Proving the Proving

Proving the Proving.

A Double-Blind Placebo – Controlled Pilot Study of a Proving.

Edward Shalts, MD, Paul Herscu, ND – USA.

“…The true physician must investigate the tools intended for the cure of natural diseases…”

Samuel Hahnemann “Organon of Medicine”, § 105.

“…Medicines, upon which depend people’s life and death, health and disease, must be nicely, very exactly distinguished from each other and therefore proved on the healthy through careful, pure experiments…”

Samuel Hahnemann “Organon of Medicine”, § 120.

Proving gave birth to Homeopathy. Hahnemann writes: “As long ago as the year 1790 I made the first pure trial with cinchona bark upon myself… With this first trial broke upon me the dawn that has since brightened into the most brilliant day of the medical art…” (1).

Proving is the most important part of homeopathic theory. In essence it also reflects a principle of similars.

In reality, both principals came about together. Hahnemann took “…four drachms of good china twice daily…” (2) and experienced symptoms similar to malaria (Proving) which led him to postulate that the substance that causes symptoms in a healthy individual can cure similar symptoms in the sick individual (principal of Similars).

To practice homeopathy one needs to match the symptoms of the patient to symptoms produced in healthy individuals during the process of Proving. Hahnemann wrote: “The curative power of medicines consists exclusively in their propensity to produce disease symptoms in the healthy and remove them from the sick.”(3). And, later :”This therapy chooses from among all the remedies whose action upon the healthy have been established that one which has the power and propensity to produce the artificial disease condition most similar to the one being treated.” (4).

Any testing of homeopathy has to have proving as a primary test. Essentially, if one can not tell the difference between placebo and verum applied in healthy individuals, practice of homeopathy is not possible.

The overwhelming majority of controlled research trials and scientific reviews published in conventional medical publications concentrated their attention on the Principle of Similars and High Dilutions (5, 6,7,8). There is also a significant number of double-blind, placebo-controlled studies on clinical effects of homeopathy.

To date, Proving has been mentioned as an important part of homeopathic practice in only one review in a conventional medical publication (9).

The first documented homeopathic trial that used blinding and placebo dates back to 1885 (10). A famous American homeopath James Tyler Kent talks about blinded placebo-controlled Provings as a standard in his “Lectures on Homeopath_c Philosophy” first published in 1900 (11).

While in homeopathic community Provings is a reality of daily life with more and more new remedies being added to our therapeutic armamentarium (12, 13) , only one study on a double-blind assessment of the existing (Belladonna) proving has been published to date.

Detailed methodology of provinds has been described by Hahnemann (15, 16) and numerous other prominent homeopaths (11, 17, 18). A very thorough description of the theory and protocol of proving was provided by George Vithoulkas (19).

Still, there is no agreement on the exact protocol and methodology used in provings. Various techniques of data collection and assessment, including dream, meditation, song, word, movie provings.

In this pilot study we attempted to lay a foundation for a thorough, scientific approach to the assessment of the single most important, cornerstone principle of homeopathy – Proving. The single most important question that we attempted to answer was: can a homeopath see the difference between the verum (a known active homeopathic remedy) and placebo administered to healthy volunteers in concentration 30C.

Materials and Methods.

Due to a lack of funding the study was designed as a brief pilot that lasted for no longer than 48 hours. Although a wash-out period of 30 days and a full homeopathic interview prior to the study are highly desirable, none of it was done for the pilot (due to financial limitations). Subjects were not screened even for pre-existing or existing acute or chronic illnesses. No warning was given to subjects prior to the study.

The recruitment, administration of the remedy and homeopathic evaluation of volunteers was carried out at the seminar of the New England School of Homeopathy, Amherst, Massachusetts, USA by Paul Herscu, ND. All subjects were students of homeopathy of both sexes aages 20 to 45/ A homeopathic remedy Belladonna 30C manufactured by Dolisos was purchased in the local health food store in Manhattan, New York City as an over- the- counter medication by Edward Shalts, MD. Codes were created and maintained by the research director of the Continuum Center of Health and Healing, Beth Israel Medical Center, New York (CCHH) and broken only after all data were collected. Placebo was purchased previously from Dolisos. Both Verum (Belladonna 30C) and Placebo had identical shape, size, color and taste. The randomization was performed at CCHH by a research assistant without Dr. Shalts or Dr. Herscu having any access to the procedure. Glass vials with numbers 1 to 10 were sealed in the envelope and hand-delivered to Dr.Herscu’s office.

Two sets of experiments were conducted with 10 subjects each. Each set of vials contained 5 verum and 5 placebo.

Results.

Raw data of both sets of experiments are presented in Table 1 and Table 2 below.

Subjects were observed for 48 to determine whether any of the 6 pre-selected symptoms of Belladonna 30C occurred. Raw data are presented in Table 1, where 1 = mild presentation; 2 = moderate presentation and 3 = strong presentation of the symptom. No entry in a cell indicates that no symptoms appeared. A "diagnosis" of Belladonna occurred if there were 4 or more symptoms present. Otherwise, a judgment of "no judgment" was made, since lack of symptoms can be due to receiving the inert placebo, but can also be due to the fact that some individuals may not have been sensitive to that particular homeopathic remedy.

Table 1. Experiment of 02/10/02.

Vial #	Headache	Nasal Congestion	Flushed Face	Irritability	Vertigo	Tingling
1===1/1		1
2===4/11	2		3		3	3
3===1/1	1
4===3/7	2				2	3
5===2/3	1	2
6===1/1		1
7===3/5			1	3	1
8===1/1						1
9===1/2	2
10===4/8	2	2	3		1

Table 2. Experiment of 03/01/02.

Vial #	Headache	Nasal Congestion	Flushed Face	Irritability	Vertigo	Tingling
1===3/4			1.		2.	1
2===5/11	3	2	2	1	3
3===4/9	3	2	1	3
4===6/12	1	3	1	1	3	3
5===2/3	1	2
6===0/0
7===4/7	1	1	3			2.
8===6/12	3	1	2	2	2	2
9===4/6	1	2		1		2
10== 2/4	3				1

Notes provided by Dr. Herscu prior to the opening of the randomization codes:

02/10/02

From this list (table 1) I can look at and see that Vial #2,4,7, and 10 had the most responses that fit Belladonna 30 c.

Of these #2, 4, and 10 had marked symptoms that were strong within minutes. Number 7 had a very strong response to irritability and is included because of that strong response.

It looked like the others had a weak response to one extent or another so I would discount them. Complication it all was the fact that many in the class were ill with a cold. This complicated the situation as Belladonna was a common remedy during this infection. This made the decision even harder, as people who did have the verum and people who were ill had similar symptoms to a certain extent.

The process we went through was that I gave these volunteers the vials and had a 5 minutes follow up onr hour follow up , three hour follow up, 6 hour follow up, a follow up in 24 hours and one more in30 hours and a last one in 48 hours.

Vials 2, 4, and 10 were all agreed to have been verum by me and the whole class, from the first follow up to the last. Vial 7 was included on the 24 follow up.

Vial 1 symptom was after the 5 minutes follow up but not after that.

Vial 3 headache was after the 5 minutes follow up but not after that.

Vial 5 developed after 8 hours

Vial 6 developed after the 5 minutes but not after that

Vial 8 developed minor symptom after 5 minutes, with major urticaria after 12 hours, but none after that.

Vial 9 developed symptom after 5 minutes but none after that.

Besides vials 2,4, 10 all others took a second dose after 3 hours.

03/01/02

From this list I can look at and see that Vial #2,3,4,7,8 and 9 had the most responses that fit Belladonna 30c.

Of these #2, 4, 8 had marked symptoms that were strong within minutes. Even though they were ill I think they fit within the cut off. Putting them in sequence would be 8, 4, and 2.

Vials #3, 7, and 9 also came up strongly, and more or less the same. And of these, taking account when they got sick, I would order them in the following way, 3, 7, and lastly 9.

Of the last vials 1, 5, 6, and 10, Vials 6 and then 5 have few symptoms and go last. Then comes Vial 1 and first is vial # 10.

As a result, if you order the vials by degrees of likelihood, then the vials that are most likely to be the verum coming in first place followed by the last likely, you have the following list:

8>4>2>3>7>9>10>1>5>6

Complication it all was the fact that many in the class were ill with a cold. You can see this by the fact that most people had symptoms. This was especially most true of the person taking vial 4 and vial 8, who was, unknown to us having the flu. This makes the test both difficult, but if the test comes up strongly positive, then it becomes even more significant. This complicated the situation as Belladonna was a common remedy during this infection. This made the decision even harder, as people who did have the verum and people who were ill had similar symptoms to a certain extent.

The process we went through was that I gave these volunteers the vials and had a 5 minutes follow up one hour follow up, three hour follow up, 6 hour follow up, a follow up in 24 hours and one more in 30 hours and a last one in 48 hours.

Vial 1 Symptom was within one minute, she was very anxious about the proving and therefore was panicky when she took the remedy, when that stopped the symptoms she reported were present. As such I think they should be discounted.

Vial 2 Symptoms were strong and clear and soon after the remedy taken.

Vial 3 She is in the middle of a cold, has the symptoms that she reported but she thinks that the symptoms were much worse after taking the remedy.

Vial 4 She was recovering from a bad cold at the time when she reported these symptoms, but she was clear that they all got worse during the proving, becoming more symptomatic within minutes.

Vial 5 She was tired and was ill at the time and developed some mild symptoms, not enough to be counted in.

Vial 6 She reports that she did not develop symptoms at all.

Vial 7 He developed symptoms soon after taking the remedy, within seconds he developed the flushed face and a buzzing sensation.

Vial 8 She was ill before taking the remedy and developed a slight increase of symptoms soon after taking the remedy. By 2 hours she was even more symptomatic.

Vial 9 She developed symptom after 5 minutes with a headache getting worse over time.

Vial 10 had a fleeting headache and was more inward. The headache was intense and sudden and clear but there were no other clear symptoms.

Besides vials 2, 3, 4, 7, 8 all others took a second dose after 3 hours.

The ones to consider were ones that had three or more responses plus had strong responses to one criterion. The cutoff I should have is equal to or greater than 3 responses and a total score of at least 6. Using this criterion we have 6 possibles. However, if you look at the sequence it gives us 8>4>2>3>7 as the most likely.

Table 3. Experiment 1 comparative analysis.

Vial #	Verum (V) / Placebo (P) randomization assignment	Clinical Assessment	Commentary
1	p
2	V	+	Symptoms within minutes after taking the remedy
3	V
4	V	+	Symptoms within minutes after taking the remedy
5	p
6	p
7	p	+	Developed strong irritability. Other symptoms – weak.
8	p
9	V
10	V	+	Symptoms within minutes after taking the remedy

Table 4. Experiment 2 Comparative Analysis.

Vial #	Verum (V) / Placebo (P) randomization assignment	Clinical Assessment	Commentary
1	p
2	V	+	Symptoms within minutes after taking the remedy
3	p	+	Had a cold
4	p	+	Recovering from a cold
5	V		Tired
6	V
7	V	+	Symptoms within minutes after taking the remedy
8	p	+	Ill before taking the remedy, more symptomatic as the experiment progressed.
9	V	+	Symptoms within minutes after taking the remedy
10	p

Discussion.

1. Interestingly, in each set of experiments two out of 5 subjects (40%) that received Verum did not develop significant symptoms. This observation emphasizes the importance of assessment of individual sensitivity of each prover to a particular substance tested.

2. Subjects sensitive to Belladonna 30C developed prominent symptoms within first 5 to ten minutes of the experiment.

3. If an adequate screening process, including the assessment for the presents of an acute or a significant chronic illness and a full homeopathic interview were performed, subjects who suffered from cold/flu would be excluded from the study and, consequently from the furtheer analysis.

4. Proving can only reveal subjects SENSITIVE to Verum. The prover who did not respond to Verum can not be automatically placed in the Placebo group, as the lack of response could be due to both, Placebo and the lack of sensitivity to this particular substance by this particular individual.

5. Further studies must employ a full protocol of the Proving. Most importantly:

q Taking the case prior to the administration of the remedy

q Listing the symptoms provers already have

q Removing ill subjects from the study

References.

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