Abstract PD4-7: A randomized placebo-controlled trial of acupuncture and gabapentin for hot flashes among breast cancer survivors

Purpose Hot flashes are a common and debilitating symptom negatively affecting the quality of life of breast cancer survivors. We sought to compare the short and long term effects of electro-acupuncture (EA) vs. gabapentin for hot flashes among breast cancer survivors. Patients and Methods We conducted a randomized controlled trial of EA vs. gabapentin vs. placebos (sham acupuncture [SA] or placebo medication) in women with breast cancer who had completed primary cancer treatments and experienced bothersome hot flashes twice daily or greater. Acupuncturists performed ten EA/SA treatments over eight weeks using a manualized protocol with 2 Hz electro-stimulation delivered by a TENS unit. Acupuncturists administered SA using Streitberger (non-penetrating) needles at non-traditional acupuncture points without electro-stimulation. Gabapentin (900 mg daily) or placebo medication were continued for eight weeks and then weaned off. The primary endpoint was the hot flash composite score measured by the daily diary at the end of the intervention (Week 8). A secondary endpoint, durability of response, was evaluated at Week 24 from randomization. Longitudinal mixed effects models were used to evaluate change in outcomes over time and group differences. Results Of 120 randomly assigned patients, the mean age was 52.3, 75% were White, 12.5% were peri-menopausal, and 20%/25%/37.5% had natural/surgically/chemically induced menopause, respectively. By Week 8, significant group differences were observed. Mean reduction in hot flash composite scores was greatest in the EA group, followed by SA and gabapentin, with placebo medication having the lowest reduction in hot flashes (-7.4 vs. –5.9 vs. –5.2 vs. –3.4, p=0.0003). By Week 24 and off treatment, reduction in hot flashes in the EA group persisted whereas the hot flashes in the gabapentin group retuned to baseline. The reduction in hot flashes was greatest in the EA group, followed by SA, placebo medication, and gabapentin (-8.5 vs. –6.1 vs. –4.6 vs. –2.8, p=0.0024). No serious adverse events were reported in any groups. The gabapentin group had the highest percentage of participants reporting treatment- related adverse events followed by placebo medication, EA, and SA (48.4% vs. 29.0% vs. 19.3% vs. 3.2%, p=0.004). Conclusion: Electro-acupuncture was more effective than gabapentin, sham acupuncture, or placebo medication in reducing hot flashes for breast cancer survivors both short term and long term with few side effects. Gabapentin produced significant short term reduction in hot flashes that did not persist off medication and was associated with more side effects. Clinical Trial Registration: NCT01005108. Citation Format: Jun J Mao, Sharon X Xie, Marjorie A Bowman, Deborah Bruner, Susan Q Li, Angela DeMichele, John T Farrar. A randomized placebo-controlled trial of acupuncture and gabapentin for hot flashes among breast cancer survivors [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr PD4-7.