| BackgroundMixed urinary incontinence (MUI) is a kind of complicated disorder in bladder and urethra, because it has the characteristics of stress urinary incontinence (SUI) and urgency urinary incontinence (UUI). There is no universal treatment available for MUI since patients responds poorly to both pharmacological and surgical interventions. Therefore, it is meaningful to find an effective therapy for MUI.Traditional Chinese medicine (TCM) has advantages on a number of chronic diseases due to its modulation function for the whole body of human beings. Some studies have shown the effectiveness of TCM on MUI. However, these studies cannot provide high-quality of evidence due to the defect in study design, which limits the usage of TCM in clinical practice.The outcomes from our previous study have demonstrated that TCM therapy based on TCM theory of modulating spleen and stomach is effective on MUI. Our current study try to further evaluate the efficacy of Chinese herbal and acupuncture therapy on MUI through a well-designed, randomized, controlled clinical trial.Aims of our study(1) To evaluate the effectiveness of Yiqi Suoquan decoction and acupuncture, which are based on TCM theory of modulating spleen and stomach, on MUI.(2) To assess the therapeutic synergy of Yiqi Suoquan decoction and acupuncture on MUI.(3) To explore the therapeutic synergy of acupuncture and anticholinergic on MUI.MethodsOur study is a prospective, randomized, controlled clinical trial. In it,124 female patients with MUI were allocated into receiving acupuncture, Chinese herbal decoction, acupuncture combined with Chinese herbal decoction or acupuncture combined with anticholinergic for eight weeks. For patients receiving acupuncture,the selected acupoints included bilateral BL32 (Ci Liao), BL35 (Hui Yang), SP6 (San Yin Jiao), and ST36 (Zu San Li). After the acupuncture needles were inserted into acupoints, a portable electro-acupuncture machine was connected to the handles of acupuncture needles to provide the electrical stimulation for 30 minutes. A low-frequency (20 Hz) disperse-dense wave stimulation was applied. Each patient was treated three times a week. Patients in Chinese herb group received Yiqi Suoquan decoction, which is composed of Radix Astragali 30g, Radix Codonopsis pilosula 10g, Radix Angelica sinensis 10g, Radix Atractylodis Macrocephalae 10g, Fructus Alpiniae Oxyphyllae 10g, Radix Linder a aggregata 6g, Rhizoma Dioscoreae 10g, Pericarpium citri reticulatae 10g, Rhizoma Cimicifuga 10g, Radix Bupleuri 10g, Fructus Rubi 15g, Semen raphani 10g,200ml twice a day. Patients in combination group of acupuncture and Chinese herb were given Yiqi Suoquan decoction and acupuncture at same time, while the counterparts in combination group of acupuncture and anticholinergic took Tolterodine 4 mg once a day besides acupuncture therapy. The primary end point is the daily leakage evaluated by 24 h pad test. The secondary end points includes the symptoms of urinary incontinence (UI) assessed by ICIQ-SF questionnaire, the frequency of UI assessed by 72 h bladder diary, patients’ quality of life evaluated by I-QOL questionnaire, and patients’ function of bladder and urethra assessed by urodynamics. In addition, the adverse events in each group was also recorded. Patients were considered cured if their urine leakage on the 24h pad test was less than 8g after treatment and those were considered improved if their 24 hour urine leakage (change in pad weights) decreased more than 50%. The response cases include cured and improved ones.Statistical analyses were based on the intention-to-treat (ITT) analysis set, which was defined as patients that have received at least one treatment. For quantitative data, when they met the normal distribution ANOVA was used, otherwise Kruskal-Wallis H test was adopted to detect the difference among four groups. For quality data, RXC table Chi-Square test was used to find the difference among four groups. Once the overall difference was detected, the individual comparison was further conducted. For quantitative data, when they met the normal distribution student t test was used, otherwise Wilcoxon rank test was adopted to find the difference between any two groups using Tukey-Kramer adjusted t-test. For quality data, Chi-Square test or Fisher exact was used depended on the data. For difference between baseline and post-treatment, paired t test and Wilcoxon signed rank test were used for quantitative data when was proper, while McNemar test was used for qualitative data. All reported P-values were two-sided, and P<0.05 was considered statistically significant.ResultsPatient characteristics and baseline dataA total of 135 women with MUI were recruited in our study. Of those, seven patients were ruled out and four patients missed during study. The data from 124 patients who completed at least evaluation after receiving intervention were selected as the final analysis. The youngest patient was 32 years old and the eldest one was 65 years old. The mean age and body mass index was 53.22±8.99 years and 22.69±2.79 respectively. The history of MUI ranged from one to 14 years with an average of 4.5 years. As shown in Table 1, no significant differences were found among four groups at baseline.Abbreviations:BMI, body mass index; Qmax, peak flow rate; PVR, post-void residual volume. a Values are given as mean±SD and difference was compared by ANOVA. b Values are given as median (interquartile range) and difference was compared by Kruskal-Wallis H test.Primary end pointAfter eight weeks treatment, most patients in each group showed significant improvement. The cured and response rate in combination group of acupuncture and Chinese herb was 29% and 87.1% respectively. The cured and response rate in acupuncture group was 16.1% and 77.4% respectively. The cured and response rate in Chinese herb group was 15.6% and 75% respectively. The cured and response rate in Chinese herb group was 26.7% and 83.3% respectively. In terms of cured and response rate, no significant differences were found among four groups at baseline. After treatment, patients in each group presented a significant decrease in daily urinary leakage assessed by 24 h pad test (Table 2). Importantly, a more significant decrease was found in combination group of acupuncture and Chinese herb, compared to acupuncture or Chinese herb group (P<0.05). Although the patients in combination group of acupuncture and anticholinergic seemed to present this kind of decrease, no significant difference was detected.Table 2 24 h pad test in four groups at baseline and post-treatment Values are given as mean±SD and difference was compared by paired t test. Secondary end pointAfter eight weeks treatment, most patients in each group presented a significant decrease in ICIQ-SF total score, as well as the score in each question (Table 3). The ICIQ-SF total score seemed to have a more decrease in combination group of acupuncture and Chinese herb, but no significant difference was found in comparison with other groups.Abbreviations:B, baseline; P, post-treatment. Values are given as median (interquartile range) and difference was compared by Wilcoxon rank test. *versus baseline, P<0.05.After eight weeks treatment, most patients in each group experienced a decrease in urinary incontinence episodes (Table 3). Patients in combination group of acupuncture and Chinese herb seemed to have a more decrease in daily UI episodes, but no significant difference was found in comparison with other groups. Furthermore, the proportion in patients whose daily UI episodes decreased more than 50 percent after treatment was 83.9%,74.2%,71.9% and 83.3% in combination group of acupuncture and Chinese herb, acupuncture group, Chinese herb group, and combination group of acupuncture and anticholinergic respectively.Values are given as median (interquartile range) and difference was compared by Wilcoxon signed rank test,*versus baseline, P<0.05. In terms of patients quality of life, most patients in each group showed an significant increase in I-QOL total score, so did each domain (Table 5). Moreover, Patients in combination group of acupuncture and Chinese herb presented a significant higher quality of life, compared to ones in acupuncture group. Table 5 I-QOL in four groups at baseline and post-treatmentAbbreviations:B, baseline; P, post-treatment; A, avoidance and limiting behavior; P, Psychosocial impacts; S, Social embarrassment. Values are given as mean±SD and difference was compared by paired t test.During the study,43 patients completed the urodynamic assessment at baseline and after treatment. After treatment, the abdominal leak point pressure and maximum urethral pressure in each group were increased significantly (Table 6). However, no significant difference was detected among four groups. Furthermore,41.7%,38.5%, 40% and 50% of patients presented a normal abdominal leak point pressure after treatment in combination group of acupuncture and Chinese herb, acupuncture group, Chinese herb group, and combination group of acupuncture and anticholinergic respectively. Additionally, no significant difference was found in proportion of patients with detrusor overactivity in each group between baseline and post-treatment.Table 6 urodynamic characteristics in four groups at baseline and post-treatmentValues are given as median (interquartile range) and difference was compared by Wilcoxon signed rank test.During the study, a total of 11 patients reported the adverse events. It is notable that seven patients in combination group of acupuncture and anticholinergic reported adverse events, which is significant more than counterparts in other groups.Conclusion(1) Both acupuncture and Yiqi Suoquan decoction which are based on TCM theory of modulating spleen and stomach may decrease patients’ daily urinary leakage, relieve the UI symptoms, enhance patients’ quality of life and improve the function of bladder and urethra.(2) Yiqi Suoquan decoction and acupuncture have some kind of therapeutic synergy on treating female MUI.(3) The synergy of acupuncture and anticholinergic for treatment of MUI is not detected in current study. |
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