Oliveira Saulo Silva, Del Giglio Adriana Braz, Lerner Tatiana Goberstein, Zanellato Rebecca Melo, Tiemi Livia, Reifur Lucas, Santi Patrícia Xavier, Del Giglio Auro
Einstein (Sao Paulo). 2013 Dec;11(4):435-8. doi: 10.1590/s1679-45082013000400005.
To evaluated whether Paullinia cupana decrease number and severity of hot flashes in breast cancer survivors.
This was a prospective phase II pilot study. We studied female breast cancer survivors who had completed the cancer treatment 3 months previously and who were experiencing at least 14 hot flashes per week. At least 9 of the 15 patients were required to have a decrease of at least 50% in hot flash severity score in keeping with the Simon Design. Patients received 50mg of dry extract of Paullinia cupana orally twice a day for 6 weeks. We assessed both frequency and severity of hot flashes.
A total of 18 patients started the Paullinia cupana treatment, and 15 completed the study. Three patients left the study immediately after starting the treatment because of personal difficulties in participation or noncompliance. Of the 15 patients who completed the study 10 had a decrease of more than 50% in hot flash severity scores. During the 6 weeks of treatment, statistically significant decreases were seen in both numbers of hot flashes (p=0.0009) and severity scores (p<0.0001). Paullinia cupana was well tolerated, and there were no instances of discontinuation because of toxicity.
Paullinia cupana appears promising for controlling hot flashes. More extensive studies seem warranted.
评估瓜拉那是否能减少乳腺癌幸存者潮热的次数及严重程度。
这是一项前瞻性II期试点研究。我们研究的是那些在3个月前已完成癌症治疗且每周至少经历14次潮热的女性乳腺癌幸存者。根据西蒙设计,15名患者中至少有9名患者的潮热严重程度评分需降低至少50%。患者每天口服两次50毫克瓜拉那干提取物,持续6周。我们评估了潮热的频率和严重程度。
共有18名患者开始接受瓜拉那治疗,15名完成了研究。3名患者在开始治疗后因个人参与困难或不依从立即退出了研究。在完成研究的15名患者中,有10名患者的潮热严重程度评分降低了50%以上。在6周的治疗期间,潮热次数(p = 0.0009)和严重程度评分(p < 0.0001)均出现了统计学上的显著下降。瓜拉那耐受性良好,没有因毒性而停药的情况。
瓜拉那在控制潮热方面似乎很有前景。似乎有必要进行更广泛的研究。