Beste apotheek van Nederland

reported adequate allocation concealment during randomization. 312 . Only one trial received a
total Jadad score of 4 and none received a score of 5. The remaining trials received scores of 3 or
2. (Table C-1, Appendix C)
Outcomes
Only the seven studies 144,306,312-315 that assessed clinical efficacy outcomes (e.g. IIEF-EF
domain scores, sexual intercourse success, improvement in erections) are described here. Of the
trials reporting the clinical efficacy outcomes, only four reported results for sexual intercourse
success. More commonly reported outcomes were quality of erections achieved at home.
Qualitative Synthesis
Summary of the results presented in this section is also available in Tables 20–22
Topical Alprostadil versus Placebo.
Harms. According to data reported from one trial (study a), 306 in patients with mild to
moderate ED, any adverse events were more frequent in those allocated to alprostadil given at
50µg (66.7 percent), 100µg (66.7 percent) or 200µg (77.5 percent) versus placebo (52.5 percent)
the corresponding proportions in the second trial with patients with severe ED (study b) for
alprostadil given at 100µg, 200µg, 300µg versus placebo were 30, 60, and 51 versus 11 percent
respectively. The incidence of adverse events and withdrawals due to adverse events in both
patient populations conformed a dose-response trend and that urogenital pain and hypotension
occurred numerically more frequently with alprostadil than with placebo.
Efficacy. The success rate of vaginal penetration was assessed in two trials of mild to
moderate (study a) and severe patients (study b). 306 Within men with severe ED (study b),
compared with those allocated to placebo, who reported a 15.6 percent success rate of vaginal
penetration at study end, success rates for men allocated to alprostadil were 32.3 percent for
100µg, 36.2 percent for 200µg, and 38.6 percent for 300µg, with none of the between group
differences reaching statistical significance. In men with mild to moderate ED (study a), men
allocated to placebo reported a 55.3 percent success rate, while the success rates in alprostadi
groups were 69.4 percent for 50µg (p > 0.05 versus placebo), 69.1 percent for 100µg (p>0.05
versus placebo), and 82.9 percent for 200µg (p = 0.01 versus placebo).
Topical Nitroglycerine versus Placebo. Two trials compared the efficacy and harms of
nitroglycerine to placebo. 313,315
Harms. In the first trial, men allocated to nitroglycerine ointment compared with placebo
reported more adverse events (frequent burning at the application site: 12.6 versus 0 percent;
hypotension: 10.3 versus 0 percent). 313 In the second trial, men allocated to nitroglycerine plaster
had more frequent headache (35.4 versus 1.1 percent) and smarting pain (23.2 versus 1.1
percent) compared with placebo. 315 In addition, 6 percent of men allocated to nitroglycerine
withdrew from therapy due to adverse events (severe pain) versus 0 percent of placebo subjects.
Efficacy. In one trial of men with physiologic ED (n=132 randomized), 20.7 percent of those
allocated to 2.5 g nitroglycerine ointment twice daily over 2 months reported improved erections
versus 1.7 percent of those allocated to placebo. 313 In a second trial, men with predominately
psychogenic ED and at least partial in-clinic erectile response to intracavernosal papaverine
(n=19) were allocated to 10 mg nitroglycerine plaster administered at least one hour prior to
anticipated sexual activity for up to 6 doses not more often than once daily versus placebo
plaster. Among those in the nitroglycerine plaster group, 16.7 percent reported improved
erections versus 11.1 percent of those in the placebo plaster group. 315
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