N95.1
Conditions
Interventions
Group 1: Acupuncture ACU: 12 week semistandradised acupuncture treatment (once per week) in addition to hormone standard treatment
Group 2: Laser-Acupuncture LAS: 12-week laseracupuncture treatment at
Sponsors
Inselspital Bern
Eligibility
Sex/Gender
Female
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in hot flushes frequency per week after 12 weeks in comparison to group ACU and group CON. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison between the three treatment arms: •According to FDA: mean changes in frequency and severity of moderate to severe hot flushes after 4 and 12 weeks between treatment groups ACU and CON. •Rate of women after 12 weeks that do not need an increase in hormone dosage comparing treatment groups ACU and CON. •Rate of women after 24, 36 and 48 weeks, that do not need an increase in hormone dosage. •Rate of women that receive a change in the dosage of HT at any timepoint •Weekly changes in the Menopause II Rating Scale (MRS-II) across 48 weeks. •Differentes within the Menopause II Rating Scale (MRS-II) after 12, 24, 36 and 48 weeks. •Daily diary to assess flush symptoms during first 12 weeks •Frequency and severity of hot flushes across 48 weeks as well as after 12, 24, 36 and 48 weeks •Differences in quality of life (SF-12) after 12, 24, 36 and 48 weeks •Differences in Medical Outcomes Study Sleep measure after 12, 24, 36 and 48 weeks •Differences in Trier Inventory for Chronic Stress (TICS) after 12, 24, 36 and 48 weeks •Serum concentration of Estradiol, Progesterone, LH and FSH after 12, 24, 36 and 48 weeks •Credibility-Assessment before and after treatment. | — |
Countries
Switzerland
Contacts
Public ContactDinah Gafner
Study NurseFrauneklinikInselspital Bern
Outcome results
None listed