Fructus Psoraleae is the seed of Psoralea corylifolia Linn. It is the main ingredient of the herbal mixtures such as Qubaibabuqi, popular in China, India and other countries. It has been used for medicinal purposes for millennia. Thus many proponents would claim that it must be risk-free.
A recent case-report suggests that it might not be as safe as often assumed.
A 53-year-old woman was diagnosed with vitiligo in September 2017 and was treated with oral Qubaibabuqi tablets (15 tablets three times daily; Xinjiang Yinduolan Uyghur Pharmaceutical Company Limited, Urumqi, China), 10 mg of prednisone acetate tablets (Xinhua Pharmaceutical Company Limited, Zibo, China) once daily, and narrowband-ultraviolet B (NB-UVB) phototherapy (Sigma household narrowband-ultraviolet phototherapy instrument [SS-01B] pocket portable; Shanghai Sigma High Technology Co., Ltd. Shanghai, China) every other day. The prednisone acetate tablets were self-discontinued 3 months later; however, she continued to take Qubaibabuqi tablets orally and NB-UVB phototherapy was undertaken at home.
After approximately 7 months of treatment, the patient developed a severe, diffuse yellow staining of the skin and sclera in March 2018. On admission, she was diagnosed with acute cholestatic hepatitis associated with Fructus Psoraleae. Despite receiving active treatment, her condition rapidly deteriorated and she died 5 days later due to acute liver failure and multiple organ dysfunction. There are 6 further reported cases of liver injury associated with Fructus Psoraleae described in the English language literature. Cases of acute liver failure associated with the use of Fructus Psoraleae have not been previously described.
The authors of the case-report concluded that as a main ingredient in the Qubaibabuqi tablet formula, Fructus Psoraleae has potential hepatotoxicity. This potentially fatal adverse effect should be considered when physicians prescribe Qubaibabuqi tablets.
Psoralea corylifolia Linn (also known as Bu-gu-zh, Bu Ku Zi, Bol-gol-zhee, Boh-Gol-Zhee, Babchi, and Bakuchi) is a plant grown in China, India, Sri Lanka, Burma, and other countries, which is considered an important herbal medicine. It is used in TCM to tonify the kidneys, particularly kidney yang and essence. It is used for helping the healing of bone fractures, for lower back and knee pain, impotence, bed wetting, hair loss, and vitiligo. A recent review named it as one of the main herbs causing liver problems (other herbs included Polygonum multiflorum, Corydalis yanhusuo, and Rheum officinale).
Another review found that Psoralea corylifolia has cardiotonic, vasodilator, pigmentor, antitumor, antibacterial, cytotoxic, and anti-helminthic properties. About one hundred bioactive compounds have been isolated from seeds and fruits; the most important ones belong to coumarins, flavonoids, and meroterpenes groups. Psoralea corylifolia is part of many Ayurvedic and Chinese herbal mixtures.
Despite of the popularity of Psoralea corylifolia in the treatment of a very wide range of conditions, and despite the pharmacological studies into its potential therapeutic uses, there is an almost complete void as to clinical trials testing its clinical effectiveness.
The case-report is a poignant and tragic reminder of the often-neglected fact that neither a long history of usage nor popularity of a (herbal) treatment are reliable indicators for safety.
The present trial evaluated the efficacy of homeopathic medicines of Melissa officinalis (MO), Phytolacca decandra (PD), and the combination of both in the treatment of possible sleep bruxism (SB) in children (grinding teeth during sleep).
Patients (n = 52) (6.62 ± 1.79 years old) were selected based on the parents report of SB. The study comprised a crossover design that included 4 phases of 30-day treatments (Placebo; MO 12c; PD 12c; and MO 12c + PD 12c), with a wash-out period of 15 days between treatments.
At baseline and after each phase, the Visual Analogic Scale (VAS) was used as the primary outcome measure to evaluate the influence of treatments on the reduction of SB. The following additional outcome measures were used: a children’s sleep diary with parent’s/guardian’s perceptions of their children’s sleep quality, the trait of anxiety scale (TAS) to identify changes in children’s anxiety profile, and side effects reports. Data were analyzed by ANOVA with repeated measures followed by Post Hoc LSD test.
Significant reduction of SB was observed in VAS after the use of Placebo (-1.72 ± 0.29), MO (-2.36 ± 0.36), PD (-1.44 ± 0.28) and MO + PD (-2.21 ± 0.30) compared to baseline (4.91 ± 1.87). MO showed better results compared to PD (p = 0.018) and Placebo (p = 0.050), and similar result compared to MO+PD (p = 0.724). The sleep diary results and TAS results were not influenced by any of the treatments. No side effects were observed after treatments.
The authors concluded that MO showed promising results in the treatment of possible sleep bruxism in children, while the association of PD did not improve MO results.
Even if one fully subscribed to the principles of homeopathy, this trial raises several questions:
- Why was it submitted and then published in the journal ‘Phytotherapy’. All the remedies were given as C12 potencies. This has nothing to do with phytomedicine.
- Why was a cross-over design chosen? According to homeopathic theory, a homeopathic treatment has fundamental, long-term effects which last much longer than the wash-out periods between treatment phases. This effectively rules out such a design as a means of testing homeopathy.
- MO is used in phytomedicine to induce sleep and reduce anxiety. According to the homeopathic ‘like cures like’ assumption, this would mean it ought to be used homeopathically to treat sleepiness or for keeping patients awake or for making them anxious. How can it be used for sleep bruxism?
Considering all this, I ask myself: should we trust this study and its findings?
What do you think?
“Most of the supplement market is bogus,” Paul Clayton*, a nutritional scientist, told the Observer. “It’s not a good model when you have businesses selling products they don’t understand and cannot be proven to be effective in clinical trials. It has encouraged the development of a lot of products that have no other value than placebo – not to knock placebo, but I want more than hype and hope.” So, Dr Clayton took a job advising Lyma, a product which is currently being promoted as “the world’s first super supplement” at £199 for a one-month’s supply.
Lyma is a dietary supplement that contains a multitude of ingredients all of which are well known and available in many other supplements costing only a fraction of Lyma. The ingredients include:
- vitamin D3.
Apparently, these ingredients are manufactured in special (and patented) ways to optimise their bioavailabity. According to the website, the ingredients of LYMA have all been clinically trialled with proven efficacy at levels provided within the LYMA supplement… Unless the ingredient has been clinically trialled, and peer reviewed there may be limited (if any) benefit to the body. LYMA’s revolutionary formulation is the most advanced and proven super supplement in the world, bringing together eight outstanding ingredients – seven of which are patented – to support health, wellbeing and beauty. Each ingredient has been selected for its efficacy, purity, quality, bioavailability, stability and ultimately, on the results of clinical studies.
The therapeutic claims made for the product are numerous:
- it will improve your hair, skin and nails (80% improvement in skin smoothness, 30% increase in skin moisture, 17% increase in skin elasticity, 12% reduction in wrinkle depth, 47% increase in hair strength & 35% decrease in hair loss)
- it will support energy levels in both the body and the brain (increase in brain membrane turnover by 26% and increase brain energy by 14%),
- it will improve cognitive function,
- it will enhance endurance (cardiorespiratory endurance increased by 13% compared to a placebo),
- it will improve quality of life,
- it will improve sleep (reducing insomnia by 70%),
- it will improve immunity,
- it will reduce inflammation,
- it will improve your memory,
- it will improve osteoporosis (reduce risk of osteoporosis by 37%).
These claims are backed up by 197 clinical trials, we are being told.
If true, this would be truly sensational – but is it true?
I asked the Lyma firm for the 197 original studies, and they very kindly sent me dozens papers which all referred to the single ingredients listed above. I emailed again and asked whether there are any studies of Lyma with all its ingredients in one supplement. Then I was told that they are ‘looking into a trial on the final Lyma formula‘.
I take this to mean that not a single trial of Lyma has been conducted. In this case, how do we be sure the mixture works? How can we know that the 197 studies have not been cherry-picked? How can we be sure that there are no interactions between the active constituents?
The response from Lyma quoted the above-mentioned Dr Paul Clayton stating this: “In regard to LYMA, clinical trials at this stage are not necessary. The whole point of LYMA is that each ingredient has already been extensively trialled, and validated. They have selected the best of the best ingredients, and amalgamated them; to enable consumers to take them all in a convenient format. You can quite easily go out and purchase all the ingredients separately. They aren’t easy to find, and it would mean swallowing up to 12 tablets and capsules a day; but the choice is always yours.”
It’s kind, to leave the choice to us, rather than forcing us to spend £199 each month on the world’s first super-supplement. Very kind indeed!
Having the choice, I might think again.
I might even assemble the world’s maximally evidence-based, extra super-supplement myself, one that is supported by many more than 197 peer-reviewed papers. To not directly compete with Lyma, I could use entirely different ingredients. Perhaps I should take the following five:
- Vitamin C (it has over 61 000 Medline listed articles to its name),
- Vitanin E (it has over 42 000 Medline listed articles to its name),
- Collagen (it has over 210 000 Medline listed articles to its name),
- Coffee (it has over 14 000 Medline listed articles to its name),
- Aloe vera (it has over 3 000 Medline listed articles to its name).
I could then claim that my extra super-supplement is supported by some 300 000 scientific articles plus 1 000 clinical studies (I am confident I could cherry-pick 1 000 positive trials from the 300 000 papers). Consequently, I would not just charge £199 but £999 for a month’s supply.
But this would be wrong, misleading, even bogus!!!, I hear you object.
On the one hand, I agree.
On the other hand, as Paul Clayton rightly pointed out: Most of the supplement market is bogus.
*If my memory serves me right, I met Paul many years ago when he was a consultant for Boots (if my memory fails me, I might need to order some Lyma).
So-called alternative medicine (SCAM) for animals is popular. A recent survey suggested that 76% of US dog and cat owners use some form of SCAM. Another survey showed that about one quarter of all US veterinary medical schools run educational programs in SCAM. Amazon currently offers more that 4000 books on the subject.
The range of SCAMs advocated for use in animals is huge and similar to that promoted for use in humans; the most commonly employed practices seem to include acupuncture, chiropractic, energy healing, homeopathy (as discussed in the previous post) and dietary supplements. In this article, I will briefly discuss the remaining 4 categories.
Acupuncture is the insertion of needles at acupuncture points on the skin for therapeutic purposes. Many acupuncturists claim that, because it is over 2 000 years old, acupuncture has ‘stood the test of time’ and its long history proves acupuncture’s efficacy and safety. However, a long history of usage proves very little and might even just demonstrate that acupuncture is based on the pre-scientific myths that dominated our ancient past.
There are many different forms of acupuncture. Acupuncture points can allegedly be stimulated not just by inserting needles (the most common way) but also with heat, electrical currents, ultrasound, pressure, bee-stings, injections, light, colour, etc. Then there is body acupuncture, ear acupuncture and even tongue acupuncture. Traditional Chinese acupuncture is based on the Taoist philosophy of the balance between two life-forces, ‘yin and yang’. In contrast, medical acupuncturists tend to cite neurophysiological theories as to how acupuncture might work; even though some of these may appear plausible, they nevertheless are mere theories and constitute no proof for acupuncture’s validity.
The therapeutic claims made for acupuncture are legion. According to the traditional view, acupuncture is useful for virtually every condition. According to ‘Western’ acupuncturists, acupuncture is effective mostly for chronic pain. Acupuncture has, for instance, been used to improve mobility in dogs with musculoskeletal pain, to relieve pain associated with cervical neurological disease in dogs, for respiratory resuscitation of new-born kittens, and for treatment of certain immune-mediated disorders in small animals.
While the use of acupuncture seems to gain popularity, the evidence fails to support this. Our systematic review of acupuncture (to the best of my knowledge the only one on the subject) in animals included 14 randomized controlled trials and 17 non-randomized controlled studies. The methodologic quality of these trials was variable but, on average, it was low. For cutaneous pain and diarrhoea, encouraging evidence emerged that might warrant further investigation. Single studies reported some positive inter-group differences for spinal cord injury, Cushing’s syndrome, lung function, hepatitis, and rumen acidosis. However, these trials require independent replication. We concluded that, overall, there is no compelling evidence to recommend or reject acupuncture for any condition in domestic animals. Some encouraging data do exist that warrant further investigation in independent rigorous trials.
Serious complications of acupuncture are on record and have repeatedly been discussed on this blog: acupuncture needles can, for instance, injure vital organs like the lungs or the heart, and they can introduce infections into the body, e. g. hepatitis. About 100 human fatalities after acupuncture have been reported in the medical literature – a figure which, due to lack of a monitoring system, may disclose just the tip of an iceberg. Information on adverse effects of acupuncture in animals is currently not available.
Given that there is no good evidence that acupuncture works in animals, the risk/benefit balance of acupuncture cannot be positive.
Chiropractic was created by D D Palmer (1845-1913), an American magnetic healer who, in 1895, manipulated the neck of a deaf janitor, allegedly curing his deafness. Chiropractic was initially promoted as a cure-all by Palmer who claimed that 95% of diseases were due to subluxations of spinal joints. Subluxations became the cornerstone of chiropractic ‘philosophy’, and chiropractors who adhere to Palmer’s gospel diagnose subluxation in nearly 100% of the population – even in individuals who are completely disease and symptom-free. Yet subluxations, as understood by chiropractors, do not exist.
There is no good evidence that chiropractic spinal manipulation might be effective for animals. A review of the evidence for different forms of manual therapies for managing acute or chronic pain syndromes in horses concluded that further research is needed to assess the efficacy of specific manual therapy techniques and their contribution to multimodal protocols for managing specific somatic pain conditions in horses. For other animal species or other health conditions, the evidence is even less convincing.
In humans, spinal manipulation is associated with serious complications (regularly discussed in previous posts), usually caused by neck manipulation damaging the vertebral artery resulting in a stroke and even death. Several hundred such cases have been documented in the medical literature – but, as there is no system in place to monitor such events, the true figure is almost certainly much larger. To the best of my knowledge, similar events have not been reported in animals.
Since there is no good evidence that chiropractic spinal manipulations work in animals, the risk/benefit balance of chiropractic fails to be positive.
Energy healing is an umbrella term for a range of paranormal healing practices, e. g. Reiki, Therapeutic Touch, Johrei healing, faith healing. Their common denominator is the belief in an ‘energy’ that can be used for therapeutic purposes. Forms of energy healing have existed in many ancient cultures. The ‘New Age’ movement has brought about a revival of these ideas, and today ‘energy’ healing systems are amongst the most popular alternative therapies in many countries.
Energy healing relies on the esoteric belief in some form of ‘energy’ which refers to some life force such as chi in Traditional Chinese Medicine, or prana in Ayurvedic medicine. Some proponents employ terminology from quantum physics and other ‘cutting-edge’ science to give their treatments a scientific flair which, upon closer scrutiny, turns out to be little more than a veneer of pseudo-science.
Considering its implausibility, energy healing has attracted a surprisingly high level of research activity in the form of clinical trials on human patients. Generally speaking, the methodologically best trials of energy healing fail to demonstrate that it generates effects beyond placebo. There are few studies of energy healing in animals, and those that are available are frequently less than rigorous (see for instance here and here). Overall, there is no good evidence to suggest that ‘energy’ healing is effective in animals.
Even though energy healing is per se harmless, it can do untold damage, not least because it can lead to neglect of effective treatments and it undermines rationality in our societies. Its risk/benefit balance therefore fails to be positive.
Dietary supplements for veterinary use form a category of remedies that, in most countries, is a regulatory grey area. Supplements can contain all sorts of ingredients, from minerals and vitamins to plants and synthetic substances. Therefore, generalisations across all types of supplements are impossible. The therapeutic claims that are being made for supplements are numerous and often unsubstantiated. Although they are usually promoted as natural and safe, dietary supplements do not have necessarily either of these qualities. For example, in the following situations, supplements can be harmful:
- Combining one supplement with another supplement or with prescribed medicines
- Substituting supplements for prescription medicines
- Overdosing some supplements, such as vitamin A, vitamin D, or iron
Examples of currently most popular supplements for use in animals include chondroitin, glucosamine, probiotics, vitamins, minerals, lutein, L-carnitine, taurine, amino acids, enzymes, St John’s wort, evening primrose oil, garlic and many other herbal remedies. For many supplements taken orally, the bioavailability might be low. There is a paucity of studies testing the efficacy of dietary supplements in animals. Three recent exceptions (all of which require independent replication) are:
- A trial showing that the dietary supplementation with Maca increased sperm production in stallions.
- A study demonstrating that curcumin supplementation appeared to reduce arthritis pain in dogs.
- An investigation suggesting that royal jelly supplementation can improve the egg quality of hens.
Dietary supplements are promoted as being free of direct risks. On closer inspection, this notion turns out to be little more than an advertising slogan. As discussed repeatedly on this blog, some supplements contain toxic materials, contaminants or adulterants and thus have the potential to do harm. A report rightly concluded that many challenges stand in the way of determining whether or not animal dietary supplements are safe and at what dosage. Supplements considered safe in humans and other cross-species are not always safe in horses, dogs, and cats. An adverse event reporting system is badly needed. And finally, regulations dealing with animal dietary supplements are in disarray. Clear and precise regulations are needed to allow only safe dietary supplements on the market.
It is impossible to generalise about the risk/benefit balance of dietary supplements; however, caution is advisable.
SCAM for animals is an important subject, not least because of the current popularity of many treatments that fall under this umbrella. For most therapies, the evidence is woefully incomplete. This means that most SCAMs are unproven. Arguably, it is unethical to use unproven medicines in routine veterinary care.
I was invited several months ago to write this article for VETERINARY RECORD. It was submitted to peer review and subsequently I withdrew my submission. The above post is a slightly revised version of the original (in which I used the term ‘alternative medicine’ rather than ‘SCAM’) which also included a section on homeopathy (see my previous post). The reason for the decision to withdraw this article was the following comment by the managing editor of VETERINARY RECORD: A good number of vets use these therapies and a more balanced view that still sets out their efficacy (or otherwise) would be more useful for the readership.
Robert Verkerk, Executive & scientific director, Alliance for Natural Health (ANH), seems to adore me (maybe that’s why I kept this post for Valentine’s Day?). In 2006, he published this article about me (it is lengthy, and I therefore shortened a bit, but feel free to study it in its full beauty):
START OF QUOTE
PROFESSOR EDZARD ERNST, the UK’s first professor of complementary medicine, gets lots of exposure for his often overtly negative views on complementary medicine. He’s become the media’s favourite resource for a view on this controversial subject…
The interesting thing about Prof Ernst is that he seems to have come a long way from his humble beginnings as a recipient of the therapies that he now seems so critical of. Profiled by Geoff Watts in the British Medical Journal, the Prof tells us: ‘Our family doctor in the little village outside Munich where I grew up was a homoeopath. My mother swore by it. As a kid I was treated homoeopathically. So this kind of medicine just came naturally. Even during my studies I pursued other things like massage therapy and acupuncture. As a young doctor I had an appointment in a homeopathic hospital, and I was very impressed with its success rate. My boss told me that much of this success came from discontinuing main stream medication. This made a big impression on me.’ (BMJ Career Focus 2003; 327:166; doi:10.1136/bmj.327.7425.s166)…
After his early support for homeopathy, Professor Ernst has now become, de facto, one of its main opponents. Robin McKie, science editor for The Observer (December 18, 2005) reported Ernst as saying, ‘Homeopathic remedies don’t work. Study after study has shown it is simply the purest form of placebo. You may as well take a glass of water than a homeopathic medicine.’ Ernst, having done the proverbial 180 degree turn, has decided to stand firmly shoulder to shoulder with a number of other leading assailants of non-pharmaceutical therapies, such as Professors Michael Baum and Jonathan Waxman. On 22 May 2006, Baum and twelve other mainly retired surgeons, including Ernst himself, bandied together and co-signed an open letter, published in The Times, which condemned the NHS decision to include increasing numbers of complementary therapies…
As high profile as the Ernsts, Baums and Waxmans of this world might be—their views are not unanimous across the orthodox medical profession. Some of these contrary views were expressed just last Sunday in The Sunday Times (Lost in the cancer maze, 10 December 2006)…
The real loser in open battles between warring factions in healthcare could be the consumer. Imagine how schizophrenic you could become after reading any one of the many newspapers that contains both pro-natural therapy articles and stinging attacks like that found in this week’s Daily Mail. But then again, we may misjudge the consumer who is well known for his or her ability to vote with the feet—regardless. The consumer, just like Robert Sandall, and the millions around the world who continue to indulge in complementary therapies, will ultimately make choices that work for them. ‘Survival of the fittest’ could provide an explanation for why hostile attacks from the orthodox medical community, the media and over-zealous regulators have not dented the steady increase in the popularity of alternative medicine.
Although we live in a technocratic age where we’ve handed so much decision making to the specialists, perhaps this is one area where the might of the individual will reign. Maybe the disillusionment many feel for pharmaceutically-biased healthcare is beginning to kick in. Perhaps the dictates from the white coats will be overruled by the ever-powerful survival instinct and our need to stay in touch with nature, from which we’ve evolved.
END OF QUOTE
Elsewhere, Robert Verkerk even called me the ‘master trickster of evidence-based medicine’ and stated that Prof Ernst and his colleagues appear to be evaluating the ‘wrong’ variable. As Ernst himself admitted, his team are focused on exploring only one of the variables, the ‘specific therapeutic effect’ (Figs 1 and 2). It is apparent, however, that the outcome that is of much greater consequence to healthcare is the combined effect of all variables, referred to by Ernst as the ‘total effect’ (Fig 1). Ernst does not appear to acknowledge that the sum of these effects might differ greatly between experimental and non-experimental situations.
Adding insult to injury, Ernst’s next major apparent faux pas involves his interpretation, or misinterpretation, of results. These fundamental problems exist within a very significant body of Prof Ernst’s work, particularly that which has been most widely publicised because it is so antagonistic towards healing cultures that have in many cases existed and evolved over thousands of years.
By example, a recent ‘systematic review’ of individualised herbal medicine undertaken by Ernst and colleagues started with 1345 peer-reviewed studies. However, all but three (0.2%) of the studies (RCTs) were rejected. These three RCTs in turn each involved very specific types of herbal treatment, targeting patients with IBS, knee osteoarthritis and cancer, the latter also undergoing chemotherapy, respectively. The conclusions of the study, which fuelled negative media worldwide, disconcertingly extended well beyond the remit of the study or its results. An extract follows: “Individualised herbal medicine, as practised in European medical herbalism, Chinese herbal medicine and Ayurvedic herbal medicine, has a very sparse evidence base and there is no convincing evidence that it is effective in any [our emphasis] indication. Because of the high potential for adverse events and negative herb-herb and herb-drug interactions, this lack of evidence for effectiveness means that its use cannot be recommended (Postgrad Med J 2007; 83: 633-637).
Robert Verkerk has recently come to my attention again – as the main author of a lengthy report published in December 2018. Its ‘Executive Summary’ makes the following points relevant in the context of this blog (the numbers in his text were added by me and refer to my comments below):
- This position paper proposes a universal framework, based on ecological and sustainability principles, aimed at allowing qualified health professionals (1), regardless of their respective modalities (disciplines), to work collaboratively and with full participation of the public in efforts to maintain or regenerate health and wellbeing. Accordingly, rather than offering ‘fixes’ for the NHS, the paper offers an approach that may significantly reduce the NHS’s current and growing disease burden that is set to reach crisis point given current levels of demand and funding.
- A major factor driving the relentlessly rising costs of the NHS is its over-reliance on pharmaceuticals (2) to treat a variety of preventable, chronic disorders. These (3) are the result — not of infection or trauma — but rather of our 21st century lifestyles, to which the human body is not well adapted. The failure of pharmaceutically-based approaches to slow down, let alone reverse, the dual burden of obesity and type 2 diabetes means wider roll-out of effective multi-factorial approaches are desperately needed (4).
- The NHS was created at a time when infectious diseases were the biggest killers (5). This is no longer the case, which is why the NHS must become part of a wider system that facilitates health regeneration or maintenance. The paper describes the major mechanisms underlying these chronic metabolic diseases, which are claiming an increasingly large portion of NHS funding. It identifies 12 domains of human health, many of which are routinely thrown out of balance by our contemporary lifestyles. The most effective way of treating lifestyle disorders is with appropriate lifestyle changes that are tailored to individuals, their needs and their circumstances. Such approaches, if appropriately supported and guided, tend to be far more economical and more sustainable as a means of maintaining or restoring people’s health (6).
- A sustainable health system, as proposed in this position paper, is one in which the individual becomes much more responsible for maintaining his or her own health and where more effort is invested earlier in an individual’s life prior to the downstream manifestation of chronic, degenerative and preventable diseases (7). Substantially more education, support and guidance than is typically available in the NHS today will need to be provided by health professionals (1), informed as necessary by a range of markers and diagnostic techniques (8). Healthy dietary and lifestyle choices and behaviours (9) are most effective when imparted early, prior to symptoms of chronic diseases becoming evident and before additional diseases or disorders (comorbidities) have become deeply embedded.
- The timing of the position paper’s release coincides not only with a time when the NHS is in crisis, but also when the UK is deep in negotiations over its extraction from the European Union (EU). The paper includes the identification of EU laws that are incompatible with sustainable health systems, that the UK would do well to reject when the time comes to re-consider the British statute books following the implementation of the Great Repeal Bill (10).
- This paper represents the first comprehensive attempt to apply sustainability principles to the management of human health in the context of our current understanding of human biology and ecology, tailored specifically to the UK’s unique situation. It embodies approaches that work with, rather than against, nature (11). Sustainability principles have already been applied successfully to other sectors such as energy, construction and agriculture.
- It is now imperative that the diverse range of interests and specialisms (12) involved in the management of human health come together. We owe it to future generations to work together urgently, earnestly and cooperatively to develop and thoroughly evaluate new ways of managing and creating health in our society. This blueprint represents a collaborative effort to give this process much needed momentum.
My very short comments:
- I fear that this is meant to include SCAM-practitioners who are neither qualified nor skilled to tackle such tasks.
- Dietary supplements (heavily promoted by the ANH) either have pharmacological effects, in which case they too must be seen as pharmaceuticals, or they are useless, in which case we should not promote them.
- I think ‘some of these’ would be more correct.
- Multifactorial yes, but we must make sure that useless SCAMs are not being pushed in through the back-door. Quackery must not be allowed to become a ‘factor’.
- Only, if we discount cancer and arteriosclerosis, I think.
- SCAM-practitioners have repeatedly demonstrated to be a risk to public health.
- All we know about disease prevention originates from conventional medicine and nothing from SCAM.
- Informed by…??? I would prefer ‘based on evidence’ (evidence being one term that the report does not seem to be fond of).
- All healthy dietary and lifestyle choices and behaviours that are backed by good evidence originate from and are part of conventional medicine, not SCAM.
- Do I detect the nasty whiff a pro-Brexit attitude her? I wonder what the ANH hopes for in a post-Brexit UK.
- The old chestnut of conventional medicine = unnatural and SCAM = natural is being warmed up here, it seems to me. Fallacy galore!
- The ANH would probably like to include a few SCAM-practitioners here.
Call me suspicious, but to me this ANH-initiative seems like a clever smoke-screen behind which they hope to sell their useless dietary supplements and homeopathic remedies to the unsuspecting British public. Am I mistaken?
The objective of this ‘real world’ study was to evaluate the effectiveness of integrative medicine (IM) on patients with coronary artery disease (CAD) and investigate the prognostic factors of CAD in a real-world setting.
A total of 1,087 hospitalized patients with CAD from 4 hospitals in Beijing, China were consecutively selected between August 2011 and February 2012. The patients were assigned to two groups:
- Chinese medicine (CM) plus conventional treatment, i.e., IM therapy (IM group). IM therapy meant that the patients accepted the conventional treatment of Western medicine and the treatment of Chinese herbal medicine including herbal-based injection and Chinese patent medicine as well as decoction for at least 7 days in the hospital or 3 months out of the hospital.
- Conventional treatment alone (CT group).
The endpoint was a major cardiac event [MCE; including cardiac death, myocardial infarction (MI), and the need for revascularization].
A total of 1,040 patients finished the 2-year follow-up. Of them, 49.4% received IM therapy. During the 2-year follow-up, the total incidence of MCE was 11.3%. Most of the events involved revascularization (9.3%). Cardiac death/MI occurred in 3.0% of cases. For revascularization, logistic stepwise regression analysis revealed that age ⩾ 65 years [odds ratio (OR), 2.224], MI (OR, 2.561), diabetes mellitus (OR, 1.650), multi-vessel lesions (OR, 2.554), baseline high sensitivity C-reactive protein level ⩾ 3 mg/L (OR, 1.678), and moderate or severe anxiety/depression (OR, 1.849) were negative predictors (P<0.05); while anti-platelet agents (OR, 0.422), β-blockers (OR, 0.626), statins (OR, 0.318), and IM therapy (OR, 0.583) were protective predictors (P<0.05). For cardiac death/MI, age ⩾ 65 years (OR, 6.389) and heart failure (OR, 7.969) were negative predictors (P<0.05), while statin use (OR, 0.323) was a protective predictor (P<0.05) and IM therapy showed a beneficial tendency (OR, 0.587), although the difference was not statistically significant (P=0.218).
The authors concluded that in a real-world setting, for patients with CAD, IM therapy was associated with a decreased incidence of revascularization and showed a potential benefit in reducing the incidence of cardiac death or MI.
What the authors call ‘real world setting’ seems to be a synonym of ‘lousy science’, I fear. I am not aware of good evidence to show that herbal injections and concoctions are effective treatments for CAD, and this study can unfortunately not change this. In the methods section of the paper, we read that the treatment decisions were made by the responsible physicians without restriction. That means the two groups were far from comparable. In their discussion section, the authors state; we found that IM therapy was efficacious in clinical practice. I think that this statement is incorrect. All they have shown is that two groups of patients with similar diagnoses can differ in numerous ways, including clinical outcomes.
The lessons here are simple:
- In clinical trials, lack of randomisation (the only method to create reliably comparable groups) often leads to false results.
- Flawed research is currently being used by many proponents of SCAM (so-called alternative medicine) to mislead us about the value of SCAM.
- The integration of dubious treatments into routine care does not lead to better outcomes.
- Integrative medicine, as currently advocated by SCAM-proponents, is a nonsense.
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:
- People take this ‘evidence’ seriously. In this case, many patients might pay with their lives for this collective incompetence.
- 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
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.
The DAILY MAIL is by no means my favourite paper (see, for instance, here, here and here). This week, the Mail published another article which, I thought, is worth mentioning. The Mail apparently asked several UK doctors which dietary supplements they use for their own health (no mention of the number they had to approach to find any fitting into this category). The results remind me of a statement by the Permanent Secretary, Sir Humphrey Appleby in the famous TV series YES MINISTER: “if nobody knows anything then nobody can accuse anybody else of knowing nothing, and so the one thing we do know is that nobody knows anything, and that’s better than us knowing nothing”.
Below, I present the relevant quotes by the doctors who volunteered to be interviewed and add the most up-to date evidence on each subject.
Professor Christopher Eden, 57, is a consultant urological surgeon at the Royal Surrey County Hospital in Guildford.
“I take a 1g supplement of vitamin C daily. (The recommended daily amount, or RDA, is 40mg, which is equivalent to a large orange.) This amount of vitamin C makes the urine mildly acidic and increases the levels of an antimicrobial protein called siderocalin, found naturally in urine, which makes the environment less favourable to bad bacteria and reduces the risk of infection.”
Louise Newson, 48, is a GP and menopause specialist based in Stratford-upon-Avon.
“Women going through the menopause or perimenopause may get bowel symptoms such as bloating which are due to hormone imbalances affecting the balance of gut bacteria. Probiotic (good bacteria) supplements correct this imbalance and are also linked to levels of the brain chemical serotonin, which can improve mood. This is important during the menopause. I make sure I take a probiotic daily, specifically one with a high bacteria count including Lactobacillus acidophilus. I look for one that has to be kept in the fridge, as this is a sign of a quality product.”
Professor Tony Kochhar, 45, is a consultant orthopaedic surgeon at London Bridge Hospital.
“Having taken statins for a couple of years, I developed tendonitis, inflammation in the foot, which caused pain around the outside of it. My GP told me to stop taking the statins, which helped, and I now control my condition with diet. I also take a supplement of collagen (a natural protein found in the tendons) to build up tendon structure and reduce pain. I take two 1,200mg collagen supplements daily and it has really helped. Within two weeks of starting them, my pain had gone.”
Dr Anne Rigg, 51, is a consultant oncologist at London Bridge Hospital.
“One theory is that vitamin D may help control normal breast cell growth and may even stop breast cancer cells from growing. The body creates vitamin D from sunlight on the skin when we are outdoors, but because of the British weather and the rightful use of sunscreen, it’s easy to become deficient. I take the recommended daily dose of 10mcg. [Fatty fish such as salmon and mackerel are good sources, too, but you’d have to eat them in large amounts to get the recommended daily dosage.] It’s vital not to overdose, as it can increase the risk of kidney stones: the vitamin helps absorb calcium from the diet, which can build up into stones.”
Dr Rob Hogan, 62, is an optometrist at iCare Consulting.
“I’m aware, too, of the increased risk of age-related macular degeneration (AMD), a leading cause of sight loss in people over 60. This is where the small central portion of the retina (the macula) at the back of the eye deteriorates. So I take MacuShield, a supplement which, studies have found, can help improve vision and keep the back of the eye healthy. It contains a mixture of natural compounds — lutein, zeaxanthin and meso-zeaxanthin — which are antioxidants that have been found in studies to improve vision and eye health. I take one a day, usually with a meal.”
In early AMD, macular pigment can be augmented with a variety of supplements, although the inclusion of MZ may confer benefits in terms of panprofile augmentation and in terms of contrast sensitivity enhancement.
Dr Milad Shadrooh, 37, is a dentist in Basingstoke, Hampshire.
“I take a varied supplement daily to maintain good health and, specifically, healthy teeth. It contains calcium (an adult’s RDA is 700mg, which is equivalent to three 200ml cups of milk) as most people, including me, don’t get enough in their diet.”
Dr Joanna Gach, 49, is a consultant dermatologist at University Hospitals Coventry and Warwickshire NHS Trust.
“Every so often, I take a multivitamin capsule containing zinc, selenium and biotin. These are all helpful for sorting out my brittle nails and maintaining healthy hair.”
… no evidence supports the use of vitamin supplementation with vitamin E, vitamin C (ascorbic acid), vitamin A, retinoids, retinol, retinal, silicon, zinc, iron, copper, selenium, or vitamin B12 (Cyanocobalamin) for improving the nail health of well-nourished patients or improving the appearance of nails affected by pathologic disease.
Luke Cascarini, 47, is a consultant maxillofacial surgeon at Guy’s and St Thomas’ Hospital in London.
“I take a daily vitamin drink containing a high-dose vitamin B complex, which is necessary for good oral health.”
The published research reveals only a possible relationship between vitamins and minerals and periodontal disease. Vitamin E, zinc, lycopene and vitamin B complex may have useful adjunct benefits. However, there is inadequate evidence to link the nutritional status of the host to periodontal inflammation. More randomized controlled trials are needed to explore this association.
Dr Jenni Byrom, 44, is a consultant gynaecologist at Birmingham’s Women’s and Children’s Hospital.
“I take evening primrose oil for premenstrual symptoms such as breast pain. I take 1g of evening primrose oil daily and have found it really makes a difference.”
Evening primrose oil has not been shown to improve breast pain, and has had its licence withdrawn for this indication in the UK owing to lack of efficacy (it is still available to purchase without prescription).
Dr Sarah Myhill, 60, is a GP based in Wales.
“I take 10g of vitamin C dissolved in a glass of water every day before I start my shift — and I never get colds. I believe that high doses of vitamin C can kill bad microbes on contact — or, at least, help reduce the severity of infections such as colds and sore throats.”
Jonathan Dearing, 49, is a consultant orthopaedic surgeon specialising in sports injuries at BMI Carrick Glen Hospital in Ayrshire.
“I carry a vitamin D oral spray and use it after exercise, as it helps improve muscle recovery by regulating various processes that help them repair and grow.”
… supraphysiological dosages of vitamin D3 have potential ergogenic effects on the human metabolic system and lead to multiple physiological enhancements. These dosages could increase aerobic capacity, muscle growth, force and power production, and a decreased recovery time from exercise. These dosages could also improve bone density. However, both deficiency (12.5 to 50 nmol/L) and high levels of vitamin D (>125 nmol/L) can have negative side effects, with the potential for an increased mortality. Thus, maintenance of optimal serum levels between 75 to 100 nmol/L and ensuring adequate amounts of other essential nutrients including vitamin K are consumed, is key to health and performance. Coaches, medical practitioners, and athletic personnel should recommend their patients and athletes to have their plasma 25(OH)D measured, in order to determine if supplementation is needed. Based on the research presented on recovery, force and power production, 4000-5000 IU/day of vitamin D3 in conjunction with a mixture of 50 mcg/day to 1000 mcg/day of vitamin K1 and K2 seems to be a safe dose and has the potential to aid athletic performance. Lastly, no study in the athletic population has increased serum 25(OH)D levels past 100 nmol/L, (the optimal range for skeletal muscle function) using doses of 1000 to 5000 IU/day. Thus, future studies should test the physiological effects of higher dosages (5000 IU to 10,000 IU/day or more) of vitamin D3 in combination with varying dosages of vitamin K1 and vitamin K2 in the athletic population to determine optimal dosages needed to maximize performance.
Dr Glyn Thomas, 46, is a cardiologist and cardiac electrophysiologist at the Bristol Heart Institute.
“I take a magnesium supplement as it can help address an extra heartbeat — something I suffered with for 20 years.”
Firstly, let me congratulate those colleagues who actually might have got it right:
- Dr Hogan
- Dr Shadrooh
- Mr Cascarini
- Mr Dearing
I say ‘MIGHT HAVE GOT IT RIGHT’ because, even in their cases, the evidence is far from strong and certainly not convincing.
Secondly, let me commiserate those who spend their money on unproven supplements. I find it sad that this group amounts to two thirds of all the ‘experts’ asked.
Thirdly, let me remind THE DAILY MAIL of what I posted recently: journalists to be conscious of their responsibility not to mislead the public and do more rigorous research before reporting on matters of health. Surely, the Mail did us no favour in publishing this article. It will undoubtedly motivate lots of gullible consumers to buy useless or even harmful supplements.
And lastly, let me remind all healthcare professionals that promoting unproven treatments to the unsuspecting public is not ethical.
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.