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Acupuncture for Hot Flushes in Menopause (ACUFLASH)

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ClinicalTrials.gov Identifier: NCT00284492
Recruitment Status : Completed
First Posted : January 31, 2006
Last Update Posted : May 14, 2012
Sponsor:
Collaborators:
The Research Council of Norway
University of Tromso
Information provided by (Responsible Party):
University Hospital of North Norway

Study Description
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Brief Summary:
In a pragmatic study investigate whether Traditional Chinese Medicine acupuncture-care decreases the frequency of hot flushes and increases health related quality of life among postmenopausal women. The intervention group will receive 10 sessions of acupuncture, the control group will engage in self care only. The study period lasts for 12 weeks.

Condition or disease Intervention/treatment Phase
Menopause Hot Flashes Procedure: Traditional chinese medicine type acupuncture Behavioral: Self Care Not Applicable

Detailed Description:

The study objective is to determine whether Traditional Chinese Medicine (TCM) acupuncture-care together with self-care is more effective than self-care alone, to relieve climacteric complaints among women who seek alternatives to hormonal replacement therapy (HRT). Study design is a pragmatic randomised controlled trial with two parallel arms. Study participants are postmenopausal women who document a mean value of 7 flushes/24 hours and who are not using HRT or other prescribed medication that may influence climacteric complaints. The treatment group will receive 10 sessions of TCM acupuncture-care and self-care; the control group will engage in self-care only.

The duration of intervention period is 12 weeks with evaluations at baseline, 4, 8, 12 weeks, and follow up at 6 and 12 months after baseline. Primary endpoint is change in daily hot flush frequency in the two groups from baseline to 12 weeks; secondary endpoint is health related quality of life. N in each treatment group: 143 (286 altogether).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 286 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Acupuncture-care for Treatment of Hot Flushes Among Postmenopausal Women
Study Start Date : February 2006
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2008

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Lifestyle advice Behavioral: Self Care
Lifestyle advice on diet, physical activity
Experimental: Lifestyle advice and acupuncture therapy Procedure: Traditional chinese medicine type acupuncture
10 acupuncture sessions


Outcome Measures
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Primary Outcome Measures :
  1. Frequency of hot flushes [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Health related quality of life (Women's Health Questionnaire) [ Time Frame: 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Postmenopausal women (at least one year past the last menstrual period) who are willing to receive acupuncture and who during two weeks of self-completed diaries10 document a mean value of 7 flushes/24 hours or more (or 50 flushes or more over a period of seven consecutive days), will be randomized after a baseline evaluation.
  • Current users prescribed medications that influence hot flush rate (e. g. HRT, SSRI's) can be included after a washout period. The washout-periods are eight weeks for SSRI's and systemic (including transdermal) HRT and four weeks for local estradiol preparations

Exclusion Criteria:

  • Surgical menopause
  • History of cancer within the past five years
  • Use of anticoagulant drugs
  • Heart valve disease
  • Poorly controlled hypertension
  • Hypothyroidism
  • Hyperthyroidism or diabetes mellitus
  • Organ transplant
  • Mental disease
  • Overt drug or alcohol dependency
  • Inability to complete study forms
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00284492


Locations
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Norway
Clinical Research Center, University Hospital of North Norway
Tromsø, Norway, No-9038
Sponsors and Collaborators
University Hospital of North Norway
The Research Council of Norway
University of Tromso
Investigators
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Principal Investigator: Sameline Grimsgaard, MD, MPH, PhD University Hospital of North Norway. No-9038 Tromsø, Norway
More Information
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Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT00284492    
Other Study ID Numbers: P REK NORD 102/2005
First Posted: January 31, 2006    Key Record Dates
Last Update Posted: May 14, 2012
Last Verified: May 2012
Keywords provided by University Hospital of North Norway:
Women
Acupuncture
Menopause
Hot flashes
Health related quality of life
Additional relevant MeSH terms:
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Hot Flashes