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Original Investigation
July 10, 2018

Effect of Acupuncture vs Sham Acupuncture or Waitlist Control on Joint Pain Related to Aromatase Inhibitors Among Women With Early-Stage Breast Cancer: A Randomized Clinical Trial

Author Affiliations
  • 1Columbia University Medical Center, New York, New York
  • 2Fred Hutchinson Cancer Research Center, Seattle, Washington
  • 3SWOG Statistics and Data Management Center, Seattle, Washington
  • 4Mount Sinai Hospital, New York, New York
  • 5Kaiser Permanente Medical Center, Walnut Creek, California
  • 6Spectrum Health Medical Group, Grand Rapids, Michigan
  • 7NCORP of the Carolinas (Greenville Health System), Greenville, South Carolina
  • 8St Luke’s Mountain States Tumor Institute (PCRC NCORP), Boise, Idaho
  • 9Division of Cancer Prevention, National Cancer Institute, Bethesda, Maryland
  • 10AIM Specialty Health, Chicago, Illinois
  • 11University of Utah Huntsman Cancer Institute, Salt Lake City
JAMA. 2018;320(2):167-176. doi:10.1001/jama.2018.8907
Key Points

Question  Does acupuncture reduce joint pain related to aromatase inhibitors among postmenopausal women with early-stage breast cancer?

Findings  In this multicenter randomized clinical trial of 226 women with early-stage breast cancer, patients in the acupuncture group, compared with those in the sham acupuncture group or the waitlist control group, had significant reductions in changes in joint pain scores from baseline to 6 weeks (between-group difference vs sham acupuncture, 0.92 points and 0.96 points vs the waitlist control group [0- to 10-point scale]).

Meaning  Acupuncture was associated with statistically significant reductions in aromatase inhibitor–related joint pain at 6 weeks, although the magnitude of the improvement was of uncertain clinical importance.


Importance  Musculoskeletal symptoms are the most common adverse effects of aromatase inhibitors and often result in therapy discontinuation. Small studies suggest that acupuncture may decrease aromatase inhibitor–related joint symptoms.

Objective  To determine the effect of acupuncture in reducing aromatase inhibitor–related joint pain.

Design, Setting, and Patients  Randomized clinical trial conducted at 11 academic centers and clinical sites in the United States from March 2012 to February 2017 (final date of follow-up, September 5, 2017). Eligible patients were postmenopausal women with early-stage breast cancer who were taking an aromatase inhibitor and scored at least 3 on the Brief Pain Inventory Worst Pain (BPI-WP) item (score range, 0-10; higher scores indicate greater pain).

Interventions  Patients were randomized 2:1:1 to the true acupuncture (n = 110), sham acupuncture (n = 59), or waitlist control (n = 57) group. True acupuncture and sham acupuncture protocols consisted of 12 acupuncture sessions over 6 weeks (2 sessions per week), followed by 1 session per week for 6 weeks. The waitlist control group did not receive any intervention. All participants were offered 10 acupuncture sessions to be used between weeks 24 and 52.

Main Outcomes and Measures  The primary end point was the 6-week BPI-WP score. Mean 6-week BPI-WP scores were compared by study group using linear regression, adjusted for baseline pain and stratification factors (clinically meaningful difference specified as 2 points).

Results  Among 226 randomized patients (mean [SD] age, 60.7 [8.6] years; 88% white; mean [SD] baseline BPI-WP score, 6.6 [1.5]), 206 (91.1%) completed the trial. From baseline to 6 weeks, the mean observed BPI-WP score decreased by 2.05 points (reduced pain) in the true acupuncture group, by 1.07 points in the sham acupuncture group, and by 0.99 points in the waitlist control group. The adjusted difference for true acupuncture vs sham acupuncture was 0.92 points (95% CI, 0.20-1.65; P = .01) and for true acupuncture vs waitlist control was 0.96 points (95% CI, 0.24-1.67; P = .01). Patients in the true acupuncture group experienced more grade 1 bruising compared with patients in the sham acupuncture group (47% vs 25%; P = .01).

Conclusions and Relevance  Among postmenopausal women with early-stage breast cancer and aromatase inhibitor–related arthralgias, true acupuncture compared with sham acupuncture or with waitlist control resulted in a statistically significant reduction in joint pain at 6 weeks, although the observed improvement was of uncertain clinical importance.

Trial Registration  ClinicalTrials.gov Identifier: NCT01535066