A Cochrane review [Abstract] 1 included 8 studies with a total of 744 subjects. Study duration ranged from 4 to 17 weeks. The mean age of participants was 68 years; pretreatment mean International Prostate Symptom Score (IPSS) = 17.8 and mean peak urine flow (Qmax) = 9.5 mL/s (milliliters/second). No trials compared naftopidil to placebo. Naftopidil in doses of 25 to 75 mg/d (milligrams/day) showed a mean IPSS improvement similar to low-dose tamsulosin (0.2 mg/d) (8.4 versus 8.9 points; 5 studies, n=419). Compared to a phytotherapy preparation (eviprostat), naftopidil significantly improved total IPSS (-5.9 versus 0.4; P < 0.0002; 1 study). Addition of anticholinergic drugs (oxybutynin or propiverine hydrochloride) to naftopidil did not offer any significant improvement for IPSS or Qmax in comparison to treatment with naftopidil alone (1 study). Although IPSS did not significantly differ between high- (75 mg/d) and low-dose (25mg/d) naftopidil, high dose significantly improved Qmax compared to low dose (1.2 mL/s versus 0.2 mL/s). Adverse events reported were few, mild and similar to those seen with 0.2 mg/d tamsulosin.
Comment: The quality of evidence is downgraded by study quality (unclear allocation concealment), by inconsistency (heterogeneity in the treatment protocols), and by indirectness (lack of placebo controls and failure to use approved doses of active comparators).
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