Beste apotheek van Nederland

131,137,138,142,143,147,151,155,156,161,166,167,171 and proportion of patients with improved erection (GEQ–
79-90,93-98,107-109,112,115,124-126,128,131,133,137,138,142,143,147,149, 151,156,165,167-169,171
Q1).
Several trials reported mean IIEF scores for individual questions (e.g. Q1–Q2 and Q5–
Q15) 78,94,101,123,124,126,131,138,143,150,162,165 as well as the mean total IIEF score. 91,106,123,128,155,164,175
Other reported outcomes were mean severity score of ED (based on the modified 5-item
IIEF), 111,123,135,158 time to onset of erections/intercourse attempts (i.e., mean/median number of
minutes), 122,130,161 proportion of responders (erection rigidity >60 percent or erection grades 3–
4), 130,146 duration of erections (≥60 percent or ≥80 percent rigidity), 93,105,132,146,168 mean number
(per week or month) of penile erections (grade 3–4), 85,88,89,93,95,96,138,142,168 peak systolic/end
diastolic velocity (PSV/EDV) in cm/s, 104,108,112,157 mean EDITS score, 84,90,109,143,147,156,160,161,167
mean score of responses to Self-Esteem and Relationship questionnaire (SEAR), 156,160,166,171
nocturnal penile tip and base tumescence/rigidity (in mean activity units), 110,134 and endothelial
function (brachial artery flow-mediated dilation). 158
Study and Reporting Quality
The mean of Jadad total score for the 73 trials was 3.3. The Jadad total score for the
individual trials ranged from 1 99,124,132,150,178,179 to 5. 81,91,94,95,115,123,128,143,162,168 The method for
generating the sequence of randomization was described in only 26 trials, 81,84,89,91,94,95,99,101,104,106,
107,109,112,115,123,128,143,155-157,162,164,165,167,168,171 and in four of these 89,99,104,112 the method was
determined to be inappropriate.(Table C-1, Appendix C)
Of the 73 trials, 64 (88 percent) were described as double- blind 79-91,93-99,101,102,104,105,107-109,
111,112,115,122,123,125,126,128,130,131,133-135,137,138,142,143,146,147,149,151,156,158,160-162,164-169,171,175 and nine trials
as open-label. 78,106,110,124,132,150,155,157,180 Of the 64 double-blind trials, 42 (66 percent) reported
79-83,86-91,94,95,97,98,102,104,107,108,112,115,122,123,125,128, 30,
some description of the blinding methods. 133,134,137,138,142,143,151,158,162,164,168,169,173,175 The blinding methods reported for two trials 102,146 were
judged to be inappropriate.
Information on methods for allocation concealment was reported for only 11 trials. 81,91,
94,95,101,106,107,112,123,156,165 The methods reported for 10 trials were judged to be adequate, 81,91,94,95,
101,106,107,112,123,165 and for one trial inadequate. 156 The methods used to conceal the treatment
allocation for the remaining 61 trials could not be ascertained (i.e., these were rated “unclear”).
Of the 21 crossover studies, seven (33 percent) reported the use of washout periods, 85,130,132,
146,150,165 and one study reported not to have employed a washout period. 89 For the remaining 13
78,93,99,102,105,108,130,131,134,149, 161,
trials, it was not clear whether any washout periods were applied. 164,168 The length of washout period for the seven crossover trials was 4 days, 150 85, 130,132,
7 days,
146 and 2 weeks. 165
Qualitative Synthesis
Sildenafil (mono or combination therapy) versus placebo. In four placebo-controlled
trials 158, 161,162,169 the efficacy and safety profiles of sildenafil and placebo were not compared
(see sildenafil dose/dosage one versus dose/dosage two and sildenafil mono versus sildenafil in
combination sections). Thus, results provided here are based on data obtained from 62 placebocontrolled
78-91,93-99,101,102,104,105,107-111,115,122,123,125,126, 128,130­
trials.
135,137,138,142,143,146,147,149,151,156,160,164-168,171,175
Harms. In the majority of the placebo-controlled trials, the proportion of patients with at least
one adverse event was greater either numerically or with statistical significance for participants
taking sildenafil compared with those taking placebo. For example, in one trial of flexible dose
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