Overview

Biomarkers of Homeopathy in Fibromyalgia

Status:
Completed
Trial end date:
2002-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Center for Complementary and Integrative Health (NCCIH)
Criteria
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.