MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

supplements

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Ginkgo biloba is a well-researched herbal medicine which has shown promise for a number of indications. But does this include coronary heart disease?

The aim of this systematic review was to provide information about the effectiveness and safety of Ginkgo Leaf Extract and Dipyridamole Injection (GD) as one adjuvant therapy for treating angina pectoris (AP) and to evaluate the relevant randomized controlled trials (RCTs) with meta-analysis. (Ginkgo Leaf Extract and Dipyridamole Injection is a Chinese compound preparation, which consists of ginkgo flavone glycosides (24%), terpene lactones (ginkgolide about 13%, ginkgolide about 2.9%) and dipyridamole.)

RCTs concerning AP treated by GD were searched and the Cochrane Risk Assessment Tool was adopted to assess the methodological quality of the RCTs. A total of 41 RCTs involving 4,462 patients were included in the meta-analysis. The results indicated that the combined use of GD and Western medicine (WM) against AP was associated with a higher total effective rate [risk ratio (RR)=1.25, 95% confidence interval (CI): 1.21–1.29, P<0.01], total effective rate of electrocardiogram (RR=1.29, 95% CI: 1.21–1.36, P<0.01). Additional, GD combined with WM could decrease the level of plasma viscosity [mean difference (MD)=–0.56, 95% CI:–0,81 to–0.30, P<0.01], fibrinogen [MD=–1.02, 95% CI:–1.50 to–0.54, P<0.01], whole blood low shear viscosity [MD=–2.27, 95% CI:–3.04 to–1.49, P<0.01], and whole blood high shear viscosity (MD=–0.90, 95% CI: 1.37 to–0.44, P<0.01).

The authors concluded that comparing with receiving WM only, the combine use of GD and WM was associated with a better curative effect for patients with AP. Nevertheless, limited by the methodological quality of included RCTs more large-sample, multi-center RCTs were needed to confirm our findings and provide further evidence for the clinical utility of GD.

If one reads this conclusion, one might be tempted to use GD to cure AP. I would, however, strongly warn everyone from doing so. There are many reasons for my caution:

  • All the 41 RCTs originate from China, and we have repeatedly discussed that Chinese TCM trials are highly unreliable.
  • The methodological quality of the primary RCTs was, according to the review authors ‘moderate’. This is not true; it was, in fact, lousy.
  • Dipyridamole is not indicated in angina pectoris.
  • To the best of my knowledge, there is no good evidence from outside China to suggest that Ginkgo biloba is effective for angina pectoris.
  • Angina pectoris is caused by coronary artery disease (a narrowing of one or more coronary arteries due to atherosclerosis), and it seems implausible that this condition can be ‘cured’ with any medication.

So, what we have here is yet another nonsensical paper, published in a dubious journal, employing evidently irresponsible reviewers, run by evidently irresponsible editors, hosted by a seemingly reputable publisher (Springer). This is reminiscent of my previous post (and many posts before). Alarmingly, it is also what I encounter on a daily basis when scanning the new publications in my field.

The effects of this incessant stream of nonsense can only have one of two effects:

  1. People take this ‘evidence’ seriously. In this case, many patients might pay with their lives for this collective incompetence.
  2. People conclude that alt med research cannot be taken seriously. In this case, we are unlikely to ever see anything useful emerging from it.

Either way, the result will be profoundly negative!

It is high time to stop this idiocy; but how?

I wish, I knew the answer.

After 25 years of full-time research into alternative medicine, I thought that I have seen it all. But I was wrong! Here is an article that surpasses every irresponsible stupidity I can remember. It is entitled ‘Ginger is the monumentally superior alternative to chemotherapy‘:

Let’s say that your doctor has given you a cancer diagnosis. Let’s revisit animal wisdom. If a squirrel was looking over a tasty morsel of ginger on one side, or a vial full of Mehotrexate, Danorubicin or Tioguanine on the other, what would that intelligent squirrel choose? The answer is obvious. And it’s the right answer, because ginger roots, after being dried and cooked, manifest an ingredient called 6-shogaol.

This naturally occurring element is up to 10,000 times more effective at killing cancer cells than those vials of destructive drugs, reports David Guiterrez from Natural News, who states that “researchers found that 6-shogaol is active against cancer stem cells at concentrations that are harmless to healthy cells. This is dramatically different from conventional chemotherapy, which has serious side effects largely because it kills healthy as well as cancerous cells.”

END OF QUOTE

As David Guiterrez from Natural News might not be the most reliable of sources, I did a bit of searching for evidence. This is what I found:

A study examining the efficacy of ginger, as an adjuvant drug to standard antiemetic therapy, in ameliorating acute and delayed CINV in patients with lung cancer receiving cisplatin-based regimens. It concluded that as an adjuvant drug to standard antiemetic therapy, ginger had no additional efficacy in ameliorating CINV in patients with lung cancer receiving cisplatin-based regimens.

A randomized, double-blind, placebo-controlled, multicenter study in patients planned to receive ≥2 chemotherapy cycles with high dose (>50 mg/m2) cisplatin. Patients received ginger 160 mg/day (with standardized dose of bioactive compounds) or placebo in addition to the standard antiemetic prophylaxis for CINV, starting from the day after cisplatin administration. The authors found that in patients treated with high-dose cisplatin, the daily addition of ginger, even if safe, did not result in a protective effect on CINV. 

Yes, there are also a few trials to suggest that ginger is effective for reducing nausea and vomiting after chemotherapy, but by and large they are older and less rigorous. And anyway, this is besides the point. The question here is not whether there is good evidence to show that ginger is helpful against chemo-induced nausea; the question is whether Ginger is clinically effective in ‘killing cancer cells’. And the answer is an emphatic

NO!!!

And this means the above-quoted article irresponsible, unethical, perhaps even criminal to the extreme. I shudder to think how many cancer patients have read it and consequently given up their conventional treatments opting for Ginger instead.

I have just been in Sao Paulo to give a lecture at the opening of a new university institute, ‘Question of Science‘. Under the leadership of Natalia Pasternak, the institute will promote scepticism in Brazil, particularly in the area of alternative medicine. Brazil currently has no less than 29 types of alternative medicine paid for with public money, and even homeopathy is officially being recognised and taught at all Brazilian medical schools.

But the most peculiar case of Brazilian quackery must surely be phosphoethanolamine. Gilberto Chierice, a Chemistry Professor at the University of São Paulo, used resources from a campus laboratory to unofficially manufacture, distribute, and promote the chemical to cancer patients claiming that it was a cheap cure for all cancers without side-effects. Remarkably, this was in the total absence of through clinical testing. In September 2015, university administrators therefore began preventing him from continuing with this practice. However, in October 2015, several courts in Brazil ruled in favour of plaintiffs who wanted the compound to remain available. In an unusual move of defence of common sense, a state court overturned the lower courts’ decision a month later, and the secretary for Brazil’s science and technology ministry promised to fund further research on the compound. In 2016, a law was passed in Brazil allowing the sale of synthetic phosphorylethanolamine for cancer treatment. Due to opposition from the Brazilian Medical Association, the Brazilian Society of Clinical Oncology, and the regulatory agency ANVISA, the country’s Supreme Court then suspended the law. I was told that a stepwise plan of clinical testing had been implemented. As the drug even failed to pass the most preliminary tests, the program had to be aborted.

This story seems like a re-play of many similar tales of bogus cancer cures of the past. They all seem to follow a similar pattern:

  1. Someone dreams up a ‘cure’ for all cancers that is cheap and free of side-effects.
  2. This appeals to many desperate cancer patients who are fighting for their lives.
  3. It also attracts several entrepreneurs who are hoping to make a fast buck.
  4. The story is picked up by the press and consequently a sizable grass-roots movement of support emerges.
  5. Populist politicians jump on the vote-winning band-waggon.
  6. The experts caution that the bogus cancer ‘cure’ is devoid of evidence and might put patients’ lives at risk.
  7. The legislators get involved.
  8. Law suits start left, right and centre.
  9. Eventually, the cancer ‘cure’ is scientifically tested and confirmed to be bogus.
  10. Eventually, the law rules against the bogus ‘cure’.
  11. A conspiracy theory emerges stating that the cancer ‘cure’ was unjustly suppressed to protect the interests of Big Pharma.
  12. A few years later, the subject re-surfaces and the whole cycle starts from the beginning.

Such stories remind us that fighting bogus claims is hugely important, even if it does not always succeed or turns out to be merely an exercise of damage limitation. Every life saved by the struggle against quackery makes it worthwhile.

I wish the new Institute ‘Question of Science‘ all the luck it richly deserves and desperately needs.

I regularly scan the new publications in alternative medicine hoping that I find some good quality research. And sometimes I do! In such happy moments, I write a post and make sure that I stress the high standard of a paper.

Sadly, such events are rare. Usually, my searches locate a multitude of deplorably poor papers. Most of the time, I ignore them. Sometime, I do write about exemplarily bad science, and often I report about articles that are not just bad but dangerous as well. The following paper falls into this category, I fear.

The aim of this systematic review was to assess the efficacy and safety of herbal medicines for the induction of labor (IOL). The researchers considered experimental and non-experimental studies that compared relevant pregnancy outcomes between users and non-user of herbal medicines for IOL.

A total of 1421 papers were identified and 10 studies, including 5 RCTs met the authors’ inclusion criteria. Papers not published in English were not considered. Three trials were conducted in Iran, two in the USA and one each in South Africa, Israel, Thailand, Australia and Italy.

The quality of the included trial, even of the 5 RCTs, was poor. The results suggest, according to the authors of this paper, that users of herbal medicine – raspberry leaf and castor oil – for IOL were significantly more likely to give birth within 24 hours than non-users. No significant difference in the incidence of caesarean section, assisted vaginal delivery, haemorrhage, meconium-stained liquor and admission to nursery was found between users and non-users of herbal medicines for IOL.

The authors concluded that the findings suggest that herbal medicines for IOL are effective, but there is inconclusive evidence of safety due to lack of good quality data. Thus, the use of herbal medicines for IOL should be avoided until safety issues are clarified. More studies are recommended to establish the safety of herbal medicines.

As I stated above, I am not convinced that this review is any good. It included all sorts of study designs and dismissed papers that were not in English. Surely this approach can only generate a distorted or partial picture. The risks of herbal remedies for mother and baby are not well investigated. In view of the fact that even the 5 RCTs were of poor quality, the first sentence of this conclusion seems most inappropriate.

On the basis of the evidence presented, I feel compelled to urge pregnant women NOT to consent to accept herbal remedies for IOL.

And on the basis of the fact that far too many papers on alternative medicine that emerge every day are not just poor quality but also dangerously mislead the public, I urge publishers, editors, peer-reviewers and researchers to pause and remember that they all have a responsibility. This nonsense has been going on for long enough; it is high time to stop it.

Several previous studies have suggested improvements in sperm quality after vitamin supplementation, and several reviews have drawn tentatively positive conclusions:

Most of the primary trials lacked scientific rigour, however. Now a new study has emerged that overcomes many of the flaws of the previous research.

Professor Anne Steiner from the University of North Carolina at Chapel Hill, USA, presented her study yesterday at the 34th Annual Meeting of ESHRE in Barcelona. This clinical trial of 174 couples has found that an antioxidant formulation taken daily by the male partner for a minimum of three months made no difference to sperm concentration, motility or morphology, nor to the rate of DNA fragmentation. The study was performed in eight American fertility centres.

All men in the study had been diagnosed with male factor infertility, reflected in subnormal levels of sperm concentration, motility, or morphology, or higher than normal rates of DNA fragmentation. These parameters were measured at the start of the trial and at three months. In between, the men allocated to the antioxidant intervention were given a daily supplement containing vitamins C, D3 and E, folic acid, zinc, selenium and L-carnitine; the control group received a placebo.

At three months, results showed only a “slight” overall difference in sperm concentration between the two groups, and no significant differences in morphology, motility, or DNA fragmentation measurements. Sub-group analysis (according to different types of sperm abnormality) found no significant differences in sperm concentration (in oligospermic men), motility (in asthenospermic men), and morphology (in teratospermic men).(1) There was also no change seen after three months in men with high rates of DNA fragmentation (28.9% in the antioxidant group and 28.8 in the placebo group).

Natural conception during the initial three month study period did also not differ between the two groups of the entire cohort – a pregnancy rate of 10.5% in the antioxidant group and 9.1% in the placebo. These rates were also comparable at six months (after continued antioxidant or placebo for the male partner and three cycles of clomiphene and intrauterine insemination for the female partner).

The authors concluded that “the results do not support the empiric use of antioxidant therapy for male factor infertility in couples trying to conceive naturally”.

The story about supplements and health claims seems to be strangely repetitive:

  • the claim that supplements help for condition xy is heavily promoted, e. g. via the Internet;
  • a few flimsy trials seem to support the claim;
  • these results are relentlessly hyped;
  • the profit of the manufacturers grows;
  • eventually a rigorous, independently-funded trial emerges with a negative finding;
  • the card house seems to collapse;
  • the manufacturers claim that the trial’s methodology was faulty (e. g. wrong does, wrong mixture of ingredients);
  • thus another profitable card house is built elsewhere.

In the end, the only supplement-related effects are that 1) the consumers produce expensive urine and 2) the manufacturers have plenty of funds to start a new campaign based on yet another bogus heath claim.

When NHS England announced several months ago that they plan to stop the reimbursement of homeopathy, UK homeopaths were understandably upset and decided to launch a legal challenge to this decision. Yesterday, the result of this challenge has been published in a NHS press-release:

START OF QUOTE

NHS chief Simon Stevens has today welcomed the High Court’s decisive rejection of a legal challenge by the British Homeopathic Association to overturn plans to no longer routinely fund homeopathy on the NHS.

As part of action to clamp down on waste, over the last two years NHS England has taken action to curb prescriptions for medicines that can be bought over the counter or are of low value.

At the end of last year NHS England published guidance to curb prescriptions for 18 ineffective, unsafe or low clinical priority treatments, such as coproxamol, some dietary supplements, herbal treatments and homeopathy, saving up to £141 million a year. Earlier this year NHS England published a further list of 35 minor, short-term conditions for which over the counter medicines should not routinely be prescribed, saving around a further £100 million a year.

Savings form a key building block of the NHS’s 10 point efficiency plan contained in the Next Steps on the NHS Five Year Forward View, published in March 2017.

NHS chief, Simon Stevens said: “There is no robust evidence to support homeopathy which is at best a placebo and a misuse of scarce NHS funds.

“So we strongly welcome the High Court’s clear cut decision to kick out this costly and spurious legal challenge.”

Guidance on items which should not be routinely prescribed in primary care is available on the NHS England website.

END OF QUOTE

The reaction of UK homeopaths was as swift and deluded as it was predictable. The British Homeopathy Association, for instance, commented thus:

… The charity’s main claims against NHS England were that the consultation misrepresented homeopathy and therefore was unfair; and a report used in the consultation to inform the public was so complicated it would deter rather than encourage people to respond. Although the judge found there were sufficient grounds for a judicial review, after four days of lengthy legal arguments he dismissed the claims. Margaret Wyllie, BHA Chair, said the case highlighted how health bosses were unfairly manipulating the consultation process and making decisions about healthcare services without genuine patient engagement. “That NHS England attracted fewer than 3,000 responses from patients to a national consultation that ran for three months highlights its failure to genuinely engage with the public on important decisions about healthcare provision. Although 18 medicines were under review the only negative statement in NHS England’s press release promoting its public consultation was about homeopathy. The statement was so prejudicial it was widely reported in the media that the decision to deny patients homeopathic medicines had already been taken. How the judge failed to recognise that this was a deliberate attempt by NHS England to unfairly influence the public is astonishing,” said Mrs Wyllie.

In The Telegraph, Wyllie is quoted saying: It appears NHS England can fail to engage with patients properly on removing services and get away with it. That is not good enough, for it is important to remember that the real losers in this case are the patients who are now being refused a treatment on which they have come to depend.”

One can only marvel at the lack of insight and self-criticism. I should to add that the BHA is a charity; with this court case, they have wasted significant amounts of public money for their own, hopelessly misguided interests. To me, this indicates that they no longer deserve a charitable status.

Personally, I had very little doubt that the court would decide as it did. The evidence was simply overwhelming and indisputable. In the written judgement, the judge stated that “I am satisfied that NHSE was rigorous in the discharge of the duty to have “due regard” to relevant matters, and that it was entitled, on the evidence before it, to conclude that the Guidance would not have an adverse impact on the statutory equality objectives, but rather, as the Analysis found, “would [enable] patients to have access to the most effective medications to achieve the best outcomes”.

 

In all this, the open questions, in my view, were whether

  1. Prince Charles, the prime defender of quackery in the UK, would intervene,
  2. and whether his intervention might change anything.

So, did he try to intervene?

I do not know. It could be that, after all the hoo-ha about his spider memos, he now is a little more cautions about meddling in health politics. It could also be that, as he is getting ready to become king, he wants to keep a low profile about his more bizarre ideas. Lastly, it could be that his opinion does not weigh as heavily as I had feared.

In any case, The High Court ruling is most welcome and unquestionably just, progressive, and long-overdue. I applaud all who have worked hard to bring it about, and am sure that (most of) my readers agree.

‘HELLO’ is, of course, a most reliable source of information when it comes to healthcare (and other subjects as well, I am sure). Therefore, I was thrilled to read their report on Meghan Markle’s list of supplements which, ‘HELLO’ claim, she takes for “calming any stress or nerves ahead of the royal wedding on 19 May.” The list includes the following:

  • Magnesium,
  • Vitamin B-12,
  • Multivitamins,
  • ‘Cortisol Manager’ (30 tablets cost US$ 65)
  • Ashwagandha.

Not only does ‘HELLO’ provide us with this most fascinating list, it tells us also what exactly these supplements are best used for:

Magnesium helps to keep blood pressure normal, increase energy, relieves muscle aches and spasms, and calms nerves, all of which will be beneficial to Meghan. Meanwhile, B12 drops will ensure Meghan doesn’t become deficient in the vitamin due to her diet, which is largely plant-based and contains very little animal products, which are one of the main sources of B12.

A multivitamin will provide Meghan with her recommended daily intake of various vitamins and minerals, while Cortisol Manager is a “stress hormone stabiliser”, which is designed to support the body’s natural rise and fall of cortisol, helping promote feelings of relaxation and aid better sleep. The supplement contains L-Theanine, Magnolia, Epimedium and Ashwagandha – although Meghan said she sometimes takes additional doses of the herb, likely at periods of high stress.

Ashwagandha is a herb that helps to moderate the body’s response to stress, bringing inner calm and also boosting energy. The supplement comes from the root of the ashwagandha plant and can be taken in tablet form…

I hope I don’t spoil the Royal wedding if I run a quick reality check on these supplements. Assuming she is generally healthy (she certainly looks it), and now being aware that Meghan eats a mostly plant-based diet, here are the most likely benefits of the above-listed supplements/ingredients:

  • Magnesium: NONE
  • Vitamin B-12: DEBATABLE
  • Multivitamins: NONE
  • L-Theanine: NONE
  • Magnolia: NONE
  • Epimedium: NONE
  • Ashwagandha: NONE

Personally, I find Ashwagandha the most intriguing of all the listed ingredients, not least because Meghan said she sometimes takes additional doses of the herb. Why might that be? There is very little reliable research on this (or any of the other above-listed) remedy; but I found one placebo-controlled study which concluded that Ashwagandha “may improve sexual function in healthy women”.

Before my readers now rush out in droves to the next health food shop, I should issue a stern warning: the trial was flimsy and the results lack independent confirmation.

PS

She also seems to have a weakness for homeopathy

Most diabetics need life-long medication. Understandably, this makes many fed-up, and some think that perhaps natural remedies might be a less harmful, less intrusive way to control their condition. They don’t have to look far to find an impressively large choice.

This article in the Canadian Journal of Diabetes was aimed at reviewing CAM, including natural health products (NHP) and others, such as yoga, acupuncture, tai chi and reflexology, that have been studied for the prevention and treatment of diabetes and its complications. It claims that, in adults with type 2 diabetes, the following NHP have been shown to lower glycated hemoglobin (A1C) by at least 0.5% in randomized controlled trials lasting at least 3 months:

Ayurveda polyherbal formulation

Citrullus colocynthis

Coccinia cordifolia

Eicosapentaenoic acid

Ganoderma lucidum

Ginger (Zingiber officinale)

Gynostemma pentaphyllum

Hintonia latiflora

Lichen genus Cladonia BAFS “Yagel-Detox”

Marine collagen peptides

Nettle (Urtica dioica)

Oral aloe vera

Pterocarpus marsupium (vijayasar)

Salacia reticulate

Scoparia dulcis porridge

Silymarin

Soybean-derived pinitol extract

Touchi soybean extract

Traditional Chinese medicine herbs:

Berberine

Fructus Mume

Gegen Qinlian Decoction (GQD)

Jianyutangkang (JYTK) with metformin

Jinlida with metformin

Sancaijiangtang

Shen-Qi-Formula (SQF) with insulin

Tang-Min-Ling-Wan (TM81)

Xiaoke (contains glyburide)

Zishentongluo (ZSTL)

Trigonella foenum-graecum (fenugreek)

Even though the authors caution that these remedies should not be recommended for routine use, I fear that such lists do motivate diabetics to give them a try. If they do, the outcome could be that:

  • Nothing at all happens other than the patient wasting some money on useless remedies. The clinical trials on which the above list is based are usually so flimsy that their findings are next to meaningless and quite possibly false-positive.
  • The patient might, if the remedy does affect blood sugar levels, develop hypoglycaemia. If severe, this could be life-threatening.
  • The patient might trust in a natural remedy and thus discontinue the prescribed anti-diabetic medication. In this case, she could develop hyperglycaemia. If severe, this could be life-threatening.

It seems obvious that none of the possible outcomes are in the patients’ interest. I fear that it is dangerous to tempt diabetics with the possibility that a natural remedy. Even if such treatments did work, they are not well-researched, unreliable and do not have sufficiently large effects (a 0.5% decrease of glycated haemoglobin is hardly impressive) to represent realistic options.

“In my medical practice, writes Sheila Patel, M.D. on the website of Deepak Chopra, I always take into consideration the underlying dosha of a patient, or what their main imbalance is, when choosing treatments out of the many options available. For example, if I see someone who has the symptoms of hypertension as well as a Kapha imbalance, I may prescribe a diuretic, since excess water is more likely to be a contributing factor.  I would also encourage more exercise or physical activity, since lack of movement is often a causative factor for these individuals.  However, in a Vata-type person with hypertension, a diuretic may actually cause harm, as the Vata system tends to have too much dryness (air and space). I’ve observed that Vatas often have more side effects and electrolyte imbalances due to the diuretic medication.  For these individuals, a beta-blocker may be a better choice, as this “slows” down the excitatory pathways in the body. In addition, I recommend meditation and calming activities to settle the excess energy as an adjunct to (or at times, instead of) the medicine. Alternatively, for someone with hypertension who is predominantly a Pitta type or who has a Pitta imbalance, I may choose a calcium-channel blocker, as this medication may be more beneficial in regulating the process of “energy exchange” in the body, which is represented by the fire element of Pitta. This is just one example of the way in which we can tailor our choice of medication to best suit the individual.

“In contrast with conventional medicine, which until very recently has assumed that a given disorder or disease is the same in all people, Ayurveda places great importance on recognizing the unique qualities of individual human beings. Ayurveda’s understanding of constitutional types or doshas offers us a remarkably accurate way to pinpoint what is happening inside each individual, allowing us to customize treatment and offer specific lifestyle recommendations to prevent disease and promote health and longevity. Keeping the doshas balanced is one of the most important factors in keeping the whole mind-body system in balance.  When our mind-body system is in balance and we are connecting to our inner wisdom and intelligence, then we are most able to realize our full human potential and achieve our optimal state of being…”

END OF QUOTE

From such texts, some might conclude that Ayurvedic medicine is gentle and kind (personally, I am much more inclined to feel that Ayurvedic medicine is full of BS). This may be true or not, but Ayurvedic medicines are certainly anything but gentle and kind. In fact, they can be positively dangerous. I have repeatedly blogged about their risks, in particular the risk of heavy metal poisoning (see here, here, and here, for instance).

My 2002 systematic review summarised the evidence available at the time and concluded that heavy metals, particularly lead, have been a regular constituent of traditional Indian remedies. This has repeatedly caused serious harm to patients taking such remedies. The incidence of heavy metal contamination is not known, but one study shows that 64% of samples collected in India contained significant amounts of lead (64% mercury, 41% arsenic and 9% cadmium). These findings should alert us to the possibility of heavy metal content in traditional Indian remedies and motivate us to consider means of protecting consumers from such risks.

Meanwhile, new data have emerged and a new article with important information has recently been published by authors from the Department of Occupational and Environmental Health , College of Public Health, The University of Iowa and the State Hygienic Laboratory at the University of Iowa, USA. They present an analysis based on reports of toxic metals content of Ayurvedic products obtained during an investigation of lead poisoning among users of Ayurvedic medicine. Samples of Ayurvedic formulations were analysed for metals and metalloids following established US. Environmental Protection Agency methods. Lead was found in 65% of 252 Ayurvedic medicine samples with mercury and arsenic found in 38 and 32% of samples, respectively. Almost half of samples containing mercury, 36% of samples containing lead, and 39% of samples containing arsenic had concentrations of those metals per pill that exceeded, up to several thousand times, the recommended daily intake values for pharmaceutical impurities.

The authors concluded that lack of regulations regarding manufacturing and content or purity of Ayurvedic and other herbal formulations poses a significant global public health problem.

I could not have said it better myself!

Sipjeondaebo-tang is an East Asian herbal supplement containing Angelica root (Angelicae Gigantis Radix), the rhizome of Cnidium officinale Makino (Cnidii Rhizoma), Radix Paeoniae, Rehmannia glutinosa root (Rehmanniae Radix Preparata), Ginseng root (Ginseng Radix Alba), Atractylodes lancea root (Atractylodis Rhizoma Alba), the dried sclerotia of Poria cocos (Poria cocos Sclerotium), Licorice root (Glycyrrhizae Radix), Astragalus root (Astragali Radix), and the dried bark of Cinnamomum verum (Cinnamomi Cortex).

But does this herbal mixture actually work? Korean researchers wanted to find out.

The purpose of their study was to examine the feasibility of Sipjeondaebo-tang (Juzen-taiho-to, Shi-Quan-Da-Bu-Tang) for cancer-related anorexia. A total of 32 participants with cancer anorexia were randomized to either Sipjeondaebo-tang group or placebo group. Participants were given 3 g of Sipjeondaebo-tang or placebo 3 times a day for 4 weeks. The primary outcome was a change in the Anorexia/Cachexia Subscale of Functional Assessment of Anorexia/Cachexia Therapy (FAACT). The secondary outcomes included Visual Analogue Scale (VAS) of anorexia, FAACT scale, and laboratory tests.

The results showed that anorexia and quality of life measured by FAACT and VAS were improved after 4 weeks of Sipjeondaebo-tang treatment. However, there was no significant difference between changes of Sipjeondaebo-tang group and placebo group.

From this, the authors of the study concluded that sipjeondaebo-tang appears to have potential benefit for anorexia management in patients with cancer. Further large-scale studies are needed to ensure the efficacy.

Well, isn’t this just great? Faced with a squarely negative result, one simply ignores it and draws a positive conclusion!

As we all know – and as trialists certainly must know – controlled trials are designed to compare the outcomes of two groups. Changes within one of the groups can be caused by several factors unrelated to the therapy and are therefore largely irrelevant. This means that “no significant difference between changes of Sipjeondaebo-tang group and placebo group” indicates that the herbal mixture had no effect. In turn this means that a conclusion stating that “sipjeondaebo-tang appears to have potential benefit for anorexia” is just fraudulent.

This level of scientific misconduct is remarkable, even for the notoriously poor 

I strongly suggest that:

  1. The journal is de-listed from Medline because similarly misleading nonsense has been coming out of this rag for some time.
  2. The paper is withdrawn because it can only mislead vulnerable patients.
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