Abstract / Summary
Abstract Background Cyclic mastalgia (CM) significantly impairs women’s quality of life, yet effective treatment options are limited. While acupuncture may offer relief for breast pain, its long-term efficacy remains uncertain. This study aimed to assess the long-term effects of manual acupuncture (MA) versus sham acupuncture (SA) in women with CM. Method This 36-week multicenter, sham-controlled, randomized clinical trial enrolled adult women with CM and was conducted in outpatient settings at three clinical centers in China. Participants were randomized in a 1:1 ratio to receive either MA or SA intervention. Both groups underwent 18 acupuncture sessions over 12 weeks. The primary outcome was the Visual Analogue Scale for Breast Pain (VAS-BP) score change from baseline to week 12. Secondary outcomes included response rate, duration of pain days and quality of life. Results Of the 108 participants enrolled, 94 (87.0%) completed the trial. In the intention-to-treat (ITT) analysis ( N = 108), the MA group showed a reduction in VAS-BP score at week 12 compared with the SA group (between-group difference, − 2.0; 95% CI, − 2.5 to − 1.4), sustained through week 36 (difference, − 2.2; 95% CI, − 2.8 to − 1.6). The MA group also demonstrated a significant reduction in breast pain days at week 12 (difference, − 2.0 days; 95% CI, − 3.0 to − 1.0) and week 36 (difference, − 3.0 days; 95% CI, − 4.0 to − 2.0). The MA group achieved greater improvements in WHOQOL-BREF total score (13.5 points; 95% CI, 5.1 to 21.7) and physical health domain score (1.0 points; 95% CI, 0.2 to 1.8). The response rate at week 12 was 72.2% (39/54) in the MA group versus 22.2% (12/54) in the SA group. Three mild adverse events occurred in the MA group; none were reported in the SA group. Therefore, MA interventions were more clinically effective in reducing CM over 36 weeks than SA. Conclusion In this randomized clinical trial, MA significantly reduced breast pain and improved quality of life in women with CM compared with SA. These effects were sustained for up to 24 weeks post-treatment. Trial registration ClinicalTrials.gov Identifier: NCT05408377, Registered 7 June 2022.