Monthly Archives: March 2018
“In my medical practice, writes Sheila Patel, M.D. on the website of Deepak Chopra, I always take into consideration the underlying dosha of a patient, or what their main imbalance is, when choosing treatments out of the many options available. For example, if I see someone who has the symptoms of hypertension as well as a Kapha imbalance, I may prescribe a diuretic, since excess water is more likely to be a contributing factor. I would also encourage more exercise or physical activity, since lack of movement is often a causative factor for these individuals. However, in a Vata-type person with hypertension, a diuretic may actually cause harm, as the Vata system tends to have too much dryness (air and space). I’ve observed that Vatas often have more side effects and electrolyte imbalances due to the diuretic medication. For these individuals, a beta-blocker may be a better choice, as this “slows” down the excitatory pathways in the body. In addition, I recommend meditation and calming activities to settle the excess energy as an adjunct to (or at times, instead of) the medicine. Alternatively, for someone with hypertension who is predominantly a Pitta type or who has a Pitta imbalance, I may choose a calcium-channel blocker, as this medication may be more beneficial in regulating the process of “energy exchange” in the body, which is represented by the fire element of Pitta. This is just one example of the way in which we can tailor our choice of medication to best suit the individual.
“In contrast with conventional medicine, which until very recently has assumed that a given disorder or disease is the same in all people, Ayurveda places great importance on recognizing the unique qualities of individual human beings. Ayurveda’s understanding of constitutional types or doshas offers us a remarkably accurate way to pinpoint what is happening inside each individual, allowing us to customize treatment and offer specific lifestyle recommendations to prevent disease and promote health and longevity. Keeping the doshas balanced is one of the most important factors in keeping the whole mind-body system in balance. When our mind-body system is in balance and we are connecting to our inner wisdom and intelligence, then we are most able to realize our full human potential and achieve our optimal state of being…”
END OF QUOTE
From such texts, some might conclude that Ayurvedic medicine is gentle and kind (personally, I am much more inclined to feel that Ayurvedic medicine is full of BS). This may be true or not, but Ayurvedic medicines are certainly anything but gentle and kind. In fact, they can be positively dangerous. I have repeatedly blogged about their risks, in particular the risk of heavy metal poisoning (see here, here, and here, for instance).
My 2002 systematic review summarised the evidence available at the time and concluded that heavy metals, particularly lead, have been a regular constituent of traditional Indian remedies. This has repeatedly caused serious harm to patients taking such remedies. The incidence of heavy metal contamination is not known, but one study shows that 64% of samples collected in India contained significant amounts of lead (64% mercury, 41% arsenic and 9% cadmium). These findings should alert us to the possibility of heavy metal content in traditional Indian remedies and motivate us to consider means of protecting consumers from such risks.
Meanwhile, new data have emerged and a new article with important information has recently been published by authors from the Department of Occupational and Environmental Health , College of Public Health, The University of Iowa and the State Hygienic Laboratory at the University of Iowa, USA. They present an analysis based on reports of toxic metals content of Ayurvedic products obtained during an investigation of lead poisoning among users of Ayurvedic medicine. Samples of Ayurvedic formulations were analysed for metals and metalloids following established US. Environmental Protection Agency methods. Lead was found in 65% of 252 Ayurvedic medicine samples with mercury and arsenic found in 38 and 32% of samples, respectively. Almost half of samples containing mercury, 36% of samples containing lead, and 39% of samples containing arsenic had concentrations of those metals per pill that exceeded, up to several thousand times, the recommended daily intake values for pharmaceutical impurities.
The authors concluded that lack of regulations regarding manufacturing and content or purity of Ayurvedic and other herbal formulations poses a significant global public health problem.
I could not have said it better myself!
As I often said, I find it regrettable that sceptics often say THERE IS NOT A SINGLE STUDY THAT SHOWS HOMEOPATHY TO BE EFFECTIVE (or something to that extent). This is quite simply not true, and it gives homeopathy-fans the occasion to suggest sceptics wrong. The truth is that THE TOTALITY OF THE MOST RELIABLE EVIDENCE FAILS TO SUGGEST THAT HIGHLY DILUTED HOMEOPATHIC REMEDIES ARE EFFECTIVE BEYOND PLACEBO. As a message for consumers, this is a little more complex, but I believe that it’s worth being well-informed and truthful.
And that also means admitting that a few apparently rigorous trials of homeopathy exist and some of them show positive results. Today, I want to focus on this small set of studies.
How can a rigorous trial of a highly diluted homeopathic remedy yield a positive result? As far as I can see, there are several possibilities:
- Homeopathy does work after all, and we have not fully understood the laws of physics, chemistry etc. Homeopaths favour this option, of course, but I find it extremely unlikely, and most rational thinkers would discard this possibility outright. It is not that we don’t quite understand homeopathy’s mechanism; the fact is that we understand that there cannot be a mechanism that is in line with the laws of nature.
- The trial in question is the victim of some undetected error.
- The result has come about by chance. Of 100 trials, 5 would produce a positive result at the 5% probability level purely by chance.
- The researchers have cheated.
When we critically assess any given trial, we attempt, in a way, to determine which of the 4 solutions apply. But unfortunately we always have to contend with what the authors of the trial tell us. Publications never provide all the details we need for this purpose, and we are often left speculating which of the explanations might apply. Whatever it is, we assume the result is false-positive.
Naturally, this assumption is hard to accept for homeopaths; they merely conclude that we are biased against homeopathy and conclude that, however, rigorous a study of homeopathy is, sceptics will not accept its result, if it turns out to be positive.
But there might be a way to settle the argument and get some more objective verdict, I think. We only need to remind ourselves of a crucially important principle in all science: INDEPENDENT REPLICATION. To be convincing, a scientific paper needs to provide evidence that the results are reproducible. In medicine, it unquestionably is wise to accept a new finding only after it has been confirmed by other, independent researchers. Only if we have at least one (better several) independent replications, can we be reasonably sure that the result in question is true and not false-positive due to bias, chance, error or fraud.
And this is, I believe, the extremely odd phenomenon about the ‘positive’ and apparently rigorous studies of homeopathic remedies. Let’s look at the recent meta-analysis of Mathie et al. The authors found several studies that were both positive and fairly rigorous. These trials differ in many respects (e. g. remedies used, conditions treated) but they have, as far as I can see, one important feature in common: THEY HAVE NOT BEEN INDEPENDENTLY REPLICATED.
If that is not astounding, I don’t know what is!
Think of it: faced with a finding that flies in the face of science and would, if true, revolutionise much of medicine, scientists should jump with excitement. Yet, in reality, nobody seems to take the trouble to check whether it is the truth or an error.
To explain this absurdity more fully, let’s take just one of these trials as an example, one related to a common and serious condition: COPD
The study is by Prof Frass and was published in 2005 – surely long enough ago for plenty of independent replications to emerge. Its results showed that potentized (C30) potassium dichromate decreases the amount of tracheal secretions was reduced, extubation could be performed significantly earlier, and the length of stay was significantly shorter. This is a scientific as well as clinical sensation, if there ever was one!
The RCT was published in one of the leading journals on this subject (Chest) which is read by most specialists in the field, and it was at the time widely reported. Even today, there is hardly an interview with Prof Frass in which he does not boast about this trial with truly sensational results (only last week, I saw one). If Frass is correct, his findings would revolutionise the lives of thousands of seriously suffering patients at the very brink of death. In other words, it is inconceivable that Frass’ result has not been replicated!
But it hasn’t; at least there is nothing in Medline.
Why not? A risk-free, cheap, universally available and easy to administer treatment for such a severe, life-threatening condition would normally be picked up instantly. There should not be one, but dozens of independent replications by now. There should be several RCTs testing Frass’ therapy and at least one systematic review of these studies telling us clearly what is what.
But instead there is a deafening silence.
Why?
For heaven sakes, why?
The only logical explanation is that many centres around the world did try Frass’ therapy. Most likely they found it does not work and soon dismissed it. Others might even have gone to the trouble of conducting a formal study of Frass’ ‘sensational’ therapy and found it to be ineffective. Subsequently they felt too silly to submit it for publication – who would not laugh at them, if they said they trailed a remedy that was diluted 1: 1000000000000000000000000000000000000000000000000000000000000 and found it to be worthless? Others might have written up their study and submitted it for publication, but got rejected by all reputable journals in the field because the editors felt that comparing one placebo to another placebo is not real science.
And this is roughly, how it went with the other ‘positive’ and seemingly rigorous studies of homeopathy as well, I suspect.
Regardless of whether I am correct or not, the fact is that there are no independent replications (if readers know any, please let me know).
Once a sufficiently long period of time has lapsed and no replications of a ‘sensational’ finding did not emerge, the finding becomes unbelievable or bogus – no rational thinker can possibly believe such a results (I for one have not yet met an intensive care specialist who believes Frass’ findings, for instance). Subsequently, it is quietly dropped into the waste-basket of science where it no longer obstructs progress.
The absence of independent replications is therefore a most useful mechanism by which science rids itself of falsehoods.
It seems that homeopathy is such a falsehood.
The plethora of dodgy meta-analyses in alternative medicine has been the subject of a recent post – so this one is a mere update of a regular lament.
This new meta-analysis was to evaluate evidence for the effectiveness of acupuncture in the treatment of lumbar disc herniation (LDH). (Call me pedantic, but I prefer meta-analyses that evaluate the evidence FOR AND AGAINST a therapy.) Electronic databases were searched to identify RCTs of acupuncture for LDH, and 30 RCTs involving 3503 participants were included; 29 were published in Chinese and one in English, and all trialists were Chinese.
The results showed that acupuncture had a higher total effective rate than lumbar traction, ibuprofen, diclofenac sodium and meloxicam. Acupuncture was also superior to lumbar traction and diclofenac sodium in terms of pain measured with visual analogue scales (VAS). The total effective rate in 5 trials was greater for acupuncture than for mannitol plus dexamethasone and mecobalamin, ibuprofen plus fugui gutong capsule, loxoprofen, mannitol plus dexamethasone and huoxue zhitong decoction, respectively. Two trials showed a superior effect of acupuncture in VAS scores compared with ibuprofen or mannitol plus dexamethasone, respectively.
The authors from the College of Traditional Chinese Medicine, Jinan University, Guangzhou, Guangdong, China, concluded that acupuncture showed a more favourable effect in the treatment of LDH than lumbar traction, ibuprofen, diclofenac sodium, meloxicam, mannitol plus dexamethasone and mecobalamin, fugui gutong capsule plus ibuprofen, mannitol plus dexamethasone, loxoprofen and huoxue zhitong decoction. However, further rigorously designed, large-scale RCTs are needed to confirm these findings.
Why do I call this meta-analysis ‘dodgy’? I have several reasons, 10 to be exact:
- There is no plausible mechanism by which acupuncture might cure LDH.
- The types of acupuncture used in these trials was far from uniform and included manual acupuncture (MA) in 13 studies, electro-acupuncture (EA) in 10 studies, and warm needle acupuncture (WNA) in 7 studies. Arguably, these are different interventions that cannot be lumped together.
- The trials were mostly of very poor quality, as depicted in the table above. For instance, 18 studies failed to mention the methods used for randomisation. I have previously shown that some Chinese studies use the terms ‘randomisation’ and ‘RCT’ even in the absence of a control group.
- None of the trials made any attempt to control for placebo effects.
- None of the trials were conducted against sham acupuncture.
- Only 10 studies 10 trials reported dropouts or withdrawals.
- Only two trials reported adverse reactions.
- None of these shortcomings were critically discussed in the paper.
- Despite their affiliation, the authors state that they have no conflicts of interest.
- All trials were conducted in China, and, on this blog, we have discussed repeatedly that acupuncture trials from China never report negative results.
And why do I find the journal ‘dodgy’?
Because any journal that publishes such a paper is likely to be sub-standard. In the case of ‘Acupuncture in Medicine’, the official journal of the British Medical Acupuncture Society, I see such appalling articles published far too frequently to believe that the present paper is just a regrettable, one-off mistake. What makes this issue particularly embarrassing is, of course, the fact that the journal belongs to the BMJ group.
… but we never really thought that science publishing was about anything other than money, did we?
The British Homeopathic Association (BHA) is a registered charity founded in 1902 which aims to promote and develop the study and practice of homeopathy and to advance education and research in the theory and practice of homeopathy. The British Homeopathic Association’s overall priority is to ensure that homeopathy is available to all…
One does not need a particularly keen sense of critical thinking to suspect that this aim is not in line with a charitable status. Homeopathy for all would not be an improvement of public health. On the contrary, the best evidence shows that this concept would lead to a deterioration of it. It would mean less money for effective treatments. Who could argue that this is a charitable aim?
Currently, the BHA seems to focus on preventing that the NHS England stops the reimbursement of homeopathic remedies. They even have initiated a petition to this effect. Here is the full text of this petition, entitled ‘Stop NHS England from removing herbal and homeopathic medicines’:
NHS England is consulting on recommendations to remove herbal and homeopathic medicines from GP prescribing. The medicines cost very little and have no suitable alternatives for many patients. Therefore we call on NHS England to continue to allow doctors to prescribe homeopathy and herbal medicine.
Many NHS patients either suffer such severe side-effects from pharmaceutical drugs they cannot take them, or have been given all other conventional medicines and interventions with no improvement to their health. These patients will continue to need treatment on the NHS and will end up costing the NHS more with conventional prescriptions. There will be no cost savings and patient health will suffer. It is clear stopping homeopathic & herbal prescriptions will not help but hurt the NHS.
I find the arguments and implications of this petition pathetic and misleading. Here is why:
- NHS England is not considering to remove homeopathy from GPs’ prescribing. To the best of my knowledge, the plan is for the NHS to stop paying for homeopathic remedies. If some patients then still want homeopathy, they can get it, but will have to pay for it themselves. That seems entirely fair and rational. Why should we, the tax payers, pay for ineffective treatments?
- Because homeopathic remedies are not effective for any condition, it seems misleading to call them ‘medicines’.
- That homeopathy costs very little is not true; and even if it were correct, it would be neither here or there. The initiative is not primarily about money, it is about the principle: either the NHS adheres to EBM and ethical standards, or not.
- Homeopathy is not a ‘suitable alternative’ for anything, and it is misleading to call it thus.
- Even if NHS England decides against the funding homeopathic remedies, GPs could still be allowed to prescribe them; the only change would be that the NHS would not pay for them.
- Patients who ‘will continue to need treatment on the NHS’ under the described circumstances will not be helped by ineffective treatments like homeopathy.
- It is simply wrong to claim with certainty that there will be no cost savings.
- If the NHS scraps ineffective treatments, patients will suffer not more but less because they might actually receive a treatment that does work.
- It is fairly obvious that stopping to pay for homeopathic remedies will bring progress, help the NHS, patients and the general public.
Nine false or misleading statements in such a short text might well be a new record, even for homeopaths. Perhaps the BHA should apply for an entry in the Guinness Book of Records.
Should we start a petition?
What an odd title, you might think.
Systematic reviews are the most reliable evidence we presently have!
Yes, this is my often-voiced and honestly-held opinion but, like any other type of research, systematic reviews can be badly abused; and when this happens, they can seriously mislead us.
A new paper by someone who knows more about these issues than most of us, John Ioannidis from Stanford university, should make us think. It aimed at exploring the growth of published systematic reviews and meta‐analyses and at estimating how often they are redundant, misleading, or serving conflicted interests. Ioannidis demonstrated that publication of systematic reviews and meta‐analyses has increased rapidly. In the period January 1, 1986, to December 4, 2015, PubMed tags 266,782 items as “systematic reviews” and 58,611 as “meta‐analyses.” Annual publications between 1991 and 2014 increased 2,728% for systematic reviews and 2,635% for meta‐analyses versus only 153% for all PubMed‐indexed items. Ioannidis believes that probably more systematic reviews of trials than new randomized trials are published annually. Most topics addressed by meta‐analyses of randomized trials have overlapping, redundant meta‐analyses; same‐topic meta‐analyses may exceed 20 sometimes.
Some fields produce massive numbers of meta‐analyses; for example, 185 meta‐analyses of antidepressants for depression were published between 2007 and 2014. These meta‐analyses are often produced either by industry employees or by authors with industry ties and results are aligned with sponsor interests. China has rapidly become the most prolific producer of English‐language, PubMed‐indexed meta‐analyses. The most massive presence of Chinese meta‐analyses is on genetic associations (63% of global production in 2014), where almost all results are misleading since they combine fragmented information from mostly abandoned era of candidate genes. Furthermore, many contracting companies working on evidence synthesis receive industry contracts to produce meta‐analyses, many of which probably remain unpublished. Many other meta‐analyses have serious flaws. Of the remaining, most have weak or insufficient evidence to inform decision making. Few systematic reviews and meta‐analyses are both non‐misleading and useful.
The author concluded that the production of systematic reviews and meta‐analyses has reached epidemic proportions. Possibly, the large majority of produced systematic reviews and meta‐analyses are unnecessary, misleading, and/or conflicted.
Ioannidis makes the following ‘Policy Points’:
- Currently, there is massive production of unnecessary, misleading, and conflicted systematic reviews and meta‐analyses. Instead of promoting evidence‐based medicine and health care, these instruments often serve mostly as easily produced publishable units or marketing tools.
- Suboptimal systematic reviews and meta‐analyses can be harmful given the major prestige and influence these types of studies have acquired.
- The publication of systematic reviews and meta‐analyses should be realigned to remove biases and vested interests and to integrate them better with the primary production of evidence.
Obviously, Ioannidis did not have alternative medicine in mind when he researched and published this article. But he easily could have! Virtually everything he stated in his paper does apply to it. In some areas of alternative medicine, things are even worse than Ioannidis describes.
Take TCM, for instance. I have previously looked at some of the many systematic reviews of TCM that currently flood Medline, based on Chinese studies. This is what I concluded at the time:
Why does that sort of thing frustrate me so much? Because it is utterly meaningless and potentially harmful:
- I don’t know what treatments the authors are talking about.
- Even if I managed to dig deeper, I cannot get the information because practically all the primary studies are published in obscure journals in Chinese language.
- Even if I did read Chinese, I do not feel motivated to assess the primary studies because we know they are all of very poor quality – too flimsy to bother.
- Even if they were formally of good quality, I would have my doubts about their reliability; remember: 100% of these trials report positive findings!
- Most crucially, I am frustrated because conclusions of this nature are deeply misleading and potentially harmful. They give the impression that there might be ‘something in it’, and that it (whatever ‘it’ might be) could be well worth trying. This may give false hope to patients and can send the rest of us on a wild goose chase.
So, to ease the task of future authors of such papers, I decided give them a text for a proper EVIDENCE-BASED conclusion which they can adapt to fit every review. This will save them time and, more importantly perhaps, it will save everyone who might be tempted to read such futile articles the effort to study them in detail. Here is my suggestion for a conclusion soundly based on the evidence, not matter what TCM subject the review is about:
OUR SYSTEMATIC REVIEW HAS SHOWN THAT THERAPY ‘X’ AS A TREATMENT OF CONDITION ‘Y’ IS CURRENTLY NOT SUPPORTED BY SOUND EVIDENCE.
On another occasion, I stated that I am getting very tired of conclusions stating ‘…XY MAY BE EFFECTIVE/HELPFUL/USEFUL/WORTH A TRY…’ It is obvious that the therapy in question MAY be effective, otherwise one would surely not conduct a systematic review. If a review fails to produce good evidence, it is the authors’ ethical, moral and scientific obligation to state this clearly. If they don’t, they simply misuse science for promotion and mislead the public. Strictly speaking, this amounts to scientific misconduct.
In yet another post on the subject of systematic reviews, I wrote that if you have rubbish trials, you can produce a rubbish review and publish it in a rubbish journal (perhaps I should have added ‘rubbish researchers).
And finally this post about a systematic review of acupuncture: it is almost needless to mention that the findings (presented in a host of hardly understandable tables) suggest that acupuncture is of proven or possible effectiveness/efficacy for a very wide array of conditions. It also goes without saying that there is no critical discussion, for instance, of the fact that most of the included evidence originated from China, and that it has been shown over and over again that Chinese acupuncture research never seems to produce negative results.
The main point surely is that the problem of shoddy systematic reviews applies to a depressingly large degree to all areas of alternative medicine, and this is misleading us all.
So, what can be done about it?
My preferred (but sadly unrealistic) solution would be this:
STOP ENTHUSIASTIC AMATEURS FROM PRETENDING TO BE RESEARCHERS!
Research is not fundamentally different from other professional activities; to do it well, one needs adequate training; and doing it badly can cause untold damage.
A few days ago, the German TV ‘FACT’ broadcast a film (it is in German, the bit on homeopathy starts at ~min 20) about a young woman who had her breast cancer first operated but then decided to forfeit subsequent conventional treatments. Instead she chose homeopathy which she received from Dr Jens Wurster at the ‘Clinica Sta Croce‘ in Lucano/Switzerland.
Elsewhere Dr Wurster stated this: Contrary to chemotherapy and radiation, we offer a therapy with homeopathy that supports the patient’s immune system. The basic approach of orthodox medicine is to consider the tumor as a local disease and to treat it aggressively, what leads to a weakening of the immune system. However, when analyzing all studies on cured cancer cases it becomes evident that the immune system is always the decisive factor. When the immune system is enabled to recognize tumor cells, it will also be able to combat them… When homeopathic treatment is successful in rebuilding the immune system and reestablishing the basic regulation of the organism then tumors can disappear again. I’ve treated more than 1000 cancer patients homeopathically and we could even cure or considerably ameliorate the quality of life for several years in some, advanced and metastasizing cases.
The recent TV programme showed a doctor at this establishment confirming that homeopathy alone can cure cancer. Dr Wurster (who currently seems to be a star amongst European homeopaths) is seen lecturing at the 2017 World Congress of Homeopathic Physicians in Leipzig and stating that a ‘particularly rigorous study’ conducted by conventional scientists (the senior author is Harald Walach!, hardly a conventional scientist in my book) proved homeopathy to be effective for cancer. Specifically, he stated that this study showed that ‘homeopathy offers a great advantage in terms of quality of life even for patients suffering from advanced cancers’.
This study did, of course, interest me. So, I located it and had a look. Here is the abstract:
BACKGROUND:
Many cancer patients seek homeopathy as a complementary therapy. It has rarely been studied systematically, whether homeopathic care is of benefit for cancer patients.
METHODS:
We conducted a prospective observational study with cancer patients in two differently treated cohorts: one cohort with patients under complementary homeopathic treatment (HG; n = 259), and one cohort with conventionally treated cancer patients (CG; n = 380). For a direct comparison, matched pairs with patients of the same tumour entity and comparable prognosis were to be formed. Main outcome parameter: change of quality of life (FACT-G, FACIT-Sp) after 3 months. Secondary outcome parameters: change of quality of life (FACT-G, FACIT-Sp) after a year, as well as impairment by fatigue (MFI) and by anxiety and depression (HADS).
RESULTS:
HG: FACT-G, or FACIT-Sp, respectively improved statistically significantly in the first three months, from 75.6 (SD 14.6) to 81.1 (SD 16.9), or from 32.1 (SD 8.2) to 34.9 (SD 8.32), respectively. After 12 months, a further increase to 84.1 (SD 15.5) or 35.2 (SD 8.6) was found. Fatigue (MFI) decreased; anxiety and depression (HADS) did not change. CG: FACT-G remained constant in the first three months: 75.3 (SD 17.3) at t0, and 76.6 (SD 16.6) at t1. After 12 months, there was a slight increase to 78.9 (SD 18.1). FACIT-Sp scores improved significantly from t0 (31.0 – SD 8.9) to t1 (32.1 – SD 8.9) and declined again after a year (31.6 – SD 9.4). For fatigue, anxiety, and depression, no relevant changes were found. 120 patients of HG and 206 patients of CG met our criteria for matched-pairs selection. Due to large differences between the two patient populations, however, only 11 matched pairs could be formed. This is not sufficient for a comparative study.
CONCLUSION:
In our prospective study, we observed an improvement of quality of life as well as a tendency of fatigue symptoms to decrease in cancer patients under complementary homeopathic treatment. It would take considerably larger samples to find matched pairs suitable for comparison in order to establish a definite causal relation between these effects and homeopathic treatment.
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Even the abstract makes several points very clear, and the full text confirms further embarrassing details:
- The patients in this study received homeopathy in addition to standard care (the patient shown in the film only had homeopathy until it was too late, and she subsequently died, aged 33).
- The study compared A+B with B alone (A=homeopathy, B= standard care). It is hardly surprising that the additional attention of A leads to an improvement in quality of life. It is arguably even unethical to conduct a clinical trial to demonstrate such an obvious outcome.
- The authors of this paper caution that it is not possible to conclude that a causal relationship between homeopathy and the outcome exists.
- This is true not just because of the small sample size, but also because of the fact that the two groups had not been allocated randomly and therefore are bound to differ in a whole host of variables that have not or cannot be measured.
- Harald Walach, the senior author of this paper, held a position which was funded by Heel, Baden-Baden, one of Germany’s largest manufacturer of homeopathics.
- The H.W.& J.Hector Foundation, Germany, and the Samueli Institute, provided the funding for this study.
In the film, one of the co-authors of this paper, the oncologist HH Bartsch from Freiburg, states that Dr Wurster’s interpretation of this study is ‘dishonest’.
I am inclined to agree.
We have repeatedly discussed the journal ‘Evidence-Based Complementary and Alternative Medicine’ (see for instance here and here). The journal has recently done something remarkable and seemingly laudable: it retracted an article titled “Psorinum Therapy in Treating Stomach, Gall Bladder, Pancreatic, and Liver Cancers: A Prospective Clinical Study” due to concerns about the ethics, authorship, quality of reporting, and misleading conclusions.***
Aradeep and Ashim Chatterjee own and manage the Critical Cancer Management Research Centre and Clinic (CCMRCC), the private clinic to which they are affiliated. The methods state “The study protocol was approved by the Institutional Review Board (IRB approval Number: 2001–05) of the CCMRCC” in 2001, but a 2014 review of Psorinum therapy said CCMRCC was founded in 2008. The study states “The participants received the drug Psorinum along with allopathic and homeopathic supportive treatments without trying conventional or any other investigational cancer treatments”; withholding conventional cancer treatment raises ethical concerns.
We asked the authors and their institutions for documentation of the ethics approval, the study protocol, and a blank copy of the informed consent form. However, the corresponding author, Aradeep Chatterjee, was reported to have been arrested in June 2017 for allegedly practising medicine without the correct qualifications and his co-author and father Ashim Chatterjee was reported to have been arrested in August; the Chatterjees and their legal representative did not respond to our queries. The co-authors Syamsundar Mandal, Sudin Bhattacharya, and Bishnu Mukhopadhyay said they did not agree to be authors of the article and were not aware of its submission; co-author Jaydip Biswas did not respond.
A member of the editorial board noted that although the discussion stated that “The limitation of this study is that it did not have any placebo or treatment control arm; therefore, it cannot be concluded that Psorinum Therapy is effective in improving the survival and the quality of life of the participants due to the academic rigours of the scientific clinical trials”, the abstract was misleading because it implied Psorinum therapy is effective in cancer treatment. The study design was described as a “prospective observational clinical trial”, but it cannot have been both observational and a clinical trial.
(*** while I wrote this blog (13/3/18) the abstract of this paper was still available on Medline without a retraction notice)
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In case you wonder what ‘psorinum therapy’ is, this website explains:
A cancer specialist and Psorinum clinical researcher, Aurodeep Chaterjee, believes Psorinum Therapy is less time consuming and more economical for treatment of cancer. ‘The advantage of this treatment is that the patient can continue this treatment while staying home and the hospitalization is less required,’ said Chaterjee. He added that it’s an immunotherapy treatment in which the medicine is in liquid form and the technique of consumption is oral.
Though no chemo or radiation sessions are required in it but they can be used parallel to it depending upon the stage of the cancer. He claimed that more than 30 types of cancers could be treated from this therapy. Some of them include gastrointestinal cancer, liver cancer, gall bladder cancer, ovarian cancer, stomach cancer, etc. The process requires two months duration in which the patient has to undergo 12 cycles and the cost is just Rs 5000. Moli Rapoor 55, software engineer from USA who is suffering from ovarian cancer said on Thursday (June 20) that after three chemo cycles when her cancer did not cure after being diagnosed in 2008, she decided to take up Psorinum therapy.
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I am sorry, but the retraction of such a paper is far less laudable than it seems – it should not have been retracted, but it should have never been published in the first place. There are multiple points where the reviewers’ and editors’ alarm bells should have started ringing loud and clear. Take, for instance, this note at the end of the paper:
Funding
Dr. Rabindranath Chatterjee Memorial Cancer Trust provided funding for this study.
Conflict of Interests
The authors declare that they have no conflict of interests.
I think that this should have been a give-away, considering the names of the authors: Chatterjee A1, Biswas J, Chatterjee A, Bhattacharya S, Mukhopadhyay B, Mandal S.
What this story shows, in my view, is that the journal ‘Evidence-Based Complementary and Alternative Medicine’ (EBCAM) operates an unacceptably poor system of peer-review, and is led by an editor who seems to shut both eyes when deciding about publication or rejection. And why would an editor shut his/her eyes to abuse? Perhaps the journal’s interesting business model provides an explanation? Here is what I wrote about it previously:
What I fail to understand is why so many researchers send their papers to this journal. In 2015, EBCAM published just under 1000 (983 to be exact) papers. This is not far from half of all Medline-listed articles on alternative medicine (2056 in total).
To appreciate these figures – and this is where it gets not just puzzling but intriguing, in my view – we need to know that EBCAM charges a publication fee of US$ 2500. That means the journal has an income of about US$ 2 500 000 per annum!
END OF QUOTE
To put it in a nutshell: in healthcare, fraud and greed can cause enormous harm.
On this blog, we had many chiropractors commenting that their profession is changing fast and the old ‘philosophy’ is a thing of the past. But are these assertions really true? This survey might provide an answer. A questionnaire was sent to chiropractic students in all chiropractic programs in Australia and New Zealand. It explored student viewpoints about the identity, role/scope, setting, and future of chiropractic practice as it relates to chiropractic education and health promotion. Associations between the number of years in the program, highest degree preceding chiropractic education, institution, and opinion summary scores were evaluated by multivariate analysis of variance tests.
A total of 347 chiropractic students participated. For identity, most students (51.3%) hold strongly to the traditional chiropractic theory but also agree (94.5%) it is important that chiropractors are educated in evidence-based practice. The main predictor of student viewpoints was a student’s chiropractic institution. Chiropractic institution explained over 50% of the variance around student opinions about role/scope of practice and approximately 25% for identity and future practice.
The authors concluded that chiropractic students in Australia and New Zealand seem to hold both traditional and mainstream viewpoints toward chiropractic practice. However, students from different chiropractic institutions have divergent opinions about the identity, role, setting, and future of chiropractic practice, which is most strongly predicted by the institution. Chiropractic education may be a potential determinant of chiropractic professional identity, raising concerns about heterogeneity between chiropractic schools.
Traditional chiropractic theory is, of course, all the palmereque nonsense about ‘95% of all diseases are caused by subluxations of the spine’ etc. And evidence-based practice means knowing that subluxations are a figment of the chiropractic imagination.
Imagine a physician who believes in evidence and, at the same time, in the theory of the 4 humours determining our health.
Imagine a geologist thinking that the earth is flat and also spherical.
Imagine a biologist subscribing to both creationism and evolution.
Imagine a surgeon earning his livelihood with blood-letting and key-hole surgery.
Imagine a doctor believing in vital energy after having been taught physiology.
Imagine an airline pilot considering the use of flying carpets.
Imagine a chemist engaging in alchemy.
Imagine a Brexiteer who is convinced of doing the best for the UK.
Imagine a homeopath who thinks he practices evidence-based medicine.
Imagine a plumber with a divining rod.
Imagine an expert in infectious diseases believing is the miasma theory.
Imagine a psychic hoping to use her skills for winning a fortune on the stock market.
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Once you have imagined all of these situations, I fear, you might know (almost) all worth knowing about chiropractic.
Dr. Dietmar Payrhuber is not famous – no, by no means. I had never heard of him until a watched this TV discussion about homeopathy (it’s in German, and well-worth watching, if you understand the language). I found the discussion totally mesmerising: Payrhuber is allowed to come out with case after case alleging he cured cancer of various types with homeopathy. Prof Frass is also there to defend the indefensible, but hardly intervenes, other than repeatedly and pompously stating that he is a professor with 200 publications who runs a homeopathy clinic at the university hospital of Vienna and therefore he is a cut above.
There are also three very bright and eloquent sceptical disputants who do their best to oppose Payrhuber’s moronic monstrosities. One of them even alerts us (and the broadcaster!) to the fact that some cancer patients might watch this and conclude that homeopathy cues cancer. Yes, TV can be dangerous!
After watching Payrhuber, I felt the urge to learn more about this man. On TV, he mentioned repeatedly his publications, so I first of all conducted a Medline search; it turns out that Medline lists not a single article in his name. However, I did find his (self-published) book: ‘HOMOEOPATHIE UND KREBS’ (HOMEOPATHY AND CANCER). It greatly impressed me – but not in a positive sense.
The preface (in English) is by Jan Scholten (who IS quite famous in the realm of homeopathy); here is a short quote from it:
[Payrhuber’s book] … is an important book for several reasons. The first reason is that it shows that homeopathy is a real healing art. Often homeopathy is seen as good for superficial, light and self-healing diseases such as colds, eczema’s, bronchitis and the like. Together with this view goes the opinion that it is not a real medicine, because it cannot treat „real diseases“. But this shows the opposite: cancer can be healed, cured with homeopathy. It shows that homeopathy can have very profound effect and can really cure deeply. Of course cancer was cured already in the past with homeopathy by famous homeopaths such as Grimmer and Resch. But Dietmar shows that it can be done in a consistent way. Homeopathy cannot be set aside as superficial anymore…But it gets worse! Payrhuber himself is equally clear that homeopathy can cure cancer; here is a quote that I translated from his German text into English:
The book shows options to treat cancer; this is not an exclusive option of homeopathy. However, it offers an alternative for therapy-resistant and slow-responding cases treated conventionally… The question whether homeopathy is an alternative or a complementary therapy is superfluous. As the cases presented here demonstrate, homeopathy is part of medicine, a method which is more scientific than conventional medicine, because it has clear principles and laws. In certain cases or in certain phases of cancer, homeopathy is quite simply indicated! Homeopathy is holistic and puts the whole patient rather than a local symptom in the centre.
We must not keep homeopathy from cancer patients, because it offers in many cases a cure which cannot be achieved by other means.
(For those who can read German, here is the original: Das Buch zeigt Möglichkeiten auf, Krebs zu behandeln, es stellt keinen Alleinanspruch der Homöopathie dar. Es bietet allerdings alternative Möglichkeiten für therapieresistente und therapieträge Behandlungsverläufe bei konventioneller Therapie an….
Es erübrigt sich die Frage, ob Homöopathie eine alternative oder komplementäre Medizin ist. Wie die vorliegenden Fälle zeigen, ist sie ein Teil der Medizin, eine Methode, die „eher wissenschaftlicher ist als die Schulmedizin, weil die Homöopathie deutliche Prinzipien und Gesetze hat“. Die Homöopathie ist in bestimmten Fällen oder in bestimmten Phasen der Behandlung schlicht und einfach indiziert! Sie ist ganzheitlich, setzt den Menschen ins Zentrum und nicht das Lokalsymptom…
Die Homöopathie darf dem Patienten nicht vorenthalten werden, da sie in vielen Fällen Heilungsmöglichkeiten bietet, die auf andere Weise nicht erreicht werden können…)
END OF QUOTE
As I said, Payrhuber is not famous – he is infamous!
This sad story left me with three questions:
- Can someone please stop Payrhuber before he does more damage to cancer patients?
- And can someone please tell the medical faculty of the university of Vienna (my former employer) that running a homeopathy clinic for cancer patients is not ethical?
- Can someone please teach journalists that, in healthcare, giving a voice to dangerous nonsense can do serious harm?
Newsweek recently reported that a herbalist has been charged with the death of a 13-year-old diabetic boy. Allegedly, the therapist replaced the boy’s insulin with herbal remedies. Tim Morrow, 83, was charged with
- child abuse causing death
- and with practicing medicine without a license.
Morrow stated that god had guided him to use herbs rather than conventional medicine and that he successfully treated treat his own prostate cancer in this way. Marrow can be seen on multiple YouTube videos from his ‘University of Common Sense’ promoting his bizarre ideas of health and disease.
Perhaps god also guided Marrow to make lots of money? He runs regular seminars and a thriving herbal on-line business, the ‘Common Sense Herbal Products‘. There are few ailments, for which ‘Common Sense Herbal Products’ do not seem to offer a herbal cure.
One of the remedies, ‘Pancreas Reg‘, for instance, claims to “act as natural insulin”. The 270 Tablets tub of this product costs US $74.22. It is easy to see, I find, how bold claims attract gullible customers depriving them not just of their money but also of their health.
Morrow started treating the boy suffering from Type 1 diabetes after he met his mother at one of his seminars. When the boy subsequently became semi-comatose, Morrow told his parents to treat their son with his herbal remedies rather than insulin which had been prescribed by qualified medical doctors. The boy, Edgar L., died only hours later. There is little doubt that he would have survived, if he had undergone conventional treatment, the medical examiner concluded.
“The allegations in this case underscore the serious health and safety risks of taking medical advice from someone who lacks a license and the proper training that goes with it,” the medical examiner said in a statement. “No family should have to suffer the tragedy of losing a child because of irresponsible, un-credentialed medical advice.”
On this blog, during lectures etc., I often stress that by far the biggest danger of seemingly harmless alternative therapies is that they are used to replace effective treatments for serious conditions. Diabetes is such a condition, and there are numerous instances where the advice of incompetent practitioners has endangered the lives of diabetics.
Three examples will have to suffice as examples of the plethora of such unethical neglect:
- “In homeopathy, diabetes is seen as a reflection of the body’s inability to function optimally. There is an imbalance that results in the body’s incapacity to effectively utilize the insulin that it produces, or to produce sufficient insulin for its needs. While symptoms often disappear after conventional treatment, the vital force does not. Homoeopathy can be used effectively in the treatment of diabetes. Here we mainly concentrate on functioning of the pancreas in efficient insulin production. The metabolic condition of a patient suffering from diabetes requires both therapeutic and nutritional measures to correct the illness. Homeopathy can regulate sugar metabolism while helping to resolve the metabolic disturbances that lead to diabetes. Furthermore, homeopathy helps stimulate the body’s self-healing powers in order to prevent complications such as open leg sores and other dysfunctions of the blood vessel, loss of vision, kidney failure. Homeopathic treatment does not target one illness, an organ, a body part or a symptom. Remedies are prescribed based on an assembly of presenting symptoms, their stresses in life.”
- “Management of Blood sugar. The commonly used remedies are Uranium Nitricum, Phosphoric Acid, Syzygium Jambolanum, Cephalandra Indica etc. These are classical Homeopathic remedies. These are used in physiologically active doses such as Mother tincture, 3x etc. depending up on the level of the blood sugar and the requirement of the patient. Several pharmaceutical companies have also brought in propriety medicines with a combination of the few Homeopathic medicines. Biochemic remedies which is a part of Homeopathy advocates Biocombination No 7 as a specific for Diabetes. Another Biochemic medicine Natrum Phos 3x is widely used with a reasonable success in controlling the blood sugar. Scientific studies on the impact of homeopathic medicines in bringing down blood sugar are limited, but many of the above remedies have some positive effects either as a stand-alone remedy or as an adjunct along with other medications.”
- “Modern medicine has no permanent cure for diabetes but alternative medicines like yoga ,mudra,ayurveda is very useful to control and even cure diabetes.Ayurveda is an alternative medicine to cure diabetes.”
But these are very rare instances!!!
That’s what apologists usually respond.
Yet, the truth is that NOBODY knows how often such harm occurs.
Why?
There is no monitoring system anywhere that would provide such information.
