Original Research On the Efficacy of Anthroposophical Medicines
  

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By: Michael R. Evans MB ChB

Reprinted From Complementary Medicine/Compendium II

Summary
Inspired by a German study of a herbal medicine, a questionnaire/semi-structured interview technique was used to gather and collate the clinical experiences of medical practitioners prescribing anthroposophical medi­cines. 18 medicines emerged (Table 1) as having been observed to be efficacious with a high degree of certainty on the part of the doctor concerned, and his observation independently reported by at least three practitioners. The method included questions to test the practitioner's ability to be self critical regarding the results of his prescribing. A smaller number of medicines emerged where practitioners had questions about their efficacy as presently prepared and prescribed. Information on the indications and prescribing details of the medicines observed as efficacious was also gathered (Table 2) and observations regarding the side-effects of these medicines. Additionally, the practitioners were given the opportunity of commenting on the fundamental assumptions on which the study was based.

Introduction
Anthroposophical medicine is an extension of conventional medicine, inspired by Rudolf Steiner and practiced by conven­tionally trained doctors. It is most widely practiced in Holland, Germany and Switzerland by many hundreds of general prac­titioners, and is the main approach used in a number of general hospitals, including the University Teaching Hospital in Herdecke, Germany. A numerically smaller group of doctors make up the Anthroposophical Medical Association in this country, the largest group of which practices this approach to medicine as NHS GPs. The medicines used include many substances from the Materia Medica of classical homoeopathy and medical herbalism, together with further medicines developed specifi­cally by anthroposophical doctors and pharmacists. Although many of the medicines used may also be found within medical herbalism and classical homeopathy, the rationale for their prescribing is different, based on a different understanding of pathology and a more qualitative understanding of the plant or mineral from which the medicine is prepared.

With the exception of Iscador and other viscum preparations used in the treatment of cancer 1,2,3,4, few systematic studies of the efficacy of these medicines have been made. The evidence of the efficacy of these medicines has been the clinical experience of doctors prescribing them and the subjective experience of their patients. The scientific limitations of randomized trials, even for conventional medicines, have been examined in a number of papers as well as the problems involved 5,6,7,8, and the particular problems of applying them to the methods of complementary medical practice 9. Anthro­posophy, the Weltanschauung standing behind anthro­posophical medicine, recognizes the value of natural science in examining the weighable, measurable and countable in the universe, but points to other methodologies which are required to grasp the nature of life, sentience and self-consciousness. The practical possibility and value of applying the method of randomized control trials to these medicines is questioned by many doctors who use this approach.

The aim
The aim of this study was to develop and apply a method of studying the efficacy of the medicines prescribed within anthroposophical medicine which, in the first instance, would be in keeping with the anthroposophical approach and which its representatives would recognize and find of value, and secondly be a step towards what could be recognized by others as of more 'objective' value.

Method
The method chosen and developed was partly modeled on the semi-structured interview technique developed by the Institute of Social Scientific Research in Medicine (GESOMED), associ­ated with the University of Freiburg, Germany, which examined the efficacy of herbal products at the instigation of the Federal Health Office of West Germany 10,11. The conclusion was that valuable evidence and data on the efficacy of a herbal medicine could be gained through such a technique and identified a number of factors determining the value of the data. These included the expertise of the practitioners interviewed and their ability to exercise a degree of critical self-assessment vis-a-vis their prescribing results.

In the present study the main question was for details of those anthroposophical medicines which clinical experience had led the prescriber to be most convinced of their efficacy (see Appendix). Tile doctors were also asked to list those medicines to which they had a strong relationship but had never directly observed any therapeutic effectiveness. This latter question was intended to give a measure of the doctor's ability to be self-critical about the questions of his prescribing, as well as to prepare a list of medicines whose efficacy might be question­able and thus require further study regarding their preparation and use.

The questionnaire (see Appendix) described the fundamental assumptions of the project and gave the doctor the opportunity to agree or disagree with these and make comments. Specifically, the doctors were asked to list the ten medicines of which they had greatest certainty of their efficacy, based on their experience, and were then asked detailed questions concerning each: e.g. the indications for which they found them most definitely efficacious, the dosage and pharmaceutical form, etc. They were also asked to give some measure of the degree of certainty they felt, (scored 1 to 5), some indication of the number of patients for whom they had prescribed it, and the nature of the response. They were also specifically asked about any side-effects they had observed, and the degree of their knowledge of, and relationship to, the medicine concerned.

Of the 26 doctors known to have regularly prescribed anthroposophical medicines in this country, 23 agreed to take part in the project, of whom all but one completed the questionnaire. The doctors who had agreed to take part in the study were sent a questionnaire and asked to fill in as much as they felt able and to return it; they then had an interview based on the questionnaire, concentrating on areas needing clarification. Where more than ten medicines had been listed, (for which the doctor had a high degree of certainty regarding efficacy), more detailed information was sought on these medicines. The interviews helped clarify the questions and answers given, and were particularly helpful in raising enthusiasm and motivation for the study, and in providing a positive stimulus for the doctors to review their prescribing experiences more critically.

Results
Fundamental assumptions
There was general agreement with the fundamental assump­tions of the project. This included the acknowledgment that the physician's relationship with the substance, as well as the doctor/patient relationship, are legitimate elements of the therapeutic process, but that the medicine itself evokes a healing response from the organism when correctly prescribed.

There was a general consensus that the effect of the medicine was not always one of a simple cause and effect relationship, but either as an indirect effect or a catalyst in the healing process. In addition, some of the effects in the realm of patients' vitality, sentience and self-consciousness, could not be directly observed, being strictly speaking beyond the realm of ordinary sense perception and measurement.

Medicines whose efficacy was experienced as most certain

Based on the number of times that a medicine was indepen­dently listed in the 'top ten' individual doctors felt most certain about, and on the answers regarding the degree of certainty that each doctor experienced with respect to its efficacy, the following 'league table' emerged (Table 1).

Table I

Medicines independently mentioned by more than a third of the doctors in their lists of 10 most certain medicines (in order of certainty scores)

Medicine                     Number of positive doctors              Average certainty score*

Choleodoron                                       10                                         4.6

Iscador                                                9                                         4.1

Arnica (oral)                                         8                                         3.4

 
Medicines mentioned positively by at least 3 doctors but less than a third (less than 8) in order of certainty scores.

Medicine                     Number of positive doctors              Average certainty score*

Combududoron                                                                     
 
Lotion &
  Ointment                                           5                                              4.7

Chamomilla                                         4                                              4.7

Silica                                                   3                                              4.5

Calendula
  Ointment                                           5                                              4.4

Formica                                               4                                              4.3

Apis                                                     4                                              4.3

Belladonna                                          3                                               4.0                                                                      
Erysidoron I and
  II together                                         4                                              4.0

Ferrum
  Sidereum                                           5                                              3.8

Cuprum per
  Chamomilla                                       3                                              3.7

Menodoron                                         5                                              3.6

Gencydo                                             5                                              3.2

Disci preparations
  in general                                           5                                              3.2

Bidor                                                   7                                              3.1

Phosphorus                                          4                                              3.1

* In being asked to indicate their degree of certainty of the efficacy of the medicine concerned, the doctors were given the following options: absolutely certain - 5 points; very certain - 4 points; very probable - 3 points; probable - 2 points; think efficacious but uncertain - 1 point. Negatively listed, i.e. one of the medicines mentioned that the doctor had not observed to be efficacious, scored zero. In calculating the average, the number of doctors by which the total was divided was increased by the addition of the number of negative mentions.

The indications for which the medicine was observed to be most definitely efficacious were collated, along with the dos­ages and potencies used (Table 2).

Table 2

Dosage and indication information for the 18 medicines whose efficacy was experienced as most certain

Apis D2 and D3 by injections daily, indicated for sciatica and other forms of neuritis and acute muscle spasm.

Arnica (a) externally: Lotion and ointment applied externally for non-lacerating soft tissue injury/bruising and sprains.

Arnica (b) internally: D6, D20 and D30 all indicated for shock, of either physical or emotional nature and the sequelae of shock, in particular post-concussion. In addition, indicated for convulsive or epileptic tendencies, in which case higher potencies may be indicated.

Belladonna - D3, D4, D6 as well as D20 and D30 for pyrexic conditions, particularly when there is a risk of febrile convulsions, as well as for use in epileptiform and epileptic convulsions.

Bidor (a preparation of Silica, honey and Ferrous sulphate) - 1%, and 5% tablets, 2-6 tablets daily for headaches and migraine in patients with a migrainous constitution.

Calendula - externally, as ointment, indicated for open wounds, cuts and abrasions and problems of wound healing, such as non-granulation and wound infection. As a lotion, diluted in hot water, for bathing or compresses for boils, abscesses, mastitis and infected wounds. As an ointment also indicated for eczema.

Chamomilla - tea and D3 indicated for gastro-intestinal symptoms such as peptic ulceration, gastro-enteritis, diarrhea and intestinal colic, Also indicated for other visceral cramps or spasms such as dysmenorrhea. Particularly useful in treating children. Indicated in higher potencies particularly for children with sleep disturbances and possibly also in high potency for teething.

Cuprum per Chamomilla (Chamomilla Cupro Culta) - 0.1 and 1%, 5-10 drops t.d.s. indicated for intestinal colic in babies, children and adults.

Choleodoron   (Chelidonium/Curcuma) 7-10 drops t.d.s. for a wide variety of gall-bladder disorders, from cholecystitis, cholelithiasis and disorders of the gastro-intestinal tract attributable to gallbladder dysfunction.

Combudoron (Arnica/Urtica) - used either as the lotion diluted in water, approximately 1 in 10, for bathing or compresses, or the external application of the gel or ointment, indicated for first or second degree burns and scalds, also for sunburn and inflamed insect bites and wasp stings.

Disci Comp. preparations from Wala as ampoules for injection, in particular Disco Comp. cum Argentum and Disci Comp. cum Stannum, indicated for a wide variety of acute and chronic back and neck conditions including sciatica, lumbago, shoulder/arm syndrome and other neuralgic symptoms originating from the vertibral column. (It may also be helpful for other rheumatic conditions not confined to the back.)

Erysidoron I (Apis D2/Belladonna D2 either alone or in combination with Erysidoron 2 (Carbo/Betula and Sulphur D1) given as five to ten drops every 2-4 hours, for acute local infections and inflammation, and acute tonsillitis, cellulitis, crysipelas and abscesses.

Ferrum Sidereum - D6 - D20, either orally or by injection, is indicated for anxiety and anxiety-related symptoms, circulatory disorders including hypertension. Problems associated with the 9-year-old stage of' child development, and adults who have problems being fully awake and getting hold of life. (In anthroposophical terms, tending to excarnate.)

Formica - D3 to D6 by injection, indicated for joint pain in osteoarthritis, rheumatoid arthritis and gout, and as Formica Comp by injection for pain relief, particularly associated with malignant disease.

Gencydo (Citrus Medica-Cydonia) - 1, 2 or 5% ampoules, 2-3 times a week, for hayfever, allergic rhmitis and asthma. Also for hayfever prevention, 2-3 times a week for three to six weeks before the hay-fever season starts.

Iscador (Viscum album) and other Viscum album preparations, such as Viscum Abnoba, given by injection, 2 or 3 times a week, in series of seven injections, for all forms of cancer and precancerous conditions, is found to improve patients' physical and mental condition, relieving pain and improving nutritive state and aiding psychological adjustment to the illness. Also indicated in diseases of diminished immunity such as AIDS and ME as well as for certain psychologist conditions characterized by emotional fixity, such as obsessional compulsive disorders and chronic undigested psychological experiences.

Menodoron - prescribed as 10 to 20 drops t.d.s., indicated for a wide variety of menstrual problems, including irregular periods, amenorrhoea, dysmenorrhoea, menorrhagia and premenstrual tension.

Phosphorus - D6 in the mornings and D30 at night, indicated for sleep disturbance.

Silica - D10 to D22, either alone or in combination with Argentum nitricum and Be1ladonna in Silica Comp. (WALA) § indicated for acute sinusitis and chronic catarrhal symptoms associated with upper respiratory tract infections, also for a heightened susceptibility to cold. 

§ WALA is an anthroposophical pharmaceutical company based in Bad Boll/Eckwalden, Germany, whose products arc distributed by Weleda (UK) Ltd., Ilkeston, Derbyshire, which manufactures and/or distributes all the other medicines listed.

Re-analysis based on the criticalness of the doctors
Those doctors replying affirmatively when asked whether there were medicines to which they had a strong relationship but had never observed any therapeutic effectiveness, and who went on to list ten or more examples, were categorized as very critical; the group who replied affirmatively but could name less than ten examples were classified as moderately critical; and those replying negatively were classified as uncritical. There were four doctors in the highly critical group, eleven in the moderately critical and seven in the uncritical group. A separate analysis and comparison was made of medicines listed as most certainly efficacious by the three different groups of doctors. There was surprisingly little difference between the top ten listed by the three groups. Seven of the ten listed by the 'uncritical' group were also listed by the 'highly critical' and 'moderately critical' group.

Contentious medicines
Apart from highlighting a list of 18 medicines where there is considerable independent experience of their efficacy, a list of three medicines emerged where three or more doctors had listed them positively, and the same number, negatively. One medicine emerged as being listed negatively by three or more doctors and none positively. These medicines clearly need to be studied further by anthroposophical doctors and pharmacists to review whether they are being optimally prepared and prescribed.

Side effects
Doctors were asked if they had observed side-effects specifically from the medicines listed positively. Among their responses were: exacerbations of eczema from Sulphur given orally, pain and local reactions from injections of low potency Apis, Formica, Gencydo and Iscador by injection, and allergic skin reactions to Arnica applied externally to sensitized patients.

Conclusion
This questionnaire/semi-structured interview method has provided evidence of efficacy on 18 frequently used anthroposophical medicines.  The nature of the evidence may be regarded as having an intermediate level of objectivity between the experience of a single practitioner or patient in isolation, and the objectivity of a randomized controlled trial. It is suggested that, while not having the objectivity of the latter, the data gathered has a high degree of detail and practice relevance. It is also drawn from the reality of medical practice, unlike many trials which by their nature have to create more artificial situations.

For full questionnaire as a 4-page word document, click on this link: questionaire.doc

This study has provided a wealth of primary observations which could be a basis for designing further studies of one or more individual medicines, able to yield evidence of efficacy of a greater degree of objectivity.  Such a method may also prove useful in other fields of complementary medical practice, where it may serve as a useful initial survey of the field.
 

Michael R. Evans MB ChB
Secretary, Medicines Committee
Anthro0posophical Medical Association

Further correspondence to
Dr MR Evans, Park Attwood Center,
Trimpley, Worcs. DY12 1RE

 

References

1. Rentea R, Lyon E, Hunter R. Biologic properties of Iscador, a Viscum Album preparation. Laboratory Investigation 1981, 44(1): 43-48.

2. Bock D, Salzer G, Morphological evidence for the efficacy of Iscador in the treatment of malignant pleural effusions including clinical results. Eng. trans. from Krebsgeschenen  1980; 12: 50-53.

3. Salzer G, Muller H. Local treatment of malignant pleural effusions with the mistletoe preparation Iscador. Eng. trans. from Praxis und Klinik der Pneumonologic 1987; 32: 721-729.

4, Evans MR, Preece AW. Viscum album - a possible treat­ment for cancer? Bristol Medico/Chirugical J, 1974: 88,

5. Burkhardt R, Kienle G. Controlled clinical trials and medi­cal ethics. Lancet 1978; 2: 1356-1359.

6. Burkhardt R, Kienle G. Controlled clinical trials and drug regulations, a report of recent developments in the Federal Republic of Germany. Controlled Clinical Trials 1980; 1: 151-164.

7. Fincke M. Strafrechtswidrige Methoden der klinischen Pruefung. Dtsch Aerztebl 1978; 75: 2519-2522.

8. Kienle G. Arznemittelsichterheit und Gesellschaft - Eine kritische Untersuchung. Stuttgart/New York: FK Schattauer, Verlag,

9. Mills S. Conflicting research needs in complementary medi­cine. Comp Med Res 1986; 1: 40-47.

10. Reimann K. Arztliche Erfahrung and Arzneimittelgesetz. Zeitshrift fur Phytotherapie 1986; 7: 43-44

11. Reimann K. Die Bedeutung von medizinischem erfahrungsmaterial fur die Nachzulassung von Phytopharmake, Pharma/PPI 1984; 23 & 24: 12-15.





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