A randomised sham-controlled single-blind trial of the efficacy of needle acupuncture vs sham acupuncture in reducing hot flush score in postmenopausal women

niversity of Melbourne0 个研究点目标入组 360 人开始时间: 2011年4月14日最近更新: 2020年1月13日

适应症

试验速览

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•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 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.

发起方

niversity of Melbourne