Endometriosis : Traditional Medicine vs Hormone Therapy

Original Study ID : R21 AT000453-01

NCT ID : NCT00034047

Brief Title : Endometriosis : Traditional Medicine vs Hormone Therapy

Official Title : Endometriosis : Traditional Medicine vs Hormone Therapy

Brief Summary : This 36-week study will determine whether traditional Chinese medicine (acupuncture and Chinese herbs) is as effective as hormone therapy for alleviating endometriosis-related pelvic pain.

Source : National Center for Complementary and Alternative Medicine (NCCAM)

Detailed Description :
Endometriosis is a significant public health problem affecting 10-15% of women of
childbearing age, many of whom suffer persistent pelvic pain and infertility. Therapeutic
options include surgery and hormone therapy that are often temporarily effective but produce
unwanted side-effects. The present proposal, based on case series reports of the
effectiveness of Traditional Chinese Medicine (TCM: acupuncture and Chinese herbs) for this
condition, aims to evaluate whether TCM is as effective as hormone therapy for alleviating
endometriosis-related chronic pain.

Women with laparoscopy-diagnosed endometriosis will be randomly assigned to either TCM or
hormone therapy. Women assigned to TCM will be divided into four sub-groups on the basis of
the diagnostic categories of endometriosis recognized by TCM. A pre-established acupuncture
protocol and herbal formula specific for each sub-group will be followed. This aspect of the
research design permits an important feature of the clinical practice of TCM (matching
treatment to sub-group diagnosis) to be adopted in a clinical trial. Women assigned to
hormone therapy will be treated with the gonadotropin releasing hormone agonist (GnRHa),
nafarelin, chosen for this study on the basis of its clinical trial-established efficacy,
ease of patient usage via intranasal spray and milder side-effect profile relative to other
GnRHa's. Pelvic pain symptoms (patient-scored) and signs (physician-scored) will be assessed
at baseline, after 12 weeks of treatment, and at 12- and 24-week post-treatment follow-up.
Pelvic examination scores will be determined by a physician blinded to the treatment group
assignments. Side effects, including those of pseudomenopause known to result from GnRHa
therapy, will be recorded in both groups at 4-week intervals during the 12-week treatment,
and at each follow-up time. A further objective is to make a preliminary assessment of
whether diagnostic sub-groups of endometriosis recognized by TCM serve as predictors of
differential response to hormone therapy. Data obtained from this study, on treatment
effectiveness, side effect profiles, recurrence of symptoms, compliance with therapy and
drop-out rates, will be used to design a large-scale clinical trial.

Overall Status : Completed

Start Date : September 2002

End Date : August 2006

Completion Date : August 2006

Official Title : Phase 1/Phase 2

Phase : Interventional

Study Design : Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Enrollment : 50

Verification Date : January 2008

First Received Date : April 19, 2002

Trial Eligibility

Criteria :
Inclusion Criteria:

- Women with laparoscopy-confirmed endometriosis within the past 6 years

- Experiencing chronic pelvic pain, dysmenorrhea (painful periods) and dyspareunia
(painful intercourse), at least one of which is moderate to severe

Exclusion Criteria:

- Use of traditional Chinese medicine for endometriosis. If previous treatment with
hormone therapy, must have responded positively but not have been on hormone therapy
within the past 6 months

- Use of any form of hormone-based contraception during the 12-week treatment and
24-week follow-up periods

- Diagnosed with any chronic condition other than endometriosis, or any other acute
condition that causes pain

- Pregnancy or breast feeding

Gender : Female

Minimum Age : 18 Years

Maximum Age : 45 Years

Healthy Volunteers : No

Facilities

Facility Name : Oregon Health Sciences University, Women's Health Research Unit

City : Portland

State : Oregon

Zip Code : 97201

Country : United States

Facility Name : Oregon College of Oriental Medicine Clinic

City : Portland

State : Oregon

Zip Code : 97216

Country : United States

Clinical Trial Name -Endometriosis : Traditional Medicine vs Hormone Therapy