Methods |
|
Participants |
|
Interventions |
|
Outcomes |
|
Notes |
See Table 8
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
"Subjects wishing to participate were assigned to 1 of the 3 treatment groups by a table of random numbers" |
Allocation concealment (selection bias) |
Unclear risk |
Not described. |
Blinding (performance bias and detection bias)
Subjective outcomes |
High risk |
Participants aware of group assignment. |
Blinding (performance bias and detection bias)
Objective outcomes |
Unclear risk |
Study did not address objective outcomes. |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
"One subject withdrew after consenting, but before data collection." Group allocation or reason not described. Data described for all included participants. |
Selective reporting (reporting bias) |
Unclear risk |
Unknown if selective outcome reporting. |
Protection from contamination? |
Low risk |
Interventions administered on an individual basis. |