Efficacy of paracetamol for acute low-back pain: a double-blind, randomised controlled trial.

Abstract

BACKGROUND:

Regular paracetamol is the recommended first-line analgesic for acute low-back pain; however, no high-quality evidence supports this recommendation. We aimed to assess the efficacy of paracetamol taken regularly or as-needed to improve time to recovery from pain, compared with placebo, in patients with low-back pain.

METHODS:

We did a multicentre, double-dummy, randomised, placebo controlled trial across 235 primary care centres in Sydney, Australia, from Nov 11, 2009, to March 5, 2013. We randomly allocated patients with acute low-back pain in a 1:1:1 ratio to receive up to 4 weeks of regular doses of paracetamol (three times per day; equivalent to 3990 mg paracetamol per day), as-needed doses of paracetamol (taken when needed for pain relief; maximum 4000 mg paracetamol per day), or placebo. Randomisation was done according to a centralised randomisation schedule prepared by a researcher who was not involved in patient recruitment or data collection. Patients and staff at all sites were masked to treatment allocation. All participants received best-evidence advice and were followed up for 3 months. The primary outcome was time until recovery from low-back pain, with recovery defined as a pain score of 0 or 1 (on a 0-10 pain scale) sustained for 7 consecutive days. All data were analysed by intention to treat. This study is registered with the Australian and New Zealand Clinical Trial Registry, number ACTN 12609000966291.

FINDINGS:

550 participants were assigned to the regular group (550 analysed), 549 were assigned to the as-needed group (546 analysed), and 553 were assigned to the placebo group (547 analysed). Median time to recovery was 17 days (95% CI 14-19) in the regular group, 17 days (15-20) in the as-needed group, and 16 days (14-20) in the placebo group (regular vs placebo hazard ratio 0·99, 95% CI 0·87-1·14; as-needed vs placebo 1·05, 0·92-1·19; regular vs as-needed 1·05, 0·92-1·20). We recorded no difference between treatment groups for time to recovery (adjusted p=0·79). Adherence to regular tablets (median tablets consumed per participant per day of maximum 6; 4·0 [IQR 1·6-5·7] in the regular group, 3·9 [1·5-5·6] in the as-needed group, and 4·0 [1·5-5·7] in the placebo group), and number of participants reporting adverse events (99 [18·5%] in the regular group, 99 [18·7%] in the as-needed group, and 98 [18·5%] in the placebo group) were similar between groups.

INTERPRETATION:

Our findings suggest that regular or as-needed dosing with paracetamol does not affect recovery time compared with placebo in low-back pain, and question the universal endorsement of paracetamol in this patient group.

FUNDING:

National Health and Medical Research Council of Australia and GlaxoSmithKline Australia.

• Authors: Christopher M Williams, Christopher G Maher, Jane Latimer, Andrew J McLachlan, Mark J Hancock, Richard O Day, Chung-Wei Christine Lin
• Journal: Lancet (London, England) (Lancet) Vol. 384 Issue 9954 Pg. 1586-96 (Nov 01 2014) ISSN: 1474-547X [Electronic] England
• PMID: 25064594 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2014 Elsevier Ltd. All rights reserved.

Chemical References

• Analgesics, Non-Narcotic
• Acetaminophen

Topics

• Acetaminophen (administration & dosage, therapeutic use)
• Acute Pain (drug therapy)
• Adult
• Analgesics, Non-Narcotic (administration & dosage, therapeutic use)
• Double-Blind Method
• Drug Administration Schedule
• Female
• Humans
• Kaplan-Meier Estimate
• Low Back Pain (drug therapy)
• Male
• Medication Adherence (statistics & numerical data)
• Middle Aged
• Pain Measurement (methods)
• Socioeconomic Factors
• Treatment Outcome