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What does the Swiss Government really think about homeopathy?

By Sven Rudloff and Zeno

Jump to Postscript

A lot has been made by homeopaths about the ‘neutral’ Swiss Government’s report and its unequivocal support of homeopathy. It’s been lauded by the luminaries of the homeopathic world as further proof — as if any was needed, of course — that homeopathic ‘medicines’ are superior in every way to those dangerous and expensive pharmaceutical drugs.

Arch proponent of homeopathy, Dana Ullman, proclaimed:

The Swiss government’s exceedingly positive report on homeopathic medicine The Swiss government has a long and widely-respected history of neutrality, and therefore, reports from this government on controversial subjects need to be taken more seriously than other reports from countries that are more strongly influenced by present economic and political constituencies. … In late 2011, the Swiss government’s report on homeopathic medicine represents the most comprehensive evaluation of homeopathic medicine ever written by a government and was just published in book form in English (Bornhoft and Matthiessen, 2011). This breakthrough report affirmed that homeopathic treatment is both effective and cost-effective and that homeopathic treatment should be reimbursed by Switzerland’s national health insurance program. … The provisional reimbursement for these alternative treatments ended in 2005, but as a result of this new study, the Swiss government’s health insurance program once again began to reimburse for homeopathy and select alternative treatments. (Source, cached)

Ullman again:

this report from the Swiss government has confirmed the efficacy and cost-effectiveness of homeopathic treatment. (Source, cached)

The Society of Homeopaths:

Swiss scientists endorse homeopathy evidence Report says homeopathic medicine is clinically effective A comprehensive and authoritative research study by Swiss scientists has offered an unambiguous endorsement of the evidence base for homeopathy as a clinically effective system of medicine. Their report, part of a Swiss government evaluation of complementary and alternative medicines, gives a massive boost to the growing body of research underpinning the therapeutic effects of homeopathic medicine. (Source, cached)

The Faculty of Homeopathy and the British Homeopathic Association:

Evidence for homeopathy builds Long-awaited English translation of Swiss study endorses evidence for homeopathy This important report addresses the evidence for the effectiveness of homeopathic therapy in everyday use (i.e. the real world), its safety and its cost-effectiveness. The authors, Doctor Gudrun Bornhöft and Professor Peter Matthiessen, state: “There is sufficient evidence for the preclinical effectiveness and the clinical efficacy of homeopathy and for its safety and economy compared with conventional treatment.” Following on from the initial publication of this report, a public referendum in Switzerland in 2009 supported the inclusion of homeopathy and other complementary and alternative medicines in the Swiss national health insurance, with 67% of the people voting in favour. Earlier this month, the Swiss government passed legislation to enact the referendum’s conclusion. (Source, cached and source, cached)

GP and homeopath Dr Andrew Sikorski:

In 2009 a Swiss national referendum voted in favour of complementary medicine being part of the public health service which is now covered by the obligatory public health insurance system. This decision was partly informed by the findings of the 2006 Health Technology Assessment report commissioned by the Swiss Government on the effectiveness, safety and cost-effectiveness of homeopathy in general practice. (Source, cached)

Many other websites have echoed these sentiments, with many taking their lead from Ullman’s article and possibly placing far too much reliance on what he had to say, eg Swiss Government finds homeopathy effective and cost efficient (cached).

You’d think from all this that the ‘neutral’ Swiss Government had taken to homeopathy like the proverbial quacking duck to water.

Of course, to state in this context that the Swiss Government has a ‘widely-respected history of neutrality’ is to conflate political neutrality with scientific objectivity.

As usual, research of truly homeopathic proportions, misrepresentation and cherry picking are the order of the day.

Health Technology Assessment

Background

Even less skeptical academic doctors will regard many interpretations [of the HTA] as very optimistic and not scientifically convincing.

To understand this report properly, we need to look at its context, its purpose and what it led to.

Switzerland has a universal compulsory private health insurance scheme, regulated by the Federal Health Insurance Act of 1994 (Krankenversicherungsgesetz — KVG). The KVG details the treatments for which the treatment provider will be reimbursed.

In 1998, the Swiss Department for the Interior (Eidgenössische Departement des Inneren — EDI) and the Federal Service Commission (Eidgenössische Leistungskommission — ELK) decided to allow insurance companies to be reimbursed for five alternative therapies: homeopathy, anthroposophic medicine, neural therapy, phytotherapy (herbal) and Traditional Chinese herbal therapy (TCM). This was a temporary measure that expired in June 2005.

These therapies were provisionally included in the reimbursement scheme while evidence was sought for their efficacy, appropriateness and cost-benefit so that a decision could be made in 2005 whether to end the reimbursement or add it permanently to the insurance scheme.

For this, an elaborate Complementary Medicine Evaluation Program (Programm Evaluation Komplementärmedizin — PEK) was set up, eventually costing the Swiss taxpayer six million Francs (~£4 million).

The PEK issued three different kinds of reports to inform a comprehensive evaluation:

Health Technology Assessments (HTAs) for all five therapies

Qualitative reviews of existing literature on indicators for effectiveness, security, utilisation, and cost-effectiveness.

The HTAs were all written by specialists and proponents for the respective therapies. They were coordinated by the PANMEDION Trust (Switzerland), founded in 2001 to promote complementary medicine, and prepared in cooperation with the Chair for Medical Theory and Complementary Medicine (Lehrstuhl für Medizintheorie und Komplementärmedizin) of the Witten-Herdeck University (Germany) and the Institute for Applied Epistemology and Medical Methodology (Institut für angewandte Erkenntnistheorie und medizinische Methodologie e.V. — IFAEMM), a registered anthroposophic organisation in Freiburg (Germany).

Witten-Herdecke University was founded by anthroposophic doctor Gerhard Kienle, who was also key in establishing special legal status for homeopathic, herbal and anthroposophic therapies in the German public health system in the 1970s. Gerhard Kienle’s daughter Gunver Kienle is senior scientist at IFAEMM and authored the PEK HTA on anthroposophic medicine.

Meta-analyses for three therapies (homeopathy, phytotherapy, TCM)

Quantitative reviews of existing clinical studies, specifically on the efficacy of the therapies compared to placebo.

No meta-analyses were done for anthroposophic medicine and neural therapy because the researchers did not find sufficient usable studies.

All meta-analyses were prepared by the Institute for Social and Preventive Medicine (Institut für Sozial- und Präventivmedizin — ISPM) of the University of Bern (Switzerland), specialised on research on public health issues.

Original PEK studies

A series of surveys amongst doctors and hospitals, to gauge the extent to which the five therapies are used in Switzerland (utilisation), what the typical patient and conditions look like, and the therapies’ safety and patient satisfaction, as subjectively perceived by the practitioners.

This was complemented by health economy studies, estimating the costs of the therapies in comparison to conventional treatments. PEK originally aspired to also commission original clinical studies on the efficacy of the five therapies, but this approach was eventually scrapped for time, cost and ethical reasons.

The original reports prepared for the PEK have not been made public as part of the process itself. However, their respective authors were allowed to properly publish their work in scientific papers or books after conclusion of the PEK. On homeopathy, this includes the HTA, written by Bornhöft et al., and the meta-analysis, famously known as Shang et al.

Homeopathy HTA (Bornhöft et al.)

The many positive results of smaller homeopathy studies can also be explained through biases, therefore an efficacy for homeopathy cannot be seen as proven.

A summary of the homeopathy HTA was first published in 2006 as an article in “Forschung zur Komplementärmedizin”, a German CAM journal. In the same year, authors Bornhöft et al. published a German book version, which was then extended and published in English in 2011.

It is this eventual book that the English-speaking homeopathy world is so unjustifiably ecstatic about.

The HTA looked at various studies, including existing meta-analyses (no new clinical studies or meta-analyses were conducted). Summary tables of the assessment were given in an appendix, included with the summary HTA.

It is interesting to note how many of the original studies’ conclusions the HTA ‘re-interpreted’ to be more favourable towards homeopathy, and their attempted justification for doing so.

We will leave others to look closely at the detail of the HTA itself, but, unsurprisingly, it disparages randomised controlled trials as being unsuitable for homeopathy and is awash with special pleadings.

Even then, the HTA only looked specifically at evidence for upper respiratory tract infections and allergic reactions, so even if their conclusions were valid, they cannot be extrapolated to the homeopathic treatment of any other condition.

Finally, whether homeopathy was cost-effective was also partially addressed by the HTA. They cautiously indicated potential positive cost effects of homeopathy. However, the HTA authors themselves also recognised that they had found only a few and very diverse studies to form a conclusion on the subject, leading them to make the final statement:

Further well-designed studies and analyses of existing databases for homeopathy are encouraged in order to support informed decisions in European health-care systems.

We will come back to this topic further below in the wider PEK context.

Homeopathy meta-analysis (Shang et al.)

In parallel to the original HTA, the PEK commissioned meta-analyses to look at the quantitative evidence on the efficacy of the therapies against placebo. For homeopathy, the respective Shang et al. meta-analysis was eventually published in The Lancet in August 2005.

Shang matched 110 homeopathy trials and 110 conventional-medicine trials and concluded:

Biases are present in placebo-controlled trials of both homoeopathy and conventional medicine. When account was taken for these biases in the analysis, there was weak evidence for a specific effect of homoeopathic remedies, but strong evidence for specific effects of conventional interventions. This finding is compatible with the notion that the clinical effects of homoeopathy are placebo effects.

This was yet another damning blow to homeopathy.

Since this analysis was done in parallel to the original HTA, the 2006 German publications by Bornhöft et al. do not mention it. However, their 2011 book has been extended with a critique of Shang et al.

They attempt to re-interpret the findings and we look at this matching below.

Neutrality? What neutrality?

As shown by the quotes at the beginning, the HTAs has been hailed by homeopaths as vindication of homeopathy because it was a Swiss Government report, and who could be more neutral than the Swiss?

The report was certainly commissioned by a Swiss Government department, but it was written by alternative therapy apologists. We cannot be certain who were involved in the original HTA on homeopathy, but the summary report published in 2006 was written by:

Gudrun Bornhöft and Peter Matthiessen: Chair in Medical Theory and Complementary Medicine, University of Witten/Herdecke, Germany and PanMedion Foundation, Zurich

Ursula Wolf: Institute for Complementary Medicine (KIKOM), Inselspital, University of Berne and PanMedion Foundation, Zurich

Klaus von Ammon, Stephan Baumgartner and André Thurneysen: Institute for Complementary Medicine (KIKOM), Inselspital, University of Berne

Marco Righetti: Medical Practice, Zurich

Stefanie Maxion-Bergemann: PanMedion Foundation, Zurich

No wonder homeopaths think the HTA was a good report — it was written by supporters of alternative therapies.

Verdict of the PEK report

All individual reports were submitted to the PEK office by early 2005 and summarised in a final report by a review panel. This panel consisted of the two lawyers tasked with running the PEK, a health economist, one (some sources say two) medical doctors of the Federal Health Office (Bundesamt für Gesundheit — BAG), and Dieter Melchart, Professor of Naturopathy and Complementary Medicine (in Zürich at the time, now mainly in Munich).

It can be said, then, that it is the PEK report that more accurately reflects the view of the Swiss Government, not the HTA.

So what does the PEK report actually say about the HTA and homeopathy in general?

Here is the PEK report’s summary of results (Table 18 in the original report), translated into English:

Click to enlarge

In the following, we will focus on the key question of efficacy. That CAM therapies are in high demand (utilisation), that patients subjectively like them (satisfaction) and that many of them are relatively safe and cheap is quite obvious. The question is whether they actually consistently work better than alternatives.

As you can see, homeopathy was in a unique situation, as its efficacy was seen as very positive in the HTA (but downgraded by the PEK review panel) and very negative by the meta-analysis (but upgraded by the review panel). What’s behind this?

Here is what the PEK report says about the HTAs:

For all five assessments, it is very obvious that all or some of the authors have a positive attitude towards the treatments in question or are convinced about their efficacy. Unquestionably, strict proponents of the usual hierarchy of evidence will regard the presented evaluations as scientifically untenable and unreasonably positive (except for some specific aspects of phytotherapy). Even less skeptical academic doctors will regard many interpretations as very optimistic and not scientifically convincing.

This is why the review panel downgraded all the HTAs in their view on efficacy, as shown in the table above.

Specifically, on the homeopathy HTA, the report concludes:

The positive interpretation of the current evidence seems understandable, as long as one does not require especially high evidence standards, given the low plausibility of homeopathy in the light of established scientific knowledge. Very skeptical people will regard the reviewed evidence as not very convincing.

Somehow Bornhöft, Matthiessen and the fans of their HTA fail to mention this part of the Swiss Government’s report.

Cost-effectiveness

Although the HTA noted that the authors believed that homeopathy had positive cost effects, the PEK had more to say.

The PEK had also commissioned economic studies and used these to inform their final conclusions about cost-effectiveness.

On cost factors, only a very limited number of studies is available. High-quality cost-benefit analyses in connection with pragmatic randomised trials are not available at all. Since again the original data obtained by the PEK studies is much more relevant than the few studies found in the literature by the HTAs, we only briefly summarise the key results: […] Similarly [to anthroposophic medicine], there are a few studies on homeopathy, indicating that potentially higher direct costs through [longer] consultation may at least be compensated by lower lab and technical costs as well as positive effects on sick leave. […]

The PEK review panel concluded:

Due to insufficient data, no reliable statements on the cost-effectiveness of the 5 complementary therapies are possible based on the HTAs.

So, although the writers of the HTA might have thought homeopathy could be cost-effective, the PEK, even with much more data, was nowhere near as positive.

However, this still misses the fundamental point: a useless treatment is just as useless whatever it costs.

Like for like?

“But wait”, homeopathists may say, “the Shang et al. meta-analysis has also been criticized! And it showed that homeopathy studies are of higher quality than conventional studies!”

Well, yes and no.

From the summary of the meta-analyses in the PEK report:

Included in the analyses were 110 studies on homeopathic interventions […] and 110 conventional interventions, matched regarding condition and target criterion. […] The methodological quality of both homeopathic and conventional studies was similar for most criteria, though overall somewhat higher for the homeopathy studies: 19% of homeopathy studies and 8% of conventional studies were classified as of ‘higher quality’.

So, yes, the proportion of higher quality studies was higher for homeopathy. This is actually to be expected if you first find 110 homeopathy studies and then have to find 110 roughly comparable conventional studies that match the homeopathic studies regarding condition and target criteria.

In any case, a higher proportion of higher quality studies doesn’t seem to have helped homeopathy at all:

When the results of the eight large, methodologically better homeopathy studies were pooled, no significant effect above placebo could be found. […] However, for the six large, methodological better studies for conventional interventions a significant effect was found. […] The authors conclude that the current results support the hypothesis that the clinical effects of homeopathy — compared to effects of conventional medicine — are unspecific placebo or context effects.

The review panel criticised the meta-analysis, but effectively for this last sentence only:

Due to the basic methodological issues, the results of the meta-analyses should be interpreted conservatively. However, in the light of their depth and high technical quality, several conclusions can likely be derived reliably: […] The issue of potentially overestimating effect sizes due to biases [like small sample size] appears especially large for homeopathy studies. […] When looking only at large studies with higher methodological quality, the effects compared to placebo remain statistically significant for phytotherapy and most conventional treatments, but not for homeopathy. This supports general efficacy for the first two, whereby the many positive results of smaller homeopathy studies can also be explained through biases, therefore an efficacy for homeopathy cannot be seen as proven. The review panel however regards as too extensive the [meta-analysis’ authors’] conclusion that the lack of a significant effect in the larger, high quality homeopathy studies and the meta-regression indicate that the clinical effects of homeopathy are placebo effects.

This is why the review panel upgraded the meta-analysis rating for homeopathy — even though to a still negative rating.

Mostly harmless

Overall, the review panel concluded on homeopathy:

From a conventional, scientific perspective, there is no plausible mechanism for homeopathy. […] The efficacy analysed in the literature leads to a negative result in the meta-analysis of placebo controlled studies, and to a positive result in the HTA when other feedback is considered. The demand for homeopathy in Switzerland is rather high. The clinical potential for damage caused by this special drug therapy in the hands of medical basic care providers is negligible. The customer base is broad, but children with their typical conditions as well as women with psychological conditions, pregnancy or post-menstrual conditions form key groups. For these indications often there is no conventional alternative or only pharmacological treatments with a significantly higher risk potential than for homeopathic remedies.

According to some sources, in an early draft the review panel recommended the continued reimbursement of homeopathy (and for two other therapies), but the respective passages were removed from the final version. Looking at wording of the summary above, this actually looks quite likely. The summary essentially says: there is demand; people like it; it rarely hurts; it’s not clear whether it really works; but it’s cheap so what the hell.

Excluded

Following the final report, the ELK decided — on the basis of the HTA and the subsequent PEK report — to not include the five alternative therapies in the statutory reimbursement after June 2005 (except for some herbal drugs that were put on a speciality list).

A predictable outcry by the alternative medicine community ensued.

There was a lot of discussion about the cumbersome PEK process — in the beginning caused by prolonged controversy between conventional and alternative medical practitioners and methodologists about the ‘correct’ study designs — the PEK’s seemingly rushed final stages, and the apparent dislike of alternative medicine by the Swiss Health Secretary in office at the time.

Referendum

Based on the popularity of CAM, the campaign Yes to complementary medicine (Ja zur Komplementärmedizin) gained traction in the following years, seeking to include consideration of CAM in the Swiss constitution. The Swiss parliament made a somewhat softened counter-proposal to the campaign’s phrasing, and in 2009 a public referendum endorsed it by a two to one majority.

After the referendum, the organisations for the five therapies officially requested reimbursement again from the BAG in 2010. The BAG reviewed their applications, and asked the Union of Swiss CAM Organisations (Union der Komplementärmedizinischen Ärztegesellschaften) to name experts for each therapy that could be further questioned.

the clinical effects of homeopathy — compared to effects of conventional medicine — are unspecific placebo or context effects.

The application material plus the experts’ statements were then sent by the BAG to a commission for a recommendation to the EDI. This commission, the Federal Commission for General Services and Policy Issues ( Eidgenössische Kommission für allgemeine Leistungen und Grundsatzfragen — ELGK) consisted of 20 representatives of Swiss doctors (including a CAM one, following the referendum), pharmacists, health insurance companies, patients, Swiss cantons, as well as experts on lab analytics and ethics and which advises the EDI on what to reimburse.

Their recommendation was that, even when considering new studies, none of the five therapies complied with the criteria of efficacy, appropriateness and cost-effectiveness.

According to their verdict, there was nothing new that would merit overturning the decision from 2005. The commission felt that covering the five therapies would require a change of the law.

Because these therapies did not meet the established criteria for full and permanent inclusion for reimbursement, they ended up with the new, temporary solution again with reimbursement from 2012 until 2017, with the obligation to finally prove compliance of these therapies with the key criteria of efficacy, appropriateness and cost-effectiveness by end of 2015.

This will be done via: Re-evaluation of existing material, led by the Union of Swiss CAM Organisations and coordinated by Prof. André Busato and the Institute for Complementary Medicine (Kollegiale Instanz für Komplementärmedizin — KIKOM) at the University of Bern. Both were already involved in the PEK.

A new comprehensive HTA, prepared by an internationally recognised research institute outside Switzerland, which has yet to be appointed by the BAG.

Another bite of the cherry

So, the proponents of homeopathy, etc get yet another chance.

They tried and failed miserably in 2005 to convince the Swiss Government because of the lack of good evidence for their pet therapies.

They failed again in 2010.

It’ll be interesting to see if they can come up with anything better — and more objective — in the next few years.

Homeopaths can praise the HTA under the PEK if they want. But in the eyes of the PEK review panel and the Swiss Government it was biased and overly optimistic, and taking everything else into account, they decided that homeopathy was quite likely ineffective but harmless.

Hardly something homeopaths can be proud of and not quite the story they want us to believe.

Postscript

01 November 2013

Some six months after we published this and after more articles by homeopathists lauding this ‘Swiss Government Report’ as the last word on the scientific evidence for homeopathy, an official of the Swiss Government wrote to the Swiss Medical Weekly to correct many of their errors.

It was then that we realised that we couldn’t trust homeopaths to even get the title of the report correct. As Felix Gurtner of the Federal Office of Public Health FOPH, Health and Accident Insurance Directorate in Bern, Switzerland, had to point out:

This review was declared to be an HTA by the authors (the final PEK [5] report does not classify the literature reviews as HTA reports) and published later as a book [7] under their responsibility without any consent of the Swiss government or administration. [Original reference numbers]

So now we know: their ‘book’ wasn’t an HTA after all, just a biased and limited ‘literature review’ that was not even published by the Swiss Government or with their permission.

Of course, homeopaths have now corrected themselves and no longer misrepresent this as an authoritative ‘Swiss Government HTA’.

Don’t be silly; of course they haven’t.

References and further reading

1. Swiss Health Office page with all relevant documents: Programm Evaluation Komplementärmedizin (PEK) — Publikationen

2. The final PEK report: Schlussbericht PEK, April 2005.

3. Shang et al. (2005) in The Lancet: Are the clinical effects of homoeopathy placebo effects?

4. Bornhöft et al. (2006), their first publication on the homeopathy HTA, a summary article in Forschende Komplemtärmedizin (Research in Complementary Medicine), with a summary in English (the article itself requires registration).

5. Swiss Government page on the 2009 referendum, with referendum results and link to the referendum wording (including background).

6. Swiss Health Office press release on the new 2012–2017 trial period.

Acknowledgements

Thanks to Sven Rudloff for translating large sections of the various reports and for writing the majority of this blog post.

Thanks to Mojo for pointing out the PEK report that got us looking into this.

But thanks mostly to homeopath Nancy Malik for highlighting the existence of the PEK report in the first place. Her contribution to the understanding of science and the continued lack of scientific evidence for homeopathy is duly noted.