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: "The patients were randomized (ratio 1:1) to receive PTX or placebo for 10 days"
Comment: Allocation sequence probably random. No information on allocation concealment. |
| Deviations from intervention |
Low |
Quote: "PTX (made by Arya company) and placebo capsules were exactly the same in color, shape, and packaging. The clinicians and clinical pharmacists responsible for evaluating the study outcomes as well as the patients were blind to the intervention"
Comment: Blinded study (participants and personnel/carers). Our analysis for the binary outcome is an intention-to-treat analysis. This method was considered appropriate to estimate the effect of assignment to intervention. Risk assessed to be low for the outcomes: Mortality (D28). Clinical improvement (D28). WHO score 7 and above (D28). |
| Missing outcome data |
Some concerns |
Comment: 102 participants randomized; 72 participants analyzed.
Data not available for all or nearly all participants randomized; 29% missing data. No evidence that the result is not biased. Reasons: Non-regular use of medication due to lack of cooperation of the nurse (4 [7.7%] vs 5 [10%]), Discharge with personal consent (5 [9.6%] vs 8 [15.4%]), Other reasons (3 [5.8%] vs 3 [6%]) Missingness could depend on the true value of the outcome. Not likely that missingness depended on the true value of the outcome; reasons and proportions of missing data were similar between arms. Risk assessed to be some concerns for the outcomes: Mortality (D28). Clinical improvement (D28). WHO score 7 and above (D28). |
| 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). Clinical improvement (D28). WHO score 7 and above (D28). |
| Selection of the reported results |
Some concerns |
Comment: The registry was available (dated 25 November 2020, registered while recruiting).
Mortality outcome was pre-specified. Results were not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified. Risk assessed to be low for the outcome: Mortality (D28). Clinical improvement or WHO score t or above according to ordinal scale were not pre-specified as outcomes in the registry. No information on whether the result was selected from multiple outcome measurements or analyses of the data. Trial not analyzed as pre-specified. Risk assessed to be some concerns for the outcomes: Clinical improvement (D28). WHO score 7 and above (D28). |
| Overall risk of bias |
Some concerns |