Table 1.
GRADE evaluation of interventions for erectile dysfunction
| Important outcomes | Improvement in sexual function, adverse effects | ||||||||
| Number of studies (participants) | Outcome | Comparison | Type of evidence | Quality | Consistency | Directness | Effect size | GRADE | Comment |
| What are the effects of phosphodiesterase inhibitors in men with erectile dysfunction of any cause? | |||||||||
| 30 (more than 2979 men)[6] [7] [8] [9] [10] [11] [12] [13] [14] [15] [16] [17] [18] [19] [20] [21] [22] [23] | Improvement in sexual function | Sildenafil v placebo in men with erectile dysfunction of any cause | 4 | 0 | 0 | 0 | 0 | High | |
| At least 20 (at least 4146)[25] [7] [26] [27] [28] [29] [30] [31] [32] [33] [34] | Improvement in sexual function | Tadalafil v placebo in men with erectile dysfunction of any cause | 4 | 0 | 0 | 0 | 0 | High | |
| 8 (3995)[7] [37] [38] [39] [40] [41] | Improvement in sexual function | Vardenafil v placebo in men with erectile dysfunction of any cause | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for methodological weaknesses in some RCTs (including results post crossover) |
| What are the effects of phosphodiesterase inhibitors on erectile dysfunction in men with diabetes? | |||||||||
| 20 (1923)[6] [43] | Improvement in sexual function | Sildenafil v placebo in men with diabetes | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for subgroup analysis |
| 2 (514)[44] [45] | Improvement in sexual function | Tadalafil v placebo in men with diabetes | 4 | 0 | 0 | −1 | 0 | Moderate | Directness point deducted for differences in regimens between studies |
| 2 (770)[36] [46] | Improvement in sexual function | Vardenafil v placebo in men with diabetes | 4 | 0 | 0 | 0 | 0 | High | |
| What are the effects of phosphodiesterase inhibitors on erectile dysfunction in men with cardiovascular disease? | |||||||||
| More than 2 RCTs (739) [6] [47] [48] | Improvement in sexual function | Sildenafil v placebo in men with heart disease | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for subgroup analysis |
| What are the effects of phosphodiesterase inhibitors on erectile dysfunction in men with spinal cord injury? | |||||||||
| 3 (245)[53] [54] [55] [56] | Improvement in sexual function | Sildenafil v placebo in men with spinal cord injury | 4 | −2 | 0 | 0 | 0 | Low | Quality points deducted for results post crossover and composite outcome in largest RCT |
| 1 (186)[58] | Improvement in sexual function | Tadalafil v placebo in men with spinal cord injury | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
| What are the effects of phosphodiesterase inhibitors on erectile dysfunction in men with prostate cancer or undergoing prostatectomy? | |||||||||
| 2 (176)[6] [60] | Improvement in sexual function | Sildenafil v placebo in men after radical prostatectomy or prostate cancer | 4 | −2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and for subgroup analysis |
| 2 (363)[61] [62] [63] | Improvement in sexual function | Tadalafil v placebo in men after radical prostatectomy or prostate cancer | 4 | −2 | 0 | 0 | 0 | Low | Quality points deducted for incomplete reporting in 1 RCT and for results post crossover in the other RCT |
| 1 (440)[36] | Improvement in sexual function | Vardenafil v placebo in men after prostatectomy | 4 | −2 | 0 | −1 | 0 | Very low | Quality points deducted for incomplete reporting of results and inclusion of unpublished study. Directness point deducted for inclusion of previous responders to treatment |
| What are the effects of drug treatments other than phosphodiesterase inhibitors in men with erectile dysfunction of any cause? | |||||||||
| 3 (1828)[64] | Improvement in sexual function | Intraurethral alprostadil v placebo in men with erectile dysfunction of any cause | 4 | −2 | 0 | −1 | 0 | Very low | Quality points deducted for incomplete reporting of results and methodological weaknesses (uncertainty about randomisation and whether allocation concealment was performed). Directness point deducted for pre-selecting treatment responders affecting generalisability to clinical practice |
| 1 (270)[65] | Improvement in sexual function | Intraurethral alprostadil v placebo in men after radical prostatectomy | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for uncertainty about randomisation and whether allocation concealment was performed |
| 3 (274)[66] [67] [68] | Improvement in sexual function | Intraurethral alprostadil v intracavernosal alprostadil in men with erectile dysfunction of any cause | 4 | −2 | 0 | −2 | 0 | Very low | Quality points deducted for methodological weaknesses (lack of blinding and uncertainty about randomisation and whether allocation concealment was performed). Directness points deducted for pre-selecting treatment responders affecting generalisability to clinical practice, and inclusion of additional treatment in 1 RCT |
| 4 (1834)[69] [70] [71] | Improvement in sexual function | Topical alprostadil v placebo in men with erectile dysfunction of any cause | 4 | −1 | 0 | 0 | 0 | Moderate | Quality points deducted for not reporting methods of randomisation/allocation concealment |
| 1 (40)[81] | Improvement in sexual function | Papaverine v papaverine plus phentolamine (bimix) in men with erectile dysfunction of any cause | 4 | −2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and results post crossover |
| 1 (30)[83] | Improvement in sexual function | Papaverine plus phentolamine (bimix) v placebo in men with erectile dysfunction of any cause | 4 | −2 | 0 | −1 | 0 | Very low | Quality points deducted for sparse data and incomplete reporting. Directness point deducted for no direct statistical comparison between groups |
| 2 (356)[73] [74] | Improvement in sexual function | Intracavernosal alprostadil v placebo in men with erectile dysfunction of any cause | 4 | −3 | 0 | 0 | 0 | Very low | Quality points deducted for incomplete reporting of results, and for methodological weaknesses (randomisation/allocation concealment, subjective assessment of outcome, and unblinded assessment of outcome) |
| 3 (235)[75] [76] [77] | Improvement in sexual function | Intracavernosal alprostadil v papaverine in men with erectile dysfunction of any cause | 4 | −3 | 0 | 0 | 0 | Very low | Quality points deducted for incomplete reporting and methodological weaknesses (uncertainty about methods of randomisation and allocation concealment, subjective assessment of outcome, and results post crossover) |
| 2 (142)[74] [78] | Improvement in sexual function | Intracavernosal alprostadil v papaverine plus phentolamine (bimix) in men with erectile dysfunction of any cause | 4 | −3 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data, and for methodological weaknesses (uncertainty about methods of randomisation and allocation concealment, subjective assessment of outcome, and results post crossover) |
| 2 (114)[78] [79] | Improvement in sexual function | Intracavernosal alprostadil v alprostadil plus papaverine plus phentolamine (trimix) in men with erectile dysfunction of any cause | 4 | −3 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data, and for methodological weaknesses (uncertainty about methods of randomisation and allocation concealment, subjective assessment of outcome, and results post crossover |
| 1 (44)[86] | Improvement in sexual function | Intracavernosal papaverine, phentolamine, and alprostadil (trimix) v vacuum devices in men with erectile dysfunction of any cause | 4 | −3 | 0 | −1 | 0 | Very low | Quality points deducted for sparse data, and for methodological weaknesses (uncertainty about methods of randomisation and allocation concealment, results post crossover). Directness point deducted for not using validated outcome assessments |
| What are the effects of psychological/behavioural treatments in men with erectile dysfunction of any cause? | |||||||||
| At least 6 (at least 159)[89] [90] | Improvement in sexual function | Psychosexual counselling v waiting list control in men with erectile dysfunction of any cause | 4 | −3 | 0 | −1 | 0 | Very low | Quality points deducted for sparse data, incomplete reporting of results, and for methodological weaknesses (quasi-randomisation of 1 RCT included in analysis). Directness point deducted for restricted population in 1 RCT (men with psychogenic erectile dysfunction only) |
| 1 (69)[90] | Improvement in sexual function | Psychosexual counselling v interpersonal therapy in men with erectile dysfunction of any cause | 4 | −3 | 0 | −1 | 0 | Very low | Quality points deducted for sparse data, incomplete reporting of results, and for methodological weaknesses (uncertainty about methods of randomisation and allocation concealment). Directness point deducted for restricted population in 1 RCT (men with psychogenic erectile dysfunction only) |
| What are the effects of alternative treatments in men with erectile dysfunction of any cause? | |||||||||
| 6 (349)[93] | Improvement in sexual function | Ginseng v placebo in men with erectile dysfunction of any cause | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for methodological weaknesses in included RCTs |
| 8 (448)[95] [96] | Improvement in sexual function | Yohimbine v placebo in men with erectile dysfunction of any cause | 4 | −3 | 0 | 0 | 0 | Very low | Quality points deducted for incomplete reporting and for methodological weaknesses (uncertainty about method of randomisation, lack of homogeneity in study design and outcome assessments, and results post crossover) |
Type of evidence: 4 = RCT; 2 = Observational. Consistency: similarity of results across studies.Directness: generalisability of population or outcomes.Effect size: based on relative risk or odds ratio.