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Zinc acetate lozenges for the treatment of the common cold: a randomised controlled trial.

ABSTRACT: OBJECTIVE:To examine a commercially available zinc acetate lozenge for treating the common cold. DESIGN:Randomised, double-blinded, placebo-controlled trial. SETTING:Working population in Finland. PARTICIPANTS:We included men and women aged ?18 years who usually had ?1?cold per winter. Exclusions were pregnancy, lactation, chronic runny nose or chronic cough. INTERVENTION:We randomised 253 participants to receive a package of lozenges to be taken if they caught the common cold. Of the 253 participants, 88 contracted the common cold and 87 were included in our primary analysis. Zinc acetate lozenges contained 13?mg elemental zinc and placebo lozenges contained sucrose octa-acetate to camouflage the taste of zinc. Instruction to use was six times per day for the maximum of 5 days. PRIMARY OUTCOME:Rate of recovery from the common cold analysed by Cox regression. RESULTS:There was no difference in the recovery rate between zinc and placebo participants during the 10-day follow-up (rate ratio for zinc vs placebo=0.68, 95% CI 0.42 to 1.08; p=0.10). The recovery rate for the two groups was similar during the 5-day intervention, but for 2 days after the end of zinc/placebo use, the zinc participants recovered significantly slower compared with the placebo participants (p=0.003). In the zinc group, 37% did not report adverse effects, the corresponding proportion being 69% in the placebo group. CONCLUSIONS:A commercially available zinc acetate lozenge was not effective in treating the common cold when instructed to be used for 5 days after the first symptoms. Taste has been a common problem in previous zinc lozenge trials, but a third of zinc participants did not complain of any adverse effects. More research is needed to evaluate the characteristics of zinc lozenges that may be clinically efficacious before zinc lozenges can be widely promoted for common cold treatment. TRIAL REGISTRATION NUMBER:NCT03309995.

SUBMITTER: Hemila H

PROVIDER: S-EPMC7045205 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Zinc acetate lozenges for the treatment of the common cold: a randomised controlled trial.

Hemilä Harri H Haukka Jari J Alho Marianne M Vahtera Jussi J Kivimäki Mika M

BMJ open 20200123 1

<h4>Objective</h4>To examine a commercially available zinc acetate lozenge for treating the common cold.<h4>Design</h4>Randomised, double-blinded, placebo-controlled trial.<h4>Setting</h4>Working population in Finland.<h4>Participants</h4>We included men and women aged ≥18 years who usually had ≥1 cold per winter. Exclusions were pregnancy, lactation, chronic runny nose or chronic cough.<h4>Intervention</h4>We randomised 253 participants to receive a package of lozenges to be taken if they caugh ...[more]

PMID: 31980506

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Project description:ObjectiveTo determine the feasibility of a randomised controlled trial (RCT) of rhinothermy for the common cold.DesignOpen label, randomised, controlled feasibility study.SettingSingle-centre research institute in New Zealand recruiting participants from the community.Participants30 adult participants with symptoms of a common cold, presenting within 48?hours of the onset of symptoms.InterventionsParticipants were randomly assigned 2:1 to receive either 35?L/min of 100% humidified air at 41°C via high flow nasal cannulae, 2?hours per day for up to 5?days (rhinothermy), or vitamin C 250?mg daily for 5?days (control).Primary and secondary outcome measuresThe primary outcome was the proportion of screened candidates who were randomised. Secondary outcomes included: proportion of randomised participants who completed the study; modified Jackson scores from randomisation to 10 days after initiation of randomised regimen; time until feeling 'a lot better' compared with study entry; time until resolution of symptoms or symptom score at 10 days postrandomisation; proportion of organisms identified by PCR analysis of nasal swabs taken at baseline; the patterns of use of the rhinothermy device; estimated adherence of the control group; and rhinothermy device tolerability.ResultsIn all 30/79 (38%, 95%?CI 27% to 50%) of potential participants screened for eligibility were randomised. Rhinothermy was well tolerated, and all randomised participants completed the study (100%, 95%?CI 88% to 100%). The reduction from baseline in the modified Jackson score was greater with rhinothermy compared with control at days 2, 3, 4, 5 and 6, with the maximum difference at day 4 (-6.4, 95%?CI -9.4 to -3.3). The substantial clinical benefit threshold for modified Jackson score was a 5-unit change.ConclusionsThis study shows that an RCT of rhinothermy compared with low-dose vitamin C in the treatment of the common cold is feasible.Trial registration numberACTRN12616000470493; Results.

Project description:BackgroundThe common cold is the most common infectious disease affecting humans and has a substantial economic impact on society. Human rhinoviruses, which cause almost two-thirds of colds, have demonstrated temperature-dependent replication which is optimal between 33°C and 35°C.MethodsThis randomised, single-blind, parallel-group trial completed at a single-centre in New Zealand, recruited 170 participants aged 18-75 years (mean age 27.5 years) who were within 48 hours of common cold symptom onset and had a symptom score (the Modified Jackson Score (MJS)) ≥7 and a negative point-of-care test for influenza. Participants were blinded to the intervention and randomised (1:1) to 5 days of either nasal high flow rhinothermy (rNHF) (100% humidified air delivered at 35 L/min and 41°C for 2 hours daily) (n=85) or 'sham' rhinothermy (100% humidified air delivered at 10 L/min and 31°C for 10 min daily) (n=85) and completed daily symptom diaries, which included the MJS, for 14 days, to investigate whether rNHF reduced common cold symptom severity and duration compared with 'sham' rhinothermy.ResultsAn intention-to-treat superiority analysis included all randomised participants and showed no difference between treatment groups for the primary outcome, the day 4 MJS analysed by analysis of covariance: mean (SD) 6.33 (3.97) for rNHF vs 5.8 (3.15) for 'sham'; estimated difference (95% CI) 0.37 (-0.69 to 1.42), p=0.49. There was no difference in time until resolution of symptoms: mean (SD) 5.96 (4.47) days for rNHF vs 6.42 (4.09) days for 'sham'; estimated difference (95% CI) 1.02 (0.75 to 1.38), p=0.91. There were no serious adverse events related to the study treatments.ConclusionsThis well-powered, single-blind randomised controlled trial does not provide evidence that 5 days of rNHF (100% humidified air heated to 41°C delivered at 35 L/min for 2 hours daily) reduces common cold symptom severity or duration. However, investigation of rNHF in the treatment of influenza is warranted.Trial registration numberACTRN12617001340325.

Dataset Information

Zinc acetate lozenges for the treatment of the common cold: a randomised controlled trial.

Publications

Zinc acetate lozenges for the treatment of the common cold: a randomised controlled trial.

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