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

This multicenter randomized clinical trial investigated the efficacy of true acupuncture compared with sham acupuncture and waitlist control for the treatment of aromatase inhibitor-related arthralgias in women with early-stage breast cancer. The study was conducted at 11 academic and community centers in the United States between March 2012 and February 2017 and represents one of the largest and most rigorous studies on acupuncture for this specific condition. Aromatase inhibitor-induced arthralgias are a common adverse effect that affects approximately 50% of patients and often leads to treatment discontinuation, negatively impacting disease-free survival. The study methodology was carefully designed to address limitations of previous studies, including small samples, inadequate blinding, and single-center implementation.

The acupuncture protocol was developed by expert consensus based on prior studies and followed STRICTA recommendations. A 2:1:1 randomization resulted in 110 patients in the true acupuncture group, 59 in the sham group, and 57 on the waitlist. The protocol consisted of 12 sessions of 30-45 minutes over 6 weeks (twice weekly), followed by one session per week for an additional 6 weeks. True acupuncture used sterile needles inserted at traditional depths at specific points for up to three of the most painful joints, while sham acupuncture used superficial insertion at non-acupuncture points.

The primary outcome was the Brief Pain Inventory worst pain score (BPI-WP) at 6 weeks, with a pre-specified clinically meaningful difference of 2 points. Results showed mean observed reductions in BPI-WP of 2.05 points in the true acupuncture group, 1.07 points in the sham group, and 0.99 points in the waitlist group. Adjusted differences were 0.92 points (95% CI: 0.20-1.65; p=0.01) for true acupuncture vs sham and 0.96 points (95% CI: 0.24-1.67; p=0.01) for true acupuncture vs waitlist. Although statistically significant, these differences did not meet the pre-specified 2-point threshold for clinical significance.

Secondary analyses showed consistent improvements in measures of pain, stiffness, and function. A post hoc analysis revealed that 58% of patients in the true acupuncture group experienced a reduction of at least 2 points, compared with 33% in the sham group and 31% in the waitlist group. Effects were partially maintained during the maintenance and follow-up periods. The study demonstrated excellent retention (91.1%) and a low incidence of adverse events, primarily mild bruising.

Strengths of the study include its multicenter design, rigorous standardized acupuncturist training, the use of multiple control groups, and high methodological quality. Limitations include the inability to blind the waitlist group, partial unblinding between acupuncture groups, and uncertainty about the clinical importance of the observed differences. This study contributes significantly to the literature on acupuncture in oncology, providing evidence that acupuncture may offer modest but statistically significant benefits for aromatase inhibitor-induced arthralgias, although clinical relevance remains uncertain.