conflict of interest
Radix Salviae Miltiorrhizae (Danshen) is a herbal remedy that is part of many TCM herbal mixtures. Allegedly, Danshen has been used in clinical practice for over 2000 years.
But is it effective?
The aim of this systematic review was to evaluate the current available evidence of Danshen for the treatment of cancer. English and Chinese electronic databases were searched from PubMed, the Cochrane Library, EMBASE, and the China National Knowledge Infrastructure (CNKI), VIP database, Wanfang database until September 2018. The methodological quality of the included studies was evaluated by using the method of Cochrane system.
Thirteen RCTs with 1045 participants were identified. The studies investigated the lung cancer (n = 5), leukemia (n = 3), liver cancer (n = 3), breast or colon cancer (n = 1), and gastric cancer (n = 1). A total of 83 traditional Chinese medicines were used in all prescriptions and there were three different dosage forms. The meta-analysis suggested that Danshen formulae had a significant effect on RR (response rate) (OR 2.38, 95% CI 1.66-3.42), 1-year survival (OR 1.70 95% CI 1.22-2.36), 3-year survival (OR 2.78, 95% CI 1.62-4.78), and 5-year survival (OR 8.45, 95% CI 2.53-28.27).
The authors concluded that the current research results showed that Danshen formulae combined with chemotherapy for cancer treatment was better than conventional drug treatment plan alone.
I am getting a little tired of discussing systematic reviews of so-called alternative medicine (SCAM) that are little more than promotion, free of good science. But, because such articles do seriously endanger the life of many patients, I do nevertheless succumb occasionally. So here are a few points to explain why the conclusions of the Chinese authors are nonsense:
- Even though the authors claim the trials included in their review were of high quality, most were, in fact, flimsy.
- The trials used no less than 83 different herbal mixtures of dubious quality containing Danshen. It is therefore not possible to define which mixture worked and which did not.
- There is no detailed discussion of the adverse effects and no mention of possible herb-drug interactions.
- There seemed to be a sizable publication bias hidden in the data.
- All the eligible studies were conducted in China, and we know that such trials are unreliable to say the least.
- Only four articles were published in English which means those of us who cannot read Chinese are unable to check the correctness of the data extraction of the review authors.
I know it sounds terribly chauvinistic, but I do truly believe that we should simply ignore Chinese articles, if they have defects that set our alarm bells ringing – if not, we are likely to do a significant disservice to healthcare and progress.
The aim of this new systematic review was to evaluate the controlled trials of homeopathy in bronchial asthma. Relevant trials published between Jan 1, 1981, and Dec 31, 2016, were considered. Substantive research articles, conference proceedings, and master and doctoral theses were eligible. Methodology was assessed by Jadad’s scoring, internal validity by the Coch-rane tool, model validity by Mathie’s criteria, and quality of individualization by Saha’s criteria.
Sixteen trials were eligible. The majority were positive, especially those testing complex formulations. Methodological quality was diverse; 8 trials had “high” risk of bias. Model validity and individualization quality were compromised. Due to both qualitative and quantitative inadequacies, proofs supporting individualized homeopathy remained inconclusive. The trials were positive (evidence level A), but inconsistent, and suffered from methodological heterogeneity, “high” to “uncertain” risk of bias, incomplete study reporting, inadequacy of independent replications, and small sample sizes.
The authors of this review come from:
- the Department of Homeopathy, District Joint Hospital, Government of Bihar, Darbhanga, India;
- the Department of Organon of Medicine and Homoeopathic Philosophy, Sri Sai Nath Postgraduate Institute of Homoeopathy, Allahabad, India;
- the Homoeopathy University Jaipur, Jaipur, India;
- the Central Council of Homeopathy, Hooghly,
- the Central Council of Homeopathy, Howrah, India
They state that they have no conflicts of interest.
The review is puzzling on so many accounts that I had to read it several times to understand it. Here are just some of its many oddities:
- According to its authors, the review adhered to the PRISMA-P guideline; as a co-author of this guideline, I can confirm that this is incorrect.
- The authors claim to have included all ‘controlled trials (randomized, non-randomized, or observational) of any form of homeopathy in patients suffering from persistent and chronic bronchial asthma’. In fact, they also included uncontrolled studies (16 controlled trials and 12 uncontrolled observational studies, to be precise).
- The authors included papers published between Jan 1, 1981, and Dec 31, 2016. It is unacceptable, in my view, to limit a systematic review in this way. It also means that the review was seriously out of date already on the day it was published.
- The authors tell us that they applied no language restrictions. Yet they do not inform us how they handled papers in foreign languages.
- Studies of homeopathy as a stand alone therapy were included together with studies of homeopathy as an adjunct. Yet the authors fail to point out which studies belonged to which category.
- Several of the included studies are not of homeopathy but of isopathy.
- The authors fail to detail their results and instead refer to an ‘online results table’ which I cannot access even though I have the on-line paper.
- Instead, they report that 28 studies were included and ‘thus, the level of evidence was graded as A.’
- No direction of outcome was provided in the results section. All we do learn from the paper’s discussion section is that ‘the majority of the studies were positive, and the level of evidence could be graded as A (strong scientific evidence)’.
- Despite the high risk of bias in most of the included studies, the authors suggest a ‘definite role of homeopathy beyond placebo in the treatment of bronchial asthma’.
- The current Cochrane review (also authored by a pro-homeopathy team) concluded that there is not enough evidence to reliably assess the possible role of homeopathy in asthma. Yet the authors of this new review do not even attempt to explain the contradiction.
Confusion?
Incompetence?
Scientific misconduct?
Fraud?
YOU DECIDE!
Spinal manipulative therapy (SMT), especially hyperextension and rotation. have often been associated with cervical artery dissection (CAD), a tear in the internal carotid or the vertebral artery resulting in an intramural haematoma and/or an aneurysmal dilatation. But is the association causal? This question is often the subject of fierce discussions between chiropractors and the real doctors.
The lack of established causality relates to the chicken and egg discussion, i.e., whether the CAD symptoms lead the patient to seek cervical SMT or whether the cervical SMT provokes CAD along with the non-CAD presenting headache and/or neck complaint.
The aim of a new review was to provide an updated step-by-step risk-benefit assessment strategy regarding manual therapy and to provide tools for clinicians to exclude cervical artery dissection.
In light of the evidence provided, the reality, according to the review-authors, is:
- a) that there is no firm scientific basis for direct causality between cervical SMT and CAD;
- b) that the internal carotid artery (ICA) moves freely within the cervical pathway, while 74% of cervical SMTs are conducted in the lower cervical spine where the vertebral artery (VA) also moves freely;
- c) that active daily life consists of multiple cervical movements including rotations that do not trigger CAD, as is true for a range of physical activities;
- d) that a cervical manipulation and/or grade C cervical mobilization goes beyond the physiological limit but remains within the anatomical range, which theoretically means that the artery should not exceed failure strain.
These factors underscore the fact that no serious adverse event (AE) was reported in a large prospective national survey conducted in the UK that assessed all AEs in 28,807 chiropractic treatment consultations, which included 50,276 cervical spine manipulations.
The figure outlines a risk-benefit assessment strategy that should provide additional knowledge and improve the vigilance of all clinicians to enable them to exclude CAD, refer patients with suspected CAD to appropriate care, and consequently prevent CAD from progressing.
It has been argued that most patients present with at least two physical symptoms. The clinical characteristics and recommendations in the figure follow this assumption. This figure is intended to function as a knowledge base that should be implemented in preliminary screening and be part of good clinical practice. This knowledge base will likely contribute to sharpening the attention of the clinicians and alert them as to whether the presenting complaint, combined with a collection of warning signs listed in the figure, deviates from what he or she considers to be a usual musculoskeletal presentation.
Even though this is a seemingly thoughtful analysis, I think it omits at least two important points:
- The large prospective UK survey which included 50,276 cervical spine manipulations might be less convincing that it seems. It recorded about one order of magnitude less minor adverse effects of spinal manipulation than a multitude of previously published prospective surveys. The self-selected, relatively small group of participating chiropractors (32% of the total sample) were both experienced (67% been in practice for 5 or more years) and may not always have adhered to the protocol of the survey. Thus they may have employed their experience to intuitively select low-risk patients rather than including all consecutive cases, as the protocol prescribed. This hypothesis would firstly account for the unusually low rate of minor adverse effects, and secondly, it would explain why no serious complications occurred at all. Given that about 700 such complications are on record, the low incidence of serious adverse events could well be a gross underestimate.
- The effect of chiropractic spinal manipulative therapy is probably due to a placebo response. This means that it should probably not be done in the first place.
Whenever there are discussions about homeopathy (currently, they have reached fever-pitch both in France and in Germany), one subject is bound to emerge sooner or later: its cost. Some seemingly well-informed person will exclaim that USING MORE HOMEOPATHY WILL SAVE US ALL A LOT OF MONEY.
The statement is as predictable as it is wrong.
Of course, homeopathic remedies tend to cost, on average, less than conventional treatments. But that is beside the point. A car without an engine is also cheaper than one with an engine. Comparing the costs of items that are not comparable is nonsense.
What we need are proper analyses of cost-effectiveness. And these studies clearly fail to prove that homeopathy is a money-saver.
Even researchers who are well-known for their pro-homeopathy stance have published a systematic review of economic evaluations of homeopathy. They included 14 published assessments, and the more rigorous of these investigations did not show that homeopathy is cost-effective. The authors concluded that “although the identified evidence of the costs and potential benefits of homeopathy seemed promising, studies were highly heterogeneous and had several methodological weaknesses. It is therefore not possible to draw firm conclusions based on existing economic evaluations of homeopathy“.
Probably the most meaningful study in this area is an investigation by another pro-homeopathy research team. Here is its abstract:
OBJECTIVES:
This study aimed to provide a long-term cost comparison of patients using additional homeopathic treatment (homeopathy group) with patients using usual care (control group) over an observation period of 33 months.
METHODS:
Health claims data from a large statutory health insurance company were analysed from both the societal perspective (primary outcome) and from the statutory health insurance perspective (secondary outcome). To compare costs between patient groups, homeopathy and control patients were matched in a 1:1 ratio using propensity scores. Predictor variables for the propensity scores included health care costs and both medical and demographic variables. Health care costs were analysed using an analysis of covariance, adjusted for baseline costs, between groups both across diagnoses and for specific diagnoses over a period of 33 months. Specific diagnoses included depression, migraine, allergic rhinitis, asthma, atopic dermatitis, and headache.
RESULTS:
Data from 21,939 patients in the homeopathy group (67.4% females) and 21,861 patients in the control group (67.2% females) were analysed. Health care costs over the 33 months were 12,414 EUR [95% CI 12,022-12,805] in the homeopathy group and 10,428 EUR [95% CI 10,036-10,820] in the control group (p<0.0001). The largest cost differences were attributed to productivity losses (homeopathy: EUR 6,289 [6,118-6,460]; control: EUR 5,498 [5,326-5,670], p<0.0001) and outpatient costs (homeopathy: EUR 1,794 [1,770-1,818]; control: EUR 1,438 [1,414-1,462], p<0.0001). Although the costs of the two groups converged over time, cost differences remained over the full 33 months. For all diagnoses, homeopathy patients generated higher costs than control patients.
CONCLUSION:
The analysis showed that even when following-up over 33 months, there were still cost differences between groups, with higher costs in the homeopathy group.
A recent analysis confirms this situation. It concluded that patients who use homeopathy are more expensive to their health insurances than patients who do not use it. The German ‘Medical Tribune’ thus summarised the evidence correctly when stating that ‘Globuli are m0re expensive than conventional therapies’. This quote mirrors perfectly the situation in Switzerland which as been summarised as follows: ‘Globuli only cause unnecessary healthcare costs‘.
But homeopaths (perhaps understandably) seem reluctant to agree. They tend to come out with ever new arguments to defend the indefensible. They claim, for instance, that prescribing a homeopathic remedy to a patient would avoid giving her a conventional treatment that is not only more expensive but also has side-effects which would cause further expense to the system.
To some, this sounds perhaps reasonable (particularly, I fear, to some politicians), but it should not be reasonable argument for responsible healthcare professionals.
Why?
Because it could apply only to the practice of bad and unethical medicine: if a patient is ill and needs a medical treatment, she does certainly not need something that is ineffective, like homeopathy. If she is not ill and merely wants a placebo, she needs assurance, compassion, empathy, understanding and most certainly not an expensive and potentially harmful conventional therapy.
To employ the above analogy, if someone needs transport, she does not need a car without an engine!
So, whichever way we twist or turn it, the issue turns out to be quite simple:
WHITHOUT EFFECTIVENESS, THERE CAN BE NO COST-EFFECTIVENESS!
The aim of this systematic review was to determine the efficacy of conventional treatments plus acupuncture versus conventional treatments alone for asthma, using a meta-analysis of all published randomized clinical trials (RCTs).
The researchers included all RCTs in which adult and adolescent patients with asthma (age ≥12 years) were divided into conventional treatments plus acupuncture (A+B) and conventional treatments (B). Nine studies were included. The results showed that A+B could improve the symptom response rate and significantly decrease interleukin-6. However, indices of pulmonary function, including the forced expiratory volume in one second (FEV1) and FEV1/forced vital capacity (FVC) failed to be improved with A+B.
The authors concluded that conventional treatments plus acupuncture are associated with significant benefits for adult and adolescent patients with asthma. Therefore, we suggest the use of conventional treatments plus acupuncture for asthma patients.
I am thankful to the authors for confirming my finding that A+B must always be more/better than B alone (the 2nd sentence of their conclusion is, of course, utter nonsense, but I will leave this aside for today). Here is the short abstract of my 2008 article:
In this article, we test the hypothesis that randomized clinical trials of acupuncture for pain with certain design features (A + B versus B) are likely to generate false positive results. Based on electronic searches in six databases, 13 studies were found that met our inclusion criteria. They all suggested that acupuncture is effective (one only showing a positive trend, all others had significant results). We conclude that the ‘A + B versus B’ design is prone to false positive results and discuss the design features that might prevent or exacerbate this problem.
Even though our paper was on acupuncture for pain, it firmly established the principle that A+B is always more than B. Think of it in monetary terms: let’s say we both have $100; now someone gives me $10 more. Who has more cash? Not difficult, is it?
But why do SCAM-fans not get it?
Why do we see trial after trial and review after review ignoring this simple and obvious fact?
I suspect I know why: it is because the ‘A+B vs B’ study-design never generates a negative result!
But that’s cheating!
And isn’t cheating unethical?
My answer is YES!
(If you want to read a more detailed answer, please read our in-depth analysis here)
Here is the abstract of a paper that makes even the most senior assessor of quackery shudder:
Objective:
The purpose of this report is to describe the manipulation under anesthesia (MUA) treatment of 6 infants with newborn torticollis with a segmental dysfunction at C1/C2.
Clinical Features:
Six infants aged 4 1/2 to 15 months previously diagnosed with newborn torticollis were referred to a doctor of chiropractic owing to a failure to respond adequately to previous conservative therapies. Common physical findings were limited range of motion of the upper cervical spine. Radiographs demonstrated rotational malpositions and translation of atlas on axis in all 6 infants, and 1 had a subluxation of the C1/C2 articulation.
Interventions and Outcome:
Selection was based on complexity and variety of different clinical cases qualifying for MUA. Treatment consisted of 1 mobilization and was performed in the operating room of a children’s hospital by a certified chiropractic physician with the author assisting. Along with the chiropractor and his assistant, a children’s anesthesiologist, 1 to 2 operating nurses, a children’s radiologist, and in 1 case a pediatric surgeon were present. Before the mobilization, plain radiographs of the cervico-occipital area were taken. Three infants needed further investigation by a pediatric computed tomography scan of the area because of asymmetric bony conditions on the plain radiographs. Follow-up consultations at 2, 3, 5, or 6 weeks were done. Patient records were analyzed for restriction at baseline before MUA compared with after MUA treatment for active rotation, passive rotation, and passive rotation in full flexion of the upper cervical spine. All 3 measurements showed significant differences. The long-term outcome data was collected via phone calls to the parents at 6 to 72 months. The initial clinical improvements were maintained.
Conclusion:
These 6 infants with arthrogenic newborn torticollis, who did not respond to previous conservative treatment methods, responded to MUA.
___________________________________________________________________
After reading the full text, I see many very serious problems and questions with this paper; here are 14 of the most obvious ones.
1. A congenital torticollis (that’s essentially what these kids were suffering from) has a good prognosis and does not require such invasive treatments. There is thus no plausible reason to conduct a case series of this nature.
2. A retrospective case series does not allow conclusions about therapeutic effectiveness, yet in the article the author does just that.
3. The same applies to her conclusions about the safety of the interventions.
4. It is unclear how the 6 cases were selected; it seems possible or even likely that they are, in fact, 6 cases of many more treated over a long period of time.
5. If so, this paper is hardly a ‘retrospective case series’; at best it could be called a ‘best case series’.
6. The X-rays or CT scans are unnecessary and potentially harmful.
7. The anaesthesia is potentially very harmful and unjustifiable.
8. The outcome measure is unreliable, particularly if performed by the chiropractor who has a vested interest in generating a positive result.
9. The follow-up by telephone is inadequate.
10. The range of the follow-up period (6-72 months) is unacceptable.
11. The exact way in which informed consent was obtained is unclear. In particular, we would need to know whether the parents were fully informed about the futility of the treatment and its considerable risks.
12. The chiropractor who administered the treatments is not named. Why not?
13. Similarly, it is unclear why the other healthcare professionals involved in these treatments are not named as co-authors of the paper.
14. It is unclear whether ethical approval was obtained for these treatments.
The author seems inexperienced in publishing scientific articles; the present one is poorly written and badly constructed. A Medline research reveals that she has only one other publication to her name. So, perhaps one should not be too harsh in judging her. But what about her supervisors, the journal, its reviewers, its editor and the author’s institution? The author comes from the Department of Chiropractic Medicine, Medical Faculty University, Zurich, Switzerland. On their website, they state:
The Faculty of Medicine of the University of Zurich is committed to high quality teaching and continuing research-based education of students in health care professions. Excellent and internationally recognised scientists and clinically outstanding physicians are at the Faculty of Medicine devoted to patients and public health, to teaching, to the support of young researchers and to academic medicine. The interaction between research and teaching, and their connection to clinical practice play a central role for us…
The Faculty of Medicine of the University of Zurich promotes innovative research in the basic fields of medicine, in the clinical application of knowledge, in personalised medicine, in health care, and in the translational connection between all these research areas. In addition, it encourages the cooperation between primary care and specialised health care.
It seems that, with the above paper, the UZH must have made an exception. In my view, it is a clear case of scientific misconduct and child abuse.
I have just given two lectures on so-called alternative medicine (SCAM) in France.
Why should that be anything to write home about?
Perhaps it isn’t; but during the last 25 years I have been lecturing all over the world and, even though I live partly in France and speak the language, I never attended a single SCAM-conference there. I have tried for a long time to establish contact with French SCAM-researchers, but somehow this never happened.
Eventually, I came to the conclusion that, although the practice of SCAM is hugely popular in this country, there was no or very little SCAM-research in France. This conclusion seems to be confirmed by simple Medline searches. For instance, Medline lists just 171 papers for ‘homeopathy/France’ (homeopathy is much-used in France), while the figures for Germany and the UK are 490 and 448.
These are, of course, only very rough indicators, and therefore I was delighted to be invited to participate for the first time in a French SCAM-conference. It was well-organised, and I am most grateful to the organisers to have me. Actually, the meeting was about non-pharmacological treatments but the focus was clearly on SCAM. Here are a few impressions purely on the SCAM-elements of this conference.
TERMINOLOGY
Already the title of the conference, ‘Non-pharmacological Interventions: Integrative, Preventive, Complementary and Personalised Medicines‘, contained a confusing shopping-list of terms. The actual lectures offered even more. Clear definitions of these terms were not forthcoming and are, as far as I can see, impossible. This meant that much of the discussion lacked focus. In both my presentations, I used the term ‘alternative medicine’ and stressed that all such umbrella terms are fairly useless. In my view, it is therefore best to name the precise modality (acupuncture, osteopathy, homeopathy etc.) one wants to discuss.
INTEGRATIVE MEDICINE
The term that seemed to dominate the conference was ‘INTEGRATIVE MEDICINE’ (IM). I got the impression that it was employed uncritically by some for bypassing the need for proper evaluation of any specific SCAM. The experts seemed to imply that, because IM is the politically and socially correct approach, there is no longer a need for asking whether the treatments to be integrated actually generate more good than harm. I got the impression that most of these researchers were confusing science with promotion.
RESEARCH METHODOLOGY
The discussions regularly touched upon research methodology – but they did little more than lightly touch it. People tended to lament that ‘conventional research methodology’ was inadequate for assessing SCAM, and that we therefore needed different methods and even paradigms. I did not hear any reasonable explanations in what respect the ‘conventional methodology’ might be insufficient, nor did I understand the concept of an alternative science or paradigm. My caution that double standards in medicine can only be detrimental, seemed to irritate and fell mostly on deaf ears.
RESEARCH QUESTIONS
My own research agenda has always been the efficacy and safety of SCAM; and I still have no doubt that these are the issues that need addressing more urgently than any others. My impression was that, during this conference, the researchers seemed to aim in entirely different directions. One speaker even explained that, if a homeopath is fully convinced of the assumptions of homeopathy, he is entirely within the ethical standards to treat his patients homeopathically, regardless of the fact that homeopathy is demonstrably wrong. Another speaker claimed that there is no doubt any longer about the efficacy of acupuncture; the research question therefore must be how to best implement it in routine healthcare. And yet another expert tried to explain TCM with quantum physics. I have, of course, heard similar nonsense before during such conferences, but rarely did it pass without objection or debate.
RESEARCH FUNDING
The lack of research funding was bemoaned repeatedly. Most researchers seemed to think that they needed dedicated funding streams for SCAM to take account of the need of softer methodologies and the unique nature of SCAM. The argument that there should be only one set of standards for spending scarce research funds – scientific rigor and relevance – was not one shared by the French SCAM enthusiasts. The US example was frequently cited as the one that we ought to follow. In my view, the US example foremost shows impressively that a ring-fenced funding stream for SCAM is a wasteful mistake.
THE COLLEGE
To my surprise I learnt during a conference presentation that there is such a thing as the ‘Collège Universitaire de Médecines Intégratives et Complémentaires‘ (How could I have been unaware of it all those years? Why did I never see any of their published work? Why did they never contact me and cooperate?). Its president is Prof Jacques Kopferschmitt from the University of Strasbourg, and many French Universities are members of this organisation. Here is the abstract of Kopferschmitt’s lecture on the topic of this College:
The multitude of complementary therapies or non-pharmacological interventions (NPIs) first requires pedagogical semantic harmonization to bring down the historical tensions that persist. If users often remain very or too seduced, it is not the same with health professionals! Behind the words, there are concepts that disturb because between efficiency and efficiency the nuances are subtle. However, nothing really stands in the way of modern western medicine, but there are really gaps that we could fill in the face of the growing scale of chronic diseases, the prerogative of the Western world. The need for a university investment in verification, validation and certification is essential in the face of the diversity of offers. The main beneficiaries are health professionals who need to invest in an integrative approach, particularly in France. The CUMIC promotes a different vision of efficiency and effectiveness with a broader vision of multidisciplinary evaluation, which we will discuss the main targets.
Kopferschmitt is Professor of Medical Therapy, which introduced him to a pluralism of approach to health concerns, including innovative by the introduction of the CT in the first and second cycle of medical studies. He is responsible for the teaching of Acupuncture, Auriculotherapy and hypnosis clinic. He is vice President of the Groupe d’Évaluation des Thérapies complémentaires Personnalisées (GETCOP). By founding the association of complementary Therapies at the University hospitals of Strasbourg he coordinates the introduction, teaching and research in both in Hospital and in University, who was organized many seminars on CT. He currently chairs the French University of Integrative and Complementary Medicine College (CUMIC).
This sounded odd to me; however, it got truly bizarre after I looked up what SCAM-research Kopferschmitt or any of the other officers of the College have published. I could not find a single SCAM-article authored by him/them.
DIFFERENT PLANET
Altogether I found the conference enjoyable and was pleased to meet many interesting and very kind people. But I often felt like having arrived on a different planet. Many of the discussions, lectures, ideas, comments, etc. reminded me of 1993, the year I had arrived in the UK to start our research in SCAM. What is more, I fear that French experts involved in real science might feel the same about those colleagues who seem to engage themselves in SCAM research with more enthusiasm than expertise, scientific rigour or track record. The planet I had landed on was one where critical thinking was yet to be discovered, I felt.
ADVICE
Who am I to teach others what to do?
Yes, I do hesitate to give advice – but, after all, I have researched SCAM for 25 years and published more on the subject that any researcher on the planet; and I too was once more of a SCAM-enthusiast as is apparent today. So, for what it’s worth, here is some hopefully constructive advice that crossed my mind while driving home through the beautiful French landscape:
- Sort out the confusion in terminology and define your terms as accurately as you can.
- Try to focus on the research questions that are justifiably the most important ones for improving healthcare.
- Do not attempt to re-invent the wheel.
- Once you have identified a truly relevant research question, read up what has already been published on it.
- While doing this, differentiate between rigorous research and fluff that does not meet this criterion.
- Remember to abandon your own prejudices; research is about finding the truth and not about confirming your beliefs.
- Avoid double standards like the pest.
- Publish your research in top journals and avoid SCAM-journals that nobody outside SCAM takes seriously.
- If you do not have a track record of publishing articles in top journals, please do not pretend to be an expert.
- Involve sceptics in discussions and projects.
- Remember that criticism is a precondition of progress.
I sincerely hope that this advice is not taken the wrong way. I certainly do not mean to hurt anyone’s feelings. What I do want is foremost that my French colleagues don’t have to repeat all the mistakes we did in the UK and that they are able to make swift progress.
Dengue is a viral infection spread by mosquitoes; it is common in many parts of the world. The symptoms include fever, headache, muscle/joint pain and a red rash. The infection is usually mild and lasts about a week. In rare cases it can be more serious and even life threatening. There’s no specific treatment – except for homeopathy; at least this is what many homeopaths want us to believe.
This article reports the clinical outcomes of integrative homeopathic care in a hospital setting during a severe outbreak of dengue in New Delhi, India, during the period September to December 2015.
Based on preference, 138 patients received a homeopathic medicine along with usual care (H+UC), and 145 patients received usual care (UC) alone. Assessment of thrombocytopenia (platelet count < 100,000/mm3) was the main outcome measure. Kaplan-Meier analysis enabled comparison of the time taken to reach a platelet count of 100,000/mm3.
The results show a statistically significantly greater rise in platelet count on day 1 of follow-up in the H+UC group compared with UC alone. This trend persisted until day 5. The time taken to reach a platelet count of 100,000/mm3 was nearly 2 days earlier in the H+UC group compared with UC alone.
The authors concluded that these results suggest a positive role of adjuvant homeopathy in thrombocytopenia due to dengue. Randomized controlled trials may be conducted to obtain more insight into the comparative effectiveness of this integrative approach.
The design of the study is not able to control for placebo effects. Therefore, the question raised by this study is the following: can an objective parameter like the platelet count be influenced by placebo? The answer is clearly YES.
Why do researchers go to the trouble of conducting such a trial, while omitting both randomisation as well as placebo control? Without such design features the study lacks rigour and its results become meaningless? Why can researchers of Dengue fever run a trial without reporting symptomatic improvements? Could the answer to these questions perhaps be found in the fact that the authors are affiliated to the ‘Central Council for Research in Homoeopathy, New Delhi?
One could argue that this trial – yet another one published in the journal ‘Homeopathy’ – is a waste of resources and patients’ co-operation. Therefore, one might even argue, such a study might be seen as unethical. In any case, I would argue that this study is irrelevant nonsense that should have never seen the light of day.
Power Point therapy (PPT) is not what you might think it is; it is not related to a presentation using power point. Power According to the authors of the so far only study of PPT, it is based on the theories of classic acupuncture, neuromuscular reflexology, and systems theoretical approaches like biocybernetics. It has been developed after four decades of experience by Mr. Gerhard Egger, an Austrian therapist. Hundreds of massage and physiotherapists in Europe were trained to use it, and apply it currently in their practice. The treatment can be easily learned. It is taught by professional PPT therapists to students and patients for self-application in weekend courses, followed by advanced courses for specialists.
The core hypothesis of the PPT system is that various pain syndromes have its origin, among others, in a functional pelvic obliquity. This in turn leads to a static imbalance in the posture of the body. This may result in mechanical strain and possible spinal nerve irritation that may radiate and thus affect dermatomes, myotomes, enterotomes, sclerotomes, and neurotomes of one or more vertebra segments. Therefore, treating reflex zones for the pelvis would reduce and possibly resolve the functional obliquity, improve the statics, and thus cure the pain through improved function. In addition, reflex therapy might be beneficial also in patients with unknown causes of back pain. PPT uses blunt needle tips to apply pressure to specific reflex points on the nose, hand, and feet. PPT has been used for more than 10 years in treating patients with musculoskeletal problems, especially lower back pain.
Sounds more than a little weird?
Yes, I agree.
Perhaps we need some real evidence.
The aim of this RCT was to compare 10 units of PPT of 10 min each, with 10 units of standard physiotherapy of 30 min each. Outcomes were functional scores (Roland Morris Disability, Oswestry, McGill Pain Questionnaire, Linton-Halldén – primary outcome) and health-related quality of life (SF-36), as well as blinded assessments by clinicians (secondary outcome).
Eighty patients consented and were randomized, 41 to PPT, 39 to physiotherapy. Measurements were taken at baseline, after the first and after the last treatment (approximately 5 weeks after enrolment). Multivariate linear models of covariance showed significant effects of time and group and for the quality of life variables also a significant interaction of time by group. Clinician-documented variables showed significant differences at follow-up.
The authors concluded that both physiotherapy and PPT improve subacute low back pain significantly. PPT is likely more effective and should be studied further.
I was tempted to say ‘there is nothing fundamentally wrong with this study’. But then I hesitated and, on second thought, found a few things that do concern me:
- The theory on which PPT is based is not plausible (to put it mildly).
- It would have been easy to conduct a placebo-controlled trial of PPT. The authors justify their odd study design stating this: This was the very first randomized controlled trial of PPT. Therefore, the study has to be considered a pilot. For a pivotal study, a clearly defined primary outcome would have been essential. This was not possible, as no previous experience was able to suggest which outcome would be the best. In my view, this is utter nonsense. Defining the primary outcome of a back pain study is not rocket science; there are plenty of validated measures of pain.
- The study was funded by the Foundation of Natural Sciences and Technical Research in Vaduz, Liechtenstein. I cannot find such an organisation on the Internet.
- The senior author of this study is Prof H Walach who won the prestigious award for pseudoscientist of the year 2012.
- Walach provides no less than three affiliations, including the ‘Change Health Science Institute, Berlin, Germany’. I cannot find such an organisation on the Internet.
- The trial was published in a less than prestigious SCAM journal, ‘Forschende Komplementarmedizin‘ – its editor in-chief: Harald Walach.
So, in view of these concerns, I think PPT might not be nearly as promising as this study implies. Personally, I will wait for an independent replication of Walach’s findings.
As you can imagine, I get quite a lot of ‘fan-post’. Most of the correspondence amounts to personal attacks and insults which I usually discard. But some of these ‘love-letters’ are so remarkable in one way or another that I answer them. This short email was received on 20/3/19; it belongs to the latter category:
Dr Ernst,
You have been trashing homeopathy ad nauseum for so many years based on your limited understanding of it. You seem to know little more than that the remedies are so extremely dilute as to be impossibly effective in your opinion. Everybody knows this and has to confront their initial disbelief.
Why dont you get some direct understanding of homeopathy by doing a homeopathic proving of an unknown (to you) remedy? Only once was I able to convince a skeptic to take the challenge to do a homeopathic proving. He was amazed at all the new symptoms he experienced after taking the remedy repeatedly over several days.
Please have a similar bravery in your approach to homeopathy instead of basing your thoughts purely on your speculation on the subject, grounded in little understanding and no experience of it.
THIS IS HOW I RESPONDED
Dear Mr …
thank you for this email which I would like to answer as follows.
Your lines give the impression that you might not be familiar with the concept of critical analysis. In fact, you seem to confuse my criticism of homeopathy with ‘trashing it’. I strongly recommend you read up about critical analysis. No doubt you will then realise that it is a necessary and valuable process towards generating progress in healthcare and beyond.
You assume that I have limited understanding of homeopathy. In fact, I grew up with homeopathy, practised homeopathy as a young doctor, researched the subject for more than 25 years and published several books as well as over 100 peer-reviewed scientific papers about it. All of this, I have disclosed publicly, for instance, in my memoir which might interest you.
The challenge you mention has been taken by me and others many times. It cannot convince critical thinkers and, frankly, I am surprised that you found a sceptic who was convinced by what essentially amounts to little more than a party trick. But, as you seem to like challenges, I invite you to consider taking the challenge of the INH which even offers a sizable amount of money, in case you are successful.
Your final claim that my thoughts are based purely on speculation is almost farcically wrong. The truth is that sceptics try their very best to counter-balance the mostly weird speculations of homeopaths with scientific facts. I am sure that, once you have acquired the skills of critical thinking, you will do the same.
Best of luck.
Edzard Ernst
