critical thinking
The hallmark of the Trump administration is the discrepancy between its appointees’ responsibilities and their qualifications/competence for their jobs. A well-known anti-vaccine activist assigned the job of reviewing the supposed link between vaccination and autism is a recent case in point. The Washington Post reported that David Geier has been nominated for a study on possible links between immunizations and autism. Retraction Watch recently dedicated an article to Geier pointing out that he has a long history of promoting the debunked claim of a link between vaccines and autism. In 2011, the Maryland State Board of Physicians even had to disciplin Geier for practicing medicine without a license!
The Trump administration has also announced that it will prioritize replicating medical research. At least 20 percent of the NIH budget will now be directed towards replication efforts. But studies of a link between vaccines and autism have failed to find a connection time and time again. “We have already done that many times over. It wastes valuable resources to revisit the same question instead of using them to address critical health challenges,” commented David Higgins, a practicing pediatrician and health services researcher at the University of Colorado Anschutz Medical Campus. “Re-examining settled questions that have already been repeated, replicated, and tested many times is not healthy skepticism; it’s cynicism and science denial.”
The news of the HHS study comes as measles cases in Texas increase, and further outbreaks have been reported in numerous other states, while Kennedy has downplayed the role of vaccination. As of 27 March, the US Centers for Disease Control and Prevention (CDC) has confirmed 483 measles cases in the US this year. This is the highest number of infections since 2019, when there were more than 1200 confirmed cases. The CDC is aware of more potential measles cases but is waiting for confirmation before including them in the case count.
David Geier and his father Mark Geier, MD, are known for several discredited studies claiming that thimerosal, a preservative containing low levels of ethylmercury used in some vaccines, increased the risk of autism. But Thimerosal has been reduced or eliminated from vaccines for decades, and all vaccines recommended for children 6 and younger are available in formulations that do not contain thimerosalopens in a new tab or window.
“The [Geier] studies were poorly done; they were full of confounding variables,” commented Paul Offit, MD, of Children’s Hospital of Philadelphia. The American Academy of Pediatrics warned that it contained “numerous conceptual and scientific flaws, omissions of fact, inaccuracies, and misstatements,” and failed to show a connection between thimerosal and autism.
______________________
They say that, if you elect a clown, you’ll get a circus. So, to make the farce complete, why does RFKJr not recruit our friend Andrew Wakefield to the team of clowns, jesters and illusionists?
A long article on chiropractic casts doubt that chiropractic is useful. Here is an abbreviated version of it:
The chemistry and biology graduate from the University of Georgia, 28-year-old Caitlin Jensen, visited a chiropractor to sort out her lower back pain. During the session, the therapist performed an adjustment. It severed four arteries in her neck. She collapsed shortly after, unable to speak or move. The injury had caused her to suffer a series of strokes. Today, she has regained some movement in her head, legs and arms but she is still unable to speak, is partially blind and relies on a wheelchair.
- One 66-year-old grandmother said a visit to a chiropractor to treat her sore shoulder left her covered in bruises, hearing ringing in her ears and with a splitting pain in her jaw. She was later diagnosed by doctors with trigeminal neuralgia – a chronic pain disorder caused by a trapped or irritated nerve in the neck that causes sudden, electric shock-like pain in the face. She believes the condition – which, three years later, still sometimes leaves her unable to open her mouth wide enough to speak to her grandchildren – was triggered by a chiropractic adjustment of her neck.
- A 55-year-old woman was left with chronic neck and shoulder pain after visiting a chiropractor for a sore back. The pain was so bad she once spent 72 hours immobile and unable to sleep despite taking a concoction of painkillers.
- And a 66-year-old man says his back went into spasm as he was leaving his first chiropractor appointment – which left him hospitalised and bedbound for weeks. The intense treatment, he later learned, had pushed one of the discs of his spine out of place, causing him to lose feeling in his right leg for ever.
RUDOLF STEINER died 100 years ago today – a good reason, I think, to remember the utter nonsense he postulated (not only) in the realm of healthcare. Here is a slightly abbreviated section from my recent book:
Rudolf Steiner was born on 25 February 1861 in Kraljević, Austrian-Hungarian empire. At the age of 9, Steiner allegedly had his first spiritual experience; he saw the spirit of his deceased aunt. Realizing Rudolf’s potentials, his father sent his son first to a ‘Realschule’ in Wiener Neustadt and then to the ‘Technische Hochschule’ (Technical University) in Vienna where he studied mathematics, physics, chemistry, botany, biology, literature, and philosophy. While Steiner was still a student, he was appointed as the natural science editor of a new edition of Goethe’s works.
In 1890, Steiner moved to Weimar, Germany, where he was employed at the Schiller-Goethe Archives. Concurrently, he started working for his doctoral degree, which he received in 1891 from the University of Rostock; the title of his dissertation, later published as a book, was ‘Wahrheit und Wissenschaft’ (Truth and Science).
In 1897, Steiner moved to Berlin, where he joined esoteric circles and studied Eastern and occult religions. In 1899, he married Anna Eunicke. Subsequently, Steiner met Marie von Sivers, an actress from the Baltic region and also a devotee of anthroposophy. They got married in 1914.
Steiner had by then joined the Theosophical Society and, in 1902, was made its General Secretary. Years of disagreement with key members of the organisation prompted him to leave the society in 1912. On 28 December of that year, Rudolf Steiner, along with a group of prominent German theosophists, founded the Anthroposophic Society.
Anthroposophy, a term borrowed from the 19th-century Swiss philosopher and physician Ignaz Troxler, is based on the notion that there is a spiritual world that is accessible only to the highest faculties of mental knowledge. Steiner rejected experimentation as a means of gaining knowledge; instead, he relied on imagination, inspiration and intuition. He claimed that his anthroposophy centered on “knowledge produced by the higher self in man.” He believed that humans once participated more fully in spiritual processes of the world through a dreamlike consciousness, but had since become restricted by their attachment to material things.
In 1913 at Dornach, near Basel, Switzerland, Steiner built the first ‘Goetheanum’, which he called a “school of spiritual science.” The building was destroyed by a fire in 1922 and subsequently replaced by the new ‘Goetheanum’ that still exists today. Steiner also worked on various other projects, including education (Waldorf schools) and biodynamic agriculture.
In the late 1910s, Steiner and his mistress, Ita Wegman, started working with medical doctors to create his anthroposophic medicine. In 1920, they founded the ‘Klinisch-Therapeutische Institut’ in Arlesheim, and on 21 March 1921, they organised the first of a series of courses for doctors in Dornach. This day is now considered to be the birth of anthroposophic medicine. In the same year, pharmacists and physicians gathered under Steiner’s guidance to create the pharmaceutical company, ‘Weleda’. At around the same time, Wegman founded the first anthroposophic medical clinic, the ‘Ita Wegman Clinic’ in Arlesheim.
Anthroposophic medicine cannot be adequately described through a single therapeutic modality. It has been aptly called a ‘pluriversum of theories and practices under the umbrella of an anthroposophic worldview’. The anthroposophic concept comprises a range of medications many (but not all) of which are plant-based, as well as art therapy, eurhythy (dance therapy), special dietary approaches, physiotherapy and other modalities. According to Steiner, humans have four ‘bodies’: The physical body, the ‘etheric’ body – which is based on formative forces, the ‘astral’ body – which reflects a person’s emotions and inner drives, and a conscious body – which is the domain of the ego and self.
For non-anthroposophist, these concepts are hardly comprehensible. They are based on associations between planets, metals and organs, from which therapeutic rules are derived. These affinities also form the basis of the many anthroposophical medicines, which are produced by liquefaction, aeration, solidification, combustion, potentiation and other processes. The history of the constituents of anthroposophic remedies is often considered to be more important than their material composition. According to Steiner and his substantial writings, “the spirit of the plant, which is drawn out of the tree by the parasitic plant act on the astral”. During the years before his death, Steiner, who had no medical background, often saw patients himself. He would then stare at them and divine both the diagnosis and the treatment; in other words, he acted as a clairvoyant lay-healer.
The Nazi movement had an ambivalent attitude to Steiner and to anthroposophic medicine. On the one hand, several leading Nazis such as Hess were clearly in favour of anthroposophic medicine. Steiner’s wife, Marie Steiner-von Sivers (1867 – 1948) who made significant contributions to anthroposophic medicine had publicly expressed sympathy for the Nazi regime since its beginnings. On the other hand, a political theorist of the Nazi movement, Dietrich Eckart, criticised Steiner in 1919 and (wrongly) suggested that he was a Jew. In 1921, Adolf Hitler accused Steiner of being a tool of the Jews, while other Nazis even called for a “war against Steiner”. In 1922, Steiner gave a lecture in Munich which was disrupted by Nazi thugs. Such hostilities led Steiner to leave his home in Berlin and move to Dornbach; he stated that, if the Nazis came to power in Germany, it would no longer be possible for him to live in Germany.
From 1923 on, Steiner showed signs of increasing frailness. He nonetheless continued to lecture widely. His last lecture was given in late September 1924. Steiner died at Dornach on 30 March 1925 in the presence of Ita Wegman.
The aim of this recent review was to investigate the efficacy of non-surgical and non-interventional treatments for adults with low back pain compared with placebo. It included all randomised controlled trials evaluating non-surgical and non-interventional treatments compared with placebo or sham in adults (≥18 years) suffering from non-specific low back pain.
Random effects meta-analysis was used to estimate pooled effects and corresponding 95% confidence intervals on outcome pain intensity (0 to 100 scale) at first assessment post-treatment for each treatment type and by duration of low back pain—(sub)acute (<12 weeks) and chronic (≥12 weeks). Certainty of the evidence was assessed using the Grading of Recommendations Assessment (GRADE) approach.
A total of 301 trials (377 comparisons) provided data on 56 different treatments or treatment combinations. One treatment for acute low back pain: (non-steroidal anti-inflammatory drugs (NSAIDs)), and five treatments for chronic low back pain:
- exercise,
- spinal manipulative therapy,
- taping,
- antidepressants,
- transient receptor potential vanilloid 1 (TRPV1) agonists)
were found to be efficacious. However, effect sizes were small and of moderate certainty. Three treatments for acute low back pain (exercise, glucocorticoid injections, paracetamol), and two treatments for chronic low back pain (antibiotics, anaesthetics) were not efficacious and are unlikely to be suitable treatment options; moderate certainty evidence. Evidence is inconclusive for remaining treatments due to small samples, imprecision, or low and very low certainty evidence.
The authors concluded that the current evidence shows that one in 10 non-surgical and non-interventional treatments for low back pain are efficacious, providing only small analgesic effects beyond placebo. The efficacy for the majority of treatments is uncertain due to the limited number of randomised participants and poor study quality. Further high-quality, placebo-controlled trials are warranted to address the remaining uncertainty in treatment efficacy along with greater consideration for placebo-control design of non-surgical and non-interventional treatments.
This is an important analysis, not least because of the fact that the research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. The methodology is sound and the results thus seem reliable.
The findings are in keeping with what we have been discussing at nauseam here: no treatment works really well for back pain. For acute symptoms no so-called alternative medicine (SCAM) at all is efficacious. For chronic pain, spinal manipulation therapy (SMT) have small effects. As SMT is neither cheap nor free of risks, excercise is much preferable.
Considering that most SCAMs are heavily promoted for low back pain (e.g. acupuncture, Alexander technique, cupping, Gua Sha, herbal medicine, homeopathy, massage, mind-body therapies, reflexology, Reiki, yoga), this verdict is sobering indeed!
The US Health Secretary Robert F Kennedy (JFKJr) famously claimed that vitamin A could work “as a prophylaxis” of measles infection. That claim is not just wrong, it also is dangerous. Overuse of vitamin A can have serious health consequences. As a result of JFKJr yet again promoting dangerous nonsense, doctors treating patients during the measles outbreak in Texas and New Mexico are now facing the problem of vitamin A toxicity.
At Covenant Children’s Hospital in Lubbock, near the outbreak’s epicenter, several patients have been found to have abnormal liver function on routine lab tests, a probable sign that they’ve taken too much of the vitamin, according to Dr. Lara Johnson, pediatric hospitalist and chief medical officer for Covenant Health-Lubbock Service Area.
Vitamin A is fat-soluble. It therefore accumulate in organs like the liver when over-doesed. Excess vitamin A can cause dry skin and eyes, blurry vision, bone thinning, skin irritation, liver damage and other serious issues. In pregnant women, it can even lead to birth defects. Recovery for patients with acute toxicity is normally rapid, if the vitamin is discontinued. But the more serious problems with vitamin A toxicity are not always reversible.
The Council for Responsible Nutrition, a trade association for dietary supplement and functional food manufacturers, issued a statement warning parents against using high doses of vitamin A to try to keep their children from getting measles. “While vitamin A plays an important role in supporting overall immune function, research hasn’t established its effectiveness in preventing measles infection. CRN is concerned about reports of high-dose vitamin A being used inappropriately, especially in children,” the statement says.
JFKJr made his remarks in an interview with Fox News medical correspondent Dr. Marc Siegel. Snippets of the interview were featured in four Fox News or Fox Business segments airing on March 4. “They have treated most of the patients, actually, over 108 patients in the last 48 hours. And they’re getting very, very good results, they report from budesonide, which is a steroid, it’s a 30-year-old steroid,” Kennedy said in the longest of the segments. “And clarithromycin [an antibiotic] and also cod liver oil, which has high concentrations of vitamin A and vitamin D. We need to look at those therapies and other therapies,” he said in another segment. “We need to really do a good job of talking to the front-line doctors and see what is working on the ground, because those therapeutics have really been ignored by the agency for a long, long time.”
Local doctors are increasingly concerned about the growing popularity of unproven remedies for preventing and treating measles. They fear that they are causing people to delay critical medical treatment and to reject vaccination, the only proven way to prevent a measles infection.
The measles outbreak has now affected at least 379 people across Texas, New Mexico and Oklahoma. Kansas has reported 23 measles cases, and officials said that they may also be linked to the outbreak. The best measure to get to grips with the outbreak, I think, would be to make JFKJr shut up and let those who understans the issues get on with it.
Qi-gong is a branch of Traditional Chinese Medicine that employs meditation, exercise, deep breathing and other techniques with a view of strengthening the assumed life force ‘qi’ and thus improving health and prolong life. Qi-gong has ancient roots in China and has recently also become popular in other countries. There are several distinct forms of qi-gong which can be categorized into two main groups, internal qi-gong and external qi-gong. Internal qi-gong refers to a physical and mental training method for the cultivation of oneself to achieve optimal health in both mind and body. Internal qi-gong is not dissimilar to tai chi but it also employs the coordination of different breathing patterns and meditation. External qi-gong refers to a treatment where qi-gong practitioners direct their qi-energy to the patient with the intention to clear qi-blockages or balance the flow of qi within that patient. According to Taoist and Buddhist beliefs, qi-gong allows access to higher realms of awareness.
The assumptions of qi-gong are not scientifically plausible. But this does not stop enthusiasts to submit it to clinical trials.
A quasi-experimental pretest-posttest study was conducted with 231 adolescent girls aged 13-17 years suffering from premenstrual syndrome (PMS). Participants underwent a 4-week Qi Gong therapy program, with five 45-minute sessions weekly. Data were collected using a demographic questionnaire and Modified PMS Scale, analysing pre- and post-intervention symptoms through descriptive statistics, paired t-tests and chi-square tests.
The intervention significantly reduced PMS severity, with mild PMS cases increasing from 48 (20.78%) to 166 (71.86%) post-intervention. Paired t-tests revealed a highly significant mean difference in PMS scores (T = 12.251, p < 0.001).
The authors concluded that Qi Gong therapy offers a holistic, non-invasive approach for managing PMS by addressing both physiological and emotional dimensions to the condition. Its ability to balance hormones, alleviate stress and improve overall quality of life makes it a valuable addition to PMS care.
This study originated from the Department of Obstetrics and Gynecological Nursing, Nootan college of Nursing, Sankalchand Patel university, Visnagar, Gujarat, India; the Department of Pediatric Nursing of the same institution and the Department of Psychiatric Nursing of the same institution. One would have hoped that its authors know better than to draw such conclusions from such a study. Here are some points of concern:
- There is no reason why the treatment should be holistic.
- The study did not have a control group; causal inferences are thus not waarranted.
- The study did not produce any evidence to show that the treatment addressed either physiological or emotional dimensions.
- The study did not produce any evidence to show that the treatment did anything to hormones.
- The study did not produce any evidence to show that the treatment alleviated stress.
- The study did not produce any evidence to show that the treatment improved quality of life.
- I see no resason why the treatment should be promoted as a valuable addition to PMS care.
- The PMS severity changed after the treatment and not necessarily because of it.
- The true reasons it changed might be multifold, e.g.: placebo, regression towards the mean, social desirability.
- Misleading the public by drawing far-reaching conclusions has the potential to do untold harm.
I have said it often, and it saddens me to have to say it again:
If the quality of research into so-called alternative medicine (SCAM) does not improve dramatically, nobody can blame the public to not take SCAM seriously any more.
Robert F. Kennedy Jr. (RFK Jr.), America’s anti-vaxer in-chief, famously claimed his brain has been eaten by a worm. While this assumption is as ridiculous as the man himself, the actions and delusions of RFK Jr. seem almost to confirm that something fundamental must be wrong with his intellectual abilities.
Recently he said that he will be working to get cell phones out of schools. “Cell phones produce electric magnetic radiation, which has been shown to do neurological damage to kids when it’s around them all day … It’s also been shown to cause cellular damage and even cancer … Cell phone use and social media use on the cell phone has been directly connected with depression, poor performance in schools, suicidal ideation, and substance abuse … The states that are doing this have found that it is a much healthier environment when kids are not using cell phones in schools.”
There are two separate issues here:
- Limiting children’s use of cell phones might be – for several (not health-related) reasons – a reasonable idea.
- The assumption that cell phones cause the type of damage that RFK Jr. claimed is nonsense.
There is plenty of evidence on the subject, some more reliable than others. The most reliable data do not support what RFK Jr. claims. Here are a few systematic reviews on the subject:
A recent systematic review included 63 aetiological articles, published between 1994 and 2022, with participants from 22 countries, reporting on 119 different E-O pairs. RF-EMF exposure from mobile phones (ever or regular use vs no or non-regular use) was not associated with an increased risk of glioma [meta-estimate of the relative risk (mRR) = 1.01, 95 % CI = 0.89-1.13), meningioma (mRR = 0.92, 95 % CI = 0.82-1.02), acoustic neuroma (mRR = 1.03, 95 % CI = 0.85-1.24), pituitary tumours (mRR = 0.81, 95 % CI = 0.61-1.06), salivary gland tumours (mRR = 0.91, 95 % CI = 0.78-1.06), or paediatric (children, adolescents and young adults) brain tumours (mRR = 1.06, 95 % CI = 0.74-1.51), with variable degree of across-study heterogeneity (I2 = 0 %-62 %). There was no observable increase in mRRs for the most investigated neoplasms (glioma, meningioma, and acoustic neuroma) with increasing time since start (TSS) use of mobile phones, cumulative call time (CCT), or cumulative number of calls (CNC). Cordless phone use was not significantly associated with risks of glioma [mRR = 1.04, 95 % CI = 0.74-1.46; I2 = 74 %) meningioma, (mRR = 0.91, 95 % CI = 0.70-1.18; I2 = 59 %), or acoustic neuroma (mRR = 1.16; 95 % CI = 0.83-1.61; I2 = 63 %). Exposure from fixed-site transmitters (broadcasting antennas or base stations) was not associated with childhood leukaemia or paediatric brain tumour risks, independently of the level of the modelled RF exposure. Glioma risk was not significantly increased following occupational RF exposure (ever vs never), and no differences were detected between increasing categories of modelled cumulative exposure levels.
Another recent systematic review included 5 studies that reported analyses of data from 4 cohorts with 4639 participants consisting of 2808 adults and 1831 children across three countries (Australia, Singapore and Switzerland) conducted between 2006 and 2017. The main source of RF-EMF exposure was mobile (cell) phone use measured as calls per week or minutes per day. For mobile phone use in children, two studies (615 participants) that compared an increase in mobile phone use to a decrease or no change were included in meta-analyses. Learning and memory. There was little effect on accuracy (mean difference, MD -0.03; 95% CI -0.07 to 0.02) or response time (MD -0.01; 95% CI -0.04 to 0.02) on the one-back memory task; and accuracy (MD -0.02; 95%CI -0.04 to 0.00) or response time (MD -0.01; 95%CI -0.04 to 0.03) on the one card learning task (low certainty evidence for all outcomes). Executive function. There was little to no effect on the Stroop test for the time ratio ((B-A)/A) response (MD 0.02; 95% CI -0.01 to 0.04, very low certainty) or the time ratio ((D-C)/C) response (MD 0.00; 95% CI -0.06 to 0.05, very low certainty), with both tests measuring susceptibility to interference effects. Complex attention. There was little to no effect on detection task accuracy (MD 0.02; 95% CI -0.04 to 0.08), or response time (MD 0.02;95% CI 0.01 to 0.03), and little to no effect on identification task accuracy (MD 0.00; 95% CI -0.04 to 0.05) or response time (MD 0.00;95% CI -0.01 to 0.02) (low certainty evidence for all outcomes). No other cognitive domains were investigated in children. A single study among elderly people provided very low certainty evidence that more frequent mobile phone use may have little to no effect on the odds of a decline in global cognitive function (odds ratio, OR 0.81; 95% CI 0.42 to 1.58, 649 participants) or a decline in executive function (OR 1.07; 95% CI 0.37 to 3.05, 146 participants), and may lead to a small, probably unimportant, reduction in the odds of a decline in complex attention (OR 0.67;95%CI 0.27 to 1.68, 159 participants) and a decline in learning and memory (OR 0.75; 95% CI 0.29 to 1.99, 159 participants). An exposure-response relationship was not identified for any of the cognitive outcomes.
A 2022 systematic review concluded that the body of evidence allows no final conclusion on the question whether exposure to RF EMF from mobile communication devices poses a particular risk to children and adolescents.
That RFK Jr. spouts BS almost every time he opens his mouth should be an embarrassment to all US citizens. For the rest of the world, it is more than that. In fact, it is fast becoming a serious concern: sooner or later, his insane delusions will affect public health on a global scale!
- pain,
- anxiety,
- fatigue,
- feelings (eg, happy, calm)
on 0- to 10-point numeric rating scales. Data were analyzed with Wilcoxon signed rank tests.
- What on earth is a ‘mixed-method, feasibility, pilot study’? A hallmark of pseudo-researchers seems to be that they think they can invent their own terminology.
- There is no objective, validated outcome measure.
- The conclusion that ‘Reiki is feasible‘ has been known and does not need to be tested any longer.
- The conclusion that ‘Reiki improved positive emotions and feelings and decreased negative measures’ is false. As there was no control group, these improvements might have been caused by a whole lot of other things than Reiki – for instance, the extra attention, placebo effects, regression towards the mean or social desirability.
- The conclusion that ‘implementing Reiki in clinical practice should be further explored to improve mental health and well-being’ is therefore not based on the data provided. In fact, as Reiki is an implausible esoteric nonsense, it is a promotion of wasting resources on utter BS.
Does it matter?
Why not let pseudo-scientists do what they do best: PSEUDO-SCIENCE?
I think it matters because:
- Respectable institutions like the Mayo Clinic should not allow its reputation being destroyed by quackery.
- The public should not be misled by charlatans.
- Patients suffering from mental health problems deserve better.
- Resources should not be wasted on pseudo-research.
- ‘Academic journals like ‘Glob Adv Integr Med Health’ have a responsibility for what they publish.
- ‘The ‘Academic Consortium for Integrative Medicine & Health‘ that seems to be behind this particular journal claim to be “the world’s most comprehensive community for advancing the practice of whole health, with leading expertise in research, clinical care, and education. By consolidating the top institutions in the integrative medicine space, all working in unison with a common goal, the Academic Consortium is the premier organizational home for champions of whole health. Together with over 86 highly esteemed member institutions from the U.S., Australia, Brazil, Canada and Mexico, our collective vision is to transform the healthcare system by promoting integrative medicine and health for all.” In view of the above, such statements are a mockery of the truth.
I don’t know whether you noticed but everyone seems to be going on about the new wonder SCAM (so-called alternative medicine) ‘BLACK SEED OIL’ (BSO). If you go on the Internet, you’ll find all sorts of health claims for it, e.g.:
- -Reduces Inflammation
- -High in Antioxidants
- -Can Lower Cholesterol
- -Helps to Fight Cancer
- -Can Kill Off Bacteria
- -Balances Blood Sugar
- -Helps to Lower Blood Pressure
Interesting?
I am – as always – doutful. Nonetheless, I had a look at BSO to find out more.
BSO (also known as black caraway, black cumin or kalonji oil) is derived from the tiny black seeds of Nigella sativa (N. sativa) that grows in hot areas like Eastern Europe, Northern African, and Southwestern Asia, etc. The Wikipedia entry states that “despite considerable use of N. sativa in traditional medicine practices in Africa and Asia, there is insufficient high-quality clinical evidence to indicate that consuming the seeds or oil can be used to treat human diseases”.
But Wiki is often not up-to-date, and I therefore looked into Medline. To my surprise, I found research to be extraordinarily active.
Nigella sativa contains several phytochemical compounds, such as thymoquinone, p-cymene, α-thujene, longifolene, β-pinene, α-pinene, and carvacrol. They confer an antioxidant effect to the seeds, leading to a potent anti-inflammatory effect. Particularly, thymoquinone increases the levels of antioxidant enzymes that counter oxidative stress in the liver. Additionally, the essential oil in N. sativa seeds effectively inhibits intestinal parasites and shows moderate activity against some bacteria, including Bacillus subtilis and Staphylococcus aureus. Thymoquinone exhibits minimum inhibitory concentrations (MICs) of 8-16 μg/mL against methicillin-resistant Staphylococcus aureus (MRSA) and exhibits MIC 0.25 µg/mL against drug-resistant mycobacteria. Similarly, quercetin shows a MIC of 2 mg/mL against oral pathogens, such as Streptococcus mutans and Lactobacillus acidophilus. Furthermore, endophytic fungi isolated from N. sativa have demonstrated antibacterial activity. Further mechanisms involve inducing apoptosis, and inhibiting migration and invasion. N Sativa supplementation significantly decreases serum C-reactive protein, tumor necrosis factor-alpha, and malondialdehyde levels. It also improves total antioxidant capacity and superoxide dismutase levels.
But these effects do not neccessarily mean that BSO is clinically effective for any condition, particularly in view of its low bioavailability. So, what does the clinical evidence tell us? Here are just 9 of the most recent studies and reviews:
- This study aimed to investigate the possible beneficial cardioprotective effect of Nigella sativa in pediatric patients with type 1 diabetes mellitus. Sixty children and adolescents with type 1 diabetes were randomized into two groups: group I (n = 30) who received Nigella sativa seed oil 450 mg twice daily after meals for 3 months in addition to insulin, and group II (n = 30) who received insulin alone. Echocardiographic examinations were performed before and after the treatment. The lipid profile, malondialdehyde, nitric oxide, tumor necrosis factor-α, transforming growth factor-β, and troponin I were also measured before and after Nigella sativa treatment. After 3 months of Nigella sativa administration, group I had significantly lower cholesterol and low-density lipoprotein-cholesterol, malondialdehyde, nitric oxide, tumor necrosis factor-α, transforming growth factor-β, and troponin I levels compared with their pretreatment levels and compared with group II. In addition, group I had a significantly higher left ventricular E’/A’ ratio and two-dimensional left ventricular global longitudinal strain (2D-LV GLS) compared with baseline values and compared with group II after treatment. Conclusions: Nigella sativa can improve subclinical left ventricular dysfunction in pediatric patients with type 1 diabetes mellitus.
- This study evaluated the effects of Nigella sativa L. extract on glycemia among adolescents with PCOS. This secondary analysis used data from a randomized controlled trial conducted between March 2022 and March 2023. One hundred sixteen adolescent girls aged 12-18 years with PCOS were randomized into two groups. The intervention group received 1000 mg/day of Nigella sativa extract for 16 weeks, while the control group received 10 mg/day of medroxyprogesterone for 10 days per menstrual cycle over the same period. Fasting plasma glucose (FPG) and one- and two-hour post-prandial glucose levels were measured at baseline and after the intervention. 103 completed the study (50 in the Nigella sativa group and 53 in the control group). At baseline, there were no significant differences in FPG (p = 0.294), though the control group had higher one-hour (p = 0.002) and two-hour (p = 0.006) post-prandial glucose levels. Post-intervention, significant interaction effects were observed for FPG (p = 0.004) and two-hour post-prandial glucose (p = 0.023), indicating more significant reductions in the Nigella sativa group compared to the control group. Conclusions: Considering the observed effect of Nigella sativa supplementation on FPG and two-hour post-prandial glucose, it may offer a complementary approach to managing glycemia in adolescent PCOS. However, further research is warranted.
- This systematic review and meta-analysis of randomized controlled trials (RCTs) sought to evaluate the effects of Nigella sativa (N. sativa) consumption on glycemic index in adults. A systematic literature search up to December 2023 was completed in PubMed, Scopus, and Web of Science, to identify eligible RCTs. Random effects models were assessed based on the heterogeneity tests, and pooled data were determined as weighted mean differences with a 95 % confidence interval. Finally, a total of 30 studies were found to be eligible for this meta-analysis. The pooled results using random effects model indicated that N. sativa supplementation significantly reduced FBS (SMD: -1.71; 95 % CI: -2.11, -1.31, p <0.001; I2= 92.7 %, p-heterogeneity <0.001) and HA1c levels (SMD: -2.16; 95 % CI: -3.04, -1.29, p <0.001; I2= 95.7 %, p-heterogeneity <0.001) but not effect on insulin (SMD = 0.48; 95 % CI: -0.53, 1.48, P = 0.353; I2= 96.1 %, p-heterogeneity <0.001), and HOMA-IR (SMD: -0.56; 95 % CI: -1.47, 0.35, p=0.229; I2= 95.0 %, p-heterogeneity <0.001). Conclusion: the evidence supports the consumption of N. sativa to reduce FBS and HA1c levels. Additional research, featuring extended durations and robust study designs, is necessary to determine the ideal dosage and duration of N. sativa supplementation for achieving a positive impact on glycemic markers.
- In this systematic review, the objective is to assess the effects of Nigella Sativa on parameters that reflect metabolic syndromes, such as lipid profile, blood pressure, blood glucose, and anthropometry indices. Six out of 8 randomised controlled trials (n:776) demonstrated a significant improvement in lipid profile (p <0.05), 5 out of 7 trials (n:701) showed a significant reduction in glycaemic indices (p <0.05), 1 out of 5 trials (n:551) demonstrated significant improvements in blood pressure (p <0.05), and 2 out of 7 trials (n:705) showed a significant reduction in anthropometric measurements (p <0.05). Conclusion: Nigella Sativa has proved to have a significant positive effect on lipid profile and glycaemic index. The results showed in the parameters of blood pressure and anthropometric indices are less convincing, as results were inconsistent across studies. Nigella Sativa can therefore be recommended as an adjunct therapy for metabolic syndrome.
- This study was designed to investigate the effect of Nigella sativa supplementation on polycystic ovary syndrome (PCOS) symptoms and their severity in adolescents. The current randomized clinical trial was conducted on 114 adolescents with PCOS who were referred to gynecologist offices and clinics in Gonabad, Iran from March 2022 to March 2023. Participants were randomly allocated to the intervention (Nigella sativa 1000 mg/day) and control (10 mg/day medroxyprogesterone from the 14th day of the cycle for 10 nights) groups. The study duration was 16 weeks. Ovarian volume (measured by ultrasound), anthropometric and blood pressure; serum testosterone, dehydroepiandrosterone (DHEA), dehydroepiandrosterone sulfate (DHEA-S), luteinizing hormone (LH), hirsutism severity (Ferriman-Gallwey score) levels were evaluated before and after the study. Data from 103 participants (control group = 53, intervention group = 50) were analyzed. The mean age of participants was 17.0 (Interquartile range [IQR]:2.0). The mean difference in hirsutism score changes (p < 0.001), right (p = 0.002), and left (p = 0.010) ovarian volume, serum LH (p < 0.001) and testosterone (p = 0.001) were significantly higher in the intervention group compared to the control group. The frequency of oligomenorrhea, menometrorrhagia, and amenorrhea, were significantly reduced after the study in the intervention group compared to the control group (ps < 0.001). Conclusions: Short-term Nigella sativa supplementation may be effective in reducing ovarian volume and improving hormonal balance, and menstrual irregularities in adolescents with PCOS. Further research and long-term studies are warranted to validate the potential therapeutic effects of Nigella sativa in adolescents with PCOS.
- This study evaluates the efficacy of a novel mucoadhesive patch containing Nigella sativa 10% extract compared to triamcinolone 0.1% in alleviating symptoms and reducing lesion severity in patients with erosive-atrophic oral lichen planus. A pilot study comprising two groups, each with 10 patients, was conducted. The intervention group received mucoadhesive patches containing N. sativa 10% extract, while the control group received triamcinolone acetonide 0.1% patches. Pain and burning intensity, measured through visual analog scale, and lesion severity based on the Thongprasom scale were assessed weekly for 4 weeks. Descriptive records were kept for side effects and patient satisfaction. Pain and burning intensity decreased in both groups throughout the sessions, with the N. sativa group showing a greater reduction than the triamcinolone group. The reduction in burning intensity within each group was significant (p < .001), and there was a significant difference between groups only in the second session (p = .045). The overall difference between groups was not significant (p > .05). Lesion severity also decreased significantly in both groups (p < .001), with a significant difference between groups observed in the third session (p = .043) and overall throughout the study (p = .006). Conclusion: The use of N. sativa extract in mucoadhesive patches was as effective as corticosteroids in reducing pain, burning, and lesion severity in patients with oral lichen planus, with N. sativa showing superior results in some sessions. Notably, no significant complications were observed with N. sativa use, making it a promising treatment option for lichen planus.
- This study aimed to explore the impact of N. sativa supplementation on the lipid profile of adult participants. We searched Scopus, Web of Science, PubMed, Cochrane, and Web of Science databases until December 2022. Random effects models were used, and pooled data were determined as standardized mean differences with a 95% confidence interval. The findings of 34 studies with 2278 participants revealed that N. sativa supplementation significantly reduced total cholesterol (TC) (SMD: -1.78; 95% CI: -2.20, -1.37, p < 0.001), triglycerides (TG) (SMD: -1.2725; 95% CI: -1.67, -0.83, p < 0.001), and low-density lipoprotein cholesterol (LDL-C) (SMD: -2.45; 95% CI: -3.06, -1.85; p < 0.001) compared to control groups. However, a significant increase was found in high-density lipoprotein cholesterol (HDL-C) (SMD: 0.79; 95% CI: 0.38, 1.20, p < 0.001). Conclusion: N. sativa has improved effects on TG, LDL-C, TC, and HDL-C levels. Overall, N. sativa may be suggested as an adjuvant anti-hyperlipidemic agent.
- In this double-blind clinical trial, 70 nulliparous pregnant women referred to Hajar Hospital and Imam Ali clinics of Shahrekord and had missed abortion before the 12-week gestational age were selected and randomly divided into two interventions and control groups. The intervention group received 5 g of Nigella sativa oil alone daily for up to 3 days and the control group received a placebo. In case of nonresponse, 3 days after the last dose of medication or placebo, 800 μg of misoprostol (vaginal) were used. Data were analyzed by SPSS software. The chi-square test, Fisher’s exact test, independent t-test and paired t-test were used for analytical statistics. According to the results, 18 cases (51.4%) in the intervention group and seven cases (20%) in the control group showed complete evacuation of uterine contents which had a significant difference (p < 0.05). The frequency of vagina physical examination and type of hemorrhage did not show any significant difference between the two groups before and after the intervention. After the intervention, human chorionic gonadotropin (HCG) was significantly decreased in the intervention group but did not change in the control group (p < 0.05). The frequency of adverse events in the intervention group was three (8.6%) and in the control group was one (2.9%) which had no significant difference. Conclusion: Nigella sativa improves the outcome of missed abortion by reducing HCG and facilitating cervix dilatation and delivery of uterine contents.
- This systemaatic review evaluated the role of Nigella spp in managing allergic rhinitis (AR), a comprehensive review through systematic reviews and meta-analyses was conducted. To carry out a meta-analysis of clinical trials that used Nigella spp in treating AR based on current data. A meta-analysis of randomized controlled trials (RCTs) was performed. Various databases, including PubMed, Web of Science, Embase, Science Direct, Springer Link and the Cochrane Library, were searched until October 2023 to obtain RCTs assessing impact of Nigella spp in the control of AR. The current meta-analysis was carried out with a random-effects model. There were 8 studies enrolled, and our meta-analysis findings revealed that, relative to the control group, observation group exhibited the markedly increased total effective rate for allergic rhinitis treatment (odds ratio [OR] = 4.24, 95% confidence interval [CI] (2.57, 7.27), and p < 0.00001); three studies showed that the effect of Nigella spp for nasal symptoms treatment among patients with allergic rhinitis was superior in observation group to control group [mean difference = -2.60, 95% CI (-2.82, -2.38), p < 0.00001]; adverse effects occurred in five studies, all of which were transient, did not require medical intervention, and were not statistically significant between the two groups [OR = 1.01, 95% CI (0.59, 1.73), p = 0.98]. Conclusion: The observation group demonstrated relative safety and had an enhanced effect on allergic rhinitis treatment and total nasal symptom improvement than the control group. The inclusion of fewer studies and the lower quality of trial design might affect the stability of the results. However, the evidence-based findings that Nigella spp for allergic rhinitis treatment is more accurate should be validated in future large-scale, multicenter, and well-designed RCTs.
Yes, I know: the evidence is not perfect for any of the indications. In addition, there is a problem with low bioavailability. And I am suspicious of any SCAM that seems to be effective for an incredibly long list of conditions.
At the same time, I have to admit that, collectively, the research on BSO is impressive. As BSO has been used for centuries (as a spice etc.), serious adverse effects seem unlikely. The evidence regarding its effectiveness might not be fully convincing but, in my book, it is encouraging.
On this blog, we have discussed all sorts of so-called alternative medicine (SCAM) but only rarely we scrutinize any of the many gadets and devices that are being promoted under the SCAM umbrella. Therefore, I will in future try to fill this gap.
This study investigated the effects of a magnetic pain relief patch (MPRP) on gait variability in adults. In 10 young men and women, MPRP was attached to 18 bilateral lower limb muscle areas (biceps femoris, gastrocnemius medialis, gastrocnemius lateralis, rectus femoris, soleus, semitendinosus, tibialis anterior, vastus medialis, and vastus lateralis) for 24 hours. Gait parameters collected from the accelerometer sensor were ground contact time, cadence, stance phase, swing phase, double support, stride length, and swing width, and were analyzed as gait variability. Data analysis was performed using the Wilcoxon signed-rank test.
Significant differences were found in the left and right gait cycle time coefficient of variation (CV) (p=0.047 in left, p=0.028 in right), cadence CV (p=0.047 in left and right), and double support CV (p=0.028 in left and right) before and after attachment of the MPRP.
The author concluded that MPRP enhances gait variability and can be utilized as a potential tool to complement noninvasive pain management and rehabilitation strategies. However, further studies are required to prove the long-term benefits and optimal application protocol of MPRP use.
My interpretation is very different!
Background: Static magnets are marketed with claims of effectiveness for reducing pain, although evidence of scientific principles or biological mechanisms to support such claims is limited. We performed a systematic review and meta-analysis to assess the clinical evidence from randomized trials of static magnets for treating pain.
Methods: Systematic literature searches were conducted from inception to March 2007 for the following data sources: MEDLINE, EMBASE, AMED (Allied and Complementary Medicine Database), CINAHL, Scopus, the Cochrane Library and the UK National Research Register. All randomized clinical trials of static magnets for treating pain from any cause were considered. Trials were included only if they involved a placebo control or a weak magnet as the control, with pain as an outcome measure. The mean change in pain, as measured on a 100-mm visual analogue scale, was defined as the primary outcome and was used to assess the difference between static magnets and placebo.
Results: Twenty-nine potentially relevant trials were identified. Nine randomized placebo-controlled trials assessing pain with a visual analogue scale were included in the main meta-analysis; analysis of these trials suggested no significant difference in pain reduction (weighted mean difference [on a 100-mm visual analogue scale] 2.1 mm, 95% confidence interval -1.8 to 5.9 mm, p = 0.29). This result was corroborated by sensitivity analyses excluding trials of acute effects and conditions other than musculoskeletal conditions. Analysis of trials that assessed pain with different scales suggested significant heterogeneity among the trials, which means that pooling these data is unreliable.
Interpretation: The evidence does not support the use of static magnets for pain relief, and therefore magnets cannot be recommended as an effective treatment. For osteoarthritis, the evidence is insufficient to exclude a clinically important benefit, which creates an opportunity for further investigation.
Our systematic review did evidently not stop the author to do his own study – good for him!
But what a study it is!!!
Alert readers will have noticed that the study has no control group. Others might have remarked that the notion of static magnets of this kind doing anything meaningful to our bodies lacks plausibility. Thus the observed effects cannot possibly attributed to the magnet therapy. Most likely they are due to the considerable attention the volunteers received.
Some might argue that such gadgets do no harm – so, why not use them? I would disagree with this notion. Firstly, they cost money and thus harm the finances of gullible consumers. Secondly, they distract people from effective treatments and thus have the potential to prolong the suffering of patients.
In view of all this, I feel I should rewrite the conclusions as follows:
Attention can improve pain and enhance gait variability. MPRP is neither biologically plausibe nor has it been shown to be clinically effective. Responsible clinicians should stop using MPRP and employ effective treatments instead. Future research on MPRP must be categorized as a waste of resources.
