Irritable bowel syndrome in children: the placebo response rate and influencing factors a meta-analysis.

BACKGROUND: Irritable bowel syndrome is common in children and exhibits a high placebo response. This study was to explore the placebo response rate and its influencing factors in children with irritable bowel syndrome. METHODS: A systematic search was performed on Pubmed, Embase, MEDLINE, Cochrane Library, CNKI, Wanfang, and CBM from database inception to March 2022. Randomized controlled trials of irritable bowel syndrome in children were included in the study. The primary outcome was the placebo response rate of improvement. RESULTS: Thirteen studies were included, with 445 patients in the placebo group. The rate of improvement and abdominal pain disappearance were 28.2% (95% CI, 16.6-39.9%) and 5% (95% CI, 0-18.4%). The placebo response based on the abdominal pain score was 0.675 (95% CI, 0.203-1.147). The mode of administration (P < 0.01), dosing schedule (P < 0.01), and clinical outcome assessor (P = 0.04) have a significant impact on the magnitude of placebo effect. CONCLUSIONS: The placebo response rate for pediatric irritable bowel syndrome was 28.2%. In clinical trials, reducing dosing frequency, selecting appropriate dosage forms, and using patient-reported outcomes can help mitigate the placebo effect. IMPACT: This is the first meta-analysis to assess the placebo response rates for improvement and disappearance in children with IBS. The finding suggested that the mode of administration, dosing schedule, and clinical outcome assessor could potentially influence the magnitude of the placebo effect in children with IBS. This study would provide a basis for estimating sample size in clinical trial design with a placebo control.

Comparative effectiveness of Chinese herbal injections treating for rotavirus enteritis in children: A systematic review and Bayesian network meta-analysis.

Background: Rotavirus enteritis (RVE) accounts for 37% of all death in children (<5 years) with diarrhea. Chinese herbal injections (CHIs) have drawn more attention from practitioners because of the valid effects for RVE. However, the most beneficial one has not yet been determined. Methods: Eight databases were searched from their inception up to September 3rd, 2022. The primary outcome was clinical effective rate and the secondary outcomes were time for disappearance of diarrhea, time of defervescence, time for disappearance of vomiting, and adverse drug reactions or adverse drug events. OpenBUGS 3.2.3 and STATA 14.0 software were employed to carry out the NMA. Results: 58 randomized controlled trials (RCTs) with 6436 child patients were included in this Bayesian NMA. Four CHIs were investigated including Yanhuning injection (YHN), Xiyanping injection (XYP), Reduning injection (RDN), and Zedoary Turmeric Oil injection (ZTO). The results showed that YHN [OR=6.16, 95% CI (4.39, 8.77)] had a superior effect in improving clinical effective rate compared to Ribavirin based on Western medicine (WM). According to SUCRA values, YHN (84.1%) ranked highest. As for the secondary outcomes, XYP was the better intervention in shortening the time for disappearance of diarrhea. Regarding time for defervescence, RDN had obvious advantages and also performed well in time for disappearance of vomiting. Conclusion: CHIs combined with WM could be beneficial than Ribavirin in improving clinical effective rate, and YHN was the optimum treatment. From the comprehensive evaluations of both the clinical effective rate and other outcomes, YHN also indicated a favorable therapeutic effect in RVE. Study registration: PROSPERO, CRD42022357149.

The Value of the Alvarado Score for the Diagnosis of Acute Appendicitis in Children: A Systematic Review and Meta-Analysis.

BACKGROUND: Relevant guidelines recommend the use of the Alvarado score (AS) to assist in the diagnosis of acute appendicitis (AA) in children. To provide reference evidence for the clinical application of AS, we performed a meta-analysis of studies related to the diagnostic accuracy of AS in children with AA. METHODS: We searched the relevant literature from databases including CNKI, WanFangdata, VIP, CBM, the Cochrane Library, PubMed, Embase, and Web of Science databases from the date of database creation to April 30, 2022, and screened them according to nadir criteria, followed by data extraction and then combined effect sizes to assess the accuracy of AS for diagnosis in children. RESULTS: Twenty-six studies involving 2579 cases were finally included, including 19 studies with Alvarado score and 8 studies with modified Alvarado Score (1 study included both Alvarado Score and modified Alvarado Score). The combined sensitivity (SE) of AS for diagnosing AA in children was 76.0% (95% CI 74.0-78.0%; I2 = 95.1%); combined specificity (SP) was 71.0% (95% CI 68.0-74.0%; I2 = 86.4%); combined positive likelihood ratio (LR+) was 2.43 (95% CI 1.92- 3.07; I2 = 78.7%); combined negative likelihood ratio (LR-) was 0.28 (95% CI 0.20-0.41; I2 = 94.2%); combined AUC = 0.8092, Q∗ = 0.7439; combined diagnostic ratio (DOR) was 8.96 (95% CI 5.65 -14.21; I2 = 76.2%). The combined effect size I2 was greater than 50% for all children with a modified AS diagnosis of AA, so all analyses used a random-effects model, which showed a combined SE of 87.0% (95% CI 85.0 - 88.0%; I2 = 85.5%); the combined SP was 47.0% (95% CI 43.0 - 51.0%. I2 = 88.7%); combined LR+ was 1.68 (95% CI 1.31-2.17; I2 = 85.9%); combined LR-was 0.28 (95% CI 0.20-0.39; I2 = 74.3%); combined AUC = 0.8672 and Q∗ = 0.7978. The combined DOR was 6.43 (95% CI 3.38-12.26; I2 = 80.0%). CONCLUSION: The results of this meta-analysis suggest that the accuracy of AS in diagnosing AA in children is moderate, and AS can be an auxiliary tool for the diagnosis of AA in children, relying on AS alone for the diagnosis of AA is not recommended; AS can be further improved scientifically to increase its diagnostic value.

A novel carbonized derivative of Fe-Cu bimetallic organic framework (Fe-Cu-MOF@C): preparation and optimization.

A carbon derivative with Fe-Cu bimetallic organic framework (Fe-Cu-MOF@C) was prepared by microwave synthesis and pyrolysis. Using potassium persulfate (PS) as oxidant and 2,4-dichlorophenol (2,4-DCP) as target pollutant, the optimal preparation conditions of Fe-Cu-MOF@C were studied. The factors affecting the synthesis of Fe-Cu-MOF include microwave power, microwave time, microwave temperature, the molar ratio of metal ions to organic ligands, the molar ratio of iron and copper, etc. In addition, the influence of pyrolysis temperature on the performance of Fe-Cu-MOF@C cannot be ignored. The results show that Fe-Cu-MOF@C has the best catalytic performance when the microwave time is 30 min, the microwave power is 600 W, the microwave temperature is 150 °C, the molar ratio of (Fe2+ + Cu2+)/H2BDC is 10:3, the molar ratio of Fe2+/Cu2+ is 10:1, and the pyrolysis temperature is 700 °C. After 90 min of reaction, 2,4-DCP was completely removed. Repeatable experiments show that Fe-Cu-MOF@C has good stability and its service life can be restored by heat treatment. In this study, a heterogeneous catalyst with strong catalytic capacity, high stability and easy recovery was prepared by a simple and efficient process, which is conducive to the development of advanced oxidation technology and the progress of water environmental protection.

Efficacy and safety of Jiu-Wei-Xi-Feng granules for treating tic disorders in children: study protocol for a randomized controlled equivalence trial.

BACKGROUND: Tic disorders (TD) is a neuropsychiatric disease with twitch as the main manifestation in childhood. Jiu-Wei-Xi-Feng granules has been marketed in China for treating children with TD. As Long Gu (Os Draconis) in the composition of this Chinese patent medicine is a rare and expensive medicinal material protected by the Chinese government, therefore, we consider replacing it with Mu Li (Concha Ostreae) that has the same effect and is cheaper. This study is designed to evaluate the clinical equivalence between Jiu-Wei-Xi-Feng granules (Os Draconis replaced by Concha Ostreae) (JWXFD) and Jiu-Wei-Xi-Feng granules (original formula) (JWXFO) in children with TD (consumption of renal yin and liver wind stirring up internally syndrome). METHODS/DESIGN: This is a multicenter, randomized, double-blind, equivalence trial comparing the efficacy and safety of JWXFD and JWXFO in treating Children with tic disorders (consumption of renal yin and liver wind stirring up internally syndrome). A total of 288 patients will be recruited and randomly assigned to two groups in a 1:1 ratio. The treatment course is 6 weeks, with a 2 weeks follow-up. The primary outcome is the mean change value from baseline to 6th week by the Yale Global Tic Severity Scale total tic score (YGTSS-TTS). Secondary outcomes include total effective rate of tic, Yale Global Tic Severity Scale (YGTSS) scores and its factor scores (the degree of motor tics, phonic tics and social function damage), Clinical Global Impression-Severity scale, and TCM syndrome efficacy. DISCUSSION: The design of this study refers to a large number of similar research design points, and asked for opinions of peer experts, and finally reached a consensus. This trial will provide high-quality evidence on the clinical equivalence between JWXFD and JWXFO and provide a basis for the marketing of JWXFD. TRIAL REGISTRATION: ChiCTR2000032312 Registered on 25 April 2020, http://www.chictr.org.cn/showproj.aspx?proj=52630.

Evaluation on immediate analgesic efficacy and safety of Kai-Hou-Jian spray (children's type) in treating sore throat caused by acute pharyngitis and tonsillitis in children: study protocol for a randomized controlled trial.

BACKGROUND: Acute pharyngitis and tonsillitis are common respiratory diseases for which children seek medical care. Their main clinical manifestation is sore throat which interferes with patients' quality of life. However, there is no proven effective or safe method to treat it. It is necessary to find an excellent strategy to reduce sore throat and reduce the burden of acute illness. We designed the randomized controlled trial with the characteristics of traditional Chinese medicine (TCM) to determine the clinical positioning of Kai-Hou-Jian spray (children's type) (KHJS) through evidence-based research. This trial aims to evaluate the immediate analgesic efficacy of KHJS on sore throat caused by acute pharyngitis and tonsillitis (wind-heat syndrome/heat exuberance in lung and stomach syndrome) in children and to observe its safety. METHODS/DESIGN: This is a prospective, multicenter, randomized, double-blind, parallel-group, placebo-controlled trial. It will include 240 children with acute pharyngitis/tonsillitis from 7 study sites across China. All participants are randomly assigned to two parallel treatment groups, one with KHJS and the other with placebo sprays, for 5 consecutive days. The primary outcome is the time of analgesic onset. Secondary outcomes include duration of analgesic effect, area under time curve of 0-3 h Wong-Baker FACES Pain Rating Scale (WBS) score (AUC0-3 h), rate of analgesic onset, rate of disappearance of sore throat, changes of WBS score (in days), effective rate of pharyngeal signs, and effective rate of TCM syndrome. The incidence of adverse events during the trial is the primary safety outcome. In addition, vital signs and laboratory tests before and after medication are monitored. DISCUSSION: To our knowledge, this will be the first clinical trial to explore the immediate analgesic efficacy of a Chinese patent medicine spray for acute pharyngitis/tonsillitis induced sore throat in children in a multicenter, randomized, double-blinded, parallel-group, placebo-controlled manner. Not only might it prove the efficacy and safety of KHJS in the treatment of sore throat caused by acute pharyngitis/tonsillitis in children, but it might also provide evidence for the treatment of acute sore throat with Chinese herbal medicine. TRIAL REGISTRATION: A multicenter, randomized, double-blind, very low-dose, parallel controlled trial for the immediate analgesic effect and safety of Kai-Hou- Jian spray (children's type) in the treatment of sore throat caused by acute pharyngitis and tonsillitis in children. Chinese Clinical Trial Registry ChiCTR2000031599 . Registered on 5 April 2020.