Placebo Response Reduction and Accurate Pain Reporting Training Reduces Placebo Responses in a Clinical Trial on Chronic Low Back Pain: Results From a Comparison to the Literature

• Published in: The Clinical journal of pain Vol. 36; no. 12; pp. 950 - 954
• Main Authors: Erpelding, Nathalie, Evans, Kathryn, Lanier, Ryan K., Elder, Harrison, Katz, Nathaniel P.
• Format: Journal Article
• Language: English
• Published: United States Lippincott Williams & Wilkins 01-12-2020; Copyright Wolters Kluwer Health, Inc. All rights reserved
• Subjects: Humans; Low Back Pain - drug therapy; Placebo Effect; Randomized Controlled Trials as Topic
• ISSN: 0749-8047; 1536-5409
• DOI: 10.1097/AJP.0000000000000873

OBJECTIVE:A literature review was conducted to compare placebo responses in a recent trial—which implemented an accurate pain reporting (APR) and placebo response reduction (PRR) training program—with placebo responses in similar previous trials in chronic lower back pain (CLBP) that did not use such training.
METHODS:A literature search was performed to find parallel design, randomized, controlled trials of pharmacological treatments administered orally or through intravenous injection for CLBP. Studies were assessed for the proportion of placebo responders, defined as the proportion of patients in the placebo group with ≥30% reduction in pain intensity. A χ analysis was performed on the proportion of responders from the SPRINT trial and from other similar studies.
RESULTS:Of 844 studies identified in the initial screening process, 16 studies were included for comparison. The percentage of placebo responders was statistically significantly lower in the SPRINT study (19.1%) compared with other CLBP trials (38.0%) (P=0.003). Our results show that the placebo response was lower in the SPRINT trial than other comparable studies on CLBP.
DISCUSSION:These findings are consistent with results from other studies showing that neutralizing subject and study staff expectations of therapeutic benefit can decrease the placebo response in clinical trials. The results of this study suggest training participants and staff to improve pain reporting accuracy, neutralize expectations, and decrease external cues that may bias participants’ pain ratings in clinical trials may effectively decrease the placebo response leading to increased assay sensitivity.