Methods |
|
Participants |
|
Interventions |
|
Outcomes |
|
Notes |
See Table 8
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
"Random assignment was made equally to one of three groups by drawing slips of paper indicating the group to which the subject would be assigned." |
Allocation concealment (selection bias) |
Unclear risk |
Not described. |
Blinding (performance bias and detection bias)
Subjective outcomes |
High risk |
Participants aware of group allocation. |
Blinding (performance bias and detection bias)
Objective outcomes |
Unclear risk |
Study did not address objective outcomes. |
Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Withdrawals described: "one subject was eliminated from the study because she was unable to cooperate with data collection". It is unclear if there is any missing data. |
Selective reporting (reporting bias) |
Unclear risk |
Not known. |
Protection from contamination? |
Low risk |
Interventions administered on an individual basis. |