Department of Urology and Andrology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.
Department of Dermatology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.
BMJ Open. 2021 Nov 18;11(11):e049314. doi: 10.1136/bmjopen-2021-049314.
Prostate cancer (PCa), as a malignant tumour with rapid development in recent years, significantly affects men's health, work, life and economy. Androgen deprivation therapy (ADT) plays an important role in the treatment of PCa and can be used as a complementary therapy in the late stage of castration-resistant prostate cancer. Though ADT targeting PCa shows an effective therapeutic effect, the underlying side effects (cognitive disorder, hot flashes, a decrease in sexuality) cannot be ignored. At present, cognitive behavioural therapy (CBT) has been widely used for patients with PCa after ADT due to its confirmed efficacy, fewer side effects and lower economic burden. However, the effectiveness of CBT for patients with PCa after ADT is still controversial. Therefore, we will conduct a systematic review and meta-analysis of the effectiveness of CBT for patients with PCa after ADT.
Literatures will be searched from establishment of the database to 31 May 2021 with the language restrictions of English and Chinese in eight online databases (PubMed, Embase, the Web of Science, Cochrane Library, VIP, CNKI, CBM, and WAN FANG). This study will include RCTs that performed CBT as the main method of the experimental group for patients with PCa after ADT. Two or more reviewers will independently conduct the selection of studies, data extraction and data analysis. The risk ratios with 95% CIs will be used to present the data synthesis result of dichotomous data, while weighted mean differences or standardised mean differences with 95% CIs will be used to present the data synthesis result of continuous data. Meanwhile, evidence quality of outcome will be assessed by using the Grading of Recommendations Assessment, Development and Evaluation method. Stata V.13.0 and Review Manager software V.5.3 will be used for analysis and synthesis.
This protocol is a second study based on a completed randomised controlled study. Thus, ethical approval is not required, and no additional data are available.
DOI 10.17605/OSF.IO/FUVEA.
前列腺癌（PCa）是一种近年来发展迅速的恶性肿瘤，严重影响男性健康、工作、生活和经济。雄激素剥夺疗法（ADT）在 PCa 的治疗中起着重要作用，并且可以作为去势抵抗性前列腺癌晚期的辅助治疗。尽管针对 PCa 的 ADT 具有有效的治疗效果，但不能忽视其潜在的副作用（认知障碍、热潮红、性欲降低）。目前，由于认知行为疗法（CBT）的疗效已得到证实，且副作用较少，经济负担较低，因此已广泛应用于 ADT 后的 PCa 患者。然而，CBT 对 ADT 后 PCa 患者的疗效仍存在争议。因此，我们将对 ADT 后 PCa 患者的 CBT 有效性进行系统评价和荟萃分析。
从数据库建立到 2021 年 5 月 31 日，将使用语言限制为英语和中文的 8 个在线数据库（PubMed、Embase、Web of Science、Cochrane Library、VIP、CNKI、CBM 和 WAN FANG）进行文献检索。本研究将包括以 CBT 作为实验组主要方法的 RCT 研究，用于 ADT 后的 PCa 患者。两名或更多评审员将独立进行研究选择、数据提取和数据分析。将使用风险比（95%CI）表示二分类数据的综合结果，而使用加权均数差或标准化均数差（95%CI）表示连续数据的综合结果。同时，使用推荐评估、制定和评估方法（Grading of Recommendations Assessment, Development and Evaluation，GRADE）对结局的证据质量进行评估。Stata V.13.0 和 Review Manager 软件 V.5.3 将用于分析和综合。
本方案是基于已完成的随机对照研究的二次研究。因此，不需要伦理批准，也没有额外的数据。
OSF 注册号：DOI 10.17605/OSF.IO/FUVEA。
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