The present HTA report on homeopathy, now published in book format, was part of the ‘Complementary
Medicine Evaluation Programme’ (PEK1) which was set up following a decision by
the Swiss government in 1998 to ‘provisionally’ include the complementary medical disciplines
– anthroposophic medicine, homeopathy, traditional Chinese medicine, phytotherapy and neural
therapy – in the list of services covered by the national statutory health insurance.
HTA is short for Health Technology Assessment, an established scientific procedure which,
in contrast to the meta-analyses and systematic reviews specified by the Cochrane Collaboration
Standards, examines not only the efficacy of a particular intervention, but especially also
its ‘real-world effectiveness’, its appropriateness, safety and economy. HTAs are therefore much
wider in scope and politically more informative. They include material that is ‘normally’ not
taken into consideration, such as observational studies, good case series and longitudinal cohort
studies.
The specialities named were to be examined for their real-world effectiveness, appropriateness
and cost-effectiveness, and the result was intended to inform the decision regarding their
future within primary health care (cf. Chap. 2 of this book and Wolf 2006).
The motivation for the project and how it evolved reflect the polarities and diverging streams
that are now ubiquitous in many countries with regard to complementary and alternative medicines
(CAM) while also elucidating institutional processes:
The PEK programme was prompted by the high demand and widespread use and acceptance
of complementary medical treatment, as well as by the political hope for its economic and
preventive use. At the same time, mainstream medicine frequently expressed its concern that
complementary medical treatment was ineffective, if not harmful. The question was: how could
one arrive at a decision that would satisfy society while meeting the requirements of scientific
medicine?
Following a 5-year preparation phase, the evaluation project was split into a practical component
(field study), as part of which special trials were conducted on parameters relevant for
practitioners and patients, and a literary component (HTA reports) to assess international
publications for evidence of the (real-world) effectiveness, appropriateness, safety and economy
of the treatments. The latter was extended by a smaller sub-project that encompassed a quantitative
analysis of the quality of clinical trials in the CAM disciplines mentioned above compared
with those of conventional medicine.
After the above-mentioned 5-year preparation phase, less than 2 years remained for the
completion of the projects.
Before the overall project was finalized, the results of the smaller quantitative sub-study,
which – contrary to the implicit intention of an HTA – had evaluated only experimental trials
(randomized double-blind trials), became known out of context. While the overall conclusion
was that studies of homeopathy and phytotherapy were of better quality than comparable studies
of conventional medicine, the subsidiary meta-analysis of the qualitatively best trials (according
to internal validity criteria) demonstrated efficacy for the interventions of conventional
medicine and phytotherapy but no significant difference to placebo for homeopathic
treatment. (Concerning the problem of reducing qualitative evaluations to purely internally
valid criteria cf. Chaps. 5 and 13.)
The ‘negative result’ for homeopathy caused a massive furore prior to conclusion of the PEK
project and following its subsequent publication (Shang et al. 2005), culminating in the unfortunately
titled Lancet editorial ‘The end of homeopathy’ (editorial 2005).
In contrast to this subsidiary result, which was of little relevance for the political decision,
the much more comprehensive and differentiated HTAs ascertained that the individual CAM
interventions, especially homeopathy, were effective, under Swiss conditions safe and, as far
as could be judged from the trial situation, also cost-efficient.
In their overall assessment the PEK review committee attested good quality and replicable
results with scientifically tenable conclusions to the HTAs on anthroposophic medicine, homeopathy,
phytotherapy and TCM phytotherapy. The editorial of the journal Forschende Komplementärmedizin
(Walach and Heusser 2006), which published short versions of the HTAs on
homeopathy (Bornhöft et al. 2006), anthroposophic medicine (Kienle et al. 2006) and traditional
Chinese medicine (Maxion-Bergemann et al. 2006), speaks of high, partly even highest,
quality also because ‘the model validities of individual studies, such as in the field of homeopathy,
were never before […] so critically and constructively integrated in the evaluation results’.
It emphasizes that the HTA reports of the PEK project underwent a multi-stage quality assurance
procedure, which means that the quality of their information can be regarded as scientifically
confirmed. Walach and Heusser consider the PEK’s HTA reports to be fundamentally of
higher value than reviews of experimental studies, including the above-mentioned meta-analyses.
With regard to the further political decision process they report: ‘It will also not be concealed
that the evaluation committee employed by the Swiss Federal Office of Public Health
(FOPH) for the overall assessment of the PEK results recommended in its final report that anthroposophic
medicine, homeopathy and phytotherapy, on the basis of their documented utility,
should continue to be covered by the statutory health insurance. Under pressure from the
authorities, however, this recommendation was removed from the final version of the report,
and in June 2005 Federal Councillor Pascal Couchepin excluded complementary medical services
by physicians from the statutory health insurance scheme.’
The present, corrected and partly revised book picks up the controversies of the discussion
on methods. It especially re-evaluates Shang et al.’s (2005) quantitative analysis, taking into
consideration criteria of external and model validity as well as of internal validity – with a truly
remarkable result in favour of homeopathy – and adds it to the original text (Chap. 5). The
chapter also throws light on the field of tension between an ‘objective’ and strongly formalized
evaluation by investigators who are not specialists in the given field and the replicability of the
subjectively generated empirical knowledge of practising physicians, and their respective
strengths and weaknesses.
Further changes to the 2004 version include a restructuring of the result presentations in
Chaps. 7 and 10, in-depth discussions (Chap. 13) and the subdivision of the HTA into individual
chapters with allocation of authors