Acupuncture for Hot Flushes in Menopause (ACUFLASH)

University Hospital of North Norway

Status: Completed

Conditions: Menopause; Hot Flashes

Treatments: Procedure: Traditional chinese medicine type acupuncture; Behavioral: Self Care

Study type: Interventional

Funder types: Other

Identifiers

NCT00284492

P REK NORD 102/2005

Details and patient eligibility

About

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.

Full 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).

Enrollment: 286 patients

Sex: Female

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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286 participants in 2 patient groups

Lifestyle advice

Active Comparator group

Treatment:

Behavioral: Self Care

Lifestyle advice and acupuncture therapy

Experimental group

Treatment:

Procedure: Traditional chinese medicine type acupuncture