Purified Dry Paullinia cupana (PC-18) Extract for Chemotherapy-Induced Fatigue: Results of Two Double-Blind Randomized Clinical Trials
Purified Dry Paullinia cupana (PC-18) Extract for Chemotherapy-Induced Fatigue: Results of Two Double-Blind Randomized Clinical Trials
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DOI：
10.1080/19390211.2017.1384781
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发表时间：
2018-01-01
影响因子：
2.5
通讯作者：
del Giglio, Auro
中科院分区：
文献类型：
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作者：
de Melo Sette, Claudia Vaz;Ribas de Alcantara, Barbara Bonaparte;del Giglio, Auro
疲劳在肿瘤患者中很常见。在我们之前的研究中，未纯化的泡桐干提取物对化疗引起的疲劳显示出令人鼓舞的结果。我们报告了两项随机、双盲研究，使用标准化干燥纯化的泡桐提取物（名为 PC-18）。对于这两项研究，我们招募了早期乳腺癌患者，他们在第一个辅助化疗周期后疲劳评分有所增加。在第一项研究中，我们将每天两次口服 37.5 毫克 PC-18 剂量与安慰剂进行了比较。在第二项研究中，我们检查了每天两次口服 7.5 或 12.5 毫克的 PC-18 与安慰剂的比较。在这两项研究中，根据 Chalder 和简短疲劳量表 (BFI) 疲劳问卷的评估，PC-18 并不优于安慰剂，这可能反映了安慰剂出乎意料的良好抗疲劳活性。由于两项研究中使用的所有胶囊均含有约 100 毫克硅酸镁作为赋形剂，因此我们回顾性评估了第二项研究中的冷冻血清样本，发现患者接受安慰剂后镁水平显着增加。通过多变量分析，较高的随机化前镁水平和较高的 BFI 评分以及使用 12.5 mg 剂量的 PC-18 均与较高的治疗后 BFI 评分显着相关。我们在所有试验中均未观察到明显的毒性。我们的结论是，PC-18 和安慰剂之间没有差异可能是由于这些研究中安慰剂具有出乎意料的高抗疲劳活性。需要进一步研究评估补充镁对化疗引起的疲劳的作用。
Fatigue is frequent among oncologic patients. Unpurified Paullinia cupana dry extract showed encouraging results for chemotherapy-induced fatigue in our previous studies. We report two randomized, double-blind studies with a standardized dry purified Paullinia cupana extract named PC-18. For both studies, we recruited early breast cancer patients who had an increase in their fatigue scores after their first cycle of adjuvant chemotherapy. In the first study, we compared an oral dose of 37.5 mg of PC-18 twice daily with placebo. In the second study, we examined PC-18 at either 7.5 or 12.5 mg orally twice daily versus placebo. In both studies, PC-18 was not superior to placebo as assessed by both Chalder and Brief Fatigue Inventory (BFI) fatigue questionnaires, probably reflecting unexpectedly good placebo antifatigue activity. Since all capsules employed in both studies contained about 100 mg of magnesium silicate as an excipient, we retrospectively evaluated frozen serum samples from the second study and found a significant increase in magnesium levels after patients received placebo. By multivariate analysis, higher prerandomization magnesium levels and higher BFI scores together with the use of a 12.5 mg dose of PC-18 all correlated significantly with higher posttreatment BFI scores. We observed no significant toxicities in any of the trials. We conclude that the absence of differences between PC-18 and placebo may be due to the unexpectedly high antifatigue activity of the placebo in these studies. Further studies evaluating the role of magnesium supplementation for chemotherapy-induced fatigue are needed.