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Testosterone 1% Gel + Sildenafil 100mg vs. Placebo Gel + Sildenafil 100mgShabsigh 2004 One patient on testosterone withdrew from the study because of an AE. Nofurther details were provided.Testosterone (oral) + Sildenafil (50 or 100mg) vs. Testosterone alone or Sildenafil (50 or100mg) aloneShamloul 2005No significant adverse events observed (mild headache in three patients onsildenafil 100mg)Slight increase in serum PSA (NS)Testosterone 50 mg/d Gel + Tadalafil 20 mg vs. Testosterone 50 mg GelYassin 2006No adverse events observed* Derogatis Sexual Performance Scale. Range 0 (not at all) to 8 (4 or more times/day)174
175Table 27: Miscellaneous Treatments: Efficacy and Adverse EventsAuthor (year)CountryMann (2001)GermanyPiha (2003)FinlandReiter (1998)AustriaSafarinejad(2001)IranSommer(2006)GermanySommer (2006)ItalyStudy Population13 (6/7) mendiagnosed withpsychogenic ED11 hypertensivemen 41–58 yearsold40 (20/20) menwith low serumDHEAS (<1.5µmol/L), and EDunrelated to anyother knownorganic cause44 men 28–55years old withvasculogenic ED18 (NR) men withED (no etiologyreported)176 (NR)men withDM type IIand ED oflonger thanInterventions(Dose and duration)• Oral moclobemide,450 –600 mg/wk; 8wks• Placebo• Oral moxonidine, 0.4–0.6 mg/d;8 wks• Oral metoprolol,100–200 mg/d;8 wks• Oral dehydroepiandrosterone(DHEA)• Placebo• Oral isoxsuprinehydrochloride, 60mg/d; 30 d• Placebo• Oral (BH4) + VSS,200 or 500 mg; once• Placebo; once• Oral myoinositol +folic acidCombination, 4g +400µg; 12 wks• Placebo; 12 wksSelf rated ErectionEnd Points• Clinical GlobalImpression (GCI),NS betweengroups••IIEF–5: positivechanges in 9/11(82%) vs. 0,p<0.0002IIEF, mean scoresin all 5 domainsimproved in DHAEvs. placebo• Complete erectileresponse 8.3% vs.8.3% (NS)• NR• Mean IIEF–5change:8 vs. -1Outcomes • Any Event• Serious EventRigiScan MeasuresNocturnal penileresponse: improvementNS between groupsNRNRNRImproved duration of>60%: at base 33.1 and36.1 min; at tip by 29.4and 33.7 min (200 and500 mg respectively)• Withdrawals Due toAdverse Eventn (%)• 3 (50) vs. 3 (43)• 0• NRNR• 0• 0• 0• 70% vs. 15%• 1 (2.3) vs. 0• NR• 3 (17) vs. 1 (5.6)• NR• NRNR • NR
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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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Page 155: Table 7: Prevalence of Hyperprolact
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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 and 194: Study/patientCharacteristicsClopper
Page 195 and 196: Study/patientCharacteristicsOutcome
Page 197 and 198: Table 26: Testosterone Treatment: P
Page 199: McNicholas2002Patients reporting
Page 205: 177Table 28: Nonarteritic Anterior
Page 209 and 210: Table 29: Penile Fibrosis in Studie
Page 211 and 212: StudyStudyDesignPatientsage range 4
Page 213 and 214: Figure 6. Improved erection (GEQ-Q1
Page 215 and 216: Figure 11. Visual disturbances (all
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
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Page 229 and 230: Figure 55. Serious adverse events (
Page 231 and 232: Figure 61. Mean per-patient percent
Page 233 and 234: Figure 67. Any adverse events (all-
Page 235 and 236: Figure 73. Any adverse events (all-
Page 237 and 238: in men with erectile dysfunction. J
Page 239 and 240: parameters in obese men with erecti
Page 241 and 242: comparative crossover study. Androl
Page 243 and 244: 153. Shabsigh R. Efficacy of silden
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Page 247 and 248: treatment of men with erectile dysf
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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-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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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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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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Buvat J, Montorsi F. Safety and tol
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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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Hamed S, Mohamed K, El-taher A et a
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Mann R D. Introduction - Tadalafil.
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Montorsi F, Burnett A L. Erectile d
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Ramasubbu Rajamannar. Switching to
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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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