Use acupuncture to relieve perimenopausal syndrome: study protocol of a randomized controlled trial

Table 1 Trial processes chart

	Baseline	Treatment phase			Follow-up phase
	Week −1	Week 0	Week 4	Week 12	Week 16	Week 24	Week 36
Patients
Enrollment	×
Informed consent	×
Signed informed consent		×
Medical history	×
Physical examination	×		×	×
Laboratory test	×			×		×
Breast and gynecological ultrasound	×			×
Randomization		×
Expectation of acupuncture		×
Intervention
Acupuncture plus auricular acupressure treatment group (n = 103)			28 sessions of acupuncture
Comparison
Climen® control group (n = 103)			E₂V 2 mg/day for days 1 to 11 and E₂V 2 mg + CPA 1 mg/day for days 12 to 21
Outcomes
MRS		×	×	×	×	×	×
MENQOL		×	×	×	×	×	×
Average hot flash score during 24 hours		×	×	×	×	×	×
Serum estradiol, FSH and LH levels	×			×		×
Patients’ satisfaction			×	×
Trial evaluation
Safety of acupuncture			×	×
Cost–benefit analysis				×
Reasons of drop-outs or withdrawals							×
Patients’ compliance							×
Adverse events							×
Medicine alliance							×

CPA, cyroterone acetate; E₂V, estradiol valerate; FSH, follicle-stimulating hormone; LH, luteinizing hormone; MRS, Menopause Rating Scale; MENQOL, Menopause-Specific Quality of Life. Climen® from Bayer Healthcare Company Limited (Guangzhou, China).

ISSN: 1745-6215