Time-to-onset of cold and flu symptom relief: a randomized, double-blind, placebo controlled pilot study for a multi-symptom combination product
Abstract
Objective Evaluate effects of a multisymptom tablet on cold and flu symptoms within 4 hours post-administration. Materials and methods This was a randomized, double-blind, placebo-controlled study in adults with cold and flu symptoms. Eligible participants with at least moderate common cold or flu symptoms and symptom onset ≤ 48 hours before screening were assigned to a single multiple-active-ingredient tablet (containing paracetamol, pseudoephedrine hydrochloride, dextromethorphan hydrobromide, and chlorpheniramine maleate) or placebo tablet. Participants rated severity of each symptom (sore throat, headache, extremity pain, nasal congestion, sneezing, runny nose, and cough) from 0 (absent) to 3 (severe) at 15 and 30 minutes and 1, 2, 3, and 4 hours post administration. The total symptom score (TSS) was calculated as the sum of the individual symptom scores (primary endpoint). Participants rated global response to treatment on a scale from 0 (ineffective) to 4 (excellent). Adverse events (AEs) were recorded throughout. Results Of 53 participants randomized, 52 received active tablet (n = 25) or placebo tablet (n = 27). Change from baseline in TSS throughout the 4-hour post-administration period was similar between groups. An efficacy criterion of 30% decrease in TSS at assessment points was not met (range, -1.91 to 8.94%). There were also no significant differences between groups in mean symptom scores for individual symptoms or global response to treatment. Four non-serious…
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In Zhang 2018, there was no difference in total symptom score on any of the evaluation times, nor at the global evaluation point.
“Zhang 2018 found no difference in total symptom score on any of the evaluation times, nor at the global evaluation point.”
From Oral antihistamine-decongestant-analgesic combinations for the common cold (2022) · cites this paper as Zhang 2018
Zhang 2018 reported three participants with adverse effects in the control group and one participant with an adverse effect in the treatment group.
“Zhang 2018 reported three participants with adverse effects in the control group and one participant with an adverse effect in the treatment group.”
From Oral antihistamine-decongestant-analgesic combinations for the common cold (2022) · cites this paper as Zhang 2018
In Zhang 2018, one participant experienced somnolence.
“In Zhang 2018, one participant experienced somnolence.”
From Oral antihistamine-decongestant-analgesic combinations for the common cold (2022) · cites this paper as Zhang 2018
Three trials showed no effect of the antihistamine-decongestant-analgesic treatment on global effectiveness.
“Three trials showed no effect of the treatment.”
From Oral antihistamine-decongestant-analgesic combinations for the common cold (2022) · cites this paper as Zhang 2018
Zhang 2018 found no significant difference in decrease of severity of cough on a four-point severity score at any of the evaluation times, despite the presence of dextromethorphan in the active treatment.
“Zhang 2018 found no significant difference in decrease of severity of cough on a four‐point severity score at any of the evaluation times, despite the presence of dextromethorphan in the active treatment.”
From Oral antihistamine-decongestant-analgesic combinations for the common cold (2022) · cites this paper as Zhang 2018
Zhang 2018 found no significant difference in the decrease of severity of rhinorrhoea on a five-point severity score at any of the evaluation times.
“Zhang 2018 found no significant difference in the decrease of severity of rhinorrhoea on a five‐point severity score at any of the evaluation times.”
From Oral antihistamine-decongestant-analgesic combinations for the common cold (2022) · cites this paper as Zhang 2018
Zhang 2018 found no significant difference between groups in decrease of severity of nasal obstruction on a five-point severity score at any of the evaluation times.
“Zhang 2018 found no significant difference between groups in decrease of severity of nasal obstruction on a five‐point severity score at any of the evaluation times.”
From Oral antihistamine-decongestant-analgesic combinations for the common cold (2022) · cites this paper as Zhang 2018
Zhang 2018 found no significant difference in decrease of severity of sneezing on a five-point severity score at any of the evaluation times.
“Zhang 2018 found no significant difference in decrease of severity of sneezing on a five‐point severity score at any of the evaluation times.”
From Oral antihistamine-decongestant-analgesic combinations for the common cold (2022) · cites this paper as Zhang 2018
The included study was randomized.
“RCT”
From Oral antihistamine-decongestant-analgesic combinations for the common cold (2022) · cites this paper as Zhang 2018
The included study was double-blind.
“double‐blind”
From Oral antihistamine-decongestant-analgesic combinations for the common cold (2022) · cites this paper as Zhang 2018
The included study had follow-up for 52 of 53 participants (98%).
“98% follow‐up”
From Oral antihistamine-decongestant-analgesic combinations for the common cold (2022) · cites this paper as Zhang 2018
The included study was placebo-controlled.
“placebo‐controlled”
From Oral antihistamine-decongestant-analgesic combinations for the common cold (2022) · cites this paper as Zhang 2018
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Oral antihistamine-decongestant-analgesic combinations for the common cold
De Sutter, A. I., Eriksson, L., & van Driel, M. L. (2022) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd004976.pub4 · Cited by 26 · see citing works
Sun, L., Wang, D., Xu, Y., Qi, W., & Wang, Y. (2020) · Evidence-based Complementary and Alternative Medicine · doi:10.1155/2020/8873371 · Cited by 11 · see citing works
Combined drugs in the treatment of acute respiratory viral infections: a review of research results
Цветков, В. В. (2021) · Meditsinskiy sovet = Medical Council · doi:10.21518/2079-701x-2021-4-205-211 · Cited by 3 · see citing works
Pugach, P., & Sadeghi‐Latefi, N. (2024) · PLoS ONE · doi:10.1371/journal.pone.0301959 · Cited by 2 · see citing works
Bateman, M. T., BRUNTON, S. A., & Wright, W. L. (2025) · Postgraduate Medicine · doi:10.1080/00325481.2025.2603034 · Cited by 2 · see citing works
UNIYAL, O., & Sharma, M. K. (2026) · International Journal of Pharmacological and Pharmaceutical Innovations (IJPPI) · doi:10.67540/ijppi.v1.i2.013 · Cited by 2 · see citing works
Antihistamínicos como tratamiento del resfriado común
García, M. R., & Ponsá, Á. L. (2023) · Actualización en Medicina de Familia · doi:10.55783/amf.190607
- Authors
- Zhang, Y., & Mallefet, P.
- ORCID
- Zhang, Yi
- Venue
- Int. Journal of Clinical Pharmacology and Therapeutics
- Publisher
- Dustri-Verlgag Dr. Karl Feistle
- Published
- 2018-12-01
- Volume
- 56
- Issue
- 12
- Pages
- 604-611
- ISSN
- 0946-1965 (ISSN-L)
- OpenAlex
- W2891383113
- Cited by
- 7
- References
- 0
- Citations by year
- 2026: 1 · 2025: 1 · 2024: 1 · 2023: 1 · 2022: 1 · 2021: 1 · 2020: 1
- FWCI
- 0.39
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- International Journal of Clinical Pharmacology and Therapeutics (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 › Health Professions › Emergency Medical Services › Pediatric health and respiratory diseases
- Keywords
- common cold, influenza, symptom onset, paracetamol, pseudoephedrine, dextromethorphan, chlorpheniramine, over-the-counter cold remedies, symptom severity, adverse events
- MeSH terms
- Acetaminophen, Administration, Oral, Adult, Antitussive Agents, China, Chlorpheniramine, Common Cold, Dextromethorphan, Double-Blind Method, Drug Combinations, Female, Histamine H1 Antagonists, Humans, Influenza, Human, Male, Middle Aged, Pilot Projects, Remission Induction, Tablets, Time Factors, Nasal Decongestants, Treatment Outcome, Patient Satisfaction, Analgesics, Non-Narcotic, Pseudoephedrine
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