bogus claims
Remember the Bavarian Homeopathy Study? I reported about it only a few days ago. Now the ‘German Homeopathic Doctors Association’ has published an interview with someone who allegedly knows more about it. Here is my translation:
Dr. Springer, what does it actually mean politically that this study came about at all?
First of all, it means that the work of several years was worthwhile and that we were able to convince those responsible with a carefully elaborated study design. It also shows how enormously important it is to have solid political contacts with parties, MPs, parliamentary groups, and spokespersons in health committees. In addition to persuasion, personal credibility and professional competence are indispensable for the growth of such contacts. This is also shown by the fact that LIMed (List of Integrative Medicine) in Bavaria (as in some other federal states) has succeeded in sending committed colleagues to the representations of the State Medical Association and the Medical District and County Association.
What is special about this study?
As far as I know, it is the first study worldwide to be carried out with hand-shaken high potencies (C 200 and C 1000). If the results were positive, the mechanism of action of homeopathy would not be clarified, but it would be proven that highly potentised medicinal substances have a healing effect that can be objectified scientifically.
Who is the sponsor of this study?
The Bavarian Parliament voted with an absolute majority to scientifically investigate the role of complementary medicine in the fight against increasing antibiotic resistance. Several study designs were submitted on this question, and our study approach won the bid in the end. The Bavarian State Ministry of Health and Care is financing the study and has won the Technical University of Munich as a partner – after all, it is one of Germany’s universities of excellence. This removes all doubts about the correct scientific conduct of the study.
What is to be investigated in the study?
It relates to a diagnosis with great relevance to healthcare: Women often suffer from recurrent urinary tract infections, which are often treated with antibiotics. This is always associated with the risk of causative bacteria developing resistance to antibiotics. As homeopathically qualified doctors, we know from decades of experience that we can reduce and even end the frequency of recurrent urinary tract infections and their occurrence with our homeopathic remedies. We want to put this experience to the test scientifically with this study.
How do you see the chances for a positive study result?
As doctors, we know what we do and what we can do. We will do everything in our power to show that we can do it! I would also like to take this opportunity to thank all those who have made this study possible and who are providing us with professional and scientific support!-
The interview was conducted by Ulf Riker, MD.
___________________________
The interview raises several questions:
- Dr. Springer confirms that the existence of the study and its financial support is mostly due to political influence. Is this how good science should be generated?
- Is it true that the study is the first to investigate potency homeopathy? Considering that the bestselling homeopathic, Oscillococcinum, is sold in the C200 potency, this seems to be a very questionable statement.
- If the results were to come out positive, would we really re-write the textbooks of physics and chemistry which state that the absence of an active molecule cannot have an effect?
- Does the involvement of the Technical University truly remove all doubts about the correct scientific conduct of the study?
- If the homeopathically qualified doctors conducting the study already claim to know from decades of experience that they can reduce and even end the frequency of recurrent urinary tract infections with homeopathic remedies, are they not going to be too biased in conducting such a study?
- If the trialists are determined to do everything in their power to show that homeopathy works, will the study generate a reliable result?
- My last question is, how reliable is Dr. Springer? I found another interview of him dated 2021. In it he stated about the homeopathic treatment of COVID patients: ” [There is a} group of Covid-19 patients … [to] whose successful treatment we as homeopathic physicians can certainly contribute. The symptomatology of these patients is considerable, sometimes severe, but not life-threatening. They suffer from headaches and pain in the limbs, dizziness, fever, have the often-quoted “dry cough”, sweat, and usually feel very weak. But they have not yet developed clinical symptoms of pneumonia. These patients – and they are by no means few – can be helped by medical homeopathy, I am firmly convinced, curatively. Provided, of course, that a very precise, individual homeopathic anamnesis is carried out, the patient is closely followed, the course of the disease is closely observed and the remedy administered is adjusted if necessary. By preventing an acute condition and hospitalization in these patients homeopathy could make a not inconsiderable contribution to overcoming these greatest health and social challenges in one hundred years.” That, I think might answer my question.
As I pointed out before, the study design looks rigorous. After reading this interview, I have my doubts that its execution will be rigorous as well.
I recently came across a truly baffling article. As it is in German, I translated it for you:
Supply shortages have kept pharmacies on tenterhooks for months, with more than 400 common medicines missing. The German Central Association of Homeopathic Doctors (DZVhÄ) suggests switching to alternative medicine as a solution: “We have homeopathic medicines that have been tried and tested in practice for more than 200 years and can replace many medicines that are currently not available,” says the president of the DZVhÄ , Dr Michaela Geiger.
The DZVhÄ is convinced that homeopathic medical practices can replace fever-reducing medicines, but in many cases also antibiotics and much more. However, Geiger qualifies: “Due to our medical training, we also know that cancer drugs such as the often cited Tamoxifen cannot be replaced by homeopathy”.
The homeopathic doctors respond directly to the sharpest argument of their critics: “But let’s assume that homeopathy only works via the placebo effect, as is being rumored, even then it would be an option, especially if other options are lacking,” says DZVhÄ vice-president Dr. Ulf Riker. Since homeopathically trained doctors can judge the general course of a disease, they can also distinguish a placebo effect from a medicinal effect.
…
If fever medication for children is lacking, parents should not be deprived of another “therapy option”, Riker said. “If you do not get your conventional fever medication in the coming weeks, visit a specialist pharmacy for naturopathy and homeopathy. If you are due for a medical consultation, experienced homeopathic doctors can prescribe a suitable homeopathic medicine for you,” he says.
Why do I find this so intriguing?
Essentially, what we have learned from the article is the following:
- “Tried and tested in practice for more than 200 years” is ‘homeopathy speak’ for “effective”, even if the evidence tells us otherwise.
- Homeopathic remedies can replace many evidence-based conventional medications such as fever-reducing medicines, antibiotics, and much more, even if the evidence tells us otherwise.
- Homeopaths know that cancer drugs cannot be replaced by homeopathy – except for those homeopaths who seem to have forgotten this simple lesson.
- Homeopathic placebos are a realistic option when there is a supply problem with effective drugs, even if the evidence tells us otherwise.
- Homeopathically trained doctors can distinguish a placebo effect from a medicinal effect, even if there is no evidence that any clinician can reliably do this.
- Homeopathic doctors prescribe suitable homeopathic medicine. Suitable for whom? As it is ineffective, it is unsuitable for the patient. Therefore, Riker is probably talking about the homeopath.
So, what have we really learned from this article? I don’t know about you, but I got the impression that the president and the vice president of the DZVhÄ do not seem to mind putting patients in danger, as long as they can promote homeopathy.
Wellness seems to be everywhere these days – I mean of course the term, not the state or condition. On Medline, we find in excess of 500 000 articles on wellness, just for the year 2022! Wellness is en vogue, sexy, politically correct, etc. It looks good to talk and write about it. Most importantly it is good business. A report by the Global Wellness Institute stated that in 2020 the wellness industry was valued at $4.5 trillion and continues to grow at a frightening rate.
Having studied some of the recent literature on the subject, I get the impression that, for many, wellness is foremost an excuse for waffling utter nonsense. Let me, therefore, today ask just 5 simple questions about wellness that are likely to reduce the wellness of the ‘wellness brigade’:
1.What is wellness?
It is quite evidently a sector that is unable to define itself. Here are just a few of the definitions that have been suggested. Wellness is:
- the active pursuit of activities, choices and lifestyles that lead to a state of holistic health
- the result of personal initiative, seeking a more optimal, holistic and balanced state of health and well-being across multiple dimensions
- an active process of becoming aware of and making choices towards a healthy and fulfilling life
- the state of being in good health, especially as an actively pursued goal
- a state beyond absence of illness but rather aims to optimize well-being
- the act of practicing healthy habits on a daily basis to attain better physical and mental health outcomes
- an active process through which people become aware of, and make choices toward, a more successful existence
- the optimal state of health of individuals and groups
A 2018 review revealed that there is a lack of a uniform definition of wellness and showed that there is insufficient evidence to support the clinical utility of a single particular wellness instrument.
2. How do we measure wellness?
The short answer to this question is: nobody is quite sure. There simply is no generally accepted, well-validated measure. A few domains come to mind:
- physical functioning,
- somatic symptoms, e.g. pain,
- psychological symptoms,
- social functioning,
- needs and satisfaction.
But there is no simple means to quantify wellness. If you think that I am exaggerating, consider this recent review: 79 mental wellness instruments were identified. Most studies did not provide a definition for mental wellness. We identified thirteen mental wellness concepts from 97 studies, namely: life satisfaction, mental wellbeing [general], resilience, self-efficacy, self- esteem, connectedness, coping, self-control, mindfulness/spiritual, hope, sense of coherence, happiness, and life purpose.
3. What affects wellness?
The short answer is: potentially everything. My very own wellness, for instance, deteriorates sharply, if I have to read yet another nonsensical article about it.
4. Which interventions improve wellness?
As we have seen in my previous post, this is where so-called alternative medicine (SCAM) comes in. Since there is no measure to quantify wellness, we just have to take the word of SCAM proponents for it: SCAM improves wellness!!!
It’s obvious!
Which specific SCAM?
Can I see the evidence?
Sorry, no questions allowed!
And if you dare to insist on evidence, the ‘wellness brigade’ would just give you a pitiful smile and say: wellness has to be experienced, not measured.
5. Are there risks?
Yes, of course! Here are just some of them:
- The treatments advocated for wellness almost invariably cost money.
- The treatments advocated for wellness almost invariably cause direct and indirect harm, as discussed in many of my previous posts.
- Wellness treatments tend to give the impression that one can buy wellness like an expensive piece of clothing without putting in any real effort oneself.
Considering all this, I’d like to offer my very own definition of the sector:
Wellness is a fashionable paradise for charlatans in which they are protected from scientific scrutiny and feel at liberty to bullshit to their hearts’ content.
Drip IV is “Australia’s first and leading mobile healthcare company specialising in assisting with nutritional deficiencies”. They claim to provide a mobile IV service that is prescribed and tailored individually to your nutritional needs. Treatment plans and customised infusions are determined by a medical team to suit individual requirements. They deliver vitamins, minerals and amino acids directly to the body via the bloodstream, a method they state allows for optimal bioavailability.
These claims are a little puzzling to me, not least because vitamins, minerals and amino acids tailored individually to the nutritional needs of the vast majority of people would mean administering nothing at all. But I guess that virtually every person who consults the service will get an infusion [and pay dearly for it].
The Australian Therapeutic Goods Administration (TGA) seems to have a similarly dim view on Drip IV. The TGA has just issued 20 infringement notices totalling $159,840 to the company and to one of its executive officers. The reason: unlawful advertising of intravenous infusion products to Australian consumers on a company website and social media. Ten notices totalling $133,200 were issued to the company and ten notices totalling $26,640 were issued to an executive officer. The TGA considers the intravenous infusion products to be therapeutic goods because of the claims made about them, and the advertising to be unlawful because the advertisements allegedly:
- contained prohibited representations, such as claims regarding cancer.
- contained restricted representations such as that the products would alleviate fatigue caused by COVID-19, assist in the treatment of Graves’ Disease and Alzheimer’s Disease, and support the treatment of autoimmune diseases such as Multiple Sclerosis. No TGA approval had been given to make such claims.
- referred to ingredients that are prescription only, such as glutathione. Prescription medicines cannot be advertised directly to the public in Australia.
- contained a statement or picture suggesting or implying the products were ‘TGA Approved’. Advertising of therapeutic goods cannot include a government endorsement.
- contained a statement or picture expressing that the goods were ‘miraculous’.
Vitamin infusions have become very popular around the globe. There are now thousands of clinics offering this service, and many of them advertise aggressively with claims that are questionable. Here is just one example from the UK:
Modern life is hectic. If you are looking to boost your wellbeing, increase your energy levels, lift your mood and hydrate your body, Vitamin IV Infusions are ideal. Favoured by celebrities such as Madonna, Simon Cowell and Rihanna, Vitamin IV Infusions are an easy, effective way of delivering vitamins, minerals and amino acids directly into your bloodstream via an IV (intravenous) drip. Vitamins are essential for normal growth and staying healthy – but our bodies can’t produce all of the nutrients we need to function and thrive. That’s why more than one in three people take daily vitamin supplements – often without realising that only 15% of the active nutrients consumed orally actually find their way into their bloodstream. With Vitamin IV Infusions, the nutrients enter your bloodstream directly and immediately, and are delivered straight to your cells. We offer four different Vitamin IV Infusions, so you can choose the best combination for your personal needs, while boosting your general health, energy and wellbeing.
My advice to consumers is a little different and considerably less costly:
- to ensure you get enough vitamins, minerals, and amino acids, eat a balanced diet;
- to boost your well-being, sit down and calculate the savings you made by NOT using such a service;
- to increase your energy levels, take a nap;
- to lift your mood, recount the money you saved and think of what nice things you might buy with it;
- to hydrate your body drink a glass of water.
Perhaps it is time the authorities in all countries had a look at what these clinics are offering and what health claims they are making. Perhaps it is time they act as the TGA just did.
If you think that scanning through dozens of new scientific articles every week is a dry and often somewhat tedious exercise, you are probably correct. But every now and then, this task is turned into prime entertainment by some pseudoscientists trying to pretend to be scientists. Take, for instance, the latest homeopathy study by Indian researchers with no less than 9 seemingly impressive affiliations:
- 1Department of Organon of Medicine and Homoeopathic Philosophy, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Salt Lake, Kolkata, West Bengal, India.
- 2Department of Organon of Medicine and Homoeopathic Philosophy, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Block GE, Sector III, Salt Lake, Kolkata, West Bengal, India.
- 3Department of Homoeopathy, State Homoeopathic Dispensary, Karaila, Pratapgarh, Uttar Pradesh, India.
- 4Department of Homoeopathy, State Homoeopathic Dispensary, Tulsipur, Shrawasti, Uttar Pradesh, India.
- 5Department of Materia Medica, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Salt Lake, Kolkata, West Bengal, India.
- 6State Homoeopathic Dispensary, Mangalbari Rural Hospital, Matiali Block, Jalpaiguri, West Bengal, under Department of Health & Family Welfare, Govt. of West Bengal, India.
- 7Department of Repertory, The Calcutta Homoeopathic Medical College and Hospital, Govt. of West Bengal, Kolkata, West Bengal, India.
- 8Department of Homoeopathy, East Bishnupur State Homoeopathic Dispensary, Chandi Daulatabad Block Primary Health Centre, Village and Post Office: Gouripur (South), Police Station Bishnupur, West Bengal, under Department of Health & Family Welfare, Govt. of West Bengal, India.
- 9Department of Repertory, D. N. De Homoeopathic Medical College and Hospital, Govt. of West Bengal, Tangra, Kolkata, West Bengal, India.
Now that I have whetted your appetite, here is their study:
Lumbar spondylosis (LS) is a degenerative disorder of the lumbar spine. Despite substantial research efforts, no gold-standard treatment for LS has been identified. The efficacy of individualized homeopathic medicines (IHMs) in lumbar spondylosis (LS) is unknown. In this double-blind, randomized, placebo-controlled trial, the efficacy of IHMs was compared with identical-looking placebos in the treatment of low back pain associated with LS. It was conducted at the National Institute of Homoeopathy, West Bengal, India.
Patients were randomized to receive IHMs or placebos; standardized concomitant care was administered in both groups. The Oswestry low back pain and disability questionnaire (ODQ) was used as the primary outcome measure; the Roland-Morris questionnaire (RMQ) and the short form of the McGill pain questionnaire (SF-MPQ) served as secondary outcome measures. They were measured at baseline and every month for 3 months. Intention-to-treat analyses (ITT) were used to detect any inter-group differences using two-way repeated measures analysis of variance models overall and by unpaired t-tests at different time points.
Enrolment was stopped prematurely because of time restrictions; 55 patients had been randomized (verum: 28; control: 27); 49 could be analyzed by ITT (verum: 26; control: 23).
The results are as follows:
- Inter-group differences in ODQ (F 1, 47 = 0.001, p = 0.977), RMQ (F 1, 47 = 0.190, p = 0.665) and SF-MPQ total score (F 1, 47 = 3.183, p = 0.081) at 3 months were not statistically significant.
- SF-MPQ total score after 2 months (p = 0.030) revealed an inter-group statistical significance, favoring IHMs against placebos.
- Some of the SF-MPQ sub-scales at different time points were also statistically significant: e.g., the SF-MPQ average pain score after 2 months (p = 0.002) and 3 months (p = 0.007).
- Rhus Toxicodendron, Sulphur, and Pulsatilla nigricans were the most frequently indicated medicines.
The authors concluded that owing to failure in detecting a statistically significant effect for the primary outcome and in recruiting a sufficient number of participants, our trial remained inconclusive.
Now that I (and hopefully you too) have recovered from laughing out loud, let me point out why this paper had me in stitches:
- The trial was aborted not because of a “time limit” but because of slow recruitment, I presume. The question is why were not more patients volunteering? Low back pain with LS is extremely common. Could it be that patients know only too well that homeopathy does not help with low back pain?
- If a trial gets aborted because of very low patient numbers, it is probably best not to publish it or at least not to evaluate its results at all.
- If the researchers insist on publishing it, their paper should focus on the reason why it did not succeed so that others can learn from their experience by avoiding their mistakes.
- However, once the researchers do run statistical tests, they should be honest and conclude clearly that, because the primary outcome measure showed no inter-group difference, the study failed to demonstrate that the treatment is effective.
- The trial did not “remain inconclusive”; it was squarely negative.
- The editor of the journal HOMEOPATHY should know better than to publish such nonsense.
A final thought: is it perhaps the ultimate proof of homeopathy’s ‘like cures like’ assumption to use sound science (i.e. an RCT), submit it to the homeopathic process of endless dilutions and succussions, and – BINGO – generate utter nonsense?
Migraines are common headache disorders and risk factors for subsequent strokes. Acupuncture has been widely used in the treatment of migraines; however, few studies have examined whether its use reduces the risk of strokes in migraineurs. This study explored the long-term effects of acupuncture treatment on stroke risk in migraineurs using national real-world data.
A team of Taiwanese researchers collected new migraine patients from the Taiwan National Health Insurance Research Database (NHIRD) from 1 January 2000 to 31 December 2017. Using 1:1 propensity-score matching, they assigned patients to either an acupuncture or non-acupuncture cohort and followed up until the end of 2018. The incidence of stroke in the two cohorts was compared using the Cox proportional hazards regression analysis. Each cohort was composed of 1354 newly diagnosed migraineurs with similar baseline characteristics. Compared with the non-acupuncture cohort, the acupuncture cohort had a significantly reduced risk of stroke (adjusted hazard ratio, 0.4; 95% confidence interval, 0.35–0.46). The Kaplan–Meier model showed a significantly lower cumulative incidence of stroke in migraine patients who received acupuncture during the 19-year follow-up (log-rank test, p < 0.001).
The authors concluded that acupuncture confers protective benefits on migraineurs by reducing the risk of stroke. Our results provide new insights for clinicians and public health experts.
After merely 10 minutes of critical analysis, ‘real-world data’ turn out to be real-bias data, I am afraid.
The first question to ask is, were the groups at all comparable? The answer is, NO; the acupuncture group had
- more young individuals;
- fewer laborers;
- fewer wealthy people;
- fewer people with coronary heart disease;
- fewer individuals with chronic kidney disease;
- fewer people with mental disorders;
- more individuals taking multiple medications.
And that are just the variables that were known to the researcher! There will be dozens that are unknown but might nevertheless impact on a stroke prognosis.
But let’s not be petty and let’s forget (for a minute) about all these inequalities that render the two groups difficult to compare. The potentially more important flaw in this study lies elsewhere.
Imagine a group of people who receive some extra medical attention – such as acupuncture – over a long period of time, administered by a kind and caring therapist; imagine you were one of them. Don’t you think that it is likely that, compared to other people who do not receive this attention, you might feel encouraged to look better after your health? Consequently, you might do more exercise, eat more healthily, smoke less, etc., etc. As a result of such behavioral changes, you would be less likely to suffer a stroke, never mind the acupuncture.
SIMPLE!
I am not saying that such studies are totally useless. What often renders them worthless or even dangerous is the fact that the authors are not more self-critical and don’t draw more cautious conclusions. In the present case, already the title of the article says it all:
Acupuncture Is Effective at Reducing the Risk of Stroke in Patients with Migraines: A Real-World, Large-Scale Cohort Study with 19-Years of Follow-Up
My advice to researchers of so-called alternative medicine (SCAM) and journal editors publishing their papers is this: get your act together, learn about the pitfalls of flawed science (most of my books might assist you in this process), and stop misleading the public. Do it sooner rather than later!
About a century ago, Royal Raymond Rife developed special microscopes and claimed he could visualize living microorganisms, including viruses too small to be seen with any other existing technology, via the color of auras emitted as they vibrated. In 1961, he explained this as follows: “A special risley prism which works on a counter rotation principle selects a portion of the light frequency which illuminates these viruses in their own characteristic chemical colors by emission of coordinative light frequency and the viruses become readily identifiable by the colors revealed on observation.”. The principles and alleged function of these microscopes have never been validated, and they have never been adopted for use.
Rife went on to postulate that the microorganisms he was seeing were involved in human diseases, including cancer . He also invented a machine that he claimed could transmit radio frequency energy into a person and vibrate these microorganisms at a “mortal oscillatory rate”, thereby killing them and improving the disease they were causing. The concept that diseases can be cured by radio frequency energy, originally proposed by Albert Abrams and referred to as ‘radionics’, was later investigated and disproven. Nonetheless, there remain enthusiasts who believe in Rife’s work, claim it was suppressed as part of an elaborate conspiracy. and continue to sell energy-transmitting devices and cures.
Rife machines (also called a Rife frequency generator.) produce low electromagnetic energy waves. These waves are similar to radio waves. Supporters of the treatment claim that the Rife machine can treat different conditions including cancer. There is no reliable evidence that the Rife machine works as a cure for cancer.
The Rife machine produces low-energy waves, also called radiofrequency electromagnetic fields. They have low energy compared to x-rays or radiotherapy.
Here is what proponents of the Rife therapy say:
… Although no official health claims are made for Rife therapy, testimonials from many countries point to its efficacy in the support of the body in maintaining or regaining good, natural health. A good Rife machine normally contains all of the original Royal Rife frequencies plus others that have been researched and utilised over the years.
WHAT IS THE PROCEDURE?
In most Rife sessions the client is seated. They have their feet on footplate electrodes and in their lap they hold in their hands plasma tubes. Thus they get the frequencies in normal form through the feet and in radio wave form through their hands. There are variations on this but this is the basic set up.
Some practitioners will occasionally employ something called a Beam Ray Tube. This is essentially a large plasma tube on a stand that plugs into the machine. The client just sits in front of it, about 3 feet away, while the frequencies are generated. In this instance the client does not have to hold anything or have their feet on footplates.
HOW LONG DO SESSIONS LAST?
The length of a session varies, depending on what is being addressed. Any session would be a minimum of 30 minutes but in serious or chronic conditions can last over 2 hours, occasionally more. However, clients can take breaks during the therapy.
HOW FREQUENT ARE TREATMENTS?
Once a week or once a fortnight is a common pattern of treatments. But in the case of more frequent sessions a minimum of 48 hours should be left between therapy. The duration of treatments varies on the condition being addressed. Sometimes it’s just a few visits…for conditions like Lyme Disease the treatments are ongoing for well over a year. The practitioner will answer your specific questions on this.
There are also frequencies to support regeneration and boost functions such as the immune system, the adrenals and several others.
ARE THERE ANY CONTRAINDICATIONS?
Rife therapy is not suitable for people with pacemakers or similar devices. It should not be given to children under 4 years of age. If a client is undergoing radiotherapy or frequency therapy for kidney stones etc there should should be no Rife sessions administered during these periods.
The day after some sessions a client may occasionally get a Herxheimer’s reaction. This is a feeling of tiredness, almost as if one is about to go down with flu. It was named after Dr Herxheimer who, along with one other doctor, discovered that when the liver and kidneys etc get overworked in disposing of waste products, this phenomena happens. The answer is just to drink lots of fluid to help the body dispose of the cells or toxins that have been eliminated by the Rife session. The day after that, the client is back to normal and usually feeling better than before the session.
I think that such promotional texts could and should be much shorter, more truthful, and hugely more informative, e.g.:
Rife therapy is not biologically plausible, has never been shown to be effective for any condition, might have adverse effects, and is not cheap. Therefore, we have a responsibility to warn consumers and patients not to use it.
In this study, the impact of a multimodal integrative oncology pre- and intraoperative intervention on pain and anxiety among patients undergoing gynecological oncology surgery was explored.
Study participants were randomized into three groups:
- Group A received preoperative touch/relaxation techniques, followed by intraoperative acupuncture, plus standard care;
- Group B received preoperative touch/relaxation only, plus standard care;
- Group C (the control group) received standard care.
Pain and anxiety were scored before and after surgery using the Measure Yourself Concerns and Wellbeing (MYCAW) and Quality of Recovery (QOR-15) questionnaires, using Part B of the QOR to assess pain, anxiety, and other quality-of-life parameters.
A total of 99 patients participated in the study: 45 in Group A, 25 in Group B, and 29 in Group C. The three groups had similar baseline demographic and surgery-related characteristics. Postoperative QOR-Part B scores were significantly higher in the treatment groups (A and B) when compared with controls (p = .005), including for severe pain (p = .011) and anxiety (p = .007). Between-group improvement for severe pain was observed in Group A compared with controls (p = .011). Within-group improvement for QOR depression subscales was observed in only the intervention groups (p <0.0001). Compared with Group B, Group A had better improvement of MYCAW-reported concerns (p = .025).
The authors concluded that a preoperative touch/relaxation intervention may significantly reduce postoperative anxiety, possibly depression, in patients undergoing gynecological oncology surgery. The addition of intraoperative acupuncture significantly reduced severe pain when compared with controls. Further research is needed to confirm these findings and better understand the impact of intraoperative acupuncture on postoperative pain.
Regular readers of my blog know only too well what I am going to say about this study.
Imagine you have a basket full of apples and your friend has the same plus a basket full of pears. Who do you think has more fruit?
Dumb question, you say?
Correct!
Just as dumb, it seems, as this study: therapy A and therapy B will always generate better outcomes than therapy B alone. But that does not mean that therapy A per se is effective. Because therapy A generates a placebo effect, it might just be that it has no effect beyond placebo. And that acupuncture can generate placebo effects has been known for a very long time; to verify this we need no RCT.
As I have so often pointed out, the A+B versus B study design never generates a negative finding.
This is, I fear, precisely the reason why this design is so popular in so-called alternative medicine (SCAM)! It enables promoters of SCAM (who are not as dumb as the studies they conduct) to pretend they are scientists testing their therapies in rigorous RCTs.
The most disappointing thing about all this is perhaps that more and more top journals play along with this scheme to mislead the public!
Gut microbiota can influence health through the microbiota–gut–brain axis. Meditation can positively impact the regulation of an individual’s physical and mental health. However, few studies have investigated fecal microbiota following long-term (several years) deep meditation. Therefore, this study tested the hypothesis that long-term meditation may regulate gut microbiota homeostasis and, in turn, affect physical and mental health.
To examine the intestinal flora, 16S rRNA gene sequencing was performed on fecal samples of 56 Tibetan Buddhist monks and neighboring residents. Based on the sequencing data, linear discriminant analysis effect size (LEfSe) was employed to identify differential intestinal microbial communities between the two groups. Phylogenetic Investigation of Communities by Reconstruction of Unobserved States (PICRUSt) analysis was used to predict the function of fecal microbiota. In addition, we evaluated biochemical indices in the plasma.
The α-diversity indices of the meditation and control groups differed significantly. At the genus level, Prevotella and Bacteroides were significantly enriched in the meditation group. According to the LEfSe analysis, two beneficial bacterial genera (Megamonas and Faecalibacterium) were significantly enriched in the meditation group. The functional predictive analysis further showed that several pathways—including glycan biosynthesis, metabolism, and lipopolysaccharide biosynthesis—were significantly enriched in the meditation group. Moreover, plasma levels of clinical risk factors were significantly decreased in the meditation group, including total cholesterol and apolipoprotein B.
The Chinese authors concluded that the intestinal microbiota composition was significantly altered in Buddhist monks practicing long-term meditation compared with that in locally recruited control subjects. Bacteria enriched in the meditation group at the genus level had a positive effect on human physical and mental health. This altered intestinal microbiota composition could reduce the risk of anxiety and depression and improve immune function in the body. The biochemical marker profile indicates that meditation may reduce the risk of cardiovascular diseases in psychosomatic medicine. These results suggest that long-term deep meditation may have a beneficial effect on gut microbiota, enabling the body to maintain an optimal state of health. This study provides new clues regarding the role of long-term deep meditation in regulating human intestinal flora, which may play a positive role in psychosomatic conditions and well-being.
This study is being mentioned on the BBC new-bulletins today – so I thought I have a look at it and check how solid it is. The most obvious question to ask is whether the researchers compared comparable samples.
The investigators collected a total of 128 samples. Subsequently, samples whose subjects had taken antibiotics and yogurt or samples of poor quality were excluded, resulting in 56 eligible samples. To achieve mind training, Tibetan Buddhist monks performed meditation practices of Samatha and Vipassana for at least 2 hours a day for 3–30 years (mean (SD) 18.94 (7.56) years). Samatha is the Buddhist practice of calm abiding, which steadies and concentrates the mind by resting the individual’s attention on a single object or mantra. Vipassana is an insightful meditation practice that enables one to enquire into the true nature of all phenomena. Hardly any information about the controls was provided.
This means that dozens of factors other than meditation could very easily be responsible for the observed differences; nutrition and lifestyle factors are obvious prime candidates. The fact that the authors fail to even discuss these possibilities and more than once imply a causal link between meditation and the observed outcomes is more than a little irritating, in my view. In fact, it amounts to very poor science.
I am dismayed that a respected journal published such an obviously flawed study without a critical comment and that the UK media lapped it up so naively.
Brillia for Children is probably the most amazing homeopathic quackery I have ever encountered:
Uses: Enhance clarity, improve concentration of attention, reduce feelings of anxiety & stress, excitability, irritability and hyperactivity to improve attention, focus and mood regulation.
Active Ingredient: Lapine S-100 immune globulin mixture of homeopathic dilutions 12C, 30C and 50C.
Brillia is a unique combination of antibody science and homeopathic formulation. The active ingredient of Brillia is antibodies to the brain-specific S100 protein (S100B). This protein is an important regulator of many different intracellular and extracellular brain processes, e.g. various enzymes activities, calcium homeostasis, communication between neurons, etc. Since almost all mental and neurological diseases as well as temporal stress-induced conditions are accompanied by disturbance of the above-mentioned processes, especially communication between neurons, the normalization of these processes is considered to be a prospective way to treat people with such undesirable conditions. Brillia is an antibody conjugated to the S100B protein and does not alter the concentration of the S100B protein in the bloodstream. Brillia’s efficacy stems from its ability to regulate the activity of the S100B protein and does not alter its concentration. In order for a protein to have an effect in the body, it needs to bind to its target, such as an enzyme. Proteins have very specific conformations that ensure that only the correct protein binds to the correct target molecule. Once the protein correctly orients itself into the active site of the target molecule, this is when the protein causes an effect in the body. When Brillia binds to the S100B protein, the overall shape of the protein is altered, hindering its ability to bind to its target molecule and thereby controlling its activity in the body. In short, Brillia stops the S100B protein from acting in the body by changing its shape, consequently regulating levels of anxiety and hyperactivity.
PARENT TOOL | WATCH: DISCOVER BRILLIA
WATCH: WHY & HOW BRILLIA WORKS
Inactive Ingredients: Lactose monohydrate, magnesium stearate, microcrystalline cellulose. Does not contain artificial colors or artificial flavors.
Food Allergy Warning: This product contains lactose. Brillia is gluten free and nut free.
About active ingredients, the website tells us this:
Let’s start off with the active ingredient, registered with the FDA as Lapine S-100B immune globulin. Now we know this name can be intimidating, so we are going to break it down for you. Working backwards, “immune globulin” is just the “sciency” way of saying “antibody”, and don’t worry, we will get into what an antibody actually is in just a second. Next, “S-100B” is the name of the protein the antibody is designed to recognize in the body. Lastly, “Lapine” is just a descriptor of the origin of the antibody, just like the millions of other antibodies used each and every day in laboratories all across the world.
So, what exactly is an antibody? Antibodies are a naturally occurring protein and component of our immune system that are individually programmed to target a very specific protein, in the case of Brillia, the S-100B protein. It is important to understand that antibodies are one of the most specific and targeted molecules in our bodies, resulting in zero off-target effects — meaning that antibodies specifically look for and attach to their target only. This is why Brillia has no harmful side effects, because it only interacts with the S-100B protein. Not only does Brillia have absolutely zero side effects, it also has no contraindications with any other medications or supplements your child may be taking. This is due to Brillia’s extremely high level of target specificity, meaning that Brillia is so well targeted to the S-100B protein, it won’t even think about touching anything else in the body, including any other drugs or supplements.
Now that we know more about the active ingredient, let’s talk about its target, the S-100B protein.
The S-100B protein is a naturally occurring protein and is most prevalent in the brain. It is an important regulator of many processes such as regulating calcium levels and helping neurons communicate, but in our case, we care about how it influences the symptoms we mentioned earlier, such as anxiety and hyperactivity.
Given that S-100B protein influences these symptoms, it is quite intuitive that when the S-100B protein doesn’t do its job properly, these symptoms become more prevalent, and this is exactly what happens in those who suffer from anxiety, hyperactivity, stress and lack of focus.
So, what makes the S-100B protein, for a lack of a better term, mess up? The answer is quite simple, when the S-100B protein is overproduced or overactive, its activity becomes unnecessarily high, making it capable of causing these symptoms.
The firm even has something vaguely resembling evidence: a study that “shows that over the course of 12 weeks, Brillia had a significantly better effect on the severity of anxiety over those that did not take Brillia, therefore proving Brillia’s efficacy.” They show some actual results but the methods or source of the study are not disclosed. On Medline, I could not find it either. Therefore, I asked the firm to send it to me. This is the answer I got:
“Our studies were conducted in Europe and then published on our website. Please click here to view the full details found on our site.”
So, they have a study that they commissioned in Europe; it was done by researchers unnamed. The firm then put some data of it on their website. In other words:
- we don’t know who was responsible for the study;
- we cannot evaluate how rigorous it was;
- it has never been peer-reviewed;
- it is now being used for promotional purposes.
Personally, I don’t find this acceptable. In my view, this does not provide a legitimation to make far-reaching claims about the remedy. Until I have evidence to the contrary, I thus deem it safe to conclude that Brillia has no effect other than enriching the manufacturer.
