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Table 22: Topical Treatment: Patients with Adverse EventsStudy Adverse EventTreatmentGroup% (n/N)ControlGroup% (n/N)Absolute RiskDifference[95% CI]Alprostadil vs. PlaceboGoldstein Patients withdrawn2001 from therapy due toadverse eventsPenile erythemaPadma-Nathan 20036 weeksPatients withmild-tomoderateED(Study a)Padma-Nathan 20036 weeksPatients withsevere EDMild/minor warmth orburning, tingling, andcoolnessUrogenital pain 13.2% (16/121)0/31 0/29NR–Reported by most patients afterboth alprostadil and placeboapplication –0 (0/40)–12%: 50µg15%: 100µg13%: 200µgHypotension 5.0% (6/121)2.0%: 50µg3.0%: 100µg1.0%: 200µgUrogenital pain 5.5% (6/109)Hypotension0%: 100µg9.0%: 200µg8.0%: 300µg6.4% (7/109)NR0 (0/40)NR0 (0/35)NR0 (0/35)(Study b)0%: 100µg11.0%: 200µg NR8.0%: 300µgTopical PgE1 with or without Calcium Thioglycolate or Methyl Salicylate vs. PlaceboFoldavi 1998 Patients with ≥ 1 AE No local AEs were observed–during the studyAminophylline + Isosorbide dinitrate + Co-Dergocrine vs. Placebo,Gomaa 1996 Patients with ≥ 1 AE No Patient reported prolonged–erection/priapism, clinicallysignificant cardiovascular eventsor complaints from patients’partnersLe Roux 1999 No AE reported – – –Nitroglycerin vs. PlaceboCavallini 1994 Patients with ≥ 1 AE 44.80 45.0 [36.0–(52/116) (0/116) 54.0]Burning at application 12.60 12.0 [6.0–18.0]site(14/116)Hypotension 10.3(12/116)(0/116)0(0/116)––––10.0 [5.0–16.0]160
StudyAdverse EventCavallini 1991 Patients with ≥ 1 AE(burning at applicationsite, headache,hypotension)Nitroglycerin vs. MinoxidilCavallini 1994 Patients with ≥ 1adverse eventBurning at applicationsiteTreatmentGroup% (n/N)45.5(15/33)44.8(52/116)12.6(14/116)ControlGroup% (n/N)0(0/33)6.0(7/116)6.0(7/116)Absolute RiskDifference[95% CI]–39.0 [29.0–49.0]6.0 [-1.0, 13.0]Hypotension 10.3(12/116)0(0/116)–Minoxidil vs. PlaceboPatients with ≥ 1 AE 6.0 (7/116) 0 (0/116) –Cavallini 1994 Burning at application 6.0 (7/116) 0 (0/116) –siteHypotension 0 (0/116) 0 (0/116) –Cavallini 1991Patients with ≥ 1adverse event (burningat application site)6.1 (2/33) 0 (0/33) –Nitroglycerine vs. PlaceboGramkow1999Claes 1992Patients withdrawnfrom therapy due toadverse events1/18 due tosevere painfrom plasterHeadache (mild) 35.4 (35/99)plasters usedSmarting pain 23.2 (23/99)plasters usedPatients withdrawnfrom therapy due toAEs1.1 (1/92)plasters used1.1 (1/92)plasters used4 patients due to headache(unclear if due to activetreatment)Topical sildenafil + Oral Placebo vs. Oral Sildenafil + Topical PlaceboYonessi 2005 Headache 10.0 (4/40) 5.0 (2/40)1 case each ofdyspepsia andvisualdisturbance0/18 –34.0 [25.0–44.0]22.0 [14.0–31.0]–5.0 [-6.0, 16.0]Intranasal Cyclic Heptapeptide Melanocortin Analog (PT–141) vs. PlaceboDiamond 2004 Flushing 16.7 (8/48) 4.2 (1/24) 13.0 [-1.0, 26.0]Nausea 10.4 (5/48) 0 (0/24) –Feeling hot 4.2 (2/48) 4.2 (1/24) –161
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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
Page 135: 123Study details 1 Study Design Set
Page 139: 125Table 2: Prevalence of Hypogonad
Page 143: 127Study Details 2 Study Design Set
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: TreatmentStudy ED Etiology Group% (
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 and 200: McNicholas2002Patients reporting
Page 201: 175Table 27: Miscellaneous Treatmen
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
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-
Page 235 and 236: 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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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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Hatch J P. Psychophysiological aspe
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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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Giammusso B, Gattuso U, Vanaclocha
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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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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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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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