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Ibuprofen, paracetamol, and steam for patients with respiratory tract infections in primary care: pragmatic randomised factorial trial

Ibuprofen, paracetamol, and steam for patients with respiratory tract infections in primary care: pragmatic randomised factorial trial
Ibuprofen, paracetamol, and steam for patients with respiratory tract infections in primary care: pragmatic randomised factorial trial
Objective: To assess strategies for advice on analgesia and steam inhalation for respiratory tract infections.

Design: Open pragmatic parallel group factorial randomised controlled trial.

Setting: Primary care in United Kingdom.

Participants: Patients aged ?3 with acute respiratory tract infections.

Intervention: 889 patients were randomised with computer generated random numbers in pre-prepared sealed numbered envelopes to components of advice or comparator advice: advice on analgesia (take paracetamol, ibuprofen, or both), dosing of analgesia (take as required v regularly), and steam inhalation (no inhalation v steam inhalation).

Outcomes: Primary: mean symptom severity on days 2-4; symptoms rated 0 (no problem) to 7 (as bad as it can be). Secondary: temperature, antibiotic use, reconsultations.

Results: Neither advice on dosing nor on steam inhalation was significantly associated with changes in outcomes. Compared with paracetamol, symptom severity was little different with ibuprofen (adjusted difference 0.04, 95% confidence interval ?0.11 to 0.19) or the combination of ibuprofen and paracetamol (0.11, ?0.04 to 0.26). There was no evidence for selective benefit with ibuprofen among most subgroups defined before analysis (presence of otalgia; previous duration of symptoms; temperature >37.5°C; severe symptoms), but there was evidence of reduced symptoms severity benefit in the subgroup with chest infections (ibuprofen ?0.40, ?0.78 to ?0.01; combination ?0.47; ?0.84 to ?0.10), equivalent to almost one in two symptoms rated as a slight rather than a moderately bad problem. Children might also benefit from treatment with ibuprofen (ibuprofen: ?0.47, ?0.76 to ?0.18; combination: ?0.04, ?0.31 to 0.23). Reconsultations with new/unresolved symptoms or complications were documented in 12% of those advised to take paracetamol, 20% of those advised to take ibuprofen (adjusted risk ratio 1.67, 1.12 to 2.38), and 17% of those advised to take the combination (1.49, 0.98 to 2.18). Mild thermal injury with steam was documented for four patients (2%) who returned full diaries, but no reconsultations with scalding were documented.

Conclusion: Overall advice to use steam inhalation, or ibuprofen rather than paracetamol, does not help control symptoms in patients with acute respiratory tract infections and must be balanced against the possible progression of symptoms during the next month for a minority of patients. Advice to use ibuprofen might help short term control of symptoms in those with chest infections and in children.
0959-8138
1-13
Little, P.S.
1bf2d1f7-200c-47a5-ab16-fe5a8756a777
Moore, M.
1be81dad-7120-45f0-bbed-f3b0cc0cfe99
Kelly, J.
b7094829-aeb1-4bc1-b64c-7b7c716f73b5
Williamson, I.
12381296-edbf-4ac5-969b-dcb559c22f27
Leydon, G.
c5cdaff5-0fa1-4d38-b575-b97c2892ec40
McDermott, L.
5e895229-decd-4a30-8d08-dd9cc5b8f443
Mullee, M.
fd3f91c3-5e95-4f56-8d73-260824eeb362
Stuart, B.
ab5138db-f67f-4bc3-a424-0bf0220cfc92
on behalf of the PIPS investigators
Little, P.S.
1bf2d1f7-200c-47a5-ab16-fe5a8756a777
Moore, M.
1be81dad-7120-45f0-bbed-f3b0cc0cfe99
Kelly, J.
b7094829-aeb1-4bc1-b64c-7b7c716f73b5
Williamson, I.
12381296-edbf-4ac5-969b-dcb559c22f27
Leydon, G.
c5cdaff5-0fa1-4d38-b575-b97c2892ec40
McDermott, L.
5e895229-decd-4a30-8d08-dd9cc5b8f443
Mullee, M.
fd3f91c3-5e95-4f56-8d73-260824eeb362
Stuart, B.
ab5138db-f67f-4bc3-a424-0bf0220cfc92

Little, P.S., Moore, M., Kelly, J., Williamson, I., Leydon, G., McDermott, L., Mullee, M. and Stuart, B. , on behalf of the PIPS investigators (2013) Ibuprofen, paracetamol, and steam for patients with respiratory tract infections in primary care: pragmatic randomised factorial trial. British Medical Journal, 347 (f6041), 1-13. (doi:10.1136/bmj.f6041). (PMID:24162940)

Record type: Article

Abstract

Objective: To assess strategies for advice on analgesia and steam inhalation for respiratory tract infections.

Design: Open pragmatic parallel group factorial randomised controlled trial.

Setting: Primary care in United Kingdom.

Participants: Patients aged ?3 with acute respiratory tract infections.

Intervention: 889 patients were randomised with computer generated random numbers in pre-prepared sealed numbered envelopes to components of advice or comparator advice: advice on analgesia (take paracetamol, ibuprofen, or both), dosing of analgesia (take as required v regularly), and steam inhalation (no inhalation v steam inhalation).

Outcomes: Primary: mean symptom severity on days 2-4; symptoms rated 0 (no problem) to 7 (as bad as it can be). Secondary: temperature, antibiotic use, reconsultations.

Results: Neither advice on dosing nor on steam inhalation was significantly associated with changes in outcomes. Compared with paracetamol, symptom severity was little different with ibuprofen (adjusted difference 0.04, 95% confidence interval ?0.11 to 0.19) or the combination of ibuprofen and paracetamol (0.11, ?0.04 to 0.26). There was no evidence for selective benefit with ibuprofen among most subgroups defined before analysis (presence of otalgia; previous duration of symptoms; temperature >37.5°C; severe symptoms), but there was evidence of reduced symptoms severity benefit in the subgroup with chest infections (ibuprofen ?0.40, ?0.78 to ?0.01; combination ?0.47; ?0.84 to ?0.10), equivalent to almost one in two symptoms rated as a slight rather than a moderately bad problem. Children might also benefit from treatment with ibuprofen (ibuprofen: ?0.47, ?0.76 to ?0.18; combination: ?0.04, ?0.31 to 0.23). Reconsultations with new/unresolved symptoms or complications were documented in 12% of those advised to take paracetamol, 20% of those advised to take ibuprofen (adjusted risk ratio 1.67, 1.12 to 2.38), and 17% of those advised to take the combination (1.49, 0.98 to 2.18). Mild thermal injury with steam was documented for four patients (2%) who returned full diaries, but no reconsultations with scalding were documented.

Conclusion: Overall advice to use steam inhalation, or ibuprofen rather than paracetamol, does not help control symptoms in patients with acute respiratory tract infections and must be balanced against the possible progression of symptoms during the next month for a minority of patients. Advice to use ibuprofen might help short term control of symptoms in those with chest infections and in children.

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Accepted/In Press date: 23 September 2013
Published date: 25 October 2013
Organisations: Primary Care & Population Sciences

Identifiers

Local EPrints ID: 359306
URI: https://eprints.soton.ac.uk/id/eprint/359306
ISSN: 0959-8138
PURE UUID: 6b52b0a4-496f-4499-b7ea-84dd94bc49f8
ORCID for M. Moore: ORCID iD orcid.org/0000-0002-5127-4509
ORCID for G. Leydon: ORCID iD orcid.org/0000-0001-5986-3300

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Date deposited: 28 Oct 2013 10:47
Last modified: 20 Jul 2019 00:57

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Contributors

Author: P.S. Little
Author: M. Moore ORCID iD
Author: J. Kelly
Author: I. Williamson
Author: G. Leydon ORCID iD
Author: L. McDermott
Author: M. Mullee
Author: B. Stuart

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