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Home > "E" Clinical Trials Conditions > Endometriosis : Traditional Medicine vs Hormone Therapy  Endometriosis : Traditional Medicine vs Hormone Therapy
Endometriosis : Traditional Medicine vs Hormone Therapy
For Condition: Pelvic Pain,Endometriosis
Status: Recruiting
Sponsor(s): National Center for Complementary and Alternative Medicine (NCCAM) ,
Synopsis: 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.
Details: 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. The study is designed as a prospective trial of 66 women, with laparoscopy-diagnosed endometriosis, randomized to 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:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/45 Years
Genders: Female
Protocol Entry Criteria: Criteria: - Women with laparoscopy-confirmed endometriosis within the past 3 years. - Experiencing chronic pelvic pain, dysmenorrhea (painful periods) and dyspareunia (painful intercourse), at least one of which is moderate to severe. - Agreement not to use any form of hormone-based contraception during the 12-week treatment and 24-week follow-up periods. - Must not have received 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. - Must not have been diagnosed with any chronic condition other than endometriosis, or any other acute condition that causes pain. - Must not be pregnant or breast feeding.
Total Enrollment: 66
Location and Contact Information:
Overall Study Official:
KennethBurry, , Oregon Health and Science University
Oregon Health Sciences University, Women's Health Research Unit *Recruiting*
Portland, Oregon, 97201
United States
Recruiting Christine Toomey
Oregon College of Oriental Medicine Clinic *Recruiting*
Portland, Oregon, 97216
United States
Recruiting Barbara Krauss 503-253-3443
Additional Information:
Study ID Numbers: 1 R21 AT00453-01;
Study Start Date: September 2002
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00034047
Other Endometriosis Studies:
1. Pelvic Pain in Women with Endometriosis
2. Endometriosis : Traditional Medicine vs Hormone Therapy
3. The Safety and Effectiveness of Surgery with or without Raloxifene for the Treatment of Pelvic Pain Caused by Endometriosis
Related Studies:
Other Endometriosis Clinical Trials
Other Oregon Clinical Trials
Other Portland Clinical Trials
Endometriosis : Traditional Medicine vs Hormone Therapy
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