An official report on Homeopathy in Healthcare in Switzerland

Summary of “Homeopathy in Healthcare - effectiveness, appropriateness, safety and costs. An HTA report on homeopathy as part of the Swiss Complementary Medicine Evaluation Programme” edited by Gudrun Bornhöfft and Peter M. Matthiessen.[1]


Background of the report


In Switzerland, like in many other countries, there is a high demand, use and acceptance of complementary alternative medicine (CAM) yet like in many other countries there is a concern that CAMmight be ineffective and harmful.


Therefore, the Swiss government included provisionally anthroposophy medicine, homeopathy, traditional Chinese medicine, phytotherapy, and neural therapy into their national statutory health insurance for five years in 1998. Furthermore, the government set up an Evaluation Program on the above mentioned complementary alternative medicines. (see also History of homeopathy in Germany, Austria and Switzerland)


They examined the efficacy and real world effectiveness, appropriateness, safety and economy of homeopathy and published this in book format in German in Nov 2006[2]. The English version of that report is partly revised with a re-evaluation of the often mentioned and highly controversial Shang et al article (Chapter 5.3) and has been published in December 2011.


Unlike traditional evaluation, this Health Technology Assessment (HTA) report uses not only statistical methods but also includes observational studies, good case series, and longitudinal cohort studies. Hence, it has a very high level of Evidence Based Medicine for evaluation of the efficacy, safety, and costs of a medicinal therapy and has more validity than reviews or clinical studies.


Therefore, this report is probably the most comprehensive and fundamental work of the current scientific research in homeopathy.


Homeopathy in Switzerland

 

Homeopathy has a long tradition in Switzerland. It is practiced by medical doctors, non-medical practitioners and is offered in two hospitals (the Oncology Department of the Clinica Santa Cruce in Locarno and partly in the Aeskulap Clinic in Brunnen). Often demand exceeds supply which results in long waiting lists. (p.93)


In Switzerland, medical homeopathy is based on the classical approach which means according to the totality of symptoms a single remedy is administered in a strictly individual fashion. New approaches like complex homeopathy, isopathy or organotropic homeopathy is of little importance. (p.92)


Interestingly, the report clearly states that mixed or combination preparations on short term application “may well serve to alleviate less severe acute conditions. In the long-term or with more frequent application they can blur the symptom picture, induce drug-proving symptoms and render any subsequent classical homeopathic treatment more difficult” (p.13).


The homeopathic remedies (medicines) prepared according to the German Homoeopathic Pharmacopoeia are sold through pharmacies or by direct shipment from specialized Swiss manufacturers.

 

Research in Homeopathy


Research is performed in botanical studies, in animal studies and in vitro studies with human cells and such preclinical studies have shown that homeopathic remedies have regulatory, i.e. balancing, or normalizing effect (p.19).


Randomized, controlled Trials (RCT) in homeopathy?


For evaluating homeopathy, the sceptics often ask for Randomized clinical trials in homeopathy. Are these really the right strategy to show that homeopathy is effective? However, the sceptics are also ignoring the controversies within the evidence-based medicine especially when applied to complex systems like psychotherapy (p. 20).

 

Some arguments concerning the appropriateness of RCTs which are listed on page 28/29 are

  • “The absence of a positive or any RCT result is no proof of ineffectiveness”
  • “A negative RCT result is also not valid proof of ineffectiveness because many factors can be involved in causing false negative RCT results”
  • Individualized medical care is more and more being replaced by standardized treatment methods to ensure comparability and reproducibility of study outcomes
  • In order to get a significant result many patients need to be recruited and the following questions arises: “One must ask how many people can be expected to use a medication that is of no benefit to them in order to help one individual in the group” – an ethical issue
  • “reproducibility is surprisingly low even with “hard” RCT”

In Homeopathy, the remedy is only effective when exactly chosen according to the individual symptom picture of the person. Prescribing a placebo reduces the internal (“the strength of the association between treatment and outcome of a study” (page 32)) and external validity (which describes the transferability to possible target groups (page 32)).

 

Hence, “homeopathy experts continue to claim that the great majority of existing homeopathy trials (RCT trials) were conducted with inadequate means, that their designs ignore essential principles of homeopathy and thus increase the likelihood of false negative results” but nevertheless several studies were performed in recent years. (p.16)

 

Therefore, epidemiological studies, which evaluate the whole system of classical homeopathic therapy under real world conditions, would be of more value (p.20).

 

The methods and the materials used in the Health Technology Assessment of Homeopathy


According to accepted guidelines “for the compilation of HTA report the authors worked closely together with experts on methodology, specialist association, and expert advisers.” (p.48)


In 22 databases (p. 60) the term “homeopathy” was searched for and resulted in almost 23.000 hits. About 133 studies were randomized controlled studies, 296 were clinical studies, 393 were review article or meta-analysis articles, 1 cohort study and 59 case studies (Table 6.3 of the Report).


A literature research on the evaluation on the clinical efficacy of homeopathy produced 60 review articles. 22 review articles with a total of 667 studies analyzed met the predefined inclusion and exclusion criteria (p.103).


The examination of these 22 studies revealed that often “conventional quality criteria cannot necessarily be transferred to homeopathic studies without adaptation.”


Especially the randomization and blinding does not justify real practice situation because with a complementary method like homeopathy one has to assume that patients consciously decide in favor of it. Hence, one cannot easily transfer randomized clinical trials to real life situation in homeopathy. (p.112) Because 10 review articles included as an inclusion criteria randomized clinical trials or double blind trials the authors concluded that these trials “hold too high a risk of false-negative results” (p.115) and thus overruled the downgrading in ten cases of the efficacy.


In most studies the external validity factors important for homeopathic treatments, like for example (see p. 114)

  •  individualized therapy for homeopathy
  •  assessment of qualification of treating physician
  • obvious differentiation of clinical parameters and quality of life
  • assessment and adequate homeopathic evaluation of “adverse events” (like the occasional initial aggravation, return of old symptoms according to Hering’s law)

are not documented.

 

Thus one can conclude “that the external validity was sacrificed in favor of internal validity and the research are therefore of little value for actual homeopathic practice.” (p.118)

 

Nevertheless, one can also conclude, “20 of the 22 reviews found at least a trend in favor of homeopathy.” The authors think “with five of the studies the results even clearly proved the effectiveness of a homeopathic intervention.” (p.117)

 

Additionally from the homeopathic point of view some of the “excluded reviews and overviews with their extensive data and their positive results, are much more significant in favor of homeopathy than some of the work that has been included. The excluded titles with their wealth of positive evidence in favor of homeopathy therefore clearly support the thesis of that homeopathy is effective.” (p.124)


Clinical studies on the effectiveness of homeopathy for upper respiratory tract infection and allergic reactions

 

The Health Technology Assessment also systematically researched the effectiveness of homeopathy for upper respiratory tract infections and allergic reactions. 29 trials were evaluated with 11 trials using individual treatment, 4 clinical homeopathy, 7 complex homeopathy and 7 isopathy. In only 23 trials, the internal and external validity could be assessed. “Only 4 trials showed good external validity. One of the studies using individualized treatment clearly showed significant superiority for homeopathy over conventional medicine.


Even though the internal and external validity were restricted, the authors concluded, “the trial results showed probable effectiveness of homeopathy for allergies and infectious diseases of the upper respiratory tract.” (p.145)


The authors point out that “Friese et al (1997c) and Frei (2001) both registered a definitive decrease in antibiotic consumption for the homeopathically treated groups. The trial by Eizayaga and Eizayaga (1996) showed that homeopathic treatment as an adjunct for corticosteroid – dependent asthma resulted in reduction of conventional medication and alleviation of the obviously severe side effects caused by conventional medicine. … These results are significant not only clinically (…) but also economically, as the homeopathic medication used is much more cost-effective” (p. 144)


The population using Complementary alternative treatments


Several studies are focusing on the profile of the patient population using CAM treatments. The following trend is noticeable (see p. 79) among CAM users

  • The average user is between 30 and 50 years thus younger than the non-CAM-users
  • More women are using CAM
  • The level of education is higher and
  • the income level is higher

Safety of homeopathy

 

Although many supporters of homeopathy insist on the absence of side effect the authors stress that “adverse reactions can be caused through incorrect applications such as dosage repetition in too quick succession” (p.160)

In very low potencies (lower than 12c) unprofessionally used, systemic toxic effect can occur (i.e arsenic, lead and mercury). Furthermore, the authors also point out that:

  •  “An isopathic studymentioned up to 24% initial aggravation (Reilly et al 1986) which were probably caused by too frequent drug dosages….
  •  If homeopathic substances are taken as standard combinations (complex homeopathy) or simultaneously (“proven indications, clinical homeopathy), it is not possible to determine, and thus avoid, the component causing adverse reaction….
  • Any homeopathic remedies, incompetently applied by qualified or lay person, can cause suppression and adversely affect the course of the disease….” (p.160)·                    

In summary “medical homeopathy in Switzerland has few side effects if professionally executed, and the use of medium and high potencies is free from toxic and unexpected organ effects.” (p. 162)


Cost-effectiveness of homeopathy


The authors sum up their results by citing Schüppel et al (2003) “that with the current costs of pharmaceutical products, the use of homeopathy has the potential to lower pharmaceutical spending” and Maxion-Bergemann et al that “available data suggest potential cost savings due to the use of homeopathy….” (p.188)


The conclusion


“The comprehensive and differentiated Health Technology Assessment (HTAs) ascertained that 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.” (p.3)