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
Abstract
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.
Introduction
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).
The study
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.
Study results
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
[1] 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.1354860 Responses to A thorough analysis of Prof M. Frass’ recent homeopathy trial casts serious doubts on its reliability
Leave a Reply
This site uses Akismet to reduce spam. Learn how your comment data is processed.
I cannot see a graph. It only says “image preview.” Perhaps my Ipad’s fault, or is it missing/not showing due to ???
we will look into it
Fixed now! Sorry about that.
This is a good example of how fraud can be uncovered by careful statistical analysis. The same approaches are also useful, for instance, with lottery and election fraud.
I hope the editors of The Oncologist will take note and retract the paper.
To be honest, a casual analysis of Prof M. Frass’ recent homeopathy trial would cast serious doubts on its reliability.
Because:
1) It finds a positive result for homeopathy, contrary to all other well-conducted research. And all that we know about science.
And
2) It’s by Michael Frass who hasn’t published a decent piece of research on homeopathy ever and who has previously p-hacked and Texas sharpshot his way to a bunch of notionally positive studies.
We also needn’t get too excited. Dana will probably yammer about this but the rest of science and medicine will – rightly – ignore it. Homeopathy has no place in any healthcare, particularly oncology.
agreed – yet, it is still very important to demonstrate clearly what looks like scientific misconduct to me.
I feel that the 2 authors deserve our appreciation for that.
Maybe academia does ignore homeopathy, maybe some countries are free of it – but unfortunately both in Germany and Austria this is not the case. This study is often cited in public discussions on TV, internet and anywhere else to “prove” to the laypeople that homeopathy is effective after all. Only recently there was a TV discussion in Austria, note: the public TV, not some obscure private channel, where some representatiove of a homeopathic organisation wanted to present exactly this paper as valid evidence only to be cut short by the moderator with respect to time (Link, in German, min 23:00 https://tvthek.orf.at/profile/MERYNS-sprechzimmer/12486668/MERYNS-sprechzimmer-Alternativmedizin-Wirklich-alles-nur-Placebo/14095018). And if you can read German, just refer to the teaser below the video screen.
With some bad luck, this study might as well find its way into the official German set of guidelines for treatment of cancer patients – just as the cancer study from 2015 already did (Link in German, refer to page 105. https://www.leitlinienprogramm-onkologie.de/fileadmin/user_upload/Downloads/Leitlinien/Komplement%C3%A4r/Version_1/LL_Komplement%C3%A4r_Langversion_1.01.pdf)
We have yet a lot to do.
Fraud is more reprehensible than bad science. If it is confirmed, there must be consequences.
A thorough dismantling of the study in question. I wonder what the results would show if the original, eg, exclusion criterion were to be applied?
let me guess…
Even Nostradamus could predict it 😉
Short update: The Medical University of Vienna forwarded this case to the Austrian Agency for Scintific Integrity for investigation into possible scientific misconduct.
Things get moving.
very good!
I hope the agency is truly independent, objective, and rigorous.
At least the medical expert of the agency resides in the Netherlands, he is not somebody entangled in the local folklore.
https://oeawi.at/vereinsorgane/#kommission
that’s good to hear!
“Members of Austrian universities and research institutions cannot be nominated as members of the Commission.” – Statutes of ÖAWI, §16 (5) (https://oeawi.at/en/statutes-3/)
Seems they are trying to set up a commission to really be free of domestic entanglements.
good!
Good news, indeed.
Norbert, why do you have to lie? Mathie, and ironically Shang and first australian report when not manipulating protocol, are consistent in demonstrating that homeopathy has a robust effect beyond placebo. I’ve had enough of reading your absurdities and they rely on doing ” simulations “of what”should happen”. Your work is very similar to that of your colleague Alexander Panchin when he tried to “prove” that glyphosate had no adverse effects on living systems. It’s a shame that your fate is the same as your colleague’s: getting caught up in manipulating data trying to invalidate facts they don’t like. Add the conflict of interests with your german lobbyist organization.
https://edzardernst.com/2017/05/a-method-of-ending-discussions-with-belligerent-twits/
@ Zhang:
Frass et al. are not Norbert Aust’s colleages. You’re mixing something up.
You sure you refer to the same evidence that I do?
I would doubt it. There is no “first report”. All I know is a report issued by the NHMRC back in 2015 and some garbaged draft of a report of a consultant which failed in many ways. Like one time evidence level C is “unclear evidence” on other occasions “encouraging evidence” and other crap. And no solid evidence for homeopathy of any kind. And even this piece of rubbish does not show any positive evidence in conditions that homeopathy claims to be perticularly valuable at. Like hay fever, ADHD, headaches and stuff. It could not be worse for homeopathy, can it?
And, please do not mind my saying, you should not stop reading papers when you think a sentence sounds good, but carry on and see what restrictions the authors put forward in the next sentence. Like the quality of the studies being too poor to come to any conclusion.
In a nutshell: Try to come up with something more sensible things than the worn-out and long debunked points you make.
Ernst, how stupid do you think the others are? A few hours ago your blog said that the article had been ” scrutinized “by two other experts” (https://web.archive.org/web/20210612030150/https://edzardernst.com/2021/06/a-thorough-analysis-of-prof-m-frass-recent-homeopathy-trial-casts-serious-doubts-on-its-reliability/), and now you change the edition to “group of members of the „INH“ and „Initiative für Wissenschaftliche Medizin“. This rather than helping you makes it clear that the activity of the German anti-homeopathy lobby is desperate to retract Dr. Frass ‘ paper. Where do you make up that Norbert Aust is an “expert”? Since when is an industrial engineer “expert” in statistical analysis in medicine?
Wait a minute, Aust had already tried to retract Frass paper claiming that there was data manipulation, but then Frass and his team showed that Aust was the one who manipulated the data. Perhaps this is a good opportunity to demonstrate that Aust is dedicated to the fine art of manipulating data to invalidate results.
Wait another minute, Viktor appears as a member of the GWUP. That says it all.
Seems you know more than I do. Please indicate where Frass an colleagues showed that I was the one to manipulate data.
Norbert, you forgot to dilute the data. An unacceptable intervention from a homeopathic point of view.
but, according to Frass, one dilutes selectively … or did I perhaps misunderstand this?
That’s right. Exactly what is needed is potentized 😉
No, I did not forget it. But something went wrong after I poured the solvent into my laptop computer.
You just have to harmonize the Hahnemannian spirit-like forces with the software.
This works under Windos 10 home edition?
Hello Zhang,
Yes, I am a member of the GWUP. What is the problem with it? I pay my annual membership fee to them. And I am member of other associations, too, where I pay my membership fees.
I would be delighted if You came up with some scientifically sound rebuttal of our findings instead of firing ad hominem attacks. Please read our findings thoroughly, download the documents freely available, and criticize them. I admit that sorting out the stuff is quite confusing, it took us also some time to get clear sight through it.
Have a nice day and enjoy summer which has finally come!
@ Norbert:
If you believe in it hard enough, maybe.
I’m late to this party, but there are two major gatekeepers that need to be considered.
1. The protocol was reviewed by the Ethical (sic) Committee of the Medical University of Vienna. Any changes to the protocol should also have been reviewed. The committee chairperson should be asked for the minutes of meetings at which these reviews took place.
2. Were the peer reviewers of the manuscript qualified to assess this study? Were they provided with all relevant documents? Did they know about the protocol amendments?
very good points!
Those are very good points indeed, but I fear, we cannot answer them. What we did, though, was to inform the Ethics Committee of the Medical University of Vienna, that consented to this study in 2010, about this issue. We had contacted them before to get a copy of the document that was submitted on this behalf, but did not receive any answer.
About the same with the Journal: We submitted our letter to the editor, where we pointed out the various issuues, but did not receive any answer yet. I guess they should review their peer-reviewing-process.
not getting any response from the ethics committee nor from the journal reflects VERY badly on both.
I would send regular reminders.
From author Christian Kreil (STIFTUNG GURUTEST) in “Der Standard”
Scientific sensation or fraud? Study on homeopathy for lung cancer under scrutiny
Skeptics meticulously list the inconsistencies surrounding a successful study by university professor Michael Frass
https://www.derstandard.at/story/2000127344797/wissenschaftliche-sensation-oder-betrug-studie-zu-homoeopathie-bei-lungenkrebs-am
Christian Kreil points out that Michael Frass advertised amulets against electosmog 10 years ago: Frass’ research should always be viewed with caution, Kreil says. He is right.
I am about to finalize a new post about this; it will be up later today.
Are the so-callled “homoepathic” remedies in the “study” actually the contested high dilutions?
Or, are they just commonly accepted remedies — in the shape of globuli?
highly diluted
Thank you, Edzard.
Would you happen to know the doses of the D dilusions (delusions?) used in the “study”?
this is what the article (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8108047/) tells us:
Homeopathy uses a wide variety of source materials, which means that various methods of preparation are necessary depending on the substance being processed. Homeopathic medicines are derived from plants, herbs, minerals, or animal products [23].
All study medications (D, CH, LM, and Q‐Potencies) were prepared (Maria Treu Pharmacy, Vienna, Austria) in accordance with the current version of the European Pharmacopoeia (Ph.Eur.), the German Homoeopathic Pharmacopoeia (GHP), and the Q‐potencies according to Hahnemann’s 6th edition of the Organon of Medicine [17]. In brief, the constituents of the homeopathic medicinal products (HMP) are mainly plants, minerals, or of animal origin. The HMPs are manufactured by stepwise dilution and succussion, thereby preparing stable GMP‐grade formulations.
Homeopathic medicines were produced through sequential agitated dilutions in alcohol/water or by trituration in powdered lactose in decimal (1:10), centesimal (1:100) or quinquaginta millesimal (1:50,000) potencies (Q‐potencies) / LM‐ potencies (Table (Table5)5) [23].
Table 5
Preparation of the Q‐potencies at the pharmacy and instructions for use of the Q‐potencies by the patient
An external file that holds a picture, illustration, etc.
Object name is ONCO-25-e13548-g003.jpg
Abbreviations: Q‐potencies, quinquagintamillesimal (1:50,000) potencies; CH3, centesimal potencies.
All homeopathic therapies started with Q1 potencies of the selected remedies for 3 weeks, and continued in ascending order with Q2, Q3, of either the same remedy or a selected alternative (3 weeks each) toward Q30. Where the study substance was changed, whatever the reason, the new cycle started from the beginning with Q1. A primary reason for changing the study substance was disease deterioration.
The Q‐potencies were applied as liquids, after being shaken and diluted daily by the patient (Table (Table5).5). The package leaflet also mentions the number of succussions to be carried out by the patient every day and the number of drops or spoonfuls to be taken [23]. They were used in the trial as constitutional medication based on the mental, emotional, and physical symptoms displayed by any patient. The D‐, C‐, and LM‐potencies were applied as sugar granules. Five pellets comprised one dose, which was taken orally by sucking.
Dear Edzard,
thank you for reply. Unfortunately, the passage tells us very little about the D-dilutions used (probably for a good reason).
“The D‐[…]‐potencies were applied as sugar granules.”
If that is so, which substances were used as D-potencies?
And how highly were they diluted, D1 (10%), D2 (1%), …?
As far as I see, the authors do not make this clear, and there is still a possibility (small, but not to be dismissed) that D1-granules contain a traceable amount of pharmaceutical agent.
Could this not be an important point?
The author’s statement the “D-potencies” were used hardly says anything about the daily dosis. Should this not be sufficient evidence to question the publication of this “study” in a reputed journal?
I wonder whether this point is taken into account by the commission now investigating the issue.
one would expect that they carefully consider all aspects of the study.
@ AB
“and there is still a possibility (small, but not to be dismissed) that D1-granules contain a traceable amount of pharmaceutical agent.”
But the daily dose the patient would ingest is way too small to achieve any effect, even with really active ingredients.
“Five pellets comprise one dose”. Those pellets in use in Germany and Austria weigh about 10 mg each, the dose would be 50 mg of pellets (sugar).
To prepare the pellets 1 % of the pellets’ weight is the amount of potentised solvent, that is sprayed onto the sugar pills. Consequence: one dose of five pellets contains the remnants of 0.5 mg of potentized solution.
If this solution is potentised to D1 only, the amount of mother tincture ingested per dose would be 0.05 mg.
Now homeopaths usually do not start with a pure active drug, but with plants, animals or parts thereof. For instance Apis mellifica: One bee weighs about 80 to 100 mg and may contain 0.1 mg of bee venom. But the mother tincture is prepared from the whole animal. So roughly we may assume with Apis mellifica D1 one dose comprises of 0.000 05 mg of active ingredient – and a lot more of anything else from the animal that is soluble in alcohol. Not to mention the impurities of the raw materials used for the pellets.
With other ingredients, table salt for example, the mother tincture really might be near to 100 % pure original material, so one dose of five pellets would contain about 0.05 mg of table salt. Compare this to the 3,000 mg we usually consume per day together with our food.
There may be active drugs around that may cause some effects when you ingest 0.05 mg only – but such drugs would not be available in the market in so low a potency. Example: Botulinum, a homeopathic preparation of botulin toxin is available in D12 as the minimum potency only. While the lethal dsoe of a grown up human is about 90 ng (“nanograms”) the content of one dose is 0.000 000 000 000 050 mg = 0,000 000 050 ng.
If you can read German here is an article where I discuss the various issues about low potency homeopathic preparations: http://www.beweisaufnahme-homoeopathie.de/?p=5276
hmm, let me insist that the problem of the D dilutions generally does not receive the attentions it deserves.
Even if we do not agree on this, let us keep an eye on how this issue will be treated in the things to come.
Since the missing numbers about the doses (dilutions) have not been an issue so far (also in this thread), there is a realistic possibility that this aspect will be overlooked.
I admire your efforts over all these years and everything you have achieved.
Unfortunately, in all respect that is certainly due, I will have to hold that the numbers are important (or, their absence).
I never doubted that the dilution number is important.
But if there have been irregularities in this trial, they probably are found in other aspects.
The suspicion is that selected patients were omitted to prettify the results.
@ AB
I do not see any new aspect in these D-dilutions that would necessitate a new discussion on efficacy. The lowest D-potency is 10 times more concentrated than the smallest C-potency – but both seem to be in use in very rare occasions only. After that the preferred D- and C-potencies correspond to each other (D6-C3, D12-C6, D24-C12 etc.).
Dear Dr. Ernst, dear Dr. Aust,
thank you for your kind replies.
I wholly agree with your rejection of Homeopathy. The problems that I wish to point out are anyhow of some importance.
1.
The study professes to be a study on the on the efficiency of certain medications.
However, in the study the doses of the medications are not made clear.
This is a major flaw.
2.
A “D1” dilution designates a dilution that contains 10% of the agent.
If a D1 dilution is prescribed as a fluid, and drunk by the patient,
there is a high probability that the effect is caused not only by the placebo effect.
In any case, I hope we can continue this thread in a cooperative tone, since we a working towards the same goal, and there is probably some food for thought for everyone.
@ AB
“as a fluid, and drunk by the patient”
… but this is not the way homeopathic dilutions are deployed: One dose is five droplets.
See here: https://www.dhu-globuli.de/homoeopathie/haeufig-gestellte-fragen/ (in German).
expand “Wie ist die Dosierung homöopathischer Arzneimittel?”
@ AB,
I suggest you read the document: “Guidelines for Manufacturing Homeopathic Medicines”, Homœopathic Pharmacopœia Convention of the United States.
You wrote: “If a D1 dilution is prescribed as a fluid…”.
A better term is “liquid” because the term “fluid” encompasses the states of matter: liquid; gas; plasma.
Does homeopathy even recognise the existance of plasma, given that its basic precepts contradict the molecular theory of matter?
@ Julian,
Samuel Hahnemann 10 April 1755 – 2 July 1843.
“Plasma was first identified in laboratory by Sir William Crookes. Crookes presented a lecture on what he called ‘radiant matter’ to the British Association for the Advancement of Science, in Sheffield, on Friday, 22 August 1879 [my emphasis]. However, systematical studies of plasma began with the research of Irving Langmuir and his colleagues in 1920’s. Langmuir also introduced the term ‘plasma’ as a description of ionized gas in 1928 [my emphasis]”
https://en.m.wikipedia.org/wiki/Plasma_(physics)
> One dose is five droplets.
Thank you.
Yes, as a rule, that is certainly true. Five droplets of a D1 dilution will usually not have much of an effect.
However, this is only the non-binding DHU recommendation.
Some homeopaths will recommend, for example, 20 droplets of Valeriana officinalis D1, 3 times a day ( http://www.homoeopathiewelt.com/einzelmittel/valeriana-officinalis-radix-valerianae/ ).
Others recommend, for example, 10 droplets of Foeniculum D1 “several times” a day in the case of digestive disorders.
Correct me if I’m wrong, but it seems that with these amounts of 10% dilutions, doses can be reached which have a real pharmacological effect, let alone that the agent can be proven to physically exist in the medicament.
D dilutions have already been presented in respected media as a scientific proof for homeopathy. For a general audience, D1 and C30 sound just the same. This will happen again in the future.
I would therefore like to suggest once more not to dismiss the matter easily.
In this professed double-blind study, Echinacea D1 was allegedly used.
https://link.springer.com/article/10.1007/s00106-006-1480-x
Due to the paywall, I cannot see which doses were given to the patients.
It was published in Nature that water has a memory. This was in 2005.
But as a result this will not help homeopathy.
Becaus this memory fades away very fast–ultrafast. Memory fades away in about 50 fsec (femto seconds)- not compatible with any expiry date for a medicinal product. It expires during production.
Ultrafast memory loss and energy redistribution in the hydrogen bond network of liquid H2O. Covan et al
Nature . 2005 Mar 10;434(7030):199-202. doi: 10.1038/nature03383.
link: https://pubmed.ncbi.nlm.nih.gov/15758995/
Just to keep the dimensions right: 50 fsec is the time that light needs to travel 0.015 mm. That means water memory expires about 30,000 times before you even see the outcome of this step for the first time.
Ah but you forget the First Law of Pseudoscience – “the more impossible something is the more certain it is to be true”.
Or at least believed.
It’s related to the Second Law – “the complete lack of evidence for something is the definitive proof that they are covering it up”.
Made my day. Especially the second law.