OBJECTIVETo compare the efficacy and safety of different doses of cernilton in preventing the clinical progression of benign prostatic hyperplasia (BPH).

METHODSA total of 240 BPH patients with the International Prostate Symptom Score (IPSS) >7 were equally allocated to an experimental and a control group and treated with oral cernilton (Prostate), the former at the dose of 750 mg, the latter at 375 mg, both twice a day for 4 years. Changes, of IPSS, prostate volume, postvoid residual urine, maximum flow rate (Qmax), prostate specific antigen (PSA), the incidence of urine retention and the rate of surgery were compared between the two groups after the treatment.

RESULTSIn the experimental group, the IPSS, prostate volume, postvoid residual urine and Qmax were 10.5 +/- 5.6, (29.2 +/- 9.5) ml, (15.2 +/- 3.1) ml and (16.2 +/- 4.5) ml/s after the treatment, as compared with 20.1 +/- 4.1, (37.8 +/- 12.5) ml, (42.5 +/- 6.6) ml and (10.0 +/- 3.5) mVs before the treatment, while in the control group, the four indexes were 14.9 +/- 4.3 vs 19.2 +/- 3.8, (34.7 +/- 9.8) ml vs (37.1 +/- 11.9) ml, (25.6 +/- 4.6) ml vs (41.8 +/- 6.1) ml and (13.5 +/- 4.1) ml/s vs (10.2 +/- 3.8) ml/s, with a more obvious improvement in the experimental group than in the control after the 4-year treatment (P < 0.0001). Compared with pre-treatment, the IPSS and Qmax were improved 3 months (16.7 +/- 3.9, P < 0. 000 1) and 6 months ([13.2 +/- 4.1] ml/s, P < 0. 0001) respectively after the treatment in the experimental group, compared with 6 months (17.6 +/- 3.3, P = 0.0010) and 9 months ([12.0 +/- 3.7] ml/s, P = 0.0005) in the control; the prostate volume was improved 1 year after the treatment in the former ( [ 15.6 +/- 3.2 ] ml,P = 0.0487) but not at 4 years in the latter ([25.6 +/- 4.6] ml,P = 0.1040). The postvoid residual urine was improved at 3 months in both the experimental ([38.7 +/- 6.1] ml, P < 0.000 1) and the control group ([40.2 +/- 5.5] ml, P = 0.0422). The incidence of urine retention was lower in the former than in the latter (5 vs 16 person-times, P = 0.0147), and so was the rate of surgery (2 vs 8 person-times, P = 0.046 2). There were no significant differences in PSA between the pre-and post-treatment either in the experimental (P = 0.349 6) or in the control group (P = 0.3805). No toxical and adverse effects were observed.

CONCLUSIONLong-term administration of cernilton at the dose of 750 mg may achieve faster and more obvious efficacy than at 375 mg in improving symptomatic BPH and preventing the clinical progression of BPH, with no adverse events.