None listed
Conditions
Brief summary
Hot flushes and night sweats are common during menopause, and can be bothersome. Effective treatment of hot flushes carries risks, including cancer and heart disease. This small preliminary study aims to assess the feasibility of conducting a larger trial on acupuncture for hot flushes. The hypothesis is that acupuncture is more effective than placebo acupuncture in relieving hot flush severity and frequency, and in improving quality of life. Lessons learned from this pilot study will assist in conducting a larger trial which will investigate whether acupuncture improves the number and severity of hot flushes.
Interventions
Needle acupuncture will be given to women randomised to the intervention group. They will receive ten sessions of acupuncture over eight weeks. Treatments will be given twice weekly for the first fortnight then weekly. Needles will be retained for 20-30 minutes and will be stimulated manually every 10 minutes. Needles will be inserted into points on ankles, elbows, wrists and abdomen. To maintain blinding, a base unit comprising a guide tube and base plate (see below - control group) will also b
Needle acupuncture will be given to women randomised to the intervention group. They will receive ten sessions of acupuncture over eight weeks. Treatments will be given twice weekly for the first fortnight then weekly. Needles will be retained for 20-30 minutes and will be stimulated manually every 10 minutes. Needles will be inserted into points on ankles, elbows, wrists and abdomen. To maintain blinding, a base unit comprising a guide tube and base plate (see below - control group) will also be used in the intervention group.
Sponsors
University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Women who are having an average of 7 hot flushes or more a day over a week; and whose Traditional Chinese Medicine (TCM) diagnosis is predominantly Kidney Yin Deficiency, as assessed by a Chinese medicine questionnaire and a history and examination
Exclusion criteria
1. younger than 40yo (therefore diagnosed as having Premature Ovarian Failure), 2. any medical reason to be amenorrheic (Pregnancy, hyperprolactinemia, Cushing’s syndrome etc), 3. poorly controlled hyper or hypothyroidism, 4. menopausal as a result of surgery, 5. breast cancer or suffering hot flushes as a result of aromatase inhibitor therapy, 6. have commenced using any pharmacological or complementary therapy for hot flushes in the past eight weeks, 7. unable to read or write sufficiently in English to complete hot flush diaries and Menopause - Specific Quality of Life (MENQOL) questionnaires (the questionnaire requires a Grade 6 reading level)[19], 8. any needle acupuncture treatment in the past, 9. relative contraindications to acupuncture (use of anticoagulant drugs, heart valve disease, poorly controlled diabetes mellitus), 10. unwilling or unable to attend for acupuncture/placebo acupuncture for 8 weeks 11. unable to give informed consent
Outcome results
None listed