Dawn L. Hershman, MD, MS1; Joseph M. Unger, PhD, MS2,3; Heather Greenlee, ND, PhD2; et al

• 1Columbia University Irving Medical Center, New York, New York

• 2Fred Hutchinson Cancer Center, Seattle, Washington

• 3SWOG Statistics and Data Management Center, Seattle, Washington

• 4Department of Urology, Mount Sinai Hospital, New York, New York

• 5Division of Cancer Prevention, National Cancer Institute, Bethesda, Maryland

• 6AIM Specialty Health, Chicago, Illinois

• 7Department of Medicine, University of Michigan, Ann Arbor

JAMA Netw Open. 2022;5(11):e2241720. doi:10.1001/jamanetworkopen.2022.41720

Key Points

Question  Does short-term acupuncture confer long-term reduction of joint pain related to aromatase inhibitors among women with breast cancer?

Findings  In this multicenter randomized clinical trial of 226 women with early-stage breast cancer, patients in the true acupuncture group who received 12 weeks of acupuncture, compared with those in the sham acupuncture group or the waiting list control group, had statistically significant reductions in joint pain scores at 52 weeks.

Meaning  Acupuncture was associated with a statistically significant decrease in aromatase inhibitor–related joint pain that persisted at 40 weeks after discontinuation of the intervention, suggesting long-term benefits of this therapy.

Abstract

Importance  Aromatase inhibitors (AIs) have proven efficacy for the treatment of hormone-sensitive breast cancer; however, arthralgias (pain and stiffness) contribute to nonadherence with therapy for more than 50% of patients.

Objective  To examine the effect of acupuncture in reducing AI-related joint pain through 52 weeks.

Design, Setting, and Participants  A randomized clinical trial was conducted at 11 sites in the US from May 1, 2012, to February 29, 2016, with a scheduled final date of follow-up of September 5, 2017, to compare true acupuncture (TA) with sham acupuncture (SA) or waiting list control (WC). Women with early-stage breast cancer were eligible if they were taking an AI and scored 3 or higher on the Brief Pain Inventory Worst Pain (BPI-WP) item (score range, 0-10; higher scores indicate greater pain). Analysis was conducted for data received through May 3, 2021.

Interventions  Participants were randomized 2:1:1 to the TA (n = 110), SA (n = 59), or WC (n = 57) group. The TA and SA protocols were composed of 6 weeks of intervention at 2 sessions per week (12 sessions overall), followed by 6 additional weeks of intervention with 1 session per week. Participants randomized to WC received no intervention. All participants were offered 10 acupuncture sessions to be used between weeks 24 and 52.

Main Outcomes and Measures  In this long-term evaluation, the primary end point was the 52-week BPI-WP score, compared by study group using linear regression, adjusted for baseline pain and stratification factors.

Results  Among 226 randomized women (mean [SD] age, 60.7 [8.6] years; 87.7% White; mean [SD] baseline BPI-WP score, 6.7 [1.5]), 191 (84.5%) completed the trial. In a linear regression, 52-week mean BPI-WP scores were 1.08 (95% CI, 0.24-1.91) points lower in the TA compared with the SA group (P = .01) and were 0.99 (95% CI, 0.12-1.86) points lower in the TA compared with the WC group (P = .03). In addition, 52-week BPI pain interference scores were statistically significantly lower in the TA compared with the SA group (difference, 0.58; 95% CI, 0.00-1.16; P = .05). Between 24 and 52 weeks, 12 (13.2%) of TA, 6 (11.3%) of SA, and 5 (10.6%) of WC patients reported receipt of acupuncture.

Conclusions and Relevance  In this randomized clinical trial, women with AI-related joint pain receiving 12 weeks of TA had reduced pain at 52 weeks compared with controls, suggesting long-term benefits of this therapy.

Trial Registration  ClinicalTrials.gov Identifier: NCT01535066