Insulin-like Growth Factor-1 (IGF1)
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 to Phase I clinical trials outlined in the Code of Federal Regulation (CFR) and the European Community (EC) guidelines for clinical research.

Clinical Investigators
Proving Director - David Riley, MD
Proving Supervisors - Ann Seipt, N.D., Aimee Zagon, PA-C
Proving Coordinator - Olivia Mason, R.P.T., M.S.
Adminstrative Asst. - Anna Bell Romero

Methodology
Data Collecting - Diary/journal format
Study Design - Single group 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 Botanical Laboratories, Inc. in Ferndale, Washington as a liquid in a 6C potency.

Subject Population
There were 25 subjects: 19 women and 6 men ranging in age from 23 to 56 years. 23 subjects received verum, 2 received placebo. Placebo provers were IGF-07 and IGF-18 and symptoms are included in the final report. There was one dropout from this homeopathic drug proving, IGF-14, who felt unable to find the time to keep a journal. Two provers did not experience symptoms, provers IGF-04 and IGF-25, and are not included in the report.

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. Laboratory tests consisting of a CBC, Chem-20, and ESR were ordered on three separate occasions as follows: before onset of receiving remedy at week two, on or shortly after the last day of ingesting verum or placebo, and after the proving journal was completed.
• 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 - no 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
• was under the age of 18 or lacking complete competence

General Drug Proving Outline
This homeopathic drug proving was conducted between March 28, 1997 and June 24, 1997. 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 how to keep a homeopathic drug proving journal upon 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 10 weeks per subject. Phase I was a two week pre-proving observation period which established the baseline rhythm of each subject's daily life in a diary format. Phase II was a five week medication (placebo Run-in and verum) and journaling phase. Phase III was a three 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 the medication phase, a placebo run-in week, and placebo controls. Symptoms noted during the medication phase were compared with the pre-proving observation period.

Medication Adminstration
The homeopathic medication was administered one week apart in a similar fashion. The first administration of the medication was a placebo run-in period. The medication was administered 3 times daily (10 drops sublingually or dissolved in purified water) until the subject developed symptoms or for three days. The medication was allowed to dissolve under the tongue and food was not eaten for 15 minutes prior to or after taking the medication. Subjects stopped taking the medication if no symptoms occurred after three days. They continued keeping their journal throughout this phase of the clinical trial. Each subject reported an potential symptoms to the proving director or supervisors as soon as possible. After one week 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 five weeks and were in daily contact with the proving director of supervisor. The symptoms experienced after the administration of the medication were compared with baseline pre-proving observations and evaluated according to the criteria mentioned at the beginning of this report. All symptoms from the placebo run-in period were eliminated for all subjects. Symptoms experienced during the randomization phase were excluded for a subject if they were the identical to symptoms experienced during the placebo run-in phase. Symptoms from those subjects receiving placebo after the placebo run-in phase are included in this report and noted by the letter "P". All subjects completed an exit interview where each symptom experienced was reviewed again for additional clarification. All symptoms were reviewed by all of the proving supervisors and the proving director. Some subjects experienced a relief from chronically experienced symptoms which 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	8	9	10
Initial Interview	x
Inclusion/Exclusion Criteria	x
Initial Evaluation	x
Subject Education	x
Phase I: Pre-proving observation	x	x
Phase II: Placebo run-in phase				x
Phase II: Medication/Placebo				x
Data collection in Journal	x	x	x	x	x	x	x
Phase III: Exit Interview								x
Phase III: Post-proving observation								x	x	x
Contact with Subject	x	x	x	x	x	x	x	x	x	x
Observation for adverse effects			x	x	x	x	x	x	x	x
Symptom organization/Final Report									x	x

Materia Medica - Insulin-like Growth Factor

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
Strange, disturbing quality to provers' dream life. Difficulty concentrating. Headache in the forehead. Nasal congestion. Cramping abdominal pain associated with diarrhea or stool. Constipation with ineffectual urging. Strong uterine cramping with the menses. Premenstrual breast tenderness and swelling. Nausea. An aversion to chocolate and sweets. An increased appetite.

Mind
Nightmares. Difficulty concentrating. Remembered or unremembered dreams. Colorful, vivid dreams, Strange dreams. Discontented, impatient about small matters, reproachful of himself. Irritable and weepy premenstrually (cured symptom). Sensitive and desires to be by himself. Fear of heart attack.

Generalities
Energy increased (cured symptom) and energy decreased. Sluggish, weak, muscle stiffness. Sensation of heat with nausea. Desires apples, coffee, meat, rich foods. Averse to chocolate and sweets. Motion aggravates.

Head Pain
Localized most frequently to the forehead, and also behind the eyes, above the root of the nose, or in the vertex. Pain quality was pressing as from a weight or like a band. Also throbbing with ear pressure. Dull pain behind the eye. Headache with heartburn. Headache extending to the neck. Stitching in the left temple. On waking. Lasting two to three days. With dizziness. Pressure ameliorates.

Eye
Blurry, Watery, Photophobic.

Nose
Congestion to the nose (cured symptom). Sneezing. Post-nasal drip. Rawness. Pimples in the nose.

Face
Heat internally and sensation of heat of the cheeks. Acne of the forehead.

Mouth
Apthae.

Teeth
Sensitive to cold. Sense of pressure on the molars.

Throat
Inflamed with mucus, mucus in the throat. Sore and dry, especially at night. Sensations of scraping and scratching.

Voice
Hoarseness.

Stomach
Nausea. An increase in appetite. Burning pain. Pain of a drawing nature. Pain ameliorated by bending. Pain with nausea. Easily satiated (cured symptom). Nausea with diarrhea, with burping, with heated feeling and thirst. Nausea ameliorated after eating. Heartburn, A full sensation.

Abdomen
Cramping associated with stool or diarrhea. Distension from gas. Gurgling. Pressing pain before stool. Forward bending aggravates.

Rectum
Constipation with a feeling of urging, but without movement. Flatus with stool. Burning with stool.

Stool
Frequent and scanty. Comes out in hard pieces.

Bladder
Involuntary urination with sneezing.

Urine
Pungent odor.

Genitalia, Female
Uterine cramping during the menstrual cycle (cured symptom). Cramping before the menstrual cycle. Uterine cramping that is pulsating. mid-cycle spotting while walking. Menses early, late, short, or painful or with profuse bleeding.

Chest
Premenstrual breast tenderness and swelling (cured symptom). Heart palpitation. Sensation of heaviness in the chest.

Back
Aching back pain associated with the menses. Stiffness. Tightness in the dorsal region.

Extremities
Swelling of the feet premenstrually. Ankle swelling, Leg stiffness. Profuse sweating of the feet. Swelling of the feet, hands and knees during menses.

Extremity Pain
Stiffness, Aching of the hips and joints. Cramp-like pain in the feet while sitting still.

Sleep
Restless or deep. Sleeps uncovered.

Perspiration
At night. Absent. clammy.