A clinical research of Lingshao-Zaoren granule for the female with overactive bladder symptom: a randomized, double-blind, placebo-controlled trial / 国际中医中药杂志

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.