Acupuncture Helps AI Pain; Insurers Should Cover, Say Trialists

Nick Mulcahy

December 08, 2017

SAN ANTONIO ― Acupuncture administered twice a week for 6 weeks significantly improved joint pain and stiffness among women with early-stage breast cancer who were taking aromatase inhibitors (AI), according to the results from a large, multicenter, randomized clinical trial sponsored by the National Cancer Institute.

Joint pain and stiffness are the most common side effects of AIs and are a "major cause" of treatment noncompliance, said lead investigator Dawn Hershmann, MD, a medical oncologist at the Herbert Irving Comprehensive Cancer Center, Columbia University, New York City. She was speaking at a press briefing here at the San Antonio Breast Cancer Symposium (SABCS) 2017.

Dr Dawn Hershmann

The 226-patient study had two comparison arms. Some women received no treatment for the symptoms, whereas others received either true accupunture or sham accupunture. For the sham accupunture, needles that were smaller than are normally used were administered at sites near to but not on the points of the body that had been identified as appropriate for relief of therapy-related joint pain.

"We have shown consistently, with multiple measures assessing pain and stiffness, that true acupuncture generated better outcomes," Dr Hershman summarized.

Accupuncture could "possibly increase aromatase inhibitor adherence and subsequent breast cancer outcomes," she added.

The results of the study, which is the largest of its kind, were robust enough that the investigators, who are from nine large community practices and two academic centers, called for a major change in the way acupuncture, a traditional Chinesse medicine modality, is seen by payers.

"We feel there is now sufficient evidence to support insurance coverage of acupuncture for AI arthralgia," Dr Hershman told reporters.

We feel there is now sufficient evidence to support insurance coverage. Dr Dawn Hershmann

Acupuncture is already "used commonly" by women in the United States, and there are many practitioners of acupuncture in the United States, she asserted.

In the study, the patients who received true acupuncture (n = 110) twice a week for 6 weeks experienced a statistically significant reduction in the "worst pain" score at 6 weeks, which was the study's primary endpoint, compared to the patients who received sham acupuncture (n = 59) or no treatment (n = 57).

The 6-week mean worst-pain scores were 0.92 points lower (as correlated with less pain) in the true acupuncture arm compared with the sham arm (95% confidence interval [CI], 0.20 - 1.65; P = .01) and 0.96 points compared to the no-treatment arm (95% CI, 0.24 - 1.67; P = .01).

Of patients in the true acupuncture arm, 58% experienced a clinically meaningful (>2) reduction in worst-pain score (ie, an improvement of symptoms), compared to 31% for patients in the sham treatment arm (P < .009) and 30% (P < .004) for those who received no treatment.

The study was designed such that the patients initially received two treatments a week for 6 weeks, after which they received one treatment a week for 6 weeks. The patients were then followed for another 12 weeks. In total, the study ran for 24 weeks.

Dr Hershman reported that the worst-pain scores were maintained to week 24, indicating the durability of the effect.

True acupuncture also provided symptom improvement compared to sham acupuncture at week 6, as assessed using all other pain measures: average pain (P = .04), pain interference (P = .02), pain severity (P = .05;), and worst stiffness (P =.02). The improvement in these measures was also maintained to the study's end at week 24, she said.

Dr Herschman described how life-altering AI-induced joint pain can be. "Some of my patients have difficulty getting out of a chair," she said in a press statement.

Ann Partridge, MD, a medical oncologist at the Dana Farber Cancer Institute in Boston, Massachusetts, welcomed the results from the study, which was conducted by SWOG, the cancer clinical trials network funded by the National Cancer Institute.

"This is great news in that women are often looking for nondrug ways to decrease the musculoskeletal symptoms they might experience on aromatase inhibitors, a class of drugs that is very effective in the treatment of hormone-sensitive breast cancer," she told Medscape Medical News in an email.

However, Dr Partridge, who was not involved in the study, had some reservations about the treatment.

"All acupuncture is not created equal, and it is very practitioner dependent in terms of techniques, so that could affect how women will benefit in the real world," she said.

Furthermore, Dr Partridge pointed out that it is not known how long the treatment effect would last beyond the 24-week study period, and there are no data as to whether maintenance or booster sessions might be needed. "This is important because the aromatase inhibitors are usually prescribed for at least 5 years," she explained.

Dr Hershman noted that the cost of the 12-week intervention, which included a total of 18 treatment sessions, was about $1250, or $65 to $75 a session.

She suggested that the treatment might help with the current pain treatment crisis in the United States: "Identification of non-opioid options for pain control is a public health priority."

Dr Hershman also pointed out that "many women don't want to take pills to relieve symptoms caused by other pills."

The study was supported by the National Institutes of Health. Dr Hershman has disclosed no relevant financial relationships. Dr Partridge has served in a consulting or advisory role with Pfizer.

San Antonio Breast Cancer Symposium (SABCS) 2017: Abstract GS4-04, presented December 7, 2017.

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