ABSTRACT PURPOSE: To test the safety and efficacy of acupuncture in reducing hot flashes in men with advanced prostate cancer (CaP) undergoing androgen deprivation therapy. METHODS: A single-arm, pilot study was undertaken to evaluate acupuncture treatment for hot flashes experienced by CaP patients undergoing hormonal therapy. Sixteen advanced CaP patients undergoing androgen deprivation therapy (ADT) received standardized full body and auricular acupunc-ture 1x/week for 14 weeks. Patients were evaluated at 0, 7, 14, and an additional 14-wk follow-up (F/U) (28-wks). Safety was measured by monitoring for adverse events over the treatment period. Serum testosterone was measured at 0 and 14-wks. Quality of life (QOL) was measured by the hormone domain of the Expanded Prostate Index Composite (EPIC), at the 0, 7, 14, and 28-wks and patient reported hot flash frequency was assessed weekly. Safety endpoints were serum testosterone and analysis of adverse events. Efficacy endpoints were scores on the EPIC and the number of pa-tient reported hot flashes. RESULTS: 17 patients were enrolled and 15 completed the trial. Of 15 evaluable patients the median age was 68 ± 8.19. Serum analysis demonstrated no change in testosterone at baseline 9.5 ng/ml ± 8.9 vs. end-point 14 ± 8.78 (p = 0.101). No adverse events were reported. Data analysis of the EPIC demonstrated a trend toward improvement after 7 wks and a significant improvement following 14 wks of acupuncture (p = 0.01). Analysis of patient reported frequency showed a significant reduction in the number of hot flashes at 7-wk (6, p = 0.04), 14-wk (2.6, p = 0.001), and 28-wk F/U (3.2, p = 0.01) as compared to baseline 9.57 ± 3.98. CONCLUSIONS: The administration of acupuncture in men with advanced CaP appears to significantly decrease the frequency of hot flashes. No serious ad-verse events were noted and serum testosterone levels were unchanged from baseline suggesting that the mechanism of action of acupuncture for hot flash amelioration is not via increase in testosterone.
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