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Endometriosis : Traditional Medicine vs Hormone Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00034047
Recruitment Status : Completed
First Posted : April 22, 2002
Last Update Posted : January 25, 2008
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

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.

Condition or disease Intervention/treatment Phase
Endometriosis Pelvic Pain Procedure: Acupuncture Drug: Chinese Products Drug: Nafarelin Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endometriosis : Traditional Medicine vs Hormone Therapy
Study Start Date : September 2002
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Pain assessments

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00034047

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United States, Oregon
Oregon Health Sciences University, Women's Health Research Unit
Portland, Oregon, United States, 97201
Oregon College of Oriental Medicine Clinic
Portland, Oregon, United States, 97216
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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Principal Investigator: Richard Hammerschlag, PhD Oregon College of Oriental Medicine
Principal Investigator: Kenneth Burry, MD Oregon Health and Science University
Layout table for additonal information Identifier: NCT00034047    
Other Study ID Numbers: R21AT000453-01 ( U.S. NIH Grant/Contract )
First Posted: April 22, 2002    Key Record Dates
Last Update Posted: January 25, 2008
Last Verified: January 2008
Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
Pelvic pain
Chinese herbs
Hormone therapy
Additional relevant MeSH terms:
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Pelvic Pain
Genital Diseases, Female
Neurologic Manifestations
Signs and Symptoms
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs