A Randomized Controlled Trial of Chinese Patent Medicine Xiao'er Biantong Granules in the Treatment of Functional Constipation in Children.

OBJECTIVE: To confirm the effect and safety of Xiao'er Biantong (XEBT) granules for treating chronic constipation in children. METHODS: This randomized, double-blind, multicenter study enrolled 480 children with age of 1-14 years who had FC. All of them were randomly assigned to receive either XEBT granules or its placebo in the ratio of 3 : 1. The primary efficacy outcome was the frequency of spontaneous bowel movements (SBM) for 14 days, and secondary outcomes were effectual time, score of main symptoms, effect of constipation, disappearance rate of accompanying symptoms, and recurrence rate. We also observed the adverse event (AE) and adverse drug reaction (ADR) to evaluate safety. RESULTS: The sociodemographic characteristics and efficiency data were comparable in the two groups at baseline. The mean values of SBM for 14 days were 8.89 and 5.63 in the XEBT group and the placebo group, respectively, and there were 86.87% and 30.91% subjects in two groups up to SBM ≥ 3/week, respectively. There were significant differences between the two groups. The effects in the XEBT group on median effectual time of defecation, main symptom score, disappearance rate of symptoms, and the differences were significant. The conclusions based on full analysis set (FAS) and per protocol set (PPS) were consistent. Nine AEs were reported, of which 7 were in the XEBT group (2.02%) while 2 were in the placebo group (1.77%). There were no significant differences in the occurrence rate of AE and ADR between the two groups. CONCLUSIONS: Xiao'er Biantong granules have superior efficacy compared to the placebo for the treatment of functional constipation in children and are well tolerated.

Corrigendum to "A Randomized Controlled Trial of Chinese Patent Medicine Xiao'er Biantong Granules in the Treatment of Functional Constipation in Children".

[This corrects the article DOI: 10.1155/2018/4941505.].

[Efficacy and safety of Choudongning capsule (CDN)in children with Tourette's syndrome of spleen deficiency and phlegm accumulation].

To evaluate the efficacy and safety of Choudongning (CDN)capsule in children with Tourette's syndrome of spleen deficiency and phlegm accumulation through a randomized double-blind three-arm controlled phase Ⅲ study in 588 patients from 8 hospitals. The included patients were randomly divided into test group, positive control group and placebo group at the ratio of 3∶1∶1. Patients in the test group orally took CDN capsules and simulated Tiapridal tablets; the patients in positive control group took Tiapridal tablets and simulated CDN capsules; whereas the patients in placebo group orally took the simulated agents of the above two drugs. The treatment course was 6 weeks for three groups. The global grading rates, YGTSS scores and its factor scores, the degree of social function damage, as well as traditional Chinese medicine syndrome efficacy were evaluated as the outcome measures on efficacy. The AEs/ADRs, vital signs and laboratory testing were observed as outcome measures on safety. The total effective rate of YGTSS was 75.92% in the test group, 72.65% in the positive control group, and 37.29% in the placebo group. Non inferiority test stands between the test group and the positive control group, and they were superior to placebo group in efficacy with statistical difference. Significant difference had also been found among the 3 groups in YGTSS tics score, motor tics score, vocal tics, degree of social function damage and traditional Chinese medicine syndrome efficacy. During the study, there were 5 (1.42%)ADRs in the test group, 10 (8.55%)in the positive control group and 3 (2.54%)in the placebo group. The incidence of ADRs in the test group was lower than that in the positive control group, with statistical difference. It is clear to say that CDN capsule can effectively treat the Tourette's syndrome of spleen deficiency and phlegm accumulation. Its efficacy is not inferior to the commonly used Tiapridal tablets, with even less adverse reactions, so it has clinical application value.

[Analysis of Applying Chinese Medical Clinical Pathway for Treating Attention-deficit Hyperactivity Disorder].

OBJECTIVE: To evaluate the application effect of Chinese medical clinical pathway for treating attention-deficit hyperactivity disorder (ADHD), and to provide evidence for further improving clinical pathways. METHODS: Totally 270 ADHD children patients were recruited and treated at pediatrics clinics of 9 cooperative hospitals from December 2011 to December 2012. The treatment course for all was 3 months. Scores of attention deficit and hyperactivity rating scale, scores of behavior, Conners index of hyperactivity (CIH), and Chinese medical syndrome scores were compared between before and after treatment. The efficacy difference in various sexes, ages, and disease courses were evaluated by judging standards for Chinese medical syndrome and ADHD. RESULTS: Fifteen children patients who entered clinical pathway dropped out, and the rest 255 completed this trial. Compared with before treatment, total scores of attention deficit and hyperactivity rating scale, scores of attention deficit and hyperactivity rating scale, CIH, and Chinese medical syndrome scores obviously decreased (all P < 0.01). The total effective rate in disease efficacy was 87.8% (224/255 cases), and the total effective rate in Chinese medical syndrome curative effect was 87.5% (223/255 cases). The clinical curative effect was not influenced by age, gender, or course of disease when statistically analyzed from judging standards for Chinese medical syndrome or for disease efficacy. CONCLUSION: Intervention by Chinese medical clinical pathway could improve ADHD patients' symptoms, and its efficacy was not influenced by sex, age, or course of disease.

[Xifeng zhidong tablet and the placebo control treatment of tic disorder children patients of internal disturbance of Gan-wind with phlegm syndrome: a clinical study].

OBJECTIVE: To assess the efficacy and safety of Xifeng Zhidong Tablet (XZT) in treating tic disorder children patients of internal disturbance of Gan-wind with phlegm syndrome (IDGWPS). METHODS: A stratified randomized, double-blinded, parallel control of placebo, multi-center trial was conducted in 160 subjects from 5 hospitals in China. They were randomly assigned to 2 groups, the test group and the control group, 80 in each group. Those in the test group were treated with XZT, while those in the control group were treated with placebos. The therapeutic course was 4 weeks for all. The effectiveness indicators covered main indicators and secondary indicators. Yale global tic severity scale (YGTSS) was taken as the main indicators. The amelioration of social function impairment, efficacy, single index of Chinese medical syndromes, Chinese medical syndrome efficacy as well as disappearance rate of single Chinese medical symptoms were evaluated as secondary indicators. The safety indicators included clinical adverse events, vital signs, blood/urine/stool routines, renal and liver functions, and electrocardiogram (ECG). RESULTS: As for main indicators, the score of YGTSS decreased from 22.10 +/- 6.38 to 11.34 +/- 6.58 in the test group, while it decreased from 22.65 +/- 6.70 to 16.82 +/- 6.53 in the control group, showing statistical difference when compared with the same group before treatment (P < 0.01). Besides, the decrement was more significant in the test group after treatment (P < 0.05). As for secondary indicators, the total effective rate was 83.54% in the test group and 34.18% in the controlled group, showing statistical difference between the two groups (P < 0.05). As for social function impairment, 20,38, 16, 3, 1 case(s) in the test group were ranked as normal, minimal, mild, moderate, obvious degree, while 1, 24, 45, 7, and 0 case(s) in the control group were ranked as normal, minimal, mild, moderate, obvious degree. Better effect was obtained in the test group (P < 0.05).As for Chinese medical syndrome efficacy, it was 87.34% in the test group and 64.56% in the control group (P < 0.05). As for single index of Chinese medical syndromes, the disappearance rate of motor tics, irritability, dreaminess, abnormal tongue proper,abnormal tongue fur, and abnormal tongue pulse condition was 78.67%, 34.72%, 62.26%, 34.62%, 58.97%, and 39.74%, respectively in the test group, while they were 34.67%, 13.11%, 21.82%, 15.58%, 25.97%, and 19.48%, respectively in the control group. Better results were shown in the test group (P < 0.05). Totally 5 adverse events occurred. The incidence of adverse events was 3.75% in the test group and 2.53% in the control group. CONCLUSIONS: After 4 weeks of XZT treatment, the integral of YGTSS could be obviously reduced, the degree of social function impairment ameliorated, and Chinese medical syndromes improved. In addition, no adverse reaction occurred in this study.

Clinical research of acupoint application for "treatment of winter disease in summer" used to prevent and treat bronchial asthma in children.

OBJECTIVE: To preliminarily analyze key factors influencing curative effect through clinical observations of acupoint application for "treatment of winter disease in summer" used to prevent and treat bronchial asthma in children. METHODS: In an observational study and prospective cohort study, we observed children in remission of asthma at three class III grade A TCM hospitals in Liaoning, Hubei, and Chengdu. RESULTS: A total of 609 children conformed to diagnostic and inclusive standards for remission of bronchial asthma. Through follow-up visits, we observed their skin reactions and the time and chance of treatment with different therapies in the three hospitals; we also compared and analyzed different drugs, acupoints, and preparations. We found that the key Chinese drugs were Bai Jie Zi (Semen Sinapis Albae) and Yian Hu Suo (Rhizoma Corydalis); the key acupoints were Feishu (BL 13), Gaohuang (BL 43), Dingchuan (EX-B1), Tiantu (CV 22), and Shanzhong (CV 17); and the best preparation was a mixture of drugs, ginger juice, and musk. Acupoint application was practiced on the hottest days of summer and the coldest days of winter for 0.5 to 2 h with the lowest rate of asthma relapse. CONCLUSIONS: The present data analysis shows that the curative effect of acupoint application for "treatment of winter disease in summer" may be influenced by recipes of Chinese drugs, preparations, prescriptions of acupoints, chance, time, and skin reactions. A curative effect is the result of the comprehensive action of these factors.

[Study on the mechanism of acupoint sticking therapy with Chuan fuling for treatment of asthma model rats].

OBJECTIVE: To investigate the mechanism of the acupoint sticking therapy with Chuanfuling for preventing and treating asthma. METHODS: Thirty male SD rats were randomly divided into a control group (normal saline, p.i. +no acupoint sticking+ normal saline, spray inhalation), model group (normal saline with ovalbumin, p.i. +no acupoint sticking+ normal saline with ovalbumin, spray inhalation), and acupoint sticking group (normal saline with ovalbumin, p.i. +acupoint sticking with Chuan fuling+normal saline with ovalbumin, spray inhalation), 10 rats in each group. The incubation period of nodding breath, symptom of asthmatic attack, expression level of interleukin-4 mRNA (IL-4 mRNA) and interferon-gamma mRNA (IF-gamma mRNA), as well as pathological changes on the middle leaf of right lung, were observed in each group. RESULTS: (1) Comparing with the control group, the model group was showed that the expression level of IL-4 mRNA in the peripheral blood cells (PBMC) was increased, while hyperemia, edema and eosinocyte (EOS) invasion of lung tissue was more serious (P < 0.01). (2) Comparing with the model group, the acupoint sticking group was showed that the expression level of IL-4 mRNA in PBMC was decreased, the incubation period of nodding breath was prolonged for induced asthma on the fifth and seventh time with lower frequency, while in the lung tissue EOS invasion was reduced (P < 0.05), but there were no significant changes on the hyperemia and edema (P > 0.05). CONCLUSION: Acupoint sticking for treating asthma of model rats with Chuanfuling can inhibit the expression level of IL-4 mRNA in PBMC, and the release of the inflammatory mediator and cytokine from the EOS to the air passage, in order to reduce the injury of epithelial layer and high reaction on the air passage.