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StudyRosen 2004AE > 5% inboth treatmentarmsAdverse eventTreatmentGroup% (n/N)Nausea 24.0 (6/25)4 mg36.4 (8/22)6 mgControlGroup% (n/N)0 (0/24)Absolute riskdifference (%)[95% CI]–Headache 36.0 (9/25)4 mg0 (0/24)–27.3 (6/22)6 mgVomiting 8.0 (2/25)4 mg0 (0/24) –9.1 (2/22)6 mgDiaphoresis 8 (2/25)4 mg0 (0/24) –Exacerbation ofhypertension9.1 (2/22)6 mg9.1 (2/22)4 mg0 (0/24) –Apomorphine vs. PlaceboSegraves1991Eight of 12 patients reported adverse events: yawning, drowsiness and nausea.Two patients had severe nausea and hypotensionTable 17: Intra-urethral Treatment: Sexual IntercourseTreatment Control RelativeStudy ED Etiology OutcomeGroup% (n/N)Group% (n/N)Risk[95% CI]Alprostadil vs. Placebo. Patients randomized included only men who had a maximal penile response(Grade of 4 or 5 on the Erection Assessment Scale) with at least one dose of alprostadilTotal successfulPadma-Nathan* 1997Physiologic:100%attempts (diary selfreport)after 3 months50.4(2485/4933)10.4 (454/4346) 4.82[4.40–28.00]Total successful152
Study ED Etiology OutcomeWilliams*1998Physiologic:100%attempts (diary selfreport)after 3 monthsTreatmentGroup% (n/N)ControlGroup% (n/N)RelativeRisk[95% CI]51.1 (390/763) 7.5 (46/611) 6.79[5.10–9.04]IPadma-Nathan* 1997Williams*1998IIPadma-Nathan* 1997Physiologic:100%Physiologic:100%Physiologic:100%Total successfulattempts for men whohad successfulintercourse at leastonce (diary selfreport)after 3 monthsTotal successfulattempts for men whohad successfulintercourse at leastonce (diary selfreport)after 3 monthsTotal successfulintercourse attemptsor orgasm (diary selfreport)after 3 months69.2(2485/3593)61.4(390/635)56.3(2770/4921)10.4 (454/4346) 6.62[6.05–7.24]7.5 (46/611) 8.16[6.14–10.84]15.4 (668/4331) 3.65[3.39–3.93]Padma-Nathan* 1997Williams*1998IIIPadma-Nathan* 1997Williams*1998Physiologic:100%Physiologic:100%Physiologic:100%Physiologic:100%Alprostadil (IU) vs. Alprostadil (ICI)Shokeir 1999Physiologic:100%Patients reportingsuccessfulintercourse at leastonce (diary selfreport)after 3 monthsPatients reportingsuccessfulintercourse at leastonce (diary selfreport)after 3 monthsPatients reportingsuccessfulintercourse at leastonce (diary selfreport)after 3 monthsPatients reportingsuccessfulintercourse at leastonce (diary selfreport)after 3 monthsTotal successfulattempts (diary selfreport)after 3 months61.6 (299/485)All menrandomized59.0 (46/78)All menrandomized64.9 (299/461)Men with ≥ 1administration68.7 (46/67)Men with ≥ 1administration18.2 (93/511)All menrandomized9.9 (8/81)All menrandomized18.6 (93/500)Men with ≥ 1administration7.5 (8/73)Men with ≥ 1administration55.0 (198/360) 85.1 (206/242)3.39[2.78–4.12]5.97[3.01–11.83]3.49[2.87–4.24]6.26[3.19–12.29]0.65[0.58–0.72]Shokeir 1999Physiologic:100%Patients reportingsuccessfulintercourse at leastonce53.3 (16/30) 86.7 (26/30)0.62[0.43–0.88]153
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This report is based on research co
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This document is in the public doma
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AcknowledgmentsThe authors would li
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ContentsExecutive Summary..........
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Table 17: Intra-urethral Treatment:
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Figure 63. Absolute Mean Change Fro
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associated with ED treatments. Two
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ED as a main complaint. In only one
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different formulations/modes of app
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Evidence Report
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flaccidity are no less important th
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prostatectomy, antipsychotic agents
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disease). Furthermore, there is ins
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Analytic FrameworkFigure 1. Analyti
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KQ 3. Harms of pharmaceutical treat
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Figure 2. Modified QUOROM Flow Char
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that included intervention characte
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Prevalence of Hypogonadism (Total S
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stimulation and a challenge test wi
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Overview of Trials79-84,86-88,90,91
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131,137,138,142,143,147,151,155,156
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pectoris occurred in a participant
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statistical test results for the ob
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individual Q1-Q15 items, 104,106,15
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Proportion of participants with hea
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erectile maintenance frequency, IIE
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Oral Treatments — Phosphodiestera
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Patients were instructed to take th
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Results obtained from two trials 19
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improved erections was higher in pa
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Clinically homogenous groups of pat
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Oral Treatments — Phosphodiestera
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The approximate proportion of smoke
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value was not reported). Even thoug
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Tadalafil (20 mg) versus tadalafil
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scheduled dosing regimen (90 percen
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Proportion of patients with improve
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Sublingual Treatments - Apomorphine
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been taking over the past two or fo
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apomorphine (5 and 6 mg: 38 and 49
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heterogeneity with respect to popul
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Finally, two studies reported on wh
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the second study, prolonged erectio
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Moxisylate versus placebo. One tria
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Quantitative SynthesisThere was a l
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erection” versus one placebo trea
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methods of allocation concealment.
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Prazosin (IU) versus placebo. One t
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reported adequate allocation concea
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Hormonal Treatments Literature Sear
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Harms. In the first trial, the diff
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sex with partner (scale 1-6, with =
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daily for 4 weeks followed by concu
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(MEDQoL) score (range 0-100) compar
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group (16.7, 12.5, and 8.3 percent,
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Question 3a. What Are the harms of
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Chapter 4. DiscussionThis evidence
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Question 1: What is the Clinical Ut
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Questions 2-3: What are the Benefit
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Harms. There were no obvious differ
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alone. Compared with trimix alone,
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PhentolamineEfficacy. The results i
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Page 129 and 130: Methodological and Logistic Limitat
Page 131: Tables and Figures.Summary TablesTa
Page 135: 123Study details 1 Study Design Set
Page 139: 125Table 2: Prevalence of Hypogonad
Page 143: 127Study Details 2 Study Design Set
Page 147: 129Table 4: Prevalence of Hypogonad
Page 151: 131Study Details 5 Study Design Set
Page 155: Table 7: Prevalence of Hyperprolact
Page 159: 135StudyEDDetails 8 Study Design Se
Page 163 and 164: Table 10: Serious Adverse Events in
Page 165 and 166: Table 11: Efficacy Results of Tadal
Page 167 and 168: Treatment Control Relative RiskStud
Page 169 and 170: Treatment Control Relative RiskStud
Page 171 and 172: Table 14: Intracavernosal Injection
Page 173 and 174: StudyAdverse EventsTreatmentGroup%
Page 175 and 176: StudyAdverse EventsTreatment Contro
Page 177: Study / Typeof PatientsOutcome Defi
Page 181 and 182: Physiologic:60.0 (18/30) 90.0 (27/3
Page 183 and 184: StudyAdverse EventTreatmentGroup% (
Page 185 and 186: TreatmentStudy ED Etiology Group% (
Page 187 and 188: StudyAdverse EventCavallini 1991 Pa
Page 189 and 190: Study/patient CharacteristicsGooma
Page 191 and 192: Aversa 2003Men witharteriogenicEDYa
Page 193 and 194: Study/patientCharacteristicsClopper
Page 195 and 196: Study/patientCharacteristicsOutcome
Page 197 and 198: Table 26: Testosterone Treatment: P
Page 199 and 200: McNicholas2002Patients reporting
Page 201: 175Table 27: Miscellaneous Treatmen
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Page 209 and 210: Table 29: Penile Fibrosis in Studie
Page 211 and 212: StudyStudyDesignPatientsage range 4
Page 213 and 214: Figure 6. Improved erection (GEQ-Q1
Page 215 and 216: Figure 11. Visual disturbances (all
Page 217 and 218: Figure 16. Any adverse events (trea
Page 219 and 220: Figure 23. The mean IIEF-Q4 score:
Page 221 and 222: Figure 30. Improved erection (GEQ-Q
Page 223 and 224: Figure 37. Visual disturbances (all
Page 225 and 226: Figure 43. IIEF-EF ≥ 26 at follow
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Figure 55. Serious adverse events (
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Figure 61. Mean per-patient percent
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Figure 67. Any adverse events (all-
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Figure 73. Any adverse events (all-
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in men with erectile dysfunction. J
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parameters in obese men with erecti
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comparative crossover study. Androl
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153. Shabsigh R. Efficacy of silden
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190.191.Stief C, Porst H, Saenz dT,
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treatment of men with erectile dysf
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randomized trial. J Urol 1997 Oct;1
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moderate and severe ED. Int J Impot
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349.350.351.randomized, placebo-con
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395. Moher D, Schulz KF, Altman DG.
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PSVRCTRIRIASBPSCSDSETTGTRTWMDpeak s
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dDegDept.Ff/uFHxhrHxIGMmaxminmoNANI
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30. or/24-2931. (ANIMALS not HUMAN)
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27. limit 26 to yr="1990 - 2008"28.
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5. exp clinical trials/6. random$.m
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20. or/17-1921. 16 and 2022. limit
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A systematic review of harms associ
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B-4Summary Table- Randomized Contro
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The Quality Assessment of Studies o
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AuthorFundingN; study design; eligi
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C-10 AuthorFundingN; study design;
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C-146 C5-Intracavernousal Injection
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C-202 C8-Topical Treatments of ED A
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C-216 C9-Testosterone Treatment of
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men with erectile dysfunction and s
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symptoms associated with benign pro
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(84) Zinner N. Do food and dose tim
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Baldwin D S. Sexual dysfunction ass
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Douglass M A, Lin J C. Update on th
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Hatch J P. Psychophysiological aspe
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Lau D H, Mumtaz F H, Thompson C S e
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Morales A, Heaton J P. Hormonal ere
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Roehrborn C G, McNicholas T. The Ma
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Uckert S, Stief C G, Jonas U. Curre
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Leungwattanakij S, Flynn V, Hellstr
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Musacchio Najah S, Hartrich Molly,
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Akkus E, Kadioglu A, Esen A et al.
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Ashok S, Sigman M. Bioavailable tes
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Briganti A, Salonia A, Gallina A et
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Dundar S O. Visual loss associated
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Giammusso B, Gattuso U, Vanaclocha
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The UO-EPC gratefully acknowledges
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AuthorYearHellstrom 2005 37 Jadad Q
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AuthorYearJadad Q-1 Jadad Q-2 Jadad
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AuthorTotal AllocationJadad Q-1 Jad
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AuthorYearSaylan 2006 265 Jadad Q-1
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F-10STUDY IDQ1:SpectrumQ2.Selection
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Figure G-2. Sildenafil (any dose) v
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Figure G-8. Sildenafil (25 mg) vs.
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Figure G-10. Vardenafil (any dose)
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Tadalfil20 mg vs. PlaceboFigure G-1
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Figure G-14. Tadalafil (20 mg) vs.
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Figure G-16. Tadalafil (20mg) vs. T
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5 = Eleven+ attempts Q7: When you a
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The IIEF-5 score is the sum of ques
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El Malik EMA. Erectile dysfunction:
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