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C-245 AuthorFundingN; study design;eligibilityParticipantscharacteristicsDiagnosis details Intervention OutcomesMann, K (2001)254Fundingsource:Hoffmann-LaRoche,Grenzach-WyhlenN screened = NRN randomized = 13IG1 screened = NRIG1 randomized = 6IG2 screened = NAIG2 randomized =CG screened = NRCG randomized = 7Inclusion: EDExclusion: lifetimediagnosis of anypsychiatric disorderexcept for sexualdysfunction; hx ofalcohol or othersubstance abuse;current or recentevidence of sign.medical disorder; sleepdisturbances; taking anydrugsAge, mean (sd): IG149.3 (SD 8.9)CG 37.8 (SD 8.2)Race (%): NRCo-morbidities(unrelated to disease):NRBlood glucose (orHbA1C)(%): NRPrevious EDtreatment: NRBMI (kg/m 2 ): NRSmoking status: NRInitial body weight: NROther:Degree of severity ofED (Clinical GlobalImpression scale, mean[and standard error])IG1 5.17 (0.31)CG 5.00 (0.37)Concomitantmedications: NRDuration of ED (yr):IG1 3.8, CG 2.8Underlying disease(diagnosis) (N or %of diseased/grp): NRPsychogenic ED: 13Physiologic ED: 0Mixed ED: 0IG1: moclobemideorally orallyIG2: NACG: placebo orallyIG1:Dose: 450 mg duringwk 1, 600 mg duringwk 2-8Duration: 8 wkFrequency: 1dose/dayCompliance (%): NRIG2: NADose:Duration:Frequency:Compliance (%):CG:Dose: placeboDuration: 8 wkFrequency: 1dose/dayCompliance (%): NRRun In period: NRWash out period:NAF/u duration (bothon and offtreatment): 8 wkPrimary outcome results:Clinical Global Impression severitysubscale at 8 wk (1=normal,2=borderline ill, 3=mildly ill,4=moderately ill, 5=markedly ill,6=severely ill, 7=among most extremelyill)IG1 3.50, CG 4.50Clinical Global Impression improvementsubscale at 8 wk (–3=very much worse,–2=much worse, –1=minimally worse,0=no change, 1=minimally improved,2=much improved, 3=very muchimproved)IG1 1.50, CG 0.50Change in mean nocturnal tumescenceand rigidity of penis base and tip(averaged of the two) at 8 wkTumescence, cm: IG1 –0.24, CG –0.13Rigidity, %: IG1 2.58, CG 2.67List (narrative) other outcomesassessed: NAITT analysis used for primaryoutcome?Y N/NR NWithdrawals/drop-outs/loss to f/u [Nand/or %]: 1 (CG)WDAE (N and/or %): 1 (CG)TAE:IG1: 4 events in 3 patientsCG: 7 events in 3 patientsSAE: 0Ascertainment of outcomesassessed: RigiScan RigidityAssessment System
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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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Padma-Nathan H. Efficacy and tolera
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Appendix E. Additional Acknowledgme
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Appendix F. Quality AssessmentRando
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AuthorYearJadad Q-1 Jadad Q-2 Jadad
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AuthorYearJadad Q-1 Jadad Q-2 Jadad
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Jadad Q-1AuthorYearJadad Q-2 Jadad
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Quality Assessment of Observational
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Appendix G. Funnel PlotsSildenafilF
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Figure G-3. Sildenafil (any dose) v
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VardenafilAny dose vs. PlaceboFigur
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Figure G-11. Vardenafil (any dose)
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Figure G-13. Tadalafil (20 mg) vs.
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20 mg vs. 10 mgFigure G-15. Tadalaf
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Appendix H. Instruments Used in the
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1 = Very dissatisfied2 = Moderately
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Appendix I. List of Unobtained Arti
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