Beste apotheek van Nederland

Finally, two studies reported on whether erections were “valid for intromission,” and one on
whether patients were “satisfied with treatment.” Trials that reported clinically relevant efficacy
outcomes or harms are emphasized in the Outcomes section below.
Qualitative Synthesis
Tables 12–14 illustrate the results.
PGE 1 versus no treatment. One trial, involving men who had undergone nerve-sparing
radical retropubic prostatectomy, compared efficacy and harms of PGE1 to those of no
treatment. 265
Harms. In total, 6.7 percent and 13.3 percent of participants treated with PGE 1 reported
prolonged erection and hematoma, respectively. No untreated participants reported these adverse
event s.
Efficacy. In total, 66.7 percent of participants receiving PGE 1 had improved erections versus
20 percent of those who did not receive any treatment. The absolute risk difference (RD)
between the two groups was 47 percent (95 percent CI: 13–80).
PGE 1 versus placebo. Six trials compared efficacy and/or harms of PGE1 versus
placebo. 266,268,274,281,282,292
Harms. Penile pain was reported in four trials and occurred numerically more commonly in
participants treated with PGE 1 . In one trial, penile pain was reported by 22.7 percent of the
participants treated with PGE 1 271 and in another in 13.3 percent of the participants. 282 Neither
study reported data on pain for the placebo groups. A third trial reported pain to have occurred in
35 percent of the participants who received PGE 1 versus 0 percent of the placebo-treated
participants 266 The fourth trial observed similar proportions of patients with pain between the
treatment groups (PGE 1 : 11.7 percent versus placebo: 10.9 percent). 274 Prolonged erection or
priapism was reported by 15 percent 266 and 2.5 percent 271 of the PGE 1 –treated participants. In
placebo-treated subjects, none of the participants had priapism in the first trial, and no priapismrelated
data were reported for the second trial. In a single trial, hematoma was reported for 1.5
percent of injections with PGE 1 , with no data reported for the placebo group. 282
Efficacy. In four crossover trials, between 28.9 and 66 percent of participants reported
improved erections in the PGE 1 treatment groups. In two of these trials, placebo-treated
participants did not experience improved erections 266,268 The other two trials did not report any
outcomes data for the placebo groups. 281,292
In one parallel trial, none of the placebo-treated participants reported improved erections, as
compared with 35 percent of the participants treated with PGE 1. The observed pattern conformed
a dose-response trend (17 percent with 2.5µg PGE 1 , 27 percent with 5µg, 45 percent with 10µg,
and 50 percent with 20µg). 271
PGE 1 versus PGE 1 (comparison of timing of treatment initiation or dose delivery). One
trial compared the harms related to fast versus slow PGE1 injection (i.e., 5-second injection
versus 60-second injection). 270 A second trial, involving men who had undergone non–nervesparing
radical prostatectomy, compared the efficacy and harms of early versus late postprostatectomy
PGE1 treatment (i.e., 1–3 months post-operatively versus 4–12 months postoperatively).
256
Harms. In the first trial, 54.5 percent of those receiving fast PGE 1 injections reported pain
during injection versus 18.2 percent of those receiving slow injections. 270 In the second trial, 8.3
percent of participants who received early PGE 1 treatment reported prolonged erections versus 0
percent of those who received late PGE 1 treatment. 256
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