herbal medicine
We all have heard a lot about this year’s Nobel Prizes, I’m sure. One claim that I came across regularly is the notion that the US are the leading nation in Nobel awards. And for once, it’s not even fake news. Here is the list of the 10 leading countries :
Rank – Country – Number of laureates – Number of prizes
- United States 424 (427 prizes)
- United Kingdom 144 (145 prizes)
- Germany 116
- France 77 (78 prizes)
- Sweden 34
- Japan 33
- Russia/Soviet Union 30
- Canada 28
- Switzerland 27
- Austria 25
Impressive!
But hold on, that’s grossly misleading! Surely, we need to account for the size of each country!
Once we do that, the list looks very different, and the US fall into 15th place. Here is the list ranking countries by Nobel laureates per 10 million people, including all prizes and based on a common compilation up to 2013:
Since this blog is about so-called alternative medicine (SCAM), let’s also see what the contribution of SCAM has been. Here is a list of Nobel prizes in Physiology/Medicine by healthcare professions:
The global aging population faces increasing risks of supplement-drug interactions due to rising polypharmacy and widespread use of nutritional supplements. Older adults, particularly those with chronic conditions, frequently combine prescription medications with dietary supplements, yet healthcare providers often overlook these interactions, leading to preventable adverse effects.
This review synthesized evidence from 16 international studies spanning nearly three decades, examining the intersection of supplement and medication use in older adults. Key findings reveal a high prevalence of concurrent use (23-82.5%), significantly increasing the likelihood of adverse interactions, particularly with antithrombotics (e.g., warfarin and ginkgo) and absorption-disrupting minerals (e.g., calcium and levothyroxine). A critical systemic failure in patient-provider communication exacerbates these risks, as clinicians often neglect to inquire about supplement use. Despite widespread potential interactions, actual clinical harm appears concentrated in high-risk combinations. The review calls for proactive clinical strategies, including standardized supplement screening, targeted patient education, and pharmacist-led medication management. Its limitations include cross-sectional study designs and self-reported data, underscoring the need for longitudinal and intervention-based research.
The authors concluded that future studies should prioritize causal evidence, standardized methodologies, and data from low- and middle-income countries to mitigate risks in aging populations.
All of this is true. Yet, I feel that several important points is missing:
THE RISKS OF SUPPLEMENT/DRUG INTERACTIONS ARE BY NO MEANS CONFINED TO THE AGING POPULATION!
On the contrary, many surveys suggest that middle-aged, affluent consumers use more of both and therefore are at an even higher risk than the eldely.
Communication with your physician seems a logical solution, but is it? There is plenty of evidence to show that doctors rarely know much about these interactions (and practitioners of so-called alternative medicine (SCAM) know even less). It gets worse: there is a deplorable lack of research into this subject. Consequently, the knowledge in this area is woefully inclomplete.
If I am right, all this means that we need to
- do the necessary research as a matter of urgency,
- inform ourselves (this applies to healthcare practitioners as well as consumers)
- communicate the existing knowledge and warn consumers.
Failing to do this – as we now have done for many decades – means putting millions of consumers at risk.
Mehmet Oz has featured regularly on this blog, e.g.:
- Donald Trump nominated SCAM promoter, Mehmet Oz, to lead the Centers for Medicare and Medicaid Services (CMS)
- Columbia University cut ties with Dr. Mehmet Oz … or did they?
- Quackery promoter, Dr. Mehmet Oz, is running for the U.S. Senate
- Trump, Kennedy and Oz just announced plenty of untruths about autism and its treatment
Currently, he serves in Trump’s administration as “Administrator of the Centers for Medicare & Medicaid Services” (CMS). He also is (or was?) a “Global Advisor & Stakeholder” for the company ‘iHerb’, and was appointed to that role in 2023. The company itself is a global e-commerce platform that was founded in 1996 and has its headquarters in California. iHerb specializes in health and wellness products. iHerb’s mission is to make health and wellness products accessible to everyone. The company operates as a direct-to-consumer retailer. iHerb sells a wide variety of products, including:
- Vitamins, minerals, and supplements (VMS)
- Sports nutrition
- Beauty and personal care products
- Grocery items
- Baby and pet care products
Crucially, iHerb sells several products with leucovorin, i.e. folinic acid, the drug that, even though unproven, is now officially used for autism in the US. As far as I can see, most of the products that Oz promotes are not based on sound evidence.
Based on available information from a financial disclosure analysis, Mehmet Oz’s work as an advisor for ‘iHerb’ has earned him as much as $25 million in company stock. The disclosure, which lists asset values in ranges rather than precise figures, shows that this stock was part of his overall financial portfolio.
Several experts have raised concerns that Oz’s financial interests in various healthcare and supplement companies, including iHerb, could create a conflict of interest. As the Administrator of the Centers for Medicare and Medicaid Services (CMS), a position that oversees a vast budget and a significant portion of the U.S. healthcare system, his past and present ties to the industry have been highlighted as potential issues. The concern is that a government official in such a powerful position could use their influence to benefit their own financial holdings or those of companies they are affiliated with. This is especially relevant given that Medicare Advantage, a program he would oversee, allows customers to use prepaid cards to buy over-the-counter medicines and supplements—a market that companies like iHerb are in.
Mehmet Oz has publicly disclosed his financial interests. A financial filing shows that his investments in ‘iHerb’ represented one of his largest financial holdings. In a filing with the Office of Government Ethics, Oz has committed to divesting his equity holdings in healthcare companies, including his iHerb stock, within 90 days of confirmation. He has also pledged to resign from his advisory role with ‘iHerb’. The Office of Government Ethics has stated that based on its review, it believes Oz is in compliance with applicable laws and regulations concerning conflicts of interest. The situation remains a point of public discussion and has drawn the attention of consumer advocacy groups. For example, the group Public Citizen has asked the Federal Trade Commission (FTC) to investigate whether Oz’s social media posts promoting iHerb violated FTC guidelines on undisclosed endorsements, as his posts did not always clearly state his financial connection to the company.
Based on current public information, there are serious questions and concerns about whether Mehmet Oz has divested all of his interests as pledged, particularly with respect to his holdings in ‘iHerb’. The latest publicly available filings detail his assets and his intent to divest, but do not show the final completed sale. iHerb itself has publicly stated that the company is no longer affiliated with Dr. Oz and is not working with him or the administration. However, this does not independently confirm the liquidation of his personal vested stock.
A failure to timely follow the pledge can and should trigger a chain of events that leads to serious civil and criminal penalties, as well as significant political repercussions.
It has been reported that the US surgeon general nominee, Casey Means, earned hundreds of thousands of dollars promoting supplements and other health and wellness products, details likely to invite new scrutiny about potential conflicts of interest for the author and entrepreneur.
Means, a close ally of health secretary Robert F. Kennedy Jr. and the sister of White House adviser Calley Means, has not yet been scheduled to appear before Congress for her confirmation hearing. But a filing dated Sept. 10 and posted by the Office of Government Ethics suggests her nomination cleared conflict-of-interest checks within the federal government.
The supplements industry has ties with several members of the Trump administration, including Medicaid director Mehmet Oz and health adviser Calley Means. An AP investigation this summer found that Casey Means had repeatedly failed to disclose her partnerships with supplements companies and other businesses promoted in her
newsletter, social media accounts, and elsewhere.
Among the payments included in the new disclosures for newsletter sponsorship and partnership fees are $12,000 from herbal remedies firm Apothekary; $27,431 from algae supplements company ENERGYbits; $16,461 from fiber supplements company Florasophy; $27,000 from probiotics company Pendulum Therapeutics; $46,000 from
supplements company Pique; $536 from prenatal vitamin company WeNatal; and $16,104 from basil seed supplements company Basil Seed Works. Means received a total of more than $130,000 in sponsorship fees from supplement company Amazentis, including a $55,000 book tour sponsorship.
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In May this year, I wrote this about Means:
RFK Jr wrote on X: “The Surgeon General is a symbol of moral authority who stands against the financial and institutional gravities that tend to corporatize medicine. Casey Means was born to hold this job. She will provide our country with ethical guidance, wisdom, and gold-standard medical advice.” Yet her suitability for Surgeon General is a contentious issue.
Means holds a 2014 MD from Stanford University and a bachelor’s degree in human biology. She is an advocate for addressing chronic diseases through nutrition, exercise, and lifestyle changes. Her book “Good Energy”, co-authored with her brother Calley, argues that metabolic dysfunction is a root cause of most chronic illnesses. As a “wellness influencer”, Means has demonstrated an ability to communicate health concepts to a broad audience.
Critics point out that Means dropped out of her residency at Oregon Health & Science University months before completion. This means she is not board-certified and has very limited clinical experience; for instance, she never saw patients without supervision. Her medical license has been inactive since 2024, and she has done as good as no own original research. Unlike past Surgeons General, who had extensive backgrounds in public health administration and infectious disease, Means has no government or public health leadership experience. Her focus is on functional medicine and wellness, both areas that lack rigor and are close to quackery.
It gets worse: Means has expressed skepticism about vaccines, suggesting in a 2024 newsletter that the current vaccine schedule contributes to the decline of pediatric health. Her endorsement of dangerous nonsense like energy healing and raw milk seems worrying. Moreover, Means also co-founded Levels, a company selling continuous glucose monitors to non-diabetics, and markets supplements and other dubious health products. RFKJr’s claim that Means will offer “ethical guidance” seems particularly odd: she has no training in medical ethics and some of her past actions are outright unethical. Physicians like Dr. Neil Stone have therefore called Means “grossly underqualified”.
The Surgeon General must provide science-based guidance, oversee >6,000 officers, and address diverse and serious public health issues. Means’ inexperience and narrow focus limits her effectiveness. Crucially, her history of promoting of vaccine skepticism and quack medicine undermines trust in science-based policies.
In summary, Means seems wholly unsuited for the job of Surgeon General. In the interest of the US public health, her appointment should not be confirmed by the Senate.
SAY NO MORE!
Weleda is the anthroposophic firm, founded in 1921 by Ita Wegman, the lover of Rudolf Steiner, that produces anthroposophic and homeopathic remedies as well as cosmetic products. It has been reported that the company is to re-examine its Nazi-era history amid revelations that it benefited from gruesome human experiments in a Nazi concentration camp during the Holocaust.
The German historian Anne Sudrow exposed the Weleda experiments in a new book under the auspices of the Dachau memorial. In response to the revelations, the company, now headquartered in Arlesheim, Switzerland, said it will re-examine its Nazi-era history. An in-house study, published last year, failed to uncover Weleda’s role in human experiments.
As reports of the revelations emerged, the company denounced Nazism in a corporate statement. “At Weleda, we condemn the atrocities of National Socialism in the strongest possible terms,” it said. “Fascism, anti-Semitism, racism, or right-wing extremist ideology have no place in our company. Weleda is a place of humanity. ‘Never again’ expresses our stance.”
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I have not yet read Anne Sudrow’s book (it’s not yet available as a hard copy), but I fear that the above cited article is not entirely correct. I think it erroneously conflates two seperate experiements by Sigmund Rascher: the hypothermia experiments and the ones on the Weleda frostbite cream. The latter seemed to have been much smaller and did not cause a high number of fatalities. Importantly, the research was unethical, fraaudulent and lousy!
The other allegation, namely that anthroposophic or biodymamic agricultural research took place in the Dachau “herb garden”, an annexe of the concentration camp where inmates were cruelly exploited for slave labor, is to the best of my knowledge correct. This work was carried out, I think, under the supervision of ex-Weleda employees. The main aim was to grow plenty of medicinal plants and render the Third Reich independent from foreign supplies.
But don’t take my word for it; perhaps I am mistaken – I will report back once I have read the book.
Ashwagandha (Withania somnifera) is a widely hyped herbal panacea that we have discussed several times previously, e.g.:
- Ashwagandha, an Ayurvedic wonder herb?
- Are herbal remedies the answer to hair loss?
- Ayurvedic medicine in the management of hypertension: how to kill millions with quackery and bullshit
- Why does the BBC mislead the public on matters related to so-called alternative medicine (SCAM)?
Although it is generally considered safe, rare adverse neurological effects may occur. This paper presents the case of a previously healthy adult male who developed acute-onset dystonia following the initiation of Ashwagandha supplementation.
A 40-year-old Asian male presented to the neurology outpatient clinic with a two-week history of intermittent abnormal neck movements, sustained conjugate ocular deviation to the left, and unsteady gait. His symptoms were characterized by painful involuntary neck muscle contractions, transient speech difficulty (aphonia), and episodes of sustained eye deviation. According to his wife, he also experienced intermittent delayed responsiveness and several near-falls, veering unpredictably while walking.
The onset of these symptoms had occurred approximately one week after initiating daily self-administration of a commercially available Ashwagandha (Withania somnifera) supplement. He had taken it for a total of 25 days prior to presentation, primarily to alleviate stress and improve sleep. He denied recent infections, fever, head trauma, seizures, alcohol or recreational drug use, or exposure to known neurotoxins. There was no history of psychiatric illness, and he was not on any chronic prescription medications except for intermittent use of diazepam 2.5 mg twice daily for anxiety, which he had started before initiating Ashwagandha and had not recently adjusted. His past medical history was significant for hyperlipidemia, for which he was not actively treated. Family history was notable for premature coronary artery disease. There was no personal or family history of movement disorders or neuropsychiatric conditions. Extensive diagnostic evaluation failed to identify an alternative etiology. Discontinuation of Ashwagandha and initiation of symptomatic treatment led to the resolution of symptoms.
The authors concluded that this case underscores the importance of considering herbal supplements as potential contributors to neurological presentations.
The active constituents of the plant, withanolides and alkaloids, have been shown to modulate gamma-aminobutyric acid (GABA) receptor activity, reduce cortisol levels, and exert antioxidative and anti-inflammatory actions. Whether these effects explain the present case seems doubtful. One might even doubt that a causal link exists at all. What is beyond doubt, however, is the fact that traditional herbal remedies can cause serious problems either because of their active ingredients, contaminations, adulteerations, or interactions with synthetic drugs.
My advice, therefore, is to be cautious and to disbelief the often-voiced notions that its long tradition of usage or its naturalness means that a treatment is risk-free.
I came across a new systematic review of the herbal remedy, FEVERFEW, as a preventative treatment for migraine. Here is the abstract:
Review just published in ‘The American Journal of Natural Medicines, Facts’
Migraine, a neurological condition, affects approximately 1.1 billion people worldwide, making it the third leading cause of disability. It significantly impacts quality of life and incurs an annual economic burden exceeding $78 billion in the United States. This systematic review and meta-analysis aims to evaluate the efficacy of Feverfew Dietary Supplement in migraine prophylaxis, with migraine frequency considered as the primary outcome. Three trials (n=237) were included in the meta-analysis (MA) of migraine frequency, and an additional three trials were synthesized narratively in the systematic review. In the MA, feverfew showed a non-significant reduction in migraine frequency compared to placebo (Overall effect size, Cohen’s d: -0.19; 95% CI: -0.52 to 0.14; I² = 34%, p = 0.26). These findings suggest that Feverfew might offer some benefit in individual patients, but given the small, non-significant effect size, it should not be recommended as a primary prophylactic agent over established treatments. Feverfew may not be effective as a standalone prophylactic supplement for migraines; however, its potential in combination therapies seems promising and requires further evaluation. Larger trials with standardized parthenolide content and extended durations are necessary to clarify feverfew’s definitive role in migraine prophylaxis.
The subject is no doubt interesting: migraine is a common contition that severely reduces quality of life and is difficult to treat or prevent. Thus an effective herbal remedy would be more than welcome. Based on such considerations, my co-workers and I had conducted a Cochrane review which was last updated in 2015. Here is its abstract:
Background: This review is an update of a previously published review in the Cochrane Database of Systematic Reviews on ‘Feverfew for preventing migraine’ (2004, Issue 1). Feverfew (Tanacetum parthenium L.) extract is a herbal remedy, which has been used for preventing attacks of migraine.
Objectives: To systematically review the evidence from double-blind randomised controlled trials (RCTs) assessing the clinical efficacy and safety of feverfew monopreparations versus placebo for preventing migraine.
Search methods: For this updated version of the review we searched CENTRAL, MEDLINE, EMBASE and AMED to January 2015. We contacted manufacturers of feverfew and checked the bibliographies of identified articles for further trials.
Selection criteria: We included randomised, placebo-controlled, double-blind trials assessing the efficacy of feverfew monopreparations for preventing migraine in patients of any age. We included trials using clinical outcome measures, while we excluded trials focusing exclusively on physiological parameters. There were no restrictions regarding the language of publication.
Data collection and analysis: We systematically extracted data on patients, interventions, methods, outcome measures, results and adverse events. We assessed risk of bias using the Cochrane ‘Risk of bias’ tool and evaluated methodological quality using the Oxford Quality Scale developed by Jadad and colleagues. Two review authors (BW and MHP for this update, MHP and EE for the original version) independently selected studies, assessed methodological quality and extracted data. We resolved disagreements concerning evaluation of individual trials through discussion.
Main results: We identified one new study for this update, resulting in six trials (561 patients) meeting the inclusion criteria. Five of the six trials reported on the main outcome, migraine frequency. Although five of the trials were generally of good methodological quality, all studies were either of unclear or high risk of bias with regards to sample size. Pooled analysis of the results was not possible due to the lack of common outcome measures and heterogeneity between studies in terms of participants, interventions and designs.The most recent trial added to this version of the review is rigorous and larger (n = 218), using a stable feverfew extract at a dose determined by a previous dose-finding trial. It reports that feverfew reduced migraine frequency by 1.9 attacks from 4.8 to 2.9 and placebo by 1.3 from to 4.8 to 3.5 per month, resulting in a difference in effect between feverfew and placebo of 0.6 attacks per month. For the secondary outcome measures intensity and duration of migraine attacks, incidence and severity of nausea and vomiting, and global assessment no statistically significant differences were reported. Results of previous trials are not convincing: three trials reporting positive effects of feverfew are all of small sample size (17 to 60 participants), while two rigorous trials (n = 50, 147) did not find significant differences between feverfew and placebo. Only mild and transient adverse events, most commonly gastrointestinal complaints and mouth ulcers, were reported in the included trials.
Authors’ conclusions: Since the last version of this review, one larger rigorous study has been included, reporting a difference in effect between feverfew and placebo of 0.6 attacks per month. This adds some positive evidence to the mixed and inconclusive findings of the previous review. However, this constitutes low quality evidence, which needs to be confirmed in larger rigorous trials with stable feverfew extracts and clearly defined migraine populations before firm conclusions can be drawn. It appears from the data reviewed that feverfew is not associated with any major safety concerns.
The question that I ask myself is this: what exactly does the new review add to the existing knowledge?
I fear, the answer is VERY LITTLE! Arguably, the new review is even less rigorous, transparent, thorough and informative than our paper.
If that is so, why conduct and publish it?
The process of doing this is an unethical waste of resources, and the habit of publishing redundant papers is irritating and arguably also unethical.
All this would be rather trivial, of course, if not for the fact that this form of science abuse is happening all the time in the realm of so-called alternative medicine. Responsible journal editors and reviewers should remember that they have the duty to prevent it.
We are about half way through 2025 which is an opportune occasion to again check how research-active the various branches of so-called alternative medicine (SCAM) currently are. To get a rough impression, I yesterday went on Medline and did a few very simple searches. They all used this search term:
“2025, [name of therapy in question], clinical trial”.
The findings are, I think, impressive. Here are some SCAM modalities ranked by the number of hits I received:
- dietary supplements 790
- herbal medicine 455
- acupuncture 407
- mindfulness 338
- massage 129
- yoga 98
- tai chi 60
- essential oil 31
- chiropractic 19
- osteopathic manipulative therapy 13
- homeopathy 11
- naturopathy 6
I should stress that not all of these hits are truly clinical trials (Medline is not precise in that), neither does Medline capture all SCAM journals. So, the figures are by no means accurate but they do give a rough picture of what is going on.
And what is going on?
Unsurprisingly, commercial products are heading the list. Acupuncture in the 3rd place might surprize some; here I must add that the 407 articles come to ~90% (my guess) from China. I have often warned on this blog to not take these papers seriously, as they are predominantly promotion rather than science. Mindfulness on the 4th place is, I think, a reflection of the current hype around this therapy.
The rest is as one might expect – except for the dismal ranking of chiropractic, osteopathy, homeopathy and naturopathy. The suggestion here is, I fear, that these practitioners seem to have very little interest in doing research. Why? Perhaps they know that their treatments cannot withstand the rigor of a decent clinical trial?
In fact, with a bit of fantasy, one could even see an interesting correlation between the evidence-base and the research-activity of SCAM: the treatments that are best supported by evidence seem to have the highest level of research-activity. Conversely, the ones that have the weakest evidence-base seem to have the least research going on.
PS
My analysis does, of course, say nothing about the quality of the science which is, as we often discuss here on this blog, frequenlty dismal.
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!
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.
