Imagine: you consult your doctor and he says: “I am so sorry, but I have bad news: the tests have shown that you have cancer”. You go home and feel as though someone has hit you with a sledge hammer. You cry a lot and your thoughts go round in circles. A complete nightmare unfolds; you sometimes think you are dreaming but reality soon catches up with you.
A few days later, you have an appointment with the oncologist who explains the treatment plan. You feel there is no choice and you agree to it. After the first chemotherapy, you lose your hair, your well-being, your dignity, your control and your patience – time to investigate what else there is on offer. There must be an alternative!
By then lots of well-wishers will have mentioned to you that the conventional route is but one of many: there are, in fact, alternatives!!! You go on the internet and find not just a few, you find millions of website promoting hundreds of solutions – anything from diets to herbal remedies, from homeopathy to faith-healing. All are being promoted as cures for your cancer, and all are free of those nasty side-effects which make your life hell at the moment. You think “there is a choice after all”.
Who would not be tempted by these options advertised in the most glorious terms? Who would not begin to distrust the oncologists who kindly but firmly insist that ‘alternative cancer cures’ are bogus? Who would not want to get rid of the cancer and the side-effects in one genial master-stroke?
Cancer patients yearn for hope and are extremely vulnerable to such influences. I do not know a single one who, faced with the diagnosis and all it entails, has not looked at the ‘alternatives’. This is why it would be so very important that the websites informing patients and their carers convey accurate and responsible information. But do they?
One of our research projects at Exeter had been aimed at assessing the quality of the websites advising patients on alternative treatments for cancer. For this purpose, we evaluated a total of 32 sites which cancer patients were most likely to consult according to pre-defined criteria – in other words, we assessed the most frequented websites for cancer.
Our results were shocking: many of these sites were of poor quality and most of them recommended a plethora of unproven treatments for cancer, most frequently herbal remedies, diets and mind-body therapies. In our estimation, at least three of them were outright dangerous and had the potential to harm patients.
The level of misinformation in this area is sickening. Patients are being sold false hope by the truck-load. Yet they deserve better; they deserve impartial information on their illness and the best treatment for it – cancer patients especially so. What they get instead is a total disgrace: commercially driven lies about ‘treatments’ which are not just unproven but which would, if used as instructed, hasten their death. Some alternative therapies have potential for palliative and supporting care, BUT NONE OFFER A CURE OR A REDUCTION OF THE TUMOR BURDEN OR A CHANGE IN THE NATURAL HISTORY OF THE DISEASE.
Colonic irrigation is the alternative therapy of celebrities (and those who like to imitate them): they tend to use it for all sorts of ailments, predominantly for loosing weight. And it works! When they have paid for the session, they are relieved of some cash as well as of about half a kilo of body weight. By the time they wake up the next morning, the money is still gone, but the weight is back. This is a most effective method for getting rid of some £s, but NOT an effective way for shedding a few pounds.
Numerous synonyms for colonic irrigation exist, e.g. colonic treatment, colon cleansing, rectal irrigation, colon therapy, colon hydrotherapy, colonic. The treatment is based on the ancient but obsolete theory of ‘autointoxication’, i.e. the body is assumed to poison itself with, ‘autotoxins’ which, in turn, cause various illnesses. So, it is implausible and there is also no evidence to suggest it is effective. But this does not stop professional organisations to make claims which are good for business.
My analysis of the claims made by professional organisations of practitioners of colonic irrigation across the globe aimed at assessing the therapeutic claims made by these institutions. Six such organisations were identified, and the contents of their websites were studied. The results showed that all of the six organisations make therapeutic claims on their websites. Frequently mentioned themes are ‘detoxification’, normalisation of intestinal functions, treatment of inflammatory bowel diseases and body weight reduction. The claims are mostly confined to symptomatic improvements – but there are exceptions, e.g. prevention of bowel cancer or sorting out Irritable Bowel Syndrome ‘once and for all’ . Other therapeutic claims pertain to asthma, menstrual irregularities, circulatory disorders, skin problems, improvement in energy levels and no longer requiring pharmacotherapy. All these claims represent testable hypotheses.
The question therefore arises whether these hypotheses have been tested and, if so, what the results of such investigations suggest? The use of colonic irrigation by alternative practitioners for any indications is not supported by any sound evidence at all. There are simply no trials to show effectiveness. Even worse is the fact that, although touted as safe, colonic irrigation can lead to serious complications.
The conclusion is therefore simple: colonic irrigation is neither demonstrably effective nor safe, and the information supplied by its professional organisations is therefore a significant contributor to the sea of misinformation in the realm of alternative medicine.
The UK ‘Society of Homeopaths’ (SoH) is the largest professional organisation of UK non-doctor, so-called lay- homeopaths. On their website, the SoH made very specific claims about homeopathy; in particular, they listed conditions for which homeopathy had allegedly been proven to be effective. These claims have now thoroughly been debunked, and the evidence the SoH produced in support of their claims has been shown to be misleading, cherry-picked or misinterpreted.
I have no idea who conducted the above-named investigation and made a youtube video of it, but I think it is essentially correct and well worth watching. My own experiences with the SoH relate mainly to two encounters.
The first was a complaint I made about one of their high-ranking officers, Ralf Jeutter. He had been promotiong homeopathic vaccinations on his website (needless to stress, I think, that there is no evidence to support the notion that homeopathic vaccinations are effective). As I felt that the SoH dragged their feet pursuing my complaint, I had to send several reminders. Eventually, they considered it and concluded that Reuter had done nothing wrong. This, presumably, is the reason why, even today, he can state on his website that Homeopathy is used to help individuals in dealing better with kinds of infections such as leptospirosis, meningitis and cholera. All is fine, it seems as long as a disclaimer is added: Any information obtained here is not to be construed as medical OR legal advice. The decision to vaccinate and how you implement that decision is yours and yours alone. The evidence for the efficacy of homeopathic immunisation is ‘anecdotal’. That means it is based on individuals’ reports past and present.
My second encounter with the SoH relates to my 2010 analysis of the SoH code of ethics and their adherence to it. The code demanded that:
- ‘all speculative theories will be stated as such and clearly distinguished’
- ‘no advertising may be used which expressly or implicitly claims to cure named diseases’
- ‘Advertising shall not be false, fraudulent, misleading, deceptive, extravagant or sensational.’
Encouraged by these assurances, I decided to study the websites of some members of the SoH, and soon discovered numerous and very obvious violations of the above-mentioned imperatives. In an attempt to find the root of these transgressions, I scrutinised the SoH’s own website where I found a multitude violations on all levels of the SoH’s own code of ethics. Many of the violations related to claims which were not supported by evidence. In other words, the largest professional UK organisation of lay- homeopaths misled the public in several rather devious ways:
they pretended to adhere to a code of ethics which forbids members to mislead the public
SoH -members nevertheless did mislead the public in ways that public health at risk
and they did so not least because the SoH followed exactly the same strategy
thus the SoH violated its own code of ethics to the detriment of public health.
My analysis was conducted a while ago, and some might hope that the SoH has stopped systematically misleading the public. This hope, however, is harshly disappointed when you watch the brand-new video entitled TESTING HOMEOPATHY mentioned above. As the SoH is about to celebrate 35 years of wisdom, courage, knowledge and prosperity, I do wonder whether this should not be 35 years of dangerously misleading the public.
What do you think?
In my last post and several others before, I have stated that consumers are incessantly being mislead about the value of alternative medicine. This statement requires evidence, and I intend to provide it – not just in one post but in a series of posts following in fast succession.
I start with an investigation we did over a decade ago. Its primary aim was to determine which complementary therapies are believed by their respective representing UK professional organizations to be suited for which medical conditions.
For this purpose, we sent out 223 questionnaires to CAM organizations representing a single CAM therapy (yes, amazingly that many such institutions exist just in the UK!). They were asked to list the 15 conditions which they felt benefited most from their specific CAM therapy, as well as the 15 most important contra-indications, the typical costs of initial and any subsequent treatments and the average length of training required to become a fully qualified practitioner. The conditions and contra-indications quoted by responding CAM organizations were recorded and the top five of each were determined. Treatment costs and hours of training were expressed as ranges.
Only 66 questionnaires were returned. Taking undelivered questionnaires into account, the response rate was 34%. Two or more responses were received from CAM organizations representing twelve therapies: aromatherapy, Bach flower remedies, Bowen technique, chiropractic, homoeopathy, hypnotherapy, magnet therapy, massage, nutrition, reflexology, Reiki and yoga.
The top seven common conditions deemed to benefit from all twelve therapies, in order of frequency, were: stress/anxiety, headaches/migraine, back pain, respiratory problems (including asthma), insomnia, cardiovascular problems and musculoskeletal problems. It is perhaps important at this stage to point out that some of these conditions are serious, even life-threatening. Aromatherapy, Bach flower remedies, hypnotherapy, massage, nutrition, reflexology, Reiki and yoga were all recommended as suitable treatments for stress/anxiety. Aromatherapy, Bowen technique, chiropractic, hypnotherapy, massage, nutrition, reflexology, Reiki and yoga were all recommended for headache/migraine. Bowen technique, chiropractic, magnet therapy, massage, reflexology and yoga were recommended for back pain. None of the therapies cost more than £60 for an initial consultation and treatment. No correlation between length of training and treatment cost was noted.
I think, this article provides ample evidence to show that, at least in the UK, professional organisations of alternative medicine readily issue statements about the effectiveness of specific alternative therapies which are not supported by evidence. Several years later, Simon Singh noted that phenomenon in a Guardian-comment and wrote about the British Chiropractic Association “they happily promote bogus claims”. He was famously sued for libel but won the case. Simon had picked the BCA merely by chance. The frightening thought is that he could have targeted any other of the 66 organisations from our investigation: they all seem to promote bogus claims quite happily.
Several findings from our study stood out for being particularly worrying: according to the respective professional organisation, Bach Flower Remedies were deemed to be effective for cancer and AIDS, for instance. If their peers put out such irresponsible nonsense, we should not be amazed at the claims made by the practitioners. And if the practitioners tell such ‘tall tales’ to their clients, to journalists and to everyone else, how can we be amazed that we seem to be drowning in a sea of misinformation?
A single, tiny mosquito can make my life a misery. It can rob me of a night’s sleep and turn me into a frantic lunatic. But now there is a remedy that, according to its manufacturer, makes my mosquito-phobia a distant memory. Mosquito-maniacs like myself can finally breathe a sigh of relief!
According to the manufacturer’s web-site, Mozi-Q is formula to reduce the frequency of bites as well as the reactions that people have to bites. No more itching and big red bumps! No more smelly sprays or stinky coils…what a great ally for camping, golfing, hiking, biking. This could revolutionize the whole outdoor experience! Some of the product’s features include:
- It works within 30 minutes of taking it.
- There are no side effects.
- It works on other bugs aside from mosquitoes like ticks and head lice.
- Product can be taken every 3-5 hours starting right before you go outside.
- There are no contraindications.
- Homeopathic medicine is by definition non-toxic…
Mozi-Q is a formula containing five homeopathic remedies:
- Ledum palustre
- Urtica urens
They are in low C and D potencies, thereby acting at the physical level for their common indication, to reduce the frequency and severity of insect bites….
I am sure that most readers will, by now, ask themselves: is there any good evidence for these claims? The manufacturer’s site is pretty affirmative:
In the ’60s a homeopath by the name of HR. Trexler studied Staphysagria for its effectiveness at preventing mosquito bites. In a study of 421 subjects over a 4 year period, he found this remedy to be 90% effective…We have tested this remedy in our clinic over four mosquito seasons and found the response from the public confirmatory of Trexler’s findings.
Sounds great? Yes, but it turns out that the Trexler trial did not test the mixture contained in Mozi-Q at all; it used just one of its ingredients. Moreover, it seemed to have lacked a control group and therefore constitutes no reliable evidence. And the manufacturer’s own tests? I don’t know, they tell us nothing about them.
At this stage, the mosquito-phobe is disappointed. It seems to me that this product is not supported by sound evidence – more trick than treatment.
And why would this important? Because some people like me might lose a bit of sleep? No! It is important because mosquitos, ticks and other insects transmit diseases, some of which can be deadly. If someone claims that there is a preparation which protects us from insect-bites, some consumers will inevitably trust this claim. And this would not just be unfortunate; it could be life-threatening.
One thing that unites all (well, almost all, in my experience) proponents of alternative medicine is their intense dislike for BIG PHARMA. Essentially, they see this sector as:
- Driven by profit
- Employing unethical means to maximise profit
- Not caring for the needs of patients
- Attacking alternative medicine for fear of losing profit
And, of course, they claim that alternative medicine, LITTLE ALT MED, is fundamentally different from the cynically capitalist, malign BIG PHARMA.
I have no intention to defend the ways of the pharmaceutical industry – neither on this blog nor anywhere else. This industry is usually responsible to their share-holders and that constellation can lead to excesses which are counter-productive to our needs, to put it mildly. However, what I will question is the notion that LITTLE ALT MED is fundamentally different from BIG PHARMA.
We all have to make a living; to some extend at least we are therefore all driven by our desire to earn money. In alternative medicine, there are certainly not as many mega-enterprises as in the pharmaceutical industry but nobody can deny that many sizable firms exist which make a profit selling alternative remedies of one type or another.
And those parts of alternative medicine which are not into the sale of remedies, you may well ask – think of acupuncture, for instance. Well, those therapists are not exempt either from the need to make a living. Sure, this is on a different scale from BIG PHARMA, but it constitutes still a need for profit. If we multiply the relatively small sums involved by the vast number of therapists, the grand total of LITTLE ALT MED might approach similar orders of magnitude as that of BIG PHARMA.
Ok, but the alternative sector would not employ unethical means for securing or maximising profits! Wrong again, I am afraid.
My 20 years of experience of LITTLE ALT MED have let me witness several incidents which I would not hesitate to call unethical. One of the most recent and least pleasant, from my point of view, was the discovery that several German homeopathic manufacturers had given money to a ‘journalist’ who used these funds to systematically defame me.
What about the charge that BIG PHARMA does not care for the suffering patient? LITTLE ALT MED would never do that!!! Sadly this is a myth too.
Alternative practitioners and their organisations make a plethora of therapeutic claims which are not substantiated. Who would deny that misleading patients into making wrong health care decisions is not the opposite from ‘caring’? What seems even worse, in my view, is the behaviour that might follow the exposure of such behaviour. If someone is courageous enough to disclose the irresponsibility of bogus claims, he might be attacked or even taken to court by those who, in reality should be in the dock or, at least, do their utmost to get their house in order.
Finally, we have the notion of BIG PHARMA trying to suppress LITTLE ALT MED. I call this a myth too because I see absolutely no evidence for this rumour. Even those who circulate it can, when challenged, not produce any.
And, anyway, we all know how many of the big pharmaceutical firms buy into the alternative medicine market as soon as they see a commercially viable opportunity. Does that look like suppression?
So, what is the conclusion? BIG PHARMA can behave badly, no doubt, and when they do, I am as disgusted as the next man. However, LITTLE ALT MED also can behave badly – in fact, wherever there is money to be made, some people will behave badly some of the time.
Perhaps we should not judge an entire sector just by the bad actions of some of its members, but perhaps we should also consider whether or not it has done any good. Who would doubt that BIG PHARMA has helped to save lives – millions of lives?!
And now ask yourself: can we honestly say the same about LITTLE ALT MED?
Hot flushes are a big problem; they are not life-threatening, of course, but they do make life a misery for countless menopausal women. Hormone therapy is effective, but many women have gone off the idea since we know that hormone therapy might increase their risk of getting cancer and cardiovascular disease. So, what does work and is also risk-free? Acupuncture?
Together with researchers from Quebec, we wanted to determine whether acupuncture is effective for reducing hot flushes and for improving the quality of life of menopausal women. We decided to do this in form of a Cochrane review which was just published.
We searched 16 electronic databases in order to identify all relevant studies and included all RCTs comparing any type of acupuncture to no treatment/control or other treatments. Sixteen studies, with a total of 1155 women, were eligible for inclusion. Three review authors independently assessed trial eligibility and quality, and extracted data. We pooled data where appropriate.
Eight studies compared acupuncture versus sham acupuncture. No significant difference was found between the groups for hot flush frequency, but flushes were significantly less severe in the acupuncture group, with a small effect size. There was substantial heterogeneity for both these outcomes. In a post hoc sensitivity analysis excluding studies of women with breast cancer, heterogeneity was reduced to 0% for hot flush frequency and 34% for hot flush severity and there was no significant difference between the groups for either outcome. Three studies compared acupuncture with hormone therapy, and acupuncture turned out to be associated with significantly more frequent hot flushes. There was no significant difference between the groups for hot flush severity. One study compared electro-acupuncture with relaxation, and there was no significant difference between the groups for either hot flush frequency or hot flush severity. Four studies compared acupuncture with waiting list or no intervention. Traditional acupuncture was significantly more effective in reducing hot flush frequency, and was also significantly more effective in reducing hot flush severity. The effect size was moderate in both cases.
For quality of life measures, acupuncture was significantly less effective than HT, but traditional acupuncture was significantly more effective than no intervention. There was no significant difference between acupuncture and other comparators for quality of life. Data on adverse effects were lacking.
Our conclusion: We found insufficient evidence to determine whether acupuncture is effective for controlling menopausal vasomotor symptoms. When we compared acupuncture with sham acupuncture, there was no evidence of a significant difference in their effect on menopausal vasomotor symptoms. When we compared acupuncture with no treatment there appeared to be a benefit from acupuncture, but acupuncture appeared to be less effective than HT. These findings should be treated with great caution as the evidence was low or very low quality and the studies comparing acupuncture versus no treatment or HT were not controlled with sham acupuncture or placebo HT. Data on adverse effects were lacking.
I still have to meet an acupuncturist who is not convinced that acupuncture is not an effective treatment for hot flushes. You only need to go on the Internet to see the claims that are being made along those lines. Yet this review shows quite clearly that it is not better than placebo. It also demonstrates that studies which do suggest an effect do so because they fail to adequately control for a placebo response. This means that the benefit patients and therapists observe in routine clinical practice is not due to the acupuncture per se, but to the placebo-effect.
And what could be wrong with that? Quite a bit, is my answer; here are just 4 things that immediately spring into my mind:
1) Arguably, it is dishonest and unethical to use a placebo on ill patients in routine clinical practice and charge for it pretending it is a specific and effective treatment.
2) Placebo-effects are unreliable, small and usually of short duration.
3) In order to generate a placebo-effect, I don’t need a placebo-therapy; an effective one administered with compassion does that too (and generates specific effects on top of that).
4) Not all placebos are risk-free. Acupuncture, for instance, has been associated with serious complications.
The last point is interesting also in the context of our finding that the RCTs analysed failed to mention adverse-effects. This is a phenomenon we observe regularly in studies of alternative medicine: trialists tend to violate the most fundamental rules of research ethics by simply ignoring the need to report adverse-effects. In plain English, this is called ‘scientific misconduct’. Consequently, we find very little published evidence on this issue, and enthusiasts claim their treatment is risk-free, simply because no risks are being reported. Yet one wonders to what extend systematic under-reporting is the cause of that impression!
So, what about the legion of acupuncturists who earn a good part of their living by recommending to their patients acupuncture for hot flushes?
They may, of course, not know about the evidence which shows that it is not more than a placebo. Would this be ok then? No, emphatically no! All clinicians have a duty to be up to date regarding the scientific evidence in relation to the treatments they use. A therapist who does not abide by this fundamental rule of medical ethics is, in my view, a fraud. On the other hand, some acupuncturists might be well aware of the evidence and employ acupuncture nevertheless; after all, it brings good money! Well, I would say that such a therapist is a fraud too.
The NHS tells us that our “choices include more than just which GP or hospital to use. You also have choices about your treatment decisions…” In most other countries, similarly confusing statements about PATIENT CHOICE are being made almost on a daily basis, often by politicians who have more ambition to win votes than to understand the complex issues at hand. Consequently, patients and consumers might be forgiven to assume that PATIENT CHOICE means we are all invited to indulge in the therapy we happen to fancy, while society foots the bill. Certainly, proponents of alternative medicine are fond of the notion that the principle of PATIENT CHOICE provides a ‘carte blanche’ for everyone who wants it to have homeopathy, Reiki, Bach Flower Remedies, crystal healing, or other bogus treatments – paid for, of course, by the taxpayer.
Reality is, however, very different. Anyone who has actually tried to choose his/her hospital will know that this is far from easy. And deciding what treatment one might employ for this or that condition is even less straight forward. Choice, it turns out, is a big word, but often it is just that: a word.
Yet politicians love their new mantra of PATIENT CHOICE; it is politically correct as it might give the taxpayer the impression that he/she is firmly installed in the driving seat. Consequently PATIENT CHOICE has become a slogan that is used to score points in public debates but that, in fact, is frequently next to meaningless. More often than not, the illusion of being in control has to serve as a poor substitute for actually being in control.
To imply that patients should be able to choose their treatment has always struck me as a little naïve, particularly in the way this is often understood in the realm of alternative medicine. Imagine you have a serious condition, say cancer: after you have come over the shock of this diagnosis, you begin to read on the Internet and consider your options. Should you have surgery or faith healing, chemotherapy or homeopathy, radiotherapy or a little detox?
Clearly PATIENT CHOICE, as paid for by society, cannot be about choosing between a realistic option and an unrealistic one. It must be confined to treatments which have all been shown to be effective. Using scarce public funds for ineffective treatments is nothing short of unethical. If, for a certain condition, there happen to be 10 different, equally effective and safe options, we may indeed have a choice. Alas, this is not often the case. Often, there is just one effective treatment, and in such instances the only realistic choice is between accepting or rejecting it.
And, anyway, how would we know that 10 different treatments are equally effective and safe? After going on the Internet and reading a bit about them, we might convince ourselves that we know but, in fact, very few patients have sufficient knowledge for making complex decisions of this nature. We usually need an expert to help us. In other words, we require our doctor to guide us through this jungle of proven benefits and potential risks.
Once we accept this to be true, we have arrived at a reasonable concept of what PATIENT CHOICE really means in relation to deciding between two or more treatments: the principle of shared decision making. And this is a fundamentally different concept from the naïve view of those alternative medicine enthusiasts who promote the idea that PATIENT CHOICE opens the door to opting for any unproven or disproven pseudo-therapy.
To be meaningful, ethical and responsible, choice needs to be guided by sound evidence – if not, it degenerates into irresponsible arbitrariness, and health care deteriorates into some kind of Russian roulette. To claim, as some fans of alternative medicine do, that the principle of PATIENT CHOICE gives everyone the right to use unproven treatments at the expense of the taxpayer is pure nonsense. But some extreme proponents of quackery go even further; they claim that the discontinuation of payment for treatments that have been identified as ineffective amounts to a dangerous curtailment of patients’ rights. This, I think, is simply a cynical attempt to mislead the public for the selfish purpose of profit.
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….
S.O. Hansson from the Royal Institute of Technology, Stockholm, Sweden recently published an interesting comment on the law regulating the labelling of homeopathic products. In it he points out that, in the European Union (EU), all pre-packaged food products must contain a list of ingredients and their quantities. The list should be “accurate, clear and easy to understand for the consumer.” Similar requirements apply to pharmaceutical drugs and products – with one notable exception: homeopathic preparations.
For such products, the ingredients need not be disclosed on the label, which should instead specify “the scientific name of the stock or stocks followed by the degree of dilution.” The degree of homeopathic dilutions is, in turn, given in an understandable jargon, such as “C60”, which actually describes a dilution of 1:10120.
The point Hansson is trying to make is that very few health care professionals and even fewer consumers would understand such abbreviations and jargon. This means that, manufacturers of homeopathic products are legally permitted to hide the fact from their customers that their remedies typically contain no active ingredient at all. Considering that homeopathic products are typically bought ‘over the counter’ (OTC), i.e. without interference from a health care professional, just like food products, the exemption seems most surprising.
The most OTC homeopathic remedies are in the “C30” potency; this signifies a dilution of 1: 1 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000. The likelihood that any potency higher than “C12” might contain a single molecule of active ingredient is very close to zero. In order to comprehend the degree of dilution in homeopathy more fully, a visual approach might be best: for it to have a reasonable chance to contain just one single molecule of active ingredient, a homeopathic pill in a “C30” potency would need to have a diameter roughly equal to the distance between the earth and the sun. Homeopathy is truly impossible to swallow.
If homeopathic manufacturers were obliged to provide a description that is “accurate, clear and easy to understand for the consumer”, it would need to state that any dilution beyond “C12” contains no active molecule. It seems clear that such accurate, clear and understandable information would discourage most consumers to spend their hard-earned money for such nonsense. It seems thus to be obvious that the EU exemption of homeopathic remedies from honest labelling protects the interests of the homeopathic industry.
But surely, this is deeply wrong. Regulations in health care are not supposed to protect commercial interests, they should protect the consumer. In my view, it is time to change such profoundly misguided EU-regulation – in the interest of honesty, single standards, transparency and foremost in the interest of the patient and the consumer.