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 |
Comment: Allocation sequence probably random. No information on allocation concealment. No information on baseline characteristics. |
| Deviations from intervention |
Some concerns |
Quote: “double-blind, placebo-controlled”
Comment: Blinded study (patients, Care Provider, Investigator [registry]). No information on adherence to interventions or on co-interventions Data were analyzed using intention-to-treat analysis. |
| Missing outcome data |
High |
Comment: No information on how many patients randomized; 373 patients analyzed.
Number of patients not included in analysis unclear. Number of patients in each treatment group unclear. Risk assessed to be high for the outcome: Clinical improvement (not extracted). |
| Measurement of the outcome |
Low |
Comment: Blinded study (outcome assessor [registry]).
Risk assessed to be low for the outcome: Clinical improvement (not extracted). |
| Selection of the reported results |
High |
Results were selected from multiple outcome measurements. Only one of multiple outcome measurements was reported. |
| Overall risk of bias |
High |