2.6. Data Synthesis
One study used three different concentrations of astodrimer gel as
following: 0.5%, 1%, and 3%.23 We considered each
dose as a separate study during statistical analysis. Another study
reported the findings of two stand-alone clinical trials, both of which
used the same dose of 1%.22 Likewise, we considered
each clinical trial as a separate study during statistical analysis. We
analyzed dichotomous data using the Mantel-Hanszel method and reported
outcomes as risk ratios (RR) with 95% confidence intervals (95% CI).
The analysis of efficacy endpoints was conducted using the Review
Manager Software version 5.3. The analysis of safety outcomes was
conducted using the OpenMeta[Analyst] software. Two main tests were
used to indicate inconsistency among studies, namely p-value of the
Chi-square test and I-square test (I2).28 Values of p<0.1 and I²>50%
were considered significant identifiers of heterogeneity. Homogeneous
data were analyzed under a fixed-effects model while heterogeneous data
were analyzed under a random-effects model. A sensitivity analysis
(leave-one-out) would be performed to resolve heterogeneity, if
applicable. This would be achieved by excluding one study at a time and
witnessing whether the heterogeneity would be resolved. Moreover, we
performed a subgroup analysis at 9-12 and 21-30 days for selected
efficacy outcomes. We could not assess publication bias of the included
studies using Egger’s funnel plots. This is because the number of
included studies was less than the minimum required number, which is ten
studies.29