Effectiveness of pseudoephedrine plus acetaminophen for treatment of symptoms attributed to the paranasal sinuses associated with the common cold
Abstract
Background Little data exist on the cause and treatment of subfacial pain and pressure and other discomfort attributed to the paranasal sinuses that develop early during the course of the common cold. The purpose of this study was to determine the efficacy of the combination of pseudoephedrine hydrochloride with acetaminophen for the treatment of early symptoms during colds, which are attributed by the patient to the sinuses. Methods Four hundred thirty subjects (216, pseudoephedrine and acetaminophen recipients; 214, placebo recipients) with cold symptoms of 48 hours or less who reported overall "sinus" symptoms of at least moderate severity were enrolled in this randomized double-blind placebo-controlled 2-dose study. Self-reported symptoms were scored (0 to 4, absent to severe) before and at 2 hours after the first and second doses. The 2 primary were measured 2 hours after the second dose were the overall sinus symptom assessment and a weighted composite assessment of sinus pressure, pain, and congestion (sinus symptoms). Results Compared with baseline, 2 hours after the second dose, the mean +/- SEM overall sinus symptom assessment score had decreased by 1.30 +/- 0. 06 in the pseudoephedrine and acetaminophen-treated subjects compared with 0.93 +/- 0.06 in the placebo-treated subjects (P Conclusion Our results suggest that pseudoephedrine plus acetaminophen is effective for relief of symptoms attributable to the paranasal sinuses that may develop early in the course of a…
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In three trials, dry mouth occurred in 2.6% of participants in the active treatment group and 1.8% in the control group (OR 1.43, 95% CI 0.53 to 3.83; 3 studies, 764 adults; low certainty evidence).
“In three trials dry mouth was noted as an adverse effect (Eccles 2006a; Middleton 1981; Sperber 2000), occurring in 2.6% of participants in the active treatment group and 1.8% of participants in the control group (OR 1.43, 95% CI 0.53 to 3.83; 3 studies, 764 adults; low certainty evidence due to imprecision and inconsistency; Analysis 3.4).”
From Oral antihistamine-decongestant-analgesic combinations for the common cold (2022) · cites this paper as Sperber 2000
In Sperber 2000, after the second administration the difference was still significant but smaller (P = 0.03).
“After the second administration the difference was still significant, but smaller (P = 0.03).”
From Oral antihistamine-decongestant-analgesic combinations for the common cold (2022) · cites this paper as Sperber 2000
In Sperber 2000, two hours after the first dose there was a clear decrease (P = 0.002) in nasal congestion score in favour of active treatment.
“Two hours after the first dose there was a clear decrease (P = 0.002) in favour of active treatment.”
From Oral antihistamine-decongestant-analgesic combinations for the common cold (2022) · cites this paper as Sperber 2000
There was no significant effect of an analgesic-decongestive combination on the subjective severity of sneezing.
“There was no significant effect.”
From Oral antihistamine-decongestant-analgesic combinations for the common cold (2022) · cites this paper as Sperber 2000
In Sperber 2000, the difference was at most 1.06 severity points on a five-point scale.
“in the second trial of Sperber 2000, the difference was at most 1.06 severity points on a five‐point scale”
From Oral antihistamine-decongestant-analgesic combinations for the common cold (2022) · cites this paper as Sperber 2000
The same two trials evaluated the effect on cough and found no effect.
“The same two trials also evaluated the effect on cough, finding no effect (Middleton 1981; Sperber 2000).”
From Oral antihistamine-decongestant-analgesic combinations for the common cold (2022) · cites this paper as Sperber 2000
None of the three trials assessing subjective severity of rhinorrhoea showed a favourable treatment effect.
“None of these trials showed a favourable treatment effect.”
From Oral antihistamine-decongestant-analgesic combinations for the common cold (2022) · cites this paper as Sperber 2000
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Background
- Authors
- Sperber, S. J.
- Affiliations
- Hackensack University Medical Center (US)
- Corresponding author
- Sperber, S. J.
- Venue
- Archives of Family Medicine
- Publisher
- CLOCKSS Archive
- Published
- 2000-11-01
- Volume
- 9
- Issue
- 10
- Pages
- 979-985
- ISSN
- 1063-3987 (ISSN-L)
- OpenAlex
- W1990035536
- Semantic Scholar
- 29d2e772fa25a8e48057b15499aadc79fbfeef66
- Cited by
- 28
- References
- 13
- Citations by year
- 2025: 2 · 2023: 1 · 2022: 1 · 2021: 1 · 2015: 3 · 2014: 1 · 2013: 2 · 2012: 1
- FWCI
- 0.80
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Archives of Family Medicine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Epidemiology › Respiratory viral infections research
- Health Sciences › Medicine › Otorhinolaryngology › Sinusitis and nasal conditions
- Health Sciences › Medicine › Complementary and alternative medicine › Herbal Medicine Research Studies
- Keywords
- pseudoephedrine, paracetamol, common cold, sinus pain, nasal congestion, headache, rhinorrhea, combination therapy, symptom relief, adverse effects
- MeSH terms
- Acetaminophen, Adolescent, Adult, Aged, Common Cold, Double-Blind Method, Drug Combinations, Ephedrine, Facial Pain, Female, Humans, Male, Middle Aged, Paranasal Sinuses, Treatment Outcome, Adrenergic Agents, Analgesics, Non-Narcotic
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