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

The commonly used terms "sham acupuncture" and "placebo acupuncture" in clinical acupuncture research is compared and analyzed in this article. In terms of their respective characteristics, sham acupuncture has a wider scope, including various types of acupoints, needle insertion at non-acupoint or non-insertion at acupoints, while placebo acupuncture mainly focuses on non-insertion at acupoints. Sham acupuncture mainly emphasizes the appearance similarity to real acupuncture, while placebo acupuncture emphasizes both similarity in appearance and the absence of therapeutic effects. Properly distinguishing and applying sham acupuncture and placebo acupuncture can help standardize their usage in terminology. Considering the difficulty in setting up qualified placebo acupuncture, it is suggested that researchers use the term "sham acupuncture" to describe the acupuncture control methods used in clinical research.
Humans ; Acupuncture Therapy ; Needles ; Research Personnel ; Clinical Trials as Topic

BACKGROUND: Early fluid resuscitation is one of the fundamental treatments for acute pancreatitis (AP), but there is no consensus on the optimal fluid rate. This systematic review and meta-analysis aimed to compare the efficacy and safety of aggressive vs. controlled fluid resuscitation (CFR) in AP. METHODS: The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and Web of Science databases were searched up to September 30, 2022, for randomized controlled trials (RCTs) comparing aggressive with controlled rates of early fluid resuscitation in AP patients without organ failure on admission. The following keywords were used in the search strategy: "pancreatitis," "fluid therapy,""fluid resuscitation,"and "randomized controlled trial." There was no language restriction. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework was used to assess the certainty of evidence. Trial sequential analysis (TSA) was used to control the risk of random errors and assess the conclusions. RESULTS: A total of five RCTs, involving 481 participants, were included in this study. For primary outcomes, there was no significant difference in the development of severe AP (relative risk [RR]: 1.87, 95% confidence interval [CI] 0.95-3.68; P = 0.07; n = 437; moderate quality of evidence) or hypovolemia (RR: 0.98, 95% CI: 0.32-2.97; P = 0.97; n = 437; moderate quality of evidence) between the aggressive and CFR groups. A significantly higher risk of fluid overload (RR: 3.25, 95% CI: 1.53-6.93; P <0.01; n = 249; low quality of evidence) was observed in the aggressive fluid resuscitation (AFR) group than the controlled group. Additionally, the risk of intensive care unit admission ( P = 0.02) and the length of hospital stay ( P <0.01) as partial secondary outcomes were higher in the AFR group. TSA suggested that more studies were required to draw precise conclusions. CONCLUSION: For AP patients without organ failure on admission, CFR may be superior to AFR with respect to both efficacy and safety outcomes. REGISTRATION PROSPERO; https://www.crd.york.ac.uk/PROSPERO/ ; CRD 42022363945.
Humans ; Randomized Controlled Trials as Topic ; Fluid Therapy ; Hypovolemia ; Pancreatitis/therapy*

This study aimed to evaluate the efficacy and safety of various oral Chinese patent medicines in the adjuvant treatment of rotavirus gastroenteritis(RVGE) in children based on network Meta-analysis. Randomized controlled trial(RCT) of oral Chinese patent medicine in the adjuvant treatment of RVGE in children was retrieved from the databases such as CNKI, Wanfang, VIP, SinoMed, PubMed, Cochrane Library, EMbase, and Web of Science from database inception to October 22, 2022. The quality of the included RCT was evaluated according to the Cochrane risk-of-bias tool, and the data were analyzed by RevMan 5.4 and Stata 16 software. Sixty-three RCTs were included, with 11 oral Chinese patent medicines involved, including Xingpi Yanger Granules, Weichang'an Pills, Qiuxieling Mixture, Erxieting Granules, and Changyanning Granules/Syrup. The results of the network Meta-analysis showed that in terms of clinical total effective rate, the top 3 optimal interventions were Changyanning Granules/Syrup, Xiaoer Guangpo Zhixie Oral Liquid, and Xiaoer Shuangjie Zhixie Granules combined with conventional western medicine. In terms of the anti-diarrheal time, the top 3 optimal interventions were Shenling Baizhu Granules, Qiuxieling Mixture, and Shuangling Zhixie Oral Liquid combined with conventional western medicine. In terms of the antiemetic time, the top 3 optimal interventions were Changyanning Granules/Syrup, Xingpi Yanger Granules, and Xiaoer Shuangjie Zhixie Granules combined with conventional western medicine. In terms of the antipyretic time, the top 3 optimal interventions were Shenling Baizhu Granules, Xiaoer Shuangjie Zhixie Granules, and Qiuxieling Mixture combined with conventional western medicine. In terms of the negative conversion rate of rotavirus, the top 3 optimal interventions were Xingpi Yanger Granules, Erxieting Granules, and Cangling Zhixie Oral Liquid combined with conventional western medicine. In terms of reducing creatine kinase isoenzyme MB(CK-MB) level, the top 3 optimal interventions were Weichang'an Pills, Xingpi Yanger Granules, and Xiaoer Shuangjie Zhixie Granules combined with conventional western medicine. In terms of adverse reactions, no se-rious adverse reactions were reported in all studies. Oral Chinese patent medicines in the adjuvant treatment of children with RVGE have their own advantages, Specifically, Changyanning Granules/Syrup + conventional western medicine focuses on improving the clinical total effective rate and shortening the antiemetic time, Shenling Baizhu Granules + conventional western medicine on shortening the anti-diarrheal time and antipyretic time, Xingpi Yanger Granules + conventional western medicine on improving the negative conversion rate of rotavirus, and Weichang'an Pills + conventional western medicine on reducing the CK-MB level. Limited by the quantity and quality of literature included in this study, the results need to be verified by high-quality RCT with a larger sample size.
Child ; Humans ; Adjuvants, Pharmaceutic ; Antiemetics ; Antipyretics ; Drugs, Chinese Herbal/therapeutic use* ; Enteritis/drug therapy* ; Network Meta-Analysis ; Nonprescription Drugs/therapeutic use* ; Rotavirus ; Randomized Controlled Trials as Topic

PURPOSE: The aim of this study was to analyze if any difference exists on the type of immobilisation (above elbow vs. below elbow) in the conservative treatment of distal end radius fractures in adults. METHODS: The study was performed in accordance with Preferred Reporting Items for Systematic Reviews and Meta-analyses. An electronic literature search was performed up to 1st October 2021 in Medline, Embase, Ovid and Cochrane database using the search terms, "distal end radius fractures OR fracture of distal radius", "conservative treatment OR non-surgical treatment", "above elbow immobilisation" and "below elbow immobilisation". Randomized clinical trials written in English, describing outcome of distal end radius fractures in adults by conservative or non-surgical means using above elbow immobilisation or below elbow immobilisation were included and assessed according to the risk of bias assessment (RoB2) tool by Cochrane collaboration. Non-randomized clinical trials, observational studies, retrospective studies, review articles, commentaries, editorials, conference presentations, operative techniques and articles without availability of full text were excluded from this review. The meta-analysis was performed using Review Manager version 5.4.1 (The Cochrane Collaboration, Copenhagen, Denmark). RESULTS: Six randomized clinical trials were included for quantitative review. High heterogeneity (I² > 75%) was noted among all the studies. The standard mean difference (MD) between the disability of the arm, shoulder and hand scores in both the groups was 0.52 (95% CI: -0.28 to 1.32) which was statistically non-significant. There was no statistical difference in the radial height (MD = 0.10, 95% CI: -0.91 to 1.12), radial inclination (MD = 0.5, 95% CI: -1.88 to 2.87, palmar tilt (MD =1.06, 95% CI: -0.31 to 2.43) and ulnar variance (MD = 0.05, 95% CI: -0.74 to 0.64). It was observed that shoulder pain occurred more commonly as a complication in above elbow immobilisation and the values were statistically significant (above elbow: 38/92, 41.3%; below elbow: 19/94, 20.2%). CONCLUSION This two-armed systematic review on the above elbow or below elbow immobilisation to be used for conservative treatment of the distal end radius fracture in adults resulted in non-significant differences in terms of functional and radiological scores among the 2 groups but significant increase in the complication rates in the above elbow group.
Humans ; Adult ; Elbow ; Fracture Fixation/methods* ; Conservative Treatment ; Retrospective Studies ; Randomized Controlled Trials as Topic ; Wrist Fractures ; Radius Fractures/surgery*

BACKGROUND: Primary dysmenorrhea (PD) is the most common complaint associated with menstruation and affects up to three-quarters of women at some stage of their reproductive life. In Chinese medicine, navel therapy, treatment provided at Shenque (CV 8), is used as a treatment option for PD. OBJECTIVE: To evaluate the effect of navel therapy on pain relief and quality of life in women with PD, compared with Western medicine (WM). METHODS: China National Knowledge Infrastructure (CNKI), Chinese Scientific Journal Database (VIP), SinoMed and Wanfang Database, MEDLINE, the Cochrane Library, Embase, Web of Science, and the International Clinical Trial Registry of the U.S. National Institutes of Health were searched from their inceptions to April 1, 2021. Randomized controlled trials (RCTs) assessing therapeutic effects of navel therapy on PD were eligible for inclusion. RevMan 5.4 software was used for data analyses. The certainty of the evidence was assessed using the online GRADEpro tool. RESULTS: Totally 24 RCTs involving 2,614 participants were identified. Interventions applied to acupuncture point CV 8 included: herbal patching, moxibustion or combined navel therapy (using at least 2 types of stimulation). Compared to placebo, there was a significant effect in favor of navel therapy on reducing overall menstrual symptom scores at the end of treatment [mean difference: -0.82, 95% confidence interval (CI): -1.00 to -0.64, n=90; 1 RCT]. As compared with Western medicine, navel therapy had a superior effect on pain intensity as assessed by Visual Analogue Scale at the end of treatment [standardized mean difference (SMD): -0.64, 95% CI: -1.22 to -0.06, I²=80%, n=262; 3 RCTs]; on symptom resolution rate at 3-month follow-up (risk ratio: 1.94, 95% CI: 1.47 to 2.56, n=1527, I²=38%; 13 RCTs); and on global menstrual symptoms score at the end of treatment (SMD: -0.67, 95% CI: -0.90 to -0.45, I²=63%, n=990; 12 RCTs). Subgroup analyses showed either a better or an equivalent effect comparing navel therapy with Western medicine. No major adverse events were reported. The methodological quality of included trials was poor overall. CONCLUSIONS Navel therapy appears to be more effective than Western medicine in decreasing menstrual pain and improving overall symptoms of PD. However, these findings need to be confirmed by well-designed clinical trials with adequate sample size (Systematic review registration at PROSPERO, No. CRD42021240350).
United States ; Female ; Humans ; Dysmenorrhea/drug therapy* ; Medicine, Chinese Traditional ; Randomized Controlled Trials as Topic ; Moxibustion ; Pain Management

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 <i>European Hernia Society guidelines on prevention and treatment of parastomal herniai> 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 (<i>RRi>=1.55, 95%<i>CIi> 1.25-1.91, <i>Pi><0.001). The similar correlation between prenatal steroid exposure and hypoglycemia in late preterm neonates was all found in the following subgroups: North America (<i>RRi>=1.57, 95%<i>CIi> 1.37-1.80, <i>Pi><0.001), enrolling pregnant women with gestational diabetes (<i>RRi>=1.62, 95%<i>CIi> 1.26-2.08, <i>Pi><0.001), A-grade literature quality (<i>RRi>=1.43, 95%<i>CIi> 1.14-1.79, <i>Pi>=0.002), criteria for hypoglycemia ≤40 mg/dl (1 mg/dl=0.056 mmol/L, <i>RRi>=1.49, 95%<i>CIi> 1.28-1.73, <i>Pi><0.001), sample size of 501-1 500 (<i>RRi>=1.69, 95%<i>CIi> 1.19-2.40, <i>Pi>=0.003) and >1 500 (<i>RRi>=1.65, 95%<i>CIi> 1.48-1.83, <i>Pi><0.001), steroid injection dosage and frequency of 12 mg 2 times (<i>RRi>=1.66, 95%<i>CIi> 1.50-1.84, <i>Pi><0.001), the time interval from antenatal corticosteroid administration to delivery of 24-47 h (<i>RRi>=1.98, 95%<i>CIi> 1.26-3.10, <i>Pi>=0.003), unadjusted gestational age (<i>RRi>=1.78, 95%<i>CIi> 1.02-3.10,<i>Pi>=0.043) and unadjusted birth weight (<i>RRi>=1.80, 95%<i>CIi> 1.22-2.66, <i>Pi>=0.003). Meta-regression results showed that steroid injection frequency and dose were the main sources of high heterogeneity among studies (<i>Pi>=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

Humans ; Research Design ; Clinical Trials as Topic

The successful report of total mesorectal excision (TME)/complete mesocolic excision (CME) has encouraged people to apply this concept beyond colorectal surgery. However, the negative results of the JCOG1001 trial denied the effect of complete resection of the "mesogastrium" including the greater omentum on the oncological survival of gastric cancer patients. People even believe that the mesentery is unique in the intestine, because they have a vague understanding of the structure of the mesentery. The discovery of proximal segment of the dorsal mesogastrium (PSDM) proved that the greater omentum is not the mesogastrium, and further revised the structure (definition) of the mesentery and revealed its container characteristics, i.e. the mesentery is an envelope-like structure, which is formed by the primary fascia (and serosa) that enclose the tissue/organ/system and its feeding structures, leading to and suspended on the posterior wall of the body. Breakdown of this structure leads to the simultaneous reduction of surgical and oncological effects of surgery. People quickly realized the universality of this structure and causality which cannot be matched by the existing theories of organ anatomy and vascular anatomy, so a new theory and surgical map- membrane anatomy began to form, which led to radical surgery upgraded from histological <i>en bloci> resection to anatomic <i>en bloci> resection.
Humans ; Fascia/anatomy & histology* ; Laparoscopy ; Lymph Node Excision/methods* ; Mesentery/surgery* ; Mesocolon/surgery* ; Omentum ; Serous Membrane ; Clinical Trials as Topic