Comparison of Acupuncture vs Sham Acupuncture or Waiting List Control in the Treatment of Aromatase Inhibitor-Related Joint Pain: A Randomized Clinical Trial

Joint pain is one of the leading reasons why women with breast cancer discontinue treatment with aromatase inhibitors, medications essential for preventing disease recurrence. This problem affects more than half of patients using this hormonal therapy, which is known for its efficacy in treating hormone-sensitive breast cancer. The search for safe and effective alternatives to control these joint pains, called arthralgias, has been a priority in oncology, especially considering that early discontinuation of treatment may significantly compromise patients' chances of cure.

This study, coordinated by the Southwest Oncology Group, was a randomized clinical trial that followed 226 women with early-stage breast cancer for 52 weeks to evaluate the lasting effects of acupuncture on joint pain caused by aromatase inhibitors. The study was conducted at 11 medical centers in the United States between 2012 and 2016, with follow-up through 2017. Participants were randomly divided into three groups: one group received true acupuncture, another received sham acupuncture (in which needles are inserted superficially at non-therapeutic points), and a third group remained on a waiting list with no treatment. To participate, women had to be using aromatase inhibitors for at least 30 days and present joint pain of intensity 3 or greater on a 0 to 10 scale.

The acupuncture protocol consisted of 12 weeks of treatment, with two weekly sessions during the first six weeks, followed by one weekly session for another six weeks.

The results demonstrated durable benefits of true acupuncture compared with the control groups. After 52 weeks, patients who received true acupuncture showed a significant reduction in pain intensity, with a mean difference of 1.08 points on the pain scale compared with the sham acupuncture group and 0.99 points compared with the waiting list group. These differences remained statistically significant even 40 weeks after the end of acupuncture treatment. In addition to the reduction in pain intensity, the true acupuncture group also showed less interference of pain in daily activities and lower need for analgesic medications during the study.

Approximately 45% of patients in the true acupuncture group who were not using pain medications at baseline needed to start such medications during follow-up, compared with about 68% in the control groups.

The clinical implications of these findings are significant for both patients and health professionals. For patients, the results suggest that acupuncture may offer a safe and effective alternative for controlling joint pain associated with aromatase inhibitors, potentially reducing the need for analgesic medications and improving quality of life. The fact that the benefits persisted for many months after the end of treatment is especially encouraging, suggesting that a relatively short course of acupuncture may provide lasting relief. For oncologists, these data provide robust scientific evidence to recommend acupuncture as a complementary therapy, especially considering that adherence to hormonal therapy is crucial to prevent breast cancer recurrence.

Integrating acupuncture into multidisciplinary care may help patients complete the recommended five-year course of hormonal therapy.

The study has some important limitations that should be considered when interpreting the results. Pain assessment is subjective and may be influenced by several factors beyond medication and the treatment studied. There is no scientific consensus on what magnitude of pain reduction should be considered clinically significant, although the results obtained are consistent with other positive studies on pain control. The placebo effect, common in pain studies, was partially controlled by the use of both sham acupuncture and a waiting list group, but improvement was observed in all groups over time.

In addition, approximately 10% of patients in each group received additional acupuncture between weeks 24 and 52, which may have reduced the differences observed between groups. Access to acupuncture may also be limited by health insurance coverage issues in many locations. This study reinforces the importance of acupuncture as a valuable therapeutic tool for women with breast cancer who face joint pain due to hormonal therapy, offering an option with durable benefits and a favorable safety profile.