Risk of bias within studies
Figure 3a displays risk of bias assessment for the efficacy outcome in
nine studies. Three had low overall risk of bias, three were high, and
three were unclear. Randomization processes were adequate in all
studies, but only four followed the intended interventions for the
participants. Two studies had high risk of bias due to intervention
deviations for failure to report the analysis used to estimate the
effect of assignment to intervention and failure to analyze participants
in the group to which they were randomized. Three had unclear risk of
bias for not reporting blinding or possible deviations.
One study did not report the reason for missing outcomes. Two studies
may have used inappropriate outcome measurement methods. Three studies
had unclear risks due to selective reporting and insufficient result
detail.
Figure 3b shows bias risk for safety outcomes in eight studies. Three
had low overall bias risk, three high, and two were unclear. Unclear and
high risks were due to intended intervention deviations, missing outcome
data, inappropriate outcome measurement, and selective reporting of
results.