Table 1 Study characteristics.
From: A systematic review of non-surgical management in Peyronieʼs disease
Study | Study design | Intervention/control | Acute or chronic | Duration of symptoms (months) | Follow up Period | Total number of patients | N intervention | N control |
|---|---|---|---|---|---|---|---|---|
Oral | ||||||||
Vitamin E | ||||||||
Paulis et al. [20] | Non-blinded RCT | Peironimev-plus (vitamin E + other antioxidants…) + verapamil vs. verapamil | Acute? | 12 to 13 | 6 months? | 64 | 32 | 32 |
Paulis et al. [19] | Prospective RCT | Vitamin E + propolis + blueberry + verapamil + topical diclofenac vs without Vit E | Not defined | 13.14 (intervention), 13.85 (control) (0.560) | ? | 70 | 35 | 35 |
Prieto Castro et al. [18] | Single blind RCT | Vit E (600 mg) + colchicine 1 mg vs. ibuprofen (control) | Acute | 4.3 (intervention), 4.8 (control) | 6 months | 45 | 23 | 22 |
Safarinejad et al. [17] | Double blind RCT | 4 groups, A- 300 mg Vit E BD, B - 1 gm carnitine BD, C- combination D - placebo | Chronic | 18 | 16 months | 236 | A - 58 B - 59 | C - 60 D - 59 |
Tamoxifen | ||||||||
Teloken et al. [21] | Non-blinded RCT | Tamoxifen 20 mg Vs Placebo (3 month) | Not defined | ? | 4 months | 25 | 13 | 12 |
POTABA | ||||||||
Weidner et al. [23] | RCT, placebo controlled double blind | 3 g POTABA vs. placebo | Acute | 6 | 12 months | 103 | 51 | 52 |
PDE5-i | ||||||||
Ozturk et al. [25] | RCT | Vit E 400IU OD vs 50 mg sild OD | Acute | ? | 12–13 weeks | 39 | 21 | 19 |
Colchicine | ||||||||
Safarinejad [26] | Double blind RCT | colchicine 1 mg OD increased to 2.5 mg vs placebo | Not defined | 14 (intervention), 16 (control) | 16 months | 84 | 42 | 42 |
Carnitine | ||||||||
Safarinejad et al. REPEAT [17] | Double blind RCT | 4 groups, A- 300 mg Vit E BD, B - 1 gm carnitine BD, C- combination D - placebo | chronic | 18 | 16 months | 236 | A - 58 B - 59 | C - 60 D - 59 |
Biagiotti and Cavallini [27] | Prospective RCT | Tamoxifen vs acetyl -l-carnitine | Mixed | ? | 3 months | 48 | 24 | 24 |
Co-Enzyme Q10 | ||||||||
Safarinejad [28] | Double blind RCT | 300 mg Co-Q10 vs placebo | Chronic | 19.4 | 24 weeks | 186 | 93 | 93 |
Intralesional | ||||||||
Intralesional CCH | ||||||||
Gelbard et al. [30] | RCT | 9 injections. CCH vs. placebo injection and modelling vs. no modelling after injections | Chronic | ? | 18, 24, 36 weeks | 147 | 111 | 36 |
Gelbard et al. (IMPRESS I and II) [29] | RCT double blind (combined analysis of IMPRESS I and II) | 9 injections | Chronic | 49.2 | 52 weeks | 612 | 401 | 211 |
Interferon | ||||||||
Hellstrom et al. [33] | Prospective single blind RCT | 5 × 10^5 IFN for 6 injections | Chronic | 24 | at least 10 weeks | 103 | 50 | 53 |
Kendirci et al. [34] | Prospective RCT | 5 × 10^6 IFN for 6 injections | Not defined | ? | 12 weeks | 39 | 19 | 20 |
Intralesional CCB | ||||||||
Alizadeh et al. [40] | Prospective RCT | Verapamil vs pentoxy vs combination | Not defined | ? | 6 months | 90 | 30 | 30 |
Sharma et al. [37] | RCT single blind | 10 mg 6 injections vs placebo | Not defined | ? | 3 months | 67 | 35 | 32 |
Shirazi et al. [39] | RCT | 10 mg twice weekly for 12 weeks vs placebo | Not defined | 20.6 | 24 weeks? | 80 | 40 | 40 |
Soh et al. [38] | RCT single blind | 10 mg Nicardipine vs NS control 6 bi-weekly injections | Not defined | ? | 48 weeks | 74 | 37 | 37 |
HA | ||||||||
Favilla et al. [42] | RCT double blind | intralesional injection of HA vs. injection of verapamil | Acute | ? | 12 weeks | 132 | 63 | 69 |
Intralesional thiocolchicine | ||||||||
Toscano et al. [43] | Prospective RCT - single blind | 4 mg thiocolchicine vs. 5 mg verapamil intralesional | <18 months (chronic) | Stable for 5.48 months | 1 month | 25 | 13 | 12 |
Topical | ||||||||
ESWT | ||||||||
Chitale et al. [45] | RCT double blind | 6 sessions | chronic | 33 | 6 months | 36 | 16 | 20 |
Hatzichristodoulou et al. [46] | RCT single blind | ESWT vs placebo (interposition of plastic preventing transmission) | chronic | ? | 4 weeks | 102 | 51 | 51 |
Sokolakis et al. [48] | 3-year outcomes for above study | |||||||
Palmieri et al. [47] | RCT double blind | four weekly sessions 12 weeks | Not defined | 8.62 (placebo), 8.74 (intervention) | 12, 24 weeks | 100 | 50 | 50 |
Electromotive | ||||||||
Di Stasi et al. [50] | RCT single blind | Electromotive with verapamil and dexa vs lidocaine | Not defined | ? | 1 month | 73 | 37 | 36 |
Greenfield et al. [51] | Double Blind RCT | electromotive verapamil vs saline | chronic | 19 | 3 months | 42 | 23 | 19 |
Mehrsai et al. [52] | Prospective Randomised trial | electromotive of dexa and verapamil vs. intralesional | Not defined | ? | 1, 3 months | 60 | 30 | 30 |
Montorsi et al. [49] | Prospective Randomised trial | electromotive dexa-orgotein and lidocaine | Not defined | 8.5 | 3 months | 40 | Cross-over study | Cross-over study |
Traction device | ||||||||
Joseph et al. [54] | Non-blinded RCT | RestoreX traction device | Not defined | Stable for 32.85 | 3 months | 90 | 29 (daily treatment), 23 (twice daily), 11 (thrice daily) | 27 |
Moncada et al. [53] | Non-blinded RCT | Penimaster PRO traction device vs. no intervention | Chronic | 19 (int), 20 (non-int) | 3 months | 80 | 41 | 39 |
Laser | ||||||||
Allameh et al. [55] | Double blind RCT | Laser + verapamil vs. sham + verapamil | Mixed? | 11.03 (control), 11.06 (int) | 3, 9 months | 38 | 18 | 20 |
Topical therapy | ||||||||
Fitch III et al. [56] | RCT double blind | Topical verapamil | Not defined | ? | 9 months | 57 | N/A | N/A |
Riedl et al. [57] | RCT double blind with crossover design at 8 weeks | Topical Liposomal Recombinant Human Superoxide Dismutase (2 mg) | Not defined | ? | 12 weeks | 39 | 19 | 20 |
Twidwell and Levine [58] | RCT with crossover design | Topical gel h100 vs. placebo | Acute | 7.2 | 3, 6 months | 22 | 11 | 11 |
Combination | ||||||||
Cavallini et al. [59] | Prospective Randomised + double blind trial | Verapamil + carnitine vs verapamil + tamoxifen | Chronic | 13 | 6 months | 60 | 30 | 30 |
Dell’Atti [61] | Prospective Randomised Trial | Verapamil (Group A) vs PDE5-I (Group B) vs combination (Group C) | Not defined | ? | 3 months | 59 | 23 | 18 [17] |
Favilla et al. [62] | Prospective Randomised trial | Verapamil vs. verapamil + antioxidant | Acute | 3 | 3 months | 105 | 52 | 53 |
Inal et al. [63] | Prospective RCT | 5 × 106 interferon vs. Vit E vs both | Acute | 10.6 | 6 months | 30 | 10 | 10 [10] |
Palmieri et al. [64] | Prospective double blind RCT | ESWT vs. ESWT + tadalafil | Acute | 9 | 12 weeks, 24 weeks | 100 | 50 | 50 |
Ralph et al. [65] | Randomised open label study | 0.58 mg CCH 2 injections of 4 cycles + vacuum pump therapy vs same and modelling | chronic | ? | 36 weeks | 30 | 15 | 15 |
Maretti and Canale [60] | Non-blinded RCT | TCARE + HEP + verapamil vs. TCARE | Mixed? | ? | 3 months | 61 | 31 | 30 |
Cai et al. [66] | Prospective RCT | oral and intralesional HA vs. intralesional HA | Acute | ? | 3 months | 81 | 41 | 40 |
