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Author yearCappelleri (2000)Albuquerque (2005)Pickering (2004)Glina (2001)McVary (2007)Althof (2006)O’Leary (2006)ED PopulationCountry/EthnicityAll etiologiesUS–NRHypertensive menBrazilMen with historyof atrialhypertensionItaly-NRAll etiologiesMexico-Brazilian/MexicanMen with lowerurinary tractsyndromesassociated withprostatichyperplasiaUS: 82% WhiteAll causesMulti-nation:White 55.5%;Black 15%; Asian5.5%; Other23.5%All causes (alsowith low selfesteem)US: 62% White;25% BlackSerious AdverseEvents n/N (%)Sildenafil3/124(2.0%)3/61(5.0%)2/281(<1%)1/124(<1%)2/189(1.0%)1/274(<1%)Placebo3/123(2.0%)1/59(1.7%)2/287(<1%)5/121(4%)3/181(2.0%)1/279(<1%)0/129 1/127(<1%)Active doseFlexible 25–100 mgFlexible 25–100 mgFlexible 25–100 mgFlexible 25–100 mgFlexible 25–100 mgDescription of AdverseEvents (study arm)described• NR• Cerebrovascularaccident (IG)• Pulmonary edema/heartfailure (IG)• Atrialfibrillation/arrhythmia (IG)• polytrauma (CG)• NR• NR• Worsening of kneearthralgia (100 mg/ IG)• Severe acutecerebrovascular stroke(100 mg/ IG)• Remaining 3 caseswere not describedNR • Severe coronary arterydisease (IG)• Urinary tract infection(CG)Flexible 25–100 mgNR=not reported; CG=control group; IG=intervention group; pt(s)=patient(s)• Death (CG)138
Table 11: Efficacy Results of Tadalafil by ED Severity GroupsStudy ID Dose Mild ED Moderate ED Severe EDMean change in IIEF–EF scores from baselineMcMahon (2005) 20 mg 3.0 10.7 11.6Eardley (2004) 20 mg 6.1 13.2 14.3Sefte (2004) 20 mg 5.6 10.7 11.0Carrier (2005) 10 mg 4.5 8.4 8.3Carrier (2005) 20 mg 5.2 9.0 11.5Costa, (2006) On demand 6.2 11.5 14.2Costa (2006) 3 x week 6.4 11.8 14.6Saylan (2006) 20 mg 6.3 8.2 14.8Yip (2006) 20 mg 5.3 9.1 12.5EF mean end point scoresMcMahon (2005) 20 mg 24.4 23.9 19.0Rajfer (2007) 2.5 mg 24.3 21.0 13.8Rajfer (2007) 5 mg 26.2 21.9 15.5Guo(2006) 10 mg 24.0 22.3 18.1Guo(2006) 20 mg 23.5 23.0 21.6Nagao (2006) 5 mg 25.6 22.7 15.8Nagao (2006) 10 mg 26.0 24.0 20.2Nagao (2006) 20 mg 25.3 23.0 21.9Patients with normal EF at end point (%)Eardley (2004) 20 mg 80 73 55Sefte (2004) 20 mg 72.1 52.4 34.3Saylan (2006) 20 mg 84.4 43.2 40.7Change from baseline in SEP–3 (% of patients with successful penetration)Young (2005) 10 mg* 13.1 46.0 29.2Young (2005) 20 mg* 38.5 68.9 41.3Costa, (2006) On demand 41.7 59.7 55.8Costa, (2006) 3 x week 44.4 61.3 57.1Rajfer (2007) 2.5 mg 72.5 56.3 27.4Rajfer (2007) 5 mg 82.2 61.3 32.6Nagao (2006) 5 mg 74.2 50.3 31.1Nagao (2006) 10 mg 80.4 64.5 49.4Nagao (2006) 20 mg 76.8 67.8 62.1Change from baseline in SEP–2 (% of patients with successful penetration)Rajfer (2007) 2.5 mg 90.0 74.8 38.9Rajfer (2007) 5 mg 91.9 82.2 44.9Nagao (2006) 5 mg 89.2 79.2 48.7Nagao (2006) 10 mg 98.8 84.2 63.4Nagao (2006) 20 mg 94.2 80.8 73.1139
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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,
Page 113 and 114: Question 3a. What Are the harms of
Page 115 and 116: Chapter 4. DiscussionThis evidence
Page 117 and 118: Question 1: What is the Clinical Ut
Page 119 and 120: Questions 2-3: What are the Benefit
Page 121 and 122: Harms. There were no obvious differ
Page 123 and 124: alone. Compared with trimix alone,
Page 125 and 126: PhentolamineEfficacy. The results i
Page 127 and 128: Question 2a-b: Do Specific Patient
Page 129 and 130: Methodological and Logistic Limitat
Page 131: Tables and Figures.Summary TablesTa
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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: Table 10: Serious Adverse Events in
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 and 178: Study / Typeof PatientsOutcome Defi
Page 179 and 180: Study ED Etiology OutcomeWilliams*1
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
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Page 213 and 214: Figure 6. Improved erection (GEQ-Q1
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Figure 11. Visual disturbances (all
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Figure 16. Any adverse events (trea
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Figure 23. The mean IIEF-Q4 score:
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Figure 30. Improved erection (GEQ-Q
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Figure 37. Visual disturbances (all
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Figure 43. IIEF-EF ≥ 26 at follow
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Figure 49. Dyspepsia (all cause)Fig
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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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(117) Carrier S, Brock GB, Pommervi
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(150) Hagemann JH, Berding G, Bergh
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(183) Moriel EZ, Rajfer J. Sodium b
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(255)(256)dysfunction. Psychopharma
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Anonymous. Surgery & watchful waiti
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Baker Christine D. A cognitive-beha
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Bayes M, Rabasseda X, Prous J R. Ga
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Bhatnagar V, Stewart S T, Huynh V e
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Boswell-Smith V, Spina D, Page C P.
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Burke J P, Jacobson D J, McGree M E
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Chen Y. Acupuncture treatment of fu
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Cooke B M, Breedlove S M, Jordan C
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Daitch J A, Angermeier K W, Lakin M
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Derouet H, Jost W H, Osterhage J et
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Doust J, Miller E, Duchesne G et al
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Elhilali M M. Alfuzosin: An a1-rece
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Ferri C, Giuggioli D, Cazzato M et
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Frucht S J. Parkinson disease: An u
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Ghofrani H A, Pepke-Zaba J, Barbera
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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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Chinegwundoh F, Anie K A. Treatment
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Dundar S O. Visual loss associated
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Giammusso B, Gattuso U, Vanaclocha
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Hawton Keith, Catalan Jose, Fagg Jo
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Kell P. Cardiovascular safety of si
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Laumann Edward O, West Suzanne, Gla
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Matthew A G, Goldman A, Trachtenber
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Mulhall J P. Deciphering erectile d
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Parsons J K, Marschke P, Maples P e
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Shabsigh R. Testosterone therapy in
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Tam S W, Worcel M, Wyllie M. Yohimb
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Webb D J, Freestone S, Allen M J et
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Katlowitz N M, Albano G J, Morales
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Sparwasser C, Treiber U, Bahren W e
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van Basten J P, Van Driel M F, Jonk
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Youssef A F, Fort F L, Ronsen B et
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Cooper A J. Evaluation of I-C papav
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Armstrong D K, Convery A, Dinsmore
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Buvat J, Montorsi F. Safety and tol
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Hatzichristou D G, Apostolidis A, T
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Terradas C, Levalle O, Nagelberg A
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Anonymous. New erectile dysfunction
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Hamed S, Mohamed K, El-taher A et a
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Ramasubbu Rajamannar. Switching to
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Montorsi F, Guazzoni G, Bergamaschi
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Padma-Nathan H, Goldstein I, Klimbe
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Reznik I, Zemishlany Z, Kotler M et
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Shamloul Rany, Kamel Ihab, E-Mail A
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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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