Diagnosis and treatment of human dormancy syndrome

• US 20030228628A1
• Filed: 05/23/2003
• Published: 12/11/2003
• Est. Priority Date: 05/23/2002
• Status: Active Grant

• Current Assignee: Michael Powell
• Original Assignee: Michael Powell
• Inventors: Powell, Michael
• Granted Patent: US 7,288,257 B2
• Time in Patent Office: Days
• US Class Current: 435/7.1
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: G01N 33/6896 Neurological disorders, e.g. Alzheimer's disease
• CPC Class Codes: G01N 33/78 Thyroid gland hormones , e.g. T3, T4, TBH, TBG or their receptors
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

New methods for diagnosis of human dormancy syndrome are provided. Human dormancy syndrome is characterized by elevated serum ratio of rT3/fT3 compared to a population of normal subjects from which subjects suffering from fibromyalgia, chronic fatigue, obesity, dementias including Alzheimer'"'"'s Disease and related dormancy conditions are excluded, and the presence of one or more findings related to reduced activity including torpor, chronic fatigue, insulin resistance, dementias, obesity and the like. Treatment of human dormancy syndrome is directed toward increasing fT3 levels or decreasing rT3 levels, or both, using pharmaceutical and/or behavioral methods. Other conditions that are associated with HDS can also be treated using T3 therapy, with or without specific psychological, behavioral or pharmaceutical therapies.

Claims

1. A method for diagnosing human dormancy syndrome in a human, comprising the steps of:

(a) measuring serum levels of rT3 and fT3;

(b) calculating the ratio of rT3/fT3, wherein said ratio is above about 4; and

(c) determining the presence of one or more findings associated with human dormancy syndrome.

2. The method of claim 1, wherein said one or more findings is selected from the group consisting of persistent fatigue, cognitive impairment, weight gain, depression, alopecia, constipation, insomnia, sleep apnea, loss of libido, cold intolerance, exercise intolerance, addiction to stimulants, history of Raynaud'"'"'s Syndrome, dislipidemia, atherosclerosis, syndrome X, peripheral vascular disease, type II diabetes, dementia, Alzheimer'"'"'s Disease, demyelinating disease, muscle tension headache, migraine, fibrocystic breast disease, breast cancer, prostate cancer, ovarian cancer, other cancers, cholelithiasis, pulmonary artery hypertension, pulmonary fibrosis, COPD, asthma, systemic hypertension, infertility, fibromyalgia, chronic fatigue syndrome, chronic wide spread pain and other chronic pain states, and obesity. autoimmune conditions such as lupus, scleroderma, rheumatoid arthritis, sarcoidosis, vasculitis, myositis, ankylosising spondylitis, psoriatic arthris, reactive arthritis, Reiter'"'"'s syndrome, Becet'"'"'s disease, polymyalgia rheumatica. viral infection, bacterial infection, fungal infection, septic shock, pneumonia, narcolepsy, hypertension, liver disease, esophageal dysmotility, inflammatory bowel disease, renal disease, Parkinson'"'"'s disease, coma, impaired stage 4 sleep, irritable bowel syndrome, elevated CRH, elevated sympathetic nervous system activity, dysregulated HPA, low serotonin, altered nitric oxide metabolism and NOS activity, low oxytocin levels, mitochondrial impairment and structural changes with decreased membrane permeability, compulsivity, hypervigilance, dissociation, impaired natural killer cell activity, elevated CSF substance P levels, blunted growth hormone response during provocation testing, orthostatic hypotension, and altered cerebral blood flow.

3. A method for treating human dormancy syndrome in a patient, comprising:

identifying a patient having a finding associated with human dormancy syndrome; and

reducing the ratio of serum rT3 to serum fT3 to below about 6 and said finding returns substantially to normal.

25. The method of claim 3, wherein said finding is an autoimmune disorder.

26. The method of claim 3, wherein said finding is rheumatoid arthritis.

27. The method of claim 3, wherein said finding is systemic lupus erythematosus.

28. The method of claim 3, wherein said finding is post-Lyme disease arthritis.

29. The method of claim 3, wherein said finding is psoriatic arthritis.

30. The method of claim 3, wherein said finding is myositis.

31. The method of claim 3, wherein said finding is chronic back pain.

32. The method of claim 3, wherein said finding is scleroderma.

33. The method of claim 3, wherein said finding is reflex sympathetic dystrophy.

4. A method for treating human dormancy syndrome in a patient, comprising:

identifying a patient having a finding associated with human dormancy syndrome; and

inhibiting the enzyme 5-D1 to elevate serum fT3 levels, so that the ratio of serum rT3/fT3 decreases to below about 6.

5. The method of claim 4, wherein said human dormancy syndrome is associated with at least one finding selected from the group consisting of persistent fatigue, cognitive impairment, weight gain, depression, alopecia, constipation, insomnia, sleep apnea, loss of libido, cold intolerance, exercise intolerance, addiction to stimulants, history of Raynaud'"'"'s Syndrome, dislipidemia, atherosclerosis, syndrome X, peripheral vascular disease, type II diabetes, dementia, Alzheimer'"'"'s Disease, demyclinating disease, muscle tension headache, migraine, fibrocystic breast disease, breast cancer, prostate cancer, ovarian cancer, other cancers, cholelithiasis, pulmonary artery hypertension, pulmonary fibrosis, COPD, asthma, systemic hypertension, infertility, fibromyalgia, chronic fatigue syndrome, chronic wide spread pain and other chronic pain states, and obesity. autoimmune conditions such as lupus, scleroderma, rheumatoid arthritis, sarcoidosis, vasculitis, myositis, ankylosising spondylitis, psoriatic arthris, reactive arthritis, Reiter'"'"'s syndrome, Becet'"'"'s and polymyalgia rheumatica. viral infection, bacterial infection, fungal infection, septic shock, pneumonia, narcolepsy, hypertension, liver disease, esophageal dysmotility, inflammatory bowel disease, renal disease, Parkinson'"'"'s disease, coma, impaired stage 4 sleep, irritable bowel syndrome, elevated CRH, elevated sympathetic nervous system activity, dysregulated HPA, low serotonin, altered nitric oxide metabolism and NOS activity, low oxytocin levels, mitochondrial impairment and structural changes with decreased membrane permeability, compulsivity, hypervigilance, dissociation, impaired natural killer cell activity, elevated CSF substance P levels, blunted growth hormone response during provocation testing, orthostatic hypotension, and altered cerebral blood flow.

6. A method for treating human dormancy syndrome in a patient, comprising stimulating the enzyme 5′

-D1 to increase T3 production so that the ratio of serum rT3/fT3 decreases to below about 6.

7. A method for treating human dormancy syndrome in a patient, comprising inhibiting the enzyme 5-D1 and stimulating at least one of the enzymes 5′

-D2 and 5′

-D1 so that the ratio of serum rT3/fT3 is below about 6.

8. A method for treating human dormancy syndrome in a patient, comprising administering T3 to decrease the ratio of serum rT3/fT3 to below about 6.

9. The method of claim 8, further comprising at least one therapy selected from the group consisting of physical therapy and occupational therapy.

10. The method of claim 8, further comprising at least one therapy selected from the group consisting of psychotherapy, cognitive behavioral therapy, exposure therapy, beta-adrenergic antagonist therapy, serotonin reuptake inhibitor therapy, MgSO₄ therapy, magnesium therapy, oxytocin therapy, dopamine increasing therapy, glucocorticoid therapy, ACTH therapy, and nitric oxide enhancing therapy.

11. A method for treating dementia, comprising the steps of:

(a) providing a subject suffering from dementia; and

(b) increasing serum T3 levels in said subject, said increase in serum T3 being associated with an improvement in at least one finding selected from the group consisting of memory impairment, cognitive improvement, increased energy level and increased physical activity.

12. The method of claim 11 wherein said dementia is associated with Alzheimer'"'"'s disease.

13. The method of claim 11, wherein said step of increasing serum T3 levels is carried out using exogenously added T3.

14. The method of claim 11, wherein said step of increasing serum T3 levels is carried out by providing an effective amount of an agent that increases the production of endogenous T3.

15. The method of claim 11, wherein said step of increasing serum T3 levels is carried out by providing an effective amount of an agent that decreases the production of endogenous rT3.

16. The method of claim 11, wherein said improvement is assessed using dementia rating scale-2 (“

DMS-2”

).

17. The method of claim 11, wherein said step of increasing serum T3 levels is carried out using an effective amount of an agent that decreases metabolism of T3.

18. The method of claim 11, wherein said step of increasing serum T3 levels is carried out using sustained-release preparation of T3.

19. The method of claim 11, further comprising using at least one adjunct therapy.

20. The method of claim 19, wherein said adjunct therapy is behavioral therapy or cognitive therapy.

21. The method of claim 19, wherein said adjunct therapy is carried out using a pharmaceutical agent.

22. The method of claim 21, wherein said pharmaceutical agent is a serotonin re-uptake inhibitor.

23. The method of claim 22, wherein said serotonin re-uptake inhibitor is (±

)fluoxetine, fluvoxamine, paroxetine, sertaline, (±

) venlafaxine, or St. John'"'"'s Wort.

24. The method of claim 21, wherein said pharmaceutical agent is one or more of melatonin, testosterone, oxytocin, selenium, iodine, magnesium and nitroglycerin.