Long-term results from a randomized blinded sham- and waitlist-controlled trial of acupuncture for joint symptoms related to aromatase inhibitors in early stage breast cancer (S1200).
Authors: Hershman Dawn L. , Unger Joseph M. , Greenlee Heather , Capodice Jillian , Lew Danika , Darke Amy , Minasian Lori M. , Fisch Michael Jordan , Henry Norah Lynn , Crew Katherine D. 
Published: June 2021

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Background: Musculoskeletal symptoms are the most common side effect of aromatase inhibitors (AIs) among breast cancer (BC) survivors. We previously reported that true acupuncture (TA) resulted in better pain outcomes than either sham acupuncture (SA) or wait-list controls (WC) at 6 weeks with durable effects through 24 weeks, with minimal toxicity. We now report the 52-week outcomes. Methods: We conducted a SWOG multicenter randomized controlled trial among postmenopausal women with early-stage BC. Patients taking an AI for ≥30 days and reporting a worst pain score of ≥3 out of 10 using the Brief Pain Inventory-Worst Pain (BPI-WP) were eligible. Subjects were randomized 2:1:1 to TA vs. SA vs. WC. Both the TA and SA protocols consisted of a 12-week intervention, with 2 sessions per week for 6 weeks, followed by 1 session per week for 6 additional weeks. At 24 weeks, all subjects remained blinded to intervention arm but were offered 10 sessions of true acupuncture. Endpoints included BPI scores, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for hips and knees, the Modified Score for the Assessment of Chronic Rheumatoid Affections of the Hands (M-SACRAH), PROMIS Pain Inventory Short Form (PI-SF), and Functional Assessment of Cancer therapy Endocrine Symptoms (FACT-ES). Results: Among 226 patients registered, 110 were randomized to TA, 59 to SA and 57 to WC. Baseline characteristics were similar among the arms. At 52 weeks, follow-up assessments were available for 91 (82.7%) TA, 53 (89.8%) SA, and 47 (82.5%) WC patients. In a linear regression adjusting for the baseline score and stratification factors, 52-week mean BPI-WP scores were 1.08 points lower (correlating with less pain) in the TA compared to SA arm (95% CI: 0.24-1.91, p =.01), and were 0.99 points lower in the TA compared to WC arm (95% CI: 0.12-1.86, p =.03). The proportion of patients experiencing a clinically meaningful (>2) reduction (i.e. improvement) in BPI-WP was 64% for TA compared to 45% on SA and 53% on WC. Patients randomized to TA had reduced BPI pain interference at 52 weeks compared to SA (adjusted difference = 0.58, 95% CI: 0.00-1.16, p =.05) but not compared to WC (adjusted difference = 0.33, 95% CI: -0.28-0.93, p =.29). Also, at 52 weeks, patients randomized to TA had improved PROMIS PI-SF T-scores compared to SA (adjusted difference = 2.35, 95% CI: 0.07-4.63, p =.04) but not compared to WC (adjusted difference = 1.28, 95% CI: -1.09-3.66, p =.29). No statistically significant differences were observed in other measures. Conclusions: Women with breast cancer receiving AI therapy and treated with 12 weeks of TA for joint symptoms had reduced levels of worst pain compared to control patients, an effect that was durable through one year despite completion of protocol acupuncture at 12 weeks, and the offering of acupuncture to all participants at 24 weeks. Clinical trial information: NCT01535066.