This pragmatic, randomised controlled trial was conducted between September 2018 and February 2021 and compared the difference between primary homoeopathic and conventional paediatric care in treating acute illnesses in children in their first 24 months of life. It was conducted at the Central Council for Research in Homoeopathy (CCRH) Collaborative Outpatient Department of the Jeeyar Integrated Medical Services (JIMS) Hospital in Telangana, India, a tertiary-care hospital that provides integrated patient-centric care, using homoeopathy and Ayurveda alongside conventional medicine.
One hundred eight Indian singleton newborns delivered at 37 to 42 weeks gestation were randomised at birth (1:1) to receive either homoeopathic or conventional primary care for any acute illness over the study period. In the homoeopathic group, conventional medical treatment was added when medically indicated. Clinicians and parents were unblinded.
The study’s primary outcome was a comparison of the number of sick days due to an acute illness experienced during the first 24 months of life by children receiving homoeopathic vs. conventional treatment. Sick days were defined as days with any acute illness (febrile or afebrile) reported by the parent and confirmed by the physician. Febrile illness was recorded when body temperature, measured via the ear canal, exceeded 37.5 °C.
The secondary outcomes compared were as follows:
- The number of sickness episodes, defined as illness events (febrile or afebrile), reported by the parent and confirmed by the physician.
- Number of respiratory illness episodes and days during the 24 months. Respiratory illnesses included infections in any part of the respiratory tract (nose, middle ear, pharynx, larynx, trachea, bronchi, bronchioles, and lungs) .
- Number of diarrhoeal episodes and days during the 24 months. Diarrhoea was defined as three or more episodes of watery stool/day, with or without vomiting, with indications of dehydration, weight loss, or defective weight gain.
- Anthropometric data included weight (measured by electronic scales to the nearest 5 g), height (measured in triplicate to the nearest 0.2 cm using a rigid-length board), head circumference (HC), and mid-upper arm circumference (MUAC) (measured with a standard measuring tape to the nearest 0.2 cm every 3 months until the 24th month).
- Developmental status was evaluated according to the Developmental Assessment Scales for Indian Infants (DASII) every 6 months from the age of 6 to 24 months.
- Direct cost of treatment for illnesses during the 24 months, including cost of medications, inpatient admissions, investigations, supplements, and treatment outside the hospital facility or study site (consultation and/or medicines).
- Use of antibiotics during the 24 months, defined as the number of antibiotic episodes during the study.
- Mortality: death due to any acute illness episode.
The results show that children in the homoeopathic group experienced significantly fewer sick days than those in the conventional group (RR: 0.37, 95% CI: 0.24-0.58; p < 0.001), with correspondingly fewer sickness episodes (RR: 0.53, 95% CI: 0.32-0.87; p = .013), as well as fewer respiratory illnesses over the 24-month period. They were taller (F (1, 97) = 8.92, p = .004, partial eta squared = 0.84) but not heavier than their conventionally treated counterparts. They required fewer antibiotics, and their treatment cost was lower.
The authors concluded that homoeopathy, using conventional medicine as a safety backdrop, was more effective than conventional treatment in preventing sick days, sickness episodes, and respiratory illnesses in the first 24 months of life. It necessitated fewer antibiotics and its overall cost was lower. This study supports homoeopathy, using conventional medicine as a safety backdrop, as a safe and cost-effective primary care modality during the first 2 years of life.
Here we have another study designed in such a way that a positive result was inevitable. Both groups of children received the necessary conventional care and treatment. The verum group received homeopathy in addition. There were no placebo controls and everyone knew which child belonged to which group. Thus the verum group benefitted from a poweful placebo effect, while the control group experience disappointment over not receiving the extra attention and medication. One might argue that newborn babies cannot experience a placebo response nor disappointment. Yet, one would be wrong and in need of reading up about placebo effects by proxy.
A+B is always more than B alone
To boldy entitle the paper ‘Homoeopathy vs. conventional primary care in children during the first 24 months of life’ and state that the trial aimed to “compared the difference between primary homoeopathic and conventional paediatric care in treating acute illnesses in children in their first 24 months of life”, is as close to scientific misconduct as one can get, in my view!
Yet again, I might ask: what do we call a study that is designed in such a way that a positive result was inevitable?
- misleading?
- waste of resources?
- unethical?
- fraud?
And again, I let you decide.
PS
I feel disappointed that a decent journal published this paper without even a critical comment!
42 Responses to Homoeopathy vs. conventional primary care in children during the first 24 months of life
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“And again, I let you decide.”
Well, I decided when I got to “In the homoeopathic group, conventional medical treatment was added when medically indicated. Clinicians and parents were unblinded.”
Edzard on Monday 21 October 2024
“I feel disappointed that a decent journal published this paper without even a critical comment!”
misleading?
waste of resources?
unethical?
fraud?
Why would that be so? If I remember correctly, your father, a homeopath, did not even use conventional care in bringing you up. You did good.
Why would that be unethical?
To understand that, you would need to read up about medical ethics!
“If I remember correctly, your father, a homeopath, did not even use conventional care in bringing you up.”
You remember nothing of the sort because that is complete fantasy!
Edzard on Monday 21 October 2024 at 10:03
I did seem to get that wrong. It was not your father. It was your family doctor. He was a homeopath. What was he doing in your home with your father and Grand father being conventional doctors? Prescribing placebos that you would not take? You were brought up on homeopathic medicines? How did your father allow this ?
” But Ernst didn’t set out to wage war against the unconventional. Indeed, fresh from his studies, he began his career in a homeopathic hospital. “To me, homeopathy wasn’t as strange as it would be to many other people because, in a way, I was brought up on homeopathy – our family doctor was a homeopath,” he says. But something didn’t quite fit. “I had of course noticed that in medical school you don’t hear about [homeopathy] except when the pharmacologists go into a blind range about it.”
So it was not just you, but the whole family. You managed to grow up and start medical career in homeopathy. Until then it was all homeopathic remedies?
https://www.theguardian.com/science/2014/oct/19/edzard-ernst-outspoken-professor-of-complementary-medicine
“I did seem to get that wrong.”
you seem to get almost everything wrong.
Edzard on Tuesday 22 October 2024 at 06:45
Would it be OK to presume that as your “FAMILY doctor”, he treated your parents and grandfather also when the situation arose? He would not be a “FAMILY doctor” if he was to be only treating you?
This complicates the subject even further. With your father and grandfather as conventional doctors(?), why would they be still requiring a homeopath to treat family?
I know you are just trolling.
However, in case someone wants to know my personal history, it’s all there:
https://www.amazon.co.uk/Scientist-Wonderland-Searching-Finding-Trouble/dp/1845407776
Krishna please stop this stupid irrelevant trolling.
If you have something to say that addresses the ‘controlled trial’ that is the subject of this Thread, then post that, not this ‘whataboutery’ nonsense. I don’t think you realise what a bad advert for homeopathy you are.
@DavidB
In theory, his stupidity, his lies, his arrogance and his general trolling should be the most effective remedy against these very human traits – according to the law of similars, that is.
He just neglected to sufficiently dilute them …
“In theory, his stupidity, his lies, his arrogance and his general trolling should be the most effective remedy against these very human traits – according to the law of similars, that is.
He just neglected to sufficiently dilute them …”
These are deep thoughts, Richard. I suggest too, that one should not forget the relevance of a good shaking…..
Edzard on Wednesday 23 October 2024 at 08:20
“I know you are just trolling.”
No. I have no interest in your personal history. Going a step back to check validity of your statements.
“My father, like many doctors in Germany at that time, knew of homeopathy and sometimes prescribed it. When I was five, my parents got divorced and I lived with my mother who was very keen on homeopathy. Our family doctor was a homeopath. So I grew up with homeopathy and for me, there was no difference between homeopathy and medicine. I didn’t think critically about it at all.”
If homeopathy worked for you all the way without conventional drugs, as also for my extended family, why should it not work for others????????? Why should it be misleading? unethical? fraud?
Then you go on to state:
“And then I finished my studies and was looking for a job. At that time, there were too many doctors in Germany. By coincidence, I landed a job at the only homeopathic hospital at that time, in Munich. It still exists. There I was confronted with homeopathy and learned how to practice homeopathy. I stayed in this hospital for half a year and I was impressed.”
Six months? To learn to practice homeopathy? What did you learn? Law of similars? Case taking? Repertorizing? What did you practice? Choosing between 2 remedies? Choosing between symptoms and cause? ……….The hospital allowed you to start attending to and prescribing to patients, day 1? Doing what exactly? I am amazed. You have no clue about homeopathy. Its education, training and practice.
The standard course for Homeopathy is 4 years. Followed by one year of internship. This is STANDARD program to become a homeopath.
Zdroj: https://www.idnes.cz/technet/veda/edzard-ernst-homeopathy-interview-alternative-complementary-medicine-prague.A200123_231620_veda_pka
are you sure you’re not a troll?
@Krishna
Q: And what have they learned in those 4 years?
A: How to sell shaken water and sugar crumbs as ‘medicines’.
So basically, homeopathy courses are not only a complete and utter scam themselves, but they teach students who are dumb enough to enrol how to defraud sick people.
Edzard on Wednesday 23 October 2024 at 14:20
“are you sure you’re not a troll?”
Why would you treat it as trolling? I am quoting YOU, VERBATIM and providing link. With what motive you brought in your supposed exposure to homeopathy, I can only guess.
This is what Dr BM Hegde (http://www.bmhegde.com/resume1.html) has to say about your “critical measure” of medicines.
“Do thoughts exist? Do emotions have any role in human physiology? If the answer is yes, then we need a change of paradigm in science, at least in medical science, where the randomized controlled studies, have been sold as the last word in medical research. The truth is that there is everything wrong with this approach. No two human beings could be compared based on a few of their phonotypical features.
The results are there for all to see. Most, if not all, RCTs have given unreliable results in the long run.” (Dr Hegde has many more degrees in medicine than you, spent more time with patients and medical students than you.)
A large number of drugs after clearing DBRCT, have to be recalled for either providing no benefit or numerous adverse effect. VIOXX for example. Meaningless Drugs that kill or maim are used with abandon because these supposedly passed tests. Aspirin. Paracetamol. (all pass test?) Drugs that are known to create long term disasters. Antibiotics. (This is not addressed in trials nor follow up studies?)
The list is long and endless. This is the real SCAM. The supposedly drugs that are being pushed in guise of “scientific medicine” and then blame poor doctors for medical errors for killing patients.
https://www.youtube.com/watch?v=1OmI2PikrcM
https://www.youtube.com/watch?v=xNVs_ClVw7U
Also, if any doctor, spoke against the system, revoke his certification.
“Why would you treat it as trolling?”
BECAUSE IT IS!!
QUOTE B. M. Hegde, Wikipedia
He has supported homeopathy[4] a pseudoscientific system of alternative medicine and quantum healing.[5]
5. Hegde BM: “Modern Medicine and Quantum Physics” Kuwait Medical Journal: March 2003: 35(1): 1–3
https://en.m.wikipedia.org/wiki/B._M._Hegde
END OF QUOTE
See:
“MODERN MEDICINE AND QUANTUM PHYSICS”, Prof. B. M. Hegde.
https://www.bmhegde.com/quantumphysics.html
@Pete Attkins
[B.M. Hegde]
Ah, so that’s the source of the lies and nonsense that Krishna is parroting … The dumb sod can’t even come up with anything by himself. What a loser …
@Krishna: you are a pathological liar and a fraud.
This is an egregious lie. I checked several hundred FDA recalls over the past 7 years, and NOT ONE product on that list was recalled for lack of efficacy or for unacceptable adverse events.
So far, you have come up with only one example where harmful side effects were indeed the cause of a recall: Vioxx. For all the rest, recalls due to side effects or lack of efficacy are very, very rare. I bet you can’t even come up with a list of a dozen or so such recalls.
The overwhelming majority of the 4500 or so annual recalls happen because of simple production or labelling errors, or because of microbial or chemical contamination, NOT because products are found to cause more harm than benefit after passing all clinical trials.
And this is just one of your many lies about modern science-based medicine – which, contrary to what you keep proclaiming, has given us a hugely increased life span, an even bigger decrease in child mortality, and a better overall health than we have ever had before in history.
Pete Attkins on Thursday 24 October 2024 at 19:18
Shooting the messenger is one very old, illogical and wasteful process.
Compare your own qualification on the subject (medicine) with that of messenger. Deplorably inadequate?
Richard Rasker on Thursday 24 October 2024 at 22:03
“I checked several hundred FDA recalls over the past 7 years, and NOT ONE product on that list was recalled for lack of efficacy or for unacceptable adverse events.”
The new age RIP VAN WINKLE?
https://en.wikipedia.org/wiki/List_of_withdrawn_drugs
Not the complete list. Only “Significant withdrawals”.
https://www.rheingoldlaw.com/dangerous-drugs-lawsuit/actos-recalled-in-europe-fda-adds-to-warning/
“An important medical update for those taking type-2 diabetes pills: media outlets are reporting that specific brands of these diabetes pills are linked to breast and bladder cancer. Takeda Pharmaceuticals is officially withdrawing Actos — a drug that treats type-2 diabetes by helping control blood sugar levels in conjunction with diet and exercise — from the market in France after studies indicated that patients taking the drug had a higher risk of bladder cancer.”
Do you know how long time does it take for the patient to develop cancer after starting on ACTOS? How many such possible outcomes coming up?
Iqbal Krishna,
Compare your qualification on the subject (medicine) with that of the messenger. Deplorably inadequate.
Compare your qualification on the subject (quantum physics) with that of the messenger. Both of you present as being deplorably inadequate.
See:
“MODERN MEDICINE AND QUANTUM PHYSICS”, Prof. B. M. Hegde.
https://www.bmhegde.com/quantumphysics.html
@Ignoramus Krishna
First: A “recall” of a drug ist not the same as the withdrawal. These are two different processes.
Second: You are comparing apples with pears. Richard Rasker had referred to the FDA’s homepage, while the Wikipedia article describes the withdrawal worldwide.
https://en.wikipedia.org/wiki/List_of_withdrawn_drugs
https://en.wikipedia.org/wiki/Drug_recall
Krishna, instead of making up stories about Professor Ernst’s father, would you like to give your opinion on the quality and content of the Paper that is the subject of this thread? In that way, one will be less inclined to think you a Troll……
@DavidB
Krishna knows nothing about homeopathy (or about real medicine, for that matter). And given his lies, his nonsensical claims and his colossal arrogance he must indeed be a troll.
So I wouldn’t hold my breath waiting for any sensible comment on that piece of HomeoPropaganda that is today’s topic. AFAICT, he never contributed even one sensible, on-topic comment.
@Edzard:
Your post about this rubbish A+B study reminded me that the idiotic, unnecessary Bavarian homeopathy study should be close to it´s completion (est. 31.01.2025).
https://clinicaltrials.gov/study/NCT05545514?a=8
I bet that the results of the great Bavarian study will finally completely change your understanding of science 😉
I’m not holding my breath
Some observations on my initial reading:
1. There is a serious question on the validity of the primary outcome variable (number of sick days). It is a reported outcome by the parent. It is like saying Kerala (a state in India) is not safe for women because it sees more reported rape cases. But the fact is that Kerala sees more rape cases because Kerala women report more rape cases. The reporting bias cannot be brushed off so easily.
2. The authors themselves wrote in Discussion (Page9 Col2) that there could be several biases due to the open-label nature of this experiment. In that case, I think it is too early to claim causality (that Homeo ‘affected’ health). Causality can only be claimed after dealing with all the biases and there are a plenty here.
3. Leakages! How sure are we that parents of the conventional medicine group didn’t take their kids to other clinics? Nothing is written about this.
Re: your observation 1.
Yes exactly. If the parent doesn’t report, there is no question of confirmation by the physician. Are we ready to go easy on the reporting bias?
Couple that up with the unblinded nature of the study. So the homeopaths and physicians working in a homeopathy institution know the participants’ group. Don’t you see the possibility of bias there?
@Sai Krishna Dammalapati
Also note that it would have been quite feasible to get at least clinician blinding, simply by having sick children diagnosed by independent physicians who are not aware of the assigned group. Any subsequent treatment can then be relegated to physicians in the unblinded group.
I think this would have improved the study quality quite a bit.
In my opinion, the issue of reporting bias (which applies to both groups) is overshadowed by the deliberate study design of:
● A+B vs B, combined with
● modified intention-to-treat analysis (mITT).
QUOTE Intention-to-treat analysis, Wikipedia
Issues
Medical investigators often have difficulties in completing ITT analysis because of clinical trial issues like missing data or poor treatment protocol adherence.[3]
To address some of these issues, many clinical trials have excluded participants after the random assignment in their analysis, which is often referred to as modified intention-to-treat analysis or mITT. Trials employing mITT have been linked to industry sponsorship and conflicts of interest by the authors.[4]
https://en.m.wikipedia.org/wiki/Intention-to-treat_analysis#Issues
END OF QUOTE
Another issue..
The IQR for the number of sickness episodes for Homeopathy group is 0-2. Which means that 25% of the homeopathy group didn’t get sick.
And the paper reads:
“Illness episodes in children in the homoeopathic group were treated with individualised homoeopathic medicines”
So, 25% of the homeopathy group didn’t receive any treatment?
And it raises a question of sampling bias as well. 25% of the group is so healthy (without any treatment).
First of al this is A versus B and not
And I consider it ethically and medically correct (and so do all responsible homeopaths) to add conventional medicine if homeopathy alone does not bring about the immediate [!] clear improvements.
So, apart from the lack of double-blinding [which would be ethically difficult to accept], this study is quite remarkable and by no means scandalous!
It may not be entirely to your taste, but it still produces a striking result…
In the homoeopathic group, conventional medical treatment was added when medically indicated.
Why?
Please elaborate.
A+B+B+A = ABBA for all the homeopaths care.
With this paper being widely reported in India, eg The Times of India, it looks like it is SOS for Edzard and Money, Money Money for the homeopaths.
Author Menachem Oberbaum[8], along with Michael Frass no less, wrote the following rather amusing grumble:
Frass M, Etter-Kalberer G, Keusgen M, Geiger M, Brunnthaler-Tscherteu R, Pichler E, Zauner B, Oberbaum M[8], Weiermayer P.
Letter to the Editor regarding the article by Borkens Y, Endruscheit U, Lübbers CW. Homeopathy-A lively relic of the prescientific era. Wien Klin Wochenschr 2023:1-8.
Wien Klin Wochenschr. 2024 Mar;136(5-6):185-186.
doi:10.1007/s00508-023-02233-0.
Epub 2023 Aug 22.
PMID: 37606734;
PMCID: PMC10937759.
https://pmc.ncbi.nlm.nih.gov/articles/PMC10937759/
Affiliations
Author Menachem Oberbaum has the following affiliation:
8. The Center for Integrative Complementary Medicine, Shaare Zedek Medical Center, Jerusalem, Israel.
And co-authored this endlessly trotted out paper:
Davenas E, Beauvais F, Amara J, Oberbaum M, Robinzon B, Miadonna A, Tedeschi A, Pomeranz B, Fortner P, Belon P, et al. Human basophil degranulation triggered by very dilute antiserum against IgE. Nature. 1988 Jun 30;333(6176):816-8. doi:10.1038/333816a0. PMID: 2455231.
Author Raj Kumar Manchanda has the following affiliations:
2. Central Council for Research in Homoeopathy, Ministry of AYUSH, New Delhi, India.
15. Homoeopathic Sectional Committee, Ayush Department Bureau of Indian Standards, Government of India, New Delhi, India.
16. Nehru Homoeopathic Medical College & Hospital, New Delhi, India.
https://www.facultyofhomeopathy.org/pages/raj-manchanda
E&OE.
Dear Prof Ernst,
We appreciate your taking the time and effort to critically review our paper. However, we take issue with several of your criticisms.
Your main point seems to be that homeopathy treatment was “add-on”, beyond conventional treatment which all received. This is inaccurate. Patients were randomized to receive either homeopathy for all their acute medical needs, or conventional care. In the homeopathic group, conventional care was offered only in cases which it was appraised that children’s wellbeing was threatened. This was done out of obvious ethical considerations.
Placebo control was considered unethical in this study design, thus the control group received standard conventional care. As you are certainly aware, comparison with an accepted standard of care is a more stringent level of proof than against placebo (assuming the standard of care has some degree of effectiveness). Even for adults, the WHA 2013 World Medical Association Declaration of Helsinki regarding placebo-controlled trials for treatments with proven cures [1] states that “The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention.” India’s National Health Policy also advocates integrative care is such research. Given these constraints, a placebo-controlled blinded design would have been blatantly unethical. We chose conventional standard of care as a positive control group to ensure ethical conduct of the trial. Attacking this study as unethical is groundless.
Lack of blinding of parents and physicians is indeed a limitation, which we openly address in our discussion section. Blinding is an important aspect of clinical trials, but is not a sine-qua-non requirement. This is particularly true in cases where blinding is impossible (i.e. comparing surgical approaches, surgical vs. medical interventions, etc) or unethical (behavioral or lifestyle interventions (e.g., diet, exercise, etc) [2-5] .A fully blinded, double-placebo design would have been unwieldly, intolerable and potentially unethical.
We cannot deny the potential for a “placebo-effect”, but have no indication as to which way it would have leaned. If extra attention is the measure, then certainly children in the conventional group received more: more episodes of illness, more sick days, more respiratory illness and more antibiotics. We presume this infers more doctor visits and more doctor’s attention, though we did not measure this variable directly. We do not doubt the potential for placebo effects by proxy.
We reject the claim that a positive result was inevitable. We set out to undertake a unique, exploratory study, using a novel design never before performed to the best of our knowledge. Much hard work, creative thinking and time were invested in this study. We openly address the study’s limitations and possible biases, and have controlled for these to the best of our ability. We in no way claim that we have performed the perfect or definitive study of the effectiveness of homeopathy in young children. “Scientific misconduct” along with “fraud” are slanderous terms which shouldn’t be used among scientists, and it would seem more appropriate to limit ourselves to concrete, professional, critiques, to which we will gladly respond.
Dr. Menachem Oberbaum
Jerusalem, Israel
1. World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. PMID: 24141714
2. Boutron, I., et al. Extending the CONSORT Statement to Randomized Trials of Nonpharmacologic Treatment: Explanation and Elaboration. Annals of Internal Medicine, 2008;148: 295–309.
3. Schulz, KF, et al. CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomised Trials. BMJ 2010; 340, c332
4. Sackett, DL. Bias in Analytic Research.” Journal of Chronic Diseases 1979; 32: 51–63.
5. Emanuel, EJ, et al. What Makes Clinical Research Ethical?” JAMA 2000; 283: 2701–2711.
“conventional care was offered only in cases which it was appraised that children’s wellbeing was threatened”
does that mean that in the control group conventional treatments were administered when not indicated???
“We reject the claim that a positive result was inevitable.”
I am sorry that you fail to understand the simple argument of A+B vs B.
“We openly address the study’s limitations and possible biases, and have controlled for these to the best of our ability.”
Yet, you concluded: “We openly address the study’s limitations and possible biases, and have controlled for these to the best of our ability.”
Do you really think that this is justified?
@Mr. Oberbaum
If you want to do a properly designed homeopathy study, then I suggest that you use at least the following 2 groups: verum and anti-verum.
As the name implies, the verum group receives the optimal homeopathic preparations, i.e. the treatment that a homeopath would normally administer in each respective case.
The anti-verum group,however, receives homeopathic preparations that should have the opposite effect, and thus should aggravate instead of improving the recipients’ conditions.
Blinding is not difficult: homeopathic practitioners can simply go about their business as usual treating patients, collecting symptoms, selecting the best matching preparation, and evaluating the results over time.
However, a second homeopath is the one responsible for dispensing the preparation, and will at the start of each treatment decide by coin toss whether the patient in question will henceforth receive the verum or the anti-verum for the duration of the treatment or the trial (whichever is longer).
As a result, primary homeopaths and their patients do not know whether a particular patient receives the verum or the anti-verum. From their point of view, the treatment is like any other homeopathic treatment, at least until the blinding is lifted, at the end of the trial period.
If homeopathy actually does something, then the verum group should do significantly better than the anti-verum group.
My prediction: you will not observe any difference whatsoever – which of course means that homeopathy does not do anything.
Note to the readers:
The study leaves me without a shadow of a doubt that he “played a pivotal role in mentoring the teams during study monitoring”.