Early-stage breast cancer patients dealing with painful side effects from powerful estrogen-squelching drugs known as aromatase inhibitors got good news today from a team of researchers who led a large and rigorous acupuncture study.
It’s now been scientifically proven that acupuncture relieves joint pain for these patients.
The results, shared at the San Antonio Breast Cancer Symposium, came from a blinded, randomized, multicenter trial conducted by SWOG, a global network of researchers that designs and conducts cancer clinical trials. It is the latest in a series of studies to give breast cancer patients better tools — pharmaceutical and otherwise — to combat the debilitating joint and muscle pain commonly associated with aromatase inhibitors, or AIs.
Dr. Dawn Hershman of the Herbert Irving Comprehensive Cancer Center at Columbia University and lead author of the trial said AI joint pain is “probably the most commonly cited reason breast cancer patients stop taking AI medication.” This trial, she said, provides “a solution that doesn’t include opioids or drugs that can be addictive or have serious side effects.”
Photo by Robert Hood / Fred Hutch News Service
The SWOG study involved 226 breast cancer patients from 11 cancer centers. Patient participants, who were required to be unfamiliar with acupuncture, were divvied up into three separate arms: one received a specially designed standardized acupuncture protocol; one received “sham” acupuncture, in which practitioners superficially inserted needles in non-therapeutic locations; and a third group received no treatment as part of the study. Participants in the first two arms received twice-weekly treatments for six weeks then weekly maintenance for another six weeks. Results consistently showed the patients who received true acupuncture had less pain than other participants and that the pain relief continued for as long as 24 weeks.
Co-author Dr. Heather Greenlee, a Fred Hutchinson Cancer Research Center epidemiologist, naturopathic physician and director of the Integrative Medicine Program at Seattle Cancer Care Alliance called the study a “milestone.”
“It is wonderful that we now have data from a large-scale, well-conducted trial showing that acupuncture works for managing a very specific type of pain,” she said. “It’s a milestone for SWOG and the National Cancer Institute to support this kind of trial, and it’s really great for patients to have solid data to inform their treatment decisions. We’re excited that a nonpharmacological agent like acupuncture has been shown to effectively reduce pain long term.”
Aromatase inhibitors: a mixed blessing
Aromatase inhibitors are commonly prescribed to early stage postmenopausal breast cancer patients with estrogen-receptor-positive disease following standard treatments like surgery, radiation and chemotherapy. The daily pill further tamps down the body’s ability to produce estrogen, essentially cutting off the cancer’s food supply.
But like some dark German fairy tale, there’s a trade-off. The daily pill allows you to live longer (hopefully) but ages you before your time. As estrogen dwindles, patients experience all the side effects that come with advanced age: loss of bone density, loss of libido, insomnia, hot flashes, night sweats and, most especially, joint stiffness and pain in feet, knees, hips, shoulders, wrists and hands. This ongoing pain makes it difficult for many patients to walk, sit, climb stairs or perform simple tasks like typing or driving, let alone exercise, which is often prescribed to breast cancer patients to reduce their risk of recurrence.
As a result, up to 50 percent of women stop taking the AI before the recommended five years; fewer still are able to endure it for 10. Studies confirm that women who stop the drug have “reduced disease-free survival.”
“Patients tell me they feel much older,” said Dr. Julie Gralow, a Fred Hutch clinical researcher and SCCA breast cancer oncologist who enrolled some of her patients in the study. “They tell me, ‘I feel slower and my joints aren’t moving the same. I feel like a creaky old lady.’ That goes along with the vaginal dryness and all the other side effects.”
Photo by Robert Hood / Fred Hutch News Service
Acupuncture study a ‘huge success’
Gralow, who serves as vice-chair of SWOG’s breast cancer committee, said the acupuncture finding was “very good news for patients.”
“We need to help these women stay on these drugs and maintain a high quality of life,” she said. “We need to do all we can. These are important drugs and staying on them for at least five years is optimal in terms of reducing recurrence and death.”
In the last few years, SWOG has conducted a handful of trials to staunch the persistent joint pain of AIs, she said, including a trial of omega-3 fatty acids, which had lackluster results, and a just-published trial involving the depression/anxiety drug duloxetine (Cymbalta), which showed a beneficial effect.
Unfortunately, the drug can be expensive, has side effects and may not be covered by insurance, Gralow said. The acupuncture trial, though, was a “huge success.”
“We think of acupuncture as a quote-unquote alternative therapy but now there is good, solid scientific evidence that shows it should be considered a mainstream therapy,” she said. “It’s evidence-based, conventional medicine.”
Fred Hutch file photo
Avoiding the placebo effect
Fred Hutch’s Dr. Joseph Unger, a health services researcher and biostatistician and the primary statistician for SWOG’s Symptom Control and Quality of Life Committee, said one difficulty surrounding past acupuncture trials is the placebo effect.
“In prior studies where patients given acupuncture were compared to no treatment, big differences were found in terms of patients on the acupuncture arm responding better,” he said. “But it could be a kind of placebo effect or response bias. Patients are under care so they could be responding to that instead of the mechanism of the acupuncture itself.”
The SWOG researchers were able to get around this by having one group of patients think they were receiving acupuncture when they were in fact just getting random needle pricks.
“As far as they knew, they were receiving acupuncture, but the needles weren’t directed at the meridian points, the hypothesized locations in the body that reduce pain,” he said. “They were essentially harmless needle pricks.”
Unger said SWOG trained the dozen or so practitioners to deliver true acupuncture — or the sham version — in the same manner. Fred Hutch and SCCA’s Greenlee, who recently published clinical practice guidelines for integrative therapies during and after breast cancer treatment, worked with the research team to develop the standardized protocol and training materials for the acupuncturists.
“This adds important information to the body of work on the use of integrative therapies for breast cancer survivors,” Greenlee said. “Patients, providers and policymakers all need evidence on which to base their decisions so that they know they are using something that is likely to work, and so they don’t waste their time and money on treatments that don’t work. This study provides just that.”
Photo courtesy of Jodi Monroe
‘Your body feels so good’
How do participants feel about using acupuncture for AI pain relief?
Jodi Monroe, a 52-year-old community land trust executive and “old athlete” from Mount Vernon, Washington, had so much bone pain from the aromatase inhibitor she was given, she thought she was experiencing a cancer recurrence.
“I’m a tough cookie, mentally and physically,” she said. “I never complain. And I finally called the cancer center because I was sure the cancer was in my bones. I was in so much pain. I couldn’t sit through meetings. I would wake up at 3:30 in the morning because my hips hurt. I couldn’t take it.”
Gralow, her oncologist, told Monroe about the acupuncture trial and she eagerly signed on, much preferring a non-pharmacological approach.
“I don’t use oxycodone or any of that stuff,” she said. “Not even ibuprofen. People are so prone to popping a pill, but that’s not how I handle things.”
She was randomized to one of the study’s treatment arms but has not yet been told whether she was getting true acupuncture or sham. The treatments provided so much pain relief though, Monroe continued on with the same acupuncturist after the trial ended.
“I went religiously and I really think I got the real thing because the results to me were the same,” she said. “I didn’t need anyone to drive me home after radiation or chemotherapy, but I needed a driver after acupuncture because it put me in such a good frame of mind. I felt like I was floating. And that feeling continues when you leave. Your body feels good, you have peace of mind. I got that from day one.”
Acupuncture’s potential as an alternative to opioids
Both Unger and Greenlee said nonpharmacologic approaches like acupuncture are particularly important in light of the current opioid epidemic.
“There’s a lot of concern nowadays about patients becoming accustomed to painkillers like opioids,” Unger said. “Between these two trials [Cymbalta and acupuncture], patients now have pharmacologic and nonpharmacologic options. SWOG has really helped to advance the science of symptom control.”
The acupuncture trial has also advanced the case for using integrative therapies in cancer centers.
“In my experience, there was always doubt about these alternative treatments,” he said. “But you can’t dismiss them without examining them, and now they’re being examined thoroughly and rigorously. Some work and some don’t — that’s what we’ve found so far.”
Considering the positive results, will acupuncture soon become a clinical norm?
“This is the type of study that provides strong evidence for guiding treatment-coverage decisions and could lead to acupuncture becoming an option for standard care,” Unger said.
Funding for the study came from the National Institutes of Health National Center for Complementary and Integrative Health, the Office of Research on Women’s Health and the NIH/National Cancer Institute's Division of Cancer Prevention.
Diane Mapes is a staff writer at Fred Hutchinson Cancer Research Center. She has written extensively about health issues for NBC News, TODAY, CNN, MSN, Seattle Magazine and other publications. A breast cancer survivor, she blogs at doublewhammied.com and tweets @double_whammied. Email her at email@example.com.
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