Abstract
BackgroundPlacebo 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.MethodsIn 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.ResultsPatients 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.ConclusionsOptimizing 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.Trial registrationEthical approval for the study was obtained from the IRB of the Medical School, University of Marburg, and the trial was registered at (NCT01407055) on July 25, 2011.
Highlights
Placebo effects contribute substantially to outcome in most fields of medicine
Patient expectations to personally control the disease were significantly higher after the psychological intervention for EXPECT, but not for Supportive Therapy (SUPPORT) or standard medical care (SMC)
Improvements in disability were significantly larger in the EXPECT (−12.6; −17.6 to −7.5) compared to the SMC group (−1.9; −6.6 to +2.7), with intermediate effects in the SUPPORT group (−6.7; −11.8 to 1.7)
Summary
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. We aimed to optimize these expectations to improve outcome in patients undergoing coronary artery bypass graft (CABG) surgery. If patients undergoing coronary artery bypass graft surgery (CABG) expected to remain disabled after the surgery, it is more likely that these patients would still suffer from substantial disability post-surgery, even if their surgeons predicted a good patient recovery [9,10,11]. Such patient expectations are naturally occurring expectations, and not systematically induced expectations during clinical encounters. We report on the long-term effects (6 months) of a randomized controlled trial investigating PSYchological preoperative interventions to improve outcome in HEART surgery patients (PSY-HEART trial)
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
