Method and kit for treating illnesses

• US 20010044408A1
• Filed: 03/30/2001
• Published: 11/22/2001
• Est. Priority Date: 10/31/1994
• Status: Active Grant

• Current Assignee: Donald P. Reitberg
• Original Assignee: Donald P. Reitberg
• Inventors: Reitberg, Donald P.
• Granted Patent: US 6,579,888 B2
• Time in Patent Office: Days
• US Class Current: 514/1
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 20/00 ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients

Abstract

Methods and kits for determining appropriate treatment for illnesses in humans or animals are disclosed. The method includes:

providing a test kit containing a random arrangement of drug(s) and placebo(s) and/or alternative treatment(s) along with a questionnaire or other instrument designed to elicit data concerning the safety, efficacy and desirability of a treatment;

administering the drug(s) and placebo(s) and/or alternative treatments to each member of the pool in a random, double blind fashion and following up on patient outcomes as appropriate post-study;

assembling a database from the completed pool questionnaires and revealing the random schedule to uncover drug and placebo treatment periods;

providing the same kit to a patient in need of the same treatment and comparing the results obtained from the single patient trial with those obtained from the pool to determine an optimal treatment for the patient with the drug; and

administering a treatment consistent with the optimal treatment.

Claims

1. A method of treating an illness in humans or animals, comprising:

a) providing a pool of humans or animals in need of such treatment a test kit containing;

i) a supply of a drug indicated for the treatment of said illness;

ii) a supply of a placebo substantially identical in appearance to said drug,

iii) a questionnaire designed to elicit from said pool information concerning the actual usage, safety, efficacy and desirability of said treatment;

b) administering said drug and said placebo to each member of the pool according to a random, double-blind schedule;

c) assembling a database by eliciting from said pool answers to said questionnaire;

d) revealing the random schedule to uncover drug and placebo treatment periods;

e) providing said test kit to a human or animal in need of such treatment;

f) administering said drug and said placebo to said human according to a random, double-blind schedule;

g) assembling a second database by eliciting from said human or animal answers to said questionnaire;

h) revealing the random schedule to evaluate drug and placebo treatment periods;

i) comparing said pool set of data with said set of data obtained in step g) to determine an optimal treatment of said human or animal with said drug; and

j) administering to said human or animal a treatment consistent with said optimal treatment.

2. The method of

claim 1

, wherein said illness is selected from the group consisting of asthma, cancer, epilepsy, schizophrenia, minimal brain dysfunction, mania, depression, anxiety, hypertension, angina, congestive heart failure, cardiac arrhythmias, pain, diabetes, immune system disorders, endocrine disorders and allergic disorders.

3. The method of

claim 1

, wherein said drug is selected from the group consisting of anti-asthmatic agents, anti-epileptic agent, anti-psychotic agents, anti-depressants, cardiovascular agents, antihypertensive agents, diabetic agents, steroidal and non-steroidal anti-inflammatory agents, opiates, narcotic and non-narcotic analgesics, musculoskeletal agents, gastrointestinal agents and anti-allergy medications.

4. The method of

claim 1

, wherein said human or animal in need of treatment is not a member of said pool.

5. The method of

claim 1

, wherein said drug in said kit is methylphenidate.

6. The method of

claim 1

, wherein said drug in said kit comprises an estrogenic substance.

7. A method of determining a therapeutic alternative to a drug in a human or animal requiring a treatment for which said drug is indicated, comprising:

a) providing said human or animal a test kit containing;

i) a supply of a drug indicated for the treatment of said chronic illness;

ii) a supply of a therapeutic alternative substantially identical in appearance to said drug,

iii) a questionnaire designed to elicit from said human or animal or caretaker information concerning the safety, efficacy and desirability of said treatment for said human or animal;

b) administering said drug and said therapeutic alternative to said human or animal according to a random, double-blind schedule;

c) eliciting from said human or animal a set of data as a result of said questionnaire; and

d) revealing the random arrangement schedule to determine the effectiveness of said therapeutic alternative in said human based on data obtained by knowing drug and therapeutic treatment periods.

8. The method of

claim 7

, further comprising the steps of:

e) providing said test kit to a pool of humans or animals in need of such treatment and obtaining from said pool a second set of data concerning the safety, efficacy and desirability of said treatment with said drug and said therapeutic alternative; and

f) comparing said data obtained as a result of step 8 c) with said second set of data to verify the effectiveness of said therapeutic alternative.

9. The method of

claim 7

, wherein said therapeutic alternative is a generic equivalent for said drug.

10. The method of

claim 7

, wherein said therapeutic alternative is a different dosage or dosage form of said drug.

11. The method of

claim 7

, wherein said therapeutic alternative is said drug.

12. The method of

claim 7

, wherein said therapeutic alternative is a non-prescription drug.

13. The method of

claim 8

, wherein said therapeutic alternative is a non-drug form of therapy.