diverse range of therapeutic and diagnostic methods that have little in common, other than being excluded from mainstream medicine.
2.Who uses it and why?
Predominantly women! Statistics say about 30-70% of the general population use SCAM. And with patient populations, the percentage can be close to 100%. They use it because they are told over and over again that SCAM is natural and thus safe, as well as effective for all sorts of conditions.
3.Focusing on terminology, is there a difference between «complementary» and «alternative» medicine?
Theoretically, there is a big difference between «complementary» and «alternative» medicine. The former is supposed to be used as an add-on to, while the latter is a replacement of mainstream medicine. In practice, this dividing line is very blurred; most SCAMs are used in both ways, depending on the actual situation and circumstance.
4.Are users different from non-users?
Yes, there has been much research on this and my reading of it is that SCAM users tend to be less intelligent, more religious, more superstitious, less trusting in science, and more prone to conspiracy theories, for instance.
5.Which forms of alternative medicine are the most popular?
There are certain national differences, but in most European countries herbal medicine, acupuncture, chiropractic, osteopathy, homeopathy, aromatherapy, and reflexology are amongst the most popular SCAMs.
6.Does it work?
With such a wide range – someone once counted over 400 modalities and my last book evaluated 202 of them (Alternative Medicine: A Critical Assessment of 202 Modalities (Copernicus Books): Amazon.co.uk: Ernst, Edzard: 9783031107092: Books) – it is impossible to answer with yes or no. In addition we need to consider the conditions that are being treated. Acupuncture, for example, is touted as a panacea, but might just work for pain. If you take all this into account, I estimate that less than 3% of the therapeutic claims that are being made for SCAM are supported by sound evidence.
Is it safe?
Again, impossible to say. Some treatments are outright dangerous; for instance, chiropractic neck manipulations can injure an artery and the patient suffers a stroke of which she can even die. Other treatments are assumed to be entirely harmless; for example homeopathy. But even that is untrue: if a cancer patient relies exclusively on homeopathy for a cure, she might easily hasten her death. Sadly, such things happen not even rarely.
Do its benefits outweigh its risks?
That depends very much on the treatment, the disease, and the precise situation. Generally speaking, there are very few SCAMs that fulfill this condition.
You said that these were the research questions that occupied all your life in Exeter. Did you find the answers?
We published more on SCAM than any other research group, and we found mostly disappointing answers. But still, I am proud of having found at least some of the most pressing answers. Even negative answers can make an important contribution to our knowledge.
7.What is the problem with the placebo effect?
All therapies can prompt a placebo effect. Thus an ineffective treatment can easily appear to be effective through generating a placebo effect. This is why we need to rely on properly conducted, if possible placebo-controlled trials, if we want to know what works and what not.
8.Is it true that some alternative medicines can cause significant harm?
see above
9.What about herbal remedies? What do studies show about them?
Many of our modern drugs originate from plants, Therefore, it is not surprising that we find herbal remedies that are effective. But careful! This also means that plants can kill you – think of hemlock, for instance. In addition herbal medicine can interact powerfully with synthetic drugs. So, it is wise to be cautious and get responsible advice.
10.Which alternative therapies are overrated and why?
In my view, almost all SCAMs are over-rated. If you go on the Internet, you find ~5 000 000 websites on SCAM. 99% of them try to sell you something and are unreliable or even dangerous. We need to be aware of the fact that SCAM has grown into a huge business and many entrepreneurs are out to get your money based on bogus claims.
11.On the contrary, which therapies could be seen as an integration in routine care?
The best evidence can be found in the realm of herbal medicine, for instance St John’s Wort. Some mind-body interventions can be helpful; also a few massage techniques might be worth a try. Not a lot, I’m afraid.
12.Would you tell us what happened in 2005 with Prince Charles?
He complained about my actions via his private secretary to my University. A 13 month investigation followed. At the end, I was found not guilty but my funding, my team, my infrastructure had been dismantled. So, in effect, Charles managed to close down what was the only research group that looked critically and systematically into SCAM. A sad story – not so much for me but for progress and science, I think.
3.Why is alternative medicine still a controversial subject?
Mainly because the gap between the claims and the evidence is so very wide – and getting wider all the time.
14.Would you suggest the «right way» to approach it?
I often recommend this: if it sounds too good to be true, it probably is! I might add that, if you want reliable advice, don’t listen to those who profit from giving it.
We have discussed the homeopathic obscession with bovine mastitis before. For instance, we have looked at this systematic review which did exactly that. Its authors are highly respected and come from institutions that are not likely to promote bogus claims:
- Département de Sciences Cliniques, Faculté de Médecine Vétérinaire, Université de Montréal, Canada
- Département de Sciences Cliniques, Faculté de Médecine Vétérinaire, Université de Montréal, Canada
- Canadian Bovine Mastitis and Milk Quality Research Network, Canada
- Canadian Bovine Mastitis and Milk Quality Research Network, Canada
- Sherbrooke Research and Development Centre, Agriculture and Agri-Food Canada
- Canadian Bovine Mastitis and Milk Quality Research Network, Canada
- Département de Pathologie et Microbiologie, Faculté de Médecine Vétérinaire, Université de Montreal, Canada.
A total of 2,451 manuscripts were first identified and 39 manuscripts corresponding to 41 studies were included. Among these, 22 were clinical trials, 18 were experimental studies, and one was an observational study. The treatments evaluated were conventional anti-inflammatory drugs (n = 14), oxytocin with or without frequent milk out (n = 5), biologics (n = 9), homeopathy (n = 5), botanicals (n = 4), probiotics (n = 2), and other alternative products (n = 2). All trials had at least one unclear or high risk of bias. Most trials (n = 13) did not observe significant differences in clinical or bacteriological cure rates in comparison with negative or positive controls. Few studies evaluated the effect of treatment on milk yield. In general, the power of the different studies was very low, thus precluding conclusions on non-inferiority or non-superiority of the treatments investigated. No evidence-based recommendations could be given for the use of an alternative or non-antimicrobial conventional treatment for clinical mastitis. The authors concluded that homeopathic treatments are not efficient for management of clinical mastitis.
Did this finally stop homeopaths from claiming that their placebos work for mastitis?
I would not count on it!
Will it stop homeopaths to conduct trials of the subject?
No!
Recently a new study has emerged. Its aim was to assess the potential of a novel homeopathic complex medicine in managing bovine mastitis. Twenty-four lactating Holstein cows with mastitis were divided into two groups: the homeopathic complex group received a homeopathic complex daily for 60 days at a dose of 20 g/d; the placebo group received the calcium carbonate vehicle without homeopathic medicines at the same dose and repetition. The main outcome measure was somatic cell count (SCC; cells/mL), with additional outcome measures including milk production (kg/d), milk constituents (percentage of protein, fat, lactose and total milk solids), and serum levels of cortisol, glucose, ammonia and lactic acid. All outcomes were measured at the beginning of the study and after 30 and 60 days. Milk samples were also collected from all animals at the beginning of the study, confirming a high (>0.2) MAR index for isolated bacterial cultures.
Assessment of SCC showed a statistically significant difference favoring the homeopathic complex versus placebo group at day 60. A reduction in serum cortisol levels and an increase in fat, lactose and total milk solids in animals treated with the homeopathic complex at day 60 were also seen. Other outcome measures did not show statistically significant inter-group differences.
The authors from the Paranaense University-Praça Mascarenhas de Moraes, Umuarama, Paraná, Brazil, concluded that the results of this non-randomized, open-label, placebo-controlled trial suggest the potential for a novel homeopathic complex medicine in management of multiple antibiotic-resistant bovine mastitis, thus offering dairy farmers an additional option to antibiotics and making dairy products safer for consumer health and milk production more sustainable.
Here are just some of the most obvious points of concern:
- The trial was supported by the manufacturer of the homeopathic product, yet the authors declare no conflicts of interest.
- The exact nature of the product remains unknown to anyone like me who tried to obtain the information by searching the websites of the manufacturer, etc.
- The trial was non-ramdomized and open label, i.e. wide open to bias, yet the authors do not shy away from drawing firm conclusions.
- There is no plausible rationale for homeopathy in this (or any other) indication.
- Homeopathy for animals contradicts the gospel of Hahnemann, its inventor.
- Overwhelmingly, the evidence fails to show that homeopathy is effective for bovine mastitis.
I do understand that manufacturers smell a lucrative market, but I still think that, for serious veterianarians, scientists, journal editors, etc., the subject should be closed.
Much of the discussions on this blog are directly or indirectly related to the subject of research integrity. Research integrity refers to the ethical and professional standards that researchers must adhere to while conducting research. It involves conducting research in a way that allows others to have confidence and trust in the methods and findings of the research. Research integrity includes honesty, rigour, transparency, open communication, care and respect for all participants, and accountability. According to the ‘Concordat To Support Research Integrity‘, the core elements of research integrity are:
- Honesty in all aspects of research, including in the presentation of research goals, intentions and findings; in reporting on research methods and procedures; in gathering data; in using and acknowledging the work of other researchers; and in conveying valid interpretations and making justifiable claims based on research findings.
- Rigour, in line with prevailing disciplinary norms and standards, and in performing research and using appropriate methods; in adhering to an agreed protocol where appropriate; in drawing interpretations and conclusions from the research; and in communicating the results.
- Transparency and open communication in declaring potential competing interests in the reporting of research data collection methods; in the analysis and interpretation of data; in making research findings widely available, which includes publishing or otherwise sharing negative or null results to recognise their value as part of the research process; and in presenting the work to other researchers and to the public.
- Care and respect for all participants in research, and for the subjects, users and beneficiaries of research, including humans, animals, the environment and cultural objects. Those engaged with research must also show care and respect for the integrity of the research record.
- Accountability of funders, employers and researchers to collectively create a research environment in which individuals and organisations are empowered and enabled to own the research process. Those engaged with research must also ensure that individuals and organisations are held to account when behaviour falls short of the standards set by this concordat.
These points apply to all types and aspects of research and to all individuals involved in it. Obviously, they apply also to research of so-called alternative medicine (SCAM). I will therefore briefly discuss each point in respect of SCAM research.
Ad 1
Honesty in research is an important ethical prerequisite. In SCAM, we regularly see that the honesty seems to be in short supply. There are many ways in which lack of honesty shows itself. For me, the most impressive one is when SCAM researchers disclose – as they often do – that their aim is to demostrate that their assumptions/theories/hypotheses are correct. In such cases, they abuse the tools of science which are not for confirming hypotheses but for testing, i.e. trying to falsifying them. This blog offers plenty of examples for this phenomenon (e.g. here or here)
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The lack of rigor in much of SCAM research is legend and has become a constant theme on this blog. How often have we seen useless and unnecessary observational studies or pilot studies on subjects where controlled trials already exist? How often have we lamented over misinterpretation of a study’s findings? How often have we reported research that was ill-conceived from the outset, unable to answer any meaningful research question? My all time favourite examples of drawing a wrong conclusions are from the area of homeopathy, e.g. here and here.
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Much of SCAM research is being conducted by SCAM enthusiasts who have no qualitification or experience in research or science. Inevitably, this must lead to bias. Just think of the fact that some countries, e.g. China, or some SCAM journals, or some SCAM researchers (e.g. THE ALTERNATIVE MEDICINE HALL OF FAME) publish as good as no negative findings
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Lack of respect for research subjects has many guises. For instance, if clinical trials are being conducted of treatments that are utterly implausible. This, in my view, constitutes an abuse of the willingness of volunteers to make a contribution to research. Another example is the incessant flow of untrustworthy research by SCAM enthusiasts which eventually can only erode the public’s trust in research and is bound to render the essential cooperation of researchers and volunteers more and more problematic.
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When I think of accountability, I think yet again of the men and women in my ALTERNATIVE MEDICINE HALL OF FAME. As any of its members ever been held accountable for misleading the public through their pseudo-research? Sadly, the answer, as far as I know, is NO.
