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.
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.
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:
Many cancer patients seek homeopathy as a complementary therapy. It has rarely been studied systematically, whether homeopathic care is of benefit for cancer patients.
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).
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.
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.
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)
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.
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:
Dr. Rabindranath Chatterjee Memorial Cancer Trust provided funding for this study.
Conflict of Interests
The authors declare that they have no conflict of interests.
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!
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To put it in a nutshell: in healthcare, fraud and greed can cause enormous harm.
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Antiretroviral Therapy (ART) is recommended for each and every case of AIDS where CD4 count goes less than 350. Aura Homeopathy does not offer cure for AIDS. However, several research and clinical studies done by various Research centre including few from CCRH (Central Council for Research in Homeopathy, Govt. of India), have prove the supportive role of homeopathic medicines. Homeopathy medicine only relief symptoms but also reduced frequency of opportunistic infections, increase appetite, weight, and sense of well being, etc. At Aura Homeopathy, we apply classical homeopathy protocols on HIV/AIDS patients, as a part of our Clinical trial and Research projects. The results were very encouraging.
At Aura Homeopathy, we have seen an increase in the CD4 count in number of patients, after using Aura homeopathy medicines. Dr.Abhishek recommend’s Homeopathy as supporting line of therapy for all HIV patients.
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When I read this I wanted to be sick; but instead I did something a little more sensible: I conducted a quick Medline search for ‘homeopathy, AIDS’.
It returned 30 articles. Of these, there were just 4 that presented anything remotely resembling data. Here are their abstracts:
Allopathic practitioners in India are outnumbered by practitioners of traditional Indian medicine and homeopathy (TIMH), which is used by up to two-thirds of its population to help meet primary health care needs, particularly in rural areas. India has an estimated 2.5 million HIV infected persons. However, little is known about TIMH use, safety or efficacy in HIV/AIDS management in India, which has one of the largest indigenous medical systems in the world. The purpose of this review was to assess the quality of peer-reviewed, published literature on TIMH for HIV/AIDS care and treatment.
Of 206 original articles reviewed, 21 laboratory studies, 17 clinical studies, and 6 previous reviews of the literature were identified that covered at least one system of TIMH, which includes Ayurveda, Unani medicine, Siddha medicine, homeopathy, yoga and naturopathy. Most studies examined either Ayurvedic or homeopathic treatments. Only 4 of these studies were randomized controlled trials, and only 10 were published in MEDLINE-indexed journals. Overall, the studies reported positive effects and even “cure” and reversal of HIV infection, but frequent methodological flaws call into question their internal and external validity. Common reasons for poor quality included small sample sizes, high drop-out rates, design flaws such as selection of inappropriate or weak outcome measures, flaws in statistical analysis, and reporting flaws such as lack of details on products and their standardization, poor or no description of randomization, and incomplete reporting of study results.
This review exposes a broad gap between the widespread use of TIMH therapies for HIV/AIDS, and the dearth of high-quality data supporting their effectiveness and safety. In light of the suboptimal effectiveness of vaccines, barrier methods and behavior change strategies for prevention of HIV infection and the cost and side effects of antiretroviral therapy (ART) for its treatment, it is both important and urgent to develop and implement a rigorous research agenda to investigate the potential risks and benefits of TIMH and to identify its role in the management of HIV/AIDS and associated illnesses in India.
2nd paper (I am a co-author of this one)
The use of complementary and alternative medicine (CAM) is widespread. Yet, little is known about the evidence supporting its use in HIV/AIDS. We conducted a systematic review of randomized clinical trials assessing the effectiveness of complementary therapies for HIV and HIV-related symptoms. Comprehensive literature searches were performed of seven electronic databases. Data were abstracted independently by two reviewers. Thirty trials met our predefined inclusion/exclusion criteria: 18 trials were of stress management; five of Natural Health Products; four of massage/therapeutic touch; one of acupuncture; two of homeopathy. The trials were published between 1989 and 2003. Most trials were small and of limited methodological rigour. The results suggest that stress management may prove to be an effective way to increase the quality of life. For all other treatments, data are insufficient for demonstrating effectiveness. Despite the widespread use of CAM by people living with HIV/AIDS, the effectiveness of these therapies has not been established. Vis à vis CAM’s popularity, the paucity of clinical trials and their low methodological quality are concerning.
Homeopathic medicine developed significant popularity in the nineteenth century in the United States and Europe as a result of its successes treating the infectious disease epidemics during that era. Homeopathic medicine is a medical system that is specifically oriented to using nanopharmacologic and ultramolecular doses of medicines to strengthen a person’s immune and defense system rather than directly attacking the microbial agents.
To review the literature referenced in MEDLINE and in nonindexed homeopathic journals for placebo-controlled clinical trials using homeopathic medicines to treat people with AIDS or who are human immunodeficiency virus (HIV)-positive and to consider a different theoretical and methodological approach to treating people with the viral infection.
A total of five controlled clinical trials were identified. A double-blinded, placebo-controlled study was conducted on 50 asymptomatic HIV-positive subjects (stage II) and 50 subjects with persistent generalized lymphadenopathy (stage III) in whom individualized single-remedy homeopathic treatment was provided. A separate body of preliminary research was conducted using homeopathic doses of growth factors. Two randomized double-blinded, placebo-controlled studies were conducted with a total of 77 people with AIDS who used only natural therapies over a 8-16-week period. Two other studies were conducted over a 2.5-year period with 27 subjects in an open-label format.
The first study was conducted by the Regional Research Institute for Homeopathy in Mumbai, India, under the Central Council for Research in Homeopathy, with the approval of the Ministry of Health and Family Welfare, Government of India. The second body of studies was conducted in clinic settings in California, Oregon, Arizona, Hawaii, New York, and Washington.
The first study found no statistically significant improvement in CD4 T-lymphocytes, but did find statistically significant pretest and post-test results in subjects with stage III AIDS, in CD4 (p = 0.008) and in CD8 (p = 0.04) counts. The second group of studies found specific physical, immunologic, neurologic, metabolic, and quality-of-life benefits, including improvements in lymphocyte counts and functions and reductions in HIV viral loads.
As a result of the growing number of people with drug-resistant HIV infection taking structured treatment interruptions, homeopathic medicine may play a useful role as an adjunctive and/or alternative therapy.
In 1996, [name removed] was convicted on charges of conspiracy and introducing an unapproved drug into interstate commerce and the 2nd U.S. Circuit Court of Appeals upheld the conviction. [Name removed]’s company, Writers and Researchers Inc. sold a drug called 714X to individuals and physicians, promoting it as a nontoxic therapy for AIDS, cancer, and other chronic diseases. The Food and Drug Administration (FDA) warned [name removed] that his marketing was illegal because the product had not been proven safe and effective for use in treating disease. [Name removed] argued that the product was a homeopathic drug, revealed by FDA tests to contain 94 percent water, and a mixture of nitrate, ammonium, camphor, chloride, ethanol, and sodium. The courts found that 714X was subject to FDA scrutiny because it was touted as a cure for cancer and AIDS.
So, what does this collective evidence tell us?
I think it makes it abundantly clear that there is no good reason to suggest that HIV/AIDS patients can be helped in any way by homeopathy. On the contrary, homeopathy might distract them from essential conventional care and it would needlessly harm their bank balance. It follows that claims to the contrary are bogus, unethical, reckless, and possibly even criminal.
Clinical trials are a most useful tool, but they can easily be abused. It is not difficult to misuse them in such a way that even the most useless treatment appears to be effective. Sadly, this sort of thing happens all too often in the realm of alternative medicine. Take for instance this recently published trial of homeopathy.
The objective of this study was to investigate the usefulness of classical homeopathy for the prevention of recurrent urinary tract infections (UTI) in patients with spinal cord injury (SCI). Patients were admitted to this trial, if they had chronic SCI and had previously suffered from at least three UTI/year. They were treated either with a standardized prophylaxis alone, or with a standardized prophylaxis in combination with homeopathy. The number of UTIs, general and specific quality of life (QoL), and satisfaction with homeopathic treatment were assessed prospectively over the period of one year. Ten patients were in the control group and 25 patients received adjunctive homeopathic treatment. The median number of self-reported UTI in the homeopathy group decreased significantly, whereas it remained unchanged in the control group. The domain incontinence impact of the KHQ improved significantly, whereas the general QoL did not change. The satisfaction with homeopathic care was high.
The authors concluded that adjunctive homeopathic treatment lead to a significant decrease of UTI in SCI patients. Therefore, classical homeopathy could be considered in SCI patients with recurrent UTI.
Where to begin?
Here are just some of the most obvious flaws of and concerns with this study:
- There is no plausible rationale to even plan such a study.
- The sample size was far too small for allowing generalizable conclusions.
- There was no adequate randomisation and patients were able to chose the homeopathy option.
- The study seems to lack objective outcome measures.
- The study design did not allow to control for non-specific effects; therefore, it seems likely that the observed outcomes are unrelated to the homeopathic treatments but are caused by placebo and other non-specific effects.
- Even if the study had been rigorous, we would need independent replications before we draw such definitive conclusions.
- Two of the authors are homeopaths, and it is in their clinics that the study took place.
- Some of the authors have previously published a very similar paper – except that this ‘case series’ included no control group at all.
- The latter paper seems to have been published more than once.
- Of this paper, one of the authors claimed that ” the usefulness of classical homeopathy as an adjunctive measure for UTI prophylaxis in patients with NLUTD due to SCI has been demonstrated in a case series”. He seems to be unaware of the fact that a case series cannot possible lend itself to demonstrate this.
- I do wonder: did they just add a control group to their case series thus pretending it became a controlled clinical trial?
What strikes me most with such pseudo-research is its abundance and the naivety – or should I call it ignorance? – of the enthusiasts who conduct it. Most of them, I am fairly sure do not mean to do harm; but by Jove they do!
Yesterday, I saw a Tweet stating:
It was followed by a list of specific indications:
- Anxiety and much more…
I responded to this Tweet by tweeting:
Homeopath in Cornwall specialising in misleading women
Minutes later I received a response from a homeopathy-fan:
That could be called libel Edzard. I would be careful.
So, should I be careful, and if so why?
Reading the thinly veiled threat, I wasn’t exactly shaking in my boots with fear (I was deeply involved in helping Simon Singh in his defence against the BCA’s libel action), but I nevertheless wanted to be sure of my position and conducted some ‘rough and ready’ searches for recent evidence to suggesting that homeopathy is effective for any of the conditions mentioned above. Here is what I found:
- Pregnancy. Yes, there is an RCT! It concluded that “homeopathy does not appear to prevent excessive body mass gain in pregnant women…” And another one concluding that “neither Pentazocine, or Chamomilla recutita offer substantial analgesia during labor.”
- Infertility. No RCT or other sound evidence.
- PCOS. Nothing
- PMS. No clinical trials.
- Fibroids. No clinical trials
- Depression. Even leading homeopaths seem to agree that there is no good evidence.
- Anxiety. Again, I could not find any sound evidence.
Don’t get me wrong, these statements are not based on full systematic reviews; that would take a while and hardly seems worth it. (If you want a good systematic review, I recommend this one; it concluded: “Homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness. People who are considering whether to use homeopathy should first get advice from a registered health practitioner. Those who use homeopathy should tell their health practitioner and should keep taking any prescribed treatments.“) But my quick glance at the evidence is enough, I think, to justify my statement that the above claims by a homeopath are misleading. In fact, I believe that I could have used much stronger terminology without the slightest risk of being sued.
PERHAPS NEXT TIME!
Yesterday, a press-release about our new book has been distributed by our publisher. As I hope than many regular readers of my blog might want to read this book – if you don’t want to buy it, please get it via your library – I decided to re-publish the press-release here:
Governments must legislate to regulate and restrict the sale of complementary and alternative therapies, conclude authors of new book More Harm Than Good.
Heidelberg, 20 February 2018
Commercial organisations selling lethal weapons or addictive substances clearly exploit customers, damage third parties and undermine genuine autonomy. Purveyors of complementary and alternative medicine (CAM) do too, argue authors Edzard Ernst and Kevin Smith.
The only downside to regulating such a controversial industry is that regulation could confer upon it an undeserved stamp of respectability and approval. At best, it can ensure the competent delivery of therapies that are inherently incompetent.
This is just one of the ethical dilemmas at the heart of the book. In all areas of healthcare, consumers are entitled to expect essential elements of medical ethics to be upheld. These include access to competent, appropriately-trained practitioners who base treatment decisions on evidence from robust scientific research. Such requirements are frequently neglected, ignored or wilfully violated in CAM.
“We would argue that a competent healthcare professional should be defined as one who practices or recommends plausible therapies that are supported by robust evidence,” says bioethicist Kevin Smith.
“Regrettably, the reality is that many CAM proponents allow themselves to be deluded as to the efficacy or safety of their chosen therapy, thus putting at risk the health of those who heed their advice or receive their treatment,” he says.
Therapies covered include homeopathy, acupuncture, chiropractic, iridology, Reiki, crystal healing, naturopathy, intercessory prayer, wet cupping, Bach flower therapy, Ukrain and craniosacral therapy. Their inappropriate use can not only raises false hope and inflicts financial hardship on consumers, but can also be dangerous; either through direct harm or because patients fail to receive more effective treatment. For example, advice given by homeopaths to diabetic patients has the potential to kill them; and when anthroposophic doctors advise against vaccination, they can be held responsible for measles outbreaks.
There are even ethical concerns to subjecting such therapies to clinical research. In mainstream medical research, a convincing database from pre-clinical research is accumulated before patients are experimented upon. However, this is mostly not possible with CAM. Pre-scientific forms of medicine have been used since time immemorial, but their persistence alone does not make them credible or effective. Some are based on notions so deeply implausible that accepting them is tantamount to believing in magic.
“Dogma and ideology, not rationality and evidence, are the drivers of CAM practice,” says Professor Edzard Ernst.
Edzard Ernst, Kevin Smith
More Harm than Good?
1st ed. 2018, XXV, 223 p.
Softcover $22.99, €19,99, £15.99 ISBN 978-3-319-69940-0
Also available as an eBook ISBN 978-3-319-69941-7
END OF PRESS RELEASE
As I already stated above, I hope you will read our new book. It offers something that has, I think, not been attempted before: it critically evaluates many aspects of alternative medicine by holding them to the ethical standards of medicine. Previously, we have often been asking WHERE IS THE EVIDENCE FOR THIS OR THAT CLAIM? In our book, we ask different questions: IS THIS OR THAT ASPECT OF ALTERNATIVE MEDICINE ETHICAL? Of course, the evidence question does come into this too, but our approach in this book is much broader.
The conclusions we draw are often surprising, sometimes even provocative.
Well, you will see for yourself (I hope).
Sipjeondaebo-tang is an East Asian herbal supplement containing Angelica root (Angelicae Gigantis Radix), the rhizome of Cnidium officinale Makino (Cnidii Rhizoma), Radix Paeoniae, Rehmannia glutinosa root (Rehmanniae Radix Preparata), Ginseng root (Ginseng Radix Alba), Atractylodes lancea root (Atractylodis Rhizoma Alba), the dried sclerotia of Poria cocos (Poria cocos Sclerotium), Licorice root (Glycyrrhizae Radix), Astragalus root (Astragali Radix), and the dried bark of Cinnamomum verum (Cinnamomi Cortex).
But does this herbal mixture actually work? Korean researchers wanted to find out.
The purpose of their study was to examine the feasibility of Sipjeondaebo-tang (Juzen-taiho-to, Shi-Quan-Da-Bu-Tang) for cancer-related anorexia. A total of 32 participants with cancer anorexia were randomized to either Sipjeondaebo-tang group or placebo group. Participants were given 3 g of Sipjeondaebo-tang or placebo 3 times a day for 4 weeks. The primary outcome was a change in the Anorexia/Cachexia Subscale of Functional Assessment of Anorexia/Cachexia Therapy (FAACT). The secondary outcomes included Visual Analogue Scale (VAS) of anorexia, FAACT scale, and laboratory tests.
The results showed that anorexia and quality of life measured by FAACT and VAS were improved after 4 weeks of Sipjeondaebo-tang treatment. However, there was no significant difference between changes of Sipjeondaebo-tang group and placebo group.
From this, the authors of the study concluded that sipjeondaebo-tang appears to have potential benefit for anorexia management in patients with cancer. Further large-scale studies are needed to ensure the efficacy.
Well, isn’t this just great? Faced with a squarely negative result, one simply ignores it and draws a positive conclusion!
As we all know – and as trialists certainly must know – controlled trials are designed to compare the outcomes of two groups. Changes within one of the groups can be caused by several factors unrelated to the therapy and are therefore largely irrelevant. This means that “no significant difference between changes of Sipjeondaebo-tang group and placebo group” indicates that the herbal mixture had no effect. In turn this means that a conclusion stating that “sipjeondaebo-tang appears to have potential benefit for anorexia” is just fraudulent.
This level of scientific misconduct is remarkable, even for the notoriously poor Evid Based Complement Alternat Med.
I strongly suggest that:
- The journal is de-listed from Medline because similarly misleading nonsense has been coming out of this rag for some time.
- The paper is withdrawn because it can only mislead vulnerable patients.
Some say that Chinese herbal medicine offers a solution.
This Chinese multi-centre RCT included 588 mothers considering breastfeeding. The intervention group received the Chinese herbal mixture Zengru Gao, while the control group received no therapy. The primary outcomes were the percentages of fully and partially breastfeeding mothers, and a secondary outcome was baby’s daily formula intake.
At day 3 and 7 after delivery, significant differences were found in favour of Zengru Gao group on the percentage of full/ partial breastfeeding. At day 7, the percentage of full/ partial breastfeeding of the active group increased to 71.48%/20.70% versus 58.67%/30.26% in the control group, the differences remained significant. No statistically significant differences were detected on primary measures at day. While intake of formula differed between groups at day 1 and 3, this difference did not achieve statistical significance, but this difference was apparent by day 7.
The authors concluded that the Chinese Herbal medicine Zengru Gao enhanced breastfeeding success during one week postpartum. The approach is acceptable to participants and merits further evaluation.
To the naïve observer, this study might look rigorous, but it is a seriously flawed RCT. Here are just some of its most obvious limitations:
- All we get in the methods section is this explanation: Participants were randomly allocated to the blank control group or the intervention group: Zengru Gao, orally, 30 g a time and 3 times a day. This seems to indicate that the control group got no treatment at all which means there was no blinding nor placebo control. The authors even comment on this point in the discussion section of their paper stating that because we included new mothers who received no treatment as a control group, we were able to prove that the improvement in breastfeeding was not due to the placebo effect. However, this is a totally nonsensical argument.
- The experimental treatment is not reproducible. The authors state: Zengru Gao, a Chinese herbal formula, which is composed of 8 herbs: Semen Vaccariae, Medulla Tetrapanacis, Radix Rehmanniae Praeparata, Radix Angelicae Sinensis, Radix Paeoniae Alba,Rhizoma Chuanxiong, Herba Leonuri, Radix Trichosanthis. This is not enough information to replicate the study outside China where the mixture is not commercially available.
- The primary outcome was the percentage of fully, and partially breastfeeding mothers. Breastfeeding was defined as mother’s milk given by direct breast feeding. Full breastfeeding meant that no other types of milk or solids were given. Partially breastfeeding meant that sustained latch with deep rhythmic sucking through the length of the feed, with some pause, on either/ or both breasts. We are not being told how the endpoint was quantified. Presumably women kept diaries. We cannot guess how accurate this process was.
- As far as I can see, there was no correction for multiple testing for statistical significance. This means that some or all of the significant results might be false-positive.
- There is insufficient data to show that the herbal mixture is safe for the mothers and the babies. At the very minimum, the researchers should have measured essential safety parameters. This omission is a gross violation of research ethics.
- Towards the end of the paper, we find the following statement: The authors would like to thank the Research and Development Department of Zhangzhou Pien Tze Huang Pharmaceutical co., Ltd. … The authors declare that they have no competing interests. And the 1st and 3rd authors are “affiliated with” Guangzhou Hipower Pharmaceutical Technology Co., Ltd, Guangzhou, China, i. e. work for the manufacturer of the mixture. This does clearly not make any sense whatsoever.
I have seen too many flawed studies of alternative medicine to be shocked or even surprised by this level of incompetence and nonsense. Yet, I still find it lamentable. But, in my view, the worst is that supposedly peer-reviewed journals such as ‘BMC Complement Altern Med’ publish such overt rubbish.
It would be easy to shrug one’s shoulder and bin the paper. But the effect of such fatally flawed research is too serious for that. In our recent book MORE HARM THAN GOOD? THE MORAL MAZE OF COMPLEMENTARY AND ALTERNATIVE MEDICINE, we discuss that such flawed science amounts to a violation of medical ethics: CAM journals allocate peer review tasks to a narrow range of CAM enthusiasts who often have been chosen by the authors of the article in question. The raison d’être of CAM journals and CAM researchers is inextricably tied to a belief in CAM, resulting in a self-referential situation which is permissive to the acceptance of weak or ﬂawed reports of clinical effectiveness… Defective research—whether at the design, execution, analysis, or reporting stage—corrupts the repository of reliable medical knowledge. Ultimately, this leads to suboptimal and erroneous treatment decisions…
We probably all heard about the horrific stories related to Larry Nassar who, on January 24, 2018, was sentenced to 40 to 175 years in a Michigan state prison after pleading guilty to the sexual assault of numerous minors and US gymnasts. But few of us, I think, had any idea that these stories also relate to alternative medicine. This is an excerpt from an article in the LOS ANGELES TIMES.
… McKayla Maroney, the Olympic gold medalist who says she was paid $1.25 million by the United States Olympic Committee and USA Gymnastics to stop her from speaking out, put it flatly: “Dr. Nassar was not a doctor.”
No wonder the survivors chose to crush that word. “Doctor” was Nassar’s supreme and founding lie. It notarized him as a professional pledged to heal, and launched his 20-year child-molestation spree, gaining him a sturdy disguise, a complicity network, access to victims and a savage sense of entitlement.
What allowed Nasser to use the honorific? In 1993, he received a doctorate in osteopathic medicine from Michigan State University. MSU, of course, went on to protect and pay Nassar, the almighty and trusted doctor, as a faculty member for 20 years. Lou Anna Simon, MSU’s president, resigned this week amid charges that the university covered for Nassar and enabled him. USA Gymnastics, where Nassar also passed as a doctor, is similarly accused of giving safe harbor to a known criminal, while hushing and deceiving his victims. Under pressure, the group announced this week that the entire USAG board would resign.
Osteopathic medicine focuses on the joints, muscles and spine. Historically, though, osteopathy — its original name — was closely associated with a set of esoteric massage styles that some researchers now consider ineffective or worse. For its part, MSU’s College of Osteopathic Medicine still teaches these unusual manipulations — a special “benefit” unique to osteopathic medicine — describing them as a form of “hands-on diagnosis and treatment.”
Some historical context: Andrew Taylor Still, the founder of osteopathy, wrote of his medical discoveries in 1897: “I could twist a man one way and cure flux … shake a child and stop scarlet fever … cure whooping cough in three days by a wring of the child’s neck.”
Modern osteopathic medicine uses none of these techniques to treat infections — or anything else. But the specter of violence and child abuse that Still conjured in his early writings continues to haunt the fringes of osteopathic medicine. These practices include intravaginal manipulation. Fisting. This was the “medical procedure” Nassar performed on so many young girls.
According to his victims, Nassar’s attention wasn’t on their hamstrings or ACLs; instead, he focused on their anuses, breasts and vaginas. In January 2017, one victim spelled it out in her complaint: “Nassar digitally penetrated Plaintiff Jane A. Doe’s vagina multiple times without prior notice and without gloves or lubricant.” Other victims describe Nassar’s forcing his “dry fingers” into their anuses and vaginas. The violent fisting was excruciating. “I’d want to scream,” said Kassie Powell, an MSU pole vaulter. As Amy Labadie, a gymnast, put it: “My vagina was sore during my competition because of this man.”
Then came the gaslighting. When the girls blew the whistle, Nassar and his enablers tirelessly reasserted his privileges as a doctor. “We were manipulated into believing that Mr. Nassar was healing us as any normal doctor is supposed to do,” Capua testified. Just last year, the American Osteopathic Assn. released a statement to MLive.com, the Michigan news service, saying that intravaginal manipulations are indeed an approved, if rare, osteopathic treatment for pelvic pain…
END OF EXCERPT
I feel sick and am speechless.
But before my detractors point it out: yes, such monserous transgressions do occur in conventional healthcare too. And no, I am not implying that all osteopaths are criminal perverts.