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stimulation and a challenge test with clomiphene citrate. Twenty-nine percent of men presentedwith a reduced LH level and 5 percent with a reduced FSH level. 69Prevalence of Hypogonadism and Hyperprolactinemia by AgeWe descriptively examined patients’ age distribution (mean and range) in individual studiesto determine whether age could account for the between-study differences in the reportedprevalence rates of hypogonadism and hyperprolactinemia. The results did not reveal anynumerical trends between the age distribution and the prevalence rates.Studies reporting age-stratified prevalence rates of hypogonadism. Buvat et al. 1997 38reported the prevalence of hypogonadism in patients older than 50 years as being twice as highas that among patients younger than 50 years (9 percent versus 4 percent). 38 In Fahmy et al.1999 64 the corresponding rates were 24.2 percent versus 14.3 percent, respectively. In anotherstudy, the prevalence rate in men older than 50 years was 20.25 percent (all patients were olderthan 50 years). 73 All three studies indicated higher prevalence of hypogonadism in men aged 50years or older compared with those under 50 years of age.Studies reporting age-stratified prevalence rates of hyperprolactinemia or abnormallevels of LH/ FSH. There was no report providing evidence on prevalence ofhyperprolactinemia, or on abnormal levels of LH/FSH, by age group among patients with ED.The Efficacy of Hormonal Therapy in Treating Erectile Dysfunction in Patients with Hormonal Abnormalities Overview of TrialsTwo studies were identified and were judged to be eligible to address the present question.Both trials were randomized 5,77 comparing the efficacy of combined treatment of testosterone(gel or patch) plus sildenafil to that of sildenafil alone in ED patients with low testosterone levelswho failed to respond (score of 2–3 on IIEF–Q3/Q4) to prior treatment with sildenafil. Moredetailed information on trial design, patient population, and efficacy/harms results for these trialsare presented in the section for Questions 2-3, Hormonal Treatments. (Evidence Table F-9,Appendix F)Gel testosterone plus sildenafil versus sildenafil. In this double-blind trial 5 75 hypogonadalmen (mean age: 58 years; total testosterone <400 ng/dL) with ED were randomized to 1 percentgel testosterone plus 100 mg sildenafil versus 100 mg sildenafil for 12 weeks. At the end of thestudy, the proportions of men with scores of 4-5 on IIEF–Q3/Q4 was statisticallynonsignificantly greater in the combination therapy group than in the sildenafil only group (51.4versus 39.4 percent; RR = 1.30, 95 percent CI 0.77–2.21). Men who received gel testosteroneplus sildenafil also had greater mean change from baseline in the IIEF “EF” domain score atweek 4 (4.4 versus 2.1, 95 percent CI: 0.3–4.7). One patient withdrew from the combinationtreatment arm due to an adverse event.Testosterone patch plus sildenafil versus sildenafil. In this open label trial,77 20hypogonadal men (mean age:56 years; total testosterone:10-13 nmol/L) with ED wererandomized to receive either 5 mg patch testosterone plus 100 mg sildenafil or 100 mg sildenafilplus placebo patch. After one month of treatment, patients in the patch testosterone plussildenafil group had either numerically or statistically significant improvements for the followingoutcomes: “EF domain” score (21.8 +/- 2.1 versus 14.2 +/- 0.7, WMD = 7.60, 95 percent CI:28
6.23–8.97), number of sexual intercourses (2.8 +/- 0.9 versus 1.5 +/- 0.5, WMD = 1.30, 95percent CI: 0.66–1.94), intercourse satisfaction (12.1 +/- 1.6 versus 7.7 +/- 1.2, WMD = 4.40, 95percent CI: 3.16–5.64), and reported improved erections (80 versus 10 percent, RR = 8.00, 95percent CI: 1.21–52.69).Questions 2-3. What is the Evidence of the Relative ClinicalBenefits and Harms of Pharmaceutical Treatments (e.g. OralMedications) for Men Diagnosed With Erectile Dysfunction?Oral Treatments — Phosphodiesterase Type 5 (PDE–5) Inhibitors - Sildenafil Literature SearchIn total, 90 unique trials (reported in 100 publications) reporting relative efficacy and harmsrelated to sildenafil use (mono or combined therapy) met the eligibility criteria and wereincluded in the review. 5,77-175Seventeen (reported in 16 publications) of the 90 trials are described in the following sectionsof the review: Question 1-3, 5,77 Topical, 144 Hormonal, 145,170 Injections, 119,172 103,118, 121,Tadalafil, 163 and Sublingual (apomorphine). 114,117,120,148,159This section reviews the remaining 73 unique trials (reported in 84 publications). 78-102,104-113,115,116,122-143,146,147,149-158,160-162,164-169,171,173-175In 5 publications, 85,86,90,130,152 two separate unique trials were described (a and b). 12 uniquetrials were reported in two or more publications. The following list shows the referenceidentifications for these 12 unique trials and their corresponding publications (each row).The first reference (author, year, citation) denotes primary publications (i.e., those reportingthe most relevant and complete data for the trial), which are used throughout the Sildenafilsection. (Tables F-1, in Appendices F):1. Palmer 2000 78 and Palmer 1999 1362. Seidman 2001 79 and Rosen 2004 1133. Goldstein 1998a, 86 Padma-Nathan 1999, 154 and Barry 1998a 1524. Tan 2000 87 and Lim 2002 1295. Meuleman 2001 88 and Hartmann 1999 1406. Eardley 2002 130 and Eardley 1999 1397. Incrocci 2001 131 and Incrocci 2003 928. Cappelleri 2000 135 and Lewis 2001 1009. Padma-Nathan 1998, 142 Goldstein 1998b 86 and Young 1999, 141 and Barry b, 152 andShabsigh 1999b 15310. Glina 2001 151 , and Glina 2002 12711. Perimenis 2007 155 , Perimenis 2004 11612. Sharma 2006 165 , and Salonia 2007 174 29
Page 1 and 2: This report is based on research co
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Page 5 and 6: AcknowledgmentsThe authors would li
Page 7 and 8: ContentsExecutive Summary..........
Page 9 and 10: Table 17: Intra-urethral Treatment:
Page 11 and 12: Figure 63. Absolute Mean Change Fro
Page 13 and 14: associated with ED treatments. Two
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Page 19 and 20: Evidence Report
Page 21 and 22: flaccidity are no less important th
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Page 27: Analytic FrameworkFigure 1. Analyti
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Page 40 and 41: Overview of Trials79-84,86-88,90,91
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Page 44 and 45: pectoris occurred in a participant
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Page 54 and 55: Oral Treatments — Phosphodiestera
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Page 60 and 61: improved erections was higher in pa
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Page 68 and 69: value was not reported). Even thoug
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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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The Quality Assessment of Studies o
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(117) Carrier S, Brock GB, Pommervi
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(255)(256)dysfunction. Psychopharma
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Adams Henry E, Motsinger Patrice, M
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Anonymous. Surgery & watchful waiti
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Bayes M, Rabasseda X, Prous J R. Ga
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Burke J P, Jacobson D J, McGree M E
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Carson C C. Combination of phosphod
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Chen Y. Acupuncture treatment of fu
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Cooke B M, Breedlove S M, Jordan C
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Daitch J A, Angermeier K W, Lakin M
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Derouet H, Jost W H, Osterhage J et
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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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Ghofrani H A, Pepke-Zaba J, Barbera
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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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Rojewski M T, Korper S, Schrezenmei
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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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Isidori A M, Giannetta E, Gianfrill
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Armstrong D K, Convery A, Dinsmore
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Buvat J, Montorsi F. Safety and tol
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De Rose A F, Giglio M, Traverso P e
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Gana T E, Quizanos L F, Castell R e
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Hatzichristou D G, Apostolidis A, T
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Kim E D, McVary K T. Topical prosta
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Lundberg L, Olsson J-O, Kihl B. Lon
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Moncada I, Jara J, Subira D et al.
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Rajpurkar A, Dhabuwala C B. Compari
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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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Chen J, Greenstein A, Kaver I et al
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Derby C A, Barbour M M, Hume A L et
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Foulks C J, Cushner H M. Sexual dys
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Hamed S, Mohamed K, El-taher A et a
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Jeong S-J, Park K, Moon J-D et al.
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La Pera G, Franco Giannotti C, Tagg
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Mann R D. Introduction - Tadalafil.
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Montorsi F, Burnett A L. Erectile d
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Ozdel O, Oguzhanoglu A, Oguzhanoglu
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Ramasubbu Rajamannar. Switching to
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Schwartz E J, Wong P, Graydon R J.
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Stolk E A, Busschbach J J, Caffa M
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Vitezic D. A risk-benefit assessmen
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Bancroft J, Smith G, Munoz M et al.
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Knispel H H, Huland H. Influence of
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Padma-Nathan H, Eardley I, Kloner R
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Bai W J, Zhu J C, Jiang H et al. [A
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Carosa E, Martini P, Brandetti F et
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Doggrell S A. Comparison of clinica
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Gingell C, Buvat J, Jardin A et al.
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Heaton J P, Morales A, Adams M A et
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Kloner R A, Mitchell M, Emmick J T.
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Marks L S, Duda C, Dorey F J et al.
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Shamloul Rany, Kamel Ihab, E-Mail A
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Tsujimura A, Yamanaka M, Takahashi
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Zippe C D, Kedia A W, Kedia K et al
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Anonymous. Diagnostic and therapeut
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Briganti A, Chun F K H, Salonia A e
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Clough J. CNS-targeted sexual dysfu
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Emilien G. Alprox-TD NexMed Inc. Cu
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Gryglewska B, Grodzicki T. Betaxolo
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Kadioglu A, Erdogru T, Tellaloglu S
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Mealy N E. GPI-1485. Drugs of the F
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AuthorYearHellstrom 2005 37 Jadad Q
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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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