Traditional herbal medicine (THM) is frequently used in pediatric populations. This is perticularly true in many low-income countries. Yet THM has been associated with a range of adverse events, including liver toxicity, renal failure, and allergic reactions. Despite these concerns, its impact on multi-organ dysfunction syndrome (MODS) risk has so far not been thoroughly investigated.
This study aimed to investigate the incidence and predictors of MODS in a pediatric intensive care unit (PICU) in Ethiopia, with a focus on the association between THM use and the risk of MODS. It was designed as a single-center prospective cohort study conducted at a PICU in the university of Gondar Comprehensive Specialized hospital, Northwest Ethiopia. The researchers enrolled eligible patients aged one month to 18 years admitted to the PICU during the study period. Data on demographic characteristics, medical history, clinical and laboratory data, and outcome measures using standard case record forms, physical examination, and patient document reviews. The predictors of MODS were assessed using Cox proportional hazards models, with a focus on the association between traditional herbal medicine use and the risk of MODS.
A total of 310 patients were included in the final analysis, with a median age of 48 months and a male-to-female ratio of 1.5:1. The proportion and incidence of MODS were 30.96% (95% CI:25.8, 36.6) and 7.71(95% CI: 6.10, 9.40) per 100-person-day observation respectively. Renal failure (17.74%), neurologic failure (15.16%), and heart failure (14.52%) were the leading organ failures identified. Nearly one-third of patients (32.9%) died in the PICU, of which 59.8% had MODS. The rate of mortality was higher in patients with MODS than in those without. The Cox proportional hazards model identified renal disease (AHR = 6.32 (95%CI: 3.17,12.61)), intake of traditional herbal medication (AHR = 2.45, 95% CI:1.29,4.65), modified Pediatric Index of Mortality 2 (mPIM 2) score (AHR = 1.54 (95% CI: 1.38,1.71), and critical illness diagnoses (AHR = 2.68 (95% CI: 1.77,4.07)) as predictors of MODS.
The authors concluded that the incidence of MODS was high. Renal disease, THM use, mPIM 2 scores, and critical illness diagnoses were independent predictors of MODS. A more than twofold increase in the risk of MODS was seen in patients who used TMH. Healthcare providers should be aware of risks associated with THM, and educate caregivers about the potential harms of these products. Future studies with larger sample sizes and more comprehensive outcome measures are needed.
I do fully agree with the authors about the high usage of herbal and other so-called alternative medicines by children. We have shown that, in the UK the average one-year prevalence rate was 34% and the average lifetime prevalence was 42%. We have furthermore shown that the evidence base for these treatments in children is weak, even more so than for general populations. Finally, we can confirm that adverse effects are far from rare and often serious.
It is therefore high time, I think, that national regulators do more to protect children from SCAM practitioners who are at best uncritical about their treatments and at worse outright dangerous.
An alarming story of research fraud in the area of so-called alternative medicine (SCAM) is unfolding: Bharat B. Aggarwal, the Indian-American biochemist who worked at MD Anderson Cancer Center, focused his research on curcumin, a compound found in turmeric, and authored more than 125 Medline-listed articles about it. They reported that curcumin had therapeutic potential for a variety of diseases, including various cancers, Alzheimer’s disease and, more recently, COVID-19.
The last of these papers, entitled “Curcumin, inflammation, and neurological disorders: How are they linked?”, was publiched only a few months ago. Here is its abstract:
Background: Despite the extensive research in recent years, the current treatment modalities for neurological disorders are suboptimal. Curcumin, a polyphenol found in Curcuma genus, has been shown to mitigate the pathophysiology and clinical sequalae involved in neuroinflammation and neurodegenerative diseases.
Methods: We searched PubMed database for relevant publications on curcumin and its uses in treating neurological diseases. We also reviewed relevant clinical trials which appeared on searching PubMed database using ‘Curcumin and clinical trials’.
Results: This review details the pleiotropic immunomodulatory functions and neuroprotective properties of curcumin, its derivatives and formulations in various preclinical and clinical investigations. The effects of curcumin on neurodegenerative diseases such as Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS), brain tumors, epilepsy, Huntington’s disorder (HD), ischemia, Parkinson’s disease (PD), multiple sclerosis (MS), and traumatic brain injury (TBI) with a major focus on associated signalling pathways have been thoroughly discussed.
Conclusion: This review demonstrates curcumin can suppress spinal neuroinflammation by modulating diverse astroglia mediated cascades, ensuring the treatment of neurological disorders.
The Anderson Cancer Center initially appeared to approve of Aggarwal’s work. However, in 2012, following concerns about image manipulation raised by pseudonymous sleuth Juuichi Jigen, MD Anderson Cancer Center launched a research fraud probe against Aggarwal which eventually led to 30 of Aggarwal’s articles being retracted. Moreover, PubPeer commenters have noted irregularities in many publications beyond the 30 that have already been retracted. Aggarwal thus retired from M.D. Anderson in 2015.
Curcumin doesn’t work well as a therapeutic agent for any disease – see, for instance, the summary from Nelson et al. 2017:
“[No] form of curcumin, or its closely related analogues, appears to possess the properties required for a good drug candidate (chemical stability, high water solubility, potent and selective target activity, high bioavailability, broad tissue distribution, stable metabolism, and low toxicity). The in vitro interference properties of curcumin do, however, offer many traps that can trick unprepared researchers into misinterpreting the results of their investigations.”
Despite curcumin’s apparent lack of therapeutic promise, the volume of research produced on curcumin grows each year. More than 2,000 studies involving the compound are now published annually. Many of these studies bear signs of fraud and involvement of paper mills. As of 2020, the United States National Institutes of Health (NIH) has spent more than 150 million USD funding projects related to curcumin.
This proliferation of research has fueled curcumin’s popularity as a dietary supplement. It is estimated that the global market for curcumin as a supplement is around 30 million USD in 2020.
The damage done by this epic fraud is huge and far-reaching. Hundreds of millions of taxpayer dollars, countless hours spent toiling by junior scientists, thousands of laboratory animals sacrificed, thousands of cancer patients enrolled in clinical trials for ineffective treatments, and countless people who have eschewed effective cancer treatment in favor of curcumin, were encouraged by research steeped in lies.
The so-called ‘Miracle Mineral Solution’ (MMS) – bleach for you and me – is a SCAM that keeps on giving. On this blog, we have featured MMS several times before, e.g.:
- Selling bleach as ‘miracle’ cure (MMS): Father and three sons are going to prison
- Selling bleach solution as ‘miracle’ cure? No, it’s a dangerous ‘snake oil’!
- Miracle Mineral Supplement (MMS): accidental ingestion by an infant
- Beware of the ‘Bleach Boys’ – hydrogen peroxide and chlorine dioxide
Now,it has been reported that a New Zealand anti-vaxxer has been jailed for selling more than $100,000 worth of an industrial bleach as a “miracle” cure for Covid-19. Roger Blake, who describes himself as a “human man”, was sentenced to just over 10 months’ imprisonment after being found guilty at trial of 29 charges in the Hamilton District Court.
Blake advertised and sold MMS products, claiming it could treat, prevent and cure coronavirus. However, New Zealand’s Ministry of Health had not approved the product, and detailed that when ingested became chlorine dioxide – a bleach commonly used for water treatment, bleaching textiles and paper.
The court heard Blake had marketed the product as a cure in New Zealand from the start of the pandemic between December 2019 and December 2020. Medsafe, the health ministry’s safety authority, said Blake’s company had sales of NZ$160,000 in that period – with sales spiking in March when the country was placed in lockdown.
Judge Brett Crowley said Blake’s behaviour had been “utterly disgraceful”. He added that Blake had “seized upon the tragedy” of the pandemic for financial gain. Before selling MMS as a “cure” for the coronavirus, Blake had marketed the product as a preventive of other diseases and illnesses such as cancer, Alzheimer’s, diabetes and HIV.
Medsafe prosecuted him under the Medicines Act, with compliance manager Derek Fitzgerald saying the “fake cure” Blake spruiked presented a “significant public health risk”. “He targeted the vulnerable, preyed on public fears and exposed people to harm”, he said. “This decision sends a strong message that people who engage in selling so called ‘miracle cures’ will be held to account and face fines or imprisonment.”
The website which sold MMS in New Zealand was registered to US-based Mark Grenon, who set up the “Genesis II Church of Health and Healing”. As reported previously, Grenon and his three sons were jailed in October for several years in the US for selling more than US$1m of the product. Michael Homer, an assistant US lawyer who prosecuted the case, said at the time the family targeted people suffering from life-threatening illnesses. The Grenons poisoned thousands of people with their bogus miracle cure, which was nothing more than industrial bleach,” he said.
Medsafe warns: “Drinking MMS is the same as drinking bleach and can cause dangerous side effects, including severe vomiting, diarrhoea, and life-threatening low blood pressure. We strongly encourage people to only go to trusted sources, such as your doctor, to get reliable information”.
Medsafe received three reports of people requiring hospitalizations after drinking MMS. “His conduct presented a significant risk to public health, and that is why Medsafe acted. His actions were in stark contrast to the requirements of the Medicines Act 1981, which is public welfare legislation designed to protect the public” said Mr Fitzgerald.
Mushrooms are somewhat neglected in medical research, I often feel. This systematic review focused on clinical studies testing the effectiveness of mushrooms in cancer care. A total of 39 met the authors’ inclusion criteria. The studies included 12 different mushroom preparations. Some of the findings were encouraging:
- A survival benefit was reported using Huaier granules (Trametes robiniophila Murr) in 2 hepatocellular carcinoma studies and 1 breast cancer study.
- A survival benefit was also found in 4 gastric cancer studies using polysaccharide-K (polysaccharide-Kureha; PSK) as an adjuvant therapy.
- Eleven studies reported a positive immunological response.
- Quality-of-life (QoL) improvement and/or reduced symptom burden was reported in 14 studies using various mushroom supplements.
- Most studies reported adverse effects of grade 2 or lower, mainly nausea, vomiting, diarrhea, and muscle pain.
The authors caution that limitations included small sample size and not using randomized controlled trial design. Many of the reviewed studies were observational. Most showed favorable effects of mushroom supplements in reducing the toxicity of chemotherapy, improving QoL, favorable cytokine response, and possibly better clinical outcomes.
The authors concluded that the evidence is inconclusive to recommend the routine use of mushrooms for cancer patients. More trials are needed to explore mushroom use during and after cancer treatment.
The use of mushrooms for medicinal purposes has a long history in many cultures. Some mushrooms are known to be highly poisonous, some have hallucinogenic effects, and some are assumed to have pharmacological effects that have therapeutic potential. Some mushrooms possess pharmacologic properties such as anti-tumour, immunomodulating, antioxidant, cardiovascular, anti-hypercholesterolemic, anti-viral, anti-bacterial, anti-parasitic, anti-fungal, detoxification, hepatoprotective, and anti-diabetic effects.
Many modern medicines were derived from fungi. The best-known example is penicillin; others include several cancer drugs, statins and immunosuppressants. In Traditional Chinese Medicine, numerous herbal mixtures contain mushrooms; examples are reishi, maitake and shiitake which are all assumed to have anti-cancer properties.
As the review authors point out, there is a paucity of clinical trials testing the effectiveness of mushrooms, and the existing studies tend to be of poor quality. At present, most of our knowledge comes from traditional use or test-tube studies. The adverse effects depend on the specific mushroom in question and, can in some instances, be serious.
Considering the potential and the complexity of mycomedicine, I find it surprising to not see much more research into this subject.
Despite effective vaccines, there is still a need for effective treatments for COVID, especially for people in the community. Dietary supplements have long been used to treat respiratory infections, and preliminary evidence indicates some may be effective in people with COVID-19. This study tested whether a combination of vitamin C, vitamin D3, vitamin K2 and zinc would improve overall health and decrease symptom burden in outpatients diagnosed with COVID-19.
Participants were randomised to receive either vitamin C (6 g), vitamin D3 (1000 units), vitamin K2 (240 μg) and zinc acetate (75 mg) or placebo daily for 21 days and were followed for 12 weeks. An additional loading dose of 50 000 units vitamin D3 (or placebo) was given on day one. The primary outcome was participant-reported overall health using the EuroQol Visual Assessment Scale summed over 21 days. Secondary outcomes included health status, symptom severity, symptom duration, delayed return to usual health, frequency of hospitalisation and mortality.
A total of 90 patients (46 control, 44 treatment) were randomised. The study was stopped prematurely due to insufficient capacity for recruitment. The mean difference (control-treatment) in cumulative overall health was -37.4 (95% CI -157.2 to 82.3), p=0.53 on a scale of 0-2100. No clinically or statistically significant differences were seen in any secondary outcomes.
The authors concluded that, in this double-blind, placebo-controlled, randomised trial of outpatients diagnosed with COVID-19, the dietary supplements vitamin C, vitamin D3, vitamin K2 and zinc acetate showed no clinically or statistically significant effects on the documented measures of health compared with a placebo when given for 21 days. Termination due to feasibility limited our ability to demonstrate the efficacy of these supplements for COVID-19. Further research is needed to determine clinical utility.
In several ways I am puzzled by this study. On the other hand, I should congratulate the naturopathic authors for honestly reporting such a squarely negative result. One could, of course, argue that the study was under-powered and that thus the findings are not conclusive. However, the actual survival curve depicting the results show clearly that there was not even the tiniest trend for the supplement to show any effect. In other words, a larger sample would have most likely yielded the same result.
Participants randomised to the treatment arm received:
- Vitamin D3 50 000 units orally once on day 1 of the study (capsule).
- Vitamin K2/D3 120 μg/500 units orally two times per day for 21 days (liquid).
- Vitamin C/Zinc acetate 2 g/25 mg orally three times daily for 21 days (capsule).
I fail to understand why the researchers might have conceived the hypothesis that such a mixture would be effective. Only 90 of a planned 200 participants were enrolled in this study which ran between September 2021 and April 2022. I fail to understand why recruitment was so poor that the study eventually had to be aborted. My speculation is that the naturopaths in charge of running the trial were too inexperienced in conducting such research to make it a success.
The study was supported by the Ottawa Integrative Cancer Centre Foundation and by Mavis and Martin Sacher. All investigational products for this study were provided in-kind by New Roots Herbal. Perhaps in future these sponsors should think again before they support amateurs pretending to be scientists?
The case of a 2.5-year-old boy who accidentally ingested a 25% sodium chlorite solution was reported. The solution had been recommended to the grandfather as a “bowel cure” by a naturopath. Although the boy tried to spit the solution out again, he was unable to do so or only partially succeeded. Vomiting and diarrhoea soon set in and the child’s condition deteriorated rapidly.
On admission to hospital, a greyish-pale skin colour, lip cyanosis and an oxygen saturation of 67% were already apparent. The child had to be intubated. Blood gas analysis revealed marked methaemoglobinaemia, which was treated with methylene blue and ascorbic acid. Erythrocyte concentrates were also transfused due to haemolytic anaemia. In the oesophagogastroduodenoscopy the next day, the gastric mucosa was completely covered with bloody erosions. Later, aspiration pneumonia was suspected and antibiotics with piperacillin and tazobactam i.v. were administered for five days. After clinical restitution, the child was discharged.
The author added the following comment:
Several health authorities (including in the USA, Switzerland, Canada and the UK) have issued warnings about MMS in recent years and in some cases have also taken specific measures to protect consumers. In July 2012, the German Federal Institute for Risk Assessment (BfR) strongly advised against the consumption and use of MMS.
In February 2015, the Federal Institute for Drugs and Medical Devices (BfArM) classified two MMS products as requiring authorisation. These were considered to be so-called presentation drugs because the manufacturer made clear healing promises and stated medicinal purposes. Furthermore, precise dosage information and references to the possibility of severe side effects such as diarrhoea and nausea were given, as well as references to the book “The Breakthrough” by Jim Humble, in which the use and effectiveness of MMS is described for malaria and cancer, for example. This means that the products would have to be authorised as medicinal products and could then only be placed on the market if the pharmaceutical company had proven their efficacy, quality and safety.
In addition, the BfArM categorised both products as questionable medicinal products in accordance with Section 5 of the German Medicinal Products Act because their use is associated with harmful effects that go beyond an acceptable level.
On this blog, we have repeatedly discussed the MMS, e.g.:
- Miracle Mineral Solution (MMS) = potentially lethal
- MMS-salesman Andreas Kalcker has been arrested in Argentina
- Beware of the ‘Bleach Boys’ – hydrogen peroxide and chlorine dioxide
I urge everyone who might be tempted to try MMS to think again.
Omega-3 fatty acids (fish oil) supplementation reduces the occurrence of cardiovascular disease (CVD) and CVD-related mortality in patients at high-risk of CVD and in patients with elevated plasma triglyceride level. Yet, some studies have found an increased risk of atrial fibrillation (AF). AF is the most common sustained cardiac arrhythmia worldwide. It is associated with high morbidity and mortality rates and significant public health burden. Previous studies of the effect of omega-3 fatty acids on AF occurrence have reported contradictory results.
This review evaluated the effect of omega-3 fatty acids on the risk of AF. The results suggest that omega-3 fatty acids supplementation is associated with increased AF risk, particularly in trials that used high doses. Therefore, several factors should be considered before prescribing omega-3 fatty acids, including their dose, type, and formulation (fish, dietary fish oil supplements, and purified fatty acids), as well as patient-related factors and atrial mechanical milieu. Because the benefits of omega-3 fatty acids are dose-dependent, the associated AF risk should be balanced against the benefit for CVD. Patients who take omega-3 fatty acids, particularly at high doses, should be informed of the risk of AF and followed up for the possible development of this common and potentially hazardous arrhythmia.
Another recent review included 54,799 participants from 17 cohorts. A total of 7,720 incident cases of AF were ascertained after a median 13.3 years of follow-up. In multivariable analysis, EPA levels were not associated with incident AF, HR per interquintile range (ie, the difference between the 90th and 10th percentiles) was 1.00 (95% CI: 0.95-1.05). HRs for higher levels of DPA, DHA, and EPA+DHA, were 0.89 (95% CI: 0.83-0.95), 0.90 (95% CI: 0.85-0.96), and 0.93 (95% CI: 0.87-0.99), respectively.
The authors concluded that in vivo levels of omega-3 fatty acids including EPA, DPA, DHA, and EPA+DHA were not associated with increased risk of incident AF. Our data suggest the safety of habitual dietary intakes of omega-3 fatty acids with respect to AF risk. Coupled with the known benefits of these fatty acids in the prevention of adverse coronary events, our study suggests that current dietary guidelines recommending fish/omega-3 fatty acid consumption can be maintained.
Faced with contradictory results based on non-RCT evidence, we clearly need an RCT. Luckily such a trial has recently been published. It was an ancillary study of a 2 × 2 factorial randomized clinical trial involving 25 119 women and men aged 50 years or older without prior cardiovascular disease, cancer, or AF. Participants were recruited directly by mail between November 2011 and March 2014 from all 50 US states and were followed up until December 31, 2017.
Participants were randomized to receive EPA-DHA (460 mg/d of EPA and 380 mg/d of DHA) and vitamin D3 (2000 IU/d) (n = 6272 analyzed); EPA-DHA and placebo (n = 6270 analyzed); vitamin D3 and placebo (n = 6281 analyzed); or 2 placebos (n = 6296 analyzed). The primary outcome was incident AF confirmed by medical record review.
Among the 25 119 participants who were randomized and included in the analysis (mean age, 66.7 years; 50.8% women), 24 127 (96.1%) completed the trial. Over a median 5.3 years of treatment and follow-up, the primary end point of incident AF occurred in 900 participants (3.6% of study population). For the EPA-DHA vs placebo comparison, incident AF events occurred in 469 (3.7%) vs 431 (3.4%) participants, respectively (hazard ratio, 1.09; 95% CI, 0.96-1.24; P = .19). For the vitamin D3 vs placebo comparison, incident AF events occurred in 469 (3.7%) vs 431 (3.4%) participants, respectively (hazard ratio, 1.09; 95% CI, 0.96-1.25; P = .19). There was no evidence for interaction between the 2 study agents (P = .39).
The authors concluded that among adults aged 50 years or older, treatment with EPA-DHA or vitamin D3, compared with placebo, resulted in no significant difference in the risk of incident AF over a median follow-up of more than 5 years. The findings do not support the use of either agent for the primary prevention of incident AF.
So, does the regular supplementation with omega-3 fatty acids increase the risk of atrial fibrillation? The evidence is not entirely clear but, on balance, I conclude that the risk is low or even non-existent.
“Acute Fulminant Hepatic Failure in 23-Year-Old Female Taking Homeopathic Remedy” is not a title we see often on a scientific paper. Naturally, it attrackted my interest. In the paper, a US team presented a case of a 23-year-old otherwise healthy woman with body mass index 32.3 and a history of polycystic ovarian syndrome who presented with acute liver failure (ALF) ultimately requiring orthotopic liver transplantation. The patient was originally from India where she reported taking homeopathic medications for various indications for several years without known toxicity. She had no history of alcohol, tobacco, or other drug use. At the time of her presentation, she was living and working in the US and reported she was unable to refill her homeopathic product with the primary ingredient of eggshells from India. She was off of all medications and supplements with the exception of Berberis vulgaris for approximately 1 month before obtaining a similarly named homeopathic product with the primary ingredient of eggshells from Amazon. She reported originally taking 4 pills/d for 10 days, and then increased to 10 pills/d for 10 days as she was unsure of the appropriate dose.
She subsequently developed orange discoloration of her urine and nausea, reportedly without any preceding muscle-related effects or symptoms, and she discontinued all of her medications/supplements. Approximately 2 weeks later, she presented to the emergency department for nausea and malaise, where a blood test revealed abnormal liver enzymes. Mononucleosis screen and hepatitis panel were negative. She had no evidence of hepatic encephalopathy at that time. Ultrasound of the abdomen was notable for hypoechoic liver parenchyma only.
She was discharged home with gastroenterology telehealth follow-up. She was seen 1 week later and reported worsening nausea, vomiting, anorexia, jaundice, and fatigue. She presented to a local emergency department where she received intravenous vitamin K and underwent further laboratory evaluation. She was transferred to another hospital for higher level of care and admitted with acute liver injury. There she received intravenous N-acetylcysteine per institutional protocol, ursodiol, albumin, vitamin K, and fresh frozen plasma transfusions given for coagulopathy. Magnetic resonance cholangiopancreatography was performed and demonstrated no evidence of biliary obstruction or chronic liver disease (no ascites, contour nodularity, mass, or lymphadenopathy), though liver size noted to be small (11.5 cm in span). At 21 to 28 days after the onset of symptoms, her lab results were still highly abnormal and her mental status deteriorated. She was intubated for airway protection given severe encephalopathy, “cooling protocols” were initiated, and she was transferred again to a higher level of care at a center for emergent liver transplant evaluation. She was evaluated and listed as status 1A for acute liver failure. Her clinical status continued to decline and her labs continued to worsen.
An appropriate organ became available 28 hours after listing. At the time of her surgery, her explanted liver was noted to have massive parenchymal loss with hemorrhage, and pathology confirmed near complete collapse of the organ’s framework with only small foci of steatotic hepatocytes remaining. After her initial operation, her hospital course was complicated by coagulopathy, hypotension, leukocytosis, kidney failure requiring temporary dialysis, and multiple operations for completion of biliary anastomoses and delayed complex abdominal wall closure with mesh given large donor size. She was discharged from the hospital 2 weeks after transplant and her outpatient course continues to go well over 1 year after liver transplantation.
The product in this case has not been previously reported to be toxic. Its primary ingredient is calcium from “toasted eggshells,” which is also not generally known to cause liver failure or disease. However, the authors point out that it is not uncommon for supplements such as this one to contain other potentially toxic agents that are not specifically listed on the bottles’ label. For example, toxic metals including lead, mercury, and arsenic have reportedly been discovered in many (almost 20%) naturopathic medicines manufactured in India, particularly those sold by US websites. As such, the authors hypothesize that this patient’s ALF was likely caused by a contaminant (also consumed in higher quantities than intended) in her homeopathic product with the primary ingredient of eggshells.
The authors of this paper repeatedly state that the product was a homeopathic remedy; however, on other occasions they claim that it was a herbal supplement. In their Figure 1, they name the product as ‘OVA TOSTA’; on Amazon USA, I did indeed find a remedy by that name. Sadly, I was unable to obtain any information about its exact ingredients or composition.
Regardless whether the product was herbal or homeopathic, this case report is a poignant reminder that, in so-called alternative medicine (SCAM) many dangerous remedies are offered for sale. Therefore, it is advisible to be cautious and insist on sound information about the quality, safety, and efficacy before trying any such therapy.
It has been reported that a cancer patient died of multiple organ failure after he took a herbalist’s remedy that included mistletoe. Retired electrician Haydn Owen Jones had been receiving a third course of treatment for his multiple myeloma when he turned to a herbalist. Alongside two chemotherapy drugs and a steroid, Jones started using a remedy which included mistletoe, yarrow, lily of the valley, cat’s claw, echinacea, and corn silk. Days later he fell ill with a fever, swelling and a rash. He was treated for sepsis but never recovered as his liver function deteriorated. Coroner concluded that it was probable the mix of cancer drugs and the alternative therapy proved deadly to him.
As with all tragic cases of this nature, it is difficult or even impossible to establish what caused the death. Was the herbal remedy involved at all? If so, it could be the toxicity of one or more of its ingredients, interactions between them, interactions with prescribed drugs, or contaminations/adulterations of the remedy. If there is a lesson at all to learn from this case, it is, I think, this: be very cautious about using herbal remedies, particularly when combined with other medicines, and seek professional advice, preferably NOT from a herbalist.
This study investigated whether Tongxinluo,a traditional Chinese medicine compound that has shown promise in in vitro, animal, and small human studies for myocardial infarction, could improve clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI). The randomized, double-blind, placebo-controlled clinical trial was conducted among patients with STEMI within 24 hours of symptom onset from 124 hospitals in China. Patients were enrolled from May 2019 to December 2020; the last date of follow-up was December 15, 2021.
Patients were randomized 1:1 to receive either Tongxinluo or placebo orally for 12 months. A loading dose of 2.08 g was given after randomization, followed by the maintenance dose of 1.04 g, 3 times a day, in addition to STEMI guideline-directed treatments. The primary end point was 30-day major adverse cardiac and cerebrovascular events (MACCEs), a composite of cardiac death, myocardial reinfarction, emergent coronary revascularization, and stroke. Follow-up for MACCEs occurred every 3 months to 1 year.
Among 3797 patients who were randomized, 3777 (Tongxinluo: 1889 and placebo: 1888; mean age, 61 years; 76.9% male) were included in the primary analysis. Thirty-day MACCEs occurred in 64 patients (3.4%) in the Tongxinluo group vs 99 patients (5.2%) in the control group. Individual components of 30-day MACCEs, including cardiac death, were also significantly lower in the Tongxinluo group than the placebo group. By 1 year, the Tongxinluo group continued to have lower rates of MACCEs and cardiac death. There were no significant differences in other secondary end points including 30-day stroke; major bleeding at 30 days and 1 year; 1-year all-cause mortality; and in-stent thrombosis. More adverse drug reactions occurred in the Tongxinluo group than the placebo group, mainly driven by gastrointestinal symptoms.
The authors concluded that in patients with STEMI, the Chinese patent medicine Tongxinluo, as an adjunctive therapy in addition to STEMI guideline-directed treatments, significantly improved both 30-day and 1-year clinical outcomes. Further research is needed to determine the mechanism of action of Tongxinluo in STEMI.
Tongxinluo is mixture of various active ingredients, including
- Paeonia lactiflora,
- cicada slough,
- woodlouse bug,
With chaotic mixtures of this type, it is impossible to name all the potentially active ingredients, list their actions, or identify the ones that are truly relevant. According to the thinking of TCM proponents, this would also be the wrong way to go about it – such mixtures work as a whole, they would insist.
Tongxinluo is by no means a mixture that has not been studied before.
A previous systematic review of 12 studies found that Tongxinluo capsule is superior to conventional treatment in improving clinical overall response rate and hemorheological indexes and is relatively safe. Due to the deficiencies of the existing studies, more high-quality studies with rigorous design are required for further verification.
A 2022 meta-analysis indicated that the mixture had beneficial effects on the prevention of cardiovascular adverse events, especially in TVR or ISR after coronary revascularization and may possibly lower the incidence of first or recurrent MI and HF within 12 months in patients with CHD, while insufficient sample size implied that these results lacked certain stability. And the effects of TXLC on cardiovascular mortality, cerebrovascular events, and unscheduled readmission for CVDs could not be confirmed due to insufficient cases. Clinical trials with large-sample sizes and extended follow-up time are of interest in the future researches.
A further meta-analysis suggested beneficial effects on reducing the adverse cardiovascular events without compromising safety for CHD patients after PCI on the 6-month course.
Finally, a systematic review of 10 studies found that the remedy is an effective and safe therapy for CHD patients after percutaneous coronary interventions.
So, should we believe the new study with its remarkable findings? On the one hand, the trial seems rigorous and is reported in much detail. On the other hand, the study (as all previous trials of this mixture) originates from China. We know how important TCM is for that country as an export item, and we know how notoriously unreliable Chinese research sadly has become. In view of this, I would like to see an independent replication of this study by an established research group outside China before I recommend Tongxinluo to anyone.
Let’s not forget:
if it sound too good to be true, it probably is!