Endometriosis : Traditional Medicine vs Hormone Therapy

Endometriosis Clinical Trial

Official title:

Endometriosis : Traditional Medicine vs Hormone Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00034047
• Other study ID #: R21AT000453-01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 19, 2002
• Last updated: January 23, 2008
• Start date: September 2002
• Est. completion date: August 2006

Study information

• Verified date: January 2008
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometriosis
• Pelvic Pain

Intervention

Procedure:
• Acupuncture

Drug:
• Chinese Products

• Nafarelin

Locations

Country	Name	City	State
United States	Oregon College of Oriental Medicine Clinic	Portland	Oregon
United States	Oregon Health Sciences University, Women's Health Research Unit	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain assessments