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Endometriosis : Traditional Medicine vs Hormone Therapy

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00034047
First received: April 19, 2002
Last updated: January 23, 2008
Last verified: January 2008

April 19, 2002
January 23, 2008
September 2002
August 2006   (final data collection date for primary outcome measure)
Pain assessments
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Complete list of historical versions of study NCT00034047 on ClinicalTrials.gov Archive Site
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Endometriosis : Traditional Medicine vs Hormone Therapy
Endometriosis : Traditional Medicine vs Hormone Therapy

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Endometriosis
  • Pelvic Pain
  • Procedure: Acupuncture
  • Drug: Chinese Products
  • Drug: Nafarelin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
August 2006
August 2006   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00034047
R21 AT000453-01
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National Center for Complementary and Alternative Medicine (NCCAM)
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Principal Investigator: Richard Hammerschlag, PhD Oregon College of Oriental Medicine
Principal Investigator: Kenneth Burry, MD Oregon Health and Science University
National Center for Complementary and Alternative Medicine (NCCAM)
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP