None listed
Conditions
Brief summary
This study aims to test if acupuncture is effective in treating hot flushes after the menopause.
Interventions
Women in the intervention group will receive ten sessions of acupuncture given twice weekly over the first two weeks then weekly for the subsequent six weeks, a total of eight weeks duration of treatment. Acupuncture will be administered by trained practitioners of Traditional Chinese medicine who have five years of more clinical experience and are registered with the Chinese Medicine Registration Board. Six acupoints will be needled at each visit (Kidney 6, Kidney 7, Spleen 6, Conception Vessel
Women in the intervention group will receive ten sessions of acupuncture given twice weekly over the first two weeks then weekly for the subsequent six weeks, a total of eight weeks duration of treatment. Acupuncture will be administered by trained practitioners of Traditional Chinese medicine who have five years of more clinical experience and are registered with the Chinese Medicine Registration Board. Six acupoints will be needled at each visit (Kidney 6, Kidney 7, Spleen 6, Conception Vessel 4, Heart 6 and Liver 3). Needles will be retained for twenty minutes and manually stimulated at ten minutes. No cointerventions are allowed.
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
Inclusion criteria will be postmenopausal women at least 12 months since final menstrual period, who have a mean hot flush score of at least 14 over a 7 day period (assessed on a validated hot flush diary and who meet the criteria for the traditional Chinese medicine diagnosis of Kidney Yin deficiency (determined by a structured Chinese Medicine history and examination. )
Exclusion criteria
Exclusion criteria include contraindications to acupuncture (anticoagulation, heart valve disease, poorly controlled diabetes mellitus); past experience of needle acupuncture in the preceding two years; hot flushes starting or worsening after surgical or chemotherapy-induced menopause or after diagnosis with or treatment of breast cancer; premature ovarian failure; endocrine or other medical disorders (uncontrolled thyroid disease, medical reasons to be amenorrheic eg uncontrolled hyperprolactinemia or Cushing’s syndrome); hormonal treatment prior to screening, depending on route of administration, ranging from 4 weeks for vaginal to 6 months for injectable pellets; phytoestrogen therapy in the preceeding 6 months; other treatments for hot flushes within 8 weeks of screening (including complementary medicines); unable to give informed consent or use outcome measurement tools; or unable to attend for acupuncture sessions as per protocol.
Outcome results
None listed