MD, PhD, FMedSci, FSB, FRCP, FRCPEd

homeopathy

The website of ‘HOMEOPATHY 360’ has just published a new post offering a handy instruction for killing patients suffering from acute appendicitis. If you do not believe me – I don’t blame you, I too found it hard to believe – read this short excerpt advocating homeopathy for this life-threatening condition (for readers without a medical background: if acute appendicitis is not treated promptly, the inflamed appendix might burst, spilling faecal material into the abdominal cavity, resulting in a life-threatening peritonitis):

The post is entitled “A Cure of Acute Appendicitis Using Frequent Homeopathic Doses in Solution

Here is the abstract:

“Placing centesimal potencies in solution and prescribing them frequently for acute conditions is not widely practiced. It can be superior to dry doses in many cases, where a persistent mild medicinal action is preferred to a strong aggravation. By prescribing dissolved doses of Arnica Montana 1m, a case of acute appendicitis was cured quickly. This suggests that centesimal potencies given frequently in solution may be more efficacious, prompt and gentle than treatment with dry doses.”

Fascinating, isn’t it?

Here are more details demonstrating that the author has done his homework:

“When treating a patient with acute medical condi­tion, in certain cases we fail to cure. Even though our case taking, evaluation, analysis, remedy and potency selection seem correct. What is the cause? In the Organon 5th edition (1833) Dr. Hahnemann introduced olfaction and dissolved centesimal remedies as a new method of administering doses. Around the year 1840 Hahnemann began to introduce LM potencies into his practice. From 1840 to 1843 he used both centesimal and LM potencies side by side in medicinal solutions. By these methods he hoped to avoid unwanted aggravations and provide rapid cure.

In some acute cases the aggravation can be discouragingly pro­longed and often cannot be discerned from the patient’s own disease. Many times we change the original prescrip­tion which could very well have been the simillimum. In acute diseases, a dry dose will many times produce an un­necessary aggravation because of the patient’s increased susceptibility. I have much experience now with what I call a “watery dose.” To prepare it, one or two globules of size 10 are diluted in 15ml. of distilled water in which 5 drops of alcohol added with 20 to 30 succussions. From this solution 10 drops are added to another 15 ml of water, and from this solution 5 to 10 drops dose repeated according to the severity of the disease. In such diluted solutions the correct number of drops must be precise. Every time be­fore taking the dose the solution is succussed 5 to 10 times. The same solution can be used for several days or weeks. Hahnemann recommended using carefully measured and dosed solutions with sensitive patients. Many times I have used this method with great success. It is not necessary to take 4 oz. to 8 oz. of water, Just fifteen ml. of distilled water is sufficient. This technique of dosing is also known as a split dose because it uses one or two pills in a solution that is then split over several days or weeks.

The results using this type of dosing can be very dif­ferent from dry doses. There is continuous amelioration of the complaints without aggravation. This comes closer to the ideal of strengthening the weakened vital force than is seen when we simply produce a similar stronger artificial disease in the patient.”

The author also provides a detailed case history of a patient who survived this treatment (of course, without mentioning that acute appendicitis can, in rare cases, have a spontaneous recovery).

MY ADVICE:

I would not recommend Arnica or any other homeopathic remedy for routine use in acute appendicitis (or any other condition) – unless, of course, you want to kill a maximum number of your patients suffering from this medical/surgical emergency.

The website of the HOMEOPATHY HUB gives us intriguing access to the brain of a homeopath. It tells us that “protecting patient choice is at the heart of everything we do. Homeopathy, which is the second largest system of medicine in the world, is a form of treatment which plays a vital role in the lives of hundreds of thousands of people across the UK. There is, however, a movement to try and withdraw homeopathy from the public and make homeopathic medicines difficult to secure. Our intention is to be a central “hub” for accurate information on current campaigns to retain access to homeopathy and details on how you can get involved and make your voice heard. Without public and patient support we will not be successful.”

Here are a few of the above statements that I find doubtful:

  • protecting patient choice – choice requires reliable information; as we will see, this is not provided here;
  • second largest system of medicine in the world – really?
  • plays a vital role – where is the evidence for that claim?
  • movement to try and withdraw homeopathy from the public and make homeopathic medicines difficult to secure – nobody works towards this aim, some people are trying to stop wasting public funds on useless therapies, but that’s quite different, I find;

The HOMEOPATHY HUB recently alerted its readers to the fact that the Charity Commission (CC) is currently conducting a public consultation on whether organisations promoting the use of complementary and alternative medicines (CAM) should have charitable status (https://www.gov.uk/government/consultations/consultation-on-complementary-and-alternative-medicines) and urged its readers to defend homeopathy by responding to the CC offering a “few helpful points” to raise. These 7 points give, I think, a good insight into the thinking of homeopaths. I therefore copy them here and add a few of my own comments below:

  1. there are many types of evidence that should be considered when evaluating the effectiveness of a therapy. These include scientific studies, patient feedback and the clinical experience of  doctors  who  have trained in a CAM discipline.  Within Homeopathy there is considerable evidence which can be found (https://www.hri-research.org)
  2. many conventional therapies and drugs  have inconclusive evidence or prove to be useful in only some cases, for example SSRIs (anti-depressants).  Inconsistent evidence is often the result  of the complexity of both  the medical  condition being treated and the therapy being used. It is not indicative of a therapy that doesn’t work
  3. removing all therapies or interventions that  have inconsistent or inconclusive evidence would seriously limit the  public and the medical profession’s  ability to help treat and ease patients suffering.
  4. all over the world there are doctors, nurses, midwives, vets  and other healthcare professional  who integrate  CAM therapies into their daily  practice because they see effectiveness. They would not use these therapies if they  did  not see their patients  benefitting from them.  For example in the UK, within the NHS hospital setting, outcome studies demonstrate effectiveness of homeopathy. (http://www.britishhomeopathic.org/evidence/results-from-the-homeopathic-hospitals/)
  5. practitioners of many CAM therapies belong to registering bodies which expect their members to comply to the highest professional standards in regards to training and practice
  6. In the UK the producers and suppliers of  CAM treatments (homeopathy, herbal medicine etc) are strictly regulated
  7. as well as  providing valuable information to the  growing  number of people seeking to use CAM as part of their healthcare, CAM charities frequently fund treatment for those people, particularly the elderly and those on a low income, whose health has benefitted from these therapies but who cannot  afford them. This meets the charity’s criterion of  providing a public benefit.

MY COMMENTS

  1. “Patient feedback and the clinical experience of  doctors” may be important but is not what can be considered evidence of therapeutic effectiveness.
  2. Yes, in medicine evidence is often inconsistent; this is why we need to rely on proper assessments of the totality of the reliable data. If that fails to be positive (as is the case for homeopathy and several other forms of alternative medicine), we are well advised not to employ the treatment in question in routine healthcare.
  3. Removing all treatments for which the best evidence fails to show effectiveness – such as homeopathy – would greatly improve healthcare and reduces cost. It is one of the aims of EBM and an ethical imperative.
  4. Yes, some healthcare professionals do use useless therapies. They urgently need to be educated in the principles of EBM. Outcome studies have normally no control groups and therefore are no adequate tools for testing the effectiveness of medical interventions.
  5. The highest professional standards in regards to training and practice of nonsense will still result in nonsense.
  6. The proper regulation of nonsense can only generate proper nonsense.
  7. Yes, CAM charities frequently fund bogus treatments; hopefully (and with the help of readers of this blog), the CC will put an end to this soon.

I think these 7 points by the HOMEOPATHY HUB are a very poor defence of homeopathy. In fact, they are so bad that it is not worth analysing more closely than I did above. Yet, they do provide us with an insight into the homeopathic mind-set and show how illogical, misguided and wrong the arguments of homeopathy enthusiasts really are.

I do encourage you to give your response to the CC – it wound be hard to use better arguments than the homeopaths!!!

Regular readers of this blog will have noticed: when homeopathy-fans run out of arguments, they tend to conduct an ‘ad hominem’ attack. They like to do this in several different ways, but one of the most popular version is to shout with indignation: YOU ARE NOT QUALIFIED!!!

The aim of this claim is to brand the opponent as someone who does not know enough about homeopathy to make valid comments about it. As this sort of thing comes up regularly, it is high time to ask: WHO ACTUALLY IS AN EXPERT IN HOMEOPATHY?

This seems to be an easy question to answer, but – come to think of it – it is more complex that one first imagines. Someone could be an expert in homeopathy in more than one way; for instance, one could be an expert:

  • in the history of homeopathy,
  • in the manufacture of homeopathics,
  • in the regulation of homeopathy,
  • in the clinical use of homeopathy in human patients,
  • in the clinical use of homeopathy in animals,
  • in the use of homeopathy in plants (no, I am not joking!),
  • in basic research of homeopathy,
  • in clinical research of homeopathy.

This blog is almost entirely devoted to clinical research; therefore, we should, for the purpose of this post, narrow down the above question to: WHO IS AN EXPERT IN CLINICAL RESEARCH OF HOMEOPATHY?

I had always assumed to be such an expert – until I was accused of being a swindler and pretender, that is. I have no formal qualifications for practising homeopathy (and never claimed otherwise), and this fact has prompted many homeopathy-fans to claim that I am not qualified to comment on the value of homeopathy. Do they have a point?

Rational thinkers have often pointed out that one does not need such qualifications for practicing homeopathy. In many countries, anyone can be a homeopath, regardless of background. In all the countries I know, one certainly can practise homeopathy, if one is qualified as a doctor. Crucially, do you really need to know how to practice homeopathy for conducting a clinical trial or a systematic review of homeopathy? Homeopaths seem to think so. I fear, however, that they are wrong: you don’t need to be a surgeon, psychiatrist or rheumatologist to organise a trial or conduct a review of these subjects!

Anyway, my research of homeopathy is not valid, homeopaths say, because I lack the formal qualifications to call myself a homeopath. Let me remind them that I have:

  1. been trained by leading homeopaths,
  2. practised homeopathy for quite some time,
  3. headed a team of scientists conducting research into homeopathy,
  4. conducted several clinical trials of homeopathy,
  5. published several systematic reviews of homeopathy,
  6. no conflicts of interest in regards to homeopathy.

However, this does not impress homeopath, I am afraid. They say that my findings and conclusions about their pet therapy cannot be trusted. In their eyes, I am not a competent expert in clinical research of homeopathy. They see me as a fraud and as an impostor. They prefer the real experts of clinical research of homeopathy such as:

  • Robert Mathie
  • Jos Kleinjen
  • Klaus Linde

These three researchers who are fully accepted by homeopaths; not just accepted, loved and admired! They all have published systematic reviews. Intriguingly, their conclusion all contradict my results in one specific aspect: THEY ARE POSITIVE.

I do not doubt their expertise for a minute, yet have always found this most amusing, even hilarious.

Why?

Because none of these experts (I know all three personally) is a qualified homeopath, none of them has any training in the practice of homeopathy, none of them has ever practised homeopathy on human patients, none of them has even worked for any length of time as a clinician.

What can we conclude from these insights?

We could, of course, descend to the same level as homeopaths tend to do and conclude that homeopathy-fans are biased, barmy, bonkers, stupid, silly, irrational, deluded, etc. However, I prefer to draw a different and probably more accurate conclusion: according to homeopathy-fans, an expert in clinical research of homeopathy is someone who has published articles that are favourable to their trade. Anyone who fails to do likewise is by definition not competent to issue a reliable verdict about it.

As the data suggesting that homeopathy is effective for improving health is – to put it mildly – less than convincing, a frantic search is currently on amongst homeopaths and their followers to identify a specific condition for which the evidence is stronger than for all conditions pooled into one big analysis. If they could show that it works for just one disease, they could celebrate this finding and henceforth use it for refuting doubters stating that highly diluted homeopathic remedies are pure placebos. One such condition is allergic rhinitis; there have been several trials suggesting that homeopathy might be effective for it, and therefore it is only logical that homeopathy-promoters want to summarise these data in order to silence sceptics once and for all.

A new paper ought to be seen in this vein. It is systematic review by the Mathie group with the stated aim “to evaluate the efficacy and effectiveness of homeopathic intervention in the treatment of seasonal or perennial allergic rhinitis (AR).”

Randomized controlled trials evaluating all forms of homeopathic treatment for AR were included in a systematic review (SR) of studies published up to and including December 2015. Two authors independently screened potential studies, extracted data, and assessed risk of bias. Primary outcomes included symptom improvement and total quality-of-life score. Treatment effect size was quantified as mean difference (continuous data), or by risk ratio (RR) and odds ratio (dichotomous data), with 95% confidence intervals (CI). Meta-analysis was performed after assessing heterogeneity and risk of bias.

Eleven studies were eligible for SR. All trials were placebo-controlled except one. Six trials used the treatment approach known as isopathy, but they were unsuitable for meta-analysis due to problems of heterogeneity and data extraction. The overall standard of methods and reporting was poor: 8/11 trials were assessed as “high risk of bias”; only one trial, on isopathy for seasonal AR, possessed reliable evidence. Three trials of variable quality (all using Galphimia glauca for seasonal AR) were included in the meta-analysis: nasal symptom relief at 2 and 4 weeks (RR = 1.48 [95% CI 1.24-1.77] and 1.27 [95% CI 1.10-1.46], respectively) favoured homeopathy compared with placebo; ocular symptom relief at 2 and 4 weeks also favoured homeopathy (RR = 1.55 [95% CI 1.33-1.80] and 1.37 [95% CI 1.21-1.56], respectively). The single trial with reliable evidence had a small positive treatment effect without statistical significance. A homeopathic and a conventional nasal spray produced equivalent improvements in nasal and ocular symptoms.

The authors concluded that the low or uncertain overall quality of the evidence warrants caution in drawing firm conclusions about intervention effects. Use of either Galphimia glauca or a homeopathic nasal spray may have small beneficial effects on the nasal and ocular symptoms of AR. The efficacy of isopathic treatment of AR is unclear.

Extracts of Galphimia glauca (GG) have been used traditionally in South America for the treatment of allergic conditions, with some reports suggesting effectiveness. A 1997 meta-analysis of 11 clinical trials (most of them of very poor quality) of homeopathic GG suggested this therapy to be effective in the treatment of AR. In 2011, I published a review (FACT 2011, 16 200-203) focussed exclusively on the remarkable set of RCTs of homeopathic Galphimia glauca (GG). My conclusions were as follows: three of the four currently available placebo-controlled RCTs of homeopathic GG suggest this therapy is an effective symptomatic treatment for hay fever. There are, however, important caveats. Most essentially, independent replication would be required before GG can be considered for the routine treatment of hay fever. Since then, no new studies have emerged.

I am citing this for two main reasons:

  • There is nothing homeopathic about the principle of using GG for allergic conditions; according to homeopathic theory GG extracts would need to cause allergies for GG to have potential as a homeopathic allergy remedy. Arguably, the GG trials should therefore have been excluded from this meta-analysis for not following the homeopathic principal of ‘like cures like’.
  • All the RCTs of GG were done by the same German research group. There is not a single independent replication of their findings!

Seen from this perspective, the conclusion by Mathie et al, that the use of either Galphimia glauca … may have small beneficial effects on the nasal and ocular symptoms of AR, seems more than a little over-optimistic.

On this blog, we have had (mostly unproductive) discussions with homeopath so often that sometimes they sound like a broken disk. I don’t want to add to this kerfuffle; what I hope to do today is to summarise  a certain line of argument which, from the homeopaths’ point of view, seems entirely logical. I do this in the form of a fictitious conversation between a scientist (S) and a classical homeopath (H). My aim is to make the reader understand homeopaths better so that, future debates might be better informed.

HERE WE GO:

S: I have studied the evidence from studies of homeopathy in some detail, and I have to tell you, it fails to show that homeopathy works.

H: This is not true! We have plenty of evidence to prove that patients get better after seeing a homeopath.

S: Yes, but this is not because of the remedy; it is due to non-specific effect like the empathetic consultation with a homeopath. If one controls for these factors in adequately designed trials, the result usually is negative.

I will re-phrase my claim: the evidence fails to show that highly diluted homeopathic remedies are more effective than placebos.

H: I disagree, there are positive studies as well.

S: Let’s not cherry pick. We must always consider the totality of the reliable evidence. We now have a meta-analysis published by homeopaths that demonstrates the ineffectiveness of homeopathy quite clearly.

H: This is because homeopathy was not used correctly in the primary trials. Homeopathy must be individualised for each unique patient; no two cases are alike! Remember: homeopathy is based on the principle that like cures like!!!

S: Are you saying that all other forms of using homeopathy are wrong?

H: They are certainly not adhering to what Hahnemann told us to do; therefore you cannot take their ineffectiveness as proof that homeopathy does not work.

S: This means that much, if not most of homeopathy as it is used today is to be condemned as fake.

H: I would not go that far, but it is definitely not the real thing; it does not obey the law of similars.

S: Let’s leave this to one side for the moment. If you insist on individualised homeopathy, I must tell you that this approach can also be tested in clinical trials.

H: I know; and there is a meta-analysis which proves that it is effective.

S: Not quite; it concluded that medicines prescribed in individualised homeopathy may have small, specific treatment effects. Findings are consistent with sub-group data available in a previous ‘global’ systematic review. The low or unclear overall quality of the evidence prompts caution in interpreting the findings. New high-quality RCT research is necessary to enable more decisive interpretation.

If you call this a proof of efficacy, I would have to disagree with you. The effect was tiny and at least two of the best studies relevant to the subject were left out. If anything, this paper is yet another proof that homeopathy is useless!

H: You simply don’t understand homeopathy enough to say that. I tried to tell you that the remedy must be carefully chosen to fit each unique patient. This is a very difficult task, and sometimes it is not successful – mainly because the homeopaths employed in clinical trials are not skilled enough to find it. This means that, in these studies, we will always have a certain failure rate which, in turn, is responsible for the small average effect size.

S: But these studies are always conducted by experienced homeopaths, and only the very best, most experienced homeopaths were chosen to cooperate in them. Your argument that the trials are negative because of the ineffectiveness of the homeopaths – rather than the ineffectiveness of homeopathy – is therefore nonsense.

H: This is what you say because you don’t understand homeopathy!

S: No, it is what you say because you don’t understand science. How else would you prove that your hypothesis is correct?

H: Simple! Just look at individual cases from the primary studies within this meta-analysis . You will see that there are always patients who did improve. These cases are the proof we need. The method of the RCT is only good for defining average effects; this is not what we should be looking at, and it is certainly not what homeopaths are interested in.

S: Are you saying that the method of the RCT is wrong?

H: It is not always wrong. Some RCTs of homeopathy are positive and do very clearly prove that homeopathy works. These are obviously the studies where homeopathy has been applied correctly. We have to make a meta-analysis of such trials, and you will see that the result turns out to be positive.

S: So, you claim that all the positive studies have used the correct method, while all the negative ones have used homeopathy incorrectly.

H: If you insist to put it like that, yes.

S: I see, you define a trial to have used homeopathy correctly by its result. Essentially you accept science only if it generates the outcome you like.

H: Yes, that sounds odd to you – because you don’t understand enough of homeopathy.

S: No, what you seem to insist on is nothing short of double standards. Or would you accept a drug company claiming: some patients did feel better after taking our new drug, and this is proof that it works?

H: You see, not understanding homeopathy leads to serious errors.

S: I give up.

The aim of this paper was to systematically review surveys of 12-month prevalence of homeopathy use by the general population worldwide. Studies were identified via database searches to October 2015. Study quality was assessed using a six-item tool. All estimates were in the context of a survey which also reported prevalence of any complementary and alternative medicine use. A total of 36 surveys were included. Of these, 67% met four of six quality criteria.

Twelve-month prevalence of treatment by a homeopath was reported in 24 surveys of adults (median 1.5%, range 0.2–8.2%). Estimates for children were similar to those for adults. Rates in the USA, UK, Australia and Canada all ranged from 0.2% to 2.9% and remained stable over the years surveyed (1986–2012). Twelve-month prevalence of all use of homeopathy (purchase of over-the-counter homeopathic medicines and treatment by a homeopath) was reported in 10 surveys of adults (median 3.9%, range 0.7–9.8%) while a further 11 surveys which did not define the type of homeopathy use reported similar data. Rates in the USA and Australia ranged from 1.7% to 4.4% and remained stable over the years surveyed. The highest use was reported by a survey in Switzerland where homeopathy is covered by mandatory health insurance.

The authors concluded that each year a small but significant percentage of these general populations use homeopathy. This includes visits to homeopaths as well as purchase of over-the-counter homeopathic medicines.

These data thus indicate that the percentage of the adult general population using homeopathy over the previous 12 months was in the range of 0.7–9.8%, with a median estimate of 3.9%, and the percentage accessing treatment by a homeopath over the previous 12 months was in the range of 0.2–8.2%, with a median estimate of 1.5%. The data also suggest that, over the last few decades, use of homeopathy has remained fairly stable. These facts are in sharp contrast to the claims by homeopaths that:

  • Homeopathy is hugely popular.
  • Homeopathy is being used by more and more people across the globe.
  • Homeopathy is the medicine of the future.

The well-documented and undeniable unpopularity of homeopathy begs the question, I think, why so many people seem to get so excited about homeopathy. The level of usage is nothing to write home about! Therefore, why don’t we just put it down to an aberration like believing the earth is flat? Why don’t we just concede that some minor, harmless stupidity will always exist in some people’s minds?

Here are some reasons why:

  • It is not about the amount of people using homeopathy, but about the principle that any of the increasingly scarce public funds for healthcare are wasted on something as irrational and useless as homeopathy.
  • Homeopathy makes a mockery of EBM.
  • Homeopathy and homeopaths are by no means harmless.
  • Homeopaths tell too many lies to be allowed to get away with them.
  • Homeopathy and its followers systematically undermine rational thought.

 

 

The ‘SOCIETY OF HOMEOPATHS’ (SoH) have published an official complaint they recently filed with the BBC. As it gives an intriguing insight into their mind-set, I could not resist reproducing it here (warts and all):

“Prompted by the interview with Simon Stevens of NHS England on the Today Programme, on 31st March, the Society of Homeopaths deplores the lack of balance in the BBC’s coverage of Homeopathy and urges you to review your approach to coverage of the subject.

During the Today interview, following wide-ranging discussion of issues around the future of the NHS, Sarah Montague suddenly threw in a question about the amount spent on Homeopathy within the NHS, evidently catching Mr Stevens unawares.

The annual budget of the NHS is approximately £110billion.  Of this, £4million per year (0.0036 of the NHS budget) is spent on Homeopathy.  This hardly justifies the unbalanced and hectoring approach from Sarah Montague.

We acknowledge that it is not always possible or necessary to achieve balance on a particular topic within a single programme but the BBC seems to have a consistent line across all of its platforms of opposition to, and disparagement of, Homeopathy.  A recent example is a piece on the Health section of the BBC website in October 2106 by Nick Tiggle which displayed no balance at all and denigrated Homeopathy and Homeopaths with little or no space given to alternative views.

From these and other instances, it seems clear that the BBC has a biased attitude towards Homeopathy, which may be the result of relying too heavily on a small number of ‘experts’, who openly and persistently campaign against complementary and alternative medicine. These ‘experts’ operate in a similar way to climate change deniers, referring to a limited range of research, often of poor quality, to support their claims that there is ‘no evidence for homeopathy’.

We look forward to BBC programmes which fulfill its mission to explain and provide balance and coverage of the positive effects of Homeopathy.

Mark Taylor Chief Executive Society of Homeopaths”

END OF QUOTE

This hardly needs a comment – perhaps just 6 short points:

  • To the best of my knowledge, the BBC has a policy of not being seen to be biased. The discussion referred to above was about the NHS stopping to pay for treatments that are either not effective (e. g. cough syrups) or cheaper to buy OTC than on prescription (e. g. paracetamol). Homeopathy is both. Therefore it would have even been biased NOT to bring homeopathy into the discussion.
  • To claim the BBC-interviewer caught Stevens off guard is just silly: when you go on the radio to discuss such issues, homeopathy MUST be on your mind.
  • To claim that the BBC is generally biased against homeopathy (on the basis of two anecdotes) is equally silly. The SoH should have done some systematic research on this – perhaps they did and found it failed to support their point? – this would have shown that there is plenty of (far too much) pro-homeopathy stuff on the BBC.
  • To say or imply that homeopathy is of debatable or even no value to the NHS does not disclose bias; on the contrary, it is a reflection of the scientific truth which the BBC has an obligation to report.
  • With their complaint, the SoH disclose an embarrassing degree of naivety and an alarming detachment from reality.
  • Whichever way a rational observer might look at this, the BBC should in future become a much more outspoken defender of the scientific truth – on homeopathy and everything else!!!

The recent meta-analysis by Mathie et al for non-individualised homeopathy (recently discussed here) identified just 3 RCTs that were rated as  ‘reliable evidence’. But just how rigorous are these ‘best’ studies? Let’s find out!

THE FIRST STUDY

The objective of the first trial was “to evaluate the efficacy of the non-hormonal treatment BRN-01 in reducing hot flashes in menopausal women.” Its design was that of a multicentre (35 centres in France), randomized, double-blind, placebo-controlled. One hundred and eight menopausal women, ≥50 years of age, were enrolled in the study. The eligibility criteria included menopause for <24 months and ≥5 hot flashes per day with a significant negative effect on the women’s professional and/or personal life. Treatment was either BRN-01 tablets, a registered homeopathic medicine [not registered in the UK] containing Actaea racemosa (4 centesimal dilutions [4CH]), Arnica montana (4CH), Glonoinum (4CH), Lachesis mutus (5CH), and Sanguinaria canadensis (4CH), or placebo tablets, prepared by Laboratoires Boiron according to European Pharmacopoeia standards [available OTC in France]. Oral treatment (2 to 4 tablets per day) was started on day 3 after study enrolment and was continued for 12 weeks. The main outcome measure was the hot flash score (HFS) compared before, during, and after treatment. Secondary outcome criteria were the quality of life (QoL) [measured using the Hot Flash Related Daily Interference Scale (HFRDIS)], severity of symptoms (measured using the Menopause Rating Scale), evolution of the mean dosage, and compliance. All adverse events (AEs) were recorded. One hundred and one women were included in the final analysis (intent-to-treat population: BRN-01, n = 50; placebo, n = 51). The global HFS over the 12 weeks, assessed as the area under the curve (AUC) adjusted for baseline values, was significantly lower in the BRN-01 group than in the placebo group (mean ± SD 88.2 ± 6.5 versus 107.2 ± 6.4; p = 0.0411). BRN-01 was well tolerated; the frequency of AEs was similar in the two treatment groups, and no serious AEs were attributable to BRN-01. The authors concluded that BRN-01 seemed to have a significant effect on the HFS, compared with placebo. According to the results of this clinical trial, BRN-01 may be considered a new therapeutic option with a safe profile for hot flashes in menopausal women who do not want or are not able to take hormone replacement therapy or other recognized treatments for this indication.

Laboratoires Boiron provided BRN-01, its matching placebo, and financial support for the study. Randomization and allocation were carried out centrally by Laboratoires Boiron. I would argue that the treatment time in this study was way too short for generating a therapeutic response. The evolution of the HFS in the two groups was assessed by analysis of the area under the curve (AUC) of the mean scores recorded weekly from each patient in each group over the duration of the study, including those at enrollment (before any treatment). I wonder whether this method was chosen only when the researchers noted that the HFS at the pre-defined time points did not yield a significant result or whether it was pre-determined (elsewhere in the methods section we are told that “The primary evaluation criterion was the effect of BRN-01 on the HFS, compared with placebo. The HFS was defined as the product of the daily frequency and intensity of all hot flashes experienced by the patient, graded by the women from 1 to 4 (1 = mild; 2 = moderate; 3 = strong; 4 = very strong). These data were recorded by the women on a self-administered questionnaire, assisted by a telephone call from a clinical research associate. Data were collected (i) during the first 2 days after enrolment and before any medication had been taken; (ii) then every Tuesday and Wednesday of each week until the 11th week of treatment, inclusive; and (iii) finally, every day of the 12th week of treatment.”). Two of the authors of this paper are employees of Boiron.

THE SECOND STUDY

The second trial was aimed at finding out “whether a well-known and frequently prescribed homeopathic preparation could mitigate post-operative pain.” It was a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of the homeopathic preparation Traumeel S® in minimizing post-operative pain and analgesic consumption following surgical correction of hallux valgus. Eighty consecutive patients were randomized to receive either Traumeel tablets or an indistinguishable placebo, and took primary and rescue oral analgesics as needed. Maximum numerical pain scores at rest and consumption of oral analgesics were recorded on day of surgery and for 13 days following surgery. Traumeel was not found superior to placebo in minimizing pain or analgesic consumption over the 14 days of the trial, however a transient reduction in the daily maximum post-operative pain score favoring the Traumeel arm was observed on the day of surgery, a finding supported by a treatment-time interaction test (p = 0.04). The authors concluded that Traumeel was not superior to placebo in minimizing pain or analgesic consumption over the 14 days of the trial. A transient reduction in the daily maximum post-operative pain score on the day of surgery is of questionable clinical importance.

Traumeel is a mixture of 6 ingredients, 4 of which are in the D2 potency. Thus it neither is administered as a homeopathic remedy (no ‘like cures like’) nor is it highly diluted. In fact, it is not homeopathy at all but belongs to a weird offspring of homeopathy called ‘homotoxicology’ [this is an explanation from my book: Homotoxicology is a method inspired by homeopathy which was developed by Hans Heinrich Reckeweg (1905 – 1985). He believed that all or most illness is caused by an overload of toxins in the body. The toxins originate, according to Reckeweg, both from the environment and from the malfunction of physiological processes within the body. His treatment consists mainly in applying homeopathic remedies which usually consist of combinations of single remedies, because health cannot be achieved without ridding the body of toxins. The largest manufacturer and promoter of remedies used in homotoxicology is the German firm Heel.] The HEEL Company (Baden-Baden, Germany) provided funding for the performance and monitoring of this project, supplied the study medication and placebo, and prepared the randomization list. The positive outcome mentioned in the authors’ conclusion refers to a secondary endpoint. I would argue that the authors should not have noted it there and should have made it clear that the trial generated a negative result.

THE THIRD STUDY

Finally, the third of the 3 ‘rigorous’ studies “evaluated the effectiveness of the homeopathic preparation Plumbum Metallicum  (PM) in reducing the blood lead levels of workers exposed to this metal.” The Brazilian researchers recruited 131 workers to this RCT who took PM in the CH15 potency or placebo for 35 days (10 drops twice daily). Thereafter, the percentage of workers whose lead level had fallen by at least 25% did not differ between the groups, both on intention to treat and per protocol analyses. The authors concluded that PM “had no effect in this study in terms of reducing serum lead in workers exposed to lead.”

This study lacks a power calculation, and arguably the period might have been too short to show an effect. The trial was published in the journal HOMEOPATHY which, some might argue, has not the most rigorous of peer-review procedures.

CONCLUDING REMARKS

The third study seems the most rigorous by far, in my view. The other two trials are seriously under-whelming in several respects, primarily because we cannot be sure how much influence the commercial interests of the sponsor had on their findings. I am sure others will spot weaknesses in all three trials that I failed to see.

Mathie et al partly disagree with my assessment when they write in their paper: “We report separately our model validity assessments of these trials, evaluating consequently their overall quality based on a GRADE-like principle of ‘downgrading’ [14]: two trials [23, 25] rated here as reliable evidence were downgraded to ‘low quality’ overall due to the inadequacy of their model validity; the remaining trial with reliable evidence [24] was judged to have adequate model validity. The latter study [24] thus comprises the sole RCT that can be designated ‘high quality’ overall by our approach, a stark finding that reveals further important aspects of the preponderantly low quality of the current body of evidence in non-individualised homeopathy.”

References 23, 24 and 25 are Padilha (the paper on Plumbum Metallicum), Colau (the RCT on menopausal women) and Singer (the Traumeel trial) respectively. This means that – as per Mathie’s assessment – just the Colau study remains as the sole trial with ‘reliable evidence’ for non-individualised homeopathy.

What Mathie et al seem to forget entirely is that none of the 3 RCTs is a trial of homeopathy as defined by treatment according to the ‘like cures like’ principle. The authors of the second study acknowledge this fact by stating: “Homeopathic purists may find fault in the administration of a standardized combination homeopathic formula to all patients, based upon clinical diagnosis – as opposed to the individualized manner dictated by standard homeopathic practice.”

So, which ever way we look upon this evidence, we cannot possibly deny that the evidence for non-individualised homeopathy is rubbish.

‘What Doctors Don’t Tell You’ (WDDTY) have been shown to be strangely economical with the truth many times before (for instance here, here and here). Now they have published an article entitled ‘Ombudsman investigates ‘flawed’ homeopathic study that claimed it doesn’t work’ It attacks in no uncertain terms the ‘NHMRC Statement on Homeopathy and NHMRC Information Paper – Evidence on the effectiveness of homeopathy for treating health conditions’ which I believe to be a sound evaluation of homeopathy and therefore have mentioned repeatedly on this blog. Here is what WDDTY stated:

START OF QUOTE

A major and influential review of homeopathy concluded that the controversial therapy doesn’t work—but it was so riddled with error and bad science that it’s sparked an official ombudsman investigation.

The world’s media announced that homeopathy was a scam after the Australia government’s National Health and Medical Research Council (NHMRC) published its findings in 2015 that “there are no health conditions for which there is reliable evidence that homeopathy is effective.”

But now the Commonwealth Ombudsman is investigating the review’s procedures after receiving reports of inaccuracies, mishandling of evidence and conflicts of interest.

The review has been triggered by the Australian Homeopathic Association (AHA), supported by the Homeopathic Research Institute (HRI), which began questioning the review’s processes after several solid studies that demonstrated homeopathy’s benefits had been overlooked.

The NHMRC review team set arbitrary parameters that only studies that involved more than 150 people—and which met standards that even drug trials rarely achieve—would be considered. Those requirements reduced the number of qualifying studies to just five—from an initial pool of more than 1,800 trials—and none of these showed that homeopathy was effective.

One of the NHMRC’s own reviewers produced a mysterious first report that has never been published, and hasn’t been released despite Freedom of Information requests.

And the AHA has discovered that Prof Peter Brooks, chair of the NHMRC committee that carried out the homeopathy review, never declared that he was a member of the anti-homeopathy lobby group, Friends of Science in Medicine.

There are solid studies that demonstrate homeopathy is effective against childhood diarrhea, sinusitis and hay fever—but they all involve fewer than 150 people, said HRI chief executive Rachel Roberts. “The public has a right to know that there are high quality studies showing homeopathy works for some medical conditions—information that was lost only due to NHMRC’s mishandling of the evidence.”

The homeopaths aren’t alone in challenging the NHMRC review: Australia’s independent Cochrane Centre said its conclusions are not an accurate reflection of the evidence, and a second expert also said he felt “uncertain of the definitive nature of the report’s conclusions.”

END OF QUOTE

As it happens, I am in contact with the lead author of this report, Paul Glasziou, not least because he very kindly wrote the foreword for my book HOMEOPATHY, THE UNDILUTED FACTS. So, we corresponded and discussed the latest WDDTY diatribe. Thus I am now in a position to put a few things straight (I hope Paul does not mind).

ISSUE 1. – The NHMRC review team set arbitrary parameters that only studies involving more than 150 people—and which met standards that even drug trials rarely achieve—would be considered.

The truth is that report focused on systematic reviews of trials, not individual trials. The 57 included systematic reviews found 176 individual trials which covered 61 conditions: an average of about 3 trials per condition. But some conditions only had 1 trial, and one small trial would, of course, not be considered a reasonable basis for reliable conclusions. GRADE – the international standard for assessing evidence – downgrades reviews for “imprecision” – the GRADE Handbook suggests “whenever there are sample sizes that are less than 400, review authors and guideline developers should certainly consider rating down for imprecision.” Hence the criterion of 150 which the Australians decided to use is considerably more lenient than the current GRADE guideline.

ISSUE 2 – Those requirements reduced the number of qualifying studies to just five—from an initial pool of more than 1,800 trials—and none of these showed that homeopathy was effective.

This is simply not correct. The report found 57 systematic reviews that contained 176 individual trials, not 5. These 176 trials, which covered 61 conditions, formed the body of evidence for the NHMRC report’s conclusions.

ISSUE 3 – There are solid studies that demonstrate homeopathy is effective against childhood diarrhoea, sinusitis and hay fever—but they all involve fewer than 150 people, said HRI chief executive Rachel Roberts.

The NHMRC report focused on systematic reviews that covered all trials for individual conditions. Given the conventional p-value of 0.05, one would expect 1 in 20 single trials to be “false positives”. So with 176 trials, we expect about 9 “false positive” trials. But using systematic reviews that combine all trials for individual conditions, reduces this risk of false positives. Most national evidence review bodies require more than 1 trial, e.g, the FDA requires 2 positive trials, whereas many others require a systematic review which has at least 2 trials. Replication of findings is obviously a cornerstone of science.

ISSUE 4 The homeopaths aren’t alone in challenging the NHMRC review: Australia’s independent Cochrane Centre said its conclusions are not an accurate reflection of the evidence, and a second expert also said he felt “uncertain of the definitive nature of the report’s conclusions.”

The truth is that the Cochrane Centre, which provided an independent check during the processes of the NHMRC review, concluded that “Overall, the conclusions arising from the review appear justified based on the evidence presented.”

I REST MY CASE.

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This new systematic review by proponents of homeopathy (and supported by a grant from the Manchester Homeopathic Clinic) tested the null hypothesis that “the main outcome of treatment using a non-individualised (standardised) homeopathic medicine is indistinguishable from that of placebo“. An additional aim was to quantify any condition-specific effects of non-individualised homeopathic treatment. In reporting this paper, I will stay very close to the published text hoping that this avoids both misunderstandings and accusations of bias on my side:

Literature search strategy, data extraction and statistical analysis followed the methods described in a pre-published protocol. A trial comprised ‘reliable evidence’ if its risk of bias was low or it was unclear in one specified domain of assessment. ‘Effect size’ was reported as standardised mean difference (SMD), with arithmetic transformation for dichotomous data carried out as required; a negative SMD indicated an effect favouring homeopathy.

The authors excluded the following types of trials: studies of crossover design; of radionically prepared homeopathic medicines; of homeopathic prophylaxis; of homeopathy combined with other (complementary or conventional) intervention; for other specified reasons. The final explicit exclusion criterion was that there was obviously no blinding of participants and practitioners to the assigned intervention.

Forty-eight different clinical conditions were represented in 75 eligible RCTs; 49 were classed as ‘high risk of bias’ and 23 as ‘uncertain risk of bias’; the remaining three trials displayed sufficiently low risk of bias to be designated reliable evidence. Fifty-four trials had extractable data: pooled SMD was -0.33 (95% confidence interval (CI) -0.44, -0.21), which was attenuated to -0.16 (95% CI -0.31, -0.02) after adjustment for publication bias. The three trials with reliable evidence yielded a non-significant pooled SMD: -0.18 (95% CI -0.46, 0.09). There was no single clinical condition for which meta-analysis produced reliable evidence.

A meta-regression was performed to test specifically for within-group differences for each sub-group. The results showed that there were no significant differences between studies that were and were not:

  • included in previous meta-analyses (p = 0.447);
  • pilot studies (p = 0.316);
  • greater than the median sample (p = 0.298);
  • potency ≥ 12C (p = 0.221);
  • imputed for meta-analysis (p = 0.384);
  • free from vested interest (p = 0.391);
  • acute/chronic (p = 0.796);
  • different types of homeopathy (p = 0.217).

After removal of ‘C’-rated trials, the pooled SMD still favoured homeopathy for all sub-groups, but was statistically non-significant for 10 of the 18 (included in previous meta-analysis; pilot study; sample size > median; potency ≥12C; data imputed; free of vested interest; not free of vested interest; combination medicine; single medicine; chronic condition). There remained no significant differences between sub-groups—with the exception of the analysis for sample size > median (p = 0.028).

Meta-analyses were possible for eight clinical conditions, each analysis comprising two to 5 trials. A statistically significant pooled SMD, favouring homeopathy, was observed for influenza (N = 2), irritable bowel syndrome (N = 2), and seasonal allergic rhinitis (N = 5). Each of the other five clinical conditions (allergic asthma, arsenic toxicity, infertility due to amenorrhoea, muscle soreness, post-operative pain) showed non-significant findings. Removal of ‘C’-rated trials negated the statistically significant effect for seasonal allergic rhinitis and left the non-significant effect for post-operative pain unchanged; no higher-rated trials were available for additional analysis of arsenic toxicity, infertility due to amenorrhoea or irritable bowel syndrome. There were no ‘C’-rated trials to remove for allergic asthma, influenza, or muscle soreness. Thus, influenza was the only clinical condition for which higher-rated trials indicated a statistically significant effect; neither of its contributing trials, however, comprised reliable evidence.

The authors concluded that the quality of the body of evidence is low. A meta-analysis of all extractable data leads to rejection of our null hypothesis, but analysis of a small sub-group of reliable evidence does not support that rejection. Reliable evidence is lacking in condition-specific meta-analyses, precluding relevant conclusions. Better designed and more rigorous RCTs are needed in order to develop an evidence base that can decisively provide reliable effect estimates of non-individualised homeopathic treatment.

I am sure that this paper will lead to lively discussions in the comments section of this blog. I will therefore restrict my comments to a bare minimum.

In my view, this new meta-analysis essentially yield a negative result and confirms most previous, similar reviews.

  • It confirms Linde’s conclusion that “insufficient evidence from these studies that homeopathy is clearly efficacious for any single clinical condition”.
  • It confirms Linde’s conclusion that “there was clear evidence that studies with better methodological quality tended to yield less positive results”.
  • It confirms Kleinjen’s conclusion that “most trials are of low methodological quality”.
  • It also confirms the results of the meta-analysis by Shang et al (much-maligned by homeopaths) than “finding is compatible with the notion that the clinical effects of homoeopathy are placebo effects.”
  • Finally, it confirms the conclusion of the analysis of the Australian National Health and Medical Research Council: “Homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness. People who are considering whether to use homeopathy should first get advice from a registered health practitioner. Those who use homeopathy should tell their health practitioner and should keep taking any prescribed treatments.”

Another not entirely unimportant point that often gets missed in these discussions is this: even if we believe (which I do not) the most optimistic interpretation of these (and similar data) by homeopaths, we ought to point out that there is no evidence whatsoever that homeopathy cures anything. At the very best it provides marginal symptomatic relief. Yet, the claim of homeopaths that we hear constantly is that homeopathy is a causal and curative therapy.

The first author of the new meta-analysis is an employee of the Homeopathy Research Institute. We might therefore forgive him that he he repeatedly insists on dwelling on largely irrelevant (i. e. based on unreliable primary studies) findings. It seems obvious that firm conclusions can only be based on reliable data. I therefore disregard those analyses and conclusions that include such studies.

In the discussion, the authors of the new meta-analysis confirm my interpretation this by stating that they “reject the null hypothesis (non-individualised homeopathy is indistinguishable from placebo) on the basis of pooling all studies, but fail to reject the null hypothesis on the basis of the reliable evidence only.” And, in the long version of their conclusions, we find this remarkable statement: “Our meta-analysis of the current reliable evidence base therefore fails to reject the null hypothesis that the outcome of treatment using a non-individualised homeopathic medicine is not distinguishable from that using placebo.” A most torturous way of stating the obvious: the more reliable data show no difference between homeopathy and placebo.

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