A randomized, double-blind, placebo-controlled study of the effects of pomegranate extract on rising PSA levels in men following primary therapy for prostate cancer
A randomized, double-blind, placebo-controlled study of the effects of pomegranate extract on rising PSA levels in men following primary therapy for prostate cancer
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DOI：
10.1038/pcan.2015.32
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发表时间：
2015-09-01
影响因子：
4.8
通讯作者：
Heber, D.
中科院分区：
文献类型：
--
作者：
Pantuck, A. J.;Pettaway, C. A.;Heber, D.
背景技术背景：本研究的主要目的是比较石榴汁对PSA倍增时间（PSADT）的影响与PSA水平上升后，主要治疗前列腺癌METHODS：双盲，安慰剂对照的多机构研究，评估石榴液体提取物对血清PSA水平的影响。本研究的主要终点是血清PSADT的变化。额外的次要和探索性目标是评估石榴汁的安全性，并确定锰超氧化物歧化酶（MnSOD）AA基因型和石榴治疗PSADT.Results的相互作用：183名合格的受试者被随机分配到活性和安慰剂组的比例为2：1（提取物N = 102;安慰剂N = 64;果汁N = 17）。大多数不良事件为中度或轻度。安慰剂组的中位PSADT从基线时的11.1个月增加到15.6个月（P < 0.001），而提取物组从基线时的12.9个月增加到14.5个月（P = 0.13），果汁组从基线时的12.7个月增加到20.3个月（P = 0.004）。但三组间差异无统计学意义（P > 0.05）。安慰剂AA患者的中位PSADT从基线时的10.9个月至12.7个月发生了1.8个月的变化（P = 0.22），而提取物患者的中位PSADT从基线时的13.6个月变化为25.6个月结论：与安慰剂相比，石榴提取物并没有显著延长前列腺癌患者的PSADT与PSA上升后的主要治疗。在治疗组和安慰剂组中均观察到PSADT显著延长。具有MnSOD AA基因型的男性可能代表了对石榴对PSADT的抗增殖作用更敏感的一组;然而，这一发现需要前瞻性假设检验和验证。
BACKGROUND: The primary objective of this study was to compare the effects of pomegranate juice on PSA doubling times (PSADT) in subjects with rising PSA levels after primary therapy for prostate cancer.METHODS: Double-blind, placebo-controlled multi-institutional study, evaluated the effects of pomegranate liquid extract on serum PSA levels. The primary end point of this study was change in serum PSADT. Additional secondary and exploratory objectives were to evaluate the safety of pomegranate juice and to determine the interaction of manganese superoxide dismutase (MnSOD) AA genotype and pomegranate treatment on PSADT.RESULTS: One-hundred eighty-three eligible subjects were randomly assigned to the active and placebo groups with a ratio of 2: 1 (extract N = 102; placebo N = 64; juice N = 17). The majority of adverse events were of moderate or mild grade. Median PSADT increased from 11.1 months at baseline to 15.6 months in the placebo group (P < 0.001) compared with an increase from 12.9 months at baseline to 14.5 months in the extract group (P = 0.13) and an increase from 12.7 at baseline to 20.3 in the juice group (P = 0.004). However, none of these changes were statistically significant between the three groups (P > 0.05). Placebo AA patients experienced a 1.8 month change in median PSADT from 10.9 months at baseline to 12.7 months (P = 0.22), while extract patients experienced a 12 month change in median PSADT from 13.6 at baseline to 25.6 months (P = 0.03).CONCLUSIONS: Compared with placebo, pomegranate extract did not significantly prolong PSADT in prostate cancer patients with rising PSA after primary therapy. A significant prolongation in PSADT was observed in both the treatment and placebo arms. Men with the MnSOD AA genotype may represent a group that is more sensitive to the antiproliferative effects of pomegranate on PSADT; however, this finding requires prospective hypothesis testing and validation.