Acupuncture for Hot Flushes in Menopause

Menopause Clinical Trial

— ACUFLASH  

Official title:

Effectiveness of Acupuncture-care for Treatment of Hot Flushes Among Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00284492
• Other study ID #: P REK NORD 102/2005
• Status: Completed
• Phase: N/A
• First received: January 30, 2006
• Last updated: May 11, 2012
• Start date: February 2006
• Est. completion date: May 2008

Study information

• Verified date: May 2012
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: May 2008
• Est. primary completion date: May 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hot Flashes
• Menopause

Intervention

Procedure:
• Traditional chinese medicine type acupuncture
10 acupuncture sessions

Behavioral:
• Self Care
Lifestyle advice on diet, physical activity

Locations

Country	Name	City	State
Norway	Clinical Research Center, University Hospital of North Norway	Tromsø

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital of North Norway	The Research Council of Norway, University of Tromso

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of hot flushes		12 weeks	No
Secondary	Health related quality of life (Women's Health Questionnaire)		12 weeks	No