Table 1.
Characteristics of clinical trials included in the meta-analysis
| n | Mean age (years) | Length of treatment | Entry criteria | Prostate volume (ml)/ size (g) | Average dose (mg/day) | % Discontinued (tx/placebo) | % Withdrawn due to AE (tx/placebo) | Jadad score | |
|---|---|---|---|---|---|---|---|---|---|
| A1Bs | |||||||||
| Alfuzosin | |||||||||
| van Kerrebroecket al. (AFORTI) (23) | 154 | 64.9 | 12 weeks | > 50 years, IPSS ≥ 13, Qmax = 5–12, VV ≥ 150, PRV ≤ 350 | – | 10 | 11.2/6.5 | – | 3 |
| Roehrborn (ALFUS) (24) | 177 | 64.3 | 12 weeks | > 50 years, IPSS ≥ 13, Qmax = 5–12, VV ≥ 150, PRV ≤ 350,QOL index ≥ 3 (0–6 scale), PSA ≤ 10 ng/ml | 40.2/– | 10 | 11/11 | 4.5/2.2 | 3 |
| ALFOTAM – alfuzosin (25) | 154 | 64.6 | 12 weeks | > 50 years, IPSS ≥ 13, Qmax = 5–12, VV ≥ 150, PRV < 350, nocturia ≥ 2 | – | 10 | 5.8/7.8 | 2.6/3.2 | 4 |
| Roehrborn (ALTESS) (26) | 759 | 66.4 | 2 years | > 55 years, IPSS 13, Qmax = 5–12, VV ≥ 150, PRV ≤ 350, prostate ≥ 30 g, PSA 1.4–10 | 46.9/– | 10 | 30.3/37.1 | 9.4/8.1 | 4 |
| Tamsulosin | |||||||||
| Kawabe et al. (27) | 59 | 68 (allpatients in study | 4 weeks | 43–84 years, mild BPH, Qmax < 15 or Qave < 7.5, VV ≥ 50, PR ≥ 30 | – | 0.4 | – | – | 4 |
| Abrams et al. (28) | 198 | 63.3 | 12 weeks | ≥ 45 years, Boyarsky > 6, Qmax = 4–12, VV ≥ 120, PRV ≤ 400 | ≈33/≈34 | 0.4 | 7/6 | 4/3 | 5 |
| Chapple et al. (29) | 382 | 63.6 | 12 weeks | ≥ 45 years, Boyarsky > 6, Qmax = 4–12, VV ≥ 120, PRV ≤ 400 | – | 0.4 | 8/7 | 4/4 | 5 |
| ALFOTAM – tamsulosin (25) | 158 | 63.9 | 12 weeks | > 50 years, IPSS ≥ 13, Qmax = 5–12, VV ≥ 150, PRV < 350, nocturia ≥ 2 | – | 0.4 | 6.0/7.8 | 3.8/3.2 | 4 |
| Abrams et al. (30) | 30 | ≈65 (allpatients in study) | 4 weeks | 50–85 years, Qmax < 15, VV > 100,PRV ≤ 400, urethralresistance (detrusor pressure/Qmax2)≥ 0.5 | 32.5/– (allpatients in study) | 0.4 | – | 3.3/7.1 | 5 |
| Lepor (17,18) | 254 | * | 13 weeks | ≥ 45 years, AUA-SI ≥ 13, Qmax = 4–15, PRV < 400, DBP ≥ 65, PR ≤ 120 | 0.4 | 16/19 | 7/9 | 5 | |
| Narayan and Tewari (31) | 248 | 58 (all patientsin study) | 13 weeks | ≥ 45 years,moderate-to-severesigns and Sx of BPH | – | 0.4 | – | – | 4 |
| Chapple et al. (32) | 1065 | 61.3 | 12 weeks | ≥ 45 years, IPSS ≥ 13, Qmax = 4–12, VV ≥ 120 | 43–45 | 0.4 | 11/6 | 0/0 | 4 |
| Terazosin | |||||||||
| Lepor and Laddu (33) | 192 | – | 12 weeks | Boyarsky ≥ 1 on≥ 2 obstructive Sx, Qmax = 5–12,VV > 150, PRV ≤ 200 | – | 6 | – | – | 3 |
| Lepor et al. (34) | 216 | 61.8 | 12 weeks | 44–77 years, Boyarsky ≥ 1 on≥ 2 obstructive Sx, ensp;Qmax = 5–12, VV > 150, DBP < 115 | –/≈36.7 | 2/5/10 | 16.2/18.8 | 6.9/4.3 | 5 |
| Lloyd 1992 (35) | 66 | 65.7 | 8 weeks | > 45 years, 2 obstructive Sx, Qmax ≤ 12, VV ≥ 100, PRV < 150, DBP ≤ 115 | – | 6 | – | 6/0 | 3 |
| Brawer et al. (36) | 81 | 64 | 24 weeks | ≥ 45 years, Boyarsky ≥ 1 on≥ 2 obstructive Sx, Qmax = 5–12 | – | 7 | – | 14.8/8.9 | 5 |
| Roehrborn et al. (11) | 1053 | 65.7 | 1 year | ≥ 55 years, AUA-SI ≥ 13, AUA-BS ≥ 8, Qmax = 5–12, VV ≥ 150, PRV ≤ 350 | – | 5/10 | 38/46 | 16/11.1 | 3 |
| Elhilali et al. (37) | 80 | 64.1 | 24 weeks | 50–80 years, Boyarsky ≥ 1 on≥ 2 obstructive Sx, Qmax ≤ 15,VV > 150, PRV < 250, DBP ≤ 115 | – | 1–10 | – | 8.8/4.9 | 4 |
| Lepor et al. (38) | 305 | 65.6 | 1 year | 45–80 years, AUA-SI ≥ 8, Qmax = 4–15, VV ≥ 125, PRV < 300, BP ≥ 90/70 | 37.5/– | 5/10 | 16/16.7 | 5.9/1.6 | 5 |
| Doxazosin GITS | |||||||||
| Roehrborn et al.(39) (Dox GITS) | 108 | 63.5 | 2 weeks | 50–80 years, IPSS ≥ 12, Qmax = 5–15, VV ≥ 150, PRV ≤ 200, BP ≥ 90/60,enlarged prostate, PSA < 4 (PSA 4–10if malignancy ruled out by 2 tests) | – | 4 | – | 4.6/1 | 5 |
| Andersen et al.(40) (Dox GITS) | 317 | 64.9 | 13 weeks | 50–80 years, IPSS ≥ 12, Qmax = 5–15, VV ≥ 150, PSA ≤ 10 | – | 6.2 | 6.9/5.1 | 3.5/0.6 | 4 |
| Doxazosin | |||||||||
| Janknegt and Chapple (41)(The Netherlands) | 50 | – | 5 weeks | ≈ 50–80 years, Qmax ≤ 15 | – | 2 | – | – | 3 |
| Christensen et al. (42) | 52 | 66.7 | 9 weeks | Moderate-to-severe Sx of BPH | – | 4 | 7.7/10.4 | 0/4.2 | 3 |
| Chapple et al. (43) | 67 | 67 | 12 weeks | Qmax < 15, VV > 150, PRV < 200, Sx of BOO | – | 4 | 10.4/7.4 | 3/0 | 3 |
| Fawzy et al. (44) | 50 | 62.1 | 14 weeks | ≥ 45 years, AUA-SI ≥ 10,Qmax = 5–15, VV 125–500,PRV < 250, DBP < 90 | – | 7 | 22/22.9 | 14/2.1 | 3 |
| Gillenwater et al. (45) (htn) | 199 | 64 | 14 weeks | ≥ 45 years, mild-to-moderate hypertension,Qmax = 5–15, VV 150–500,PRV < 200, DBP 90–114, frequency ≥ 4, nocturia > 2, PSA ≤ 10 | – | 7 | 34.7/36.7 | 11.1/4.1 | 3 |
| Andersen et al. (40) (dox) | 322 | 65.3 | 13 weeks | 50–80 years, IPSS ≥ 12, Qmax = 5–15, VV ≥ 150, PSA ≤ 10 | – | 5.7 | 11.8/5.1 | 6.2/0.6 | 4 |
| Kirby et al. (PREDICT) (10) | 275 | 63 | 1 year | 50–80 years, IPSS ≥ 12, Qmax = 5–15, VV ≥ 150, enlarged prostate,PRV ≤ 200, DBP ≥ 95/60 | –/36.3 | 6.4 | 28.4/28.1 | 11.6/11.1 | 4 |
| McConnell et al. (MTOPS) (9) | 756 | 62.7 | 4.5 year | ≥ 50 years, AUA 8–30, Qmax = 4–15, VV ≥ 125, DBP ≥ 90/70, PSA ≤ 10 | 36.9/– | 4/8 | 27/– | – | 5 |
*
Mean age is not provided, but patients in tamsulosin group were reported as being significantly younger (p = 0.005). A1B, α1-adrenergic receptor blockers; AUA-BS, American Urological Association bother score; AUA-SI, American Urological Association symptom index; BOO, bladder outlet obstruction; BP, blood pressure; BPH, benign prostatic hyperplasia; DBP, diastolic blood pressure; IPSS, International Prostate Symptom Score; PR, pulse rate; PRV, postvoiding residual volume; PSA, prostate-specific antigen; Qave, average urinary flow rate; Qmax, maximum urinary flow rate; QOL, quality of life; Sx, symptoms; Tx, treatment; VV, voided volume.