Presenter: E. M. Walker, MD Presenter's Affiliation: Henry Ford Health System Department of Radiation Oncology, Detroit, MI Type of Session: Scientific
Anti-estrogen hormonal therapy given as treatment for breast cancer can induce early menopause, and often causes patients to experience debilitating vasomotor symptoms, mainly hot flashes, excessive sweating, and fatigue.
Most women undergoing menopause also experience these same symptoms, and are often treated with hormone replacement therapy (HRT). Unfortunately, HRT is contraindicated in breast cancer patients.
Physicians often prescribe the anti-depressant drug, venlafaxine (or Effexor) to patients to help relieve hot flashes. It is a selective serotonin reuptake inhibitor, and has been shown be effective in this setting.
However, venlafaxine can produce many undesirable side effects, such as sexual dysfunction, nausea, insomnia, and fatigue. Therefore, patients often refuse this treatment option.
Recent studies, mostly performed in Europe, have suggested that acupuncture may be an effective treatment for reducing vasomotor symptoms.
Acupuncture is an ancient Chinese technique of inserting and manipulating very thin needles into specific points on the body to relieve pain and for therapeutic purposes of other illnesses.
The mechanism of action for acupuncture is unknown; however it has been theorized that the placement of needles may release endorphins.
The objective of this study was to test the hypothesis that acupuncture reduces vasomotor symptoms in patients with breast cancer being treated with hormonal therapy using a randomized clinical trial. In addition, the authors attempted to test whether acupuncture produces fewer side effects than venlafaxine.
Materials and Methods
Stage 0-III breast cancer patients receiving either Tamoxifen or Arimidex who reported >14 hot flashes were randomized to receive a 12 week course of venlafaxine or acupuncture.
Patients had to be < 5 years post-systemic treatment and have a KPS>70.
In the venlafaxine (V) arm, patients received 37.5 mg of the drug daily x 1 week followed by 75 mg/day for 11 weeks.
In the acupuncture (A) arm, patients had 2 treatments per week for 12 weeks. They were performed by 2 acupuncturists and the primary points it was delivered too were K13, SP6, and BL23.
Outcome measures that were studied include:
1) NCCTG Hot Flash Diary – Patients were required to log daily the number and severity of their hot flashes.
2) menopause-specific quality of life
3) general health status (SF-12)
4) Beck Depression Inventory
5) patient-reported side effects from treatment
These measures were examined at baseline (1 week prior to treatment), during treatment, and at 3, 6, 9, and 12 months post treatment.
ANOVA and paired T-test were used for analysis.
47 patients completed the study: 25 patients in the A arm and 22 patients in the V arm.
239 additional patients were evaluable, but excluded: 149 patients did not meet eligibility criteria, 27 patients were unwilling to be randomized to the Effexor group, 45 patients were no-shows for their consults, and it is not clear why the remaining 21 were excluded.
A significant initial decrease in hot flashes from baseline was seen in both groups. This difference did not differ between the 2 groups.
The effect of treatment plateaued after this initial decrease for the A arm. The V arm had and increase in hot flashes 1-2 weeks after the initial decrease seen but eventually this change plateaued as well.
18 patients in the V arm reported multiple negative side effects including nausea, dry mouth, headache, difficulty sleeping, dizziness, double vision, increased blood pressure, constipation, fatigue, anxiety, and body jerking at night.
3 patients actually dropped out of the trial secondary to side effects of venlafaxine.
No patients in the A arm reported side effects of treatment with acupuncture. Patients in the A group also reported increased energy, sexual desire, and overall sense of well-being compared to baseline.
The authors concluded that acupuncture is at least as effective in reducing hot flashes as venlafaxine in this population of patients.
In addition, acupuncture is safe with fewer side effects than venlafaxine, and actually has positive side effects of increased energy and sexual desire.
Accupuncture provides a viable alternative to pharmacologic drugs for treating patients with breast cancer suffering from hot flashes caused by hormonal therapy.
Future studies should focus on determining the mechanism of action and optimal duration and frequency of acupuncture treatment. In addition, it may be tested in other cancers or as treatment for other side effects.
As current pharmacologic options for treating hot flashes in women undergoing hormonal therapy for breast cancer are limited and cause unwanted side effects, alternative treatment strategies are needed.
This randomized trial provides interesting information about the use of acupuncture for treatment of hot flashes.
Although this data may seem promising, one must be aware that this trial has a significant patient selection bias, and likely attracted patients who were interested in trying acupuncture or believed in its effectiveness. The authors even pointed out that many of the patients did not want to be randomized to the V arm, and therefore dropped out of the study.
Furthermore, the patients were not blinded, which makes it quite difficult to tease out a placebo effect.
Data used to measure outcomes was all secondary to patient reporting. This is a very subjective measure which is not standardized, and introduces another form of bias.
In addition, even though the data has been collected in a randomized trial, the sample size is small. To determine its clinical relevance, this hypothesis should be tested in a larger randomized trial.
The combination of complementary therapies with current treatments for cancer is an exciting field and warrants further investigation with larger studies.
Until further studies are done, acupuncture should not be used in this setting outside of a clinical trial.
In conclusion, the data presented in this study are interesting, but it is a very small study and the results should be used in clinical practice with caution.
Apr 24, 2014 - Acupuncture is as effective as the drug venlafaxine in relieving vasomotor symptoms caused by anti-estrogen hormone treatment for breast cancer, and it does not cause adverse events, according to a study published Dec. 28 in the Journal of Clinical Oncology.