Human Growth Hormone (hGH)
Proving Report

Proving Report
Symptoms in the language of the prover are organized in the traditional homeopathic format (as found in Boericke) and selected according to the following criteria:

• modalities (something which makes a symptom better or worse)
• concomitants (something occurring in conjunction with a symptom)
• timing of the symptom (periodicity, specificity of timing)
• localization (sides, extension)
• unique descriptions of a symptom (descriptive adjectives)
• intensity of the symptom
• a symptom is new or has not been experienced in the past 12 months
• a symptom occurred after taking the medication on at least two occasions during the homeopathic drug proving
• a symptom experienced when the proving started which disappeared or is significantly ameliorated after the administration of the proving medication, is classified as a cured symptom
• a symptom was experienced in more than one prover

Proving Protocol

Clinical Trial Design
Homeopathic drug provings are similar but not identical to Phase I clinical trials outlined in the Code of Federal Regulation (CFR) and the European Union (EU) guidelines for clinical research. These guidelines have been used to design this trial.

Clinical Investigators
Proving Director - David Riley, MD
Proving Supervisors - Sally Lenetsky, RN
Proving Coordinator - Anna Bell Romero

Methodology
Data Collecting - Diary/journal format
Study Design - Double group (6X and 6C) with placebo run-in
Method of Binding - Double-Blind
Controls - Intra-individual controls, placebo run-in, placebo controls

Medications
The medication used in this homeopathic drug proving was prepared by Dolisos in the United States according to HPCUS guidelines.

Subject Populations
There were 50 subjects in this homeopathic drug proving, 20 subjects received HGH in a 6X potency, 20 subjects received HGH in a 6C potency, and 10 subjects received a placebo. 50 subjects: 39 women and 11 men ranging in age from 23 to 56 years. 40 subjects received verum, 10 received placebo. There were 4 dropouts from this homeopathic drug proving.

Subject Inclusion Criteria - each subject

• was in a general state of good health for that person according to the proving director, proving supervisor and the subject.
• agreed in advance to comply with instructions for keeping a journal. The subject observed and described symptoms experienced from taking a homeopathic medication.
• did not engage in any elective medical treatments (such as surgery or dental procedures) for the duration of the homeopathic drug proving.
• did not undergo any major life changes (moving, getting married or divorced, etc.) and continued the usual habits and patterns of daily life.
• was over the age of 18, competent, and signed the informed consent.
• was given a Myers-Briggs Type Indicator

Subject Exclusion Criteria - each subject

• was in ongoing medical treatment during the homeopathic drug proving
• had surgery within the past 6 weeks
• was on prescription medication
• had taken birth control pills in the past 6 months
• was pregnant or nursing
• failed to complete the journal as instructed

General Drug Proving Outline
This homeopathic drug proving was conducted between December 1998 and February 1999. Subjects were recruited by advertisement. Subjects were included according to the above criteria and signed an informed consent upon entry into the proving. They attended at least two training sessions about homeopathy and a homeopathic drug proving prior to being accepted into the homeopathic drug proving. Each subject was given a copy of a previously conducted proving at the first training session. A routine medical evaluation was performed on all accepted subjects.

This homeopathic drug proving lasted 7 weeks per subject. Phase I was a one week pre-proving observation period which established the baseline rhythm of each subject's daily life in a diary format. Phase II was a two week placebo run-in phase. Phase III was a two week medication phase during which subjects were randomized to one of three groups, 6X HGH, 6C HGH, or placebo. Phase IV was a two week post-proving observation phase. This was a single case-study with three types of control: an intra-individual control comparing the pre-medication phase with medication phase, a placebo run-in control as the first medication phase, and placebo controls during the second medication phase.

Medication Adminstration
The homeopathic medications were administered two weeks apart in a similar fashion. The first administration of the medication was a placebo. The medication was administered 3 times daily until the subject developed symptoms or for seven days. They continued keeping their journal throughout this phase of the clinical trial. Each subject reported any potential symptoms to the proving director or supervisors as soon as possible. After two weeks the subjects were given a second medication administered in a similar fashion for seven days. The second bottle was verum or placebo according to a randomized code known only by the sponsor.

Symptom Collection and Evaluation
Subjects noted symptoms in their journals for the duration of the homeopathic drug proving and were in regular contact with the proving director or supervisor. The symptoms experienced after the administration of the medication were compared with the baseline pre-proving observations and evaluated according to the criteria mentioned at the beginning of this report. Symptoms experienced during the randomization phase were excluded for a subject if they were the same symptoms experienced during the placebo run-in phase. All subjects completed an exit interview where each symptom experienced was reviewed again for additional clarification. All symptoms were reviewed by the proving supervisors and the proving director. Some subjects experienced a relief from chronically experienced symptoms; these have been included in the final report. There were no adverse effects noted at the time of the exit interview or during the post-proving observation period.

Proving Time-line

Week	1	2	3	4	5	6	7
Initial Interview	x
Inclusion/Exclusion Criteria	x
Initial Evaluation	x
Subject Education	x
Phase I: Pre-proving observation	x
Phase II: Placebo run-in phase		x
Phase II: Medication/Placebo				x
Data collection in Journal	x	x	x	x	x
Phase III: Exit Interview					x
Phase III: Post-proving observation						x	x
Observation for adverse effects		x	x	x	x	x	x

Materia Medica - Human Growth Hormone

Materia medicus (encyclopedia of drug effects) represents the therapeutic indications for the tested drug as a result of the proving.

The essential characteristics (in bold) are defined as those symptoms that occurred the most frequently in the provers.

Precise detailed toxicological studies have been conducted for the majority of the modern drugs in use today, i.e., in practice, their overdose effects are known. These effect could be compared to a homeopathic "proving." Thus, according to homeopathic reasoning, it should be possible to obtain therapeutic results using diluted, dynamized preparations of these drugs in two situations: a) patients with symptoms similar to those notoriously caused by the drug on healthy subjects, b) patients presenting such symptoms as adverse effects of the drug administered at high doses.

Essential Characterisitcs
Many vivid dreams were noted by a variety of provers. Mental concentration was noted to be improved. In general there was a consistent observation in seven of the subjects of a noticeable increase in their level of energy and in related areas of mental concentration and strength. Appetites were usually increased (11 subjects) or occasionally decreased. Nasal congestion. Ulcerations of the mouth. Cramping pains in various parts of the body.

Mind
Vivid dreams. Improvement in concentration. Colorful , vivid dreams. Strange dreams. Discontented, impatient and irritable. Headaches.

Generalities
Energy increased (cured symptom) as well as decrease in energy. Desires for a variety of foods and flavors including salty, chocolate, sweets, and soups.

Head Pain
Headaches: worse in the temples and behind the ears and also behind the eyes. Pain quality was like a band. Headaches worse on the left side.

Eye
Irritation with watering

Nose
Congestion with sneezing. Congestion alternating with coryza.

Face
Tightness. Irritation. Dryness.

Mouth
Apthae.

Throat
Irritation with scratching and cough with phlegm.

Stomach
Increase in appetite in 11 subjects as well as a decrease in two subjects. Increase in thirst.

Abdomen
Cramping in the lower abdomen, worse on the left side.

Rectum
Constipation without a feeling of urging. Pain in the rectum when urinating.

Stool
Sticky consistency.

Bladder
Pain in the rectum when urinating.

Genitalia, Female
Uterine cramping. One case of return of normal menses (cured symptom).

Chest
Cramping in the area of the ribcage.

Back
Cramping.

Extremities/Extremity Pain
Cramping with pain throughout the extremities, worse in the calves. Eruptions on the thighs.

Sleep
Restless or deep sleep