Clinical trial NCT00284492: Acupuncture for Hot Flushes in Menopause
Official title: Effectiveness of Acupuncture-care for Treatment of Hot Flushes Among Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Hot Flashes
Keywords: Women
Acupuncture
Menopause
Hot flashes
Health related quality of life
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
name: University of Tromso
First posted: 2006-01-31
Enrollment: 286
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Frequency of hot flushes
timeFrame: 12 weeks
Secondary outcomes:
measure: Health related quality of life (Women's Health Questionnaire)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: Clinical Research Center, University Hospital of North Norway
Study officials:
affiliation: University Hospital of North Norway. No-9038 Tromsø, Norway
name: Sameline Grimsgaard, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References: