3.3. Analysis of efficacy outcomes
3.3.1. Clinical cure rate
Three RCTs were meta-analyzed (Figure 3 ).22,
23 The pooled RR significantly favored the astodrimer gel group over
placebo group (RR=2.10 [1.76, 2.51], p<0.01). Subgroup
analysis showed that clinical cure rates were significantly higher in
the astodrimer gel group at 9-12 days (RR=2.86 [2.25, 3.64],
p<0.01) and 21-30 days (RR=1.39 [1.06, 1.83], p=0.02) when
compared to the placebo group. The pooled analyses were homogeneous
(p=0.94 and p=0.2, respectively).
3.3.2. Nugent cure rate
Three RCTs were meta-analyzed (Figure 4 ).22,
23 The pooled RR significantly favored the astodrimer gel group over
placebo group (RR=4.41 [2.49, 7.81], p<0.01). Subgroup
analysis showed that Nugent cure rates were significantly higher in the
astodrimer gel group at 9-12 days (RR= 4.65 [2.44, 8.89],
p<0.01) and 21-30 days (RR= 3.55 [1.03, 12.22], p=0.04)
when compared to the placebo group. The pooled analysis were homogeneous
(p=0.56 and p=0.91, respectively).
3.3.3. Percentage of patients with self-reported absence of vaginal odor
Three RCTs were meta-analyzed (Figure 5 ).22,
23 The pooled RR significantly favored the astodrimer gel group over
placebo group (RR=1.57 [1.40, 1.77], p<0.01). Subgroup
analysis showed that the astodrimer group was significantly superior to
placebo group with respect to the percentage of patients with absence of
vaginal odor at 9-12 days (RR=1.83 [1.57, 2.14], p<0.01)
and 21-30 days (RR= 1.33 [1.12, 1.58], p<0.01). The pooled
analyses were homogeneous (p=0.3 and p=0.27, respectively).
3.3.4. Percentage of patients with self-reported absence of vaginal
discharge
Three RCTs were meta-analyzed (Figure 6 ).22,
23 The pooled RR significantly favored the astodrimer gel group over
placebo group (RR=1.45 [1.29, 1.64], p<0.01). Subgroup
analysis showed that the astodrimer group was significantly superior to
placebo group with respect to the percentage of patients with absence of
vaginal discharge at 9-12 days (RR=1.57 [1.33, 1.85],
p<0.01) and 21-30 days (RR=1.34 [1.12, 1.60],
p<0.01). The pooled analyses were homogeneous (p=0.42 and
p=0.19, respectively).
3.3.5. Percentage of patients with resolution of Amsel criteria
Two RCTs were meta-analyzed (Figure 7 ).22, 23The overall RR significantly favored astodrimer gel group over placebo
group with regard to resolution of pH (RR=2.85 [1.81, 4.48],
p<0.01), resolution of Whiff test (RR=2.36 [1.79, 3.10],
p<0.01), resolution of clue cells (RR=2.27 [1.74, 2.95],
p<0.01) and resolution of vaginal discharge (RR=2.46 [1.89,
3.18], p<0.01) at 9-12 days. The pooled analyses were
homogenous (p=0.46, p=0.58, p=0.17 and p=77, respectively).
3.3.6. Percentage of patients who received rescue therapy
Three RCTs were meta-analyzed (Figure 8 ).22,
23 The pooled RR significantly favored the astodrimer gel group over
placebo group (RR=0.70 [0.54, 0.90], p=0.005). The pooled analysis
was heterogeneous (p=0.04). Heterogeneity was resolved by removing the
results of Waldbaum 2020 (1%) and the overall RR still significantly
favored astodrimer gel group over placebo group (RR=0.79 [0.67,
0.93], p=0.004; heterogeneity I2=10%, p=0.34).