Preoperative optimization of patient expectations improves long-term outcome in heart surgery patients: results of the randomized controlled PSY-HEART trial
Preoperative optimization of patient expectations improves long-term outcome in heart surgery patients: results of the randomized controlled PSY-HEART trial
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DOI：
10.1186/s12916-016-0767-3
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发表时间：
2017-01-10
期刊：
影响因子：
9.3
通讯作者：
Moosdorf, Rainer
中科院分区：
文献类型：
--
作者：
Rief, Winfried;Shedden-Mora, Meike C.;Moosdorf, Rainer
背景：在大多数医学领域，安慰剂效应对结果有很大影响。虽然临床试验通常试图控制或最小化这些影响，但安慰剂机制改善结果的潜力很少使用。患者对治疗效果和结果的期望是导致这些安慰剂效应的主要机制。我们旨在优化这些期望，以改善接受冠状动脉旁路移植(CABG)手术的患者的预后。方法：在一项前瞻性的三臂随机临床试验中，124名预定接受CABG手术的患者被随机分为两组，一组是简单的术前心理干预以优化结果预期(Expect)；另一组是侧重于情感支持和一般建议的心理控制干预，而不是期望(支持)；或者是标准医疗护理(SMC)。为了在心脏手术环境下可行，干预措施保持简短；两种术前干预措施的治疗剂量是相同的。主要结果是术后6个月致残。结果：Expect组患者的残疾改善(-12.6；-17.6至-7.5)显著高于SMC组(-1.9；-6.6至+2.7)；支持组患者(-6.7；-11.8至1.7)与SMC组无差异。比较跟踪评分和基线评分的期望和支持的可变残疾只显示了倾向于期望组(P=0.09)。与支持相比，期望在精神生活质量和工作健康(每周工作时间)方面具有特定优势。与SMC患者相比，术前心理干预引起的促炎细胞因子浓度的增加不那么明显，反映为术后IL-8水平下降，而Expect组患者在随访时IL-6水平下降。这两种术前干预的特点是患者可接受性很高，没有不良反应。考虑到这种方法的创新性质，需要在更大规模的多中心试验中进行复制。结论：优化患者的术前期望有助于改善治疗后6个月的结果。这意味着使用安慰剂机制有可能改善高度侵入性医疗干预的长期结果。有必要进行进一步的研究，以便将这种方法推广到其他医学领域。
Background: Placebo effects contribute substantially to outcome in most fields of medicine. While clinical trials typically try to control or minimize these effects, the potential of placebo mechanisms to improve outcome is rarely used. Patient expectations about treatment efficacy and outcome are major mechanisms that contribute to these placebo effects. We aimed to optimize these expectations to improve outcome in patients undergoing coronary artery bypass graft (CABG) surgery.Methods: In a prospective three-arm randomized clinical trial with a 6 month follow-up, 124 patients scheduled for CABG surgery were randomized to either a brief psychological pre-surgery intervention to optimize outcome expectations (EXPECT); or a psychological control intervention focusing on emotional support and general advice, but not on expectations (SUPPORT); or to standard medical care (SMC). Interventions were kept brief to be feasible with a heart surgery environment; "dose" of therapy was identical for both pre-surgery interventions. Primary outcome was disability 6 months after surgery. Secondary outcomes comprised further clinical and immunological variables.Results: Patients in the EXPECT group showed significantly larger improvements in disability (-12.6; -17.6 to -7.5) than the SMC group (-1.9; -6.6 to +2.7); patients in the SUPPORT group (-6.7; -11.8 to 1.7) did not differ from the SMC group. Comparing follow-up scores and controlling for baseline scores of EXPECT versus SUPPORT on the variable disability only revealed a trend in favor of the EXPECT group (P = 0.09). Specific advantages for EXPECT compared to SUPPORT were found for mental quality of life and fitness for work (hours per week). Both psychological pre-surgery interventions induced less pronounced increases in pro-inflammatory cytokine concentrations reflected by decreased interleukin-8 levels post-surgery compared to changes in SMC patients and lower interleukin-6 levels in patients of the EXPECT group at follow-up. Both pre-surgery interventions were characterized by great patient acceptability and no adverse effects were attributed to them. Considering the innovative nature of this approach, replication in larger, multicenter trials is needed.Conclusions: Optimizing patients' expectations pre-surgery helps to improve outcome 6 months after treatment. This implies that making use of placebo mechanisms has the potential to improve long-term outcome of highly invasive medical interventions. Further studies are warranted to generalize this approach to other fields of medicine.