supplements
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.
Mistletoe contains Phoratoxin and Viscotoxin – both of which are poisonous when ingested. While a more severe reaction is caused from eating the berries than the leaves, possible symptoms can include nausea, heart problems and fever.
_____________________
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
- ginseng,
- leech,
- scorpion,
- Paeonia lactiflora,
- cicada slough,
- woodlouse bug,
- centipede,
- sandalwood.
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!
So-called alternative medicine (SCAM) interventions are growing in popularity and are even advocated as treatments for long COVID symptoms. However, comprehensive analysis of current evidence in this setting is still lacking. This study aims to review existing published studies on the use of SCAM interventions for patients experiencing long COVID through a systematic review of randomized controlled trials (RCTs).
A comprehensive electronic literature search was performed in multiple databases and clinical trial registries from September 2019 to January 2023. RCTs evaluating efficacy and safety of SCAM for long COVID were included. Methodological quality of each included trial
was appraised with the Cochrane ‘risk of bias’ tool. A qualitative analysis was conducted due to heterogeneity of included studies.
A total of 14 RCTs with 1195 participants were included in this review. Study findings demonstrated that SCAM interventions could benefit patients with long COVID, especially those suffering from
- neuropsychiatric disorders,
- olfactory dysfunction,
- cognitive impairment,
- fatigue,
- breathlessness,
- mild-to-moderate lung fibrosis.
The main interventions reported were:
- self-administered transcutaneous auricular vagus nerve stimulation,
- neuro-meditation,
- dietary supplements,
- olfactory training,
- aromatherapy,
- inspiratory muscle training,
- concurrent training,
- online breathing programs,
- online well-being programs.
The authors concluded that SCAM interventions may be effective, safe, and acceptable to patients with symptoms of long COVID. However, the findings from this systematic review should be interpreted with caution due to various methodological limitations. More rigorous trials focused on CAM for long COVID are warranted in the future.
Such wishy-washy conclusions seem to be popular in the fantasy land of SCAM. Yet, they are, in my view, most ojectionable because:
- they tell us nothing of value;
- that something “MAY BE EFFECTIVE” has been known before and cannot be the result of but is the reason for a systematic review;
- a review of 14 RCTs of almost as many interventions cannot possibly tell us anything about the SAFETY of these treatments;
- it also does not provide evidence of effectiveness and merely indicates a lack of independent replications;
- if the abstract mentions an assessment of the study rigor, one expects that it also informs us about this important aspect.
Once we do come around looking at the methodological quality of the primary studies we realize that it is mostly miserable. This means that the conclusions of the review are not just irritating but plainly misleading. Responsible researchers should have concluded along the following lines:
The quantity and the quality of the evidence are both low. Therefore, the effectiveness and safety of SCAM interventions for long COVID remains unproven.
PS
This project was financially supported by The HEAD Foundation, Singapore and in part by the grant from the NIH R61 AT01218.
Shame on the authors, journal editors, peer-reviewers, and funders of this dangerous nonsense!
Anja Zeidler (born 1993) became known in 2012 as the most successful fitness personality in Switzerland. After joining the bodybuilding scene in Los Angeles, a phase of self-discovery followed. Anja published her development and became what one nowadays calls an ‘INFLUENCER’. As Managing Director and Content Director of her own company, Anja Zeidler GmbH, Anja has made a name for herself as a public figure far beyond the fitness market with her activities as a ‘Selflove Influencer’, blogger, book author, motivational speaker, presenter and expert in the food & health sector. Furthermore, she is completing a degree at the Academy of Naturopathy for Holistic Health.
About a year and a half ago, Anja Zeidler had a desmoid tumor removed from under her left breast – and now it was reported to be back. The conventional treatment methods are clear: another surgical procedure or radiation. But Zeidler said she wants to wait with such interventions. For the time being, she has decided to go her own way. She wants to “balance any imbalances” with her naturopathic doctor and wishes to fight the disease on her own and with a “positive mindset.”
“On a spiritual level, they say that tumors can be related to trauma. That’s why I’ve tried breathing exercises and cocoa ceremonies. With these methods, I get into my subconscious and get closer to traumas, which I am not aware of, and try to dissolve them. So far, blatant things have come up that I had long forgotten and repressed,” she says enthusiastically. In addition, Zeidler wants to give up refined sugar with immediate effect, keep better control of her diet in general – even in her stressful everyday life – and drink freshly squeezed celery and beetroot juice every morning. In addition, she relies on “natural capsules with and grape seed OPC.” “I’ve read in studies that certain types of fungi and strong antioxidants like OPC are supposed to fight tumor cells.” There I follow the motto: ‘if it doesn’t help, at least it does not harm.'”
Zeidler’s tumor is a desmoid tumor, an abnormal growth that arises from connective tissues. These tumors are generally not considered malignant because they do not spread to other parts of the body; however, they can aggressively invade the surrounding tissue and can be very difficult to remove surgically. These tumors often recur, even after apparently complete removal.
Zeidler commented: “I am convinced that with a positive mindset you can contribute extremely much to the healing process. If the checks reveal rapid growth, I will of course seek medical treatment. Then I would opt for radiation.”
The trouble with ‘influencers’ is that they are gullible and influence the often gullible public to become more gullible. Thus their influence might cost many lives. Personally, I hope that the young woman does well with her erstwhile refusal of evidence-based treatments. Yet, I fear that the ‘Academy of Naturopathy for Holistic Health’ will teach her a lot of BS about the power of natural cancer cures. The sooner she agrees to have her tumor treated based on evidence, the better her prognosis, I’m sure.
This randomised, double blind controlled trial compared the efficacy of curcumin versus omeprazole in improving patient reported outcomes in people with dyspepsia.
The interventions were:
- curcumin alone (C),
- omeprazole alone (O),
- curcumin plus omeprazole (C+O).
Patients in the combination group received two capsules of 250 mg curcumin, four times daily, and one capsule of 20 mg omeprazole once daily for 28 days.
Main outcome measure was unctional dyspepsia symptoms on days 28 and 56, assessed using the Severity of Dyspepsia Assessment (SODA) score. Secondary outcomes were the occurrence of adverse events and serious adverse events.
A total of 206 patients were enrolled in the study and randomly assigned to one of the three groups; 151 patients completed the study. Demographic data (age 49.7±11.9 years; women 73.4%), clinical characteristics and baseline dyspepsia scores were comparable between the three groups. Significant improvements were observed in SODA scores on day 28 in the pain (−4.83, –5.46 and −6.22), non-pain (−2.22, –2.32 and −2.31) and satisfaction (0.39, 0.79 and 0.60) categories for the C+O, C, and O groups, respectively. These improvements were enhanced on day 56 in the pain (−7.19, –8.07 and −8.85), non-pain (−4.09, –4.12 and −3.71) and satisfaction (0.78, 1.07, and 0.81) categories in the C+O, C, and O groups, respectively. No significant differences were observed among the three groups and no serious adverse events occurred.
The authors concluded that curcumin and omeprazole had comparable efficacy for functional dyspepsia with no obvious synergistic effect.
This study, which was funded by the Thai Traditional and Alternative Medicine Fund, has been picked up by the press and is being lauded as a solid proof of efficacy. Its authors too are not half proud of their splendid trial:
This multicentre randomised controlled trial provides highly reliable evidence for the treatment of functional dyspepsia. PPIs, widely used and approved for over-the-counter use, were compared with curcumin, a popular herbal remedy. The study design, including double blind randomisation, minimised biases. Participants met strict criteria, underwent endoscopy and were tested for H pylori infection. Furthermore, we implemented measures to minimise biases by ensuring that the individuals administering the drugs, participants receiving the drugs and individuals conducting the assessment remained blinded to the type of medications administered to the participants. The trial was carried out in hospitals, and certified individuals used standardised questionnaires for assessments. Statistical methods were appropriate and followed accepted principles.
Two follow-up appointments were scheduled, and blood tests showed no abnormal symptoms or liver function abnormalities. However, participants with high body mass index indicated a trend towards liver function impairment in the curcumin group, suggesting the need for larger studies. Some participants did not provide follow-up information, which is a study weakness. However, the number of participants who provided this information was sufficient for statistical analysis and the majority of the participants attended the follow-up visit. Therefore, it can be deduced from the results that even if the number of participants followed after drug administration increased, the study findings would not be significantly different. Another limitation of this study was the absence of long term follow-up data for all patients after treatment. This is a question that will require further investigation.
The strength of the study lies in its relevance to daily clinical practice, providing additional drug options in addition to PPIs alone, without added side effects. The study was unbiased, partially funded by government organisations and the first well designed trial comparing curcumin with PPI for functional dyspepsia, with confirmation through endoscopy and ruling out H pylori infection. Limitations of this study included the small number of patients who were lost to follow-up and the lack of long term follow-up data.
However, I am far less impressed.
Why?
Curcumin is bright yellow and has a very distinct taste/smell. Even though curumin was given in capsules, patients can easily tell what they are taking. I therefore doubt that they were adequately blinded. In fact, the authors seem to agree when they state the following:
We observed that despite improvements in pain and non-pain scores, there was no significant improvement in the SODA satisfaction scores in the O and C+O groups (table 3). A possible explanation for this observation could be related to the taste and/or smell of curcumin, which might have caused reduced pleasantness for the participants while ingesting it. This potential discomfort could offset the improvements in pain and non-pain symptoms, leading to the non-significant change in satisfaction score. Further studies may be needed to explore this hypothesis as well as to improve the palatability of curcumin.
Sadly, the success of blinding (which under such circumstances should always be tested) was not reported and probably not even quantified. If many patients were de-blinded, it seems inevitable that their expectation influenced the results. In other words, the much-lauded effect of curcumin might just be due to placebo and curcumin might be entirely useless. Or, to put it bluntly, the trial was not nearly as good as many made it out to be.
PS
Sad to see that the reviewers of a reputable journal failed to pick up on this significant flaw.
We have discussed the currently fashionable herbal remedy, ‘kratom‘, before:
Inadequate regulation of Kratom supplements put consumers at risk
News about Kratom: the herb was recently (semi-)legalized in Thailand
Kratom: a ‘herbal drug’ with the potental to do more harm than good
A quick recap:
Kratom is made of the leaves of Mitragyna speciosa, a tree endogenous to parts of Southeast Asia. It has been used traditionally for its stimulant, mood-elevating, and analgesic effects. The plant’s active constituents, mitragynine and 7-hydroxymitragynine, have been shown to modulate opioid receptors, acting as partial agonists at mu-opioid receptors and competitive antagonists at kappa- and delta-opioid receptors. Both alkaloids are G protein-biased agonists of the mu-opioid receptor and therefore, may induce less respiratory depression than classical opioid agonists. The Mitragyna alkaloids also appear to exert diverse activities at other brain receptors (including adrenergic, serotonergic, and dopaminergic receptors), which may explain the complex pharmacological profile of raw kratom extracts. By the early 2000s, kratom was increasingly used in the US as a substitute for prescription and illicit opioids for managing pain and opioid withdrawal by people seeking abstinence from opioids. There are numerous assessments where people have been unable to stop using kratom and withdrawal signs and symptoms are problematic. Kratom does not appear in normal drug screens and, when taken with other substances of abuse, may not be recognized.
Now it has been reported that the family of a Florida woman who died in 2021 after ingesting kratom has been awarded more than $11m from a distributor of the herbal extract. “There is of course no amount of money that will make up for the pain and suffering that Ms Talavera’s children are enduring because of their mother’s death,” Middlebrooks wrote in court records addressing the sanction against Kratom Distro. “The law nonetheless recognizes that the defendant must pay something, however inadequate.”
The US Drug Enforcement Agency in 2016 had imposed its strictest restrictions on kratom, which is made from the leaves of an evergreen tree and is often used by people to self-treat pain, anxiety, depression, and opioid addiction as well as withdrawal. There was an intense, immediate public backlash to that approach, however, and it prompted the DEA to rescind its prohibition of kratom, which is sold in stores and online.
The US Food and Drug Administration nonetheless has warned consumers over possible safety and addiction risks associated with kratom, and it has spoken in favor of more research aimed at gaining a better understanding of “the substance and its components”.
Friends of Talavera, a resident of the Florida community of Boynton Beach, introduced her to kratom years before her death. Her family said she regarded it as a safe, natural supplement and had taken some after buying it online from the Kratom Distro when her partner and the father of her youngest child – Biagio Vultaggio – found her unconscious in the living room on 20 June 2021. The 39-year-old Talavera was face down on the ground next to an open bag of a kratom derivative marketed as a “space dust”, her family has said. Vultaggio called paramedics, and they took Talavera to a hospital where she was pronounced dead. An autopsy later listed Talavera’s cause of death as acute intoxication from mitragynine, the main kratom component. The local coroner wrote in a report that “at high concentrations, mitragynine produces opioid-like effects, such as respiratory failure”.
________________________
Kratom Disro claims that 
Product Consistency
- Our kratom powder is sourced directly from Indonesia monthly. Your order was literally on a farm in Indonesia two months ago. No old powder.
- Our kratom extracts are produced in the US by a licensed chemist and a professionally trained staff.
- We only use delicious flavors and quality ingredients.
Complete Transparency
- Every batch of products we receive is lab tested and will not ship out without meeting our meticulous quality standards.
- Current labs – We will never show you an out-of-date lab with our products.
- Guaranteed purity levels and free of all toxins.
Get It When You Want It
- Many orders shipped same day.
- USPS shipping on all orders under 6 pounds.
- Larger orders can ship USPS Priority for a small additional charge.
_________________________________
Back to the above lawsuit:
One of the attorneys for Talavera’s family, Tamara Williams, said in a statement that the judgment won by her clients “should be a wakeup call to the kratom industry”. Williams’s law firm had also recently won a $2.5m jury verdict against a kratom manufacturer in Washington state after a separate lawsuit alleging wrongful death. A colleague of Williams called on government officials to take steps “to protect other families from having to deal with unnecessary kratom overdose deaths”.
Sobrenix (Kudzu, Milk Thistle, B Vitamins & More) is “designed to reduce alcohol cravings and help you detoxify your body so you can successfully manage alcohol consumption. Even better, taken before drinking, Sobrenix’s ingredients help you stop before you’ve had too much. DETOXIFY YOUR BODY with a powerful formula that combines herbs and nutrients that support liver health, curb cravings, and help you wake up without a nasty hangover. Sobrenix kick-starts the detoxification process with essential herbs like Milk Thistle and Chanca Piedra. Additionally, the formula contains the critical B-Vitamins that alcohol washes away so you can wake up happy and healthy again!”
Yes, you suspected correctly: this is pure BS!
Not only that but the Federal Trade Commission is taking action under the FTC Act and the Opioid Addiction Recovery Fraud Prevention Act of 2018 (OARFPA) against the makers of Sobrenix. According to the FTC’s complaint, the makers, a company, Rejuvica, and its owners, Kyle Armstrong and Kyle Dilger, made numerous unsubstantiated and false claims about Sobrenix and used paid endorsers in deceptively formatted advertising. The defendants also used bogus review sites to deceive consumers about their products.
As a result of the FTC’s suit, the defendants have agreed to a proposed court order that would permanently ban them from making any unsubstantiated claims about healthcare products or services, as well as require them to pay $650,000 to the FTC to be used for providing refunds to consumers.
“We will not tire in our pursuit of those who prey on individuals struggling with alcohol or other substance use disorders,” said Samuel Levine, Director of the Bureau of Consumer Protection. “This case evidences the breadth of the FTC’s authority to pursue such wrongdoing under both the FTC Act and OARFPA.”
The FTC charges that the defendants marketed Sobrenix with messages like:
- “STRUGGLING TO CONTROL YOUR ALCOHOL CONSUMPTION? Sobrenix is designed to reduce alcohol cravings and help you detoxify your body so you can successfully manage alcohol consumption. Even better, taken before drinking, Sobrenix’s ingredients help you stop before you’ve had too much.”
The FTC charges that Rejuvica and its owners lacked adequate evidence to support these claims. The complaint charges that Rejuvica, Armstrong, and Dilger violated both the FTC Act and OARFPA. The proposed order contains a total monetary judgment of $3,247,737, which is partially suspended based on the defendants’ inability to pay the full amount. The defendants will be required to pay $650,000 to the FTC to be used to refund consumers. If the defendants are found to have lied to the FTC about their financial status, the full judgment will be immediately due.
______________________________
A few short comments might be in order:
- Regulators have the duty to protect consumers from false health claims.
- It is commendable that some authorities sometimes do their duty and go after some of the people responsible for making false claims related to dietary supplements.
- Such actions should, however, occur MUCH more often.
- They ought to happen also in countries other than the US.
- Similar actions should be initiated against ALL false claims made for healthcare products and services.
- This means that all practitioners of so-called alternative medicine (SCAM) would need to review their advertising, websites, etc., and erase therapeutic claims that are not supported by evidence.
- This would unquestionably amount to an enormously valuable service to public health.
- Most countries already have legislation that would make such steps possible; my question, therefore, is this:
WHY ARE CONSUMERS NOT ADEQUATELY PROTECTED BY THEIR NATIONAL REGULATORS FROM CHARLATANS WHO SELL INEFFECTIVE AND OFTEN DANGEROUS SCAMs AT HIGH COSTS?
