Program for Evaluating Complementary Medicine

In 1998, the Swiss government began a comprehensive Program for Evaluating Complementary Medicine (PEK : Programm Evaluation Komplementärmedizin = Program for Evaluating Complementary Medicine) to study the role and effectiveness of complementary medicine, which was playing an ever-increasing role in the Swiss medical system.

According to the PEK Report, results of the evaluation were inconclusive, and in June 2005, the five complementary therapies under evaluation - anthroposophical medicine, homeopathy, neural therapy, phytotherapy and traditional Chinese medicine (more precisely, traditional Chinese herbal therapy) - were removed from the list of services covered by the compulsory health insurance scheme (KLV).

Controversy surrounds the events leading up to the publication of the report.

ummary of the PEK Report

The complete text of the 24 April 2005 version of the "Programm Evaluation Komplementärmedizin" Report, (also referred to as PEK, "Program for Evaluating Complementary Medicine" and "Complementary Medicine Evaluation Programme"), is available from the Swiss Parliament website [http://biblio.parlament.ch/e-docs/139404.pdf Complete text of the official PEK report.] (In German, with summaries in German, French, Italian and English.) Accessed June 2007.] and also from the Swiss Federal Office of Health (BAG) PEK download webpageVarious PEK related documents, mostly in German, but some also in French, Italian and English, (including the report on the PEK study) can be downloaded from the [http://www.bag.admin.ch/themen/krankenversicherung/00305/02363/index.html Swiss Federal Office of Health (BAG) PEK download page.] Accessed August 2007.] .

The 96 page report (plus annexes) is written in German, but includes introductions in German (pages i-iv) and French (v-ix), and summaries of the report (and the study results) in German (pages 5-7), French (8-10), Italian (11-13), and English (14-16).

The official data is available (in German and French) from the Swiss Federal Office of Public Health (BAG) [http://de.wikipedia.org/wiki/Bundesamt_f%C3%BCr_Gesundheit German Language Wikipedia page for Bundesamt für Gesundheit (BAG).] ] data download page [ [http://www.bag.admin.ch/kv/forschung/d/index.htm BAG Health Insurance Statistic Reports download page.] (In German and French.) Accessed August 2007.] .

The following sections are extracts from the English summary of the PEK report:

Background

Following the decision taken by the Swiss Federal Department of Home Affairs (DHA) on 9 July 1998, five complementary therapies - anthroposophical medicine, homeopathy, neural therapy, phytotherapy and traditional Chinese medicine (more precisely, traditional Chinese herbal therapy) - were included on 1 July 1999 for a limited period (until 30 June 2005) in the list of services covered by the compulsory health insurance scheme (KLV). These five services were only eligible for reimbursement if they were provided by physicians who had the relevant proficiency certificates, issued by the Swiss Medical Association (FMH).

The decision on whether these complementary methods would be retained within the basic health insurance scheme was to be based on their efficacy, appropriateness and cost-effectiveness being demonstrated. To this end, the Complementary Medicine Evaluation Programme (PEK) was carried out from 1998 to 2005.

Design of the PEK

A basic procedure was defined, comprising two parts.

In Part 1 (evaluation of the provision of complementary medicine for patients in Switzerland), empirical studies were to be carried out, permitting conclusions as to: :a) how prevalent the five therapies are in Switzerland, :b) which physicians offer these therapies, :c) which patients have recourse to them, :d) what results are achieved with these treatments, and :e) what impact these therapies have on costs.For points b), c), and e), comparisons were made with conventional medicine. On account of methodological and time-related problems, however, point d) could not be evaluated.

In Part 2 (literature analysis), the literature available internationally on efficacy, appropriateness (here primarily defined in terms of safety and utilization) and cost-effectiveness was to be systematically compiled and reviewed.

Results of Part 1 (Evaluation)

In 2002, 10.6% of the Swiss population had recourse to at least one of the five complementary therapies, with homeopathy being the individual method most frequently mentioned.

Practitioners of complementary medicine can be distinguished from physicians providing conventional healthcare with regard to the nature, location and technical resources of their practice. The patients they treat tend to be younger, female and better educated. These patients tend to have a favourable attitude towards complementary medicine and to exhibit chronic and more severe forms of disease. Technical diagnostic procedures are performed more rarely, and patients’ wishes are taken into account more frequently in the choice of treatment. On average, the consultation lasts markedly longer than in conventional care.

Patients are more satisfied with the care provided in practices offering complementary medicine.

Side effects are reported by markedly fewer patients than with conventional care – with the exception of phytotherapy.

With complementary medicine, the total annual costs are markedly lower than the average for conventional care. Overall, however, complementary practitioners treat fewer patients, and more frequently younger and female patients. Adjusted for these factors, the total patient-related costs do not differ significantly from those for conventional care. The cost structure is characterized by a greater weighting for consultation costs and a lower weighting for drug costs.

The actual increase in costs resulting from the inclusion of the five complementary therapies in Switzerland’s basic healthcare provision proved to be markedly lower than expected.

On the basis of the statistics produced by the PEK, the question of whether complementary medicine should be regarded as being utilized in addition to or, rather, instead of conventional care cannot be definitively answered.

Results of Part 2 (Literature Analysis)

The analysis of the literature involved two different projects:
#For each of the five complementary therapies, a comprehensive overall evaluation (evaluation report) was prepared.
#In addition, meta-analyses (systematic reviews including statistical evaluation of aggregated data) of placebo-controlled clinical studies were prepared for homeopathy, phytotherapy and traditional Chinese herbal therapy. Insufficient data were available for meta-analyses of anthroposophical medicine and neural therapy.

As regards the first project, the assessment of efficacy was favourable in all of the evaluation Reports. For phytotherapy and homeopathy in particular, this was based on the evaluation of published systematic reviews and randomized clinical studies. In the case of traditional Chinese herbal therapy, while numerous randomized studies of Chinese origin exist, they are scarcely available in Western countries.

In the view of the evaluation committee, the interpretation of the available evidence on efficacy in the evaluation reports appears to be overly optimistic for all of the methods reviewed, and especially for neural therapy. The safety of all five therapies is favourably assessed, with certain reservations in the case of neural therapy and traditional Chinese herbal therapy.

Data concerning utilization are only available for complementary medicine as a whole; for many countries, the uptake is shown to be high and still increasing.

As regards the second project, in the view of the authors of the meta-analyses, the available placebo-controlled studies on homeopathy do not demonstrate any clear effect over and above placebo. For phytotherapy, in contrast, a positive result is shown, as in the evaluation report, and for traditional Chinese herbal therapy an unequivocal assessment is not possible. Here, too, the validity of the conclusions of the meta-analyses should be regarded as limited from a methodological perspective.

Controversy

The terms-of-reference for the PEK study stated that the results of the study would determine which complementary medicines, if any, would continue to be supported by the national insurance program in Switzerland. However, before the study was completed and the final draft report reviewed by the international Review Board, the government announced that it would withdraw support for all complementary approaches to medicine [http://www.unipublic.unizh.ch/magazin/gesundheit/2005/1996.html Unipublic Zurich University.] Accessed August 2007.] .

Considerable uproar followed, including protests from many scientists involved in the study (including the scientific director of the program) about political interference in the scientific process::"The international review board of PEK has publicly protested at political interference in the scientific process." [Peter Fisher, "Homeopathy and the Lancet" from "Evidence-Based Complementary and Alternative Medicine", 2006 3(1):145-147 [http://ecam.oxfordjournals.org/cgi/content/full/3/1/145 Online at OxfordJournals.org.] Accessed August 2007.] :"There is a consensus among the review board members that the final PEK process deviated from what would have been expected by conventional standards."Walach H, Linde K, Eichenberger R, Stalder H, Kristensen FB, Kleijnen J. "Summary Consensus Statement of the PEK Review Board regarding the PEK process and the PEK products", 27th September 2005. English and German versions available from the [http://www.bag.admin.ch/themen/krankenversicherung/00305/02363/index.html BAG PEK download page.] Accessed August 2007.]

ECH evaluation of PEK report

According to the European Committee for Homeopathy's evaluation of the PEK report [http://www.homeopatiaveterinaria.com.br/Report%20on%20PEK%20study.pdf European Committee for Homeopathy's evaluation of the PEK report, Dr Ton Nicolai (ECH President), June 2005.] (In English.) Accessed August 2007.] , the results were, for the government, surprisingly positive towards complementary medicines. According to the ECH evaluation:

*The PEK study showed that the quality of homeopathic care was superior to that of conventional care. This difference could not be explained by the seriousness of the illnesses, because homeopathic doctors saw even more seriously and chronically ill people. (Page 2)

*Whereas the authors of the overall PEK report drew the conclusion that there is sufficient evidence for the effectiveness of homeopathy, the authors of the meta-analysis came to a different conclusion. This seems rather odd, because both groups of authors based their conclusions on the same extensive literature search and predefined inclusion criteria. (Page 4)

*The Swiss Association of Homeopathic Doctors (SVHÄ) highly criticizes the PEK report and asserts that the study has serious flaws. (Page 5)

*The meta-analysis was conducted at the Department of Social and Preventive Medicine (ISPM) of the Bern University, under the direction of Prof. Dr Matthias Egger. The ISPM did not include any expert from the field of homeopathy. It was not before January 2005 that homeopathic experts were allowed to peruse the meta-analysis. ISPM Director Prof Egger repeatedly has pronounced his conviction that homeopathy cannot be effective because its working mechanism is implausible. This does not seem to be a particularly unbiased position. (Page 6)

*Although homeopathy and other CAM therapies proved to be cost-effective and may save millions of Swiss Francs on the health budget, the Swiss government decided to exclude all CAM therapies from the compulsory health insurance scheme as from 30 June 2005. (Page 6)

*A conference scheduled for April 2005 to present and discuss the results of the PEK was cancelled because the National Health Office suppressed the publication of the study data. (Page 7)

*Some collaborators were coerced into deleting all PEK related data from their computers. (Page 7)

*A final meeting of the international Review Board (of 6 professors from Switzerland, Germany, Denmark and the UK responsible for the scientific quality of the PEK) to be held in June 2005 for a final assessment of the project, was cancelled. (Page 7)

*A recommendation in the report's final draft to keep homeopathy, anthroposophical medicine and herbal medicine in the compulsory health insurance scheme was deleted in the final publication. (Page 7)

International Review Board's "Consensus Statement"

The international review board's "Summary Consensus Statement of the PEK Review Board regarding the PEK process and the PEK products" criticised both the PEK process, and the final report:
*Especially disconcerting was the fact that the products of the PEK process ... were sent to the board members but no discussion, commenting, or reviewing was solicited by the responsible agencies. In fact, those responsible even cancelled the final review board meeting. It was only through a public opinion campaign that the responsible agency reconvened the review board for a last discussion, but only after the political decision on public insurance coverage in relation to complementary medicine had been taken.
*For a fully informed political decision it would have been desirable that there had been a discourse between the researchers, the political agencies, and the review board concerning the interpretation, the methodological strength, and the content of the data provided by PEK. This could then have gone into a public discussion process, which would then have had an informative character for a political decision. As it happened, this process was reversed. The review board unanimously disapproves of this reversal of normal procedures.
*What is especially disconcerting is the fact that part of the decision seems to be due to analyses of the federal office of health (BAG) which rest on data and procedures which cannot be publicly checked.
*There was no agreement as to whether the political decision was backed by the data and the results of the PEK process. If the final report of all PEK products is considered valid, then the decision made is not backed by the PEK outcome. However, if one considers some of the elements of the PEK process and data as invalid, one could also agree with the decision. It is unlikely that any final consensus can be reached on this issue since such a consensus is highly dependent on the primary presuppositions made.

References