EFFECTIVE TREATMENT FOR FIBROMYALGIA & CHRONIC FATIGUE SYNDROME - A PLACEBO CONTROLLED STUDY

J Teitelbaum, M.D.*1, B Bird, M.T., C.L.S., R Greenfield, M.D. 1, A Weiss, M.D. 1, L Muenz, Ph.D.2, L Gould.3

[* Annapolis Research Center For Effective FMS/CFIDS Therapies, 466 Forelands Rd., Annapolis, MD 21401; 1) Anne Arundel Medical Center, Annapolis, MD; 2) Gaithersburg, MD; 3) USDA, Beltsville, MD]

Objectives: Hypothalamic dysfunction has been suggested in Fibromyalgia (FMS) and Chronic Fatigue Syndrome (CFIDS). This may result in disordered sleep, subclinical hormonal deficiencies, immune dysfunction (with opportunistic bowel infections and associated nutritional deficiencies) and autonomic dysfunction (e.g., neurally mediated hypotension (NMH)). Our previously published open trial showed that patients usually improve, often dramatically, by treating all the above processes simultaneously. Our current study re-explored this using a randomized, double-blind design with an intent to treat analysis.

Methods: 72 FMS patients (66 female; 6 male; Avg. Age 44.6 years; 69 also met CFIDS criteria) received all active or all placebo therapies as a unified intervention. Patients were treated, as indicated by symptoms and/or lab testing, for: (1) subclinical thyroid, gonadal, and/or adrenal (Cortisol and DI-IBA) insufficiency, (2) disordered sleep (Zolpidem, Valerian/Melissa, Trazodone, Amitriptyline, Cyclobenzaprine, Carisoprodol and/or Clonazepam), (3) suspected NMH (Fludrocortisone ), ( 4) opportunistic infections ( e.g., parasites, Clostridia Difficile, fungal overgrowth), and (5) suspected nutritional deficiencies (multivitamin, magnesium glycinate/malic acid, B12, and iron).

Results: 38 patients were in the active group and 34 in the placebo group. 32 patients in each group completed the study. At the final visit, in the active group, 16 were "much better", 13 "better", 2 "same", 0 "worse", and 1 "much worse" vs 3, 9, 11, 6 and 3 in the placebo group (p < .0001, Mantel-Haenszel trend test). Significant improvement in the FMS Impact Questionnaire (FIQ) scores (decreasing from 54.8 to 33.2 vs 51.4 to 47.7, p < .0001, t-test), Analog scores (improving from 176.1 to 311.1 vs 211.3, p < .0001), and Tender Point Index (TPI) (31.7 to 15.5 vs 35.0 to 32.3, p < . 000 I) were seen.

Conclusions: Significantly greater benefit was seen in the active group than in the placebo group for all primary outcomes, confinning that effective treatment is now available for Fibromyalgia and Chronic Fatigue Syndrome.

"We would like to thank the To Your Health company for graciously supplying their excellent products, Fibro-CareTM and Valerian RestTM (and the matching placebos) for use in our study. Many of the treatments for CFIDS/FMS are nutritional and can be taken without prescription. To Your Health is an excellent source for many of these treatments." ... Jacob Teitelbaum, M.D.