NCT05922800

Effectiveness of Electro-Press Needle and Gamma-Oryzanol for Menopause-associated Hot Flashes

Effectiveness and Safety of Electro-press Needle and Gamma-oryzanol for Menopause-associated Hot Flashes: Protocol of a Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Dongzhimen Hospital, Beijing · Academic / Other
• Sex: Female
• Age: 40 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The investigators plan to conduct the randomized controlled trial to evaluate the effectiveness of electro-press needle (EPN), a novel acupuncture needle combining shallow and gentle insertion with transdermal electrical stimulation, on menopause-associated hot flash in comparison with gamma-oryzanol group among women during menopausal transition and postmenopausal periods.

Detailed description

As the most common type of menopause-associated symptoms, hot flashes affect up to 85% of women aging between 40 and 65 years . In China, women suffer from hot flushes as long as 4 to 5 years on average, some of whom may bear the symptoms for 12 years.Hormone replacement therapy (HRT) is generally recommended to relieve menopause-associated hot flashes.However, long-term usage of HRT may increase the incidence of endometrial, breast and ovarian cancer, thrombosis and strokes.Results of previous studies indicated that acupuncture might help to relieve the symptoms.There is insufficient evidence supporting its effectiveness for relieving the hot flash symptom.

Conditions

• Hot Flashes
• Acupuncture Therapy
• Perimenopausal Disorder
• Postmenopausal Symptoms

Interventions

Type	Name	Description
DEVICE	Electro Press Needle	Body acupoints will be stimulated by the press needles 0.25mm in diameter and 2mm in length and ear acupoints will be stimulated by the press needles 0.25mm in diameter and 0.9mm in length (all from ZhenXing Brand, Hangzhou Yuanli Medical Appliance Factory, China). After sterilization of the local skin, the needle will be pressed to the acupoints and the tape will be sticked to the skin. Then, the electric device (φ44×15.8mm Type ZXHPAMDZB-02C) together with the electrode patch will be sticked to the surface of skin (on top of the sticky tapes of the press needle) in the area of CV4 and bilateral EX-CA1, and bilateral SP6 respectively. The electric device will be switch to the mode of "dense intermittent wave", and the current intensity will be increased gradually till the muscles around jumps slightly.All the needles on the body acupoints will be removed after each session, while those on the auricular acupoints can be kept for as long as 6 hours (removed before going to bed).
DRUG	Gamma-Oryzanol	The patients in this group were given orally gamma-oryzanol tablets 20mg each time, three times a day, for 6 months.

Timeline

• Start date: 2023-06-19
• Primary completion: 2023-12-31
• Completion: 2024-06-30
• First posted: 2023-06-28
• Last updated: 2023-06-28