Guest post by Norbert Aust, Udo Endruscheit, and Edzard Ernst
How do we know whether a treatment is reasonable or just some so-called alternative medicine (SCAM) that is at best useless? A simple answer is that the former is evidence-based, while the latter is not. But how can we tell the difference? High-quality studies, with independent replications or even a systematic review, are the sort of things we are usually looking for. But there is an underlying assumption, namely that, in science, bogus studies are prevented from polluting the scientific database or, if such trials have emerged, there are ways to identify and eliminate them.
And what if this assumption is wrong?
What if respectable universities and research organizations venture into the realm of pseudoscience either knowingly or because it had slipped their attention?
What if the editorial board of a top journal passes bogus studies to peer review?
What if such a paper is eventually reviewed by a proponent of the implausible therapy?
What if the readers of the article, once it is published, are too lethargic to object and do not write letters to the editor in protest?
And what if skeptics do formulate a protest but the journal editor refuses to publish it?
Well, if all the checks that should prevent faulty results from entering the scientific knowledge fail, we have fake evidence: a study that looks like sound science but that, in fact, is invalid. It is not hard to imagine what would happen if SCAM therapies are supported by seemingly respectable studies published in top journals. The fake evidence would accumulate as part of the body of evidence and eventually enter mainstream clinical practice, education, politics, etc., etc. Thus the reputation of bogus therapies would grow unjustifiably.
If you think this cannot happen, you are in the wrong. After the infamous study by Frass et al about homeopathy as an add-on treatment for lung cancer, another homeopathy paper was published in 2022 by Gaertner et al. in Pediatric Research (PR), a Medline-indexed journal with a two-year impact factor of 3.95 belonging to the nature-group of journals. According to this meta-analysis ‘individualized homeopathy showed a clinically relevant and statistically robust effect in the treatment of ADHD’. Shortly after the publication of this paper, we sent a letter to the editor to point out the shortcomings of this study. Here it is:
with this letter we like to comment on the systematic review and meta-analysis on childhood ADHD by Gaertner et al. recently published in your journal.
First off, we are surprised, that your journal that is connected to nature does publish a paper on a treatment that has no a-priory probability at all and thus can only contain false positives if any. And this review is no exception as will be seen presently.
Our concerns are:
Out of the six studies included three were mere pilot trials (Fibert_2019, Jacobs_2005, Oberai_2013, ) which cannot provide any evidence for the shortcomings involved in pilots. Three of the six trials show severe issues in blinding (Fibert_2016, Fibert_2019, Oberai_2013), with two of them concerning both of the participants and the test personnel. This usually leads to massive bias in favour of the treatment [Zitat Cochrane Handbook].
Then we compared data from two trials with the data reported in the review and found some major misrepresentations:
(1) Jacobs et al. report an improvement in the T-score of their main outcome (CGI-P) of 4.1 for homeopathy and 9.1 for controls, that is placebo outperformed the homeopathic intervention. But the authors give an effect size of 0.272 in favour of homeopathy which is the opposite of the findings in the trial.
(2) Oberai et al. report effect sizes for their three main outcomes of 0.22, 0.59 and 0.54 (CPRS-R, CGISS, CGIIS repectively). There is no way that this yields a pooled effect size of 1.436 as given in the review.
We conclude that the positive result obtained by the authors is due to a combination of the inclusion of biased trials unsuitable to build evidence together with some major misreporting of study outcomes.
Our recommendation would be that the authors reconsider their review and improve their report. Maybe the editors would like to add a caution-notice to the paper – if not to withdraw it completely.
In June 2023, a full year after our submission, we were informed that Pediatric Research would not publish our criticism because the priority given to it was not sufficient to justify publication. But we were assured, that the journal would take the matter seriously, that they will investigate this matter and take appropriate editorial action. But as of today (End of June 2023) no expression of concern has been published.
Did the journal receive other comments or criticisms related to the paper in question? No, apparently there were none, at least none was published and the paper remains unchallenged to this day. This means that it might be taken for reliable evidence on the effectiveness of homeopathy and mislead patients, carers, practitioners, decision-makers, etc.
We feel this is unacceptable and therefore again wrote to the editors asking to reconsider their decision. Here is our letter:
together with my co-authors we would like to comment your decision about our letter to the editor about an extremely faulty and misleading paper that may well create harm to patients. In fact we find it very hard to accept your decision not to publish our comment.
We understand that Pediatric Research is a high impact journal with a 2-year IF of nearly 4. Your journal is member of COPE and is indexed with quite a few first rank institutions. By all standards, any reader will be convinced that a paper published in Pediatric Research is based on solid research and the results are derived by rigorous methodology and are as reliable as can be. Especially if this paper remains unchallenged by any reader’s comments for a full year after publication. This is your responsibility to the scientific community. And to the children that might receive treatment based on knowledge spread through your journal.
How then can it be, that an article about homeopathy, a thoroughly implausible lore, in the treatment of ADHD is published in Pediatric Research, where the authors come to the conclusion “that individualized homeopathy showed a clinically relevant and statistically robust effect in the treatment of ADHD”?
In our comment we point out that the authors made a lot of errors – to say it mildly. They deny the doubtful quality of the studies they included in their meta-analysis, they did not stick to their own exclusion criteria, the data the authors report do not resemble the findings of the studies they were allegedly taken from, the one study setting the results is a mere pilot study.
The reason you give for our letter not being published is that it was not given enough priority to justify publication. We would like to know: Which issues can conceivably receive higher priority than the fact that a paper in your journal is downright wrong and misleading?
What do you need to deem a comment important? Up to now the paper is unchallenged by any reader’s comments, so apparently there was no other letter to the editor that might be given higher priority than ours.
We ask you to review your decision, or better still, consider a retraction of the paper altogether. If so, an expression of concern should be issued at once. After all, the COPE-guidelines for retraction state “clear evidence, that the findings are unreliable, either as a result of major error (…), or as a result of fabrication (…) or faslification (…)’ as a reason to consider retraction.
Otherwise the malpractice of homeopathy will have a first class evidence that will be helpful to promote homeopathy to parents and their children.
Watch this space!
It has been reported that a GP has been erased from the medical register after a disciplinary tribunal concluded yesterday that her statements on vaccines amounted to misconduct.
Dr Jayne Donegan, who no longer works as an NHS GP, was found by the tribunal to have ‘encouraged parents to mislead healthcare professionals about their children’s diet or immunization history’. The UK General Medical Council (GMC) brought several allegations against Dr Donegan, about statements made between 2019 and 2020, however, the determination of impaired fitness to practise (FTP) and subsequent erasure was based solely on her suggestions to parents.
The tribunal determined that her misconduct ‘posed an ongoing risk to patient safety given her lack of insight and lack of remediation’ and that ‘public confidence would be undermined’ if such a doctor was allowed to remain in practice. An immediate order of suspension was imposed, which the tribunal determined necessary for the ‘protection of the public’. Other GMC allegations, such as Dr. Donegan’s statements failing to ‘give balanced information on the risks and benefits of immunization’, were proved true by the tribunal but were not determined to be serious misconduct.
Dr. Donegan works as a homeopathic and naturopathic practitioner and has been ‘researching disease ecology and vaccination since 1994’, according to her website. The tribunal considered statements made by Dr. Donegan in a consultation with an undercover reporter and during her lectures on vaccination. She had said that the historical decline in deaths from whooping cough was because of sanitation and surgeons, not vaccinations. She had also suggested to audiences at her lectures that they could avoid answering questions from healthcare professionals about their child’s immunization history. When asked by an audience member about this, Dr. Donegan had said: ‘I thought what am I going to do because if I were you, I could just forge something but I can’t do that because I am a doctor and I would get struck off and I really would get struck off. What can I do? I thought maybe I can do something homeopathic because they are not having it. In the meantime, I wrote “Yes, I’ll get it done” thinking what will I do and they never came back to me, so when the next one went I just said “yes. The main thing is, don’t stick your head above the parapet because you make it difficult for them. If you say they are not vaccinated, they say they can’t go on the trip or they say “They could but the insurers won’t insure us”, so just keep saying “yes” but don’t say I said that.’
The tribunal concluded that comments like this made it clear Dr. Donegan was aware this was a ‘serious matter that could result in her being struck off’, despite her defense that she was simply ‘making people laugh’. The MPTS tribunal chair Mr Julian Weinberg said: ‘The Tribunal considered that honest and accurate communication of an individual’s medical history forms an essential part of ongoing patient healthcare and that any attempt to undermine this risks the safety of patients. It noted that whilst no dishonesty was found against Dr. Donegan, the Tribunal has found that she encouraged parents to be dishonest with healthcare professionals by, for example, forging medical documents/records, thereby undermined this essential quality of the doctor/patient relationship.’ Mr Weinberg highlighted that the tribunal’s findings did not concern ‘the rights or wrongs of her views on immunization’ but rather her encouragement to parents to mislead healthcare professionals.
Dr. Donegan said in response to the decision: ‘I boycotted the GMC’s political show trial against me which ended today. Serious irregularities include bogus dishonesty charges and bogus accusations that I put newborns at risk of serious harm.’ She added: ‘Being struck off by a corrupt GMC is a small price to pay for taking a lawful ethical stand for the safety of British children.’
Apparently, Dr. Donegan even claimed that she is delighted to be struck off the register of medical practitioners – and so, I presume, are many of us reading this post!
This article by a Postgraduate Trainee (Dept. of Case Taking and Repertory, National Institute of Homoeopathy, Govt. of India) an Assistant Professor (Dept. of Surgery, National Institute of Homoeopathy Govt. of India) and another Assistant Professor (Dept. of Obstetrics & Gynaecology, Midnapore Homoeopathic Medical College & Hospital, Govt. of West Bengal) might not be available online (Clinical Medicine and Health Research Journal, Volume 03, Issue 03, May – June 2023 Page No. 444-446) but it is I think worth discussing. Here is its abstract:
Warts are one of the common dermatological disorders caused by human papilloma viruses encountered in our day to day life. These are cutaneous or mucosal infection needs proper care and treatment to prevent its transmission and complete healing. Although mostly warts are dealt with the therapeutic approach, i.e. on the basis of its peculiar type and location but it can even be successfully treated by constitutional approach. This article is regarding a case of warts treated successfully with Rhus Tox followed by Ferrum Met selected as the simillimum and proved its effectiveness in a short period of time.
As the abstract is not very informative, let me show you also some sections from the paper itself:
The patient presented with warts on right wrist for 1 year. There were plane warts at back of wrist, which was smooth, slightly elevated and skin coloured. There was no history of warts or other benign skin disease in the family. This case treated with individualized homoeopathic medicine showed complete resolution of the warts. There is no cure for wart in conventional medicine except removal of them with various methods. Although it does not rule out the chance of recurrence, later on may deep organic disease. That is why a substantial number of warts patients resort to Complementary and Alternative Medicine (CAM), especially homoeopathy.
In this case, Ferrum Metallicum 0/1 was selected as a ‘similimum’ based on totality of symptoms, repertorial analysis and consultation with Homoeopathic Materia Medica, which was given more priority in this case. After seeing improvement, succeeding potency was prescribed. After Ferrum Met 0/4 all her complaints including warts disappeared. Thus, the outcome of this case of Plane Warts of the lady shows the success of individualized homoeopathic medicine in treatment of wart.
This case report suggests homoeopathic treatment as a promising complementary or alternative therapy and emphasizes the need of repertorisation in individualized homoeopathic prescription. This case shows a positive role of homoeopathic in treating Warts. However, this is a single case study and requires well designed studies which may be taken up for future scientific validation.
This case report reminded me of an exciting and quite lovely story: at Exeter, we once conducted a wart study. It was a placebo-controlled, double-blind trial where the verum group received distant healing and the controls nothing at all. After planning the study, I was no longer involved in its running. As I happened to have a wart at the time, I offered myself to my team as a patient. They checked me out and admitted me into the study. For the next weeks, I either received the distant healing energy or nothing; neither I nor my team knew which. My wart was photographed and measured regularly.
And then it happened: shortly after the treatment period was over, my wart had gone. Everyone was excited, especially the UK healing scene. But we had to wait until the trial was finished, the results were calculated, and the random code was opened. The result: no difference between verum and placebo! We concluded that distant healing from experienced healers had no effect on the number or size of patients’ warts.
And my own, very personal wart?
It had disappeared spontaneously – I had been in the control group!
I know Indian homeopaths have a thing about healing warts (we discussed this before) but I am afraid the conclusions of this new paper ought to be re-written:
This case report does not suggest that homeopathic treatment is a promising complementary or alternative therapy. It shows the natural history of the condition in the disappearance of warts.
At first glance, the article entitled ‘Homeopathy: A State of the Science Review With Recommendations for Practical Therapies in Midwifery Practice‘ looks interesting and fairly solid; it was published in a mainstream, peer-reviewed midwifery journal; it is lengthy and thus seems thorough; it cites 125 references; and its two American authors have respectable affiliations (Art of Nursing Care Inc., Playa del Ray, California. Sonoran University of Health Sciences, Tempe, Arizona.). Yet, it does not take long to discover that ‘solid’ is not the term to describe it accurately. In fact, the paper is one of the worst examples of pseudo-science that I have ever come across. Let me just show you its conclusions:
This state of the science review has explored the history of homeopathy, its evidence base, manufacturing, regulation, and licensure. We have examined some of the controversies between homeopathy and conventional medicine in an effort to provide an overview and understanding of homeopathic science. Suggestions for practical therapies for use in midwifery practice have been given.
Despite misperceptions, homeopathy has become a well-established global practice with a growing body of research to support its benefits. Homeopathic medicines provide a comprehensive treatment approach to the myriad of conditions encountered in the midwifery practice model of care. With homeopathy’s generally accepted safety profile, low risk of side effects, few drug interactions, and low risk of overdose, midwives educated in homeopathic science can be confident that homeopathy provides a satisfactory complement for patients seeking alternative practices.
Increased opportunities for clinical research of homeopathic medicines by large funding organizations is recommended to advance patient care, understanding, and acceptance of the whole person and inform future health policy. Researchers around the world have begun to investigate the unanswered questions verifying the safety and efficacy of homeopathic treatment and the future of homeopathic research is promising. As homeopathic science continues to evolve, many health care professionals, including midwives, now seem open to adding homeopathy to complement their system of care for the whole person.
In the article, we find two short paragraphs dealing with the effectiveness of homeopathy:
Essential to these debates are questions surrounding theories of homeopathy, such as the Law of Minimum Dose, like cures like, nonstandardized dosing, and symptom evaluation in a manner different from that of conventional medicine. It has been argued that the homeopathic paradigm is different from conventional scientific concepts associated with evidence-based medicine such as independent replication, confirmation of findings, measurement, and interpretation of results based on homeopathy’s reliance on individualized treatments and it basic tenets of the Principle of Similars and Law of Minimum Dose.69, 68 Conventional medicine practitioners find it counterintuitive that further dilution of a substance is believed to enhance its healing power when compared with a less dilute substance.65 For example, if the level of dilution is unmeasurable, how can the active ingredient be found, and is it even there?22 Recent research using nanopharmacology is beginning to uncover, identify, and characterize these ingredients in ultradiluted remedies and may help to answer these questions.39, 70 Debates arise concerning why individuals with similar symptoms often receive different treatments.22 Others ask whether homeopathic remedies perhaps inadvertently lead consumers to forgo conventional treatments that have been proven to work.5, 21, 22, 65
Interestingly, studies examining placebo therapies have appeared in scientific literature with increasing frequency, and some have compared the effectiveness of placebos with homeopathic remedies.68, 71–73 Multiple studies that have examined homeopathic treatments have found them equivalent to or no more effective than placebo,65, 68 whereas other studies found either measurable success or that patients perceived their outcomes as improved following homeopathic treatment.26, 75, 74 Mathie et al conducted a systematic review and meta-analysis focused on randomized controlled trials of nonindividualized homeopathic treatments. Authors reported that the quality of evidence was too low to determine whether homeopathic treatment results were distinguishable from those of placebo.72 These issues cited above represent some of the inconsistencies surrounding the theoretical basis and effectiveness of homeopathic therapies.
WHY WOULD ANY RESPECTABLE AUTHOR WRITE SUCH MISLEADING NONSENSE?
WHY WOULD ANY RESPECTABLE JOURNAL PUBLISH IT?
The answers to these questions might be found at the end of the paper:
Support for this supplement has been provided by Boiron USA. Boiron representatives provided no input into the article content.
Sharon Bond, CNM, PhD, who was an Associate Editor of the Journal of Midwifery & Women’s Health during the initial drafting of the manuscript, received compensation from Boiron USA for the assistance she provided the authors with editing and proofreading of the manuscript. Dr. Bond was not involved in the editorial review of or decision to publish this article.
The findings and conclusions in this supplement are those of the authors and do not necessarily reflect the official position of the host organizations, the American College of Nurse-Midwives, John Wiley & Sons, Inc., or the opinions of the journal editors.
I would argue that publishing such an article is unethical and amounts to scientific misconduct!
The COVID-19 pandemic has posed an unprecedented challenge to global health. Classical homeopathy may, according to homeopaths, have a role to play in alleviating this burden. The objective of this study was to curate data on the treatment effect of classical homeopathy for COVID-19 in a real-world scenario to guide future scientific investigations.
Classical homeopaths from the International Academy of Classical Homeopathy (IACH) were asked to provide details on cases they treated by filling out a standardized questionnaire. COVID-19 cases were defined according to World Health Organization (WHO) criteria as suspected/probable/confirmed cases, with intervention provided being either stand-alone classical homeopathy or combined with conventional therapy for COVID-19. Cases were followed up with main outcomes being ‘improved’, ‘not improved’, or ‘progressed’ post-treatment. Details of the homeopathic remedies used and the main symptoms at the presentation were gathered. Factors associated with main outcomes were investigated with correlational and regression analyses.
367 patients (male 166, female 201) met eligibility criteria (mean age 42.75 years). The mean follow-up period was 6.5 (standard deviation, SD=5.3) days. 255 were confirmed COVID-19 cases, with 61 probable and 51 suspected cases, respectively. The most used remedy was Arsenicum album. Over 73% of COVID-19 patients (and about 79% of severe cases) improved under classical homeopathic treatment. The number of remedies required per individual was negatively correlated to improvement (P< 0.01). Fever, the most common symptom at presentation (74.4%), was associated with an increased likelihood of improvement (P<0.01). Improvement was negatively associated with advanced age, but not associated with sex (P<0.01).
The authors conclude that this study suggests that classical homeopathy was associated with improvement in COVID-19, including severe cases. Despite limitations from study design and data sources, our findings should prompt further studies on the role of classical homeopathy in the management of COVID-19.
I BEG TO DIFFER!
These cases suggest nothing of the sort. If anything, these highly selected cases suggest that about 27% of the exemplary patients did not improve, perhaps they even died. This implies to me that classical homeopathy worsens the prognosis of patients infected with COVID-19.
The ‘International Academy of Classical Homeopathy‘ is led by the ‘Ueber-Homeopath’, George Vithoulkas. His vision is that this Academy will become a center of real knowledge which will provide an education that will far exceed the technical and strictly “medical” aspect of one’s learning. One might ask what fanatics like he truly want to achieve – is it perhaps the promotion of ‘euthanasia homoeopathica’?
I have to admit that I do not regularly read the DMZ, a German paper. In fact, until a minute ago, I did not know it existed. Nor do I know Anton Aeberhard. I saw his DMZ homeopathy article on the Internet and find it excellent; so much so that I translated parts of it for you:
… Because this pseudoscience is considered by some people to be an effective alternative to conventional medicine, it is important to understand the potential dangers and risks of homeopathy…
Homeopathy is based on the principle of the rule of similars and extreme dilution of substances. However, there is no scientific evidence that homeopathic remedies have any therapeutic effect beyond the placebo effect. Most studies that purport to show efficacy are methodologically flawed. Homeopathy contradicts fundamental principles of biology, chemistry, and physics. It is therefore irresponsible to consider this practice a legitimate medical treatment.
One of the greatest and real dangers of homeopathy is that it can cause people to refuse or delay effective medical treatments. By believing in homeopathic remedies, life-threatening conditions such as cancer, heart disease, or infections may not be treated appropriately. This can lead to worsening health conditions and increase the risk of complications or even death…
Homeopathy is a pseudoscientific practice based on outdated principles and a lack of scientific evidence. The dangers of this practice should not be underestimated. It can cause people to reject or delay effective medical treatments, which can endanger their health and lives. It is important to make informed decisions about health care and to rely on evidence-based medicine to provide the best possible treatment and care.
Homeopathy is a joke.
Thank you Anton Aeberhard!
It is not often that we find a journalist who has the courage to defy the demand for ‘balance’. In the case of clear nonsensical issues, this demand becomes a demand for misleading people, a demand for FALSE balance!
When a journalist writes about the planet, he does not require a representative of the FLAT EARTH SOCIETY to add his views. Similarly, when someone writes about homeopathy, there is no need to interview the chair of a homeopaths’ association saying: “But we have 200 years of experience and we therefore know it works…”
Psoriasis is a chronic inflammatory skin disorder, affecting the trunk and extensor surfaces of limbs and scalp predominantly. Its prevalence ranges between 0.1 and 11.4% and in India between 0.4 and 2.8%. Psoriasis remains a frequently encountered condition in homeopathy practice, but there is a dearth of evidence supporting its use.
This 6-month, double-blind, randomized trial was conducted on 51 patients suffering from psoriasis at the National Institute of Homoeopathy, India. Patients were randomized to receive either individualized homeopathic medicines (IHMs; n = 25) in LM potencies or identical-looking placebos (n=26). Psoriasis area and severity index (PASI; primary), psoriasis disability index (PDI), and dermatological life quality index (DLQI; secondary) were measured at baseline, and every 2 months, up to 6 months. The intention-to-treat sample was analyzed using a two-way repeated measure analysis of variance.
Although intra-group changes were significant in both groups, improvements were significantly greater in the IHMs group than in the placebo group regarding the PASI scores after 6 months (F1, 49 = 10.448, P = 0.002). DLQI daily activity subscale scores also yielded similar significant results favoring IHMs against placebos after 6 months (F1, 49 = 5.480, P = 0.023). Improvement in PDI total (F1, 49 = 0.063, P = 0.803), DLQI total (F1, 49 = 1.371, P = 0.247), and all remaining subscales were higher in the IHMs group than placebos after 6 months, but non-significant statistically. Calcarea carbonica, Mercurius solubilis, Arsenicum album, and Petroleum were the most frequently prescribed medicines.
The authors concluded that IHMs exhibited better results than placebos in the treatment of psoriasis. Further research is warranted.
- Psoriasis is a genetically determined condition, and I find it hard to believe that homeopathy can change its natural history.
- The symptoms of psoriasis fluctuate and can be influenced by a range of factors, including stress.
- We learn nothing about any concomitant interventions which are always necessary, e.g. creams, or compliance with them.
- It is conceivable that patients in the verum group received inadvertent reassurance which, in turn, reduced stress and improved compliance with external treatments.
- It is unclear whether patients were successfully blinded or whether inadvertent de-blinding occurred.
In any case, I would caution that this trial needs independent replications before we can take its findings seriously.
Thanks to several readers, I now have the full text and can add the following points:
- The authors report adverse events as follows: ” No adverse events were reported during the treatment period from either group that could be attributed causally to either IHMs or placebos. Some minor events unrelated to study medications, like common cold and injury occurring in both groups were treated with acute homeopathic medicines irrespective of allocated codes, and once those acute phases were over, the patients were returned to originally allocated groups again.” This is odd because homeopaths would expect aggravations in a high percentage of cases.
- I am not sure that I understand the blinding procedure; it is described as follows: “Double-blinding method was adopted by masking the trial participants, investigators, outcome assessors, pharmacists, and data entry operators throughout the trial. Identical-looking vials were coded as either “1” or “2” and contained either medicines or placebos. The codes remained the same for all the randomized participants. Codes were assigned randomly and confidentially by another independent third party. Both medicines and placebos were repacked in identical glass bottles and labeled with code, name of medicine, and potency, and were dispensed according to the random number list. The vials were destined for each patient by the random number chart. The participants got the medicines dispensed personally at the hospital pharmacy. Codes were broken at the end of the trial after the dataset was frozen.”
- The affiliations of the authors are interesting:1 Dept. of Materia Medica, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Block GE, Sector 3, Salt Lake, Kolkata 700106, West Bengal, India; affiliated to The West Bengal University of Health Sciences, Govt. of West Bengal, India
2 Dept. of Repertory, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Block GE,
Sector 3, Salt Lake, Kolkata 700106, West Bengal, India; affiliated to The West Bengal University of
Health Sciences, Govt. of West Bengal, India 3 Dept. of Repertory, The Calcutta Homoeopathic Medical College and Hospital, Govt. of West Bengal, 265, 266, Acharya Prafulla Chandra Road, Kolkata 700009, West Bengal; affiliated to The West Bengal University of Health Sciences, Govt. of West Bengal, India
4 East Bishnupur State Homoeopathic Dispensary, Chandi Daulatabad Block Primary Health Centre,
Village and Post Office: Dakshin Gouripur, Police Station Bishnupur, South 24 Parganas 743503, West
Bengal, under Department of Health & Family Welfare, Govt. of West Bengal, India 5 Dept. of Repertory, D. N. De Homoeopathic Medical College and Hospital, Govt. of West Bengal, 12, Gobinda Khatick Road, Tangra, Kolkata 700046, West Bengal; affiliated to The West Bengal University
of Health Sciences, Govt. of West Bengal, India.
I think it is safe to repeat that independent replications would be essential.
Menopausal symptoms are systemic symptoms that are associated with estrogen deficiency after menopause. Although widely practiced, homeopathy remains under-researched in menopausal syndrome in terms of quality evidence, especially in randomized trials. The efficacy of individualized homeopathic medicines (IHMs) was evaluated in this double-blind, randomized, placebo-controlled trial in the treatment of the menopausal syndrome.
Group 1 (n = 30) received IHMs plus concomitant care, while group 2 (n = 30) had placebos plus concomitant care. The primary outcome measures were the Greene Climacteric Scale (GCS) total score and the menopause rating scale (MRS) total score. The secondary endpoint was the Utian quality of life (UQOL) total score. Measurements were taken at baseline and every month up to 3 months.
Intention-to-treat sample (n = 60) was analyzed. Group differences were examined by two-way (split-half) repeated-measure analysis of variance, primarily taking into account all the estimates measured at monthly intervals, and secondarily, by unpaired t-tests comparing the estimates obtained individually every month. The level of significance was set at p < 0.025 two-tailed. Between-group differences were nonsignificant statistically—GCS total score (F1, 58 = 1.372, p = 0.246), MRS total score (F1, 58 = 0.720, p = 0.4), and UQOL total scores (F1, 58 = 2.903, p = 0.094). Some of the subscales preferred IHMs significantly against placebos—for example, MRS somatic subscale (F1, 56 = 0.466, p < 0.001), UQOL occupational subscale (F1, 58 = 4.865, p = 0.031), and UQOL health subscale (F1, 58 = 4.971, p = 0.030). Sulfur and Sepia succus were the most frequently prescribed medicines. No harm or serious adverse events were reported from either group.
The authors concluded that, although the primary analysis failed to demonstrate clearly that the treatment was effective beyond placebo, some significant benefits of IHMs over placebo could still be detected in some of the subscales in the secondary analysis.
The article was published in the recently re-named JICM, a journal that, when it was still called JCAM, featured regularly on this blog. As such, the paper is remarkable: who would have thought that this journal might publish a trial of homeopathy with a squarely negative result?
Yes, I know, the surprise is tempered by the fact that the authors make much in the conclusions of their article about the significant findings related to secondary analyses. Should we tell them that these results are all but irrelevant?
“The decline of homeopathy, the ‘medicine’ that doesn’t cure anything” is the title of a remarkable article in EL PAIS of which I take the liberty of showing you a few key passages:
In the more than 200 years that have passed since its invention, no one has been able to prove that homeopathy is actually capable of curing anything with its alleged medicines that have no active ingredients…
…EL PAÍS reached out to some of its main promoters, such as the pharmaceutical company Boiron, leader in the sector; the Spanish Association of Homeopathy Pharmacists and the Spanish Society of Homeopathic Doctors. In the absence of a response from all three, the explanations are given by experts who are more critical of the discipline.
Many people who used to consume homeopathy were not even aware that this was the case. Fernando Frías, one of the activists who worked to undermine the discipline’s remaining prestige, recalls that people did not believe them when they were told that compounds with diluted Berlin Wall were sold to overcome the feelings of oppression and anxiety. This was actually commercialized under the premise that “like cures like”: if the Berlin Wall oppressed, a piece of it diluted in water should remedy it. “Many were under the impression that it was just a natural therapy and that we were making things up to attack it,” says Frías…
… There has been a lot of debate about how to regulate an alleged drug whose only effect is, in truth, the placebo effect. In 2001, the European Parliament issued a directive that covered its use in countries with a homeopathic tradition; sources explain that this happened due to the pressure exerted by both the industries and the governments of countries where pseudoscience is deep-rooted, such as France (where Boiron is headquartered) or Germany, where its consumption is much higher than in others, such as Spain.
“Having regard to the particular characteristics of these homeopathic medicinal products, such as the very low level of active principles they contain and the difficulty of applying to them the conventional statistical methods relating to clinical trials, it is desirable to provide a special, simplified registration procedure for those homeopathic medicinal products which are placed on the market without therapeutic indications in a pharmaceutical form and dosage which do not present a risk for the patient,” states the directive.
In its more than two centuries of history, this is not the first time that homeopathy loses ground. Still, Frías warns, it cannot be ruled out that at some point something will come up that will make it fashionable again. “Look at the example of chemtrails [the condensation trails left by airplanes that some conspiracy theorists believe are a way of poisoning the population from the air]. It seemed that no one remembered them anymore, but now they’re back,” he says. Frías cites the astrophysicist and disseminator Javier Armentia, who states that beliefs are like a rubber duck: no matter how much they sink, they always resurface. “Especially if there is money behind,” he adds.
As reported previously, homeopathy and other forms of so-called alternative medicine (SCAM) have come under fire in Spain. In 2017, ‘HOMEOPATHY PLUS‘ reported that “in a reversal of the 2015 Royal Legislative Decree, the Minister of Health has withdrawn homeopathic remedies and outlawed the practice in Spain’s national health services.” In 2018, more than 400 people signed an open letter triggered by the case of a cancer patient who died after preferring homeopathy to regular treatment. “Let’s be clear: pseudoscience kills,” begins the letter. Since then, the struggle of Spanish rational thinkers to stop misleading information about SCAM in general and homeopathy, in particular, has only intensified.
Spain is thus joining other European countries in opposing misinformation about homeopathy. Contrary to what some have claimed (for instance, in the comments section of this blog), most of the opponents do not want to restrict the public’s choice. People who wish to use homeopathy should be able to do so (but should pay for it themselves). However, the choice must be based on evidence-based information.
It has been reported, at the German Medical Congress (DÄT) a year ago, that it was decided to delete the additional title of homeopathy from the model further training regulations of the German Medical Association. And Federal Health Minister Karl Lauterbach (SPD) tweeted applause: “Homeopathy has no place in modern medicine.”
Now the ‘ Bundesverband der Pharmaziestudierenden in Deutschland’ (BPhD), the German Pharmacists Organization, even goes a few steps further. The position paper distinguishes between evidence-based medicine (EBM) and unproven therapeutic methods. According to the BPhD, these include homeopathy, but also anthroposophy, traditional Chinese medicine, and traditional medicines.
Among other things, the BPhD is disturbed by the way homeopathy presents itself as an alternative, because an alternative means “a choice between two equally suitable possibilities” to achieve a goal, and this is not the case. Compared to evidence-based medicine (EBM), homeopathy is a “constructed, illusory concept” and “the principles of homeopathic teachings and principles” are to be rejected as “unscientific”. According to the BPhD, a designation as “alternative” for advertising purposes should no longer be allowed.
They would also like to see a demarcation from naturopathy; the clear distinction between homeopathy and phytopharmacy has been lacking up to now. The advertising attribute “natural” should therefore also be banned in order to prevent equalization in advertising, the position paper states.
Like doctors, pharmacy students point to the lack of proof of efficacy beyond the placebo effect. According to the BPhD, the dogma WER HEILT HAT RECHT, “he who heals is right” would “disregard all processes that work towards healing and glorify the result”. The “gold standard” of EBM – randomized, double-blind studies with placebo control – should in future also have to be fulfilled by homeopathic medicines, experience reports are not sufficient, it continues.
Homeopathic medicines are only registered as medicinal products without indication, which requires neither proof of efficacy nor clinical studies. The BPhD, therefore, demands that a warning be placed on the preparations that they have “no proven efficacy beyond the placebo effect”. Up to now, without this warning, patients have been “deceived about the efficacy”, and there is an “urgent need for detailed public information and counseling on homeopathy since its unjustified reputation poses a danger of not seeking treatment”. The BPhD also demands that the status of homeopathic medicines is withdrawn and that the pharmacy obligation for the preparations is abolished…
“In the health professions, no trivialization of unproven therapeutic procedures should be tolerated, as inadequate counseling or ignorance poses a danger to patients,” the BPhD said.
When I first read this article – I translated and shortened it for those who cannot read German- I was truly dazzled. These are the suggestions that I have been making for around 20 years now, not specifically for Germany but for pharmacists in general. For many years, the Germans seemed the least likely to agree with me. But now they seem to be ahead of everyone else in Europe!
I suspect and hope that our recent initiative might have something to do with it.
Let’s hope that the pharmacists of other countries follow the German example.