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Trial record 4 of 43 for:    (complementary OR alternative) medicine AND (woman OR women OR female) | pain

Endometriosis : Traditional Medicine vs Hormone Therapy

This study has been completed.
Information provided by:
National Center for Complementary and Integrative Health (NCCIH) Identifier:
First received: April 19, 2002
Last updated: January 23, 2008
Last verified: January 2008
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 Intervention Phase
Endometriosis Pelvic Pain Procedure: Acupuncture Drug: Chinese Products Drug: Nafarelin Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endometriosis : Traditional Medicine vs Hormone Therapy

Resource links provided by NLM:

Further study details as provided by National Center for Complementary and Integrative Health (NCCIH):

Primary Outcome Measures:
  • Pain assessments

Estimated Enrollment: 50
Study Start Date: September 2002
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
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.


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00034047

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)
Principal Investigator: Richard Hammerschlag, PhD Oregon College of Oriental Medicine
Principal Investigator: Kenneth Burry, MD Oregon Health and Science University
  More Information Identifier: NCT00034047     History of Changes
Other Study ID Numbers: R21AT000453-01 ( U.S. NIH Grant/Contract )
Study First Received: April 19, 2002
Last Updated: January 23, 2008

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
Pelvic pain
Chinese herbs
Hormone therapy

Additional relevant MeSH terms:
Pelvic Pain
Genital Diseases, Female
Physiological Effects of Drugs
Fertility Agents, Female
Neurologic Manifestations
Signs and Symptoms
Hormones, Hormone Substitutes, and Hormone Antagonists
Fertility Agents
Reproductive Control Agents processed this record on August 17, 2017