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Quantitative Synthesis - Meta-analysis of Trials






Monotherapy (any dose: 10, 25, 50, 100 mg) versus placebo. In 62 trials the efficacy and harm-related effects of sildenafilcompared with placebo in the treatment of ED were investigated.7891, 9399, 101, 102, 104, 105, 107111, 115, 122, 123, 125, 126, 128, 130135, 137, 138, 142, 143, 146, 147, 149, 151, 156, 160, 164, 168, 171, 175

The quantitative analysis was considered separately for two groups of trials (n = 62), as follows:

Trials conducted in clinically heterogeneous groups of participants with ED (with no established specific organic cause) (n = 34)

Trials conducted in clinically homogenous groups of participants with ED (participants diagnosed additionally with specific clinical conditions (2a-2e) (n = 28) The 34 clinically heterogenous trials were potentially eligible for the meta-analyses (24 parallel-arm and 10 crossover).80, 82, 83, 8590, 9597, 105, 110, 111, 122, 125, 126, 130, 132, 134, 135, 137, 138, 142, 146, 149, 151, 156, 166, 171 None of the 10 crossover trials85, 89, 105, 130, 132, 134, 146, 149 however, were incorporated in the meta-analyses (pre-crossover phase data were not reported), leaving 24 trials for further consideration.80, 82, 83, 8688, 90, 9597, 110, 111, 122, 125, 126, 135, 137, 138, 142, 151, 156, 166, 171

Efficacy. Absolute endpoint mean IIEF “EF” domain score. The meta-analysis was based on two trials. 88, 126 The pooled estimate of mean difference was 6.39 (95 percent CI: 2.89–9.90), indicating a statistically significant improvement in the mean IIEF “EF” domain score for participants receiving sildenafil (any dose) compared with those receiving placebo (Figure 3).

Absolute endpoint mean IIEF-Q3/Q4 scores. The two meta-analyses yielded statistically significant pooled estimates of mean differences for both IIEF-Q3 (mean difference 1.46, 95 percent CI: 1.26–1.65) and IIEF-Q4 (mean difference 1.52, 95 percent CI: 1.21–1.82). Thus, the use of sildenafil was associated with statistically significant improvements with respect to penetration and erectile maintenance frequency (Figures 4–5).






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