Effectiveness of Pseudoephedrine Plus Acetaminophen for Treatment of Symptoms Attributed to the Paranasal Sinuses Associated With the Common Cold

Sperber, Steven J.; Turner, Ronald B.; Sorrentino, James V.; O'Connor, Robert R.; Rogers, James L.; Gwaltney, Jack M.

doi:10.1001/archfami.9.10.979

Cited by 24 publications

(8 citation statements)

References 9 publications

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“…No animal or clinical data validating the use of the FDC for treatment of cough and common cold was available for majority of the formulations. Results of studies of only 12 FDCs marketed in 2007 were available [19][20][21][22][23][24][25][26][27][28][29][30]. Because our objective was to determine the availability of animal or human trial data on these FDCs and not assessment of their efficacy, we have not analyzed the results of these trials.…”

Section: Discussionmentioning

confidence: 99%

Fixed‐dose combinations for cough and common cold in India: an assessment of availability and rationality

Roy¹,

Malhotra

Tayal

et al. 2011

Fundamemntal Clinical Pharma

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This study was conducted to determine the number and composition of the various cough and cold formulations available in the Indian market and to study their pharmacological rationale over a period of 7 years. Data for the study was collected from an annual Drug Compendium entitled ‘THE DRUG TODAY’ of the years 2001, 2004, and 2007. Medications were assessed for total number, different formulations, and number of constituents present in each formulation, their pharmacological group and amount of each constituent per dose. Rationality of available preparations was assessed on a seven‐point scoring criteria. There are over thirteen hundred drug products for cough and cold in the Indian market, which is an increase of 71.2% from the year 2001. More than 90% of the preparations were fixed‐dose combinations (FDCs). Majority of the cough and cold preparations had 3–4 constituents. Many preparations contained more than one constituent of the same pharmacological group. Some preparations had constituents with opposing action. A wide variation in the amount of each constituent present per dose in different formulations was observed. The number of banned drug combinations for cough and cold showed an increase from 9 in 2001 to 27 in 2007. Rationality assessment of the FDC preparations revealed that most of the preparations were irrational and had no documented benefit in the treatment of common cold. Availability of such a large number of irrational FDCs for cough and cold requires serious review of the legal provisions in India for drug manufacturing and marketing.

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Section: Discussionmentioning

confidence: 99%

Fixed‐dose combinations for cough and common cold in India: an assessment of availability and rationality

Roy¹,

Malhotra

Tayal

et al. 2011

Fundamemntal Clinical Pharma

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“…16,17 In one study, pseudoephedrine was shown to decrease rhinorrhea during the common cold, presumably related to its vasoconstrictor properties. 21 In the same study, pseudoephedrine had no effect on the symptom of sneezing. In clinical studies using pseudoephedrine, some efficacy in controlling sneezing, rhinorrhea, and itch has been reported.…”

Section: Commentmentioning

confidence: 87%

Comparison of Montelukast and Pseudoephedrine in the Treatment of Allergic Rhinitis

Mucha¹,

deTineo²,

Naclerio³

et al. 2006

Arch Otolaryngol Head Neck Surg

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To compare montelukast sodium and pseudoephedrine hydrochloride in the treatment of seasonal allergic rhinitis. Design: A 2-week, parallel, randomized, double-blind study with rolling enrollment. Setting: Tertiary care medical center. Patients: A total of 58 adult subjects with ragweed allergic rhinitis as documented by positive findings on a skin test to ragweed and history of symptoms during previous seasons. Interventions: After recording their own baseline nasal symptoms, nasal peak inspiratory flow (NPIF), and diurnal and nocturnal rhinoconjunctivitis quality of life (QOL) scores, subjects were randomized to receive daily morning oral doses of either pseudoephedrine hydrochloride (240 mg) or montelukast sodium (10 mg) for 2 weeks. They recorded their nasal symptoms and NPIF twice daily during this time, and at the end of the study, they completed another QOL questionnaire and 2 tolerability profiles. Main Outcome Measures: Nasal symptoms, NPIF, QOL scores, and tolerability profiles. Results: Both active treatments resulted in significant improvements from baseline in all symptoms of allergic rhinitis as well as in all the domains of the QOL questionnaires. When changes from baseline were compared between treatments, there were no significant differences except in the symptom of nasal congestion, for which pseudoephedrine was more effective than montelukast. Both treatments resulted in a significant increase in NPIF over baseline with no significant difference between treatments. Both drugs were well tolerated with no differences in the tolerability profiles between treatments. Conclusions: Pseudoephedrine and montelukast are equivalent in improving symptoms and QOL and increasing nasal airflow in patients with seasonal allergic rhinitis. The lack of the usual adverse effects in the pseudoephedrine group is ascribed to morning dosing.

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“…Furthermore, it should be mentioned that this concept would also explain why medications addressing nasal mucosa are effective in reducing headache in ARS (i.e. intranasal corticosteroids ( 12 ), decongestants ( 13 )). Finally, it should be underlined that our study does not confirm causality between ARS and headache despite the above described rationale.…”

Section: Discussionmentioning

confidence: 99%

COVID-19-related headache and sinonasal inflammation: A longitudinal study analysing the role of acute rhinosinusitis and ICHD-3 classification difficulties in SARS-CoV-2 infection

Straburzyński¹,

Nowaczewska

Budrewićz

et al. 2021

Cephalalgia

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Background The genesis of headache in coronavirus disease 2019 (COVID-19) is currently unclear and the multitude of disease symptoms often further hinders locating the source of pain. Interestingly, many subjects with COVID-19 have symptoms of acute rhinosinusitis. The relation between nasal symptoms and headache in SARS-CoV-2 infection remains unknown. Methods This bi-center longitudinal study evaluated symptoms in consecutive COVID-19 patients in the participating practices. The first assessment was performed during the initial consultation after infection confirmation. That was followed up by a second consultation after a median 9 days. Results 130 patients were included in the study (80 women, 50 men; mean age 46.9 years). Headache was highly prevalent at the first visit (72%) and significantly associated with acute rhinosinusitis symptoms. The odds ratio for headache in subjects with rhinosinusitis was 3.5. Headache could be attributed to systemic viral infection in 96% and to acute rhinosinusitis in 51% of cases according to 3rd edition of the International Classification of Headache Disorders. Criterium C.3 (exacerbation of headache by pressure applied over paranasal sinuses) and C.4 (ipsilaterality of headache and sinusitis) had low sensitivity in headache attributed to acute rhinosinusitis. Conclusions Nasal inflammation is associated with headache in COVID-19, although the pain mechanism lies probably in a systemic reaction to the virus. 3rd edition of the International Classification of Headache Disorders criteria for headache attributed to acute rhinosinusitis need adjusting to the current understanding of acute sinonasal infection.

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Effectiveness of Pseudoephedrine Plus Acetaminophen for Treatment of Symptoms Attributed to the Paranasal Sinuses Associated With the Common Cold

Abstract: 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 cold. Arch Fam Med. 2000;9:979-985

Cited by 24 publications

References 9 publications

Fixed‐dose combinations for cough and common cold in India: an assessment of availability and rationality

Fixed‐dose combinations for cough and common cold in India: an assessment of availability and rationality

Comparison of Montelukast and Pseudoephedrine in the Treatment of Allergic Rhinitis

COVID-19-related headache and sinonasal inflammation: A longitudinal study analysing the role of acute rhinosinusitis and ICHD-3 classification difficulties in SARS-CoV-2 infection

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