BACKGROUND: The effects of acupuncture have varied in different randomized controlled trials (RCTs), and there are many factors that influence treatment effect of acupuncture in different outcomes, with conflicting results. OBJECTIVE: To identify factors and their impact on the treatment effect of acupuncture in different outcomes. METHODS: Acupuncture RCTs were searched from 7 databases including Medline (PubMed), Embase, Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, Wanfang Database, VIP Database, and China Biology Medicine disc between January 1st, 2015 and December 31st, 2019. Eligible studies must compare acupuncture to no acupuncture, sham acupuncture, or waiting lists, and report at least 1 patient-important outcome. A multi-level meta-regression was conducted using a 3-level robust mixed model and univariate analyses were performed for all independent variables, even those excluded from the multivariable model due to collinearities. We used thresholds of 0.2 and 0.4 for the difference of standardized mean differences (SMDs), categorising them as small (<0.2), moderate (0.2-0.4), or large (>0.4) effects. RESULTS: The pain construct analysis involved 211 effect estimates from 153 studies and 14 independent variables. High-frequency acupuncture treatment sessions produced larger effects compared to low-frequency sessions [large magnitude, the difference of adjusted SMDs 0.46, 95% confidence interval (CI) 0.07 to 0.84; P=0.02]. The non-pain symptoms construct analysis comprised 323 effect estimates from 231 studies and 15 independent variables. Penetrating acupuncture showed moderately larger effects when compared to non-penetrating acupuncture (0.30, 95% CI 0.06 to 0.53; P=0.01). The function construct analysis included 495 effect estimates from 274 studies and 14 independent variables. Penetrating acupuncture and the flexible acupuncture regimen showed moderately larger effects, compared to non-penetrating acupuncture and fixed regimen, respectively (0.40, 95% CI 0 to 0.80; P=0.05; 0.29, 95% CI 0.06 to 0.53; P=0.01). CONCLUSIONS High-frequency acupuncture sessions appear to be a more effective approach to managing painful symptoms. Penetrating acupuncture demonstrated greater effect in relieving non-painful symptoms. Both penetrating acupuncture type and flexible acupuncture regimen were linked to significant treatment effects in function outcomes. Future studies should consider the factors that are significantly associated with the effects of acupuncture in patient-important outcomes.
Humans ; Randomized Controlled Trials as Topic ; Acupuncture Therapy/methods* ; Pain ; Pain Management ; China

OBJECTIVE: To analyze the report status of outcomes and measurement instruments of randomized controlled trials (RCTs) of acupuncture for post-stroke dysphagia, so as to provide a basis for designing clinical trials and developing the core outcome set in acupuncture for post-stroke dysphagia. METHODS: RCTs of acupuncture for post-stroke dysphagia were searched in databases i.e. CNKI, SinoMed, Wanfang, PubMed, EMbase, Web of Science and clinical trial registries i.e. ClinicalTrials.gov and Chinese Clinical Trial Registry (ChiCTR), from January 1st, 2012 to October 30th, 2021. By literature screening and data extraction, outcomes and measurement instruments were summarized and analyzed. RESULTS: A total of 172 trials (including 165 RCTs and 7 ongoing trials registrations) were included, involving 91 outcomes. The outcomes could be classified into 7 domains according to functional attributes, namely clinical manifestation, physical and chemical examination, quality of life, TCM symptoms/syndromes, long-term prognosis, safety assessment and economic evaluation. It was found that there were various measurements instruments with large differences, inconsistent measurement time point and without discriminatively reporting primary or secondary outcomes. CONCLUSION The status quo of outcomes and measurement instruments of RCTs of acupuncture for post-stroke dysphagia is not conducive to the summary and comparison of each trial's results. Thus, it is suggested to develop a core outcome set for acupuncture for post-stroke dysphagia to improve the normative and research quality of their clinical trial design.
Humans ; Deglutition Disorders/therapy* ; Randomized Controlled Trials as Topic ; Acupuncture Therapy ; Databases, Factual ; Physical Examination ; Stroke/complications*

Female ; Humans ; Pregnancy ; Septate Uterus ; Uterus/surgery* ; Hysteroscopy/methods* ; Estrogens ; Tissue Adhesions/surgery* ; Randomized Controlled Trials as Topic ; Multicenter Studies as Topic

OBJECTIVES: To evaluate the methodological quality of randomized controlled trials (RCTs) of traditional Chinese medicines for the treatment of gastric precancerous lesions in the past 20 years. METHODS: The RCTs on traditional Chinese medicines for gastric precancerous lesions were searched from the CNKI, Wanfang database, VIP, PubMed, and Embase from January 2001 to December 2021. The retrieved articles were screened, extracted and evaluated based on the 2010 edition of CONSORT statement, Cochrane Risk of Bias Assessment Scale and additional evaluation indicators. RESULTS: A total of 840 papers were included. According to the Cochrane Risk of Bias Assessment Scale, the high risk of bias in the application of randomized methods was 5.95%; the risk of uncertainty for the allocation scheme concealment was 98.93%; the risk of uncertainty for blinding of patients or testers was 98.69%; the risk of uncertainty for blinding of the outcome assessor was 100.00%; the risk of bias for completeness of the outcome data was 2.86%; and the risk of uncertainty for selective reporting was 98.45%. The CONSORT statement evaluating the quality of reporting showed that 100.00% of the RCT articles reported the 8 entries; 36.79% of the literature mentioned the method of randomized sequence generation, but only 27.62% of the literature mentioned who implemented the randomized program, 1.07% of the literature hid the randomized program and 1.31% of the studies were blinded; 36.67% of the literature reported adverse reactions; no literature reported sample size prediction methods. Additional evaluation indicators showed that 17.02% of the studies had ethical approval; 43.81% of the literature specified Chinese medicine evidence; 16.55% of the studies excluded severe heterotrophic hyperplasia; 7.26% of the studies conducted follow-up; and 65.12% of the literature used composite efficacy indicators; 46.67% of the literature applied pathological histological evaluation; 2.62% of the literature applied quality of life evaluation. CONCLUSIONS The overall risk of bias in RCTs of traditional Chinese medicines for gastric precancerous lesions is high, and the quality of most of the study reports needs to be improved. In the future, it is necessary to strengthen the study design of RCTs and refer to appropriate traditional Chinese medicines evidence grading standards, select study protocols according to different purposes, provide objective and strong evidence for clinical studies on traditional Chinese medicines, and carry out clinical study design and result reporting suitable for traditional Chinese medicines according to the CONSORT principle.
Humans ; Medicine, Chinese Traditional ; Randomized Controlled Trials as Topic ; Precancerous Conditions/drug therapy*

OBJECTIVE: To summarize and identify the available instruments/methods assessing the adequacy of acupuncture in randomized controlled trials (RCTs) for proposing a new improved instrument. METHODS: A systematic literature search was carried out in 7 electronic databases from inception until 21st November 2022. Any study evaluating the adequacy or quality of acupuncture, specifying specific acupuncture treatment-related factors as criteria of subgroup analysis, or developing an instrument/tool to assess the adequacy or quality of acupuncture in an RCT was included. Basic information, characteristics and contents of acupuncture adequacy assessment were presented as frequencies and percentages. RESULTS: Forty studies were included in this systematic review. Thirty-five studies (87.50%) were systematic reviews, none of which used formal methods to develop the assessment instruments/methods of acupuncture adequacy; of 5 methodological studies, only 1 study used a relatively formal method. Thirty-two studies (82.05%) assessed the components of acupuncture, while 7 (17.95%) assessed the overall quality of acupuncture. An independent assessment instrument/method was used to assess acupuncture adequacy in 29 studies (74.35%), whereas as one part of a methodological quality assessment scale in 10 (25.65%). Only 9 (23.00%) studies used the assessment results for subgroup analysis, sensitivity analysis or the criteria for inclusion in the meta-analysis. CONCLUSION Assessment contents for adequacy or quality of acupuncture in RCTs hadn't still reached consensus and no widely used assessment tools appeared. The methodology of available assessment instruments/scales is far from formal and rigorous. A new instrument/tool assessing adequacy of acupuncture should be developed using a formal method.
Acupuncture Therapy/methods* ; Randomized Controlled Trials as Topic

BACKGROUND: Ventricular remodeling after acute anterior wall ST-segment elevation myocardial infarction (AAMI) is an important factor in occurrence of heart failure which additionally results in poor prognosis. Therefore, the treatment of ventricular remodeling needs to be further optimized. Compound Danshen Dripping Pills (CDDP), a traditional Chinese medicine, exerts a protective effect on microcirculatory disturbance caused by ischemia-reperfusion injury and attenuates ventricular remodeling after myocardial infarction. OBJECTIVE: This study is designed to evaluate the efficacy and safety of CDDP in improving ventricular remodeling and cardiac function after AAMI on a larger scale. METHODS: This study is a multi-center, randomized, double-blind, placebo-controlled, parallel-group clinical trial. The total of 268 patients with AAMI after primary percutaneous coronary intervention (pPCI) will be randomly assigned 1:1 to the CDDP group (n=134) and control group (n=134) with a follow-up of 48 weeks. Both groups will be treated with standard therapy of ST-segment elevation myocardial infarction (STEMI), with the CDDP group administrating 20 tablets of CDDP before pPCI and 10 tablets 3 times daily after pPCI, and the control group treated with a placebo simultaneously. The primary endpoint is 48-week echocardiographic outcomes including left ventricular ejection fraction (LVEF), left ventricular end-diastolic volume index (LVEDVI), and left ventricular end-systolic volume index (LVESVI). The secondary endpoint includes the change in N terminal pro-B-type natriuretic peptide (NT-proBNP) level, arrhythmias, and cardiovascular events (death, cardiac arrest, or cardiopulmonary resuscitation, rehospitalization due to heart failure or angina pectoris, deterioration of cardiac function, and stroke). Investigators and patients are both blinded to the allocated treatment. DISCUSSION This prospective study will investigate the efficacy and safety of CDDP in improving ventricular remodeling and cardiac function in patients undergoing pPCI for a first AAMI. Patients in the CDDP group will be compared with those in the control group. If certified to be effective, CDDP treatment in AAMI will probably be advised on a larger scale. (Trial registration No. NCT05000411).
Humans ; ST Elevation Myocardial Infarction/therapy* ; Stroke Volume ; Ventricular Remodeling ; Prospective Studies ; Microcirculation ; Ventricular Function, Left ; Myocardial Infarction/etiology* ; Treatment Outcome ; Percutaneous Coronary Intervention/adverse effects* ; Heart Failure/drug therapy* ; Drugs, Chinese Herbal/therapeutic use* ; Randomized Controlled Trials as Topic ; Multicenter Studies as Topic

OBJECTIVE: To systematically review safety and tolerance of enteral nutrition (EN) in a prone position, as well as the risks of increased gastric residual volume (GRV), vomiting, aspiration, and ventilator-associated pneumonia, and determine the ways to improve EN tolerance in patients with acute respiratory distress syndrome (ARDS). METHODS: Databases including PubMed, Embase and Wanfang Medical data of the English and Chinese literatures were retrieved up from January 1979 to January 2022 to collet the randomized controlled trial (RCT), non-RCT, and observational studies, concerning safety and tolerance of EN in a prone position with ARDS. All trials must have a minimum of two patient groups, one of which must be prone to ARDS and receive EN. Data searching extracting and quality evaluation were assessed by two reviewers independently. RevMan 5.4 software was used for analysis. RESULTS: A total of 9 studies were included, including 2 RCTs, 2 non-RCTs, 4 prospective observational studies, and 1 retrospective observational study. The starting and increasing rate of EN were typically well tolerated in the prone position compared to the supine position in patients with ARDS, there was no significant increase in GRV (mL: 95 vs. 110), and the incidence of vomiting was not noticeably higher (0%-35% vs. 33%-57%). The incidence of ventilator-associated pneumonia with EN was not significantly higher in the prone position than in the supine position in patients with ARDS (6%-35% vs. 15%-24%). Aspiration occurred at a similar rate in patients in the nasogastric tube and post-pyloric feeding groups with EN in patients with ARDS in the prone position (22% vs. 20%). EN tolerability with nasogastric and nasojejunal tubes was similar in prone positions, with no significant difference in EN intolerance incidences (15% vs. 22%). Head elevation (30 degree angle-45 degree angle) improved EN tolerance in the prone position in patients with ARDS, thereby increasing the early EN dose [odds ratio (OR) = 0.48, 95% confidence interval (95%CI) was 0.22-1.08, P = 0.08]. Additionally, prophylactic application of gastrointestinal motility drugs, such as erythromycin, at the start of EN in a prone position significantly improved patients' EN tolerance (OR = 1.14, 95%CI was 0.63-2.05, P = 0.67). CONCLUSIONS The use of gastric tube for EN in prone position and similar feeding speed to the supine position in patients with ARDS is safe and well tolerated. The initiation and dosing of EN should not be delayed in the prone position. EN tolerance may be increased by elevating the head of the bed during enteral feeding in a prone position, and gastrointestinal motility medications should be promptly administered with EN initiation in patients with ARDS.
Humans ; Pneumonia, Ventilator-Associated/etiology* ; Enteral Nutrition ; Prone Position ; Respiration, Artificial/adverse effects* ; Respiratory Distress Syndrome/etiology* ; Randomized Controlled Trials as Topic ; Observational Studies as Topic

This study systematically searched and sorted out randomized controlled trial(RCT) of acupuncture-moxibustion treatment for non-specific low back pain by scoping review, so as to demonstrate the current state of the research evidence and provide a reference point for future clinical research and healthcare decision-making. Eight commonly used Chinese and English databases were searched, and the search time was from the establishment of the databases to July 7, 2023, so as to analyze the characteristics of the current status of the current research through visualization methods. A total of 50 studies were included, including 23 studies in Chinese and 27 studies in English. The overall number of studies showed an increasing trend. The percentage of studies published in Chinese non-core journals was 42.0%. The disease subtypes of interest were mainly chronic non-specific low back pain, accounting for 68.0% of the studies. The sample sizes of the studies were mainly concentrated in the range of 50-100 cases. A total of 15 types of interventions were categorized, with acupuncture interventions being the most studied. Duration of treatment did not exceed one month in 80.0% of the studies. Only 8.0% of the studies used minimal clinical important difference(MCID) as a basis for judgment. The follow-up period was set within 3 months in 28.0% of the studies, and 82.0% of the studies concluded that acupuncture-moxibustion was effective in the treatment of non-specific lower back pain. Adverse events were reported in 20.0% of the studies. The risk of bias in the included studies was dominated by low risk of bias and uncertain risk of bias, with fewer studies focusing on high risks of bias. In most of the studies, acupuncture-moxibustion was significantly more effective than the control group. The research on acupuncture-moxibustion treatment for non-specific low back pain is developing rapidly, but there are still insufficient studies on psychological state, safety, and other indicators, and there are still some studies with uncertain risks of bias, which is not conducive to the generalization and application of the findings. Therefore, future studies should improve and refine these shortcomings.
Humans ; Acupuncture Therapy/methods* ; Low Back Pain/etiology* ; Moxibustion/methods* ; Randomized Controlled Trials as Topic

The incidence of parastomal hernia is substantially high, significantly affecting the quality of life of patients with stoma. How to effectively solve the problem of parastomal hernia is a long-term focus of hernia and abdominal wall surgery and colorectal surgery. The European Hernia Society guidelines on prevention and treatment of parastomal hernia published in 2018 has recommended the use of a prophylactic mesh to prevent parastomal hernia for the first time. In the following 5 years, more randomized controlled trials of multi-center, large-sample, double-blind, long-term follow-up have been published, and no significant effect of mesh prophylaxis has been observed on the incidence of parastomal hernia. However, whether mesh could decrease surgical intervention by limiting the symptoms of parastomal hernias would become a potential value of prophylaxis, which requires further research to elucidate.
Humans ; Hernia, Ventral/surgery* ; Surgical Mesh/adverse effects* ; Quality of Life ; Incisional Hernia/prevention & control* ; Surgical Stomas/adverse effects* ; Evidence-Based Medicine ; Colostomy/adverse effects* ; Randomized Controlled Trials as Topic

Objective: To systematically evaluate the correlation between prenatal steroid exposure and hypoglycemia in late preterm neonates. Methods: Eight databases in either Chinese or English, including PubMed, the Cochrane Library, Embase, Medline, Scopus, CNKI, Wanfang and VIP, were searched to extract the studies on the correlation between prenatal steroid exposure and hypoglycemia in late preterm neonates published from the establishment of each database to December 2022. The Meta-analysis was performed using Stata 14.0 statistical software. Results: A total of 9 studies were included in this Meta-analysis, including 6 retrospective cohort studies, 2 prospective cohort studies and 1 randomized controlled trial (RCT) study, involving 9 143 premature infants. The Meta-analysis showed that prenatal steroid exposure increased the risk of late preterm neonatal hypoglycemia (RR=1.55, 95%CI 1.25-1.91, P<0.001). The similar correlation between prenatal steroid exposure and hypoglycemia in late preterm neonates was all found in the following subgroups: North America (RR=1.57, 95%CI 1.37-1.80, P<0.001), enrolling pregnant women with gestational diabetes (RR=1.62, 95%CI 1.26-2.08, P<0.001), A-grade literature quality (RR=1.43, 95%CI 1.14-1.79, P=0.002), criteria for hypoglycemia ≤40 mg/dl (1 mg/dl=0.056 mmol/L, RR=1.49, 95%CI 1.28-1.73, P<0.001), sample size of 501-1 500 (RR=1.69, 95%CI 1.19-2.40, P=0.003) and >1 500 (RR=1.65, 95%CI 1.48-1.83, P<0.001), steroid injection dosage and frequency of 12 mg 2 times (RR=1.66, 95%CI 1.50-1.84, P<0.001), the time interval from antenatal corticosteroid administration to delivery of 24-47 h (RR=1.98, 95%CI 1.26-3.10, P=0.003), unadjusted gestational age (RR=1.78, 95%CI 1.02-3.10,P=0.043) and unadjusted birth weight (RR=1.80, 95%CI 1.22-2.66, P=0.003). Meta-regression results showed that steroid injection frequency and dose were the main sources of high heterogeneity among studies (P=0.030). Conclusion: Prenatal steroid exposure may be a risk factor for hypoglycemia in late preterm neonates.
Female ; Humans ; Infant ; Infant, Newborn ; Pregnancy ; Birth Weight ; Hypoglycemia/chemically induced* ; Infant, Premature ; Randomized Controlled Trials as Topic ; Steroids/adverse effects* ; Prenatal Exposure Delayed Effects