Acupuncture was as effective as venlafaxine for the treatment of vasomotor symptoms in women with hormone receptor-positive breast cancer, according to what is thought to be the first study directly comparing the complementary therapy with a drug.
Based on this research, “I think people should be more open to looking at acupuncture to manage vasomotor symptoms,” said Eleanor M. Walker, MD, Division Director of Breast Radiation Oncology at Henry Ford Hospital, the lead author of the study, published in the February 1 issue of the Journal of Clinical Oncology (2010:28:634–640). “Although this study included a small number of patients , the results were statistically significant and showed that acupuncture was equivalent to venlafaxine with no side effects.”
In addition to not wanting to contend with the adverse events associated with venlafaxine—for example, dry mouth, nausea, decreased appetite, and constipation—women simply do not want to take another pill, especially if they are already taking tamoxifen or trastuzumab, Dr. Walker said.
Moreover, she added, earlier data (Steams et al: JNCI 2003;95:1758-1764) indicate that when selective serotonin reuptake inhibitors (SSRIs) such as venlafaxine are given to breast cancer patients to treat their hot flashes they may decrease the efficacy of tamoxifen.
Still, said Charles Loprinzi, MD, a long-time researcher in this area who is the Regis Professor of Breast Cancer Research at the Mayo Clinic, despite acupuncture's potential benefits, how physicians treat hot flashes in women with hormone receptor-positive breast cancer is unlikely to change based on the new study: “This was an interesting trial, but it was a small, non-blinded study, and, consequently, will probably not change practice.”
The 50 patients in the study were randomized to either undergo 12 weeks of acupuncture or receive venlafaxine with one-year follow-up to measure health outcomes and duration of response.
The 25 patients in the medication group received venlafaxine at 37.5 mg daily for one week, and then 75 mg daily for the remaining study period if they could tolerate a higher dose. Those in the acupuncture group received treatments twice a week for the first month, then once a week for the remaining two months. Patients were evaluated at three, six, nine, and 12 months.
Both groups had a 50% statistically significant decrease in hot flashes from pretreatment to posttreatment. The number of hot flashes significantly increased by two weeks after treatment in the venlafaxine group but remained low in the acupuncture group.
At two months, acupuncture patients reported that the number of hot flashes was similar to what they were experiencing at one month. At three months, they reported that frequency had recently increased.
For both groups, the severity of hot flashes decreased from pretreatment to posttreatment, and then returned to baseline levels at later follow-up.
Both the venlafaxine and acupuncture groups had significant improvements in mental health and quality of life from pretreatment to posttreatment.
About a quarter of women in the acupuncture group had increased sex drive, while most reported improvement in their energy, clarity of thought, and sense of well-being.
Patients in the acupuncture group did not have any adverse events, while those in the venlafaxine group reported 18 incidences of side effects, including nausea, dry mouth, headache, dizziness, difficulty sleeping, fatigue, and anxiety.
K. Simon Yeung, PharmD, LAc, MBA, an acupuncturist and a research pharmacist in the Integrative Medicine Service of Memorial Sloan-Kettering Cancer Center, noted that this was one of the first studies that compared the effect of acupuncture with a drug for the treatment of hot flashes. Previous studies compared the use of the technique with a placebo.
This was a unique comparison of drug versus nondrug therapy, agreed Jun Mao, MD, MSCE, a complementary and alternative medicine researcher and Assistant Professor of Family Medicine and Community Health at the Hospital of the University of Pennsylvania. Additionally, “some claims such as improvement in sexual energy were really promising, but we need more data on this potential benefit.”
In addition to Dr. Loprinzi's caveat that it was a small study—for example, only 25 patients in each group rather than the usual number of at least 50 that are considered to be needed for a comparative trial—another drawback was that the study was not blinded with sham acupuncture or placebo arms. Without a sham arm, researchers don't know how well the acupuncture is actually working, and without a placebo arm, they don't know whether the adverse events and toxicities such as nausea and dizziness in the venlafaxine group were actually attributable to the drug or whether they would have also been experienced by patients taking a sugar pill, a phenomenon known as the nocebo effect, he explained.
Asked about this, though, Dr. Walker countered that there was no reason to conduct a study with a sham acupuncture arm or a placebo arm because such research has already been published—Deng G et al: JCO 2007;25:5584-5590 and Hervik and Mjaland: Breast Cancer Res Treat 2009;116:311-316.
Potential Cost Savings
While this study explored the health benefits of acupuncture in women with breast cancer, another advantage of this complementary therapy may be cost savings, Dr. Walker noted. For insurance companies, it may be cheaper to pay for initial acupuncture treatments and occasional booster treatments than it would be for daily medication, she explained.
Whether acupuncture is ultimately more affordable than daily medication needs to be supported with specific data, Dr. Mao said. Acupuncture treatments can cost $40 to more than $100 per session, but patients don't always need maintenance treatments for long-term benefits. On the other hand, generic drugs to treat vasomotor symptoms can be fairly cheap, he said.
Still, in the short-term acupuncture may not be more cost effective, said Dr Yeung. A three-month supply of drugs is likely to be less expensive than three months of visiting an acupuncturist at a rate of twice weekly for one month, and then weekly for two additional months, as in the Walker et al study, he said. However, with follow-up treatments once a month or once every two to three months, the benefits of acupuncture can last up to a year, making it the more cost-effective modality.
Mechanism of Action Not Completely Understood
Dr. Mao said that while there is increasing evidence that acupuncture is an effective alternative for treating vasomotor symptoms, more research is still needed about the mechanisms of action of acupuncture and hot flashes.
Researchers don't completely understand how acupuncture works to treat vasomotor symptoms, Dr. Yeung added. The modulation of neurotransmitters that produce beta-endorphins and alter dopamine and serotonin in the brain may be one explanation, mechanisms known to help manage pain.
Dr. Mao speculated that hot flashes may occur because of estrogen withdrawal, but as with the situation with acupuncture, the mechanisms of action are not fully known.
Further research should explore the duration and frequency of acupuncture treatment in this setting, said K. Simon Yeung, PharmD, LAc, MBA, an acupuncturist and a research pharmacist in the Integrative Medicine Service of Memorial Sloan-Kettering Cancer Center. For example, receiving acupuncture twice a week for a month may have different health effects than receiving it once a week for two months. “Short-term treatment may not be as good as longer-term treatment, he said.
How often boost treatments should be given also needs to be explored, said the study's lead author, Eleanor Walker, MD. “I think that patients probably would require additional boost treatments every three months after an initial course of 12 weeks.” Such treatment might consist of acupuncture sessions twice a week for one month or it could be some other regimen.
A better understanding of which patients respond to medication for hot flashes and which individuals respond to acupuncture would be useful as well, said Jun Mao, MD, MSCE, a complementary and alternative medicine researcher and Assistant Professor of Family Medicine and Community Health at the Hospital of the University of Pennsylvania.
In the meantime, “acupuncture gives patients another treatment option that doesn't cause side effects,” noted Dr. Walker.
“I think clinicians need to keep an open mind and remember that complementary modalities of acupuncture are available in addition to traditional medicine,” Dr. Yeung concluded.