Fibromyalgia
Conditions
Keywords
fibromyalgia, homeopathy, EEG, EKG, chronic pain
Brief summary
The purpose of this study is to evaluate the efficacy of individualized classical homeopathy in treatment of persons with fibromyalgia and to determine the usefulness of electroencephalographic and electrocardiographic measures to serve as markers of differences between active and placebo treatment.
Interventions
DRUGActive liquid remedy
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ACR diagnosis of fibromyalgia; * Willing to take daily active or placebo liquid remedy under double blind conditions for 6 months, involving daily succussion and dilution of source liquid from a stock bottle; * Willingness/ability to comply with dietary and lifestyle restrictions, i.e., no coffee in any form, no comphor or menthol-containing products; no electric blankets, no strong aromatics, no routine vaccinations, no concomitant use of acupuncture, chiropractic, polarity therapy, psychic healing, or magnet therapy; * No dental drilling, MRI scans unless emergent; * Withhold food or drink 30 mins before/after therapy; * Stable conventional care for 2 months prior to entry; * Willing to undergo 3 diagnostic physical exams, and to permit videotaping of interview sessions; * Willing to fill out questionnaires
Exclusion criteria
* Steroid-dependent medical conditions; * Chronic benzodiazepine or anticonvulsant use; * Use of tricyclic antidepressants, antihypertensives, and other drugs that alter orthostasis; * Pregnancy; * History of seizure disorder or syncope; * Life-threatening medical conditions; * Current active asthma; * History of anaphylactic shock; * Insulin-dependent diabetes; * Active suicidal ideation or psychosis.
Countries
United States
Outcome results
None listed