MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

research

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It has been announced that Susan and Henry Samueli have given US$ 200 million to medical research at the University of California, Irvine (UCI). Surely this is a generous and most laudable gift! How could anyone doubt it?

As with any gift, one ought to ask what precisely it is for. If someone made a donation to research aimed at showing that climate change is a hoax, that white supremacy is justified, or that Brexit is going to give Brits their country back, I doubt that it would be a commendable thing. My point is that research must always be aimed at finding the truth and discovering facts. Research that is guided by creed, belief or misinformation is bound to be counter-productive, and a donation to such activities is likely to be detrimental.

Back to the Samuelis! The story goes that Susan once had a cold, took a homeopathic remedy, and subsequently the cold went away. Ever since, the two Samuelis have been supporters not just of homeopathy but all sorts of other alternative therapies. I have previously called this strikingly common phenomenon an ‘epiphany‘. And the Samuelis’ latest gift is clearly aimed at promoting alternative medicine in the US. We only need to look at what their other major donation in this area has achieved, and we can guess what is now going to happen at UCI. David Gorski has eloquently written about the UCI donation, and I will therefore not repeat the whole, sad story.

Instead I want to briefly comment on what, in my view, should happen, if a wealthy benefactor donates a large sum of money to medical research. How can one maximise the effects of such a donation? Which areas of research should one consider? I think the concept of prior probability can be put to good use in such a situation. If I were the donor, I would convene a panel of recognised experts and let them advise me where there are the greatest chances of generating important breakthroughs. If one followed this path, alternative medicine would not appear anywhere near the top preferences, I dare to predict.

But often, like in the case of the Samuelis, the donors have concrete ideas about the area of research they want to invest in. So, what could be done with a large sum in the field of alternative medicine? I believe that plenty of good could come it. All one needs to do is to make absolutely sure that a few safeguards are in place:

  • believers in alternative medicine must be kept out of any decisions processes;
  • people with a solid background in science and a track-record in critical thinking must be put in charge;
  • the influence of the donor on the direction of the research must be minimised as much as possible;
  • a research agenda must be defined that is meaningful and productive (this could include research into the risks of alternative therapies, the ethical standards in alternative medicine, the fallacious thinking of promoters of alternative medicine, the educational deficits of alternative practitioners, the wide-spread misinformation of the public about alternative medicine, etc., etc.)

Under all circumstances, one needs to avoid that the many pseudo-scientists who populate the field of alternative or integrative medicine get appointed. This, I fear, will not be an easy task. They will say that one needs experts who know all about the subtleties of acupuncture, homeopathy, energy-healing etc. But such notions are merely smoke-screens aimed at getting the believers into key positions. My advice is to vet all candidates using my concept of the ‘trustworthiness index’.

How can I be so sure? Because I have been there, and I have seen it all. I have researched this area for 25 years and published more about it than any of the untrustworthy believers. During this time I trained about 90 co-workers, and I have witnessed one thing over and over again: someone who starts out as a believer, will hardly ever become a decent scientist and therefore never produce any worthwhile research; but a good scientist will always be able to acquire the necessary knowledge in this or that alternative therapy to conduct rigorous and meaningful research.

So, how should the UCI spend the $ 200 million? Apparently the bulk of the money will be to appoint 15 faculty chairs across medicine, nursing, pharmacy and population health disciplines. They envisage that these posts will go to people with expertise in integrative medicine. This sounds extremely ominous to me. If this project is to be successful, these posts should go to scientists who are sceptical about alternative medicine and their main remit should be to rigorously test hypotheses. Remember: testing a hypothesis means trying everything to show that it is wrong. Only when all attempts to do so have failed can one assume that perhaps the hypothesis was correct.

My experience tells me that experts in integrative medicine are quite simply intellectually and emotionally incapable of making serious attempts showing that their beliefs are wrong. If the UCI does, in fact, appoint people with expertise in integrative medicine, it is, I fear, unavoidable that we will see:

  • research that fails to address relevant questions;
  • research that is of low quality;
  • promotion masquerading as research;
  • more and more misleading findings of the type we regularly discuss on this blog;
  • a further boost of the fallacious concept of integrative medicine;
  • a watering down of evidence-based medicine;
  • irreversible damage to the reputation of the UCI.

In a nutshell, instead of making progress, we will take decisive steps back towards the dark ages.

The UK ‘Faculty of Homeopathy’ (FoH) is the professional body of British doctors who specialise in homeopathy. As doctors, FoH members have been to medical school and should know about evidence, science etc., I had always thought. But perhaps I was mistaken?

The FoH has a website with an interesting new post entitled ‘Scientific evidence and Homeopathy’. Here I have copied the section on CLINICAL TRIALS OF HOMEOPATHY. I have read it several times and must admit: it is a masterpiece, in my view – not a masterpiece in accurate reporting, but a masterpiece in misleading the public. The first and most obvious thing that struck me is the fact that is cites not a single clinical trial. But read for yourself (the numbers in round brackets were inserted by me and refer to my comments below):

START OF QUOTE

By August 2017 1,138 clinical trials of homeopathy had been published (1). Details can be found on the CORE-HOM database also maintained by the Carstens Foundation and accessible without charge: http://archiv.carstens-stiftung.de/core-hom

Four (2) systematic review/meta-analyses of homeopathy for all conditions have been published.[26],[27],[28]  Of these, three (3) reached a positive conclusion: that there is evidence that homeopathy is clinically effective (4). The exception is the review by Shang et al.46  This meta-analysis was controversial, particularly because its conclusions were based on only eight clinical trials whose identity was concealed until several months after the publication, precluding informed examination of its results (5) (6). The only undisputed conclusion (7) of this paper is that clinical trials of homeopathy are of higher quality than matched trials of conventional medicine: of 110 clinical trials each of homeopathy and conventional medicine, 21 trials of homeopathy but only 9 trials of conventional medicine were of ‘higher quality’.[29] [30]

A leading Swedish medical researcher (8) remarked: To conclude that homeopathy lacks clinical effect, more than 90% of the available clinical trials had to be dis­regarded.  Alternatively, flawed statistical methods had to be applied.”[31] Higher quality equates to less risk of bias, Mathie et al analysed randomized clinical trials of individualized homeopathy, showing that the highest quality trials yielded positive results (9).[32]

Systematic reviews of randomized controlled trials of homeopathy in specific clinical situations have also yielded positive results, including: allergies and upper respiratory tract infections (2 systematic reviews),[33],[34] (10) (11) Arnica in knee surgery,[35] (12) Childhood diarrhoea,[36] Post-operative ileus,[37] (13) Rheumatic diseases,[38] (14) Seasonal allergic rhinitis (hay fever) (2 systematic reviews),[39] [40] (15) (16) and vertigo.[41] (17)

END OF QUOTE

MY COMMENTS:

  1. This is a wild exaggeration which was made possible by counting all sorts of clinical reports as ‘clinical trials’. A clinical trial  “follows a pre-defined plan or protocol to evaluate the effects of a medical or behavioral intervention on health outcomes.” This would exclude most observational studies, case series, case reports. However, the figure cited here includes such reports.
  2. The author cites only three!
  3. Does the author mean ‘two’?
  4. This is not quite true! I have dedicated an entire post to this issue.
  5. True, the Shang meta-analysis has been criticised – but exclusively by homeopaths who, for obvious reasons, were unable to accept its negative findings. In fact, it is a solid piece of research.
  6. Why does the author not mention the most recent systematic review of homeopathy?  Perhaps because 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.
  7. Really? Undisputed? Even by the logic of the author’s last sentence, this would be disputed.
  8. The ‘leading researcher’ is Prof Hahn who has featured many times on my blog. He seems to be more than a little unhinged when it comes to the topic of homeopathy.
  9. The author forgot to mention that Mathie – who was sponsored by the British Homeopathic Association – included this little caveat in his conclusions: The low or unclear overall quality of the evidence prompts caution in interpreting the findings.
  10. Reference 33 is the infamous ‘Swiss report’ that has been shown to be fatally flawed over and over again.
  11. Reference 34 refers to a review that fails to adhere to almost all the criteria of a systematic review.
  12. This review concluded: In all three trials, patients receiving homeopathic arnica showed a trend towards less postoperative swelling compared to patients receiving placebo. However, a significant difference in favour of homeopathic arnica was only found in the CLR trial. Only a deluded homeopath can call this a ‘positive result’.
  13. This is a systematic review by my team. It showed that several flawed trials produced a false positive result, while the only large multicentre trial was negative. Our conclusions therefore include the statement that  several caveats preclude a definitive judgment. Only a deluded homeopath can call this a ‘positive result’.
  14. This reference refers to the following abstract: Despite a growing interest in uncovering the basic mechanisms of arthritis, medical treatment remains symptomatic. Current medical treatments do not consistently halt the long-term progression of these diseases, and surgery may still be needed to restore mechanical function in large joints. Patients with rheumatic syndromes often seek alternative therapies, with homeopathy being one of the most frequent. Homeopathy is one of the most frequently used complementary therapies worldwide. Only a deluded homeopath can call this a ‘positive result’.
  15. The first reference refers to a paper where the author analysed three of his own studies.
  16. Reference 40 refers to a review that fails to adhere to almost all the criteria of a systematic review.
  17. This reference refers to a review of Vertigoheel@ that includes observational studies. One of its authors was an employee of the manufacturer of the product. Vertigoheel is not a homeopathic remedy (it does not adhere to the ‘like cures like’ principle) but a homotoxicologic product. Homotoxicology is a method inspired by homeopathy which was developed by Hans Heinrich Reckeweg (1905 – 1985). He believed that all or most illness is caused by an overload of toxins in the body. The toxins originate, according to Reckeweg, both from the environment and from the malfunction of physiological processes within the body. His treatment consists mainly in applying homeopathic remedies which usually consist of combinations of single remedies, because health cannot be achieved without ridding the body of toxins. The largest manufacturer and promoter of remedies used in homotoxicology is the German firm Heel. Our own systematic review of RCTs of homotoxicology included 7 trials which were mostly of a high methodological standard, according to the Jadad score. The trials tested the efficacy of seven different medicines for seven different indications. The results were positive in all but one study. Important flaws were found in all trials. These render the results of the primary studies less reliable than their high Jadad scores might suggest. Despite mostly positive findings and high ratings on the Jadad score, the placebo-controlled, randomised clinical trials of homotoxicology fail to demonstrate the efficacy of this therapeutic approach.

So!

What do we make of all this?

To say that it is disappointing would, I think, be an understatement. The FoH is not supposed to be a lobby group of amateurs ignorant of science and evidence; it is a recognised professional organisation who must behave ethically. Patients and consumers should be able to trust the FoH. The fact that the FoH publish misinformation on such a scale should, in my view, be a matter for the General Medical Council.

In my previous post, I reported that the NHS has included homeopathy and herbal medicine on the list of medications that might no longer get reimbursed. The news was reported by most newspapers in the UK. All of the papers correctly quote NHS England giving their reasons for black-listing homeopathy and herbal remedies. Some papers also quote critics of homeopathy providing short ‘sound bites’ and opinions. None of the articles bother to explain in any detail why homeopathy is so ridiculously implausible or how strong the evidence against it has become. In this post, I intend to analyse some of this press coverage by copying those excerpts from the newspaper articles which I find odd or misleading and by adding short comments by myself.

THE DAILY MAIL claimed that homeopathic remedies are treatments using heavily diluted forms of plants, herbs and minerals. This is factually incorrect; think of remedies like X-ray! The Mail also quoted Don Redding, director of policy at National Voices, stating: ‘Whilst some treatments are available to purchase over the counter, that does not mean that everyone can afford them. There will be distinct categories of people who rely on NHS funding for prescriptions of remedies that are otherwise available over the counter. Stopping such prescriptions would break with the principle of an NHS “free at the point of use” and would create a system where access to treatments is based on a person’s ability to pay.’  This argument might apply to medicines that are proven to work; it does, however, not apply to homeopathy.

THE INDEPENDENT cited Professor Helen Stokes-Lampard, chair of the Royal College of GPs, who said: “If patients are in a position that they can afford to buy over the counter medicines and products, then we would encourage them to do so rather than request a prescription – but imposing blanket policies on GPs, that don’t take into account demographic differences across the country, or that don’t allow for flexibility for a patient’s individual circumstances, risks alienating the most vulnerable in society.” Again, this argument might apply to medicines that are proven to work; it does, however, not apply to homeopathy.

THE DAILY TELEGRAPH also reported the quote from Don Redding, Director of Policy at National Voices which I cited above.

THE DAILY MIRROR quoted The Royal Pharmaceutical Society claiming that such a move raised “serious concerns” for poorer Brits. RPS England Board Chair Sandra Gidley said: “A blanket ban on prescribing of items available to buy will not improve individual quality of life or health outcomes in England. “Those on low incomes will be disproportionately affected.” THE MIRROR also reported what had to say and added that the NHS constitution states that: “Access to NHS services is based on clinical need, not an individual’s ability to pay; NHS services are free of charge, except in limited circumstances sanctioned by parliament.”

THE NEWS & STAR repeated the above quote from The Royal Pharmaceutical Society.

THE GUERNSEY PRESS repeated what RPS England board chair Sandra Gidley said: “We would encourage people with minor health problems to self-care with the support of a pharmacist and to buy medicines where appropriate and affordable to the individual. However, expecting everyone to pay for medicines for common conditions will further increase health inequalities and worsen the health of patients who cannot afford them. A blanket ban on prescribing of items available to buy will not improve individual quality of life or health outcomes in England. Those on low incomes will be disproportionately affected. They should not be denied treatment because of an inability to pay.”

THE TIMES also quoted the RPS and Don Redding misleadingly (see above and below) and concluded their article by citing Cristal Summer, chief executive of the British Homeopathic Association saying: Patients will be prescribed more expensive conventional drugs in place of homeopathy, which defeats the object of the exercise. The NHS also claims it wants to reduce the amount of prescription drugs patients take, then stops offering complementary therapies which can help achieve this. This clearly ignores the fact that ‘the object of the exercise’ for any health service must be to provide effective treatments and avoid placebo therapies like homeopathy. 

THE SUN quoted The Royal Pharmaceutical Society saying such a move raised “serious concerns” for poorer Brits. But it said banning NHS-funded homeopathy was long overdue. THE SUN continued by citing John O’Connell, Chief Executive of the TaxPayers’ Alliance: “The NHS are absolutely right to look at removing homeopathy from their approved prescription list and it’s astonishing that it hasn’t happened sooner.”

METRO pointed out that actress Gwyneth Paltrow, ex-Beatle Paul McCartney and world record sprinter Usain Bolt are all known to swear by homeopathic remedies.

Generally speaking, the newspaper coverage was not bad, in my view. The exception evidently is THE TIMES (see above). Several other articles also have a slight whiff of false balance, introducing seemingly rational counter-arguments where none exist. Even though the headlines invariably focus on homeopathy, some of the quotes used by the papers are clearly about other medicines black-listed. This seems particularly obvious with the quotes by the RPS. Many readers might thus be misled into thinking that there is opposition by reputable organisations to the ban on homeopathy. None of the articles that I read quoted a homeopath at the end saying something like  WE KNOW OF MANY PATIENTS WHOSE LIVES WERE SAVED BY HOMEOPATHY. JUST BECAUSE WE DON’T UNDERSTAND HOW IT WORKS DOES NOT MEAN IT DOES NOT WORK. A BAN WOULD PUT PUBLIC HEALTH AT RISK.

Only a few years ago, this type of conclusion to an article on homeopathy would have been inevitable! Could it be that UK journalists (with the exception of those at THE TIMES?) are slowly learning?

 

In my previous post, I mentioned the current volume of the ‘Allgemeinen Homöopathischen Zeitung’ which contains the abstracts of the ‘Homeopathic World Congress 2017’ (btw: the remarkable opening speech for the WORLD CONFERENCE ON HOMEOPATHY 1937, in Berlin might also be of interest; excerpts from it can be found here). Amongst these abstracts, the collector can find many true gems. Today I have for you a few more abstracts that I found remarkable; they are from what I call pre-clinical (or non-clinical) research.

Homeopathy has a polarized image. Many people experience homeopathic cure, but critics say this is only a placebo-effect. However, there, are 3800 studies and evidence is steadily growing. All comprehensive investigations prove that homeopathy is more efficient than placebo. What are the reasons for this controversy? How do we improve the image of homeopathy? Methods Data collection regarding effectiveness, benefits and mechanisms over 30 years. Order development to archive all data according to their scientific content. Systematic analysis of criticisms towards homeopathy over the last 12 years. Discussions with sceptics to understand their rejections. Findings Main reasons for controversy are: ▪ Since homeopathy does not meet the contemporary scientific concepts, people believe that homeopathy is implausible. ▪ Different homeopathic methods appear contradictory. ▪ Conventional medicine rejects homeopathy.  Missing overview regarding scientific principles. ▪ Modern studies are no more understandable. Due to our fast-moving times, people quickly form opinion with their own personal logic, influenced by media information. This causes a systematic interpretation bias. Results The knowledge of homeopathy and potentized remedies will be publicly illustrated: ▪ Information about different methods. ▪ Basics of holistic thinking and limitations of science in medicine. ▪ State of the art regarding effectiveness and benefits. ▪ Scientific principles and body of evidence. ▪ Correcting wrong media information. A special didactic structure was developed to provide this information at the portal: “Homeopathy & potentized medicines” (www.dellmour.org, available autumn 2016). Physicians and patients will find comprehensible information to aquire a plausible picture of homeopathy.

The use of agrochemicals has been associated with environmental and ecological damages. Excessive use of fertilizers, for example, can lead to the groundwater contamination with nitrate, rendering it unfit for consumption by humans or livestock. Water containing large concentrations of nitrate can poison animals by partial immobilization of the hemoglobin in blood, reducing the ability to transport oxygen. These and other environmental effects in the use of agrochemicals are unfortunate consequences in the application of these chemical tools. Researchers are constantly searching for non-chemical solutions in dealing with many of these agricultural needs. Much attention is being paid, for example, to developing “organic” methods of enhancing soil fertility and dealing with pests. The application of homeopathy in agriculture (agrohomeopathy) is an alternative that can help solve the problems caused by agrochemicals. Several countries have begun to implement this new option to solve the problems that have been caused by agrochemicals. The use of agrohomeopathy allows a control of diseases in plants, caused by bacteria, fungi, viruses and pests, it also helps to improve and promote seed germination, as well as by enhancing the growth of plants. Moreover, with the application of agrohomeopathy it is possible to decontaminate soils that have been exposed to agrochemical treatments. The goal of this study is to analyze the major results obtained in agrohomeopathy. Also we demonstrate the importance of botanical models to find out or clarify the mechanism of homeopathy in living organisms.

Dr. Hahnemann improvised homeopathy to such an extent, that his discovery of potentization of homeopathic medicines questioned the fundamental belief systems of the basic sciences. This resulted in a constant disapproval of homeopathic system by the main stream science and was accused as a placebo therapy, yet the clinical efficacy of homeopathy remained unquestionable. Objectives The present study was done to analyze the presence/absence of particles in aurum metallicum 6C to CM and carbo vegetabilis 6C to CM potencies. This is a part of the 31 homeopathic drugs studied by using HRTEM&EDS and FESEM&EDS in Centesimal scale 6C, 30, 200, 1M, 10M, 50M and CM and LM scale in LM1, LM6, LM12, LM18, LM24 and LM30 potencies. Method HRTEM (High Resolution Transmission Electron Microscope), FESEM (Field Emission Scanning Electron Microscope) and EDS (Energy dispersive Spectroscopy) were used for the analysis of samples. Results Plenty of particles in nanometer and Quantum Dots (QD – less than 10nm) scale were seen in aur. with presence of gold in all the potencies of aur. Enormous particles were identified in all the potencies of carb-v. in nanometer scale composed of carbon and oxygen. Conclusion The presence of NPs & QDs in all potencies must be the reason for the cure in diseases and also produce signs and symptoms in Hahnemannian drug proving. This discovery of NPS in all the drug potencies is an important evidence which substantiate the individualized drug selection and place homeopathy an established “individualized nanomedicine” with 200 years of collective clinical experience.

In March 2015, the Australian National Health and Medical Research Council (NHMRC) published an Information Paper on homeopathy. This document, designed for the general public, provides a summary of the findings of a review of systematic reviews, carried out by NHMRC to assess the evidence base for effectiveness of homeopathy in humans. ’The Australian report’, concludes that ”there are no health conditions for which there is reliable evidence that homeopathy is effective … no goodquality, well-designed studies with enough participants for a meaningful result reported either that homeopathy caused greater health improvements than placebo, or caused health improvements equal to those of another treatment”. Such overly-definitive negative conclusions are immediately surprising, being inconsistent with the majority of comprehensive systematic reviews on homeopathy. In-depth analysis has revealed the report’s multiple methodological flaws, which explain this inconsistency. Most crucially, NHMRC’s findings hinge primarily on their definition of reliable evidence: for a trial to be deemed ’reliable’ it had to have at least 150 participants and a quality score of 5/5 on the Jadad scale (or equivalent on other scales). Trials that failed to meet either of these criteria were dismissed as being of ’insufficient quality and/or size to warrant further consideration of their findings’. Setting such a high quality threshold is highly unusual, but the n=150 minimum sample size criterion is arbitrary, without scientific justification, and unprecedented in evidence reviews. Out of 176 trials NHMRC included in the homeopathy review, only 5 trials met their definition of ’reliable’, none of which, according to their analysis, demonstrated effectiveness of homeopathy. This explains why NHMRC concluded there is ’no reliable evidence’ that homeopathy is effective. A distillation of other detailed findings, presented at conference, reveals further significant flaws in this highly influential report, providing critical awareness of its misrepresentation of the homeopathy evidence base.

An extensive review of the literature dealing on the results obtained by homeopathy during epidemics has revealed important findings about the efficacy of homeopathic treatment. The main findings of this research are: ▪ With more than 25,000 volumes, the homeopathic literature is vast and rich in reports about results obtained by homeopathy during epidemics. The speaker has uncovered over 7,000 references addressing this subject. ▪ Results obtained by homeopathy during epidemics reveal a very important and clear constancy: a very low mortality rate. This constancy remains, regardless of the physician, time, place or type of epidemical disease, including diseases carrying a very high mortality rate, such as cholera, smallpox, diphtheria, typhoid fever, yellow fever and pneumonia. ▪ Interestingly, this low mortality rate is always superior to the results obtained not only by allopathy practiced at that particular time but, as a rule, by allopathy of today, despite benefiting from modern nursing and hygienic care. ▪ Even the lesser-trained homeopaths obtained, as a rule, better results than the highest authorities of the allopathic school. However, the most consistent, predictable and impressive results were obtained by the ones who practiced genuine homeopathy whom are known as Hahnemannians. ▪ Homeopathic remedies have been successfully used to protect large segments of the population from upcoming infectious diseases. Homeopathic prophylaxis is safe and effective combining inexpensive costs. ▪ The results obtained by homeopathy during epidemics cannot be explained by the placebo effect.

It is often considered that a physico-chemical explanation of homeopathy would require a major rewriting of much of physics, chemistry and biochemistry. Yet, despite the fact that the bio-activity of homeopathic dilutions appears to fly in the face of modern science, such an upheaval might not actually be necessary. The aim of this presentation is to demonstrate that we can indeed formulate a plausible and testable theory of homeopathy based on current physics and chemistry. We will start by going over the requirements made of an explanation of homeopathy, such as: memory of the starting substance, compatibility with the dilution/succussion process and finally bio-activity. We will then formulate a minimal set of physical assumptions able to explain the experimental results found in homeopathy. We will show how these assumptions are validated both from the theoretical physics and experimental physico-chemistry side. On the one hand we have, the theoretical predictions of Preparata and DelGuidice of the existence in water structures. These predict the formation of distinct water domains through the stabilising effect of electromagnetic oscillations. On the other hand, we will present a set of experiments from within and outside the field of homeopathy (Demangeat, Elia, Pollack and others). These experiments support the idea that water does form relatively stable structures under certain conditions and that these structures have electromagnetic properties, which could be at the root of the specific biological effects seen in clinical and animal studies. Thus we will show that it is possible to formulate a plausible physico-chemical explanation of homeopathy based on current physic and chemistry. Crucially this formulation is testable, providing important parameters and suggestions for the design of future experiments.

Hilarious, isn’t it? There are many sentences that are memorable treasures in these abstracts. One is almost tempted to book a ticket to Leipzig and listen to the presentations. I particularly love the following statements:

  • All comprehensive investigations prove that homeopathy is more efficient than placebo…
  • …the clinical efficacy of homeopathy remained unquestionable…
  • …overly-definitive negative conclusions are immediately surprising…
  • Homeopathic prophylaxis is safe and effective…
  • …we can indeed formulate a plausible and testable theory of homeopathy based on current physics and chemistry…

The naivety, ignorance and chutzpa that we observed in the abstracts of clinical studies is mirrored here very clearly.  I am therefore inclined to repeat the questions I asked in part 1 of this post: How can a scientific committee reviewing these abstracts let them pass and allow the material to be presented at the ‘World Congress’? How can a Health Secretary accept the patronage of such a farce?

The current volume of the ‘Allgemeinen Homöopathischen Zeitung’ contains all the abstracts of the ‘Homeopathic World Congress 2017’ which will be hosted in Leipzig, 14-17 July this year by the ‘Deutschen Zentralvereins Homöopathischer Ärzte’ under the patronage of the German Health Secretary, Annette Widmann-Mauz. As not many readers of this blog are likely to be regular readers of this important journal, I have copied six of the more amusing abstracts below:

A male patient with bilateral solid renal mass was investigated and given an individualized homeopathic remedy. Antimonium crudum in 50000 potency was selected after proper case taking and evaluation. Investigations were done before and after treatment. Follow ups took place monthly. Results The patient had symptomatic relief from pain in flanks, acute retention and hematuria. The ultrasonography suggests a reduction in size of both lesions over a period of two years. A small number of lymph nodes of the para-aortic group are still visible. There is a normal level of urea and creatinine, no anemia or hypertention. The patient is surviving since 2014. Conclusion In the present day when malignancies are treated with surgeries, chemo and radiotherapies, homeopathy has a significant role to play as seen in the above case. This case with bilateral solid renal mass, probably a renal cell carcinoma, received an individualized homeopathic remedy-treatment compliant with the totality of symptoms, and permitted the patient to live longer without anemia, hypertension, anorexia or weight loss. The quality of life was maintained without the side effects of surgery, radiotherapy and chemotherapy. Acute retentions, which he used to suffer also remained absent, thereafter. The result of this case suggests to take up further studies on individualized homeopathic treatment in malignant diseases.

Urinary tract infections (UTI) are often a complaint in the homeopathic practice, mainly as uncomplicated infections in the form of a one time event. Some patients, however, have a tendency to develop recurrent or complicated urinary tract infections. Methods It is shown on the basis of case documentation that UTI should be treated homeopathic, variably. The issue of prophylaxis will be discussed. Results If there is a tendency to complicated UTI, chronic treatment after case taking of the symptom-totality of the affected must take place during a free interval. In contrast, the chronically recurring and flaming up of UTI, as well as the uniquely occurring of uncomplicated UTI, are handled as an acute illness. The treatment is based on the striking, characteristic symptoms of the infected. Conclusion The homeopathic treatment of UTI in the acute case of uncomplicated forms is usually very successful, The chronic treatment of complicated UTI shows certain difficulties. A safe homeopathic prophylaxis, in terms of conventional medicine, is problematical.

The homeopathic clinic of the Municipal Public Servant Hospital of São Paulo (HSPM – Brazil) has among patient records some cases of thyroid gland diseases (hypothyroidism or hyperthyroidism), which were treated whith the systemic homeopathic method of Carillo. This study evaluates patients with diseases of thyroid gland, analyzing improvements using a Iodium-like equalizer, adjacent to the systemic medication. The reviewed 21 cases using Iodium equalizer for the disease, adjacent to the systemic medication, in the homeopathic clinic of the HSPM, from 2000 to 2013. In four cases, it was possible to reduce the dose of allopathic medicine and finally terminate it due to normalization of the thyroid gland function. There was one case of hyperthyroidism and it was possible to terminate the use of methimazole. There were four cases, in which the function of the thyroid gland was normalized without the associated use of hormone. In three cases it was possible to reduce the dose of hormone. There were nine cases, in which it was not possible to reduce the dose of the hormone. In cases where there was an improvement applying homeopathic treatment, TSH and free T4 returned to the normal reference value. In cases that were not effective, TSH and free T4 had not normalized. Therefore, the effectiveness of Iodium depends on the ability and stability of the gland thyroid to increase or decrease hormone production, in addition to the treatment of a chronic disease, that affects the thyroid gland.

Cystitis composes infections in the urinary system, especially bladder and urethra. It has multiple causes, but the most common is infection due to microorganisms such as E. coli, streptococcus, staphylococcus etc. If the system is attacked by pathogenetic agents, the defense must include more powerful noxious agents which can fight and destroy the attacking organisms, here is the role of nosodes. Nosodes are the potentised remedies made up from dangerous noxious materials. The use of nosodes in cystitis is based on the aphorism 26– Therapeutic Law of Nature: A weaker one is always distinguished by the stronger one! Colibacillinum, streptococcinum, staphylococcinum, lyssinum, medorrhinum, psorinum and tuberculinum are useful in handling cystitis relating to the organism involved [as found in urine test] and symptom similarity. Method An observational prospective study on a group of 30 people proves the immediate, stronger defensive action of nosodes. Result Amazing! Nosodes given in low potency provided instant relief to patients. Repetition of the same, over several months offered immunity for further attacks of cystitis, as Hering had already testified nosodes have prophylactic action. Conclusion According to law of similia – as per the pathology, as per the defense! By inducing a strong artificial disease, homeopathy can eliminate the natural disease from the body. Usually nosodes are used as intercurrent drugs which play the role of catalysts, on the journey to recovery, but they are also very effective in cystitis as an acute remedy. Acute cystitis is a very troublesome state for the patients, to cure it homeopathy has an arsenal of nosodes.

In 1991, no antiretroviral therapy (ART) treatment was available. The Central Council for Research in Homeopathy had established a clinical research unit at Mumbai for undertaking investigations in HIV/AIDS. So far 2502 cases have been enrolled for homeopathic treatment and three studies have been published since then. In this paper we will highlight the impact of long term homeopathic management of cases, which have been followed up for more than 15 years. Method The HIV positive cases enrolled in different studies are continuously being managed in this unit and even after study conclusion. All the cases are being treated solely with individualised homeopathy. The cases are assessed clinically (body weight, opportunistic infections, etc.) as well as in respect to CD4 counts and CD4/CD8 ratio. Results The CD4 count was maintained in all patients, except in one case. Three patients had the CD4 level in the range of 500–1200, four in the range of 300–500, one had a 272 CD4 count. There has been a decline of CD4/ CD8 ratio since baseline, but the patients have maintained their body weights and remained free from major HIV related illnesses and opportunistic infections. The frequently indicated remedies were pulsatilla pratensis, lycopodium clavatum, nux vomica,tuberculinum bovinum, natrum muriaticum, rhus toxicodendron, medorrhinum, arsenicum album, mercurius solubilis, thuja occidentalis, nitic acid, sulphur, bryonia alba and hepar sulph. Conclusion In the emergent scenario of drug resistance and adverse reactions of ART in HIV infections, there may be a possibility of employing homeopathy as an adjuvant therapy to existing standard ART treatment. Further studies are desirable.

In the last 20 years we have treated in the Clinica St. Croce many patients with cancer. We often deal with palliative states and we aim at pain relief and improvement of life-quality, and if possible a prolongation of life. Is this possible by prescribing a homeopathic therapy? Methodology The exact application and the knowledge of the responses to the Q-potencies often give indications for the correct choice of remedy. Acute conditions of pain often need a more frequent repetition of the C-potencies needed for pain relief. Results Even with severe pain or in so-called final stages homeopathy can offer great assistance. On the basis of case reports from Clinica St. Croce, the procedure for the homeopathic treatment of cancer, and the treatment of pain and final states will be illustrated and clarified. In addition, some clinically proven homeopathic remedies will be presented for the optimal palliation in the treatment of end-states and accompanying the dying. Conclusions With the precise application and knowledge of the responses to the Q- and C-potencies, the homeopathic doctor is given a wonderful helper to treat even the most serious palliative states and can accomplish, sometimes, a miraculous healing.

MY BRIEF COMMENT

These abstracts are truly hilarious and show how totally unaware some homeopaths are of the scientific method. I say ‘some’, but perhaps it is most or even all? How can a scientific committee reviewing these abstracts let them pass and allow the material to be presented at the ‘World Congress’? How can a Health Secretary accept the patronage of such a farce?

These abstracts are therefore not just hilarious but also truly depressing. If we had needed proof that homeopathy has no place in real healthcare of today, these abstracts would go a long way in providing it. To realise that politicians, physicians, patients, consumers, journalists etc. take such infantile nonsense seriously is not just depressing but at the same time worrying, I find.

Therapeutic Touch is a therapy mostly popular with nurses. We have discussed it before, for instance here, here, here and here. To call it implausible would be an understatement. But what does the clinical evidence tell us? Does it work?

This literature review by Iranian authors was aimed at critically evaluating the data from clinical trials examining the clinical efficacy of therapeutic touch as a supportive care modality in adult patients with cancer.

Four electronic databases were searched from the year 1990 to 2015 to locate potentially relevant peer-reviewed articles using the key words therapeutic touch, touch therapy, neoplasm, cancer, and CAM. Additionally, relevant journals and references of all the located articles were manually searched for other potentially relevant studies.

The number of 334 articles was found on the basis of the key words, of which 17 articles related to the clinical trial were examined in accordance with the objectives of the study. A total of 6 articles were in the final dataset in which several examples of the positive effects of healing touch on pain, nausea, anxiety and fatigue, and life quality and also on biochemical parameters were observed.

The authors concluded that, based on the results of this study, an affirmation can be made regarding the use of TT, as a non-invasive intervention for improving the health status in patients with cancer. Moreover, therapeutic touch was proved to be a useful strategy for adult patients with cancer.

This review is badly designed and poorly reported. Crucially, its conclusions are not credible. Contrary to what the authors stated when formulating their aims, the methods lack any attempt of critically evaluating the primary data.

A systematic review is more than a process of ‘pea counting’. It requires a rigorous assessment of the risk of bias of the included studies. If that crucial step is absent, the article is next to worthless and the review degenerates into a promotional excercise. Sadly, this is the case with the present review.

You may think that this is relatively trivial (“Who cares what a few feeble-minded nurses do?”), but I would disagree: if the medical literature continues to be polluted by such irresponsible trash, many people (nurses, journalists, healthcare decision makers, researchers) who may not be in a position to see the fatal flaws of such pseudo-reviews will arrive at the wrong conclusions and make wrong decisions. This will inevitably contribute to a hindrance of progress and, in certain circumstances, must endanger the well-being or even the life of vulnerable patients.

A recently published study was aimed at evaluating the efficacy and safety of potentized estrogen compared to placebo in homeopathic treatment of endometriosis-associated pelvic pain (EAPP). This 24-week, randomized, double-blind, placebo-controlled trial included 50 women aged 18-45 years old with diagnosis of deeply infiltrating endometriosis based on magnetic resonance imaging or transvaginal ultrasound after bowel preparation, and score≥5 on a visual analogue scale (VAS: range 0 to 10) for endometriosis-associated pelvic pain. Potentized estrogen (12cH, 18cH and 24cH) or placebo was administered twice daily. The primary outcome measure was change in the severity of EAPP global and partial scores (VAS) from baseline to week 24, determined as the difference in the mean score of five modalities of chronic pelvic pain (dysmenorrhea, deep dyspareunia, non-cyclic pelvic pain, cyclic bowel pain and/or cyclic urinary pain). The secondary outcome measures were mean score difference for quality of life assessed with SF-36 Health Survey Questionnaire, depression symptoms on Beck Depression Inventory (BDI), and anxiety symptoms on Beck Anxiety Inventory (BAI).

The EAPP global score (VAS: range 0 to 50) decreased by 12.82 in the group treated with potentized estrogen from baseline to week 24. Group that used potentized estrogen also exhibited partial score (VAS: range 0 to 10) reduction in three EAPP modalities: dysmenorrhea (3.28;), non-cyclic pelvic pain (2.71), and cyclic bowel pain (3.40). Placebo group did not show any significant changes in EAPP global or partial scores. In addition, the potentized estrogen group showed significant improvement in three of eight SF-36 domains (bodily pain, vitality and mental health) and depression symptoms (BDI). The placebo group showed no significant improvement in this regard. These results demonstrate superiority of potentized estrogen over placebo. Few adverse events were associated with potentized estrogen.

The authors concluded that potentized estrogen (12cH, 18cH and 24cH) at a dose of 3 drops twice daily for 24 weeks was significantly more effective than placebo for reducing endometriosis-associated pelvic pain.

The study is unusual in several ways. For instance, contrary to most trials of homeopathy, its protocol had been published in ‘Homeopathy’ in August 2016. Here is the abstract:

BACKGROUND:

Endometriosis is a chronic inflammatory disease that causes difficult-to-treat pelvic pain. Thus being, many patients seek help in complementary and alternative medicine, including homeopathy. The effectiveness of homeopathic treatment for endometriosis is controversial due to the lack of evidences in the literature. The aim of the present randomized controlled trial is to assess the efficacy of potentized estrogen compared to placebo in the treatment of chronic pelvic pain associated with endometriosis.

METHODS/DESIGN:

The present is a randomized, double-blind, placebo-controlled trial of a homeopathic medicine individualized according to program ‘New Homeopathic Medicines: use of modern drugs according to the principle of similitude’ (http://newhomeopathicmedicines.com). Women with endometriosis, chronic pelvic pain and a set of signs and symptoms similar to the adverse events caused by estrogen were recruited at the Endometriosis Unit of Division of Clinical Gynecology, Clinical Hospital, School of Medicine, University of São Paulo (Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo – HCFMUSP). The participants were selected based on the analysis of their medical records and the application of self-report structured questionnaires. A total of 50 women meeting the eligibility criteria will be randomly allocated to receive potentized estrogen or placebo. The primary clinical outcome measure will be severity of chronic pelvic pain. Statistical analysis will be performed on the intention-to-treat and per-protocol approaches comparing the effect of the homeopathic medicine versus placebo after 24 weeks of intervention.

DISCUSSION:

The present study was approved by the research ethics committee of HCFMUSP and the results are expected in 2016.

END OF QUOTE

As far as I can see, this study has no major flaws (I do not have access, however, to the full article). It seems to suggest that highly diluted homeopathic remedies are efficacious. I am aware of the fact that this will be difficult to accept for many readers of this blog.

So, what should we make of this new trial?

Should we recommend homeopathic estrogen to women suffering from endometriosis? I don’t think so. On the contrary, I recommend a healthy dose of scepticism. Clinical trials can produce false results sometimes by chance or through fraud. In any case, we hardly ever rely on the findings of a single study. The sensible course of action always is to wait for an independent replication (and, of course, study the full text of the paper).

 

One phenomenon that can be noted more frequently than any other in alternative medicine research is that studies arrive at wrong or misleading conclusions. This is more than a little disappointing, not least because it is the conclusion of a trial that is often picked up by health writers and others who in turn mislead the public. On this blog, we must have seen hundreds of examples of this irritating phenomenon. Here is yet another one. This study, a randomized, parallel, open-label exploratory trial, evaluated and compared the effects of systemic manual acupuncture, periauricular electroacupuncture and distal electroacupuncture for treating patients with tinnitus. It included patients who suffered from idiopathic tinnitus for more than two weeks were recruited. They were divided into three groups:

  1. systemic manual acupuncture group (MA),
  2. periauricular electroacupuncture group (PE),
  3. distal electroacupuncture group (DE).

Nine acupoints (TE 17, TE21, SI19, GB2, GB8, ST36, ST37, TE3 and TE9), two periauricular acupoints (TE17 and TE21), and four distal acupoints (TE3, TE9, ST36, and ST37) were selected. The treatment sessions were performed twice weekly for a total of 8 sessions over 4 weeks. Outcome measures were the tinnitus handicap inventory (THI) score and the loud and uncomfortable visual analogue scales (VAS). Demographic and clinical characteristics of all participants were compared between the groups upon admission using one-way analysis of variance (ANOVA). One-way ANOVA was used to evaluate the THI, VAS loud, and VAS uncomfortable scores. The least significant difference test was used as a post-hoc test. In total, 39 subjects were eligible for analysis. No differences in THI and VAS loudness scores were observed between groups. The VAS uncomfortable scores decreased significantly in MA and DE compared with those in PE. Within the group, all three treatments showed some effect on THI, VAS loudness scores and VAS uncomfortable scores after treatment except DE in THI. The authors concluded that there was no statistically significant difference between systemic manual acupuncture, periauricular electroacupuncture and distal electroacupuncture in tinnitus. However, all three treatments had some effect on tinnitus within the group before and after treatment. Systemic manual acupuncture and distal electroacupuncture have some effect on VAS. Neither of the three treatments tested in this study have been previously proven to work. Therefore, it is quite simply nonsensical to compare them. Comparative studies are indicated only with therapies that have a solid evidence-base. They are called ‘superiority trials’ and require a different statistical approach as well as much larger sample sizes. In other words, this study was an unethical waste of resources from the outset. With this in mind, there is only one conclusion that fits the data: there was no statistically significant difference between the three types of acupuncture. The data are therefore in keeping with the notion that all three are placebos. Alternatively one might conclude more clearly for those who are otherwise resistant to learning a lesson: POORLY DESIGNED CLINICAL TRIALS ARE UNETHICAL AND NEVER LEND THEMSELVES TO MEANINGFUL CONCLUSIONS.

One of the questions I hear frequently is ‘HOW CAN I BE SURE THIS STUDY IS SOUND’? Even though I have spent much of my professional life on this issue, I am invariably struggling to provide an answer. Firstly, because a comprehensive reply must inevitably have the size of a book, perhaps even several books. And secondly, to most lay people, the reply would be intensely boring, I am afraid.

Yet many readers of this blog evidently search for some guidance – so, let me try to provide a few indicators – indicators, not more!!! – as to what might signify a good and a poor clinical trial (other types of research would need different criteria).

INDICATORS SUGGESTIVE OF A GOOD CLINICAL TRIAL

  • Author from a respected institution.
  • Article published in a respected journal.
  • A clear research question.
  • Full description of the methods used such that an independent researcher could repeat the study.
  • Randomisation of study participants into experimental and control groups.
  • Use of a placebo in the control group where possible.
  • Blinding of patients.
  • Blinding of investigators, including clinicians administering the treatments.
  • Clear definition of a primary outcome measure.
  • Sufficiently large sample size demonstrated with a power calculation.
  • Adequate statistical analyses.
  • Clear presentation of the data such that an independent assessor can check them.
  • Understandable write-up of the entire study.
  • A discussion that puts the study into the context of all the important previous work in this area.
  • Self-critical analysis of the study design, conduct and interpretation of the results.
  • Cautious conclusion which are strictly based on the data presented.
  • Full disclosure of ethics approval and informed consent,
  • Full disclosure of funding sources.
  • Full disclosure of conflicts of interest.
  • List of references is up-to-date and includes also studies that contradict the authors’ findings.

I told you this would be boring! Not only that, but each bullet point is far too short to make real sense, and any full explanation would be even more boring to a lay person, I am sure.

What might be a little more fun is to list features of a clinical trial that might signify a poor study. So, let’s try that.

WARNIG SIGNALS INDICATING A POOR CLINICAL TRIAL

  • published in one of the many dodgy CAM journals (or in a book, blog or similar),
  • single author,
  • authors are known to be proponents of the treatment tested,
  • author has previously published only positive studies of the therapy in question (or member of my ‘ALT MED HALL OF FAME’),
  • lack of plausible rationale for the study,
  • lack of plausible rationale for the therapy that is being tested,
  • stated aim of the study is ‘to demonstrate the effectiveness of…’ (clinical trials are for testing, not demonstrating effectiveness or efficacy),
  • stated aim ‘to establish the effectiveness AND SAFETY of…’ (even large trials are usually far too small for establishing the safety of an intervention),
  • text full of mistakes, e. g. spelling, grammar, etc.
  • sample size is tiny,
  • pilot study reporting anything other than the feasibility of a definitive trial,
  • methods not described in sufficient detail,
  • mismatch between aim, method, and conclusions of the study,
  • results presented only as a graph (rather than figures which others can re-calculate),
  • statistical approach inadequate or not sufficiently detailed,
  • discussion without critical input,
  • lack of disclosures of ethics, funding or conflicts of interest,
  • conclusions which are not based on the results.

The problem here (as above) is that one would need to write at least an entire chapter on each point to render it comprehensible. Without further detailed explanations, the issues raised remain rather abstract or nebulous. Another problem is that both of the above lists are, of course, far from complete; they are merely an expression of my own experience in assessing clinical trials.

Despite these caveats, I hope that those readers who are not complete novices to the critical evaluation of clinical trials might be able to use my ‘warning signals’ as a form of check list that helps them to tell the chaff from the wheat.

The common cold is one of the indications for which homeopathy is deemed to be effective… by homeopaths that is! Non-homeopaths are understandably critical about this claim, not least because there is no good evidence for it. But, hold on, there is a new study which might change all this.

This study was recently published in COMPLEMENTARY THERAPIES IN MEDICINE which is supposed to be one of the better journals in this area. According to its authors, it was conducted “to determine if a homeopathic syrup was effective in treating cold symptoms in preschool children.” Children diagnosed with an upper respiratory tract infection were randomized to receive a commercial homeopathic cold syrup containing allium cepa 6X, hepar sulf calc 12X, natrum muriaticum 6X, phosphorous 12X, pulsatilla 6X, sulphur 12X, and hydrastasis 6X or placebo. Parents administered the study medication as needed for 3 days. The primary outcome was change in symptoms one hour after each dose. Parents also assessed the severity of each of the symptoms of runny nose, cough, congestion and sneezing at baseline and twice daily for 3 days, using a 4-point rating scale. A composite cold score was calculated by combining the values for each of the four symptoms. Among 261 eligible participants, data on 957 doses of study medication in 154 children were analyzed. There was no significant difference in improvement one hour after the dose for any symptom between the two groups. Analysis of twice daily data on the severity of cold symptoms compared to baseline values found that improvements in sneezing, cough and the composite cold score were significantly greater at both the first and second assessments among those receiving the cold syrup compared to placebo recipients.

The authors concluded that the homeopathic syrup appeared to be effective in reducing the severity of cold symptoms in the first day after beginning treatment.

Where to start? There are so many problems with this study that I find it difficult to chose the most crucial ones:

  • The study had a clearly defined primary endpoint; it was not affected by the homeopathic treatment which doubtlessly makes the study a negative trial. The only correct conclusion therefore is that THE HOMEOPATHIC SYRUP FAILED TO AFFECT THE PRIMARY OUTCOME MEASURE OF THIS STUDY. THEREFORE THE TRIAL DID NOT PRODUCE ANY EVIDENCE TO ASSUME THAT THE EXPERIMENTAL TREATMENT WAS EFFICACIOUS.
  • I don’t think that many of the primary or secondary outcome measures are validated or reliable.
  • All the positive results reported in the abstract and the article relate to secondary endpoints which are purely explanatory by nature. They should, in my view, not be mentioned in the conclusions at all.
  • The fact that some results turned out to be positive can be explained by the fact that the investigators ran dozens of tests for statistical significance which means that, by simple chance, some will turn out to produce a positive result.
  • A further explanation for the seemingly positive results might be the fact disclosed in the text of the article that the children in the homeopathy group received more conventional drugs than those in the placebo group.
  • Whatever the reason for these positive results, they certainly had nothing to do with the homeopathic syrup.
  • The study was funded by the company producing the syrup and for which one of the authors was employed as a consultant. This might be an explanation for the abominably poor science. In other words, this paper is not an exercise in testing a hypothesis but one in marketing.

While I might forgive the company for trying to maximise their sales figures, I do find it harder to forgive the authors, reviewers and editors for publishing such overtly false conclusions. In my view, they are all guilty of scientific misconduct.

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