Acupuncture for menopausal vasomotor symptoms: a randomized controlled trial

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

1. Be deemed postmenopausal (at least 12 months past the final menstrual period) or in the late menopausal transition (Follicular Stimulating Hormone/FSH level of 25 IU or greater, amenorrhoea of >=60 days and currently experiencing VMS). (Women who have had a hysterectomy are included if an FSH level is greater than 40 IU and they are between 40 and 60 years);
2. Record a mean hot flush score of at least 14 over 7 days during the run-in period (equivalent to an average of seven moderately-severe hot flushes a day and assessed using a validated Hot Flush Diary);
3. Meet the criteria for the Traditional Chinese medicine ( TCM) diagnosis of Kidney Yin deficiency determined using a structured Chinese medicine history and examination (sensations of heat in the body with sweating; aching and soreness in the lower back and knees/dizziness or tinnitus; feelings of heat in the palms, soles and chest / dry mouth or dry hard stool/ dry vagina/ insomnia and dreaminess(at least two of four); red tongue with scant coat; rapid fine pulse).

Exclusion Criteria

1. Younger than 40 years of age (therefore diagnosed as having Premature Ovarian Failure) or have previously been diagnosed with premature ovarian failure when they are less than 40 years of age;
2. Have had a bilateral salpingo-oophorectomy;
3. Have any medical reason to be amenorrheic (for example pregnancy, hyperprolactinemia, Cushings syndrome);
4. Have poorly controlled hyperthyroidism or hypothyroidism;
5. Are experiencing VMS that started or became worse after diagnosis of breast cancer or commencing treatment for breast cancer;
6. Are currently taking HRT, with the following washout periods to be observed: transdermal (four weeks), oral or intrauterine HRT (eight weeks), progestin implant/oestrogen injectable, phytoestrogen therapy (three months), oestrogen pellet/progestin injectable (six months);
7. Have ceased any other treatment for hot flushes within twelve weeks of screening (including complementary medicines);
8. Have commenced using any other pharmacological or complementary therapy for hot flushes in the past eight weeks;
9. Have commenced using vaginal oestrogen therapy in the past twelve weeks;
Have relative contraindications to acupuncture (use of anticoagulant drugs, heart valve disease, poorly controlled diabetes mellitus).