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Patients were instructed to take the study medication one hour before their sexual activity 182­
184,189-192,194,196,204-206 or as needed 181,198 for maximum of one dose per day. In one trial patients
were instructed to take the dose 8 hours before sexual activity for up to one dose a day. 203 Five
trials did not report the dosage instructions clearly. 180,197,199-201
Outcomes
Harms. The presence or absence of any adverse events was reported in eight trials. 182-184,189,
191,193,200,203 The presence or absence of serious adverse events was reported in 18 trials. 181-184,190­
198,200,201,203-205 The presence or absence of withdrawals due to adverse events was reported in 19
trials. 181-184,189-199,201,203-205
Efficacy. The most commonly reported outcomes that measured the degree of ED were: the
mean IIEF scores for the “Erectile Function” domain (endpoint or mean change from
baseline); 181-184,189-192,194,196-201,203-206 the mean endpoint score/mean score changes on questions
two and three of the Sexual Encounter Profile (SEP–Q2: “Were you able to insert your penis into
your partner’s vagina?” and SEP–Q3: “Did your erection last long enough for you to have
successful intercourse?”) 181-184,190-192,196-201,203-205 and a Global Assessment Question (GAQ–Q1:
“Has the treatment you are taking improved your erection?”). 181-184,189-192,196,199-201,203
Other commonly reported outcomes were total mean scores for the following IIEF domains:
“Intercourse Satisfaction,” 183,194,198,204 “Overall Satisfaction,” 183,194,198,204 “Orgasmic
Function,” 183,194,204 “Sexual Desire,” 194,204 and the mean scores for individual IIEF questions
Q3/Q4 (i.e., penetration and maintenance frequency). 183,189,194,200,205
Other less frequently reported outcomes were measured using the following instruments:
Center for Epidemiologic Studies Depression Scale (CES-D), 183,190,199 the quality of life (QoL)
Fugl-Meyer assessment, 189,190,194 the Rosenberg Self-Esteem Scale, 199,200 tip and base rigidity
activity unit (RAU) and tumescence activity units (TAU), 193,195 the duration of erection with
rigidity of >60 percent (or >80 percent), 193,195 patient’s diary of satisfaction with
erection/ejaculation, 191 ED severity, 206 endothelial function of cavernous and brachial arteries
(flow mediated dilation: FMD), 180 and sexual quality of life domain from the modified Sexual
Life Quality Questionnaire (mSLQQ). 197
Study and Reporting Quality
The mean total Jadad score for the 22 trials was 3.3 (Appendix C, Table C-1). The Jadad total
score for the individual trials ranged from one 206 to five. 191,197 The methods for generating the
sequence of random assignment were described for four studies 183,191,192,197 and were judged to
be appropriate. All trials except for one 206 were described as double-blind. For all trials except
for one 189 the methods for treatment allocation concealment were judged to be “unclear.” The
method of allocation concealment reported in the above-mentioned trial was deemed to be
appropriate. 189 Both crossover trials 193,195 employed a washout period of five days.
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