Clinical researchers have not yet demonstrated therapeutic effectiveness of any single intervention that can target the polysymptomatic nature of FM, a chronic debilitating nonarticular rheumatic disorder. Classical homeopathy, a controversial alternative therapy, claims to provide such an integrative intervention to treat the totality of symptoms. This revised R21, 2-year exploratory effectiveness study will involve a 3-month parallel group (N=60), randomized, placebo-controlled, double-blind clinical trial, with an additional 3-month optional crossover, double-blind trial of individualized homeopathic treatment of FM. We will use self-report questionnaires, tender point examinations, and physiological markers of response to the homeopathic remedies and placebo (i.e., EEG alpha activity and orthostatic HRV.
Specific aims and hypotheses are: 1) to evaluate the effectiveness of individually-chosen homeopathic treatment for the mental, emotional and somatic symptomatology of FM under double-blind conditions in which active and placebo-treated groups receive the same amount of attention using the same treatment procedures and differ only in the contents of the dispensed drug vials. The investigators hypothesize that individually chosen homeopathic remedies will lead to improvement in spiritual, mental, emotional, and somatic symptoms of FM than will placebo; 2) to determine the ability of acute changes in EEG alpha activity to differentiate active from placebo homeopathic remedies upon olfactory administration in FM patients and to predict subsequent responders and non-responders to treatment. The prediction is that active homeopathic remedies will lead to greater EEG alpha blocking than placebo; and 3) to assess resting EEG alpha power and orthostatic HRV as markers of global clinical improvement in FM over time. Global clinical improvement in FM will correlate with parallel improvements in resting EEG and orthostatic HRV.
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