For Physicians: Case for Microdose Therapy^tm

Microdose Therapy^tm is patient self-administration of glucocorticoids simultaneous with inflammation source control to arrest long-term, destructive inflammation. It excels for control of arthritis, inflammatory disorders and autoimmune diseases.

Microdose Therapy^tm clinical trials:

1) One group of rheumatoid arthritis patients left on existing medications received placebo and the second on prednisone. Both were taught self-administration. The two groups were switched at midpoint in a double-blind clinical trial. When on prednisone, patients averaged consuming 3 mg per day and 75% additional improvement. On placebo patients either experienced little improvement or lost control of the improvement using patient self-administration of prednisone. No significant side effects were observed.

Stenberg VI, Fiechtner JJ, Rice JR, et al. Endocrine control of inflammation: rheumatoid arthritis double-blind, crossover clinical trial. Int J Clin Pharm Res. 1992; 12(1): 11-18.

2) Using Microdose Therapy^tm in an open clinical trial, 1,806 patients with arthritis, inflammatory and/or autoimmune diseases left on existing medicines were treated with Microdose Therapy^tm:

Disease	Relief, %	Disease	Relief, %
Ankylosing spondylitis	60	Irritable bowel syndrome	85
Arthritis, undifferentiated	76	Macular degeneration	36
Asthma	70	Multiple sclerosis	70
Back pain, upper	71	Myofacial syndrome	73
Back pain, lower	70	Osteoarthritis	78
Bursitis	79	Parkinson’s disease	66
Carpal tunnel syndrome	83	Polymyalgia rheumatica	80
Chronic fatigue syndrome	79	Psoriatic arthritis	69
Crohn’s disease	91	Rheumatoid arthritis (RA)	77
Fibromyalgia	77	Spinal stenosis	78
Headache, migraine	94	Systemic lupus erythematosis	55

Microdose Therapytm is superior to the biologics for rheumatoid arthritis

RA Treatment	Administration	Relief, average
Microdose Therapy	Cortisol self-administration	77%
Adalimumab	Varied dosage and administration frequency 41-61%	41-61%
TNFR:Fc	Varied dosage and administration frequency 8-51%	8-51%
Infliximab	Varied dosage and administration frequency 23-47%	23-47%
Abatacept	Varied dosage and administration frequency 29-44%	29-44%

Orencia = abatacept; Enbrel = TNFR:Fc; Humira = adalimumab; Remicade = infliximab

Higher average relief percentages within average relief ranges are achieved with simultaneous methotrexate administration.

Microdose Therapy^tm patients average consuming less than the safe limits of glucocorticoid use.

1) The safe use of prednisone is defined to be 3.5-9 mg prednisone per day (15-40 mg cortisol per day).

Slocumb CH, Polley HF, Ward L. Diagnosis, treatment and prevention of hypercortisonism in patients with rheumatoid arthritis. Staff Meetings of the Mayo Clinic, 32(a): 227-238, 1957.

2) One group took aspirin or phenylbutazone and the other 10 mg prednisolone per day (50 mg cortisol per day equivalent). After two years using X-ray analyses, erosion, subluxation and osteoporosis were worse in the aspirin group.

*Joint Committee of the Medical Research Council and Nuffield Foundation, Ann Rheum Dis 18, 173-188, 1959.

3) One group took aspirin and the other 70 mg cortisone/day (70 mg cortisol per day equivalent). After two years and using X-ray analysis, the joint erosion was more in the aspirin group than in the cortisone group.

*Empire Rheumatism Council, Ann Rheum Dis 14, 353-370, 1955; 16, 777-789, 1957.

4) Louis A. Healey summarizes: “A low dose such as 7.5 mg prednisone per day is not cumulative and is thought to be useable indefinitely without producing osteoporosis or other serious adverse effects.” Healey LA, Changing Therapy, Medical World News, December 12, 1988.

Microdose Therapy^tm avoids adrenal suppression.

Patients incorporate 33% cortisol holidays. During these days, the adrenal glands exercise.

Low Dose Glucocorticoids such as Microdose Therapy^tm arrest joint destruction.

In patients with early, active rheumatoid arthritis, 7.5 mg prednisolone (equivalent to 37.5 mg cortisol) given daily for two years substantially reduced the rate of radiologically-detected progression of disease. The statistical analysis of radiologically-detected changes was based on 106 patients. After two years, the Larsen scores increased by a mean of 0.72 units in the prednisolone group indicating very little change, and by 5.37 units in the placebo group, indicating substantial joint destruction (P=0.004).

*Kirwan JR New England Journal of Medicine, 333, 142-146, 1995.

Microdose Therapy^tm delays and avoids pending surgeries and reduces medicine use.

Pending surgeries delayed/avoided: four hip, two knee, one back, one shoulder, and two undefined.

Medicines discontinued (number of patients):Prednisone (10), Ibuprofen [Motrin] (11),Tylenol (9), Methotrexate (6), Celebrex (6),Aleve (5),Naproxen (3), Plaquenil (2),Lyrica (2), Mobic [meloxicam] (2),Hydrocodone (2), Darvocet (2),Advil (2),Bextra (3), Tramadol (1),Aleve (1), Imitrex (1),Azathioprine [Imuran] (1),Enbrel (1),Remicade (1),Kineret (1),Cymbalta (1),Percocet (1),Ambien (1),Asthma inhalers (1),Nabumetone [Relafen] (1),Sulfasalazine [Azulfidine] (1), Vioxx (1),Vicodin (1),Flexeril (1),Oxycodone (1), Trazadone (1), Piroxicam [Feldene] (1), Amitriptyline (1), Tramadol (1).*

Stenberg VI, unpublished data: 137 respondents to questionnaires of Microdose Therapy^tm graduates 2005-2009.