Tablet Longqing with or without levofloxacin for the treatment of IIIA chronic prostatitis

Abstract

Objective To investigate the safety and efficacy of Tab Longqing and levefloxacin alone or combined to treat ⅢA prostatitis. Methods Between June 2012 and July 2013, a randomized, parallel, double blind with dummy, positive and placebo controlled multi-center clinical trial was designed. 337 patients were enrolled in this study. All of them were diagnosed as ⅢA prostatitis. And the NIH-CPSI scores showed moderate to severe degree in all cases. The EPS or urine post EPS samples showed the number of WBCs were more than 10/hp. No additional medications were given to those patients before initiating the study. Patients were randomized to 4 groups with 1∶1∶1∶1 ratio, including Tab Longqing group (group Q, Tab Longqing with dummy levofloxacin; n=84); Combined group (group C, Tab Longqing combined with Tab levofloxacin; n=84); Tab levofloxacin group(group L, levofloxacin with dummy Longqing; n=85) and placebo controlled group(group P, both dummy; n=84). There was no significant differences of patients' characters among those groups(P>0.05). NIH-CPSI pain score were measured pretreatment, 4 weeks or 8 weeks post-treatment. The WBCs in EPS or urine post EPS samples were also evaluated at the same time point. Results 337 patients were enrolled in the study with 273 cases into Per-protocol set, including 69 cases in group Q, 67 cases in group C, 68 cases in group L and 69 cases in group P. Before study, the baseline of pain scores was 11.04±2.95, 10.81±2.67, 9.66±2.51, 9.49±2.76 in each group, which didn't show the statistical difference (P<0.05). Four weeks after the study, the pain score was 6.52±2.68, 5.88±2.91, 7.22±2.86 and 7.14±3.03 in every group. It seemed that the Tab Longqing group and the combined group were better than the levofloxacin group and placebo group(P<0.05). There is no difference between Tab Longqing group and the combined group, or between levofloxacin group and placebo group. Eight weeks after the study, the pain score was 3.99±2.30, 4.61±2.33, 6.13±3.27 and 6.51±2.81 in every group, which were better than those at four weeks. The statistical results were similar to those at four weeks. However, Tab Longqing group seemed to be superior to other group. Conclusions To ⅢA prostatitis, Tab Longqing alone is efficacy and safe, which need not to be combined with levofloxacin. Key words: Prostatitis, chronic; Clinical trial; Tablet Longqing; Levofloxacin