PHILADELPHIA — Acupuncture can decrease the joint pain side effects often reported by breast cancer patients taking aromatase inhibitors (AIs), according to results of a new randomized trial conducted by a research team from the Abramson Cancer Center of the University of Pennsylvania. Their findings were published online this month in the European Journal of Cancer.
Aromatase inhibitors are the most commonly used medications to prevent disease recurrence among post-menopausal women with early-stage, hormone receptor positive breast cancer. Despite their efficacy, the drugs cause arthralgia, or joint pain, in nearly half of the women taking them – the symptoms can be so severe that previous studies have shown that nearly half of women stop taking AIs too soon, potentially depriving themselves of the drugs’ lifesaving benefits. The new Penn study is the first to establish a clinical benefit associated with the use of electro-acupuncture to relieve these symptoms, which could potentially help keep more women on the drugs for as long as they’re recommended.
“We see patients every day in the clinic who report that they have benefited from acupuncture, but until now, we have not had the scientific evidence we need to support what we hear from these women,” said the study’s lead author, Jun Mao, MD, MSCE, an associate professor of Family Medicine and Community Health in Penn’s Perelman School of Medicine, who directs the Integrative Oncology program in the Abramson Cancer Center. “This study is not the final answer, but it does provide strong evidence that acupuncture can play a role in controlling pain for breast cancer patients with AI related arthralgia. We saw a significant reduction in pain levels in the acupuncture groups with only very mild, short-term adverse effects.”
The Penn study enrolled 67 women with a history of early breast cancer who were receiving an AI (Anastrozole, Letrozole or Exemestane), had reported having joint pain related to their treatment for at least three months and rated their pain at least a four on an 11-point scale. That rating is significant because patients with pain ratings of four or more are more likely to discontinue their AI treatment. The study participants were randomized into three groups: those receiving electro-acupuncture (EA), those receiving sham acupuncture (SA) and those in the wait-list control group (WLC). Women in the EA group received a total of 10 treatments over an eight week period. The SA group received the same number of treatments but the needles used were similar to stage daggers, with a needle that retracts without actually being inserted into the skin. The WLC group was told that they would receive 10 acupuncture treatments once the study ended. All patients received education on joint pain and the importance of physical activity, and all agreed to continue their AIs for the duration of the trial.
By the eighth week of the trial, the EA group experienced a 43 percent reduction in pain severity and 53 percent reduction in their reports of pain that interfered with their ability to conduct their normal activities, as compared to their baseline or beginning scores. The study used the Brief Pain Inventory (BPI) that allows patients to measure their own pain and the extent to which it is interfering with their lives. Using a different scale, more patients in the EA group than the WLC group also reported their pain as “much improved” or “very much improved.” The patient reported data were supported by physical assessments.
The SA group also showed a statistically significant decrease in their BPI severity score compared to the WLC control group. The benefits to both groups persisted at the follow up evaluation at Week 12. Mao noted, however, that the study size was too small to distinguish the benefits of actual EA treatment from that of the Sham group. Since sham acupuncture is not a true placebo – Mao notes that it is still an active intervention with a real sensory effect on the skin – additional studies will be necessary to detect the real differences between the two methods.
“We are very encouraged that this study achieved its primary goal of demonstrating that acupuncture can significantly reduce the severity of pain in women with arthralgia related to AI therapy,” said Dr. Mao. “We were also encouraged that the follow up data provide evidence that this benefit does not disappear after we discontinue the acupuncture. The magnitude of the effect we see in this study is stronger than what we have seen in the literature, such as psycho-educational approaches.”
The research team also hopes that the new evidence will help provide a basis for eventual insurance reimbursement for acupuncture services to manage their symptoms. As a next step, the Penn researchers plan to launch larger, more definitive studies with longer follow ups of six to 12 months.
“We are increasingly in a world that demands evidence to justify paying for treatments. It is critical to bring the same level of evidence to our studies that focus on quality of life as we do to other clinical outcomes,” Mao says. “This is particularly important in gaining insurance coverage for all of our patients who need these treatments. Right now, we don’t have that reimbursement system, which in effect blocks access to acupuncture for women who are unable to afford paying for the treatments out of pocket.”
The study was funded by grants from the National Institutes of Health/National Center for Complementary and Alternative Medicine (R21 AT004695 and K23 AT004112).
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