September 26, 2008 — In a small clinical trial involving 47 patients, acupuncture was found to be as effective as conventional drug therapy in relieving vasomotor symptoms in breast cancer patients who were taking tamoxifen or the aromatase inhibitor anastrozole (Arimidex; AstraZeneca).
Presenting the results at the American Society for Therapeutic Radiology and Oncology (ASTRO) 50th Annual Meeting in Boston, Massachusetts, lead author Eleanor Walker, MD, from the Henry Ford Hospital in Detroit, Michigan, explained that hot flashes are a very common problem in this patient population, affecting up to 80% of breast cancer survivors.
"Our study shows that physicians and patients have an additional therapy for something that affects the majority of breast cancer survivors and actually has benefits, as opposed to more side effects," Dr. Walker commented. The effect from acupuncture is more durable vs the drug and, ultimately, is more cost effective for insurance companies, she said in a statement.
Women taking part in this trial had at least 14 hot flashes per week, and the drug used was the selective serotonin reuptake inhibitor antidepressant venlafaxine (Effexor; Wyeth), which is commonly used for these symptoms, Dr. Walker said. Participants were asked to keep a daily log of hot flashes for 1 week before treatment, during the 12-week treatment course, and then at regular intervals during the subsequent year.
Both groups reported a similar and significant decrease in hot flashes. There was also a significant decrease in other menopausal symptoms, in quality-of-life measures, and in depressive symptoms in both groups. "These changes were similar in the 2 groups, indicating that acupuncture is at least as effective as venlafaxine in reducing the vasomotor and other symptoms associated with antiestrogen hormonal treatment of breast cancer," Dr. Walker reported.
However, there was a big difference between the 2 groups in adverse events reported. "Numerous patients treated with venlafaxine reported negative side effects, including nausea, dry mouth, headache, difficulty sleeping, dizziness, double vision, increased blood pressure, constipation, fatigue, anxiety, feeling 'spaced out,' and body jerking during the night," the researchers said.
In contrast, women treated with acupuncture reported no negative adverse effects and reported positive effects, such as increased energy, clarity of thought, sexual desire, and overall sense of well-being vs pretreatment levels.
The results of this study suggest that adding acupuncture to breast cancer treatment regimens establishes an integrative approach that is more effective in managing symptoms because it has fewer adverse effects than conventional pharmacotherapy, the researchers concluded.
Lack of Appropriate Control Group
"Acupuncture is relatively safe, without significant side effects, and I see no reason why a woman should not try it if she wants to," said Nancy Avis, PhD, director of the Cancer Control Program at Wake Forest University School of Medicine, in Winston-Salem, North Carolina. "However, more research needs to be done to determine the effectiveness of acupuncture for the treatment of vasomotor symptoms," she told Medscape Oncology.
Previous studies have shown a large placebo effect with treatments for vasomotor symptoms, and these symptoms tend to decline with time, Dr. Avis pointed out. "Without a usual-care group, a nontreatment group, or a group that controls for attention [to hot flashes], it was not possible to determine [the degree to which] the reduction in hot flashes in the acupuncture group was due to acupuncture, time, or the placebo effect," she said.
However, finding an appropriate control group is a particular challenge in the area of mind-body interventions, Dr. Avis wrote in a recent editorial in the Journal of Clinical Oncology about the search for nonhormonal treatments of hot flashes in breast cancer survivors.
The editorial was prompted by a study, published in the same issue, by Gary Elkins, PhD, from the Department of Psychology and Neuroscience at Baylor University in Waco, Texas, and colleagues. It showed that hypnosis was useful and better than no treatment in these patients. Sixty women who were randomized to receive 5 weekly sessions of hypnosis reported a 62% reduction in hot flashes as well as reductions in sleep problems, anxiety, and depression. This reduction is "impressive," Dr. Avis said, especially because the no-treatment group reported little improvement.
However, both the hypnosis and the acupuncture studies have the same limitation — the lack of a placebo control, Dr. Avis commented. This is also true of previous studies showing benefit from yoga, cognitive-behavioral therapy, and relaxation training. "A substantial placebo effect found in other studies of hot flashes suggests that attention alone or expectancies on the part of study participants may be sufficient to reduce hot flashes," she writes.
Despite the challenge in proving benefits from these mind-body interventions, it is important to continue investigating these approaches, Dr. Avis said. They convey minimal or no risk, have no adverse effects, and are generally low cost.
Tamoxifen and aromatase inhibitors are increasingly being used in postmenopausal women with hormone-receptor–positive breast cancer, and these drugs should be continued for years. But many women stop taking them because of hot flashes and related symptoms. Mind-body approaches offer potentially safe and effective interventions for these symptoms and are particularly appropriate for breast cancers survivors, said Dr. Avis.
The researchers have disclosed no relevant financial relationships.
American Society for Therapeutic Radiology and Oncology (ASTRO) 50th Annual Meeting: Abstract 228. Presented on September 24, 2008.
J Clin Oncol. Published online before print September 22, 2008.
Pearls for Practice
* In a small clinical trial, acupuncture was as effective as venlafaxine in ameliorating vasomotor symptoms in breast cancer patients who are taking tamoxifen or anastrozole. Both treatment groups had a similar and significant decrease in hot flashes, other menopausal symptoms, and depressive symptoms, and improvement in quality-of-life measures.
* Tolerability was much better with acupuncture vs venlafaxine. With drug therapy, many patients reported nausea, dry mouth, headache, difficulty sleeping, dizziness, diplopia, increased blood pressure, constipation, fatigue, anxiety, disorientation, and nocturnal myoclonus. Women treated with acupuncture reported no negative adverse effects and reported positive effects including increased energy, clarity of thought, sexual desire, and overall sense of well-being.