The Impact of Acupuncture on Ultralow Dose Hormone Therapy for the Climacteric Syndrome
- Conditions
- N95.1Menopausal and female climacteric states
- Registration Number
- DRKS00011038
- Lead Sponsor
- Inselspital Bern
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 320
• postmenopausal
• A minimum of 50 moderate to severe hot flushes per week
• Menopause Rating Scale II (MRS-II) initial score = 20
• Women >40 years have documentation of a negative screening mammogram and normal clinical breast examination
• Women scheduled for an oral ULD-HT by the Menopause Clinic
• Voluntariness
• Disposition to be allocated to one of the four trial groups
• Intake of estrogen alone or estrogen/progestin containing drug products,
• Hypersensitivity to estrogens
• known or suspected estrogen-dependent neoplasia
• Endometrial hyperplasia
• undiagnosed vaginal bleeding
• anamnestic thromboembolic disorders
• cerebrovascular accident
• chronic renal or hepatic disease
• myocardial infarction or ischemic heart disease
• pregnancy or lactation
• Life-threatening disease
• Psychiatric record in medical history limiting quality of life
• Continuous uptake of antipsychiatric medication, tranquilizers or neuro-enhancers
• Acupuncture treatment within the last 4 weeks
• Other accompanying CAM treatment within the last 4 weeks
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Changes in hot flushes frequency per week after 12 weeks in comparison to group ACU<br>and group CON.
- Secondary Outcome Measures
Name Time Method