A Double-Blind, Crossover Controlled Evaluation of a Syrup for the Night-Time Relief of the Symptoms of the Common Cold, Containing Paracetamol, Dextromethorphan Hydrobromide, Doxylamine Succinate and Ephedrine Sulphate

Abstract

Seventy subjects suffering from the common cold were recruited at general practitioner surgeries and were treated with an evening dose of a syrup† containing 600 mg paracetamol, 15 mg dextromethorphan hydrobromide, 8 mg ephedrine sulphate, 7.5 mg doxylamine succinate per 30 ml or an identical-appearing and flavoured control syrup without the active ingredients, in a double-blind crossover design study, lasting two days. Subjects were randomly allotted to two equal groups. One group took active formulation the first evening followed by the control formulation the second evening. The second group took the two formulations in the reverse order. Evaluation of symptomatic relief on a 6-point rating scale against eight major cold symptoms was carried out by each subject at 10 a.m. following the administration of active or control formulation the previous evening. Following combination of data for the two groups, results showed a significant degree of relief provided by the active formulation compared to control for the following symptoms, cough, nasal congestion, nasal discharge, sneezing, generally feeling unwell, headache, sore throat, disturbed sleep, the difference between the two preparations in relief of cough being highly significantly in favour of the “active” preparation. Additionally, a highly significant number of the subjects expressed a preference for the global symptomatic relief provided by the active formulation as compared to control. These results have demonstrated that the “active” formulation provides effective therapy for night-time symptomatic relief of the eight major symptoms of the common cold.