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 demonstrate…
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In Thackray 1978, 19 adverse effects occurred, of which 11 (16%) could be attributed to the formulations; these were equally distributed between the active and control groups.
“In Thackray 1978, 19 adverse effects occurred, of which 11 (16%) could be attributed to the formulations; these were equally distributed between the active and control groups.”
From Oral antihistamine-decongestant-analgesic combinations for the common cold (2022) · cites this paper as Thackray 1978
In Thackray 1978, seven participants with the active treatment and four with the placebo felt giddy or drowsy.
“In Thackray 1978, seven participants with the active treatment and four with the placebo felt giddy or drowsy.”
From Oral antihistamine-decongestant-analgesic combinations for the common cold (2022) · cites this paper as Thackray 1978
The antihistamine-decongestant-analgesic combination showed some effect on global effectiveness in two trials (Mizoguchi 2007; Thackray 1978).
“The combination showed some effect in two trials (Mizoguchi 2007; Thackray 1978).”
From Oral antihistamine-decongestant-analgesic combinations for the common cold (2022) · cites this paper as Thackray 1978
Adverse effects were reported in five trials and included drowsiness, somnolence, gingival swelling, hypersomnia, insomnia, dizziness, palpitations, giddiness, diarrhoea, headache, abdominal pain, and vomiting.
“Adverse effects were reported in five trials and included drowsiness, somnolence, gingival swelling, hypersomnia, insomnia, dizziness, palpitations, giddiness, diarrhoea, headache, abdominal pain, and vomiting (Blanco 2000; Mizoguchi 2007; Thackray 1978; Unuvar 2007; Zhang 2018).”
From Oral antihistamine-decongestant-analgesic combinations for the common cold (2022) · cites this paper as Thackray 1978
In pooled data from two trials, measured in the morning after an evening dose, significantly more participants evaluated the active evening dose treatment as beneficial (OR 0.47, 95% CI 0.33 to 0.67; 2 studies, 548 adults; low certainty evidence due to risk of bias and imprecision).
“Measured in the morning after an evening dose, significantly more participants evaluated the active evening dose treatment as beneficial (OR 0.47, 95% CI 0.33 to 0.67; 2 studies, 548 adults; low certainty evidence due to risk of bias and imprecision; Analysis 4.1).”
From Oral antihistamine-decongestant-analgesic combinations for the common cold (2022) · cites this paper as Thackray 1978
In Thackray 1978, more participants receiving active treatment scored the active syrup as 'good' to 'excellent' compared with those receiving placebo syrup (exact P value not provided).
“More participants receiving the active treatment scored the active syrup as 'good' to 'excellent' compared with those receiving the placebo syrup (exact P value not provided).”
From Oral antihistamine-decongestant-analgesic combinations for the common cold (2022) · cites this paper as Thackray 1978
Thackray 1978 showed no beneficial effect of an antihistamine-decongestive-analgesic combination on the subjective severity of sneezing compared with placebo (P = 0.14).
“The trial showed no beneficial effect compared with placebo (P = 0.14).”
From Oral antihistamine-decongestant-analgesic combinations for the common cold (2022) · cites this paper as Thackray 1978
In Thackray 1978, there was a clear difference between the number of participants rating the formulation as 'good, very good or excellent' on the morning after the dose received the night before (P < 0.01).
“In Thackray 1978, there was a clear difference between the number of participants rating the formulation as 'good, very good or excellent' on the morning after the dose received the night before (P < 0.01).”
From Oral antihistamine-decongestant-analgesic combinations for the common cold (2022) · cites this paper as Thackray 1978
Six trials assessed the effect of an antihistamine-decongestant-analgesic combination on the subjective severity of rhinorrhoea, of which four showed some effect.
“Six trials assessed the effect of an antihistamine‐decongestant‐analgesic combination on the subjective severity of rhinorrhoea, of which four showed some effect.”
From Oral antihistamine-decongestant-analgesic combinations for the common cold (2022) · cites this paper as Thackray 1978
In Thackray 1978, more participants with active treatment scored the active syrup as good to excellent than those with placebo syrup (exact P value not provided).
“More participants with active treatment scored the active syrup as good to excellent than those with the placebo syrup (exact P value not provided).”
From Oral antihistamine-decongestant-analgesic combinations for the common cold (2022) · cites this paper as Thackray 1978
Five trials assessed the effect of the antihistamine-decongestant-analgesic combination on the subjective severity of nasal obstruction, and all showed some effect.
“Five trials assessed the effect of the antihistamine‐decongestant‐analgesic combination on the subjective severity of nasal obstruction, all of which showed some effect.”
From Oral antihistamine-decongestant-analgesic combinations for the common cold (2022) · cites this paper as Thackray 1978
Two trials showed some effect of an antihistamine-decongestant-analgesic combination on cough (Mizoguchi 2007; Thackray 1978).
“Two trials showed some effect (Mizoguchi 2007; Thackray 1978).”
From Oral antihistamine-decongestant-analgesic combinations for the common cold (2022) · cites this paper as Thackray 1978
In Thackray 1978, more participants evaluated the active syrup as beneficial for rhinorrhoea compared with placebo (exact P value not provided).
“In Thackray 1978, more participants evaluated the active syrup as beneficial for rhinorrhoea compared with placebo (exact P value not provided).”
From Oral antihistamine-decongestant-analgesic combinations for the common cold (2022) · cites this paper as Thackray 1978
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References 4 · Cited by 21
- Authors
- Thackray, P.
- Affiliations
- Medical Director, Vick International Division of Richardson-Merrell Ltd., Slough, England
- Corresponding author
- Thackray, Peter
- Venue
- Journal of International Medical Research
- Publisher
- SAGE Publications
- Published
- 1978-03
- Volume
- 6
- Issue
- 2
- Pages
- 161-165
- ISSN
- 0300-0605 (ISSN-L)
- 1473-2300
- OpenAlex
- W2099375503
- Cited by
- 21
- References
- 4
- Citations by year
- 2025: 1 · 2023: 1 · 2022: 1 · 2016: 1 · 2015: 2 · 2014: 1 · 2012: 2
- FWCI
- 0.00
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of International Medical Research (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Epidemiology › Respiratory viral infections research
- Health Sciences › Medicine › Complementary and alternative medicine › Herbal Medicine Research Studies
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Respiratory and Cough-Related Research
- Keywords
- common cold, over-the-counter cold remedies, syrup formulation, paracetamol, dextromethorphan, doxylamine succinate, cough relief, nasal congestion, rhinorrhea, sneezing, headache, sore throat, sleep disorders, patient preferences
- MeSH terms
- Acetaminophen, Adolescent, Adult, Clinical Trials as Topic, Common Cold, Dextromethorphan, Double-Blind Method, Doxylamine, Drug Combinations, Drug Evaluation, Ephedrine, Female, Humans, Male, Middle Aged
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