A clinical research of Lingshao-Zaoren granule for the female with overactive bladder symptom: a randomized, double-blind, placebo-controlled trial

Abstract

Objective To evaluate the effectiveness of Lingshao-Zaoren granule in the treatment of female overactive bladder. Methods A total of 60 female OAB patients who met the inclusion criteria were randomly divided into 2 groups, 30 cases in each group. The control group recieved the Tolterodine Tartrate Sustained Release Tablets and the Lingshao-Zaoren granule placebo, and the treatment group used the Tolterodine Tartrate Sustained Release Tablets and the true Lingshao-Zaoren granule treatment. Both groups were treated for 4 weeks. Overactive bladder symptom scale (OABSS) was used to determine the severity of OAB. Results After treatment 14, 28 d, OABSS scores of the treatment group (5.3 ± 2.3, 1.4 ± 1.2 vs. 8.4 ± 2.4, F=137.209), and control group (7.8 ± 1.9, 6.8 ± 1.4 vs. 8.6 ± 2.6, F=8.927), were significantly lower than the baseline of each group respectively (P<0.01). Besides, OABSS scores of the treatment group after 14 and 28 d were significantly lower than the control group (t=4.668, 15.678, P<0.01). The pain scores (5.9 ± 1.9, 2.7 ± 1.1 vs. 9.5 ± 2.3, F=108.819) of treatment group at 14 and 28 d were significantly lower than the baseline (P<0.01); and the pain scores of treatment group at 14 and 28 d were significantly lower than the control group (t=6.342, 14.812, P<0.01). The lower abdomen discomfort scores at 14, 28 d in treatment group (1.9 ± 1.4, 1.1 ± 1.0 vs. 3.3 ± 1.1, F=28.762), and control group (2.7 ± 1.0, 2.4 ± 0.8 vs. 3.4 ± 1.2, F=12.103) were significantly lower than the baseline of each group (P<0.01); and the abdominal discomfort scores of treatment group at 14, 28 d were significantly lower than the control group (t=2.521, 5.041, P<0.05 or P<0.01). Conclusions The Lingshao-Zaoren granule could decrease OABSS score, pain score, abdominal discomfort symptoms, improve clinical symptoms of the female patients with OAB. Key words: Urinary bladder, overactive; Female; Lingshao-Zaoren granule; Integrated Chinese traditional and western medicine therapy; Overactive bladder symptom scale