Acupuncture reduced joint pain caused by aromatase inhibitor treatment in a randomized, Phase III clinical trial
Acupuncture significantly reduced joint pain for postmenopausal women with early-stage breast cancer receiving treatment with an aromatase inhibitor compared with both sham acupuncture and no treatment, according to data from the randomized, phase III SWOG S1200 clinical trial presented at the 2017 San Antonio Breast Cancer Symposium, held Dec. 5–9.
"Aromatase inhibitors are among the most common and most effective treatments for postmenopausal women diagnosed with hormone receptor–positive breast cancer; however, many patients suffer from side effects that cause them to miss treatments or stop treatment altogether," said Dawn L. Hershman, MD, leader of the Breast Cancer Program at the Herbert Irving Comprehensive Cancer Center at NewYork-Presbyterian/Columbia University Medical Center. "We need to identify strategies to control these side effects, the most common of which is debilitating joint pain and stiffness.
"The data from this randomized, phase III clinical trial indicate that health care practitioners should discuss the possibility of acupuncture with patients experiencing aromatase inhibitor–related joint pain and stiffness because it has the potential to improve their quality of life," continued Hershman, who is also a vice chair of SWOG, the global cancer clinical trials network funded by the National Cancer Institute (NCI). "We hope that by reducing the debilitating side effects of aromatase inhibitor treatment, acupuncture may improve adherence to treatment and thereby outcomes, but we need to conduct further studies to determine if this is indeed the case."
Hershman explained that many patients don't want to take more medications to relieve symptoms caused by aromatase inhibitor treatment. Acupuncture is a traditional Chinese method of medical treatment involving the insertion of fine, single-use, sterile needles in defined acupoints. A number of small, single-institution studies have suggested that it may provide an alternative approach to reducing aromatase inhibitor–related joint pain and stiffness.
Therefore, Hershman and colleagues designed and conducted a multicenter, randomized, blinded trial evaluating whether acupuncture could reduce aromatase inhibitor–related joint symptoms in postmenopausal women diagnosed with early-stage, hormone receptor–positive breast cancer.
The researchers enrolled 226 patients in the trial: 110 were randomized to true acupuncture; 59 to sham acupuncture, which involves superficially inserting needles in nonacupoints; and 57 to waitlist control, which meant no treatment. Patients receiving true acupuncture or sham acupuncture had twice-weekly sessions for six weeks followed by one session per week for six more weeks. Patients reported on their pain before, during, and after treatment using various methods, including the Brief Pain Inventory–Short Form (BPI), a self-administered 14-item questionnaire used to evaluate the severity of a patient's pain on a 0 to 10 scale, where higher scores indicate more pain, and the impact of this pain on the patient's daily functioning.
After six weeks, patients in the true acupuncture treatment arm reported significantly lower BPI worst pain scores compared with those in the sham acupuncture and the waitlist control arms. The mean BPI worst pain for the true acupuncture arm was 0.92 points lower than the mean BPI worst pain for the sham acupuncture arm and 0.96 points lower than the mean BPI worst pain for the waitlist control arm. In addition, the proportion of patients who had a large reduction in BPI worst pain, a reduction of two or more points, was significantly greater in the true acupuncture arm than in the sham acupuncture and the waitlist control arms: 58 percent compared with 33 percent and 31 percent, respectively. The differences remained statistically significant when assessed at 24 weeks, even though the intervention was 12 weeks.
The most common adverse event reported among those receiving true and sham acupuncture was bruising.
"We were very pleased to see acupuncture had durable beneficial effects with no significant side effects in a large, rigorous clinical trial," said Hershman. "We hope that these data will not only encourage health care practitioners to discuss acupuncture as a complementary therapy for patients receiving aromatase inhibitors, but that they will also enhance payers' willingness to reimburse these patients for acupuncture."