| 1 Objectives1.1 To investigate the efficacy of traditional Chinese medicine combined with pelvic floor muscle training in the treatment of female stress urinary incontinence and provide evidence-based medical evidence for clinical practice;1.2 To observe the effect of Qishi granule in the treatment of female stress urinary incontinence and the changes of ICI-Q-SF score and urine pad test during the above process. To study the effect of Qishi granule combined with pelvic floor muscle training in the treatment of female stress urinary incontinence and the changes of ICI-Q-SF score and urine pad test during the above process. To provide clinical evidence for the treatment of female stress urinary incontinence through Chinese Medicine;1.3 To investigate the changes of the symptoms of female stress urinary incontinence with the combination of Qishi granule with pelvic floor muscle training in time-dependent manner.2 Methods2.1 Chinese database were retrieved, including China National Knowledge Infrastructure(CNKI), VIP Chinese sci-tech periodical infrastructure (VIP),Wanfang full-text database and Chinese biomedical literature database (CBM); foreign language database including PubMed. All the retrieval time was from the database construction until January 2016. The literature retrieval language was Chinese and English. Manually retrieved relevant magazines and meeting documents in both Chinese and English, using Google and other search engines to look up relevant literature and track the references of the literature that has been checked out, and looked up the grey literature, including the journal articles, collection of conference papers and graduate thesis. A meta-analysis of the efficacy of traditional Chinese medicine and pelvic muscles exercise for female patients with stress urinary incontinence was made.2.2 The selected 70 cases of mild-to-moderate SUI patients of Urology clinic at Xi Yuan Hospital of China Academy of Chinese Medical Sciences were divided according to random number table into treatment group and control group with 35 cases for each group. Treatment group used Qishi granule; Control group used pelvic muscles exercise therapy. The two groups of ICI-Q-SF scores, changes of urinary incontinence and comparisons of clinical efficacy were observed, where all the statistics of efficacy for treatment of 4 weeks were made.2.3 A total of 62 cases of adult female patients with mild-to-moderate SUI were admitted to Urology clinic at Xi Yuan Hospital Controlled for randomized、 double-blind clinical trials. Treatment group used Qishi granule and pelvic muscles functional exercise; Control group used placebo and pelvic muscles functional exercise. Medication was taken for 56 days, with follow-up visit every 2 weeks. The curative effect evaluation was carried out by ICI-Q-SF score, I-QOL score and urinary incontinence frequency record of 24-hour voiding diary.3 Results3.1 Meta-analysis results of traditional Chinese medicine and pelvic muscles exercise for female patients with stress urinary incontinence.Traditional Chinese medicine and pelvic muscles exercise for female patients with stress urinary incontinence was effective; Traditional Chinese medicine and pelvic muscles exercise for female patients with stress urinary incontinence was better than pelvic muscles exercise therapy only. Due to the relatively lower quality of the included literature, the application of the results from this study needs to be careful. The disease location of urinary incontinence was mainly spleen and kidney, so the clinical application of TCM reinforcing spleen and kidney combined with pelvic muscles exercise may have some efficacy for the prevention and treatment of stress urinary incontinence. As the recent studies are rare, the studies’qualities are low and the outcomes are not same, so that we could not draw the conclusion that traditional Chinese medicine has efficacy for SUI in female patients and the efficacy need further tests by many randomized clinical trials with more sample size and the standardized quantitative outcomes.3.1.1 The general situation of literatureFrom the viewpoint of the basic situation of the included literature, there was a relatively small number of published literature. Although the authenticity and credibility of the literature was higher, the fund support of the literature was little and the majority of the related studies are single-centered.3.1.2 Randomization, allocation, blind methodThis system included 4 research documents, which only mentioned randomization, not showing allocation method, where the correctness of the randomization could not be judged, so the overall quality of randomization was not high. None of them described whether the concealment of allocation scheme was implemented, so there was a significant possibility of select bias. None of them described the specific application of the blind method, with a low rate of using blind method, inevitably biased from the viewpoint of quality evaluation standard.3.1.3 Dropout, loss to follow-up, adverse reaction case recordsNone of the 4 research documents mentioned the standard of follow-up time, or described dropout and loss to follow-up cases, so there was no dropout and loss to follow-up cases from the results of the research. None of them described the serious adverse events, so the safety of medication could not be judged.3.1.4 Outcome indicators and statistical methodsThe indicators of curative effect observation were not unified, so as to affect the judgment of curative effect and analysis of the results, without the characteristics of traditional Chinese medicine in overall research. None of the 4 research documents in this study showed statistical methods, but from the viewpoint of the data provided in the reports, the statistical methods were correct, with specific statistics and P values.3.2 Clinical observation results of the efficacy of Qishi granule and pelvic muscles exercise on SUI in female3.2.1 Comparison of two groups of ICI-Q-SF score and quantity of urinary incontinence after treatmentThe two groups of ICI-Q-SF score and quantity of urinary incontinence 2 weeks after treatment were significantly improved as compared to the same group before treatment (P<0.01); When compared to the same group 4 weeks after treatment, the difference of the treatment group was statistically significant (P<0.01), but the control group had no significant change (P>0.05). When the treatment group was compared to the control group in 2 weeks and 4 weeks after treatment, the difference in curative effect was statistically significant (P<0.05, P<0.01).3.2.2 Comparison of clinical efficacyAfter treatment, total effective rate was 67.7% for the treatment group and 37.0% for the control group; When the total effective rates of the two groups were compared, the difference was statistically significant (P<0.01).3.3 Clinical observation results of the influence of Qishi granule and pelvic muscles exercise on ICI-Q-SF and Ⅰ-QOLI-Ⅲ score of Ⅰ-Ⅲ degrees of SUI in female.3.3.1 Comparison of ICI-Q-SF score of test group with control groupFor intra-group comparison, test group ICI-Q-SF score had been reduced as compared to previous visit since 2 weeks after treatment, where the reduced score was statistically significant (P<0.005 for 2 weeks after treatment, and P<0.0001 for all 4 weeks,6 weeks and 8 weeks after treatment). For control group ICI-Q-SF score compared with the baseline 2 weeks after treatment, the changes of curative effect had no statistical significance, but from 4 weeks after treatment compared with the previous visit, the score was reduced to some extent, where the reduced value was statistically significant (P<0.0001).When the test group was compared with the control group of ICI-Q-SF baseline value, P value was 0.6825, without statistical significance; Since 2 weeks of medication, until 4 weeks later, the test group compared with control group of ICI-Q-SF value had no statistical significance (P values were 0.2625 and 0.1063, respectively); But after 6 weeks of medication, P value was 0.0095, and P value was 0.0003 after 8 weeks, with significant difference in comparing the two groups.3.3.2 Comparison of test group with control group I-QOL scoreFor intra-group comparison, test group QOL score had been increased as compared to previous visit since 2 weeks after treatment, where the increased score was statistically significant (P<0.05 for 2 weeks after treatment, and P<0.0001 for all 4 weeks,6 weeks and 8 weeks after treatment). For control group QOL score compared with the baseline 2 weeks after treatment, the changes of curative effect had no statistical significance, but from 4 weeks after treatment compared with the previous visit, the increment was statistically significant (P<0.0001).When the test group was compared with the control group of I-QOL baseline value, P value was 0.687, without statistical significance; After 2 weeks of medication, the test group compared with control group of ICI-Q-SF value had no statistical significance, where P value was 0.905; But after 4 weeks、6 weeks and 8 weeks of medication. P values were 0.0317,0.0003, <0.0001, with statistically significant difference.3.3.3 Comparison of test group with control group of 24-hour urinary incontinence frequencyFor intra-group comparison, the urinary incontinence frequency of test group had been reduced as compared to previous visit since 2 weeks after treatment, where the reduced frequency was statistically significant (P<0.0005 for 2 weeks after treatment, and P<0.0001 for 6 weeks and 8 weeks after treatment). For the urinary incontinence frequency of control group compared with the baseline 2 weeks after treatment, the changes had no statistical significance, but from 4 weeks after treatment compared with the previous visit, the reduced urinary incontinence frequency was statistically significant (all P values<0.0001).When the test group was compared with the control group of urinary incontinence frequency baseline value, P value was 0.498, without statistical significance; After 2 weeks and 4 weeks of medication, the test group compared with control group of urinary incontinence frequency had no statistical significance, where P values were 0.0938 and 0.078; But after 6 weeks and 8 weeks of medication, P values were 0.0071 and 0.0002, with statistically significant difference.3.3.4 Analysis of urine leakage before and after treatmentBoth the improvement rate of urine leakage of test group when coughing or sneezing and the improvement rate of urine leakage in time of activities or sports were greater than the control group.4 Conclusions4.1 Traditional Chinese medicine and pelvic muscles exercise for female patients with stress urinary incontinence was effective;4.2 The efficacy of Qishi granule alone for treatment of mild-to-moderate SUI in female was better than the group of pelvic muscles exercise;4.3 Traditional Chinese medicine Qishi granule and pelvic muscles exercise could improve ICI-Q-SF score, I-QOL score and 24-hour urinary incontinence frequency for mild-to-moderate SUI in female; and the efficacy was better than the control group of pelvic muscles exercise;4.4 Traditional Chinese medicine Qishi granule and pelvic muscles exercise for treatment of SUI in female had significant time-dependent relief pattern. |
PDF Full Text Request