causation
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?
This prospective study aimed to identify an optimal lifestyle profile to protect against memory loss in older individuals from areas representative of the north, south, and west of China. Individuals aged 60 years or older who had normal cognition and underwent apolipoprotein E (APOE) genotyping at baseline in 2009 were included. Participants were followed up until death, discontinuation, or 26 December 2019.
Six lifestyle factors were assessed:
- a healthy diet (adherence to the recommended intake of at least 7 of 12 eligible food items),
- regular physical exercise (≥150 min of moderate intensity or ≥75 min of vigorous intensity, per week),
- active social contact (≥twice per week),
- active cognitive activity (≥twice per week),
- never or previously smoked,
- never drinking alcohol.
Participants were categorised into the favourable group if they had 4-6 healthy lifestyle factors, into the average group for two to three factors, and into the unfavourable group for zero to one factor.
Memory function was assessed using the World Health Organization/University of California-Los Angeles Auditory Verbal Learning Test, and global cognition was assessed via the Mini-Mental State Examination. Linear mixed models were used to explore the impact of lifestyle factors on memory in the study sample.
A total of 29 072 participants were included (mean age of 72.23 years; 48.54% (n=14 113) were women; and 20.43% (n=5939) were APOE ε4 carriers). Over the 10-year follow-up period (2009-19), participants in the favourable group had slower memory decline than those in the unfavourable group (by 0.028 points/year, 95% confidence interval 0.023 to 0.032, P<0.001). APOE ε4 carriers with favourable (0.027, 95% confidence interval 0.023 to 0.031) and average (0.014, 0.010 to 0.019) lifestyles exhibited a slower memory decline than those with unfavourable lifestyles. Among people who were not carriers of APOE ε4, similar results were observed among participants in the favourable (0.029 points/year, 95% confidence interval 0.019 to 0.039) and average (0.019, 0.011 to 0.027) groups compared with those in the unfavourable group. APOE ε4 status and lifestyle profiles did not show a significant interaction effect on memory decline (P=0.52).
The authors concluded that a healthy lifestyle is associated with slower memory decline, even in the presence of the APOE ε4 allele. This study might offer important information to protect older adults against memory decline.
This is an important and meticulously reported study. It is the first large-scale investigation that assesses the effects of different lifestyle profiles, APOE ε4 status, and their interactions on longitudinal memory trajectories over a 10-year follow-up period. The results show that lifestyle is associated with the rate of memory decline in cognitively normal older individuals, including in people who are genetically susceptible to memory decline. The authors are rightly careful to avoid causal inferences between lifestyle and memory decline. To demonstrate causality beyond doubt, we would need different study designs.
The authors also discuss several weaknesses of the study:
- Firstly, the assessments of lifestyle factors were based on self-reports and are, therefore, prone to measurement errors.
- Secondly, several participants were excluded due to missing data or not returning for follow-up evaluations, which might have led to selection bias.
- Thirdly, the proportion of individuals with an unhealthy lifestyle might have been underestimated in the study because people with poor health were less likely to have participated in the study.
- Fourthly, given the nature of the study design, it could not assess whether maintaining a healthy lifestyle had already started influencing memory by the time of enrolment in the study.
- Fifthly, the evaluation of memory using a single neuropsychological test that does not comprehensively reflect overall memory function. However, the Auditory Verbal Learning Test is an effective instrument for memory assessment, and a composite score was used based on four Auditory Verbal Learning Test subscales to represent memory conditions to the greatest extent possible.
- Sixthly, as participants might become familiar with repeated cognitive testing, a learning effect could have influenced the results.
- Finally, memory decline was studied solely among older adults; however, memory problems commonly affect young individuals as well.
The authors, therefore, state that further studies should be conducted to facilitate a more extensive investigation into the effects of a healthy lifestyle on memory decline across the lifespan. This approach would help to elucidate the crucial age window during which a healthy lifestyle can exert the most favourable effect.
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!
Chronic kidney disease is common, often progressive, and difficult to treat or prevent. Effective interventions would therefore be more than welcome. This paper explored the relation of habitual fish oil use with the risk of chronic kidney diseases (CKD).
A total of 408,023 participants (54.2% female) without prior CKD and with completed information regarding their consumption of major food groups and fish oil in the UK Biobank were enrolled. Fish oil use and dietary intakes were assessed by touch screen questionnaire and food frequency questionnaire, respectively. Incident CKD was recorded from hospital inpatient records.
At baseline, 128,843 (31.6%) participants reported taking fish oil supplements. During a median follow-up period of 12.0 years, a total of 10,782 (2.6%) participants developed CKD. With adjustments for important confounders, habitual fish oil use was associated with a significantly lower hazard of incident CKD (hazard ratio [HR], 0.90; 95% confidence interval [CI], 0.87-0.95), compared with non-use. Consistently, participants reporting ≥2 servings/week of oily fish (HR, 0.86; 95% CI, 0.79-0.94) and nonoily fish (HR, 0.86; 95% CI, 0.77-0.97) consumption had a lower hazard of incident CKD compared to those reporting no consumption ever. Additionally, among the 97,914 participants with data on plasma fatty acid, there were significant inverse relationships of plasma omega-3 polyunsaturated fatty acid (PUFA) (per SD increment, HR, 0.89, 95% CI, 0.84-0.94) and eicosatetraenoic acid (per SD increment, HR, 0.91, 95% CI, 0.87-0.96) with incident CKD.
The authors concluded that habitual fish oil use was associated with a lower hazard of CKD, which was further confirmed by the consistent inverse relations between fish consumption and circulating omega-3 PUFA concentration with incident CKD.
I like this paper! It shows in an exemplary fashion how to interpret an association between two variables: fish oil consumption does not necessarily CAUSE the lower risk, it is merely associated with it and there might be a number of non-causal explanations for the link. Whether there is a true cause-effect relationship needs to be investigated in further, differently designed studies. The present paper does not overstate its conclusions but it is nevertheless important, as it hopefully will prompt others to clarify the crucial issue of causality.
Wouldn’t it be nice, if researchers of so-called alternative medicine (SCAM) finally learned this simple lesson?
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!
The impact of drug-induced liver injury (DILI) on patients with chronic liver disease (CLD) is unclear. There are few reports comparing DILI in CLD and non-CLD patients. In this study, the researchers aimed to determine the incidence and outcomes of DILI in patients with and without CLD.
They collected data on eligible individuals with suspected DILI between 2018 and 2020 who were evaluated systematically for other etiologies, causes, and the severity of DILI. They compared the causative agents, clinical features, and outcomes of DILI among subjects with and without CLD who were enrolled in the Thai Association for the Study of the Liver DILI registry. Subjects with definite, or highly likely DILI were included in the analysis.
The researchers evaluated the causal relationship between the clinical pattern of liver injury and the suspected drugs or SCAM products with the Roussel Uclaf Causality Assessment Method (RUCAM) system. RUCAM is a validated and established tool to quantitatively assess causality in cases of suspected DILI and/or SCAM product-induced liver injury. They also used the Clinical Assessment of Causality Scale to assess the association as definite (>95% likelihood), highly likely (75–95%), probable (50–74%), possible (25–49%) or unlikely (<25%).
A total of 200 subjects diagnosed with DILI were found in the registry. Of those, 41 had CLD and 159 had no evidence of CLD. So-called alternative medicine (SCAM) products were identified as the most common class of DILI agents. Approximately 59% of DILI in the CLD and 40% in non-CLD group were associated with SCAM use. Individuals with pre-existing CLD had similar severity including mortality. Twelve patients (6%) developed adverse outcomes related to DILI including seven (3.5%) deaths and five (2.5%) with liver failure. Mortality was 4.88% in CLD and 3.14% in non-CLD subjects over median periods of 58 (8-106) days and 22 (1-65) days, respectively.
The authors concluded that, in this liver disease registry, the causes, clinical presentation, and outcomes of DILI in subjects with CLD and without CLD patients were not different. Further study is required to confirm our findings.
Consumers often prefer SCAM to conventional medicine because SCAM is viewed as gentle and safe. The notions are that they
- are natural and therefore harmless;
- have been in use for ages and thus have stood the test of time.
Readers of this blog will appreciate that both notions are, in fact, fallacies:
- appeal to nature;
- appeal to tradition.
This new paper is an impressive reminder that SCAM’s reputation as a safe option is not justified, and that SCAM relies more on fallacies than on facts.
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.
It has been reported that a German consumer association, the ‘Verbraucherzentrale NRW’, has first cautioned the manufacturer MEDICE Arzneimittel Pütter GmbH & Co. and then sued them for misleading advertising statements. The advertisement in question gave the wrong impression that their homeopathic remedy MEDITONSIN would:
- for certain generate a health improvement,
- have no side effects,
- be superior to “chemical-synthetic drugs”.
The study used by the manufacturer in support of such claims was not convincing according to the Regional Court of Dortmund. The results of a “large-scale study with more than 1,000 patients” presented a pie chart indicating that 90% of the patients were satisfied or very satisfied with the effect of Meditonsin. However, this was only based on a “pharmacy-based observational study” with little scientific validity, as pointed out by the consumer association. Despite the lack of evidence, the manufacturer claimed that their study “once again impressively confirms the good efficacy and tolerability of Meditonsin® Drops”. The Regional Court of Dortmund disagreed with the manufacturer and agreed with the reasoning of the consumer association.
“It is not permitted to advertise with statements that give the false impression that a successful treatment can be expected with certainty, as suggested by the advertising for Meditonsin Drops,” emphasizes Gesa Schölgens, head of “Faktencheck Gesundheitswerbung,” a joint project of the consumer centers of North Rhine-Westphalia and Rhineland-Palatinate. According to German law, this is prohibited. In addition, the Regional Court of Dortmund considered consumers to be misled by the advertising because the false impression was created that no harmful side effects are to be expected when Meditonsin Drops are taken. The package insert of the drug lists several side effects, according to which there could even be an initial worsening of symptoms after taking the drug.
The claim of advantages of the “natural remedy” represented by the manufacturer in comparison with “chemical-synthetic medicaments, which merely suppress the symptoms”, was also deemed to be inadmissible. Such comparative advertising is inadmissible.
__________________________________
This ruling is, I think, interesting in several ways. The marketing claims of so-called alternative medicine (SCAM) products seem all too often not within the limits of the laws. One can therefore hope that this case might inspire many more legal cases against the inadmissible advertising of SCAMs.
This meta-analysis of randomized clinical trials (RCTs) was aimed at evaluating the effects of massage therapy in the treatment of postoperative pain.
Three databases (PubMed, Embase, and Cochrane Central Register of Controlled Trials) were searched for RCTs published from database inception through January 26, 2021. The primary outcome was pain relief. The quality of RCTs was appraised with the Cochrane Collaboration risk of bias tool. The random-effect model was used to calculate the effect sizes and standardized mean difference (SMD) with 95% confidential intervals (CIs) as a summary effect. The heterogeneity test was conducted through I2. Subgroup and sensitivity analyses were used to explore the source of heterogeneity. Possible publication bias was assessed using visual inspection of funnel plot asymmetry.
The analysis included 33 RCTs and showed that MT is effective in reducing postoperative pain (SMD, -1.32; 95% CI, −2.01 to −0.63; p = 0.0002; I2 = 98.67%). A similarly positive effect was found for both short (immediate assessment) and long terms (assessment performed 4 to 6 weeks after the MT). Neither the duration per session nor the dose had a significant impact on the effect of MT, and there was no difference in the effects of different MT types. In addition, MT seemed to be more effective for adults. Furthermore, MT had better analgesic effects on cesarean section and heart surgery than orthopedic surgery.
The authors concluded that MT may be effective for postoperative pain relief. We also found a high level of heterogeneity among existing studies, most of which were compromised in the methodological quality. Thus, more high-quality RCTs with a low risk of bias, longer follow-up, and a sufficient sample size are needed to demonstrate the true usefulness of MT.
The authors discuss that publication bias might be possible due to the exclusion of all studies not published in English. Additionally, the included RCTs were extremely heterogeneous. None of the included studies was double-blind (which is, of course, not easy to do for MT). There was evidence of publication bias in the included data. In addition, there is no uniform evaluation standard for the operation level of massage practitioners, which may lead to research implementation bias.
Patients who have just had an operation and are in pain are usually thankful for the attention provided by carers. It might thus not matter whether it is provided by a massage or other therapist. The question is: does it matter? For the patient, it probably doesn’t; However, for making progress, it does, in my view.
In the end, we have to realize that, with clinical trials of certain treatments, scientific rigor can reach its limits. It is not possible to conduct double-blind, placebo-controlled studies of MT. Thus we can only conclude that, for some indications, massage seems to be helpful (and almost free of adverse effects).
This is also the conclusion that has been drawn long ago in some countries. In Germany, for instance, where I trained and practiced in my younger years, Swedish massage therapy has always been an accepted, conventional form of treatment (while exotic or alternative versions of massage therapy had no place in routine care). And in Vienna where I was chair of rehab medicine I employed about 8 massage therapists in my department.
