It is evident that homeopathy associations are dealing with critical arguments more intensively than before, e.g. with the work of the Information Network on Homeopathy (INH), a Germany-based team of doctors, pharmacists and other scientists with a skeptic’s approach on homeopathy. The Homeopathy Research Institute (HRI) on the other hand is a London-based organization that promotes more homeopathy research and tries to present homeopathy as scientifically proven.

On the HRI website, you can find a menu item “FAQ Homeopathy”, where they try to argue some of the key statements made by homeopathy critics. The articles are presented in English, German and a few other languages. These articles seem to be meant as templates to refute critics like us, and they were used for a small brochure by DHU (Deutsche Homöopathie Union), which will very likely be distributed at the various lectures and training sessions DHU promotes. DHU by their own account is the leading manufacturer of homeopathic preparations in Germany, offering and sponsoring trainings for doctors, pharmacists, midwives etc., not to forget their support for a lot of health-related websites targeted at a lay audience.

In a short series of articles, we want to examine how and why we homeopathy critics come to our conclusions, and what to think of the counter-arguments of homeopathy promoters. Our articles will be published in three text versions in German, which will be posted simultaneously on my blog, on the website of the INH, and at Susannchen; and if these pieces are received favorably, we will translate the most detailed version to English, too (this is what you see here).

Background: Why do we need scientific evidence of efficacy?

It certainly is of advantage if the doctor you consult for your complaints uses a therapy that they know is suitable for having a beneficial effect on your complaints. The therapist’s personal experience is certainly not enough to establish the efficacy of a therapy – not to mention the question of what happens to the patients on whom the experience is gathered by trial and error.

After all, it is not so easy to identify if a therapy is successful. One of the reasons is the pronounced tendency to self-healing, without which we would have gone extinct as a species long ago. This means that people (or animals or plants) become healthy and may recover even from life-threatening conditions without the help of medical interventions. Even in severe infectious diseases, there are people who survive them. If a doctor administers a therapy and the patient recovers afterwards, it is not certain that it was the therapy that caused the improvement. In pre-scientific times, for example, a lot of things were considered effective cures that today seem outright bizarre, like using the dust of church bells, crushed sketches of saints, or the fat and bones of executed criminals. Assuming that not all doctors from the Middle Ages up to the middle of the 19th century were charlatans, these people were convinced that they could actually heal with their cures, simply because they saw that patients became healthy afterwards, sometimes maybe even despite their interventions. The gathering of experience by the therapist may lead to misconceptions about the power of his cures.

It is obvious that medicine will improve – and has done so in the recent past – by identifying and discarding ineffective therapies. Doctors of today have a wide range of effective methods at their disposal, with data on the conditions they may be useful for, and the probabilities of success, or they can find out risks and benefits. Waiving evidence of efficacy would mean a step backwards into the pre-scientific era, when it was more or less a matter of good luck whether the doctor prescribed an actually helpful medicine.

Background: What is scientific evidence?

Evidence of efficacy requires a drug to show an effect in patients which is established by scientific experiments. Such trials are performed on a larger number of patients so that the results are not distorted by individual patients’ characteristics. The participants are randomly divided into two groups, one of which takes the drug to be tested (“verum group”), the other a placebo without any active substance (“control group”). It is important that the patients themselves are “blinded” and do not know whether or not they received the actual medication. The same holds for the doctors or caregivers, so that all the patients receive the same care. Scientifically sound evidence of efficacy will be based on such studies. This is the gold standard of evidence, the placebo-controlled, randomized, double-blinded clinical trial (PCT). This study design is suitable for the individualized therapy approach of homeopathy as well. There are a number of such studies (also systematic reviews of them): all subjects go through the initial consultation and a drug is prescribed. In the pharmacy either the prescribed drug or a placebo is randomly supplied to the patient.

If the remedy under test is effective, the outcomes between the two groups will differ, but it is necessary to determine whether the difference observed really is likely to be caused by the drug. Even in a control group that actually remains untreated, improvements occur which are evidently not caused by the drug. This may be due to the self-healing powers of the immune system, natural self-limiting disease propagation, or the often-cited placebo effect, in which the patient’s expectations and trust in the cure cause an improvement in the patient’s condition, or at least they strongly promote the improvement.

Since both the placebo and verum group usually show improvements in symptoms, the result must be evaluated with statistical methods to check if different outcomes between the groups may have been caused by chance alone, due to allocation of the patients to their groups. So the result of a clinical study is not a clear yes-or-no. Only if the probability that the difference between the groups has been caused by chance is below a scientifically agreed threshold of 5%, it is concluded that the drug may have caused the difference, and hence may be having an effect.

However, even ineffective drugs may produce improbable results occasionally, that look like a telltale sign of a less than 5% probability, but still are a product of mere chance alone. Therefore a single positive study cannot be a scientific “proof”, but it must be replicated independently – at least by a different team of researchers with a different set of patients. Almost certainly there will be fluctuations during replications, some may even yield quite different results. To arrive at a final conclusion from a set of trials, a systematic review is required, in which all published studies on a particular cure for a given clinical condition are examined and an overall result is determined. It is important that all available studies are taken into consideration, not only the positive ones. Such a review would then be considered reliable evidence if the data basis is adequate – but still would not be considered an eternal “proof” in the sense that it’s impossible for this conclusion to be wrong. Individual studies can only provide a more or less strong indication of potential efficacy.

To note: Even if a systematic review would yield positive findings for homeopathy, this could establish the effectiveness of homeopathy for the specific condition under investigation only. No study or review can prove the efficacy of homeopathy in general.

Background: Why are case studies and individual reports not proof of an effect?

Due to the self-healing powers already referred to, which certainly exist at different levels in different individuals, there are always people who can improve even in serious conditions without any cure – people that can survive the most serious infectious diseases or even cancer, for example. There may be only a few of them, but they do exist. “Mortality of 80% when untreated” indicates that 20% of untreated people survive. As a result, there will always be patients who can report that they have (supposedly) been cured because of this or that therapy, or because of whatever they did – like prayer, or promising to be good in the future, or erecting a church, or whatever –, even if it did not contribute anything real to progress their recovery. On the other hand, there always will be people who do not respond to an otherwise effective treatment and who may die from a disease despite a usually successful cure.

Consider the results of a recent study on alternative medical treatment of cancer. The results seven years after diagnosis and after alternative or conventional treatment looked like this (data transformed to meaningful numbers and entities) [1]:

Patients after seven years	Alternative Therapy	Conventional Therapy
Survived	144	208
Deceased	136	72

From the 144 patients who survived for seven years under the alternative therapy, certainly a whole lot of case studies can be derived, all of which indicate the success of alternative medicine. You may even refer to the 72 patients that died under conventional cancer therapy to stress the point of alleged superior performance of the alternative therapy.

Even if positive cases under conventional therapy may find their way into case studies as well: what for sure will remain unnoticed is the fact that considerably more of the conventionally treated patients survived than under alternative treatment. And for sure there will be very few case studies of the deaths under alternative treatment, if any at all. At least the author of this piece is not aware of any such case studies from alternative medicine that had a negative outcome. But this does not mean, they do not exist – only that the therapist is unwilling to share his failure.

The fact that considerably more patients under alternative medicine died than in the conventional group is completely lost in case studies. After all, those who have died in excess are lying in their graves and do not boast their failure in talk shows, books, or interviews.

After all, it is hardly to be expected that therapists will publish their failures in case studies and disseminate them as widely as their positive results advertising them with the same rigor: A very important point to assess the effectiveness of a therapy is therefore missing. That would be like counting only the goals that your team scored – forgetting they received a lot more from their opponents.

In a nutshell: Case studies of successful treatments, even in large numbers, only show that there are a number of people who recover under the alternative treatment – and nothing else. There is no denying that these cases exist, but this is no indication if there might be many more patients who did not fare so well. But the real patients and their therapists would need some information on the chances of recovery – which includes the ratio of failed treatments.

Facts: What evidence is available?

HRI states that by the end of 2014 there have been 189 randomized controlled clinical studies, 104 of which compared homeopathy with placebo. Of these, 43 allegedly showed positive results for homeopathy, 5 were negative, and 56 were “unclear” – which brings them to the conclusion, that there are more positive than negative studies which is considered to indicate some efficacy of homeopathy.

What’s strange: Apparently, the authors of this HRI article consider the fact that the efficacy of a homeopathic remedy is “unclear”, that is it cannot be reliably distinguished from a placebo, i. e. it works in the same way as a piece of sugar, is not a negative result. That’s quite amazing. One wonders whether patients who spend their money on an ineffective, sugar-like remedy and perhaps hope for an improvement of their condition would see it the same way?

In any case, by no means the majority of studies have yielded positive results.

The ratio of more than 40% of successful studies looks impressive at first, but is misleading still.

First of all, because of the probability of the false-positive results of 5%, it is to be expected that there will be some positive studies, which are nevertheless random results.

Then there is the so-called publication bias, also known as file-drawer effect: the fact that positive results are readily and willingly published, whereas negative ones tend to remain in the file-drawer forever, never to be spoken or heard of again.

In addition, there are shortcomings in the published studies, such as inadequate blinding of the test subjects, or inappropriate methods of evaluation, which can lead to the results being skewed in a positive direction, and a lot more issues that render a study of poor quality. All of this increases the proportion of positive studies in the database.

As already explained, evidence for efficacy of homeopathy for any indication can only be derived if studies have been independently repeated and the results of all of them pooled in a systematic review. It goes without saying that this review should cover the entire available evidence, not just the positive results.

Such reviews do exist indeed. Starting with a work by Kleijnen et al. from 1991 [2] to the recent work by Mathie et al. in 2019 [3], there are twelve major reviews, which examine homeopathy across indications, and all more or less yield the same result: On first glance the evidence in total may indicate that there could be small effects above placebo, but the quality of the available studies is so poor that no reliable conclusions can be drawn. Neither for homeopathy in general nor for any indication is there reliable evidence that homeopathy outperforms placebo. The largest review published so far, the one by the Australian Ministry of Health in 2015, comes to this conclusion [4], as does Mathie whose affiliation is the Homeopathy Research Institute.

Conclusion
There is in fact no scientific evidence that homeopathy works.

 

What homeopaths tell us about it

The HRI muses that 43% of positive studies are the same ratio of success as in conventional medicine. So what? What is such a comparison supposed to show? If I want to compare my literary skills with those of Charles Dickens, it is certainly not helpful to ascertain that my ratio of torn and discarded pages may be the same as his. It would be important to compare what remains – in terms of quality of course, not quantity. Or does this article sound anything like David Copperfield?

Such an approach based on the motto “Who won?” is absurd. In addition, homeopathic studies are confirmation research, i. e. the search for a positive result. In the lore of homeopathy there is no need for clinical trials, and in Europe homeopathic preparations are exempt from providing data on evidence in the recognition process to become a medicine to be sold in pharmacies only. This may well lead to an increased confirmation bias. Compared to real research you should expect the positive evidence might be expected to be exaggerated due to lack of scientific skepticism. Taking into account the strong claim of homeopaths that their treatment is on the same level as conventional medicine – if not better –, you should expect a much more convincing database of positive evidence than there is available today.  You should expect the homeopaths to take great pains to explain how the negative results came about; their ratio of successful trials looks very poor for such a powerful treatment.

Another aspect is raised, namely the lack of public funding for research into homeopathy. Please note the following: DHU belongs to the Dr. Willmar Schwabe group, like the largest manufacturer of homeopathic medicines in Austria, Peintner. According to their website, Schwabe sells products for 900 million euros per year and spends a meager 32 million euros on research. Typical research spending for the pharmaceutical industry is about 14%, for Schwabe this would be around 125 million euros. There seems a lot of potential room for further research funding. [5, 6].

Quintessence:

We critics of homeopathy maintain our position: there is no scientific evidence for an effect of homeopathy that exceeds placebo – and this is not due to the lack of money that could be invested in research.

 

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Dr.-Ing. Norbert Aust,
Informationsnetzwerk Homöopathie (INH)
drnorbertaust@t-online .de

Thanks to Udo Endruscheit and Sven Rudloff for their support in preparing this english version. 

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Sources / References:

1. Johnson SB, Park HS, Gross CP, Yu JB: ”Use on Alternative Medicine for Cancer and its Impact on Survival”; JNCI J Natl Cancer Inst (2018) 110(1): djx145, doi: 10.1093/jnci/djx145 [https://academic.oup.com/jnci/article/doi/10.1093/jnci/djx145/4064136]
2. Kleijnen J, Knipschild P, ter Riet G: “Clinical trials of homeopathy“, BMJ 1991; 302:316-23, [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1668980/pdf/bmj00112-0022.pdf]
3. Mathie RT et al.: Systematic Review and Meta-Analysis of Randomised, Other-than-Placebo Controlled, Trials of Non-Individualised Homeopathic Treatment.
4. National Health and Medical Research Council. 2015. “NHMRC Statement on Homeopathy“, Canberra: NHMRC 2015  [https://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/cam02_nhmrc_statement_homeopathy.pdf]
5. NN: „Statistics 2015 – Die Arzneimittelindustrie in Deutschland“, vfa-Brochure, S. 10, [https://www.vfa.de/embed/statistics-2015.pdf]
6. Website Fa. Wilmar Schwabe, Facts and Figures per December 31, 2016 [https://www.schwabepharma.com/about-us/facts-figures/]

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Update, May 2019: Supplemented by the latest study situation (Mathie 2019)

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Picture credits: Fotolia_130625327_XS

 

The second part of our series about the “homeopathic criticism on criticism on homeopathy” covers why critics conclude that there is no reliable evidence for the efficacy of homeopathy beyond placebo.

„There is not a single good quality trial showing homeopathy works“

This is how the UK-based Homeopathic Research Institute (HRI) cites their critics on their website “Homeopathy FAQs” [1]. The above statement is absolutely correct, though somewhat trivial: One single study never can “show” that “homeopathy” works. At best, if a trial is of good quality, it may give an indication that homeopathy might be more effective than placebo in the one medical condition that was tested in the trial, but not more. For reasons why this is the case, please refer to our previous article “Criticism on criticism on Homeopathy Pt.1: There is no evidence” [2].

“There is no reliable evidence that homeopathy is more effective than placebo in any clinical condition“

This is the correct, no longer trivial statement of the critics on homeopathy, for it can be falsified by presenting reliable evidence for efficacy in the case of a single clinical condition only. Though HRI does not explicitly refer to the proper wording, it is clear they want to argue against the notion of non-existing positive results. To identify examples of clinical conditions where homeopathy is shown as effective beyond placebo is a proper way in the attempt to contradict us critics, for the existence of just one such condition would prove the statement wrong.

Background: What is reliable evidence?

State-of-the-art evidence would include clinical trials designed as placebo-controlled double-blinded randomized clinical trials (RCT), which we explained comprehensively in part 1 of this series [2].

However, one single study alone cannot be reliable evidence. Evidence requires at least that a study has been replicated independently, i. e. repeated with other patients by another independent research team, which came to similar results. Since it is usually not easy to evaluate and pool different studies, a systematic review is required to build a solid conclusion, in which all available studies are considered, not just the most favorable ones.

To properly appreciate a study it is essential to consider its quality, which indicates how reliable it resembles reality. This is done by checking whether some essential criteria are met. Current procedure is to check for the “risk of bias” as set forth by the Cochrane Collaboration [3]. Eventually, a study is rated to be of “low”, “unclear” or “high” risk of bias from what could be expected in the real world. Naturally, a low risk would indicate a good quality study, a high risk of bias a poor one.

To determine this risk of bias, researchers refer to a list of criteria mainly to assess if the procedures for blinding and randomization were sufficient, and if the results of all the patients are reported completely. Authors must disclose these items in their report, otherwise the study is considered to be of unclear risk of bias, which indicates neither good nor bad quality.

It should be evident that reliable evidence can consist of low risk of bias studies only, where chances are good that the result is for real. If, for example, blinding of patients was insufficient, then patients in the placebo group, who now know they did not receive a possibly active treatment, might not attribute any positive development to the treatment and might not report it. On the other hand, patients who know of having received the (possibly) active drug, might be on a lookout for any positive development and might overrate its impact. Especially in studies on homeopathy, many of the data are assessed by asking for a patient’s subjective ratings of their experience, which renders it very important that the patient is “unbiased” in filling out the questionnaire or in answering the interviewers.

Not only insufficient blinding is likely to distort the outcome of a clinical study in favor of homeopathy. As evidence indicates, on average any shortcoming in quality does the same and yields more positive results [3, Chapter 8.5]

In a nutshell:

Reliable evidence consists of a number of independently replicated RCTs, a systematic review checking the quality of all the relevant studies in the field, and compiling a conclusion which resembles the best guess at what is to be expected in the real world.

HRI does quite acknowledge that more research is needed to replicate the available “promising” studies and that this has not yet been done sufficiently. But what does that mean for the question of existing evidence? Well, an independent replication may or may not yield similar results as before, which gives way to a somewhat unclear position: Homeopaths are certainly wrong assuming that future replications will surely corroborate the original findings, while critics cannot prove that successful replications are impossible. Consequently, the statement “there is no reliable evidence” is an absolutely correct scientific statement, not excluding that this could change in the future. This is in fact the strongest possible reservation against the evidence base in homeopathy, in accordance with todays sciences self-perception – which should not be misunderstood as assertion about that this might not happen in the future.

What good evidence is available?

However, the HRI points out positive studies on homeopathy for some clinical conditions, in order to refute the above statement of the critics. Here is a short overview:

(1) Individualized homeopathic treatment of childhood diarrhea

There is a review by Jacobs et al. where three studies with herself as lead author are considered [4]. All studies were performed under the same protocol. So, this is certainly not a summary of independent replications. Any shortcomings in study design or protocol or even handling might go unnoticed.

In the review of Jacobs, three studies are considered:

Jacobs (1993) with a small number of children in Nicaragua [5],
Jacobs (1994) with a larger number of children also in Nicaragua [6],
Jacobs (2000) with children in Nepal [7].

In the CORE-Hom database of the Carstens-Foundation [8] only one more study for the same clinical condition is listed (Cadena (1991)), but the record indicates that no statistical evaluation was included in that particular study. The three studies above thus completely reflects the available evidence for the homeopathic treatment of childhood diarrhea.

An assessment of the quality of these studies can be found in the systematic review on individualized homeopathy by Mathie et al. [9]: Only the paper from 1994 was rated “unclear risk of bias”, while the other two were rated as “high risk of bias”, that is, of poor quality.

Conclusion: Due to the poor quality of the available studies, there is no reliable evidence for a homeopathic treatment of childhood diarrhea. Note: There is a fourth paper on childhood diarrhea by the same author using non-individualized homeopathy, which could not show any advantage of homeopathy either.

(2) Individualized homeopathic treatment of otitis media in children

The HRI cites two works here:

Jacobs (2001) [10]
In the review of Mathie (2014), this study is rated as of medium quality only [9]. In this preliminary study the results were not statistically significant, some minor advantages of homeopathy beyond placebo occurred but are likely to be attributed to random effects. In order to prove this effect, the authors wrote that a considerably larger study would be required (243 evaluated subjects, not only 72, as in this paper).

Sinha (2012) [11]
According to the authors of this study, this was only a pilot study that was carried out without any blinding – which prevents it from being reliable. This study was not yet subject to quality assessment in any systematic review. But even on first glance the study looks very doubtful: The authors compared homeopathy to standard treatment, which, in this setting in India, consisted in 95 % of the cases of the use of antibiotics, which most authors consider useless as the condition is mostly caused by viral infection. Also, they looked at a condition which according to German guidelines remits in 78% of the cases within two to seven days. This corresponds very poorly with the study’s timeline of observations at 3, 7, 14, and 21 days after diagnosis, whereby the first three days remained without intervention – which renders the only statistically significant result occurring at day three meaningless.

A review performed by the Australian Ministry of Health lists another study, Harrison (1999), which was judged to be of poor quality only [21].

The CORE-Hom database lists another PCT [8]. In this work by Mössinger (1985) the data of 38 children were analyzed. According to the database, no significant advantage beyond placebo was achieved.

Conclusion: There is not a single high-quality study here that would have produced a reliable positive result.

(3) Use of the homeopathic remedy Galphimia glauca against hay fever

Here the HRI refers to a work by Wiesenauer (1996), which represents a systematic review of essentially his own work on this subject [13]. He comes to a positive conclusion, not shared by other authors:

Linde (1997) investigates four works by Wiesenauer [14], which pooled together show a positive effect (odds ratio 2.03 in favor of homeopathy), although Linde concludes that he has found no indication for which there is sufficient evidence that homeopathy is effective beyond placebo. Obviously, this statement is not based on the figures alone but allows for the questionable quality of the studies.

Mathie in his systematic review of non-individualized homeopathy found insufficient quality in three of Wiesenauer’s studies (1 medium, 2 poor) and has included two other works in his meta-analysis of hay fever (”allergic rhinitis“) [15]. He also concludes that there is a lack of reliable evidence for the efficacy of homeopathy for any clinical condition.

The review by the Australian Ministry of Health comes to the same conclusion.

Conclusion: In contrast to the author of the one review cited by HRI, all other reviews agree that there is no reliable evidence. Since the lead author of the studies himself is probably more prone to be biased in favor of his results, the negative assessment from the other three reviews appears more solid.

(4) Use of pollen C30 as an isopathic remedy against hay fever

HRI cites a study by Reilly (1986) [16], which is indeed considered by most reviewers to be of high quality – except for Mathie (2017). He considers this paper of poor quality due to unclear reporting of the blinding and incomplete reporting of results [15].

Even if we admitted that this study was rated as good quality by most reviewers and yielded a positive result, there is still no replication of this promising work for homeopathy – for more than 30 years now. Why this is the case is open to speculation: it is impossible to judge whether an attempt to replicate the positive result has failed or not.

(5) Use of the homeopathic remedy Oscillococcinum for the treatment of influenza

The HRI indicates a study in which Oscillococcinum is supposed to be effective against influenza. This work by Mathie (2012) is a Cochrane review, i. e. a systematic review carried out according to strict rules [17] and, if the statement of the HRI would apply, should actually be counted as reliable evidence.

First of all, it was not influenza that was treated, but influenza-like infections, i. e. common colds. Then Mathie, who works for the Homeopathy Research Institute himself and for sure is not an opponent of homeopathy, comes to the conclusion:

“There is not enough evidence to draw solid conclusions about Oscillococcinum for the prevention or treatment of influenza or flu-related infections. Our results do not exclude the possibility that Oscillococcinum may have a useful clinical effect, because of the low quality of the studies in question, the evidence is not convincing.“

Well, a reliable proof of thoroughly positive effects looks different.

(6) Use of the homeopathic complex remedy Vertigoheel against vertigo

The paper by Schneider et al. is a review of four papers that examined the remedy Vertigoheel for the treatment of vertigo in comparison to other therapies [18]. Only two of the papers (Weiser 1998 [19] and Issing 2004 [20]) were randomized controlled studies. Unfortunately, these works are not included in Mathie’s reviews. In the review of the NHMRC, the work of Issing is rated at medium to high risk of bias, while the work of Weiser is rated at medium risk [21].

In all four papers, it was found that the results obtained with Vertigoheel did not differ from the conventional therapies – although this is only meaningful if these conventional treatments are effective beyond placebo themselves and have been applied properly.

If Vertigoheel actually was effective, however, this is a point more against the teaching of homeopathy than in favor. The prescription was not based on an individual assessment of similarity between symptoms and the drug’s “remedy-picture”, which should be established in a detailed first session. Instead it was based on the not very specific diagnosis of ”dizziness“, which can have a large variety of different causes. Secondly, Vertigoheel is a complex remedy of four different homeopathic remedies, which, according to homeopathic teachings, at least makes it very difficult to achieve healing. It should be noted that Heel’s complex remedies are not considered to be homoeopathic drugs, but should act in accordance with homotoxicology, a doctrine of salvation based on the alleged detoxification of the body and not on influencing the alleged vital force as in homeopathy [22].

Conclusion: Once again there is no reliable evidence of homeopathy as an effective treatment for this condition. Based on the quality of the relevant studies, the results should not be considered as valid. But if homeopaths insist on their validity, then the studies rather indicate that the foundations of homeopathy are wrong.

In summary

At best, there is only a single good study that showed some benefit of homeopathy – Reilly – amongst all the examples given by the HRI. It is unclear how many clinical conditions were considered in PCTs of homeopathy, as many different figures are given: The UK-based Faculty of Homeopathy says 61 conditions, 85 conditions were considered in the review by the Australian Ministry of Health, and the German CORE-Hom database lists more than 50 indications under the letter “A” alone. With the standard risk of an Type I error (false positive result) of 5%, it is to be expected that there are a few studies that are of good quality and in favor of homeopathy. In this respect, Reilly’s study seems more the exception proving the rule (which is further mitigated by the fact that this work has not been reproduced for decades – or has been reproduced with a negative result, but this never came to be published – we don’t know that).

Clinical relevance

It is well known that homeopathy raises strong claims of its efficacy:

“A carefully selected homeopathic medicine can relieve quickly, safely, gently and without side-effects the symptoms of severe, acute and chronic complaints, such as migraine, neurodermitis, bronchial asthma, colitis, rheumatism and many other diseases. This also applies to acute conditions of a bacterial or viral origin.” [23]

This is what the president of the German Central Association of Homeopathic Doctors, essentially the highest German homeopath, writes on her practice homepage. Thus the patient who decides in favor of homeopathic therapy can expect that their state of health will improve substantially more and/or faster than if they hadn’t done anything at all. Therefore, studies of homeopathy should not only result in a statistically significant benefit beyond placebo; this would only mean that the effect is just strong enough to be recognized in sophisticated statistical analysis and might be of no practical benefit. But it should also be clinically relevant, i. e. show a noticeable and substantial improvement for the patient.

The clinical relevance in a study results from two aspects: On one hand, if the study authors have chosen a characteristic as main outcome measure that meets the expectations of the patient well enough for them to judge the treatment as a success or not. On the other hand, however, the difference must also be substantial, so the benefit should be of a magnitude the patient can really experience. Irrespective of the quality of the studies cited by the HRI – i. e. their credibility – here is a short look into what their results indicate regarding clinical relevance:

Childhood diarrhea:

Jacobs chooses the number of unformed stoolson the third day of treatment. At this point in time, this figure has decreased significantly in both study groups, from an average of 7.7 events per day to 3.1 in the control group and to 2.1 under homeopathic treatment. This advantage of only one event per day disappeared completely on day 4:2.0 events in the homeopathic group, 2.1 under placebo, i. e. hardly distinguishable. By the way: the third day is the only day with a significant result. The difference of one event on day three alone certainly is some relief for the family – but is it a substantial improvement over placebo?

Otitis media:

Jacobs‘ placebo-controlled study did not even yield a significant benefit, so there is no need to worry about clinical relevance.

Galphimia glauca in hay fever:

Two weeks after the start of treatment, 34 (of 41) patients in the homeopathy group were free of symptoms or experienced significant relief, in the control group it was 21 (of 45) patients. After four weeks, 30 (of only remaining 37) patients in the homeopathy group were free of symptoms or had a significant improvement. In the control group, it was 20 (of only 35) patients [24]. Further out, only relative figures from other works are available, which do not permit an assessment of relevance.

Whether this will show a substantial effect remains to be seen.

Pollen C30 against hay fever:

In Reilly’s work, the severity of hay fever symptoms was determined by the patients themselves ever day, given on a visual analogue scale ranging from 0 to 100 (0 = no symptoms at all, 100 = extremely bad). At the beginning, the mean value in both groups was about 45, but with a big variance. The same showed in the changes: In the homeopathy group, scores ranged from an improvement by 80 points to a deterioration by 50 points. Practically the same thing happened in the control group: The range was from an improvement by 80 points to a deterioration by 60 points. If the patients had compared their results, they would not have been able to identify individual patients whose results were so good or so bad as to clearly identify them to be of the homeopathy or control group. The higher mean improvement of 17.1 points in homeopathy compared to only 2.1 points in the control group is a difference that no patient can actually perceive.

Oscillococcinum for influenza:

In the two works by Ferley [25] and Papp [26] the success of the therapy is judged by the recovery rate on the second day after start of treatment. In fact, there is a statistically significant advantage of the homeopathy group – which is only present on this very day, neither the day before nor the day after. This is illustrated in the graphic, which also shows how „radical“ homeopathy has been.

The graph shows the results of Ferley’s work [25], which were converted to even numbers of participants in both groups. From day 1 to day 2, the homeopathy group has achieved a small advantage indeed, but the parallel curves show otherwise that the recovery rates are practically the same.

The average duration of the illness was reduced only by about 6 hours, which should be meaningless, especially at night, if they happen while the patient is asleep. This is certainly not the therapeutic success that patients would want to achieve.

Vertigoheel against dizziness:

No comparison with placebo possible, as the drug was not compared with placebo but with other therapies.

In summary:

Even if one ignores the lack of credibility of the studies and takes a look at the results alone, the assertion that homeopathy can quickly achieve a drastic improvement of the patient’s situation is by no means apparent in the studies quoted by the HRI. At best, there is one potential use, Galphimia glauca in hay fever, but this would still have to be verified on the basis of independent study replications.

Quintessence

The works presented by the HRI as ”good studies“do not satisfy this claim – by far. Studies have been judged to be of inadequate quality in existing reviews of homeopathy. At best, there could be just one indication where a good study shows a positive result. This promising work on isopathy in hay fever has not been replicated for thirty years now, however. In addition, for statistical reasons, it is to be expected that even good studies will occasionally yield positive results, due to the risk of a Type I error (probability for false-positive results).

The clinical effects, on the other hand, are relatively minor and in no way support the claim of homeopathy to be a thoroughly effective therapy, helping patients to a substantial degree.

The HRI’s arguments against ”There is not a single good quality trial showing homeopathy works“ is thus not supported by evidence.

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Acknowledgement:

This article is published here with kind permission of the author, Dr. Norbert Aust. The author would like to thank Udo Endruscheit and Sven Rudloff for their help with this English version of his original blog-article: http://www.beweisaufnahme-homoeopathie.de/?p=3312

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References

[1] NN.: „There isn’t a single good quality trial showing homeopathy works“, webpage of the Homeopathy Research Institute, checked 01.12.2017, Link

[2] Aust, N: Criticism on criticism on Homeopathy Pt. 1: There is no evidence, blog-article (Link) and INH website (Link)

[3] Higgins JPT, Green S.: Cochrane Handbook for Systematic Reviews of Interventions; The Cochrane Library, 2008. Link
(Chapter 8: Asessing Risk of Bias)

[4] Jacobs J, Jonas WB, Jiminez-Perez M et al.: “Homeopathy for childhood diarrhea: combined results and metaanalysis from three randomized, controlled clinical trials“, Pediatr Infect Dis J (2000);22:228-234 Link

[5] Jacobs J, Jiminez LM, Gloyd S et al.:“Homoeopathic treatment of acute childhood diarrhea – a randomized clinical trial in Nicarague“,British Homeopathic Journal (1993);82:83-86

[6] Jacobs J, Jiminez LM, Gloyd SS et al.: “Treatment of Acute Childhood Diarrhea with Homeopathic Medicine: A Randomized Trial in Nicaragua“, Pediatrics(1994);93(5):719-725 Link

[7] Jacobs J, Jiminez M, Mathouse S et al.: “Homeopathic Treatment of Acute Childhood Diarrhea: Results from a Clinical Trial in Nepal“, Journal of Alternative and Complementary Medicine(2000);6(2):131-139 Link

[8] NN: “CORE-Hom database, A database on Clinical Outcome Research in Homeopathy“, database of the Carstens-Foundation, free access requires registration , Link

[9] Mathie RT, Lloyd SM, Legg LA et al.: “Randomised placebo-controlled trials of individualised homeopathic treatment: systematic review and meta-analysis“, Systematic Reviews 2014;3:142, Link

[10] Jacobs J, Springer DA, Crothers D: “Homeopathic treatment of acute otitis media in children: a preliminary randomized placebo-controlled trial“, Pediatr Infect Dis J (2001);20(2):177-83 Link 

[11] Sinha MN, Siddiqui VA, Nayak C et al.: “Randomized controlled pilot study to cpmpare Homeopathy and Conventional therapy in Acute Otitis Media“, Homeopathy (2012);101:5-12, Link

[12] NN: DEGAM-Leitlinie Nr. 7: Leitlinie „Ohrenschmerzen“, aktualisierte Fassung 2014, Deutsche Gesellschaft für Allgemeinmedizin und Familienmedizin, AWMF-Registernummer 053/009 Link (in German)

[13] Wiesenauer M, Lüdtke R:“A Meta-Analysis of the Homeopathic treatment of Pollinosis with Galphimia Glauca“, Forschende Komplementärmedizin (1996);3:230-234, Link

[14] Linde K, Clausius N, Ramirez G et al.: “Are the clinical effects of homeopathy placebo effects? A meta-analysis of placebo-controlled trials“, The Lancet (1997);350:834-843 Link

[15] Mathie RT, Ramparsad N, Legg LA et al.: “Randomised, double-blind, placebo-controlled trials of non-individualised homeopathic treatment: Systematic review and meta-analysis“, Systematic Reviews 2017;6:663 Link

[16] Reilly TR, Taylor MA, McSharry C et al.: “Is homeopathy a placebo response? Controlled trial of homoeopathic potency, with pollen in hayfever as model“, The Lancet (1986) 328:8512:811-816 Link

[17] Mathie RT, Frye J, Fisher P:“Homeopathic Oscillococcinum (R) for preventing an treating influenza and influenzy-like illness (Review)“, Cochrane Database of Systematic Reviews 2012 Issue 12 Art.No.: CD001957 Link

[18] Schneider B, Klein P, Weiser M: “Treatment of Vertigo with a Homeopathic Complex Remedy Compared with Usual treatments“, Arnzneim.-Forsch./Drug Res.(2005);55(1):23-29 Link

[19] Weiser M, Strösser W, Klein P: “Homeopathic vs. Conventional Treatment of Vertigo: A Randomized Double-blind Controlled Clinical Study“, Arch Otolaryngol Head Neck Surg. (1998);124(8):879-995 Link

[20] Issing W, Klein P, Weiser M: “The Homeopathic Preparation Vertigoheel(R) Versus Gingko biloba in the Treatment of Vertigo in an Elderly Population: A Double-Blinded, Randomized, Controlled Trial“, J. Altern. Complement. Med. (2005);11(1):155-160 Link

[21] National Health and Medical Research Council. 2015. “NHMRC Information Paper: Evidence on the effectiveness of homeopathy for treating health conditions “, Canberra: NHMRC;2015 Link

[22] NN: Homotoxikologie, article in Homöopedia.eu (in German) Link

[23] Entry „Homöopathie“ on the website of C. Bajic  Link  – checked 25.11.2017 (in German)

[24] Wiesenauer M, Häussler S, Gaus W: “Pollinosis-Therapie mit Galphimia Glauca”, Fortschr. Med (1983);101(17): 811-814 Link

[25] Ferley JP, Tmirou D, D’Adhemar D et al.: “Evaluation of a Homeopathic Preparation in the Treatment of Influenza-Like Syndromes“, Br. J. clin Pharmac. (1989);27:329-335  Link

[26] Papp R, Schuback G, Beck E, et al.: “Oscillococcinum(R) in patients with influenzy-like syndromes: A placebo-controlled double-blind evaluation“, British Homeopathic Journal (1998);87(2):69-76 Link

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Picture credits: Fotolia_130625327_XS

“Scientists claim that homeopathy is not possible”

… states the Homeopathy Research Institute as allegedly supposed dictum of critics on homeopathy.

The third part of our series about homeopathic criticism on criticism of homeopathy deals with the Homeopathy Research Institute’s statement: “Scientists claim homeopathy is impossible”.

Whether scientists would use this wording to express their views on homeopathy seems to be rather doubtful, the Homeopathy Research Institute (HRI) does not offer any reference of such a statement in their article anyway (https://www.hri-research.org/resources/homeopathy-faqs/scientists-say-homeopathy-is-impossible/). However, this is not very likely, because a serious scientist would utter such a statement only if there was clear evidence for anything. But this is impossible in our case, since the non-existence of something cannot be proven. What scientists actually say about homeopathy is:

• Scientific mechanisms of action—where we conclude that the claims for homeopathy are implausible and inconsistent with established scientific concepts.
• Clinical efficacy—we acknowledge that a placebo effect may appear in individual patients but we agree with previous extensive evaluations concluding that there are no known diseases for which there is robust, reproducible evidence that homeopathy is effective beyond the placebo effect. There are related concerns for patient-informed consent and for safety, the latter associated with poor quality control in preparing homeopathic remedies. [1]

So there is no statement of homeopathy being “impossible” as such, but only that it contradicts everything we know from science, technology and everyday life about how nature works. Of course, this can be all wrong, since our knowledge is an approximation of reality only. Therefore, a scientist will always refer to the current state of knowledge –  which does not necessarily mean that they consider it likely that this will really be proven false.

Background: Why is homeopathy implausible?

The world exists and develops quite obviously in a multitude of processes and phenomena. The fundamental laws that control these processes and which are being researched by science must therefore be compatible and must not contradict each other. A natural law cannot be valid in one case and invalid in another under the same conditions. If such problems arise, this is an indication that our understanding of the matter is not yet complete, e.g. some important conditions might not have been identified yet.

Any inconsistency in our knowledge indicates an error in our understanding. Usually this triggers research to find the root cause and to result in a better understanding of nature’s laws. Consequently, to be plausible in science, any doctrine would have to be consistent, showing no internal contradictions and not being in conflict with other branches of science.

Homeopathy does not meet these requirements, because it is full of internal contradictions and there is no reasonably plausible explanation for any effectiveness of the remedies in use, which would not be in conflict with well-established knowledge.

To cover all the issues in detail would exceed the limits of an article as this one, so a few examples will have to suffice.

• Internal contradictions

According to the homeopathic “law of similarity”, a remedy is able to cure the symptoms in an ill person that it can invoke in a healthy one. This is one of the pillars of homeopathy; it is even where the name is derived from (“homeopathy” = “similar to suffering”). Obviously, this must also apply in the reversal, so that a remedy can trigger the symptoms in a healthy person that it can cure in an ill one. Homeopathic drug “provings”, and with this the homeopathic database for prescribing proper remedies to patients, is dependent on the fact that healthy subjects take a remedy and record the symptoms that occur afterwards.

First off, if this was true, homeopathic remedies would be extremely dangerous –  after all, according to homeopaths, you can cure and therefore cause all kinds of acute and chronic illnesses with homeopathic remedies, which is in contrast to the claimed gentleness and safety of their use. Homeopathy follows the logic that every intake of their remedies will cause an “effect”, a healing one when it was “perfectly appropriate” and a harmful one when this is not the case. Either a homeopathic remedy can cause undesirable effects (“side effects”) , or the drug trials do not work, and therefore the bases of homeopathic prescriptions, the so-called Materia Medica, are rubbish.

Either way, any specific therapy of patients would be impossible. Either because the doctrine is wrong, and the remedies are ineffective, or because the properties of the remedies are unknown and the effects a practitioner may evoke are unpredictable.

Homeopaths even agree that not being able to identify the right remedy at first go is quite possible, meaning that homeopathic remedies are wrongly prescribed quite frequently. This would turn homeopathy into a very risky therapy: since the wrong remedy would identify the patient as “healthy” concerning the drug-specific symptoms and start to create them.  Or does the remedy somehow know, even if it was wrongly prescribed, that the person is ill, though concerning another drug, and then it suppresses its urge to cause its own individual proving symptoms?

Over-the-counter sale of homeopathic medicines without a prescription would have to be banned, because a layperson would be far less able to identify the proper remedy for themselves. And by the way: Either a detailed anamnesis is required for the proper choice of drugs – then the OTC-sale of the remedies is a kind of fraud –, or the remedies can be ordered according to perfunctory diagnosis, then the extensive first anamnesis is humbug.

• Outer contradictions

An explanation, i.e. an effective model of homeopathy, should be able to describe, for example, how the efficacy of a source material is enhanced by dilution and shaking. And how this is transferred to the patient when the source material is diluted out of the solution, and how the remedies differentiate whether the patient is ill or not.

Even for this basic process there is no explanation that would not fundamentally contradict our current understanding of physics, chemistry and physiology in one form or another. Of course, this explanation should also include why under similar conditions in similar processes these effects do not occur outside of homeopathy.

In technology and day-to-day life, there are many procedures where the “efficacy” of a substance is controlled by maintaining certain concentrations of the active substance in question. Drinking water is treated by removing the accompanying impurities of the natural surface water to such an extent that the maximum concentrations of pollutants are within the limits prescribed in the regulations for potable water. It’s similar for the treatment of water for medical purposes, the production of decaffeinated coffee, alcohol-free beer, skimmed milk, etc. None of these substances have as yet been found to be affected by shaking – for example, by vigorously slamming the coffee cup on the table. The effect of dilution could never be completely or partially removed – better: inverted – by succussion. Shaking or stirring is often used to mix substances and homogenize the concentrations. If homeopathic assumptions were correct, the very first bump on the table would increase the strength of the coffee.  After all, potentizing is said to be very powerful: 10 beats of shaking are sufficient to transfer the effectiveness to 99 times the volume of the solvent – and to even enhance the effect.

It is also inexplicable why this immense increase of power only happens when the solution is diluted in advance, and not when the liquid is shaken without being diluted before. An explanation has to account for this, too. Otherwise, at least liquid homeopathic drugs should not be sold, because random shaking movements during transport to the pharmacy, or later in the shopping bag or a pocket, would result in random increases of efficacy, which in turn would have to lead to an unpredictable result with the patient (Hahnemann, the inventor of homeopathy, was sure of this – it is reported that this was initial for the idea of using globules; therapists who could not see such an “transport effect” were taunted by him).

Furthermore, the model would have to provide an explanation for the fact that the amplification only affects the substance used as a mother tincture – and only the desired properties that is, not a toxic effect for instance – not the inevitable impurities of alcohol or water used as a solvent.

• Conclusion

It may not be exactly correct to postulate the “impossibility” of such a model, because this cannot be proven. One can, however, consider how much of current science needs to be rewritten in order to explain the alleged mode of operation of homeopathy as well as the non-occurrence of these effects outside the homeopathic environment.

Revolutionary insights are usually honored with a Nobel Prize. In order to illustrate the extent of the contradiction between homeopathy and the natural sciences, the German physicist Martin Lambeck once pointed out how many Nobel Prizes would have to be awarded if the assumptions of homeopathy were actually scientifically proven [2]. His count reached well over 90. The introduction of the theory of relativity or quantum physics were mere trifles in comparison.

What scientists really say

Homeopaths like to quote scientists as witnesses for the claimed efficiency of their drugs and remedies, but quite frequently do so in a crude and misleading way, as found in HRI’s reference of Luc Montagnier.

Montagnier is a virologist who in 2008 was awarded the Nobel Prize for his work on the AIDS virus. In 2010, he gave an interview to the journal Science in which he answered questions about one of his – by the way highly controversial – papers [3]. In this article, he claimed to have found that some bacteria emit electromagnetic waves – and that these can be detected in the solution even when the bacteria are filtered off and the solution is further diluted [4]. The HRI quotes a passage from the interview, but only three short sentences out of context in which Montagnier sounds as if he would actually confirm homeopathy. However, here is the complete quote with HRI’s partial quote highlighted:

Q: Do you think there’s something to homeopathy as well?
L.M.: I can’t say that homeopathy is right in everything. What I can say now is that the high dilutions are right. High dilutions of something are not nothing. They are water structures which mimic the original molecules. We find that with DNA, we cannot work at the extremely high dilutions used in homeopathy; we cannot go further than a 10-18 dilution, or we lose the signal. But even at 10-18, you can calculate that there is not a single molecule of DNA left. And yet we detect a signal. 
(original wording)

A wonderful example of cherry-picking: Montagnier actually said the phrase the HRI quotes, yes, but in the same breath he also contradicted some basic assumptions of homeopathy. If the HRI had the intention to inform its readers about the real background of Montagnier‘s work, then they should have mentioned:

• It’s the DNA that causes the effect. The efficacy of inorganic substances or simple organic compounds would therefore remain unexplained.
• Not even all organisms seem to produce the effect, but only certain bacteria.
• The dilutions were only active in a comparatively narrow range, depending on the species of bacteria, between D8 and D12, i.e. not in the absurdly high dilutions as is customary in homeopathy (C200 and even higher).
• The effects last only for a comparatively short period of less than 48 hours, and in no case for such a long period of time in which homeopathic remedies may even reach their customer.
• The effect becomes weaker with increasing dilution and disappears completely above D18, whereas in homeopathy considerably higher potencies with correspondingly stronger dilutions are in use and are regarded as particularly effective.

There’s nothing there to support homeopathy.

Change in science

Again and again, according to the HRI, science is subject to constant change, which is supposed to suggest that the present knowledge is probably false:

“What the scientific establishment considers impossible at one point in time is a proven fact at a later stage “.

This statement is complete nonsense and is based on a completely wrong understanding of science.

In fact, science is constantly evolving and gaining better and more comprehensive insights in the processes of nature. Of course, “mistakes” also occur, meaning that hypotheses are made and considered to be confirmed, but later prove to be inaccurate. Finding errors and shortcomings, gradually and laboriously pushing out the limits of knowledge, improving the inadequate, replacing the wrong with (probably) more correct things, this is the core of scientific work. Usually, scientists who have disproved particularly sound hypotheses are awarded a Nobel Prize. These included, for example, Barry Marshall and Robin Warren, who were awarded the Nobel Prize in Medicine in 2005 for demonstrating that gastric ulcers can be attributed to bacterial infections, which was previously considered impossible because bacteria were not believed to survive gastric acid (this was, by the way, considered impossible, but not completely incompatible with natural laws).

This example, which is also cited by the HRI, does not prove that our knowledge is wrong, but rather that true science can detect and correct errors and thus obtain ever better knowledge of the actual facts. There are conclusions and hypotheses that may prove to be inaccurate later on, and these may be considered valid for quite a long time before, but with the scientific methodology it is possible to exclude inaccurate views.

If you want to describe the situation in one sentence, you can use a quote from the Swiss internist Wilhelm Löffler (Link):

“Almost all the errors of medicine that live on in popular belief were once scientifically accepted theories.”

There are also laws of nature that cannot be modified or replaced by anything else. These laws of nature are the absolute limit to speculation on “everything is possible” and “science cannot yet understand…”. It is by no means the case that everything that is considered impossible today will almost inevitably represent proven wisdom tomorrow, like the HRI tries to suggest. Perpetua mobilia are impossible and will remain so, also like a speed beyond the speed of light. And: where there is nothing, there is nothing that works.

Summary

Even though our knowledge of the ways of the world is still far from complete, it is very unlikely that one day a medical efficacy of homeopathic preparations will be explained, especially with the effects claimed in the various homeopathic repertories. The contradiction between homeopathic teaching and established knowledge of science, technology and everyday life is far too big. In the end, it would not only be necessary to find an explanation of the efficacy, but also to show why these effects do not occur in similar processes outside homeopathy. This means that for large parts of physics, biology and chemistry, completely new and contradiction-free explanatory models must be presented (the physicist and science theorist Thomas S. Kuhn expressly demanded the replacement of old paradigms only “including central concepts”).

This is so highly improbable that it can be considered impossible with highest probability, comparable to the probability of finding an atom/molecule of the mother tincture in a bottle of C200 potency. 1:10³⁸⁰ is not equal to zero – however, it is small enough for all practical purposes to be taken as zero.

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Sources / References:

[1] European Academies Science Advisory Council: “Homeopathic products and practices: assessing the evidence and ensuring consistency in regulating medical claims in the EU“, EASAC:September 2017, Link

[2] Lambeck M.: Irrt die Physik? Über alternative Medizin und Esoterik, 3. erweiterte Auflage, Verlag C.H.Beck 2015, ISBN 3406670962

[3] Newsmaker Interview ‚French Nobelist Escapes ‚intellectual Terror‘ to Persue Radical Ideas in China‘, Science 330 (2010) p. 1732

[4] Montagnier L, Aissa J, Ferris S, Montagner JL, Lavalle C: Electromagnetic Signals are Produced by Aqueous Nanostructures Derived from Bacterial DNA Sequences‘, Intersiscip Sci Comput Life Sci (2009) 1: 81-90

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Picture credits: Fotolia_130625327_XS