Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal.
Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal.
BMC Cardiovasc Disord. 2022 May 14;22(1):223. doi: 10.1186/s12872-022-02658-x.
Some patients with chronic coronary syndromes undergo invasive procedures but the efficacy of such interventions remains to be robustly established by randomised sham-controlled trials (RCTs).
To determine the sham effect in patients with chronic coronary syndromes enrolled in RCTs by performing a systematic review and meta-analysis.
In April 2022, we performed a literature search for published patient-blind RCTs (CENTRAL, MEDLINE®, PsycINFO, and reference lists) with sham procedures, reporting the pre-post effects in the invasive sham arm among patients with Canadian cardiovascular society (CCS) angina or angina equivalents.
16 RCTs were included with 546 patients in the sham arm. Pooled results showed that sham interventions were associated with: improvement of 7% (95% CI 2-11%; I = 0%) in exercise time; decrease of 0.78 (95% CI - 1.10 to - 0.47; I = 75%) in CCS angina class; decrease of 53% (95% CI 24-71%; I = 96%) and 25% (95% CI 20-29%; I = 0%) in anginal episodes and nitroglycerine (NTG) use, respectively. Pooled results also showed an improvement in the physical functioning, angina frequency, treatment satisfaction, and disease perception domains of the Seattle Angina Questionnaire (SAQ).
Sham interventions in patients with chronic coronary syndromes were associated with a significant decrease in anginal episodes, NTG use, and CCS angina class and increased SAQ quality of life and exercise time. These results highlight the need for previous non sham-controlled trials to be interpreted with caution, and the importance of new invasive interventions to be evaluated versus a sham procedure.
一些慢性冠状动脉综合征患者接受了有创性治疗，但随机假手术对照试验（RCT）仍未能充分证实这些干预措施的疗效。
通过系统评价和荟萃分析，确定慢性冠状动脉综合征患者在 RCT 中接受假手术的假手术效应。
2022 年 4 月，我们对发表的患者盲法 RCT（CENTRAL、MEDLINE、PsycINFO 和参考文献列表）进行了文献检索，这些 RCT 报告了加拿大心血管学会（CCS）心绞痛或等效心绞痛患者中侵袭性假手术组的术前-术后效果。
纳入 16 项 RCT，共有 546 例患者接受假手术。汇总结果显示，假手术干预与以下方面有关：运动时间改善 7%（95%CI：2-11%；I=0%）；CCS 心绞痛分级降低 0.78（95%CI：-1.10 至-0.47；I=75%）；心绞痛发作减少 53%（95%CI：24-71%；I=96%）和 25%（95%CI：20-29%；I=0%），硝酸甘油（NTG）使用减少；西雅图心绞痛问卷（SAQ）的身体功能、心绞痛发作频率、治疗满意度和疾病认知领域也得到了改善。
慢性冠状动脉综合征患者接受假手术干预与心绞痛发作、NTG 使用、CCS 心绞痛分级减少以及 SAQ 生活质量和运动时间增加显著相关。这些结果强调了需要谨慎解释以前没有假手术对照的试验，并强调了需要评估新的有创干预措施与假手术相比的效果。
