1. JAMA. 2018 Jul 10;320(2):167-176. doi: 10.1001/jama.2018.8907.

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.

Hershman DL(1), Unger JM(2)(3), Greenlee H(2), Capodice JL(4), Lew DL(2)(3),
Darke AK(2)(3), Kengla AT(5), Melnik MK(6), Jorgensen CW(7), Kreisle WH(8),
Minasian LM(9), Fisch MJ(10), Henry NL(11), Crew KD.

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

Comment in
    JAMA. 2018 Dec 4;320(21):2269-2270.
    JAMA. 2018 Dec 4;320(21):2270.

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.

DOI: 10.1001/jama.2018.8907 
PMID: 29998338  [Indexed for MEDLINE]