Characteristics of the controlled and uncontrolled studies of monotherapy and combination therapy
Authors | Design | Type of AB | Daily dose | AB use | No. of patients | Age | IPSS at baseline | Measured outcomes | Follow-up | |
(Before stopping) | (Stop phase) | (Mean) | (Mean) | Primary | Secondary | (months) | ||||
Controlled trials | ||||||||||
Monotherapy | ||||||||||
Fabricius et al 13 | Double-blind RCT | TER | 10 mg | 24 weeks | 27 | 68 | – | Q-max, Q-avg, PVR, | AEs | 3 |
Debruyne et al 12 | Double-blind RCT | TER | 5 mg/10 mg | 26 weeks | 167 | 63.6 | 19.1 | IPSS, Q-max, QoL | AEs | 6 |
Gerber et al 16 | NRT | DOX | 4 mg | 3 months | 37 | 65 | C=20.9; DC=21.5 | IPSS | Restart | 12 |
Kaplan et al 15 | Open-label RCT (quasi-randomised) | ALF | 7.5 mg | 3 months | 53 | 60.5 | 15.6 | IPSS, Q-max | AEs | 3/6 |
Yanardag et al 14 | Open-label RCT | TAM | 0.4 mg | 3 months | 57 | 61.3 | 12.3 | IPSS, Q-max, Q-avg, PVR | AEs | 3/6 |
Combination therapy | ||||||||||
Barkin et al 21 | Double-blind RCT | TAM | 0.4 mg | 24 weeks | 277 | C=67.6; DC=66.9 | C=16.4; DC=16.5 | IPSS, QoL | AEs | 3 |
Liaw and Kuo25 | Open-label RCT (quasi-randomised) | TAM | 0.2–0.4 mg | 1 year | 47 | C=70.7; DC=72.1 | 15.6 | IPSS, Q-max, QoL | Restart | 3/6/12 |
Lee et al 24 | Open-label RCT | TAM | 0.2 mg | 48 weeks | 69 | 68 | 15.3 | IPSS, Q-max, QoL | Restart, AEs | 6 |
Lin et al 23 | Open-label RCT | DOX | 4 mg | 2 years | 230 | 75 | C=13.1; DC=15.6 | IPSS, Q-max, PVR | Restart | 12 |
Matsukawa et al 22 | Open-label RCT | SIL | 8 mg | 12 months | 117 | C=70.1; DC=69.1 | C=17.4; DC=17.2 | IPSS, Q-max, PVR, QoL | AEs | 12 |
Uncontrolled studies | ||||||||||
Monotherapy | ||||||||||
Kobayashi et al 18 | CS | TAM | 0.2 mg | 28.5±26.8 months | 33 | 70.4 | 16.3 | Restart | 6 | |
Yokoyama et al 20 | CS | NAF/ TAM /URA | 25–50 mg/0.2 mg/30 mg | 2–200 months | 60 | 70 (median) | 15.9 | Restart | 12 | |
Nickel et al 19 | CS | ALF/DOX/ TAM /TER | No data | 9 months | 220 | 66.1 (total sample) | 19.9 | Restart | 9 | |
Chung et al 17 | CS | ALF | 10 mg | 12 weeks | 58 | 68.6 (total sample) | 16.7 (total sample) | Restart | 6 | |
Combination therapy | ||||||||||
Baldwin et al 26 | CS | DOX | 2–8 mg | 3–12 months | 240 | 66 (total sample) | Range: 20–33 (total study sample) | Restart | 1 | |
Both* | ||||||||||
Kuo27 | CS | DIB | 20 mg | 6 months | ABM=71; ABC=65 | ABM=66.3; ABC=66.8 | ABM=21.2; ABC=22.5 | Restart | 1 |
*Both monotherapy and combination therapy discontinuation.
AB, alpha-blocker; ABC, alpha-blocker combination treatment; ABM, alpha-blocker monotherapy; AEs, adverse events;ALF, alfuzosin; C, continuation group; CS, cohort study; DC, discontinuation group;DIB, dibenyline; DOX, doxazosin; NAF, naftopidil; NRT, non-randomised controlled trial; ns, not stated; PVR, post-void residual urine volume; Q-avg, average urine flow rate; Q-max, peak urine flow rate; SIL, silodosin; TAM, tamsulosin; TER, terazosin; URA, urapidil.