| 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 |