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been taking over the past two or four weeks improved your erections?”) combined with an
improvement of ≥ 5 points in the “erectile function” domain of the IIEF.
Global Assessment Questions (GAQs) were evaluated and reported in three trials, 117,159,251 as
a secondary response endpoint. In one trial 117 the endpoint was defined as the proportion of
patients who answered “yes” to two GAQ questions, and in the other trial 251 the corresponding
endpoint was treated as a continuous variable whereby responses to one GAQ were given on an
ordinal scale (1 = very satisfied, 5 = very dissatisfied).
The treatment preference/satisfaction was measured and reported in three trials. 117,120,251 In
one trial the treatment satisfaction was measured as a proportion of patients satisfied with one
drug only, alternative drug only, both drugs, or none of the drugs. 120 In two trials, 117,159 the
treatment-arm specific differences in IIEF “Overall Satisfaction” domain and the Erectile
Dysfunction Index of Treatment Satisfaction (EDITS) questionnaire-based mean scores were
used to evaluate the patient’s satisfaction with treatment regimens. In their trial, Lammers et
al., 251 employed the Visual Analogue Scale (VAS; range 0–100) to assess patients’ treatment
satisfaction. The endpoint was the post-treatment mean VAS satisfaction score calculated for
patients in each treatment arm.
The authors of one trial 251 measured and reported the mean Sexual Encounter Profile (SEP)
questionnaire-based overall score.
Penile rigidity was reported in two trials. 250,251 In one trial, 251 it was measured on VAS as the
mean VAS rigidity (range 0–100), and in the other trial, 250 it was measured using a RigiScan and
expressed as the percentage rigidity (i.e., percent of linear displacement of the loops due to the
constant force). A post-treatment rigidity of at least 40 percent was considered a positive
treatment response.
Study Quality and Reporting
The mean (range) of Jadad’s total score for the 12 included trials was 2.36 (1 114 – 5 249 ). Six
of the 12 trials were reported to be double-blind. 248,249,251-253 Of these, only two trials 249,253
provided some description of blinding method(s) used. Only one trial reported some information
on the adequacy of allocation concealment. 249 The adequacy of allocation concealment for the 11
remaining trials was unclear.
Of the eight crossover trials, 114,117,120,148,159,251,252 only one 251 failed to report whether a
washout period was applied between the treatment periods. The length of the washout period for
six trials 114,117,120,159,252 ranged from 24–96 hours 252 to 2 weeks, 117,159 and for one trial this
duration was 4 weeks. 148
Qualitative Synthesis
Apomorphine versus placebo. In total, there were five placebo-controlled trials. 248-250,252,253
Harms. The occurrence of any adverse events across the trials was reported poorly. In one
trial, 248 the rate of any adverse events was numerically slightly higher in patients receiving
apomorphine than in those receiving placebo (37.8 versus 24.5 percent, respectively). Another
trial 250 reported only two patients who had experienced headaches after receiving placebo. Only
one trial 248 explicitly stated that none of the patients died during the trial. In two trials, 248,250 the
rate of serious adverse events did not differ between patients receiving apomorphine and
placebo. In the first trial, 248 four patients had one or more serious adverse events. Specifically, of
the two patients in the apomorphine arms (2–3 mg), one had chest infection/severe cough/cough
syncope and the other one had moderate unstable angina pectoris. In the placebo arm, two
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