6.16Sexual dysfunction

SRs
Review detailsInterventionPopulationResultsQuality assessment+
Author (year)
Burls (1998)[435]

Objective
To evalute the effectiveness, safety and cost-effectiveness of sildenafil (viagra) for the treatment of male erectile dysfunction.

Number of included studies
21 RCTs (n= approximately 4000)
Sildenafil compared to placebo (21 RCTs) (n=approximately 4000)Men with erectile dysfunction.All trials showed a statistically significant improvement in erectile function in patients using sildenafil compared to placebo. Around 75–80% of men showed a clinically significant improvement in erectile or sexual function on sildenafil compared to around 25% on placebo. The number needed to treat was around 2. Many of the patients in the studies had some baseline erectile function and it is probable that in clinical practice where the erectile function tends to be more impaired, the NNT may be higher.

The drug has a relatively safe side-effect profile. Tha major contra-indication is concurrent use of nitrates.
1: Good
2: Good
3: Good
4: Good
5: Good
Author (year)
Ernst (1998)[434]

Objective
To assess the efficacy and tolerability of yohimbine monotherapy for erectile dysfunction.

Number of included studies
7 RCTs (n=419)
Yohimbine hydrochloride capsules compared to placebo (7 RCTs) (n=419). Dose ranges between 15 mg – 30 mg daily. Treatment duration between 4 – 10 weeks.Males with erectile dysfunction due to organic or non-organic etiology.The meta-analysis demonstrated that yohimbine is superior to placebo in the treatment of erectile dysfunction (odds ratio 3.85, 95% confidence interval 6.67 – 2.22). Serious adverse reactions were infrequent and reversible.1: Good
2: Good
3: Good
4: Good
5: Good
Author (year)
Fink (1924)[433]

Objective
To determine the efficacy and safety of sildenafil citrate in the treatment of male erectile dysfunction.

Number of included studies
27 RCTs (n=6659)
Sildenafil versus placebo; dose range 25 – 300 mg; treatment duration range 1 – 26 weeks. (23 RCTs) (drug taken when needed); 4 RCTs (drug taken daily).Males with erectile dysfunction; Approximately half of the men had purely organic ED, 19% had purely psychogenic ED and nearly 30% had a mixed cause.In results pooled from 14 parallel-group, flexible as-needed dosing trials, sildenafil was more likely than placebo to lead to successful sexual intercourse, with a higher percentage of successful intercourse attempts (57% vs 21%; weighted mean difference, 33.7; 95% confidence interval (CI), 29.2 – 38.2; ; n=2283 men) and a greater percentage of men experiencing at least 1 intercourse success during treatment (83% vs 45%; relative benefit increase, 1.8; 95% CI, 1.7 – 1.9; n=2205 men).

In data pooled from 6 parallel-group, fixed-dose trials, efficacy appeared slightly greater at higher doses. Treatment response appeared to vary between patient subgroups, although relative to placebo, sildenafil significantly improved erectile function in all evaluated subgroups. Specific adverse events with sildenafil included flushing (12%), headache (11%), dyspepsia (5%), and visual disturbance (3%). All adverse events were significantly less likely to occur with placebo. Sildenafil was not significantly associated with serious cardiovascular events or death.
1: Good
2: Good
3: Good
4: Good
5: Good
Author (year)
Wilt (1999)[432]

Objective
To review the evidence for the effectiveness of treatment for erectile dysfunction

Number of included studies
46 RCTs and 2 CCTs
Sildenaifl vs placebo (15 RCTs) (n=4081)

Yohimbine vs placebo (n=8) or active control (n=1) (9 RCTs) (6 included in Ernst review) (n=469)

Phentolamine vs placebo (1 RCTs and 2 CCTs) (n=792)

Trazadone vs placebo (4 RCTs) (n, not reported)

Combination cream (Aminophylline + Isosorbide Dinitrate + Co-Dergocrine) vs placebo (1 RCT) (n=36)

Buflomedil Transdermal Electromotive Administration (1 RCT) (n=25)

Intraurethral Alprostradil (MUSE) vs placebo (2 RCTs) (n=1155)

Intracavernous injections (7 RCTs) (n=1070)

Alprostadil + Phentolamine + Papaverine (4 RCTs) (n=382)

Phentolamine + Papaverine (2 RCTs) (n=80)
Men with erectile dysfunctionCurrently available treatments for primarily organic ED include vacuum constriction devices, intrauretral (IU)(alpostadil) and intracavernosal (IC) vasoactive drug infection therapy (alpostradil montehrapy; papaverine plus phentolamine; and a combination of all three agents), surgical implantation of a penile prosthesis and oral medications (sildenafil and yohimbine). Inconsistent or lack of clinically relevant reported outcomes, lack of long term follow-up or comparisons with active treatments, and selection bias of enrolled patients limit study results. Compared to other therapies, studies of sildenafil and intrauretrhal alprostadil involved the most patients, were of greatest duration and used standardised validated outcome measures.1: Good
2: Good
3: NA
4: Good
5: Good

From: Appendix I, Evidence tables

Cover of Multiple Sclerosis
Multiple Sclerosis: National Clinical Guideline for Diagnosis and Management in Primary and Secondary Care.
NICE Clinical Guidelines, No. 8.
National Collaborating Centre for Chronic Conditions (UK).
Copyright © 2004, Royal College of Physicians of London.

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