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Study/patientCharacteristicsOutcomeTreatmentGroupControlGroupRelative risk(RR) or weightedmean difference(WMD)[95% CI] orp valueMcNicholas2002208 aging,hypogonadalmenWang 2000227hypogonadalmenMean number ofspontaneouserections/week atbaselineMean change inspontaneouserections/week aftertherapy (90 days)T 50: 0.8T 100: 0.8T 50: +0.6T 100: +0.5% of full erections at T 50: 53baseline (estimated fromgraph)T 100: 60% of full erections at day90 (estimated from graph) T 50: 67T 100: 68Andropatch0.9Andropatch+0.3Andropatch57%Andropatch65%T 50: p <0.05 vs.baselineT 100: p <0.05 vs.baselineNRp = 0.0001 for allgroups vs.baselineTestosterone 0.8% + Isosorbide Dinitrate + Co-Dergocrine Cream vs. PlaceboGooma 200689 men with lowtestosteronelevelsFull erection aftertreatment(2 months)40.0%(18/45)All patients68.8%(11/16)Psychogenic0/44 –11.1% (1/9)Vascular37.5% (3/8)Neurogenic25% (3/12)MixedTestosterone 0.8% + Isosorbide Dinitrate + Co-Dergocrine Cream vs. Testosterone 0.8%creamGomaa 200142 aged menwith ED andhypoactivesexual desireMean number of fullerections with satisfactoryintercourse at 1 month.6.46 (2.7) 4.05 (1.8) WMD = 2.41[1.43–3.39]168
Study/patientCharacteristicsOutcomeTreatmentGroupControlGroupRelative risk(RR) or weightedmean difference(WMD)[95% CI] orp valueNumber of patients withfull erections andsatisfactory intercourse at1 month66.7%(28/42)All patients84.2%(16/19)Psychogenic55.6%(10/18)Vascular31.0%(13/42)All patients57.9%(11/19)Psychogenic11.1%(2/18)Vascular0% (0/5)NeurogenicRR = 2.15[1.31–3.55]RR = 1.45[0.95–2.24]RR = 5.00[1.27–19.68]–40.0% (2/5)NeurogenicTestosterone (oral) vs. Propionyl-L carnitine + Acetyl-L carnitineCavallini 200495 men > 60with symptomsof androgendecline anddepressedmoodIIEF Erectile function(range 1–30): Medianscore at baselineIIEF Intercoursesatisfaction: Median scoreat end of therapy (6months)8 (5–19) 8 (5–22) NR16 (6–29) 24 (8–29)Testosteronep <0.01 vs.baselineCarnitinesp <0.01 vs.baselineTestosterone 5 mg/d Patch + Sildenafil 100mg vs. Placebo Patch + Sildenafil 100mgAversa 200320 men witharteriogenic EDGlobal AssessmentQuestionnaire: “hastreatment improvederections”IIEF** Intercoursesatisfaction (range 1–30):mean score at baselineIIEF Intercoursesatisfaction: mean scoreat 1 month80% (8/10) 10% (1/10) RR = 8.00[1.21–52.69]14.4 (1.4) 13.2 (1.1) WMD = 1.20[0.10–2.30]21.8 (2.1) 14.2 (0.7) WMD = 7.60[6.23–8.97]Testosterone 1% Gel + Sildenafil 100mg vs. Placebo Gel + Sildenafil 100mg169
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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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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 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: Study/patientCharacteristicsClopper
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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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
Page 227 and 228: Figure 49. Dyspepsia (all cause)Fig
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Page 231 and 232: Figure 61. Mean per-patient percent
Page 233 and 234: Figure 67. Any adverse events (all-
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Page 237 and 238: in men with erectile dysfunction. J
Page 239 and 240: parameters in obese men with erecti
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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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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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Shabsigh R. Testosterone therapy in
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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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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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