meta-analysis
Robert F Kennedy Jr. (RFKJr.)recently said that he’s aiming to know the cause of the “autism epidemic” by September, and will be able to “eliminate those exposures” that he says are behind the condition. This and other statements lay bare the embarrassing ignorance of RFKJr. as it contains a surprising number of errors:
- There is no epidemic of autism. The figures he likes to quote are hugely inflated. According to a meta-analysis, 0.77% of children globally are diagnosed with ASD, with boys comprising 1.14% of this group. Notably, Australia showed the highest prevalence rate, with an effect size of 2.18, highlighting it as a critical area for public health focus. The increase observed by many is largely due to a widening of diagnostic criteria.
- He presupposes that autism is due to some type of exposure (he claimed: “We know it’s an environmental exposure.”). However, this is far from proven and several other possibilities exist; most experts think that a genetic predisposition is the most important factor.
- Even if he can identify an exposure, it is unclear that and how he might eliminate it.
- To do the necessary research by September is not realistic.
RFKJr. has hired another pseudo-scientist, David Geier, to conduct the research. If they approached the subject rationally, they would start by looking what research has already been done. Few areas of inquiry are more active that research into autism (Medline currently lists ~ 84 ooo papers on the subject).
Here are some examples of conclusions from recent meta-analyses showing subject areas where research might yield relevant findings and those that are likely to be dead ends:
Probable dead ends
- For children, strength of evidence was high for no increased risk of autism following measles, mumps, and rubella (MMR) vaccine.
- Our study provides evidence that in utero exposure to ADHD medications does not increase the risk of long-term neurodevelopmental disorders in offspring. This study replicates safety data for methylphenidate and extends it with new safety data on amphetamines and atomoxetine. These findings are crucial for informing clinical guidelines and helping healthcare providers and expectant mothers make informed decisions.
- This study indicates that individuals with Kawasaki disease have a higher risk for ADHD but not for Autism Spectrum Disorder (ASD).
- Results found no evidence to support a link between genetically predicted Human Herpesviruses infection and the risk of NDDs based on existing datasets.
- These findings indicate that prenatal painkiller exposure is unlikely to be a major determinant of the severity of neurodevelopmental outcomes in autistic children.
Possibly relevant
- Our study summarized research evidence on the genetic variants of ASD and provides a broad and detailed overview of ASD risk genes.
- Maternal diabetes is associated with an increased risk of neurodevelopmental disorders and impaired neurodevelopmental performance in children. Further high-quality research is needed to establish causality and clarify the associations between specific types of diabetes and the full spectrum of neurodevelopmental disorders.
- Suggestive evidence included the associations between pregnancy O3 exposure and autism spectrum disorder.
- Gestational exposure to valproate was associated with an increased risk of autism spectrum disorder.
- This study indicated that Bisphenol A (BPA) exposure was associated with an increased risk of neurodevelopmental disorders and problems (NDPs) in children, particularly in boys, underscoring the importance of considering BPA exposure as a potential risk factor for children’s brain health.
- Our study found a significant difference in dental caries severity between children and adolescents with Autism Spectrum Disorder (ASD) and those without ASD.
- The development of childhood ASD may be associated with screen exposure.
- The total number of cannabis exposed pregnancies (with ASD and ADHD as the outcomes) in world literature is small. However, cannabis use during pregnancy is, at the very least, a clear marker for adverse neurodevelopmental outcomes
- In this meta-analysis, the relationships between air pollutants and ASD risk revealed significant associations, particularly for PM2.5 and NO2. Exposure during preconception exhibited a protective trend, while postnatal exposure, particularly during the second year of life uncovered substantially higher ASD risk.
- While there was weak evidence for associations between antibiotic use in early-life and later neurodevelopmental outcomes, these were attenuated in sibling-controlled subgroup analyses. Thus, associations may be explained by genetic and familial confounding, and studies failing to utilise sibling-control groups must be interpreted with caution.
- The current findings suggest that Anorexia Nervosa (AN) frequently overlaps with both autistic traits and autistic symptomatology. Therefore, it is essential to evaluate autism and autistic traits in individuals with AN to tailor individualized treatment plans.
- Increased risk of autism in children is significantly associated with greater parents’ ages.
- Parental PMADs are significantly associated with an increased risk of NDDs in children.
Above, I wrote that rational scientists would approach the subject by evaluating the research that has already been done. So, why will Kennedy, Geier et al not do that?
Simple!
The very first meta-analysis cited above (confirmed by multiple further reviews) firmly establishes that the pursuit of RFKJr.’s obsession (vaccines cause autism) is a dead end! The issue has been researched, re-researched ad nauseam and laid to bed.
So, in order to confirm his belief, RFKJr. needs to spend all this money in order to find (or manipulate) some evidence that questions a rock-solid consensus. Once he has succeeded in this task, he will to do what all pseudo-scientists do best: he will pretend that correlations are prove of causation.
In the end, this will amount to a spectecular waste of money. Because some people will nevertheless believe RFKJr., it will also strengthen the anti-vax movement and thus further endanger public health.
WATCH THIS SPACE!
Dr. Stephan Baumgartner, Deputy Director of the “Institute of Complementary and Integrative Medicine” in Bern, Switzerland, and Dr. Alexander Tournier, Research Associate at the same institution are well known defenders of homeopathy. They just published a paper entitled SCIENTIFIC EVIDENCE ON HOMEOPATHY. Needless to say that such an article is relevant for my blog and attracted my interest.
In their abstract, they claim that “the most recent meta-analyses of RCTs across all indications concluded that there is evidence for specific effects of homeopathic remedies superior to placebo when prescribed by a qualified homeopath. Furthermore, there are several meta-analyses on specific indications (e.g. allergic complaints, childhood diarrhoea) which provide evidence for specific effects of homeopathic preparations superior to placebo.”
As I have published several such papers, I had a look at which of them – if any – they quoted. It turns out they only cited the one entitled “Homeopathy for postoperative ileus? A meta-analysis“. Here is its abstract:
Homeopathic remedies are advocated for the treatment of postoperative ileus, yet data from clinical trials are inconclusive. We therefore performed meta-analyses of existing clinical trials to determine whether homeopathic treatment has any greater effect than placebo administration on the restoration of intestinal peristalsis in patients after abdominal or gynecologic surgery. We conducted systematic literature searches to identify relevant clinical trials. Meta-analyses were conducted using RevMan software. Separate meta-analyses were conducted for any homeopathic treatment versus placebo; homeopathic remedies of < 12C potency versus placebo; homeopathic remedies of > or = 12C potency versus placebo. A “sensitivity analysis” was performed to test the effect of excluding studies of low methodologic quality. Our endpoint was time to first flatus. Meta-analyses indicated a statistically significant (p < 0.05) weighted mean difference (WMD) in favor of homeopathy (compared with placebo) on the time to first flatus. Meta-analyses of the three studies that compared homeopathic remedies > or = 12C versus placebo showed no significant difference (p > 0.05). Meta-analyses of studies comparing homeopathic remedies < 12C with placebo indicated a statistically significant (p < 0.05) WMD in favor of homeopathy on the time to first flatus. Excluding methodologically weak trials did not substantially change any of the results. There is evidence that homeopathic treatment can reduce the duration of ileus after abdominal or gynecologic surgery. However, several caveats preclude a definitive judgment. These results should form the basis of a randomized controlled trial to resolve the issue.
And here is the paragraph from the article by Baumgartner and Tournier citing our paper:
Barnes et al. (1997) performed a systematic review and meta-analysis of controlled clinical
trials investigating the effects of a homeopathic treatment of postoperative ileus. Meta
analysis yielded a statistically significant (p < 0.05) weighted mean difference (WMD) in favour
of homeopathy (compared with placebo) on the time to first flatus. The exclusion of
methodologically weak trials did not substantially alter the results. The authors concluded
that “our analyses suggest that homeopathic treatment administered immediately after
abdominal surgery may reduce the time to first flatus when compared with placebo
administration”.
(The bits that I have put in bold print are the ones that appear in this paragraph.)
Are you puzzled?
Me too!
What they also forgot to mention is the fact that, in our paper, we explained that the partly positive outcome was produced by several small and flawed trials. They were the reason why eventulally a large and rigorous study was conducted. Its results showed homeopathy to be no better than placebo. Yet, in the meta-analysis this study was not large enough to out-weigh the rigorous trial (this is a well-known weakness of meta-analyses and requires carefull attention when interpreting the findings).
It seems important to note that after the rigorous trial, no further studies of homeopathy for post-operative ileus have emerged. The reason, it seems, is that this trial was conclusive and thus put the notion to rest that homeopathy might work for this highly prevalent condition.
Finally, as I merely looked at one single aspect, I wonder whether there are further misrepresentations in the Baumgartner/Tournier paper.
Here is my question to my readers: does the behavior of Baumgartner and Tournier amount to
- honest error,
- sloppiness,
- wishful thinking,
- dishonesty,
- fraud,
- scientific misconduct?
PLEASE, DO LET ME KNOW WHAT YOU THINK
In a recent post, I mentioned a new report which allegedly claimed that “employing chiropractors in the [English] health service could save £1.5 billion“. Thanks to ‘Blue Wode’, we can now read the original report, and I had a critical look at it. Here are some quotes of crucial passages from the report:
The objective of this analysis was to establish how chiropractors could help to address the unmet need of people with MSK [musculoskeletal] conditions, who are currently absent from work due to these conditions, on NHS MSK physiotherapy waiting lists …
To assess the available evidence on the relative effectiveness of chiropractors, physiotherapists and osteopaths a pragmatic literature review was undertaken. This consisted of a rapid, pragmatic search of existing literature evidence to explore the effectiveness of chiropractic interventions (in terms of productivity/return to work) compared with physiotherapists and/or osteopaths … The strategies were not designed to be ‘comprehensive’ but focused to target records for relevant studies whilst retrieving record numbers that were manageable within the project timescales and available resources…
The results of the analysis are based on the assumption that there are equivalent work-related outcomes associated with MSK physiotherapy and chiropractic care…
1,270 records were retrieved from the database searches and 41 records were sent by the BCA. 101 duplicates were removed, and the remaining 1,210 references were screened for inclusion. 18 studies met the eligibility criteria and were included in data extraction (see Appendix B for the study flow diagram). Included studies had the following study designs: five systematic reviews [29-32] (of which one was only a summary [33]), three non-systematic reviews [34, 35] with one running a meta analysis [36], five randomised controlled trials [37-41], three cohort studies [42-44], and two case series studies [26, 45]…
A pragmatic review of literature found that evidence of the effectiveness of chiropractors in helping people with MSK conditions to get back to work is sparse and poor quality. There is weak evidence to suggest that chiropractors treating MSK conditions would be able to achieve equivalent return-to-work outcomes as physiotherapists. If more robust evidence could be developed, it is feasible that chiropractors could be used to address supply shortages in treatment for MSK conditions. This would require the NHS to consider closely the clinical governance arrangements it would need to put in place to ensure patient safety. It would also need to review the type of treatment and advice that chiropractors were able to provide for people with MSK conditions.
The initial analysis carried out for this study estimated that there are almost 1.6 million people unable to work due to an MSK condition in the UK. Spare capacity in the chiropractic profession indicates that around 114,000 more people per year could be treated by chiropractors. This represents around 7% of the current waiting list. Chiropractors have an average waiting time of 1.5 weeks compared with a minimum of 11 weeks for physiotherapists.
If the spare chiropractor capacity was used to address MSK conditions preventing people from working, then this could improve workforce productivity by reducing the time people are waiting for treatment. Adopting a simple analysis, assuming that all of the spare capacity could be used in the most efficient way, the estimated value of the improvement in productivity is £612 million per year. Using the Markov model to factor in a wider range of potential outcomes provides a more conservative, more robust estimated value of £399 million per year. If minimum rather that median wages are used to value the productivity gain based on an 11 week wait then it would reduce to £258 million.
A range of factors may increase or decrease the potential productivity gains. If the 11-week waiting time for physiotherapists is an under-estimate and the waiting times are 18 or 24 weeks, then the productivity gain would increase to £713 million and £1 billion respectively.
This analysis focused on productivity costs only, but people may also potentially have better health outcomes and lower treatment costs if they are treated more quickly.
Recommendations
Key recommendations emerging from this research are:
- The NHS should consider commissioning pilot research studies to generate evidence to make the case for the use of chiropractors in providing treatment for people with MSK conditions to allow them to return to work more quickly.
- The NHS should consider how the potential use of chiropractors to provide treatment and advice for people with MSK conditions can help to address the demand, capacity and financial challenges facing the health and social care system. This would need to be within the constraints of clinical guidelines and governance, to ensure safety and effective outcomes.
_______________________________________
And here are a few critical points:
- What on earth is a “pragmatic literature review”; was the term invented to disguise tha fact that the review is not systematic and thus is a bonanza in cherry-picking? I had a look at the cited literature and can confirm that any critical assessment of chiropractic has been excluded.
- “The results of the analysis are based on the assumption that there are equivalent work-related outcomes associated with MSK physiotherapy and chiropractic care.” Are you kidding me? I thought the aim was to “assess the available evidence on the relative effectiveness of chiropractors, physiotherapists and osteopaths”. How can you then assume equivalent outcomes as a basis for conducting the research?
- “Included studies had the following study designs: five systematic reviews [29-32] (of which one was only a summary [33]), three non-systematic reviews [34, 35] with one running a meta analysis [36], five randomised controlled trials [37-41], three cohort studies [42-44], and two case series studies [26, 45].” So, just 5 RCTs are the basis of the evaluations? What did you do with the dozens of other RCTs in this area? Did they perhaps not fit your conclusions?
- “If more robust evidence could be developed, it is feasible that chiropractors could be used to address supply shortages in treatment for MSK conditions.” However, I predict that more robust evidence will show the opposite of what you seem to wish!
- “Ensure patient safety”. Yes, thanks for mentioning safety. The report neglects safety completely. In view of the known risks of chiropractic this seems a serious mistake!
- “The estimated value of the improvement in productivity is £612 million per year.” From my comments above, it follows that this wild and largely unsubstantiated estimate was guided by little more than wishful thinking.
- “This analysis focused on productivity costs only, but people may also potentially have better health outcomes and lower treatment costs if they are treated more quickly.” More likely people experience health outcomes that are very similar to those of doing nothing at all. In this case, it would follow that a lot of money might be saved if we scrap MSK treatments altogether.
This report is a transparent and dilettante attempt to push more chiropractic on the NHS, a move that would not improve much and could even put a few patients in wheelchairs.
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!
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!
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.
- slightly improved BPH symptoms measured with the International Prostate Symptom Score (IPSS) at follow-ups of up to 12 months (standardized mean difference [SMD] -2.06, 95% confidence intervals [CI] [-3.22, -0.91] very low certainty evidence, 6 studies),
- reduced prostate specific antigen (PSA) levels (mean difference [MD] -0.37 ng/ml, 95% CI [-0.50, -0.23] low certainty evidence, 4 studies)
- had little effect on quality of life (SMD -0.59, 95% CI [-1.57, 0.38] very low certainty evidence, 2 studies).
The main reasons for downgrading the evidence were study limitations (studies judged to be at an unclear or high risk of bias), inconsistency (considerable heterogeneity), and imprecision (small effect sizes and wide confidence intervals around effect estimates). All six studies reported no adverse-effects.
- positive but not truly honest about the limitations of the evidence (we see this regularly on my blog);
- or they are sufficiently critical and thus arrive, like our above paper, at unequivocal (and sadly not very helpul) conclusions.
As this is so, we see very few SRs that conclude “there is sound evidence to show that SCAM xy is effective (or ineffective)”. Yet, such verdicts would be what consumers need.
The cause of the first scenario (false-positive conclusion) is that reviewers are biased and want to demonstrate that SCAM works. Such authors behave unethically, in my view, because they mislead the public and might cause untold harm. The cause of the second scenario (unequivocal conclusion) is the poor quality of the primary studies. This phenomenon too is mostly due to over-enthusiastic researchers who want to prove their SCAM instead of testing it. Conducting a clinical trial is far from easy or cheap. It is beyond me, why so many SCAM trialists do not try their best to do it well!
If you think of it, the most likely reason is that they are not really interested in finding the truth but mainly want to promote their agenda. If you don’t believe me, have a look at my ALTERNATIVE MEDICINE HALL OF FAME and the amazing men and women in it.
It is time, I think, that SCAM researcher learn the most basic principle of their profession: science is not a game where you set out to confirm what you believe. Science works by
- formulating a hypothesis,
- doing your very best to prove your hypothesis wrong,
- only if it cannot be proven wrong, assuming that it probably is correct.
To put it bluntly: investigators who use science to prove their point are not scientists but pseudo-scientists, and sadly SCAM has more than its fair share of such charlatans (drunken men using a lamp-post for support rather than enlightenment!). To put it even more bluntly: to prevent serious harm – because that sort of thing does a lot of real harm! – researchers who repeatedly show themselves to be incapable of doing unbiased science (again, see my ALTERNATIVE MEDICINE HALL OF FAME), should be banned from doing research.
According to the authors of a recent paper, “the placebo response in clinical trials has four components: regression to the mean (RTM), measurement artefacts, natural tendency (NT) of the disease, and the genuine placebo effect”. The objective of their analysis was to determine what contributes to the size of the placebo effect in clinical drug trials by meta-regressions of randomized placebo-controlled clinical trials.
The authors identified 5 diseases where data on the rates of NT were available to search for a sample of n=150 (5×30) RCTs. They extracted various study descriptors and performed meta-regressions to predict improvement in treatment and placebo groups. The investigators sampled 30 trials each from the following diagnoses:
- osteoarthritis of the knee,
- irritable bowel syndrome,
- depression,
- sleep disorders,
- migraine,
and extracted relevant information. They estimated the effects due to RTM and NT and analyzed the improvement in the placebo and treatment groups by fitting two regression models. Both models were highly significant, explaining 72% of the variance. Improvement in the placebo group can be significantly predicted by improvement in the treatment group (beta= .84), whether a study was analyzed according to intention to treat (beta= -.10) or was a multicenter study (beta= .12). Improvement in the treatment group can be explained by the improvement in the placebo group (beta= .83), whether a study was a multi-center trial (beta = -.16), and by RTM (beta= -.18). The treatment effect is smaller in sleep studies (beta= -.17).
The authors concluded that the high correlation of r= .73 between placebo improvement and treatment improvement rates is genuine and not explainable by study or disease characteristics. We conclude from our data that the placebo-effect is the major driver of treatment effects in clinical trials that alone explains 69% of the variance. This leaves only limited space for effects due to pharmacological substances. Context effects are more important than pharmacological ones in the conditions studied by us.
Walach (senior author of the paper) offers the following explanation for the findings:
“The design of a clinical study, with blinding and randomisation, fulfils the formal criteria necessary to establish a generalised entanglement correlation [6-8]. This would mean: part of the therapeutic effect of a pharmacological substance is also found in the control group; but only because an entanglement correlation was generated by the blinding and randomisation. To put it another way: it is not really possible to draw any conclusions about the true effects of verum interventions based on such studies. Rather, one would have to use very different study types and extract the effect by combining the different data, as we once proposed. If one were to take these effects really seriously, the methodological canon would crumble quite quickly. But they are also the reason why, in interventions where the specific effects may be very small, it is not possible to separate ‘real’ from ‘fake’ effects by means of blinded, placebo-controlled studies.”
I might suggest an alternative explanation:
SLOPPY SCIENCE.
Let me explain:
- The authors lumped together trials of various drugs as though they are a homogeneous entity in terms of effectiveness beyond placebo (which, of course, they are not).
- The placebo response is the measured improvement of a patient in a clinical trial after receiving a sham treatment. Yet, the authors claim “the placebo response in clinical trials has four components: regression to the mean (RTM), measurement artefacts, natural tendency (NT) of the disease, and the genuine placebo effect”. This is nonsense, and I even fear that the authors know it.
- The paper’s ‘highlight’ claims that contextual factors like expectations and doctor-patient interactions drive healing. Yet, these phenomena are seperate from the placebo-effect and were not the subject of this investigation.
- Correlation is not causation.
I am surprised that the Journal of Clinical Epidemiology published this rubbish!
Do Chiropractors Break Necks? This is an interesting question. “Dr.” Greg Malakoff (Chiropractor/Neurologist, Board Certified) provided the following answer (never mind that he seems to mean ‘do chiros cause strokes?’):
… The total disinformation that seems to be republished monthly on the news concerning chiropractors and strokes is based on a study performed in the 1950’s, that has been totally discredited. However, students these days are rather lazy and every time a meta analysis is performed on this old study it reaches all the news stations because their main sponsors are drug companies and they don’t want you having the opportunity to get well without their products. A meta analysis is simply someone reading the old study, and writing a book report on it.
If they were to actually study what has been discovered since the 1950’s, which is a tremendous amount of valid scientific research, not one done on a cadaver and deliberately making false conclusions, they would discover a few things, that I feel you should know.
The typical stroke victim if they survive has stroke posture, which consists of the arm being flexed and a lower leg extended. That would be a whole lot of brain damage, but we don’t see the entire motor strip damaged on brain scans. We typically see just a small area with an infarct. That area is the internal capsule. Picture a vase with all it’s stems entering into the narrow portion of it. All the neurons in the brain that leave it from different areas of the motor cortex with long nerves that go to innervate the muscles that you want to move are exiting through this narrow opening called the internal capsule.
Why is that important to know if you ever want a chance at being healthy? The arteries in the back of your neck, called the vertebral arteries do not go there, they do not go to the internal capsule where we see the stroke damage. That part of the brain is being fed by the carotid arteries that are in the front of your neck. That means the chiropractor is not the problem, we are not affecting those arteries. Case closed.
However, there is a type of more severe stroke related to the back of the neck arteries called vertebral artery dissection. These arteries feed the brain stem and the vital centers in there. The vital centers are what keep you breathing and your heart beating. That means, that I have never been sued by a victim of this because they are going to be dead before they get off of the table. That doesn’t happen, well it hasn’t happened to me or just about any other chiropractor. People can get this type of artery damage, but it is proven to be practically impossible to tear those arteries by a chiropractic adjustment. It would require hundreds of pounds of force to tear those arteries with a chiropractic adjustment. So unless your chiropractor is the size of a Polar Bear, there is a good chance you are remaining sick or in pain for no reason at all.
I know, what about that playboy model who died from the chiropractor that she went to? The incompetent medical examiner said that was the cause, but apparently he and all the media don’t read well. She had fallen and hurt the arteries in her neck a month earlier. The E.R. didn’t bother to do an ultrasound Doppler study of her arteries and if they had, they might have realized that she was injured more severely. Instead, she sought help for her neck pain a month later from a chiropractor. Most chiropractors do not have ultrasound Doppler equipment in their office. Neither do most urgent medical care centers. In this case, the adjustment aggravated the severe insult that she had sustained a month earlier. Perhaps he is guilty of taking for granted that the E.R. had done it’s job properly. She should never have been released from the E.R.
While it was all over the news everyday, every hour of every day for weeks, just how often does something like this occur? You are more likely to get blown up out of the sky by a terrorist, and as you are falling to earth still in your seat, get struck by lightning and shot and stabbed by terrorists that have parachuted out of another plane to make sure they had finished their job. However, they too get struck by lightning and you fall to the ground safely where you are now eaten by a land shark.
With that in mind, millions of people are suffering daily for decades because they are afraid of a chiropractic adjustment. This is the safest and most powerful form of treatment known to modern medical science. The number 3 leading cause of death in America is from medicine. Compare that to the one woman that died from a chiropractor in Canada. The case is kind of famous because that was the case that had Chiropractic outlawed in a province. The patient was obese, smoked, was diabetic, and took birth control pills. She had died of a stroke a month after going to the chiropractor. She was the perfect storm of walking disease and as I stated earlier, if the chiropractor was to have caused the stroke, she was not walking out of his office.
There are millions of dollars to be made off of your medical misery. You being sick helps fuel our economy. However, if you want the opportunity to be healthy it can’t be achieved with a lifestyle of drugs. Chiropractors have been labeled back pain doctors, but we are really brain doctors. Our treatment affects your brain and your brain is responsible for creating good health. If you are a drug company, then you would want people to be sick and miserable enough to buy your product. If you are sick and tired of being sick and tired your best chance of not staying that way is to visit a chiropractor. Don’t let all the disinformation keep you miserable and unhealthy.
___________________
I find Malakoff’s answer relevant nnot least because it demonstrates a few points that are important:
- Some chiros call themselves doctors and manage to fool consumers in assuming that they are medically competent.
- Some even call themselves neurologists, it seems.
- They are the exact opposite of competent.
- They understand neither science, nor medicine, nor the methodologies used.
- They have misunderstood so much about [patho)physiology that it’s frightening to think they treat ill people.
- Despite all this they love to use pseudo-scientific language.
- They use it to impress and to white-wash their quackery and the chiropractic profession.
- They have an unrealistic view about the value of chiropractic.
- They are in denial about the risks of spinal manipulation.
- They are consumed by conspiracy theories without even attempting to provide evidence in their support.
The year 2024 brought many disappointments. But let’s not dwell on those, lets get in the mood for tonights celebrations! And what could be more fitting for that than a review of the positive cardiovascular effects of wine drinking? After all wine involves both aromatherapy as well as antioxidants, botanical medicine and naturopathy! As luck would have it, we even have some recent evidence on this very subject.
The objectives of this systematic review and meta-analysis were:
- (i) to examine the association between wine consumption and cardiovascular mortality, cardiovascular disease (CVD), and coronary heart disease (CHD),
- (ii) to analyse whether this association could be influenced by personal and study factors, including the participants’ mean age, the percentage of female subjects, follow-up time and percentage of current smokers.
The searched several databases for longitudinal studies from their inception to March 2023.
A total of 25 studies were included in the systematic review, and 22 could be included the meta-analysis. The pooled risk ration (RR) for the association of wine consumption and the risk of CHD using the DerSimonian and Laird approach was 0.76 (95% CIs: 0.69, 0.84), for the risk of CVD was 0.83 (95% CIs: 0.70, 0.98), and for the risk of cardiovascular mortality was 0.73 (95% CIs: 0.59, 0.90).
The authors concluded that their research revealed that wine consumption has an inverse relationship to cardiovascular mortality, CVD, and CHD. Age, the proportion of women in the samples, and follow-up time did not influence this association. Interpreting these findings with prudence was necessary because increasing wine intake might be harmful to individuals who are vulnerable to alcohol because of age, medication, or their pathologies.
What, you suspect that this paper was sponsored by the wine industry?
No, you are mistaken! It was funded by FEDER funds, by a grant from the University of Castilla-La Mancha, and by a grant from the science, innovation and universities.
So, maybe just for tonight we put the worries about our livers aside and enjoy a (non-homeopathic) dose of wine.
