[Yimusake Tablet: safe and efficacious for premature ejaculation].

OBJECTIVE: To objectively evaluate the efficacy and safety of Yimusake Tablet in the treatment of premature ejaculation (PE) through a multi-centered large-sample trial. METHODS: We conducted a multi-centered, open, fixed-dose, and self-compared clinical trial among 300 patients with diagnosed PE. The trial lasted 12 weeks, including 4 weeks without any medication and 8 weeks of treatment with Yimusake Tablet, 2 pills (1 g) per night. We observed the intravaginal ejaculation latency time (IELT) before and after treatment, evaluated the safety of medication, and performed a questionnaire investigation on the patients' satisfaction. RESULTS: Of the 300 PE patients, 288 accomplished the clinical trial. The patients ranged in age from 22 to 60 years, averaging at 31.6 years. The mean IELT of the patient was 62.5 seconds at baseline, 168.9 seconds after 4 weeks of treatment with Yimusake Tablet, and 222.2 seconds after 8 weeks of medication. Among the 157 patients with normal erectile function (IIEF >21), the mean IELT was 71.4 seconds before treatment, 147.4 seconds after 4 weeks of medication, and 172.5 seconds after 8 weeks of medication. The patients' satisfaction was significantly increased after treatment. Those complicated by mild to moderate erectile dysfunction achieved different degrees of improvement in the IIEF-5 score, with a mean increase of 3.8. Only a few patients experienced mild adverse events, including constipation, dry mouth, nose bleeding, abdominal pain, and lumbosacral pain, which were all relieved without drug withdrawal. CONCLUSION: Yimusake Tablet is a safe and effective medicine for the treatment of PE.

[Qianlie Beixi Capsules for unliquefiable semen: a multi-center clinical study].

OBJECTIVE: To investigate the efficacy and possible action mechanism of Qianlie Beixi Capsules in the treatment of unliquefiable semen. METHODS: A total of 190 patients with unliquefiable semen were treated with Qianlie Beixi Capsules for 1 or 2 courses (3 weeks per a course). The seminal changes were observed and recorded. RESULTS: Of the 190 patients in the 1-course treatment arm, 99 were cured and 91 failed to respond after the first course. And the effectiveness rate was 52.1%. Of the 122 patients in the 2-course treatment arm, 81 were cured and 41 failed to respond after the second course. And the effectiveness rate was 66.4%. The efficacy of 2-course regimen was obviously better than that of 1-course regiment. In the meantime, sperm density improved in the 2-course treatment arm. Sperm motility improved slightly in the effective subjects of 1-course treatment arm. All the above results had statistically significant differences (P < 0.05). CONCLUSION: Qianlie Beixi Capsules is both safe and effective for unliquefiable semen and may shorten the time of seminal liquefaction.

[Safety and efficacy of QianlieanSuppository for chronic prostatitis of damp-heat and blood-stasis syndrome: a randomized, single-blind, parallel controlled, multi-centered phase III clinical trial].

OBJECTIVE: To evaluate the safety and efficacy of Qianliean Suppository in the treatment of chronic prostatitis of damp-heat and blood-stasis syndrome. METHODS: We conducted a randomized, single-blind, parallel-controlled, multi-centered clinical trial among 467 subjects, who were assigned to a trial group (n = 349) and a control group (n = 118), the former treated with Qianliean Suppository anally one pill per night for 28 days and the latter given Yejuhua Suppository in the same way. The efficacy was evaluated by the TCM syndrome, NIH-CPSI, main clinical symptoms and WBC count in EPS. RESULTS: After the treatment, the total rates of recovery, excellence and effectiveness for the TCM syndrome were 4.4%, 58.0% and 90.7% respectively in the trial group, significantly higher than 0.9%, 33.1% and 70.4% in the control group (P < 0.025). Remarkable decreases were observed in the NIH-CPSI total score and the scores on pain and discomfort, voiding symptoms and quality of life in the former group compared with the latter (P < 0.025). The trial group also showed a marked alleviation of such main chronic prostatitis symptoms as urgent micturition and perineal pain and discomfort (P < 0.05), as well as an obvious improvement (55.2%) of the WBC count in EPS as compared with 32.4% in the control group (P < 0.05). No serious adverse events occurred in either of the two groups (0.56% [2/349 ] vs 0.83% [1/118]). CONCLUSIONS: Qianliean Suppository is safe and effective for the treatment of chronic prostatitis of damp-heat and blood-stasis syndrome.