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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
The Acupause study: Acupuncture for postmenopausal hot flushes
Scientific title
A randomised sham-controlled single-blind trial of the efficacy of needle acupuncture vs sham acupuncture in reducing hot flush score in postmenopausal women
Secondary ID [1] 259940 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postmenopausal vasomotor symptoms 265574 0
Condition category
Condition code
Reproductive Health and Childbirth 265719 265719 0 0
Menstruation and menopause
Alternative and Complementary Medicine 265796 265796 0 0
Other alternative and complementary medicine

Study type
Description of intervention(s) / exposure
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.
Intervention code [1] 264361 0
Treatment: Devices
Comparator / control treatment
Women in the sham group will receive ten sessions of sham acupuncture according to the same schedule as the intervention group. Sham needles are blunt and do not penetrate the skin. Six non-acupuncture points will be "needled" and "retained" for twenty minutes, again with manual stimulation at ten minutes.
Control group

Primary outcome [1] 266482 0
Hot flush score (comprising hot flush severity and frequency measures) using seven-day hot flush diaries
Timepoint [1] 266482 0
End of treatment (8 weeks)
Secondary outcome [1] 273863 0
Quality of life as measured by the Menopause-Specific-Quality of Life Questionnaire (MENQOL)
Timepoint [1] 273863 0
End of treatment (8 weeks), 3 and 6 months post end of treatment
Secondary outcome [2] 273864 0
Hot flush score (comprising hot flush severity and frequency measures) using seven-day hot flush diaries
Timepoint [2] 273864 0
3 and 6 months post end of treatment
Secondary outcome [3] 273865 0
Expectancy and beliefs about acupuncture, and credibility of the sham control, as measured by the Credibility and Expectancy questionnaire
Timepoint [3] 273865 0
Immediately following the first treatment session

Key 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. )
Minimum age
40 Years
Maximum age
No limit
Can healthy volunteers participate?
Key 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
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A research assistant will randomly allocate the participants to either real or sham acupuncture using a computer generated randomisation schedule, stratified by practitioner and blocked randomised. She will inform the practitioner of group allocation by SMS or fax, depending on the practitioner’s preference. The group allocation will be indicated only by the point prescription to avoid unblinding should the participant inadvertently see the fax or SMS.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be computer-generated
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3898 0
Recruitment postcode(s) [2] 3899 0
Recruitment postcode(s) [3] 3900 0
Recruitment postcode(s) [4] 3901 0
Recruitment postcode(s) [5] 3902 0
Recruitment postcode(s) [6] 3903 0
Recruitment postcode(s) [7] 3904 0
Recruitment postcode(s) [8] 3905 0

Funding & Sponsors
Funding source category [1] 264834 0
Government body
Name [1] 264834 0
National Health and Medical Research Council
Address [1] 264834 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 264834 0
Primary sponsor type
University of Melbourne
Grattan St
Parkville 3052
Secondary sponsor category [1] 263988 0
Name [1] 263988 0
Address [1] 263988 0
Country [1] 263988 0

Ethics approval
Ethics application status
Ethics committee name [1] 266794 0
Human Research Ethics Committee
Ethics committee address [1] 266794 0
University of Melbourne
Ethics committee country [1] 266794 0
Date submitted for ethics approval [1] 266794 0
Approval date [1] 266794 0
Ethics approval number [1] 266794 0

Brief summary
This study aims to test if acupuncture is effective in treating hot flushes after the menopause.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 32445 0
Address 32445 0
Country 32445 0
Phone 32445 0
Fax 32445 0
Email 32445 0
Contact person for public queries
Name 15692 0
Dr Carolyn Ee
Address 15692 0
200 Berkeley St
Victoria 3053
Country 15692 0
Phone 15692 0
+61 413319830
Fax 15692 0
Email 15692 0
Contact person for scientific queries
Name 6620 0
Dr Marie Pirotta
Address 6620 0
200 Berkeley St
Victoria 3053
Country 6620 0
Phone 6620 0
+613 83449723
Fax 6620 0
Email 6620 0

No information has been provided regarding IPD availability
Summary results
No Results