Efficacy and Safety of Brazilian Green Propolis in Biochemically Recurrent Prostate Cancer after Radical Prostatectomy: A Single-Arm Phase II Study

Journal of International Translational Medicine Pub Date : 2022-12-17 DOI:10.3390/ijtm2040047

Takayuki Goto, H. Kimura, T. Yoshino, A. Sawada, S. Akamatsu, Takashi Kobayashi, Toshinari Yamasaki, Shigemi Tazawa, M. Fujimoto, Y. Hidaka, R. Uozumi, S. Morita, Osamu Ogawa, Takahiro Inoue

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Abstract

Background: Radiation or hormonal therapy is considered for prostate cancer patients with biochemical recurrence (BCR) after radical prostatectomy (RP). However, these therapies have their own complications. To delay the start of these therapies, we investigated the efficacy and safety of Brazilian green propolis for the treatment for BCR after RP. Materials and Methods: This single-center, single-arm open trial included 22 patients who experienced BCR after RP between 2016 and 2019. The patients received nine softgels of Brazilian green propolis (containing 40 mg propolis per capsule) daily for 6 months. The primary outcome was the prostate-specific antigen (PSA) response rate. The secondary outcomes included progression-free time, PSA slope (1/PSA doubling time) response rate, quality of life, and safety profile. Results: The PSA response rate was 0%. The mean PSA slopes before and after baseline were 0.12 month−1 and 0.08 month−1, respectively. Fifteen patients (68%) showed a decreased PSA slope after treatment. There were no negative effects on quality of life or serious adverse events leading to treatment discontinuation. Conclusion: There was no significant anticancer response in patients who received Brazilian green propolis. However, the PSA slope was decreased after propolis administration. Further, Brazilian green propolis may be safely consumed by patients.

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巴西绿蜂胶治疗根治性前列腺切除术后复发前列腺癌的疗效和安全性:一项单组II期研究

背景:放疗或激素治疗是根治性前列腺切除术(RP)后生化复发(BCR)患者的首选治疗方法。然而，这些疗法有其自身的并发症。为了推迟这些治疗的开始，我们研究了巴西绿蜂胶治疗RP后BCR的有效性和安全性。材料和方法:这项单中心、单臂开放试验包括22例2016年至2019年期间RP术后BCR的患者。患者每天服用9粒巴西绿蜂胶软胶囊(每粒含40毫克蜂胶)，持续6个月。主要终点是前列腺特异性抗原(PSA)应答率。次要结局包括无进展时间、PSA斜率(1/PSA加倍时间)反应率、生活质量和安全性。结果:PSA有效率为0%。基线前后的平均PSA斜率分别为0.12个月和0.08个月。15例(68%)患者治疗后PSA斜率下降。没有对生活质量的负面影响或导致治疗中断的严重不良事件。结论:接受巴西绿蜂胶治疗的患者无明显的抗癌反应。蜂胶处理后，PSA斜率降低。此外，巴西绿色蜂胶可被患者安全食用。

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来源期刊

Journal of International Translational Medicine MEDICINE, RESEARCH & EXPERIMENTAL-

自引率

0.00%

发文量

317

审稿时长

8 weeks

期刊介绍： Journal of International Translational Medicine (JITM, ISSN 2227-6394), founded in 2012, is an English academic journal published by Journal of International Translational Medicine Co., Ltd and sponsored by International Fderation of Translational Medicine. JITM is an open access journal freely serving to submit, review, publish, read and download full text and quote. JITM is a quarterly publication with the first issue published in March, 2013, and all articles published in English are compiled and edited by professional graphic designers according to the international compiling and editing standard. All members of the JITM Editorial Board are the famous international specialists in the field of translational medicine who come from twenty different countries and areas such as USA, Britain, France, Germany and so on.