Herbal medicine is popular. Consumers seem to be attracted by the notion that they are natural – and if it’s natural, it must be safe!!! But do we really know what is in the product that we might be buying? A recently published analytical study aimed to investigate herbal product integrity and authenticity with the goal of protecting consumers from health risks associated with product substitution and contamination.
The researchers used DNA barcoding to conduct a blind test of the authenticity for (i) 44 herbal products representing 12 companies and 30 different species of herbs, and (ii) 50 leaf samples collected from 42 herbal species. They also assembled the first standard reference material (SRM) herbal barcode library from 100 herbal species of known provenance that were used to identify the unknown herbal products and leaf samples.
DNA barcodes from 91% of the herbal products and all leaf samples could be recovered. 59% of the products tested contained DNA barcodes from plant species not listed on the labels. 48% of the products could be authenticated but one-third of these also contained contaminants and or fillers not listed on the label. Product substitution occurred in 30 of the 44 products tested and only 2 of the 12 companies sold products without any substitution, contamination or fillers. Some of the contaminants we found pose serious health risks to consumers.
Based on these findings, the authors drew the following conclusions: Most of the herbal products tested were of poor quality, including considerable product substitution, contamination and use of fillers. These activities dilute the effectiveness of otherwise useful remedies, lowering the perceived value of all related products because of a lack of consumer confidence in them. We suggest that the herbal industry should embrace DNA barcoding for authenticating herbal products through testing of raw materials used in manufacturing products. The use of an SRM DNA herbal barcode library for testing bulk materials could provide a method for ‘best practices’ in the manufacturing of herbal products. This would provide consumers with safe, high quality herbal products.
These findings are fairly alarming. I have previously blogged about the fact that herbal products are far to often adulterated or contaminated. Now it seems that we have to add to this list of dangers the substitution of the herbal ingredient with a presumably less expensive but potentially toxic herb that should not legally be there at all.
One cannot very well write a blog about alternative medicine without giving full credit to the biggest and probably most determined champion of quackery who ever hugged a tree. Prince Charles certainly has done more than anyone else I know to let unproven treatments infiltrate real medicine. To honour his unique achievements, I am here presenting a fictitious interview with him. It never did take place, of course, and the questions I put to him are pure imagination. However, the ‘answers’ are in a way quite real: they have been taken unaltered from various speeches he made and articles he wrote. To avoid being accused of using dodgy sources which might have quoted him inaccurately or sympathetically, I have exclusively used HRH’s very own official website as a source for his comments. It seems safe to assume that HRH identifies with them more fully than with the many other statements he made on this subject.
I have not changed a single word in his statements and I have tried to avoid quoting him out of context; I did, however, take the liberty of putting sentences side by side which do not always originate from the same speech or article, i.e. I have used quotes from different communications to appear as though they originally were in sequence. It will be clear from the text that the fictitious interview is dated before Charles’ Foundation folded because of money laundering and fraud.
It is, of course, hugely tempting to comment on the various statements by Charles. However, I have resisted this temptation; I wanted the reader to enjoy his wisdom in its pure and unadulterated beauty. Anyone who feels like it will have plenty of opportunity to post comments, if they so wish.
To make clear what is what, my questions appear in italics, while his ‘answers’ are in Roman typeface.
Q I believe you have no training in science or medicine; yet you have long felt yourself expert enough to champion bizarre forms of therapies which many of our readers might call quackery.
As you know by now, this is an area to which I attach the greatest importance and where I have tried to make a particular contribution. For many years, the NHS has found complementary medicine an uncomfortable bedfellow – at best regarded as ‘fringe’ and in some quarters as ‘quack’; never viewed as a substitute for conventional medicine and rarely as a genuine partner in providing therapy.
I look back to the rather “lukewarm” response I received in 1983 as President of the British Medical Association when I first spoke about integration and complementary and alternative medicine. We have clearly travelled a very long way since that time.
Q Alternative medicine is mainly used by those who can afford it; at present, little of it is available on the NHS. Why do you want to change this situation?
The very popularity of non-conventional approaches suggests that people are either dissatisfied with the kind of orthodox treatment they are receiving, or find genuine relief in such therapies. Whatever the case, it is only reasonable to try to identify the factors that are contributing to their increased use. And if advantages are found, clearly they should not be limited only to those people who can pay, but should be made more widely available on the NHS.
Q If with a capital “I”?
I believe it is because complementary and alternative approaches to healthcare bring a different emphasis to bear which often unlocks an individual’s inner resources to aid recovery or help to manage living with a serious chronic illness. It is also because complementary and alternative therapies often offer more effective and less intrusive ways of treating illness.
Q Really? Are you sure that they are more effective that conventional treatments? What is your evidence for that?
In 1997 the Foundation for Integrated Medicine, of which I am the president and founder, identified research and development based on rigorous scientific evidence as one of the keys to the medical establishment’s acceptance of non-conventional approaches. I believed then, as I do now, that the move to a more integrated provision of healthcare would ultimately benefit patients and their families.
Q But belief is hardly a good substitute for evidence. In this context, it is interesting to note that chiropractors and osteopaths received the same status as doctors and nurses in the UK. Is this another of your achievements? Was it based on belief or on evidence?
True healing is a synergy that comes not by courtesy of a medical diploma.
Q What do you mean?
As we know, the professions of Osteopathy and Chiropractice are now regulated in the same way as doctors and dentists, with their own Acts of Parliament. I’m very proud to have played a tiny role in trying to push for that Act of Parliament over the years. It has also been reassuring to see the progress being made by the other main complementary professions and I look forward to the further development of regulatory frameworks enabling high standards of training, clinical practice and professional behaviour.
Q Some might argue that statutory regulation made them not more professional but merely improved their status and thus prevented asking question about evidence. Why did they need to be regulated in that way?
The House of Lord’s Select Committee Report on Complementary and Alternative Medicine in 2000, quite sensibly recommended that only complementary professions which were statutorily regulated, or which had well-established arrangements for voluntary self-regulation, should be made available through the NHS.
Q Integrated healthcare seems to be your new buzz-word, what does it mean? Is it more than a passing fad?
Integrated Healthcare is, I believe, here to stay. The public want it and need it. It is not a takeover of the orthodox by CAM or the other way around, but is rather the bringing together of the best from both for the ultimate benefit of the patient.
Q Your lobby-group, Foundation for Integrated Medicine, what has it ever done to justify its existence?
In 1997 the steering group of The Foundation for Integrated Medicine (FIM), of which I am proud to be president, published a discussion document ‘Integrated Healthcare – A Way Forward for the Next Five Years?’
Q Sorry to interrupt, but if so many people are already using them, why do you feel compelled to promote unproven treatments even more? Why is ‘a way forward’ in promotion actually needed? Why did we need a lobby group like FIM?
Homoeopaths, osteopaths, reflexologists, acupuncturists, T’ai chi instructors, art therapists, chiropractors, herbalists and aromatherapists: these practitioners were working alongside NHS colleagues in acute hospitals, on children’s wards, in nursing homes and in particular in primary healthcare, in GP practices and health clinics up and down the country.
Q Exactly! Why then even more promotion of unproven treatments?
All well and good, perhaps, but if there are advantages in this approach, clearly they should not be limited only to those who can pay.
Q Yes, if again with a capital “I”, presumably . Anyway, do you believe these therapies should be tested like other treatments?
One of the obstacles always raised is that it is very difficult to trial complementary therapies in the rigorous randomised way that mainstream medicine deems to be the gold standard. This is ironic as there are, of course, un-evaluated orthodox practices which continue to be funded by the NHS.
Q Are you an expert on research methodology as well?
At the same time, we should be mindful that clinically controlled trials alone are not the only pre-requisites to apply a healthcare intervention. Consumer-based surveys can explore WHY people choose complementary and alternative medicine and tease out the therapeutic powers of belief and trust
These “rationalist selves” would be enormously relieved to see the effectiveness of these treatments proven through the “double-blind randomized controlled trial” – the gold-standard of medical research. However, we know that some complementary and alternative medicine disciplines (and indeed other forms of medical or surgical intervention) do not lend themselves to this research method.
Q Are you sure? This sounds like something someone who is ignorant of research methodology has told you.
… it has been suggested that we need a research method for complementary treatment that is, to use that awful expression, “fit for purpose”. Something that is entirely practical – what has been called “applied” research – which takes into account the whole person and the whole treatment as it is actually given in the surgery or the hospital. Something that might offer us a better idea of the cost-effectiveness of any given approach. It would also help to provide the right sort of evidence that health service commissioners require when they decide which services they wish to commission for their patients.
Q Hmm – anyway, would you promote unproven treatments even for serious conditions like cancer?
Two surveys have indicated that up to eighty per cent of cancer patients try alternative or complementary treatments at some stage following diagnosis and seventy-five per cent of patients would like to see complementary medicine available on the N.H.S.
Q Yes, but why the promotion?
There is a major role for complementary medicine in bowel cancer – as a support to more conventional approaches – in helping to prevent it through lifestyle changes, helping to boost our immune systems and in helping sufferers to come to terms with, and maintain, a sense of control over their own lives and wellbeing. My own Foundation For Integrated Medicine is, for example, involved in finding ways to integrate the best of complementary and alternative medicine.
Q And what do you understand by “the best”? In medicine, this term should mean “the most effective”, shouldn’t it?
Many cancer patients have turned to an integrated approach to managing their health, finding complementary therapies such as acupuncture, aromatherapy, reflexology and massage therapy extremely therapeutic. I know of one patient who turned to Gerson Therapy having been told that she was suffering from terminal cancer, and would not survive another course of chemotherapy. Happily, seven years later she is alive and well. So it is therefore vital that, rather than dismissing such experiences, we should further investigate the beneficial nature of these treatments.
Q Gerson? Is it ethical to promote an unproven starvation diet for cancer?
…many patients use and believe in Gerson Therapy, yet more evidence needs to be available as to who might benefit or what adverse effects there might be. But, surely, we need to take a wider view of the most appropriate types of research methodology – a wider view of what research will help patients.
Q You are a very wealthy man; will you put your own money into the research that you regularly demand?
Complementary medicine is gaining a toehold on the rockface of medical science.
Q I beg your pardon.
Complementary medicine’s toehold is literally that, and it’s an inescapable fact that clinical trials, of the calibre that medical science demands, cost money. Figures from the Department of Complementary Medicine at the University of Exeter show that less than 8p out of every £100 of NHS funds for medical research was spent on complementary medicine. In 1998-99 the Medical Research Council spent no money on it at all, and in 1999 only 0.05% of the total research budget of UK medical charities went to this area.
Q Hmm – Nature; you are very fond of all things natural, aren’t you?
The garden is designed to remind people of our interconnectedness with Nature and of the beneficial medicinal properties She provides through countless plants, flowers and trees. Throughout the 20th century so much ancient, accumulated, traditional wisdom has been thrown away – whether in the fields of medicine, architecture, agriculture or education. The baby was thrown out with the bathwater, so this garden is designed to bring the baby back again and to remind us of that priceless, traditional knowledge before we lose that rich store of Nature’s healing gifts for the benefit of our descendants.
When you think about it, what on earth is the point of throwing away our lifeline; of abandoning the priceless knowledge and wisdom accumulated over 1,000’s of years relating to the treatment of the human condition by natural means? It is sheer folly it seems to me to forget that we are a part of Nature and to imagine we can survive on this Earth as if we were merely a mechanical process divorced from, and in opposition to, the unity of the world around us.
Q …and herbalism?
Medical herbalists talk about ‘synergy’, the result of a complex mix of active ingredients in a plant that create a more powerful therapeutic effect together than if isolated. It’s a concept that has a wider application. As the 17th century poet John Donne famously wrote, “No man is an Island, entire of itself; every man is a piece of the Continent, a part of the main.”
Q I am not sure I understand; what does that mean?
Medical herbalists, who make up their own preparations from combinations of fresh or dried plants, believe that this mix within individual herbs as well as in traditional mixtures of plant medicines creates what is called synergy, in which all the chemical components contribute to the remedy’s specific therapeutic effects.
At a time when farmers everywhere are struggling to make ends meet, the development of a natural pharmacy of organically grown herbs offers an alternative means of earning a living. Yet without protective measures, herbs are easily adulterated or their quality compromised.
Q …and homeopathy?
I went to open the new Glasgow Homeopathic Hospital for instance a couple of years ago, I met a whole lot of students who were studying homeopathy, I think, and I’ve never forgotten when they said to me ‘Are you interested in homeopathy’ and I thought – I don’t know, why do I bother?
Q And why exactly do you bother, if I may ask?
By allowing patients treatment choice, negative emotions can, in part, be alleviated. Many complementary practitioners provide time, empathy, hope and reassurance – skills that are referred to as the “human effect” – which can improve the confidence of cancer patients, alter mindsets and produce major positive changes in the immune system. As a result the “human effect” can greatly prolong life: it has been demonstrated that in a variety of cancers, such as breast cancer, that attitude of mind can not only raise the quality of life but in some cases can even prolong life. At the same time, we need specific treatments that are designed to improve the quality of patients’ lives, and to provide relief from the unpleasant symptoms of cancer – anxiety; pain; sleeplessness; skin irritation; poor appetite; nausea and depression, to name but a few.
Q At heart you seem to be a vitalist who believes in a vital force or energy that interconnects anything with everything and determines our health.
Research in the new field of psychoneuroimmunology – or mind-body medicine as it is sometimes called – is discovering that there is a constant interplay between our emotions, thoughts and actions and our body systems. It seems that the food we eat, the air we breathe, the exercise we take, our relationships with other people, all have a direct bearing on our health and natural healing processes. Complementary medicine has always known this and I believe it is one of the reasons for its enormous popularity.
Q Clarence House made several statements assuring the British public that you never overstep your constitutional role by trying to influence health politics; they were having us on, weren’t they?
A few days ago I launched an initiative to promote the provision of more complementary medicine in the NHS. For many years I have been working towards this goal.
Q Does that mean these statements were wrong?
I am convinced there is no better moment than now to create a real integration of our healthcare, particularly when there is talk of a Patient-Centred NHS. So much ill-health and disease is due to the misery, stress and alienation we see in our community.
Realgar, a commonly used traditional Chinese medicine, has – according to the teachings of Traditional Chinese Medicine (TCM) – acrid, bitter, warm, and toxic characteristics and is affiliated with the Heart, Liver and Stomach meridians. It is used internally against intestinal parasites and treat sore throats, and is applied externally to treat swelling, abscesses, itching, rashes, and other skin disorders.
Chemically, it is nothing other than arsenic sulphide. Despite its very well-known toxicity, is thought by TCM-practitioners to be safe, and it has been used in TCM under the name ‘Xiong Huang’ for many centuries. TCM-practitioners advise that the typical internal dose of realgar is between 0.2 and 0.4 grams, decocted in water and taken up to two times per day. Some practitioners may recommend slightly higher doses (0.3-0.9 grams). Larger doses of realgar may be used if it is being applied topically.
Toxicologists from Taiwan report a case of fatal realgar poisoning after short-term use of a topical realgar-containing herbal medicine.
A 24-year-old man with atopic dermatitis had received 18 days of oral herbal medicine and realgar-containing herbal ointments over whole body from a TCM-practitioner. Seven days later, he started to develop loss of appetite, dizziness, abdominal discomfort, an itching rash and skin scaling. Subsequently he suffered generalized oedema, nausea, vomiting, decreased urine amount, diarrhoea, vesico-oedematous exanthemas, malodorous perspiration, fever, and shortness of breath.
He was taken to hospital on day 19 when the dyspnoea became worse. Toxic epidermal necrolysis complicated with soft tissue infection and sepsis were then diagnosed. The patient died shortly afterwards of septic shock and multiple organ failure. Post-mortem blood arsenic levels were elevated at 1225 μg/L. The analysis of the patient’s herbal remedies yielded a very high concentration of arsenic in three unlabelled realgar-containing ointments (45427, 5512, and 4229 ppm).
The authors of this report concluded that realgar-containing herbal remedy may cause severe cutaneous adverse reactions. The arsenic in realgar can be absorbed systemically from repeated application to non-intact skin and thus should not be extensively used on compromised skin.
The notion that a treatment that ‘has stood the test of time’ must be safe and effective is very wide-spread in alternative medicine. This, we often hear, applies particularly to the external use of traditional remedies – what can be wrong with putting a traditional Chinese herbal cream on the skin?? This case, like so many others, should teach us that this appeal to tradition is a classical and often dangerous fallacy. And the ‘realgar-story’ also suggests that, in TCM, the ‘learning-curve’ is very flat indeed.
Chinese and Ayurvedic remedies are often contaminated with toxic heavy metals. But the bigger danger seems to be that some of these traditional ‘medicines’ contain such toxins because, according to ‘traditional wisdom’, these constituents have curative powers. I think that, until we have compelling evidence that any of these treatments do more good than harm, we should avoid taking them.
Rudolf Steiner was a weird guy by any stretch of imagination. He was the founding father of anthroposophy, an esoteric “philosophy” that created a new dimension of obtrusiveness. Not only that, he also dabbled in farming methods, devised an educational technique and created an entire school of health care, called anthroposophical medicine. The leading product in its range of homeopathy-inspired “drugs” is a mistletoe-extract which is, according to Steiner, a cure for cancer. His idea was simple: the mistletoe plant is a parasite that lives off host trees sapping its resources until, eventually, it might even kill its host – just like cancer threatening the life of a human being!!!
So, what is more logical than to postulate that extracts from mistletoe are a cure for cancer? Medicine seems simple – particularly, if you do not understand the first thing about it!
But here comes the odd thing: some ingredients from mistletoe do actually have anti-cancer properties. So, was the old Steiner an intuitive genius who somehow sensed that mistletoe would be a life-saver for cancer patients? Or is all this just pure luck? Or was it perhaps predictable?
Many plants produce molecules that are so toxic that they can kill (cancer) cells, and many conventional cancer drugs were originally derived from plants; the fact that mistletoe has some anti-cancer activity therefore comes as a surprise only to those who have little or no knowledge of phyto-pharmacology.
Ok, mistletoe might have some ingredients which possess pharmacological activity. But to claim that it is a cancer cure is still a huge leap of faith. This fact did not stop promoters of anthroposophical medicine to do just that.
Due to decades of clever promotion, it is now hard in many countries (including for instance Germany) to find cancer patients who have not tried mistletoe; indeed, selling mistletoe preparations to desperate cancer patients has become a mega-business.
But does it actually work? Do these extracts achieve what proponents advertise?
The claims for mistletoe are essentially twofold:
1) Mistletoe cures cancer.
2) Mistletoe improves the quality of life (QoL) of cancer patients.
The crucial question clearly is: are these claims based on good evidence?
According to our own systematic review, the answer is NO. In 2003, we looked at all the clinical trials and demonstrated that some of the weaker studies implied benefits of mistletoe extracts, particularly in terms of quality of life. None of the methodologically stronger trials exhibited efficacy in terms of quality of life, survival or other outcome measures. The current Cochrane review (of which I am not a co-author) concluded similarly : The evidence from RCTs to support the view that the application of mistletoe extracts has impact on survival or leads to an improved ability to fight cancer or to withstand anticancer treatments is weak.
But both reviews have one major weakness: they included all of the many available extracts of mistletoe – and one cannot deny that there are considerable differences between them. The market leader in this area is Weleda (avid readers of science blogs might remember that this firm has been mentioned before); they produce ISCADOR, the mistletoe extract that has been tested more than any other such preparation.
Perhaps it would be informative to focus specifically on this product then? A German team from the “Center for Integrative Medicine, Faculty of Health, University of Witten/Herdecke” has done just that; despite the fact that these authors are not really known for their critical analyses of anthroposophical medicine, their conclusion is also cautious: The analyzed studies give some evidence that Iscador treatment might have beneficial short-time effects on QoL-associated dimensions and psychosomatic self-regulation.
So, what is the bottom line? Sceptics would say that almost a century of research without a solid proof of efficacy is well and truly enough; one should now call it a day. Proponents of mistletoe treatment, however, insist: we need more and better studies. Well, there is more! A new RCT of Iscador has just been published.
It included chemotherapy-naive advanced non-small-cell lung cancer (NSCLC) patients to assess Iscador’s influence on chemotherapy-related adverse-effects and QoL. Patients with advanced NSCLC were randomised to receive chemotherapy alone or chemotherapy plus Iscador thrice weekly until tumour progression. Chemotherapy consisted of 21-day cycles of carboplatin combined with gemcitabine or pemetrexed. Seventy-two patients were enrolled of whom 65% were in stage IV, and 62% had squamous histology. Median overall survival in both groups was 11 months. Median time to tumour progression was not significantly different between the two groups. Differences in grade 3-4 haematological toxicity were not significant, but more control patients had chemotherapy dose reductions, grade 3-4 non-haematological toxicities, and hospitalisations.
The authors’ conclusion: No effect of Iscador could be found on quality of life or total adverse events. Nevertheless, chemotherapy dose reductions, severe non-haematological side-effects and hospitalisations were less frequent in patients treated with Iscador, warranting further investigation of Iscador as a modifier of chemotherapy-related toxicity.
So, does Steiner’s notion based on the weirdest of intuitions contain some kernel of truth? I am not sure. But for once I do agree with the proponents of mistletoe: we need more and better research to find out.
It hardly is a secret: we have a growing problem with obesity. Worldwide it is predicted to cause millions of premature deaths – unless, of course, we come up with a safe and effective treatment that patients find acceptable.
Many herbal remedies are being promoted as the solution to this serious problem. My team looked at the evidence for such treatments in much detail. Sadly the results were less than impressive.
But now, there seems to be new hope! Two recent studies of a specific herbal mixture report amazingly good results – or are they perhaps too good to be true?
Stern JS, Peerson J, Mishra AT, Sadasiva Rao MV and Rajeswari KP from the Department of Nutrition and the Department of Internal Medicine, University of California Davis, have just published an RCT in 60 subjects with body mass index (BMI) between 30 and 40 kg/square meter. Participants received either 400 mg herbal capsules with extracts from Sphaeranthus indicus and Garcinia mangostana or 400 mg placebo capsules twice daily. During the study period, participants consumed a standard diet (2,000 kcal per day) and walked 30 min 5 days per week.
After 8 weeks of this treatment, significant reductions in body weight (3.7 kg), BMI (1.6 kg/m2), and waist circumference (5.4 cm) were observed in the herbal group compared with placebo. Additionally, a significant increase in serum adiponectin concentration was found in the herbal group versus placebo. Adverse events were mild and were equally distributed between the two groups.
The authors’ conclusion leave no doubt: Supplementation with the herbal blend resulted in a greater degree of weight loss than placebo over 8 weeks.
As our own review had suggested that extracts of Garcinia cause small short-term weight reductions, the results did not come as a complete surprise to me. What did strike me as odd, however, was the fact that almost simultaneously another article was published. It was authored by Stern JS, Peerson J, Mishra AT, Mathukumalli VS and Konda PR from the Department of Nutrition, University of California-Davis, and it reported the pooled data from the above plus another, similarly designed trial.
The two studies together enrolled 100 patients who were treated either with the same herbal formula or with placebo. All subjects received 2000 kcal/day throughout the study and walked 5 days a week for 30 min. The primary outcome was the reduction in body weight. Secondary outcomes were reductions in BMI and in waist and hip circumference. Serum glycaemic, lipid, and adiponectin levels were also measured. Ninety-five subjects completed the trials, and the data from these two studies were pooled and analysed.
At study conclusion (8 weeks), statistically significant reductions in body weight (5.2 kg), BMI (2.2 kg/m2), as well as waist (11.9 cm) and hip circumferences (6.3 cm) were observed in the pooled herbal groups compared with placebo. A significant increase in serum adiponectin concentration was also found in the herbal groups versus placebo at study conclusion along with reductions in fasting blood glucose (12.2%), cholesterol (13.8%), and triglyceride (41.6%) concentrations. No changes were seen across organ function panels, multiple vital signs, and no major adverse events were reported. The minor adverse events were equally distributed between the two groups.
And what should be odd about that? Authors are entitled to pool the data of two of their own trials! Yes, of course, but what confuses me is the fact that the data from the second study of 40 patients cannot be found anywhere. I would have liked to see how it is possible that the results from just 40 more patients (actually just 35 seemed to have been included in the analysis) raise the average weight loss from 3.7 kg in the first RCT to a remarkable 5.2 kg in the two RCTs together. As a rough estimate, this means that, in the second trial, patients who took the herbal mixture must have lost about one kilo per week more than those who were on placebo. If true, this outcome is pretty sensational! It could signal the end of the obesity epidemic. It would also mean that the manufacturer of this herbal wonder mixture stands to earn billions.
Considering the potential importance of these findings, I would also like to know what precisely the Californian researchers’ involvement has been in these two studies. In the second article they state that: The two clinical trials were performed at Alluri Sitarama Raju Academy of Medical Sciences (ASRAM), Eluru, Andhra Pradesh, India from November 2009 to April 2010 (clinical trial registration number: ISRCTN45078827) and from March 2010 to July 2010 (clinical trial registration number: ISRCTN52261953). I find this puzzling.
Moreover, it would be interesting to learn what happened to the following co-authors of the first study: Sadasiva, Rao MV and Rajeswari KP. As authors of the largest of the two trials, I would have thought their names would have to be included in the article reporting the pooled data of the two studies.
Call me sceptical, perhaps even cynical, but I do wonder about trials which seem to beg so many intriguing questions. In case you want to know who funded these studies and who thus stands to make the above-named billions, the answer is provided in the second paper: This work was supported by an unrestricted grant from InterHealth Nutraceuticals Inc., Benicia, CA, to J.S.S.
So, do I think that we have finally identified a safe and effective treatment to combat the worldwide epidemic of obesity? Well….
One of the best-selling supplements in the UK as well as several other countries is evening primrose oil (EPO). It is available via all sorts of outlets (even respectable pharmacies – or is that supposedly respectable?), and is being promoted for a wide range of conditions, including eczema. The NIH website is optimistic about its efficacy: “Evening primrose oil may have modest benefits for eczema.” Our brand-new Cochrane review was aimed at critically assessing the effects of oral EPO or borage oil (BO) on the symptoms of atopic eczema, and it casts considerable doubt on this somewhat uncritical view.
Here is what we did: We searched six databases as well as online trials registers and checked the bibliographies of included studies for further references to relevant trials. We corresponded with trial investigators and pharmaceutical companies to identify unpublished and ongoing trials. We also performed a separate search for adverse effects. All RCTs investigating oral intake of EPO or BO for eczema were included.
Two experts independently applied eligibility criteria, assessed risk of bias, and extracted data. We pooled dichotomous outcomes using risk ratios (RR), and continuous outcomes using the mean difference (MD). Where possible, we pooled study results using random-effects meta-analysis and tested statistical heterogeneity.
And here is what we found: 27 studies with a total of 1596 participants met our inclusion criteria: 19 studies tested EPO, and 8 studies assessed BO. A meta-analysis of results from 7 studies showed that EPO failed to improve global eczema symptoms as reported by participants and doctors. Treatment with BO also failed to improve global eczema symptoms. 67% of the studies had a low risk of bias for random sequence generation; 44%, for allocation concealment; 59%, for blinding; and 37%, for other biases.
Our conclusions were clear: Oral borage oil and evening primrose oil lack effect on eczema; improvement was similar to respective placebos used in trials. Oral BO and EPO are not effective treatments for eczema.
The very wide-spread notion that EPO is effective for eczema and a range of other conditions was originally promoted by the researcher turned entrepreneur, D F Horrobin, who claimed that several human diseases, including eczema, were due to a lack of fatty acid precursors and could thus be effectively treated with EPO. In the 1980s, Horrobin began to sell EPO supplements without having conclusively demonstrated their safety and efficacy; this led to confiscations and felony indictments in the US. As chief executive of Scotia Pharmaceuticals, Horrobin obtained licences for several EPO-preparations which later were withdrawn for lack of efficacy. Charges of mismanagement and fraud led to Horrobin being ousted as CEO by the board of the company. Later, Horrobin published a positive meta-analysis of EPO for eczema where he excluded the negative results of the largest published trial, but included results of 7 of his own unpublished studies. When scientists asked to examine the data, Horrobin’s legal team convinced the journal to refuse the request.
The evidence for EPO is negative not just for eczema. To the best of my knowledge, there is not a single disease or symptom for which it demonstrably works. Our own review of the data concluded ” EPO has not been established as an effective treatment for any condition”
Our new Cochrane review might help to put this long saga to rest. In my view, it is a fascinating tale of a scientist being blinded by creed and ambition. The results of such errors can be dramatic. Horrobin misled all of us: patients, health care professionals, scientists, regulators, decision makers, businessmen. This caused unnecessary expense and set back research efforts in a multitude of areas. I find the tale also fascinating from other perspectives; for instance, it begs the question why so many ‘respectable’ manufacturers and retailers are still allowed to make money on EPO. Is it not time to debunk the EPO-myth and say it as clearly as possible: EPO helps only those who financially profit from misleading the public?
I think I must have mentioned this once or twice before: I am constantly on the look-out for new evidence which shows or suggests that some form of alternative medicine works. Today, it seems, I have been lucky.
In this randomised, double-blind, placebo-controlled clinical trial, 200 patients suffering from chronic obstructive pulmonary disease (COPD) were randomly allocated to receive oral therapy with 3 × 30 drops/day of an extract of Pelargonium sidoides (EPs 7630) or placebo. Both treatments were administered in addition to standardised COPD- therapies, and the treatment period lasted 24 weeks. The primary endpoint of this study was the time to the next exacerbation of COPD. Secondary endpoints were the number of such exacerbations, consumption of antibiotics, quality of life, patient satisfaction, inability to work, and the tolerability of the treatment.
The results show that the median time to exacerbation was significantly prolonged with the herbal treatment compared to placebo (57 versus 43 days). The superiority of EPs 7630 over placebo was also confirmed in secondary endpoints, e.g., fewer exacerbations, less patients with antibiotic use, improved quality of life, higher patient satisfaction, and less days of inability to work. The incidence of minor gastrointestinal adverse events was higher in the EPs 7630 group.
The authors of the study conclude that “the results demonstrate a statistically significant and clinically relevant superiority of add-on therapy with EPs 7630 over placebo and a good long-term tolerability in the treatment of moderate to severe COPD. EPs 7630 prolonged time to exacerbations and reduced exacerbation frequency and antibiotic use.”
Chronic obstructive pulmonary disease, is a progressive and serious condition linked to smoking which makes breathing increasingly difficult. The symptoms of COPD typically include a productive cough, wheezing, shortness of breath and chest tightness. Long-term exposure to other lung irritants—such as air pollution, chemical fumes, or dust may contribute to COPD. The condition is a major cause of disability, and currently it is the third leading cause of death, which means that millions of people suffer from COPD.
There is no cure for COPD; the damage to the airways and lungs is not reversible. Various symptomatic treatments exist, for instance, antibiotics, bronchio-dilators, steroids and physiotherapy. Lifestyle changes can further improve the situation, help patients to stay more active, and slow the progress of the disease.
It is clear that COPD is a very serious condition, that the burden of suffering for individual patients can be immense, that therapeutic options are limited and often associated with adverse-effects. In this situation, any new effective and safe therapy would be more than welcome. Pelargonium has previously shown promise in the treatment of asthma, acute bronchitis as well as other respiratory infections. It seems generally safe but is not totally devoid of adverse-effects.
This new study gives hope to COPD-sufferers as it suggests that Pelargonium sidoides might alleviate their symptoms. The trial seems rigorous but the benefit is not huge and the treatment is not a cure of COPD. Moreover, I should point out that any new finding of this nature requires independent confirmations. I do think that the trial is an important step in the right direction, yet I feel that it is too early for issuing general recommendations.
The developed world is in the middle of a major obesity epidemic. It is predicted to cause millions of premature deaths and billions of dollars, money that would be badly needed elsewhere. The well-known method of eating less and moving more is most efficacious but sadly not very effective, that is to say people do not easily adopt and adhere to it. This is why many experts are searching for a treatment that works and is acceptable to all or at least most patients.
Entrepreneurs of alternative medicine have long jumped on this band waggon. They have learnt that the regulations are lax or non-existent, that consumers are keen to believe anything they tell them and that the opportunities to make a fast buck are thus enormous. Today, they are offering an endless array of treatments which are cleverly marketed, for instance via the Internet.
Since many years, my research team are involved in a programme of assessing the alternative slimming aids mostly through systematic reviews and occasionally also through conducting our own clinical trials. Our published analyses include the following treatments:
Supplements containing conjugated linoleic acid
There are, of course, many more but, for most, no evidence exist at all. The treatments listed above have all been submitted to clinical trials. The results show invariably that the outcomes were not convincingly positive: either there were too few data, or there were too many flaws in the studies, or the weight reduction achieved was too small to be clinically relevant.
Our latest systematic review is a good example; its aim was to evaluate the evidence from randomized controlled trials (RCTs) involving the use of the African Bush Mango, Irvingia gabonensis, for body weight reduction in obese and overweight individuals. Three RCTs were identified, and all had major methodological flaws. All RCTs reported statistically significant reductions in body weight and waist circumference favoring I. gabonensis over placebo. They also suggested positive effects of I. gabonensis on blood lipids. Adverse events included headache and insomnia. Despite these apparently positive findings, our conclusions had to be cautious: “Due to the paucity and poor reporting quality of the RCTs, the effect of I. gabonensis on body weight and related parameters are unproven. Therefore, I. gabonensis cannot be recommended as a weight loss aid. Future research in this area should be more rigorous and better reported.”
People who want to loose weight are often extremely desperate and ready to try anything. They are thus easy victims of the irresponsible promises that are being made on the Internet and elsewhere. Despite the overwhelmingly evidence to the contrary, consumers are led to believe that alternative slimming aids are effective. What is more, they are also misled to assume they are risks-free. This latter assumption is false too: apart from the harm done to the patient’s bank account, many alternative slimming aids are associated with side-effects which, in some cases, are serious and can even include death.
The conclusion from all this is short and simple: alternative slimming aids are bogus.
There are at least two dramatically different kinds of herbal medicine, and the proper distinction of the two is crucially important. The first type is supported by some reasonably sound evidence and essentially uses well-tested herbal remedies against specific conditions; this approach has been called by some experts RATIONAL PHYTOTHERAPY. An example is the use of St John’s Wort for depression.
The second type of herbal medicine. It entails consulting a herbal practitioner who takes a history, makes a diagnosis (usually according to obsolete concepts) and prescribes a mixture of several herbal remedies tailor-made to the characteristics of his patient. Thus 10 patients with the identical diagnosis (say depression) might receive 10 different mixtures of herbs. This is true for individualized herbalism of all traditions, e.g. Chinese, Indian or European, and virtually every herbalist you might consult will employ this individualized, traditional approach.
Many consumers know that, in principle, there is some reasonably good evidence for herbal medicine. They fail to appreciate, however, that this does only apply to (sections of) rational phytotherapy. So, they consult herbal practitioners in the belief that they are about to receive an evidence-based therapy. Nothing could be further from the truth! The individualised approach is not evidence-based; even if the individual extracts employed were all supported by sound data (which they frequently are not) the mixutres applied are clearly not.
And this is where the danger of traditional herbalism lies; over the years, herbalists have fooled us all with this fundamental misunderstanding. In the UK, they might even achieve statutory regulation on the back of this self-serving misconception. When this happens, we would have a situation where a completely unproven practice has obtained the same status as doctors, nurses and physiotherapists. If this is not grossly misleading for the consumer, I do not know what is!!!
Some claim that individualized herbalism cannot be tested in clinical trials. This notion can very easily be shown to be wrong: several such studies testing individualized herbalism have been published. To the dismay of traditional herbalists, their results fail to confirm that such treatments are effective for any condition.
Now a further trial has become available that importantly contributes to this knowledge-base. Its authors (all enthusiasts of individualized herbalism) randomized 102 patients suffering from hip or knee-osteoarthritis into two groups. The experimental group received tailor-made mixtures of 7 to 10 Chinese herbs which were traditionally assumed to be helpful. The control group took a mixture of plants known to be ineffective but tasting similar. After 20 weeks of treatment, there were no differences between the groups in any of the outcome measures: pain, stiffness and function. These results thus confirm that this approach is not effective. Not only that, it also carries more risks.
As individualized herbalism employs a multitude of ingredients, the dangers of adverse-effects and herb-drug interactions, contamination, adulteration etc. are bigger that those with the use of single herbal extracts. It seems to follow therefore that the risks of individualized herbalism do not outweigh its benefit.
My recommendations are thus fairly straight forward: if we consider herbal medicine, it is vital to differentiate between the two types. Rational phytotherapy might be fine – of course, depending on the remedy and the condition we are aiming to treat. Individualised or traditional herbalism is not fine; it is not demonstrably effective and has considerable risks. This means consulting a herbalist is not a reasonable approach to treating any human ailment. It also means that regulating herbalists (as we are about to do in the UK) is a seriously bad idea: the regulation of non-sense will result in non-sense!
I don’t suppose that many readers of this blog believe all things natural to be entirely safe, but the general public seems to be hard-wired victims of this myth: Mother Nature is benign, and herbal remedies must be harmless!
There are, of course, several reasons why supposedly “natural” herbal treatments can be unsafe. Plants extracts can be toxic, they might interact with prescribed drugs or they can be contaminated or adulterated.
The latter two terms describe similar but not identical phenomena: contamination means the accidental addition of substances which should not be present in an herbal remedy; and adulteration signifies the deliberate addition of ingredients. If the substances in question are not pharmacologically inert, their presence in herbal remedies can cause adverse effects.
Both contamination and adulteration break laws and regulations; both are therefore illegal. Sadly, this does not mean that such things do not happen.
We have recently published an overview of the existing knowledge in this area. For this purpose, we summarised the evidence from 26 previously published reviews. Our findings were interesting but far from reassuring: the most commonly found contaminants were dust, pollen, insects, rodents, parasites, microbes, fungi, mould, pesticides, and heavy metals. The adulterants invariably were prescription drugs such as steroids, anti-diabetic medications etc.
These substances were implicated in a wide range of serious adverse effects in the unfortunate patients who took the remedies in question: agranulocytosis, meningitis, multi-organ failure, stroke, arsenic poisoning, mercury poisoning, lead poisoning, caner, encephalopathy, hepato-renal syndrome, kidney damage, rhabdomyolosis, metabolic acidosis, renal failure, liver failure, cerebral oedema, coma, and intra-cerebral bleeding. Several patients did not survive.
To avoid such disasters, consumers need to know which types of herbal remedies are most frequently implicated; our review showed that these were foremost Chinese and Indian remedies. While herbal medicines from the US or Europe ought to comply with certain rules and regulations regarding their quality and safety, Chinese and Indian herbal mixtures frequently enter our countries illegally or are bought from dubious sources, for instance, over the Internet. It is this type of herbal remedy that we should be concerned about.
We have to ask whether the risks outweigh the proven benefits of Chinese or Indian herbal mixtures. The short answer to this question is NO. There is very little compelling evidence to suggest that these treatments are efficacious. In the absence of proven benefit, even small or rare risks weigh heavily.
If the risk-benefit profile for any medical intervention fails to be positive, there can only be one reasonable conclusion regarding the use of this therapy – and that is: DON’T DO IT!