Beste apotheek van Nederland

methods of allocation concealment. Participant withdrawals, drop-outs or lost to followup were
reported in all trials and ranged from 7 percent to 42 percent. The majority of the trials were
considered to be of low quality as assessed by the Jadad scale. Only one of the six trials received
a Jadad score of 3. The remaining trials received a score of 2 or less. (Table C-1, Appendix C)
Outcomes
Both clinical efficacy (e.g. sexual intercourse success, improvement in erections) and harms
(e.g. penile pain) outcomes were assessed in all six trials. 299-304 More commonly reported were
quality of erections achieved at home, without regard to whether the patient was able to achieve
successful sexual intercourse (“improvement” in erections, “full response,” full erection,” or
“grade 4 or 5 erections”). All six trials reported data on penile or urogenital pain and three trials
reported results on prolonged erections or priapism/fibrosis.
Qualitative Synthesis
Summary of qualitative synthesis for this section in presented also in Tables 17-19.
Alprostadil versus placebo. Three trials compared the efficacy and harms of IU alprostadil
to placebo. 302-304
Harms. In the first trial, compared with men in placebo group, alprostadil-treated men had
an increased frequency of penile pain (3.3 percent versus 32.8 percent) and minor urethral
trauma (1.0 percent versus 5.2 percent). 304 Urinary tract infection occurred in fewer than 1
percent of participants in both groups. No cases of prolonged erection, priapism or fibrosis were
observed in either treatment group.
In the second trial, men randomized to IU alprostadil reported an increased frequency of
urogenital burning (6.4 percent versus 0 percent), but statistically nonsignificant increase in risk
of penile pain (5.1 percent versus 1.2 percent), dizziness (2.6 percent versus 0 percent),
prolonged erection (1.3 percent versus 0 percent), and testicular pain (2.6 percent versus 0
percent). 302
Minor urethral trauma was reported by 1.3 and 1.2 percent of men allocated to IU alprostadil
and placebo, respectively.
There were no cases of priapism or fibrosis, or urinary tract infection in either treatment
group.
In the third trial, penile pain was reported by 1.7, 23.6, 20.5, 20.9 and 17.0 percent of men
allocated to placebo, 1000µg, 500µg, 250µg, and 125µg IU alprostadil, respectively, 303 The
corresponding proportions for reporting testicular pain were: 0.4, 1.8, 4.4, 4.4, and 2.0 percent.
Urethral pain was reported by 1.7, 9.1, 8.0, 5.1, and 1.0 percent of the men allocated to
placebo, 1000µg, 500µg, 250µg, and 125µg IU alprostadil, respectively.
Efficacy. Men randomized to IU alprostadil reported that 50.4 percent of their sexual
intercourse attempts during the 3 month treatment period were successful versus 10.1 percent for
men allocated to placebo. Sixty-two percent of men allocated to IU alprostadil reported at least
one successful sexual intercourse attempt during the study period versus 18.2 percent of men
allocated to placebo.
In the second trial, men randomized to IU alprostadil reported that 51.1 percent of their
sexual intercourse attempts during the 3 month treatment period were successful versus 7.5
percent for men allocated to placebo. In the third trial, 303 31 percent of men reported erections
sufficient for intercourse (grade 4 or 5) with 500µg IU alprostadil versus 14.1 percent of the men
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