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
JAMA Jul 19, 2018
Hershman DL, et al. - This study assessed the impact of acupuncture in reducing aromatase inhibitor-related joint pain among postmenopausal women with early-stage breast cancer. Researchers reported that true acupuncture vs sham acupuncture or waitlist control resulted in a statistically significant reduction in joint pain at 6 weeks among postmenopausal women with early-stage breast cancer and aromatase inhibitor-related arthralgias, though the improvement was of uncertain clinical importance.
Methods
- From March 2012 to February 2017 (final date of follow-up, September 5, 2017), randomized clinical trial conducted at 11 academic centers and clinical sites in the US.
- Study participants were postmenopausal women with early-stage breast cancer taking an aromatase inhibitor and who scored at least 3 on the Brief Pain Inventory Worst Pain (BPI-WP) item (score range, 0-10; higher scores indicate greater pain).
- For this investigation, patients were randomly allocated 2:1:1 to true acupuncture (n=110), sham acupuncture (n=59), or waitlist control (n=57) group.
- True acupuncture and sham acupuncture protocols comprised of 12 acupuncture sessions over 6 weeks (2 sessions per week), followed by 1 session per week for 6 weeks.
- No intervention was received by the waitlist control group.
- Between weeks 24 and 52, all participants were offered 10 acupuncture sessions.
- The 6-week BPI-WP score was the primary end point.
- Researchers compared mean 6-week BPI-WP scores by study group using linear regression, adjusted for baseline pain and stratification factors (clinically meaningful difference specified as 2 points).
Results
- According to the findings, out of 226 randomized subjects (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.
- 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 from baseline to 6 weeks.
- It was observed that 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).
- Compared with patients in the sham acupuncture group (47% vs 25%; P=.01), patients in the true acupuncture group experienced more grade 1 bruising.
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