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PrefaceThe Agency for Healthcare Research and Quality (AHRQ), through its Evidence-BasedPractice Centers (EPCs), sponsors the development of evidence reports and technologyassessments to assist public- and private-sector organizations in their efforts to improve thequality of health care in the United States. The American College of Physicians requested andprovided funding for this report. The reports and assessments provide organizations withcomprehensive, science-based information on common, costly medical conditions and newhealth care technologies. The EPCs systematically review the relevant scientific literature ontopics assigned to them by AHRQ and conduct additional analyses when appropriate prior todeveloping their reports and assessments.To bring the broadest range of experts into the development of evidence reports and healthtechnology assessments, AHRQ encourages the EPCs to form partnerships and enter intocollaborations with other medical and research organizations. The EPCs work with these partnerorganizations to ensure that the evidence reports and technology assessments they produce willbecome building blocks for health care quality improvement projects throughout the Nation. Thereports undergo peer review prior to their release.AHRQ expects that the EPC evidence reports and technology assessments will informindividual health plans, providers, and purchasers as well as the health care system as a whole byproviding important information to help improve health care quality.We welcome comments on this evidence report. They may be sent by mail to the Task OrderOfficer named below at: Agency for Healthcare Research and Quality, 540 Gaither Road,Rockville, MD 20850, or by e-mail to epc@ahrq.gov.Carolyn M. Clancy, M.D.DirectorAgency for Healthcare Research and QualityJean Slutsky, P.A., M.S.P.H.Director, Center for Outcomes and EvidenceAgency for Healthcare Research and QualityDavid C. Dale, M.D., F.A.C.P.PresidentAmerican College of PhysiciansBeth A. Collins Sharp, Ph.D.Acting Director, EPC ProgramAgency for Healthcare Research and QualitySteven Fox, M.D., M.P.H.EPC Program Task Order OfficerAgency for Healthcare Research and Qualityiii
AcknowledgmentsThe authors would like to thank numerous individuals for their support of the present project.Investigators thank Nathalie Lapierre, Gloria Baker, and Dorothey Ann Curran for theirassistance with screening articles and helping with data abstraction; David Mackie and MaryOcampo for helping with the evidence tables and appendices; and Tanya Horsley and KaseyParker, both of whom helped to coordinate the process. Investigators would also like to thankAnne Marie Todkill, who assisted in the editing of the report.iv
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Page 7 and 8: ContentsExecutive Summary..........
Page 9 and 10: Table 17: Intra-urethral Treatment:
Page 11 and 12: Figure 63. Absolute Mean Change Fro
Page 13 and 14: associated with ED treatments. Two
Page 15 and 16: ED as a main complaint. In only one
Page 17 and 18: different formulations/modes of app
Page 19 and 20: Evidence Report
Page 21 and 22: flaccidity are no less important th
Page 23 and 24: prostatectomy, antipsychotic agents
Page 25 and 26: disease). Furthermore, there is ins
Page 27: Analytic FrameworkFigure 1. Analyti
Page 30 and 31: KQ 3. Harms of pharmaceutical treat
Page 32 and 33: Figure 2. Modified QUOROM Flow Char
Page 34 and 35: that included intervention characte
Page 36 and 37: Prevalence of Hypogonadism (Total S
Page 38 and 39: stimulation and a challenge test wi
Page 40 and 41: Overview of Trials79-84,86-88,90,91
Page 42 and 43: 131,137,138,142,143,147,151,155,156
Page 44 and 45: pectoris occurred in a participant
Page 46 and 47: statistical test results for the ob
Page 48 and 49: individual Q1-Q15 items, 104,106,15
Page 50 and 51: Proportion of participants with hea
Page 52 and 53: erectile maintenance frequency, IIE
Page 54 and 55:
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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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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(219) Gomaa A, Shalaby M, Osman M e
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(255)(256)dysfunction. Psychopharma
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Adams Henry E, Motsinger Patrice, M
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Althof S E, Turner L A, Levine S B
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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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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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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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Rojewski M T, Korper S, Schrezenmei
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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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Isidori A M, Giannetta E, Gianfrill
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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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De Rose A F, Giglio M, Traverso P e
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Gana T E, Quizanos L F, Castell R e
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Hatzichristou D G, Apostolidis A, T
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Kim E D, McVary K T. Topical prosta
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Lundberg L, Olsson J-O, Kihl B. Lon
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Moncada I, Jara J, Subira D et al.
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Ohebshalom M, Parker M, Guhring P e
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Rajpurkar A, Dhabuwala C B. Compari
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Shabsigh R. Hypogonadism and erecti
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Terradas C, Levalle O, Nagelberg A
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Yenicerioglu Y, Kefi A, Aslan G et
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Anonymous. New erectile dysfunction
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Bolona E R, Uraga M V, Haddad R M e
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Chen J, Greenstein A, Kaver I et al
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Derby C A, Barbour M M, Hume A L et
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Foulks C J, Cushner H M. Sexual dys
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Hamed S, Mohamed K, El-taher A et a
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Jeong S-J, Park K, Moon J-D et al.
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La Pera G, Franco Giannotti C, Tagg
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Mann R D. Introduction - Tadalafil.
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Montorsi F, Burnett A L. Erectile d
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Ozdel O, Oguzhanoglu A, Oguzhanoglu
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Ramasubbu Rajamannar. Switching to
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Schwartz E J, Wong P, Graydon R J.
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Stolk E A, Busschbach J J, Caffa M
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Vitezic D. A risk-benefit assessmen
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Bancroft J, Smith G, Munoz M et al.
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Knispel H H, Huland H. Influence of
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Padma-Nathan H, Eardley I, Kloner R
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Bai W J, Zhu J C, Jiang H et al. [A
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Carosa E, Martini P, Brandetti F et
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Doggrell S A. Comparison of clinica
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Gingell C, Buvat J, Jardin A et al.
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Heaton J P, Morales A, Adams M A et
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Kloner R A, Mitchell M, Emmick J T.
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Marks L S, Duda C, Dorey F J et al.
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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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Tsujimura A, Yamanaka M, Takahashi
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Zippe C D, Kedia A W, Kedia K et al
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Anonymous. Diagnostic and therapeut
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Briganti A, Chun F K H, Salonia A e
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Clough J. CNS-targeted sexual dysfu
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Emilien G. Alprox-TD NexMed Inc. Cu
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Gryglewska B, Grodzicki T. Betaxolo
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Kadioglu A, Erdogru T, Tellaloglu S
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Lebret T, Herve J M, Gorny P et al.
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Mealy N E. GPI-1485. Drugs of the F
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O'Sullivan J D. Apomorphine as an a
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Riley Alan. Oral treatments for ere
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Silvestri A, Galetta P, Cerquetani
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Unnikrishnan A G, Rajaratnam S, Ses
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Zhao L. Clinical observation on the
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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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