The German Association of Medical Homeopaths (Deutscher Zentralverein homöopathischer Ärzte (DZVhÄ)) have recently published an article where, amongst other things, they lecture us about evidence-based medicine (EBM). If you feel that this might be a bit like an elephant teaching Fred Astaire how to step-dance, you could have a point. Here is their relevant paragraph:
… das Konzept der modernen Evidenzbasierte Medizin nach Sackett [stützt sich] auf drei Säulen: auf die klinischen Erfahrung der Ärzte, auf die Werte und Wünsche des Patienten und auf den aktuellen Stand der klinischen Forschung. Homöopathische Ärzte wehren sich gegen einen verengten Evidenzbegriff der Kritiker, der Evidenz allein auf die Säule der klinischen Forschung bzw. ausschließlich auf RCT verengen möchte und die anderen beiden Säulen ausblendet. Experten schätzen, dass bei einer solchen Auffassung von EbM rund 70 Prozent aller Leistungen der GKV nicht evidenzbasiert sei. Nötiger als eine Homöopathie-Debatte hat die deutsche Ärzteschaft aus unserer Sicht eine klare Verständigung darüber, welcher Evidenzbegriff nun gilt.
For those who cannot understand the full splendour of their argument because of the language problem, I translate as literally as I can:
… the concept of the modern EBM according to Sackett is based on three pillars: on the clinical experience of the doctors, on the values and wishes of the patient and on the current state of the clinical research. Homeopaths defend themselves against the narrowed understanding of ‘evidence’ of the critics which aims at narrowing evidence solely to the pillar of the clinical research or exclusively to RCT, while eliminating the other two pillars. Experts estimate that, with such an view of EBM, about 70% of all treatments reimbursed by our health insurances would not be evidence-based. We feel that we more urgently need a clear understanding which evidence definition applies than a debate about homeopathy.
END OF MY TRANSLATION
So, where is the hilarity in this?
I don’t know about you, but I find the following things worth a giggle:
- ‘narrowed understanding of evidence’ – this is a classical strawman; non-homeopaths tend to apply Sackett’s definition which states that ‘evidence-based medicine is the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence-based medicine means integrating individual clinical experience with the best available external clinical evidence from systematic research‘;
- as we see, Sackett’s definition is quite different from the one cited by the homeopaths;
- the three pillars cited by the homeopaths are those subsequently developed for Evidence Based Practice (EBP) and include: A) patient values, B) clinical expertise and C) external best evidence;
- as we see, these three pillars are also not quite the same as those suggested by the homeopaths;
- non-homeopaths do certainly not aim at eliminating the ‘other two pillars’;
- current best evidence clearly includes much more than just RCTs – to mention RCTs in this context therefore suggests that the ones guilty of narrowing anything might, in fact, be the homeopaths;
- even if it were true that 70% of reimbursable treatments are not evidence-based, this would hardly be a good reason to employ homeopathic remedies of which 100% are not even remotely evidence-based;
- unbeknown to the German homeopaths, the discussion about a valid definition of EBM has been intense, is as old as EBM itself, and would by now probably fill a mid-size library;
- this discussion does, however, in no way abolish the need to bring the debate about homeopathy to the only evidence-based conclusion possible, namely the discontinuation of reimbursement of this and all other bogus therapies.
In conclusion, I do thank the German homeopaths for being such regular contributors to fun and hilarity. I shall miss them, once they have fully understood EBM and are thus compelled to stop prescribing placebos.
Slowly, I seem to be turning into a masochist! Yes, I sometimes read publications like ‘HOMEOPATHY 360’. It carries articles that are enragingly ill-informed. But in my defence, I might say that some are truly funny. Here is the abstract of one that I found outstanding in that category:
The article explains about Gangrene and its associated amputations which is a clinically challenging condition, but Homeopathy offers therapy options. The case presented herein, details about how the Homeopathic treatment helped in the prevention of amputation of a body part. Homeopathy stimulates the body’s ability to heal through its immune mechanisms; consequently, it achieves wound healing and establishes circulation to the gangrenous part. Instead of focusing on the local phenomena of gangrene pathology, treatment focuses on the general indications of the immune system, stressing the important role of the immune system as a whole. The aim was to show, through case reports, that Homeopathic therapy can treat gangrene thus preventing amputation of the gangrenous part, and hence has a strong substitution for consideration in treating gangrene.
The paper itself offers no less than 13 different homeopathic treatments for gangrene:
- Arsenicum album– Medicine for senile gangrene;gangrene accompanied by foetid diarrhoea; ulcers extremely painful with elevated edges, better by warmth and aggravation from cold; great weakness and emaciation.
- Bromium – Hospital gangrene; cancerous ulcers on face; stony hard swelling of glands of lower jaw and throat.
- Carbo vegetabilis – Senile and humid gangrene in the persons who are cachectic in appearance; great exhaustion of vital powers; marked prostration; foul smell of secretions; indolent ulcers, burning pain; tendency to gangrene of the margins; varicose ulcers.
- Bothrops– Gangrene; swollen, livid, cold with hemorrhagic infiltration; malignant erysipelas.
- Echinacea– Enlarged lymphatics; old tibial ulcers; gangrene; recurrent boils; carbuncles.
- Lachesis– Gangrenous ulcers; gangrene after injury; bluish or black looking blisters; vesicles appearing here and there, violent itching and burning; swelling and inflammation of the parts; itching pain and painful spots appearing after rubbing.
- Crotalus Horridus– Gangrene, skin separated from muscles by a foetid fluid; traumatic gangrene; old scars open again.
- Secale cornatum– Pustules on the arms and legs, with tendency to gangrene; in cachectic, scrawny females with rough skin; skin shriveled, numb; mottled dusky-blue tinge; blue color of skin; dry gangrene, developing slowly; varicose ulcers; boils, small, painful with green contents; skin feels too cold to touch yet covering is not tolerated. Great aversion to heat;formication under skin.
- Anthracinum– Gangrene; cellular tissues swollen and oedematous; gangrenous parotitis; septicemia; ulceration, and sloughing and intolerable burning.
- Cantharis – Tendency to gangrene; vesicular eruptions; burns, scalds, with burning and itching; erysipelas, vesicular type, with marked restlessness.
- Mercurius– Gangrene of the lips, cheeks and gums; inflammation and swelling of the glands of neck; pains aggravated by hot or cold applications.
- Sulphuric acid– Traumatic gangrene; haemorrhages from wounds; dark pustules; blue spots like suggillations; bedsores.
- Phosphoric acid– Medicine for senile gangrene. Gunpowder, calendula are also best medicines.
But the best of all must be the article’s conclusion: “Homeopathy is the best medicine for gangrene.”
I know, there are many people who will not be able to find this funny, particularly patients who suffer from gangrene and are offered homeopathy as a cure. This could easily kill the person – not just kill, but kill very painfully. Gangrene is the death of tissue in part of the body, says the naïve little caption. What it does not say is that it is in all likelihood also the death of the patient who is treated purely with homeopathy.
And what about the notion that homeopathy stimulates the body’s ability to heal through its immune mechanisms?
Or the assumption that it might establish circulation to the gangrenous part?
Or the claim that through case reports one can show the effectiveness of an intervention?
Or the notion that any of the 13 homeopathic remedies have a place in the treatment of gangrene?
ALL OF THIS IS TOTALLY BONKERS!
Not only that, it is highly dangerous!
Since many years, I am trying my best to warn people of charlatans who promise bogus cures. Sadly it does not seem to stop the charlatans. This makes me feel rather helpless at times. And it is in those moments that I decide to look at from a different angle. That’s when I try to see the funny side of quacks who defy everything we know about healthcare and just keep on lying to themselves and their victims.
Benign prostate hypertrophy (BPH) affects many men aged 50 and older. It is caused by an enlargement of the prostate resulting in difficulties to urinate and to fully empty the bladder. There are several conventional treatment options, including life-style changes that are effective. In addition, a myriad of alternative therapies are being promoted, most of which are of doubtful effectiveness. Recently, a homeopathy-promoter, Dr Jens Behnke, triumphantly tweeted a trial of homeopathy for BPH allegedly proving that homeopathy does work after all. There is no conceivable reason why homeopathic remedies should have any effect on this (or any other) condition. Therefore, I decided to have a closer look at this paper.
The objective of this 5-centre, three-armed, open, randomised study was to evaluate the effectiveness of Homoeopathic Constitutional remedy (HC) and Homoeopathic Constitutional + Organ remedy (HCOM) in comparison to Placebo (PL) in patients suffering from BPH using International Prostate Symptom Score (IPSS), ultrasonographic changes in prostate volume, post-void residual urine, uroflowmetry and in WHO Quality of Life (QOL)-BREF. Patients were randomised into three groups in 2:2:1 ratio and were followed up for 6 months. The statistical analysis was done with modified intention-to-treat principle (mITT).
Of 461 patients screened, 254 patients were enrolled in the study and 241 patients were analysed as per mITT. The mean changes in IPSS and QOL due to urinary symptoms from baseline to end of study showed a positive trend in all the three groups. However, in the HC group, the changes were more prominent as compared to the other two groups. There was no difference between HC and HCOM groups and they were equally effective in terms of managing lower urinary tract symptoms due to BPH. With regard to secondary outcome, there was no difference between the groups. The psychological, social and environmental domains of WHOQOL-BREF have shown positive trend, but there was no statistically significant difference in intervention groups.
The authors concluded that statistical significance was found in the IPSS in all the three groups but only in HC and not in any of the objective parameters.
The paper is so badly written that I struggle to make sense of it. However, the above graph seems clear enough. The changes are perhaps statistically significant (which I find odd and cannot quite understand) but they are certainly not clinically relevant. Most likely, they are due to the fact that this study was not blind, meaning that patients and investigators were aware of the group allocations. This suggests to me that this study
- is dubious in more than one way,
- tests a hypothesis that lacks plausibility,
- yields a result that is clinically irrelevant.
In other words, it does not amount to anything remotely resembling a proof of homeopathy’s efficacy.
According to the investigators, the primary objective this study (thanks again Dr Jens Behnke) was to evaluate the effectiveness of homoeopathic remedies in improving quality of life (QoL) of chronic urticaria (CU) patients.
The study population included patients attending the Outpatient Department of State Homoeopathic Dispensary, Ahmadpur, India. Quality of Life (QoL) questionnaire (CU-Q2oL) and average Urticaria Activity Score for 7 days (UAS7) questionnaires were filled at baseline and 3rd, 6th, 9th and 12th months. The study included both male and female patients diagnosed with CU. Eighteen homoeopathic remedies were used. The individualised prescriptions were based on the totality of each patient’s symptoms.
A total of 134 patients were screened and 70 were diagnosed with CU and enrolled in the study. The results were analysed under modified intention-to-treat approach. Significant difference was found in baseline and 12th month CU-Q2oL score. Apis mellifica (n = 10), Natrum muriaticum (n = 9), Rhus toxicodendron (n = 8) and Sulphur (n = 8) were the most frequently used remedies.
The authors concluded that homoeopathic medicines have potential to improve QoL of CU patients by reducing pruritus, intensity of wheals, swelling, nervousness, and improve sleep, mood and concentration. Further studies with more sample size are desirable.
The primary objective of this study was, I would argue, to promote the erroneous idea that homeopathy is an effective therapy. It cannot have been to evaluate its effectiveness, because for such an aim one would clearly have needed a control group. Without it, the findings are consistent with the following facts:
- Homeopathy is useless.
- CU responds to placebo treatments.
- CU gets better over time.
- Regression towards the mean has contributed to the outcome.
- Homeopaths often have no idea about clinical research.
- Further trials are not needed.
- If someone disagrees with my point 6, the sample size is less important than the inclusion of a control group.
It is time, I think, to express my gratitude to Dr Jens Behnke, a German homeopath employed by the pro-homeopathy lobby group the ‘Carstens Stiftung’, who diligently tweets trials of homeopathy which he obviously believes prove the value of his convictions.
The primary objective of this new study was to evaluate the efficacy of homoeopathy for women suffering from polycystic ovary syndrome. This condition is characterised by:
- irregular periods which means your ovaries don’t regularly release eggs,
- abnormally high levels of male hormones in the body, which may cause physical signs such as excess facial or body hair,
- polycystic ovaries – ovaries become enlarged and contain many fluid-filled sacs (follicles) which surround the eggs.
There’s no cure for PCOS, but the symptoms can usually be treated. As so often in such situations, homeopaths are happy to step into the fray.
This single-blind, randomised, placebo-controlled pilot study was conducted at two research centres in India. The cases fulfilling the eligibility criteria were enrolled (n = 60) and randomised to either the homoeopathic intervention (HI) (n = 30) or placebo (P) (n = 30) with uniform lifestyle modification (LSM) for 6 months.
The menstrual regularity with improvement in other signs/symptoms was observed in 60% of the cases (n = 18) in HI + LSM group and none (n = 0) in control group. Statistically significant difference was observed in the reduction of intermenstrual duration in HI + LSM in comparison to placebo + LSM group. Significant improvements were also observed in HI+LSM group in domains of weight, fertility, emotions and menstrual problems. No change was observed in respect of improvement in the ultrasound findings. Pulsatilla was the most frequently indicated homeopathic remedy.
The authors concluded that HI along with LSM has shown promising outcome; further comparative study with standard conventional treatment on adequate sample size is desirable.
This trial might convince believers (mostly because they do not even need convincing), but it cannot convince anybody capable of critical thinking. Here is why:
- According to its authors, this trial was a pilot study; this means it should not report any results and merely focus on the feasibility of a definitive trial.
- Researchers were not blinded, meaning that they might have influenced the outcome in more than one way.
- The primary endpoint was subjective and could have been influenced by the non-blinded researchers.
- 0% success rate in achieving the primary endpoint in the placebo group is not plausible.
- Compliance to LSM was not checked; as the homeopathy group lost more weight, these patients seemed to have complied better (probably due to being better motivated by the non-blinded researchers).
My conclusion is not very original but all the more true: POORLY DESIGNED STUDIES USUALLY GENERATE UNRELIABLE RESULTS.
For some researchers, the question whether homeopathy works beyond a placebo effect is not as relevant as the question whether it works as well as an established treatment. To answer it, they must conduct RCTs comparing homeopathy with a therapy that has been shown beyond reasonable doubt to be effective, i.e better than placebo. Such a drug is, for instance, Ibuprofen.
The purpose of this study was to compare the efficacy of Ibuprofen and homeopathic Belladonna for orthodontic pain. 51 females and 21 males, were included in this study. Cases with non-extraction treatment plan having proper contacts’ mesial and distal to permanent first molar and currently not taking any analgesics or antibiotics were included in the study. They were randomly divided into two groups; one group was assigned to ibuprofen 400 mg and second group took Belladonna 6C (that’s a dilution of 1: 1000000000000). Patients were given two doses of medication of their respective remedies one hour before placement of elastomeric separators (Ormco Separators, Ormco Corporation, CA, USA) and one dose 6 h after the placement. Pain scores were recorded on a visual analogue scale (VAS) 2 h after placement, 6 h after placement, bedtime, day 1 morning, day 2 morning, day 3 morning and day 5 morning.
The comparisons showed that there were no differences between the two groups at any time point.
(Mean visual analogue scale pain score at different time intervals after separator placement in Ibuprofen and Belladonna group)
The authors concluded that Ibuprofen and Belladonna 6C are effective and provide adequate analgesia with no statistically significant difference. Lack of adverse effects with Belladonna 6C makes it an effective and viable alternative.
FINALLY, THE PROOF HOMEOPATHS HAVE BEEN WAITING FOR: HOMEOPATHY DOES WORK AFTER ALL!
Not so fast – before we draw any conclusions, let’s have a closer look at this study. Here are a few of its limitations (apart from the fact that it was published in a journal that does not exactly belong to the ‘crème de la crème’ of medical publications):
- Patients obviously knew which group they were assigned to; thus their expectations would have influenced the outcome.
- The same applies to the researchers (the study could have been ‘blind’ using a ‘double dummy’ method, but the researchers did not use it).
- The study was an equivalence trial (it did not test whether homeopathy is superior to placebo, but whether its effects are equivalent to Ibuprofen); such studies need sample sizes that are about one dimension larger than was the case here.
Therefore, all this trial does demonstrate that the sample was too small for an existing group difference in favour of Ibuprofen to show.
So sorry, my homeopathic friends!
Many people seem to be amazed at my continued activities (e. g. blog, books, lectures, interviews) aimed at telling the truth about homeopathy and other alternative modalities. They ask themselves: why does he do it? And sometimes I ask myself the same question. I certainly don’t do it because I receive any money for my work (as many of my critics have assumed in the past).
Let me briefly offer just 7 of the most obvious reasons why I feel it is important to tell the truth about homeopathy and similar treatments:
1. The truth is invaluable
I probably do not need to explain this at all. For any responsible person the truth has an intrinsic value that cannot be doubted. In our book, we conclude that “the truth-violating nature of CAM renders it immoral in both theory and practice.”
2. Untruths make a mockery of EBM
If we accept that, in the realm of alternative medicine, it is permissible to apply a different standard than in evidence-based medicine (EBM), we make a mockery of EBM. Double standards are hugely counter-productive and not in the interest of patients.
3. The truth promotes rationality
If the proponents of a modality such as homeopathy promote concepts that fly in the face of science, they undermine rational thinking. Believing in a vital force or energy is just one of many examples for this phenomenon. Undermining rationality can have negative effects far beyond healthcare and reminds me of Voltaire’s bon mot: “Those who make you believe in absurdities can make you commit atrocities.”
4. It is ethical
Healthcare have the ethical duty to work towards patients receiving the best treatments available. If a therapy like homeopathy fails to be demonstrably effective, it cannot possibly fall into this category. Therefore, responsible healthcare professionals must help to improve healthcare by disclosing the evidence against homeopathy.
5. It might save money
The money spent on homeopathy and other ineffective alternative treatments is considerable. Disclosing the fact that they are not effective will help stopping people to waste their money on them. Telling the truth about homeopathy and similarly ineffective therapies would therefore save funds that can be used more efficiently elsewhere.
6. It might save lives
Because they usually are free of active molecules, homeopathic remedies are often seen as a safe treatments. However, homeopathy can nevertheless harm and even kill patients, if they use it as an alternative medicines in cases of severe illness. It follows that telling the truth about homeopathy’s ineffectiveness can save lives.
7. It could counter-balance the multiple lies that are being told.
We all have seen the multitude of untruths that are being told about the value of homeopathy (if you haven’t, you ought to read SCAM). The multitude of falsehoods seriously misleads many consumers into believing that homeopathy is a valuable therapeutic option for many conditions. I feel strongly that it is my moral duty as an independent expert to counter-balance this plethora of lies in order to minimise the harm it is doing.
Professor Frass is well known to most people interested in homeopathy. He has also featured several times on this blog (see here, here and here). Frass has achieved what few homeopaths have: he has integrated homeopathy into a major medical school, the Medical School of the University of Vienna (my former faculty). In 2002, he started teaching homeopathy to medical students, and in 2004, he opened an out-patient clinic ‘Homeopathy for malignant diseases’ at the medical school.
This achievement was widely used for boosting the reputation of homeopathy; the often heard argument was that ‘homeopathy must be good and evidence-based, because a major medical school has adopted it’. This argument is now obsolete: Frass’ lectures have recently been axed!
Apparently, several students*** filed complaints with their dean about Frass’ lectures. This prompted the dean, Prof Mueller, to look into the matter and take drastic action. He is quoted stating that “the medical faculty rejects unscientific methods and quackery”.
Frass had repeatedly been seen on television claiming that homeopathy could be an effective adjuvant therapy for cancer, and that he had studies to prove it. Such statements had irritated Mueller who then instructed Frass in writing to abstain from such claims and to close his homeopathic out-patient clinic at the University. The matter was also brought to the attention of the University’s ethics committee which decided that Frass’ studies were not suited to provide a scientific proof.
Frass commented saying that he is not surprised about criticism because homeopathy is difficult to understand. He will retire next year from the University and will probably continue his homeopathic practice in a private setting.
(If you can read German, this article in the Austrian paper DER STANDARD has more details)
***as they had invited me to give a lecture on homeopathy some time ago, I like to think that I might have something to do with all this.
The primary objective of this paper was to assess the efficacy of homeopathy by systematically reviewing existing systematic reviews and meta-analyses and to systematically review trials on open-label placebo (OLP) treatments. A secondary objective was to understand whether homoeopathy as a whole may be considered as a placebo treatment. Electronic databases and previously published papers were systematically searched for systematic reviews and meta-analyses on homoeopathy efficacy. In total, 61 systematic reviews of homeopathy were included.
The same databases plus the Journal of Interdisciplinary Placebo Studies (JIPS) were also systematically searched for randomised controlled trials (RCTs) on OLP treatments, and 10 studies were included.
Qualitative syntheses showed that homoeopathy efficacy can be considered comparable to placebo. Twenty‐five reviews demonstrated that homoeopathy efficacy is comparable to placebo, 20 reviews did not come to a definite conclusion, and 16 reviews concluded that homoeopathy has some effect beyond placebo (in some cases of the latter category, authors drew cautious conclusions, due to low methodological quality of included trials, high risk of bias and sparse data).
Qualitative syntheses also showed that OLP treatments may be effective in some health conditions.
The authors concluded that, if homoeopathy efficacy is comparable to placebo, and if placebo treatments can be effective in some conditions, then homoeopathy as a whole may be considered as a placebo treatment. Reinterpreting homoeopathy as a placebo treatment would define limits and possibilities of this practice. This perspective shift suggests a strategy to manage patients who seek homoeopathic care and to reconcile them with mainstream medicine in a sustainable way.
The authors also mention in their discussion section that one of the most important work which concluded that homoeopathy has some effect beyond placebo is the meta‐analysis performed by Linde et al. (1997), which included 119 trials with 2,588 participants and aimed to assess the efficacy of homoeopathy for many conditions. Among these ones, there were conditions with various degrees of placebo responsiveness. This work was thoroughly re‐analysed by Linde himself and other authors (Ernst, 1998; Ernst & Pittler, 2000; Linde et al., 1999; Morrison et al., 2000; Sterne et al., 2001), who, selecting high‐quality extractable data and taking into consideration some methodological issues and biases of included trials (like publication bias and biases within studies), underscored that it cannot be demonstrated that homoeopathy has effects beyond placebo.
I agree with much of what the authors state. However, I fail to see that homeopathy should be used as an OLP treatment. I have several reasons for this, for instance:
- Placebo effects are unreliable and do occur only in some but not all patients.
- Placebo effects are usually of short duration.
- Placebo effects are rarely of a clinically relevant magnitude.
- The use of placebo, even when given as OLP, usually involves deception which is unethical.
- Placebos might replace effective treatments which would amount to neglect.
- One does not need a placebo for generating a placebo effect.
The idea that homeopathic remedies could be used in clinical practice as placebos to generate positive health outcomes is by no means new. I know that many doctors have used it that way. The idea that homeopathy could be employed as OLP, might be new, but it is neither practical, nor ethical, nor progressive.
Regardless of this particular debate, this new review confirms yet again:
HOMEOPATHY = PLACEBO THERAPY
The inventor of homeopathy, Samuel Hahnemann, was a German physician. It is therefore not surprising that homeopathy quickly took hold in Germany. After its initial success, homeopathy’s history turned out to be a bit of a roller coaster. But only recently, a vocal and effective opposition has come to the fore (see my previous post).
Despite the increasing opposition, the advent of EBM, and the much-publicised fact that the best evidence fails to show homeopathy’s effectiveness, there are many doctors who still practice it. According to one website, there are 4330 doctor homeopaths in Germany (plus, of course, almost the same number of Heilpraktiker who also use homeopathy). This figure is, however, out-dated. The German Medical Association told a friend that, at the end of 2017, there were 5612 doctors practising in Germany who hold the additional qualification (‘Zusatz-Weiterbildung’) homeopathy.
That’s a lot, I find.
Why so many?
Whenever I give lectures on the subject, this is the question that comes up with unfailing regularity. Many people who ask would also imply that, if so many doctors use it, homeopathy must be fine, because doctors have studied and know what they are doing.
My answer usually is that the phenomenon is due to many factors:
- powerful lobby groups,
- patient demand,
- homeopathy’s image of being gentle, safe and holistic,
- patients’ need to believe in something more than ‘just science’,
- the fact that most German health insurances reimburse it,
- political support,
But, in fact, the true explanation, as I have learnt recently, might be much simpler and more profane: MONEY!
A German GP gets 4.36 Euros for taking a conventional history.
If he is a homeopath taking an initial homeopathic history, (s)he gets 130 € according to the ‘Selektivvertrag’.
So, yes, doctors have studied and know that the difference between the two amounts is significant.