My first exposure to these concepts was about 20 years ago when as a medical student, I read Dr Felix Mann's book 'Acupuncture, Cure for Many Diseases'. The attraction of this form of therapy was Impressed on me again a few years later. As a newly qualified GP in a busy inner city practice, I grew increasingly disenchanted with the Cartesian view of the human organism upon which my medical training had been based. Although the idea that there was a pill for every ill was no longer currency, nonetheless the practice of holistic medicine was still very much in its infancy. Furthermore, I found that much of what I had been taught and thus had on offer for my patients seemed inadequate for their needs. Worse still was the realisation that my knowledge and skills were largely irrelevant for the problems which were daily brought to surgery. I also became increasingly aware of the very real dangers of side effects from some drugs. In one instance an elderly lady bled almost to death from a gastric erosion caused by a drug which I had prescribed only a few days earlier to relieve her arthritis pain. Acupuncture seemed a much better proposition; reputedly safe, very effective and popular with patients. If only the sceptical medical profession would wake up!
I think my experiences were not untypical judging by the number of doctors signing up for the short courses on acupuncture such as the one I subsequently attended.
But, despite the numerous satisfied patients who were recruited by the tutor for demonstration purposes, in my hands the success rate never exceeded that achievable by the use of any powerful placebo (eg one that hurts or is in some other way impresses the patient). Thus my interest soon waned. My tutor, on the other hand, had a flourishing private practice.
Acupuncture, together with herbal medicine are the principal component parts of Traditional Chinese Medicine (TCM). TCM antedates most of the anatomical and pathological discoveries upon which western medicine is based. The 'organ systems' which are recognised by practitioners of TCM frequently bear little resemblance to those familiar in our medical schools, being based on a traditional notion of function rather than structure. "Chinese medicine sees each organ as a complex system encompassing its anatomical entity and its corresponding emotion, tissue, sense organ, mental faculty, colour, climate and more" (1).
A good example of this is the spleen, which in TCM is considered to be one of the most vital of all organs, essential to the process of digestion and without which life is not sustainable. In short, in Chinese medicine, anatomy, physiology and biochemistry are irrelevant to clinical practice.
In 1987 I started working in a hospice and joined the emerging specialty of palliative medicine - the treatment of symptoms without changing the course of the underlying disease. Most of my patients had advanced cancer and presented such a plethora of very difficult problems that I once again considered exploring the potential of traditional acupuncture. My determination to understand the subject more thoroughly led me to enrol on a two year part-time course at a self styled leading specialist college. After a year of study it became apparent that the principles being taught as fact could only be taken at face value, since little or no scientific evidence for their validity was on offer. The college had no research program and no library. Reference to published work was entirely absent during the whole of that year's teaching and my repeated requests for evidence were singularly unfruitful.
Rather than enrol for the second year of the course, I decided to explore the literature and to try to assess for myself the quality of published material and hence the efficacy of acupuncture. Using Index Medicus in the local medical school library I manually scanned the extensive lists of publications for the past 10 years, my attentions being directed primarily towards papers dealing with the sorts of problems presenting in hospice work. Apart from pain, this included nausea, vomiting and breathing difficulties.
My initial impression was that most published work was generally of poor overall quality, far worse than would be tolerated in orthodox medical research. Whilst Chinese acupuncturists may accept a priori that theirs is an effective treatment and are content to publish uncontrolled case reports and anecdotes ( some even regarding placebo control as unethical), it is difficult to understand how so many western workers could apparently disregard even the most basic tenets of good research practice.
Even more baffling is that much of this work should have ever seen the light of day in journals which would be expected to insist on rigorous peer review of articles submitted for publication. Typical of these deficiencies are; studies with far too small a number of subjects to allow statistically meaningful conclusions to be drawn, lack of randomization or biased selection of subjects and hopelessly poor statistical presentation and analysis of results.
These issues were highlighted in a recent paper from the Netherlands in which the authors assessed the quality of publications dealing with the acupuncture treatment of chronic pain, using a technique called 'criteria-based meta- analysis'. Their literature search revealed 51 controlled studies meeting their basic criteria and they concluded that 'the quality of even the better studies proved to be mediocre and that the efficacy of acupuncture in the treatment of chronic pain remains doubtful', conclusions with which I totally agree.
They also drew attention to the fact that the better designed studies tended to be those which reported negative results ie failed to show any benefit for acupuncture. Given that there is a natural bias amongst authors and editors alike, against publishing negative findings, then it is probable that the less critical reader will gain a very misleading impression about the efficacy of acupuncture. In other words, the literature seems to contain an unrepresentatively high proportion of favourable reports which tend to be the least reliable because of flawed design (2).
Against this must be set a small number of very well designed studies which do show beneficial effects. Writing about the acupuncture treatment of nausea for instance, a professor of anaesthetics considered the case 'to be proven beyond reasonable doubt', although his main justification for this statement was work that he himself had published (3).
Complementary medicine commands a great deal of public support and there is increasing demand for moves to assimilate such techniques into the National Health Service. In the highly competitive internal market that now prevails, there is always the danger that decisions about resource allocation are open to influence from political expediency. This is particularly so where a treatment is claimed to be unprovable but of self-evident worth on the basis of widespread, albeit uncritical, acclaim and popularity. Without the benefit of good scientific research and evaluation to inform rational debate, then the opportunity cost of wholesale adoption of popular but worthless remedies may be very high. Something else will have to go.
Human illness is a complex business. A minority of conditions yield to a specific remedy; antibiotic treatment of meningitis for instance, and it matters little how the medicine is administered or by whom. As I discovered in my early days as a GP however, most other health problems involve an intricate interplay of physical, psychosocial and yes, even spiritual influences.
In this respect, orthodox medicine has much to relearn. In my opinion the success of so many complementary techniques rests in the fact that practitioners are able to offer the therapeutic relationship which is so often missing from modern fast-track medicine. Many complementary therapists of my acquaintance are practitioners of undoubted integrity who adhere to a very high, self imposed code of professional ethics and for whom an honest search for truth is every bit as important as their orthodox counterparts.
Skrabanek (4) suggests that what is at issue is the complex problem of demarcation between science and quackery, between reason and faith, between honest search for truth and unscrupulous exploitation of human suffering.
Like me Felix Mann, at first so enthusiastic, finally became disillusioned. In a later publication, 'Scientific Aspects of Acupuncture' Mann writes: "After some years, I felt I had to a certain extent mastered the subject: I knew what the ancients said, and also what was preached in this century in the East and the West. It was only then that I seriously examined the validity of all that I had learnt, only to discover most of it was phantasy. Acupuncture points do not exist, meridians do not exist, and most of the laws of acupuncture are laws about non-existent entities (5).
References
See also reply by Dr James Hawkins in Newsletter no 19
Copyright © HealthWatch 1994
Our primitive forefathers ate plant or animal food which might be raw or cooked, but which was otherwise unprocessed. Shortage was usual between harvests, and when food was abundant it was difficult to store the surplus. The diet was monotonous, and often contaminated with bacteria or parasites.
Today in affluent countries we have plentiful food in great variety available every day of the year. Contamination with infective agents is rare, and most of the food we eat has been processed and packaged to enhance its appearance, flavour and keeping qualities. Obesity, arising from an intake of food which is more than that required for the sedentary lifestyle of modern man, is by far the commonest nutritional disease. Diseases due to nutrient deficiencies are rare except in special groups, such as neglected old people, alcoholics, and people who, as a result of disease or drug treatment, have abnormal dietary requirements. Ironically, another group in whom nutrient deficiencies occur are dieters: people who deliberately avoid particular types of food, or who severely restrict their total food intake. This may be done for religious or philosophical reasons, or in an attempt to achieve greater health or beauty.
A vegetarian diet (which excludes meat) is adopted by an increasing number of people for various reasons, such as concern for animal welfare, conservation of global resources, or avoidance of saturated fat, which is found in animal products and which may increase the risk of cardiovascular disease. Such a diet is certainly compatible with excellent health if appropriate plant foods are chosen to supply the protein, and minerals such as iron, which are normally provided by meat in omnivorous diets. Diets which exclude not only meat but also milk and dairy products, eggs, fish and poultry have to be selected with great care if all nutrient requirements are to be met, since plants foods are not good sources of calcium, and the iron in vegetables is less well absorbed in the human intestine than iron in meat. Reliable advice on these problems is available from the Vegetarian Society.
The attraction of organically farmed food is that it will not be contaminated by synthetic weedkillers, pesticides, fertilizers or additives: the disadvantage is that crop yield is somewhat lower than normal, and consequently the price tends to be higher, and produce may show more blemishes. There is little evidence that organic food is nutritionally superior, or that agrochemicals are a significant cause of human disease, but many people are convinced that organic, free-range, stone-ground and generally "natural" foods taste better, and are ecologically superior.
There is strong scientific evidence that a diet which contains wholegrain cereals and fresh fruit and vegetables is healthier than one in which the grain has been milled to produce white flour, and fruit and vegetables are either cooked, or not eaten at all. The outer part of cereal grains (bran, in the case of wheat), and fruits and vegetables, contain dietary fibre which has a beneficial effect on bowel function, and probably also reduces risk of cardiovascular disease by improving blood cholesterol concentrations. Fresh fruit and vegetables are important sources of protective vitamins which may be destroyed by prolonged cooking. However claims for health benefits have been carried too far by some popular authors who advocate that a large proportion of the diet should be raw food which rids the body of "toxins". The nature of these toxins is never explained, not is it clear why raw food should remove them. The idea that raw food confers special benefits because it is "living food" has no scientific foundation: by the time the food is digested and absorbed into the body it is as "dead" as it would have been if it had been cooked.
The dieters who are in greatest danger are young women (usually) who are trying to achieve abnormal thinness for aesthetic reasons. The table below shows the range of weight (from A to B) which is medically desirable in young adults of a given height, and the (C) the weight at which obesity begins significantly to impair health. People whose weight is between B and C should take care not to gain more weight, and people whose weight is greater than C should seek to reduce it at a rate of about 1-2 lb /week by appropriate dieting. More rapid weight loss may involve excessive loss of lean tissue, and it is unlikely that people who lose weight too rapidly will be able to sustain the weight reduction.
The problem arises with people who weigh less than B, but who try to lose weight. "Slimming supplements" which provide compounds such as free amino acids, lecithin, choline or vitamins do not make weight loss by dieting more effective or safer. Diuretics cause water loss (and hence weight loss) but this is transient. Bulk fillers (such as guar gum) do not aid weight loss unless taken in such large amounts that they impair appetite.
It is particularly important that people near to weight A do not attempt to become even thinner, since this would probably be injurious to health.
This position paper by J Garrow
endorsed for the Executive Committee, July 1994
Natural Choice Ltd, a Guernsey-based company, were found to be in flagrant breach of the British Codes of Advertising and Sales Promotion Practice for a direct-mailing offering anti-fat capsules by mail order which included the claim that a weight loss of 1.5 stones after 1 month was guaranteed. The mailing claimed that it was possible to 'lose weight without changing your eating habits, without following a strict diet. Even cellulite will begin to disappear right from the start thanks to papaya.'
The Authority found the mailing to be in flagrant breach of the Code and was extremely concerned that despite requesting that it be withdrawn (following a previous investigation in which no evidence to support the claims made was provided) the same material was still being distributed from the same address, albeit under a different company name. Furthermore a disclaimer, now included with the mailing implied that the contents had been checked by the Authority when this was not the case. The Authority considered that a disclaimer explaining that long lasting weight loss could only be achieved through a calorie-controlled diet was insufficient to render the mailing acceptable.
The ASA also upheld a complaint against Richmond company, Natural Health Products relating to an advertisement which appeared in the Sun newspaper for Redusan which the advertisement claimed to be a 'new' Swedish diet supplement that makes pounds disappear. The advertisement described the product as a course of fibre capsules and mineral tablets. The fibre capsules, which contain the vegetable fibre glucomannan, give you a satiated feeling while the mineral tablets help keep your metabolism up'.
Natural Health Products, which has had two previous complaints upheld by the ASA during the last 12 months, submitted a number of clinical papers to substantiate their claims, but after seeking medical advice it concluded that the information was inadequate to justify the advertisements.
The ASA has expressed grave concern about the activities of City Trading Ltd in issuing an advertisement 'in clear contravention of the Code's requirements for slimming products... particularly as the advertisers had in the past been made aware of the Code’s provisions.' City Trading Ltd, trading as Natural Herbal Research attracted complaints in relation to advertisements in Sunday newspapers for Speedslim CP2000. The advertisement, accompanied by 'before' and 'after' photographs and testimonials claiming weight loss, claimed that “Speedslim CP2000 with its gradual release, will help attack body fat through the day and you could see a significant reduction in excess body fat. Lack of chromium can slow down the binding off of food for energy and excess calories are stored in the body as fat. however, Speedslim CP2OOO will help regulate metabolism and promote permanent fat loss.” The complaints were upheld, and the ASA requested the advertisers to withdraw the advertisement
Three previous complaints have been upheld against City Trading Ltd in the previous 12 months.
HealthWatch is concerned that not only are companies such as the above flouting the authority of the ASA, but that even when companies are taken to court by trading standards officers, and found to breach the Trade Descriptions Act, they still end up having gained from their deception.
The profits that can be made from the marketing of unproven slimming is clearly illustrated by an investigation into 'Sleep and Slim' tablets, sold by Bridgette Handley and Paul Monks, trading as Vitalhealth in Birmingham. The investigation ended with the prosecution and conviction of Handley and Monks for being in breach of the Trades Descriptions Act. The Birmingham Post reported that they were fined £9,000 each and were ordered to pay £2,840 costs.
Handley and Monks advertised the 'Sleep and Slim' pills in a national newspaper describing them as 'the sensational new aid to weight loss', alongside a photograph of Handley wearing a pair of trousers which were much too big for her. The advertisement implied that users would experience a substantial weight loss following a 60 day course of the tablets which cost £30. It falsely suggested that slimmers using the pills would not need to count calories and would lose weight as they slept. On investigation, the product was found to consist largely of amino acids which would have no clinical effect on weight loss.
The Birmingham Post reported that during an interview with trading standards officers, Handley and Monks admitted failing to carry out any clinical trials on the product and disclosed that over a six month period they had sold 6,500 tubs of the pills with a total value of £72,000.
Did you know that along the spinal column of each one of us are seven spinning vortices, each associated with different emotions? Or that a kinesiologist can tell the state of your health by applying pressure to your arm or leg? And that when a young woman (diagnosed as being allergic to dairy products) put a tiny crumb of cheese under her tongue, her arm immediately gave way under gentle pressure from her kinesiologist?
With hardly a hint of criticism, such beliefs are contained in The Health Education Authority Guide to Complementary Medicine and Therapies (1994). As Professor Ernst points put below, tucked away with a note about copyright the guide contains the (presumably routine) disclaimer that "the views expressed in this book are those of the author and not necessarily those of the Health Education Authority". But the book is emphatically entitled The Health Education Authority Guide.
It seems nothing is too absurd for this guide. The beliefs and superstitions of various cultures are of interest to anyone studying the human race, but they are hardly Health Education.
It is claimed that "most non conventional treatments assist in the healing process". If this claim means anything it must mean that you get quicker healing - or a higher percentage of cases completely healed - if you use these remedies than if you don't. The need for reliable comparison of results in order to get at the truth is apparently too simple and too obvious an idea for this guide.
See also letter from David Wade in Newsletter 18
Health Education Authority London, 1994, £6.99
Does the HEA guide meet this challenge? I'm afraid it doesn't! The inside cover states that the views expressed are those of the author and not necessarily those of Health Education Authority, but the outside cover carries the HEA logo. The popularity, medical credibility, scientific research and availability of each therapy is rated by a star system. The critical reader is surprised to see that acupuncture, chiropractic, homeopathy, hypnotherapy, osteopathy and yoga all get the maximum four stars on both medical credibility and scientific research. These ratings can only be based on subjective beliefs and are in contradiction to the published evidence. It appears that only evangelistic believers produced them.
The book finally becomes shockingly absurd when it addresses the indications for each therapy. To quote but a few:-
Acupressure is the best choice for circulation problems - chiropractic is best for gastrointestinal problems -hypnotherapy for gastric ulcer -osteopathy for asthma - and yoga for rheumatoid arthritis.
The foreword says that the volume provides information for patients and professionals alike and should be circulated to all GPs. If it were, present efforts to validate complementary medicines objectively (to increase the benefit and minimise the risk for the patient) could be seriously hindered.
Edzard Ernst
(Professor of Complementary Medicine, University of Exeter).
by Dr Eric Trimmer, Piatkus, London, 1994
So, Dr Trimmer can legally make health claims in this book for products for which there is no Product Licence under the Medicines Act, and for which it would be illegal to make the same claim on the package. The book is (he says, p 17) "a research-based personal statement". He has (p 11) "included those health foods that seem to me to be supported by medical research to a substantial degree."
Unfortunately he gives no references, so when he says of coenzyme Q1O (p 29) that it "has been used fairly extensively in treating many Alzheimer's disease patients, with some minor success, so it is definitely worth trying", we do not know to what research he refers. Indeed his threshold for recommendation is quite low: for example when discussing the role of "health foods" in treating stress he says charmingly (p 289) "Anything which is non-toxic, non-addictive and which might just ameliorate some of the symptoms of stress is worth trying."
To be fair, he does not endorse everything. For example he says (p95) "royal jelly scientific therapeutics seems to be a non-starter and I have been unable to find any double-blind trial to support its sensible consideration." On p 57: "Lecithin is a health food with little to support a theory that there is anything very special about it." However this healthy scepticism does not inhibit him from giving the addresses of manufacturers who supply these ineffective remedies.
Sometimes he follows a curious route to obtain evidence of efficacy. For example (p 50) "Scientific evidence of ginseng's therapeutic efficacy is not over-strong, but there is some which is difficult to ignore." It turns out that the case turns on the presence of side effects in ginseng abusers, and the "existence of side effects occurring in ginseng takers would in itself seem to indicate that there are physiological changes in takers that are very definitely the result of pharmacological action." Why pharmacological action should equate with therapeutic efficacy is not clear to this reviewer.
Probably the most controversial of Dr Trimmer's recommendation is selenium as "a cancer preventative or prophylactic par excellence" (p 197). Selenium is rated with a Gold Star but "tentatively established". In the introduction he explains that products given this accolade "were easy to select. They include health foods that are supported by double blinded clinical trials published in reputable medical or scientific journals." So what about his research base on which he rated the non-Gold Star, but recommended products? All is explained on p 247-8. Apparently there are two sorts of nutritional scientist: the old-fashioned sort who actually require evidence from controlled trials that health claims are true, and the more modern type (like Dr Trimmer) who realise that (p 12) "not all remedies and treatments can be effectively subjected to such trials", so it is OK to offer advice based on intuition, or possibly even commercial interest.
I belong to the old-fashioned group. I see no reason why all these products should not be tested by properly designed trials. If they can be shown to work we will all be pleased. In the absence of such trials this book merely serves to circumvent the protection which the Medicines Act was intended to give the public.
John Garrow, Professor of Human Nutrition
St Bartholomew's Hospital Medical College
Nutri was featured in Newsletter no 14 for a seminar it held in which health claims were made about curing a variety of serious illnesses while its products were sold at the back of the meeting room.
Nutri has decided to stop holding 'product led' seminars and has replaced them with 'a generic form of presentation'. In the latest edition of its newsletter, Supplement, the company says that increasingly strict codes about making claims about its products mean that 'this has reached the point where we can no longer hold product based seminars'.
Nutri has asked its potential delegates to avoid embarrassment by not asking specific questions about Nutri products at the seminars. But it gives a telephone number for sales enquiries which it says can be handled in the normal way.
Dr Brewin argues that this risks creating the impression that 'we approve equally of all claims and remedies no matter how little evidence there is that they are anything more than placebo'. He insists that: 'A firm distinction must surely be made between fully trained, qualified and registered medical practitioners (who are taught differential diagnosis and encouraged to follow, whether in diagnosis or in therapy, where the evidence leads) and unqualified healers with fixed beliefs who feel no need to make any such effort.'
It is argued that there is a more fundamental problem with the BMA's new approach in that it, 'can confuse the public and suggest that we have lost confidence in rational thought.' Dr Brewin is concerned that: 'We risk encouraging the damaging and misleading idea of two equally respected systems, two schools of thought, two valid cultures. If it is felt that weighing evidence is no more than just a current paradigm of Western science and Western medicine, then the alternative must be blind faith and conviction.'
The editorial is not an uncritical defence of orthodox medicine. Indeed it argues that: 'Every weakness and fault of fringe medicine can still be found today in mainstream medicine, though not to nearly the same extent as 100 years ago. Mainstream medicine has not been as honest as it should have been about its mistakes, disappointments and failures. Nor has it done enough randomised comparisons of the outcome of different treatment policies. But its record in both cases is considerably better than that of fringe medicine.'
The editorial argues that, while those who wish to choose unorthodox herbal remedies, for example, must be free to do so 'nobody can be happy about choice based on misinformation or lack of information.'
The British Medical Journal has published a letter from HealthWatch Committee member, Professor John Garrow, in response to a discussion about the potential conflicts of interest that can arise when academics choose to advise industry. Those involved in such relationships usually have to sign a secrecy agreement to ensure that commercially valuable information is not passed on. Sometimes “the fact that firm A has employed an expert in field B as a consultant is commercially sensitive, so the secrecy agreement specifies that the existence of the consultancy must be kept secret”.
“Disclosure is a good remedy for conflict of interest”, writes Professor Garrow and it is therefore, “important that academics who intend to contribute to scientific literature as authors, editors, or referees should not accept consultancies which they cannot publicly disclose.”
British Medical Journal, Feb 12; 1994; page 471
From our activities this year I would like to pick out two positive pieces of good news - satisfactory news, anyway - and two problems that have taxed us, but which we hope we will soon be able to put behind us.
Our newsletter has been widely circulated and has had some gratifying praise. It does not just go to members, but to a number of journalists and organisations. We have evidence that it serves a useful purpose, promoting our views about the need for more clinical trials in both mainstream and complementary medicine; and less unreliable information or exaggerated claims.
Secondly, we have attended both mainstream and fringe conferences (including the two day conference on Complementary Medicine in June, arranged by the EEC, with delegates from all over Europe, and the September meeting of the British Association for the Advancement of Science) and have constantly urged more randomised comparison of results, regardless of underlying mechanism.
In addition we have exchanged views at some length in private with various influential people, including:
All have received our brochure and literature. It seems that at the very least a number of misconceptions about HealthWatch have been dispelled and at best some views have been modified. Members will also have seen in Newsletter 14 our quite lengthy written evidence to the Labour Party, who want to have more Complementary Medicine provided.
On the negative side, the first problem has been the ill health of our excellent newsletter editor, Aisling Irwin, now recovering. The second that, after seeking expert legal advice, we finally felt bound to settle out of court a claim against us for libel. Nearly £3,000 had to be found. The Charity Commissioners felt that this should not come entirely from the subscriptions of our members; and it was finally found possible to raise not just some of it, but virtually all of it by accepting contributions from committee members (by far the largest coming from Professor Garrow who insisted on passing on to HealthWatch the entire fee that he had received recently for some special work done).
It is a pleasure to thank - not only on your behalf, but also personally - all those committee members who selflessly contributed in various ways. Those not mentioned by name will understand when I single out for special thanks Deborah Bender and John Garrow's secretary Shirley Churchman, who have together handled Membership; Michael Allen, who has not only continued as Treasurer, but has stepped in to supervise the newsletter when Aisling had been ill; Malcolm Brahams, our new Vice Chairman, whose work has meant that our legal expenses have been much less than they might have been; Sheila Smith, Vincent Mark's secretary; and finally the indefatigable John Garrow, who - since he completed his term as Chairman a year ago - has acted as secretary and given me vital help and support.
We have done our best to keep in mind what seem to be the two main concerns of our members. The failure of both mainstream and fringe medicine to test their remedies sufficiently. And the astonishing growth in our country, as in many others, of all kinds of alternative medicine, often coupled with an element of mysticism and a mood of anti-science, if not anti-reason. We hope that in HealthWatch we always put the interest of the patients first. We aim to combine a kind heart with a keen intellect, aiming for more sensible priorities and more real progress, rather than a retreat into ancient theories and beliefs.
Thurstan Brewin.