Inferential reproduction analysis demonstrated that “paracetamol for acute low back pain” trial conclusions were reproducible

• Published in: Journal of clinical epidemiology 2020-05, Vol.121, p.45-54
• Main Authors: Schreijenberg, Marco, Chiarotto, Alessandro, Mauff, Katya A.L., Lin, Chung-Wei Christine, Maher, Christopher G., Koes, Bart W.
• Format: Article
• Language: English
• Subjects: Acetaminophen - therapeutic use; Acute Pain - drug therapy; Adult; Analgesics; Analgesics, Non-Narcotic - therapeutic use; Back pain; Clinical medicine; Clinical trials; Confidence Intervals; Data collection; Diaries; Early Termination of Clinical Trials; Epidemiology; Female; General practice; Humans; Inferential reproduction; Intention to Treat Analysis; Low back pain; Low Back Pain - drug therapy; Male; Middle Aged; Pain; Pain Measurement; Paracetamol; Quality; Quality of Life; Questionnaires; Reanalysis; Recovering; Reproducibility; Reproducibility of Results; Sleep; Statistical analysis; Treatment Outcome
• ISSN: 0895-4356; 1878-5921
• DOI: 10.1016/j.jclinepi.2020.01.010

The aim of this study was to reanalyze and reinterpret data obtained in Paracetamol in Acute Low Back Pain (PACE), the first large randomized controlled trial evaluating the efficacy of paracetamol in acute low back pain, to assess the inferential reproducibility of the original conclusions. Mixed effects models were used to reanalyze pain intensity (primary outcome; 11-point Numeric Rating Scale) and physical functioning, health-related quality of life, sleep quality, and time until recovery (as secondary outcomes), according to the intention-to-treat principle. The original authors of the PACE study were not involved in the development of the methods for this reanalysis. The reproduction analyses indicated no effect of treatment on pain intensity and confidence intervals excluded clinically worthwhile effects (adjusted main effect for regular paracetamol vs. placebo 0.00 [−0.02, 0.01; P = 0.85]; adjusted main effect for paracetamol as-needed vs. placebo 0.00 [−0.02, 0.01; P = 0.92]). Similar results were obtained for all secondary outcomes. This study indicates that the conclusions of the PACE trial are inferentially reproducible, even when using a different analytical approach. This reinforces the notion that the management of acute low back pain should focus on providing patients advice and reassurance without the addition of paracetamol.