Effectiveness of acupuncture in the treatment of cyclic mastalgia: a study protocol for a randomized controlled trial.

BACKGROUND: About 68% of women aged 18-44 years have experienced cyclic mastalgia (CM), which occurs during the luteal phase of the menstrual cycle when elevated hormone levels induce greater breast gland thickness. CM has a moderate-to-severe impact on a woman's quality of life. Prior research has suggested that acupuncture may be beneficial for breast pain relief. In this study, we investigate the effectiveness of manual acupuncture (MA) in the treatment of CM compared with that of sham acupuncture (SA). METHODS: This is a multicenter, randomized, controlled trial. A total of 108 eligible CM patients will be randomly assigned to either MA (n = 54) or SA (n = 54) group using a 1:1 ratio and a stratified, blocked randomization. Acupuncture will be performed two weeks prior to menstruation and discontinued when menses begins. In both the MA and SA group, participants will be given acupuncture three times per week for 2 weeks per menstrual cycle for three consecutive menstrual cycles, encompassing a total of 18 sessions. The primary outcome will be the change in the average daily Breast Pain Visual Analog Scale (VAS-BP) over the first two weeks of menstruation from baseline to endpoints. The number of nominal days of breast pain (NDBP) two weeks before menstruation, World Health Organization Quality-of-Life Scale-Short Form scores, global patient assessment, breast glandular-section thickness, and breast-duct width three days before menstruation will also be measured as secondary outcomes. DISCUSSION: This prospective randomized trial will help evaluate the efficacy of acupuncture in treating CM. The results of this study will provide evidence of the therapeutic effectiveness of acupuncture on CM. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05408377 , registered on June 7, 2022.