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).