On 7/10/2020, I discussed a study suggesting that homeopathy improves the quality of life and survival of cancer patients. Now, these data have been carefully scrutinized by a group of members of the „INH“ and „Initiative für Wissenschaftliche Medizin“.
By guest bloggers Norbert Aust and Viktor Weisshäupl
The first impression of the results of the study on the adjunctive homeopathic treatment of patients with non-small cell lung cancer (NSCLC) is that of a seemingly rigorous trial with valid results. But a more thorough review yields different insights:
- The methods and definitions were pre-determined in a protocol and seem to have been maintained up to the end. But the date given in the document pointing at some point in time before enrollment began is wrong and misleading: This protocol was first published by uploading it to the register only two months after data assessment was completed with outcomes presumably available.
- The data initially saved to the register are not in agreement with the information given in the published paper: important definitions were subjected to considerable modifications while the study was underway. None of these modifications are mentioned in the paper, neither a rationale nor a comment of their impact on the results was provided.
- Some of the modifications with presumably heavy impact on the results were introduced with the upload of the protocol only, that is two months after data collection was completed. These were (a) a massive extension of the exclusion criteria: the number increased from 1 during initial registration to 20 in the final paper. and (b) an equally massive reduction of the follow-up time for the primary endpoint from two years to 18 weeks.
- The paper discloses no reason why the additional exclusion criteria were introduced. Their selection seems arbitrary without any apparent necessity arising from the trial itself.
- The patients who did not meet the added criteria and were thus excluded are not mentioned in the publication. The CONSORT flow chart does not give information either of their number or of the point in time when they were excluded.
- The survival curves of the placebo and verum groups show some aspects that arise if the inter-group difference was due to the exclusion of unfavorable data.
- It is hard to imagine that, in this trial, the homeopathic preparations had strong effects on the patients’ health, while other rigorous studies or systematic reviews failed to notice such effects.
Altogether, it seems much more plausible to assume that the positive results were achieved by post hoc data manipulation, namely by omitting patients with unfavorable outcomes, than by rigorous and valid science. A retraction of the paper seems the only appropriate measure to avoid misleading the public.
Due to its outstanding results, the study about adjunct homeopathic treatment of non-small cell lung cancer patients was met among homeopaths with enthusiasm. However, in this article, we will show that the enthusiasm is unjustified because the results may not be based on a rigorous trial meeting established scientific criteria. Crucial definitions were modified, while the study was underway or even after data collection was completed. It stands to reason that this introduced bias in favor of homeopathy.
For this analysis, we considered the following sources of information :
- the text of the published paper (link)
- the data that were uploaded during registration (link)
- the history of changes of the registered data (link)
- the study protocol included in the registration (link)
As all of this information is readily available on the internet, it is easy to double-check our findings and verify our statements. We also submitted a letter to the editor of the Oncologist, the journal where the paper was published which has not yet been published (status 06-06-2021).
At first glance, the study meets the requirements for reliable evidence.
- There is a study protocol dated January 11, 2011, well before recruiting of participants started. It provides definitions that were used until the end.
- The study was registered at ClinicalTrials.gov before recruiting started.
- The methods of randomization and blinding are suitable to meet the requirements for a low risk of bias rating.
- The presentation of the paper follows the principles set out in the CONSORT-Statement.
- The paper was published in a peer-reviewed journal of some reputation.
The study yielded formidable results in favor of homeopathy: In the group that received the adjunctive homeopathic treatment, the quality of life improved continuously throughout the follow-up time, while the patients in the placebo group deteriorated. In addition, the median survival time was only about two-thirds compared to the patients in the homeopathy group. However, the impression of a valid study does not stand up to closer scrutiny when the history of changes is taken into account.
Changes in study parameters
Between the initial registration and data upload in January 2012 (Link), shortly before recruiting started in February 2012, and the publication in October 2020, multiple changes in essential study parameters occurred:
|Registration January 2012||Publication October 2020|
|Number of participants||600||150|
|Number of study arms||2||3|
|Number of exclusion criteria||1||20|
|Follow-up time for Quality of life||104 weeks (*)||18 weeks|
|Number of cancer types||3||1|
|(*) Derived from “Time Frame: 7 Years” minus the recruitment period of 5 years.|
Note the drastic reduction in the follow-up time for quality of life by more than 80 % which was defined as the primary endpoint. Furthermore, note the substantial increase in the number of exclusion criteria. Both issues will be discussed in more detail below.
In contrast to the requirements for a rigorous and valid trial, these modifications are not mentioned in the published paper, and no rationale is given as to why they became necessary. As a consequence, the authors do not discuss the possible impact these modifications may have had on the results.
The study protocol
A study protocol is available in the registration database. It was first uploaded on September 18, 2019, about two months after the end of data collection in July 2019 (Link). The document itself is dated January 11, 2011, which would place it about a year before the study was registered. However, this date is obviously wrong: there are substantial discrepancies between the parameters specified in the protocol and the data provided one year later during initial registration:
|Protocol, allegedly January 2011||Registration January 2012|
|Number of participants||300||600|
|Number of study arms||3||2|
|Number of exclusion criteria||9||1|
|Follow-up time for Quality of life||18 weeks||104 weeks (*)|
|Number of cancer types||1||3|
|(*) Derived from “Time Frame: 7 Years” minus the recruitment period of 5 years.|
We see no sensible explanation why the parameters given in the study protocol allegedly compiled in January 2011 are in line with the publication nine years later, but not with the registration only one year after the protocol was compiled. The only sensible conclusion seems to be that this protocol was not completed on the date indicated, but at a much later point in time, maybe just shortly before its upload (September 2019). This impression is corroborated by the information presented in the document that was not available on the date given: On page 10 the software package used in data analysis is referenced as “IBM SPSS statistics 25.0” while, at the beginning of 2011, when the protocol was allegedly compiled, the current version number of this package was 19 only.
A second clue: Also on page 10 there is a reference “(EORTC-QLQ-C30 remaining dimensions; SF-36; subjective well-being)25.” with the number 25 indicating some reference. And some references that is, but not in the protocol – this does not have any references – but in the published paper, where the 25 indicates a paper on the SF-36 questionnaire. So it stands to reason that the number in the protocol originates from some messed up copy and paste procedure from the draft of the paper. Which would indicate that the paper and the protocol were at least partially developed in parallel.
It seems therefore reasonable to assume, that the protocol was finished only shortly before it being uploaded in September 2019, that is two months after data collection was completed.
However, the obviously inaccurate date given in the protocol supports the impression that the study parameters were set a year before the study began and were consistently maintained during the course of the trial, which is not the case, as the above tables show.
Change in exclusion criteria
The initial registration data list pregnancy as the only exclusion criterion. But with the upload of the protocol, which took place two months after data collection was completed, the number of exclusion criteria was increased to nine, only to be enlarged once again in the final publication to the final number of twenty. It is beyond any doubt that at least the final increase of eleven criteria took place after the data collected from the patients were available. But all this is neither disclosed in the final paper nor is there any rationale given for this action.
The patients excluded by the additional criteria never appear anywhere, they are not included in the CONSORT-flow-chart, Fig 3 in the study. It is obvious that some patients were excluded: What was the reason to define such an abundance of criteria, if they were not to be applied? As a consequence, the CONSORT diagram seems to be incomplete which would be in violation of the CONSORT statement.
Thus, an unknown number of patients seems to have been excluded from the study by criteria defined at a time after data collection was completed with outcomes available. After all, eleven of the exclusion criteria were established even after the protocol had been uploaded, at least those were established well after the patients’ results were available.
This raises the question of why these exclusion criteria were introduced. One would assume that an intervention to treat stage III and stage IV lung cancer patients should be effective under the conditions that are usually present in such patients. One would expect that patients somewhat advanced in age, like in this study, usually suffer from some health problems, regardless of their cancer condition. What is the sense of excluding patients with hematological, hepatic, or renal pathology, with coronary heart disease or rheumatism? Homeopathy is claimed to be able to treat comorbidities based on the assessment of symptoms independent of what disease they belong to. And this apparently was the idea at the start of the trial where only pregnancy was specified as an exclusion criterion, while it was understood that elderly patients to be enrolled in the study would suffer from some additional medical problems.
On the other hand, not all health conditions that are associated with advanced age were excluded. Diabetes, hypertension, gastrointestinal diseases, or COPD were no reason to exclude any patient from participation. Only very few of the criteria are somewhat self-explanatory as to why they were defined as exclusion criteria, e.g. if a patient was unwilling to give her informed consent.
Altogether, the assumption seems reasonable that more patients had participated in the trial than accounted for in the publication, and that an unknown number of them were excluded according to criteria that were not present until after data collection was completed. If so, a substantial bias was introduced.
Median survival time
Here, we will focus on the comparison between the homeopathy and placebo groups and leave aside the third group not receiving any additional treatment at all.
If the favorable result in survival really was established by dropping unfavorable data, this might be recognized in some characteristics of the survival curves. Therefore, we modeled this situation starting with two random distributions somewhat tweaked to resemble the typical shape of natural survival functions.
This graph shows the two distributions (n = 80) defined in the range of 0 to 200 as thin lines. Both are very similar to each other with median survival at 27 weeks. If 15 of the 20 patients with the shortest survival are dropped from the thin blue line this would result in the solid blue line (“Hom”). If, on the other hand, 15 out of 20 patients with the longest survival are dropped from the other distribution this would yield the solid red line (“Plac”).
The new functions show some characteristic properties:
- In the red line, median survival drops by 8 weeks to 19 weeks.
- In the blue line median survival rises by 12 Weeks to 39 weeks.
- The difference between the two functions arises from of the first 12 weeks alone. With the blue line, 8 people died, with the red line 23 people died during the first 12 weeks. After week 12 up to week 80, the same number of fatalities occur in both groups (blue: 36, red: 37).
After week 80, the two functions start to converge, which is due to the fact that at some future point all the patients of both groups will be dead. The survival functions that are reported in the study show the same characteristics.
Assuming that homeopathy did not have any effect, both groups should show more or less identical survival functions. In the paper 10.1 months = 303 days is cited from literature as to be expected under conventional care, maybe with some margin to the better because the data that yielded this value of 10.1 months were more than six years old at the time of the trial. The survival functions allegedly found in the trial show:
- Median survival time with the placebo group is reduced by 46 days compared to conventional care alone.
- Median survival time with the homeopathy group is increased by 132 days compared to conventional care alone.
- The advantage of homeopathy arises within the first 9 weeks alone, where only two patients died (out of 51) in the homeopathy group compared to 11 (out of 47) in the placebo group. After this initial phase, the groups developed in parallel: By the end of the two-year follow-up time an additional 26 patients died with homeopathy, and about the same, namely 25 patients died with placebo.
The inevitable convergence of both functions apparently started outside the two-year follow-up. In other words, the survival functions given in the study for placebo and homeopathy treatments show characteristics that match what you would be expected, if two very similar functions were manipulated by dropping unwanted results, i.e. “good” survival data from placebo and “bad” survival data from homeopathy functions. After week 9, the two functions develop parallel to each other, indicating a lack of effect of homeopathy even though the treatment continued until the death of the patient or the end of the study. However, with ongoing effective treatment, the functions should continue to diverge. It seems implausible that homeopathy should be effective on a short time basis only, with a sudden complete loss of effectiveness later on.
Reduction of observation time
Quality of life was defined as the primary endpoint. On initial registration, it was specified that patients should be observed for the entire seven-year duration of the study which, allowing for the recruitment period of five years, results in a follow-up time of two years or 104 weeks for each individual patient. According to the information provided in the study, this was indeed done: “Patients were followed up every nine weeks until death” (or until the end of the study, of course), and questionnaires were completed to determine the quality of life.
The reduction of follow-up time from 104 to 18 weeks was first introduced when the protocol was uploaded. So it is obvious that this substantial reduction occurred after data collection was completed and that data from more than 80 % of the originally defined follow-up were omitted.
Incomplete outcome reporting, especially when a larger scope was defined at the beginning of the study, is considered a source of substantial bias and a major shortcoming in clinical trials: Maybe patients initially experienced an improvement in their quality of life due to whatever effect – but what were the results after this initial phase? Why were they omitted? Perhaps because they got worse than in the placebo group? The long-term development would have been a vital aspect for the evaluation of efficacy – and the study originally was designed to evaluate such long-term effects. Yet, the authors’ conclusions on the quality of life – notably: the primary outcome criterion – are based on less than 20 % of the follow-up in which a positive effect may have occurred due to bias or by chance. To extrapolate from this short time to the total period is not justified and may be misleading. A detailed review of the quality of life results is meaningless: they do not disclose any long-term effects and they are subject to bias caused by the post hoc exclusion of patients anyway.
The overall evidence on the effectiveness of homeopathy is not encouraging. The quintessence of all systematic reviews that have looked at homeopathy as a whole is that some marginal effect may be found, if all studies are included in the review, regardless of their quality. But this result is questionable due to the generally low quality of the primary studies (Link, in German). However, when quality is taken into account, the systematic reviews do not produce robust evidence for any positive effect beyond placebo. In addition, no review could identify a single condition in which homeopathy is of well-established therapeutic benefit.
This study on NSCLC contradicts the long-established and often-confirmed evidence. During the follow-up time for the patients who actually received the prescribed homeopathic preparations, the quality of life improved steadily in all subscales – even down to the patients’ financial situation – whereas the opposite was observed in the placebo patients. In addition, the mean survival time was about two-thirds longer for the homeopathy patients than for the placebo group.
After 200 years of clinical research into homeopathy, it seems unlikely that such a powerful effect of homeopathy should not have been noticed before. Another scenario seems to be much more plausible:
- The survival times of the placebo group were worse than the data from the literature. This could be due to the fact that patients with relatively good outcomes were excluded by the introduction of additional exclusion criteria.
- The survival times of the homeopathy group were considerably better than expected. This could also be due to the additional exclusion criteria, in that patients with poor outcomes were excluded retrospectively.
- The long time frame where the survival functions run in parallel from week 9 onwards until the end of the two years observation period indicates the lack of effect of the homeopathic treatment. The advantage occurring in the first nine weeks alone seems to be the result of unwanted data being dropped.
- In the case of quality of life (after all, not a “hard” criterion, but based on information from the patients ), the advantage in survival would have initially created a positive effect for the homeopathy group. Then, reporting was discontinued, once the initial positive effects presumably caused by the selective omission of patients had ended.
In conclusion, it seems likely that the substantial modifications of crucial study parameters that occurred after the study had been started and results had become available biased the results in favor of homeopathy. Therefore, this study does not meet strict scientific standards that were established to exclude any confounding factors or biases. If our analysis is correct, the results of this study are invalid, and the authors’ conclusions are not justified. Retraction of this study seems to be appropriate.
Reference Frass M, Lechleitner P, Gründling C et al. Homeopathic Treatment as an Add-On Therapy May Improve Quality of Life and Prolong Survival in Patients with Non-Small Cell Lung Cancer: A Prospective, Randomized, Placebo-Controlled, Double-Blind, Three-Arm, Multicenter Study. The Oncologist 2020;25:e1930–e1955 https://theoncologist.onlinelibrary.wiley.com/doi/epdf/10.1002/onco.13548
The Higher Administrative Court of Bremen has rejected as inadmissible the application for a judicial review by a Bremen physician against the deletion of the ‘HOMEOPATHY’-title from the further training regulations of the Bremen Medical Association (decision of June 2, 2021). Thus, the new regulation for postgraduate training of the Bremen Medical Association without the additional designation of homeopathy has been upheld.
“We are very pleased that the Court shares our legal opinion and has rejected the plaintiff’s application,” said Heike Delbanco, Chief Executive Officer of the Bremen Medical Association. “This is also a clear signal for other German medical associations where comparable lawsuits against the removal of homeopathy from the canon of additional designations are pending.”
The Assembly of Delegates of the Medical Association had decided in September 2019 on a new training regulation, which – unlike the previous regulation – no longer provided for the postgraduate training in homeopathy. After the expiry of a transitional period, the qualification of homeopathy can therefore no longer be acquired at the Bremen Medical Association; however, titles already acquired can continue to be held.
A physician from Bremen, who holds the title of homeopathy, brought an action before the Higher Administrative Court against the cancellation of the additional title. He claimed that the removal of the additional designation from the continuing education regulations interfered with his fundamental right to freedom of profession and his fundamental right to property and complained of a violation of the general principle of equality. The medical association considered the action inadmissible.
The Higher Administrative Court now rejected the application, since a violation of the plaintiff’s rights could not be recognized. The plaintiff can continue to use his title HOMEOPATHY also under the new regulations.
The expectations presented by him – in particular, the expectation to find suitable practice representatives and to be able to sell his practice on retirement at a profit – do not justify any legal positions protected by fundamental rights and consequently also no obligation of the Bremen Medical Association to enable physicians to obtain the additional title of homeopathy in future.
As several further medical associations in Germany have banned homeopathy in the same way as Bremen and were consequently also taken to court by homeopathy enthusiasts, one can be optimistic that these cases will also go against homeopathy.
You may have noticed that my patience with homeopathy, homeopaths, and other providers of so-called alternative medicine (SCAM) has diminished. In fact, I do not think much of quacks of all shades and no longer muster much understanding. It is better, so I mean after approximately 30 years of discussions with snake oil salesmen and other charlatans, to offer such people Parole. Facts are facts, and no one should be allowed to ignore that without contradiction.
That was not always the case.
When I began as Chair of Complementary Medicine at Exeter in 1993, I was optimistic. It was clear to me that my task of scrutinizing this field would not be easy and could occasionally bring me into conflict with enthusiasts. But I was determined to build bridges, to remain polite, and to muster as much understanding as necessary.
And so I began to build a multidisciplinary team, conduct research, and publish it. My goal was to do as rigorous science as possible and, if avoidable, not to step on anyone’s toes in the process. Especially with regard to homeopathy, my general attitude was quite positive. Accordingly, my articles were as favorable as the evidence allowed. My goal was to emphasize the good aspects of homeopathy wherever possible.
What, you find that hard to believe?
Then you are in good company!
Homeopaths like to claim that I was out to malign not only homeopathy but all of SCAM from the beginning. That this assumption is not true, I tried to demonstrate in an article entitled ‘Homeopathy and I’. In this paper, I merely extracted typical passages from my publications. From them, you can probably see how my attitude slowly changed over the years. See for yourself (sorry for the length of the list):
- 1. homeopathic remedies are believed by doctors and patients to be almost totally safe (Ernst E, White A. Br J Gen Pract 1995; 45: 629-30)
- 2. it might be argued that arnica … is ineffective but homeopathy may still work (Ernst E. BMJ 1995; 311: 510-1)
- 3. homeopathy, I fear, has soon to come up with … more convincing evidence (Ernst E. Forsch Komplementarmed 1995; 2: 32)
- 4. future evaluations of homeopathy should be performed to a high scientific standard (Ernst E. Br Homeopath J 1995; 84: 229)
- 5. the best way forward is clearly to do rigorous research (Ernst E, Kaptchuk TJ. Arch Intern Med 1996; 156: 2162-4)
- 6. the most pressing question, ‘Is homeopathy clinically more effective than placebo’, needs to be answered conclusively (Ernst E. Br J Clin Pharmacol 1997; 44: 435-7)
- 7. there is evidence that homeopathic treatment can reduce the duration of ileus (Barnes J, Resch KL, Ernst E. J Clin Gastroenterol 1997; 25: 628-33)
- 8. the published evidence to date does not support the hypothesis that homeopathic remedies … are more efficacious than placebo (Ernst E, Barnes J. Perfusion 1998; 11: 4-8)
- 9. the claim that homeopathic arnica is efficacious beyond a placebo effect is not supported by rigorous clinical trials (Ernst E, Pittler MH. Arch Surg 1998; 133: 1187-90)
- 10. … the trial data … do not suggest that homeopathy is effective (Ernst E. J Pain Sympt Manage 1999; 18: 353-7)
- 11. … the re-analysis of Linde et al. can be seen as the ultimate epidemiological proof that homeopathic remedies are, in fact, placebos (Ernst E, Pittler MH.J Clin Epidemiol 2000; 53: 1188)
- 12. … homeopathy is not different from placebo (Ernst E, Pittler MH. J Clin Epidemiol 2002; 55: 103-4)
- 13. … the best clinical evidence … does not warrant positive recommendations (Ernst E. Br J Clin Pharmacol 2002; 54: 577-82)
- 14. the results of this trial do not suggest that homeopathic arnica has an advantage over placebo (Stevinson C, Devaraj VS, Fountain-Barber A, Hawkins S, Ernst E. J R Soc Med 2003; 96: 60-5)
- 15. this study provides no evidence that adjunctive homeopathic remedies … are superior to placebo (White A, Slade P, Hunt C, Hart A, Ernst E. Thorax 2003; 58: 317-21)
- 16. … this systematic review does not provide clear evidence that the phenomenon of homeopathic aggravations exists (Grabia S, Ernst E. Homeopathy 2003; 92: 92-8)
- 17. … the proven benefits of highly dilute homeopathic remedies … do not outweigh the potential for harm (Ernst E.Trends Pharmacol Sci 2005; 26: 547-8)
- 18 Our analysis … found insufficient evidence to support clinical efficacy of homeopathic therapy (Milazzo S, Russell N, Ernst E. Eur J Cancer 2006; 42: 282-9)
- 19. … promotion can be regrettably misleading, or their effectiveness? (Ernst E. J Soc Integr Oncol 2006; 4: 113-5)
- 20. … homeopathy is not based on solid evidence and, over time, this evidence seems to get more negative (Ernst E, Pittler MH, Wider B, Boddy K. Perfusion 2006; 19: 380-2)
- 21. the evidence from rigorous clinical trials … testing homeopathy for childhood and adolescence ailments is not convincing enough for recommendations in any condition (Altunc U, Pittler MH, Ernst E. Mayo Clin Proc 2007; 82: 69-75)
- 22. … context effects of homeopathy … are entirely sufficient to explain the benefit many patients experience (Ernst E. Curr Oncol 2007; 14: 128-30)
- 23. among all the placebos that exist, homeopathy has the potential to be an exceptionally powerful one (Ernst E. Br J Clin Pharmacol 2008; 65: 163-4)
- 24. … recommendations by professional homeopathic associations are not based on the evidence (Ernst E. Br J Gen Pract 2009; 59: 142-3)
These quotes speak for themselves, I think. But what was the reason for the change? As far as I can judge in retrospect, there were three main reasons.
1. The data became clearer and clearer
When I started researching homeopathy, at least the clinical evidence was not clearly negative. In 1991, Jos Kleinjen had published his much-noted systematic review in the BMJ. Here is its conclusion:
At the moment the evidence of clinical trials is positive but not sufficient to draw definitive conclusions because most trials are of low methodological quality and because of the unknown role of publication bias. This indicates that there is a legitimate case for further evaluation of homoeopathy, but only by means of well performed trials.
Subsequently, more and better clinical trials were published, and the overall picture became increasingly negative. Kleinjen, who had become somewhat of a hero in the realm of homeopathy, re-reviewed the evidence in 2000 and concluded that there are currently insufficient data to either recommend homoeopathy as a treatment for any specific condition or to warrant significant changes in the provision of homoeopathy.
The 24 citations above reflect this development quite nicely. Today, there is no longer much doubt that highly-diluted homeopathic remedies are pure placebos. This is perhaps most clearly expressed in the now numerous statements of high-ranking international bodies.
2. The lack of understanding on the part of homeopaths
So the evidence is now clear. But it may not fully explain why my patience with homeopaths diminished. To understand this better, one must consider the utter lack of insight of today’s homeopaths (think, for example, of the incredible Ebola story).
It is of course understandable that a homeopath would be less than enthusiastic about the increasingly negative evidence. But homeopaths are also physicians or at least medically untrained practitioners (lay homeopaths). As such, they have an obligation to acknowledge the overwhelming evidence and act accordingly. That they quite obviously do not do so, is not only regrettable but also highly unethical and shameful. In any case, I find it difficult to have much patience for such people.
3. Personal attacks
In the many years that I have now been scrutinizing SCAM, I have become used to being attacked. The attacks and insults I have received, especially from homeopaths, are legion. For example, when we published our arnica study, we were threatened with letter bombs. However, one should keep one thing in mind: ad hominem attacks are a victory of reason over unreason. If one is personally attacked by one’s opponent, it only shows that he has run out of rational arguments.
Perhaps the most impressive example of an attack was not directed against me personally, but across the board against all who dare to doubt homeopathy. Christian Boiron is the boss of the world’s largest homeopathic manufacturer, Boiron. In an interview he was once asked what he thought of homeopathy critics; his answer: “Il y a un Ku Klux Klan contre l’homéopathie” (There is a Ku Klux Klan against homeopathy).
Yes, many of these attacks even have something comical about them; nevertheless, they are not likely to increase my patience with homeopaths. This does not mean, however, that I will soon hang my opponents from the nearest tree in the old KKK tradition. I’ll gladly leave such tasteless ideas to Christian Boiron.
A few months ago, I started contributing to a German blog. This has been fun but only moderately successful in terms of readership. This week, I posted something about a homeopath and his strange attitude towards COVID vaccinations. This post was so far read by around 20 000 people!
As it was so unusually successful (and because there is a big conference today on the subject), I decided to translate it for my non-German readers.
Here we go:
A lot of downright silly stuff is currently being written about vaccine side effects at the moment, not least on Twitter where I recently found the following comment from a medical colleague:
I’ve been a doctor for 25 years now. I have never experienced such an amount of vaccine side effects. I can’t imagine that other colleagues feel differently.
This kind of remark naturally makes you think. So let’s think a little bit about these two sentences. In particular, I would like to ask and briefly answer the following questions:
- How reliable is this physician’s impression?
- What does the reliable evidence say?
- Is it conceivable that this doctor is mistaken?
- What might be the causes of his error?
- Who is the author?
- Why is the tweet questionable?
1. How reliable is this doctor’s impression?
A whole 25 years of professional experience! So we are dealing with a thoroughly experienced doctor. His statement about the current unusually large amount of vaccination side effects should therefore be correct. Nevertheless, one should perhaps bear in mind that the incidence of side effects cannot be determined by rough estimations, but must be precisely quantified. In addition, we also need data on the severity and duration of symptoms. For example, is it only mild pain at the injection site or venous thrombosis? Are the symptoms only temporary, long-lasting, or even permanent? In general, it must be said that the experience of a physician, while not completely insignificant, does not constitute evidence. Oscar Wilde once said, “experience is the name we give to our mistakes.”
2. What does the reliable evidence tell us?
Even if the good doctor had 100 years of professional experience and even if he could accurately characterize the side effects, his experience would be trivial compared to the hard data we have on this subject. Nearly 2 billion vaccinations have now been performed worldwide, and we are therefore in the fortunate position of having reliable statistics to guide us. And they show that side effects such as pain at the injection site, fatigue, and headaches are quite common, while serious problems are very rare. A recent summary comes to the following conclusion (my translation):
The current data suggests that the currently approved mRNA-based COVID-19 vaccines are safe and effective for the vast majority of the population. Furthermore, broad-based vaccine uptake is critical for achieving herd immunity; an essential factor in decreasing future surges of COVID-19 infections. Ensuring sufficient COVID-19 vaccination adoption by the public will involve attending to the rising vaccine hesitancy among a pandemic-weary population. Evidence-based approaches at the federal, state, city, and organizational levels are necessary to improve vaccination efforts and to decrease hesitancy. Educating the general public about the safety of the current and forthcoming vaccines is of vital consequence to public health and ongoing and future large-scale vaccination initiatives.
3. Is it conceivable that this doctor is mistaken?
In answering this question, I agree with Oscar Wilde. The evidence very clearly contradicts the physician’s impression. So the doctor seems to be mistaken — at least about the incidence of side effects that are not completely normal and thus to be expected. Even if indeed ‘other colleagues feel no differently’, such a cumulative experience would still mislead us. The plural of ‘anecdote’ is ‘anecdotes’ and not ‘evidence’.
4. What might be the causes of his error?
I wonder whether our doctor perhaps did not see or did not want to see the following circumstance: It is inevitable that a physician, at a time when soon 50% of all Germans were vaccinated, also sees a lot of patients complaining about side effects. He has never seen anything like that in his 25-year career! That’s because we haven’t been hit by a pandemic in the last 25 years. For a similar reason, the colleague will treat far fewer frostbites in midsummer than during a severe winter. The only surprising thing would be not to see more patients reporting vaccine side effects during the biggest vaccination campaign ever.
5. Who is the author?
At this point, we should ask, who is actually the author and author of the above tweet? Perhaps the answer to this question will provide insight into his motivation for spreading nonsense? Dr. Thomas Quak (no, I did not invent the name) is a practicing homeopath in Fürstenfeldbruck, Germany. Like many homeopaths, this Quak probably has a somewhat disturbed relationship to vaccination. In his case, this goes as far as recommending several vaccine-critical machinations on his website and even offering ‘critical vaccination advice’ as a special service.
Now we can immediately put the Quak tweet in a better perspective. Dr. Quak is a vaccination opponent or critic and wants to warn the public: for heaven’s sake, don’t get vaccinated folks; side effects are more common than ever!!!! Therefore, he also conceals the fact that the side-effects are completely normal, short-term vaccination reactions, which are ultimately of no significance.
6. Why is the tweet concerning?
Perhaps you feel that the Quak and his Quack tweet are irrelevant? What harm can a single tweet do, and who cares about a homeopath from Fürstenfeldbruck? As good as none and nobody! However, the importance does not lie in a single homeopath unsettling the population; it consists in the fact that such things currently happen every day thousandfold.
In their narrow-mindedness, vaccination opponents of all shades want to make us believe that they are concerned about our well-being because they know more than we and all the experts (who are of course bought by the pharmaceutical industry). But if you scratch just a little at the surface of their superficiality, it turns out that the exact opposite is true. They are ill-informed and only interested in spreading their hare-brained, misanthropic ideology.
And why do homeopaths do this? There are certainly several reasons. Although Hahnemann himself was impressed by the success of vaccination, which was invented in his time and hailed as a breakthrough, most of his successors soon sided with vaccination critics. Many do so by warning (like our Quak) of side effects, thinking that they are thus protecting their patients. However, they ignore two very important points:
- Even if the dangers of vaccinations were much greater than they actually are (no one is claiming that they are completely harmless), the benefits would still far outweigh the potential harms.
- If the Quaks (and all the quacks) of this world succeeded in dissuading a sizable percentage of the population from vaccinating and thus save them from the ‘oh-so-dangerous side effects’, they would still be doing a real disservice to public health. With regard to COVID-19, this would mean that the pandemic would remain with us in the long term and cost many more lives.
Whatever the motives of the homeopathic anti-vax brigade, it is certain that their attitude is a threat to our health. This has repeatedly made me state:
The homeopathic pills may be harmless, but unfortunately, the homeopaths are not!
- COVID-19 vaccine availability: what are the side effects? | British Journal of General Practice (bjgp.org) ︎
- Review the safety of Covid-19 mRNA vaccines: a review – PubMed (nih.gov) ︎
- Vaccination Information (doktor-quak.de) ︎
The Indian AYUSH ministry has a track record of doing irresponsible stuff. Now they have published guidelines for treating Mucormycosis (black fungus) with homeopathy. Allow me to show you the crucial passages of their announcement:
… With the increasing cases of special variety of fungal infection, Mucormycosis (black fungus) the present information have been prepared with experience of senior clinicians in treating specific fungal infections and researchers of the system, for efficient treatment of suspected and diagnosed cases of Mucormycosis with Homoeopathy. This condition requires hospital based treatment under supervision and Homoeopathic medicines can be prescribed in an integrated manner. Since mostly immune compromised patients get this infection, strict monitoring of blood sugar and other vitals is required…
As a system with holistic approach, homoeopathy medicines may be selected based on the presenting signs and symptoms of each patient(4). Fungal infections are amenable to homoeopathic treatment. Various research studies undertaken on various fungi in-vitro model showed that homoeopathy medicine could prevent the growth of the fungus(5-8). Clinical studies have shown encouraging results on fungal infections (9-10). The medicines given here are suggestive based on their clinical use.
Note: -Apart from these lists of medicines any other medicine and any other potency may be
prescribed based on the symptom similarity in each case.
END OF QUOTE
Mucormycosis (black fungus) is a disease of immunocompromised patients. Five types can be differentiated:
- rhinocerebral (most common),
- gastrointestinal (rare).
Rhinocerebral mucormycosis commonly causes headaches, visual changes, sinusitis, and proptosis. Pulmonary mucormycosis commonly presents as a cough. Late diagnosis may result in dissemination, leading to high mortality. Treatment consists of amphotericin B, surgery, and immune restoration.
It is believed that the current surge of mucormycosis in India has an overall mortality rate of 50% and is triggered by the use of steroids which are often life-saving for critically ill Covid-19 patients. It almost goes without saying that homeopathy has not been shown to be effective against this (or any other) condition. As to the AYUSH ministry, the less they interfere with public health in India, the better for the survival of patients, I fear.
This amazing announcement reached me via Twitter. It seems that the people in the AYUSH ministry are highly delusional. According to Wikipedia, the Ministry of Ayurveda, Yoga, Naturopathy, Unani, Siddha, Sowa-Rigpa and Homoeopathy (abbreviated as AYUSH) is purposed with developing education, research and propagation of indigenous alternative medicine systems in India. As per a recent notification published in the Gazette of India on 13 April 2021, the Ministry of AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy), will now be known as the Ministry of Ayush.
India is suffering from a very severe health crisis, and the ministry should stop its propaganda for useless solutions.
- Homeopathy (considered to be indigenous in India),
- Sowa-Rigpa (the traditional medicine of Tibet)
have in common that they can offer very little help to patients infected by COVID-19. In view of this fact, the announcement is ununderstandable and irresponsible, in my view.
Vaccinations lead to masturbation! This surprising claim comes from Zita Schwyter, a Swiss anti-vaxxer, and practitioner of so-called alternative medicine (SCAM). Is there any evidence for a link? The only evidence I could find seems to suggest that the causal link (if there is one) goes in the opposite direction: “Women engaging in mutual masturbation were nearly two times more likely to decline the free vaccine.”
In her practice, Schwyter offers homeopathic treatments, hara massage, “vaccination consultations”, quantum medicine, ‘Matrix Energetics’, colon cleansing, and other SCAMs. Schwyter claims that vaccinations cause “vaccination disease” with symptoms such as sleep disorders, dyslexia, stuttering, autism, brain tumors, the tendency to masturbate, allergic reactions, cancer, swelling and redness at the injection site, or aching limbs. According to Zita Schwyter, chronic diseases and autoimmune diseases have only been on the rise since vaccination was introduced, and that, according to her fallacious thinking, implies a causal relationship.
On the website of her practice, Schwyter tells us that “Fühlen Sie sich in guten Händen und vertrauen Sie Ihre Gesundheit der ganzheitlichen Gemeinschaftspraxis vor Ort an. Ein professionelles Therapeutenteam mit einem fundierten Fachwissen, jahrelangen Ausbildungen und weitreichenden Erfahrungen erwartet Sie.” (Feel in good hands and entrust your health to the holistic group practice on site. A professional team of therapists with in-depth expertise, years of training and extensive experience awaits you.) And elsewhere, she states that “Durch meine berufliche Laufbahn verstehe ich mich deshalb als kompetentes Bindeglied zwischen Schulmedizin und Naturheilkunde, spezialisiert auf dem Gebiet der Homöopathie. Die richtige Person also, die Ihre Beschwerden ganzheitlich erfassen, richtig interpretieren und Sie mit dem angemessenen Behandlungskonzept zu besserer Gesundheit führen kann.” (Through my professional career, I therefore see myself as a competent link between conventional medicine and naturopathy, specializing in the field of homeopathy. The right person, therefore, who can grasp your complaints holistically, interpret them correctly and lead you to better health with the appropriate treatment concept.)
Homeopathy, Schwyter claims on the same site, can effectively treat the following conditions:
- Joint pain
- Hay fever
- Varicose veins
- Reynauds syndrome
- Gynecological diseases
- Pregnancy pains
- Chronic headache
- Chronic bowel inflammation
- Multiple sclerosis
- Parkinson’s disease
- High blood pressure
- Diabetes mellitus
- Metabolic disorders
- Liver/gall bladder problems
- Acute and chronic childhood diseases
- Growth and development disorders in children
- Susceptibility to infections
- Otitis media
- Convalescence from acute diseases
- Chronic injury sequelae
- Sleep disorders
- Learning difficulties
- Obsessive-compulsive disorders
- Diseases resistant to conventional medicine
- And much more
Call me a skeptic, but somehow, I doubt Schwyter’s competence, expertise, and professionalism. But I do admire her humor!
‘CLAMP DOWN ON THE BOGUS SCIENCE OF HOMEOPATHY’ is the title of a comment by Oliver Klamm in The Times today. Here is the background to his article.
In September 2020, the website of Homeopathy UK, www.homeopathy-uk.org, featured a page titled “Conditions Directory” with text that stated “Please find below a list of conditions where homeopathy can help …” followed by a list of medical conditions that included depression, diabetes, infertility, psoriasis and asthma. When consumers clicked-through the links to the conditions listed on that page, they were taken to separate pages for each that contained anecdotal descriptions from doctors detailing how they had applied homeopathic methods to the relevant conditions.
The UK Advertising Standards Authority received a complainant that challenged whether the ad discouraged essential treatment for conditions for which medical supervision should be sought, namely depression, diabetes, infertility, psoriasis and asthma.
The response of ‘Homeopathy UK’ said that, as a registered charity, they sought to share information about homeopathy for the benefit of others, rather than for commercial gain, and that they would always recommend that patients seeking homeopathic care did so under the supervision of a qualified medical practitioner…
The CAP Code required that marketers must not discourage essential treatment for conditions for which medical supervision should be sought. For example, they must not offer specific advice on, diagnosis or treatment for such conditions unless that advice, diagnosis or treatment was conducted under the supervision of a suitably qualified medical professional. The ad referred to “depression”, “diabetes”, “infertility”, “psoriasis” and “asthma”, which we considered were conditions for which medical supervision should be sought. Any advice, diagnosis or treatment, therefore, must be conducted under the supervision of a suitably qualified medical professional. We acknowledged that the articles had been written by GMC-registered doctors, who we considered would be suitably qualified to offer advice, diagnosis or treatment. However, we noted that the ad and the articles to which it linked referred to homeopathy in general, rather than treatment by a specific individual. We understood that there were no minimum professional qualifications required to practice homeopathy, which could result in consumers being advised, diagnosed, or treated for the conditions listed in the ad by a practitioner with no medical qualification. We therefore considered Homeopathy UK would not be able to demonstrate that all such treatment would be conducted under the supervision of a suitably qualified health professional.
Furthermore, we understood that, although elsewhere on the website there were links to specific clinics, not all treatment would be conducted under the supervision of a suitably qualified health professional across those clinics. Because Homeopathy UK had not supplied evidence that treatment would always be carried out by a suitably qualified health professional. Also, because reference to the conditions listed in the ad, and discussed in the related articles, could discourage consumers from seeking essential treatment under the supervision of a suitably qualified health professional, we concluded that the ad had breached the Code.
On that point the ad breached CAP Code (Edition 12) rule 12.2 (Medicines, medical devices, health-related products and beauty products).
The ad must not appear again in the form complained about. We told Homeopathy UK to ensure their future marketing communications did not to refer to conditions for which advice should be sought from suitably qualified health professionals.
Depression, diabetes, and asthma have few things in common. Just two characteristics stand out, in my view:
- they are potentially fatal;
- homeopathy is ineffective in changing their natural history.
- It was therefore high time that the ASA stopped this criminally dangerous nonsense of deluded homeopaths.
The article by Oliver Klamm concludes with the following wise words about homeopathy:
“For public officials and opinion formers, the time for appeasing this dangerous quackery should be long past.”
I have not often seen a paper reporting a small case series with such an impressively long list of authors from so many different institutions:
- Hospital of Lienz, Lienz, Austria.
- WissHom: Scientific Society for Homeopathy, Koethen, Germany; Umbrella Organization for Medical Holistic Medicine, Vienna, Austria; Vienna International Academy for Holistic Medicine (GAMED), Otto Wagner Hospital Vienna, Austria; Professor Emeritus, Medical University of Vienna, Department of Medicine I, Vienna, Austria. Electronic address: email@example.com.
- Resident Specialist in Hygiene, Medical Microbiology and Infectious Diseases, Außervillgraten, Austria.
- St Mary’s University, London, UK.
- Umbrella Organization for Medical Holistic Medicine, Vienna, Austria.
- Shaare Zedek Medical Center, The Center for Integrative Complementary Medicine, Jerusalem, Israel.
- Apotheke Zum Weißen Engel – Homeocur, Retz, Austria.
- Reeshabh Homeo Consultancy, Nagpur, India.
- Umbrella Organization for Medical Holistic Medicine, Vienna, Austria; Vienna International Academy for Holistic Medicine (GAMED), Otto Wagner Hospital Vienna, Austria; Chair of Complementary Medicine, Medical Faculty, Sigmund Freud University Vienna, Austria; KLITM: Karl Landsteiner Institute for Traditional Medicine and Medical Anthropology, Vienna, Austria.
- WissHom: Scientific Society for Homeopathy, Koethen, Germany.
In fact, there are 12 authors reporting about 13 patients! But that might be trivial – so, let’s look at the paper itself. The aim of this study was to describe the effect of adjunctive individualized homeopathic treatment delivered to hospitalized patients with confirmed symptomatic SARS-CoV-2 infection.
Thirteen patients with COVID-19 were admitted. The mean age was 73.4 ± 15.0 (SD) years. The treating homeopathic doctor was instructed by the hospital on March 27, 2020, to adjunctively treat all inpatient COVID-19 patients homeopathically. The high potency homeopathic medicinal products were administered orally. Five globules were administered sublingually where they dissolved, three times a day. In ventilated patients in the ICU, medication was administered as a sip from a water beaker or 1 ml three times a day using a syringe. All ventilated patients exhibited dry cough resulting in respiratory failure. They were given Influenzinum, as were the patients at the general inpatient ward.
Twelve patients (92.3%) were speedily discharged without relevant sequelae after 14.4 ± 8.9 days. A single patient admitted in an advanced stage of septic disease died in the hospital. A time-dependent improvement of relevant clinical symptoms was observed in the 12 surviving patients. Six (46.2%) were critically ill and treated in the intensive care unit (ICU). The mean stay at the ICU of the 5 surviving patients was 18.8 ± 6.8 days. In six patients (46.2%) gastrointestinal disorders accompanied COVID-19.
The authors conclude that adjunctive homeopathic treatment may be helpful to treat patients with confirmed COVID-19 even in high-risk patients especially since there is no conventional treatment of COVID-19 available at present.
In the discussion section of the paper, the authors state this: “Given the extreme variability of pathology and clinical manifestations, a single universal preventive homeopathic medicinal product does not seem feasible. Yet homeopathy may have a relevant role to play precisely because of the number and diversity of its homeopathic medicinal products which can be matched with the diversity of the presentations. Patients with mild forms of disease can use homeopathic medicinal products at home using our simple algorithm. As this Case series suggests, adjunctive homeopathic treatment can play a valuable role in more serious presentations. For future pandemics, homeopathy agencies should be prepared by establishing rapid-response teams and efficacious lines of communication.”
There is nothing in this paper that would lead me to conclude that the homeopathic remedies had a positive effect on the natural history of the disease. All this article actually does do is this: it provides a near-perfect insight into the delusional megalomania of some homeopaths. These people are even more dangerous than I had feared.
“Time to say good-bye? Homeopathy, skeptics and thoughts on how to proceed” is the title of an article by two Swiss homeopaths which is almost touchingly naive. Here is its abstract:
Although homeopathy is frequently used by many health professionals, there are ongoing debates concerning its effectiveness. Currently no unifying explanation how homeopathy works exists. Homeopaths are frequently challenged by skeptics, and in public opinion, the swan song for homeopathy is frequently sung.
Content: Regarding the efficacy of homeopathy, several well-designed RCTs, observational studies, case studies, and case reports, have been published, demonstrating its clinical efficacy. Regarding its mode of action, the discovery of the working principle of homeopathy would be a major advance towards a thorough scientific recognition of homeopathy. Basic research has already discovered some milestones, e.g., significant and reproducible effects of homeopathic preparations in plants.
Summary: To overcome the distrust of skeptics and public opinion, the support of basic research is indispensable. Second, homeopaths should continue to design prospective randomized clinical studies in order to create robust clinical evidence for the efficacy of homeopathy. Third, they should continue to publish their treatment outcomes, as these publications document clinical effectiveness beyond doubts about its mode of action.
Outlook: These measures will not only support homeopaths in continuing their clinical work, but may lead to a better recognition of this treatment in both the scientific world and the public.
To this, I might add the following comments:
- “ongoing debates concerning its effectiveness”: this debate has been ongoing for 200 years but it has now come to a conclusion, namely that homeopathy is a placebo therapy.
- “no unifying explanation how homeopathy works exists”: we do know, however, that the laws of nature, as we understand them today, must be wrong if homeopathy did work.
- “Homeopaths are frequently challenged by skeptics”: the main challenges currently come not from skeptics but from health experts who rightly insist on sound evidence.
- “several well-designed RCTs, observational studies, case studies, and case reports, have been published, demonstrating its clinical efficacy”: arguably, this might be correct but misses the crucial point that the totality of the reliable evidence fails to show that homeopathy is efficacious for any condition of humans or animals.
- “the discovery of the working principle of homeopathy would be a major advance”: yes, so much so that it would require rewriting whole sections of the textbooks of physics and chemistry.
- “Basic research has already discovered some milestones”: these ‘milestones’ are so imposing that nobody outside the realm of homeopathy has ever recognized them.
- “the support of basic research is indispensable”: not so much indispensable as non-existent, I would say.
- “design prospective randomized clinical studies in order to create robust clinical evidence for the efficacy of homeopathy”: homeopaths believe research to be a tool for creating evidence that supports their creed; I have often tried to remind them that it is a tool for testing hypotheses – to no avail, it seems.
- “publish their treatment outcomes, as these publications document clinical effectiveness”: I have also often tried to explain to them that treatment outcomes can be due to many factors other than the specific effect of the applied therapy – again to no avail.
- “These measures will not only support homeopaths in continuing their clinical work, but may lead to a better recognition of this treatment in both the scientific world and the public”: these measures, if applied rigorously, will merely confirm what we already know, namely that homeopathy does not work beyond placebo.