Biomarkers of Homeopathy in Fibromyalgia

Sponsor

National Center for Complementary and Integrative Health (NCCIH) (NIH)

Overall Status

Completed

CT.gov ID

NCT00065702

Collaborator

(none)

Enrollment

Location

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fibromyalgia	Drug: Active liquid remedy	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double

Primary Purpose:

Treatment

Study Start Date :

Oct 1, 2000

Study Completion Date :

Sep 1, 2002

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.