Prüfungen in der Homöopathie.

 

[Izel Botha]

Towards an Integrated Methodology: C4, Sherr and Dream Provings of Protea cynaroides

Homoeopathic provings form the experimental base of clinical homoeopathy. Provings are conducted through the administration of homoeopathically prepared medicine to healthy volunteers in order to elicit disease symptoms. The symptoms are collated to formulate the materia medica of the substance.

AIM

The aim of this study was to compare the most commonly employed proving methodologies, the C4 trituration, the Sherr and the Dream proving methodology, by application in order to ascertain the validity of the claims made

in terms of the efficiency of the method to elicit reproducible symptoms. This study sought to follow the existing methodologies exactly as set out by the original developers with the aim of developing an integrated methodology. The order in which the three groups were assigned followed a logical sequence that ensured that the maximum efficiency would be obtained, and that the blinding process would not be compromised.

The claims were investigated based on the hypotheses proving symptoms are reproducible when applying identical proving methodologies in consecutive years, that different methodologies yield different numbers, types and quality symptoms, that differences exist between the symptoms yielded by the placebo and the verum groups within the same methodology, and that an integrated methodology could be developed based on the study of the

relative efficiency of the respective methodologies.

The rubrics produced in each group were statistically analysed. The results reflected a reasonable level of reproducibility, proving the first hypothesis, but highlighted the fact that different provers would result in different symptoms due to their individual susceptibility and sensitivity to the proving substance. This effectively proved the hypothesis that the proving effect was reproducible in consecutive years through the application of the same methodology.

The result of the data collection was the formulation of 1.373 rubrics utilised for analysis purposes, resulting in 881 verified rubrics, that comprise the repertory for Protea cynaroides. From the data, it was evident that the

C4 trituration and the Sherr proving methodologies yield the most rubrics. Not only do they yield a large number of rubrics, but they also yield a much larger number of rubrics than produced by the placebo portion of the

Sherr proving methodology. In the Dream proving methodology group there is much less rubrics present at each rubric level than yielded by the C4 trituration and the Sherr proving methodologies. Strong chapter affinities were observable when applying the C4 and Sherr proving methodologies. The C4 methodology seem to favour the chapters dealing with the senses, evident in the Ear, Eye, Hearing, Mouth, Nose, Skin and Vision chapters where the

C4 rubrics were more prevalent than the Sherr rubrics. The Sherr methodology was evident in the remainder of the chapters, indicating the wide applicability of this methodology. This proved the hypothesis that some proving methodologies are more effective than others. 

The hypothesis of difference between the placebo and verum groups within the Sherr proving methodology was proven as it was evident in the number of rubrics produced by each section. The verum portion elicited 63% of the total rubrics compared to the placebo portion which only elicited 28%. Placebo provers thus elicit fewer symptoms during the proving process than verum provers, demonstrating that homoeopathic drug provings are not a placebo response, but that the administration of the medicine results in the development of clearly observable symptoms in the participants.

As originally assumed, the proving did produce clearly observable symptoms in healthy provers. The symptoms gathered through the application of the methodologies were also comprehensive enough to develop a complete materia medica and repertory for Protea cynaroides.

CONCLUSION

From the data presented in the study, one can thus conclude that in order to elicit symptoms representing all 38 chapters present in the Protea cynaroides proving, the C4 trituration proving and the Sherr proving methodologies would have to be combined. Although Group two is able to elicit the majority of symptoms, it would be even more effective when it is combined with the C4 proving methodology, hence leading to the development of an integrated methodology combining these methods, proving the final hypothesis. The suggested integrated methodology thus comprises of firstly conducting a C4 trituration proving using at least 10 predominantly experienced C4 provers. This proving would serve to highlight the major themes. These themes can then be confirmed through secondly conducting a proving according to the Sherr methodology, in a group comprising of at least 17 provers, including a 10% placebo in the group. Repeated oral doses would be administered to the participants in this. At the conclusion of the second Page | v

proving stage, all the data would be collated and formatted into a materia medica and repertory.

It would, however, be important to prove the integrated methodology‘s usefulness through practical application, leading to the recommendation that the methodology be tested. Page | vi

Similia similibus curentur1 is the fundamental principle upon which homoeopathy is built, although the notion was first expressed by Paracelsus around 300 years earlier (Ball, 2007). In order to practically apply this principle,

the nature of disease and the nature of medicine need to be understood. Hahnemann (1999: 187-8), in aphorism 105, tasks every homoeopath with the mission:

1 Likes are to be cured by similar things (Winston, 1999); the biological law of equivalents (Gaier, 1991).

The second point of business of a true physician relates to acquiring a knowledge of the instruments intended for the cure of the natural diseases, investigating the pathogenic power of the medicines, in order, when called to

cure, to be able to select from among them one,…as similar as possible to the totality of the principal symptoms of the natural disease sought to be cured.

Gray (2005b: 5) quotes a conversation in which Campbell remarks:

…if the similimum had not yet been discovered, those patients must die if we had not the remedy sufficiently similar to bring them to a certain stage of improvement. Then it follows that we must still go on developing remedies, for the similimum still remains undiscovered for some diseases.

This observation highlights the importance of new provings, with the aim of developing a more comprehensive materia medica.

The development of a remedy picture is not based on provings alone. Provings are but the first step in the process and give an indication of the drug‘s possible use (Bodman, 1977). The picture must then be verified by

comparing the proving symptoms with any available toxicological data and finally prove its effectiveness in clinical use (Belon, 1995). Sherr and Quirk (2007) believe that a good proving is not about producing every possible symptom, but rather about producing good quality symptoms indicating a meaningful totality open to clinical verification.

The aim of this study was to compare the most commonly employed proving methodologies in order to ascertain the validity of the claims made by their respective developers. Each originator favours the method and describes

the method as superior in terms of efficiency and quality of symptoms produced. In studying each of these methods individually, an informed decision could be made based on the merits of each method.

Despite being called - unhomoeopathic and not understandable (Dellmour, 1998: 223-89) the C4 proving methodology is followed extensively in Germany, the Netherlands and the U.S.

1.     Trituration provings are generally conducted in groups of 5 to 25 participants and are carried out during a trituration process. Participants record all the symptoms experienced during the trituration, and discuss these

experienced during a - wrap-up conversation after the trituration process is completed. Each trituration level reveals a different level of experience, contributing to the development of a complete symptom picture. This methodology was selected as the first methodology to be tested. The trituration process carried out during the application of this methodology also completed the first stage of production, according to the German Homoeopathic Pharmacopoeia (GHP) (Benyunes, 2005) of Protea cynaroides 30CH utilised by the second and third methodologies.

2.     The second methodology identified was the Sherr methodology, as it is the most common method followed in provings conducted at the Durban University of Technology‘s Department of Homoeopathy. This

methodology utilises healthy volunteers as provers, in a group comprising of between 15 and 20 provers. The provers are required to ingest the remedy over a period of two days until symptoms arise. Placebo controls are utilised and the participants are unaware of whether they are taking the active or placebo set of powders.

3.   the Dream proving methodology which cover a limited time span and focus mainly on the provers‘ emotional responses to the dreams. There is no set protocol for the administration of the doses and no placebo control utilised. Sherr (1994: 16-7) feels that the larger totality of physical, general and long-term symptoms may be missed using these methods, which this study investigated.

Every methodology was also tested twice: in two consecutive years and during the same months to eliminate seasonal influences. At the conclusion of the study, an integrated methodology was also developed, which focused

on the strengths evident in each methodology and strove to minimise the weaknesses.

This study thus investigated whether the different methodologies yield different symptoms, both relating to the quantity and quality of prover experiences. It also aimed to investigate the reproducibility of symptoms elicited during consecutive provings of the same substance, utilising the same methodology. If the proving methodologies proved reproducible, it would negate the need for the re-proving of existing remedies. Lastly, this study investigated whether differences exist between the symptoms yielded by the placebo and the verum groups within the same methodology.

As a consequence of the proving process, a description of prover experiences emerged, which, when collated, yielded a complete homoeopathic materia medica and repertory for Protea cynaroides. This data are presented in Chapter 4 and further discussed and analysed in Chapter 5.

HYPOTHESES

With the aims discussed above in mind, the following hypotheses were formulated:

Reproducibility:

Proving symptoms are reproducible when applying identical proving methodologies in consecutive years

Relative effectiveness:

Some proving methodologies are more effective in yielding proving symptoms than others, in terms of number, type and quality of symptoms elicited.

A distinct difference exists between the symptoms yielded by the placebo and the verum groups within the same methodology

In studying the relative effectiveness of proving methodologies it is possible to develop an integrated methodology

Every art has only a few principles and has many techniques

Dale Carnegie, quoted in (Scholten, 2007: 397)

Provings, from the German Prüfung2, are the pillars upon which homoeopathic practice stands (Sherr, 1994: 7). It is important to conduct thorough and comprehensive provings to understand the nature of disease and cure (Signorini, Lubrano, Manuele, Fagone, Vittorini, Boso, Vianello, Rebuffi, Frongia, Rocco & Pichler, 2005). A large part of homoeopathic materia medica3 is based on the data obtained from a drug proving (Walach, 1997).

2 Examination or consideration (Collins, 2004)

3 A reference book documenting the pathogenic effects of medicine and its uses. It deals with the origin, composition and properties, origin and preparation and clinically established characteristics and indications of the drugs (Gaier, 1991; Hughes, 1912).

4 Potentisation is a physical process through which latent curative powers of medicines are aroused, although these powers may not be evident in the crude state of the drug. It involves quantitative deconcentration of the drug substance combined with succussion5 (Gaier, 1991).

During a homoeopathic proving, or a homoeopathic pathogenic trial (HPT), a homoeopathically prepared substance is administered to healthy volunteers with the aim of eliciting disease symptoms (Walach, 1997). The symptoms experienced when taking the potentised4 medicine show distinct similarities to the symptoms elicited when taking the crude substance, but the symptomatology is more differentiated and specific, especially with respect to the emotional, mental and modality characteristics when utilising the potentised proving substance (Whitmont, 1993). The symptoms are carefully noted for therapeutic purposes and collated to formulate the materia medica of the substance (Walach, 1997). Classifying a medicine as a homoeopathic Chapter 2 Page | 8

remedy, because it has been prepared according to homoeopathic principles and procedures, is invalid. Such a medicine can only be called a homoeopathic remedy after it has undergone a valid proving (Schuster, 1998). Homoeopathically prepared medicines only imply that the medicine is manufactured using a process of serial dilution5 and succussion6. A valid proving, however, provides the medicine with a remedy picture, indicating its possible uses in clinical practice. Provings thus form the experimental base of clinical homoeopathy (Signorini et al., 2005) and every prescription should be based on a comparison between the symptoms the patient is presenting and the symptoms elicited during the proving (Dantas, 1996).

5 Serial dilution is a process of quantitative deconcentration of a drug substance according to a set dilution ratio – 1 part drug substance to 99 parts of diluents (usually alcohol-water mixtures or milk sugar) – for centesimal potencies (Gaier, 1991).

6 Succussion is the vigorous shaking up of a liquid dilution of a homoeopathic medicine in its bottle, where each stroke ends with a jolt, by pounding the hand engaged either against the other palm or an elastic object like a leather bound book (Gaier, 1991; Hahnemann, 1999).

Investigating medicine through practical experimentation was one of the keystones of Paracelsus‘ teachings (Ball, 2007), and taking part in a proving is thus a ―more direct experiential side of homoeopathy (Sherr, 1994: 10). There may be a fear of provings, where the individuals are reluctant to take part for fear of damaging their health. But Sherr (1994) found that 80 to 90% of provers felt that they benefited from the experience. In participating, the provers learn more about themselves and gain new life experiences.

 

In 1790, Samuel Hahnemann conducted the first proving on himself when he took several doses of Cinchona officinalis to ascertain why it was effective in treating intermittent fevers. Hahnemann compared the similarities between the symptoms he observed in his own body after administering the dosages with the symptoms of the intermittent fever it was said to be able to cure (Cook, 1989; Hughes, 1912; Resch & Gutmann, 1987).

His findings led him to formulate the ―Law of similars7 and resulted in the birth of homoeopathy (Haehl, 2003a).

7 A principle in homoeopathic medicine that draws a parallel between the toxicological effect of the substance and the therapeutic powers thereof. It states that a drug capable of producing morbid symptoms in a healthy person will cure similar symptoms occurring as a manifestation of disease (Gaier, 1991; Norland, 2003b).

8 A non-medicated substance that is relatively inert pharmacologically (Gaier, 1991).

9 The active medicinal substance tested during the proving or trial.

Hahnemann continued to experiment with other natural substances and developed a method of testing a remedy with the help of healthy volunteers. He called this process a proving. It requires knowledge of both the test person and the substance, for according to Hahnemann, health can be scientifically understood, but disease can only be perceived in a healthy person, because it is a deviation from a state of health. Disease is chaotic and as a consequence not directly accessible to scientific investigation. A healthy person can thus offer a familiar basis for the experiment and by comparing the results of the effect of the remedy on the healthy body to the symptoms of a patient, it is possible to ascertain what the disease is (Resch & Gutmann, 1987). Fuller Royal (1991) points out, however, that there exists no completely healthy individual – some are simply less ill or healthier than others.

 

Placebo-controlled double-blind studies are required to illustrate whether the symptoms produced are the effect of the remedy administered, or simply a placebo effect. During such trials, randomisation is carried out by a third party, and participants are given either the active verum9 or an inactive placebo without anyone involved in the study being aware of who received which (Walach, 1997). The first double blind placebo controlled proving was conducted in 1835. This was the first double blind placebo controlled trial in the history of medicine (Fisher, 1995).

The use of blinding in provings is controversial and even the type of blinding is a hotly contended topic. Wieland (1997) points out that the use of a placebo control in conventional clinical trials serves to illustrate the

effectiveness of the drug in the treatment of a specific ailment. The purpose of a homoeopathic drug proving is however to produce symptoms and not to illustrate the effectiveness of the drug in question. The question Wieland (1997) poses is whether symptoms that appear during a proving, while taking placebo, are examples of the ―pure placebo effect. He implies that modern scientific investigation techniques may hinder the pursuit of provings to find medicines that may prove beneficial cures, as opposed to assisting the investigators in obtaining the goals. Smith (1979) also suggests that Hahnemann and his followers were aware of the effect of suggestion, but saw it as inconsequential and chose to ignore it. Given the small number of volunteers, Jansen (2008) is of the opinion that it would be more efficient to give all participants verum.

The entanglement10 theories try to explain a prover‘s susceptibility to producing symptoms during the proving. Lewith, Brien and Hyland (2006), Milgrom (2007) and Walach, Sherr, Schneider, Shabi, Bond and Rieberer (2004) suggest that there has to be a buy-in into the therapeutic intent from both the researcher and the subject. The prover would have to believe that the substance possesses the ability to elicit symptoms and the researcher needs to record and analyse the symptoms at face value first, before discarding any information as incidental or circumstantial. Entanglement theory further explains why the placebo also elicits proving symptoms similar to that of the verum in some provers, as all the provers within the group are

10 The idea of quantum entanglement originated in physics and is an algebraic argument to explain how related entities may interact. ―Entangled entities behave as one inseparable holistic unit, whose totality cannot be deduced from any of its parts (Milgrom, 2007). entangled regardless of the double blinding and placebo control. Hyland (2005) suggests that the remedy does not provide the symptom information, but rather that the symptoms are produced purely as part of the entangled state.

Many scientific trials have been conducted to investigate the role of placebo and blinding in provings. Walach et al. (2004: 182) investigated whether the proving symptoms were the result of local, non-local or placebo effects

and concluded, ―that what was experienced during the proving was different from mere background noise. He also advocated the importance of using both qualitative and quantitative methods when designing the trial and suggests the use of a double blind, placebo controlled study (Walach, 1997).

Smith (1979) suggests that the concept of double blind trials and placebo was introduced by Bellows in 1906 during the re-proving of Belladonna, whereas DeMarque (1987) believes that Bellows only perfected the technique.

A two-stage crossover trial yields the best results, according to Bayr (1986), for it allows for the verification of specific individual symptoms within a prover. This method eliminates the limitation of the double blind study

and introduces a useful intra-individual control (Walach, 1994). He is also of the opinion that the strict control during the proving and the validation of the symptoms during clinical practice should provide adequate validation

of the process. The question arises as to whether placebo blinding only serves to eliminate bias or if the process itself may introduce new unintended bias (Kaptchuk, 1996).

Signorini et al. (2005) investigated the difference between placebo controlled trial and traditional trials and found a lower number of mental symptoms in the placebo group compared to the verum group, and that unusual symptoms did not arise in the verum and placebo in a similar way. They concluded that the placebo group seemed important for the selection of real symptoms. Rosenbaum and Waissen-Priven (2006: 216) found that there are significant differences between the narratives of the placebo and verum groups. The group taking the active substance …tend to use expressions such as “I‘ve never felt that before”,  “Those weren‘t my symptoms” and “My headache is completely different”.

Provers from the placebo group seem to have vaguer descriptions and are not able to describe the symptoms and modalities clearly during cross-examination. This lead the researchers to emphasise the importance of personally verifying each of the symptoms elicited during the proving.

Jansen (2008) concludes that reliable results can be obtained by comparing the proving results with the baseline symptoms of each prover, by utilising a placebo run-in phase and by excluding old symptoms of the prover.

Recording and validation of the symptoms experienced is thus paramount to the proving process. Only reliable symptoms should be used to construct the materia medica picture (Dantas, 1996). In 1870 before beginning the proving, Dunham advised his provers to record in a notebook …a statement of her age, temperament, the sicknesses which she has had and those to which she has an inherited or acquired tendency (Dunham, 2004: 353).

This notion contributed to the use of a pre-observation run-in period to prepare the volunteer was suggested in 1895 (Dantas, Fisher, Walach, Wieland, Rastogi, Teixeira, Koster, Jansen, Eizayaga, Alvarez, Marim, Belon

& Weckx, 2007: 5).

Provings in the 19th century were collected by Allen in his Encyclopedia of Pure Materia Medica and Hughes in Cyclopedia of Drug Pathogenesy. These provings were however uncontrolled and the symptoms were unverified. Dosage and potencies were also not standardised (Fisher, 1995).

Bellows conducted the first multi-centre double-blind proving which was published in 1906 (Dantas et al., 2007).

In the following paragraphs the different methodologies will be examined.

Hahnemann held the belief that a true materia medica should be the collection of authentic, pure, reliable symptoms of the medicine itself, free from conjecture, fabrication or assumption. He minimised bias by selecting trustworthy and conscientious healthy human volunteers (Dantas et al., 2007). A standardised proving protocol was formulated as the method of obtaining the symptom picture from a substance. Hughes (1912) expressed his

doubts that all Hahnemann‘s observations were only made on the effect of the medicine on healthy provers. He claims that some may be based on observations made of the effect of the remedy during the treatment of the sick.

Hahnemann wanted the symptoms to be unadulterated and controlled the variables by setting strict rules about the diet and lifestyle of the provers (Dantas et al., 2007; Hahnemann, 1999; Raeside, 1962). Provers were only

allowed to eat vegetables with the least medicinal power, e.g. green peas, green French beans, boiled potatoes and carrots. The participants were not allowed to drink pure wine, brandy, coffee or tea. Koppers (1987) refined this

list by allowing the consumption of milk, fruit teas, barley coffee, water and fruit juices containing no preservatives. He mentioned that the food should be as non-irritant as possible, and devoid of large numbers of additives.

The provers also had to avoid over exertion of the body and mind and had to have no urgent business to distract them (Hahnemann, 1999; Nagpaul, 1987). The participants have to live

…in contentment and comparative ease. When an extraordinary circumstance of any kind… supervened during the proving, then no symptoms were recorded after such an event (Hughes, 1912: 40-1).

Hahnemann insisted that the participants devote themselves to careful self-observation and be in a good state of health. They also had to be able to express and describe the sensations and symptoms accurately (Hahnemann, 1999). To ensure this, Hahnemann insisted on personally verifying every symptom elicited to ascertain the true nature of the symptom (Hughes, 1912; Rosenbaum & Waissen-Priven, 2006).

Hahnemann felt that he never wanted to deceive his provers (Haehl, 2003b) and always informed them what substance they were taking. There was thus no utilisation of placebo or blinding during his trials. He also believed

that he first had to test the medicine on himself so that he would know what he is exposing his provers to.

As far as potencies were concerned, he initially utilised the substance in tincture form or in the first or second trituration13 (Haehl, 2003b; Walach et al., 2004). Later on, in the 6th edition of the Organon14, he advocated the

use of the 30CH potency, to be taken on an empty stomach daily. He also wanted the dry dose (four to six globules) to be dissolved in water and thoroughly mixed before it was taken orally (Hahnemann, 1999).

13 A process of homoeopathic drug preparation, whereby a drug substance (raw material) is ground with a neutral, diluting substance (usually lactose) using a mortar and pestle. This process serves to reduce the drug to a fine powder whilst amalgamating it thoroughly with lactose and attenuating it (Gaier, 1991; Hogeland & Schriebman, 2008).

14 A body of methodological doctrine comprising principles for scientific or philosophical procedures or investigation (Winston, 1999).

Hahnemann recorded all the proving data and published it in his Materia Medica Pura during 1825-1833 (Fisher, 1995).

It is questionable whether it is feasible to attempt application of this methodology taking the twenty-first century lifestyle into account. It is thus understandable that certain adaptations were made to the methodology to render it practicable in modern times, as seen in the methodology advocated by Sherr (1994).

Kent’s Methodology

Kent15 (1995) believed in the importance of self-examination prior to the commencement of the proving. He insisted that the participants devote a week preceding the proving to careful examination of all the symptoms that they normally suffer from. This would yield knowledge of the individual in their healthy state. The proving substance would then be administered to the participants, but they would be unaware of the name and nature of the substance (Kent, 1995). He emphasised that not all provers will produce symptoms from potencies, and that the physician should select the provers carefully. This is done

15 James Tyler Kent (1849-1916).

16 Susceptibility represents the individual‘s capacity, proneness or disposition to be affected by certain disease states (Gaier, 1991).

…by studying the natural traits of their life;…see their weaknesses and make use of them (Kent, 1994: 443).

This sentiment was shared by Roberts (1936) and Schadde (1997). This means that not all the individuals will produce symptoms during the proving, because they have different susceptibilities16 to diseases. If certain symptoms exist in the toxicology of a substance, provers prone to those diseases will most likely produce strong symptoms and that knowledge can be used to select sensitive provers.

The substance would be administered in tincture or potentised to the 30th centesimal potency, distributed as a single dose in a separate vial for each participant. Repetition of the dose was up to the discretion of the proving co-ordinator. If the first dose does not elicit a response, sensitivity to the substance would be created by administering the substance, dissolved in water, every two hours for 24 to 48 hours or until symptoms develop. The provers were also requested not to discuss their experiences with their fellow participants, but only to carefully note these symptoms. No great emphasis was to be placed on crude drug provings, for these are believed to only produce temporary effects (Kent, 1995).

Kent (1995) advocated the reproving of remedies to obtain greater knowledge of the substance. He also emphasised the long term health benefits of provings, in that it

…will improve the health of anybody; it will help to turn things into order (Kent, 1995: 187).

This correlates with Sherr‘s (1994) statement that provers observed that they benefited from the experience.

Very few provings were conducted in the first half of the 20th century, but the latter part saw a revival in the interest in provings. These later provings include randomisation, blinding and control groups, although the application of these scientific methods was variable (Fisher, 1995).

Dream Proving Methodology

Becker started conducting dream/group provings about 30 years ago in the Bad Boll seminars (Dam, 1998). These were single-blind studies that cover a limited time span and focus mainly on the dreams of the provers.

There are, however, some physical symptoms present. There is no set protocol for the administration of the doses — the provers can decide how they would like to be exposed to the medicine. They can take it orally, by

olfaction, hold it in the hands for a period of time, sleep on it, touch another prover who took it or be in the same room as the other provers (Dam, 1998). During these trials no placebo control were used. Pillay (2002) utilised one administration method (a single oral dose taken sublingually at bedtime) to be used by all provers to ensure standardisation. She also utilised a double blind placebo controlled methodology. The result of this study showed a 93% correlation to the symptoms produced during the Hahnemannian proving of the same substance, carried out by Wright (1999).

Briggs (1996) is of the opinion that dream provings are much safer and more feasible than other proving methods. He views the provers‘ emotional responses to the dreams as important, as the dreams have the ability to illustrate the provers‘ uncompensated feelings and reactions. Gray (2000) feels that dreams are fruitful sources of information, especially when the most sensitive people are selected as provers.

In contrast, Sherr calls the dream provings partial provings and feels that it is only advantageous in being a short cut to an inner essence of the remedy. He feels that the larger totality of physical, general and long-term symptoms may be missed using these methods (Sherr, 1994: 16-7). Signorini (2007) believes that the dream provings conducted in the Netherlands were of very low quality and that they result in greatly inflated estimates of the number of mental symptoms. He feels that they are not homoeopathic pathogenic trials and that the definition of such trials should be modified to exclude them. Scholten (2007) feels that meditation provings are more accurate than dream provings in giving the essence of the remedy, but emphasised that the remedy picture obtained through such methods are not complete and that it may be incorrect in parts. He is hesitant using the data obtained through dream provings in his publications unless the data is verified through clinical cases.

In order to accurately investigate the methodology, the researcher decided to utilise the methodology as developed by the original scholar (Becker). The methodology for dream provings would resemble that explained by Dam (1998) as opposed to the one set out by Pillay (2002), for Pillay utilised a methodology that integrated the Dam (1998), Sankaran (1995) and Sherr (1994) methodologies.

The Vithoulkas Methodology

Vithoulkas (1998) developed a methodology published in 1980 wherein he insists that a substance is only fully proven when the substance is proven using toxic, hypotoxic and highly potentised doses. Symptoms must be

recorded drawn from all three levels of the organism: mental, emotional and physical. He insisted that the participants comply with the following requirements: They must be well acquainted with homoeopathic methodology

and symptomatology, they must be aged between 18 and 45 years, they should not be hysterical or anxious people. This is in contrast with Kent, who believed that individual susceptibility to the substance was important in selecting provers, regardless of their normal state. Vithoulkas also felt that provers must be able to appreciate the seriousness of the experiment and they must lead a life as normal as possible during the course of the experiment. He further elaborated that the normal life should include definite time for sleep, walking and eating. The food must be free of chemicals, refined products, spices and stimulants. They must have stability in relationship, family

and work and avoid excessive influences.

The lifestyle described by Vithoulkas is much more defined than the requirements set out by Hahnemann, who emphasised self-observation through the avoidance of any activities that may distract the prover. Hahnemann also emphasised the importance of personal verification of every symptom, which Vithoulkas does not advocate.

According to Vithoulkas (1998), the experimental proving must always be conducted with a double-blind format and 25% of the provers are to be given placebo. The tested substance and the placebo must be packaged identically. Provers are to be given strict instructions not to communicate with each other about their symptoms or circumstances. The prover group consist of 50 to 100 provers.

The medicine is administered three times daily for a full month or until symptoms appear. The medicine is firstly given in the toxic dose (1X to 8X)17, then in a 30C18 potency when all the symptoms disappeared and finally a single dose of a 10M or 50M19 a year later to provers who produced symptoms immediately and were the most sensitive to the remedy. Fuller Royal (1991: 123) added to this, by stating that:

17 1X is equal to a deconcentration level of 10-1 of the original substance present in the dilution; 8X is equal to 10-8.

18 30C is equal to a deconcentration level of 10-60 of the original substance present in the dilution.

19 10M is equal to a deconcentration level of 10-20 000 of the original substance present in the dilution; 50M is equal to 10-100 000.

…high potency provings should only be done under the direction of a highly qualified homoeopathic physician to reduce the risk of long term reactions.

This stands in contrast to the views of Kent and Sherr, who felt that provers stand to benefit from the proving experience and that the proving process does not endanger the health of the provers.

Vithoulkas (2008) speaks out strongly against the new ideas concerning proving methodologies and slates them as the reason why the credibility of homoeopathy is brought into question. He feels that provings should mirror phase one clinical trials, thus fitting into the scientifically verifiable medical model.

The Sherr Methodology

The most common method followed in provings conducted at the Durban University of Technology‘s Department of Homoeopathy, is the method developed by Sherr (Moore, 2007; Somaru, 2008; Taylor, 2004; Wright, 1999),

also known as the standard Hahnemannian proving (Hogeland & Schriebman, 2008: XV). Sherr‘s definition of a Hahnemannian proving is a proving that include the whole totality of symptoms and is closely supervised over a sufficient period of time. These provings are double blind, non prejudiced and exacting (Sherr, 1994: 6), in contrast to Hahnemann‘s belief that his provers should not be deceived. Sherr feels that it is important to continue with

the 21st century lifestyle, for these external influences are but obstacles to cure, thus eliminating Hahnemann‘s strict dietary and lifestyle restrictions. Sherr (1994) believes that it is essential to perceive the core, which remains

the same regardless of the outside influences.

The methodology according to Sherr (1994) is a follows: The provers are the healthy individuals who volunteer to participate in the study. They must be honest and conscientious, as well as diligent to be able to supply the

accurate information required from the proving. The group of provers normally comprise of between 15 and 20 provers. Provers are required to keep notes of their normal state for one to two weeks prior to commencing the proving.

When the proving begins, the prover ingests the remedy (six doses over two days) and stops taking further doses as soon as symptoms arise. When no further symptoms arise for three or four weeks, the proving process is considered to be complete. The participants are unaware of whether they are taking the active or placebo set of powders. Dantas (1996) suggests that all the medicines utilised in the trial should be manufactured in the same manner and should look the same. He thus insists that the placebo is prepared utilising serial dilution and succussion of the alcohol/water mixture, as opposed to the utilisation of unprocessed alcohol/water mixtures.

The Sankaran Methodology

Sankaran follows a protocol midway between the seminar dream provings of Becker and the classical Hahnemannian provings. The provings are also single blind studies, but the people observe and record all physical and emotional symptoms, as well as dreams, incidents and observations of others. This method is very similar to Sherr‘s method — and can be viewed as the halfway method standing between the Sherr and dream methodologies.

He pays particular attention to the symptoms that are peculiar and characteristic. The group size is between five and 25 volunteers and the remedy is usually distributed as a single dose in the 30C potency (Sankaran, 1998: 2). Sankaran, however, feels that giving placebos to some provers may not serve any purpose, as most people in the group develop symptoms irrespective of whether they take the remedy or not (Sankaran, 1995). In presenting the proving, he deliberately leaves out any summary or conclusions, for he believes that any ideas are his own interpretation and he does not wish the readers to get fixated on his ideas of the proving, for this may lead to prejudice, where the need to be objective and faithful is paramount (Sankaran, 1998). This view is shared by Sherr (1997), as he believes that it may cast a shadow on other possible facets awaiting discovery.

The ICCH Methodology

In an attempt to standardise proving methods globally to enable consistent interpretation of results, the International Council for Classical Homoeopathy (ICCH) recommended guidelines for good provings (International Council for Classical Homoeopathy, 1999: 33). They consider what they term a full Hahnemannian proving as a standard proving and make mention of the non-Hahnemannian provings stating that all symptoms derived from such

provings should be recorded as additional interesting information as the acquisition of this data falls outside of their perceived scientific method.

Their interpretation of a Hahnemannian proving differs somewhat from the guidelines laid down by Hahnemann, especially with regards to their definition of a healthy prover, the pre-proving case history, the number of provers required and the inclusion of a placebo control. Their guidelines for a good proving include (International Council for Classical Homoeopathy, 1999: 33):

Healthy volunteers that use no drugs, have no mental pathology and have been clear of any homoeopathic remedies for at least three months

A comprehensive case must be recorded prior to the trial detailing all past symptoms and states

Participants must be over the age of 18 and pregnant and breast-feeding women are excluded

The group must consist of homoeopaths or homoeopathic students, but may also include provers from a non-homoeopathic background to balance the group. The number of provers must be between 10 and 20

The substance must be sourced from a natural source free from pollution. The precise origin of the substance should be carefully detailed, including when, where and how it was obtained, the name, species, gender, family and other pertinent data

They recommend using two to three potencies during the proving, as well as using a placebo control (10 to 30%) as a means to increase provers‘ attention.

School of Homeopathy Methodology

The School of Homeopathy base their methodology on the protocol laid out by Hahnemann in the Organon of Medicine and take into account the comments and clarifications made by Kent in Lectures on Homoeopathic Philosophy, The Dynamics and Methodology of Homoeopathic Provings and Provings Volumes I and II. The difference in their methodology arose from their observation of the dynamics of the group proving (School of Homeopathy, 2004).

This methodology is based on the premise that the whole group is involved in the proving, not only those who take the remedy. This rules out the use of a placebo control group, for they would also prove the remedy based on

the above assumption (School of Homeopathy, 2004).

Because of the field effect (or morphic field resonance), a single dose is administered and no repeat doses dispensed. The School also feel that this ensures that the primary and secondary proving effects, which refer to the

primary effect of the remedy on the prover and the secondary effect of the vital force in opposition to the administered medicine, are not confused or the remedy administered anti-doted (School of Homeopathy, 2004).

Experiences are recorded immediately after the proving commences. Images, feelings, sensations, thoughts and concepts are noted immediately after the stimulus is received. The stimulus is introduced orally (usually in a 30C or 200C potency), by looking at it, by meditating upon it or by one participant mentally visualising an image of the substance. The phenomenon is viewed as similar to an epidemic contagion, where the influence overwhelms the individuals, submerging the participants‘ symptoms temporarily, whilst expressing that of the substance (Norland, 1999).

The requirements to be a prover are as follows (School of Homeopathy, 2004):

Healthy in spirit, emotions, mind and body

Not currently liable to severe acute episodes or suffering from severe degenerative chronic states

Avoid the use of substances (for instance food and drugs) which can have a medicinal effect

Be currently in the process of homoeopathic treatment with an experienced prescriber, so that issues that are of the prover rather than the proving can be discerned in the context of current treatment

Provers are also required to study the proving process and the output generated from completed provings (School of Homeopathy, 2004). This is achieved mainly by allowing third year students at the School of Homeopathy

to participate in a proving during their study year (Norland, 2008).

A pre-proving diary is kept for a month prior to the proving, containing entries adding up to at least 14 days. Participants are also urged to keep the diary with them at all times, especially at night so that they may note down dreams immediately. The symptoms should be noted down accurately, in detail and concisely in the prover‘s own language (School of Homeopathy, 2004). The diarising is maintained for three to four months after the proving (Norland, 1999).

A supervisor is also assigned to assist the prover in examining the symptoms (School of Homeopathy, 2004). Supervision is viewed as essential, in order to have an objective view of the symptom changes (Norland, 1999).

The Herscu Methodology

Herscu (2002) describes one way of conducting a proving as a guideline to others who are interested in conducting provings. His methodology suggests a group size of 15 to 40 people, preferably closer to 30. This number

makes allowances for placebo controls and potential dropouts. He emphasises the fact that the prover‘s predisposition, i.e. sensitivity to the proving substance, should be considered when selecting the provers in order to assure

that the proving group comprise of different constitutional types. This is in contrast to Kent (1994) who believes that the substance proven should match the susceptibility of the prover, thus only including provers of a certain sensitivity.

The potency of choice according to this methodology is 30C, for Herscu feels that enough people are sensitive to this potency and there is no danger of toxicity. Higher potencies require more specific prover susceptibility,

whereas lower potencies increase the chances of toxicity. The dose will only be administered repeatedly if necessary, with a maximum of three doses in the case of a toxic substance in 30C potency. If there is no response,

a single dose of 200C or 1M potency will be administered (Herscu, 2002).

Herscu (2002) feels that the use of placebo control is paramount and rejects the concept of a collective consciousness or group dynamic as described by Norland (1999). Herscu (2002) feels that individual provers would only produce proving symptoms when the active substance is administered and that all symptoms manifested by placebo provers are resultant from environmental effects during the proving process and should thus be excluded

when reporting the symptoms experienced by the active provers. As a result Herscu (2002) advocates the inclusion of about five placebo vials in every 40 provers.

The pre-trial phase, consisting of four days to two weeks diarisation of normal symptoms, acts to clearly record the prover‘s normal state and how they respond to the normal world. This also allows for the identification and elimination of unsuitable provers. To diminish the Hawthorne Effect,20 evaluation of symptoms should commence before the administration of the substance. This should be done for a period of between $ days and 2 weeks.

The provers should be healthy individuals over the age of 18 and not pregnant. Herscu‘s definition of healthy means a steady state that does not shift too easily, does not change constantly (Herscu, 2002: 103). The provers

should follow a lifestyle that is not being traumatised, changed, or unduly stressed (Herscu, 2002: 105). Their current diet should be maintained and limited to foods they are accustomed to. The use of recreational drugs is prohibited, as is taking homoeopathic treatment in the preceding three months.

20 A concept based on an experiment conducted by Western Electric in Hawthorne, Illinois in the 1920‘s. It states that by showing interest, you are intruding on the experiment, changing the behaviour of the individuals

involved in the study, because they know that they are being observed. It is different from the placebo effect, for the participants are not so much trying to please the observer, as they are paying extra attention and becoming

more aware of their internal state (Herscu, 2002).

Nature Care College

Gray (2005a) has been conducting provings with his students since 1997. He attempts to develop standards to ensure the quality of modern provings and also verify the findings of older provings. His methodology essentially follows Sherr‘s guidelines, but also incorporates the observations made by Herscu regarding current methods employed. Gray (2006a: 6) experimented with different methodologies and comments that:

…rigid right wing Hahnemannian trials often lack richness. It‘s hard to say just what the remedy is really about...the most boring and dissatisfying to the participants was the triple blind trial conducted using the strictest

modern controls and blinding and cross over methodology.

The proving design normally comprised of a double blind trial, where neither the provers nor the coordinator knew the name of the substance proven, usually with no placebo control, although in some provings placebo was employed. The base line was established through case taking and a two week journal run in. Data was collected using a journal and supervisors contact the provers daily, either in person or by phone. The inclusion criteria were that the persons were over the age of 18 years and in a general state of good health. This was ascertained by the routine evaluation. Participants agreed in advance to comply with the instructions for keeping the journal and had to prove capable of doing so. The provers were not allowed to engage in any elective medical treatments and should not undergo major life changes for the duration of the proving. If they were found to fit the criteria, they completed and signed an informed consent document.

Prospective participants were excluded if they were undergoing current medical treatment or if they experience acute exacerbations of their chronic diseases. They were not allowed to use birth control pills in the preceding three months or to have undergone surgery in the preceding six weeks. They were also excluded if they were pregnant, nursing, if they failed to show competence in the process or if they failed to complete the journal in the pre-proving observation period.

The proving lasted a maximum of eight weeks and neither the coordinator nor the provers were aware of the substance taken until the unblinding. The remedy was administered twice daily as five drops sublingually, taken away from food and drink, until symptoms developed. If no symptoms developed within three days, the prover stopped taking the remedy, but continued to record symptoms in their diaries (Gray, 2005a, 2005b, 2006a, 2006b).

In an attempt to reconcile the diverse views of the homoeopathic community on provings, he provides three versions of each proving in his books. The first includes only the primary action symptoms. The second includes all the symptoms listed in the first, but also includes the dreams and thoughts of the provers and supervisors, fleshing out the symptoms. This section also includes the experiences of people outside the proving as a result of the group dynamic. The third section is a brief chronology highlighting the first few days‘ experience of the major provers, their immediate response to the remedy (Gray, 2005a).

Meditative Provings

Meditative provings are carried out by individuals or in groups (Scholten, 2007) and is most of the time carried out blind (Evans, 2005b). Evans (2005a) carried out her provings by having up to four groups of provers sitting in meditation circles. Each circle had between 6 - 12 members; one group all female and the other three mixed. The potencies utilised varies from 30C to 10M (Evans, 2005b).

During meditative provings all the information was intuited or channelled whilst the group is sitting in a circle meditating. The groups have been working together for at least two years prior to the provings to develop a bond

and group karma. They had spent time on their chakras removing any blocks which may prevent the reception of information. It yields symptoms on the physical level, mental and emotional level and in dreams directly before

or after the provings — if they corroborate with the proving (Evans, 2005a).

The Guild of Homoeopaths, under the guidance of Micallef, developed meditative provings from an informal tutorial to two-year postgraduate courses. The protocol for their provings involves the establishment of a meditation circle, who meet once a month. Water and Rescue Remedy23 are provided for use by participants during the proving. The remedy for the session is placed in the centre of the circle as a bottle of pills or tincture, together with a crystal that would serve as a channelling device and offer protection. Sessions last up to four hours, during which participants are not permitted to leave, as this would break the circle. The session starts with prayers for healing, peace and preparations of the chakras for receiving the information from the remedy. The remedy is then distributed to the participants, who either take the dose orally, or hold it in their hands. The meditation then commences, initially guided by Micallef. Care is taken during the meditation to limit the use of adjectives or adverbs which may influence the images conjured up. This guided meditation is followed by 20 minutes of silent meditation, after which participants are encouraged to share their experience. The sharing session is recorded by dedicated scribes. Lastly Micallef discusses the core issues of the remedy as channelled through her. The session ends with further prayers for protection and peace, and closing down the chakras. Sometimes participants would be instructed to take the remedy for the following month and record any changes noted (Griffith, 2007). In Australia, Tumminello (2005) tries to keep the meetings as natural as possible, and thus starts off by meeting and interacting like colleagues. After this initial bonding, the circle is formed and the leader would call for relaxation and encourage the participants to free themselves from their daily concerns. He would also invoke protection of the group and the integrity of each individual. An oral dose of the medicine is then taken, followed by an individual meditation lasting 20 minutes. The participants would note down all their experiences first, and then share it in the group.

23 Rescue Remedy is a special combination of five Bach flower essences created for emergency stress relief. Clematis addresses dizziness or loss of consciousness, or a feeling of being not completely here; Cherry plum loss of mental and/or physical control, breaking down in despair; Impatiens emotional tension, stress and/or pain; Rock Rose acute fear, panic and terror; and Star of Bethlehem emotional or physical trauma, shock and/or grief and loss (Hasnas, 1997; Krämer, 1995: 91).

Ross and Campbell (2002) feel that while meditative provings are far from scientific, these provings provide a new dimension to homoeopathy worthy of further research. In researching the process, they found that there is a range of meditative provings which vary in quality and in information gained. They feel that these are best done by sensitive provers, who do not know the identity of the remedy and who do not discuss their symptoms in public and the process needs to be followed up in the same way as a Hahnemannian proving — by careful validation of the symptoms. Meditative provings can offer a partial picture, but not the completely objective insight gained through Hahnemannian provings, leading Ross and Campbell to suggest combining the two methods.

Tumminello (2005) favours meditative provings for the following reasons:

The meditation process maximises the awareness of the symptoms

The experiences are deeper and more grounded, especially for sensitive provers

The risk of aggravation is lessened through the support of the different energetic make-ups of the participants

There exists a strong support system if aggravations occur

The method combines the tribal practice of being a conscious receptacle to receive the messages, with the Hahnemannian practice of taking a medicine to find its effects

Scholten (2007) is hesitant about using the data obtained through meditative provings in his publications unless the data is verified through clinical cases. The data generated during these provings have no scientific basis and could be discarded as prover imagination or as manifestations of the meditation guide‘s direction during the meditation process.

The C4 Proving Methodology

In 1993, Ehrler investigated the notion of C4 trituration through self experimentation (Hogeland & Schriebman, 2008), which resulted in the emergence of a new methodology known as the C4-trituration provings (Becker & Ehrler, 1998). During a trituration process, Ehrler experienced symptoms, physical and psychological, and got inner pictures and ideas concerning the substances triturated. He found that each step opened up a completely new dimension of the remedy, and started to triturate to the C4 level, instead of the traditional C3 described in the Organon (Becker & Ehrler, 1998; Brinton & Miller, 2004; Hogeland & Schriebman, 2008).

They argue that each trituration stage (apparently) reveals a different level of experience. C0 is used to describe the level of the physical substance in its raw, material form. At this level some substances have little or no action (O'Brien, 2006). Symptoms of the C1 are mainly experienced on the physical realm, C2 on the emotional realm, C3 show the psychic and mental and C4 expresses the spiritual aspects (Becker & Ehrler, 1998). C5 is the level of

the collective unconscious – a connection to the past generations (O'Brien, 2006). It is important to note that the ‗C‘ does not indicate that it is a potency prepared on the centesimal scale (although the triturations are prepared using the centesimal dilution ratio), but rather that it refers to one of the eight carbon levels of existence from Ehrler‘s cosmology (Hogeland & Schriebman, 2008: 7).

Trituration provings are defined by the fact that they are generally conducted in groups, during a trituration process. The trituration is carried out by hand, in a mortar usually 10 to 18 centimetres in diameter, and the person grinding the substance experiences the symptoms of the remedy (Hogeland & Schriebman, 2008). The symptoms experienced by the participants are fairly consistent even when a large group of people participate in the grinding sessions (Timmerman, 2006). Participants record all the symptoms they experience during the trituration, and discuss these experienced during a wrap-up conversation after the trituration process. The participants are usually

not aware of the substance being triturated (Shore, Schriebman & Hogeland, 2004: 172-89).

Timmerman‘s groups consist of 15 to 20 members, in order to establish a strong resonance within the group. It usually takes her group five or six days to complete the proving. Every group starts with the trituration of Lac humanum to enable members to open up and increase the group resonance. The second remedy is that of the child, Calc., followed by the successive triturations of Sil., Alum. and Nat-m. (Brinton & Miller, 2004). It was the researcher‘s experience, while attending the International Seminar 2008 of the Hahnemann Institute, that this sensitisation process does not take place when C4 provings are conducted during seminars. This does not impact

on the experience and even inexperienced provers experience intense symptomatology.

This method is mainly followed in Germany (Schultz‘s provings of Columba palumbus and Vulture gryphus) and the Netherlands (Timmerman at the Hahnemann Institute), but can also be seen in the remedies discussed by

Shore et al. (2004) and Herrick (1998) from the United States of America.

Shore et al. (2004) believe that homoeopathy is a science that stands as a bridge between the visible and the invisible. According to Shore et al. (2004), provings open the doorway into the invisible world. Following a specific methodology is thus a critical component of the process. Shore et al. followed the following protocol for their bird provings: Provers were supplied with a mortar, pestle and pre-weighed Saccharum lactis, equal to a ratio of

one part of substance to 99 parts of lactose. The lactose was divided into three parts equating to 33 parts each. The feathers (proving substance) were finely cut and ground to make it unrecognisable. A group of seven to ten

provers sat around a table, each taking turns to triturate for two to three minutes before passing the mortar on to the next prover. After seven minutes of grinding, the bowl was scraped for three minutes. At the end of 30 minutes

of triturating, one gram of triturate was removed and mixed with an additional 99 grams of Saccharum lactis. The process was repeated 4x to reach a C4. The provers were free to talk, eat and to move around the room or to go outside. They were instructed to take notes of any symptoms experiences, recorded according to each trituration level. The entire process was videotaped. At the conclusion of the process, each prover related their experience.

He then provided each prover with a 30C potency, prepared from either the C3 or the C4 triturate, of the remedy one week later which they could choose to take and they met 10 to 14 days later to give an account of their experience.

Hogeland and Schriebman (2008) attribute the following benefits to the C4 proving method:

Continuous experimentation akin to that of the founding father, Hahnemann

Remedy information is gathered in the current language and psychosocial framework

Development of a close relationship with nature

Information is focused and direct, providing a solid framework for the study of materia medica

Symptoms clarify existing remedy information

Experience of the different levels of the remedy take place in a stepwise manner

Insight into the pace and intensity of the substance

The triturator become more perceptive of him/herself and the fellow triturators

Increased sensitivity leads to better resonance with potential patients

In depth understanding of the remedy

Development of a non-polarised world view, free from judgement

Personal development and therapeutic benefits

Symptoms like spacey or drugged feelings, itchiness of the eyes, nose and skin and time distortions are common symptoms experiences during C4 provings and should thus not be over emphasised, but documented especially

if they exhibit an unusual quality (Hogeland & Schriebman, 2008).

There are, however, those who are sceptical of the C4 method. Dellmour (1998: 223-89) calls these potencies unhomoeopathic and not understandable and suggests that these provings not be included into the materia medica

or repertories. In studying the list of benefits, it does seem like personal development is paramount to the C4 experience and it is questionable whether novice C4 provers would be able to experience the different levels of the remedy. As with meditative provings, it seems that an experienced group of provers is required. Experience would also assist in identifying unique symptoms and evaluating the importance of commonly experienced symptoms.

Grouping of methodologies

In studying the methodologies presented above, a summary of which is presented in Table 1, the methodologies were grouped together and three main groups identified to be the focus of the study.

The C4 proving was identified as the first group as it allowed for the manufacture of the oral dose during the proving process. It contained some elements of the meditative provings as well. It was chosen to represent the methodologies in which no oral dose of the proving substance is administered to provers. Provers are also described as more intuitive and the duration of the proving shorter than conventional proving.

The second group was classified under the Sherr methodology, as it represented a modernisation of the Hahnemannian and Kentian methodologies. It was selected to represent scientifically acceptable proving methodologies.

This gold standard (European Committee for Homeopathy, 2004, 2008; International Council for Classical Homoeopathy, 1999) proving encompasses a double blind proving methodology which is verifiable in terms of phase

one clinical trials. It also complies with the International Council for Classical Homoeopathy guidelines for conducting provings (International Council for Classical Homoeopathy, 1999).

The last group represented the unblinded studies of meditative provings and the School of Homeopathy, grouped under the Dream proving methodology. This group represented the more intuitive provings where an oral dose of

the proving substance was administered. The duration of these provings is also than shorter that of the Sherr proving methodology.

 

Table 1 C4

(Becker & Ehrler, 1998; Brinton & Miller, 2004; Hogeland & Schriebman, 2008; O'Brien, 2006)

15-20

Single blind

No

No protocol

No protocol

Group discussion

C1 to C4

None

Trituration process

Lac Huma-num sensitisa-tion

 

Medita-tive

(Evans, 2005a, 2005b; Griffith, 2007; Tumminello, 2005)

6-12

Single blind

No

No protocol

No protocol

Group discussion

30c to 10M

Single

Touch or orally

Two years Meditation experience

 

Nature Care College

(Gray, 2005a, 2005b, 2006a, 2006b)

No definite (min1)

Double blind

No

Yes

Normal habits

Yes

6C, 30C or 200C

2 times a day for 3 days or until symptoms appear

Orally

Diary – 2 weeks

 

Herscu

(Herscu, 2002)

15-40

Double blind

5 out of 40 (12.5%)

Healthy – steady state that does not constantly change

What they are accus-tomed to – not unduly stressed

Yes

30C, else 200C or 1M

Up to 3

Orally

Diary – 4 days to 2 weeks

 

School Of Homeo-pathy

(Norland, 1999; Norland, 2008; School of Homeopathy, 2004)

Group

No protocol

No

Healthy, but in the process of homoeo-pathic treatment

No protocol

Yes

30CH or 200CH

Single

Orally, looking at it, meditating on it

Diary and under homoeopa-thic treatment

 

ICCH

(International Council for Classical Homoeopathy, 1999)

8-20

Double blind

10-30%

Yes

Normal habits. No anti-doting factors

Yes

2 – 3 potencies

Up to 6 doses (3 a day)

Orally

Diary and comprehensive case record

 

Sankaran

(Sankaran, 1995, 1998)

5-25

Single blind

No

Yes

No protocol

Yes – video recorded

30CH

Single

Orally

Pre-proving meeting

 

Sherr

(Sherr, 1994)

15-20

Double blind

10-20%

Yes

Continue as normal

Yes

Single potency: 6C, 9C, 12C, 15C, 30C or 200C

3 times a day for 2 days or until symptoms appear

Orally

Diary

 

Vithoul-kas

(Vithoulkas, 1998, 2008)

50-100

Double blind

25%

Yes

As normal as possible

Yes

Toxic, hypotoxic and highly potentised

3 times a day for a month or until symptoms appear

Orally

Diary

 

Dream

(Dam, 1998; Gray, 2000; Sankaran, 1995)

Group

Single blind

No

No protocol

No protocol

Group discussion

No protocol

No protocol

Orally, olfaction, touch

No protocol

 

Kent

(Kent, 1994, 1995)

No definite (min 1)

Single blind

No

Known diseased state

No protocol

Yes

30CH

Single, thereafter dissolved in water two-hourly

Orally

Observation of the individual‘s disease state

 

Hahne-mann

(Haehl, 2003a; Hahnemann, 1999; Hughes, 1912)

No definite (min 1)

No

No

Yes

Controlled

Yes

30CH

Dissolved in water, definite regime

Orally

No protocol

 

Reference

Number Of Provers

Blinding

Placebo

Healthy Volun-teers

Diet And Lifestyle

Symptom Verifica-tion

Potency

Dose

Admin. Route

Pre-proving

 

 

Ethical guidelines for conducting provings are a topic barely addressed in literature. In a book review of Sherr‘s The Dynamics and Methodology of Homoeopathic Provings, Treuherz (1995) mentions that a discussion of ethics

is one of the areas the book lacks, and he suggests the creation of an ethical framework to protect provers and volunteers. He however commends the book on explaining ethical protocols.

The European Committee for Homeopathy (ECH) (2004) gives a description of the ethical considerations they see pertinent to the conduction of provings, in accordance with the World Medical Association (2005) regulations:

Safety of the volunteers must be ensured — hence all risks and burdens must be compared to the benefits to the subjects or others. The risk to proving participants are minimal, due to the utilisation of high dilution, hence low toxicity. Any effects are also reversible on cessation of the administration of medicine

Subjects must give informed consent in writing. They have to be informed of the procedure and possible risks, inconveniences and benefits of the trial before the study commences

 

Kumar (2007) suggests the following ethical considerations:

The subject or prover should be in such a mental, physical and legal state as to be able to exercise fully his or her power of choice

Consent should be obtained in writing from the subject

Nature and purpose of drug proving must be explained to the provers

Proving should never be done in toxic doses – such data should be obtained from toxicological literature

Investigators should discontinue the proving if in their judgment it would be harmful to the subject if it were continued,

 

Care must be taken to ensure that nothing which may ruin the health of the participants is proposed in the proving methodology.

Homoeopathic provings need to be differentiated from conventional clinical trials despite the fact that the two processes superficially resemble each other. The phase one of clinical trials is normally conducted on a small number of healthy volunteers to ascertain the dosage required to elicit a response in the human body as well as any toxicological effects. Participants are paid for their participation (European Committee for Homeopathy, 2008; World Medical Association, 2005). The aim of homoeopathic provings, conducted at a non-toxic24 level to eliminate the possibility of toxicological effects is to provoke symptoms of artificial disease, which is reversible after discontinuation of the tested substance. These symptoms are collated and distributed throughout the homoeopathic community for clinical verification through successful prescription to sick patients. Participants do not receive remuneration in exchange for their participation (European Committee for Homeopathy, 2004, 2008).

 

 

Vorwort/Suchen.                                Zeichen/Abkürzungen.                                  Impressum.