Background
Aromatase Inhibitors (AIs) have been associated with decrements in patient-reported outcomes (PROs).
Objectives
To assess if real acupuncture (RA) compared to sham acupuncture (SA) improves PROs in breast cancer patients taking adjuvant AI.
Methods
Postmenopausal women with a stage 0-III breast cancer on AI with treatment-associated musculoskeletal symptoms were randomized to 8 weekly RA vs SA in a dual-center randomized controlled trial. National Surgical Adjuvant Breast and Bowel Project (NSABP) menopausal symptoms questionnaire, Center for Epidemiological Studies Depression (CESD), Hospital Anxiety and Depression Scale (HADS), Pittsburgh Sleep Quality Index (PSQI), Hot Flash Daily Diary, Hot Flash Related Daily Interference Scale (HFRDI) and EuroQol survey were used to assess PROs at baseline, 4, 8, and 12 weeks.
Results
The intention-to-treat analysis included 23 RA and 24 SA patients. There were no significant differences in baseline characteristics between groups. Compared to baseline, scores of RA patients improved significantly at week 8 on CESD (p=0.022), hot flash severity (p=0.006), hot flash frequency (p=0.011), HFRDI (p=0.014) and NSABP menopausal symptoms (p=0.022); scores of SA patients improved significantly on EuroQol (p=0.022), HFRDI (p=0.043) and NSABP menopausal symptoms (p=0.005). Post hoc analysis indicated that African American (AA) patients (n=9) benefited more from RA than SA when compared to non-AA patients (n=38) in reducing hot flash severity (p<0.001) and frequency (p<0.001) scores.
Conclusion
RA and SA were both associated with improvement in PROs in breast cancer patients taking AIs. We detected no significant difference between arms. Racial difference in response to acupuncture warrants further study.