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The UO-EPC gratefully acknowledges the following individuals who reviewed the initialdraft of this evidence report, and provided constructive feedback. Acknowledgements notreflect endorsement of this report.James A. Talcott, M.D., S.M.Center for Outcomes ResearchMassachusetts General Hospital Cancer CenterBoston, MAJeremy Heaton, BA, M.A. Sc., MA,Department of Urology, Queen’s UniversityKingston General HospitalKingston, ONDonald E. Casey Jr., M.D., M.P.H., M.B.A.Atlantic HealthMorristown, NJJ. Thomas Cross, M.D., M.P.H.MedStudy Corporation Inc.Colorado Springs, COAmir Qaseem, M.D., Ph.D., M.H.A.Department of Clinical ProgramsAmerican College of PhysiciansPhiladelphia, PAVincenzia Snow, M.D.Department of Clinical ProgramsAmerican College of PhysiciansPhiladelphia, PADr. Drago K. MontagueCenter for Advanced Research in HumanReproduction,Infertility and Sexual FunctionCleveland Clinic,Cleveland, OHSteven Fox, M.D., M.P.H.EPC Program Task Order OfficerAgency for Healthcare Research and QualityRockville, MDE-2
Appendix F. Quality AssessmentRandomized Controlled Trials (RCTs)Table F-1. Quality Assesment of RCTsAuthorYearPalmer 2000 1 Jadad Q-11Jadad Q-20Jadad Q-30Jadad Q-41Jadad Q-50Seidman 2001 2 1 0 1 1 1Kongkanand1 0 1 1 12003 3Stuckey 2003 4 1 1 1 1 1Choi 2003 5 1 0 1 1 1Levinson 2003 6 1 0 1 0 1DeBusk 2004 7 1 1 1 0 1Boolell 1996 8 1 0 1 0 1Goldstein 1998 9 1 0 1 1 1Tan 2000 10 1 0 1 1 1Meuleman1 0 1 1 12001 11Eardley 2001 12 1 -1 1 1 0Young 2002 13 1 0 1 1 0von Keitz 2002 14 1 -1 1 0 1Goldstein 2003 15 1 0 1 0 1Nurnberg 2003 16 1 1 1 1 1Incrocci 2003 17 1 0 1 0 1Hellstrom 2003 18 1 1 1 0 1Price 1998 19 1 0 1 0 1Rendell 1999 20 1 1 1 1 1Christiansen1 1 1 1 12000 21Olsson 2000 22 1 0 1 0 1Chen 2001 23 1 0 1 1 1Boulton 2001 24 1 0 1 1 0TotalScoresAllocationConcealment2 Unclear4 Unclear4 Unclear5 Adequate4 Unclear3 Unclear4 Unclear3 Unclear4 Unclear4 Unclear4 Unclear2 Unclear3 Unclear2 Unclear3 Unclear5 Adequate3 Unclear4 Adequate3 Unclear5 Adequate5 Adequate3 Unclear4 Unclear3 UnclearHussain 2001 25 1 0 1 0 0 UnclearLewis 2001 26 1 0 1 0 0 2 UnclearBrock 2002 27 1 0 0 0 1 2 UnclearPorst 2003 28 1 0 1 0 0 2 UnclearMontorsi 2004 29 1 0 1 0 1 2 UnclearSafarinejad1 1 1 0 1 4 Adequate2004 30Webster 2004 31 1 -1 1 0 1 2 UnclearGiuliano 2005 32 1 -1 1 0 0 1 UnclearHatzichristou1 -1 1 0 0 2 Unclear2005 33Eardley 2005 34 1 0 0 0 1 2 UnclearCavallini 2005 35 1 -1 1 1 1 3 UnclearDiamond 2005 36 1 0 1 0 1 3 UnclearF-1
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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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Question 2a-b: Do Specific Patient
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Methodological and Logistic Limitat
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Tables and Figures.Summary TablesTa
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123Study details 1 Study Design Set
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125Table 2: Prevalence of Hypogonad
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127Study Details 2 Study Design Set
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129Table 4: Prevalence of Hypogonad
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131Study Details 5 Study Design Set
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Table 7: Prevalence of Hyperprolact
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135StudyEDDetails 8 Study Design Se
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Table 10: Serious Adverse Events in
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Table 11: Efficacy Results of Tadal
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Treatment Control Relative RiskStud
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Treatment Control Relative RiskStud
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Table 14: Intracavernosal Injection
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StudyAdverse EventsTreatmentGroup%
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StudyAdverse EventsTreatment Contro
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Study / Typeof PatientsOutcome Defi
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Study ED Etiology OutcomeWilliams*1
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Physiologic:60.0 (18/30) 90.0 (27/3
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StudyAdverse EventTreatmentGroup% (
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TreatmentStudy ED Etiology Group% (
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StudyAdverse EventCavallini 1991 Pa
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Study/patient CharacteristicsGooma
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Aversa 2003Men witharteriogenicEDYa
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Study/patientCharacteristicsClopper
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Study/patientCharacteristicsOutcome
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Table 26: Testosterone Treatment: P
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McNicholas2002Patients reporting
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175Table 27: Miscellaneous Treatmen
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177Table 28: Nonarteritic Anterior
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Table 29: Penile Fibrosis in Studie
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StudyStudyDesignPatientsage range 4
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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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symptoms associated with benign pro
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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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Anonymous. Surgery & watchful waiti
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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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Carson C C. Combination of phosphod
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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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Matthew A G, Goldman A, Trachtenber
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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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Sparwasser C, Treiber U, Bahren W e
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Terradas C, Levalle O, Nagelberg A
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Anonymous. New erectile dysfunction
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Page 1024 and 1025: AuthorYearSaylan 2006 265 Jadad Q-1
Page 1027: F-10STUDY IDQ1:SpectrumQ2.Selection
Page 1030 and 1031: Figure G-2. Sildenafil (any dose) v
Page 1036 and 1037: Figure G-8. Sildenafil (25 mg) vs.
Page 1038 and 1039: Figure G-10. Vardenafil (any dose)
Page 1040 and 1041: Tadalfil20 mg vs. PlaceboFigure G-1
Page 1042 and 1043: Figure G-14. Tadalafil (20 mg) vs.
Page 1044 and 1045: Figure G-16. Tadalafil (20mg) vs. T
Page 1046 and 1047: 5 = Eleven+ attempts Q7: When you a
Page 1048 and 1049: The IIEF-5 score is the sum of ques
Page 1050: El Malik EMA. Erectile dysfunction:
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