Trial reportBMC infectious diseases2013
Symptomatic treatment of the common cold with a fixed-dose combination of paracetamol, chlorphenamine and phenylephrine: a randomized, placebo-controlled trial.
Trial report in BMC infectious diseases, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Evaluation of the Efficacy and Safety of Fixed Combination of Paracetamol, Chlorpheniramine and Phenylephrine in the Treatment of Symptomatic Common Cold and Flu Syndrome in Adults
Phase III Study Comparing Coristina® D to Resfenol® in the Symptomatic Treatment of Common Cold
Who cites it
10 citing papers in PubMed, 1 synthesis or guideline pooled it, 34 citations in OpenAlex.
- Oral antihistamine-decongestant-analgesic combinations for the common cold.The Cochrane database of systematic reviews · 2022Pooled it
- Trial
- Inosine pranobex is safe and effective for the treatment of subjects with confirmed acute respiratory viral infections: analysis and subgroup analysis from a Phase 4, randomised, placebo-controlled, double-blind study.BMC infectious diseases · 2016Trial
- Knowledge and attitudes about influenza and the common cold in Syria post COVID-19: A qualitative study.Annals of medicine and surgery (2012) · 2022Article
- Pharmacist's recommendations of over-the-counter treatments for the common cold - analysis of prospective cases in Poland.BMC family practice · 2021Article
- The analgesic and anti-inflammatory effects of zukamu granules, a traditional Chinese medical formulation.Pharmaceutical biology · 2019Article
- Treatment of signs and symptoms of the common cold using EPs 7630 - results of a meta-analysis.Heliyon · 2019Review
- Clinical Practice Guidelines for Diagnosis and Management of Cough-Chinese Thoracic Society (CTS) Asthma Consortium.Journal of thoracic disease · 2018Review
- Compatibility study of paracetamol, chlorpheniramine maleate and phenylephrine hydrochloride in physical mixtures.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2017Article
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe common cold and other viral airway infections are highly prevalent in the population, and their treatment often requires the use of medications for symptomatic relief. Paracetamol is as an analgesic and antipyretic; chlorphenamine is an antihistamine; and phenylephrine, a vasoconstrictor and decongestant. This randomized, double-blind, placebo-controlled trial sought to evaluate the efficacy and safety of a fixed-dose combination of paracetamol, chlorphenamine and phenylephrine in the symptomatic treatment of the common cold and flu-like syndrome in adults.
methodsThis study enrolled 146 individuals aged 18 to 60 years who had moderate to severe flu-like syndrome or common cold. After clinical examination and laboratory tests, individuals were randomly assigned to receive the fixed-dose combination (73) or placebo (73), five capsules per day for 48 to 72 hours. The primary efficacy endpoint was the sum of the scores of 10 symptoms on a four-point Likert-type scale. To evaluate treatment safety, the occurrence of adverse events was also measured.
resultsMean age was 33.5 (±9.5) years in the placebo group and 33.8 (±11.5) in the treatment group. There were 55 women and 18 men in the placebo group, and 46 women and 27 men in the treatment group. Comparison of overall symptom scores in the two groups revealed a significantly greater reduction in the treatment group than in the placebo group (p = 0.015). Analysis at the first 13 dose intervals (± 66 h of treatment) showed a greater reduction of symptom scores in the treatment group than in the placebo group (p < 0.05). The number and distribution of adverse events were similar in both groups.
conclusionA fixed-dose combination of paracetamol, chlorphenamine and phenylephrine was safe and more effective than placebo in the symptomatic treatment of the common cold or flu-like syndrome in adults.
trial registrationNCT01389518.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.