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, six male; average 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 DHEA) insufficiency,
(2) disordered sleep (zolpidem, valerian/melissa, trazodone, amitriptyline, cyclobenzaprine, carisoprodol and/or clonazepam),
Subscribe to the World's Most Popular ME-CFS Newsletter (it's free!)
(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. 177.1 to 211.3 p<.0001), and Tender Point Index (TPI) (31.7 to 15.5 vs. 35.0 to 32.3, p<.0001) were seen.
Conclusions: Significantly greater benefit was seen in the active group than in the placebo group for all primary outcomes.