Acupuncture for Hot Flushes in Menopause

NCT ID: NCT00284492

Last Updated: 2012-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 286 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2008-05-31

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).

Conditions

Menopause; Hot Flashes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lifestyle advice

Group Type: ACTIVE_COMPARATOR

Self Care

Intervention Type: BEHAVIORAL

Lifestyle advice on diet, physical activity

Lifestyle advice and acupuncture therapy

Group Type: EXPERIMENTAL

Traditional chinese medicine type acupuncture

Intervention Type: PROCEDURE

10 acupuncture sessions

Interventions

Traditional chinese medicine type acupuncture

10 acupuncture sessions

Intervention Type: PROCEDURE

Self Care

Lifestyle advice on diet, physical activity

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

The Research Council of Norway

OTHER

Sponsor Role: collaborator

University of Tromso

OTHER

Sponsor Role: collaborator

University Hospital of North Norway

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sameline Grimsgaard, MD, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of North Norway. No-9038 Tromsø, Norway

Locations

Clinical Research Center, University Hospital of North Norway

Tromsø, , Norway

Countries

Norway

Other Identifiers

P REK NORD 102/2005

Identifier Type: -

Identifier Source: org_study_id