EFFICACY OF ECOLOGIC-INTEGRATIVE MANAGEMENT
PROTOCOLS FOR REVERSAL OF FIBROMYALGIA:
An Open Prospective Study of 150 Patients

Objective
    To report the results of an open, prospective trial of broad-based, ecologic-integrative management protocols for the reversal of fibromyalgia in 150 patients.

Patients
    One hundred fifty patients who presented at the Institute of Integrative Medicine with fibromyalgia and for whom clinical outcome data were available for at least six months prior were included in this study. There were 116 females (range of age, 13-81 yrs) and 34 males (range of age, 14-68 yrs). The average duration of illness was 6.6 years and the average duration of clinical management was 11.5 months. Patients were divided into three groups: Group 1, when the duration of illness was less than three years; Group 2, when the duration of illness was between three and six years; and Group 3, when the duration of illness was longer than six years.

Ecologic-Integrative Management Protocols
    The comprehensive, ecologic-integrative management protocols employed were based on clinical, biochemical, and high-resolution microscopic assessment of the microecologic cellular and macroecologic tissue-organ systems of the body. Such protocols included the following: choices in the kitchen designed to provide for optimal hydration, elimination of foods causing incompatibility reactions and rapid glucose-insulin-adrenaline shifts; supplementation with vitamins, minerals, and some "redox-restorative substances" (RRSs) such as glutathione, taurine, methylsulfonylmethane (MSM), coenzyme Q10, and lipoic acid; ample herbal support for the bowel, blood, and liver ecosystems (including colon hydrotherapy and liver flushes); endocrine support, especially for the thyroid, adrenals, and sex hormones; intramuscular and intravenous nutrient protocols; oxygenative therapies, including nasal oxygen, intravenous infusions of hydrogen peroxide and ozone, and EDTA chelation; gentle stretching and noncompetitive (limbic) exercise; and training in effective methods for self- regulation, stress reduction, and guidance for spiritual surrender.

Assessment of Compliance
    Assessment of compliance was based on entries made on a specifically designed clinical outcome sheet during follow-up visits. The following scale of scores was used for assessment of compliance according to predetermined criteria: Class A, a compliance value greater than 75%; Class B, a value between 75% and 50 %; Class C, a value between 50% and 25%; and Class D, a value lower than 25%.

Assessment of Clinical Outcome
    Assessment of clinical outcome was based on concurrent evaluation of the progress made, or lack thereof, employing the clinical outcome sheet. The scale of scores for clinical improvement comprised the following: excellent outcome (Category I) when more than 90% relief of symptoms was obtained and all drug therapies were discontinued; good outcome (Category II) when the relief of symptoms was between 90% and 75%, with a similar reduction in use of drugs; fair outcome (Category III) when the relief of symptoms was between 75% and 50% with a similar reduction in symptoms; and poor outcome (Category IV) when the relief of symptoms was less than 50% with a similar reduction in the use of drugs.

Results
    The overall final outcome scores for all 150 patients were as follows: excellent outcome, 65.4%; good, 19.3%; fair, 5.3%; and poor, 10%. The final outcome scores for Group 1 (56) patients were as follows: excellent outcome, 75%; good, 10.7%; fair, 7.2%; and poor, 7.1%. The final outcome scores for Group 2 patients (26) were as follows: excellent outcome, 69.2%; good, 19.2%; fair, 7.7%; and poor, 3.9%. The final outcome scores for Group 3 patients (68) were as follows: excellent outcome, 55.9%; good, 26.5%; fair, 2.9 %; and poor, 14.7%.

Conclusion
    The data in this clinical outcome study document the efficacy of the ecologic-integrative management protocols used in reversing fibromyalgia (excellent or good outcome in 84.7%). The results provide empirical support for the view that fibromyalgia is an oxidative-dysoxygenative disorder (ODD) and that disruptions of the bowel, blood, and liver ecosystems play critical roles in its pathogenesis. The data also warrant further and larger clinical outcome studies of the efficacy of the ecologic-integrative protocols such as those employed in this study for reversing fibromyalgia, a disorder for which no pharmacologic regimens have yielded satisfactory results so far.