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.

Agency
National Institute of Health (NIH)
Institute
National Center for Complementary & Alternative Medicine (NCCAM)
Type
Exploratory/Developmental Grants (R21)
Project #
3R21AT000315-01S1
Application #
6449750
Study Section
Special Emphasis Panel (ZAT1 (03))
Program Officer
Goertz, Christine Marie
Project Start
2000-08-01
Project End
2002-05-31
Budget Start
2000-08-01
Budget End
2001-05-31
Support Year
1
Fiscal Year
2001
Total Cost
$1,517
Indirect Cost
Name
University of Arizona
Department
Psychiatry
Type
Schools of Medicine
DUNS #
City
Tucson
State
AZ
Country
United States
Zip Code
85721
Bell, Iris R; Lewis 2nd, Daniel A; Lewis, Sabrina E et al. (2004) EEG alpha sensitization in individualized homeopathic treatment of fibromyalgia. Int J Neurosci 114:1195-220
Bell, Iris R; Lewis 2nd, Daniel A; Lewis, Sabrina E et al. (2004) Strength of vital force in classical homeopathy: bio-psycho-social-spiritual correlates within a complex systems context. J Altern Complement Med 10:123-31
Bell, I R; Lewis 2nd, D A; Brooks, A J et al. (2004) Improved clinical status in fibromyalgia patients treated with individualized homeopathic remedies versus placebo. Rheumatology (Oxford) 43:577-82
Bell, Iris R; Cunningham, Victoria; Caspi, Opher et al. (2004) Development and validation of a new global well-being outcomes rating scale for integrative medicine research. BMC Complement Altern Med 4:1
Bell, Iris R; Lewis 2nd, Daniel A; Schwartz, Gary E et al. (2004) Electroencephalographic cordance patterns distinguish exceptional clinical responders with fibromyalgia to individualized homeopathic medicines. J Altern Complement Med 10:285-99
Bell, Iris R; Lewis 2nd, Daniel A; Brooks, Audrey J et al. (2004) Individual differences in response to randomly assigned active individualized homeopathic and placebo treatment in fibromyalgia: implications of a double-blinded optional crossover design. J Altern Complement Med 10:269-83
Bell, Iris R; Koithan, Mary; Gorman, Margaret M et al. (2003) Homeopathic practitioner views of changes in patients undergoing constitutional treatment for chronic disease. J Altern Complement Med 9:39-50
Bell, Iris R; Lewis 2nd, Daniel A; Brooks, Audrey J et al. (2003) Gas discharge visualization evaluation of ultramolecular doses of homeopathic medicines under blinded, controlled conditions. J Altern Complement Med 9:25-38
Bell, Iris R; Baldwin, C M; Schwartz, G E et al. (2002) Homeopathic constitutional type questionnaire correlates of conventional psychological and physical health scales: individual difference characteristics of young adults. Homeopathy 91:63-74
Bell, Iris R; Baldwin, Carol M; Schwartz, Gary E (2002) Translating a nonlinear systems theory model for homeopathy into empirical tests. Altern Ther Health Med 8:58-66

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