Note: The risk of bias by domain corresponds to the highest risk of bias among outcomes by domain.
The overall risk of bias corresponds to the overall highest risk of bias assessed among outcomes.
Bias | Author's judgement | Support for judgement |
Randomization |
Some concerns |
Quote: “Patients were randomly assigned to two groups of
25 controls or intervention by permutation block method.”
Comment: Allocation sequence random. No information on allocation concealment |
Deviations from intervention |
Low |
Quote: “double-blind, placebo-controlled”
Comment: Blinded study (patients and personnel/carers). Data for the outcome were analyzed using intention-to-treat analysis. This method was considered appropriate to estimate the effect of assignment to intervention. Risk assessed to be low for outcome: Mortality (D28). Hospitalization or death. Adverse events. |
Missing outcome data |
Low |
Comment: 52 patients randomized; 50 patients analyzed.
Data available for all or nearly all participants. Risk assessed to be low for the outcomes: Mortality (D28).Hospitalization or death. Adverse events. |
Measurement of the outcome |
Low |
Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups. Blinded study (outcome assessor). Risk assessed to be low for the outcomes: Mortality (D28). Hospitalization or death. Adverse events. |
Selection of the reported results |
Some concerns |
Comment: The trial registry was available but retrospective.
The timepoints listed in the registry were "after completion of the intervention". 14 days was the follow-up reported in the paper. No information on whether the results were selected from multiple outcome measurements or analyses of the data. No information on whether the trial was analyzed as pre-specified. Risk assessed to be some concerns for the outcomes: Mortality (D28). Hospitalization or death. Adverse events. |
Overall risk of bias |
Some concerns |