METHODS: Data on patient-reported outcomes from three cohort studies of Swedish patients diagnosed with colon, prostate or rectal cancer were combined with data on beta-blocker prescriptions retrieved from the Swedish Prescribed Drug Register. Two randomized controlled trials were emulated. Trial 1 had follow-up 1 year after diagnosis, trial 2 had follow-up 2 years after diagnosis, baseline in both trials was 12 months before follow-up. Those who initiated beta-blocker therapy between baseline and follow-up was assigned Active group, those who did not was assigned Control group. All endpoints were analysed using Bayesian ordered logistic regression.
RESULTS: Trial 1 consisted of Active group, n = 59, and Control group, n = 3936. Trial 2 consisted of Active group, n = 87, and Control group, n = 3132. The majority of participants were men, 83% in trial 1 and 94% in trial 2. The prevalence and severity of intrusive thoughts were lower in the Active group in trial 1, but no significant differences between groups were found in either trial. The prevalence of depressed mood, worse quality of life and periods of anxiety were higher in the Active group in both trials with significant differences for quality of life in trial 1 and anxiety in trial 2.
CONCLUSIONS: The emulated trials demonstrated no evidence of a protective effect of beta-blocker therapy against intrusive thoughts. The Active group had reduced quality of life and elevated anxiety compared to the Control group.
BACKGROUND: The three cohort studies were registered at isrctn.com/clinicaltrials.gov (ISRCTN06393679, NCT02530593 and NCT01477229).
方法:关于患者报告的结果的数据,来自三个被诊断为结肠的瑞典患者的队列研究,前列腺癌或直肠癌与从瑞典处方药物注册中心检索的β受体阻滞剂处方数据相结合.两项随机对照试验被模拟。试验1在诊断后1年进行随访,试验2在诊断后2年随访,两项试验的基线均为随访前12个月.那些在基线和随访之间开始β受体阻滞剂治疗的人被分配为活动组,那些没有被分配到对照组。使用贝叶斯有序逻辑回归分析所有终点。
结果:试验1由活动组组成,n=59,对照组,n=3936。试验2由活动组组成,n=87,对照组,n=3132。大多数参与者是男性,83%在试验1和94%在试验2。在试验1中,Active组的侵入性思维的患病率和严重程度较低,但在任一试验中,组间均无显著差异。情绪低落的患病率,在两项试验中,Active组的生活质量和焦虑时间较差,在试验1和试验2中,生活质量存在显著差异.
结论:模拟试验没有证据表明β受体阻滞剂治疗对侵入性思维有保护作用。与对照组相比,活动组的生活质量降低,焦虑升高。
背景:三项队列研究注册于isrctn.com/clinicaltrials.gov(ISRCTN06393679、NCT02530593和NCT01477229)。