DiPaola R S, Zhang H, Lambert G H, Meeker R, Licitra E, Rafi M M, Zhu B T, Spaulding H, Goodin S, Toledano M B, Hait W N, Gallo M A
Department of Medicine, University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswick 08901, USA.
N Engl J Med. 1998 Sep 17;339(12):785-91. doi: 10.1056/NEJM199809173391201.
Herbal mixtures are popular alternatives to demonstrated therapies. PC-SPES, a commercially available combination of eight herbs, is used as a nonestrogenic treatment for cancer of the prostate. Since other herbal medicines have estrogenic effects in vitro, we tested the estrogenic activity of PC-SPES in yeast and mice and in men with prostate cancer.
We measured the estrogenic activity of PC-SPES with transcriptional-activation assays in yeast and a biologic assay in mice. We assessed the clinical activity of PC-SPES in eight patients with hormone-sensitive prostate cancer by measuring serum prostate-specific antigen and testosterone concentrations during and after treatment.
In complementary yeast assays, a 1:200 dilution of an ethanol extract of PC-SPES had estrogenic activity similar to that of 1 nM estradiol, and in ovariectomized CD-1 mice, the herbal mixture increased uterine weights substantially. In six of six men with prostate cancer, PC-SPES decreased serum testosterone concentrations (P<0.05), and in eight of eight patients it decreased serum concentrations of prostate-specific antigen. All eight patients had breast tenderness and loss of libido, and one had venous thrombosis. High-performance liquid chromatography, gas chromatography, and mass spectrometry showed that PC-SPES contains estrogenic organic compounds that are distinct from diethylstilbestrol, estrone, and estradiol.
PC-SPES has potent estrogenic activity. The use of this unregulated mixture of herbs may confound the results of standard or experimental therapies and may produce clinically significant adverse effects.
草药混合物是已证实疗法的常用替代物。PC-SPES是一种市售的八味草药组合，用作前列腺癌的非雌激素治疗药物。鉴于其他草药在体外具有雌激素作用，我们在酵母、小鼠及前列腺癌男性患者中测试了PC-SPES的雌激素活性。
我们通过酵母转录激活试验及小鼠生物学试验测定PC-SPES的雌激素活性。我们通过测量8例激素敏感性前列腺癌患者治疗期间及治疗后的血清前列腺特异性抗原和睾酮浓度，评估PC-SPES的临床活性。
在互补的酵母试验中，PC-SPES乙醇提取物1:200稀释液的雌激素活性与1 nM雌二醇相似，在去卵巢的CD-1小鼠中，该草药混合物显著增加子宫重量。在6例前列腺癌男性患者中，PC-SPES均降低了血清睾酮浓度（P<0.05），在8例患者中，它均降低了血清前列腺特异性抗原浓度。所有8例患者均出现乳房压痛和性欲减退，1例发生静脉血栓形成。高效液相色谱、气相色谱和质谱分析表明，PC-SPES含有与己烯雌酚、雌酮和雌二醇不同的雌激素有机化合物。
PC-SPES具有强大的雌激素活性。使用这种未经监管的草药混合物可能会混淆标准治疗或实验治疗的结果，并可能产生具有临床意义的不良反应。
