Table 1

Characteristics of the controlled and uncontrolled studies of monotherapy and combination therapy

AuthorsDesignType of ABDaily doseAB useNo. of patientsAgeIPSS at baselineMeasured outcomesFollow-up
(Before stopping)(Stop phase)(Mean)(Mean)PrimarySecondary(months)
Controlled trials
  Fabricius et al 13 Double-blind RCTTER10 mg24 weeks2768Q-max, Q-avg, PVR,AEs3
  Debruyne et al 12 Double-blind RCTTER5 mg/10 mg26 weeks16763.619.1IPSS, Q-max, QoLAEs6
  Gerber et al 16 NRTDOX4 mg3 months3765C=20.9; DC=21.5IPSSRestart12
  Kaplan et al 15 Open-label RCT (quasi-randomised)ALF7.5 mg3 months5360.515.6IPSS, Q-maxAEs3/6
  Yanardag et al 14 Open-label RCTTAM0.4 mg3 months5761.312.3IPSS, Q-max, Q-avg, PVRAEs3/6
Combination therapy
 Barkin et al 21 Double-blind RCTTAM0.4 mg24 weeks277C=67.6; DC=66.9C=16.4; DC=16.5IPSS, QoLAEs3
 Liaw and Kuo25 Open-label RCT (quasi-randomised)TAM0.2–0.4 mg1 year47C=70.7; DC=72.115.6IPSS, Q-max, QoLRestart3/6/12
 Lee et al 24 Open-label RCTTAM0.2 mg48 weeks696815.3IPSS, Q-max, QoLRestart, AEs6
 Lin et al 23 Open-label RCTDOX4 mg2 years23075C=13.1; DC=15.6IPSS, Q-max, PVRRestart12
 Matsukawa et al 22 Open-label RCTSIL8 mg12 months117C=70.1; DC=69.1C=17.4; DC=17.2IPSS, Q-max, PVR, QoLAEs12
Uncontrolled studies
  Kobayashi et al 18 CSTAM0.2 mg28.5±26.8 months3370.416.3Restart6
  Yokoyama et al 20 CSNAF/ TAM /URA25–50 mg/0.2 mg/30 mg2–200 months6070 (median)15.9Restart12
  Nickel et al 19 CSALF/DOX/ TAM /TERNo data9 months22066.1 (total sample)19.9Restart9
  Chung et al 17 CSALF10 mg12 weeks5868.6 (total sample)16.7 (total sample)Restart6
Combination therapy
 Baldwin et al 26 CSDOX2–8 mg3–12 months24066 (total sample)Range: 20–33 (total study sample)Restart1
 Kuo27 CSDIB20 mg6 monthsABM=71; ABC=65ABM=66.3; ABC=66.8ABM=21.2; ABC=22.5Restart1
  • *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.