Patients with advanced non-small cell lung cancer (NSCLC) have limited treatment options. Alongside conventional anticancer treatment, additive homeopathy might help to alleviate side effects of conventional therapy. The aim of this study was to investigate whether additive homeopathy might influence quality of life (QoL) and survival in NSCLC patients.
In this prospective, randomized, placebo-controlled, double-blind, three-arm, multi-centre, phase III study, the researchers evaluated the possible effects of additive homeopathic treatment compared to placebo in patients with stage IV NSCLC, with respect to QoL in the two randomized groups and survival time in all three groups. Treated patients visited the university teaching hospital every 9 weeks: 150 patients with stage IV NSCLC were included in the study.
- 51 patients received individualized homeopathic remedies plus conventional treatments,
- 47 received placebo plus conventional treatments,
- 52 control patients without any homeopathic treatment were treated with conventional therapies and observed for survival only.
For groups 1 and 2, the study was double-blind. The constituents of the different homeopathic remedies were mainly of plant, mineral, or animal origin. The remedies were manufactured by stepwise dilution and succussion, thereby preparing stable GMP grade formulations.
QoL as well as functional and symptom scales showed significant improvement in the homeopathy group when compared with placebo after 9 and 18 weeks of homeopathic treatment (p < .001). Median survival time was significantly longer in the homeopathy group (435 days) versus placebo (257 days; p = .010) as well as versus control (228 days; p < .001). Survival rate in the homeopathy group differed significantly from placebo (p = .020) and from control (p < .001).
The authors concluded that QoL improved significantly in the homeopathy group compared with placebo. In addition, survival was significantly longer in the homeopathy group versus placebo and control. A higher QoL might have contributed to the prolonged survival. The study suggests that homeopathy positively influences not only QoL but also survival. Further studies including other tumour entities are warranted.
First of all, let me thank my friend Dana Ullman for alerting me to this new and interesting study. I have read what seems to be the full paper several times and have to admit that it puzzles me (and perhaps this version is just some type of pre-publication paper). Firstly, there seems to be no methods section (the abstract is followed by several tables and a discussion), and I am left guessing much of the details. Secondly, the paper raises several questions in my mind:
- What is the purpose of group 3? The authors call it a control group and state it allows assessing the real homeopathic effect on the homeopathic cohort as the real effect will be the natural historical effect minus the placebo effect and the homeopathic effect. Does that make sense?
- Was the study under-powered? From my reading of the text, the answer seems to be yes.
- What is the full list of conventional treatments the patients received, and did they differ between the 3 groups?
- If I understand it correctly, the study patients did not receive immuno-oncological therapy. Does that fact not render the study unethical?
- What homeopathic potencies were prescribed in group 1? The paper says: The constituents of the different homeopathic remedies were mainly of plant, mineral, or animal origin. This is unlikely, as most homeopathic remedies contain nothing.
- The authors seem to have used individualised homeopathy according to Hahnemann’s instructions. Did Hahnemann not strictly forbid combining his approach with other types of treatment?
- How well respected is THE ONCLOLOGIST, the journal that published the paper?
- Was the article peer-reviewed? If so, by whom?
- Was the placebo indistinguishable from the verum?
- Was the success of patient-blinding checked?
- Have similar findings regarding survival been reported previously? The authors call this finding ‘unexpected’; I find it more than that; it is baffling.
- Should we accept such surprising findings, or would it be more prudent to wait until independent replications are available?
- The first author of this trial is Prof Frass who has featured on this blog several times before (see for instance here, here, here, here and here). Frass has published several studies of homeopathy and invariably manages to produce positive results. Am I the only one to find this odd?
I would be most grateful, if the readers of this blog could assist me in finding answers to some of the above questions.
I too accessed the paper to which you have kindly linked, last night. I am not a scientist so my impressions are those of am interested layperson, unqualified to analyse medically.
It was late at night and my eyes tend to glaze over anyway at pages of tables and numbers, especailly on a laptop screen, so I cannot attempt an anlysis.
It struck me that a lot of space was given to describing the methodology of preparing the homeopathic ‘remedies’, and it seems to me that this could have been in a separate appendix, with the body of the study taking it for granted that the remedies were corretly prepared accoring to homeopathic principles. For all that description, I found it hard to see what potencies were used, but saw a reference to LM, putting the presence of any molecule of substaance, far, far beyond possibility.
Maybe I missed it, but I didn’t see a rationale for or description of the approach to homeopathic prescribing – was it based on “constitutional remedies” for each patient, or on totality of symptom picture only?
I have just added another point (No 6) which deals with the type of homeopathy used in this study
I was struck, too, by the questions you raise in 6 and 7. THe PDF looks nice enough, but that means very little. Not being a medic or scientist, I had no idea of the status of The Oncologist as a medical publication. Is it a high-impact mainstream oncology journal? Doubtless Dr M-K would know.
The aspect of “adding” homeopathy to, or mixing it with, other therapies has of course been mentioned before. Maybe Hahnemann is due a bit more credit than many of his followers: Some mainstream treatments of 1795 – purging, bloodletting etc – were best avoided. If you had harmless pills and tinctures to offer, you wouldn’t want that mixed with harmful treatment modalities, I guess. But homeopaths of today need to decide, and to state, just how much of Hahnemann they follow, and what they’ve abandoned and why.
Hahnemann rejected everything other than homeopathy, and not just because it was useless or even dangerous:
Indeed I had forgotten about all that!
I think even today some homeopaths say to keep the ‘medicines’ away from toothpaste, coffee, etc. No mental exercise, I could happily go with…
Anyway, I take back the credit I gave Hahnemann…..
Like the bottle of wine I bought once which said on the label that it should be stored away from loud noises. It tasted as though it had been kept in a disco.
Hahaha! Did you drink it anyway?
In my experience working with clients, herbal supplements like essential oils, coffee, etc are a problem and can antidote the action of a remedy. Most chemical drugs and supplements, while making it difficult to assess results sometimes, do not interfere with the action of the remedy very much. There are major exceptions such as long-term prednisone use.
In Dr Hahnemann’s day doctors were using many more herbs than they use now, which may be why he was more adamant about not mixing therapies.
he was adamant about mixing homeopathic remedies with just about anything, not just therapies. so do not revive the old chestnut, please.
Uh…. supplements and essential oils and the like are chemicals. Water is a chemical.
Roger and Edzard are both incorrect here. Hahnemann didn’t want patients to use other treatments because he is so scientifically-minded that he wanted to use only ONE treatment at a time so that he can be more confident if that treatment had an impact or not. By using multiple treatments, one doesn’t know which treatment provided the benefit.
That said, sometimes, it is simply more important to provide benefits to patients rather than know with greater confidence which treatment worked. And sometimes it is problematic, especially in dire cases, to “put all one’s eggs in one basket” by prescribing only one treatment. Modern classical homeopaths these various factors into determining when to provide only one treatment or more than one treatment.
Skeptics of homeopathy tend to think in black-and-white terms which are typical straw-man arguments that are curious to watch and are simply evidence of their ignorance and their avoidance of complex thinking.
I have read the Organon several times in its original version and affirm that this is not true. if you think otherwise, show me where he said this.
The case is rest!
It is not up to you to determine whether a case is closed or not. Many laymen who comment here are far more rational and possess more knowledge than the so-called homeopathic experts (like you).
You should better practice humility and remain silent.
“Firstly, there seems to be no methods section”
Silly Doctor, you’re *supposed* to take their word for it.
“Frass … invariably manages to produce positive results”
Thereby *proving* homeopathy works!
Oh, and is it just me, or does anyone else feel their stomach churning at the thought of dying people being predated by the slimy Dana and his narcissistic cohort for their own personal validation and profitable greater glory? Anyone know a good homeopathic anti-emetic I can take for these symptoms, and which direction I should turn so I’m facing Mr Ullman when I take it?
I´d love to hear what Dr. Money-Kyrle as an expert has to say to this…
One quick comment regarding point 4:
The mother of my partner died from an inoperable non-small cell lung cancer a few years ago. Witnessing her deterioration was the most horrific experience in my life. Since I tried to keep track with her options during her time of treatment, I did some reading about this back then.
To my layman´s understanding, the genetic reasons for NSCLC are quite diverse, and treatment options depend on the stage of the disease and on several genetic markers (e.g. PD-L1 expression). For several types of NSCLC, immuno-oncological treatments are not available (as was the case for my partner´s mother, who was treated with carboplatin and irradiation, before being transferred to palliative care).
When I was practising I treated genitourinary tumours, not lung cancer; my knowledge of the role of immunotherapy and PD-L1 expression in lung cancer comes from having to read a few papers and talk to colleagues in order to advise a close relative who has had the same problem.
I wouldn’t use the term “genetic reasons for NSCLC” as this might be interpreted as referring to an inherited susceptibility. However, there are many DNA mutations and changes in gene expression found in particular cancers, and increasingly has become possible to correlate these with tumour behaviour and response to particular drugs, to the point where it is now standard practice to do some sort of genetic testing for NSCLC.
The most commonly used immunotherapy for NSCLC involves so-called checkpoint inhibitors, such as pembrolizumab, which act on PD-L1 and it’s receptor, blocking its shielding effect and revealing the tumour cells to the immune system (this is a very simplistic explanation, but I am not a molecular biologist). Studies in SCLC have stratified the patients according to PD-L1 expression and differences in outcome have led to PD-L1 measurements being used clinically to decide who to treat. However, the issue is complicated; as always, initial trials have tended to be in patients who have progressed following standard treatment, and it seems that the level of PD-L1 expression predicts response to checkpoint inhibitors in patients who have failed primary chemotherapy. On the other hand, more recent data supports giving checkpoint inhibitors and chemotherapy together in newly diagnosed patients (from what I can remember this can double overall survival, though in practice some patients benefit much more than others). Crucially, in this situation an important benefit is seen even if the PD-L1 expression is low.
Clearly this is an emerging field and we have a great deal to learn here, but it is exciting for oncologists at last to have some relatively non-toxic tools for treating these very difficult tumours.
I believe the current gold standard for chemotherapy in NSCLC is cisplatin combined with pemetrexed, with the cisplatin given for foud 3-weekly cycles and the pemetrexed continuing until relapse or unacceptable toxicity, and carboplatin being substituted for cisplatin if the renal function is poor or there are other reasons not to give it (cisplatin is a very toxic drug and I have permanent high-frequency hearing loss and magnesium loss from my kidneys as a result of a single dose of it). In a newly-diagnosed patient with metastatic NSCLC this is now combined with a checkpoint inhibitor.
Please note that:
1. I have been away from clinical practice for nearly four years and the field is changing very quickly
2. I have no experience of prescribing checkpoint inhibitors or other immunotherapy myself
thank you for your explanation. Although I hold a PhD in molecular biology, this doesn´t help too much here, because photosynthesis is my area of research, not immunology, and the interplay of PD-1, PD-L1 and T cells seems to be quite complicated indeed. My partner´s mother did not have increased expression levels of PD-L1, so pembrolizumab was unfortunately not an option.
Since the parents of my partner have not background in science, I at least tried to “translate” the information from the oncologists to them, which was not an easy task. Without wanting to blame anyone, I often was surprised how little information from the doctors came across correctly.
Witnessing the helplessness and agony during the year from diagnosis to death made it very obvious to me why so many people fall for charlatans and try anything that promises help, which in turn made me despise these morally bankrupt people even more.
I used to spend a lot of my time explaining things to my patients (one of the reasons why my clinics always notoriously overrun). My wife (a clinical psychologist) has decided that I have Asperger’s, and if that is true, then what comes naturally to most people when it comes to reading expressions and the nuances of body language is something that I have had to learn. Maybe that has made me better at explaining things than many of my colleagues.
I would always start an explanation by asking what the person knew already. This would not only give me a starting point to build on, but would give me as to information about their level of education and their ability to grasp unfamiliar concepts, as well as some clues as to their hopes and fears. It also helped to build a rapport (people always come away from an encounter feeling that they have had a good conversation when they spent more time talking than listening). I would then try to fit what I said into something that I thought that they would be able to understand, sometimes checking by asking them what the important points were.
On the occasions where I have seen my colleagues explaining things I have been quite shocked at how their assumptions about the people they were talking to have interfered with their ability to get the message across. This was particularly brought home to me when I attended a mandatory 3-day course in advanced communications skills. The participants were all fairly experienced healthcare professionals (mainly NHS Consultants such as myself) and the organisers had hired actors to play the part of patients. They were very good at it – at one point one of the participants was giving bad news to the “patient” and found it so difficult to continue when they started crying that the actress suddenly snapped out of her emotional state to point out that acting was what she did professionally and she wasn’t really caving in…
One gastroenterologist demonstrated how he used to tell people that they had cancer. He was very sympathetic and clearly cared about how he did it, but the message that he got across was so confusing that most people would have come away baffled and very anxious. (My technique was to ask the patient what they thought was wrong with them. They would nearly always say something like “It’s not cancer, is it?” and I would reply “Yes, I’m afraid it is, but this is what we can do about it.”
Another consultant, a haematologist, started off by talking about all the different kinds of leukaemia and how they are classified, saying, “Well, I’m pleased to say that we haven’t found this one, and the tests for that one were all normal, as well as for this other one… We just found one abnormal test suggesting that you have acute myeloid leukaemia.” It was like reading a surveyor’s report along the lines of “Well, we took some tiles off and crawled into your attic and the roof was sound, we put probes into your walls and there is no rising damp, we tested the foundations and they were sound. In fact the only small problem with your house is the unexploded bomb in the cellar.”
Medicine is often taught in English abroad, and there are many doctors working in the UK whose first language isn’t English. They would have learned the technical names for parts of the body, diseases, bodily functions etc., which are standard for communicating between health professionals but aren’t used by normal people, and the vernacular terms wouldn’t form any part of their vocabulary when they were learning English (how many language course talk about how to describe difficulties going to the toilet, or the commonly-used terms for parts of the genitalia?).
Happily these days in cancer care in the UK each patient is assigned a key worker, usually a specialist nurse, who becomes their main point of contact and whose job plan allows time for extended sessions with their patients on multiple occasions. Printed information sheets are also in common use. I suspect that some of the “moral bankruptcy” that you describe really comes down to communication skills, which can be addressed and taught. I hope that wider recognition of these issues and better training of professional staff can continue to address the problems of bad experiences of cancer sufferers and their families.
this may have been a misunderstanding.
I am not blaming the oncologists of my girl-friends mother. I was only present one time when her parents talked directly to an oncologist, and he was doing a very good job imo.
Most of the time, I explained the doctor-letters to them (which you get after an appointment) and then noticed that many thing were unclear to them, which could have been discussed during the appointment.
Part of the miscommunication probably was because the parents did not tend to ask the doc directly when they did not understand something. Guess they had too much respect (?) to ask for clarification… or maybe they did not think that they would understand the details anyway.
When I was diagnosed 2015 with cancer, it was weird experience. It was my first visit at any urologist (kind of a “check-up”), so the doctor and I did not know each other at all.
The way he told me was quite clear and direct, something like:
“Oh, I found something that does not belong there, I have to tell you that you have […]cancer. Fortunately, though, this form can be operated and generally can be treated very well.”
Then, although I was his last patient that day, he spent quite some time calling colleagues in the hospitals in my town to try to get a surgery appointment as soon as possible for me.
Four days later I got surgery.
I am very grateful for his clear words and his help. I was lucky that I found such a good doctor, which I see since then on a regular basis for check-ups.
My despise is directed towards those morally bankrupt charlatans who offer SCAM to terminally ill persons, and make a comfortable living this way.
Consultant paediatric neurosurgeon Jay Jayamohan in his book “Everything The Makes Us Human” describes the sad case of a boy with brain cancer for which no options except palliation were left.
The Mum decided to take him to a “therapist” in Germany to get “crystal therapy”. The money for this was to be raised by selling their house. They sold it, went, and the boy died within the expected time frame, passing away peacefully with his loving family present. As would have happened at home.
But they crystal therapy guy had all their money, and they didn’t own a house any more.
On the other Hand, I – living in Vienna where we also have many 2nd language doctors – have experienced doctors born and raised abroad as the ones who usually spent more time with me or other patients than did many doctors born an raised here. Now, fortunately I never had any serious health issues so far that would have caused any problems as you describe. I have no doubt that they exist, too, and that that lack of vernacular can be a serious issue in some cases. It’s just in my experience that if the setting allows for it people who have practiced medicine in two languages and who know how difficult it is to learn another language tend to be the ones who know that talking to patients and explaining things are important parts of the treatment.
Btw, it was always the equivalent of NHS doctors I went to, I have no private health insurance. But maybe public health insurance here works better than in the UK and typically allows for a bit more room. And, of course, my experience is anecdotal and there may well be other factors at play that explain it.
This being said, I think we both agree that over all communication skills are something that was soreley missing in the education of doctors and even with the current improvements you write about this is something that partly explains the popularity of alternative “medicine”.
Why is it that whenever a study involved homeopathic medicines that people’s brains literally fall out?
Why or how do people somehow forget that blinded AND placebo controlled trials, such as this, control for factors such as the “sensitivity” of the clinician or the ability of the clinician to speak two or three or whatever languages?
Curious minds want to know…
I gave you a few reasons why the brains of the investigators seem to have fallen out:
What is the purpose of group 3? The authors call it a control group and state it allows assessing the real homeopathic effect on the homeopathic cohort as the real effect will be the natural historical effect minus the placebo effect and the homeopathic effect. Does that make sense?
Was the study under-powered? From my reading of the text, the answer seems to be yes.
What is the full list of conventional treatments the patients received, and did they differ between the 3 groups?
If I understand it correctly, the study patients did not receive immuno-oncological therapy. Does that fact not render the study unethical?
What homeopathic potencies were prescribed in group 1? The paper says: The constituents of the different homeopathic remedies were mainly of plant, mineral, or animal origin. This is unlikely, as most homeopathic remedies contain nothing.
The authors seem to have used individualised homeopathy according to Hahnemann’s instructions. Did Hahnemann not strictly forbid combining his approach with other types of treatment?
How well respected is THE ONCLOLOGIST, the journal that published the paper?
Was the article peer-reviewed? If so, by whom?
Was the placebo indistinguishable from the verum?
Was the success of patient-blinding checked?
Have similar findings regarding survival been reported previously? The authors call this finding ‘unexpected’; I find it more than that; it is baffling.
Should we accept such surprising findings, or would it be more prudent to wait until independent replications are available?
The first author of this trial is Prof Frass who has featured on this blog several times before (see for instance here, here, here, here and here). Frass has published several studies of homeopathy and invariably manages to produce positive results. Am I the only one to find this odd?
Gad…you surely know that most of your questions are innane! You want to know WHO peer-reviewed this paper? Show me the list of peer-reviewers for articles in the Lancet or the BMJ (you KNOW that this info is not available).
As for the journal, it is edited by an oncologist at Harvard…and it has a 5+ impact factor.
The purpose of the third group?…it is simply another control…if you wish, you can simply compare the first 2 groups…and therefore, please TELL us what the difference in RESULTS is here. END OF STORY.
Was the study underpowered?
What is the full list of conventional treatments the patients received and did they differ between the 3 groups?
The authors seem to have used individualized homeopathy according to Hahnemann’s instructions. Did Hahnemann not strictly forbid combining his approach with other types of treatment?
Should we accept such surprising findings, or would it be more prudent to wait until independent replications are available?
Can Frass be trusted?
“Why is it that whenever a study involved homeopathic medicines that people’s brains literally fall out?”
People’s brains do NOT literally fall out. People’s brains only literally fall out when there has been a catastrophic head injury.
No it doesn’t. At the time these patients were recruited there were very little data available to support the routine use of immunotherapy for lung cancer. It is only in the past three-to-four years that it has become the gold standard of treatment (in combination with chemotherapy) following the publication of the Keynote series of trials.
These are highly significant points, I feel.
“Informed consent” is properly a keystone of ethical medical practice. But what if the ‘information’ is of such complexity that persons even of a good level of education, let alone those who are poorly educated and bad at understanding information, struggle to comprehend fully? Is consent truly ‘informed’?
While it can be possible to reduce or simplify some complex information, using metaphors and so on, without going so far as to be entirely simplistic, consultants work within tight time constraints, and there are limits to absorption in the framework of a hospital consultation.
Patient support charities do much to help in this regard, producing well-explained booklets and so on. But patients may have already ‘consented’ to a course of treatment before they access such information.
It is easy to see the appeal of a simpler explanation, with metaphors, from a SCAM practitioner, despite the facts that 1) the simple explanation is entirely fake, 2) the metaphors are illustrating a fake thing, not a truth and 3) there is no evidence that the SCAM will help the patient more than placebo.
It does seem quite a strange paper in the way it is organised. The abstract has four sections (Background, Methods, Results, Discussion), but the paper itself has only a discussion section, the others being completely missing. Was there a technical problem causing it to be published incomplete?
The inclusion of a non-randomised control group consisting of patients who, as far as I can tell, refused to enter the study, is quite strange. Being a self-selected group and therefore subject to bias it cannot form part of any statistical analysis. However, it is interesting to look at the survival outcomes. Oncology researchers generally represent these by Kaplan-Meier curves as snapshots such as median survival can give a distorted picture. The authors have included Kaplan-Meier survival curves for the three groups towards the end, labelled “figure 1”. From these you can see that the control group did worse than the other two groups, and that the divergence of the control and placebo curves is similar to the divergence of the treatment and placebo curves. Perhaps the differences between all three curves simply illustrate the range of random variation?
The baseline values between the treatment and placebo group show them to be well-matched. So well-matched, on so many different characteristics, that they seem to be much more similar than you would expect by chance given the relatively small sample size. This is just my impression, though, not a statistical analysis.
The authors come from a number of different institutions from Austria and India; this was a multi-centre study, but I would be interested to know how the patients were distributed among the many centres. Possibly this might explain the strange list of many different tumour stages in the Baseline Characteristics table, as there seems to have been no standardisation of how tumour stage was defined within the study (what on earth is M3?). I would have expected at the very least that the authors would have made some attempt to rationalise this.
The absence of immunotherapy doesn’t worry me so much. The patients were recruited between 2012 and 2017, and much of the data supporting the routine use of primary immunotherapy (i.e. as part of first-line treatment), as far as I know, only became available towards the end of that period. The tables tell us that 30 patients in the study did receive immunotherapy at some point, I suppose after progression on chemotherapy, which is what I would have expected. Still, I would have liked to know more about what conventional treatments were given. For instance, we are told that 13 patients in total received radiotherapy, and that 28 of those 13 received whole-brain radiotherapy. We are not told how many patients received chemotherapy, which I would have thought was pretty fundamental, but we do know that 20 of them switched to carboplatin (this has a particular meaning to me as an oncologist as it is something that would normally occur after unacceptable cisplatin toxicity, but there should be some explanation here).
All in all I get the impression from this haphazard presentation of data that the authors don’t really understand what the conventional details of pathology, staging, radiotherapy and chemotherapy actually mean. For a paper looking at cancer treatment this doesn’t inspire a lot of faith.
thanks; most helpful!
I should add that I am not familiar with this journal. A quick Google search shows that it has this to say about itself:
The articles seem to cover a very wide range of different areas, including haematology, which is normally regarded as a separate specialism. Looking at their Web site it seems to be the official journal of the Society of Translational Oncology, which describes itself thus
This sounds as though it ticks some boxes, but I’m not very clear what it means.
The simple explanation that fits as a plausible answer to all the burning questions raised here about this paper, is that it is a work of fiction, deliberately falsified by medical novices to support and market homeopathy.
Do you have any evidence of fraud in the article?
“Do you have any evidence of fraud in the article?”
The simpler question would be: “Does the article contain evidence of anything else?”
Given that it’s stumping homeopathy, which flat-out contradicts everything else we understand about how this universe works, I will hazard the answer is “No”. (Which, of course, by homeopathic principles just goes to make it more powerful than we can possibly imagine.)
Religion is merely the fraud that you perpetrate on yourself first, and if it was only your funeral then nobody else would give a toss. But like all religionists you cannot help but evangelize it on others—and then it’s their funerals as well.
None of which you ever take responsibility for.
It must be so nice to go through your life never having to give a sh-t for anyone but yourself.
Do you have any evidence of fraud in the article?
Indeed. Methinks that it is the skeptic here who is the fraud. Calling “fraud” without a smidgen of evidence is the fraud in THIS case.
Lollypo & Dana
The evidence you ask for is here: https://pubmed.ncbi.nlm.nih.gov/33010094/
Homeopathy itself is a fraud, and your article offers no evidence to the contrary. A weak-ass Phase 2-esque trial with 50% extra padding offered up as feeble post-hoc rationalization for the fact you’ve already been flogging your product for years. Imagine if Big Pharma behaved like you—skipping Phase 3 and just going straight to profit—there would (rightly!) be riots.
Remember that famous Feynman line: “The first principle is that you must not fool yourself—and you are the easiest person to fool.” Which means, for starters, rigorously eliminating all confounders. So why did they not eliminate that pointless “control” group? (The placebo group is the control!) And then, having observed a non-trivial difference in survival time, they simply declare “homeopathy did it” and make no effort to explore and eliminate other possible explanations, such as overlooked confounders and simple statistical chance. Given how scientifically implausible homeopathy is, you’d think they’d want to eliminate all other sources of hoofbeats before declaring “unicorns’’. Yet nothing, just some marketing fluff for the wrap-up.
So, no, I see no obvious indication of malice, just plenty of handwaving and odd omissions which I’ll ascribe to homeopathic amateurism and its cargo cult theatrics. Happy? Because I’m not. You hold this up as your best evidence that homeopathy works, but before you start celebrating let us remind ourselves of the stakes here:
Other people’s lives.
I think that’d call for a higher standard of evidence than a few tiny trials and glowing papers.
There’s a reason real Phase 3 trials operate on populations in the 1000s: because with few exceptions (e.g. early penicillin) researchers are trying to discern a comparatively weak indication of efficacy in extremely noisy, complex, malfunctioning systems. The smaller the sample size, the greater the likelihood of an apparent signal being simple statistical noise. What was yours? 100. And that’s before we get to independent replication and post-market monitoring, because even when a Phase 3 returns a glowing result it still isn’t blindly trusted.
And real medical trials start with plausibility on their side, yet many ultimately yield a null result, either in the initial study or when others try to replicate it. So assume being “wrong” is the standard state, and be immediately suspicious of any result that deviates from that; and don’t even think of accepting it as “provisionally not wrong” until you’ve tested and eliminated every other possible explanation. Which you’ve clearly not done, and have no intention of doing so. Because you’re not pushing science, you’re pushing belief.
Were you pushing science, you would be first to declare your evidence base is not large and compelling, but thin and shaky AF. But you can’t even be honest about that.
So please, spare us your high school sophistry and painful “so when did you stop beating your wife?” contrivances. You still think it’s our job to disprove homeopathy. It’s not: it’s yours. That means whaling on it as hard as you possibly can in order to break it, not blowing gently on its sails and declaring great victory against the unbelievers.
That’s your fraud. Pretending you’ve tested homeopathy to death when you’ve not, all the while selling it to the sick and desperate telling them that it works.
It is curious to note that Julian and other skeptics here are ignoring one of the obvious conclusions one can and should make about this study…and that is, those patients given a homeopathic medicine, along with conventional treatment, experienced a better quality of life and a prolonged life.
It doesn’t matter if a different (or more “modern”) conventional treatment is offered today, THIS study confirmed that those patients given a homeopathic medicine experienced SUBSTANTIAL benefits not experienced by those who did not take a homeopathic drug, either the placebo group or the control group. The p-value was in the Oh, Oh, Oh my god range (.001).
this is the explanation that the authors offer. we don’t ignore it, we question it. it’s called critical thinking – you should try it some time!
Edzard – Dana hasn’t yet demonstrated any ability to perform ordinary thinking. Don’t expect him to cope with any of the more advanced critical processes.
sorry, I was getting ahead of myself
You are right about one of the conclusions one could draw from the study, however, given that homeopathy has consistently failed to demonstrate any efficacy beyond placebo in properly-conducted clinical trials and that all we know about maths, physics, chemistry, biology and medicine indicates that there is no reason for homeopathy to be effective, Ockham’s Razor applies and the more reasonable conclusion is that the study is a crock of shit, also a fair assertion given Professor Frass’ previous repeated demonstrations of underpowered p-hacking and Texas sharpshooting.
I think there are studies much more worth doing than studying the effect of adding nothing (homeopathy) to cancer treatment.
My neighbours Olly and Pauline (names changed) are good friends of mine, and Pauline is on a second round of chemotherapy for bowel cancer with metastases to liver and lung. She has told me that she does “water fasting” (with the permission of her oncologist) before the chemo. There is some credible evidence of benefit from this, it seems, but further studies are needed. She notes that “from the third cycle I fasted and my blood results were much better and I had no more delays due to neutropenia. Whether it had any other beneficial results we don;t know but felt it was worth a try”.
It seems to me that this kind of thing is much more worth exploring than homeopathy.
I have no idea what effect water fasting might have on neutrophil levels, but I would expect it to have a number of effects on physiological function.
Following a dose of chemotherapy the bone marrow stops producing blood cells for a few days. As the marrow recovers the newly-manufactured neutrophils need to mature before they are released, so there is a transient fall in the numbers measured in peripheral blood. Typically the nadir is at 7 – 10 days post-dose, but this depends on the drugs used. A low neutrophil count predisposes to certain kinds of common bacterial infections,. including some “opportunistic” infections which can occur when commensal bacteria normally present in the body get into the wrong place. Unfortunately in the absence of neutrophils the patient can get very sick very quickly, and this can be fatal. Oncologists are therefore paranoid about checking the neutrophil count before giving the next dose.
However, this isn’t the whole story, as the circulating neutrophils don’t necessarily reflect their functional capacity. Corticosteroids (such as dexeamethasone, prednisolone and hydrocortisone, all commonly used by oncologists) can detach neutrophils from the blood vessel walls, artificially increasing the blood count without affecting the total numbers.
The starting doses of chemotherapy are usually calculated according to the patient’s surface area. This generally takes no account of how the drugs are metabolised (though there can be corrections for liver and kidney function with some drugs), which can vary quite a lot between individuals. Therefore it is usual to adjust the dose in subsequent regimens according to toxicity in order to tailor them to the specific patient. For instance, if there is a delay due to neutropenia there is often a dose reduction for subsequent cycles. It is possible that this was the reason why your friend’s initial neutropenia wasn’t found subsequently. Though there are many other possibilities, such as the presence of a minor infection “using up” the neutrophils the first time round.
Thank you for this interesting background information. I should have explained for any here who don’t know the term (I didn’t myself) that “Water fasting” means fasting but drinking water. Whereas there are versions of fasting that are total, excluding even water, which instinctively doesn’t sound very wise to me. My friends are sensible in evaluating online ‘evidence’, and not doing anything without discussing with the oncologist. They have also together adopted a vegan diet. I found a discussion on Cancer Research UK, all anecdotal: https://www.cancerresearchuk.org/about-cancer/cancer-chat/thread/72-hr-fasting-before-and-after-chemotherapy
Dear Edzard and colleagues,
Your windy arguments, which you are trying to bring against the study with visible desperation, you should better think about and sleep on them. Somehow your rather unscientific attempts at discrediting remind me of Edzard’s once desperate exclamation:
“A new study of homeopathy suggests that highly diluted remedies are better than placebos (and I cannot fault it)”……
Homeopathy is something more than just Hahnemann’s Organon!
anyone who makes such general statements has no concrete arguments against the points raised, it seems.
Ah, a fine example of the classic Argumentum ad Homeopathie: the less evidence it offers the stronger it will be.
Here is the disclaimer on the bottom of the information page:
“While the publisher and Editorial Board make every effort to see that no inaccurate or misleading data, opinion, or statement appear in this journal, they wish to state that the data and opinions in the articles and advertisements herein are the responsibility of the contributor or advertiser concerned. Accordingly, the publisher, Editorial Board, and their respective employees, officers, and agents accept no liability whatsoever for the consequences of any such inaccurate or misleading data, opinion, or statement. While every effort is made to ensure drug doses and other quantities are presented accurately, readers are advised that new methods and techniques involving drug usage described within this journal should only be followed in conjunction with the drug manufacturer’s own published literature. It is the responsibility of the treating physician or other health care professional, relying on independent experience and knowledge of the patient, to determine drug dosages and the best treatment for the patient. This is particularly serious if the agent to be administered is a new one or one that is infrequently used. Because of the uniqueness of each patient and the need to take into account a number of concurrent considerations, this information should be used by physicians only as a general guide to determining the best treatment for each patient.”
Oncologist: Ranking within Oncology-Journals (total 367)
Ranking: 30 Oncologist journal 2.613 Q1 157 449 705 12820 3245 580 4.94 28.55
This new guy, “has,” is such a light-weight that he has not yet made any argument of substance. Instead, he relies completely on ad hominen attacks. As I said to him in a different discussion, he is the placebo response…and I don’t mean this as an ad hom, but just as an observer of what his contributions are.
Poor Dana, you seem to be terribly confused on where the burden of proof lies. Hint: It’s not on us, it’s on you. You want to claim homeopathy works, you need to learn the difference between customer satisfaction surveys and cold hard scientific research, and which one to bring with you when you pop up here to make a fool of yourself.
Your inability to understand/accept/acknowledge why, for instance, A+B vs A studies are not worth the toilet paper they’re written on says everything we need to know about your intent. You simply aren’t willing to prove yourself wrong†; so why should we do all your crapwork for you? You want—need—to be Right, and everything you say and do thereafter is in service to that goal. You are your own biggest rube, and you love it.
So why should we do anything more than point and laugh? It’s all you’ve earned.
You are literally Humpty Dumpty: you define words like “scientific” and “research” to mean exactly what you want them to mean, and then declare that Homeopathy works because your “scientific research” says it does.
You want respect? Start by making an honest effort to prove homeopathy wrong. It’s not a high bar to clear—if you’ve the stones to do so. Or admit that homeopathy is a religion and you’re its high priest. That works too.
Just don’t be telling others how much you think their sh-t stinks while you point-blank refuse to acknowledge the reek of your own. Because then we’ll just point out how you’re a pompous fraud (again) and laugh at you some more.
† Which is how science and the scientific method works, Einstein. It is impossible to prove yourself right, so you must do everything you possibly can to prove yourself wrong. If your hypothesis remains standing after you’ve pounded it within an inch of its life and then some more, then it is taken to be “provisionally correct” (i.e. not completely wrong); at least until such time that a better, more complete explanation comes along.
“The first principle [of science] is that you must not fool yourself – and you are the easiest person to fool.” – Richard Feynman
Brutal and brilliant writing, has.
Dana will not be able to respond
He never can.
Oh, Humpty will respond: he simply can’t help himself. It’ll just be his usual priggish bloviation is all. Good for mild amusement, nothing more. Eventually I’ll get bored and wander off again, but like the dumbest Energizer bunny he’ll just keep going on.
Honestly, Prof Ernst deserves a knighthood for tolerating the fool: in a cult of already world-beatingly dismal intellects, ol’ Dumpty somehow still manages to stand head and shoulders below the rest.
1) “What is the purpose of group 3? The authors call it a control group and state it allows assessing the real homeopathic effect on the homeopathic cohort as the real effect will be the natural historical effect minus the placebo effect and the homeopathic effect. Does that make sense?”
–>Yes, as stated!
4)”If I understand it correctly, the study patients did not receive immuno-oncological therapy. Does that fact not render the study unethical? –> would be unethical, but you can be shure, the ethics committee would not have allowed the study.
5)”What homeopathic potencies were prescribed in group 1? The paper says: The constituents of the different homeopathic remedies were mainly of plant, mineral, or animal origin. This is unlikely, as most homeopathic remedies contain nothing”
—> Didn´t I already tell you that your thinking within terms of matter only is a bit dusty? Physicist Dürr:”There is no matter”
6) “The authors seem to have used individualised homeopathy according to Hahnemann’s instructions. Did Hahnemann not strictly forbid combining his approach with other types of treatment?” –>I already told you: “Homeopathy is is more than just Hahnemann´s Organon!”
7) “How well respected is THE ONCLOLOGIST, the journal that published the paper?”
—> IF 5.025 Ranking 30 within 367 oncological Journals
8)”Was the article peer-reviewed? If so, by whom?”
—->As a repected journal, the oncologist would hardly publish anything without peer review! And: How long has it been, that the reviewers are named?
9) “Was the placebo indistinguishable from the verum?”
—–> Do you mean this question seriously?
10) “Was the success of patient-blinding checked?”
—> see 8) respected journal
11) “Have similar findings regarding survival been reported previously? The authors call this finding ‘unexpected’; I find it more than that; it is baffling.”
—> not for me: https://homoeopathiewirkt.wordpress.com/2020/06/16/when-is-sole-adjuvant-homeopathic-tumor-therapy-permissible-and-useful/
13) “The first author of this trial is Prof Frass who has featured on this blog several times before (see for instance here, here, here, here and here). Frass has published several studies of homeopathy and invariably manages to produce positive results. Am I the only one to find this odd?”
—>This comment is below your scientific dignity!
you really have no clue, haven’t you?
Dr. Hümmer never ever had any clue.
One proof is, among other things, that in Hans Peter Dürr he called in a dubious witness.
Well…in light of who is PETER DURR, it seems that it is YOU that live on a different planet and in your own personal orbit…
Here’s who he is:
Until 1997 he was director at the Max Planck Institute for Physics (Werner Heisenberg Institute) in Munich. He was also an important spokesman for the environmental and peace movement worldwide and was on the board of Greenpeace Germany from 1985 to 1991; he was also active for the Pugwash movement . The nuclear energy opponent Dürr was also the recipient of the alternative Nobel Prize (Right Livelihood Award 1987) and a member of the Club of Rome .
The problem HERE is that RPGNo1 is clearly out of his league. The Max Planck Institute of Physics and the Club of Rome are both clearly above RPGNo1’s pay grade. In fact, RPGNo1’s critique of Durr is in the “totally daft” league.
Are THESE organizations weird to you, my most sincere condolences.
There is a German proverb: “Schuster, bleib bei deinem Leisten.”
Which translates to “Cobbler, stick to your last.”
Dürr forget this piece of advice, as he gave his statement “There is no matter”. As did Fred Hoyle, as he mocked the big bang or promoted Panspermia. Or Linus Pauling, who invented “orthomolecular medicine”, another SCAM.
So, yes Dürr may be out of my league regarding physics. But you, Mister MPH, are clearly out of my league, too, because you have no clue about natural sciences, but must fall back to a argumentum ab auctoritate.
Poor, poor Ullman. It must be terrible to be constantly reminded about you ignorance.
Thanx for the good laugh! If THAT is all you’ve got, you’re shooting blanks.
Best laugh of the day.
WIKIPEDIA: “PSIRAM is a website close to the skeptic movement, which describes itself as a” consumer protection site “and as a” wiki of irrational systems of belief “and is against pseudoscience, esotericism and conspiracy theories. The operators and authors of the website are ANONYMOUS [!!!].”
What is the reason for such a site to have to remain ANONYMOUS like RPGNo1.
Do both have to hide something embarrassing or something monstrous?
Is there maybe just a black hole apart from ad hominem?
How boring. Again the reference to anonymity? You’re really good at making a fool of yourself.
Having delved into the Baseline Characteristics Table – Table 1 , I observe
1. Current smoking status was 55% Homeopathy, 60% Placebo and 69% Control.
2. Age >65 33% H, 34% P and 50% C
3. Liver metastases 14% H, 15% P and 17% C
Were these factors controlled for in the analysis? Otherwise the study concludes that older smokers with liver mestastases
tend to die before those who are younger, don’t smoke and don’t have liver metastases.
Who would have thunk it?
If you ignore the control group, the placebo and homeopathy groups are reasonably well-matched, and as far as I can tell, although the authors included the (non-randomised) control group in their study as a way of controlling for any placebo effects (go figure!) they seemed to be mostly comparing the homeopathy and the placebo groups with each other rather than with the “control”.
I think the main function of the control group is to make it clear to anybody with any knowledge of statistics and trial design just how ill-conceived the whole study was.
How “ill-conceived”? Oh, so now we are deeming something as “ill-conceived” by proclamation?!
Is everyone allowed to make such proclamations? What fun.
What I am really advocating is that anybody involved in conducting studies in healthcare, reporting them or indeed reading the reports should have some training in medical statistics. To base clinical practice on them without such training is reckless.
In due respect, you gave NO specifics to how or why you considered this study “ill-conceived” other than sheer pomposity.
Two other considerations. Three arm trials can throw up false results if you don’t have a Bonferonni correction.
Effectively you have a small RCT of AvBvC which provides more than two comparisons (AvB; BvC: AvC;) so conventional p values don’t work.
The other thought is that if you do 100 small RCTs some by chance would be either positive or negative at p<0.01. To learn the truth you must do a meta analysis of ALL RCTs (published and unpublished) to avoid publication bias.
IANAS but could such small numbers spread over multiple treatment centers also be a confounder? The authors describe how well they’ve randomized for age, sex, habits, disease stage, etc, but say nothing about where each was treated. If distribution was uneven I imagine that variations between centers’ practices and standards of care could easily explain the different results. As I noted upthread the authors seemed remarkably disinterested in exploring other possible explanations, almost as if they had no interest in finding themselves wrong.
(Contrast, say, the OPERA team, who may have deserved to wear a bit of egg for not double- and triple-checking all of their wiring before publicly declaring “hmm, that’s odd”, but were first to say “this is probably wrong” and acknowledge the true cause once they finally tracked it down.)
Edzard…I’m going to try a different strategy this time…
As you know, we homeopaths commonly tell others that we observe significant clinical benefits in our patients who suffer from a variety of chronic diesases. However, when we seek to conduct research in research hospitals, we are informed that it would be unethical for them to allow anything other than standard medical treatment. Therefore, homeopaths are now conducting studies with homeopathic treatment as an “add-on” to this standard treatment, and then, we seek to compare groups.
What is ethical or scientifucally problematic with this strategy?
who said that testing a therapy as an add-on is unethical?
Dana’s (inadvertently) got a point. It would be unethical to trial just homeopathy in a study treating disease because, as we know, homeopathy is an inert treatment and patients may come to harm so homeopaths are limited to A versus A+B trials.
Is there a way of structuring such a trial of an inert therapy which will return meaningful results?
all my homeopathy trials are conventional therapy + homeopathy versus placebo + homeopathy. for most situations and research questions, this seems to be the most reasonable approach.
I think you meant “conventional therapy + homeopathy versus conventional therapy + placebo”? That is ethical inasmuch as does not deprive anyone of the current best standard of care.
That said, I can understand hospitals still being discomfited by the ethics of trialing homeopathy, period. And quite right too: people’s lives should not be taken so lightly. You’d think the
Harry PotteristsHomeopaths would want to start on mice or, even better, cell lines, and ensure robust replicable results there before advancing to the higher primates. But as-per, they are far more concerned with Proving Themselves Right than finding simple, reliable, minimally harmful ways to prove themselves wrong, so it’s entirely unsurprising they should go straight to the most complex, muddy system first.
yes, that’s what I meant – sorry.
The study as I read it does not describe the placebo preparation or administration, this seems a major flaw. The placebo presumably could not simply be a sugar pill, it would have to have been tincture vehicle succussed, triturated and diluted a number of times equivalent to the test compounds in tincture-free alcohol solution before soaking the globules. Otherwise, even if we are to treat this with a liberal eye, all that is being tested in this paper is the “preparative process versus no preparative process” and not “individually tailored tinctures versus true placebo”.
I just saw the comment by Jens Behnke from the German Carstens Stiftung; he thinks the Frass study is methodologically excellent:
Dear Prof. Ernst,
as a tweet by Behnke drew my attention also to this study, I would like to make some comments about it:
about exclusion criteria: peripheral neuropathy as adjudicated by the version 2 of the common toxicity criteria was used. This definition is from 1999 and for adjudicating current side effects, version 4 was used. In current versions, for the same grading >=2, instrumental ADL must be limited by that, in 1999, no interference with ADL was needed for grade 2.
Now, that very slight problems with nerves may be excluding patients, how does that bias study populations as platin-compounds often lead to neuropathy, if I remember correctly?
then, about Rando:
“Subjects were randomized for permuted blocks randomization in a 1:1 ratio by a web‐based randomization service (…). Randomization for homeopathy and placebo medication was carried out at the pharmacy”
This is contradictory, right?
Statistics: of course, it might be easy to design the study to meet survival endpoints, but then you couldn’t use QoL as the primary outcome really, could you?
How do the following two sentences go together?
“The median survival time over the observation period of 730 days for the homeopathy group (435 days) was significantly longer than the placebo group (257 days; p = .010). ”
“Regarding patients who died within the 730‐day period, there was no significant difference in the median survival time between the homeopathy and the placebo groups (p = .172); ”
and why does it say “groups” in the second quote? Was one intervention group mixed up with a control group to reduce effects of that intervention?
Little nit-pick: why is there no “patients at risk” by group at the Kaplan-Meier-graph? Shouldn’t this be usual statistical care?
Discussion: “Unexpectedly, homeopathy also increased survival time.” > very unexpected that you even designed your study to show this effect. I also take pictures of the mountains with my tele when I expect to see nothing. Then I see an eagle and as I accidentally prepared to see an eagle I make a great picture?
Sorry for the metaphor, but also their statement does not make any sense.
Also, I have ethical concerns to give a not-yet-approved medication to patients who do not want to participate in the study. Why should you do that? What if harms outweighed the benefits?
Last sentence of the article: “Our study supports trials in other fields of complementary medicine such as acupuncture for chemotherapy‐induced peripheral neuropathy in breast cancer survivors”.
topic missed much. acupuncture is not homeopathy, neuropathy is not QoL and survival and breast cancer survivors are not patients currently in therapy.
Any flaws in my train of thought? 🙂