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group (16.7, 12.5, and 8.3 percent, respectively). 337 Another study reported 50 percent more
withdrawals due to adverse events in trazodone group versus the placebo group. 339 In the
trazodone arm of one trail, five patients experienced sedations; no information on adverse events
for other groups (i.e., testosterone, hypnosis, and placebo) was reported. 339 In a trial comparing
the efficacy and harms of trazodone to mianserin, 344 two patients (8 percent) withdrew due to
adverse events from the mianserin treatment group and two patients (8 percent) in the trazodone
group developed serious adverse events (priapism and sedation).
Efficacy. Improvement in erection measured by Index of Sexual Satisfaction was 19 and 24
percent in trazodone and placebo groups, respectively. 337 One study reported minor improvement
from baseline in trazodone group but the between-group (versus placebo) difference for base
rigidity (> 60 percent), nocturnal erection, or morning erection, was not statistically
significant. 336 For one trial, improved erections were observed in 66, 60, 80, and 39 percent of
the patients treated with trazodone, testosterone, hypnosis, and placebo, respectively. 341
The proportions of patients with positive response (3 or more successful intercourse attempts
during 30 days and rigidity ≥ 30 minutes) at the end of 30 days of treatment with 50 mg
trazodone, 20 mg ketanserin, 10 mg mianserin, and placebo were 65.2, 19.1, 31.6, 13.6 percent,
respectively. 344
Cabergoline versus placebo. Two trials were identified with a total of 452 participants
randomly assigned to treatment with cabergoline (n = 225) or placebo (n = 222). 162,350 The trials
were conducted in Germany 350 and Iran. 162 The German study recruited patients with no organic
cause of ED. The Iranian study recruited non-responders to previous sildenafil therapy. The
mean age of participants was approximately 40 years. Total Jadad scores for the two trials were
3 350 and 5. 162 The allocation concealment was unclear in one 350 and adequate in the other. 162 Both
studies were parallel design and placebo controlled. The dose of cabergoline was 0.5 mg per
day 350 or 0.5–1 mg. 162 In both trials, the IIEF was used to measure baseline severity and
treatment effect.
Harms. The number of patients with any adverse events was greater in cabergoline group
(12.2 percent versus 2.0 percent, p = 0.001). 162 Withdrawals due to adverse events were higher in
the active arm versus placebo in the study which reported this information (5.9 versus 1.01
percent). 162 No information on serious adverse events was reported in any of these trials.
Efficacy. Both trials reported numerically or statistically significant improvements in the
results with cabergoline 0.5 mg versus placebo. The German study reported a change of 11.7 in
mean scores of erectile domain of IIEF from baseline in comparison to a change of 6.9 in the
placebo group. In the Iranian trial, patients improved by 5 points in the Intercourse Satisfaction
domain of the IIEF. 162 The improvement in Q3 (frequency of penetration), and Q4 (ability to
maintain the erection after sexual penetration) was 45.5 and 51.4 percent in the cabergoline arm
versus 15 and 20 percent in the placebo arm, respectively. 162
Pentoxifylline. Three parallel design studies were included (n = 114, range 18–60). 340,343,345
Mean age of participants was approximately 60.6 years. The trials were conducted in Turkey 340
and US. 343,345 The trial duration ranged from 2 to 3 months.
Total Jadad score ranged from 1 340 to 2. 343,345 Allocation concealment methods were unclear
in all three studies.
All three trials were placebo controlled administering 1.2 g/day of pentoxifylline and
evaluating subjective measures of improvement in erection. One study also included RigiScan
outcomes (i.e., NPT, penile rigidity). 343
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