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.
Highlights
Prostate cancer (CaP) is the most commonly diagnosed cancer in American men and the second leading cause of cancer deaths
The cause of hot flashes is thought to be due to the decrease in circulating leutinzing hormone (LH) and follicle stimulating hormone (FSH) [3,4,5] and the incidence of hot flashes in men with CaP is close to 80% over the course of treatment and often continues for years even after androgen deprivation therapy (ADT) is stopped [3]
The results of our study demonstrate that acupuncture was safe, well tolerated, and significantly reduced the frequency and severity of hot flashes experienced by men
Summary
Prostate cancer (CaP) is the most commonly diagnosed cancer in American men and the second leading cause of cancer deaths. Prostate cancer (CaP) patients are living longer largely due to the benefits of androgen deprivation therapy (ADT) including androgen ablation utilizing luteinizing hormone-releasing hormone (LHRH) agonists alone or in combination with anti-androgens. This treatment has become a standard option for men with metastatic CaP (Stage 3 or 4) but frequently cause multiple side effects including gyencomastia, fatigue, hair loss and hot flashes. The most commonly prescribed medication to ameliorate hot flashes are estrogens which cause undesirable side effects [4] and in the management of patients with advance cancers, maintaining treatment compliance, minimizing side effects and preserving quality of life (QOL) are of extreme importance. Based on these facts we hypothesize that acupuncture, a popular complementary and alternative medicine (CAM) modality may offer a non-pharmacologic approach to the amelioration of hot flashes in men with advanced prostate cancer
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