Electro-acupuncture for Menopausal Transition Symptoms

Menopause Clinical Trial

Official title: A Randomized Pilot Study of Electro-acupuncture for Menopausal Transition Symptoms

Status Completed

Clinical Trial Summary

This trial aimed at exploring the efficacy as well as safety of electro-acupuncture for MT symptoms.

Clinical Trial Description

This was a RCT pilot study to assess the efficacy of Electro-acupuncture for menopausal transition participants.90 patients were randomly assigned to electro-acupuncture or sham electro-acupuncture group with a ratio of 1:1.During the whole process,all participants, evaluators and statisticians apart from acupuncturists remained strictly blinded.The changes of average 24 h hot flash scores of week8 from baseline was set as primary outcome. With statistical power of 90%, and a two-sided α at 0.05, as well as a drop-out rate less than 20%, sample size was estimated at 90 participants. Data analysis was based on ITT principles, and 89 participants were included in data analysis(1 participant didn't want to participate).According to methods of LOCF, missing data were imputed to fill any gaps according to the last visit. For comparison between baseline and treatment (average 24h hot flash scores, MRS, hormone levels), data was tested by the t test or nonparametric test; for comparison between two independent samples, data were tested with t test, nonparametric test or X2 test. P<0.05 was regarded as statistically significance. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Menopause

• NCT number: NCT02471755
• Study type: Interventional
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Status: Completed
• Phase: N/A
• Start date: April 2013
• Completion date: December 2014