A randomised controlled pilot study of the efficacy of needle acupuncture vs placebo acupuncture in reducing vasomotor symptom severity and frequency in women during the postmenopause and menopausal transition

niversity of Melbourne0 sites26 target enrollmentFebruary 11, 2009

Overview

No summary available.

Registry

who.int

Start Date

February 11, 2009

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

Female

Sponsor

niversity of Melbourne

•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

•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