Effectiveness of electro-press needle for menopause-associated hot flashes Protocol of a randomized controlled trial

Background: Hot flashes (HF) are a prevalent symptom associated with menopause affecting up to 85% of women aged 40 to 65 years. Previous studies indicated that acupuncture might relieve the symptom of HF significantly; however, its effectiveness has not been clarified quantitatively. Electro-press needles (EPN) is a novel acupuncture that combines a shallow tiny needle with an electrical transdermal stimulator. Either the needle or the electrical stimulator could function in the treatment. This study aims to evaluate the effectiveness of EPN in comparison with no intervention in relieving HF of perimenopausal and postmenopausal women. Methods/Design: This study will be a 2-arm randomized waitlist controlled trial. According to the ratio of 1:1 and block randomization, a total of 122 patients with moderate or severe HF will be randomly allocated to either EPN group or waitlist control group. The EPN group will receive 3 sessions of EPN treatment each week in consecutive 6 weeks, 18 sessions in total. The waitlist control group will get no intervention over the first 6 weeks. All the patients will be followed up in the next 24 weeks. The primary outcome will be the percentage of the participants whose 24-hour mean HF is 50% less than the baseline at Week 6. Secondary outcomes will include HF score, HF frequency, HF severity, the Menopause Rating Scale and Menopause-Specific Quality of Life Questionnaire Score. Discussion: This study will evaluate the effectiveness and safety of EPN treatment to alleviate HF symptoms in perimenopausal and postmenopausal women, excluding self-healing factors. The limitations of the trial design are its single-center scope, lack of placebo control and impossible to blind the acupuncturists and patients.