METHODS: According to a protocol (CRD42022350079), we searched multiple data sources for published and unpublished randomized controlled trials (RCTs) up to 2nd August 2022. Two review authors independently screened studies and abstracted data from the included studies. We performed statistical analyses by using a random-effects model and interpreted them according to the Cochrane Handbook for Systematic Reviews of Interventions. We used GRADE guidance to rate the certainty of evidence (CoE).
RESULTS: We found data to inform two comparisons: beta-3 adrenergic agonists versus placebo (4 RCTs) and anticholinergics (2 RCTs). Only mirabegron was used for intervention in all included studies. Compared to placebo, beta-3 adrenergic agonists may have a clinically unimportant effect on urinary symptoms score (mean difference [MD] -2.50, 95% confidence interval [CI] -4.78 to -0.22; I²=92%; 2 RCTs; 192 participants; low CoE) based on minimal clinically important difference of 3. We are very uncertain of the effects of beta-3 adrenergic agonists on quality of life (MD 10.86, 95% CI 1.21 to 20.50; I²=41%; 2 RCTs; 98 participants; very low CoE). Beta-3 adrenergic agonists may result in little to no difference in major adverse events (cardiovascular adverse events) (risk ratio 0.57, 95% CI 0.14 to 2.37; I²=0%; 4 RCTs; 310 participants; low CoE). Compared to anticholinergics, no study reported urinary symptom scores and quality of life. There were no major adverse events (cardiovascular adverse events) in either study group (1 study; 60 participants; very low CoE).
CONCLUSIONS: Compared to placebo, beta-3 adrenergic agonists may have similar effects on urinary symptom scores and major adverse events. There were uncertainties about their effects on quality of life. Compared to anticholinergics, we are either very uncertain or have no evidence about urinary symptom scores, quality of life, and major adverse events.
方法:根据协议(CRD42022350079),我们检索了截至2022年8月2日已发表和未发表的随机对照试验(RCT)的多个数据来源.两位综述作者独立筛选了研究,并从纳入的研究中提取了数据。我们使用随机效应模型进行了统计分析,并根据Cochrane干预措施系统审查手册对其进行了解释。我们使用等级指导对证据的确定性(CoE)进行评级。
结果:我们发现数据可以提供两种比较:β-3肾上腺素能激动剂与安慰剂(4个RCT)和抗胆碱能药(2个RCT)。在所有纳入的研究中,只有米拉贝隆被用于干预。与安慰剂相比,β-3肾上腺素能激动剂可能对泌尿症状评分具有临床上不重要的影响(平均差异[MD]-2.50,95%置信区间[CI]-4.78至-0.22;I²=92%;2个RCT;192名参与者;低CoE),基于3的最小临床重要差异。我们非常不确定β-3肾上腺素能激动剂对生活质量的影响(MD10.86,95%CI1.21至20.50;I²=41%;2项随机对照试验;98名参与者;CoE非常低)。β-3肾上腺素能激动剂可能导致主要不良事件(心血管不良事件)几乎没有差异(风险比0.57,95%CI0.14至2.37;I²=0%;4个RCT;310名参与者;低CoE)。与抗胆碱能药相比,没有研究报告尿路症状评分和生活质量.两组均无重大不良事件(心血管不良事件)(1项研究;60名参与者;CoE非常低)。
结论:与安慰剂相比,β-3肾上腺素能激动剂可能对泌尿症状评分和主要不良事件有类似影响。它们对生活质量的影响存在不确定性。与抗胆碱能药相比,我们要么非常不确定,要么没有关于泌尿症状评分的证据,生活质量,和主要不良事件。