Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00034047
Status:
COMPLETED
Last Update Posted:
2008-01-25
First Post:
2002-04-19
Brief Title:
Endometriosis Traditional Medicine vs Hormone Therapy
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Endometriosis Traditional Medicine vs Hormone Therapy
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 GnRHas 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
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 GnRHas 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None