herbal medicine
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”.
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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.
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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?
Charles has a well-documented weakness for so-called alternative medicine (SCAM) – not just any SCAM but predominantly the type of SCAM that is both implausible and ineffective. Therefore, nobody can be all that surprised to read in THE TIMES that he has decided to use SCAM for helping women who have difficulties getting pregnant.
If one really wanted to employ SCAM for this aim one is spoilt for choice. In fact, there are only few SCAMs that don’t claim to be useful for this purpose.
A recent review, for instance, suggested that some supplements might be helpful. Other authors advocate SCAMs such as acupuncture, moxibustion, Chinese herbal medicine, psychological intervention, biosimilar electrical stimulation, homeopathy, or hyperbaric oxygen therapy.
Yes, I know! The evidence for these treatments is lousy, and I would never issue a recommendation based on such flimsy evidence.
Yet, the SCAM project at Dumfries House, the Scottish stately home Charles restored in 2007, offers acupuncture, reflexology, massage, yoga, and hypnotherapy for infertile women.
REFLEXOLOGY for female infertility?
Reflexology, also called zone therapy, is a manual treatment where pressure is applied usually to the sole of the patient’s foot and sometimes also to other areas such as the hands or ears. According to its proponents, foot reflexology is more than a simple foot massage that makes no therapeutic claims beyond relaxation. It is based on the idea that the human body is divided into 10 zones each of which is represented on the sole of the foot. Reflexologists employ maps of the sole of the foot where the body’s organs are depicted. By massaging specific zones which are assumed to be connected to specific organs, reflexologists believe to positively influence the function of these organs. While reflexology is mostly used as a therapy, some therapists also claim they can diagnose health problems through feeling tender or gritty areas on the sole of the foot which, they claim, correspond to specific organs.
Reflexology is not merely implausible as a treatment for infertility, it also boasts of some fairly rigorous trial evidence. A clinical trial (perhaps even the most rigorous of all the trials of SCAM for female fertility problems) testing whether foot reflexology might have a positive effect on the induction of ovulation stated that “the results suggest that any effect on ovulation would not be clinically relevant”.
So, as so often before in the realm of SCAM, Charles has demonstrated that his lack of critical thinking leads him to the least promising options.
Well done, Your Majesty!
“A Nutrient Mix Designed at the Dr. Rath Research Institute is Effective Against Different Types of Coronavirus.” With these words (and the picture below), the ‘Dr. Rath Research Institute’ recently announced its sensational finding on Twitter.
Clicking on the link they provided, got me to the following article:
In this new study we wanted to find out whether certain natural substances could help fight against SARS-CoV-2 (the virus that causes COVID-19), and another type of coronavirus known as HCoV-229E which infects humans and is associated with the common cold and its symptoms.
The importance of the study relates to the fact that COVID-19 is still a big problem, especially for older people and those with weak immune systems. Current approaches using RNA- and DNA -based vaccines are not effective in preventing the infection and spread of SARS-CoV-2, or its variants such as Omicron. The anti-viral drugs used against the pandemic are similarly not fully effective. It is therefore important to develop other approaches, especially those involving safe, natural substances, that could be used alongside or instead of conventional treatments.
For the study, scientists at the Dr. Rath Research Institute used a combination of natural substances including vitamin C, polyphenols, and other nutrients. They gave the nutrient mix to mice infected with one or other of the two types of coronaviruses, to see if it could reduce the numbers of viral particles and spike proteins in the animals’ lungs.
Based on our earlier work using human cells growing in culture we already knew that the combination of nutrients in this mixture was effective in controlling key cellular mechanisms of SARS-CoV-2 infection, including inhibiting the multiplication of the virus.
We had found that the nutrient mix could inhibit an enzyme, RNA-dependent RNA polymerase (RdRp), which is needed for a virus to make copies of itself. The mix was also effective in preventing viral spike protein from binding to cell surfaces and entering cells. It additionally worked in decreasing the number of so-called ACE2 receptor proteins, which are expressed by cells in the lungs, blood vessels, and other organs, and that help the virus to get into cells.
In this latest study the nutrient mix was administered daily to mice infected with either SARS-CoV-2 or HCoV-229E, to see if it could reduce infectivity in terms of the amounts of viral particles and spike proteins found in the lungs. Infected mice in the control group were fed a normal diet without nutrient supplementation. The amounts of viral particles and spike proteins in the lungs were evaluated using special molecular-based tests. We also examined the effects of the nutrient mix on the presence of immune cells in the lungs, as an indication of tissue inflammation.
The results showed that, compared to mice in the control group, the nutrients significantly reduced the amounts of viral particles and spike proteins in the lungs of infected mice. Moreover, the mix was equally effective in mice infected with either of the two types of coronaviruses. This indicates that the nutrients affected common mechanisms of infection and were not specific to a particular type of virus. It also explains the results of our previous studies, which showed that the nutrient mix was effective in stopping SARS-CoV-2 and several of its mutated forms, including Omicron variants, from entering the cells.
Crucially, we found the nutrient mix affected not only the virus itself; it also reduced the ability of the virus to enter cells by decreasing the number of ACE2 receptors on cell surfaces. In the presence of inflammation, which is commonly associated with infections, there were similarly less ACE2 receptors on cells. Nutrient anti-inflammatory effects were also observed in the lung tissue of the mice.
In conclusion, our study showed that the nutrient mix could help reduce the infectivity of SARS-CoV-2 and the associated common cold virus HCoV-229E in mice at different stages of infectivity. The fact that different mechanisms were affected simultaneously demonstrates the superior efficacy of nutrients compared to drugs, the latter of which usually target only a single mechanism and allow the virus to escape by mutating.
The unique composition and efficacy of our nutrient mix has been awarded US and international patents. While more research is needed in order to fully confirm its efficacy in human clinical trials, the application of this safe micronutrient combination as soon as possible should ultimately benefit people worldwide and save on healthcare costs.
So, the claim that a Nutrient Mix is “Effective Against Different Types of Coronavirus” rests on some lousy experiments on rats?
Might we call this misleading or dishonest?
And what is the Dr. Rath Research Institute?
Could it belong to the Dr. Rath Foundation?
The very foundation that once published this about me:
Professor Edzard Ernst: A Career Built On Discrediting Natural Health Science?
Professor Edzard Ernst, a retired German physician and academic, has recently become a prominent advocate of plans that could potentially outlaw the entire profession of naturopathic doctors in Germany. Promoting the nonsensical idea that naturopathic medicine somehow poses a risk to public health, Ernst attacks its practitioners as supposedly having been educated in “nonsense”. Tellingly, however, given that he himself has seemingly not published even so much as one completely original scientific trial of his own, Ernst’s apparent attempts to discredit natural healthcare approaches are largely reliant instead on his analysis or review of handpicked negative studies carried out by others.
SAY NO MORE!
The current secondary analysis based on the WHO database (VigiBase) of individual case safety reports (ICSRs) focuses on the suspected cutaneous adverse drug reactions (ADRs) linked to traditional medicines (TMs).
All the ICSRs reported between 1st January 2016 and 30th June 2021 from the UN Asia region in VigiBase where at least one TM was suspected to cause cutaneous ADRs were included in the study. Data regarding demographic details, suspected drug, adverse reaction as per MedDRA term, the seriousness of the reaction, de-challenge, re-challenge, and clinical outcome for suspected cutaneous ADRs associated with TM were obtained from VigiBase and analyzed for frequency of reported events and suspected medicines.
A total of 3,523 ICSRs with 5,761 ADRs related to “skin and subcutaneous tissue disorders” were included in the analysis. Amongst these, 6.8% of ICSRs were reported as serious.
The most common ADRs were:
- pruritus (29.6%),
- rash (20.3%),
- urticaria (18.9%),
- hyperhidrosis (3.3%).
Artemisia argyi H.Lév. and Vaniot. (14.9%), Ginkgo biloba L. (5.1%), Vitis vinifera L. (4%), Vitex agnus-castus L. (3.8%), Silybum marianum (L.), Gaertn (3.5%), and Viscus album L. (2.7%) were some commonly suspected TMs for cutaneous ADRs. There were 46 cases of Stevens-Johnson syndrome and toxic epidermal necrolysis reported with TMs during the study period. Death was reported in 5 ICSRs.
The authors concluded that TMs are linked with various cutaneous ADRS ranging from pruritus to toxic epidermal necrolysis which may have serious consequences. TMs listed as suspected offending agents in this analysis, should be kept in mind while dealing with suspected cutaneous ADRs. Clinicians should be more vigilant in detecting and reporting events associated with TMs.
Herbal remedies have a reputation for being time-tested, gentle, harmless, and benign. Reports such as this one might make us doubt this cliche. More importantly, they should force us to ask whether the remedy we are tempted to try truly does generate more good than harm. In most instances, I fear, the answer is not positive.
This survey evaluated the attitude of healthcare professionals toward the use of so-called alternative medicine (SCAM) to improve current care. A questionnaire on the current practice and opinions about SCAM use was sent to healthcare professionals in Amsterdam UMC, who work for the department of hematology or oncology. Oncologists, hematologists, residents, (specialized) nurses, dieticians, (hospital)pharmacists, and pharmacy technicians were asked to participate.
Among eligible healthcare professionals, 77 responded to the questionnaire (34%). Overall, 87% of healthcare
professionals indicated it is important to be aware of their patient’s SCAM use, and all find the potential of drug–herb interactions important. However, more than half of the healthcare professionals inquire about the patient’s SCAM use infrequently. In addition, only 15% of the healthcare professionals stated they had sufficient knowledge of SCAM to advise patients on their use of SCAM.
The authors concluded that healthcare professionals are aware of the potential risks of SCAM use in combination with anti-cancer treatment. However, SCAM use is not yet discussed with every patient. This may be due to healthcare professionals’ lack of knowledge about SCAM.
This survey would in itself be fairly irrelevant; it employed only a tiny convenience sample and its findings cannot be generalized. Yet, it produced results that have been shown dozens of times before, and it might therefore be a good idea to remind ourselves of their relevance and implications.
- Patients use SCAM whether we want it or not.
- Contrary to what is often said, SCAM is not harmless.
- Therefore conventional healthcare professionals need to know about their patients’ SCAM use.
- To find out, healthcare professionals need to ask specific questions about SCAM.
- Next, they must advise their patients responsibly (this is an ethical obligation, not a choice).
- In order to do that they need to learn the essentials about SCAM.
- Failing to do this means failing their patients.
The well-known Dr. Chris van Tulleken recently joined forces with Professor Michael Heinrich and Dr. Anthony Booker from the University College London School of Pharmacy to test a range of herbal products on sale in the UK. They bought over 70 herbal products from various high street stores and internet retailers. Some of the products were ‘THR’ (traditional herbal registration) herbal medicines, and some were marketed as food supplements. They then analyzed their chemistry to see whether each one really contained what the label says. The three popular herbal remedies we tested were:-
- Milk thistle (Silybum marianum),
- Ginkgo (Ginkgo biloba),
- Evening primrose (Oenothera).
The team at UCL used two different methods of analysis to verify the identity of these herbal products and extracts. High-performance thin-layer chromatography (HPTLC) is a sophisticated technique for the analysis of herbal products and is one of the most commonly used methods in the industry. HPTLC analysis creates a chemical fingerprint of the product which the researchers can then compare to an accepted reference standard for the herb. They look for a broad spectrum of ‘marker compounds’ these are the pharmacologically active and/or chemical constituents within a plant that can be used to verify its potency or identity. For complex samples or where additional confirmation is required, researchers often turn to ¹H nuclear magnetic resonance spectroscopy (¹H-NMR) which allows individual samples to be compared in detail against other samples or to the whole group.
In every THR product tested, the product contained what was claimed on the label. However, the food supplements showed a wide range of quality.
- Of the food supplement products labeled as Ginkgo, 8 out of 30 (27%) contained little or no ginkgo extract.
- 36% of the food supplement milk thistle products contained no detectable milk thistle. Although this is quite a small sample size it is still a startling result. Furthermore, in one case of milk thistle, unidentified adulterants suspected to be synthetic compounds were present in place of milk thistle.
- All of the evening primrose food products we tested did contain what the packet claimed.
The researchers concluded that their investigation shows that a regulatory system for herbal products, like the THR scheme, ensures that people have access to safe herbal medicine products. So, if you are considering buying herbal products then do look out for the THR mark– otherwise, you might not just be wasting your money, you might be consuming other, potentially dangerous, ingredients.
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This is an interesting investigation. The researchers should be commended for it! However, I disagree with some of their conclusions. Here is why:
- The investigation merely tested the quality of the products and NOT THEIR SAFETY! To claim that the THR ensures access to safe herbal medicines is incorrect. A product might be of adequate quality but can still be unsafe. The THR only implies safety because the herbal has been used for years without problems being noted. This is not the same as ensuring that it is safe. A direct test of safety is usually not available.
- The recommendation to buy a product with a THR mark is also somewhat misleading. It implies that these products are effective. I fail to see convincing evidence that either MILK THISTLE, GINKGO, or EVENING PRIMROSE are effective for any disease or condition. Thus the responsible recommendation should, in my view, be to NOT buy them regardless of whether they are of good quality or not.
During the coronavirus disease 2019 pandemic, Ayurvedic herbal supplements and homeopathic remedies were promoted as immune boosters (IBs) and disease-preventive agents. This happened in most parts of the world but nowhere more intensely than in India.
The present study examined the clinical outcomes among patients with chronic liver disease who presented with complications of portal hypertension or liver dysfunction temporally associated with the use of IBs in the absence of other competing causes. This Indian single-center retrospective observational cohort study included patients with chronic liver disease admitted for the evaluation and management of jaundice, ascites, or hepatic encephalopathy temporally associated with the consumption of IBs and followed up for 180 days. Chemical analysis was performed on the retrieved IBs.
From April 2020 to May 2021, 1022 patients with cirrhosis were screened, and 178 (19.8%) were found to have consumed complementary and alternative medicines. Nineteen patients with cirrhosis (10.7%), jaundice, ascites, hepatic encephalopathy, or their combination related to IBs use were included. The patients were predominantly male (89.5%). At admission, 14 (73.75%) patients had jaundice, 9 (47.4%) had ascites, 2 (10.5%) presented with acute kidney injury, and 1 (5.3%) had overt encephalopathy. Eight patients (42.1%) died at the end of the follow-up period. Hepatic necrosis and portal-based neutrophilic inflammation were the predominant features of liver biopsies.
Ten samples of IBs, including locally made ashwagandha powder, giloy juice, Indian gooseberry extracts, pure giloy tablets, multiherbal immune-boosting powder, other multiherbal tablets, and the homeopathic remedy, Arsenicum album 30C, were retrieved from our study patients. Samples were analyzed for potential hepatotoxic prescription drugs, known hepatotoxic adulterants, pesticides, and insecticides, which were not present in any of the samples. Detectable levels of arsenic (40%), lead (60%), and mercury (60%) were found in the samples analyzed. A host of other plant-derived compounds, industrial solvents, chemicals, and anticoagulants was identified using GC–MS/MS. These include glycosides, terpenoids, phytosteroids, and sterols, such as sitosterol, lupeol, trilinolein, hydroxy menthol, methoxyphenol, butyl alcohol, and coumaran derivatives.
The authors concluded that Ayurvedic and Homeopathic supplements sold as IBs potentially cause the worsening of preexisting liver disease. Responsible dissemination of scientifically validated, evidence-based medical health information from regulatory bodies and media may help ameliorate this modifiable liver health burden.
The authors comment that Ayurvedic herbal supplements and homeopathic remedies sold as IBs, potentially induce idiosyncratic liver injury in patients with preexisting liver disease. Using such untested advertised products can lead to the worsening of CLD in the form of liver failure or portal hypertension events, which are associated with a high risk of mortality compared to those with severe AH-related liver decompensation in the absence of timely liver transplantation. Severe mixed portal inflammation and varying levels of hepatic necrosis are common findings on liver histopathology in IB-related liver injury. Health regulatory authorities and print and visual media must ensure the dissemination of responsible and factual scientific evidence-based information on herbal and homeopathic “immune boosters” and health supplements to the public, specifically to the at-risk patient population.
Menopausal symptoms are a domaine of so-called alternative medicine (SCAM), not least because many women are worried about hormone treatments and therefore want ‘something natural’. TCM practitioners are only too keen to offer their services. But do their treatments really work?
This study aimed to analyze the effectiveness of acupuncture combined with Chinese herbal medicine (CHM) on mood disorder symptoms for menopausal women.
A total of 95 qualified Chinese participants were randomly assigned to one of three groups:
- 31 in the acupuncture combined with CHM group (combined group),
- 32 in the acupuncture combined with CHM placebo group (acupuncture group),
- 32 in the CHM combined with sham acupuncture group (CHM group).
The patients were treated for 8 weeks and followed up for 4 weeks. The data were collected using the Greene Climacteric Scale (GCS), self-rating depression scale (SDS), self-rating anxiety scale (SAS), and safety index.
The three groups each showed significant decreases in the GCS, SDS, and SAS after treatment (p < 0.05). Furthermore, the effect on the GCS total score and the anxiety domain lasted until the follow-up period in the combined group (p < 0.05). Within the three groups, there was no difference in GCS and SAS between the three groups after treatment (p > 0.05). However, the combined group showed significant improvement in the SDS, compared with both the acupuncture group and the CHM group at 8 weeks and 12 weeks (p < 0.05). No obvious abnormal cases were found in any of the safety indexes.
The authors concluded that the results suggest that either acupuncture, or CHM or combined therapy offer safe improvement of mood disorder symptoms for menopausal women. However, the combination therapy was associated with more stable effects in the follow-up period and a superior effect on improving depression symptoms.
Previous reviews have drawn conclusions that are far less positive, e.g.:
- the observed clinical benefit associated with acupuncture may be due, in part, or in whole to nonspecific effects.
- the evidence gathered was not sufficient to affirm the effectiveness of traditional acupuncture compared with sham acupuncture.
- For natural menopause, one large study has shown acupuncture to be superior to self-care alone in reducing the number of hot flushes and improving the quality of life; five small studies have been unable to demonstrate that the effect of acupuncture is limited to any particular points, as traditional theory would suggest; and one study showed acupuncture was superior to blunt needle for flash frequency but not intensity.
- Sham-controlled RCTs fail to show specific effects of acupuncture for control of menopausal hot flushes.
It seems therefore wise to take the conclusions of the new study with a pinch of salt. The intergroup difference observed in this trial may well be due to residual biases, multiple testing, or coincidence. And the reported intragroup differences are in complete accord with the fact that the employed therapies are mere placebos.
This, of course, begs the question of whether SCAM has anything else to offer for women suffering from menopausal symptoms. To answer it, I can refer you to one of our systematic reviews:
Some evidence exists in favour of phytosterols and phytostanols for diminishing LDL and total cholesterol in postmenopausal women. Similarly, regular fiber intake is effective in reducing serum total cholesterol in hypercholesterolemic postmenopausal women. Clinical evidence also exists on the effectiveness of vitamin K, a combination of calcium and vitamin D or a combination of walking with other weight-bearing exercise in reducing bone mineral density loss and the incidence of fractures in postmenopausal women. Black cohosh appears to be effective therapy for relieving menopausal symptoms, primarily hot flashes, in early menopause. Phytoestrogen extracts, including isoflavones and lignans, appear to have only minimal effect on hot flashes but have other positive health effects, e.g. on plasma lipid levels and bone loss. For other commonly used CAMs, e.g. probiotics, prebiotics, acupuncture, homeopathy and DHEA-S, randomized, placebo-controlled trials are scarce and the evidence is unconvincing. More and better RCTs testing the effectiveness of these treatments are needed.
