MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

homeopathy

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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).

So?

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).

So, why?

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!

How come?

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:

  1. Placebo effects are unreliable and do occur only in some but not all patients.
  2. Placebo effects are usually of short duration.
  3. Placebo effects are rarely of a clinically relevant magnitude.
  4. The use of placebo, even when given as OLP, usually involves deception which is unethical.
  5. Placebos might replace effective treatments which would amount to neglect.
  6. 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:

  • history,
  • regulation,
  • misinformation,
  • 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,
  • etc.

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.

In the latest issue of ‘Simile’ (the Faculty of Homeopathy‘s newsletter), the following short article with the above title has been published. I took the liberty of copying it for you:

Members of the Faculty of Homeopathy practising in the UK have the opportunity to take part in a trial of a new homeopathic remedy for treating infant colic. An American manufacturer of homeopathic remedies has made a registration application for the new remedy to the MHRA (Medicines and Healthcare products Regulatory Agency) under the UK “National Rules” scheme. As part of its application the manufacturer is seeking at least two homeopathic doctors who would be willing to trial the product for about a year, then write a short report about using the remedy and its clinical results. If you would like to take part in the trial, further details can be obtained from …

END OF QUOTE

A homeopathic remedy for infant colic?

Yes, indeed!

The British Homeopathic Association and many similar ‘professional’ organisations recommend homeopathy for infant colic: Infantile colic is a common problem in babies, especially up to around sixteen weeks of age. It is characterised by incessant crying, often inconsolable, usually in the evenings and often through the night. Having excluded underlying pathology, the standard advice given by GPs and health visitors is winding technique, Infacol or Gripe Water. These measures are often ineffective but for­tunately there are a number of homeo­pathic medicines that may be effective. In my experience Colocynth is the most successful; alternatives are Carbo Veg, Chamomilla and Nux vomica.

SO, IT MUST BE GOOD!

But hold on, I cannot find a single clinical trial to suggest that homeopathy is effective for infant colic.

Ahhhhhhhhhhhhhhhhhhh, I see, that’s why they now want to conduct a trial!

They want to do the right thing and do some science to see whether their claims are supported by evidence.

How very laudable!

After all, the members of the Faculty of Homeopathy are doctors; they have certain ethical standards!

After all, the Faculty of Homeopathy aims to provide a high level of service to members and members of the public at all times.

Judging from the short text about the ‘homeopathy for infant colic trial’, it will involve a few (at least two) homeopaths prescribing the homeopathic remedy to patients and then writing a report. These reports will unanimously state that, after the remedy had been administered, the symptoms improved considerably. (I know this because they always do improve – with or without treatment.)

These reports will then be put together – perhaps we should call this a meta-analysis? – and the overall finding will be nice, positive and helpful for the American company.

And now, we all understand what homeopaths, more precisely the Faculty of Homeopathy, consider to be evidence.

 

 

Today is Charles’ 70th birthday! On previous occasions, I have published a detailed review of Charles’ outstanding achievements in the realm of alternative medicine. For his 70th, I feel that something else is required. How about a personal birthday card?

HAPPY BIRTHDAY YOUR ROYAL HIGHNESS!

I know, it is not easy to become 70, but you must look on the bright side: you are reasonably healthy, you are not exactly a poor man, and you even managed to change the rules and marry the woman you have always loved. What else could you wish for?

Yes, I know, your big idea of ‘Integrated Medicine’ is not doing all that brilliantly. Your book ‘Harmony‘ was viciously ridiculed, and the ‘best of both worlds’ turns out to be a bit of a strange idea. The thing is that, in healthcare, there is only one real world: the world of reality, facts and evidence. The other is the unreal world of fantasy, wishful thinking and mysticism.

We all know you love homeopathy. After listening to Laurence van der Post in your younger days, it would have been lovely for you, had the notion of a remedy based on a mystical vital force been true. It would have avoided all the complexities of reality. But now, at the age of 70, you must have realised that make belief is a poor substitute for fact.

It has become all but impossible to ignore the truth about homeopathy. Only last year, the European Academies Science Advisory Council concluded that “the claims for homeopathy are implausible and inconsistent with established scientific concepts” and that “there are no known diseases for which there is robust, reproducible evidence that homeopathy is effective beyond the placebo effect”. Such brutal realism must be painful. And now the NHS decided to ditch homeopathy completely. All your homeopathic spider memos for nothing!

Yes, it is tough to grow old. But perhaps it is not too late. You could try to forget about van der Post and all your other ill-advised ‘advisers’. Instead, you could gather a few young, energetic, bright scientists and let them inspire you with the beauty and excitement of reality and science. You could still become a force for real progress in healthcare.

Think about it and keep looking on the bright side.

Many happy returns

Edzard Ernst

 

Yesterday was the 80th anniversary of the Kristallnacht, the infamous start of the Nazi holocaust. For Cristian Becker, a German PR man who is currently spending much of his time promoting homeopathy and attacking critics of homeopathy, it was the occasion to publish this tweet:

I will try to translate it for you:

Today, on 9 November, all fundamentalist GWUP-sceptics such as Natalie Grams and Edzard Ernst reflect on what hate can bring about. First, one hates homeopathy, then advocates of homeopathy, and then it can seem as though one tolerates violence.

I struggle to respond to such vitriolic stupidity.

What makes this even more shocking is the fact that, as far as I see, none of the professional bodies of German homeopathy have distanced themselves for it.

I know Dr Grams a little, and can honestly say that neither of us ‘hates’ homeopathy nor homeopaths. And crucially, we both detest violence.

If such pseudo-arguments are now being used by the defenders of homeopathy, it mainly shows, I think, two things:

  1. They clearly have run out of real arguments which, in turn, suggests that the end of publicly funded homeopathy is imminent.
  2. Homeopathic remedies are not an effective therapy against feeble-mindedness.

The Clinic for Complementary Medicine and Diet in Oncology was opened, in collaboration with the oncology department, at the Hospital of Lucca (Italy) in 2013. It uses a range of alternative therapies aimed at reducing the adverse effects of conventional oncology treatments.

Their latest paper presents the results of complementary medicine (CM) treatment targeted toward reducing the adverse effects of anticancer therapy and cancer symptoms, and improving patient quality of life. Dietary advice was aimed at the reduction of foods that promote inflammation in favour of those with antioxidant and anti-inflammatory properties.

This is a retrospective observational study on 357 patients consecutively visited from September 2013 to December 2017. The intensity of symptoms was evaluated according to a grading system from G0 (absent) to G1 (slight), G2 (moderate), and G3 (strong). The severity of radiodermatitis was evaluated with the Radiation Therapy Oncology Group (RTOG) scale. Almost all the patients (91.6%) were receiving or had just finished some form of conventional anticancer therapy.

The main types of cancer were breast (57.1%), colon (7.3%), lung (5.0%), ovary (3.9%), stomach (2.5%), prostate (2.2%), and uterus (2.5%). Comparison of clinical conditions before and after treatment showed a significant amelioration of all symptoms evaluated: nausea, insomnia, depression, anxiety, fatigue, mucositis, hot flashes, joint pain, dysgeusia, neuropathy.

The authors concluded that the integration of evidence-based complementary treatments seems to provide an effective response to cancer patients’ demand for a reduction of the adverse effects of anticancer treatments and the symptoms of cancer itself, thus improving patient’s quality of life and combining safety and equity of access within public healthcare systems. It is, therefore, necessary for physicians (primarily oncologists) and other healthcare professionals in this field to be appropriately informed about the potential benefits of CMs.

Why do I call this ‘wishful thinking’?

I have several reasons:

  1. A retrospective observational study cannot establish cause and effect. It is likely that the findings were due to a range of factors unrelated to the interventions used, including time, extra attention, placebo, social desirability, etc.
  2. Some of the treatments in the therapeutic package were not CM, reasonable and evidence-based. Therefore, it is likely that these interventions had positive effects, while CM might have been totally useless.
  3. To claim that the integration of evidence-based complementary treatments seems to provide an effective response to cancer patients’ is pure fantasy. Firstly, some of the CMs were certainly not evidence-based (the clinic’s prime focus is on homeopathy). Secondly, as already pointed out, the study does not establish cause and effect.
  4. The notion that it is necessary for physicians (primarily oncologists) and other healthcare professionals in this field to be appropriately informed about the potential benefits of CMs is not what follows from the data. The paper shows, however, that the authors of this study are in need to be appropriately informed about EBM as well as CM.

I stumbled across this paper because a homeopath cited it on Twitter claiming that it proves the effectiveness of homeopathy for cancer patients. This fact highlights why such publications are not just annoyingly useless but acutely dangerous. They mislead many cancer patients to opt for bogus treatments. In turn, this demonstrates why it is important to counterbalance such misinformation, critically evaluate it and minimise the risk of patients getting harmed.

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