Endometriosis : Traditional Medicine vs Hormone Therapy
Condition: Endometriosis; Pelvic Pain
MeSH terms: Endometriosis; Pelvic Pain
Study type: Interventional
Phase: Phase 1/Phase 2

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
      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.
    

Intervention name(s): Acupuncture; Chinese Products; Nafarelin
Intervention type(s): Procedure; Drug; Drug
Intervention MeSH terms: Nafarelin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Endometriosis; Pelvic pain; Acupuncture; Chinese herbs; Hormone therapy; Nafarelin