2nd Proving of Propranolol 30 ch. – Dr P. Souk-Aloun

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French

Methodology of Homoeopathy
(with 10 new provings). Dr P. Souk-Aloun.

2^nd Proving of Propranolol 30 ch.

Summary:

Methodology and results of the 2^nd proving of
Propranolol, a betablocker.

Preamble.

The purpose of a proving is to reconstitute an authentic picture of the artificial
disease appearing in the provers after taking a homoeopathic preparation (the drug must be
at first well definited and really weighable; then dynamised at 30 ch).

This artificial disease is:

• slight and in relation with the constitution of each prover.
• superimposed before the background noise of prover’s usual symptoms.
• determined by the nature (chemical composition) and the form (method of dynamisation,
  potency) of the proved substance.
• formed by symptoms divided in localisation, modalities, sensations, morbid forms, and
  concomitants.

This reconstitution cannot ignore the statistical method; it still remains to find a
satisfactory solution for both the statistician and the homoeopath. The methodology can be
inspired by those of drug trial. A proving can be described in 3 phases:

• Preparation: Bibliographical data collection concerning the drug. Exploratory proving.
  Writing an experimental procedure (definition of the problem under study, criteria of
  selection of provers, their number, randomisation, roles of the participants, method of
  collection of symptoms, criteria of imputation to the drug, statistical test).
• Execution: Recruitment of provers. Randomised assignement. Follow up and collection.
• Anaysis: Statistical test. Deductions. Final writing of the pathogenesis.

The shortage of provers condition the choice of the procedure. The most adequat method
is the matched group (“série appariée”: the prover is his own control by
taking a placebo then a drug or vice versa) with the non parametric statistical test.

The problem of the usual symptoms is to bring into consideration.

Experimental procedure of the proving of Propranolol 30 ch.

Propranolol 30 ch was first proved by the “Groupe Mercurius” (Dr P.
Lentheric, 30000 Nimes, France) under the direction of B. Long and myself according to the
statistical procedure of double-blind on 20 homeopaths provers: 2 groups of 10 provers;
one take Propranolol 30 ch the other Placebo; 2 doses with the 7 days interval. Each
prover records daily his symptoms on the questionnaire during 30 days. This questionnaire
was maked after a preliminary study pointing out some symptoms (neuralgia,
eruption…). The records of this first proving are kept by the “Groupe
Dynamis” (Dr B. Long, 34000 Montpellier, France).

In 1989, the “Association Benoit Mure” and the “Ecole
d’Homoéopathie Hahnemannienne du Dauphiné-Savoie” undertook a second proving
according to the experimental procedure maked by C. Pepey and myself. The records of this
proving are kept by myself.

The experimental procedure.

1. The aims of this experimentation are: To complete the pathogenesis of Propranolol 30 ch.
   To demonstrate the reproductibility of the observed phenomena during the preceding
   experimentation with the same substance, as well as the effect of a 30 ch homoeopathic
   preparation upon human organism. To provide a basis of etablishment of a model for
   homoeopathic proving.
2. The method consist in: A matched group (série appariée) of 35 provers during 30 days
   of observation. Each prover takes one “Dose A” the first day, then one
   “Dose B” on the 15^th day; the sequence of taking (Placebo then
   Propranolol, or the reverse) is randomised by 2 chemists unconnected with the proving
   (Françoise Matteï, Marie-Hélène Tissier, 34000 Montpellier, France). The nature of the
   drug, the sequence of doses taking, and the conditions of experimental procedure are
   unknown to the provers. The directors of proving who recruit and supervise provers ignore
   the sequence of doses; they know the nature of the drug, but don’t ask or make
   recommendations over the possible effects on the provers; their roles are defined by
   instructions. The record of the symptoms by the provers is maked on a questionnaire with a
   preestablished scoring system. The used statistical test is the Wilcoxon’s T test.
3. The selection of the provers: Can be prover any person who is

• Volunteer for this purpose.
• 18 years or over or authorized by parents.
• In good health i.e. not under treatment (allopathic, homoeopathic, psychanalitic or
  other) at least 3 months before the proving does not take drug (except contraceptive
  pill).
• Free from psychiatric antecedents or notable psychological troubles.

Are not qualified to be prover any person who:

• Is not really voluntear.
• Is younger than 18 years, unless authorized by parents.
• Is in bad health, or with psychiatric troubles background, or with obvious psychological
  troubles.
• Is a pregnant woman.
• Is with an unstable and irregular lifestyle, or/and subject to numerous and
  incontrolable disturbances.
• Is very anxious.
• Know Homoeopathy and the principle of aggravation by repetition of the doses.
• Suffer regularly and frequently from headache, neuralgia or dermatosis.

4. The experimented drug and the placebo: The Propranolol (Chlorhydrate) 30 ch dose
   consists of 1 gramme of lactose pills impregnated with a Propranolol 30 ch solution. The
   Placebo dose consists of 1 gramme of lactose pills. The two doses look exactly alike
   without any difference of taste, of smell or other way; they are in pair (1 dose
   Propranolol 30 ch, 1 dose Placebo).
5. The collect of symptoms: Each prover have an experimentation notebook of 30
   questionnaires (1 questionnaire/day). The prover is also allowed to use his own terms to
   describe his symptoms.
6. The scoring of the symptoms: A symptom can be divided into components parts:
   localisation, sensation(s), morbid form, modality(ies) and concomitant(s). A symptom is
   eliminated:

• By non observance of procedure by the prover.
• By an another possible cause apart the drug.
• If it is of short duration (less than 1 minute).
• If its have an usual character and a frequent presence in the 2 halves of the proving
  (usual symptom).
• If it is present in the second half and look like to another in the first half but with
  less intensity (same symptom covering the 2 halves of proving).
• If it belong to an acute infection (for example: flu).

Valorization of the symptoms:

• according to the similarity of the components with the first proving:

+ 1 point: eruption and/or itching, headache, neuralgia, cramps, insomnia, dream or
nightmare, eye, appearance or aggravation in the morning, on exertion.

+ 2 points: similiarity at least of 2 components with 1 of the 42 symptoms of the first
proving.

• according to the moment of appearance and the duration:

+ 1 point: appearance within the 4 days after the dose.

+ 1 point: duration 1 day or more.

• according to concomitants:

+ 1 point: 2 concomitants symptoms of more than 3 points each (+1 point for each
symptom).

7. Analysis of results.

The variable on study is the symptoms appearing during the proving. The Wilcoxon’s
T test is enable to point out with a defined error risk the difference between Propranolol
30 ch and Placebo.

The test is make on the validated symptoms then on the valorized symptoms.

The Proving.

Starting with 35 provers, the final result includes only 15 provers after elimination
of those who had not observed the procedure.

The directors of proving are: C. Pepey, P. Souk-Aloun (Association Benoit Mure), N.
Deries, J. Jobert and L. Mabilon (E.H.H.D.S.).

The scoring of the validated symptoms.

The symptoms are given with in brackets the day of appearance (“a” after the
first dose, and “b” after the second). The symptoms similar by at least 2
components to 1 of the 42 symptoms of the first proving are in italic characters, and in
bold when of particular interest to therapy.

The validated provers are as follows:

PROVER A

, male, 35, architect.

Validated Symptoms A (propranolol): 1 symptom; 2 points.

1. Strange dream (catastrophes) (a1).

V.S. B (placebo): 2 symptoms; 8 points.

1. Eruption of red pimples on back of feet (b6-9).
2. Eruption of red pimples the first day, then become dry eczema on the internal face of
   left elbow (b14-21).

PROVER B

, female, 40, chemist.

No symptom.

PROVER C

, f, 40, nurse.

Validated Symptoms A (placebo): 0

V.S. B (propranolol): 2 symptoms; 7 points.

1. Continuous pain and irritation of left eye (internal coin) and nose, in the morning,
   from 10.30 to 12.30 AM (b1).
2. Pain of right eyes (internal coin) with nose discharge (b5).

PROVER D

, f, 39.

No validated symptom.

PROVER E

, f, 45.

V.S. A (propranolol): 7 s; 11 p.

1. Depression, sadness, agg. on lying down, before sleep, from 10 PM to 11 PM (a1).
2. Coldness of the head (with chattering of teeth), on lying on bed, before sleep (a1,
   about 11.45 PM during 30 minutes).
3. Pain now and then on left leg (a3).
4. Leucorrhoea, thick, yellow-greenish, with itching (a3).
5. Irritability (a5).
6. Weariness (a4).
7. Throbbing pain in forehead and vertex, violent stitching, on standing up, on yawning, on
   laughing, about 12 AM (a5).

V.S. B (placebo): 1 s; 4 p.

1. Irritation with burning sensation of left eye, beginning the first day in internal coin
   at 10 PM (b8-12).

PROVER F

, male, 35.

No validated symptom.

PROVER G

, m, 19, student.

No symptom.

PROVER H

,f, 36 tax inspector.

V.S. A (propranolol): 6 s; 15 p.

1. Continuous pain of right upper limb (forearm, wrist, hand) about 2 PM (a1).
2. Lack of psychic tonus, dozing, day-dreamer, ill-humor (a1).
3. Dozing (a1).
4. Pimple on tongue (a2,3,4,6,8).
5. Sleeplessness: difficulty to fall asleep (a6).
6. Pain of lower limbs (legs) (a11,14 – b1,2,3,8,9).

V.S. B (placebo): 5 s; 8 p.

1. Weariness (b2).
2. Throbbing pain of left ear (b3).
3. Depressed, takes everything in bad part (b8).

PROVER I

, m, 35, physician.

No symptom.

PROVER J

, m, 39, physician.

V.S. A (placebo): 1 s; 3 p.

1. Sleeplessness in the middle of the night, with feeling of heat, worried.

V.S. B (propranolol): 13 s; 18 p.

1. Soft stool (b2, b4).
2. Continuous pain of lumbar region amel. By motion (b3).
3. Intermittent pain of upper limbs (forearm, wrist, hand) (b4,5).
4. Perspiration increased (b4,8).
5. Irritability in the morning, amel. In the afternoon (b5).
6. Hunger increased (b5, 13).
7. Cheerfulness (b10).
8. Intermittent pain of lumbar region on the half of the day, from b13: continuous pain
   agg. on waking, in the morning and the evening, by sitting, by motion (b12-15+).
9. Pain now and then of shoulders (more in right first day, then left) in the second half
   of the day, from b13: continuous pain agg. on waking, in the morning and the evening, by
   sitting, by motion (b12-15+).
10. Continuous pain of wrists in the second half of the day (the day after: pain now and
    then more in the left), from b13: continuous pain agg. on waking, in the morning and the
    evening, on sitting, on motion (b12-15+).
11. Sadness (b13).
12. Pain now and then of right hip morning on waking, agg. when ascending stairs (b14-15+).

PROVER K

, m, 32, carpenter.

V.S. A (propranolol): 3 s; 12 p.

1. Continuous pain of lumbar region, agg. on motion (a1,7,8,9,12,13,14).
2. Flatus all day, pain in stomach before diner in the evening (a1), gurgling all day, pain
   of stomach in the evening before and after eating (a2), pain in belly as if getting cold
   after overheated rather in the beginning and the end of the day (a3,4).
3. Weariness (a8).

V.S. B (placebo): 0

PROVER L

, m, 13.

V.S. A (propranolol): 3 s; 13 p.

1. Pain in the dorsal lumbar region morning on waking, on bending (a3).
2. Cervical pain, left side (a4).
3. Eruption of pimples over eyebrow (a5-7).

V.S. B (placebo): 0

PROVER M

, f, 27, medical student.

V.S. A (placebo): 4 s; 9 p.

1. Throbbing pain in teeth (a1).
2. Headache now and then (a2).
3. Pain and tingling of ears (a3).
4. Nausea.

V.S. B (propranolol): 4 s; 11 p.

1. Flush of heat on face, ears and jaw, agg. by ambient heath, in the morning from 8 to
   9.45 AM (b2).
2. Sadness and grief all day long, amel. by walking in the rain (b5); between 10.05 to
   10.30 PM (b13).
3. Anxiety (b4); “I had never been so anxious as today, this can compare to someone
   waiting in vain for some bad news taking a long time to come, so I’m all day stay on
   my guard” (b6).
4. Constipation (b8-10).

PROVER N

, m, 40, anesthetist

V.S. A (propranolol): 7 s; 12 p.

1. Good sleep (a3-4), sleeplessness (a11).
2. Constipation (a3,4,6).
3. Irritation (a4).
4. Dryness of nose (a4).
5. Hunger decreased (a6).
6. Cramp in chest (a6).
7. Palpitation on rising from seat (a10).

V.S. B (placebo): 4 s; 6 p.

1. Headache in the morning (b7,10,11), agg. on motion (b11,14), in the evening (b13), now
   and then (b14), continuous pain amel. by coldness, by open window (b15).
2. Anxiety (b11).
3. Thirst increased (b15).

PROVER O

, m, 40, dentist.

V.S. A (placebo): 1 s; 2 p.

1. Burning sensation of lids (a2).

V.S. B (propranolol): 3 s; 5 p.

1. Anxiety and irritability improved in the evening (b2).
2. Loaded greenish tongue, sweetish taste of mouth (b2).
3. Mental confusion: when talking reverse words (b3).

The results.

The principle of the Wilcoxon’s T test is simple: if there is no difference
between the Propranolol 30 ch and the Placebo, the value of each pair (validated symptoms
A – validated symptoms B) is near 0. In the opposite case these values are high on one
side or the other (+, -).

For the validated symptoms, the classifying of the 9 pairs different to 0 by absolute
value:

1^st pair = 1(+)

2^nd pair = 1 (-)

3^rd, 4^th, 5^th pairs = 2 (+)

6^th, 7^th, 8^th = 3 (+)

9^th = 6(+)

T(-) = 2 (on classifying the negative pair on the second place)

T(+) = 43

The Wilcoxon,s table give for 9 pairs (n = 9), 3-42, alpha

error risk = 0,02

For the scored symptoms:

n = 10

1^st = 2(+)

2^nd = 3(+)

3^rd = 6(+)

4^th = 6(-)

5^th, 6^th, 7^th = 7(+)

8^th = 12(+)

9^th = 13(+)

10^th = 15(+)

T(-) = 4

T(+) = 51

error risk between 0,02-0,01

We hope that some day another proving team will make the third experimentation of
Propranolol 30 ch to point out the reproductibility of the phenomena. (For further
informations about the questionnaire and the symptoms of the first proving, contact Dr P.
Souk-Aloun)

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