Effects of pseudoephedrine and triprolidine, alone and in combination, on symptoms of the common cold.

Abstract

Summary and conclusions A total of 466 healthy adults from four different regions of England entered a double-blind, randomised trial to test the effectiveness of an antihistamine (triprolidine) and a decongestant (pseudoephedrine), alone or in combination, in relieving symptoms of the common cold. During the study 199 subjects reported a total of 243 colds. Subjects recorded the severity of 12 symptoms during treatment and noted separately the severity of a further seven symptoms that represented unwanted effects of treatment or served as an index of suggestibility. They were then asked about their overall improvement in symptoms during treatment and whether they thought they had taken placebo.Sneezing, nasal obstruction, and overall response to treatment were significantly improved (p <0 01) with pseudoephedrine or pseudoephedrine and triprolidine compared with placebo.

Factors associated with efficacy of an ibuprofen/pseudoephedrine combination drug in pharmacy customers with common cold symptoms

“…Specifically, pseudoephedrine was found to reduce subjective or objective measures of congestion3, 8, 10, 16 but has little effect on sneezing,8 on pain10 or on non‐congestion cold symptoms in general 3. In the present survey, the ibuprofen/pseudoephedrine combination product differentially affected the extent of intra‐individual improvement of specific symptoms.…”

“…To reflect real‐world conditions a patient survey was performed, which excludes a placebo group. This was not deemed necessary as the efficacy of ibuprofen,6 pseudoephedrine3, 6, 7, 8, 10, 14, 15, 16, 17, 18 or their combination6, 7 in the treatment of common cold symptoms has been established in multiple placebo‐controlled studies. Moreover, common cold sufferers had correctly identified whether they were on active treatment or placebo in previous studies,8 questioning the value of a placebo group in this indication.…”

“…This was not deemed necessary as the efficacy of ibuprofen,6 pseudoephedrine3, 6, 7, 8, 10, 14, 15, 16, 17, 18 or their combination6, 7 in the treatment of common cold symptoms has been established in multiple placebo‐controlled studies. Moreover, common cold sufferers had correctly identified whether they were on active treatment or placebo in previous studies,8 questioning the value of a placebo group in this indication. While a placebo‐component is likely to be part of the observed symptom improvements, the differential effects on TIRS and TPRS as well as the observed dose‐dependency (see below) support the view that the reported improvements at least partly reflect pharmacodynamic responses attributable to the active ingredients of the combination product.…”

Chemotherapy of rhinovirus colds

“…Recent controlled trials with alkylamine-type antihistamines (e.g., chlorpheniramine and triprolidine) have reported reductions in certain symptoms of natural colds (12,19,56). One multicenter study (56) of oral chlorpheniramine reported statistically significant but modest (generally <10 to 15%) reductions in symptoms of nasal discharge, sneezing, and nose blowing, compared with placebo.…”

Effects of Pseudoephedrine in Man

“…Combinations of pseudoephedrine and an antihistamine have also been recommended to give relief of the symptoms of the common cold. Their value there is difficult to prove but in one randomized, placebo-controlled, double-blind study, Bye et al (28) were able to show in a large number of subjects (466 healthy adults) that sneezing, nasal obstruction and overall response to treatment were significantly improved by pseudoephedrine or pseudoephedrine and triprolidine combined compared with placebo or triprolidine alone.…”