Beste apotheek van Nederland

C-57
Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Orr (2006) 58
Funding
source: Pfizer
Inc. Israel
N screened = 28
N randomized = 21 (cross
over)
IG/ CG, n = 21
ITT analysis used for
primary outcome:
Inclusion: men age 18-60 y,
with diagnosis of chronic
post traumatic stress
disorder (PTSD), and ED
(score of less than 50 in
IIEF, and les than 20 in IIEF­
EF domain), in a stable
relationship
Exclusion: hx of alcoholism
or substance dependence
within the last 12 mo; genital
or anatomical deformities;
SCI; poorly controlled DM;
hx of malignant
hypertension, resting SBP >
180 mm Hg, hx of stroke or
MI within the last 6 mo prior
to study entry; predisposing
to priapism; any other
unstable medical conditions;
use of nitrates, or nitric oxide
in any form use of sildenafil
more than once; tx with T;
current use of any ED tx
Age, mean (sd):
44.5 (9.69) y,
range 22-55 y
Race: NR
Co-morbidities, n
(%): psychiatric
conditions: current
major depressive
episode 47% (past
episodes 29%);
dysthyia 7%;
current maniac or
hyomanid episode
4%; anxiety
disorder: social
phobia 39%;
general anxiety
disorder 61%,
agoraphobia 61%;
obsessive
compulsive
disorder 4%,
psychotic
symptoms
reported in 38%
Previous ED
treatment: NR
Smoking status:
NR
Body weight: NR
Concomitant
medications, n (%):
SSRIs 71%, tri-cyclic
antidepressants
21%, other
antidepressants
14%, anti-psychotics
25%, mood stabilizer
25%, and
benzodiazepine 89%
Duration of ED,
mean (sd): 19.71
(10.21)
Underlying
disease, n (%): as
in co-morbidities
Psychogenic ED, n
(%): 100%
Physiologic ED, n
(%): NR
Mixed ED, n (%):
NR
IG: Sildenafil
CG: Placebo
IG1:
Dose: 50-100 mg
Duration: 4 wks
Frequency: one pill 1 hr
before sexual activity;
total of 6 pills
Compliance: NR
CG:
Dose: NA
Duration: 4 wks
Frequency: as IG
Compliance: NR
Run In period: NR
Wash out period: no
washout included
F/u duration:
Other: (pts were
randomized to 2 grps,
1 st grp started with 4
wks placebo, and 2 nd
grp started with 4 wks
sildenafil)
Primary outcome results:
IIEF, mean (sd)
Total score: baseline 20 (12.32); post
45.19 (15.05) vs. 33.04 (12.99)
EF: baseline 7.42 (5.3); post tx 18.57
(7.7) vs. 13.8 (5.3)
SD: baseline 4.58 (2.23); post tx 4.95
(2.03) vs. 4.58 (1.8)
OF: baseline 4.45 (3.74); post tx 5.59
(2.44) vs. 4.04 (2.15)
IcS: baseline 4.39 (3.75); post tx 7.22
(1.92) vs. 6.20 (2.37)
OS: baseline 3.37 (1.96); post tx 5.18
(2.55) vs. 4.20 (2.48)
Other outcomes assessed:
depression, subjective well being and
PTSD symptoms score
Withdrawals/drop-outs/loss to f/u, n
(%): 6/27 (22) in placebo phase; 1/23
(4.3%) in sildenafil phase
WDAE, n (%): NR
TAE, n (%): NR, AEs included
heartburn, decrease in appetite,
constipation, diarrhea, nausea, vision
blur, tinnitus, dizziness, headache,
tiredness, backache, stomach ache,
chest pain, hot flushes, rash,
palpitation, sweating; no sign.between
grps
SAE, n (%): NR
Ascertainment of outcomes
assessed: IIEF domains; depression,
subjective well being by SAS and ABS);
PTSD symptom scores