The Acupause study: Acupuncture for postmenopausal hot flushes

Not Applicable

Recruiting

• Conditions: Postmenopausal vasomotor symptoms; Reproductive Health and Childbirth - Menstruation and menopause; Alternative and Complementary Medicine - Other alternative and complementary medicine

• Registration Number: ACTRN12611000393954
• Lead Sponsor: niversity of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-04-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 360

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hot flush score (comprising hot flush severity and frequency measures) using seven-day hot flush diaries[End of treatment (8 weeks)]

Secondary Outcome Measures

Name	Time	Method
Quality of life as measured by the Menopause-Specific-Quality of Life Questionnaire (MENQOL)[End of treatment (8 weeks), 3 and 6 months post end of treatment];Hot flush score (comprising hot flush severity and frequency measures) using seven-day hot flush diaries[3 and 6 months post end of treatment];Expectancy and beliefs about acupuncture, and credibility of the sham control, as measured by the Credibility and Expectancy questionnaire[Immediately following the first treatment session]