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Endometriosis : Traditional Medicine Vs Hormone Therapy |
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This study is currently recruiting patients. Verified by National Center for Complementary and Alternative Medicine (NCCAM) March 2005 |
This study is currently recruiting patients. Verified by National Center for Complementary and Alternative Medicine (NCCAM) March 2005.
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):
Expected Total Enrollment: 50
Study start: September 2002; Expected completion: August 2005
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.
Eligibility
Ages Eligible for Study: 18 Years - 45 Years, Genders Eligible for Study: Female
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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00034047
Marcia Strickland 503-494-3666
Oregon
Oregon Health Sciences University, Women's Health Research Unit, Portland, Oregon, 97201, United States; Recruiting
Marcia Strickland 503-494-3666
Oregon College of Oriental Medicine Clinic, Portland, Oregon, 97216, United States; Recruiting
Beth Yohalem-Ilsley 503-253-3443 Ext. 158 byohalem@ocom.edu
Study chairs or principal investigators
Richard Hammerschlag, PhD, Principal Investigator, Oregon College of Oriental Medicine
Kenneth Burry, MD, Oregon Health and Science University
More Information
Study ID Numbers: 1 R21 AT00453-01
Last Updated: December 8, 2005
Record first received: April 19, 2002
ClinicalTrials.gov Identifier: NCT00034047
Health Authority: United States: Food and Drug Administration
Related topics
Hormones After Menopause (National Institute on Aging)
Postmenopausal Hormone Therapy and Breast Cancer (UpToDate)
Hormone Therapy for Menopausal Symptoms: The First Few Years (Endocrine Society, Hormone Foundation)
Alternatives to Hormone Replacement Therapy (UpToDate)
Menopause and Hormones (Food and Drug Administration)
Postmenopausal Hormone Replacement Therapy for Primary Prevention of Chronic Conditions (Agency for Healthcare Research and Quality)
Hormone Foundation (Hormone Foundation)
Menopause Symptoms May Come Back After Stopping Menopausal Hormone Therapy (National Heart, Lung, and Blood Institute, National Institute on Aging) |
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