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 |
Low |
Quote: "The researchers used SPSS software to generate random numbers (registry)" "Two identical opaque envelopes, one containing a card for the placebo group (group A) and the other containing a card for the M. vaccae group (group B), were put into an opaque box to conceal the allocation. One trained worker was assigned to draw an envelope after patients consented to enroll into the study, and patients were assigned to the group as indicated by the card inside the envelope"
Comment: Allocation sequence random. Allocation sequence concealed. |
| Deviations from intervention |
Low |
Quote: "randomized, double-blind controlled clinical trial"
Comment: Blinded study (participants 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 the outcomes: Mortality (D60 or more). Clinical improvement (D28). WHO score 7 and above (D60 or more). |
| Missing outcome data |
Low |
Comment: 31 participants randomized; 31 participants analyzed.
Data available for all participants randomized. Risk assessed to be low for the outcomes: Mortality (D60 or more). Clinical improvement (D28). WHO score 7 and above (D60 or more). |
| Measurement of the outcome |
Low |
Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome does not differ between groups. Blinded study (outcome assessor). Risk assessed to be low for the outcomes: Mortality (D60 or more). Clinical improvement (D28). WHO score 7 and above (D60 or more). |
| Selection of the reported results |
Some concerns |
Comment: The trial registry was available but retrospective (dated February 19th, 2020). No information on whether the result was 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 (D60 or more). Clinical improvement (D28). WHO score 7 and above (D60 or more). |
| Overall risk of bias |
Some concerns |