Interventions for treating sexual dysfunction in patients with chronic kidney disease

Mariacristina Vecchio; Sankar D Navaneethan; David W Johnson; Giuseppe Lucisano; Giusi Graziano; Valeria Saglimbene; Marinella Ruospo; Marialuisa Querques; Emmanuele A Jannini; Giovanni FM Strippoli

doi:10.1002/14651858.CD007747.pub2

Intervenciones para el tratamiento de la disfunción sexual en la nefropatía crónica

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Referencias

Referencias de los estudios incluidos en esta revisión

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Antoniou LD, Shalhoub RJ. Zinc and sexual dysfunction. Lancet 1980;320(8202):1034‐5. [MEDLINE: 6107664]

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Referencias de los estudios excluidos de esta revisión

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Campieri C, Dardeff AB, Borgnino LC, Prandini R, Orsoni G, Stefoni S. Prolactin, zinc and sexual activity in dialysis patients. Proceedings European Dialysis Transplant Association 1979;16:661‐2. [MEDLINE: 575798]

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Grover‐Paez F, Villegas RG, Guillen OR. Sildenafil citrate diminishes microalbuminuria and the percentage of A1c in male patients with type 2 diabetes. Diabetes Research & Clinical Practice 2007;78(1):136‐40. [MEDLINE: 17374416]

Mahajan SK, Prasad AS, Rabbani P, Briggs WA, Mc Donald F. Zinc deficiency: a reversible complication of uremia. American Journal of Clinical Nutrition 1982;36(6):1177‐83. [MEDLINE: 6890761]

Rodger RS, Sheldon WL, et al. Zinc deficiency and hyperprolactinaemia are not reversible causes of uraemic impotence [abstract]. Nephrology Dialysis Transplantation 1986;1(2):124. [CENTRAL: CN‐00260292]

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Schaefer RM, Kokot F, Heidland A. Impact of recombinant erythropoietin on sexual function in hemodialysis patients. Contributions to Nephrology 1989;76:273‐81. [MEDLINE: 2684527]

Sprenger KB, Schmitz J, Hetzel D, Bundschu D, Franz HE. Zinc and sexual dysfunction. Contributions to Nephrology 1984;38:119‐28. [MEDLINE: 6370592]

Tas A, Dilek K, Gullulu M, Yavus M, Ersoy A, Usta M, et al. Treatment of erectile dysfunction in hemodialysis patients and effects of sildenafil [abstract]. Nephrology Dialysis Transplantation 2001;16(6):A87. [CENTRAL: CN‐00447955]

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Zetin M, Stone RA. Effects of zinc in chronic hemodialysis. Clinical Nephrology 1980;13(1):20‐5. [MEDLINE: 6988119]

Referencias de los estudios en curso

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NCT00334477. Efficacy and safety of tadalafil 20mg for the treatment of erectile dysfunction in chronic renal patients in hemodialysis. clinicaltrials.gov/ct2/show/NCT00334477 (accessed 16 Aug 2010). [NCT00334477]

Referencias adicionales

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Bellinghieri G, Santoro D, Mallamace A, Savica V. Sexual dysfunction in chronic renal failure. Journal of Nephrology 2008;21 Suppl 13:113‐7. [MEDLINE: 18446743]

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Finkelstein F, Shirani S, Wuerth D, Finkelstein SH. Therapy insight: sexual dysfunction in patients with chronic kidney disease. Nature Clinical Practice Nephrology 2007;3(4):200‐7. [MEDLINE: 17389889]

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Hellstrom WJ, Gittelman M, Karlin G, Segerson T, Thibonnier M, Taylor T, et al. Vardenafil for treatment of men with erectile dysfunction: efficacy and safety in a randomized, double‐blind, placebo‐controlled trial. Journal of Andrology 2002;23(6):763‐71. [MEDLINE: 12399521]

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Referencias de otras versiones publicadas de esta revisión

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otras referencias

Vecchio M, Navaneethan SD, Strippoli GF. Interventions for treating sexual dysfunction in patients with chronic kidney disease. Cochrane Database of Systematic Reviews 2009, Issue 2. [DOI: 10.1002/14651858.CD007747]

Vecchio M, Navaneethan SD, Johnson DW, Lucisano G, Graziano G, Querques M, et al. Treatment options for sexual dysfunction in patients with chronic kidney disease: a systematic review of randomized controlled trials. Clinical Journal of The American Society of Nephrology: CJASN 2010;5(6):985‐95. [MEDLINE: 20498250]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

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Antoniou 1977

Methods	Study design: Placebo controlled RCT Study duration: 3‐4 months Follow‐up: 4 months Lost to follow‐up: 0
Participants	Inclusion criteria Country: USA Setting: Hospital Male patients undergoing maintenance HD Number (treatment/control): 4/4 Age (treatment/control): 49/48 years Sex: 100% male Exclusion criteria: NS
Interventions	Treatment group Zinc chloride Dose, duration, frequency, administration: 400 μg/L for 3 to 4 months Control group Placebo Dose, duration, frequency, administration: NS
Outcomes	Plasma testosterone concentration FSH level LH level
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Stated "randomised" no further information provided
Allocation concealment?	Unclear risk	NS
Blinding? All outcomes	Unclear risk	Blinding of investigators Participants outcomes assessors and data analysis: NS
Incomplete outcome data addressed? All outcomes	High risk	Patients excluded at various stage (one patient died and three others dropped out because of intercurrent illness)
Free of selective reporting?	Low risk	Primary outcomes for this review (plasma gonadotropins concentration) have been reported
Free of other bias?	Unclear risk	Funding source: NS

Bellovich 2000

Methods	Study design: Crossover RCT Study duration: 3 months Follow‐up: 3 months Lost to follow‐up: 9
Participants	Inclusion criteria Country: USA Setting: NS Male, HD patients, > 18 years and with ED Number: 14 Age: 52.4 years Sex: 100% male Exclusion criteria Patients in therapy with nitrate
Interventions	Treatment group Sildenafil citrate Dose, duration, frequency, administration: 25 or 50 mg for 1 month followed by crossover Control group Placebo Dose, duration, frequency, administration: NS
Outcomes	Questions 3 and 4 of IIEF questionnaire Karnofsjy scale score for QoL measurement
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Stated "randomised" no further information provided
Allocation concealment?	Unclear risk	NS
Blinding? All outcomes	Unclear risk	Data only available from conference proceedings abstract
Incomplete outcome data addressed? All outcomes	Unclear risk	Patients excluded at various stages (one transplanted, one died, seven lost to follow‐up)
Free of selective reporting?	Unclear risk	Primary outcomes for this review (IIEF score) have been reported, however data only available from conference proceedings abstract
Free of other bias?	Unclear risk	Funding source: NS

Blumberg 1980

Methods	Study design: Single‐blind, placebo‐controlled crossover RCT Study duration: 4 months Follow‐up: from 2 to 4 months Lost to follow‐up: 0
Participants	Inclusion criteria Country: Switzerland Setting: NS Patients on maintenance HD Number: 15 Age: NS Sex (M/F): 5/10 Exclusion criteria External organ deficiency or other illness associated with increased catabolism
Interventions	Treatment group 1.25(OH)2D3 Dose, duration, frequency, administration: starting dose of 0.25‐0.5 μg/d increased up to 0.5‐1.5 μg/d until definite rise in serum calcium concentration occurred for 2/4 months Control group Placebo Dose, duration, frequency, administration: NS
Outcomes	Endocrine parameters level assessment Testosterone LH FSH Psychiatric interview protocol
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Stated "randomised" no further information provided
Allocation concealment?	Unclear risk	NS
Blinding? All outcomes	Unclear risk	Blinding of participants Outcomes assessors and data analysis: NS
Incomplete outcome data addressed? All outcomes	Low risk	All patients followed up or accounted for
Free of selective reporting?	Low risk	Primary outcomes for this review (plasma gonadotropins concentration) have been reported
Free of other bias?	Unclear risk	Funding source: NS

Bommer 1979

Methods	Study design: Single‐blind, placebo controlled, crossover RCT Study duration: 16 weeks Follow‐up: 8 weeks Lost to follow‐up: 0
Participants	Inclusion criteria Country: Switzerland Setting: NS Home dialysis patients (on dialysis for more than 24 months), male, married, younger than 50, older than 18 years Number: 15 Age: 28‐50 years Sex: 100% male Exclusion criteria: NS
Interventions	Treatment group Bromocriptine Dose, duration, frequency, administration: 2.5 mg twice a day for 8 weeks Control group Placebo Dose, duration, frequency, administration: NS
Outcomes	Frequency of intercourse Tumescence Libido Prolactin concentration
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Stated "randomised" no further information provided
Allocation concealment?	Unclear risk	NS
Blinding? All outcomes	Unclear risk	Blinding of participants Outcomes assessors and data analysis: NS
Incomplete outcome data addressed? All outcomes	Unclear risk	Patients excluded at various stage (only 7/15 patients were able to complete the study; bromocriptine caused serious hypotension in the remaining 8 men)
Free of selective reporting?	High risk	Primary outcomes for this review not reported
Free of other bias?	Unclear risk	Funding source: NS

Brook 1980

Methods	Study design: Double‐blind, placebo‐controlled RCT Study duration: 6 weeks Follow‐up: 6 weeks Lost to follow‐up: 0
Participants	Inclusion criteria Country: UK Setting: Infirmary Male, HD patients Number (treatment/control): 7/7 Mean age ± SD Treatment group: 37.6 ± 2.2 years Control group: 37.6 ± 2.2 years Sex: 100% male Exclusion criteria: NS
Interventions	Treatment group Zinc Dose, duration, frequency, administration: to attain a final concentration of 400 μg/L for 6 weeks Control group Placebo Dose, duration, frequency, administration: NS
Outcomes	Plasma testosterone Questionnaire about sexual dysfunction Gonadotropin levels
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Stated "randomised" no further information provided
Allocation concealment?	Unclear risk	NS
Blinding? All outcomes	Low risk	Blinding of participants and investigators Outcomes assessors and data analysis: NS
Incomplete outcome data addressed? All outcomes	Low risk	All patients followed up or accounted for
Free of selective reporting?	Low risk	Primary outcomes for this review (plasma gonadotropins concentration) have been reported
Free of other bias?	Unclear risk	Funding source: NS

Demir 2006

Methods	Study design: Prospective RCT Study duration: 4 weeks Follow‐up: 4 months Lost to follow‐up: NS
Participants	Inclusion criteria Country: USA Setting: University medical faculty Male patients with stable relationship with a partner; single kidney graft with the external iliac arteries used for the vascular anastomosis Number (treatment/control): 39/21 Mean age ± SD Treatment group: 48 ± 7.4 years Control group: 50 ± 7.1 years Sex: 100% male Exclusion criteria Stroke; diabetes; myocardial infarction; coronary heart disease; overt heart failure; significant penile anatomical abnormalities; active peptic ulcer; chronic liver disease; clinically significant hypotension; blood coagulation disorders; therapy with nitrate
Interventions	Treatment group Vardenafil Dose, duration, frequency, administration: 10 mg (dose could be increased to 20 mg) for 4 weeks Control group Placebo Dose, duration, frequency, administration: NS
Outcomes	IIEF score Cyclosporin concentration
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Stated "randomised" no further information provided
Allocation concealment?	Unclear risk	NS
Blinding? All outcomes	Unclear risk	NS
Incomplete outcome data addressed? All outcomes	Low risk	All patients followed up or accounted for
Free of selective reporting?	Low risk	Primary outcomes for this review (IIEF score) have been reported
Free of other bias?	Unclear risk	Funding source: NS

Mahajan 1982

Methods	Study design: Double‐blind, placebo‐controlled RCT Study duration: 6 months Follow‐up: 6 months Lost to follow‐up: 0
Participants	Inclusion criteria Country: USA Setting: University medical centre Male patients with ESKD, normal secondary sexual characteristics, stable relationship with a partner Number (treatment/control): 10/10 Mean age ± SD Treatment group: 38 ± 7 years Control group: 41 ± 6 years Sex: 100% male Exclusion criteria Gynaecomastia; gastrointestinal disorders
Interventions	Treatment group Elemental zinc or zinc acetate Dose, duration, frequency, administration: 25‐50 mg Control group Placebo (sucrose) Dose, duration, frequency, administration: 25‐50 mg
Outcomes	Libido Frequency of intercourse Testosterone LH level FSH level Sperm counts
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Stated "randomised" no further information provided
Allocation concealment?	Low risk	Consecutively numbered sealed envelopes
Blinding? All outcomes	Low risk	Blinding of participants and investigators Outcomes assessors and data analysis: NS
Incomplete outcome data addressed? All outcomes	Low risk	All patients followed up or accounted for
Free of selective reporting?	Low risk	Primary outcomes for this review (plasma gonadotropins concentration) have been reported
Free of other bias?	Unclear risk	Funding source: NS

Mahon 2005

Methods	Study design: Prospective, double‐blind, placebo‐controlled, crossover RCT Study duration: 11 weeks Follow‐up: 1 months Lost to follow‐up: 0
Participants	Inclusion criteria Country: UK Setting: NS Patients > 18 years Number: 16 Age: 55.6 years Sex: 100% male Exclusion criteria Myocardial infarction within the last 6 months; cerebrovascular event within the last 6 months; severe hepatic impairment; penile anatomic deformities; severe cardiac disease; concomitant nitrate therapy
Interventions	Treatment group Sildenafil citrate Dose, duration, frequency, administration: 50 mg (increased to 100 mg if no response after 2 weeks) for 1 month Control group Placebo Dose, duration, frequency, administration: NS
Outcomes	Global efficacy question
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Stated "randomised" no further information provided
Allocation concealment?	Unclear risk	NS
Blinding? All outcomes	Low risk	Blinding of participants and investigators Outcomes assessors and data analysis: NS
Incomplete outcome data addressed? All outcomes	High risk	Continuous results are reported as mean and no SD
Free of selective reporting?	Unclear risk	Primary outcomes for this review (IIEF score) have not been reported
Free of other bias?	Unclear risk	Funding source: NS

Muir 1983

Methods	Study design: Double‐blind, placebo‐controlled, crossover RCT Study duration: 7 months Follow‐up: 7 months Lost to follow‐up: 11
Participants	Inclusion criteria Country: UK Setting: NS Male patients with ESKD, euthyroid and who received maintenance HD for at least 6 months, complained of impotence Number: 14 Age: 44.5 years Sex: 100% male Exclusion criteria Patients with impotence due to psychological disturbance; took some drugs known to raise serum prolactin concentration; androgen treatment; liver disease; priapism; disturbed bladder function; angina pectoris; depression; hypertension
Interventions	Treatment group Bromocriptine Dose, duration, frequency, administration: Initial dose of one‐half of one tablet was increased every fourth day by one‐half tablet until one tablet (2.5 mg when bromocriptine) was taken thrice daily by 16 days. Patient then continued on the tablets for a further 3 months. Control group Placebo Dose, duration, frequency, administration: NS
Outcomes	Testosterone concentration Frequency of spontaneous erections Frequency of all erections Quality of erections Libido
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Stated "randomised" no further information provided
Allocation concealment?	Low risk	Tablets were dispensed in code by the hospital pharmacy
Blinding? All outcomes	Low risk	Blinding of participants and investigators Outcomes assessors and data analysis: NS
Incomplete outcome data addressed? All outcomes	Unclear risk	Patients excluded at various stage (two received kidney transplants and nine stopped owing to side effects)
Free of selective reporting?	Low risk	Primary outcomes for this review (testosterone concentration) have been reported
Free of other bias?	Unclear risk	Funding source: NS

Seibel 2002

Methods	Study design: Double‐blind, placebo‐controlled RCT Study duration: 1 month Follow‐up: 1 month Lost to follow‐up: 0
Participants	Inclusion criteria Country: Brazil Setting: University teaching hospital Patients with chronic HD who had received treatment for at least 6 month in six dialysis units in the state of Rio Grande do Soul, male patients having a stable relationship with a female sexual partner Number (treatment/control): 20/21 Mean age ± SD Treatment group: 49 ± 10 years Control group: 46 ± 9 years Sex: 100% male Exclusion criteria Patients > 70 years; penile anatomic abnormalities; cirrhosis; diabetes; angina; severe anaemia; nitrate treatment; history of recent stroke or myocardial infarction; illiterate patients; patients treated for ED
Interventions	Treatment group Sildenafil citrate Dose, duration, frequency, administration: 50 mg (1 hour before each sexual intercourse) for 1 month Control group Placebo Dose, duration, frequency, administration: NS
Outcomes	IIEF SCORE
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Stated "randomised" no further information provided
Allocation concealment?	Unclear risk	"24 patients in each group received a sealed box containing the capsules"
Blinding? All outcomes	Low risk	Blinding of participants and investigators Outcomes assessors and data analysis: NS
Incomplete outcome data addressed? All outcomes	Unclear risk	Patients excluded at various stages (one patient asked to be excluded, two died, one withdrew the consent and three had initial IIEF scores higher than 26)
Free of selective reporting?	Low risk	Primary outcomes for this review (IIEF score) have been reported
Free of other bias?	Unclear risk	Funding source: NS

Sharma 2006

Methods	Study design: Double‐blind, placebo‐controlled, crossover RCT Study duration: 18 weeks Follow‐up: 8 weeks Lost to follow‐up: NS
Participants	Inclusion criteria Country: India Setting: University Males >18 years old with kidney transplant, stable graft function in the last 6 months, medically documented ED (as defined by the NIHCP), stable relationship with a female partner in the last 6 months Number: 32 Mean age ± SD: 40 ± 8 years Sex: 100% male Exclusion criteria Penile anatomic abnormalities; history of recent stroke or myocardial infarction; proliferative diabetic retinopathy; severe autonomic neuropathy; regular treatment with nitrates and androgens; spinal cord injury
Interventions	Treatment group Sildenafil citrate Dose, duration, frequency, administration: 50 mg for 8 months Control group Placebo Dose, duration, frequency, administration: NS
Outcomes	IIEF score Global efficacy question Cyclosporin level Blood urea nitrogen level Creatinine level Haemoglobin level
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Low risk	"randomisation table generated by the method of random permuted blocks"
Allocation concealment?	Unclear risk	NS
Blinding? All outcomes	Low risk	Blinding of participants and investigators Outcomes assessors and data analysis: NS
Incomplete outcome data addressed? All outcomes	Low risk	All patients followed up or accounted for
Free of selective reporting?	Low risk	Primary outcomes for this review (IIEF score) have been reported
Free of other bias?	Unclear risk	Funding source: NS

Turk 2010

Methods	Study design: Open‐label, prospective, crossover RCT Study duration: 10 weeks Follow‐up: 10 weeks Lost to follow‐up: NS
Participants	Inclusion criteria Country: Turkey Setting: NS HD patients, aged 20 to 70 years, stable heterosexual relationship for the previous 6 months, clinical diagnosis of ED for 6 months Number: 32 Mean age ± SD: 47.2 ± 10.8 years Sex: 100% male Exclusion criteria Current treatment of ED regardless of drug or method; alcohol or drug abuse; inability to follow study instructions; major haematologic or hepatic abnormalities; myocardial infarction in the preceding 6 months; concomitant treatment with nitrate and derivatives; uncontrolled hypertension or symptomatic hypotension; penile anatomical deformity; bleeding diathesis and peptic ulcer disease; schedule for kidney transplantation or alternate surgical procedure
Interventions	Treatment group Sildenafil citrate Dose, duration, frequency, administration: 50 mg, 45 min prior to sexual intercourse once per week for 4 weeks Control group Vardenafil Dose, duration, frequency, administration: 10 mg, 45 min prior to sexual intercourse once per week for 4 weeks
Outcomes	IIEF‐5 score Physical component score Mental component score
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Low risk	Computer‐generated randomisation sequence
Allocation concealment?	Low risk	Patients were randomised into either sildenafil or vardenafil groups by opening pre‐numbered sealed opaque envelopes
Blinding? All outcomes	High risk	Open‐label study
Incomplete outcome data addressed? All outcomes	Low risk	All patients followed up or accounted for
Free of selective reporting?	Low risk	Primary outcomes for this review (IIEF‐5 score) have been reported
Free of other bias?	Unclear risk	Funding source: NS

Wabrek 1982

Methods	Study design: Placebo‐controlled RCT Study duration: NS Follow‐up: NS Lost to follow‐up: 0
Participants	Inclusion criteria Country: USA Setting: Hospital's dialysis unit Male HD patients Number (treatment/control): 4/4 Mean age ± SD Treatment group: 50 ± 8 years Control group: 47 ± 8 years Sex: 100% male Exclusion criteria: NS
Interventions	Treatment group Zinc Dose, duration, frequency, administration: solution containing 400 mg/L of zinc Control group Placebo Dose, duration, frequency, administration: NS
Outcomes	NPT Penile circumference Increase of penile shaft
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Stated "randomised" no further information provided
Allocation concealment?	Unclear risk	NS
Blinding? All outcomes	Low risk	Blinding of participants, investigators and outcomes assessors Data analysis: NS
Incomplete outcome data addressed? All outcomes	Unclear risk	Data only available for 7/8 patients
Free of selective reporting?	High risk	Primary outcomes for this review have not been reported
Free of other bias?	Unclear risk	Funding source: NS

Yang 2008

Methods	Study design: Double‐blind, placebo‐controlled RCT Study duration: 4 weeks Follow‐up: 4 weeks Lost to follow‐up: 0
Participants	Inclusion criteria Country: China Setting: Wuhan, China Kidney transplant patients with ED (average 26 months after transplant and received HD average 38 months) and serum creatinine values < 2 mg/dL, no other treatment in past 4 weeks Number (treatment/control): 20/19 Age: NS Sex: 100% male Exclusion criteria: NS
Interventions	Treatment group Vardenafil Dose, duration, frequency, administration: 10 mg, one hour before coitus no more than once per day Control group Placebo Dose, duration, frequency, administration: NS
Outcomes	IIEF score Cyclosporin level Creatinine level Creatinine clearance Liver function Kidney function Lipid concentration Blood routine test Urine routine test Any other adverse events
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Stated "randomised" no further information provided
Allocation concealment?	Unclear risk	NS
Blinding? All outcomes	Low risk	Blinding of participants and investigators Outcomes assessors and data analysis: NS
Incomplete outcome data addressed? All outcomes	Low risk	All patients followed up or accounted for
Free of selective reporting?	Low risk	Primary outcomes for this review (IIEF score) have been reported
Free of other bias?	Unclear risk	Funding source: NS

Yeksan 1992

Methods	Study design: Double‐blind, placebo‐controlled RCT Study duration: 8 weeks Follow‐up: 8 weeks Lost to follow‐up: 0
Participants	Inclusion criteria Country: Turkey Setting: University teaching hospital HD patients on a low sodium diet containing 50 g/day protein Number (treatment/control): 12/12 Age (treatment/control): 35/42 years Sex: 100% male Exclusion criteria: NS
Interventions	Treatment group Oral vitamin E Dose, duration, frequency, administration: 300 mg for 8 weeks Control group Placebo Dose, duration, frequency, administration: NS
Outcomes	Prolactin LH level FSH level Testosterone level
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Stated "randomised" no further information provided
Allocation concealment?	Unclear risk	NS
Blinding? All outcomes	Low risk	Blinding of participants and investigators Outcomes assessors and data analysis: NS
Incomplete outcome data addressed? All outcomes	Low risk	All patients followed up or accounted for
Free of selective reporting?	Low risk	Primary outcomes for this review (plasma gonadotropins concentration) have been reported
Free of other bias?	Unclear risk	Funding source: NS

1,25(OH)2D3 ‐ 1,25 dihydroxycholecalciferol; ED ‐ erectile dysfunction; ESKD ‐ end‐stage kidney disease; FSH ‐ follicle‐stimulating hormone; HD ‐ haemodialysis; IIEF ‐ International Index of Erectile Function; LH ‐ luteinizing hormone; NS ‐ not stated

Characteristics of excluded studies [ordered by study ID]

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estudios incluidos
estudios en curso

Study	Reason for exclusion
Campieri 1979	Not an RCT
Grossman 2004	One off pharmacokinetic study, not an intervention for sexual dysfunction
Grover‐Paez 2007	Wrong population
Mahajan 1982a	Intervention not for sexual dysfunction
Rodger 1989	Not an RCT
Schaefer 1989	Not an RCT
Sprenger 1984	Not an RCT
Tas 2006	Not an RCT
Zetin 1980	Not an RCT

Characteristics of ongoing studies [ordered by study ID]

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estudios incluidos
estudios excluidos

NCT00334477

Trial name or title	Efficacy and safety of tadalafil 20 mg for the treatment of erectile dysfunction in chronic renal patients in haemodialysis
Methods	Study design: Double‐blind, placebo‐controlled parallel RCT Study duration: NS Blinding Participants: yes Investigators: yes Outcomes assessors: NS Data assessors: no Follow‐up: NS
Participants	Country: Brazil Setting: University teaching hospital Inclusion criteria: Men between 18 and 70 years old; diagnosed with ED for 6 months; Accept the protocol; Sign the informed consent; Renal chronic patients in haemodialysis Exclusion criteria: History of another PDE5 inhibitor use; C.C.I. grade III (NYHA)
Interventions	Treatment group Tadalafil Dose, duration, frequency, administration: 20 mg Control group Placebo Dose, duration, frequency, administration: NS
Outcomes	IIEF‐5 Adverse effect reported
Starting date	NS
Contact information	Bruno SP Carvalho: 558199757974 [email protected]
Notes

NS ‐ not stated

Data and analyses

Open in table viewer

Comparison 1. PDE inhibitors versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Sexual function using IIEF‐5 Show forest plot	4		Mean Difference (IV, Random, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.1 Comparison 1 PDE inhibitors versus placebo, Outcome 1 Sexual function using IIEF‐5.
1.1 Total score	2	101	Mean Difference (IV, Random, 95% CI)	10.65 [5.34, 15.96]
1.2 Erection frequency	3	149	Mean Difference (IV, Random, 95% CI)	1.54 [1.14, 1.93]
1.3 Erection quality (Q2)	3	165	Mean Difference (IV, Random, 95% CI)	1.78 [1.04, 2.53]
1.4 Penetration ability (Q3)	3	165	Mean Difference (IV, Random, 95% CI)	1.70 [1.16, 2.24]
1.5 Maintenance frequency of penetration (Q4)	4	193	Mean Difference (IV, Random, 95% CI)	1.60 [1.02, 2.18]
1.6 Maintenance of erection after penetration (Q5)	4	193	Mean Difference (IV, Random, 95% CI)	1.83 [1.17, 2.50]
1.7 Erection confidence (Q15)	3	165	Mean Difference (IV, Random, 95% CI)	1.39 [0.84, 1.95]
2 Sexual function using IIEF‐15 Show forest plot	2		Mean Difference (IV, Random, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.2 Comparison 1 PDE inhibitors versus placebo, Outcome 2 Sexual function using IIEF‐15.
2.1 Overall satisfaction	1	41	Mean Difference (IV, Random, 95% CI)	2.64 [1.32, 3.96]
2.2 Erectile function	2	80	Mean Difference (IV, Random, 95% CI)	10.64 [5.32, 15.96]
2.3 Orgasmic function	1	41	Mean Difference (IV, Random, 95% CI)	1.70 [0.35, 3.05]
2.4 Intercourse satisfaction	1	41	Mean Difference (IV, Random, 95% CI)	1.71 [0.11, 3.31]
2.5 Sexual desire	1	41	Mean Difference (IV, Random, 95% CI)	0.49 [‐0.67, 1.65]
3 Headache Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected
Open in figure viewer Analysis 1.3 Comparison 1 PDE inhibitors versus placebo, Outcome 3 Headache.
4 Improvement in erectile function Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected
Open in figure viewer Analysis 1.4 Comparison 1 PDE inhibitors versus placebo, Outcome 4 Improvement in erectile function.

Open in table viewer

Comparison 2. Zinc versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Serum testosterone Show forest plot	3	42	Std. Mean Difference (IV, Random, 95% CI)	0.70 [‐1.05, 2.45]
Open in figure viewer Analysis 2.1 Comparison 2 Zinc versus placebo, Outcome 1 Serum testosterone.
1.1 Zinc in dialysate	2	22	Std. Mean Difference (IV, Random, 95% CI)	0.21 [‐2.14, 2.55]
1.2 Oral zinc	1	20	Std. Mean Difference (IV, Random, 95% CI)	1.62 [0.58, 2.66]
2 Improvement of libido Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected
Open in figure viewer Analysis 2.2 Comparison 2 Zinc versus placebo, Outcome 2 Improvement of libido.
3 Plasma FSH Show forest plot	2	28	Mean Difference (IV, Random, 95% CI)	‐9.69 [‐23.72, 4.34]
Open in figure viewer Analysis 2.3 Comparison 2 Zinc versus placebo, Outcome 3 Plasma FSH.
4 Plasma LH Show forest plot	2	28	Mean Difference (IV, Random, 95% CI)	18.80 [‐26.16, 63.76]
Open in figure viewer Analysis 2.4 Comparison 2 Zinc versus placebo, Outcome 4 Plasma LH.
5 Frequency of intercourse Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected
Open in figure viewer Analysis 2.5 Comparison 2 Zinc versus placebo, Outcome 5 Frequency of intercourse.
6 Total/partial impotence Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected
Open in figure viewer Analysis 2.6 Comparison 2 Zinc versus placebo, Outcome 6 Total/partial impotence.
7 Variations in libido Show forest plot	2	34	Risk Ratio (M‐H, Random, 95% CI)	0.11 [0.01, 1.83]
Open in figure viewer Analysis 2.7 Comparison 2 Zinc versus placebo, Outcome 7 Variations in libido.
8 Nocturnal penile tumescence (NPT) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected
Open in figure viewer Analysis 2.8 Comparison 2 Zinc versus placebo, Outcome 8 Nocturnal penile tumescence (NPT).

Open in table viewer

Comparison 3. Vitamin E versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Prolactin Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected
Open in figure viewer Analysis 3.1 Comparison 3 Vitamin E versus placebo, Outcome 1 Prolactin.
2 Plasma LH Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected
Open in figure viewer Analysis 3.2 Comparison 3 Vitamin E versus placebo, Outcome 2 Plasma LH.
3 Plasma FSH Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected
Open in figure viewer Analysis 3.3 Comparison 3 Vitamin E versus placebo, Outcome 3 Plasma FSH.
4 Serum testosterone Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected
Open in figure viewer Analysis 3.4 Comparison 3 Vitamin E versus placebo, Outcome 4 Serum testosterone.

Figure 1

Flow chart showing the number of citations retrieved by individual searches and number of studies included

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Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Analysis 1.1

Comparison 1 PDE inhibitors versus placebo, Outcome 1 Sexual function using IIEF‐5.

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Analysis 1.2

Comparison 1 PDE inhibitors versus placebo, Outcome 2 Sexual function using IIEF‐15.

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Analysis 1.3

Comparison 1 PDE inhibitors versus placebo, Outcome 3 Headache.

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Analysis 1.4

Comparison 1 PDE inhibitors versus placebo, Outcome 4 Improvement in erectile function.

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Analysis 2.1

Comparison 2 Zinc versus placebo, Outcome 1 Serum testosterone.

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Analysis 2.2

Comparison 2 Zinc versus placebo, Outcome 2 Improvement of libido.

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Analysis 2.3

Comparison 2 Zinc versus placebo, Outcome 3 Plasma FSH.

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Analysis 2.4

Comparison 2 Zinc versus placebo, Outcome 4 Plasma LH.

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Analysis 2.5

Comparison 2 Zinc versus placebo, Outcome 5 Frequency of intercourse.

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Analysis 2.6

Comparison 2 Zinc versus placebo, Outcome 6 Total/partial impotence.

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Analysis 2.7

Comparison 2 Zinc versus placebo, Outcome 7 Variations in libido.

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Analysis 2.8

Comparison 2 Zinc versus placebo, Outcome 8 Nocturnal penile tumescence (NPT).

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Analysis 3.1

Comparison 3 Vitamin E versus placebo, Outcome 1 Prolactin.

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Analysis 3.2

Comparison 3 Vitamin E versus placebo, Outcome 2 Plasma LH.

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Analysis 3.3

Comparison 3 Vitamin E versus placebo, Outcome 3 Plasma FSH.

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Analysis 3.4

Comparison 3 Vitamin E versus placebo, Outcome 4 Serum testosterone.

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Table 1. Other outcomes related to sexual dysfunction as reported in the included studies

Study ID	N	Intervention	Outcome	Mean ± SD (treatment group or baseline value) or RR (95% CI)	Mean ± SD (control group or after treatment)
Antoniou 1977	8	Oral zinc versus placebo	Testosterone concentration (ng/mL)¹	8.00 ± 3.50	3.20 ± 2.00
			LH (mU/mL)¹	85.30 ± 81.00	47.30 ± 26.90
			FSH (mU/mL)¹	24.00 ± 24.30	33.00 ± 8.70
Bellovich 2000	14	Sildenafil citrate	IIEF ‐ Frequency of penetration	3.85 ± 3.10	4.43 ± 2.92
Bellovich 2000	14	Sildenafil citrate	IIEF ‐ Maintenance of erection penetration	4.43 ± 2.69	4.93 ± 2.32
Brook 1980	14	Zinc chloride versus placebo to dialysate	Improvement of libido	1.00 (0.08 to 13.02)	NA
Brook 1980	14	Zinc chloride versus placebo to dialysate	Plasma testosterone (nmol/L)²	9.00 ± 4.23	12.00 ± 1.32
Mahajan 1982	20	Oral zinc acetate versus placebo	Total/partial impotence	0.13 (0.02 to 0.82)	NA
			Decreased libido	0.11 (0.01 to 1.83)	NA
			Decreased frequency of intercourse	0.22 (0.06 to 0.78)	NA
			Increased plasma testosterone³	5.20 ± 1.58	3.00 ± 0.95
			Decreased plasma FSH³	25.00 ± 22.14	35.00 ± 15.81
			Decreased plasma LH³	49.00 ± 82.22	38.00 ± 25.3
Mahon 2005	13	Sildenafil citrate versus placebo	Global efficacy question	2.50 (1.05 to 5.96)	NA
Muir 1983	14	Bromocriptine versus placebo	Testosterone (nmol/L)¹	16.80 ± 4.49	17.00 ± 4.11
Sharma 2006	32	Sildenafil citrate versus placebo	Global efficacy question	4.33 (2.07 to 9.08)
			Blood urea nitrogen (mg/dL)²	18.3 ± 7.6	17.9 ± 51.0
			Creatinine (mg/dL)²	1.48 ± 0.4	1.4 ± 0.4
			Haemoglobin (g/dL)²	12.3 ± 1.5	13.2 ± 1.4
Wabrek 1982	8	Oral zinc versus placebo	Tumescence episodes	0.75 (0.07 to 7.73)	NA
Yeksan 1992	24	Vitamin E versus placebo*	Prolactin (ng/mL)	15.00 ± 4.28	56.23 ± 15.66
			LH (mU/mL)	4.66 ± 1.80	11.43 ± 5.70
			FSH (mU/mL)	4.23 ± 1.83	4.88 ± 2.94
			Testosterone (pg/mL)	11.79 ± 4.16	4.79 ± 1.82
¹ significance not reported; ² P value not significant; ³ P value < 0.05; * Data pre and post vitamin E treatment only is reported; IIEF ‐ International Index of Erectile Function; LH ‐ luteinizing hormone; FSH ‐ follicular stimulating hormone; SD ‐ standard deviation; RR ‐ relative risk; NA ‐ not applicable or not available.

Table 1. Other outcomes related to sexual dysfunction as reported in the included studies

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Comparison 1. PDE inhibitors versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Sexual function using IIEF‐5 Show forest plot	4		Mean Difference (IV, Random, 95% CI)	Subtotals only

1.1 Total score	2	101	Mean Difference (IV, Random, 95% CI)	10.65 [5.34, 15.96]
1.2 Erection frequency	3	149	Mean Difference (IV, Random, 95% CI)	1.54 [1.14, 1.93]
1.3 Erection quality (Q2)	3	165	Mean Difference (IV, Random, 95% CI)	1.78 [1.04, 2.53]
1.4 Penetration ability (Q3)	3	165	Mean Difference (IV, Random, 95% CI)	1.70 [1.16, 2.24]
1.5 Maintenance frequency of penetration (Q4)	4	193	Mean Difference (IV, Random, 95% CI)	1.60 [1.02, 2.18]
1.6 Maintenance of erection after penetration (Q5)	4	193	Mean Difference (IV, Random, 95% CI)	1.83 [1.17, 2.50]
1.7 Erection confidence (Q15)	3	165	Mean Difference (IV, Random, 95% CI)	1.39 [0.84, 1.95]
2 Sexual function using IIEF‐15 Show forest plot	2		Mean Difference (IV, Random, 95% CI)	Subtotals only

2.1 Overall satisfaction	1	41	Mean Difference (IV, Random, 95% CI)	2.64 [1.32, 3.96]
2.2 Erectile function	2	80	Mean Difference (IV, Random, 95% CI)	10.64 [5.32, 15.96]
2.3 Orgasmic function	1	41	Mean Difference (IV, Random, 95% CI)	1.70 [0.35, 3.05]
2.4 Intercourse satisfaction	1	41	Mean Difference (IV, Random, 95% CI)	1.71 [0.11, 3.31]
2.5 Sexual desire	1	41	Mean Difference (IV, Random, 95% CI)	0.49 [‐0.67, 1.65]
3 Headache Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

4 Improvement in erectile function Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 1. PDE inhibitors versus placebo

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Comparison 2. Zinc versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Serum testosterone Show forest plot	3	42	Std. Mean Difference (IV, Random, 95% CI)	0.70 [‐1.05, 2.45]

1.1 Zinc in dialysate	2	22	Std. Mean Difference (IV, Random, 95% CI)	0.21 [‐2.14, 2.55]
1.2 Oral zinc	1	20	Std. Mean Difference (IV, Random, 95% CI)	1.62 [0.58, 2.66]
2 Improvement of libido Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

3 Plasma FSH Show forest plot	2	28	Mean Difference (IV, Random, 95% CI)	‐9.69 [‐23.72, 4.34]

4 Plasma LH Show forest plot	2	28	Mean Difference (IV, Random, 95% CI)	18.80 [‐26.16, 63.76]

5 Frequency of intercourse Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

6 Total/partial impotence Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

7 Variations in libido Show forest plot	2	34	Risk Ratio (M‐H, Random, 95% CI)	0.11 [0.01, 1.83]

8 Nocturnal penile tumescence (NPT) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 2. Zinc versus placebo

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Comparison 3. Vitamin E versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Prolactin Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

2 Plasma LH Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

3 Plasma FSH Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

4 Serum testosterone Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

Comparison 3. Vitamin E versus placebo

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Referencias

Referencias de los estudios incluidos en esta revisión

Antoniou 1977 {published data only}

Bellovich 2000 {published data only}

Blumberg 1980 {published data only}

Bommer 1979 {published data only}

Brook 1980 {published data only}

Demir 2006 {published data only}

Mahajan 1982 {published data only}

Mahon 2005 {published data only}

Muir 1983 {published data only}

Seibel 2002 {published data only}

Sharma 2006 {published data only}

Turk 2010 {published data only}

Wabrek 1982 {published data only}

Yang 2008 {published data only}

Yeksan 1992 {published data only}

Referencias de los estudios excluidos de esta revisión

Campieri 1979 {published data only}

Grossman 2004 {published data only}

Grover‐Paez 2007 {published data only}

Mahajan 1982a {published data only}

Rodger 1989 {published data only}

Schaefer 1989 {published data only}

Sprenger 1984 {published data only}

Tas 2006 {published data only}

Zetin 1980 {published data only}

Referencias de los estudios en curso

NCT00334477 {published data only}

Referencias adicionales

Al Khallaf 2009

Anantharaman 2007

Aranda 2004

Bellinghieri 2008

Brown 2009

Campese 1990

Carson 2004

D'Amati 2002

Esposito 2004

Finkelstein 2007

Goldstein 2000

Hellstrom 2002

Higgins 2002

Higgins 2008

Keating 2003

Kimmel 1996

Kutner 2004

Laumann 1999

Lawrence 1997

Lefebvre 2008

Linet 1996

Markou 2004

Master List 2010

Mehrsai 2006

Melnik 2008

Miles 2007

Naya 2002

Padma‐Nathan 2003

Palmer 1999

Peng 2005

Peng 2007

Porst 2001

Procci 1981

Qaseem 2009

Renal Group 2010

Rosas 2001

Seidman 2006

Tsertsvadze 2009

Turk 2004

Vardi 2008

Referencias de otras versiones publicadas de esta revisión

Vecchio 2009

Vecchio 2010

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Characteristics of excluded studies [ordered by study ID]

Characteristics of ongoing studies [ordered by study ID]

Data and analyses