Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000393954
Ethics application status
Approved
Date submitted
13/04/2011
Date registered
14/04/2011
Date last updated
24/10/2011
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
Nil
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

Intervention/exposure
Study type
Interventional
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
Placebo

Outcomes
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

Eligibility
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
Sex
Females
Can healthy volunteers participate?
Yes
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
Treatment
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
19/07/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3898 0
3058
Recruitment postcode(s) [2] 3899 0
3134
Recruitment postcode(s) [3] 3900 0
3084
Recruitment postcode(s) [4] 3901 0
3053
Recruitment postcode(s) [5] 3902 0
3149
Recruitment postcode(s) [6] 3903 0
3204
Recruitment postcode(s) [7] 3904 0
3337
Recruitment postcode(s) [8] 3905 0
3182

Funding & Sponsors
Funding source category [1] 264834 0
Government body
Name [1] 264834 0
National Health and Medical Research Council
Country [1] 264834 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Grattan St
Parkville 3052
Victoria
Country
Australia
Secondary sponsor category [1] 263988 0
None
Name [1] 263988 0
Address [1] 263988 0
Country [1] 263988 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266794 0
Human Research Ethics Committee
Ethics committee address [1] 266794 0
Ethics committee country [1] 266794 0
Australia
Date submitted for ethics approval [1] 266794 0
15/02/2011
Approval date [1] 266794 0
16/06/2011
Ethics approval number [1] 266794 0
1135293

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
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
Carlton
Victoria 3053
Country 15692 0
Australia
Phone 15692 0
+61 413319830
Fax 15692 0
Email 15692 0
[email protected]
Contact person for scientific queries
Name 6620 0
Dr Marie Pirotta
Address 6620 0
200 Berkeley St
Carlton
Victoria 3053
Country 6620 0
Australia
Phone 6620 0
+613 83449723
Fax 6620 0
Email 6620 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAcupuncture for menopausal hot flashes.2016https://dx.doi.org/10.7326/M15-1380
Dimensions AIInternational Scientific Acupuncture and Meridian Symposium 20162017https://doi.org/10.1016/j.jams.2017.02.004
N.B. These documents automatically identified may not have been verified by the study sponsor.