Farr 1988b.
Study characteristics | ||
Methods | 6‐month randomised, controlled, double‐blind trial of the efficacy of virucidal nasal tissues in the prevention of natural cold, conducted in Charlottesville, Virginia, USA. Families were recruited from the Charlottesville community by advertisement in a local newspaper. Families were randomly assigned by the sponsoring company to receive either virucidal tissues or placebo‐treated tissues. Stratified randomisation was performed by computer, and the strata were defined by total number in the family. Study participants and investigators were unaware of the type of tissues each family was randomised to receive. Each family member kept a daily listing of respiratory symptoms on a record card. A nurse epidemiologist visited each family monthly to encourage recording. In addition, a study monitor visited each family bimonthly to further encourage compliance and reporting of symptoms. | |
Participants | 98 families, 58 in the active group and 40 in the placebo group. 231 families were initially recruited, 222 completed the trial, data of 98 families were analysed. The other families were excluded from the analysis because they complained of side effects (sneezing, etc.) or reported not using the tissues regularly. | |
Interventions | Use of virucidal tissues versus placebo tissues. The treated tissues were impregnated with malic and citric acids and sodium lauryl sulphate, whilst the placebo tissues contained succinic acid. Participants in the treated and placebo groups were instructed to only use tissues received through the study. | |
Outcomes | Laboratory: serological evidence: no Effectiveness: respiratory illness Safety: N/A | |
Notes | The study suggests that virucidal tissues have only a small impact on the overall rate of natural acute respiratory illnesses. The total illness rate was lower in families using virucidal tissues than in the other study group, but the difference between active and placebo groups was not statistically significant. There was a small, non‐significant drop in illness rates across families (5%). The tissues appeared to be ineffective as the drop was confined to primary illness unaffected by tissue use. The placebo (succinic acid) was not inert, and was associated with cough and nasal burning. This impacted on allocation concealment. A well‐designed and honestly reported study marred by transparent allocation | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "The randomisation was performed by computer in each trial." However, method of sequence generation is not stated. |
Allocation concealment (selection bias) | Unclear risk | "In trial II, families were randomly assigned by the sponsor to receive either virucidal tissues or placebo treated tissues." "In trial II, stratified randomisation was again used, but this time the strata were defined by total number in the family (i.e., one stratum for two‐member families, another stratum for three‐member families, and a final one for four‐member families)." Concealment of allocation not described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Study participants and investigators were unaware of the type of tissues which each family was randomised to receive in both trials." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Study participants and investigators were unaware of the type of tissues which each family was randomised to receive in both trials." |
Incomplete outcome data (attrition bias) All outcomes | High risk | "A total of 222 (of 231) families completed trial II; 9 families were terminated early (table 1). In 124 families, one or more family members reported not using the tissues regularly and/or reported having significant side effects. The data from these families were not analysed, leaving 58 families (177 persons) and 40 families (114 persons) for analysis in the virucide and placebo groups, respectively." |
Selective reporting (reporting bias) | Low risk | All indicated outcomes are reported. |