Biomarkers of Homeopathy in Fibromyalgia

National Institutes of Health (NIH)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Fibromyalgia

Treatments

Drug: Active liquid remedy

Study type

Interventional

Funder types

NIH

Identifiers

NCT00065702

BellI

R21AT000315-01

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.