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Acupuncture for Hot Flushes in Menopause (ACUFLASH)

This study has been completed.
Sponsor:
Collaborators:
The Research Council of Norway
University of Tromso
Information provided by (Responsible Party):
University Hospital of North Norway
ClinicalTrials.gov Identifier:
NCT00284492
First received: January 30, 2006
Last updated: May 11, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention
Menopause
Hot Flashes
 Procedure: Traditional chinese medicine type acupuncture
Behavioral: Self Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of Acupuncture-care for Treatment of Hot Flushes Among Postmenopausal Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital of North Norway:

Primary Outcome Measures:
  • Frequency of hot flushes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health related quality of life (Women's Health Questionnaire) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 286
Study Start Date: February 2006
Study Completion Date: May 2008
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00284492

Locations
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
Principal Investigator: Sameline Grimsgaard, MD, MPH, PhD University Hospital of North Norway. No-9038 Tromsø, Norway
  More Information

No publications provided

Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT00284492     History of Changes
Other Study ID Numbers: P REK NORD 102/2005
Study First Received: January 30, 2006
Last Updated: May 11, 2012
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by University Hospital of North Norway:
Women
Acupuncture
Menopause
Hot flashes
Health related quality of life

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013