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study withdrawalDihydrotestosterone Gel vs. Placebo GelKunelius 2002Mild headache5.0 (3/60)3.3 (2/60)2.0 [-5.0, 9.0]Mild depression3.3 (2/60)3.3 (2/60)–Hair growth1 patientTestosterone 0.8% + Isosorbide Dinitrate + Co-Dergocrine Cream vs. Testosterone 0.8%CreamGomaa 2001Mild transient headachePSA values: nosignificant increase ofreportedN = 5(phase 1 and2)0 –Testosterone (patch) vs. PlaceboMerza 2005Increase in hematocrit15 (3/20)5.3 (1/19) 10 [-9 to 28]Significant difference inthe percentage change ofhemoglobin between thetwo groups of 4% duringphase 1 (p = 0.036).n = 2withdrawals inphase 2n =1(angina)PSA: 25% increasetestosterone vs. 6% forplacebo (differencebetween the two means:NS)Seftel 2004Treatment-related62.7 (64/102)40.4 (40/99)22.0 [9.0–36.0]Skin reaction leading tostudy withdrawaln = 150–Testosterone 5 mg/d Patch + Sildenafil 100mg vs. Placebo Patch + Sildenafil 100mgAversa 2003No clinically significant adverse events were observed with both treatmentsTestosterone 50 mg Gel (T 50) vs. Testosterone 100 mg Gel (T 100) vs. Andropatch172
McNicholas2002Patients reporting ≥ 1treatment-emergent(erythema, irritation andreactions at applicationsite)35.3 (24/68)T 5029.2 (21/72)T 10063.2 (43/68)Patch-28.0 [-44.0, 12.0]-34.0 [-50.0, –19.0]Skin irritation“Very lowIncidence” –both groups47% at day30 and 53%after 90 daysWang 2000 Skin irritation 5.7 (3/53) -60.0 [-72.0, –T 5048.0]65.8 (50/76)5.3 (3/57) PatchT 100 -61.0 [-73.0, –48.0]Urogential events 9.6 (7/73)T 500 (0/76) –5.1 (4/78) PatchT 100–Serum PSA levels 1.4 (1/73)elevated to above theT 50normal range0 (0/76) –5.1 (4/78) PatchT 100–1.4 (1/73)Gynecomastia (2 of the T 50patients had preexisting0 (0/76) –gynecomastia) 3.8 (3/78) PatchT 100–One patient in T 50 grouphad depression(discontinued); onepatient in T 100 grouphad high blood pressure(discontinued), and onepatient had memoryloss/sadness(discontinued); Onepatient in Patch groupdiscontinued due toelevated hematocrit andhemoglobinTestosterone (oral) vs. Propionyl-L Carnitine + Acetyl-L CarnitineCavallini 2004 Mild headache 0 (0/40) 2.2 (1/45) ––173
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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
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 and 194: Study/patientCharacteristicsClopper
Page 195 and 196: Study/patientCharacteristicsOutcome
Page 197: Table 26: Testosterone Treatment: P
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-
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
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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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(150) Hagemann JH, Berding G, Bergh
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(183) Moriel EZ, Rajfer J. Sodium b
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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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Giammusso B, Gattuso U, Vanaclocha
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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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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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