Paracetamol is ineffective for acute low back pain even for patients who comply with treatment: complier average causal effect analysis of a randomized controlled trial
Abstract
In 2014, the PACE trial demonstrated that paracetamol had no effect compared to placebo in acute low back pain (LBP). However, non-compliance was a potential limitation of this trial. The aim of this study was to investigate the efficacy of paracetamol in acute low back pain among compliers.Using individual participant data from the PACE trial (ACTN12609000966291), Complier Average Causal Effects (CACE), Intention-to-treat (ITT) and Per Protocol (PP) estimates were calculated for pain intensity (primary), and disability, global rating of symptom change and function (all secondary) after two weeks of follow-up. Compliance was defined as intake of an average of at least four of the prescribed six tablets of regular paracetamol per day (2660 milligrams in total) during the first two weeks after enrolment. Exploratory analyses using alternative time points and definitions of compliance were conducted.Mean between-group differences in pain intensity on a 0-10 scale using the primary time point and definition of compliance were not clinically relevant (propensity weighted CACE 0.07 (-0.37, 0.50) p = 0.76; joint modelling CACE 0.23 (-0.16, 0.62) p = 0.24; ITT 0.11 (-0.20, 0.42) p = 0.49; PP 0.29 (-0.07, 0.65) p = 0.12); results for secondary outcomes and for exploratory analyses were similar.Paracetamol is ineffective for acute low back pain even for patients who comply with treatment. This reinforces the notion that management of acute low back pain should focus on providing…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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