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Effectiveness of Acupuncture for Cyclical Mastalgia (CM)

Pinggu Hospital of Beijing Traditional Chinese Medicine Hospital · 2022
ClinicalTrials.gov · Datasets · License: Public Domain · 2022
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This study is a multi-center 2-arm randomized controlled trial. According to the ratio of 1:1 and block randomization, a total of 108 eligible CM patients will be randomly allocated to either MA(n=54) or SA(n=54). All patients will undergo treatment two weeks before menstruation and treatment will be stopped at the onset of menstruation. Three times a week, six times a menstrual cycle, 3consecutive menstrual cycles for a total of 18 sessions after baseline. The primary outcome will be the change in the average daily breast pain VAS(VAS-BP) scores during the first 2 weeks of menstruation from baseline at weeks 4,8,12. Additionally, VAS-BP scores at weeks 24 and 36 will also be assessed. Secondary outcomes will include the number of nominal days of breast pain (NDBP) 2 weeks before menstruation, WHOQOL-BREF scores, patient global assessment, breast glandular section thickness, and breast duct width three days before menstruation from baseline at weeks 12. This study will evaluate the effectiveness and safety of acupuncture to alleviate cyclic breast pain and to further explore the possible mechanisms underlying the effect.
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