(467) Implementation of a Placebo Response Reduction Training Program in a Randomized Controlled Trial in Chronic Low Back Pain: Comparison with Placebo Responses in Published Studies

Abstract

The placebo effect refers to the positive clinical outcome that results from treatments that contain no active components. Placebo responses decrease the assay sensitivity of clinical trials, thus increasing sample size requirements and risk of trial failure. Several studies suggest that psychoeducational interventions to neutralize patient expectation can reduce the placebo response. We have developed a Placebo Response Reduction Training Program which has been implemented in multiple clinical trials, and most recently in a completed trial in patients with lumbosacral radiculopathy (LSR). The purpose of this study was to compare the placebo response rate from that study to comparable published studies in LSR and chronic low back pain (LBP). A systematic review of the literature was performed to identify double-blind randomized placebo-controlled parallel trials of systemic pharmacological treatments in patients with LSR or LBP of at least 3 months pain duration and a minimum of 4 weeks of follow-up. Studies of a variety of pharmacological treatments were identified. Our results show that the study using the Placebo Response Reduction Training Program had a smaller placebo response than the two comparable studies in LSR, and smaller than the placebo response in all other included studies in LBP. Because of the observational nature of this comparison, and the numerous differences between all clinical trials, it is impossible to conclude that the lower placebo response seen in our study was due to the Placebo Response Reduction Training Program. Nonetheless, the successful reduction of the placebo response in patients with LSR suggests that further exploration is warranted of the use of psychoeducational interventions to neutralize patient expectation and lower placebo responses in clinical trials.