| Methods |
|
| Participants |
|
| Interventions |
|
| Outcomes |
|
| Notes |
See Table 15
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
"Patients were randomly distributed" ‐ method of randomisation not described. |
| Allocation concealment (selection bias) |
Unclear risk |
Not described. |
| Blinding (performance bias and detection bias)
Subjective outcomes |
Unclear risk |
Study did not address subjective outcomes. |
| Blinding (performance bias and detection bias)
Objective outcomes |
Unclear risk |
Death ‐ objective outcome. Unclear blinding for bacterial infections and remission. |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Withdrawals and drop‐outs not described. It is unclear if patients with psychological problems were removed from the study or included on an ITT basis. |
| Selective reporting (reporting bias) |
High risk |
Insufficient data provided for extraction: Infection. |
| Protection from contamination? |
Low risk |
Intervention administered on an individual basis. |
